Alinity Ci-Series Operations Manual PDF [PDF]

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Alinity ci‑series Operations Manual

For use with the Alinity c processing module and the Alinity i processing module

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Table of contents

Read me first........................................................................................ 13 What's new............................................................................................................................... 14 General safety information...................................................................................................... 18 System security........................................................................................................................ 19 Customer service..................................................................................................................... 20 Intended use............................................................................................................................. 21 Proprietary statement...............................................................................................................22 Disclaimers............................................................................................................................... 23 Alinity ci‑series warranty statement for USA customers only................................................25 Alinity ci‑series agency approvals........................................................................................... 26 Intellectual Property statement................................................................................................27 Key to symbols......................................................................................................................... 28

System documentation...........................................................................33 Organization of the operations manual...................................................................................34 Conventions for the operations manual..................................................................................36 Operations manual description................................................................................................37 Toolbar.......................................................................................................................... 38 Navigation pane............................................................................................................ 38 Topic pane.................................................................................................................... 43 Operations manual use............................................................................................................45 Access the operations manual.....................................................................................45 Display and use the procedure map............................................................................46 Use the table of contents............................................................................................. 46 Scroll through a topic or the table of contents...........................................................46 Play an animation......................................................................................................... 47 Access the related information.................................................................................... 48 Use breadcrumbs to access a topic............................................................................48 Redisplay a topic...........................................................................................................49 Page through the content.............................................................................................49 Use the Toggle TOC button......................................................................................... 49 Use the index................................................................................................................ 49 Use the glossary........................................................................................................... 50 Search for a term......................................................................................................... 50 Resize, move, and close the operations manual........................................................ 50 Print a topic from the operations manual....................................................................51 Procedure map description..................................................................................................... 52 Procedure map task lists..............................................................................................53

Use or function..................................................................................... 55 Alinity ci‑series hardware overview......................................................................................... 56 Primary components of an Alinity ci‑series................................................................. 56 Alinity system software overview...........................................................................................139 Descriptions of screen elements............................................................................... 140

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Table of contents Menu bar..................................................................................................................... 144 Required consumables.......................................................................................................... 146 Reagent kits and components....................................................................................146 Controls....................................................................................................................... 148 Calibrators................................................................................................................... 149 Bulk solutions (c‑series).............................................................................................150 Bulk solutions (i‑series)..............................................................................................151 Onboard solutions (c‑series)......................................................................................152 Maintenance solutions (c‑series)...............................................................................153 ICT module (c‑series).................................................................................................154 Probe conditioning solution (i‑series)........................................................................ 154 Reaction vessels (i‑series).........................................................................................155 Sample cups............................................................................................................... 156 Required accessories............................................................................................................ 157 Racks...........................................................................................................................157 Trays............................................................................................................................158 Reagent cartridge with empty bottles (c‑series).......................................................158 Automatic processing module activities................................................................................161 System flush (c‑series).............................................................................................. 161 System flush (i‑series)............................................................................................... 161 System prime (i‑series).............................................................................................. 162 Processing module wash (c‑series).......................................................................... 162 Automatic rotation of the reagent carousel (c‑series)............................................. 163

Installation procedures and special requirements.....................................165 System installation and relocation........................................................................................ 166 System installation...................................................................................................... 166 System checkout........................................................................................................ 166 System relocation....................................................................................................... 167 System configuration............................................................................................................. 168 Configure screen, General tab.................................................................................. 168 Configure screen, Computer tab............................................................................... 216 Configure screen, Assay tab......................................................................................250 Configure screen, Maintenance & Diagnostics tab.................................................. 367 Utilities screen........................................................................................................................379 Backup/Restore screen..............................................................................................379 System Updates screen............................................................................................. 384 Troubleshooting screen.............................................................................................. 395 Current Software screen............................................................................................ 397 Current Firmware screen............................................................................................398 View or print the Licenses Report..............................................................................399

Principles of operation......................................................................... 401 Principles of operation (c‑series)..........................................................................................402 Photometric method (c‑series).................................................................................. 402 Potentiometric method (c‑series).............................................................................. 408 Assay processing (c‑series).......................................................................................414 Indirect assay processing method (c‑series)............................................................ 423

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Table of contents SmartWash feature (c‑series)....................................................................................423 Optimum sampling sequence feature (c‑series)...................................................... 424 Sample interference indices (c‑series)..................................................................... 425 Principles of operation (i‑series)...........................................................................................428 CMIA method (i‑series).............................................................................................. 428 Assay processing (i‑series)........................................................................................433

Performance characteristics and specifications....................................... 443 System characteristics...........................................................................................................444 Processing module characteristics (c‑series)...........................................................444 Processing module characteristics (i‑series)............................................................445 Specifications and requirements...........................................................................................446 Operational specifications..........................................................................................446 System capacities.......................................................................................................449 Physical specifications............................................................................................... 452 Typical floor loading................................................................................................... 453 System clearances..................................................................................................... 455 Electrical specifications and requirements............................................................... 455 Optical specifications (c‑series)................................................................................ 458 Water and liquid waste specifications and requirements.........................................459 Environmental specifications and requirements....................................................... 461 Computer and interface specifications......................................................................462 External waste pump specifications and requirements............................................ 463 Bar code label requirements......................................................................................465 Sample specifications and requirements.................................................................. 472

Operating instructions..........................................................................479 System cycle power, start, pause, and stop........................................................................ 480 Cycle power to the system.........................................................................................480 Cycle power to the processing module and the reagent and sample manager (RSM)..................................................................................................................... 484 Power on the user interface (UI) computer.............................................................. 488 Power off the user interface (UI) computer..............................................................488 Power on the processing module.............................................................................. 489 Power off the processing module..............................................................................494 Power on the reagent and sample manager (RSM).................................................497 Power off the reagent and sample manager (RSM)................................................ 499 Start the processing module and the reagent and sample manager (RSM).......... 500 Pause the processing module....................................................................................500 Pause the reagent and sample manager (RSM)...................................................... 501 Stop the processing module and the reagent and sample manager (RSM).......... 502 Perform an emergency shutdown..............................................................................502 Long-term shutdown (i‑series)................................................................................... 505 Log On screen........................................................................................................................507 Log On screen element descriptions.........................................................................507 Log on..........................................................................................................................510 Lock the user interface.............................................................................................. 510 Notepad flyout........................................................................................................................ 511

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Table of contents Notepad flyout element descriptions......................................................................... 511 Add Note flyout element descriptions........................................................................513 Add Comment flyout element descriptions................................................................513 View a note................................................................................................................. 514 Create a note.............................................................................................................. 514 Pin or unpin a note..................................................................................................... 515 Edit a note................................................................................................................... 515 Add a comment to a note...........................................................................................516 Delete a note...............................................................................................................517 Delete all unpinned notes...........................................................................................517 Home screen.......................................................................................................................... 519 Home screen element descriptions........................................................................... 520 Host Connection Status flyout....................................................................................529 Printer Status/Queue flyout........................................................................................532 Alinity PRO Connection Status flyout........................................................................ 534 LAS Connection Status flyout.................................................................................... 534 AbbottLink Connection Status flyout..........................................................................537 Abbott Mail Inbox screen............................................................................................538 Instrument statuses.....................................................................................................557 Consumable inventory management.....................................................................................561 Supplies screen.......................................................................................................... 561 Cal/QC Inventory screen............................................................................................ 587 Reagent and sample management....................................................................................... 592 Load racks and cartridges into trays......................................................................... 592 Load trays on the reagent and sample manager (RSM)..........................................594 Load racks on the reagent and sample manager (RSM).........................................595 Load bar-coded specimens for batch processing.................................................... 597 Load cartridges on the reagent and sample manager (RSM)................................. 599 Load onboard vial racks or cartridges on a specific processing module............... 602 Load onboard solutions and sample diluents on the reagent and sample manager (RSM) (c‑series).................................................................................... 604 Assign a temporary priority position to load racks and cartridges.......................... 606 Unload trays from the reagent and sample manager (RSM)...................................607 Reagent carousel inventory management.................................................................607 Sample management..................................................................................................636 Specimen, calibration, and control orders............................................................................652 Automated ordering.................................................................................................... 652 Orders screen............................................................................................................. 659 Sample Status screen................................................................................................ 693 Results screen........................................................................................................................706 Results screen, Unreleased tab element descriptions............................................. 707 Results screen, Specimen tab element descriptions................................................708 Results screen, Control tab element descriptions.................................................... 710 Results screen, Exception tab element descriptions................................................711 Results screen, Search flyout element descriptions................................................ 713 Result Details screen..................................................................................................715 Rerun Options (Specimen Order) flyout element descriptions................................ 719

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Table of contents Rerun Options (Control Order) flyout element descriptions.....................................720 Descriptions of specimen result flags....................................................................... 722 Descriptions of quality control result flags................................................................724 Descriptions of transmission statuses....................................................................... 725 View the reaction graph and absorbance data for a result (c‑series)....................726 Delete a sample result or an exception.................................................................... 727 Transmit a result or an exception to the host...........................................................727 Quality control analysis..........................................................................................................729 Westgard rule application...........................................................................................729 Levey-Jennings (Graph) screen.................................................................................733 Quality Control Summary screen...............................................................................740 Print flyout.............................................................................................................................. 751 Print flyout element descriptions................................................................................752 Report File Location window element descriptions.................................................. 754 Print a report............................................................................................................... 755 Print a screen image.................................................................................................. 756 Search flyout.......................................................................................................................... 757 Search for or filter data..............................................................................................757 Archive flyout..........................................................................................................................759 Archive flyout element descriptions...........................................................................759 Archive File Location window element descriptions................................................. 760 Archive the results...................................................................................................... 761 Archive the calibrations.............................................................................................. 762 Insert and remove a USB flash drive....................................................................................764

Calibration procedures......................................................................... 767 Calibration guidelines.............................................................................................................768 Calibration types and methods..............................................................................................769 Calibration method (c‑series potentiometric)............................................................769 Calibration types and methods (c‑series photometric)............................................ 774 Calibration types and methods (i‑series).................................................................. 784 Calibration storage.................................................................................................................793 Active calibration storage...........................................................................................793 Inactive calibration storage........................................................................................ 794 Failed calibration storage...........................................................................................794 Calibration review...................................................................................................................795 System calibration verification................................................................................... 795 Calibration Status screen........................................................................................... 796 Descriptions of calibration statuses...........................................................................804 View the assay calibration status.............................................................................. 805 Transmit a calibration to the host.............................................................................. 806 Fail a calibration......................................................................................................... 806

Operational precautions and limitations..................................................809 General requirements............................................................................................................ 810 Precautions and requirements for system operation........................................................... 811 Precautions and requirements before operation...................................................... 811 Precautions during operation..................................................................................... 811

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Table of contents Requirements for handling the consumables.......................................................................812 Requirements for storage...........................................................................................812 Requirements for use................................................................................................. 812 Requirements for handling the specimens........................................................................... 814 Limitations of result interpretation.........................................................................................816

Hazards.............................................................................................. 817 Operator responsibility........................................................................................................... 818 Safety icons............................................................................................................................819 Biological hazards..................................................................................................................821 Precautions................................................................................................................. 821 Chemical hazards.................................................................................................................. 823 General precautions................................................................................................... 823 Sodium azide...............................................................................................................824 Sensitizers................................................................................................................... 825 Dry ice......................................................................................................................... 825 Waste handling and disposal................................................................................................ 826 Liquid wastes that contain (potentially) infectious materials................................... 826 Batteries...................................................................................................................... 827 Spill cleanup...........................................................................................................................828 Requirements for decontamination....................................................................................... 829 Preparation of sodium hypochlorite solutions........................................................... 829 Sodium hypochlorite stability......................................................................................830 Electrical hazards.................................................................................................................. 832 Mechanical hazards...............................................................................................................833 Physical hazards.................................................................................................................... 835 Probes and other sharps............................................................................................835 Heavy objects..............................................................................................................835 Hot objects.................................................................................................................. 836 Tripping hazards......................................................................................................... 836

Service, maintenance, and diagnostics................................................... 837 Maintenance and diagnostics................................................................................................838 Procedures screen..................................................................................................... 838 Procedures Log screen.............................................................................................. 851 Descriptions of maintenance and diagnostic procedure statuses........................... 856 Maintenance procedure descriptions........................................................................ 857 Unscheduled cleaning................................................................................................ 873 Diagnostic procedure descriptions............................................................................ 875 Component replacement....................................................................................................... 920 Processing center component replacement (c‑series)............................................ 920 Supply and pump center component replacement (c‑series)................................. 957 Processing center component replacement (i‑series)............................................. 989 Supply center component replacement (i‑series).................................................. 1008 Optional component replacement............................................................................1017

Troubleshooting.................................................................................1023 Approach to troubleshooting............................................................................................... 1024

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Table of contents System troubleshooting variables (c‑series)...........................................................1025 System troubleshooting variables (i‑series)............................................................ 1027 Reagent troubleshooting variables (c‑series)......................................................... 1029 Reagent troubleshooting variables (i‑series).......................................................... 1030 Operator troubleshooting variables......................................................................... 1031 Environmental troubleshooting variables.................................................................1032 Alert Center flyout................................................................................................................1033 Alert Center flyout element descriptions................................................................. 1033 View the probable cause and corrective action for a message............................ 1034 View additional messages that are associated with a message........................... 1034 Delete a message from the Alert Center................................................................ 1035 Clear all messages...................................................................................................1035 System Logs screen............................................................................................................ 1036 System Logs screen, Notifications/Alerts tab element descriptions......................1036 System Logs screen, Informational tab element descriptions............................... 1038 System Logs screen, Inventory tab element descriptions......................................1039 System Logs screen, User Access tab element descriptions................................1040 System Logs screen, Configuration tab element descriptions...............................1041 System Logs screen, Interfaces tab element descriptions.................................... 1042 System Logs screen, Abbott Mail tab element descriptions.................................. 1043 System Logs screen, All Messages tab element descriptions...............................1044 System Logs screen, Search flyout element descriptions..................................... 1046 Message Details For flyout element descriptions...................................................1049 Descriptions of message types................................................................................1049 Message codes.................................................................................................................... 1051 General message codes (0001-0999).................................................................... 1051 Assay-specific message codes (1000-1999)..........................................................1108 Maintenance and diagnostic message codes (2000-2999)...................................1173 Level sense and fluidics message codes (3000-3999)......................................... 1199 Optics and bar code reader message codes (4000-4999)................................... 1259 Robotics and sensor message codes (5000-5999)................................................1269 Support system message codes (6000-6999)........................................................1346 Temperature message codes (7000-7999)............................................................ 1346 Computer hardware peripheral message codes (8000-8999)...............................1353 Software message codes (9000-9999)...................................................................1378 Observed problems..............................................................................................................1417 Processing module observed problems.................................................................. 1417 Processing module observed problems (c‑series)................................................. 1418 Processing module observed problems (i‑series).................................................. 1422 Sample results observed problems (c‑series)........................................................ 1424 Sample results observed problems (i‑series)......................................................... 1435 User interface (UI) computer observed problems.................................................. 1446 Printer observed problems....................................................................................... 1446 Miscellaneous corrective action procedures......................................................................1449 Processing module corrective action procedures.................................................. 1449 Reagent and sample manager (RSM) corrective action procedure......................1464 User interface (UI) computer corrective action procedures.................................. 1465

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Table of contents

Verification of assay claims................................................................. 1471 Limit of blank, limit of detection, and limit of quantitation.................................................1472 Verify a limit of blank (LoB) claim........................................................................... 1472 Verify a limit of detection (LoD) claim.....................................................................1475 Limit of quantitation (LoQ)....................................................................................... 1478 Precision............................................................................................................................... 1489 Verify the precision...................................................................................................1489 Evaluate the precision data......................................................................................1490 Calculate a precision verification value.................................................................. 1492 Precision worksheet (c‑series)................................................................................ 1493 Precision worksheet (i‑series)..................................................................................1495 Perform a calibration verification........................................................................................1497 Calibration verification worksheet (c‑series)...........................................................1498 Calibration verification worksheet (i‑series)............................................................1499 Verify the linearity................................................................................................................ 1501 Linearity worksheet (c‑series)..................................................................................1502 Linearity worksheet (i‑series)...................................................................................1503 Measuring interval................................................................................................................1505 Verify an automated dilution................................................................................................1506 Automated dilution verification worksheet (c‑series)..............................................1507 Automated dilution verification worksheet (i‑series)...............................................1508 Method comparison............................................................................................................. 1511 Perform a quantitative method comparison............................................................ 1511 Perform a qualitative method comparison.............................................................. 1518 Verify the reference range (expected values)................................................................... 1525 Reference range (expected values) worksheet (c‑series).....................................1526 Reference range (expected values) worksheet (i‑series)......................................1527

List numbers..................................................................................... 1529 Consumable list numbers.................................................................................................... 1530 Consumable list numbers (c‑series)...................................................................................1531 Consumable list numbers (i‑series).................................................................................... 1532 Service accessory list numbers.......................................................................................... 1533 Service accessory list numbers (c‑series)......................................................................... 1534 Service accessory list numbers (i‑series).......................................................................... 1537

Assay applications (c‑series photometric)............................................. 1539 Assay parameters (c‑series photometric, user defined)................................................... 1540 Assay Parameters screen element descriptions (c‑series photometric, user defined)................................................................................................................ 1541 Create Assay flyout element descriptions...............................................................1542 Assay Parameters screen, General tab element descriptions (c‑series photometric, user defined)..................................................................................1543 New Reagent flyout element descriptions (c‑series photometric, user defined)..1553 View/Edit Reagent flyout element descriptions (c‑series photometric, user defined)................................................................................................................ 1554

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Table of contents Assay Parameters screen, Calibration tab element descriptions (c‑series photometric, user defined)..................................................................................1556 New Cal Set flyout element descriptions (c‑series photometric, user defined)... 1563 Assay Parameters screen, Results tab element descriptions (c‑series photometric, user defined)..................................................................................1564 Assay Parameters screen, SmartWash tab element descriptions (c‑series)....... 1569 Color correction (c‑series photometric).................................................................. 1574 Dispense types (c‑series)........................................................................................ 1577 FlexRate method and absorbance range (c‑series photometric)..........................1578 Linearity flagging (c‑series)..................................................................................... 1581 Maximum absorbance variation (c‑series photometric)......................................... 1583 Maximum curve fit (c‑series photometric).............................................................. 1585 Photometric timing table (c‑series photometric).....................................................1586 Rate linearity percent (c‑series photometric)......................................................... 1587 Reaction check (c‑series photometric)................................................................... 1590 Sample dilution (c‑series photometric)................................................................... 1592 Self blank (c‑series photometric)............................................................................ 1595 Calculate a calibration factor (c‑series photometric)............................................ 1597 Create a user-defined assay (c‑series photometric)............................................. 1598 Perform an initial user-defined assay run (c‑series)..............................................1603 Reagent carryover evaluation (c‑series)............................................................................ 1605 Perform a reagent carryover evaluation (c‑series)................................................ 1605 Configure and verify SmartWash settings (c‑series)..............................................1608 Edit SmartWash settings (c‑series)......................................................................... 1610

Printed report element descriptions...................................................... 1613 Absorbance Data Report element descriptions (c‑series)................................................ 1614 Assay Information Report element descriptions.................................................................1617 Assay Installation Report element descriptions..................................................................1618 Assay Parameter Report element descriptions (c‑series).................................................1619 Assay Parameter Report element descriptions (i‑series)..................................................1632 Assay Parameter Report (Calculated) element descriptions ........................................... 1638 Calibration Details Report (Linear) element descriptions (c‑series).................................1642 Calibration Details Report (Potentiometric) element descriptions (c‑series)................... 1645 Calibration Details Report (Use Cal Factor Blank) element descriptions (c‑series)....... 1648 Calibration Details Report (Adjust) element descriptions (i‑series)..................................1651 Calibration Details Report (Full) element descriptions (i‑series)...................................... 1654 Calibration Details Report (Index) element descriptions (i‑series)................................... 1657 Calibration Summary Report element descriptions............................................................1660 Diagnostic History Report, Maintenance History Report element descriptions................ 1661 Exception List Report element descriptions....................................................................... 1664 Log Report element descriptions........................................................................................ 1666 Order List Report element descriptions..............................................................................1669 Procedure Report element descriptions............................................................................. 1671 QC Analysis Report element descriptions.......................................................................... 1673 QC Levey-Jennings Report element descriptions.............................................................. 1676 QC Summary Report element descriptions........................................................................ 1679 Reagent Status Report element descriptions.....................................................................1681 Alinity ci‑series Operations Manual

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Table of contents Rerun List Report element descriptions..............................................................................1683 Result Details Report element descriptions....................................................................... 1685 Result List Report element descriptions............................................................................. 1689 Sample Laboratory Report element descriptions...............................................................1691 System Update Details Report element descriptions.........................................................1693 System Update List Report element descriptions.............................................................. 1696 User-Defined Maintenance Details Report element descriptions..................................... 1698

Glossary.................................................................................................... 1701

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Read me first

Foreword Congratulations on becoming an operator of the Alinity ci‑series. The Alinity ci‑series has a small, compact, and scalable design to help you adapt to day-to-day and long-term needs within your laboratory. The system is supported by resourceful advocates consisting of dedicated professionals who excel in engineering, medical technology, training, and service. As part of a dedicated customer-training program, Abbott Laboratories will teach you how to operate, maintain, and troubleshoot the system. We are dedicated to helping you achieve measurably better health care with our resourceful advocates, harmonized systems, and intelligent insights by providing you with the highest quality and most reliable instrumentation. We look forward to serving your needs in any way possible. Related information... What's new, page 14 General safety information, page 18 System security, page 19 Customer service, page 20 Intended use, page 21 Proprietary statement, page 22 Disclaimers, page 23 Alinity ci‑series warranty statement for USA customers only, page 25 Alinity ci‑series agency approvals, page 26 Intellectual Property statement, page 27 Key to symbols, page 28

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What's new

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What's new The following new features and changes were introduced in Alinity ci‑series System Software Version 2.6.0. Improved search functionality in the Alinity ci‑series Operations Manual System documentation procedure Search for a term, page 50 has been updated to reflect the improved search functionality in the Alinity ci‑series Operations Manual. Distance alert New configuration items have been added for the distance alert. The operator can enable or disable specific notifications that cause the distance alert to illuminate. See the following updated topics: • Distance alert, page 68 • Distance Alert screen, page 245 • Distance Alert screen element descriptions, page 246 • Configure distance alert settings, page 248 Induction heating The induction heater wash cup is an optional hardware component that is available for the Alinity i processing module for the sample pipettor. The sample probe is heated and the wash buffer is warmed as it flows through the probe to provide improved washing. The induction heating hardware supports the future launch of i‑series assays. See the following updated and new topics: • Pipetting hardware (Alinity i), page 122 • Induction heater wash cup (Alinity i), page 126 • 2630 Manual Wash Cup Cleaning (i‑series), page 870 • 1201 Induction Heater Test (i‑series), page 902 Pre-Trigger Solution stability The Pre-Trigger Solution onboard stability has been reduced from 28 days on the system to 16 days on the system. See the following updated topics: • Bulk solutions (i‑series), page 151 • Solutions used in daily operations (i‑series), page 578

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What's new

Alinity c‑series reagent cartridges with empty bottles Revised c‑series reagent cartridges with empty bottles are available. References to the reagent cartridges have been updated to reflect the new options: • c‑series Reagent Cartridge, Black (Large), LN 04S1750 • c‑series Reagent Cartridge, Clear (Large), LN 04S1740 See the following updated topics: • Reagent cartridge with empty bottles (c‑series), page 158 • Prepare sample diluents and user-defined reagents (c‑series), page 627 • 4109 Probe Alignment Test (c‑series), page 880 • 4213 Liquid Level Sense Test (c‑series), page 884 • 4703 Reagent Supply Center Test (c‑series), page 887 • Consumable list numbers (c‑series), page 1531 Water and liquid waste specifications and requirements The incoming water quality specification of the temperature has been updated from 15°C (59°F) to 37°C (98.6°F) to match the environmental specification of the temperature during operation, which is 15°C (59°F) to 30°C (86°F). See Water and liquid waste specifications and requirements, page 459. New printer drivers Kyocera Classic Universal Driver PCL6 and Kyocera Classic Universal Driver PCL6 (A4) were added as available printer drivers. See Computer and interface specifications, page 462. Blank calibrator set name For c‑series assays that use a blank calibrator set with a different lot number than the calibrator set lot number, the blank calibrator set name, blank calibrator lot number, and expiration date are displayed in the system software and on reports. The new blank calibrator set configuration supports the future launch of c‑series assays. The blank calibrator set is not available for userdefined assays. See the following updated topics: • Assay Parameters screen, Calibration tab element descriptions (c‑series photometric), page 266 • Edit general settings of assay parameters (c‑series photometric), page 286 • Prepare and load calibrator and control vials into vial racks for onboard storage, page 624 • Prepare and load calibrator and control vials into vial racks for immediate use, page 646

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What's new

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• Automated calibration ordering, page 656 • Create Order screen, Calibration tab element descriptions, page 679 • Create a calibration order, page 688 • Calibration Status Details screen element descriptions, page 800 • Assay Parameter Report element descriptions (c‑series), page 1619 • Calibration Details Report (Linear) element descriptions (c‑series), page 1642 Displayed and printed calibrator concentration values The c‑series and i‑series calibrator concentration values are now displayed in the configured assay result units instead of the default result units. Assays that reference the calibration of another assay, such as c‑series photometric assays with the use cal factor blank calibration method and i‑series assays with the reference calibration method, display calibrator concentrations in the result units of the reference assay. See the following updated topics: • Calibration Status Details screen element descriptions, page 800 • Calibration Details Report (Linear) element descriptions (c‑series), page 1642 • Calibration Details Report (Use Cal Factor Blank) element descriptions (c‑series), page 1648 • Calibration Details Report (Adjust) element descriptions (i‑series), page 1651 • Calibration Details Report (Full) element descriptions (i‑series), page 1654 Maintenance procedures The frequency of the following Alinity c maintenance procedures has changed from quarterly to triannual and the procedure numbers have changed to reflect the new category: • 5833 Change 1 mL Syringes (c‑series), page 863 • 5834 Check and Change ICT Check Valves (c‑series), page 864 • 5835 Check and Clean High-Concentration Waste Sensor (c‑series), page 864 When software version 2.6.0 is installed on the system, the time interval tracking for the new triannual maintenance procedures will be reset. To ensure efficient tracking of the maintenance interval during the transition from the quarterly procedures to the triannual procedures, the operator may want to perform the triannual procedures after software version 2.6.0 has been installed. NOTE: Maintenance procedure 5835 Check and Clean High-Concentration Waste Sensor (c‑series), page 864 is required only if the high-concentration waste bottle is installed on the system. Maintenance procedure 2630 Manual Wash Cup Cleaning (i‑series), page 870 has been updated to reflect the new induction heating hardware.

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What's new

Diagnostic procedures The following new diagnostic procedures were added: • 4113 Pipettor Check (c‑series), page 881 • 1201 Induction Heater Test (i‑series), page 902 • 1209 Empty Bulk Solution Reservoirs (i‑series), page 905 Related information... Read me first, page 13

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General safety information

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General safety information Before operating the Alinity ci‑series, you should read and understand the safety information in this manual. For information about actions or conditions that can affect system and assay performance, carefully review Operational precautions and limitations, page 809. To become familiar with safety icons on the instrument and in this manual that indicate potentially hazardous situations, review Hazards, page 817. Comply with the hazard and safety information to minimize the potential for harm to personnel and damage to the laboratory environment. These two sections of the manual contain supplemental information. Do not use the supplemental information to supersede workplace safety requirements. Review any significant differences between the supplemental information and the workplace safety requirements with management or a workplace safety representative. Related information... Read me first, page 13

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System security

System security Abbott Laboratories is committed to the security of the Alinity systems and reducing cybersecurity risks associated with our medical devices. Abbott Laboratories recognizes the importance of incorporating cybersecurity considerations early and throughout our product design and development process. Our cybersecurity controls were designed, developed, and implemented based on leading practices, regulatory guidance, and government agencies. Although we have designed the Alinity systems with cybersecurity controls, our customers also play a vital role in protecting information security: • Use of good laboratory practices and adherence to applicable regulations is recommended at all times. • The system should be installed in a secure location. • Only authorized users should have access to the system because the system may contain protected health information (PHI) or sensitive data. • Although Alinity systems incorporate cybersecurity risk mitigation controls relating to network connectivity, each system should be installed on a secure network that adheres to best practices from a network security perspective to prevent unauthorized access to data transmission between the Alinity system and external systems, such as a printer or host. • Alinity systems also incorporate cybersecurity risk mitigation controls relating to connecting USB storage devices. Reports or other data exported to USB storage devices should be controlled with appropriate laboratory practices. Related information... Read me first, page 13

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Customer service

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Customer service For questions about the Alinity ci‑series, contact the local representative or find country-specific contact information at abbottdiagnostics.com. Related information... Read me first, page 13

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Intended use

Intended use The Alinity ci‑series is intended for In Vitro diagnostic use only. The Alinity ci‑series has a scalable design to provide full integration of clinical chemistry and immunoassay analysis. The Alinity ci‑series includes a clinical chemistry module and an immunoassay module, each performing all sample processing activities, and a system control module to provide a single user-friendly interface. Each system can be customized by combining one or more sample processing modules, in multiple configurations, with a system control module to form a single workstation. The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c processing module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c processing module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes). The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples. Related information... Read me first, page 13

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Proprietary statement

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Proprietary statement The Alinity ci‑series software programs and system documentation are protected by copyright (©2016, 2018 Abbott Laboratories, Abbott Park, Illinois). All rights are reserved. The software and manual were developed solely for use with the Alinity ci‑series as specified in the operating instructions. The information, documents, and related graphics published herein (the "Information") are the sole property of Abbott Laboratories. Permission to use the Information is granted, provided that: • the copyright notice appears on all copies; • use of the Information is for operation of ABBOTT products by Abbott trained personnel or informational use only; • the Information is not modified in any way; and • no graphics are used separate from accompanying text. Each person assumes full responsibility and all risks arising from use of the Information herein. The Information is presented "AS IS" without warranties, either express or implied, and may include technical inaccuracies or typographical errors. Abbott Laboratories reserves the right to make additions, deletions, or modifications to the Information at any time without any prior notification. Portions of the Alinity ci‑series software may include open source or third party software as further explained in the Software License Attributions document, which can be accessed on the Utilities screen. 7-Zip copyright ©1999-2016 Igor Pavlov Related information... Read me first, page 13

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Disclaimers

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Disclaimers All samples (printouts, graphics, displays or screens, etc.) are for information and illustration purposes only and shall not be used for clinical or maintenance evaluations. Data shown in sample printouts and screens do not reflect actual patient names or test results. The Information was developed to be used by Abbott Laboratories-trained personnel, by other persons knowledgeable or experienced with the operation and service of the product identified, under the supervision and with cooperation from Abbott Laboratories technical support or service representatives. In no event shall Abbott Laboratories or its affiliates be liable for any damages or losses incurred in connection with or arising from the use of the information by persons not fully trained by Abbott Laboratories. No confidential relationship shall be established in the event that any user of the Information should make any oral, written or electronic response to Abbott Laboratories (such as feedback, questions, comments, suggestions, ideas, etc.). Such response and any information submitted therewith shall be considered non-confidential, and Abbott shall be free to reproduce, publish or otherwise use such information for any purposes whatsoever including, without limitation, the research, development, manufacture, service, use, or sale of products incorporating such information. The sender of any information to Abbott is fully responsible for its content, including its truthfulness and accuracy and its non-infringement of any other person's proprietary rights. Abbott Laboratories is not engaged in rendering medical advice or services. Updates to the Information may be provided in either paper or electronic format. Always refer to the latest documents for the most current information. Master Table of Contents and / or Index - Incremental manual updates may cause the Master Table of Contents or Master Index page numbering to change. No part of this media may be reproduced, stored, retrieved, or transmitted in any form or by any means without the prior written permission of Abbott Laboratories. Data Usage Statement for AbbottLink Data collection: Abbott's AbbottLink software only collects operational and instrument data. It does not gather or access patient, sensitive health or other identifiable personal information ("Personal Data"). Use of data: AbbottLink is intended to transmit connected systems operational data, which may be used by Abbott, and third parties providing related services and products, for troubleshooting, complaint investigation, performance monitoring, product improvement, research, development, inventory management, usage analytics, billing and other related purposes. In addition, AbbottLink may be used to send system updates, to provide remote service and to facilitate Abbott's delivery of third party services and products to Customer. The terms and conditions for Customer's use of such

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Disclaimers

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third party services and products are to be provided to Customer separately by the applicable third parties. No Personal Data is transferred or accessed for company use. Data privacy assurance: All Personal Data is removed from operational data prior to AbbottLink retrieval. It is important that our customers avoid entering Personal Data in any SID (Sample Identification) or comments fields. During Remote Support Instrument Screen Sharing, data is accessed and transferred on the basis of consent provided by the user at the point of each individual screen-sharing event. Please refer to the form of consent, displayed on your analyzer screen, when taking advantage of this service. Related information... Read me first, page 13

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Alinity ci‑series warranty statement for USA customers only

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Alinity ci‑series warranty statement for USA customers only Abbott Laboratories warrants new instruments sold by Abbott Diagnostics Division to be free from defects in workmanship and materials during normal use by the original purchaser. This warranty shall continue for a period of one year from the date of shipment to the original purchaser, or until title is transferred from the original purchaser, whichever occurs first (the "Warranty Period"). If any defects occur during the Warranty period, contact your Abbott Customer Service Representative immediately, and be prepared to furnish information including the serial number, the model number, and pertinent details concerning the defect. This Warranty does not cover defects or malfunctions which: (1) are not reported to Abbott during the Warranty Period and within one week of occurrence; (2) result from chemical decomposition or corrosion; (3) are caused primarily by misuse, alteration, damage or failure to comply with any requirements or instruction contained in the applicable Abbott Operations Manual (including the substitution of any reagent not authorized by Abbott); or (4) result from maintenance, repair, or modification, performed or attempted by personnel not authorized by Abbott without Abbott's authorization. Abbott's liability for all matters arising from the supply, installation, use, repair, and maintenance of the instrument, whether arising under this Warranty or otherwise, shall be limited solely to the repair or (at Abbott's sole discretion) replacement of the instrument or of components thereof. Replaced parts shall become the property of Abbott Laboratories. In no event shall Abbott be liable for injuries sustained by third parties. The ICT module Warranty is 20,000 samples or three months post-installation, whichever occurs first. The cuvette warranty is one year post-installation. EXCEPT AS EXPRESSLY PROVIDED ABOVE, ABBOTT LABORATORIES HEREBY DISCLAIMS ALL REPRESENTATIONS AND WARRANTIES, WHETHER EXPRESS OR IMPLIED, CREATED BY LAW, CONTRACT OR OTHERWISE, INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE OR NON-INFRINGEMENT. IN NO EVENT SHALL ABBOTT LABORATORIES BE LIABLE FOR ANY INDIRECT, SPECIAL, PUNITIVE, CONSEQUENTIAL OR INCIDENTAL DAMAGES (INCLUDING WITHOUT LIMITATION LOST REVENUES, PROFITS, OR DATA) ARISING FROM OR IN CONNECTION WITH THE USE OF THE INSTRUMENT, REGARDLESS OF WHETHER ABBOTT LABORATORIES HAS BEEN ADVISED AS TO THE POSSIBILITY OF SUCH DAMAGES. Related information... Read me first, page 13

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Alinity ci‑series agency approvals

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Alinity ci‑series agency approvals The Alinity c processing module and the Alinity i processing module have been tested and found to comply with the following agency standards and European Union (EU) directives: • UL 61010-1 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 1: General Requirements • IEC/EN 61010-1 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 1: General Requirements • CAN/CSA-C22.2 No. 61010-1 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 1: General Requirements • IEC/EN 61010-2-101 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment • IEC/EN 61010-2-081 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-081: Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes • IEC/EN 61010-2-010 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of materials • Directive 2012/19/EU: Waste Electrical and Electronic Equipment (WEEE) • Directive 2011/65/EU: Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS 2) • Directive 98/79/EC: In Vitro Diagnostic (IVD) Medical Devices • IEC/BS EN 61326-1 Electrical equipment for measurement, control and laboratory use EMC requirements - Part 1: General requirements • IEC/BS EN 61326-2-6 Electrical equipment for measurement, control and laboratory use EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment

Legal Manufacturer

Abbott GmbH & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany +49-6122-580

Related information... Read me first, page 13

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Intellectual Property statement

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Intellectual Property statement The green and blue striping, ALINITY, and related brand marks are trademarks of Abbott Laboratories in various jurisdictions. Other trademarks are the property of their respective owners. No use of any Abbott trademark, trade name, or trade dress may be made without the prior written authorization of Abbott Laboratories, except to identify the product or services of Abbott Laboratories. For U.S. patent information, see abbott.us/patents. Related information... Read me first, page 13

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Key to symbols

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Key to symbols The following symbols are used on Alinity ci‑series labels and labeling. Harmonized symbols Directive 2002/96/EC Symbol

Description WEEE: Waste Electrical and Electronic Equipment NOTE: Indicates that the item needs to be disposed of in a separate waste collection for electrical and electronic equipment and must not be disposed of in the general waste or trash.

IEC 61010-1 Symbol

Description Caution: Consult accompanying documents

Caution: Hot surface

Caution: Possibility of electric shock

Off On

IEC 61010-2-101 Symbol

Description Caution: Biological RISKS

ISO 3287, ISO 3767-1, ISO 7296-1/Amd 1, ISO 11192 Symbol

Description Interior light

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Key to symbols

Read me first ISO 15223-1 Symbol

Description Consult operating instructions Date of manufacture

Manufacturer

Temperature limitation

Use by/Expiration date

Authorized Representative in the European Community Batch code/Lot number Catalog number/List number In Vitro Diagnostic Medical Device Serial number

Nonharmonized symbols Symbol

Description Caution: Probe stick hazard Disconnect Mains Plug

Priority

UL Recognized Component Mark

Acid Wash

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Key to symbols Symbol

Read me first Description Alkaline Wash Concentrated Wash Buffer Detergent A Detergent B Distributed by Distributed in the USA by For use with ICT Reference Solution Kit Manufactured by Manufactured for Pre-Trigger Solution Produced by Produced for Abbott by Product of Japan Product of Singapore Product of USA Quantity Reaction vessels Revision Sample cups Sequence number Trigger Solution

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Key to symbols

Read me first Symbol

Description Unit Wash buffer Water Bath Additive

Related information... Read me first, page 13

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Key to symbols

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NOTES

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System documentation

Introduction The Alinity ci‑series Operations Manual provides complete instructions for the use and maintenance of the Alinity ci‑series and its modules and components. Learning to use the operations manual helps to save time, avert trouble, and confidently operate the system. Related information... Organization of the operations manual, page 34 Conventions for the operations manual, page 36 Operations manual description, page 37 Operations manual use, page 45 Procedure map description, page 52

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Organization of the operations manual

System documentation

Organization of the operations manual Section

Description

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• • •

General safety information Customer service contact information Intended use of the system

System documentation

• •

Content organization and conventions Use of the operations manual

Section 1: Use or function

• • • •

Hardware overview Software overview Required consumables Required accessories

Section 2: Installation procedures and special requirements

• •

System installation and relocation System configuration

Section 3: Principles of operation

• •

Detection technology How the system translates measurements into results

Section 4: Performance characteristics and specifications

System specifications and requirements

Section 5: Operating instructions

Procedures for routine system operation

Section 6: Calibration procedures

Procedures for calibration

Section 7: Operational precautions and limitations

Operational requirements, precautions, and limitations to ensure optimal operator safety and accurate test results

Section 8: Hazards

Hazard and safety information

Section 9: Service, maintenance, and diagnostics

• • •

Section 10: Troubleshooting

34

• •

Procedures for maintenance and diagnostics Description of maintenance and diagnostic procedures Procedures for component replacement Troubleshooting basics Probable causes and corrective actions for message codes and observed problems

Appendices

Refer to the appendices for the following information: • Verification of assay claims • List numbers • Assay applications (c-series photometric) • Printed report element descriptions

Revision history

History of revisions to the operations manual

Glossary

Alphabetical listing of terms that are used in the operations manual

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Organization of the operations manual

Section

Description

Index

Alphabetical listing of subject matter with references to the location of information

Related information... System documentation, page 33

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Conventions for the operations manual

System documentation

Conventions for the operations manual Conventions are a set of defined standards that are used to communicate meaning in an expected manner. Table 1: Text conventions Description

Use

Italic font style

Indicates a reference to related information.

Bold font style

Emphasizes key words in procedures. For example, in the numbered steps, bold font style is applied to the following elements: • Toolbar, icon, and menu items • Buttons • Commands • Lists and tabs • Dialog box titles and options

Numbers in brackets (for example, [1] and [2])

Reference specific areas of a graphic.

Table 2: Content conventions Description

Use

Safety symbols and the CAUTION signal word

Identify activities that expose the operator to potentially dangerous conditions.

IMPORTANT signal word

Advises the operator to comply with precautions to prevent a negative impact on system operations or results.

NOTE signal word

Provides information that is relevant to the topic content.

Related information list

Provides references at the end of a topic that are related to the topic.

Table 3: Graphic conventions Description

Use

Numerical references on graphics

Indicate items in a graphic that are described in the legend.

Related information... System documentation, page 33

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Operations manual description

System documentation

Operations manual description The operations manual is designed to be the quickest and most accurate resource for informational needs. It is accessed from the system software. Figure 1: Operations manual

Legend: 1. 2. 3. 4. 5.

Title bar: Displays the title of the topic Toolbar: Provides elements for navigation Navigation pane: Provides an area to browse the operations manual content Topic pane: Displays the topic content Close button: Closes the operations manual

Related information... System documentation, page 33 Toolbar, page 38

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Operations manual description

System documentation

Navigation pane, page 38 Topic pane, page 43

Toolbar The toolbar contains navigation elements and a Print button. Figure 2: Toolbar

Legend: 1.

Home link

2.

Search box

3.

Procedure Map button

4.

Toggle TOC button

5.

Back and Forward buttons

6.

Previous Topic and Next Topic buttons

7.

Print button

Related information... Operations manual description, page 37

Navigation pane The navigation pane provides the primary navigation functionality. It provides an area to browse the topic content by using the Contents, Index, Glossary, or Search tab.

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Operations manual description

Figure 3: Navigation pane

Related information... Operations manual description, page 37 Contents tab, page 39 Index tab, page 41 Glossary tab, page 41 Search tab, page 42

Contents tab The Contents tab is an element in the navigation pane that displays the table of contents, which shows how information in the operations manual is organized. Topics are identified by a Book icon or a Page icon.

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Operations manual description

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Figure 4: Contents tab

Legend: 1.

Book icon (closed): Indicates that a list of subtopics is collapsed

2.

Book icon (open): Indicates that a list of subtopics is expanded

3.

Page icon: Indicates that no subtopics are available

Related information... Navigation pane, page 38

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System documentation

Operations manual description

Index tab The Index tab is an element in the navigation pane that displays an alphabetical list of all index entries in the operations manual. Entries are sorted by subject and relevance and include terms for all experience levels and informational types that range from general to specific. Figure 5: Index tab

Related information... Navigation pane, page 38

Glossary tab The Glossary tab is an element in the navigation pane that displays an alphabetical list of terms with definitions for those terms.

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Figure 6: Glossary tab

Related information... Navigation pane, page 38

Search tab The Search tab is an element in the navigation pane that displays a list of search results. The search results are topic titles in the operations manual that are associated with a search term in the Search box.

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Operations manual description

Figure 7: Search tab

Legend: 1.

Search tab

2.

Search box

Related information... Navigation pane, page 38

Topic pane The topic pane is the area under the toolbar that displays topic content. The topic content may contain navigation elements (for example, hypertext and image maps) and multimedia.

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Figure 8: Topic pane

Legend: 1. 2. 3.

Breadcrumbs: Provide a trail of topic links to show the hierarchy of topics that were previously accessed Topic content: Provides information about the system Related information: Provides links to related topics

Related information... Operations manual description, page 37

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Operations manual use

System documentation

Operations manual use The operations manual is designed for quick access to information needed to: • Understand the concepts behind system operation and performance. • Accomplish a task. • Recover from a mistake. • Troubleshoot a problem. Related information... System documentation, page 33 Access the operations manual, page 45 Display and use the procedure map, page 46 Use the table of contents, page 46 Scroll through a topic or the table of contents, page 46 Play an animation, page 47 Access the related information, page 48 Use breadcrumbs to access a topic, page 48 Redisplay a topic, page 49 Page through the content, page 49 Use the Toggle TOC button, page 49 Use the index, page 49 Use the glossary, page 50 Search for a term, page 50 Resize, move, and close the operations manual, page 50 Print a topic from the operations manual, page 51

Access the operations manual Perform this procedure to display the home page of the operations manual or the content specific to an active screen, a flyout, or a message code. • On the menu bar, tap System, and then tap Operations Manual (Help). As an alternative step, tap the Help button

at the top of the active screen.

Related information... Operations manual use, page 45

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Operations manual use

System documentation

Display and use the procedure map Perform this procedure to view a list of procedures that are related to the performance of a specific task and to display the instructions associated with each procedure. 1.

On the toolbar, tap the Procedure Map button

2.

To display a list of related tasks, tap a category on the procedure map that is displayed in the topic pane.

3.

In the expandable list of related tasks for the category, tap a task with a Right Arrow button .

.

The Right Arrow button changes to a Down Arrow button or procedures.

and displays a list of subtasks

4.

To display a procedure, tap the procedure.

5.

To return to the procedure map, tap the Procedure Map button.

Related information... Operations manual use, page 45

Use the table of contents Perform this procedure to view a list of topic titles in the operations manual and to display associated topic content. 1.

In the navigation pane, tap the Contents tab.

2.

To expand or collapse the list of topic titles, tap a Book icon

3.

At the right side of the navigation pane, slide the scroll bar to view the topic titles.

4.

To display the topic content in the topic pane, tap a topic title.

.

Related information... Operations manual use, page 45

Scroll through a topic or the table of contents Perform this procedure to move through content in a topic or to move through the table of contents. • In the topic pane or in the navigation pane, drag the scroll box up or down. The scroll box indicates the position in the topic or in the table of contents.

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Operations manual use

Figure 9: Scroll bars

Legend: 1.

Navigation pane scroll bar

2.

Topic pane scroll bar

Related information... Operations manual use, page 45

Play an animation The animation toolbar plays, pauses, and stops animations. It also can be used to seek a specific location in an animation and to switch to a full-screen display. Figure 10: Animation toolbar

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Operations manual use

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Legend: 1.

Play button

2.

Seek button

3.

Full Screen toggle button

Perform this procedure to play an animation. 1.

At the bottom of the image, tap the Play button. The animation plays and the Play button changes to a Pause button

.

NOTE: When a mouse is used to start an animation and the cursor is moved away from the toolbar, the toolbar is not displayed. Move the cursor below the animation to display the toolbar again. 2.

To specify the playback position of the animation, tap a point on the timeline to move the Seek button to that position.

3.

To display the animation in full-screen mode, tap the Full Screen toggle button.

4.

To restore the animation to its original size, tap the Full Screen toggle button again.

Related information... Operations manual use, page 45

Access the related information Perform this procedure to access the related information in a topic. 1.

In the topic pane, tap a related information hypertext link.

2.

To return to the last topic that was viewed, tap the related information hypertext link for the topic (or tap the Back button ).

Related information... Operations manual use, page 45

Use breadcrumbs to access a topic Perform this procedure to access a topic in a breadcrumb trail. As topics are selected in the navigation pane, a trail of the selected topics, or breadcrumbs, is displayed at the top of the topic pane. • At the top of the topic pane, tap a topic breadcrumb. NOTE: Topic breadcrumbs display associated topic content. The Home link displays the home page of the operations manual.

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Operations manual use

System documentation

Related information... Operations manual use, page 45

Redisplay a topic Perform this procedure to display a topic that is viewed in the active Help session. 1.

To display the last topic that was viewed, tap the Back button

2.

To display the next topic in a previously displayed sequence of topics, tap the Forward button .

.

Related information... Operations manual use, page 45

Page through the content Perform this procedure to move through a sequence of topics similar to the turning of pages of a book. 1.

On the Contents tab, tap a topic to display its content in the topic pane.

2.

On the toolbar, tap the Previous Topic button

or the Next Topic button

.

NOTE: The Previous Topic button is unavailable for the first topic in the manual. The Next Topic button is unavailable for the last topic in the manual. Related information... Operations manual use, page 45

Use the Toggle TOC button Perform this procedure to hide the navigation pane of the operations manual. The navigation pane contains the table of contents (TOC). 1.

To hide the navigation pane, tap the Toggle TOC button

2.

To display the navigation pane, tap the Toggle TOC button

. again.

Related information... Operations manual use, page 45

Use the index Perform this procedure to view index entries and to display associated topic content. 1.

In the navigation pane, tap the Index tab.

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Operations manual use

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2.

At the right side of the navigation pane, slide the scroll bar to view index headings (italic font style) and index entries (plain font style).

3.

To display the topic content in the topic pane, tap an index entry.

Related information... Operations manual use, page 45

Use the glossary Perform this procedure to view glossary terms and to display associated definitions. 1.

In the navigation pane, tap the Glossary tab.

2.

At the right side of the navigation pane, slide the scroll bar to view the glossary terms.

3.

To display a definition in the topic pane, tap a glossary term.

Related information... Operations manual use, page 45

Search for a term Perform this procedure to search the operations manual. 1.

On the toolbar, tap the Search box.

2.

With the virtual keyboard, type one or more search terms.

3.

Tap the Search icon

.

In the Search tab, results are ranked according to the frequency of the search term or terms found in each topic. Topics that include all the search terms are ranked higher than topics that contain only some of the search terms. In addition, topics that contain a search term in the title of the topic are ranked higher than topics that contain a search term in the body of the topic. 4.

In the list of search results on the Search tab, tap a topic title. In the topic pane, each word of the search term is highlighted in the topic because each word of the search term is treated individually.

Related information... Operations manual use, page 45

Resize, move, and close the operations manual Perform this procedure to change the size and the position of the operations manual and to close the manual.

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Operations manual use

System documentation 1.

To enlarge the manual to full-screen mode, at the upper-right corner of the manual, tap the Maximize button .

2.

To restore the manual to its original size and position, tap the Restore Down button

3.

To resize the navigation and topic panes of the manual, drag the divider handle the panes toward the left edge or the right edge.

4.

To change the height of the manual, drag the top edge or the bottom edge.

5.

To change the width of the manual, drag the left edge or the right edge.

6.

To move the manual, drag the title bar.

7.

To close the manual, tap the Close button

.

between

.

Related information... Operations manual use, page 45

Print a topic from the operations manual Perform this procedure to print a topic that is displayed in the topic pane. 1.

On the toolbar, tap the Print button

2.

In the Print window, tap Print.

.

Related information... Operations manual use, page 45 Clean and decontaminate the monitor, page 874

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Procedure map description

System documentation

Procedure map description The procedure map is an image map that displays categories of laboratory-related activities and provides links to lists of tasks and procedures. The procedure map is used to quickly access step-by-step instructions to help perform primary laboratory procedures. Figure 11: Procedure map

Legend: 1. 2. 3. 4. 5. 6.

52

Procedure Map button: Provides access to tasks and procedures that are grouped by categories Sample processing: Provides access to procedures used to prepare for system operation, to order tests, to load and process samples, to review results, and to print reports Quality control: Provides access to procedures used to review quality control data and to print quality control reports Manage data: Provides access to procedures used to manage system data Help on Help: Provides access to procedures that describe how to use the operations manual Maintenance: Provides access to procedures used to perform maintenance, to approve maintenance logs, and to print reports

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System documentation 7. 8. 9.

Procedure map description

Troubleshooting: Provides access to procedures used to review system logs, to perform diagnostics, to replace components, and to print diagnostic reports Setup: Provides access to procedures used to configure and view settings for the system, assays, quality control, and calibration, and to print reports Calibration: Provides access to procedures used to calibrate assays

Related information... System documentation, page 33 Procedure map task lists, page 53

Procedure map task lists Task lists are topics that are accessed from the procedure map. Each topic contains an expandable list of tasks that are related to a procedure map category or a laboratory-related activity. Each task has a list of links to related procedures.

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Procedure map description

System documentation

Figure 12: Procedure map task list

Legend: 1. 2.

Task list item that is collapsed Task list item that is expanded

Related information... Procedure map description, page 52

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Section 1

Use or function

Introduction The Alinity ci‑series of analyzers has a scalable design to provide full integration of multiple clinical chemistry and immunoassay systems, all of which are controlled by one user-friendly interface. This intuitive user interface provides a real-time display of each system’s status and a to-do list of scheduled maintenance activities, which minimizes system interaction and optimizes productivity. The Alinity ci‑series analyzers have also incorporated numerous features to prevent and reduce errors and to increase walkaway time. Related information... Alinity ci‑series hardware overview, page 56 Alinity system software overview, page 139 Required consumables, page 146 Required accessories, page 157 Automatic processing module activities, page 161 Operating instructions, page 479

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Use or function Alinity ci‑series hardware overview

Section 1

Alinity ci‑series hardware overview With the scalable design of the Alinity ci‑series family of analyzers, multiple processing modules can perform all sample-processing activities and can be physically joined to form one workstation or system. The processing modules determine the system configuration. An Alinity ci‑series can be configured as: • A chemistry system. • An immunoassay system. • A multimodule system that is a fully automated clinical chemistry assay and immunoassay system. A multimodule system includes multiple processing modules in different combinations of chemistry and immunoassay processing modules. The Alinity c‑series can be configured to process samples by using photometric and potentiometric methods. The Alinity i‑series uses the chemiluminescent microparticle immunoassay (CMIA) method. Related information... Use or function, page 55 Primary components of an Alinity ci‑series, page 56

Primary components of an Alinity ci‑series An Alinity ci‑series, regardless of type, has three primary components:

56

System control module (SCM)

Provides a common user interface among all Alinity products.

Reagent and sample manager (RSM)

Transports reagents, samples, calibrators, and controls through the Alinity ci‑series. Each system has one primary RSM regardless of the type and number of processing modules.

Processing module

Performs all sample-processing activities from sample aspiration to final result reporting. The type and number of processing modules determine the system configuration.

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Use or function Alinity ci‑series hardware overview

Section 1 Figure 13: Primary components of an Alinity ci‑series

Legend: 1. 2. 3.

Processing module RSM SCM

Related information... Alinity ci‑series hardware overview, page 56 Procedure key, page 58 System control module (SCM), page 60 Reagent and sample manager (RSM), page 70 Processing modules, page 74 Optional components, page 136

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Procedure key The procedure key provides access to the front and rear processing center covers of the Alinity ci‑series processing modules and the reagent and sample manager by overriding the interlocks for the processing module and system control module covers. The procedure key can be used to perform maintenance procedures, diagnostic procedures, and component replacement procedures. Figure 14: Procedure key for the Alinity c

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Figure 15: Procedure key for the Alinity i

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Figure 16: Procedure key for the system control module

Related information... Primary components of an Alinity ci‑series, page 56 Descriptions of procedure key settings, page 845 Use a procedure key to perform a procedure, page 846

System control module (SCM) The system control module (SCM) contains the following items: • A user interface computer provides the software interface to the Alinity ci‑series and provides an interface to a host or middleware computer. • Hardware and software operate the reagent and sample manager (RSM). • The power supply operates the user interface computer and the RSM.

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Section 1 Figure 17: Front view of the SCM

Legend: 1. 2.

3. 4. 5.

Adjustable monitor: Displays the user interface of the Alinity ci‑series and accepts on-screen selections from the operator Front SCM cover: Provides access to the RSM transport NOTE: The front SCM cover is monitored by a sensor. If the cover is opened when the instrument status of the RSM is Initializing or Running, the status transitions to Stopped. SCM shelf: Provides a small shelf for the operator and provides access to remove the bar code scanner Bar code scanner: Provides a means to scan sample bar codes and supply bar codes SCM front door: Provides access to the user interface computer and the procedure lock

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Figure 18: Rear view of the SCM

Legend: 1. 2. 3. 4. 5.

Rear SCM cover: Provides access to the user interface computer power strip Rear SCM upper access panel: Provides access to the Ethernet switch Network connectors: Provide connections for external devices, such as the host interface and AbbottLink SCM main power breaker: Powers on and powers off the SCM power supply Rear SCM lower access panel: Provides access to the power supply and RSM electronics

Related information... Primary components of an Alinity ci‑series, page 56 System control module (SCM) hardware components, page 63 Network connectors, page 64 Adjust the monitor position, page 65 Distance alert, page 68

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System control module (SCM) hardware components Hardware components of the system control module (SCM) include the user interface hardware and the reagent and sample manager (RSM) hardware. Figure 19: SCM hardware components

Legend: 1. 2.

3. 4. 5. 6.

Bar code scanner: Scans sample bar codes and supply bar codes. When the SCM shelf is accessed, the bar code scanner can be removed from the holder and can be used as a hand-held scanner. Uninterrupted power supply (UPS): Provides a temporary, continuous flow of power to the user interface (UI) computer during a power failure, which helps the operator to save data as necessary and to perform a controlled shutdown procedure. (Optional component, not provided) RSM X motor: Moves the RSM transport from position to position and from module to module. Firewall: Provides data protection between the UI computer and the supporting communications network. UI power strip: Distributes AC power to the UI computer, the adjustable monitor, and the Ethernet switch. RSM embedded computer: Provides the software control for the RSM.

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7.

Ethernet switch: Joins communication lines and facilitates the electronic transfer of information among the UI computer and the processing module embedded computer and the RSM embedded computer. 8. Network connectors: Provides connections for external devices, such as host interface and AbbottLink. 9. SCM power supply: Provides AC power to the UI power strip and DC power to the RSM hardware. 10. UI computer: Provides the software interface to the Alinity ci‑series and provides an interface to a host or middleware computer. 11. Water inlet: Provides a common area for the entrance and distribution of water for all processing modules in a system. 12. Waste manifold: Provides a common waste outlet area for all processing modules in a system.

Related information... System control module (SCM), page 60

Network connectors Network connectors provide connections from the user interface computer, through the firewall, to the wide area network (WAN) and to other external devices, such as the host interface, a middleware computer, and Alinity PRO.

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Section 1 Figure 20: Network connectors

Legend: 1. 2.

WAN connector Network connectors

Related information... System control module (SCM), page 60 Reseat network cables to the system control module (SCM), page 1469

Adjust the monitor position Perform this procedure to adjust the height and angle of the monitor. The monitor support arm has pivot points to adjust the monitor.

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Figure 21: Monitor pivot points

1.

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Position the monitor at a comfortable level to view.

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2.

Adjust the monitor so that it is an arm's length from the face (38 cm to 76 cm or 15 in. to 30 in.).

3.

Tilt the monitor slightly downward to eliminate any glare or reflection.

4.

Tilt the monitor slightly backward to use the virtual keyboard.

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5.

Move the monitor to the right side or the left side of the instrument as needed. The ideal position depends on the instrument configuration and the location of the operator.

6.

Use the attached handles to rotate the monitor to the rear of the instrument when required.

Related information... System control module (SCM), page 60

Distance alert The distance alert is an optional component on the workstation that is used to identify instrument conditions that require an operator response to maintain the optimal workflow.

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Section 1 Figure 22: Distance alert

The distance alert illuminates one of three colors (red, amber, or green) based on the status of the workstation. The following list provides descriptions of each color. If multiple conditions are present, the colors are illuminated in the following order: Red (blinking)

• The instrument status of one or more processing modules in the workstation transitions from Running or Processing to Stopped or Offline without an operator request to transition the status. • A critical alert message is generated and is displayed on the user interface.

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• If the distance alert is configured for notifications, a red badge is displayed on any icon on the menu bar. • An alert message that has not been cleared is present in the Alert Center. Amber

The instrument status of one or more processing modules in the workstation is Running, Processing, or Pausing, and one of the following conditions is present: • If the distance alert is configured for notifications, an amber badge is displayed on any icon on the menu bar except the Results icon. • If the distance alert is configured for exception notifications, an amber badge is displayed on the Results icon. • A notification message that has not been cleared is present in the Alert Center.

Green (blinking)

The instrument status of one or more processing modules, but not all modules, in the workstation is Running or Processing.

Green

The instrument status of all processing modules in the workstation is Running or Processing.

Distance alert off

The distance alert is not illuminated when one of the following conditions is present: • The distance alert is disabled. • The user interface computer is shut down. • The instrument status of one or more processing modules in the workstation is not Running, Processing, or Pausing.

Related information... System control module (SCM), page 60

Reagent and sample manager (RSM) The reagent and sample manager (RSM) is a transport system used to load calibrators, controls, specimens, reagents, and onboard solutions. The design of the RSM provides random and continuous access to load and unload sample racks, calibration and control racks, and reagent cartridges. One primary RSM transports samples and reagents through an Alinity ci‑series regardless of the type and number of processing modules. The RSM performs the following functions:

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• Lifts racks and cartridges from the loading area and moves them past the bar code reader • Positions racks and cartridges for the bar code reader to identify samples, reagents, and solutions • Moves racks and cartridges to the appropriate processing module or returns them to the loading area Figure 23: RSM components

Legend: 1.

2. 3. 4.

Sample positioner: Positions racks at the sample aspiration position. Each module has two sample positioners. A rack exchange occurs between the loading area and one sample positioner while the other sample positioner positions samples for aspiration. RSM bar code reader: An imaging camera that reads bar code labels on samples, racks, and cartridges. RSM transport: Transports racks and cartridges from the loading area to be read by the bar code reader and to be placed on the module-specific sample positioner or reagent positioner. Loading area: Positions racks and cartridges for loading and unloading.

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Related information... Primary components of an Alinity ci‑series, page 56 Loading area, page 72 Status indicators, page 73 Reagent supply center (Alinity c), page 100 Reagent supply center (Alinity i), page 133

Loading area The loading area holds racks and cartridges for routine and priority processing. Each processing module includes one loading area. Figure 24: Loading area

Legend: 1. 2. 3. 4.

72

Priority button: Temporarily assigns an RSM position as a priority position. Priority position: Designated with a blue status indicator. Racks or cartridges inserted in this position are processed before other positions. Status indicators: Indicate the status of sample processing and when samples and reagents can be accessed. Tray: Holds racks and cartridges to load on the reagent and sample manager (RSM). Each tray holds a maximum of five racks or cartridges. Empty trays may remain on the loading area to create five positions to load racks or cartridges one at a time.

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Position: Holds one rack or cartridge. Each processing module has 25 positions. Bay: Holds trays that are used to position racks and cartridges for assay processing. Each processing module contains five bays.

Related information... Reagent and sample manager (RSM), page 70 Racks, page 157 Trays, page 158 Reagent kits and components, page 146 Status indicators, page 73

Status indicators Three status indicators (blue, green, and amber) are located above each reagent and sample manager (RSM) position to indicate the status of sample processing and when racks and cartridges can be accessed. Figure 25: Status indicators

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Indicators off

No rack or cartridge is inserted in the position. [1]

Green (steady)

The rack or cartridge is inserted but is not in process. The rack or cartridge can be accessed. [2]

Amber (steady)

The rack or cartridge is in process. The rack or cartridge cannot be accessed. [4]

Green (blinking)

Processing is completed. The rack or cartridge can be accessed. If a test is added or a rerun is scheduled before the rack is removed from the loading area, the status indicator for the position changes to amber and the rack cannot be accessed.

Amber (blinking)

Unloading of a cartridge or vial rack is in process. The position is reserved and is unavailable to load a rack or cartridge.

Amber and green (alternating)

A bar code scan error or other error occurred. The rack or cartridge can be accessed.

Blue

The RSM position is designated as a priority position. [3]

Related information... Reagent and sample manager (RSM), page 70 Loading area, page 72 Unload trays from the reagent and sample manager (RSM), page 607

Processing modules Processing modules perform all sample-processing activities from sample aspiration to final result reporting. Unless otherwise indicated, "processing module" is used generically throughout this manual to refer to both types of modules. Related information... Primary components of an Alinity ci‑series, page 56 Processing center interior lights, page 74 Processing module (Alinity c), page 76 Processing module (Alinity i), page 102

Processing center interior lights Processing center interior lights are located on the top panel of the Alinity i and Alinity c. The interior lights provide additional lighting when routine maintenance and system troubleshooting is performed. With either the front processing center cover or the rear processing center covers 74

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opened the interior lights can be turned on. The interior lights are turned on by pressing the interior light button located on the front edge of the top panel, indicated by the light icon if present. The interior lights come on at a preset level of intensity. The light intensity may be adjusted through any of eight levels by pressing and holding either the front light button or the rear light button. When the light intensity reaches either the lower extreme or upper extreme the light intensity cycle will reverse. A single press to either the front light button or the rear light button will turn off the interior light. Closing both the front processing center cover and the rear processing center cover of a processing module will turn off the interior light. The power is supplied to the interior light by the system control module so the interior light will work with the processing module power turned off. Figure 26: Processing center interior light button

Related information... Processing modules, page 74 Processing center (Alinity c), page 78 Processing center (Alinity i), page 105

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Processing module (Alinity c) The Alinity c processing module is a chemistry analyzer that performs sample processing. The processing module processes a maximum of 1350 photometric and potentiometric tests per hour and has 70 positions in the reagent carousel at a controlled temperature. Figure 27: Front view of the Alinity c processing module

Legend: 1.

2. 3.

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Front processing center cover: Provides access to the components that perform assay-processing activities. NOTE: The front processing center cover is monitored by two sensors. If the cover is opened during Initializing status, Running status, or Processing status, the reagent and sample manager and the processing module transition to Stopped status. Bulk solution door: Provides access to the bulk solution storage area and the pump center. Front electronics door: Provides access to the processing module electronics and the procedure lock.

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Section 1 Figure 28: Rear view of the Alinity c processing module

Legend: 1.

2. 3. 4. 5.

Rear processing center cover: Provides access to the components that perform assay-processing activities. NOTE: The rear processing center cover is monitored by a sensor. If the cover is opened when the instrument status of the processing module is Initializing, Running, or Processing, the status transitions to Stopped. Rear access panel: Provides additional access to processing center components. Rear lower access panel: Provides access to the water management unit. Power supply panel: Provides access to the processing module power supply. Processing module main power breaker: Powers on and powers off the power supply.

Related information... Processing modules, page 74 Processing center (Alinity c), page 78 Supply and pump center (Alinity c), page 94 Reagent supply center (Alinity c), page 100 Alinity ci‑series Operations Manual

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Processing center (Alinity c) The processing center is the main activity area of the processing module. Samples and reagents are dispensed and mixed in a reaction carousel where assay processing is performed. Figure 29: Processing center (Alinity c)

Legend: 1. 2.

Pipetting hardware: Aspirates and dispenses sample and reagents Reaction carousel hardware: Positions the cuvettes for sample and reagent dispense, mixing, photometric or potentiometric analysis, and cuvette washing

Related information... Processing module (Alinity c), page 76 Pipetting hardware (Alinity c), page 78 Reaction carousel hardware (Alinity c), page 83 Processing center interior lights, page 74 Pipetting hardware (Alinity c)

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Pipetting hardware aspirates and dispenses samples, reagents, and onboard solutions. Figure 30: Pipetting hardware components (Alinity c)

Legend: 1. 2. 3.

Sample pipettor (S): Aspirates and dispenses samples into cuvettes and transfers diluted samples from one cuvette to another. Reagent pipettors (R1 and R2): Aspirate and dispense reagents and onboard solutions into cuvettes. The R1 pipettor also aspirates and dispenses diluents. Wash cups (SW, WB, LASW, R1W, and R2W): Wash any fluid that remains from the interior and exterior surfaces of probes.

Related information... Processing center (Alinity c), page 78 Pipettors (Alinity c), page 79 Wash cups (Alinity c), page 81 Sample wash solution area (Alinity c), page 82 Pipettors (Alinity c) Alinity ci‑series Operations Manual

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Pipettors detect, aspirate, transfer, and dispense samples and reagents into cuvettes. These pipettor assemblies include a fluid sense and a pressure-monitoring system to help identify aspiration errors. Three pipettors that have the following functions are located on the system: • The sample pipettor (S) detects, aspirates, transfers, and dispenses samples into cuvettes. It also transfers diluted samples from the cuvette that is used to make the dilution into the cuvette that is used for the reaction. • The reagent 1 pipettor (R1) detects, aspirates, transfers, and dispenses diluents, reagents, and onboard solutions into cuvettes. • The reagent 2 pipettor (R2) detects, aspirates, transfers, and dispenses reagents and onboard solutions into cuvettes. Figure 31: Pipettors (Alinity c)

Legend: 1. 2. 3.

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Sample pipettor Reagent 1 pipettor Reagent 2 pipettor

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Related information... Pipetting hardware (Alinity c), page 78 Wash cups (Alinity c) The Alinity c wash cups are active wash stations that use system water to clean the pipettors. The system has five pipettor wash cups. Figure 32: Wash cups (Alinity c)

Legend: 1. 2. 3. 4.

Sample wash cup (SW): Washes the fluid that remains from the probe exterior and interior between samples to eliminate carryover. Whole blood wash cup (WB): Washes the exterior of the sample probe before a whole blood sample is dispensed into the cuvette. Reagent 1 pipettor wash cup (R1W): Washes any fluid that remains from the probe exterior and interior. Reagent 2 pipettor wash cup (R2W): Washes any fluid that remains from the probe exterior and interior.

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Laboratory automation system wash cup (LASW): Washes the fluid that remains from the sample probe exterior and interior after whole blood samples to eliminate carryover. This wash cup is used only on systems that are connected to a laboratory automation system (LAS).

Related information... Pipetting hardware (Alinity c), page 78 Sample wash solution area (Alinity c) The sample wash solution area stores sample onboard wash solutions that are used for the SmartWash function and maintenance procedures. The area provides space for two sample tubes in a removable sample wash solution holder. Figure 33: Sample wash solution area (Alinity c)

Legend: 1. 2. 3.

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Sample wash solution holder Detergent A Acid Probe Wash

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Related information... Pipetting hardware (Alinity c), page 78 Reaction carousel hardware (Alinity c) The reaction carousel hardware components position the cuvettes for sample and reagent dispense, mixing, photometric or potentiometric analysis, and cuvette washing. Figure 34: Reaction carousel hardware (Alinity c)

Legend: 1.

Mixers: Mix sample with reagent

2.

ICT unit: Measures potentiometric assays (sodium, potassium, and chloride) by using integrated chip technology (ICT) Lamp: Provides the light source for photometric measurement ICT high-concentration waste area: Receives liquid waste from the ICT unit Cuvette washer: Washes and dries the cuvettes Water bath overflow and waste area: Receives overflow from the water bath, excess water from the sample pipettor, and liquid waste from the ICT Reference Solution cup

3. 4. 5. 6.

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Cuvette segments: Hold the cuvettes in the reaction carousel Reaction carousel: Positions the cuvettes for sample processing High-concentration waste pump: Works with the cuvette washer to aspirate waste from the cuvettes to the optional high-concentration waste bottle or the drain

Related information... Processing center (Alinity c), page 78 Reaction carousel (Alinity c), page 84 Cuvette segments (Alinity c), page 85 Lamp (Alinity c), page 86 Mixers (Alinity c), page 87 Cuvette washer (Alinity c), page 88 ICT unit (Alinity c), page 90 ICT high-concentration waste area (Alinity c), page 91 Water bath overflow and waste area (Alinity c), page 92 High-concentration waste pump (Alinity c), page 93 Reaction carousel (Alinity c) The reaction carousel supports a variety of assay protocols and has 17 cuvette segments surrounded by a 37°C water bath. The carousel rotates counterclockwise to position the cuvettes at the following locations: • Sample dispense • Reagent 1 dispense • Reagent 2 dispense • ICT sample aspiration • Mixing • Photometric read position • Diluted sample aspiration

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Figure 35: Reaction carousel (Alinity c)

Related information... Reaction carousel hardware (Alinity c), page 83 Cuvette segments (Alinity c) Cuvette segments suspend cuvettes in the reaction carousel. Each cuvette segment holds 11 cuvettes. The Alinity c processing module contains 17 segments for a total of 187 cuvettes in the reaction carousel.

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Figure 36: Cuvette segment (Alinity c)

Related information... Reaction carousel hardware (Alinity c), page 83 Lamp (Alinity c) The lamp is an optical device that provides the light source for photometric assay measurement.

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Figure 37: Lamp (Alinity c)

Related information... Reaction carousel hardware (Alinity c), page 83 Mixers (Alinity c) The Alinity c processing module has two mixers that mix sample with reagent in the cuvette. After each mixing operation, the exterior of the mixer is washed in the wash cup located beneath the mixer.

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Figure 38: Mixers (Alinity c)

Legend: 1. 2.

Mixer 1: Mixes the sample with reagent 1 or a diluent Mixer 2: Mixes the sample and reagent 1 mixture with reagent 2

Related information... Reaction carousel hardware (Alinity c), page 83 Cuvette washer (Alinity c) The cuvette washer is a device with eight nozzles that perform the following functions before and after each cuvette is used. The nozzles are listed in order from right to left on the cuvette washer: Nozzle 1

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Dispenses water and aspirates the sample and reagent mixture to waste

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Nozzle 2

Dispenses Alkaline Wash to clean the cuvette and aspirates the Alkaline Wash to waste

Nozzle 3

Dispenses Acid Wash to clean the cuvette and aspirates the Acid Wash to waste

Nozzles 4 and 5

Dispense water to rinse the cuvette and aspirate the water to waste

Nozzle 6

Dispenses water into the cuvette for the water blank measurement, which ensures cuvette integrity

Nozzle 7

Aspirates the water that remains in the cuvette to waste

Nozzle 8

Dries the cuvette

Figure 39: Cuvette washer (Alinity c)

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Related information... Reaction carousel hardware (Alinity c), page 83 ICT unit (Alinity c) The integrated chip technology (ICT) unit has an ICT probe and an ICT module. It is used to perform the indirect potentiometric analysis of sodium (Na+), potassium (K+), and chloride (Cl-). Figure 40: ICT unit (Alinity c)

Legend: 1. 2.

3.

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ICT module: Measures electrolytes (Na+, K+, and Cl-) at a temperature of 37°C by using integrated chip technology. ICT probe: Connects to the ICT module in the ICT unit. The ICT probe aspirates the diluted sample from the cuvettes or ICT Reference Solution from the ICT Reference Solution cup into the ICT module for processing. ICT Reference Solution cup: Located beneath the ICT probe when the ICT unit is in the home position. It contains preheated ICT Reference Solution that is aspirated by the ICT probe and measured by the ICT module. Sensors in the cup confirm that the cup fills completely and that sufficient solution aspirates during measurement.

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Section 1 Figure 41: ICT Reference Solution warming ring (Alinity c)

Legend: 1.

ICT Reference Solution warming ring: A narrow metal tube located in the water bath. The warming ring heats the reference solution to 37°C before the ICT Reference Solution cup is filled.

Related information... Reaction carousel hardware (Alinity c), page 83 ICT high-concentration waste area (Alinity c) Liquid waste from the ICT unit collects in a high-concentration waste compartment, and then the waste is removed through the high-concentration waste tubing.

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Figure 42: ICT high-concentration waste area (Alinity c)

Legend: 1.

ICT high-concentration waste area

Related information... Reaction carousel hardware (Alinity c), page 83 Water bath overflow and waste area (Alinity c) The water bath overflow and waste area is a waste collection compartment that receives overflow from the water bath, excess water from the sample pipettor, and liquid waste from the ICT Reference Solution cup. Water from the sample pipettor and waste from the ICT Reference Solution cup collect in a lowconcentration waste compartment, and then the water and waste are removed through the lowconcentration waste tubing.

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Section 1 Figure 43: Water bath overflow and waste area (Alinity c)

Legend: 1. 2.

Sample tubing: Delivers excess purified water from the sample pipettor into the low-concentration waste compartment ICT Reference Solution cup low-concentration waste tubing: Delivers liquid waste from the ICT Reference Solution cup into the low-concentration waste compartment

Related information... Reaction carousel hardware (Alinity c), page 83 High-concentration waste pump (Alinity c) The high-concentration waste pump works with the cuvette washer to aspirate waste from the cuvettes to the optional high-concentration waste bottle or the drain.

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Figure 44: High-concentration waste pump (Alinity c)

Related information... Reaction carousel hardware (Alinity c), page 83 Supply and pump center (Alinity c) The supply and pump center is the onboard storage area for processing module pumps, bulk solutions, and sample and reagent syringes and drives.

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Section 1 Figure 45: Supply and pump center (Alinity c)

Legend: 1. 2. 3. 4.

Bulk solution storage area: Provides the onboard storage for replacement bulk solution bottles Sample and reagent syringes area: Houses the sample and reagent syringes and drives Bulk solution reservoir area: Provides the onboard storage for the ICT Reference Solution, Alkaline Wash, and Acid Wash that are in use Pump center: Houses the processing module pumps

Related information... Processing module (Alinity c), page 76 Pump center (Alinity c), page 95 Bulk solution storage area (Alinity c), page 97 Bulk solution reservoir area (Alinity c), page 98 Sample and reagent syringe area (Alinity c), page 99 Pump center (Alinity c)

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The pump center houses the processing module pumps. These pumps provide the pressure that is needed to aspirate and dispense liquids into the appropriate components in the processing center. Figure 46: Pump center (Alinity c)

Legend: 1. 2.

3.

4.

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Wash solution pump: Delivers diluted Alkaline Wash and Acid Wash solutions to the cuvettes during daily operation and maintenance procedures. ICT Reference Solution pump: Uses the syringe on the left side of the pump to deliver ICT Reference Solution into the ICT Reference Solution cup. After the ICT Reference Solution is measured, the ICT Reference Solution pump uses the syringe on the right side of the pump to drain the cup. ICT aspiration pump: Uses the syringe on the right side of the pump to deliver samples or ICT Reference Solution into the ICT module for measurement. After measurement is completed, the ICT aspiration pump uses the syringe on the left side of the pump to aspirate waste from the ICT highconcentration waste area to the high-concentration waste tubing. ICT aspiration valve: Controls the direction of liquid flow while the ICT aspiration pump operates.

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Related information... Supply and pump center (Alinity c), page 94 Bulk solution storage area (Alinity c) The bulk solution storage area, which is located on the bulk solution door, provides the onboard storage for replacement bulk solution bottles. Bulk solutions from the replacement bottles fill onboard bulk solution reservoirs. Each bottle has a unique keyed cap that locks into its appropriate key slot in a bottle holder. Figure 47: Bulk solution storage area (Alinity c)

Legend: 1. 2. 3. 4.

Alkaline Wash: Used by the cuvette washer to clean the cuvettes after sample analysis. Acid Wash: Used by the cuvette washer to clean the cuvettes after sample analysis. ICT Reference Solution: Aspirated and analyzed by the ICT module before and after each sample to provide a reference potential that is used in result calculation. Bottle release button: Releases a bulk solution cap from a bottle holder to remove and replace a bulk solution bottle.

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Bottle holder: Stores a replacement bulk solution bottle. Contains a mechanism that pierces the bulk solution septum.

Related information... Supply and pump center (Alinity c), page 94 Bulk solutions (c‑series), page 150 Bulk solution reservoir area (Alinity c) The bulk solution reservoir area, which is located in the supply center, provides the onboard storage for bulk solutions in use during assay processing. When onboard bulk solution reservoirs are empty, bulk solutions from replacement bottles on the bulk solution door fill the reservoirs without an interruption in system operation. Figure 48: Bulk solution reservoir area (Alinity c)

Legend: 1. 2. 3.

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Alkaline Wash reservoir: Holds in-use Alkaline Wash solution. Acid Wash reservoir: Holds in-use Acid Wash solution. ICT Reference Solution reservoir: Holds in-use ICT Reference Solution.

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Reservoir bottle tray: Holds the bulk solution reservoirs. Slides out to access the bulk solution reservoirs.

Related information... Supply and pump center (Alinity c), page 94 Bulk solutions (c‑series), page 150 Sample and reagent syringe area (Alinity c) The sample and reagent syringe area holds the sample and reagent syringes and drives. Each drive supports a syringe that aspirates and dispenses samples, reagents, and onboard solutions. Figure 49: Sample and reagent syringe area (Alinity c)

Legend: 1. 2.

Sample syringe: Aspirates and dispenses the sample Reagent syringes 1 and 2: Aspirates and dispenses the reagent and onboard solutions

Related information... Supply and pump center (Alinity c), page 94 Alinity ci‑series Operations Manual

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Reagent supply center (Alinity c) The reagent supply center provides cooled storage at a controlled temperature for reagent cartridges, onboard solutions, sample diluents, and frequently used calibrators and controls. Cartridges and vial racks are loaded on the reagent and sample manager (RSM) and are transferred to the reagent positioner by the RSM transport. Figure 50: Reagent supply center (Alinity c)

Legend: 1.

Reagent carousel: Holds reagent cartridges and frequently used calibrators and controls. The carousel rotates to provide reagent access to reagent 1 and reagent 2 pipettors.

2.

Reagent positioner: Positions cartridges and onboard vial racks to load in the reagent carousel or onto the loading area. When the reagent positioner is in the open position, the cartridge or rack can be transferred to the loading area. When the reagent positioner is in the closed position, the cartridge or rack can be transferred to the reagent carousel. Reagent transport: Places cartridges and onboard vial racks in the reagent carousel or onto the reagent positioner.

3.

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Related information... Processing module (Alinity c), page 76 Reagent carousel (Alinity c), page 101 Reagent and sample manager (RSM), page 70 Reagent carousel (Alinity c) The reagent carousel is a rotating, circular device that performs the following functions: • Holds a maximum of 70 bar-coded reagent cartridges, onboard solutions, sample diluents, and vial racks in a cooled environment at a controlled temperature • Rotates to position reagent cartridges and onboard solutions so that reagents or solutions can be aspirated and dispensed • Rotates to position vial racks for transfer to the sample positioner so that calibrators and controls can be aspirated and dispensed Figure 51: Reagent carousel (Alinity c)

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Legend: 1.

2. 3.

Reagent segment: A section of the reagent carousel. The reagent carousel has two types of segments and 12 total segments: –

Eleven segments can hold a maximum of six cartridges. Vial racks cannot be stored in these segments.

–

The twelfth segment contains the reagent carousel calibration target. This segment can hold a maximum of four cartridges or vial racks.

The total capacity of the 12 segments is 70 cartridges. Reagent position: A section of a reagent segment that holds one cartridge or vial rack. Reagent carousel calibration target: A calibration target that is used to align the reagent pipettor and the reagent transport to cartridges and vials.

Related information... Reagent supply center (Alinity c), page 100

Processing module (Alinity i) The Alinity i processing module is an immunoassay analyzer that performs sample processing. The processing module processes a maximum of 200 chemiluminescent microparticle immunoassay (CMIA) tests per hour and has 47 positions in the reagent carousel at a controlled temperature.

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Section 1 Figure 52: Front view of the Alinity i processing module

Legend: 1.

2. 3. 4.

Front processing center cover: Provides access to the components that perform assay-processing activities. NOTE: The front processing center cover is monitored by two sensors. If the cover is opened during Initializing status, Running status, or Processing status, the reagent and sample manager and the processing module transition to Stopped status. RV hopper cover: Provides access to the RV hopper to replenish reaction vessels. Bulk solution door: Provides access to the bulk solution storage area and the RV waste storage area. Front electronics door: Provides access to the processing module electronics and embedded computer, and the procedure lock.

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Figure 53: Rear view of the Alinity i processing module

Legend: 1.

2. 3. 4. 5.

Rear processing center cover: Provides access to the components that perform assay-processing activities. NOTE: The rear processing center cover is monitored by one sensor. If the cover is opened when the instrument status of the processing module is Initializing, Running, or Processing, the status transitions to Stopped. Rear access panel: Provides additional access to processing center components. Rear electronics panel: Provides access to instrument electronics. Processing module main power breaker: Powers on and powers off the power supply. Rear fluidics panel: Provides access to pumps and syringes.

Related information... Processing modules, page 74 Processing center (Alinity i), page 105 Supply center (Alinity i), page 128 Reagent supply center (Alinity i), page 133 104

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Processing center (Alinity i) The processing center is the main activity area of the processing module. Samples and reagents are dispensed and mixed in reaction vessels (RVs) in the process and pretreatment paths where assay processing is performed. Figure 54: Processing center (Alinity i)

Legend: 1. 2. 3. 4.

Process path: Provides incubation at a controlled temperature, liquid aspiration, and wash points as necessary for assay processing Pretreatment path: Provides incubation at a controlled temperature for pretreatment assay protocols Pipetting hardware: Aspirates and dispenses samples and reagents RV loader: Provides the onboard storage for RVs and transports RVs to the process and pretreatment paths

Related information... Processing module (Alinity i), page 102 Process path light cover (Alinity i), page 106

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Process path (Alinity i), page 107 Pretreatment path (Alinity i), page 118 Pipetting hardware (Alinity i), page 122 RV loader (Alinity i), page 127 CMIA technology and reaction sequence (i‑series), page 428 Assay processing (i‑series), page 433 Assay processing for One Step 25 (i‑series), page 434 Assay processing for Two Step 18-4 (i‑series), page 435 Assay processing for pretreatment (i‑series), page 437 STAT assay processing for One Step 11 (i‑series), page 439 STAT assay processing for Two Step 4-4 (i‑series), page 440 Processing center interior lights, page 74 Process path light cover (Alinity i) The process path light cover on the process path prevents external light interference with the diverter sensors and the optics. One of two configurations will be installed on the system.

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Section 1 Figure 55: Process path light cover configurations (Alinity i)

Legend: 1. 2.

One-piece process path light cover Two-piece process path light cover

Related information... Processing center (Alinity i), page 105 Process path (Alinity i) The process path is a covered, circular path that provides incubation at a controlled temperature, liquid aspiration, and wash points as necessary for assay processing. The process path advances reaction vessels (RVs) every 18 seconds and positions them at the designated locations to process the CMIA reaction.

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Figure 56: Process path (Alinity i)

Legend: 1. 2. 3. 4. 5. 6. 7. 8. 9.

108

Vortexers (VTXR1, VTXR2, and VTXPT): Mix the reaction mixture to suspend microparticles. Diverters (LD, STD, and WZD): Move RVs in the processing module from one lane of the process path to a different lane during assay processing. Liquid waste arm: Removes the liquid from RVs. Wash zone assemblies (WZ1 and WZ2): Dispense the wash buffer into RVs, and remove and discard the unbound material from the RV reaction mixture. RV access door (RVA): Provides access to one position on the reaction lane. Use this door only for diagnostic purposes. Process path motor (PPM): Rotates the process path disk, which holds the RVs, and advances the RVs from position to position. Pre-Trigger and Trigger manifold (PTT): First dispenses Pre-Trigger Solution into RVs and then dispenses Trigger Solution into RVs. Optics: Measures the chemiluminescent emission from RVs and outputs the data that corresponds to the quantity of emission detected. RV unloader (RVU): Removes used RVs from the process path and discards them into the solid waste container after assay processing is completed.

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Related information... Processing center (Alinity i), page 105 Vortexers (Alinity i), page 109 Diverters (Alinity i), page 110 Liquid waste arm (Alinity i), page 111 Wash zone assemblies (Alinity i), page 112 RV access door (Alinity i), page 113 Process path motor (Alinity i), page 114 Pre-Trigger and Trigger manifold (Alinity i), page 115 Optics (Alinity i), page 116 RV unloader (Alinity i), page 117 Pretreatment path (Alinity i), page 118 Vortexers (Alinity i) Three vortexers are located on the process path: • R1 pipettor vortexer (VTXR1) • R2 pipettor vortexer (VTXR2) • Pre-Trigger vortexer (VTXPT) The vortexers mix the reaction mixture to suspend microparticles.

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Figure 57: Vortexer (Alinity i)

Related information... Process path (Alinity i), page 107 Diverters (Alinity i) Diverters move reaction vessels (RVs) in the processing module from one lane of the process path to a different lane during assay processing. The following three diverters are located on the process path: • The load diverter (LD) directs RVs from the load lane to the incubation lane. • The STAT diverter (STD) directs RVs from the incubation lane to the reaction lane for STAT assay processing. • The wash zone diverter (WZD) directs RVs to one of two lanes. One lane moves RVs through the wash zone where a wash occurs. The other lane moves RVs to the wash zone bypass lane where a wash does not occur.

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Figure 58: Diverter (Alinity i)

Related information... Process path (Alinity i), page 107 Liquid waste arm (Alinity i) The liquid waste arm removes the liquid from reaction vessels before the RV unloader discards them into the solid waste container.

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Figure 59: Liquid waste arm (Alinity i)

Related information... Process path (Alinity i), page 107 Wash zone assemblies (Alinity i) The wash zone assemblies (WZ1 and WZ2) dispense the wash buffer into reaction vessels (RVs), and remove and discard the unbound analyte from the reaction mixture in the RVs. Each wash zone has four positions where the following actions occur: • At each position, a magnet attracts paramagnetic microparticles to the wall of the RV. • At position 1, a dispense nozzle dispenses the wash buffer into the RV. • At position 2 and position 3, a vacuum is applied to the wash zone probes as they move to the bottom of RVs and aspirate the liquid from RVs. In addition, nozzles dispense the wash buffer into RVs. Additional wash and aspiration cycles occur at these positions. • At position 4, a wash zone probe aspirates liquid waste from the RV.

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Figure 60: Wash zone assembly (Alinity i)

Related information... Process path (Alinity i), page 107 RV access door (Alinity i) The RV access door (RVA) is an opening that provides access to one position on the reaction lane on the process path. Use this door only for diagnostic purposes and confirm that it is closed during system operation.

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Figure 61: RV access door (Alinity i)

Related information... Process path (Alinity i), page 107 Process path motor (Alinity i) The process path motor (PPM) rotates the process path disk, which holds the reaction vessels (RVs), and advances the RVs from position to position.

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Figure 62: Process path motor (Alinity i)

Related information... Process path (Alinity i), page 107 Pre-Trigger and Trigger manifold (Alinity i) The Pre-Trigger and Trigger manifold (PTT) first dispenses Pre-Trigger Solution into reaction vessels (RVs) and then dispenses Trigger Solution into RVs.

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Figure 63: Pre-Trigger and Trigger manifold (Alinity i)

Related information... Process path (Alinity i), page 107 Optics (Alinity i) The optics measures the chemiluminescent emission from reaction vessels and outputs the data that corresponds to the quantity of emission detected.

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Figure 64: Optics (Alinity i)

Related information... Process path (Alinity i), page 107 Optical system and measurement sequence (i‑series), page 431 RV unloader (Alinity i) The RV unloader (RVU) removes used reaction vessels from the process path and discards them into the solid waste container after assay processing is completed.

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Figure 65: RV unloader (Alinity i)

Related information... Process path (Alinity i), page 107 Pretreatment path (Alinity i) The pretreatment path is a covered, circular path that provides incubation at a controlled temperature for pretreatment assay protocols. The pretreatment path advances reaction vessels (RVs) in two lockstep durations. It advances RVs at 3 seconds, followed by a 15-second lockstep for a total of two positions every 18 seconds. RVs are positioned at the designated locations to process a pretreatment assay protocol. After the pretreatment assay protocol is completed, the sample is transferred to the process path.

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Section 1 Figure 66: Pretreatment path (Alinity i)

Legend: 1. 2. 3.

Pretreatment path motor (pPM): Rotates the pretreatment path disk, which holds the RVs, and advances the RVs from position to position Pretreatment vortexer (pVTX): Mixes the reaction mixture Pretreatment unload diverter (pUD): Unloads RVs used for sample pretreatments and sample dilutions from the pretreatment path into the solid waste container

Related information... Processing center (Alinity i), page 105 Pretreatment unload diverter (Alinity i), page 119 Pretreatment path motor (Alinity i), page 120 Pretreatment vortexer (Alinity i), page 121 Assay processing for pretreatment (i‑series), page 437 Process path (Alinity i), page 107 Pretreatment unload diverter (Alinity i)

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The pretreatment unload diverter (pUD) unloads reaction vessels used for sample pretreatments and sample dilutions from the pretreatment path into the solid waste container. Figure 67: Pretreatment unload diverter (Alinity i)

Related information... Pretreatment path (Alinity i), page 118 Pretreatment path motor (Alinity i) The pretreatment path motor (pPM) rotates the pretreatment path disk, which holds the reaction vessels (RVs), and advances the RVs from position to position.

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Figure 68: Pretreatment path motor (Alinity i)

Related information... Pretreatment path (Alinity i), page 118 Pretreatment vortexer (Alinity i) The pretreatment vortexer (pVTX) is located on the pretreatment path. The pretreatment vortexer mixes the reaction mixture to suspend microparticles.

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Figure 69: Pretreatment vortexer (Alinity i)

Related information... Pretreatment path (Alinity i), page 118 Pipetting hardware (Alinity i) Pipetting hardware aspirates and dispenses samples and reagents. This hardware includes sample and reagent pipettors and sample and reagent wash cups. The induction heater wash cup is an optional hardware component that can replace the sample wash cup. One of two configurations will be installed on the system.

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Section 1 Figure 70: Pipetting hardware components (Alinity i)

Legend: 1. 2. 3.

Sample pipettor (S): Aspirates and dispenses samples into reaction vessels (RVs) Reagent pipettors (R1 and R2): Aspirate and dispense reagents into RVs Wash cups (SW, R1W, and R2W): Wash any fluid that remains from the interior and exterior surfaces of probes

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Figure 71: Pipetting hardware components with the induction heater wash cup (Alinity i)

Legend: 1. 2. 3. 4.

Sample pipettor (S): Aspirates and dispenses samples into reaction vessels (RVs) Reagent pipettors (R1 and R2): Aspirate and dispense reagents into RVs Wash cups (R1W and R2W): Wash any fluid that remains from the interior and exterior surfaces of probes Induction heater wash cup (IHW): Washes any fluid that remains from the sample probe interior, exterior, and tip with wash buffer that is warmed by the heated probe

Related information... Processing center (Alinity i), page 105 Pipettors (Alinity i), page 124 Wash cups (Alinity i), page 125 Induction heater wash cup (Alinity i), page 126 Pipettors (Alinity i)

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Pipettors detect, aspirate, transfer, and dispense samples and reagents into reaction vessels (RVs). These pipettor assemblies include a pressure-monitoring system that helps to identify aspiration errors. Three pipettors that have the following functions are located on the system: • The sample pipettor (S) detects, aspirates, transfers, and dispenses samples into RVs in the process path and the pretreatment path. It also transfers pretreated samples from the pretreatment path to the process path after the appropriate incubation period. • The reagent 1 pipettor (R1) detects, aspirates, transfers, and dispenses reagents into RVs in the process path and the pretreatment path. It also transfers diluted samples from the pretreatment path to the process path as required. • The reagent 2 pipettor (R2) detects, aspirates, transfers, and dispenses reagents into RVs in the process path. Figure 72: Pipettor (Alinity i)

Related information... Pipetting hardware (Alinity i), page 122 Wash cups (Alinity i)

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Active wash cups (SW, R1W, and R2W) wash any fluid that remains from the interior and exterior surfaces of probes. In addition, a vacuum source dries the exterior surfaces of probes. Figure 73: Wash cup (Alinity i)

Related information... Pipetting hardware (Alinity i), page 122 Induction heater wash cup (Alinity i) The induction heater wash cup is an optional hardware component that is available for the Alinity i processing module. This component is an active wash cup where the sample probe dispenses excess sample and any remaining fluid is washed from the probe interior, exterior, and tip with heated wash buffer. The sample probe is heated and the wash buffer is warmed as it flows through the probe to provide improved washing. Installation of the induction heating hardware is required for some assays. For more information, see the assay documentation.

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Figure 74: Induction heater wash cup (Alinity i)

Related information... Pipetting hardware (Alinity i), page 122 RV loader (Alinity i) The RV loader system (RVL) provides the onboard storage for reaction vessels (RVs) and transports RVs to the process path and the pretreatment path. The RV loader performs the following functions: • Feeds RVs from the upper hopper to the lower hopper as needed • Lifts RVs one at a time and places them in an upright position in the linear queue • Lifts RVs from the linear queue and places them on the process path and the pretreatment path

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Figure 75: RV loader assembly (Alinity i)

Legend: 1. 2. 3. 4.

Upper hopper: Stores bulk RVs loaded by the operator. Lower hopper and RV orienter: The lower hopper stores a limited amount of RVs. The RV orienter lifts one RV at a time and places the RV in the linear queue. Linear queue: Stages upright RVs in preparation for loading. RV pick and place assembly: Moves RVs one at a time to the process path and the pretreatment path.

Related information... Processing center (Alinity i), page 105 Supply center (Alinity i) The supply center is the onboard storage area for bulk solutions and reaction vessel (RV) solid waste.

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Section 1 Figure 76: Supply center (Alinity i)

Legend: 1. 2. 3.

Bulk solution storage area: Provides the onboard storage for replacement bulk solution bottles Bulk solution reservoir area: Provides the onboard storage for in-use bulk solutions RV waste storage area: Provides the storage for used RVs

Related information... Processing module (Alinity i), page 102 Bulk solution storage area (Alinity i), page 129 Reservoir areas (Alinity i), page 130 RV waste storage area (Alinity i), page 132 Bulk solution storage area (Alinity i) The bulk solution storage area, which is located on the bulk solution door, provides the onboard storage for replacement bulk solution bottles. Bulk solutions from the replacement bottles fill onboard bulk solution reservoirs. Each bottle has a unique keyed cap that locks into its appropriate key slot in a bottle holder.

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Figure 77: Bulk solution storage area (Alinity i)

Legend: 1. 2. 3. 4. 5.

Concentrated Wash Buffer: Mixed with purified water and then pumped to sample and reagent pipettor assemblies and to wash zones during assay processing. Trigger Solution: Produces the chemiluminescent reaction that provides the final read. Pre-Trigger Solution: Separates the acridinium dye from the conjugate that is bound to the microparticle complex. This action prepares the acridinium dye for the addition of Trigger Solution. Bottle release button: Releases a bulk solution cap from a bottle holder to remove and replace a bulk solution bottle. Bottle holder: Stores a replacement bulk solution bottle. Contains a mechanism that pierces the bulk solution septum.

Related information... Supply center (Alinity i), page 128 Bulk solutions (i‑series), page 151 Reservoir areas (Alinity i)

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The bulk solution reservoir area, which is located in the supply center, provides the onboard storage for bulk solutions in use during assay processing. When onboard bulk solution reservoirs are empty, bulk solutions from replacement bottles on the bulk solution door fill the reservoirs without an interruption in system operation. Concentrated Wash Buffer from its onboard bulk solution reservoir is diluted tenfold by the system and is stored in a 4 L diluted wash buffer reservoir for use during assay processing. Figure 78: Bulk solution reservoir area (Alinity i)

Legend: 1. 2.

3. 4. 5.

Reservoir bottle tray: Holds transfer pumps, bulk solution reservoirs, and the vacuum and waste accumulator. Slides out to access the bulk solution reservoirs. Transfer pump rack: Holds transfer pumps for the Pre-Trigger Solution, the Trigger Solution, and the Concentrated Wash Buffer. The pumps transfer bulk solutions from replacement bottles to bulk solution reservoirs. Concentrated Wash Buffer reservoir: Holds in-use Concentrated Wash Buffer. Trigger Solution reservoir: Holds in-use Trigger Solution. Pre-Trigger Solution reservoir: Holds in-use Pre-Trigger Solution.

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Figure 79: Pump drawer (Alinity i)

Legend: 1.

Diluted wash buffer reservoir: Holds diluted wash buffer for use during assay processing

Related information... Supply center (Alinity i), page 128 Bulk solutions (i‑series), page 151 RV waste storage area (Alinity i) The RV waste storage area, which is located in the supply center, provides storage for the RV waste container and holds used reaction vessels (RVs).

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Section 1 Figure 80: RV waste storage area (Alinity i)

Legend: 1.

2. 3.

RV waste chute: Directs the used RVs into the RV waste container. The RV waste container can be removed during assay processing. When the container is removed, the RV waste chute closes and holds 50 RVs before the processing module pauses. RV waste container: Holds the used RVs. RV waste storage tray: Holds the RV waste container.

Related information... Supply center (Alinity i), page 128 Reagent supply center (Alinity i) The reagent supply center provides cooled storage at a controlled temperature for reagent cartridges, maintenance solutions, and frequently used calibrators and controls. Cartridges and vial racks are loaded on the reagent and sample manager (RSM) and are transferred to the reagent positioner by the RSM transport.

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Figure 81: Reagent supply center (Alinity i)

Legend: 1. 2.

3.

Reagent carousel: Holds reagent cartridges, maintenance solutions, and frequently used calibrators and controls. The carousel rotates to provide reagent access to reagent 1 and reagent 2 pipettors. Reagent positioner: Positions cartridges and onboard vial racks to load in the reagent carousel or onto the loading area. When the reagent positioner is in the open position, the cartridge or rack can be transferred to the loading area. When the reagent positioner is in the closed position, the cartridge or rack can be transferred to the reagent carousel. Reagent transport: Places cartridges and onboard vial racks in the reagent carousel or onto the reagent positioner.

Related information... Processing module (Alinity i), page 102 Reagent carousel (Alinity i), page 134 Reagent and sample manager (RSM), page 70 Reagent carousel (Alinity i)

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The reagent carousel is a rotating, circular device that performs the following functions: • Holds a maximum of 47 bar-coded reagent cartridges, maintenance solutions, and vial racks in a cooled environment at a controlled temperature • Provides microparticle dispersion by continuous rotation of microparticle reagent bottles • Rotates to position reagent cartridges and onboard solutions so that reagents or solutions can be aspirated and dispensed • Rotates to position vial racks for transfer to the sample positioner so that calibrators and controls can be aspirated and dispensed Figure 82: Reagent carousel (Alinity i)

Legend: 1.

2.

Reagent segment: A section of the reagent carousel that holds a maximum of six cartridges or vial racks. The reagent carousel has a total of eight reagent segments. One segment contains the reagent carousel calibration target. This segment holds a maximum of five cartridges or vial racks. Reagent position: A section of a reagent segment that holds one cartridge or vial rack.

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Reagent carousel calibration target: A calibration target that is used to align the reagent pipettor to cartridges and vials.

Related information... Reagent supply center (Alinity i), page 133

Optional components The following components are optional for processing modules: Uninterrupted power supply (UPS)

Provides a temporary, continuous flow of power to the processing module during a power failure.

External waste pump

Moves waste from the waste outlet to an elevated drain.

High-concentration Collects the high-concentration liquid waste from the cuvettes waste bottle (c‑series) and the ICT unit. Related information... Primary components of an Alinity ci‑series, page 56 External waste pump, page 136 Empty the high-concentration waste bottle and update the inventory (c‑series), page 583

External waste pump The external waste pump is an optional component that moves waste from the waste manifold to an elevated drain when a floor drain is not available.

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Section 1 Figure 83: Front view of the external waste pump

Legend: 1. 2. 3. 4.

Power outlet: Provides power to the external waste pump. Power switch: Turns on and turns off the power to the pump. When the power switch is turned on, the pump automatically activates to move the waste. Voltage select switch: Shifts the allowable voltage from 115 V to 230 V. Manual operating switch: Turns on the power to the pump and activates the pump.

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Figure 84: Rear view of the external waste pump

Legend: 1. 2.

Waste outlet quick disconnect: Provides a connection for tubing to an elevated drain Inlet quick disconnect: Provides a connection for tubing from the waste manifold

Related information... Optional components, page 136 External waste pump electrical specifications and requirements, page 464

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Alinity system software overview The Alinity system software has a user interface that is designed to provide access to system information, software functions, and Help for an active screen. The user interface is a display format where the operator can select icons, buttons, menu commands, and other screen elements. The user interface is common among all Alinity systems. Figure 85: User interface layout

Legend: 1.

Menu bar: Provides navigation elements and status indicators. Each icon on this bar represents a screen category. When an icon is selected, an associated screen is displayed. The Alert Center at the top of this bar indicates when alerts and notifications occur on the system and provides access to details about alerts and notifications.

2.

Screen header: Provides the screen title, the system name, the Help button, the Notepad button, the name of the logged-on operator, the Lock button, the date and time, and the software version.

3.

Information area: Provides access to all system information and functions associated with the selected screen element. Function buttons: Provide access to functions associated with the active screen. Buttons with blue text are available for use. Buttons with purple text are unavailable for use until a screen element is selected. Flyout: Provides additional details or additional functions associated with the active screen.

4.

5.

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Critical message: Provides information about conditions or errors of system operation. Help button: Provides access to the Help for the active screen, a flyout, or a message code.

Related information... Use or function, page 55 Descriptions of screen elements, page 140 Menu bar, page 144

Descriptions of screen elements Screen elements are items on each screen that are used to interact with the system software. The following list provides descriptions of screen elements: Icons

Display a screen.

Menus

Display a screen.

Tabs

Used to group the same type of information or to filter information.

Buttons

Initiate a command such as the following examples: • Display another screen or flyout. • Add items to a list. • Refresh the information on the screen. • Confirm that entered edits are saved. • Delete items from the system. • Display the Help for the active screen, flyout, or message code.

Flyouts

Display additional information or menus, or are used for specific tasks such as search, print, and update.

Badges

Used on menu buttons and icons to display status notifications such as alerts and warnings, and informational notifications such as a number on the Notepad button indicating unread notes.

Data entry boxes

• Text boxes: Used to type text. An asterisk is displayed when the information is required. • Spin boxes: Used to type text or to enter text by tapping the Up Arrow and Down Arrow buttons. An asterisk is displayed when the information is required.

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Drop-down lists

Display a list from which to select one item.

Options

Display a list of choices from which to select one item.

Check boxes

Display a list of choices from which to select one or more items.

Sliders

Used to select a value from a range of values.

Screen tips

Display an information button when a cursor is positioned over a data entry box on the user interface to display information about the type of data to be entered in the box.

Specific screen element descriptions that explain the kind of information to enter, select, or view are available for each screen and can be accessed by the links provided in the following Related information... section. Related information... Alinity system software overview, page 139 Home screen element descriptions, page 520 Supplies screen element descriptions (c‑series), page 562 Supplies screen element descriptions (i‑series), page 571 Orders screen element descriptions, page 660 Sample Status screen element descriptions, page 693 Results screen, Unreleased tab element descriptions, page 707 Results screen, Specimen tab element descriptions, page 708 Results screen, Control tab element descriptions, page 710 Results screen, Exception tab element descriptions, page 711 Calibration Status screen element descriptions, page 796 Procedures Log screen, Maintenance tab element descriptions, page 852 System Logs screen, All Messages tab element descriptions, page 1044 System Logs screen, Notifications/Alerts tab element descriptions, page 1036 System Logs screen, Informational tab element descriptions, page 1038 System Logs screen, Inventory tab element descriptions, page 1039 System Logs screen, User Access tab element descriptions, page 1040 System Logs screen, Configuration tab element descriptions, page 1041 System Logs screen, Interfaces tab element descriptions, page 1042 System Logs screen, Abbott Mail tab element descriptions, page 1043 Cal/QC Inventory screen element descriptions, page 588 Reagents screen, Current tab element descriptions, page 609 Reagents screen, Historical tab element descriptions, page 612

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Create Order screen, Specimen tab, Single Specimen element descriptions, page 669 Create Order screen, Control tab element descriptions, page 676 Create Order screen, Calibration tab element descriptions, page 679 Procedures screen element descriptions, page 839 Procedures Log screen, Diagnostics tab element descriptions, page 853 Users Import screen, Users Export screen element descriptions, page 171 Calibrator Set screen element descriptions, page 307 Calibrator Set View/Edit screen element descriptions, page 308 Import Calibrators screen element descriptions (c‑series), page 309 Install/Uninstall Assays screen, Available Files tab element descriptions, page 321 Install/Uninstall Assays screen, Installed Files tab element descriptions, page 323 Import/Export Assays screen, Export Files tab element descriptions (c‑series), page 329 Import/Export Assays screen, Import Files tab element descriptions (c‑series), page 329 Quality Control screen element descriptions, page 343 Control Create/Edit screen element descriptions, page 343 Import screen element descriptions, page 348 Westgard screen element descriptions, page 365 Install/Uninstall Procedures screen, Available Files tab element descriptions, page 368 Install/Uninstall Procedures screen, Installed Files tab element descriptions, page 369 User-Defined Maintenance screen, Create/Edit tab element descriptions, page 372 User-Defined Maintenance screen, Export tab element descriptions, page 374 Backup/Restore screen element descriptions, page 380 System Updates screen element descriptions, page 384 System Update Import screen element descriptions, page 388 Control Summary Details screen element descriptions, page 743 Assay Parameters screen element descriptions, page 252 Assay Display Order screen element descriptions, page 334 Panel Definition screen element descriptions, page 336 Current Firmware screen element descriptions, page 398 Users screen element descriptions, page 170 Create New User screen element descriptions, page 173 Edit User screen element descriptions, page 175 User Profile screen element descriptions, page 180 Modules screen, reagent and sample manager (RSM) element descriptions, page 183 Modules screen, c‑series element descriptions, page 184 Modules screen, i‑series element descriptions, page 187 Printers screen element descriptions, page 191 Bar Codes screen element descriptions, page 199 Reagents and Supplies screen, Reagents/Diluents tab element descriptions, page 202 142

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Reagents and Supplies screen, Supplies tab element descriptions, page 205 Reports screen element descriptions, page 211 Abbott Mail screen element descriptions, page 214 Audio Settings screen element descriptions, page 223 Host Setup screen element descriptions, page 225 HL7 Communication screen element descriptions, page 230 ASTM Communication screen element descriptions, page 232 Shortcuts screen element descriptions, page 236 Automatic Backup screen element descriptions, page 238 AbbottLink screen element descriptions, page 244 Cal/QC Ordering screen element descriptions, page 340 Troubleshooting screen element descriptions, page 395 Calibration Status Details screen element descriptions, page 800 Perform Procedure screen element descriptions, page 843 Log On screen element descriptions, page 507 Abbott Mail Inbox screen, All tab element descriptions, page 539 Abbott Mail Inbox screen, Assay Files tab element descriptions, page 540 Abbott Mail Inbox screen, Assay Inserts tab element descriptions, page 541 Abbott Mail Inbox screen, System Updates tab element descriptions, page 542 Abbott Mail Inbox screen, Calibrator Data tab element descriptions (c‑series), page 543 Manual File Request screen, Assay Files tab element descriptions, page 547 Manual File Request screen, Calibrator Data tab element descriptions (c‑series), page 548 Reagent Cartridge Details screen element descriptions, page 615 Order Details (Single Specimen, Control, and Calibrator) screen element descriptions, page 664 Sample Details (Specimen, Control, and Calibrator) screen element descriptions, page 698 Result Details (Specimen and Control) screen element descriptions, page 715 Quality Control Summary screen element descriptions, page 740 General Settings screen element descriptions, page 219 Levey-Jennings (Graph) screen element descriptions, page 733 Point Details screen element descriptions, page 736 Alinity PRO screen element descriptions, page 242 Distance Alert screen element descriptions, page 246 Assay Parameters screen, General tab element descriptions (c‑series photometric), page 253 Assay Parameters screen, General tab element descriptions (c‑series potentiometric), page 260 Assay Parameters screen, General tab element descriptions (i‑series), page 262 Assay Parameters screen, Calibration tab element descriptions (c‑series photometric), page 266 Assay Parameters screen, Calibration tab element descriptions (c‑series potentiometric), page 272 Assay Parameters screen, Calibration tab element descriptions (i‑series), page 274 Alinity ci‑series Operations Manual

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Order Details (Bar-Coded Batch Specimen) screen element descriptions, page 666 Create Order screen, Specimen tab, Bar-Coded Batch element descriptions, page 671 Assay Parameters screen, General tab element descriptions (calculated), page 265 Assay Parameters screen, Retest Rules tab element descriptions, page 282 Assay Parameters screen, SmartWash tab element descriptions (c‑series), page 1569 LAS Communication screen element descriptions, page 234 Assay Parameters screen, Results tab element descriptions, page 276 Current Software screen element descriptions, page 397 Assay Parameters screen element descriptions (c‑series photometric, user defined), page 1541 Assay Parameters screen, General tab element descriptions (c‑series photometric, user defined), page 1543 Assay Parameters screen, Calibration tab element descriptions (c‑series photometric, user defined), page 1556 Assay Parameters screen, Results tab element descriptions (c‑series photometric, user defined), page 1564

Menu bar The menu bar provides navigation elements that are used to display screens, flyouts, and menus. The following figure shows examples of the Alert Center flyout, status indicators, buttons, icons, and the System menu. Figure 86: Menu bar

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Legend: 1.

Alert Center: Provides the Alert Center button, which displays a flyout of status information, and provides two types of status indicators for system problems that require attention. Status indicators called badges are displayed on icons to notify the operator when a specific system problem requires attention: –

A red triangle (alert) badge indicates system problems that require immediate attention.

–

2.

3.

An amber circle (notification) badge indicates system problems that require attention that is not immediate. Icons: Navigation elements that provide access to specific screens and functions. The menu bar provides these icons: –

Home

–

Sample Status

–

Orders

–

Results

–

QC

–

CAL

–

Reagents

–

Supplies

System button: Displays a menu of commands. System menu commands that are configured as icons are not displayed on the menu. Configurable icons: Navigation elements that can be configured to provide navigation for common functions. Some of the System menu commands can be configured for these icons.

Related information... Alinity system software overview, page 139

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Required consumables Required consumables are replenishable items that are needed for sample processing on the Alinity ci‑series. Be sure to maintain an adequate inventory of required consumables. CAUTION: Many of the consumables used with the Alinity ci‑series are mixtures of chemical substances or biological substances. Some of the mixtures may be hazardous to the operator under certain conditions. See warnings or instructions provided on product-specific labels, in the product documentation, and in product-specific Safety Data Sheets. Related information... Use or function, page 55 Reagent kits and components, page 146 Controls, page 148 Calibrators, page 149 Bulk solutions (c‑series), page 150 Bulk solutions (i‑series), page 151 Onboard solutions (c‑series), page 152 Maintenance solutions (c‑series), page 153 ICT module (c‑series), page 154 Probe conditioning solution (i‑series), page 154 Reaction vessels (i‑series), page 155 Sample cups, page 156 Biological hazards, page 821 Chemical hazards, page 823

Reagent kits and components Reagent kits are one or more cartridges that contain all the necessary reagent components for an Alinity ci‑series assay. Reagent cartridges can be stored on the system according to the assay-specific instructions. For more information about onboard storage, see the assay documentation. Abbott prepackaged reagent cartridges contain a two-dimensional bar code. Each bar code includes the following information: • Reagent identifier • Reagent serial number • Test size (number of tests for each cartridge) • Expiration date

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• Master calibration information for assays that use the 2-point adjustment calibration method (only for Alinity i‑series) Figure 87: Reagent cartridges and components

Legend: 1.

2. 3.

Alinity i reagent cartridge: Provides the necessary components for an Alinity ci‑series chemiluminescent microparticle immunoassay assay. Each reagent bottle in the cartridge contains an integrated septum unless otherwise indicated in the assay documentation. Alinity c reagent cartridge: Provides the necessary components for an Alinity ci‑series photometric or potentiometric assay. Alinity Reagent Replacement Cap: Seals a reagent cartridge to prevent reagent leakage when the cartridge is removed from the system and is stored in an external refrigerator.

Related information... Required consumables, page 146 Loading area, page 72

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Controls Controls are samples that contain known concentrations of analyte. Controls are available as single-constituent and multiconstituent controls. Some controls can be stored for use in the reagent carousel. To identify the controls that are required for an assay, see the assay documentation. Figure 88: Alinity ci‑series controls

Legend: 1. 2. 3.

148

Single-constituent control: An assay-specific sample that contains known concentrations of an analyte. Multiconstituent control: A sample that contains multiple analytes. Alinity ci‑series Calibrator/Control Replacement Caps: Replace the original caps on calibrator and control vials that are loaded on the reagent and sample manager for calibration and control testing. The replacement cap seals the vial to prevent leakage when the vial is removed from the system and is stored in an external refrigerator. The original cap is not used to prevent analyte cross contamination.

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Related information... Required consumables, page 146

Calibrators Calibrators are samples that contain known concentrations of analyte. A variety of singleconstituent and multiconstituent calibrators are used on the Alinity c‑series. Single-constituent calibrators are used on the Alinity i‑series. Some calibrators can be stored in the reagent carousel. To identify the required calibrators for an assay, see the assay documentation. Figure 89: Alinity ci‑series calibrators

Legend: 1. 2. 3.

Alinity i calibrators: Include single-constituent calibrators that are used in the calibration of i‑series assays. Alinity c calibrators: Include single-constituent and multiconstituent calibrators that are used in the calibration of c‑series photometric assays. Alinity c ICT calibrators: Used in the calibration of c‑series potentiometric assays.

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Alinity ci‑series Calibrator/Control Replacement Caps: Replace the original caps on calibrator and control vials that are loaded on the reagent and sample manager for calibration and control testing. The replacement cap seals the vial to prevent leakage when the vial is removed from the system and is stored in an external refrigerator. The original cap is not used to prevent analyte cross contamination.

Related information... Required consumables, page 146

Bulk solutions (c‑series) Bulk solutions are liquid solutions that are provided in large quantities for use during sample processing. The Alinity c‑series uses three bulk solutions. Each bulk solution bottle is loaded on the bulk solution door. Figure 90: Bulk solutions (c‑series)

Legend: 1.

2.

3.

Alkaline Wash (0.5 L bottle): An alkaline wash solution that is used by the cuvette washer to clean the cuvettes after sample analysis. Alkaline Wash is stored at a temperature of 15°C to 30°C and is stable on the system for 30 days. ICT Reference Solution (975 mL in a 1 L bottle): A midconcentration standard solution that is aspirated and analyzed by the ICT module before and after each sample. The solution provides a reference potential that is used in result calculation. ICT Reference Solution is stored at a temperature of 15°C to 30°C and is stable on the system for 90 days. Acid Wash (0.5 L bottle): An acidic wash solution that is used by the cuvette washer to clean the cuvettes after sample analysis. Acid Wash is stored at a temperature of 15°C to 30°C and is stable on the system for 30 days.

Related information... Required consumables, page 146 Bulk solution storage area (Alinity c), page 97 Bulk solution reservoir area (Alinity c), page 98 Solutions used in daily operations (c‑series), page 577

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Bulk solutions (i‑series) Bulk solutions are liquid solutions that are provided in large quantities for use during assay processing. The Alinity i‑series uses three bulk solutions. Each bulk solution bottle is loaded on the bulk solution door. Figure 91: Bulk solutions (i‑series)

Legend: 1.

2.

3.

Pre-Trigger Solution, LN 06P1265 (1 L bottle): A solution that contains 1.32% (W/V) hydrogen peroxide solution that separates the acridinium dye from the conjugate that is bound to the microparticle complex. This action prepares the acridinium dye for the addition of Trigger Solution. Pre-Trigger Solution is sensitive to light, is stored at a temperature of 2°C to 8°C, and is stable on the system for 16 days. Trigger Solution, LN 06P1160 (1 L bottle): A solution that contains 0.35N sodium hydroxide solution that produces the chemiluminescent reaction that provides the final read. This solution is stored at a temperature of 2°C to 30°C and is stable on the system for a maximum of 28 days. Some assays require a shorter onboard stability period. For more information, see the assay documentation. Concentrated Wash Buffer, LN 06P1368 (2 L bottle): A solution that contains phosphate-buffered saline and antimicrobial agents. This solution is diluted tenfold by the system and then is pumped to sample and reagent pipettor assemblies and to wash zones during assay processing. This solution is stored at a temperature of 15°C to 30°C and is stable on the system for 30 days.

Related information... Required consumables, page 146 Bulk solution storage area (Alinity i), page 129 Reservoir areas (Alinity i), page 130

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Onboard solutions (c‑series) Onboard solutions are detergents that are used to wash sample probes, reagent probes, mixers, and reaction cuvettes. The solutions are used by the SmartWash feature during system operation. They may also be used during some maintenance and diagnostic procedures. Onboard solutions include Acid Probe Wash, Detergent A, and Detergent B. For specific information about each solution, see the product documentation. Figure 92: Onboard solutions (c‑series)

Related information... Required consumables, page 146 SmartWash feature (c‑series), page 423 Solutions used in daily operations (c‑series), page 577

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Maintenance solutions (c‑series) The c‑series maintenance solutions are liquid solutions that are supplied as a three-component kit and are used during the automated daily maintenance procedure. The large bottle of the maintenance cartridge is filled with Water Bath Additive, an antimicrobial solution that is used to prevent and control microbial contamination in the water bath. During maintenance, the solution is dispensed into the water bath. The small bottle of the maintenance cartridge is empty and is reserved for the reconstituted Cleaning Solution. Cleaning Solution is supplied as a lyophilized material with a diluent. The reconstituted cleaning solution is added to the small bottle. During daily maintenance, the reconstituted cleaning solution is used to clean sample and reagent probes, mixers, the ICT probe, and the ICT module. The maintenance solutions are stored at a temperature of 15°C to 30°C and are stable on the system for 14 days or 12 tests, whichever occurs first. Figure 93: Maintenance solutions (c‑series)

Related information... Required consumables, page 146 Solutions used in daily operations (c‑series), page 577 5501 Daily Maintenance (c‑series), page 858

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ICT module (c‑series) The ICT module is an integrated chip that is a component of the ICT unit and contains the sodium (Na+), potassium (K+), chloride (Cl-), and reference electrodes. The warranty for the ICT module is 20,000 samples or 3 months after installation, whichever occurs first. Figure 94: ICT module (c‑series)

Related information... Required consumables, page 146

Probe conditioning solution (i‑series) Probe conditioning solution is a solution that contains recalcified human plasma. Some maintenance procedures require this solution after the sample pipettor probe is cleaned to condition the probe to prevent the nonspecific binding of analytes in the probe. This solution is stored at a temperature of 2°C to 8°C.

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Figure 95: Probe conditioning solution (i‑series)

Related information... Required consumables, page 146

Reaction vessels (i‑series) Reaction vessels (RVs) are disposable containers in which the CMIA reaction occurs. The operator can add RVs at any time. Figure 96: Reaction vessel (i‑series)

Related information... Required consumables, page 146

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Sample cups Sample cups are 1400 μL disposable containers that hold samples. Volume graduation marks at 125 μL, 500 μL, and 1400 μL eliminate the need to pipette with precision. To facilitate the positive identification of samples, sample cups can be placed in sample tubes that have bar code labels. Figure 97: Sample cup

Related information... Required consumables, page 146

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Required accessories Required accessories are parts that are needed for sample processing on the Alinity ci‑series. Be sure to maintain an adequate inventory of required accessories. Related information... Use or function, page 55 Racks, page 157 Trays, page 158 Reagent cartridge with empty bottles (c‑series), page 158

Racks Racks are accessories that are used on the reagent and sample manager to transport specimens, calibrators, and controls to the sample pipettor. The Alinity ci‑series uses three types of racks. Figure 98: Racks

Legend: 1. 2. 3.

Vial rack: Bar-coded for identification with the letter V. Holds six open vials of calibrators or controls for immediate use. The rack cannot be stored in the reagent carousel. Onboard vial rack: Bar-coded for identification with the letter U. Holds six vials of calibrators or controls. The rack is stored in the reagent carousel. Sample rack: Bar-coded for identification. Holds six primary tubes, aliquot tubes, or sample cups. Any combination of tubes and cups can be used in the rack.

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Sample gauge: Used to verify that the amount of sample in an aliquot tube exceeds 8 mm.

Related information... Required accessories, page 157 Loading area, page 72 Reagent and sample manager (RSM) sample processing for onboard calibrators and controls, page 641 Onboard storage criteria for calibrator and control vials, page 642

Trays Trays are accessories that are used to hold multiple racks of samples, calibrators, and controls and to hold reagent cartridges. Trays of racks and cartridges are loaded on the reagent and sample manager. Each tray holds a maximum of five racks or cartridges. Empty trays may remain on the loading area to create five positions to load racks or cartridges one at a time. Figure 99: Tray

Related information... Required accessories, page 157 Loading area, page 72

Reagent cartridge with empty bottles (c‑series) The c‑series reagent cartridges with empty bottles are single-use cartridges that contain two empty reagent bottles that can be filled with saline, user-defined sample diluents, and userdefined reagents. When the bottles are filled and labeled with a one-dimensional (1D) reagent bar code, the cartridges can be loaded in the reagent carousel. The R1 bottle is the larger bottle and the R2 bottle is the smaller bottle. Two types of empty cartridges are available: Reagent Cartridge, Clear (Large), LN 04S1740 and Reagent Cartridge, Black (Large), LN 04S1720 or LN 04S1750. The c‑series Reagent Cartridge, Clear (Large), contains two empty, clear reagent bottles that can be filled with saline or non-light-sensitive user-defined sample diluents and user-defined

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reagents. The maximum fill volume of the R1 bottle is 74 mL or to the maximum fill line (MAX). The maximum fill volume of the R2 bottle is 46 mL or to the maximum fill line (MAX). The c‑series Reagent Cartridge, Black (Large), contains two empty, black reagent bottles that can be filled with saline or user-defined sample diluents and user-defined reagents. This cartridge must be used for light-sensitive user-defined sample diluents and user-defined reagents. The maximum fill volumes depend on the list number of the product used: • LN 04S1720: – R1 bottle, saline: 74 mL – R1 bottle, user-defined diluent: 50 mL – R1 bottle, user-defined reagent: 50 mL – R2 bottle, user-defined reagent: 47 mL • LN 04S1750: – R1 bottle: 74 mL – R2 bottle: 46 mL NOTE: Since the black cartridges are visually identical, if the cartridge list number cannot be determined, use the fill volumes for LN 04S1720. IMPORTANT: Do not exceed the maximum fill volumes for the reagent bottles to prevent damage to the reagent carousel. Figure 100: c‑series Reagent Cartridges, Black (Large) and Clear (Large)

Legend: 1. 2.

c‑series Reagent Cartridge, Black (Large) c‑series Reagent Cartridge, Clear (Large)

Related information... Required accessories, page 157

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Prepare sample diluents and user-defined reagents (c‑series), page 627

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Automatic processing module activities Periodically, system operations occur automatically to maintain the optimal performance and condition of the system. Related information... Use or function, page 55 System flush (c‑series), page 161 System flush (i‑series), page 161 System prime (i‑series), page 162 Processing module wash (c‑series), page 162 Automatic rotation of the reagent carousel (c‑series), page 163

System flush (c‑series) A system flush is an automated process that removes bubbles that may be present. The system performs periodic flushes at the beginning of a run on all pipettors by pumping purified water through the pipettor probes into the wash cups. ICT Reference Solution, Alkaline Wash, and Acid Wash are flushed automatically when the following situations occur: • The first time that the instrument status of the processing module transitions to Running after the module is powered on • After a bulk solution is replaced on the bulk solution door and the bulk solution reservoir is at or below the lowest detectable level Related information... Automatic processing module activities, page 161

System flush (i‑series) A system flush is an automated process that removes bubbles that may be present. The system performs periodic flushes on all pipettors by pumping wash buffer through the pipettor probes into the wash cups. To flush the wash zone assemblies and the Pre-Trigger and Trigger manifold, the system pumps fluid through a bypass valve and into the waste line. Wash buffer, Pre-Trigger Solution, and Trigger Solution are flushed automatically when one of the following situations occurs: • After 8 hours of inactivity when the instrument status of the processing module is Running • The first time that the instrument status of the processing module transitions to Running after the module is powered on

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• After a bulk solution is replaced on the bulk solution door and the bulk solution reservoir is at or below the lowest detectable level Related information... Automatic processing module activities, page 161

System prime (i‑series) A system prime is an automated process that removes air from wash zone delivery nozzles, PreTrigger delivery nozzles, and Trigger delivery nozzles. To perform a prime, the system pushes fluid through the delivery nozzles and into a reaction vessel (RV). Then, the RV is discarded automatically. The wash zone delivery nozzles, the Pre-Trigger delivery nozzles, and Trigger delivery nozzles are primed when the instrument status of the system transitions from Running to Processing. Related information... Automatic processing module activities, page 161

Processing module wash (c‑series) Processing module wash is the process that cleans hardware components that have come in contact with reagents and samples. The following table describes the wash solutions used for each hardware component. Component

Wash

Sample probes and reagent probes

• •

• Cuvette segments

• •

Mixers

• •

•

A wash with purified water is performed during assay processing. Additional washes with purified water, Acid Probe Wash, Detergent A, or Detergent B (only for reagent probes) may be performed if a SmartWash is configured in the assay parameters. Automatic washes with Detergent A and Acid Probe Wash are performed during assay processing every 1500 tests. Washes with purified water, Alkaline Wash, and Acid Wash are performed before and after each use. Additional washes with Acid Probe Wash, Detergent A, or Detergent B may be performed if a SmartWash is configured in the assay parameters. A wash with purified water is performed during assay processing. Additional washes with purified water, Acid Probe Wash, Detergent A, or Detergent B may be performed if a SmartWash is configured in the assay parameters for the corresponding reagent probe. Automatic washes with Detergent A and Acid Probe Wash are performed during assay processing every 1500 tests.

Related information... Automatic processing module activities, page 161

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Automatic rotation of the reagent carousel (c‑series) Automatic rotation of the reagent carousel is a programmed rotation that stabilizes the carousel temperature. The reagent carousel automatically rotates 18 positions every 20 minutes when the instrument status of the processing module is Running or Idle. Related information... Automatic processing module activities, page 161

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NOTES

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Installation procedures and special requirements

Introduction For accurate test results and optimal system performance, the Alinity ci‑series must be correctly installed. After the system has been installed, configure it to meet individual laboratory requirements. Related information... System installation and relocation, page 166 System configuration, page 168 Utilities screen, page 379 Assay applications (c‑series photometric), page 1539

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Installation procedures and special requirements System installation and relocation

Section 2

System installation and relocation An Abbott Laboratories representative performs the installation and the relocation of the Alinity ci‑series. Related information... Installation procedures and special requirements, page 165 System installation, page 166 System checkout, page 166 System relocation, page 167

System installation Before the installation of the Alinity ci‑series, an Abbott Laboratories representative confirms that the site is prepared. The system location must meet environmental specifications and electrical requirements before the representative can install the system. The representative unpacks, positions, and installs the system. During the installation, the representative performs the system setup and confirms that the system operates within the manufacturer's specifications. After the installation, the customization or configuration of the system may be performed before any testing is initiated. Related information... System installation and relocation, page 166 Specifications and requirements, page 446

System checkout After the Alinity ci‑series is installed, the following procedures may be performed to ensure that the system operates appropriately: • Install assay files. • Configure system settings. • Configure Abbott assays. • Configure user-defined assays. • Configure calibrator sets. • Configure quality controls. • Order and calibrate assays. • Order and run controls.

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• Perform testing that is specific to the site requirements. Related information... System installation and relocation, page 166 Install assay files, page 325 Configure screen, General tab, page 168 Configure screen, Computer tab, page 216 Configure screen, Assay tab, page 250 Orders screen, page 659

System relocation For information about the relocation of the Alinity ci‑series, contact an Abbott Laboratories representative. CAUTION: Biological RISKS. This activity or area may expose you to potentially infectious material. Before the system can be moved or can be shipped, decontamination is required. Related information... System installation and relocation, page 166 Requirements for decontamination, page 829

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System configuration Configuration settings define the information that the Alinity ci‑series needs to meet laboratoryspecific requirements. System configuration is performed after system installation. The system can be reconfigured at any time if necessary. Related information... Installation procedures and special requirements, page 165 Configure screen, General tab, page 168 Configure screen, Computer tab, page 216 Configure screen, Assay tab, page 250 Configure screen, Maintenance & Diagnostics tab, page 367

Configure screen, General tab The operator can perform the following tasks from the General tab of the Configure screen: Users

• Create new users. • Edit existing users. • Manage user PINs. • Export and import users from one Alinity ci‑series to a different Alinity ci‑series.

User Profile

• Configure a personal display theme. • Change a personal user PIN.

Modules

• Edit the quality control shift start time. • Edit parameters that are specific to a processing module.

Printers

• Add a printer. • Delete a printer. • Edit printer settings.

Bar Codes

• Enable and disable bar code types. • Configure bar code parameters.

Reagents and Supplies

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Configure reagent and supply low alerts.

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Reports

Configure automatic printing of reports.

Abbott Mail

• Enable and disable download options for Abbott Mail items. • Configure the download language for the Abbott Mail documentation.

Related information... System configuration, page 168 Users screen, page 169 User Profile screen, page 180 Modules screen, page 182 Printers screen, page 191 Bar Codes screen, page 198 Reagents and Supplies screen, page 201 Reports screen, page 211 Abbott Mail screen, page 214 System checkout, page 166

Users screen On the Users screen, the operator can view the following information for users that have been created on the system: • Operator ID • First and last names • Access level • Status • Date on which a user was created The system administrator can perform the following functions: • Create new users. • Edit a user name, the access level, and the status. • Reset a user PIN. • Import and export user data. The operator can search for a specific user. Related information... Configure screen, General tab, page 168 Users screen element descriptions, page 170

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Users Import screen, Users Export screen element descriptions, page 171 Descriptions of access levels, page 172 Create New User screen element descriptions, page 173 Create a new user, page 174 Edit User screen element descriptions, page 175 Edit a user, page 176 Inactivate or activate a user, page 177 Set PIN flyout element descriptions, page 177 Import users, page 178 Export users, page 179 Manage user PINs, page 179

Users screen element descriptions On the Users screen, the user can filter and display user profile information.

Elements Operator ID

Displays the operator ID of the user.

Last Name

Displays the last name of the user.

First Name

Displays the first name of the user.

Level

Displays one of the following access levels for the user: • General • Supervisor • Administrator

Status

Created On

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Displays one of the following statuses for the user: Active

The user can log on to the system if the status of the user profile is Active.

Inactive

The user cannot log on to the system if the status of the user profile is Inactive.

Displays the date and time that the user profile was created.

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Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Search

Displays the Search flyout.

Import

Navigates to the Users Import screen.

Export

Navigates to the Users Export screen.

Create New User

Navigates to the Create New User screen.

Edit User

Navigates to the Edit User screen.

Set PIN

Displays the Set PIN flyout.

Text Size

Increases or decreases the size of text displayed.

Related information... Users screen, page 169 Descriptions of screen elements, page 140

Users Import screen, Users Export screen element descriptions On the Users Import screen, the operator can import users on a USB flash drive. On the Users Export screen, the operator can export users to a USB flash drive.

Elements button

The Previous Folder button navigates to the previously selected folder.

button

The Selected Folders button displays all previously selected folders.

Folder name button

Displays the currently selected folder. The Home button navigates to the hard drive folder.

File Name

Displays the name of the exported user database file.

Created On

Displays the date and time that the exported user database file was created.

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Import File

Displays the file location and file name of the selected exported user database file. The element is displayed only on the Users Import screen.

Export Location

Displays the drive and folder location to which the exported user database file is exported. The element is displayed only on the Users Export screen.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Import

Imports the selected file. This function button is displayed only on the Users Import screen.

Export

Exports the users database. This function button is displayed only on the Users Export screen.

Text Size

This function button is unavailable on this screen.

Related information... Users screen, page 169 Descriptions of screen elements, page 140

Descriptions of access levels An access level is the identifier that controls the access to certain user interface functionality. The system software has three types of operator access levels: General operator

Used to display the current operator ID on various screens and to print the operator ID of the current user on printouts and reports.

Supervisor

Used to perform supervisor functions such as the following examples: • Configure automatically generated reports. • Configure quality control settings. • Configure user-defined maintenance.

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• Configure audio settings. • Configure calibrator settings. System administrator Used to perform administrator functions such as the following examples: • Configure system settings. • Approve maintenance logs. • Install and uninstall assays. • Accept Abbott Mail items. Additionally, Abbott Customer Service may provide a user name and a temporary password to operators who call for troubleshooting assistance. This logon authorizes selected functions in addition to those functions allowed by the system administrator logon. Related information... Users screen, page 169 Log On screen, page 507

Create New User screen element descriptions On the Create New User screen, the system administrator can create a new user profile.

Elements Operator ID

Displays a box to enter the operator ID of the new user.

First Name

Displays a box to enter the first name of the new user.

Last Name

Displays a box to enter the last name of the new user.

Level

Displays the following access level options for the new user: • General • Supervisor • Administrator

Status

Displays the following status options for the new user: Active

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Inactive

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The new user cannot log on to the system if this option is enabled.

PIN

Displays a box to enter the four-digit personal identification number of the new user.

Re-enter PIN

Displays a box to reenter the four-digit personal identification number of the new user.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save

Saves changes.

Text Size

This function button is unavailable on this screen.

Related information... Users screen, page 169 Descriptions of screen elements, page 140

Create a new user Operator access level System administrator Perform this procedure to create a new user. An operator ID and a PIN must be created for an operator to log on to the system software and use the system. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the General tab of the Configure screen, tap Users.

3.

On the Users screen, tap Create New User.

4.

On the Create New User screen, enter the operator ID. The operator ID can contain a maximum of 12 alphanumeric characters.

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5.

Type the first and last names.

6.

In the Level area, tap an option for the operator access level.

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In the Status area, tap a status option.

8.

Enter a unique four-digit PIN.

9.

To confirm the PIN, reenter it.

10. To save the new user settings, tap Save. To delete the new user settings, tap Cancel. 11. To create another new user, repeat steps 4, page 174 through 10, page 175. 12. To return to the Users screen, tap Done. Related information... Users screen, page 169

Edit User screen element descriptions On the Edit User screen, the system administrator can edit an existing user profile.

Elements Operator ID

Displays the operator ID of the user.

First Name

Displays the first name of the user.

Last Name

Displays the last name of the user.

Level

Displays the access level of the user. One of the following options is enabled: • General • Supervisor • Administrator

Status

Displays the status of the user. One of the following options is enabled: Active

The user can log on to the system if this option is enabled.

Inactive

The user cannot log on to the system if this option is enabled.

Created On

Displays the date and time that the user profile was created.

Created By

Displays the operator ID of the system administrator who created the user profile.

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Last Updated On

Displays the date and time that the user profile was most recently edited.

Last Updated By

Displays the operator ID of the system administrator who most recently edited the user profile.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save

Saves changes.

Text Size

This function button is unavailable on this screen.

Related information... Users screen, page 169 Descriptions of screen elements, page 140

Edit a user Operator access level System administrator Perform this procedure to edit the first name, the last name, the access level, and the status of a user. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the General tab of the Configure screen, tap Users.

3.

On the Users screen, tap an operator ID to edit. NOTE: To filter the operator IDs, tap Search.

4.

Tap Edit User.

5.

On the Edit User screen, edit any of the following information: – First Name – Last Name – Level – Status

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NOTE: A user cannot edit the level and status of the user's own profile. 6.

To save the edits to the user settings, tap Save. To delete the edits to the user settings, tap Cancel.

7.

To return to the Users screen, tap Done.

Related information... Users screen, page 169 Search for or filter data, page 757

Inactivate or activate a user Operator access level System administrator Perform this procedure to inactivate or activate a user. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the General tab of the Configure screen, tap Users.

3.

On the Users screen, tap an operator ID to inactivate or activate. NOTE: To filter the operator IDs, tap Search.

4.

Tap Edit User.

5.

In the Status area of the Edit User screen, tap one of the following options: – Tap Inactive to inactivate a user. – Tap Active to activate a user.

6.

To save the edit to the user settings, tap Save. To delete the edit to the user settings, tap Cancel.

7.

To return to the Users screen, tap Done.

Related information... Users screen, page 169 Search for or filter data, page 757

Set PIN flyout element descriptions In the Set PIN flyout, the operator can change a user PIN.

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Elements Changing PIN for

Displays the first name, last name, and operator ID of the user being edited.

Your Operator ID

Displays the operator ID of the logged-on user.

Your PIN

Displays a box to enter the current four-digit PIN of the logged-on user.

New PIN

Displays a box to enter the new four-digit PIN for the selected operator ID.

Re-enter New PIN

Displays a box to reenter and confirm the new PIN for the selected operator ID.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

?

Displays Help from the operations manual for the active screen, flyout, or message code.

Related information... Users screen, page 169 User Profile screen, page 180

Import users Required materials

USB flash drive with user file to import

Operator access level System administrator Perform this procedure to import users on a USB flash drive. 1.

Insert the USB flash drive.

2.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

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On the General tab of the Configure screen, tap Users.

4.

On the Users screen, tap Import.

5.

On the Users Import screen, tap the USB flash drive, the folder, and the file to import.

6.

Tap Import.

7.

When a confirmation message is displayed, tap Yes, and then tap OK.

8.

Remove the USB flash drive.

9.

To return to the Users screen, tap Done.

Related information... Users screen, page 169 Insert and remove a USB flash drive, page 764

Export users Required materials

USB flash drive

Operator access level System administrator Perform this procedure to export users to a USB flash drive. After the users are exported, the users can be installed on a different system. 1.

Insert the USB flash drive.

2.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

3.

On the General tab of the Configure screen, tap Users.

4.

On the Users screen, tap Export.

5.

On the Users Export screen, tap the USB drive and folder to which to export the user files.

6.

Tap Export.

7.

When a confirmation message is displayed, tap Yes, and then tap OK.

8.

Remove the USB flash drive.

9.

To return to the Users screen, tap Done.

Related information... Users screen, page 169 Insert and remove a USB flash drive, page 764

Manage user PINs Operator access level System administrator

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Perform this procedure to change one or more user PINs. System administrators can change their personal user PINs and the user PINs of other users. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the General tab of the Configure screen, tap Users.

3.

On the Users screen, tap an operator ID to edit. NOTE: To filter the operator IDs, tap Search.

4.

Tap Set PIN.

5.

In the Set PIN flyout, enter the following information: a.

Your PIN (the current four-digit PIN of the logged-on system administrator or user)

b.

New PIN (a new four-digit PIN for the selected operator ID)

c.

Re-enter New PIN (the confirmation of the new PIN for the selected operator ID)

6.

To save the edits to the user settings and return to the Users screen, tap Done.

7.

When a confirmation message is displayed, tap Yes.

8.

To delete the edits to the user settings and return to the Users screen, tap Cancel.

Related information... Users screen, page 169 Search for or filter data, page 757

User Profile screen On the User Profile screen, the operator can perform the following functions: • Configure a personal display theme. • Change a personal user PIN. Related information... Configure screen, General tab, page 168 User Profile screen element descriptions, page 180 Configure a personal display theme, page 182 Change a personal user PIN, page 182 Set PIN flyout element descriptions, page 177

User Profile screen element descriptions On the User Profile screen, the operator can change the user PIN and the display theme.

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General area Username

Displays the configured operator ID.

First Name

Displays the first name of the user.

Last Name

Displays the last name of the user.

Level

Displays one of the following access levels: • General • Supervisor • Administrator

Created On

Displays the date and time that a user was created.

Display area Theme

Displays the current theme options: Light Bar

Changes the theme bar to a light color.

Dark Bar

Changes the theme bar to a dark color.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Set PIN

Displays the Set PIN flyout. NOTE: This function button is available after a user is selected.

Cancel

Navigates to the User Profile message box where previous edits can be deleted by tapping the Continue button.

Related information... User Profile screen, page 180 Descriptions of screen elements, page 140

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Configure a personal display theme Perform this procedure to configure a display theme. General operators can configure their personal display themes but cannot configure the display themes of other users. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the General tab of the Configure screen, tap User Profile.

3.

Under Display on the User Profile screen, tap an option in the Theme area.

4.

To save the edits to the user profile settings, tap Done. To delete the edits to the user profile settings, tap Cancel.

Related information... User Profile screen, page 180

Change a personal user PIN Perform this procedure to change a user PIN. General operators can change their personal user PINs but cannot change the user PINs of other users. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the General tab of the Configure screen, tap User Profile.

3.

On the User Profile screen, tap Set PIN.

4.

In the Set PIN flyout, enter the following information: a.

Your PIN (the current four-digit PIN of the logged-on user)

b.

New PIN (a new four-digit PIN for the selected operator ID)

c.

Re-enter New PIN (the confirmation of the new PIN for the selected operator ID)

5.

To save the edits to the user profile settings and return to the User Profile screen, tap Done.

6.

To delete the edits to the user profile settings and return to the User Profile screen, tap Cancel.

Related information... User Profile screen, page 180

Modules screen On the Modules screen, the operator can view the following information: • Serial numbers for each processing module and the reagent and sample manager (RSM) 182

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• The number of assigned reagent carousel positions for onboard calibrators and controls • The quality control shift start time • The location and number of priority sections • Specific parameters for each processing module and the RSM • Instrument test cycle counts The supervisor can edit the quality control shift start time. The system administrator can perform the following functions: • Configure the module name. • Configure the number of assigned reagent carousel positions for onboard calibrators and controls. • Configure the location and number of priority sections. • Configure specific parameters for each processing module and the RSM. Related information... Configure screen, General tab, page 168 Modules screen, reagent and sample manager (RSM) element descriptions, page 183 Modules screen, c‑series element descriptions, page 184 Modules screen, i‑series element descriptions, page 187 Configure reagent and sample manager module settings, page 189 Configure c‑series module settings, page 189 Configure i‑series module settings, page 190

Modules screen, reagent and sample manager (RSM) element descriptions On the Modules screen, the operator can configure module settings for the reagent and sample manager (RSM).

Module Information area Module

Displays a drop-down list that is used to select a module to display module-specific information.

Module Type

Displays the module type.

Module Name

Displays a box that is used to enter a maximum of 12 alphanumeric characters. The box is an optional element.

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Module Details area Retest Options

Displays the Automatically Reposition Samples for Retest options: • Yes • No (default) When this option is enabled, the RSM is configured to reposition sample racks for automatic retesting.

Priority Positions

Displays the following settings: Location of Priority Positions

Displays the following options: • Leftmost: The priority position location can start at position 1. • Rightmost: The priority position location can start at position 25.

Number of Priority Positions

Displays a slider that is used to configure priority positions from 0 through 25 in increments of 5.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save

Saves changes.

Related information... Modules screen, page 182 Descriptions of screen elements, page 140

Modules screen, c‑series element descriptions On the Modules screen, the operator can configure Alinity c‑series module settings.

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Module Information area Module

Displays a drop-down list that is used to select a module to display module-specific information.

Module Type

Displays the module type.

SN

Displays the serial number of the selected module.

Module Name

Displays a box that is used to enter a maximum of 12 alphanumeric characters. The box is an optional element.

Module Details area Onboard Cal/QC

Displays the Onboard Cal/QC Positions drop-down list, which is used to configure the number of reagent carousel positions that are available for onboard vial racks. When a reagent carousel position is configured, the position is unavailable for cartridge storage. A position from 1 through 4 can be selected. The default position is 1.

Quality Control

Displays the Shift Start Time spin box, which is used to configure a shift start time and to define quality control runs with respect to Westgard rules that relate to within-run and between-run data points. To configure the shift start time, use the system-configured format (HH:MM) and type the time in the box or tap the Up Arrow and Down Arrow buttons. If the system is configured for the 12-hour clock format, tap the AM or PM button to configure the time of day.

ICT Module

Displays the Installed options: • Yes (default) • No

Liquid Waste Container

Displays the Installed options: • Yes • No (default)

Instrument Test Cycle Displays the following settings: Counts

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Displays the total number of tests that are scheduled and either have completed successfully with results or have become exceptions. NOTE: This number excludes derived results and HIL tests. Integrated chip technology (ICT) tests count only as one.

Tests Completed Count

Displays the total number of tests that have completed data reduction and a valid absorbance (c‑series photometric) or voltage (c‑series potentiometric) is generated. NOTE: This number excludes derived results and HIL tests. ICT tests count only as one.

Reagent Coolant Details

Displays the following settings: Lot Number

Displays the lot number of the reagent supply center coolant.

Replacement Date

Displays the date that the reagent supply center coolant was replaced.

Expiration Date

Displays the onboard stability expiration date of the reagent supply center coolant.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save

Saves changes.

Related information... Modules screen, page 182 Descriptions of screen elements, page 140

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Modules screen, i‑series element descriptions On the Modules screen, the operator can configure Alinity i‑series module settings.

Module Information area Module

Displays a drop-down list that is used to select a module to display module-specific information.

Module Type

Displays the module type.

SN

Displays the serial number of the selected module.

Module Name

Displays a box that is used to enter a maximum of 12 alphanumeric characters. The box is an optional element.

Module Details area Onboard Cal/QC

Displays the Onboard Cal/QC Positions drop-down list, which is used to configure the number of reagent carousel positions that are available for onboard vial racks. When a reagent carousel position is configured, the position is unavailable for cartridge storage. A position from 1 through 4 can be selected. The default position is 1.

Quality Control

Displays the Shift Start Time spin box, which is used to configure a shift start time and to define quality control runs with respect to Westgard rules that relate to within-run and between-run data points. To configure the shift start time, use the system-configured format (HH:MM) and type the time in the box or tap the Up Arrow and Down Arrow buttons. If the system is configured for the 12-hour clock format, tap the AM or PM button to configure the time of day.

Optics Values

Displays the following settings:

STAT Protocol

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Displays a box that is used to enter an optics normalization value.

Linearity

Displays a box that is used to enter an optics linearity value.

Displays the STAT Protocol Percentage slider, which is used to configure the number of reaction vessel positions that are

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allocated for STAT assay protocols. If this percentage does not reflect the actual number of STAT protocols that were run, throughput may be decreased. Instrument Test Cycle Displays the following settings: Counts Tests Initiated Count Displays the total number of tests that are scheduled and either have completed successfully with results or have become exceptions. Tests Completed Count

Reagent Coolant Details

Displays the total number of tests that have completed data reduction and a valid relative light unit (RLU) reading is generated.

Displays the following settings: Lot Number

Displays the lot number of the reagent supply center coolant.

Replacement Date

Displays the date that the reagent supply center coolant was replaced.

Expiration Date

Displays the onboard stability expiration date of the reagent supply center coolant.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save

Saves changes.

Related information... Modules screen, page 182 Descriptions of screen elements, page 140

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Configure reagent and sample manager module settings Required instrument status

Stopped, Warming, or Idle

Operator access level System administrator Perform this procedure to configure reagent and sample manager module settings. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the General tab of the Configure screen, tap Modules.

3.

In the Module Name box on the Modules screen, if a name other than the name that is displayed is needed, type a new module name.

4.

Under Retest Options, tap an option to reposition samples for retesting automatically.

5.

Under Priority Sections, enter the following information: – Location of Priority Sections – Number of Priority Sections

6.

To save the edits to the module settings, tap Save. To delete the edits to the module settings, tap Cancel.

7.

To return to the Configure screen, tap Done.

Related information... Modules screen, page 182 Automated retest of specimens, page 658

Configure c‑series module settings Required instrument status

Stopped, Warming, or Idle

Operator access level System administrator, except where noted Perform this procedure to configure c‑series module settings. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the General tab of the Configure screen, tap Modules.

3.

Under Module Information on the Modules screen, tap a c‑series module in the drop-down list.

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4.

In the Module Name box, if a name other than the name that is displayed is needed, type a new module name.

5.

In the Onboard Cal/QC Position drop-down list under Onboard Cal/QC, tap the number of reagent carousel positions that are assigned to onboard calibrators and controls.

6.

In the Shift Start Time box under Quality Control, enter the time for quality controls to be performed automatically. NOTE: A supervisor can configure the shift start time.

7.

In the Installed area under ICT Module, tap an option.

8.

In the Installed area under Liquid Waste Container, tap an option.

9.

To save the edits to the module settings, tap Save. To delete the edits to the module settings, tap Cancel.

10. To return to the Configure screen, tap Done. Related information... Modules screen, page 182 Westgard rule run descriptions, page 732

Configure i‑series module settings Required instrument status

Stopped, Warming, or Idle

Operator access level System administrator, except where noted Perform this procedure to configure i‑series module settings. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the General tab of the Configure screen, tap Modules.

3.

Under Module Information on the Modules screen, tap an i‑series module in the drop-down list.

4.

In the Module Name box, if a name other than the name that is displayed is needed, type a new module name.

5.

In the Onboard Cal/QC Position drop-down list under Onboard Cal/QC, tap the number of reagent carousel positions that are assigned to onboard calibrators and controls.

6.

In the Shift Start Time box under Quality Control, enter the time for quality controls to be performed automatically. NOTE: A supervisor can configure shift start time.

7.

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Under Optics Values, enter the values for Normalization and Linearity that are located on the optics assembly. NOTE: Normalization and linearity values need to be updated only when an optics assembly is replaced.

9.

To save the edits to the module settings, tap Save. To delete the edits to the module settings, tap Cancel.

10. To return to the Configure screen, tap Done. Related information... Modules screen, page 182 Westgard rule run descriptions, page 732

Printers screen On the Printers screen, the operator can view information for a configured printer. The system administrator can perform the following functions: • Add a new printer. • Verify a new printer. • Change the configuration of an existing printer. • Configure a printer as the default. • Access the printer queue. • Remove a configured printer from the software. Related information... Configure screen, General tab, page 168 Printers screen element descriptions, page 191 Add Printer flyout, Edit Printer flyout element descriptions, page 193 Printer Verification flyout element descriptions, page 194 Printer Queue flyout element descriptions, page 194 Add a printer, page 195 Edit a printer, page 196 Verify a printer, page 197 Change the default printer, page 197 Remove a printer, page 198

Printers screen element descriptions On the Printers screen, the system administrator can configure or edit new or existing printers.

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Elements Name

Displays the name of each configured printer.

IP Address

Displays the Internet protocol address for the printer.

Verified User

Displays the identification of the operator who verified the printer operation.

Verified Date

Displays the date and time of the last successful verification of the printer operation.

Paper Size

Displays the paper size configured for the printer: A4 or Letter.

Duplex

Displays a check mark if the printer is configured to print on both sides (duplex). If the printer is configured to print on one side (simplex), no check mark is displayed.

Default

Displays a check mark if the printer is configured as the default printer.

Status

Displays one of the following statuses for the printer: OK or Error.

Function buttons

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Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Add Printer

Displays the Add Printer flyout.

Edit Printer

Displays the Edit Printer flyout.

Verify Printer

Displays the Printer Verification flyout.

Make Default

Used to select a default printer if more than one printer is configured. A check mark is displayed in the Default column in the row of the default printer. Only one printer can be configured as the default. If only one printer is configured, the system designates the printer as the default printer.

Printer Queue

Displays the Printer Queue flyout.

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Remove Printer

Displays a message that requests confirmation to delete a configured printer. Any print jobs in the printer queue are deleted. If the currently configured default printer is deleted, the system designates the most recently configured printer in the list as the new default printer. Printer drivers are not deleted.

Text Size

Increases or decreases the size of text displayed.

Related information... Printers screen, page 191 Descriptions of screen elements, page 140

Add Printer flyout, Edit Printer flyout element descriptions In the Add Printer flyout, the operator can configure a new printer. In the Edit Printer flyout, the operator can edit printer information for an existing printer. A maximum of five printers can be configured.

Elements Name

Displays a box that is used to enter a unique printer name. The printer name can have from 1 through 20 characters.

IP Address

Displays a box that is used to enter the Internet protocol address for a new printer.

Paper Size

Displays the following options: • A4 • Letter

Print on Both Sides

Displays a check box that is used to enable printing on both sides (duplex) or on one side (simplex) of the paper.

Driver

Displays a list of the printer drivers that are installed on the system. A printer driver can be selected when a new printer is added.

Function buttons Done

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Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

?

Displays Help from the operations manual for the active screen, flyout, or message code.

Related information... Printers screen, page 191

Printer Verification flyout element descriptions The Printer Verification flyout displays a verification report that can be printed. The printed verification report can be compared to a report that is displayed to verify a printer.

Elements Print Options

Displays the print options for the Printer Verification flyout.

Report Selection

Displays a list of the reports that are available to print. A preview of the selected report is displayed before the report is printed.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Print

Prints the selected report.

Text Size

Increases or decreases the size of text displayed.

?

Displays Help from the operations manual for the active screen, flyout, or message code.

Related information... Printers screen, page 191

Printer Queue flyout element descriptions The Printer Queue flyout provides information about individual jobs in the printer queue for the selected printer. A printer queue is displayed for each configured printer.

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Elements Printer

Displays the name of the selected printer.

Status

Displays one of the following statuses for the print request: Queued, Printing, Error, Deleting, or Out of Paper.

Operator ID

Displays the identification of the operator who submitted the print request.

Date

Displays the date and time that the print request was submitted to the printer queue.

Document

Displays the name of the document in the printer queue.

Pages

Displays the number of pages for the document in the printer queue.

Size

Displays the size of the document in the printer queue.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Delete All

Deletes all print requests from the printer queue.

Delete Selected

Deletes selected print requests from the printer queue.

?

Displays Help from the operations manual for the active screen, flyout, or message code.

Related information... Printers screen, page 191

Add a printer Operator access level System administrator Perform this procedure to add a printer. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

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On the General tab of the Configure screen, tap Printers.

3.

On the Printers screen, tap Add Printer.

4.

In the Add Printer flyout, enter the following information:

Section 2

– Name – IP Address NOTE: Use the following format for the IP address: xxx.xxx.xxx.xxx – Paper Size – Print on Both Sides – Driver NOTE: Choose a universal or generic driver for the type of printer. 5.

To add the printer, tap Done. To return to the Printers screen without adding the printer, tap Cancel.

6.

To return to the Configure screen, tap Done.

After the new printer is added, the printer must be verified before it is available to print a report or document. Related information... Printers screen, page 191 Verify a printer, page 197

Edit a printer Operator access level System administrator Perform this procedure to edit the printer settings for a configured printer. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the General tab of the Configure screen, tap Printers.

3.

In the list on the Printers screen, tap a printer.

4.

Tap Edit Printer.

5.

In the Edit Printer flyout, edit any of the following information: – Name – IP Address – Paper Size – Print on Both Sides

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To save the edits to the printer settings, tap Done. To delete the edits to the printer settings, tap Cancel

7.

To return to the Configure screen, tap Done.

Related information... Printers screen, page 191

Verify a printer Operator access level System administrator Perform this procedure when a new printer is added. After the new printer is added, the printer must be verified before it is available to print a report or document. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the General tab of the Configure screen, tap Printers.

3.

In the list on the Printers screen, tap a printer.

4.

Tap Verify Printer.

5.

Under Report Selection in the Printer Verification flyout, tap Printer Verification Report.

6.

Tap Print.

7.

Compare the printed report to the report that is displayed in the Printer Verification flyout. NOTE: The printed report and the displayed report must contain the same information. Be sure that the two reports do not contain truncations, missing or cutoff borders, or any loss of information. If the two reports do not contain the same information, the printer is not verified. NOTE: To adjust the size of the text in the displayed report, tap the Text Size button.

8.

Tap Done.

9.

When a confirmation message is displayed, tap one of the following buttons: – Tap Yes if the printed report and the displayed report are identical. – Tap No if the printed report and the displayed report are not identical.

Related information... Printers screen, page 191 Add a printer, page 195

Change the default printer Operator access level System administrator

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Perform this procedure to change the default printer. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the General tab of the Configure screen, tap Printers.

3.

In the list on the Printers screen, tap a printer.

4.

Tap Make Default.

5.

To return to the Configure screen, tap Done.

Related information... Printers screen, page 191

Remove a printer Operator access level System administrator Perform this procedure to remove a printer. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the General tab of the Configure screen, tap Printers.

3.

In the list on the Printers screen, tap a printer.

4.

Tap Remove Printer.

5.

When a confirmation message is displayed, tap Yes. NOTE: If the printer that was removed is the default printer, the most recently configured printer in the list becomes the default printer.

6.

To return to the Configure screen, tap Done.

Related information... Printers screen, page 191

Bar Codes screen On the Bar Codes screen, the operator can view the following information: • Sample bar code types that are enabled or are disabled • Configuration settings for each bar code type The system administrator can perform the following functions: • Enable or disable sample bar code types.

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• Configure the transmission of checksum digits to the user interface (UI) computer. • Configure the transmission of start and stop characters to the UI computer. • Configure primary and secondary code lengths. Related information... Configure screen, General tab, page 168 Bar Codes screen element descriptions, page 199 Change sample bar code settings, page 200

Bar Codes screen element descriptions On the Bar Codes screen, the operator can configure bar code symbology settings.

Elements Bar Codes

Displays the following bar code options: • Code 128 • Code 39 • Interleaved 2 of 5 • Codabar

Bar Code Type

Displays the following options for bar code types: • Enabled • Disabled NOTE: Code 128 cannot be disabled.

Checksums

Displays the following options for checksums if the selected bar code type supports checksums: • Enabled • Disabled

Send Checksums to UI Computer

Used to specify whether the checksums are sent to the user interface (UI) computer if the selected bar code type supports it.

Send Start/Stop Characters to UI Computer

Used to specify whether the start and stop characters are sent to the UI computer if the selected bar code type supports it.

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Primary Code Length Used to specify the length for the primary bar code. The range is from 2 through 20 with an incremental value of 2. The default is 10. Secondary Code Length

Used to specify the length for the secondary bar code if a second code length is necessary. The range is from 2 through 20 with an incremental value of 2. The default is 8.

Function buttons Done

Saves changes and displays the previously viewed screen.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save

Saves changes.

Related information... Bar Codes screen, page 198 Descriptions of screen elements, page 140

Change sample bar code settings Required instrument status

Reagent and sample manager: Stopped, Warming, or Idle

Operator access level System administrator Perform this procedure to change the sample bar code settings. NOTE: For Code 128 symbology, the option is enabled and does not require additional configuration. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

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2.

On the General tab of the Configure screen, tap Bar Codes.

3.

On the Bar Codes screen, for Code 39, Codabar, and Interleaved 2 of 5 symbologies, tap the Bar Code Type option to enable or disable the bar code type.

4.

For Code 39, Codabar, and Interleaved 2 of 5 symbologies, tap the Checksums option to enable or disable checksums.

5.

For Codabar symbology, if the checksums are enabled, tap the Send Checksums to UI Computer check box to send the checksums to the user interface (UI) computer.

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For Codabar symbology, if the checksums are enabled, tap the Send Start/Stop Characters to UI Computer check box to send start and stop characters to the UI computer.

7.

For Interleaved 2 of 5 symbology, edit the following settings: – Primary Code Length – Secondary Code Length

8.

To save the edits to the bar code settings, tap Save. To delete the edits to the bar code settings, tap Cancel.

9.

To return to the Configure screen, tap Done.

Related information... Bar Codes screen, page 198 Sample bar code label guidelines, page 469

Reagents and Supplies screen On the Reagents and Supplies screen, the operator can view reagent and supply settings. The system administrator can perform the following functions: • Configure the ability to run controls for each reagent lot or reagent cartridge. • Configure the default reagent low alert for all immunoassay reagents and clinical chemistry reagents. • Configure the ability to run reagents that are beyond the reagent onboard stability expiration and the reagent lot expiration. • Configure reagent low alert settings for individual reagents. • Configure low alert settings for bulk solutions. • Configure the ability to use supplies that are beyond the supply stability expiration and the supply lot expiration. The system administrator can also perform the following functions only for c‑series modules: • Configure the ability to run calibrations for each reagent lot or reagent cartridge. • Configure low alert settings for onboard diluents and onboard solutions. • Configure which module in a multimodule system uses Detergent B. Related information... Configure screen, General tab, page 168 Reagents and Supplies screen, Reagents/Diluents tab element descriptions, page 202 Reagents and Supplies screen, Supplies tab element descriptions, page 205 Configure system level reagent settings, page 207 Configure diluent low alert settings (c‑series), page 208

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Configure individual c‑series reagent settings, page 209 Configure individual i‑series reagent settings, page 209 Configure supply settings, page 210 Print a 1D reagent bar code report (c‑series), page 630

Reagents and Supplies screen, Reagents/Diluents tab element descriptions The Reagents/Diluents tab is used to configure reagent options, diluent options, and supply low alerts.

System Level Options area Override Reagent Stability

Used to override a reagent's onboard stability. The following options are available: • On • Off (default)

Override Reagent Lot Used to override a reagent's expiration. Expiration The following options are available: • On • Off (default) Run Controls for Displays the options that are used to specify which reagent Onboard Reagents by cartridge to run for quality control: Lot

Runs the controls only on one cartridge for each lot (default)

Cartridge

Runs the controls for all cartridges in a lot

NOTE: If the control option is changed, the control option does not change in the assay parameters for individual assays that are currently installed. This change affects only the new assay files that are installed or are imported. Default Assay Calibration Interval

Displays a box that is used to enter the amount of time in hours that the calibration is valid. A value from 0 through 9999 can be entered. The default value is 720 hours. If 0 is entered, the calibration interval is not tracked. NOTE: If the calibration interval is changed, the calibration interval does not change in the assay parameters for

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individual assays that are currently installed. This change affects only the new assay files that are installed or are imported. Default i‑series Reagent Low Alert

Displays a box that is used to enter the reagent low alert for all i‑series reagents. The notification is displayed when the number of remaining tests falls below the defined value.

Default c‑series Reagent Low Alert

Displays a box that is used to enter the reagent low alert for all c‑series reagents. The notification is displayed when the number of remaining tests falls below the defined value.

Diluent Low Alert area Diluent

Displays the name of the diluent.

Low Alert (Percent)

Displays a box that is used to enter the diluent low alert percentage. The notification is displayed when the percent volume level falls below the defined value: • Range: 1% to 50% • Default: 20% NOTE: If the diluent low alert percentage is changed, the status of all onboard diluents is reevaluated.

c‑series Reagents tab Reagent

Displays a list of assay names that are configured on the system.

Calibrate Reagent By Displays the options that are used to calibrate an assay:

Reagent Low Alert (Test Count)

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Lot

Calibrates according to the lot number of the reagent

Cartridge

Calibrates each reagent cartridge according to the assay

Displays the boxes that are used to enter the reagent low alert for individual assays. The notification is displayed when the number of remaining tests for all onboard kits for a specific reagent falls below the defined value. The default for c‑series tests is 100.

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Alert Low Value

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Displays the low alert that is used by an assay: System

Uses the system low alert value

Reagent

Uses the individual reagent low alert value

i‑series Reagents tab Reagent

Displays a list of assay names that are configured on the system.

Reagent Low Alert (Test Count)

Displays the boxes that are used to enter the reagent low alert for individual assays. The notification is displayed when the number of remaining tests for all onboard kits for a specific reagent falls below the defined value. The default for i‑series tests is 50.

Alert Low Value

Displays the low alert that is used by an assay: System

Uses the system low alert value

Reagent

Uses the individual reagent low alert value

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save

Saves changes.

Print 1D Bar Code

Displays the Print 1D Bar Code flyout. This function button is available only for user-defined assays and diluents.

Text Size

This function button is unavailable on this screen.

Related information... Reagents and Supplies screen, page 201 Descriptions of screen elements, page 140

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Reagents and Supplies screen, Supplies tab element descriptions The Supplies tab is used to configure supply options and low alerts.

Elements Supply Options i‑series Supply Options

Override Stability

Used to override the i‑series bulk solutions stability dates. The following options are available: • On • Off (Default)

Override Lot Expiration

Used to override the bulk solutions lot expiration date. The following options are available: • On • Off (Default)

c‑series Supply Options

Override Stability

Used to override the c‑series bulk solutions stability dates. The following options are available: • On • Off (Default)

Override Lot Expiration

Used to override the bulk solutions lot expiration date. The following options are available: • On • Off (Default)

Override ICT Module Expiration

Used to override the ICT module expiration. The following options are available: • On

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• Off (Default) c‑series Onboard Solutions

Displays the c‑series onboard solutions by module.

Supply Low Alerts i‑series Bulk Solutions Displays text boxes that are used to enter low alert level percentages of the i‑series bulk solutions: Wash Buffer, Trigger, and Pre-Trigger. The notification is displayed when the volume falls below the defined value: • Range: 1% to 50% • Default: 20% c‑series Bulk Solutions

Displays text boxes that are used to enter low alert level percentages of the c‑series bulk solutions: ICT Reference Solution, Alkaline Wash, and Acid Wash. The notification is displayed when the volume falls below the defined value: • Range: 1% to 50% • Default: 20%

c‑series Onboard Solutions

Displays text boxes that are used to enter low alert level percentages of the c‑series onboard solutions: Sample-Acid Probe Wash, Sample-Detergent A, Reagent-Acid Probe Wash, Reagent-Detergent A, and Reagent-Detergent B. The notification is displayed when the volume falls below the defined value: • Range: 1% to 50% • Default: 20%

Function buttons

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Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save

Saves changes.

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Related information... Reagents and Supplies screen, page 201 Descriptions of screen elements, page 140

Configure system level reagent settings Required instrument status

Stopped, Warming, or Idle

Operator access level System administrator Perform this procedure to configure the following system level reagent settings: • The option to run controls for each reagent lot or each reagent cartridge • The option to run reagents that are beyond the reagent onboard stability expiration and the reagent lot expiration • Reagent low alert settings for all immunoassay reagents and clinical chemistry reagents 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the General tab of the Configure screen, tap Reagents and Supplies.

3.

Under System Level Options on the Reagents and Supplies screen, configure the following override options: – Override Reagent Stability – Override Reagent Lot Expiration NOTE: Running the system with overridden reagents is not recommended except when troubleshooting is required. All results that are generated from overridden reagents are flagged with an EXP result flag.

4.

Tap one of the following Run Controls for Onboard Reagents by options: – Lot: Run controls only on one cartridge for each lot. – Cartridge: Run controls for all cartridges in a lot. NOTE: If the control option is changed, the control option does not change in the assay parameters for individual assays that are currently installed. This change affects only the new assay files that are installed or are imported.

5.

In the Default Assay Calibration Interval box, type the number of hours that a calibration curve is valid. NOTE: The default assay calibration interval is applied to assays that do not have a defined calibration interval in the assay file during assay installation. If the calibration interval is changed, the calibration interval does not change in the assay parameters for individual

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assays that are currently installed. This change affects only the new assay files that are installed or are imported. 6.

In the Default i-series Reagent Low Alert box, type the number of remaining tests that trigger the low alert status for all i‑series reagents.

7.

In the Default c-series Reagent Low Alert box, type the number of remaining tests that trigger the low alert status for all c‑series reagents.

8.

To save the edits to the reagent settings, tap Save. To delete the edits to the reagent settings, tap Cancel.

9.

To return to the Configure screen, tap Done.

Related information... Reagents and Supplies screen, page 201 Configure diluent low alert settings (c‑series), page 208 Configure individual c‑series reagent settings, page 209 Configure individual i‑series reagent settings, page 209

Configure diluent low alert settings (c‑series) Required instrument status

Stopped, Warming, or Idle

Operator access level System administrator Perform this procedure to configure low alert settings for c‑series onboard diluents. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the General tab of the Configure screen, tap Reagents and Supplies.

3.

Under Diluent Low Alert on the Reagents and Supplies screen, for the appropriate diluent, edit the remaining low alert percentage that triggers the low alert status.

4.

To save the edits to the reagent settings, tap Save. To delete the edits to the reagent settings, tap Cancel.

5.

To return to the Configure screen, tap Done.

Related information... Reagents and Supplies screen, page 201 Configure system level reagent settings, page 207

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Configure individual c‑series reagent settings Required instrument status

Stopped, Warming, or Idle

Operator access level System administrator Perform this procedure to configure the following individual c‑series reagent settings: • The option to run calibrations for each reagent lot or each reagent cartridge NOTE: If this setting is changed for c‑series user-defined assays, both active and inactive calibration data is deleted. • Reagent low alert settings for individual c‑series reagents 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the General tab of the Configure screen, tap Reagents and Supplies.

3.

On the Reagents and Supplies screen, tap the c-series Reagents tab.

4.

For each appropriate reagent under Calibrate Reagent By on the c-series Reagents tab, tap one of the following options: – Lot: Run calibrations only on one cartridge for each lot. – Cartridge: Run calibrations for all cartridges in a lot.

5.

For each appropriate reagent under Reagent Low Alert (Test Count), edit the number of remaining tests that trigger the low alert status.

6.

To save the edits to the reagent settings, tap Save. To delete the edits to the reagent settings, tap Cancel.

7.

To return to the Configure screen, tap Done.

Related information... Reagents and Supplies screen, page 201 Configure system level reagent settings, page 207

Configure individual i‑series reagent settings Required instrument status

Stopped, Warming, or Idle

Operator access level System administrator Perform this procedure configure reagent low alert settings for individual i‑series reagents. 1.

On the menu bar, tap System, and then tap Configure.

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NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu. 2.

On the General tab of the Configure screen, tap Reagents and Supplies.

3.

On the Reagents and Supplies screen, tap the i-series Reagents tab.

4.

For each appropriate reagent under Reagent Low Alert (Test Count) on the i-series Reagents tab, edit the number of remaining tests that trigger the low alert status.

5.

To save the edits to the reagent settings, tap Save. To delete the edits to the reagent settings, tap Cancel.

6.

To return to the Configure screen, tap Done.

Related information... Reagents and Supplies screen, page 201 Configure system level reagent settings, page 207

Configure supply settings Required instrument status

Stopped, Warming, or Idle

Operator access level System administrator Perform this procedure to configure the following supply settings: • Low alert settings for bulk solutions and onboard solutions • The option to run supplies that are beyond the supply onboard stability expiration and the supply lot expiration • The c‑series modules that use Detergent B 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the General tab of the Configure screen, tap Reagents and Supplies.

3.

On the Reagents and Supplies screen, tap the Supplies tab.

4.

Under Supply Options on the Supplies tab, configure the following override options: – i-series Supply Options: • Override i-series Stability NOTE: The system tracks onboard stability for Pre-Trigger Solution and Trigger Solution. • Override i-series Lot Expiration – c-series Supply Options

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Section 2 • Override c-series Stability

NOTE: The system tracks onboard stability for sample onboard wash solutions, Detergent B, and Acid Probe Wash. • Override c-series Lot Expiration • Override ICT Module Expiration 5.

Under c-series Onboard Solutions, tap the check box for each module that uses Detergent B.

6.

For each appropriate supply under Supply Low Alerts, edit the remaining percentage that triggers the low alert status.

7.

To save the edits to the supply settings, tap Save. To delete the edits to the supply settings, tap Cancel.

8.

To return to the Configure screen, tap Done.

Related information... Reagents and Supplies screen, page 201

Reports screen On the Reports screen, the operator can view settings for automatically generated reports. The operator can configure print screen output options. The supervisor can configure settings for automatically generated reports. The system administrator can configure a facility name to display on each report. Related information... Configure screen, General tab, page 168 Reports screen element descriptions, page 211 Configure report settings, page 213 Configure the print screen file output destination, page 213

Reports screen element descriptions On the Reports screen, the operator can generate reports automatically and can identify the print screen output.

Automatic Report Generation area This area is used to enable automatic printing of the Sample Laboratory Report, the Result List Report (Released), the Calibration Details Report, and the Procedure Report (Maintenance). This area provides three automatic printing options: • Off (default) • Default Printer

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• Save to File If the Save to File option is selected, the Sample Laboratory File Location box is displayed to enter the drive and folder where the file is saved. The Browse button is used to select the drive and folder location. Sample Laboratory

Automatically prints the Sample Laboratory Report after all results for a sample are released.

Results List

Automatically prints the Result List Report for released results based on one of the following criteria: • 15 results • 15 minutes

Calibration Details

Automatically prints the Calibration Details Report after a calibration is generated and becomes active.

Maintenance Procedure

Automatically prints the Procedure Report when a maintenance procedure is completed.

Site Name

Displays a text box that is used to enter the facility name to display on each report.

Print Screen area Send Print Screen Output To

Displays options that are used to select the destination of a generated print screen: • Default Printer • Save to File (default)

Function buttons

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Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save

Saves changes.

Text Size

This function button is unavailable on this screen.

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Related information... Reports screen, page 211 Descriptions of screen elements, page 140

Configure report settings Operator access level Supervisor, except where noted Perform this procedure to configure report settings. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the General tab of the Configure screen, tap Reports.

3.

Under Automatic Report Generation on the Reports screen, enter the following information: – Sample Laboratory Report – Result List Report – Calibration Details Report – Maintenance Procedure Report – Site Name NOTE: The site name must be configured by a system administrator.

4.

Under Print Screen, tap one of the following Send Print Screen Output To options: – Default Printer – Save to File NOTE: The print screen output can be configured by a general operator.

5.

To save the edits to the report settings, tap Save. To delete the edits to the reports settings, tap Cancel.

6.

To return to the Configure screen, tap Done.

Related information... Reports screen, page 211 Procedure Report element descriptions, page 1671

Configure the print screen file output destination Perform this procedure to configure when a print screen file is generated, to print the file to default printer, or to save a copy of the file to a USB flash drive. 1.

On the menu bar, tap System, and then tap Configure.

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NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu. 2.

On the General tab of the Configure screen, tap Reports.

3.

Under Print Screen on the Reports screen, tap one of the following Send Print Screen Output To options: – Default Printer – Save to File

4.

To save the edit to the print screen file output destination, tap Save. To delete the edit to the print screen file output destination, tap Cancel.

5.

To return to the Configure screen, tap Done.

Related information... Reports screen, page 211 Print a screen image, page 756

Abbott Mail screen On the Abbott Mail screen, the operator can view the Abbott Mail download options. The system administrator can perform the following functions: • Enable or disable Abbott Mail items that can be downloaded automatically. • Configure the download language for the Abbott Mail documentation. Related information... Configure screen, General tab, page 168 Abbott Mail screen element descriptions, page 214 Configure Abbott Mail settings, page 216

Abbott Mail screen element descriptions On the Abbott Mail screen, the operator can configure download and language options.

Elements Download Options Automatically Download

214

Used to configure download options for the following items: Assay Files

• Enable: Requests for assay file updates are sent automatically. (Default)

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• Disable: Requests for assay file updates are not sent automatically. Assay Inserts

• Enable: Requests for assay inserts are sent automatically when a reagent is scanned. (Default) • Disable: Requests for assay inserts are not sent automatically when a reagent is scanned.

Assay Insert Notifications

• Enable: Requests for a new assay insert are sent automatically. (Default) • Disable: Requests for a new assay insert are not sent automatically.

Calibrator Data

• Enable: Requests for calibrator value assignment updates are sent automatically. (Default) • Disable: Requests for calibrator value assignment updates are not sent automatically.

Download Language

Displays a drop-down list that is used to specify a language for Abbott Mail from a set of available languages.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save

Saves changes.

Text Size

Increases or decreases the size of text displayed.

Related information... Abbott Mail screen, page 214 Descriptions of screen elements, page 140

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Configure Abbott Mail settings Operator access level System Administrator Perform this procedure to configure Abbott Mail settings. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the General tab of the Configure screen, tap Abbott Mail.

3.

Under Download Options on the Abbott Mail screen, enable or disable automatic downloads for the following Abbott Mail items: – Assay Files – Assay Inserts – Assay Insert Notifications NOTE: If the assay insert notifications are disabled, assay inserts are assigned automatically to the new reagent lot without being displayed on the Abbott Mail screen. The assay insert status is Current. – Calibrator Data

4.

In the Download Language drop-down list, tap the language for the Abbott Mail documentation.

5.

To save the edits to the Abbott Mail settings, tap Save. To delete the edits to the Abbott Mail settings, tap Cancel.

6.

To return to the Configure screen, tap Done.

Related information... Abbott Mail screen, page 214

Configure screen, Computer tab The operator can perform the following tasks from the Computer tab of the Configure screen: General Settings

Configure the following settings: • Date and time • Number format • Speaker volume • System name

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• System language • Online help language • Screen time-out • The disabling of sample processing when a maintenance procedure is overdue • Authentication requirement for a general user logon Audio Settings

Configure the sound for various alerts.

Host Setup

Configure the following settings: • Host interface options • Host transmission options • Specimen and control release modes

HL7 Communication

Configure the following settings: • Message headers • Sender channel • Test HL7 communication

ASTM Communication Configure the following settings: • ASTM channel settings • Test ASTM communication LAS Communication

Configure the following settings: • Laboratory automation system configuration • Sender channel

Shortcuts

Configure user-defined System menu commands as icons on the menu bar.

Automatic Backup

Configure automatic backup options.

Alinity PRO

• Enable or disable inventory sharing. • Enable or disable status update messages. • Configure status update message settings.

AbbottLink

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View AbbottLink settings.

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Distance Alert

Section 2

Enable or disable the following options: • Distance alert • Notification options

Related information... System configuration, page 168 General Settings screen, page 218 Audio Settings screen, page 223 Host Setup screen, page 225 HL7 Communication screen, page 229 ASTM Communication screen, page 232 LAS Communication screen, page 234 Shortcuts screen, page 236 Automatic Backup screen, page 238 Alinity PRO screen, page 241 AbbottLink screen, page 243 Distance Alert screen, page 245 System checkout, page 166

General Settings screen On the General Settings screen, the operator can view the following information: • Date and time zone • Number format • System information The operator can configure the speaker volume. The system administrator can perform the following functions: • Configure system date and time settings. • Configure the number format. • Adjust the speaker volume. • Configure the system name and the system language. • Configure the online help language. • Configure the Log On screen time-out setting. • Enable or disable instrument processing when maintenance is overdue. • Configure the system to require authentication for the general operator logon.

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Related information... Configure screen, Computer tab, page 216 General Settings screen element descriptions, page 219 Configure general settings, page 221

General Settings screen element descriptions The General Settings screen displays the date and time zone, the number format, the speaker volume, and the system information.

Date/Time Zone area System Date

Displays a box that is used to edit the system date.

Date Format

Displays the options that are used to edit the system date format: • MM.DD.YYYY (default) • DD.MM.YYYY • YYYY.MM.DD

Time Zone

Displays a drop-down list that is used to select the areaspecific time zone.

System Time

Displays a spin box that is used to edit the system time. To edit the system time, use the system-configured format (HH:MM) and type the time in the box or tap the Up Arrow and Down Arrow buttons. If the system is configured for the 12-hour clock format, tap the AM or PM button to configure the time of day.

Time Format

Displays the following options: • 12-hour clock • 24-hour clock NOTE: If any other language is changed to English, the time format is automatically changed from the 24-hour clock format to the 12-hour clock format.

Automatically Adjust Clock for Daylight Saving Time

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Displays a check box that is used to adjust the clock automatically for Daylight Saving Time.

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Number Format area Thousand/Decimal Separator

Displays the options that are used to edit the number format for the thousands and decimal separator: • Comma and Period (1,000,000.00) (default) • Period and Comma (1.000.000,00) • None and Period (1000000.00) • None and Comma (1000000,00)

Speaker Volume area Speaker Volume

Displays a slider that is used to adjust the speaker volume from 0 through 10. NOTE: This setting is available only if the system is configured with speakers.

System Information area System Name

Displays a box that is used to edit the system name.

SCM Serial Number

Displays the serial number of the system control module.

System Language

Displays a drop-down list that is used to select the system language. NOTE: If any other language is changed to English, the time format is automatically changed from the 24-hour clock format to the 12-hour clock format.

Online Help Language Displays a drop-down list that is used to select the online help language. Log On Screen Time- Displays a box that is used to edit the setting for the screen out time-out: • Range is from 0 minutes through 60 minutes. • Default is 15 minutes. NOTE: If the time-out is configured as zero, the system does not track inactivity.

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Disable Sample Processing When Maintenance Is Overdue

Displays a check box that is used to disable sample processing if maintenance is overdue. For the default setting, the check box is selected.

Require Authentication For General Operator

Displays a check box that is used to require a user PIN for a general operator logon. For the default setting, the check box is selected.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save

Saves changes.

Text Size

Increases or decreases the size of text displayed.

Related information... General Settings screen, page 218 Descriptions of screen elements, page 140

Configure general settings Required instrument status

Stopped, Warming, or Idle, except where noted

Operator access level System administrator, except where noted Perform this procedure to configure the general settings for the system. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Computer tab.

3.

On the Computer tab of the Configure screen, tap General Settings.

4.

Under Date/Time Zone on the General Settings screen, enter the following information: – System Date – Date Format – Time Zone

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– System Time – Time Format – Automatically Adjust Clock for Daylight Saving Time NOTE: When any of the Date/Time Zone settings are changed, the user interface (UI) computer shuts down and restarts. 5.

Under Number Format, tap an option in the Thousand/Decimal Separator area. NOTE: When the number format is changed, the UI computer shuts down and restarts.

6.

Under Speaker Volume, slide the Speaker Volume button to the right or left to increase or decrease the speaker volume. NOTE: The speaker volume can be configured at any operator level and in any instrument status.

7.

Under System Information, enter the following information: – System Name – System Language NOTE: The system language can be configured at any operator level. When the system language is changed, the UI computer shuts down and restarts. NOTE: If any other language is changed to English, the time format is automatically changed from the 24-hour clock format to the 12-hour clock format. – Online Help Language NOTE: The online help language can be configured at any operator level and in any instrument status. The online help language is the same as the system language unless the operator changes the online help language to a different language. When the online help language is changed, the system retains the online help language independent of the system language. – Disable Sample Processing When Maintenance Is Overdue – Log On Screen Time-Out NOTE: The Log On screen time-out can be configured in any instrument status. – Require Authentication for General Operator NOTE: Required authentication can be configured in any instrument status.

8.

To save the edits to the general settings, tap Save. To delete the edits to the general settings, tap Cancel.

9.

To return to the Configure screen, tap Done.

Related information... General Settings screen, page 218

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Cycle power to the processing module and the reagent and sample manager (RSM), page 484 Import a translated version of the operations manual, page 394

Audio Settings screen On the Audio Settings screen, the operator can view the following information: • Audio alert global settings • Message alert settings The supervisor can perform the following functions: • Enable or disable global settings for audible alerts. • Configure the alert volume. • Configure a unique audible alert for critical messages. • Configure a unique audible alert for alert messages. • Configure a unique audible alert for notification messages. Related information... Configure screen, Computer tab, page 216 Audio Settings screen element descriptions, page 223 Configure audio settings, page 224

Audio Settings screen element descriptions The Audio Settings screen displays the audio and message alert settings.

Global Settings area Turn Off All Audio Alerts

Displays a check box that is used to disable all audio alerts on the system. For the default setting, the check box is selected.

Alert Volume

Displays a slider that is used to adjust the volume of all audio alerts from 0 through 10. The default setting is 5.

Message Alert Settings area Displays settings that are used to select a sound for the following message types: • Critical • Alert • Notification

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Critical, Alert, Notification

Displays a drop-down list for each message type that is used to select an available sound.

Repeat

Displays a drop-down list that is used to select the number of times for an alert to repeat. The alert can repeat from 0 times through 20 times or continuously for the selected message type.

Play

Displays a button that is used to preview the audio alert before the setting is saved.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save

Saves changes.

Text Size

This function button is unavailable on this screen.

Related information... Audio Settings screen, page 223 Descriptions of screen elements, page 140

Configure audio settings Operator access level Supervisor Perform this procedure to configure the audio settings for the system. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Computer tab.

3.

On the Computer tab of the Configure screen, tap Audio Settings.

4.

Under Global Settings on the Audio Settings screen, enter the following information: – Tap the Turn Off All Audio Alerts check box to enable or disable audio alerts. – Slide the Alert Volume button to the right or left to increase or decrease the alert volume.

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Under Message Alert Settings, enter the following information for each message category: – Tap the audio sound in the message category drop-down list. – Tap the number of times to repeat the audio sound in the Repeat drop-down list. NOTE: To hear a sample of the selected sound, tap the Play button next to the drop-down list.

6.

To save the edits to the audio settings, tap Save. To delete the edits to the audio settings, tap Cancel.

7.

To return to the Configure screen, tap Done.

Related information... Audio Settings screen, page 223

Host Setup screen On the Host Setup screen, the operator can view the following information: • Interface options • Transmission options • Result release mode options The system administrator can perform the following functions: • Configure interface and query mode options. • Configure transmission options for specimen, control, calibrator, sample status, and test status. • Configure result release mode options for specimen and control. Related information... Configure screen, Computer tab, page 216 Host Setup screen element descriptions, page 225 Configure host settings, page 228

Host Setup screen element descriptions The Host Setup screen displays the interface, transmission, and result release settings.

Interface Options area Displays options that are used to configure host interface communication. Host Interface

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Displays options that are used to configure the system to receive orders from and transmit results to a host computer:

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• HL7 • ASTM • Off (default) Query Mode

Displays options that are used to configure the system to send queries for orders to the host computer: • On • Off (default)

Query Time-Out Seconds

Displays the maximum time period that the system waits for the host computer to respond to a query. The range is from 5 seconds through 60 seconds. The default is 10 seconds.

Transmission Options area Displays options that are used to define the method for transmitting the released results to the host computer. NOTE: The transmission options Calibration, Sample Status, Test Status, Assay Availability, and Assay Availability Time Interval Minutes are available only if the Host Interface option is configured for HL7. Specimens

Displays the following options: • Single • Collated (default) • Collated by Module (This option is available only for a multimodule system.)

Control

Displays the following options: • Single • Collated (default) • Collated by Module (This option is available only for a multimodule system.) • Off

Calibration

Displays the following options: • On • Off (default)

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Sample Status

Displays options that are used to configure the system to send sample status information to the host interface: • On • Off (default)

Test Status

Displays options that are used to configure the system to send test status information to the host interface: • On • Off (default)

Assay Availability

Displays options that are used to configure the system to send assay availability information for each module to the host interface: • On • Off (default)

Assay Availability Displays a box that is used to enter in minutes how often the Time Interval Minutes Alinity system sends assay availability information to the host interface. The status update interval is a range from 1 minute through 10 minutes. The default is 1 minute.

Result Release Mode Options area Displays options that are used to configure the release mode for specimens, controls, and exceptions. The following options are available for each result type: • Manual (default) • Automatic • Automatic with Exceptions • Hold NOTE: When the Hold option is selected, the operator can configure to hold results for each type of specimen result flag.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

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Save

Saves changes.

Text Size

This function button is unavailable on this screen.

Related information... Host Setup screen, page 225 Descriptions of screen elements, page 140 Descriptions of specimen result flags, page 722 Descriptions of quality control result flags, page 724

Configure host settings Prerequisite

HL7 communication or ASTM communication must be configured before the host interface type is selected.

Required instrument status

Any instrument status, except where noted

Operator access level System administrator Perform this procedure to configure the host settings for the system. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Computer tab.

3.

On the Computer tab of the Configure screen, tap Host Setup.

4.

Under Interface Options on the Host Setup screen, enter the following information: – Host Interface NOTE: To configure Host Interface, the required instrument status is Stopped, Warming, or Idle. – Query Mode – Query Time-Out Seconds

5.

Under Transmission Options, enter the following information: – Specimen NOTE: To configure Specimen, the required instrument status is Stopped, Warming, or Idle. – Control – Calibrator – Sample Status

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– Assay Availability Time Interval Minutes NOTE: The transmission options Calibrator, Sample Status, Test Status, Assay Availability, and Assay Availability Time Interval Minutes are available only if the Host Interface option is configured for HL7. 6.

Under Result Release Mode Options, enter the following information: NOTE: To configure Result Release Mode Options, the required instrument status is Stopped, Warming, or Idle, and unreleased results and unreleased exceptions must be released. – Specimen – Control NOTE: When the Hold option is selected for either Specimen or Control, the operator can configure to hold results for each type of specimen result flag or quality control flag.

7.

To save the edits to the host settings, tap Save. To delete the edits to the host settings, tap Cancel.

8.

To return to the Configure screen, tap Done.

Related information... Host Setup screen, page 225 Edit result settings of assay parameters, page 297 Host orders, page 652 Verify the HL7 communication, page 1466 Verify the ASTM communication, page 1468

HL7 Communication screen On the HL7 Communication screen, the operator can view the following information: • Message headers • Sender channel options • Receiver channel options The system administrator can perform the following functions: • Configure message headers. • Configure sender channels. • Test HL7 communication settings.

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Related information... Configure screen, Computer tab, page 216 HL7 Communication screen element descriptions, page 230 Configure HL7 communication settings, page 231

HL7 Communication screen element descriptions On the HL7 Communication screen, the operator can configure the host communications settings for the system.

Message Headers area MSH-3 Sending Application

Displays a text box that is used to enter the MSH-3 Sending Application for HL7 host messaging for a maximum of 20 alphanumeric characters.

MSH-4 Sending Facility

Displays a text box that is used to enter the MSH-4 Sending Facility for HL7 host messaging for a maximum of 20 alphanumeric characters.

MSH-5 Receiving Application

Displays a text box that is used to enter the MSH-5 Receiving Application for HL7 host messaging for a maximum of 20 alphanumeric characters.

MSH-6 Receiving Facility

Displays a text box that is used to enter the MSH-6 Receiving Facility for HL7 host messaging for a maximum of 20 alphanumeric characters.

Sender Channel area Connection Type

Displays the following options: • Active Transient (default) • Active Persistent

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IP Address

Displays a text box that is used to enter the Internet protocol (IP) address when the Active Transient or Active Persistent option is selected. The IP address is configured as four decimal numbers. The range for each number is from 0 through 255 and is separated by periods (supports the IPv4 address).

Port Number

Displays a text box that is used to enter the port number. The port number range is from 0 through 65535.

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Receiver Channel area Port Number

Displays the port number.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save/Test

Tests previously defined settings and saves changes.

Text Size

This function button is unavailable on this screen.

Related information... HL7 Communication screen, page 229 Descriptions of screen elements, page 140

Configure HL7 communication settings Required instrument status

Stopped, Warming, or Idle, except where noted

Operator access level System administrator Perform this procedure to configure the HL7 communication settings for the system. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Computer tab.

3.

On the Computer tab of the Configure screen, tap HL7 Communication.

4.

Under Message Headers on the HL7 Communication screen, enter the following information: – MSH-3 Sending Application – MSH-4 Sending Facility – MSH-5 Receiving Application – MSH-6 Receiving Facility NOTE: Message headers can be configured in any instrument status.

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Under Sender Channel, enter the following information: – Connection Type – IP Address – Port Number

6.

To save the edits to the HL7 communication settings, tap Save/Test. To delete the edits to the HL7 communication settings, tap Cancel.

7.

To return to the Configure screen, tap Done.

Related information... HL7 Communication screen, page 229 Verify the HL7 communication, page 1466 Host orders, page 652

ASTM Communication screen On the ASTM Communication screen, the operator can view ASTM channel settings. The system administrator can perform the following functions: • Configure the IP address and the port number. • Configure the character encoding setting. • Test the ASTM channel settings. Related information... Configure screen, Computer tab, page 216 ASTM Communication screen element descriptions, page 232 Configure ASTM communication settings, page 233

ASTM Communication screen element descriptions The ASTM Communication screen displays a single TCP/IP communication channel to send and receive messages to and from an ASTM host. The screen is used to open a connection to the configured port and Internet protocol (IP) address for the ASTM host channel when the following conditions are met: • The host interface is configured for ASTM. • The host connection status is enabled.

ASTM Channel Settings area IP Address

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Displays a text box that is used to enter the IP address. The IP address is configured as four decimal numbers. The range

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for each number is from 0 through 255 and is separated by periods (supports the IPv4 address). Port Number

Displays a text box that is used to enter the port number. The port number range is from 0 through 65535.

Character Encoding

Displays a drop-down list that provides the following items: • UTF-8 (default) • Shift-JIS • Windows-1252 • ASCII

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save/Test

Tests previously defined settings and saves changes.

Text Size

This function button is unavailable on this screen.

Related information... ASTM Communication screen, page 232 Descriptions of screen elements, page 140

Configure ASTM communication settings Required instrument status

Stopped, Warming, or Idle

Operator access level System administrator Perform this procedure to configure the ASTM communication settings for the system. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Computer tab.

3.

On the Computer tab of the Configure screen, tap ASTM Communication.

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Under ASTM Channel Settings on the ASTM Communication screen, enter the following information: – IP Address – Port Number – Character Encoding

5.

To save the edits to the ASTM communication settings, tap Save/Test. To delete the edits to the ASTM communication settings, tap Cancel.

6.

To return to the Configure screen tap Done.

Related information... ASTM Communication screen, page 232 Verify the ASTM communication, page 1468 Host orders, page 652

LAS Communication screen On the LAS Communication screen, the operator can view the following information: • Laboratory automation system (LAS) configuration options • Sender channel settings • Receiver channel setting The system administrator can configure sender channel settings. Related information... Configure screen, Computer tab, page 216 LAS Communication screen element descriptions, page 234 Configure LAS communication settings, page 235

LAS Communication screen element descriptions The LAS Communication screen displays the laboratory automation system (LAS) settings for the system.

LAS Configuration area LAS

Displays the following options: • On • Off (default)

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Sender Channel area IP Address

Displays a text box that is used to enter the Internet protocol (IP) address. The IP address is configured as four decimal numbers. The range for each number is from 0 through 255 and is separated by periods (supports the IPv4 address).

Port Number

Displays a text box that is used to enter the port number. The port number range is from 0 through 65535.

Receiver Channel area Port Number

Displays the port number assigned by the system. The port number is not editable.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save/Test

Tests previously defined settings and saves changes.

Text Size

This function button is unavailable on this screen.

Related information... LAS Communication screen, page 234 Descriptions of screen elements, page 140

Configure LAS communication settings Required instrument status

Stopped, Warming, or Idle

Operator access level System administrator Perform this procedure to configure the laboratory automation system (LAS) communication settings for the system. NOTE: To enable or disable LAS configuration, contact an Abbott Laboratories representative. The LAS sender channel settings must be configured before LAS configuration can be enabled.

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On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Computer tab.

3.

On the Computer tab of the Configure screen, tap LAS Communication.

4.

Under Sender Channel on the LAS Communication screen, enter the following information: – IP Address – Port Number

5.

To save the edits to the LAS communication settings, tap Save/Test. To delete the edits to the LAS communication settings, tap Cancel.

6.

To return to the Configure screen, tap Done.

Related information... LAS Communication screen, page 234 Verify the LAS communication, page 1467

Shortcuts screen On the Shortcuts screen, the operator can view the following information: • Configured menu bar shortcut icons • Available shortcut icon options The system administrator can configure two shortcuts as icons on the menu bar. Related information... Configure screen, Computer tab, page 216 Shortcuts screen element descriptions, page 236 Configure shortcut icons, page 237

Shortcuts screen element descriptions On the Shortcuts screen, the operator can configure user-defined System menu commands as icons at the bottom of the menu bar.

Elements Available Shortcuts

Displays a list of available icons that can be configured on the menu bar. The following icons are available:

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• Cal/QC inventory • Procedures (default) • Configure • Create Order (default) • Help (Operations Manual) NOTE: Only two icons can be configured at one time as shortcuts. The remaining available System menu commands can be found in the System menu on the menu bar. First Shortcut

Displays the configured icon and a drop-down list that is used to select an icon.

Second Shortcut

Displays the configured icon and a drop-down list that is used to select an icon.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save

Saves changes.

Text Size

This function button is unavailable on this screen.

Related information... Shortcuts screen, page 236 Descriptions of screen elements, page 140

Configure shortcut icons Operator access level System administrator Perform this procedure to change configurable menu bar shortcut icons. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Computer tab.

3.

On the Computer tab of the Configure screen, tap Shortcuts.

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In the First Shortcut drop-down list, tap an icon name.

5.

In the Second Shortcut drop-down list, tap an icon name.

6.

To save the edits to the shortcuts settings, tap Save.

Section 2

To delete the edits to the shortcuts settings, tap Cancel. 7.

To return to the Configure screen, tap Done.

Related information... Shortcuts screen, page 236

Automatic Backup screen On the Automatic Backup screen, the operator can view the automatic backup options. The system administrator can enable or disable the automatic backup and can configure the automatic backup options. Related information... Configure screen, Computer tab, page 216 Automatic Backup screen element descriptions, page 238 Export Location Option window element descriptions, page 239 Configure an automatic backup, page 240

Automatic Backup screen element descriptions On the Automatic Backup screen, the operator can enable system automatic backups. When the Automatically Perform Backup check box is selected, seven daily automatic backups and four weekly automatic backups are saved on the hard drive.

Automatic Backup Options area Automatically Perform Displays a check box that is used to select if an automatic Backup backup is performed daily. Time of Daily Backup Displays a spin box that is used to enter the time of day for daily automatic backups to be performed. To enter the system time, use the system-configured format (HH:MM) and type the time in the box or tap the Up Arrow and Down Arrow buttons. If the system is configured for the 12-hour clock format, tap the AM or PM button to configure the time of day. The default is 01:00 A.M. Weekly Backup on

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Displays a drop-down list that is used to select the day of the week for daily automatic backups to be saved as the weekly backup. The default is Sunday.

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Automatic Backup Location

Displays a text box that is used to enter the location for system automatic backups to be copied to removable media.

Browse

Displays a button that is used to select the drive and folder location for the automatic backup.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save

Saves changes.

Text Size

This function button is unavailable on this screen.

Related information... Automatic Backup screen, page 238 Descriptions of screen elements, page 140

Export Location Option window element descriptions In the Export Location Option window, the operator can select the drive and folder location for the automatic backup.

Elements button

Folder name button

The Previous Folder button navigates to the previously selected folder. Displays the currently selected folder. The Home button navigates to the hard drive folder.

Name

Displays the name of the drive or folder.

Last Update

Displays the date and time that the files in the folder were last updated.

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Function buttons OK

Saves the selection and closes the window.

Cancel

Cancels the operation and closes the window.

?

Displays Help from the operations manual for the active screen, flyout, or message code.

Related information... Automatic Backup screen, page 238

Configure an automatic backup Operator access level System administrator Perform this procedure to configure an automatic backup. Seven daily automatic backups and four weekly automatic backups are saved on the hard drive and a USB flash drive. The following items are saved in the backup: • System calibration data (for example, robotics data and optics data) • User-defined maintenance procedures • The system database, which includes the following items: – System configuration settings (for example, host settings, report settings, system serial number, and system name) – Reagent cartridge test counts – Assay configuration settings – Assay calibration data – Control configuration – Control results – Specimen results – Installed maintenance and diagnostic procedures and the maintenance and diagnostic procedure history – Supply data – Assay inserts – Abbott Mail items – System updates NOTE: A USB flash drive must be inserted to create automatic backups.

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Section 2 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Computer tab.

3.

On the Computer tab of the Configure screen, tap Automatic Backup.

4.

Under Automatic Backup Options on the Automatic Backup screen, tap the Automatically Perform Backup check box to enable the automatic backup.

5.

Enter the following information: – Time of Daily Backup – Weekly Backup On – Automatic Backup Location

6.

To save the edits to the automatic backup settings, tap Save. To delete the edits to the automatic backup settings, tap Cancel.

7.

To return to the Configure screen, tap Done.

Related information... Automatic Backup screen, page 238 Insert and remove a USB flash drive, page 764

Alinity PRO screen Alinity PRO is a data-sharing software application between Alinity systems and the Alinity PRO computer. Alinity PRO provides the following options: • Inventory sharing allows the laboratory to share reagents, calibrators, and controls between different instruments that are controlled by a different user interface computer. • The operational dashboard allows the operator to view a live representation of the current status of all Alinity systems from one computer. With this information, the operator can schedule activities that are needed on the instrument. On the Alinity PRO screen, the operator can view the Alinity PRO settings. The system administrator can perform the following functions: • Enable or disable the inventory-sharing feature. • Enable or disable status update message transmissions. • Configure the Internet protocol address and the port number. Related information... Configure screen, Computer tab, page 216 Alinity PRO screen element descriptions, page 242 Configure Alinity PRO settings, page 243

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Alinity PRO screen element descriptions On the Alinity PRO screen, the operator can configure the Alinity PRO settings.

Alinity PRO Settings area Inventory sharing

Displays the following options: • Enable • Disable (default)

Status Update Message

Displays the following options: • Enable • Disable (default) When this option is enabled, messages are sent from the Alinity system to Alinity PRO to update the operational dashboard. The operational dashboard allows the operator to view a live representation of the current status of all Alinity systems from one computer.

Status Update Interval Displays a text box that is used to enter in seconds how often the Alinity system sends status information to Alinity PRO. The status update interval is a range from 15 seconds through 600 seconds. The default is 30 seconds. IP Address

Displays a text box that is used to enter the Internet protocol (IP) address. The IP address is configured as four decimal numbers. The range for each number is from 0 through 255 and is separated by periods (supports the IPv4 address).

Port Number

Displays a text box that is used to enter the port number. The port number range is from 0 through 65535.

Function buttons

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Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save

Saves changes.

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Text Size

This function button is unavailable on this screen.

Related information... Alinity PRO screen, page 241 Descriptions of screen elements, page 140

Configure Alinity PRO settings Required instrument status

Stopped, Warming, or Idle

Operator access level System administrator Perform this procedure to configure the Alinity PRO settings for the system. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Computer tab.

3.

On the Computer tab of the Configure screen, tap Alinity PRO.

4.

Under Alinity PRO Settings on the Alinity PRO screen, tap Enable or Disable for the following options: – Inventory Sharing – Status Update Messages

5.

If Status Update Messages is enabled, enter the following information: – Status Update Interval – IP Address – Port Number

6.

To save the edits to the Alinity PRO settings, tap Save. To delete the edits to the Alinity PRO settings, tap Cancel.

7.

To return to the Configure screen, tap Done.

Related information... Alinity PRO screen, page 241

AbbottLink screen AbbottLink is a data-sharing software application between the laboratory instrumentation and the Abbott internal systems for the transfer of instrument data, Abbott Mail documentation, and system updates. On the AbbottLink screen, the operator can view the AbbottLink settings.

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Related information... Configure screen, Computer tab, page 216 AbbottLink screen element descriptions, page 244

AbbottLink screen element descriptions The AbbottLink screen displays the AbbottLink settings.

AbbottLink Service area Enable

Used to enable AbbottLink service. This option is the default.

Disable

Used to disable AbbottLink service.

Connection Status

Displays the connection status of AbbottLink service.

Instrument Information area Model

Displays the model name of the instrument.

Serial Number

Displays the serial number of the instrument.

AbbottLink Host

Displays the host name of the instrument.

IP Address

Displays the Internet protocol address of the instrument.

Proxy Settings area Enable

Used to enable the proxy settings.

Disable

Used to disable the proxy settings. This option is the default.

Auto-Configuration

Used to configure the host URL address. When this option is selected, the URL box is displayed and is blank. The URL box can contain a maximum of 50 characters.

HTTP and SOCKS

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Host

Used to enter the host address. When the HTTP option or the SOCKS option is selected, the Host box is displayed and is blank. The Host box can contain a maximum of 50 characters.

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Port

Used to enter the port number. When the HTTP option or the SOCKS option is selected, the Port box is displayed and is blank. The integer value of the port number can be from 0 through 65535.

Authenticate using the Used to designate that the proxy server following information requires authentication. When this check box is selected, the Username and Password boxes are displayed and are blank. Each box can contain a maximum of 50 characters.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save

Saves changes.

Text Size

Increases or decreases the size of text displayed.

Related information... AbbottLink screen, page 243 Descriptions of screen elements, page 140

Distance Alert screen On the Distance Alert screen, the operator can view the distance alert settings and can verify the distance alert function. The system administrator can perform the following functions: • Enable or disable the distance alert. • Enable or disable distance alert functionality for exception notifications. • Enable or disable distance alert functionality for badge notifications. Related information... Configure screen, Computer tab, page 216 Distance Alert screen element descriptions, page 246

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Configure distance alert settings, page 248 Verify the distance alert function, page 249

Distance Alert screen element descriptions On the Distance Alert screen, the operator can enable and disable the distance alert settings.

Distance Alert Options area Distance Alert

Displays the following options: • Enable • Disable (default) When the distance alert is enabled, it illuminates one of the following colors: • Red when a critical message or an alert message is generated • Amber when a notification message is generated

Notification Options area This area is available only if Enable was selected in the Distance Alert area. Exception Notification Displays the following options: • Enable • Disable (default) Quality Control (QC) Notification

Displays the following options: • Enable (default) • Disable When this notification option is enabled, the distance alert illuminates one of the following colors: • Amber when one or more QC tests completed processing and generated a Westgard warning • Red when one or more QC tests completed processing and are out of range or generated a Westgard failure

Calibration (CAL) Notification

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Displays the following options: • Enable (default)

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• Disable When this notification option is enabled, the distance alert illuminates one of the following colors: • Amber when a calibration is within 1 hour of expiration • Red when a calibration has expired or failed Reagents Notification Displays the following options: • Enable (default) • Disable When this notification option is enabled, the distance alert illuminates one of the following colors: • Amber when a low alert status is applied to one or more items in the reagent carousel or when an item in the reagent carousel or on the reagent and sample manager (RSM) is within 1 hour of lot or onboard stability expiration • Red when a cartridge or rack has a load status error or when a cartridge or rack with a status other than OK, Mixing, Low Alert, or Disabled is displayed on the Current tab of the Reagents screen Supplies Notification Displays the following options: • Enable (default) • Disable When this notification option is enabled, the distance alert illuminates one of the following colors: • Amber when one or more inventory items have exceeded the configured low alert setting • Red when an inventory item has a status other than OK, Overridden, or Low Procedures Notification

Displays the following options: • Enable (default) • Disable When this notification option is enabled, the distance alert illuminates one of the following colors:

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• Amber when a maintenance procedure or a diagnostic procedure that is in process has a status of "Waiting user response" • Red when a maintenance procedure is overdue

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save

Saves changes.

Test

Tests the functionality of the distance alert. When this function button is selected, the distance alert light is turned off if the light was illuminated. Then, the light blinks red three times, blinks yellow three times, and blinks green three times. When the test is completed, the light remains off.

Text Size

This function button is unavailable on this screen.

Related information... Distance Alert screen, page 245 Descriptions of screen elements, page 140

Configure distance alert settings Required instrument status

Stopped, Warming, or Idle

Operator access level System administrator Perform this procedure to configure the distance alert settings. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

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2.

On the Configure screen, tap the Computer tab.

3.

On the Computer tab of the Configure screen, tap Distance Alert.

4.

Under Distance Alert Options on the Distance Alert screen, tap Enable or Disable for the Distance Alert option.

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Under Notification Options, tap Enable or Disable for the following options: – Exception Notification – Quality Control (QC) Notification – Calibration (CAL) Notification – Reagents Notification – Supplies Notification – Procedures Notification

6.

To save the edits to the distance alert settings, tap Save. To delete the edits to the distance alert settings, tap Cancel.

7.

To return to the Configure screen, tap Done.

Related information... Distance Alert screen, page 245

Verify the distance alert function Prerequisite

The distance alert must be enabled.

Operator access level System administrator Perform this procedure to verify the functionality of the distance alert light. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Computer tab.

3.

On the Computer tab of the Configure screen, tap Distance Alert.

4.

On the Distance Alert screen, tap Test. The distance alert light is turned off if the light was illuminated. Then, the light blinks each color three times in the following order: a.

Red

b.

Yellow

c.

Green

When the test is completed, the light remains off. 5.

To return to the Configure screen, tap Done.

Related information... Distance Alert screen, page 245

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Configure screen, Assay tab The operator can perform the following tasks from the Assay tab of the Configure screen: Assay Parameters

• Configure assay settings. • Configure calibrator settings. • Add, delete, or edit SmartWash settings. • Configure result settings. • Configure retest rules.

Calibrator Set

• Create, edit, or delete a calibrator set. • Import calibrator data.

Install/Uninstall Assays

• Install new or revised assay files.

Import/Export Assays

• Import assay files from a USB flash drive.

• Uninstall assay files.

• Export assay files from a USB flash drive. Assay Display Order

Configure the order in which assays are displayed on screens and in reports.

Panel Definition

Configure assay panels for specimens, controls, or calibrations.

Cal/QC Ordering

• Configure general calibration settings. • Configure general quality control settings.

Quality Control

• Configure multiconstituent and single-constituent controls. • Import control data.

Westgard

Enable or disable Westgard rules for each assay.

Related information... System configuration, page 168 Assay Parameters screen, page 251 Calibrator Set screen, page 306 Install/Uninstall Assays screen, page 321 Import/Export Assays screen (c‑series), page 328

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Assay Display Order screen, page 333 Panel Definition screen, page 336 Cal/QC Ordering screen, page 339 Quality Control screen, page 342 Westgard screen, page 365 System checkout, page 166

Assay Parameters screen On the Assay Parameters screen, the operator can view the following information: • General settings • Calibration settings • Results settings • Retest rules • SmartWash (c‑series) The system administrator can perform the following functions: • Edit general assay settings. • Edit calibration settings. • Edit result and interpretation information. • Configure assay retest rules. • Configure SmartWash settings. • Create a user-defined assay. Related information... Configure screen, Assay tab, page 250 Assay Parameters screen element descriptions, page 252 Assay Parameters screen, General tab element descriptions (c‑series photometric), page 253 Assay Parameters screen, General tab element descriptions (c‑series potentiometric), page 260 Assay Parameters screen, General tab element descriptions (i‑series), page 262 Assay Parameters screen, General tab element descriptions (calculated), page 265 Assay Parameters screen, Calibration tab element descriptions (c‑series photometric), page 266 Assay Parameters screen, Calibration tab element descriptions (c‑series potentiometric), page 272 Assay Parameters screen, Calibration tab element descriptions (i‑series), page 274 Assay Parameters screen, Results tab element descriptions, page 276 Add Result flyout, Edit Result flyout element descriptions, page 281 Assay Parameters screen, Retest Rules tab element descriptions, page 282 Retest Assays flyout element descriptions, page 286 Alinity ci‑series Operations Manual

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Edit general settings of assay parameters (c‑series photometric), page 286 Edit general settings of assay parameters (c‑series potentiometric), page 289 Edit general settings of assay parameters (i‑series), page 290 Edit general settings of assay parameters (calculated), page 291 Edit calibration settings of assay parameters (c‑series photometric), page 293 Edit calibration settings of assay parameters (c‑series potentiometric), page 294 Edit calibration settings of assay parameters (i‑series), page 296 Edit result settings of assay parameters, page 297 Configure retest rules, page 299 Change the assay status of a correlation assay, page 301 Create a calculated assay, page 302 Create Assay flyout element descriptions, page 1542

Assay Parameters screen element descriptions The Assay Parameters screen displays the assays that are installed on the system.

Elements Installed Assays

Identifies the total number of assay parameter files that are configured on the system.

All tab

Displays all assays that are available on the system.

i‑series tab

Displays all assays that are available on one or more Alinity i processing modules.

c‑series tab

Displays all assays that are available on one or more Alinity c processing modules.

Calculated tab

Displays all calculated assays.

Function buttons

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Configure

Navigates to the previous configuration screen.

Select All

Selects or deselects all items in a list. The button switches between Select All and Deselect All.

Print

Displays the Print flyout.

Create

Navigates to the Create Assay flyout where the operator can tap one of the following options:

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• Calculated • Photometric View/Edit

Navigates to the General tab of the Assay Parameters screen for the selected assay or the first assay that is selected when multiple assays are chosen.

Text Size

Increases or decreases the size of text displayed.

Related information... Assay Parameters screen, page 251 Descriptions of screen elements, page 140 Create Assay flyout element descriptions, page 1542

Assay Parameters screen, General tab element descriptions (c‑series photometric) On the General tab of the Assay Parameters screen, the operator can view general settings. Parameters that can be accessed by the system administrator are editable. All parameters are editable for user-defined assays. For more information, see the assay applications appendix.

Elements Assay Name

Displays a text box that is used to change the default name of the assay. The new assay name cannot match an existing assay name. The assay name can have from 1 through 10 characters. NOTE: This parameter can be edited when the Assay Status parameter is not Correlation. If the correlation version of the assay is entered, CORR is appended to the assay name and is not included in the 10character limit.

Assay Type

Displays the assay protocol type. One of the following settings may be displayed: • Photometric • Potentiometric • Hemolysis • Icterus • Lipemia

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• Calculated Assay Status

Displays the assay status defined for the assay. One of the following settings may be displayed: • Primary • Correlation

Date/Time

Displays the date and time that an operator installed the assay or an operator last modified the assay parameters.

Assay Number

Displays the number of the assay file. The assay number must be the same number used for a host computer. NOTE: If an assay parameter is edited for an assay that affects result measurement, calculation, or validity checks, an asterisk is displayed next to the assay number to indicate that the assay was modified.

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Assay Version

Displays the version of the assay file.

Result Units

Displays the concentration units reported for the assay.

Operator

Displays the identification of the operator who installed the assay or the operator who last modified the assay parameters.

Assay Availability

Displays a drop-down list that is used to select one of the following settings: Enabled

The assay name is listed on all tabs of the Create Order screen. (Default)

Disabled

The assay name is displayed but is unavailable on any tab of the Create Order screen.

Patient Disabled

The assay name is included in the assay list on the Control tab and the Calibration tab of the Create Order screen. The assay name is displayed but is unavailable in the assay list on the Specimen tab of the Create Order screen.

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Module

Displays one or more check boxes to indicate the processing modules that are allocated to load the reagent of the assay. The assay is assigned to all appropriate processing modules. (Default)

Run Controls for Displays a drop-down list that is used to select which reagent Onboard Reagents by cartridges to run for quality control: Lot

Runs the controls only on one cartridge for each lot loaded on the reagent carousel.

Cartridge

Runs the controls for all cartridges and for each lot loaded on the reagent carousel.

NOTE: This parameter may only be changed from Lot to Cartridge for non-user-defined assays.

Reaction Definition area Reaction Mode

Displays the type of reaction that occurs for the assay. The following settings are available: • End Up (default) • End Down • Rate Up • Rate Down

Wavelength

Displays the primary and secondary wavelengths used to measure the assay concentration.

Read Times

Displays the starting and ending photometric read points that define the following read times:

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Main

Displays the read points used for data reduction.

Flex

Displays the read points used for data reduction when one read or no reads performed during the main read time fall within the configured absorbance range.

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Results that are calculated by using the absorbance data obtained from the flex read time are identified with a FLEX result flag. NOTE: This parameter is available only for rate assays. Color Correction

Displays the starting and ending photometric read points used to adjust the absorbance range limits based on the measured sample color.

Absorbance Range

Displays the lower and upper absorbance limits for the assay. All photometric readings need to fall within the absorbance limits if the limits are defined. Any absorbance value that is measured at the primary wavelength and falls outside the absorbance limits during the main or the flex read time is not used to calculate the result.

Last Read

Displays the last photometric read point required for result calculation. Absorbance data is not collected for photometric read points that occur after the configured value.

Sample Blank Types

Displays the assay blank type. The following settings are available: • No Blank • Self Blank

Blank Read Times

Displays the starting and ending photometric read points that define the blank read time. NOTE: This parameter is available only when the Sample Blank Types parameter is Self Blank.

Reagent area

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Reagent

Displays the reagent name used for the assay.

Diluent

Displays the sample diluent name used for the assay.

Diluent Dispense Mode

Displays the reagent-pipetting profile the system uses to aspirate and dispense diluents. The following settings may be displayed:

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• Type 1 (default) • Type 2 • Type 6 Reagent Volume

Displays the reagent 1 (R1) and reagent 2 (R2) volumes that are dispensed into the cuvette.

Water Volume

Displays the water volume dispensed with an R1 or an R2 concentrated reagent.

Dispense Mode

Displays the reagent-pipetting profile the system uses to aspirate and dispense reagents. The following settings may be displayed: • Type 1 (default) • Type 2 • Type 5 (only for R2) • Type 6 (only for R1)

Validity Checks area Reaction Check

Displays the reaction type used to evaluate unexpected reaction performance. The following settings may be displayed: • None • End Subtraction • End Ratio • Rate Subtraction • Rate Ratio NOTE: The absorbance values for the reaction check are measured only at the primary wavelength.

A Read Time, B Read Displays the starting and ending photometric read points for Time the A Read Time range and B Read Time range used for the reaction check. NOTE: This parameter is unavailable when the Reaction Check parameter is None. Calculation Limits

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Displays the lower and upper limits for the acceptable range of the calculated read time difference (A - B) or the

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calculated read time ratio (A ÷ B). If the calculated value exceeds the limits, the assay result becomes an exception and is not processed. NOTE: This parameter is unavailable when the Reaction Check parameter is None. Minimum

Displays the minimum acceptable absorbance or absorbance change during the B Read Time range. NOTE: This parameter is available only when the Reaction Check parameter is End Ratio or Rate Ratio.

Maximum Abs Variation

Displays the acceptable absorbance variation allowed for absorbance readings during the main read time. When the absorbance variation exceeds the defined limit, the assay result becomes an exception and is not processed. NOTE: This parameter is available only when the Reaction Mode parameter is End Up or End Down.

Rate Linearity%

Displays the allowable percentage change in absorbance. The validity check is performed during the main read times and the flex read times by using the first three reads and the last three reads. NOTE: This parameter is available only when the Reaction Mode parameter is Rate Up or Rate Down and a minimum of four photometric read points are defined as the main read times.

Sample area All parameters except the Dilution Factor parameter can be edited for non-user-defined assays but only if the parameters are undefined when the assay is installed.

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Dilution Name

Displays the assay dilution name. A maximum of three dilution names can be configured. The dilution name can have from 1 through 10 characters. Additional dilutions may be created when all available dilutions are not configured.

Sample

Displays the sample volume to aspirate from the sample cup or tube for each configured assay dilution. A value from 1.5 µL through 35 µL in increments of 0.1 µL can be configured.

Diluted Sample

Displays the diluted sample volume to aspirate from the cuvette for each configured assay dilution. A value from

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1.5 µL through 15 µL in increments of 0.1 µL can be configured or this parameter can be undefined. Diluent

Displays the sample diluent volume to dispense into the cuvette for each configured assay dilution. A value from 20 µL through 345 µL in increments of 1 µL can be configured or this parameter can be undefined.

Water

Displays the water volume to dispense into the cuvette for each configured assay dilution. A value from 25 µL through 300 µL in increments of 1 µL can be configured or this parameter can be undefined.

Dilution Factor

Displays the sample dilution factor that is calculated by the system software and is based on the configured sample, diluent, water, and reagent volumes.

Default Dilution

Displays the dilution protocol used as the default for sample orders. A system administrator can edit this parameter for non-user-defined assays when more than one dilution name is configured.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Print

Displays the Print flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save

Saves changes.

New Reagent

Displays the New Reagent flyout for user-defined assays.

View/Edit Reagent

Displays the View/Edit Reagent flyout for assays that use previously configured user-defined reagents.

Text Size

This function button is unavailable on this screen.

Related information... Assay Parameters screen, page 251 Descriptions of screen elements, page 140 Linearity flagging (c‑series), page 1581

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Assay applications (c‑series photometric), page 1539

Assay Parameters screen, General tab element descriptions (c‑series potentiometric) On the General tab of the Assay Parameters screen, the operator can view general settings. Parameters that can be accessed by the system administrator are editable.

Elements Assay Name

Displays a text box that is used to change the default name of the assay. The new assay name cannot match an existing assay name. The assay name can have from 1 through 10 characters.

Assay Type

Displays Potentiometric as the assay protocol type. NOTE: Only photometric and calculated assay protocol types are available for a user-defined assay.

Assay Status

Displays the assay status defined for the assay.

Date/Time

Displays the date and time that an operator installed the assay or an operator last modified the assay parameters.

Assay Number

Displays the number of the assay file. The assay number must be the same number used for a host computer. NOTE: If an assay parameter is edited for an assay that affects result measurement, calculation, or validity checks, an asterisk is displayed next to the assay number to indicate that the assay was modified.

Assay Version

Displays the version of the assay file.

Result Units

Displays the concentration units reported for the assay.

Operator

Displays the identification of the operator who installed the assay or the operator who last modified the assay parameters.

Assay Availability

Displays a drop-down list that is used to select one of the following settings: Enabled

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The assay name is listed on all tabs of the Create Order screen. (Default)

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Module

Disabled

The assay name is displayed but is unavailable on any tab of the Create Order screen.

Patient Disabled

The assay name is included in the assay list on the Control tab and the Calibration tab of the Create Order screen. The assay name is displayed but is unavailable in the assay list on the Specimen tab of the Create Order screen.

Displays one or more check boxes to indicate the processing modules that are allocated to load the reagent of the assay. The assay is assigned to all appropriate processing modules. (Default)

Run Controls for Displays a drop-down list that is used to select which reagent Onboard Reagents by cartridges to run for quality control: Lot

Runs the controls only on one cartridge for each lot loaded on the reagent carousel.

Cartridge

Runs the controls for all cartridges and for each lot loaded on the reagent carousel.

Reagent area Reagent

Displays the reagent name used for the assay.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Print

Displays the Print flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save

Saves changes.

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Text Size

Section 2

This function button is unavailable on this screen.

Related information... Assay Parameters screen, page 251 Descriptions of screen elements, page 140

Assay Parameters screen, General tab element descriptions (i‑series) On the General tab of the Assay Parameters screen, the operator can view general settings. Parameters that can be accessed by the system administrator are editable.

Elements Assay Name

Displays a text box that is used to change the default name of the assay. The new assay name cannot match an existing assay name. The assay name can have from 1 through 10 characters. NOTE: If the correlation version of the assay is entered, CORR is appended to the assay name and is not included in the 10-character limit. The name cannot be edited.

Assay Type

Displays the assay protocol type.

Assay Status

Displays the assay status defined for the assay. One of the following settings may be displayed: • Primary • Correlation

Date/Time

Displays the date and time that an operator installed the assay or an operator last modified the assay parameters.

Assay Number

Displays the number of the assay file. The assay number must be the same number used for a host computer. NOTE: If an assay parameter is edited for an assay that affects result measurement, calculation, or validity checks, an asterisk is displayed next to the assay number to indicate that the assay was modified.

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Assay Version

Displays the version of the assay file.

Result Units

Displays the concentration units reported for the assay.

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Operator

Displays the identification of the operator who installed the assay or the operator who last modified the assay parameters.

Assay Availability

Displays a drop-down list that is used to select one of the following settings:

Module

Enabled

The assay name is listed on all tabs of the Create Order screen. (Default)

Disabled

The assay name is displayed but is unavailable on any tab of the Create Order screen.

Patient Disabled

The assay name is included in the assay list on the Control tab and the Calibration tab of the Create Order screen. The assay name is displayed but is unavailable in the assay list on the Specimen tab of the Create Order screen.

Displays one or more check boxes to indicate the processing modules that are allocated to load the reagent of the assay. The assay is assigned to all appropriate processing modules. (Default)

Run Controls for Displays a drop-down list that is used to select which reagent Onboard Reagents by cartridges to run for quality control:

Cal Version

Lot

Runs the controls only on one cartridge for each lot loaded on the reagent carousel.

Cartridge

Runs the controls for all cartridges and for each lot loaded on the reagent carousel.

Displays the calibration version of the assay file.

Pretreatment options Displays the assay pretreatment protocol type.

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Dilution area Dilution Name

Displays the dilution name. The dilution name must be the same name used for a host computer.

Low

Displays the low concentration range allowed for the dilution.

High

Displays the high concentration range allowed for the dilution.

Default

Displays an option that is used to identify the dilution protocol that is used as the default for assay processing.

Assay Specific Settings area Assay-specific settings are used in assay formulas for some Alinity i assays. Assay-specific settings are not available for all assays and are displayed only when the settings are used. Name

Displays the assay-specific setting name.

Current Value

Displays a text box that is used to enter the assay-specific setting value.

Range

Displays the editable range allowed for the assay-specific setting.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Print

Displays the Print flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save

Saves changes.

Text Size

This function button is unavailable on this screen.

Related information... Assay Parameters screen, page 251 Assay processing (i‑series), page 433 Descriptions of screen elements, page 140 264

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Assay Parameters screen, General tab element descriptions (calculated) On the General tab of the Assay Parameters screen, the operator can change general assay settings for calculated assays.

Elements Assay Name

Displays a text box that is used to change the name of the calculated assay. The new assay name cannot match an existing assay name. The assay name can have from 1 through 10 characters.

Assay Type

Displays Calculated as the assay protocol type.

Date/Time

Displays the date and time that an operator created or installed the assay or an operator last modified the assay parameters.

Assay Number

Displays the number of the assay file. The assay number must be the same number used for a host computer. NOTE: If an assay parameter is edited for an assay that affects result measurement or calculation, an asterisk is displayed next to the assay number to indicate that the assay was modified.

Operator

Displays the identification of the operator who created or installed the assay or the operator who last modified the assay parameters.

Assay Availability

Displays a drop-down list that is used to select one of the following settings:

Calculated Formula

Enabled

The assay name is listed on all tabs of the Create Order screen. (Default)

Disabled

The assay name is displayed but is unavailable on any tab of the Create Order screen.

Displays the calculated formula that is created by using the numeric keypad. The calculated formula can have from 1 through 100 characters. NOTE: The numeric keypad cannot be displayed for assays that have assay numbers from 3000 through 3999. The

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calculated formula is created automatically during assay installation and cannot be edited. Lower Range

Displays a text box that is used to enter the lower limit of the assay range.

Upper Range

Displays a text box that is used to enter the upper limit of the assay range.

Selected Assay

Displays the name of the selected assay that is used in the calculated formula.

Minimum

Displays the minimum result range for the selected assay.

Maximum

Displays the maximum result range for the selected assay.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Print

Displays the Print flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save

Saves changes.

Select Assays

Displays the Select Assays flyout.

Text Size

This function button is unavailable on this screen.

Related information... Assay Parameters screen, page 251 Descriptions of screen elements, page 140 Assay applications (c‑series photometric), page 1539

Assay Parameters screen, Calibration tab element descriptions (c‑series photometric) On the Calibration tab of the Assay Parameters screen, the operator can view calibration settings. Parameters that can be accessed by the system administrator are editable. All parameters except those parameters configured on the General tab are editable for userdefined assays. For more information, see the assay applications appendix.

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Elements Assay Name

Displays the assay name.

Assay Type

Displays the assay protocol type.

Assay Status

Displays the assay status defined for the assay.

Date/Time

Displays the date and time that an operator installed the assay or an operator last modified the assay parameters.

Assay Number

Displays the number of the assay file. NOTE: If an assay parameter is edited for an assay that affects result measurement, calculation, or validity checks, an asterisk is displayed next to the assay number to indicate that the assay was modified.

Assay Version

Displays the version of the assay file.

Result Units

Displays the concentration units reported for the assay.

Operator

Displays the identification of the operator who installed the assay or the operator who last modified the assay parameters.

Calibration area Calibration Method

Displays one of the following calibration methods: • Absorbance • Factor • Linear (default) • Logit-4 • Spline • Use Cal Factor Blank

Full Calibration Interval

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Displays a text box that is used to change the amount of time in hours that the full calibration curve is valid after a full calibration is completed. The value cannot be edited to a value greater than the number of hours specified in the released assay file.

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Factor

Section 2

Displays the calibration factor when the Calibration Method parameter is Factor.

Default Ordering Type Displays the default calibration type used to create calibration orders for the assay. The following settings may displayed: • Full • Adjust NOTE: This parameter is unavailable when the Adjust Type parameter is None. Use Cal Factor From

Displays the assay to reference for calibration information used in result calculation. Configured c‑series photometric assays are used to configure this parameter. NOTE: This parameter is displayed only when the Calibration Method parameter is Use Cal Factor Blank.

Adjust Type

Displays a drop-down list that is used to select the type of adjust calibration performed for the assay: • None (default) • Blank • 1-Point • 2-Point NOTE: This parameter is available only when the Calibration Method parameter is Linear, Spline, or Logit-4.

Adjust Interval

Displays a text box that is used to enter the amount of time in hours that the adjust calibration is valid after an adjustment calibration is completed. A value from 0 through 9999 can be configured. NOTE: This parameter is unavailable when the Adjust Type parameter is None. If 0 is configured, the adjust calibration interval is not tracked.

Adjust Level

Displays a drop-down list that is used to select the calibrator level to use for the 1-Point and 2-Point adjust calibration types. The configured levels for the calibrator set are used to configure this parameter. NOTE: This parameter is unavailable when the Adjust Type parameter is None or Blank or when the Calibration Method parameter is Absorbance, Factor, or Use Cal Factor Blank.

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Calibrators area Calibrator Set

Displays the calibrator set name. For c‑series assays that use a blank calibrator set, the calibrator set name is displayed first, followed by the blank calibrator set name. The blank calibrator set is available only for non-user-defined assays. NOTE: This parameter is not displayed when the Calibration Method parameter is Absorbance or Use Cal Factor Blank.

Replicates

Displays a text box that is used to change the number of replicates to run for the blank and each configured calibrator level for assay calibration. A value from 1 through 3 can be configured.

Calibrator Level

Displays the name of the blank and displays a maximum of six calibrator levels used as points in the calibration. NOTE: This parameter is not displayed when the Calibration Method parameter is Absorbance or Use Cal Factor Blank.

Sample

Displays the sample volume dispensed into the cuvette for the blank and for each configured calibrator level.

Diluted Sample

Displays the diluted sample volume for the blank and for each configured calibrator level. The diluted sample volume is aspirated from the cuvette for dilution during calibration if a dilution protocol is defined for the calibrator.

Diluent

Displays the diluent volume for the blank and for each configured calibrator level. The diluent volume is dispensed into the cuvette for dilution during calibration if a dilution protocol is defined for the calibrator.

Water

Displays the water volume used to dilute a concentrated diluent for the blank and for each configured calibrator level. The water volume is dispensed with any aspirated diluent into the cuvette for dilution during calibration if a dilution protocol is defined for the calibrator.

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Validity Checks area Blank Absorbance Range

Displays boxes that are used to enter the lower and upper limits that define an acceptable blank absorbance value measured during calibration: Lower limit

A value from -9.9999 through 9.9998 can be configured or this parameter can be undefined.

Upper limit

A value from -9.9998 through 9.9999 can be configured or this parameter can be undefined.

NOTE: If this parameter is undefined, the check is not performed. Span

Displays a drop-down list that is used to select the calibrator level used as the upper limit of the calibration span that is evaluated for the Span Absorbance Range check. This parameter can be configured as one of the calibrator levels defined for the assay or can be undefined. NOTE: The blank defines the lower limit of the calibration span. This parameter is available only when the Calibration Method parameter is Linear, Spline, or Logit-4.

Span Absorbance Range

Displays text boxes that are used to enter the lower and upper limits that define an acceptable absolute absorbance difference between the blank and the defined calibrator level during calibration: Lower limit

A value from 0.0001 through 9.9998 can be configured or this parameter can be undefined.

Upper limit

A value from 0.0002 through 9.9999 can be configured or this parameter can be undefined.

NOTE: If this parameter is undefined, the check is not performed. Both limits must be defined to perform the check. This parameter is available only when the Calibration Method parameter is Linear, Spline, or Logit-4.

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Expected Cal Factor

Installation procedures and special requirements System configuration

Displays a text box that is used to enter the target value for the calibration factor (1/slope) when the calibration is calculated. A value from -999999.99 through 9999999.99 can be configured. NOTE: This parameter is available only when the Calibration Method parameter is Linear or Spline. For assays that use a linear calibration method, all segments of the calibration curve are evaluated. For assays that use a spline calibration method, only the first segment of the calibration curve is evaluated. If this parameter is undefined, the check is not performed.

Expected Cal Factor Tolerance %

Displays a text box that is used to enter the percent tolerance of the calibration factor that is expected when the calibration is calculated. This parameter is used with the Expected Cal Factor parameter to determine an acceptable range for the calibration factor. A value from 1 through 99 can be configured or this parameter can be undefined. NOTE: This parameter is available only when the Calibration Method parameter is Linear or Spline. For assays that use a linear calibration method, all segments of the calibration curve are evaluated. For assays that use a spline calibration method, only the first segment of the calibration curve is evaluated. If this parameter is undefined, the check is not performed.

Maximum Curve Fit

Displays a text box that is used to enter the parameter for maximum curve fit. This parameter specifies the maximum limit of the sum of the absolute values of the difference between the approximated absorbance of the calculated calibration and the measured absorbance. A value from 0.0001 through 9.9999 can be configured or this parameter can be undefined. NOTE: This parameter is available only when the Calibration Method parameter is Logit-4. If this parameter is undefined, the check is not performed.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Print

Displays the Print flyout.

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Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save

Saves changes.

New Cal Set

Displays the New Cal Set flyout for user-defined assays.

Text Size

This function button is unavailable on this screen.

Related information... Assay Parameters screen, page 251 Descriptions of screen elements, page 140

Assay Parameters screen, Calibration tab element descriptions (c‑series potentiometric) On the Calibration tab of the Assay Parameters screen, the operator can view calibration settings. Parameters that can be accessed by the system administrator are editable.

Elements Assay Name

Displays the assay name.

Assay Type

Displays the assay protocol type.

Assay Status

Displays the assay status defined for the assay.

Date/Time

Displays the date and time that an operator installed the assay or an operator last modified the assay parameters.

Assay Number

Displays the number of the assay file. NOTE: If an assay parameter is edited for an assay that affects result measurement, calculation, or validity checks, an asterisk is displayed next to the assay number to indicate that the assay was modified.

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Assay Version

Displays the version of the assay file.

Result Units

Displays the concentration units reported for the assay.

Operator

Displays the identification of the operator who installed the assay or the operator who last modified the assay parameters.

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Calibration area Full Calibration Interval

Displays a text box that is used to change the amount of time in hours that the full calibration curve is valid after a full calibration is completed. A value from 0 through 9999 can be configured. NOTE: The interval cannot exceed the limit provided in the assay parameter file. If 0 is configured, the full calibration interval is not tracked.

Slope Limit (%)

Displays text boxes that are used to enter the lower and upper limits that define an acceptable slope value for ICT assay calibrations: Lower limit

A value from 45 through 119 can be configured.

Upper limit

A value from 46 through 120 can be configured.

Calibrator Low

Displays the name of the low calibrator.

Low Concentration

Displays the concentration value of the low calibrator.

Calibrator High

Displays the name of the high calibrator.

High Concentration

Displays the concentration value of the high calibrator.

Replicates

Displays a text box that is used to change the number of replicates to run for the Low, High, and Index calibrator levels for assay calibration. A value from 1 through 3 can be configured.

Index Options area Index Used

Displays options that define whether the optional index solution is measured during ICT calibration and is used to adjust all ICT results for the assay: • Yes • No (default)

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NOTE: If Yes is selected, all Index Options parameters must be defined. Index Concentration

Displays a text box that is used to enter the concentration of the index solution. A value from 0 through 9999999 can be configured.

Index Range

Displays text boxes that are used to enter the lower and upper limits that define the acceptable range for the index concentration calculated during ICT assay calibration. Values from 0 through 9999999.9999 can be configured. NOTE: The lower limit value must be less than the upper limit value.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Print

Displays the Print flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save

Saves changes.

Text Size

This function button is unavailable on this screen.

Related information... Assay Parameters screen, page 251 Descriptions of screen elements, page 140

Assay Parameters screen, Calibration tab element descriptions (i‑series) On the Calibration tab of the Assay Parameters screen, the operator can view calibration settings. Parameters that can be accessed by the system administrator are editable.

Elements

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Assay Name

Displays the assay name.

Assay Type

Displays the assay protocol type.

Assay Status

Displays the assay status defined for the assay.

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Date/Time

Displays the date and time that an operator installed the assay or an operator last modified the assay parameters.

Assay Number

Displays the number of the assay file. NOTE: If an assay parameter is edited for an assay that affects result measurement, calculation, or validity checks, an asterisk is displayed next to the assay number to indicate that the assay was modified.

Assay Version

Displays the version of the assay file.

Result Units

Displays the concentration units reported for the assay.

Operator

Displays the identification of the operator who installed the assay or the operator who last modified the assay parameters.

Calibration area Calibration Method

Displays the data reduction method used in the calibration math model.

Calibration Type

Displays one of the following calibration types: • Adjust • Full • Index

Adjustment Method

Displays the type of adjustment used in an adjustment calibration. An adjustment method is displayed only when the Calibration Type parameter is Adjust.

Calibration Interval

Displays a text box that is used to change the amount of time in hours that the calibration curve is valid. A value from 0 through 9999 can be configured. If 0 is configured, the calibration interval is not tracked. NOTE: If an assay file contains a default calibration interval other than 0, the calibration interval can be decreased to 1 but cannot be increased.

Replicates

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Displays a text box that is used to change the number of calibrator replicates used in the calculation of the calibration.

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Reference Assay

Section 2

Displays the reference calibration assay number that is used to generate results. A reference assay number is displayed only when the Calibration Method parameter is Reference.

Calibrator Concentrations area Cal A through Cal F

Displays the concentrations of the six calibrators used as points for a Full calibration type or displays the concentrations for the master reference curve for an Adjust calibration type. Calibrator concentrations are not displayed for an Index calibration type.

Adjust

Displays the concentrations for the Cal 1 and Cal 2 adjusters. Adjust concentrations are displayed only when the Calibration Type parameter is Adjust.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Print

Displays the Print flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save

Saves changes.

Text Size

This function button is unavailable on this screen.

Related information... Assay Parameters screen, page 251 Descriptions of screen elements, page 140

Assay Parameters screen, Results tab element descriptions On the Results tab of the Assay Parameters screen, the operator can view and edit result and interpretation settings.

Elements

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Assay Name

Displays the assay name.

Assay Type

Displays the assay protocol type.

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Assay Status

Installation procedures and special requirements System configuration

Displays the assay status defined for the assay. NOTE: This element is not displayed for calculated assays.

Date/Time

Displays the date and time that an operator installed the assay or an operator last modified the assay parameters.

Assay Number

Displays the number of the assay file. NOTE: If an assay parameter is edited for an assay that affects result measurement, calculation, or validity checks, an asterisk is displayed next to the assay number to indicate that the assay was modified.

Assay Version

Displays the version of the assay file. NOTE: This element is not displayed for calculated assays.

Result Units

Displays the concentration units reported for the assay. NOTE: This element is not displayed for calculated assays.

Operator

Displays the identification of the operator who installed the assay or the operator who last modified the assay parameters.

Result Units area Result Units

Displays a drop-down list that is used to select a result unit. NOTE: For calculated assays, a text box is displayed that is used to enter a unit name. The unit name can have from 0 through 8 characters.

Decimal Places

Displays a drop-down list that is used to select the number of decimal places to display for an assay result.

Result Unit UCUM

Displays the Unified Code for Units of Measure (UCUM). The UCUM is a system of codes that represents the measurement units that are contemporarily used in international science, engineering, and business. The UCUM can be used by host computers. NOTE: For calculated assays, a text box is displayed that is used to enter a UCUM result unit. The UCUM result unit can have from 0 through 20 characters.

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Correlation Factor

Section 2

Displays a text box that is used to enter a factor for c‑series assays if results require a calculation to match another system. NOTE: This element is available only for c‑series noncalculated assays. When values are configured for the Correlation Factor and Intercept parameters, the system calculates the results by using the following equations: Samples with no (Original result x Correlation factor) + dilution factor applied Intercept Samples with either a [(Original result x Correlation factor) + manual or an Intercept] x Dilution factor automated dilution factor applied

Intercept

Displays a text box that is used to enter an intercept for c‑series assays if results require a calculation to match another system. NOTE: This element is available only for c‑series noncalculated assays. When values are configured for the Correlation Factor and Intercept parameters, the system calculates the results by using the following equations: Samples with no (Original result x Correlation factor) + dilution factor applied Intercept Samples with either a [(Original result x Correlation factor) + manual or an Intercept] x Dilution factor automated dilution factor applied

Results area Low Linearity

Displays a text box that is used to enter the low limit value of the configured measurement range. NOTE: For i‑series assays, this value can be edited only when the default dilution is the first dilution. For c‑series photometric assays, the system adjusts the configured linearity value by the sample dilution factor.

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Linearity values are adjusted by the sample dilution factor in each of the following instances: • When a user-defined assay is created that uses a standard sample dilution factor other than 1.00 • When linearity values are edited for a non-user-defined assay that uses a sample dilution factor other than 1.00 High Linearity

Displays a text box that is used to enter the high limit value of the configured measurement range. NOTE: For i‑series assays, this value can be edited only when the default dilution is the first dilution. This value cannot be edited to exceed the default high-linearity value of the assay. For c‑series photometric assays, the system adjusts the configured linearity value by the sample dilution factor. Linearity values are adjusted by the sample dilution factor in each of the following instances: • When a user-defined assay is created that uses a standard sample dilution factor other than 1.00 • When linearity values are edited for a non-user-defined assay that uses a standard sample dilution factor other than 1.00

Gender

Displays the gender for configured result flags. Result flags are evaluated based on the sample data that was configured in the Patient Details flyout. The following settings may be displayed: • Male • Female • Either NOTE: This range may be used with any gender setting (male, female, and unknown).

Age Unit

Displays the age unit for the configured age range. The following settings may be displayed: • Days • Months • Years

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Age Range

Section 2

Displays the age range for configured result flags. The following settings may be displayed: • 0 - 365 (Days) • 0 - 24 (Months) • 0 - 130 (Years)

Normal Range

Displays the normal range for the configured gender and age range.

Extreme Range

Displays the extreme range for the configured gender and age range.

NOTE: Assay results are evaluated against the configured ranges in the order in which they are displayed.

Interpretation area Interpretation settings are displayed if result interpretations are configured in the assay file. Name

Displays a drop-down list that is used to select the interpretation name. Names in the drop-down list are assay specific. The following c‑series assay and calculated assay names are available for assays that do not have configured result interpretations in the assay file: • : Customized text can be configured. • : No interpretation is provided. • : A range can be configured without interpretation text. NOTE: Interpretation settings must be configured beginning with the first row. Rows cannot be skipped and the Name text box cannot be empty. To configure a range without interpretation text, must be selected.

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Range

Displays a text box that is used to enter the range for the interpretation. If a text box is not displayed, the range is not editable.

Review Required

Displays a check box that is used to select which results are held until they are reviewed and released manually.

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NOTE: Results are held if the Hold option was configured for result release mode options and the results fall within the specified interpretation range.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Print

Displays the Print flyout.

Add Result

Displays the Add Result flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save

Saves changes.

Edit Result

Displays the Edit Result flyout.

Delete Result

Displays a message requesting confirmation to delete the selected result flag range.

Text Size

This function button is unavailable on this screen.

Related information... Assay Parameters screen, page 251 Descriptions of screen elements, page 140 Linearity flagging (c‑series), page 1581

Add Result flyout, Edit Result flyout element descriptions In the Add Result flyout, the operator can add results. In the Edit Result flyout, the operator can edit results.

Elements Gender

Displays a drop-down list that is used to select the gender for the result flag: • Either • Male • Female

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Age Unit

Section 2

Displays a drop-down list that is used to select the age unit for the defined age range: • Years • Months • Days

Age Range

Displays text boxes that are used to enter the Minimum age range and the Maximum age range.

Normal Range

Displays text boxes that are used to enter the Minimum normal range and the Maximum normal range for the defined gender and age range.

Extreme Range

Displays text boxes that are used to enter the Minimum extreme range and the Maximum extreme range for the defined gender and age range.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

?

Displays Help from the operations manual for the active screen, flyout, or message code.

Related information... Assay Parameters screen, page 251 Assay Parameters screen, Results tab element descriptions (c‑series photometric, user defined), page 1564 Assay parameters (c‑series photometric, user defined), page 1540

Assay Parameters screen, Retest Rules tab element descriptions On the Retest Rules tab of the Assay Parameters screen, the operator can configure or edit retest rules.

Elements Assay Name

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Displays the assay name.

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Assay Type

Displays the assay protocol type.

Assay Status

Displays the assay status defined for the assay. NOTE: This element is not displayed for calculated assays.

Date/Time

Displays the date and time that an operator installed the assay or an operator last modified the assay parameters.

Assay Number

Displays the number of the assay file. NOTE: If an assay parameter is edited for an assay that affects result measurement, calculation, or validity checks, an asterisk is displayed next to the assay number to indicate that the assay was modified.

Assay Version

Displays the version of the assay file. NOTE: This element is not displayed for calculated assays.

Result Units

Displays the concentration units reported for the assays. NOTE: This element is not displayed for calculated assays.

Operator

Displays the identification of the operator who installed the assay or the operator who last modified the assay parameters.

Assay Retest Rules area Assay Retest Rules

Displays a list of configured retest rules. NOTE: The retest rules are displayed in the chronological order in which the rules are created. The system runs the first rule that meets the defined criteria.

Retest Rule Name

Displays a text box that is used to change the retest rule name. The retest rule name can have from 1 through 18 characters.

Result Indicator

Displays the following options:

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Result Range

Retest criteria based on result ranges.

Interpretation

Retest criteria based on interpretations.

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Exception

Section 2

Retest criteria based on exceptions. The assay is retested if one of the following message codes is generated: • 1037 Unable to calculate result. Rate reaction linearity failure. • 1038 Unable to calculate result. Insufficient absorbance reads within absorbance range. • 1039 Unable to calculate result. Absorbance exceeded optical limits. • 1040 Unable to calculate result. No absorbance reads within absorbance range. • 1041 Unable to calculate result. Reaction check failure. • 1042 Unable to calculate result. ICT reference solution voltage drift error. • 1043 Unable to calculate result. Final RLU read is outside the specification of the highest calibrator. • 1044 Unable to calculate result. Final RLU read is outside the specification of the lowest calibrator. • 1402 Unable to process test. Activated read failure. • 1403 Unable to process test. Final read failure.

Result Range

Displays text boxes that are used to enter the result range. NOTE: The Result Range element is displayed if the Result Range option is selected as the result indicator.

Interpretation

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Displays a drop-down list that is used to select the interpretation.

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NOTE: The Interpretation element is displayed if the Interpretation option is selected as the result indicator. Original Dilution

Displays a drop-down list that is used to select the dilution for the original test. The original test must be run at this dilution to be considered for retesting. NOTE: This element is unavailable for calculated assays.

Selected Retest Assays

Displays the retest assay name. Any number of assays can be defined.

Retest Dilution

Displays a drop-down list that is used to select the retest dilution for the specific retest assay.

Replicates

Displays a drop-down list that is used to select the number of replicates for the specific retest assay and dilution.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Print

Displays the Print flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save

Saves the added rules.

Add Rule

Adds the rule to the Assay Retest Rules list and clears the screen to accept a new rule.

Delete Rule

Displays a message requesting confirmation to delete the selected rule.

Retest Assays

Displays the Retest Assays flyout.

Text Size

This function button is unavailable on this screen.

Related information... Assay Parameters screen, page 251 Descriptions of screen elements, page 140 Assay parameters (c‑series photometric, user defined), page 1540 Alinity ci‑series Operations Manual

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Retest Assays flyout element descriptions In the Retest Assays flyout, the operator can select one or more retest assays.

Element Select Retest Assays Displays the options that are available to select assays for retesting. The following options are available to filter the list of assays: All option

Displays all assays that are available for retesting on the system.

i‑series option

Displays all assays that are available for retesting on one or more Alinity i processing modules.

c‑series option

Displays all assays that are available for retesting on one or more Alinity c processing modules.

Calculated option

Displays all calculated assays that are available for retesting on the system.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

?

Displays Help from the operations manual for the active screen, flyout, or message code.

Related information... Assay Parameters screen, page 251 Assay parameters (c‑series photometric, user defined), page 1540

Edit general settings of assay parameters (c‑series photometric) Required instrument status

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Stopped, Warming, or Idle

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Operator access level System administrator Perform this procedure to edit the following general settings of assay parameters for a c‑series photometric assay: • Assay name • Assay availability • Module allocation • The option to run controls by lot or cartridge • Default dilution • The option to add a dilution protocol NOTE: A user-defined dilution protocol can be created only for assays with fewer than three configured dilution protocols. The user-defined dilution protocol is retained except when an additional dilution protocol is included with an assay file revision in the same position as the user-defined dilution protocol. NOTE: All general settings of a user-defined photometric assay can be edited. If the following general settings are edited, calibration data for the assay is deleted: • Reaction mode • Primary wavelength • Secondary wavelength • Main read times • Blank read times • Reagent name • Reagent volume • Water volume • Reagent dispense mode The assay parameters of assays with pending orders cannot be edited. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Assay tab.

3.

On the Assay tab of the Configure screen, tap Assay Parameters.

4.

On the Assay Parameters screen, tap one or more assays to edit. NOTE: To filter the list of assays, tap the c-series tab.

5.

Tap View/Edit.

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Section 2

In the Assay Name text box on the General tab of the Assay Parameters screen, edit the default name of the assay if necessary. NOTE: The assay name can contain a maximum of 10 alphanumeric characters. The assay name cannot be edited for an assay that has an assay status of Correlation.

7.

In the Assay Availability drop-down list, tap an item. NOTE: For c‑series assays that use a blank calibrator set, both the calibrator set and the blank calibrator set must be configured fully to enable the assay.

8.

In the Module area, tap the module number check boxes for the modules that are allocated to load the reagent of the assay. NOTE: This parameter is available only if the Alinity ci‑series is configured with more than one processing module of the same type.

9.

In the Run Controls for Onboard Reagents by drop-down list, tap an item.

10. Under Sample, tap an option in the Default Dilution area if more than one option is available. 11. Under Sample, enter the following information as necessary to create a new dilution protocol: – Dilution Name NOTE: The dilution name can contain a maximum of 10 alphanumeric characters. – Sample (volume) – Diluted Sample (volume) – Diluent (volume) – Water (volume) NOTE: The operator has a responsibility to confirm the performance of the configured dilution protocol. 12. To save the edits to the assay parameter settings, tap Save. To delete the edits to the assay parameter settings, tap Cancel. 13. If more than one assay was selected, at the right side of the Assay Parameters screen, tap the next assay to configure, and then repeat steps 6, page 288 through 12, page 288. 14. To return to the Assay Parameters screen, tap Done. 15. To return to the Configure screen, tap Configure. Related information... Assay Parameters screen, page 251 Linearity flagging (c‑series), page 1581

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Edit general settings of assay parameters (c‑series potentiometric) Required instrument status

Stopped, Warming, or Idle

Operator access level System administrator Perform this procedure to edit the following general settings of assay parameters for a c‑series potentiometric assay: • Assay name • Assay availability • Module allocation • The option to run controls by lot or cartridge NOTE: The assay parameters of assays with pending orders cannot be edited. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Assay tab.

3.

On the Assay tab of the Configure screen, tap Assay Parameters.

4.

On the Assay Parameters screen, tap one or more assays to edit. NOTE: To filter the list of assays, tap the c-series tab.

5.

Tap View/Edit.

6.

In the Assay Name text box on the General tab of the Assay Parameters screen, edit the default name of the assay if necessary. NOTE: The assay name can contain a maximum of 10 alphanumeric characters. The assay name cannot be edited for an assay that has an assay status of Correlation.

7.

In the Assay Availability drop-down list, tap an item.

8.

In the Module area, tap the module number check boxes for the modules that are allocated to load the reagent of the assay. NOTE: This parameter is available only if the Alinity ci‑series is configured with more than one processing module of the same type.

9.

In the Run Controls for Onboard Reagents by drop-down list, tap an item.

10. To save the edits to the assay parameter settings, tap Save. To delete the edits to the assay parameter settings, tap Cancel. 11. If more than one assay was selected, at the right side of the Assay Parameters screen, tap the next assay to configure, and then repeat steps 6, page 289 through 10, page 289.

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12. To return to the Assay Parameters screen, tap Done. 13. To return to the Configure screen, tap Configure. Related information... Assay Parameters screen, page 251

Edit general settings of assay parameters (i‑series) Required instrument status

Stopped, Warming, or Idle

Operator access level System administrator Perform this procedure to edit the following general settings of assay parameters for an i‑series assay: • Assay name • Assay availability • Module allocation • The option to run controls by lot or cartridge • Default dilution NOTE: The assay parameters of assays with pending orders cannot be edited. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Assay tab.

3.

On the Assay tab of the Configure screen, tap Assay Parameters.

4.

On the Assay Parameters screen, tap one or more assays to edit. NOTE: To filter the list of assays, tap the i-series tab.

5.

Tap View/Edit.

6.

In the Assay Name text box on the General tab of the Assay Parameters screen, edit the default name of the assay if necessary. NOTE: The assay name can contain a maximum of 10 alphanumeric characters. The assay name cannot be edited for an assay that has an assay status of Correlation.

7.

In the Assay Availability drop-down list, tap an item.

8.

In the Module area, tap the module number check boxes for the modules that are allocated to load the reagent of the assay. NOTE: This parameter is available only if the Alinity ci‑series is configured with more than one processing module of the same type.

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In the Run Controls for Onboard Reagents by drop-down list, tap an item.

10. Under Dilution, tap an option in the Default Dilution area if more than one option is available. 11. To save the edits to the assay parameter settings, tap Save. To delete the edits to the assay parameter settings, tap Cancel. 12. If more than one assay was selected, at the right side of the Assay Parameters screen, tap the next assay to configure, and then repeat steps 6, page 290 through 11, page 291. 13. To return to the Assay Parameters screen, tap Done. 14. To return to the Configure screen, tap Configure. Related information... Assay Parameters screen, page 251

Edit general settings of assay parameters (calculated) Required instrument status

Stopped, Warming, or Idle

Operator access level System administrator Perform this procedure to edit an assay that uses a mathematical formula to derive a calculated result. NOTE: The assay parameters of assays with pending orders cannot be edited. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Assay tab.

3.

On the Assay tab of the Configure screen, tap Assay Parameters.

4.

On the Assay Parameters screen, tap one or more assays to edit. NOTE: To filter the list of assays, tap the Calculated tab.

5.

Tap View/Edit.

6.

In the Assay Name text box on the General tab of the Assay Parameters screen, edit the default name of the calculated assay.

7.

In the Assay Availability drop-down list, tap an item.

8.

Tap Select Assays. NOTE: The Select Assays button is unavailable for non-user-defined calculated assays that have assay numbers from 3000 through 3999.

9.

In the Select Assays flyout, tap the constituent assays that are used in the new calculated formula.

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For example, to create an LDL calculation, tap Chol, tap Ultra HDL, and then tap Trig. NOTE: Assays are assigned to the calculator buttons in the order in which the assays are selected. 10. To save the assay selection, tap Done. To delete the assay selection, tap Cancel. 11. For each assay under Selected Assay, perform one of the following steps to enter a result range: – To define a specific result range, type a value in the Minimum text box and type a value in the Maximum text box. – To define a range where the results are less than or equal to a specific value, leave the Minimum text box blank and type a value in the Maximum text box. – To define a range where the results are greater than or equal to a specific value, type a value in the Minimum text box and leave the Maximum text box blank. NOTE: If the selected assay test result falls outside the defined result range, the calculated test result becomes an exception and the result is not reported. 12. To delete the existing calculated formula, tap the Backspace key. NOTE: The formulas cannot be edited for non-user-defined calculated assays that have assay numbers from 3000 through 3999. 13. To enter a new calculated formula, tap one or more constituent assays, which are indicated by the ASSAY1, ASSAY2, ASSAY3, and ASSAY4 buttons on the calculator, and then tap the appropriate calculator function buttons. The formula is displayed as it is entered in the Calculated Formula text box. For example, to enter the formula for an LDL calculation [Cholesterol - HDL - (Triglyceride ÷ 5)], perform the following steps: a.

On the calculator, tap ASSAY1 (Cholesterol), and then tap the Minus Sign button.

b.

Tap ASSAY2 (HDL), and then tap the Minus Sign button.

c.

Tap the Opening Parenthesis button, and then tap ASSAY3 (Triglyceride).

d.

Tap the Slash Mark (divide) button, tap 5, and then tap the Closing Parenthesis button.

14. To save the edits to the assay parameter settings, tap Save. To delete the edits to the assay parameter settings, tap Cancel. 15. To return to the Assay Parameters screen, tap Done. 16. To return to the Configure screen, tap Configure. Related information... Assay Parameters screen, page 251 Assay applications (c‑series photometric), page 1539 292

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Edit calibration settings of assay parameters (c‑series photometric) Required instrument status

Stopped, Warming, or Idle

Operator access level System administrator Perform this procedure to edit the following calibration settings of assay parameters for a c‑series photometric assay: • Full calibration interval • Adjust calibration type • Adjust calibration interval • Replicates • Validity checks NOTE: The assay parameters of assays with pending orders cannot be edited. All calibration settings of a user-defined photometric assay can be edited. If the following calibration settings are edited, calibration data for the assay is deleted: • Calibration mode • Calibrator volume specifications: – Sample volume – Diluted sample volume – Diluent volume – Water volume 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Assay tab.

3.

On the Assay tab of the Configure screen, tap Assay Parameters.

4.

On the Assay Parameters screen, tap one or more assays to edit. NOTE: To filter the list of assays, tap the c-series tab.

5.

Tap View/Edit.

6.

On the Assay Parameters screen, tap the Calibration tab.

7.

Under Calibration on the Calibration tab of the Assay Parameters screen, enter the following information: – Full Calibration Interval (Hours)

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NOTE: If an assay file contains a default calibration interval other than zero, the calibration interval can be decreased but cannot be increased. This parameter is unavailable for assays when the absorbance data reduction method and the use cal factor blank calibration method are used. – Adjust Type NOTE: This parameter is unavailable for assays when the factor data reduction method and the use cal factor blank calibration method are used. – Adjust Interval – Default Ordering Type NOTE: This parameter is available only if the Adjust Type parameter is configured with a setting other than None. 8.

Under Calibrators, type the number of replicates in the Replicates text box.

9.

Under Validity Checks, enter the following information: – Blank Absorbance Range – Span – Span Absorbance Range – Expected Cal Factor – Expected Cal Factor Tolerance %

10. To save the edits to the assay parameter settings, tap Save. To delete the edits to the assay parameter settings, tap Cancel. 11. If more than one assay was selected, at the right side of the Assay Parameters screen, tap the next assay to configure, and then repeat steps 7, page 293 through 10, page 294. 12. To return to the Assay Parameters screen, tap Done. 13. To return to the Configure screen, tap Configure. Related information... Assay Parameters screen, page 251

Edit calibration settings of assay parameters (c‑series potentiometric) Required instrument status

Stopped, Warming, or Idle

Operator access level System administrator Perform this procedure to edit the following calibration settings of assay parameters for a potentiometric assay: • Full calibration interval • Replicates

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Section 2 • Slope limit (%) • Index options

NOTE: The assay parameters of assays with pending orders cannot be edited. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Assay tab.

3.

On the Assay tab of the Configure screen, tap Assay Parameters.

4.

On the Assay Parameters screen, tap one or more assays to edit. NOTE: To filter the list of assays, tap the c-series tab.

5.

Tap View/Edit.

6.

On the Assay Parameters screen, tap the Calibration tab.

7.

Under Calibration on the Calibration tab of the Assay Parameters screen, enter the following information: – Full Calibration Interval (Hours) NOTE: If an assay file contains a default calibration interval other than zero, the calibration interval can be decreased but cannot be increased. – Replicates – Slope Limit (%)

8.

Under Index Options, enter the following information: – Index Used – Index Concentration – Index Range

9.

To save the edits to the assay parameter settings, tap Save. To delete the edits to the assay parameter settings, tap Cancel.

10. If more than one assay was selected, at the right side of the Assay Parameters screen, tap the next assay to configure, and then repeat steps 7, page 295 through 9, page 295. 11. To return to the Assay Parameters screen, tap Done. 12. To return to the Configure screen, tap Configure. Related information... Assay Parameters screen, page 251

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Edit calibration settings of assay parameters (i‑series) Required instrument status

Stopped, Warming, or Idle

Operator access level System administrator Perform this procedure to configure the calibrator replicates and the calibration interval. NOTE: The assay parameters of assays with pending orders cannot be edited. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Assay tab.

3.

On the Assay tab of the Configure screen, tap Assay Parameters.

4.

On the Assay Parameters screen, tap one or more assays to edit. NOTE: To filter the list of assays, tap the i-series tab.

5.

Tap View/Edit.

6.

On the Assay Parameters screen, tap the Calibration tab.

7.

Under Calibration on the Calibration tab of the Assay Parameters screen, enter the following information: – Calibration Interval (Hours) NOTE: If an assay file contains a default calibration interval other than 0, the calibration interval can be decreased to 1 but cannot be increased. If 0 is configured, the calibration interval is not tracked. – Replicates

8.

To save the edits to the assay parameter settings, tap Save. To delete the edits to the assay parameter settings, tap Cancel.

9.

If more than one assay was selected, at the right side of the Assay Parameters screen, tap the next assay to configure, and then repeat steps 6, page 296 through 8, page 296.

10. To return to the Assay Parameters screen, tap Done. 11. To return to the Configure screen, tap Configure. Related information... Assay Parameters screen, page 251

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Edit result settings of assay parameters Required instrument status

Stopped, Warming, or Idle

Operator access level System administrator Perform this procedure to configure the results settings of assay parameters for an assay. NOTE: The assay parameters of assays with pending orders cannot be edited. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Assay tab.

3.

On the Assay tab of the Configure screen, tap Assay Parameters.

4.

On the Assay Parameters screen, tap one or more assays to edit. NOTE: To filter the list of assays, tap the tab for i-series, c-series, or Calculated.

5.

Tap View/Edit.

6.

On the Assay Parameters screen, tap the Results tab.

7.

Under Result Units on the Results tab of the Assay Parameters screen, enter the following information: – Result Units NOTE: For non-user-defined assays, tap a unit setting in the drop-down list if more than one setting is available. For user-defined assays or calculated assays, type the unit name. – Decimal Places – Result Unit UCUM NOTE: This parameter can be edited only for user-defined assays or calculated assays. – Correlation Factor NOTE: This parameter is available only for c‑series. – Intercept NOTE: This parameter is available only for c‑series.

8.

If the Result Units parameter is edited, tap Save to update the displayed result values to the new unit.

9.

Under Results, enter the following information: – Low Linearity

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NOTE: For i‑series assays, this parameter can be edited only when the default dilution is the first dilution. – High Linearity NOTE: For i‑series assays, this parameter can be edited only when the default dilution is the first dilution. The value cannot be edited to exceed the high-linearity default of the assay. NOTE: If a c‑series assay has a standard dilution factor that is not 1.00, ensure that the entered values for low linearity and high linearity are adjusted by the standard dilution factor. 10. To add a new result range, perform the following steps: a.

Tap Add Result.

b.

In the Add Result flyout, enter the following information: • Gender • Age Unit • Age Range • Normal Range • Extreme Range NOTE: An extreme range is not required.

c.

To save the edits to the result settings, tap Done. To delete the edits to the result settings, tap Cancel.

11. To edit a result range, perform the following steps: a.

In the Results list, tap a result range.

b.

Tap Edit Result.

c.

In the Edit Result flyout, edit any of the following information: • Gender • Age Unit • Age Range • Normal Range • Extreme Range

d.

To save the edits to the result settings, tap Done. To delete the edits to the result settings, tap Cancel.

12. To delete a result range, perform the following steps:

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a.

In the Results list, tap a result range.

b.

Tap Delete Result.

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Section 2 c.

When a confirmation message is displayed, tap Yes.

13. Under Interpretation, tap an interpretation in the Name drop-down list. NOTE: If is selected, type the name of the interpretation in the Name text box. 14. In the Range text box, type an interpretation range value. NOTE: Not all interpretation names and ranges are editable. 15. For the appropriate interpretation, tap Review Required. NOTE: If the Review Required check box is selected, the results are held for manual release when the Hold option is configured for the Result Release Mode and the results are within the specific interpretation range. 16. For each available interpretation, repeat steps 13, page 299 through 15, page 299. 17. Tap Save. 18. If more than one assay was selected, at the right side of the Assay Parameters screen, tap the next assay to configure, and then repeat steps 7, page 297 through 17, page 299. 19. To return to the assay list on the Assay Parameters screen, tap Done. 20. To return to the Configure screen, tap Configure. Related information... Assay Parameters screen, page 251 Configure host settings, page 228 Linearity flagging (c‑series), page 1581 Assay Parameters screen, Results tab element descriptions (c‑series photometric, user defined), page 1564 Assay parameters (c‑series photometric, user defined), page 1540

Configure retest rules Required instrument status

Stopped, Warming, or Idle

Operator access level System administrator Perform this procedure to configure one or more retest rules with criteria based on result concentration ranges, interpretations, or exceptions. NOTE: The retest rules must be defined in order since the system runs the first rule that meets the defined criteria. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Assay tab.

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3.

On the Assay tab of the Configure screen, tap Assay Parameters.

4.

On the Assay Parameters screen, tap one or more assays to configure. NOTE: To filter the list of assays, tap the tab for i-series, c-series, or Calculated.

5.

Tap View/Edit.

6.

On the Assay Parameters screen, tap the Retest Rules tab.

7.

Under Assay Retest Rules on the Retest Rules tab of the Assay Parameter screen, type the name in the Retest Rule Name text box. NOTE: Under Assay Retest Rules, if a retest rule is selected, tap the selected rule to cancel the selection.

8.

If the criteria is based on result ranges, perform the following steps: a.

In the Result Indicator area, tap the Result Range option.

b.

To enter a result range, perform one of the following steps: • To retest all samples automatically when the original results are within a specific range, type values in both result range text boxes. • To retest all samples automatically when the original results are less than or equal to a specific value, leave the first result range text box blank and type a value in the second result range text box. • To retest all samples automatically when the original results are greater than or equal to a specific value, type a value in the first result range text box and leave the second result range text box blank.

9.

If the criteria is based on interpretations, perform the following steps: a.

In the Result Indicator area, tap the Interpretation option.

b.

In the Interpretation drop-down list, tap an interpretation.

10. If the criteria is based on exceptions, tap the Exception option in the Result Indicator area. NOTE: The assay is retested if one of the following message codes is generated: – 1037 Unable to calculate result. Rate reaction linearity failure. – 1038 Unable to calculate result. Insufficient absorbance reads within absorbance range. – 1039 Unable to calculate result. Absorbance exceeded optical limits. – 1040 Unable to calculate result. No absorbance reads within absorbance range. – 1041 Unable to calculate result. Reaction check failure. – 1042 Unable to calculate result. ICT reference solution voltage drift error. – 1043 Unable to calculate result. Final RLU read is outside the specification of the highest calibrator. – 1044 Unable to calculate result. Final RLU read is outside the specification of the lowest calibrator. – 1402 Unable to process test. Activated read failure. 300

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– 1403 Unable to process test. Final read failure. 11. In the Original Dilution drop-down list, tap an original dilution. NOTE: Ensure that the values entered in step 8.b, page 300 are adjusted by the original dilution factor. 12. Tap Retest Assays. 13. In the Retest Assays flyout, tap one or more retest assays. NOTE: To filter the list of available assays, tap the option for i-series, c-series, or Calculated. Correlation assays are unavailable for selection. 14. To save the retest assay selection, tap Done. To delete the retest assay selection, tap Cancel. 15. Under Retest Dilution, tap a retest dilution in the Retest Dilution drop-down list for each assay. 16. Under Replicates, tap the number of replicates in the Replicates drop-down list for each assay. 17. To add the retest rule, tap Add Rule. 18. To add additional retest assays, repeat steps 12, page 301 through 17, page 301. 19. To save the edits to the rule settings, tap Save. To delete the edits to the rule settings, tap Cancel. 20. If more than one assay was selected, at the right side of the Assay Parameters screen, tap the next assay to configure, and then repeat steps 7, page 300 through 19, page 301. 21. To return to the Assay Parameters screen, tap Done. 22. To return to the Configure screen, tap Configure. Related information... Assay Parameters screen, page 251 Assay parameters (c‑series photometric, user defined), page 1540

Change the assay status of a correlation assay Prerequisite

Complete all remaining orders for the correlation and primary assay versions.

Required instrument status

Stopped, Warming, or Idle

Operator access level System administrator Perform this procedure to convert a correlation assay to a primary assay after correlation studies have been completed.

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When a correlation assay is converted to a primary assay, the system software performs the following functions: • The assay status of the correlation assay is changed from Correlation to Primary. • The old version of the assay file is uninstalled and cannot be reinstalled. • Specimen results, quality control results, and calibration information for both the correlation assay and the primary assay are saved. • The calibration status for the primary assay is Inactive. • The calibration status for the correlation assay is maintained. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Assay tab.

3.

On the Assay tab of the Configure screen, tap Assay Parameters.

4.

On the Assay Parameters screen, tap one or more correlation assays to convert. NOTE: To filter the list of assays, tap the i-series tab or the c-series tab.

5.

Tap View/Edit.

6.

In the Assay Status drop-down list on the General tab of the Assay Parameters screen, tap Primary.

7.

To save the edits to the assay status settings, tap Save. To delete the edits to the assay status settings, tap Cancel.

8.

To return to the Assay Parameters screen, tap Done.

9.

To return to the Configure screen, tap Done.

Related information... Assay Parameters screen, page 251

Create a calculated assay Required instrument status

Stopped, Warming, or Idle

Operator access level System administrator Perform this procedure to create an assay that uses a mathematical formula to derive a calculated result. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

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On the Configure screen, tap the Assay tab.

3.

On the Assay tab of the Configure screen, tap Assay Parameters.

4.

On the Assay Parameters screen, tap Create.

5.

In the Create Assay flyout where the Calculated option is selected, tap Done.

6.

On the General tab of the Assay Parameters screen, type the name of the calculated assay in the Assay Name text box.

7.

In the Assay Number text box, if an assay number other than the number that is displayed is needed, type a number from 2000 through 2999. NOTE: A non-user-defined calculated assay has an assay number from 3000 through 3999 that cannot be edited.

8.

In the Assay Availability drop-down list, tap an assay availability item.

9.

Tap Select Assays.

10. In the Select Assays flyout, tap the constituent assays that are used in the calculated formula. For example, to create an LDL calculation, tap Chol, tap Ultra HDL, and then tap Trig. NOTE: Assays are assigned to the calculator buttons in the order in which the assays are selected. 11. To save the assay selection, tap Done. To delete the assay selection, tap Cancel. 12. To enter a calculated formula, tap one or more constituent assays, which are indicated by the ASSAY1, ASSAY2, ASSAY3, and ASSAY4 buttons on the calculator, and then tap the appropriate calculator function buttons. The formula is displayed as it is entered in the Calculated Formula text box. For example, to enter the formula for an LDL calculation [Cholesterol - HDL - (Triglyceride ÷ 5)], perform the following steps: a.

On the calculator, tap ASSAY1 (Cholesterol), and then tap the Minus Sign button.

b.

Tap ASSAY2 (HDL), and then tap the Minus Sign button.

c.

Tap the Opening Parenthesis button, and then tap ASSAY3 (Triglyceride).

d.

Tap the Slash Mark (divide) button, tap 5, and then tap the Closing Parenthesis button.

13. For each assay under Selected Assay, perform one of the following steps to enter a result range: – To define a specific result range, type a value in the Minimum text box and type a value in the Maximum text box. – To define a range where the results are less than or equal to a specific value, leave the Minimum text box blank and type a value in the Maximum text box.

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– To define a range where the results are greater than or equal to a specific value, type a value in the Minimum text box and leave the Maximum text box blank. NOTE: If the selected assay test result falls outside the defined result range, the calculated test result becomes an exception and the result is not reported. 14. To save the edits to the calculated assay settings, tap Save. To delete the edits to the calculated assay settings, tap Cancel. 15. Tap the Results tab. 16. Under Result Units on the Results tab of the Assay Parameters screen, enter the following information: – Result Units – Decimal Places – Result Unit UCUM 17. If the Result Units parameter is edited, tap Save to update the displayed result values to the new unit. 18. Under Results, enter the following information: – Low Linearity NOTE: For i‑series assays, this parameter can be edited only when the default dilution is the first dilution. – High Linearity NOTE: For i‑series assays, this parameter can be edited only when the default dilution is the first dilution. The value cannot be edited to exceed the high-linearity default of the assay. 19. To add a new result range, perform the following steps: a.

Tap Add Result.

b.

In the Add Result flyout, enter the following information: • Gender • Age Unit • Age Range • Normal Range • Extreme Range NOTE: An extreme range is not required.

c.

To save the edits to the result settings, tap Done. To delete the edits to the result settings, tap Cancel.

20. Under Interpretation, tap an interpretation in the Name drop-down list.

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NOTE: If is selected, type the name of the interpretation in the Name text box. 21. In the Range text box, type an interpretation range value. 22. For the appropriate interpretation, tap the Review Required check box. NOTE: If the Review Required check box is selected, the results are held for manual release when the Hold option is configured for the Result Release Mode and the results are within the specific interpretation range. 23. For each available interpretation, repeat steps 20, page 304 through 22, page 305. 24. To save the edits to the review result settings, tap Save. To delete the edits to the review result settings, tap Cancel. 25. Tap the Retest Rules tab. 26. Under Assay Retest Rules on the Retest Rules tab of the Assay Parameter screen, type the name in the Retest Rule Name text box. NOTE: Under Assay Retest Rules, if a retest rule is selected, tap the selected rule to cancel the selection. 27. If the criteria is based on result ranges, perform the following steps: a.

In the Result Indicator area, tap the Result Range option.

b.

To enter a result range, perform one of the following steps: • To retest all samples automatically when the original results are within a specific range, type values in both result range text boxes. • To retest all samples automatically when the original results are less than or equal to a specific value, leave the first result range text box blank and type a value in the second result range text box. • To retest all samples automatically when the original results are greater than or equal to a specific value, type a value in the first result range text box and leave the second result range text box blank.

28. If the criteria is based on interpretations, perform the following steps: a.

In the Result Indicator area, tap the Interpretation option.

b.

In the Interpretation drop-down list, tap an interpretation.

29. If the criteria is based on exceptions, tap the Exception option in the Result Indicator area. NOTE: The assay is retested if one of the following message codes is generated: – 1037 Unable to calculate result. Rate reaction linearity failure. – 1038 Unable to calculate result. Insufficient absorbance reads within absorbance range. – 1039 Unable to calculate result. Absorbance exceeded optical limits. – 1040 Unable to calculate result. No absorbance reads within absorbance range. – 1041 Unable to calculate result. Reaction check failure.

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– 1042 Unable to calculate result. ICT reference solution voltage drift error. – 1043 Unable to calculate result. Final RLU read is outside the specification of the highest calibrator. – 1044 Unable to calculate result. Final RLU read is outside the specification of the lowest calibrator. – 1402 Unable to process test. Activated read failure. – 1403 Unable to process test. Final read failure. 30. In the Original Dilution drop-down list, tap an original dilution. 31. Tap Retest Assays. 32. In the Select Retest Assays flyout, tap the retest assays. 33. To save the retest assay selection, tap Done. To delete the retest assay selection, tap Cancel. 34. Under Retest Dilution, tap a retest dilution in the Retest Dilution drop-down list for each assay. 35. Under Replicates, tap the number of replicates in the Replicates drop-down list for each assay. 36. To add additional retest assays, repeat steps 31, page 306 through 35, page 306. 37. To save the edits to the retest rule settings, tap Add Rule. To delete the edits to the retest rule settings, tap Cancel. 38. To save the edits to the assay file and return to the Assay Parameters screen, tap Done. 39. To return to the Configure screen, tap Configure. Related information... Assay Parameters screen, page 251 Create a user-defined assay (c‑series photometric), page 1598 Assay applications (c‑series photometric), page 1539

Calibrator Set screen On the Calibrator Set screen, the operator can perform the following functions: • View calibrator data. • View or print calibrator value sheets. • Create new calibrator lots by scanning the bar codes on the calibrator cartons. The supervisor and the system administrator can perform the following functions: • Manually create new calibrator lots or import calibrator data to create new calibrator lots. • Edit calibrator data.

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Section 2 • Delete calibrator lots.

The system administrator can delete imported calibrator data. Related information... Configure screen, Assay tab, page 250 Calibrator Set screen element descriptions, page 307 Calibrator Set View/Edit screen element descriptions, page 308 Import Calibrators screen element descriptions (c‑series), page 309 View calibrator lot data, page 310 Create a new calibrator master lot (c‑series), page 311 Create a new calibrator master lot (i‑series), page 313 Import calibrator data (c‑series), page 314 Delete imported calibrator data (c‑series), page 315 Delete a calibrator lot, page 316 Descriptions of calibrator import statuses (c‑series), page 317 Edit calibrator data (c‑series), page 317 Edit calibrator data (i‑series), page 319 View or print a calibrator value sheet (c‑series), page 320

Calibrator Set screen element descriptions The Calibrator Set screen displays the calibrator sets that are configured on the system.

Element Calibrator Sets

Displays the total number of calibrator sets that are configured on the system.

Function buttons Configure

Navigates to the previous configuration screen.

View/Edit

Navigates to the Calibrator Set View/Edit screen for the selected calibrator set.

Delete

Displays a message requesting confirmation to delete the selected items.

Import

Navigates to the Import Calibrators screen.

Text Size

Increases or decreases the size of text displayed.

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Related information... Calibrator Set screen, page 306 Descriptions of screen elements, page 140

Calibrator Set View/Edit screen element descriptions The Calibrator Set View/Edit screen displays the data for the selected calibrator set.

Elements Calibrator Set Name

Displays the name of the selected calibrator set.

Master Lot

Displays the master lot number of the selected calibrator set. The master lot number is located on the label of the calibrator vial or bottle and is designated by the CN symbol. The master lot number corresponds to the lot number of the material contained in the calibrator vial or bottle. The master lot number can have a maximum of nine characters, but a level character can be appended at the end of the number. NOTE: The lot symbol on the carton label represents the lot number of the packaged kit. The following list provides two examples: • CN 74297LI00A is Master Lot 74297LI00. • CN 49059M5001 is Master Lot 49059M500.

Default

Displays a check box that is used to identify the master lot number that is displayed as the default master lot number for the calibrator set. NOTE: The first configured master lot number is identified as the default master lot number. The default master lot number can be changed when two or more lot numbers are configured.

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Expiration Date

Displays the expiration date of the selected calibrator set.

Level

Displays the number of levels defined for the calibrator set. Concentration values must be defined for all levels of the default master lot number.

Assay

Identifies the name of the assays in the calibrator set.

Cal A through Cal F

Displays the concentrations of calibrator levels A through F.

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Cal 1 through Cal 6

Displays the concentrations of calibrator levels 1 through 6.

Low, High

Displays the concentrations of the low and high calibrators.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Print

Displays the Print flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Save

Saves changes.

Delete

Displays a message requesting confirmation to delete the selected items.

Text Size

Increases or decreases the size of text displayed.

Related information... Calibrator Set screen, page 306 Descriptions of screen elements, page 140

Import Calibrators screen element descriptions (c‑series) The Import Calibrators screen displays the calibrator files that are available for import to the selected calibrator set. The calibrator files are used to configure a new lot number for an existing calibrator set and can be located on the system or on a USB flash drive.

Elements Calibration Set

Displays the calibrator set name of the calibrator data file selected for import.

Lot Number

Displays the lot number of the calibrator data file selected for import.

Number of Levels

Displays the number of calibrator levels defined for the calibrator data file selected for import.

Expiration Date

Displays the expiration date of the calibrator data file selected for import.

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button

Folder name button

Section 2

The Previous Folder button navigates to the previously selected folder. Displays the currently selected folder. The Home button navigates to the hard drive folder.

Calibrator Files

Displays the calibrator data files in the specified folder that are available for import for the selected calibrator set.

File Assay/Number

Displays the assay name and assay number for each assay in the calibrator data file selected for import.

System Assay/Number Displays the assay name and assay number for each assay on the system that corresponds to the assay number in the calibrator data file selected for import. Status

Displays the import status of the assay. Data for an assay that has a status of OK is imported. Data is not imported for assays that have the following statuses: • No Assay • Previously Defined

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Delete

Deletes the selected calibrator file on the hard drive. Files on a USB flash drive cannot be deleted.

Import

Imports the selected calibrator file.

Text Size

Increases or decreases the size of text displayed.

Related information... Calibrator Set screen, page 306 Descriptions of screen elements, page 140

View calibrator lot data Perform this procedure to view calibrator lot data for configured calibrator sets. 1.

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On the menu bar, tap System, and then tap Configure.

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NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu. 2.

On the Configure screen, tap the Assay tab.

3.

On the Assay tab of the Configure screen, tap Calibrator Set.

4.

In the list on the Calibrator Set screen, tap a calibrator set.

5.

Tap View/Edit to display the calibrator data for the default master lot number.

6.

In the Master Lot drop-down list under Calibrator Set Configuration, tap other calibrator master lot numbers to display.

7.

To return to the list of calibrator sets on the Calibrator Set screen, tap Done.

Related information... Calibrator Set screen, page 306

Create a new calibrator master lot (c‑series) Operator access level Operator and supervisor Perform this procedure to create a new calibrator master lot for an existing calibrator set. Operators can create a new calibrator master lot by scanning a bar code on a calibrator kit. NOTE: The product documentation for calibrators that have this capability states that calibrator lots may be configured by using the bar code label on the calibrator carton. Supervisors can configure parameters manually for a new calibrator master lot and can edit calibrator values. The supervisor access level is necessary to configure a new calibrator master lot for calibrators that have lot-specific calibrator values. IMPORTANT: When the bar code on the calibrator carton is scanned, only the master lot number and the expiration date are updated. The calibrator values remain from the previously configured master lot. To configure a new master lot for calibrators that have lot-specific calibrator values, the supervisor must verify that the correct values are entered and must edit them if necessary, or the supervisor must configure the master lot by importing the calibrator data. NOTE: Calibrator data is retained on the system for a time period of 6 months past the calibrator expiration date. After the time period has elapsed, the system automatically deletes the calibrator data. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Assay tab.

3.

On the Assay tab of the Configure screen, tap Calibrator Set.

4.

In the list on the Calibrator Set screen, tap a calibrator set.

5.

Tap View/Edit to display the calibrator data for the default master lot number.

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NOTE: The first configured master lot number is designated automatically as the default master lot number. 6.

Use the bar code scanner to scan the bar code on the calibrator carton. The system automatically creates a new calibrator master lot with the master lot number and expiration date from the bar code on the calibrator carton. To manually enter the master lot number and the expiration date, perform the following steps: a.

In the Master Lot drop-down list under Calibrator Set Configuration, tap New Lot.

b.

In the Master Lot text box, type the calibrator master lot number. The master lot number is located on the label of the calibrator vial or bottle and is designated by the CN symbol. The master lot number corresponds to the lot number of the material contained in the calibrator vial or bottle. The master lot number can have a maximum of nine characters, but a character that represents the calibrator level is appended at the end of the number. The following list provides two examples: • CN 74297LI00A is Master Lot 74297LI00. • CN 49059M5001 is Master Lot 49059M500.

c. 7.

In the Expiration Date text box, type the calibrator expiration date.

To configure the new calibrator master lot as the default, tap the Default check box. NOTE: The first configured master lot number is designated automatically as the default master lot number. The default master lot can be changed when the instrument status is Running or Processing if no orders are present for the calibrator set and if the calibrator set is not loaded in the reagent carousel. The data must be defined for all assays and all levels of the default master lot.

8.

In the Store Onboard area, tap Yes or No to indicate whether the calibrator set is stored in the reagent carousel: – If Yes is selected, type the number of hours in the Onboard Stability (Hours) text box. NOTE: Onboard storage capability is available for some calibrators. To identify the calibrators that have this capability and the onboard stability time for each calibrator, see the product documentation. – If No is selected, proceed to step 9, page 312.

9.

Perform one of the following steps: – Enter a calibrator value for each assay and each level in the calibrator set. NOTE: Before entering the calibrator values, ensure that the Result Units parameter of the assay file aligns with the result units of the calibrator values to be entered. – Confirm that the entered value for each assay and each level in the calibrator set aligns with the calibrator master lot. Edit the values if necessary.

10. To save the calibrator master lot settings, tap Save. To delete the calibrator master lot settings, tap Cancel. 312

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11. To return to the list of calibrator sets on the Calibrator Set screen, tap Done. Related information... Calibrator Set screen, page 306 Automated calibration ordering, page 656 Assay parameters (c‑series photometric, user defined), page 1540 New Cal Set flyout element descriptions (c‑series photometric, user defined), page 1563

Create a new calibrator master lot (i‑series) Perform this procedure to create a new calibrator master lot for an existing calibrator set by scanning the bar code on the calibrator carton. NOTE: Calibrator data is retained on the system for a time period of 6 months past the calibrator expiration date. After the time period has elapsed, the system automatically deletes the calibrator data. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Assay tab.

3.

On the Assay tab of the Configure screen, tap Calibrator Set.

4.

In the list on the Calibrator Set screen, tap a calibrator set.

5.

Tap View/Edit to display the calibrator data for the default master lot number. NOTE: The first configured master lot number is designated automatically as the default master lot number.

6.

Use the bar code scanner to scan the bar code on the calibrator carton. The system automatically creates a new calibrator master lot with the master lot number and expiration date from the bar code on the calibrator carton. To manually enter the master lot number and the expiration date, perform the following steps: a.

In the Master Lot drop-down list under Calibrator Set Configuration, tap New Lot.

b.

In the Master Lot text box, type the calibrator master lot number. The master lot number is located on the label of the calibrator vial or bottle and is designated by the CN symbol. The master lot number corresponds to the lot number of the material contained in the calibrator vial or bottle. The master lot number can have a maximum of nine characters, but a character that represents the calibrator level is appended at the end of the number. The following list provides two examples: • CN 74297LI00A is Master Lot 74297LI00. • CN 49059M5001 is Master Lot 49059M500.

c.

In the Expiration Date text box, type the calibrator expiration date.

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To configure the new calibrator master lot as the default, tap the Default check box. NOTE: The first configured master lot number is designated automatically as the default master lot number. The default master lot can be changed when the instrument status is Running or Processing if no orders are present for the calibrator set. The data must be defined for all assays and all levels of the default master lot.

8.

To save the calibrator master lot settings, tap Save. To delete the calibrator master lot settings, tap Cancel.

9.

To return to the list of calibrator sets on the Calibrator Set screen, tap Done.

Related information... Calibrator Set screen, page 306 Automated calibration ordering, page 656

Import calibrator data (c‑series) Operator access level Supervisor Required materials

A calibrator data file on a USB flash drive or on the hard drive

Perform this procedure to import calibrator data files to create a new calibrator lot for a configured calibrator set. NOTE: Imported calibrator data is retained on the system for a time period of 6 months past the calibrator expiration date. After the time period has elapsed, the system automatically deletes the imported calibrator data. Calibrator data files may be accessed at abbottdiagnostics.com or may be requested through Abbott Mail. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Assay tab.

3.

On the Assay tab of the Configure screen, tap Calibrator Set.

4.

In the list on the Calibrator Set screen, tap a calibrator set.

5.

Tap Import. On the Import Calibrators screen, the Hard Drive button is selected.

6.

Tap the calibrator data file to import. If the calibrator data file is located on a USB flash drive, perform the following steps:

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a.

Insert the USB flash drive.

b.

Tap the USB Flash Drive button.

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Tap the appropriate folder.

d.

Tap the calibrator data file to import.

NOTE: The assay names and assay numbers for the data in the file and for the corresponding system assays are displayed with an import status. Data for all calibrator levels is imported for assays that have a status of OK. No data is imported for assays that have a status of No Assay or Previously Defined. These statuses are displayed in red text. 7.

For the selected calibrator data file, perform one of the following steps: – If no data is available to import because the assays have a status of No Assay or Previously Defined, tap Done to return to the Calibrator Set screen and end the procedure. – To import the data for assays that have a status of OK, tap Import.

8.

Under Calibrator Set Configuration on the Calibrator Set screen, tap the Default check box to configure the calibrator master lot as the default. NOTE: The first configured master lot number is designated automatically as the default master lot number. The default master lot number can be changed when the instrument status is Running or Processing if no orders are pending for the calibrator set and the calibrator set is not loaded in the reagent carousel. For all assays and all levels of the default master lot number, the data must be defined.

9.

To save the calibrator data file settings, tap Save. To delete the calibrator data file settings, tap Cancel.

10. To return to the list of calibrator sets on the Calibrator Set screen, tap Done. 11. If a USB flash drive was inserted, remove the USB flash drive. Calibrator data files that are imported from a USB flash drive are saved to an internal storage location on the system. To reinstall the calibrator data files on a future date, tap the Hard Drive button. Related information... Calibrator Set screen, page 306 Insert and remove a USB flash drive, page 764 Automated calibration ordering, page 656

Delete imported calibrator data (c‑series) Operator access level System administrator Perform this procedure to delete calibrator data files from the user interface computer. After a calibrator data file is deleted, the file is unavailable to be reinstalled.

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NOTE: This procedure cannot be used to delete calibrator data files from a USB flash drive. Imported calibrator data is deleted automatically from the system 6 months after the calibrator data has reached the expiration date. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Assay tab.

3.

On the Assay tab of the Configure screen, tap Calibrator Set.

4.

In the list on the Calibrator Set screen, tap a calibrator set.

5.

Tap Import. On the Import Calibrators screen, the Hard Drive button is selected.

6.

In the Calibrator Files list, tap the calibrator data file to delete.

7.

Tap Delete.

8.

To delete the calibrator data file, tap Continue. To cancel the delete function, tap Cancel.

9.

To return to the list of calibrator sets on the Calibrator Set screen, tap Done.

Related information... Calibrator Set screen, page 306

Delete a calibrator lot Required instrument status

Stopped, Warming, or Idle

Operator access level Supervisor Perform this procedure to delete a calibrator master lot number. NOTE: The default master lot number cannot be deleted. To delete a master lot number that is configured as the default, first change the default master lot number. The calibrator master lot number is deleted automatically from the system 6 months after the calibrator lot has reached the configured expiration date. 1.

On the menu bar, tap System and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

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2.

On the Configure screen, tap the Assay tab.

3.

On the Assay tab of the Configure screen, tap Calibrator Set.

4.

In the list on the Calibrator Set screen, tap a calibrator set.

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Tap View/Edit to display the calibrator data for the default master lot number.

6.

In the Master Lot drop-down list under Calibrator Set Configuration, tap a calibrator master lot number that is not the default.

7.

Tap Delete.

8.

When a confirmation message is displayed, tap Continue.

9.

To return to the list of calibrator sets on the Calibrator Set screen, tap Done.

Related information... Calibrator Set screen, page 306

Descriptions of calibrator import statuses (c‑series) Calibrator import status information is used to resolve issues that occur when calibrator data is imported. The system displays one calibrator import status for each assay on the Import Calibrators screen. The following list provides descriptions of the calibrator import statuses: OK

The imported assay has the same assay number and result units as the assay that was configured on the system. The data is imported.

No Assay

No assay on the system has the same assay number in the imported file. The data is not imported.

Previously Defined

The data has been manually entered or imported. The data is not imported.

Related information... Calibrator Set screen, page 306

Edit calibrator data (c‑series) Required instrument status

Stopped, Warming, or Idle

Operator access level System administrator Perform this procedure to edit calibrator data settings. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Assay tab.

3.

On the Assay tab of the Configure screen, tap Calibrator Set.

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4.

In the list on the Calibrator Set screen, tap a calibrator set.

5.

Tap View/Edit to display the calibrator data for the default master lot number.

6.

In the Master Lot drop-down list under Calibrator Set Configuration, tap a calibrator master lot number that is not the default.

7.

To configure the calibrator master lot number as the default, tap the Default check box. NOTE: The default master lot number can be changed when the instrument status is Running or Processing if no orders are pending for the calibrator set and the calibrator set is not loaded in the reagent carousel. The default master lot number can be changed when the instrument status is Idle if the calibrator set is not loaded in the reagent carousel. The default master lot number must include all assays that are assigned to the calibrator set.

8.

In the Expiration Date text box, enter the calibrator expiration date. NOTE: The expiration date cannot be edited if one of the following situations occurred: – The calibrator master lot number has expired. – The calibrator master lot number was created by scanning the bar code on the calibrator carton. – The calibrator master lot number was created by importing calibrator data.

9.

In the Store Onboard area, tap Yes or No to indicate whether the calibrator set is stored in the reagent carousel: – If Yes is selected, type the number of hours in the Onboard Stability (Hours) text box. NOTE: Onboard storage capability is available for some calibrators. To identify calibrators that have this capability and the onboard stability time for each calibrator, see the product documentation. – If No is selected, proceed to step 11, page 318.

10. For photometric assay calibrator sets, tap Level, and then enter a calibrator value to increase the number of levels in the calibrator. NOTE: The number of calibrator levels cannot be decreased for a previously configured calibrator. For all enabled assays and all levels of the default master lot number, the data must be defined. 11. Enter calibrator values for all levels of each enabled assay if the values are not present. NOTE: Calibrator values cannot be edited for a calibrator master lot number that is created by scanning the bar code on the calibrator carton label. 12. To delete the selected calibrator master lot number, perform the following steps: a.

Tap Delete.

b.

When a confirmation message is displayed, tap Continue.

NOTE: A calibrator master lot number cannot be deleted if the master lot number is the default or if the calibrator is loaded in the reagent carousel. 13. To save the edits to the calibrator master lot settings, tap Save.

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To delete the edits to the calibrator master lot settings, tap Cancel. 14. To edit another calibrator master lot number, tap a master lot number in the Master Lot drop-down list, and then repeat steps 7, page 318 through 13, page 318. 15. To return to the list of calibrator sets on the Calibrator Set screen, tap Done. Related information... Calibrator Set screen, page 306

Edit calibrator data (i‑series) Required instrument status

Stopped, Warming, or Idle

Operator access level System administrator Perform this procedure to change the default calibrator master lot number and to delete a calibrator master lot number. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Assay tab.

3.

On the Assay tab of the Configure screen, tap Calibrator Set.

4.

In the list on the Calibrator Set screen, tap a calibrator set.

5.

Tap View/Edit to display the calibrator data for the default master lot number.

6.

In the Master Lot drop-down list under Calibrator Set Configuration, tap a calibrator master lot number that is not the default.

7.

To configure the calibrator master lot number as the default, tap the Default check box. NOTE: The default master lot number can be changed when the instrument status is Running or Processing if no orders are pending for the calibrator set. The default master lot number must include all assays that are assigned to the calibrator set.

8.

To delete the selected calibrator master lot number, perform the following steps: a.

Tap Delete.

b.

When a confirmation message is displayed, tap Yes.

NOTE: A calibrator master lot number cannot be deleted if the master lot number is the default. 9.

To save the edits to the calibrator master lot settings, tap Save. To delete the edits to the calibrator master lot settings, tap Cancel.

10. To edit another calibrator master lot number, tap a master lot number in the Master Lot drop-down list, and then repeat steps 7, page 319 through 9, page 319.

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11. To return to the list of calibrator sets on the Calibrator Set screen, tap Done. Related information... Calibrator Set screen, page 306

View or print a calibrator value sheet (c‑series) Required materials

USB flash drive (Print to File option only)

Perform this procedure to view or print a calibrator value sheet or to save the calibrator value sheet as a portable document format (PDF) file. NOTE: A calibrator value sheet is available only for a calibrator master lot that was created from an imported file that has not previously been deleted on the hard drive. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Assay tab.

3.

On the Assay tab of the Configure screen, tap Calibrator Set.

4.

In the list on the Calibrator Set screen, tap a calibrator set.

5.

Tap View/Edit to display the calibrator data for the default master lot number.

6.

In the Master Lot drop-down list under Calibrator Set Configuration, tap a calibrator master lot number that is not the default.

7.

Tap Print.

8.

Under Report Selection in the Print flyout, tap Calibrator Insert.

9.

To rotate the document, use the Rotate toolbar.

10. To browse the document, use the Page toolbar. 11. To increase or decrease the font size in the document, use the Zoom toolbar. 12. To fit the document to the window width ( ) or to resize the document to fit one full page in the window ( ), use the Fit toolbar. 13. To find a word or phrase in the document, use the Find toolbar. 14. In the Print flyout, choose a printer or tap Print to File in the Print Location drop-down list. 15. To print the document, enter the number of copies to print, and then tap Print. 16. If Print to File was selected in the Print Location drop-down list, perform the following steps to indicate the file destination:

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a.

Insert a USB flash drive.

b.

Tap the appropriate USB flash drive.

c.

Tap the destination folder.

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Tap OK.

e.

Remove the USB flash drive.

17. To return to Calibrator Set Configuration on the Calibrator Set screen, tap Done. Related information... Calibrator Set screen, page 306 Insert and remove a USB flash drive, page 764

Install/Uninstall Assays screen On the Install/Uninstall Assays screen, the operator can view or print assay installation reports. The system administrator can perform the following functions: • Install assays. • Uninstall assays. • Delete assays on the hard drive. Related information... Configure screen, Assay tab, page 250 Install/Uninstall Assays screen, Available Files tab element descriptions, page 321 Install/Uninstall Assays screen, Installed Files tab element descriptions, page 323 Descriptions of file update statuses, page 324 Descriptions of assay file reagent statuses, page 325 Install assay files, page 325 Uninstall assay files, page 327 Delete assay files, page 328

Install/Uninstall Assays screen, Available Files tab element descriptions The Available Files tab displays all assay files that are available for installation on the system or on a USB flash drive.

Elements Available Assays

Displays the number of assays that are available for installation for the currently selected option.

All option

Displays all assay files that are available for installation.

i‑series option

Displays all assay files that are available for installation on one or more Alinity i processing modules.

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c‑series option

Displays all assay files that are available for installation on one or more Alinity c processing modules.

Calculated option

Displays all calculated assay files that are available for installation.

Status

Displays the status of the file installation. The status includes file integrity and file installation success or failure.

button

Folder name button

The Previous Folder button navigates to the previously selected folder. Displays the currently selected folder. The Home button navigates to the hard drive folder.

Assay Name

Displays the name of the assay file.

Assay Number

Displays the number of the assay file.

Version

Displays the version of the assay file.

Update Status

Displays the file update status of all assay files that are available on the system. The Available Files tab has five file update statuses: • Current • New • Update • Installed • Previous

Reagent Status

Displays the assay file reagent status to determine if a new reagent lot is necessary to support a new assay file. The Available Files tab has three assay file reagent statuses: • OK • New reagent needed • Unknown

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Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Select All

Selects or deselects all items in a list. The button switches between Select All and Deselect All.

Print

Displays the Print flyout.

Install

Installs the selected files on the current screen.

Delete

Displays a message requesting confirmation to delete the selected items.

Text Size

Increases or decreases the size of text displayed.

Related information... Install/Uninstall Assays screen, page 321 Descriptions of screen elements, page 140 Descriptions of assay file reagent statuses, page 325 Descriptions of file update statuses, page 324

Install/Uninstall Assays screen, Installed Files tab element descriptions The Installed Files tab displays all assay files that are installed on the system.

Elements Installed Assays

Displays the number of assays installed for the currently selected option.

All option

Displays all assay files that are available for installation.

i‑series option

Displays all assay files that are available for installation on one or more Alinity i processing modules.

c‑series option

Displays all assay files that are available for installation on one or more Alinity c processing modules.

Calculated option

Displays all calculated assay files that are available for installation.

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Status

Displays the status of the file installation. The status includes file integrity and file installation success or failure.

Assay Name

Displays the name of the assay file.

Assay Number

Displays the number of the assay file.

Version

Displays the version of the assay file

Release Status

Displays the status of the assay file. The Installed Files tab has one file status: Released.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Select All

Selects or deselects all items in a list. The button switches between Select All and Deselect All.

Print

Displays the Print flyout.

Uninstall

Displays a message requesting confirmation to uninstall files from the user interface.

Text Size

Increases or decreases the size of text displayed.

Related information... Install/Uninstall Assays screen, page 321 Descriptions of screen elements, page 140

Descriptions of file update statuses File update status information is used to determine if an assay file or a procedure file is new, is updated, or is installed on the system. The following list provides descriptions of the file update statuses. The statuses are described in the order in which they are sorted:

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Current

The file is the same version as the file that is installed on the system.

New

The file is not installed on the system.

Update

The file is a newer version than the file that is installed on the system.

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Installed

The file was installed successfully. NOTE: Installed is a temporary status that is updated after the screen is refreshed.

Previous

The file is an older version than the file that is installed on the system.

Related information... Install/Uninstall Assays screen, page 321 Install/Uninstall Assays screen, Available Files tab element descriptions, page 321 Import/Export Assays screen, Export Files tab element descriptions (c‑series), page 329 Import/Export Assays screen, Import Files tab element descriptions (c‑series), page 329 Install/Uninstall Procedures screen, page 367 Install/Uninstall Procedures screen, Available Files tab element descriptions, page 368 Install/Uninstall Procedures screen, Installed Files tab element descriptions, page 369

Descriptions of assay file reagent statuses Assay file reagent status information is used to determine if a new reagent lot is necessary to support a new assay file. The following list provides descriptions of the assay file reagent statuses. The statuses are described in the order in which they are sorted: OK

A new reagent lot is not necessary to support the new assay file.

New reagent needed

A new reagent lot is necessary to support the new assay file.

Unknown

The assay file is new and has not been installed previously on the system. The reagent lot information is unknown.

Related information... Install/Uninstall Assays screen, page 321 Install/Uninstall Assays screen, Available Files tab element descriptions, page 321

Install assay files Required instrument status

Stopped, Warming, or Idle

Operator access level System administrator Required materials

An assay file on the hard drive or on a USB flash drive

Perform this procedure to install assay files on the system. Alinity ci‑series Operations Manual

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NOTE: When an assay is installed that uses the data from a reference assay, the reference assay must be installed first. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Assay tab.

3.

On the Assay tab of the Configure screen, tap Install/Uninstall Assays. On the Available Files tab of the Install/Uninstall Assays screen, the Hard Drive button is selected. NOTE: If the assay is located on a USB flash drive, insert the USB flash drive, and then tap the USB Flash Drive button.

4.

Under Assays on the Available Files tab, tap one or more assay files to install (or tap Select All). NOTE: To filter the list of installed assay files, tap the option for i-series, c-series, or Calculated.

5.

To print the assay-specific installation information, tap Print.

6.

Review the specific information for each assay before installation. Assays may have specific installation requirements.

7.

Tap Install.

8.

When a confirmation message is displayed because an updated assay file requires a new version of the reagent, refer to the assay-specific installation information to verify the reagent requirements. Do not install the new assay file until the correct reagent has been received. Tap one of the following options: – Tap Yes to install the new assay file. – Tap No to cancel the specific assay installation. – Tap Cancel to cancel all assay file installations if more than one assay file was selected.

9.

When a confirmation message is displayed because an assay file requires an update, tap one of the following options: – Tap Yes to install a correlation version of the assay file. NOTE: The original assay file version and the correlation assay file version remain in the system software so that both versions of the assay file can be run concurrently. – Tap No to replace the original assay file with the new assay file. – Tap Cancel to cancel the assay installation and return to the Install/Uninstall Assays screen.

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10. Refer to the assay-specific installation information for specific calibration and quality control requirements. Calibration and all levels of controls may need to be run before results are reported. 11. To return to the Configure screen, tap Done. Assay files that are installed from a USB flash drive are saved to an internal storage location on the system. Related information... Install/Uninstall Assays screen, page 321 Uninstall assay files, page 327 Create a control order, page 686 Create a calibration order, page 688 System checkout, page 166 Insert and remove a USB flash drive, page 764

Uninstall assay files Required instrument status

Stopped, Warming, or Idle

Operator access level System administrator Perform this procedure to uninstall assay files from the system software. Assay files remain available to be reinstalled from the Available Files tab of the Install/Uninstall Assays screen. NOTE: An assay file cannot be uninstalled if the assay file is referenced by another assay, has pending orders, is a constituent of a calculated assay, or is a primary assay of the correlation version that is installed. When an assay file is uninstalled, calibrations for the assay file and any assay configuration including controls are deleted. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Assay tab.

3.

On the Assay tab of the Configure screen, tap Install/Uninstall Assays.

4.

On the Install/Uninstall Assays screen, tap the Installed Files tab.

5.

On the Installed Files tab, tap one or more assay files to uninstall (or tap Select All). NOTE: To filter the list of installed assay files, tap the option for i-series, c-series, or Calculated.

6.

Tap Uninstall.

7.

When a confirmation message is displayed, tap Yes.

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Section 2

To return to the Configure screen, tap Done.

Related information... Install/Uninstall Assays screen, page 321 Install assay files, page 325

Delete assay files Required instrument status

Stopped, Warming, or Idle

Operator access level System administrator Perform this procedure to delete assay files from the user interface computer. After an assay file is deleted, the assay file is unavailable to be reinstalled. NOTE: An assay file cannot be deleted if the assay file is referenced by another assay, has pending orders, or is a constituent of a calculated assay. 1.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

2.

On the Configure screen, tap the Assay tab.

3.

On the Assay tab of the Configure screen, tap Install/Uninstall Assays.

4.

On the Available Files tab of the Install/Uninstall Assays screen, tap one or more assay files to delete (or tap Select All). NOTE: To filter the list of installed assay files, tap the option for i-series, c-series, or Calculated.

5.

Tap Delete.

6.

When a confirmation message is displayed, tap Yes.

7.

To return to the Configure screen, tap Done.

Related information... Install/Uninstall Assays screen, page 321

Import/Export Assays screen (c‑series) On the Import/Export Assays screen, the operator can export assay files for import on an Alinity ci‑series by using a c‑series processing module. The system administrator can import assay files to an Alinity ci‑series by using a c‑series processing module. Related information... Configure screen, Assay tab, page 250

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Import/Export Assays screen, Export Files tab element descriptions (c‑series), page 329 Import/Export Assays screen, Import Files tab element descriptions (c‑series), page 329 Select Items window element descriptions (c‑series), page 331 Export assay files (c‑series), page 331 Import assay files (c‑series), page 332

Import/Export Assays screen, Export Files tab element descriptions (c‑series) The Export Files tab displays all c‑series photometric assay files that are available to export.

Elements Status

Displays the status of the assay to be exported or when an attempt has been made to export an assay.

Assay Name

Displays the name of the assay file.

Assay Number

Displays the number of the assay file.

Version

Displays the version of the assay file

Release Status

Displays the status of the assay file. The Installed Files tab has one file status: Released.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Select All

Selects or deselects all items in a list. The button switches between Select All and Deselect All.

Export

Initiates the process to export an assay file.

Text Size

Increases or decreases the size of text displayed.

Related information... Import/Export Assays screen (c‑series), page 328 Descriptions of screen elements, page 140 Descriptions of file update statuses, page 324

Import/Export Assays screen, Import Files tab element descriptions (c‑series) The Import Files tab displays all assay files that are available to import from a USB flash drive.

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Elements Status

button

Folder name button

Displays the status of the file import. The status includes file integrity and file import success or failure. The Previous Folder button navigates to the previously selected folder. Displays the currently selected folder. The Home button navigates to the hard drive folder.

Assay Name

Displays the name of the assay file.

Assay Number

Displays the number of the assay file.

Version

Displays the version of the assay file

Update Status

Displays the status of the assay file. The Import Files tab has five file update statuses: • Current • New • Update • Installed • Previous

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Select All

Selects or deselects all items in a list. The button switches between Select All and Deselect All.

Import

Imports the selected files.

Text Size

Increases or decreases the size of text displayed.

Related information... Import/Export Assays screen (c‑series), page 328 Descriptions of screen elements, page 140

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Select Items window element descriptions (c‑series) The Select Items window displays the drive and folders that are used to export an assay file.

Elements button

The Previous Folder button navigates to the previously selected folder.

button

The Selected Folders button displays all previously selected folders.

Folder name button

Displays the currently selected folder. The Home button navigates to the hard drive folder.

Name

Displays the name of the drive or folder.

Last Update

Displays the date and time that the files in the folder were last updated.

Function buttons OK

Saves the file and closes the window.

Cancel

Cancels the operation and closes the window.

?

Displays Help from the operations manual for the active screen, flyout, or message code.

Related information... Import/Export Assays screen (c‑series), page 328

Export assay files (c‑series) Required materials

USB flash drive

Perform this procedure to export c‑series photometric assay files. NOTE: Multiple versions of the same assay file can be exported to the same location on a USB flash drive. If an assay file is exported to a location occupied by the same assay file and version number, the data in the existing file is overwritten.

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Insert the USB flash drive.

2.

On the menu bar, tap System, and then tap Configure.

Section 2

NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu. 3.

On the Configure screen, tap the Assay tab.

4.

On the Assay tab of the Configure screen, tap Import/Export Assays.

5.

On the Export Files tab of the Import/Export Assays screen, tap one or more of the installed assay files (or tap Select All).

6.

Tap Export.

7.

On the Export screen, select the file location for the exported assay files:

8.

a.

Tap the appropriate USB flash drive.

b.

Tap the appropriate folder.

To complete the export of the assay files, tap OK. NOTE: In the Status area, a message is displayed that contains the name, number, and version of each exported assay file and is displayed for any error conditions that occur. If the USB flash drive has insufficient space for all the assay files that are exported, only the assay files that can fit on the USB flash drive are exported.

9.

To return to the Configure screen, tap Done.

10. Remove the USB flash drive. Exported assay files can only be imported. They cannot be installed on the Install/Uninstall Assays screen. Related information... Import/Export Assays screen (c‑series), page 328 Insert and remove a USB flash drive, page 764

Import assay files (c‑series) Required instrument status

Stopped, Warming, or Idle

Operator access level System administrator Required materials

One or more exported c‑series photometric assay files on a USB flash drive

Perform this procedure to import c‑series photometric assay files. NOTE: Exported assay files can only be imported. They cannot be installed on the Install/ Uninstall Assays screen.

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Insert the USB flash drive.

2.

On the menu bar, tap System, and then tap Configure. NOTE: The Configure command can be configured as an icon on the menu bar and thereby is removed from the System menu.

3.

On the Configure screen, tap the Assay tab.

4.

On the Assay tab of the Configure screen, tap Import/Export Assays.

5.

On the Import/Export Assays screen, tap the Import Files tab.

6.

On the Import Files tab, tap the appropriate USB flash drive and folder that contain the exported assay files. NOTE: Exported assay files that have an invalid checksum cannot be imported and are not displayed in the folder.

7.

Tap one or more of the exported assay files (or tap Select All).

8.

Tap Import. NOTE: In the Status area, a message is displayed that contains the name, number, and version of each imported assay file and is displayed for any error conditions that occur. The assay status of an imported assay file is Installed. The parameter for Run Controls for Onboard Reagents by is configured as the default for assay files that do not have the parameter configured. The assay-specific setting is retained for the imported assay files if the setting is configured. The import is not completed in the following instances: – An exported assay with the same version number is present on the system. – An exported assay requires a reference assay and the reference assay is not installed.

9.

To return to the Configure screen, tap Done.

10. Remove the USB flash drive. Assay files that have the parameter for Calibrator Set configured as None are enabled when they are imported. If an assay file has a setting other than None configured as the parameter for Calibrator Set, the assay file is disabled and the calibrator concentration values are deleted when the assay file is imported. Related information... Import/Export Assays screen (c‑series), page 328 Insert and remove a USB flash drive, page 764

Assay Display Order screen On the Assay Display Order screen, the operator can view assay display order settings. The system administrator can configure the assay display order on the user interface and for reports. Alinity ci‑series Operations Manual

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Related information... Configure screen, Assay tab, page 250 Assay Display Order screen element descriptions, page 334 Configure the assay display order, page 335

Assay Display Order screen element descriptions On the Assay Display Order screen, the system administrator can configure the order in which assays are displayed on screens and flyouts that have an assay list and in the following reports: • Sample Laboratory Report • Sample Status Report • QC Summary Report

Elements Display Order Applies Displays the following options to indicate the areas to which to the configured display order is applied: Reports Only

The configured assay display order is displayed only on printed reports.

Reports and Displays The configured assay display order is applied to user interface computer screens that have an assay list and to the previously listed reports. Assay

Displays a list of the assays that are installed on the system.

Display Order

Displays the assay display order list.

Function buttons

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Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Add>

Moves the selected assays from the Assay list to the Display Order list in the order in which the assays were selected.

< ? ; : ] [ \ } { ' - = ~ ! @ # $ % ^ & * ) ( _ + and . IMPORTANT: Contact the host computer vendor to verify if the host computer handles special characters (if used in SIDs) as characters rather than functions. Some computers may interpret special characters as a line return, line feed, delimiter, or wildcard character.

Batch Name

Displays a text box that is used to change the default name of the batch order. The default batch name is BATCHXX:XX:XX, where XX:XX:XX is the time that the batch was ordered in hours, minutes, and seconds. The batch name can have a maximum of 20 alphanumeric characters.

Manual Dilution: 1:

Displays a text box that is used to enter the dilution factor to calculate the sample concentration automatically and to report the result.

Comments

Displays a text box that is used to enter comments for the batch. Comments are displayed and can be printed for each sample ordered for the batch. Comments can have a maximum of 50 characters.

Assays area

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All option

Displays all assays that are available on the system.

i‑series option

Displays all assays that are available on one or more Alinity i processing modules.

c‑series option

Displays all assays that are available on one or more Alinity c processing modules.

Calculated option

Displays all calculated assays.

Panels

Displays all assay panels that are available.

Assays

Displays all assays that are available for a selected module.

Number of Selected Assays

Displays the number of assays that are selected.

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Function buttons Order Status

Navigates to the Orders screen.

Assay Options

Displays the Assay Options flyout.

Add Order

Saves the order and clears the screen to accept a new order.

Text Size

This function button is unavailable on this screen.

Related information... Create Order screen, page 668 Descriptions of screen elements, page 140

Create Order screen, Specimen tab, Patient Details flyout element descriptions In the Patient Details flyout on the Specimen tab, the operator can enter patient demographic information for the specimen.

Elements SID

Displays the bar code number or identification assigned to the specimen.

PID

Displays a text box that is used to enter the patient identification number. A maximum of 20 alphanumeric characters can be entered. NOTE: When entering a PID, enter only details that are known to be accurate. The PID is recognized as a different and unique patient if previously entered information is edited.

Last Name

Displays a text box that is used to enter the last name of the patient. A maximum of 20 alphanumeric characters can be entered.

First Name

Displays a text box that is used to enter the first name of the patient. A maximum of 20 alphanumeric characters can be entered.

M.

Displays a text box that is used to enter the middle name of the patient. A maximum of 12 alphanumeric characters can be entered.

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Date of Birth

Displays a text box that is used to enter the date of birth for the patient. This information provides an age-specific reference range if the assay is configured to provide reference ranges.

Gender

Displays the following options that are used to select the gender of the patient: • Male • Female • Unknown NOTE: This option provides a gender-specific reference range if the assay is configured to provide reference ranges.

Draw Date

Displays a text box that is used to enter the date that the sample was drawn. To enter the draw date, tap the calendar inside the box. To configure the month and year, tap the Left Arrow or Right Arrow button, and then tap the day.

Time

Displays a spin box that is used to enter the time that the sample was drawn. To enter the draw time, use the systemconfigured format (HH:MM) and type the time in the box or tap the Up Arrow and Down Arrow buttons. If the system is configured for the 12-hour clock format, tap the AM or PM button to configure the time of day.

Location

Displays a text box that is used to enter the location associated with the patient. A maximum of 20 alphanumeric characters can be entered.

Doctor

Displays a text box that is used to enter the name of the patient's doctor. A maximum of 20 alphanumeric characters can be entered.

Function buttons

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Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

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?

Displays Help from the operations manual for the active screen, flyout, or message code.

Related information... Create Order screen, page 668

Create Order screen, Specimen tab, Assay Options flyout element descriptions In the Assay Options flyout on the Specimen tab, the operator can enter assay-specific information for each test included in the specimen order.

Elements Selected Assays

Displays the names of the assays selected for the order.

Rack/Position

Displays the rack ID and position number.

SID

Displays the bar code number or identification assigned to the specimen.

Module Selection

Displays Auto and Module options that are used to select a processing module that performs the assay. If only one processing module type is configured for a system or if a specific module is not identified, the Auto option is enabled and the Module option is not displayed: Auto

The system scheduler selects the processing module.

Module

Displays an option for each processing module that performs the assay. Module options are used to override the system scheduler. NOTE: Module options are available only for multimodule systems that have more than one module of the same type.

Dilution Protocols/ Displays the dilution protocols that are available for the Number of Replicates selected assay and displays drop-down lists that are used to select the correct number of replicates for the corresponding dilution protocol.

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Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

?

Displays Help from the operations manual for the active screen, flyout, or message code.

Related information... Create Order screen, page 668

Create Order screen, Control tab element descriptions On the Control tab, the operator can create a control order.

Orders area Rack

Displays a text box that is used to enter the rack ID in which samples are placed for processing. This element is optional when bar-coded samples are used.

Position

Displays a text box that is used to enter the position of the sample in the rack. This element is optional when bar-coded samples are used.

Control Data area

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Control Name

Displays a drop-down list that is used to select the control identification name.

Control Lot

Displays a drop-down list that is used to select the control lot number.

Control Level

Displays a drop-down list that is used to select the control level.

Manual Dilution: 1:

Displays a text box that is used to enter the dilution factor to calculate the sample concentration automatically and to report the result.

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Designate Sample STAT

Displays a check box that is used to display the S code on the Orders screen, the Results screen, and the Sample Status screen. The operator must priority load the samples with the S code to process the samples first.

Assays area All option

Displays all assays that are available on the system.

i‑series option

Displays all assays that are available on one or more Alinity i processing modules.

c‑series option

Displays all assays that are available on one or more Alinity c processing modules.

Calculated option

Displays all calculated assays.

Panels

Displays all assay panels that are available.

Assays

Displays all assays that are available for a selected module.

Number of Selected Assays

Displays the number of assays that are selected.

Function buttons Order Status

Navigates to the Orders screen.

Assay Options

Displays the Assay Options flyout.

Add Order

Saves and navigates to the order on the Orders screen.

Text Size

This function button is unavailable on this screen.

Related information... Create Order screen, page 668 Descriptions of screen elements, page 140

Create Order screen, Control tab, Assay Options flyout element descriptions In the Assay Options flyout on the Control tab, the operator can enter assay-specific information for each test included in the control order.

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Elements Selected Assays

Displays the names of the assays selected for the order.

Rack/Position

Displays the rack ID and position number.

Control Lot

Displays the lot number of the control.

Control Name

Displays the name of the control.

Control Level

Displays the name of the control level.

Reagent Selection

Displays Auto, Select Cartridge, and Module options that are used to select a reagent cartridge and a processing module that performs the assay. If only one processing module type is configured for a system, the Module option is not displayed: Auto

The system scheduler selects the reagent cartridge.

Select Cartridge

Displays an option that is used to designate the reagent cartridge. When the option is selected, the following information is available: • Module ID: Displays the number of the processing module where the reagent cartridge is located. • Position: Displays the reagent carousel position where the reagent cartridge is located. • Reagent Lot: Displays the reagent cartridge lot number. • Serial Number: Displays the reagent cartridge serial number. • Cartridge Status: Displays the reagent cartridge status.

Module

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Displays an option that is used to designate the processing module. When the option is selected, a check box is displayed for each processing module that performs the assay.

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Module check boxes are used to override the system scheduler. NOTE: Module check boxes are available only for multimodule systems that have more than one module of the same type. Dilution Protocols/ Displays the dilution protocols that are available for the Number of Replicates selected assay and displays drop-down lists that are used to select the correct number of replicates for the corresponding dilution protocol.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

?

Displays Help from the operations manual for the active screen, flyout, or message code.

Related information... Create Order screen, page 668

Create Order screen, Calibration tab element descriptions On the Calibration tab, the operator can create a calibration order.

Sample Data area Rack

Displays a text box that is used to enter the rack ID in which samples are placed for processing. This element is optional when bar-coded samples are used.

Starting Position

Displays a text box that is used to enter the position of the first calibrator.

Assays area All option

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i‑series option

Displays all assays that are available on one or more Alinity i processing modules.

c‑series option

Displays all assays that are available on one or more Alinity c processing modules.

Panels

Displays all assay panels that are available.

Assays

Displays all assays that are available for a selected module. The default master lot number for a calibrator set is displayed with the assay name. The default master lot number for a blank calibrator set is listed after the calibrator set master lot number for c‑series assays that use a blank calibrator set. If an alternate calibrator master lot number is selected for a manual calibration order, the selected calibrator master lot number is displayed. NOTE: Only the default master lot number for a blank calibrator can be used to create a manual order. The assay name and the calibrator master lot number are displayed in red text if the calibrator master lot number is expired. The assay name and the blank calibrator master lot number are displayed in red text if the blank calibrator master lot number is expired. Lot numbers are not displayed for c‑series assays that use the factor data reduction method.

Number of Selected Assays

Displays the number of assays that are selected.

Function buttons Order Status

Navigates to the Orders screen.

Assay Options

Displays the Assay Options flyout.

Add Order

Saves and navigates to the order on the Orders screen.

Text Size

This function button is unavailable on this screen.

Related information... Create Order screen, page 668 Descriptions of screen elements, page 140

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Create Order screen, Calibration tab, Assay Options flyout element descriptions In the Assay Options flyout on the Calibration tab, the operator can enter assay-specific information for each test included in the calibration order.

Elements Selected Assays

Displays the names of the assays selected for the order.

Calibrator Lot

Displays the lot number of the default calibrator or displays a drop-down list that is used to select an alternate calibrator lot for the selected assay if more than one lot was configured.

Calibrator Expiration Date

Displays the expiration date of the calibrator lot.

Calibration Type

Displays the type of assay calibration to be performed for the selected assay or displays a drop-down list that is used to select an alternate calibration type if more than one type was configured.

Reagent Selection

Displays Auto, Select Cartridge, and Module options that are used to select a reagent cartridge and a processing module that performs the assay. If only one processing module type is configured for a system, the Module option is not displayed: Auto

The system scheduler selects the reagent cartridge.

Select Cartridge

Displays an option that is used to designate the reagent cartridge. When the option is selected, the following information is available: • Module ID: Displays the number of the processing module where the reagent cartridge is located. • Position: Displays the reagent carousel position where the reagent cartridge is located. • Reagent Lot: Displays the reagent cartridge lot number. • Serial Number: Displays the reagent cartridge serial number.

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• Cartridge Status: Displays the reagent cartridge status. Module

Displays an option that is used to designate the processing module. When the option is selected, a check box is displayed for each processing module that performs the assay. Module check boxes are used to override the system scheduler. NOTE: Module check boxes are available only for multimodule systems that have more than one module of the same type.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

?

Displays Help from the operations manual for the active screen, flyout, or message code.

Related information... Create Order screen, page 668

Create a single specimen order Perform this procedure to create a specimen order manually. 1.

On the menu bar, tap Orders.

2.

On the Orders screen, tap Create Order.

3.

Under Sample Data on the Specimen tab of the Create Order screen: – Enter the SID. IMPORTANT: To ensure that the processed tests include the correct information, confirm that the SID is not reused before previously pending orders are completed or are deleted. – Enter the rack ID and the position number. NOTE: If bar-coded samples are used, the rack ID and the position number are not required. If a rack and a position are entered and the bar code on the sample is not

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read, the system automatically uses the scanned rack ID as the unique rack ID and the sample is processed as entered. – If the specimen was diluted manually, type the dilution factor in the Manual Dilution: 1: box. NOTE: Not all assays support manual dilutions. Assays that do not support manual dilution are displayed as unavailable when a manual dilution is selected. For dilution information, see the assay documentation. – To display the STAT processing code for the SID, tap the Designate Sample STAT check box. NOTE: Samples that are designated as STAT must be priority loaded to be processed as STAT samples. 4.

In the Comments box, type additional information that is associated with the sample. Comments are displayed and are printed with each test that is ordered for the sample.

5.

Under Assays, tap an assay panel to run (or tap one or more of the individual assays to run). The number of selected assays is displayed. NOTE: To filter the list of available assays, tap the option for i-series, c-series, or Calculated. To order a calculated assay, perform one of the following steps: – Tap only the calculated assay. The system automatically orders the assays that are necessary to complete the calculation but does not release or report the results ordered by the system. Constituent assays for some calculated immunoassays that are installed from an assay file (assay numbers 3000 through 3999) cannot be ordered automatically by the system and must be ordered separately. For specific assay requirements, see the assay documentation. – Tap the calculated assay and one or more of its constituent assays. The system automatically orders the additional constituent assays that are necessary to complete the calculation but does not release or report the constituent results ordered by the system. – Tap the calculated assay and all of its constituent assays. The system releases and reports all results.

6.

Tap Assay Options.

7.

For each selected assay in the Assay Options flyout, perform the following steps if these situations occur: – If more than one processing module of the same type is configured for a system, under Module Selection, tap Module to specify a processing module, and then tap the appropriate module check boxes to override the system scheduler.

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– Under Dilution Protocols/Number of Replicates, if the default number of replicates for one or more dilutions is incorrect, tap the correct number of replicates for each dilution. IMPORTANT: For i‑series assays, do not order more than 10 tests for each sample that is loaded in sample cups. For c‑series ICT assays, do not order more than 15 tests for each sample that is loaded in sample cups or tubes. The total number of tests for each sample includes all assays, replicates, dilutions, and available reagent lots for the order. Ensure that the total number of tests for a c‑series sample does not exceed 220. 8.

To save the assay option selections, tap Done.

9.

Tap Patient Details.

10. In the Patient Details flyout, enter the patient demographic information. If a draw date or a time is entered, both the draw date and the time must be entered. 11. To save the patient demographic information, tap Done. 12. To save the specimen order, tap Add Order. 13. To view the specimen order, tap Order Status. Related information... Create Order screen, page 668 Load samples into sample racks, page 643 Initiate or resume sample processing, page 648 Reagent inventory processing, page 643 Perform an initial user-defined assay run (c‑series), page 1603

Create a bar-coded batch specimen order Perform this procedure to order the same tests for multiple bar-coded specimens. When running a bar-coded batch order: • Do not load calibrators. • Do not leave empty spaces in a rack. NOTE: Do not add a test to an order within a batch. If a test is added to an order that is part of the batch order, the additional test is processed instead of the batch tests. Separately order the additional test and load the sample after batch processing is completed. 1.

On the menu bar, tap Orders.

2.

On the Orders screen, tap Create Order.

3.

Under Order Type on the Specimen tab of the Create Order screen, tap Bar-Coded Batch.

4.

Under Sample Data, perform the following steps: – Enter the starting SID.

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NOTE: The ending SID must be different than the starting SID. Batch processing begins on the sample labeled with the starting SID and continues until the sample labeled with the ending SID is processed. All samples between the starting SID and the ending SID, regardless of the sequence or SID, are included in the batch process. – Edit the default name of the batch order if necessary. NOTE: The default batch name is BATCHXX:XX:XX, where XX:XX:XX is the time that the batch was ordered in hours, minutes, and seconds. The batch name can have a maximum of 20 alphanumeric characters. – If each specimen was diluted manually, type the dilution factor in the Manual Dilution: 1: box. NOTE: Not all assays support manual dilutions. Assays that do not support manual dilution are displayed as unavailable when a manual dilution is selected. For dilution information, see the assay documentation. 5.

In the Comments box, type additional information that is associated with the sample. Comments are displayed and are printed with each sample order in the batch. Comments can have a maximum of 50 characters.

6.

Under Assays, tap an assay panel to run (or tap one or more of the individual assays to run). The number of selected assays is displayed. NOTE: To filter the list of available assays, tap the option for i-series, c-series, or Calculated. To order a calculated assay, perform one of the following steps: – Tap only the calculated assay. The system automatically orders the assays that are necessary to complete the calculation but does not release or report the results ordered by the system. Constituent assays for some calculated immunoassays that are installed from an assay file (assay numbers 3000 through 3999) cannot be ordered automatically by the system and must be ordered separately. For specific assay requirements, see the assay documentation. – Tap the calculated assay and one or more of its constituent assays. The system automatically orders the additional constituent assays that are necessary to complete the calculation but does not release or report the constituent results ordered by the system. – Tap the calculated assay and all of its constituent assays. The system releases and reports all results.

7.

Tap Assay Options.

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For each selected assay in the Assay Options flyout, perform the following steps if these situations occur: – If more than one processing module of the same type is configured for a system, under Module Selection, tap Module to specify a processing module, and then tap the appropriate module check boxes to override the system scheduler. – Under Dilution Protocols/Number of Replicates, if the default number of replicates for one or more dilutions is incorrect, tap the correct number of replicates for each dilution. IMPORTANT: For i‑series assays, do not order more than 10 tests for each sample that is loaded in sample cups. For c‑series ICT assays, do not order more than 15 tests for each sample that is loaded in sample cups or tubes. The total number of tests for each sample includes all assays, replicates, dilutions, and available reagent lots for the order. Ensure that the total number of tests for a c‑series sample does not exceed 220.

9.

To save the assay option selections, tap Done.

10. To save the batch order, tap Add Order. 11. To view the batch order, tap Order Status. Related information... Create Order screen, page 668 Initiate or resume sample processing, page 648

Create a control order Perform this procedure to create a control order manually. 1.

On the menu bar, tap Orders.

2.

On the Orders screen, tap Create Order.

3.

On the Create Order screen, tap the Control tab.

4.

Under Orders on the Control tab, enter the rack ID and the position number that correspond to the sample location. NOTE: If bar-coded samples are used or if the control product is located in the reagent carousel, the rack ID and the position number are not required.

5.

Under Control Data: – Tap a control name in the Control Name drop-down list. – Tap a control lot in the Control Lot drop-down list. – Tap a control level in the Control Level drop-down list. – If the control was diluted manually, type the dilution factor in the Manual Dilution: 1: box.

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– To display the STAT processing code for the control, tap the Designate Sample STAT check box. NOTE: Controls that are designated as STAT must be priority loaded to be processed as STAT controls. 6.

Under Assays, tap an assay panel to run (or tap one or more of the individual assays to run). The number of selected assays is displayed. NOTE: To filter the list of available assays, tap the option for i-series, c-series, or Calculated. When a multiconstituent control vial is located on the reagent carousel, orders for assays that are disabled for onboard use become exceptions when the orders are run. Multiconstituent control assays that are disabled for onboard use can be ordered from vials in a vial rack, from a sample in a sample cup, or from a bar-coded sample tube in a sample rack that has QQQ added to the beginning of the SID.

7.

Tap Assay Options.

8.

For each selected assay in the Assay Options flyout, perform the following steps: – Tap a Reagent Selection option to designate the reagent cartridge or the processing module to run the control: • The default is Auto. The system determines which reagent cartridge is used to perform the test according to reagent inventory processing. • If more than one reagent cartridge is loaded in the reagent carousel, tap Select Cartridge, and then tap a reagent cartridge in the list. • If more than one processing module of the same type is configured for a system, tap Module to specify a processing module, and then tap the appropriate module check boxes to override the system scheduler. – Under Dilution Protocols/Number of Replicates, if the default number of replicates for one or more dilutions is incorrect, tap the correct number of replicates for each dilution. IMPORTANT: For i‑series assays, do not order more than 10 tests for each sample that is loaded in sample cups. For c‑series ICT assays, do not order more than 15 tests for each sample that is loaded in sample cups or tubes. The total number of tests for each sample includes all assays, replicates, dilutions, and available reagent lots for the order. Ensure that the total number of tests for a c‑series sample does not exceed 220.

9.

To save the assay option selections, tap Done.

10. To save the control order, tap Add Order. 11. To view the control order, tap Order Status.

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Related information... Create Order screen, page 668 Install assay files, page 325 Load samples into sample racks, page 643 Initiate or resume sample processing, page 648 Reagent inventory processing, page 643

Create a calibration order Perform this procedure to create a calibration order manually. NOTE: If the calibrators are in vials, a manual order is not required. The vials can be loaded into a vial rack and can be presented to the reagent and sample manager (RSM) for immediate use. 1.

On the menu bar, tap Orders.

2.

On the Orders screen, tap Create Order.

3.

On the Create Order screen, tap the Calibration tab.

4.

Under Sample Data on the Calibration tab, enter the rack ID and the starting position. NOTE: The rack ID and the starting position specify the use of samples that are loaded on the RSM. However, the ID and the position are not required if the calibration uses bar-coded samples, the calibration uses only water, or the calibrator product is loaded in the reagent carousel.

5.

Under Assays, tap an assay panel to calibrate (or tap one or more of the individual assays to calibrate). The number of selected assays is displayed. NOTE: If multiple c‑series assays that use a blank calibrator set are selected, a blank calibrator is required for each calibrator set even if all the calibrator sets compose one rack. NOTE: To filter the list of available assays, tap the option for i-series or c-series.

6.

Tap Assay Options.

7.

For each selected assay in the Assay Options flyout, perform the following steps: a.

In the Calibrator Lot drop-down list, tap a calibrator lot or confirm the default data. NOTE: Only the default master lot number for the blank calibrator can be used for a manual order.

b.

If an adjust type is available, tap it to perform an adjust calibration.

c.

Tap a Reagent Selection option to designate the reagent cartridge or the processing module to perform the calibration: • The default is Auto. The system determines which reagent cartridge is used to perform the calibration according to calibration sample processing. • If more than one reagent cartridge is loaded in the reagent carousel, tap Select Cartridge, and then tap a reagent cartridge in the list.

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• If more than one processing module of the same type is configured for a system, tap Module to specify a processing module, and then tap the appropriate module check boxes to override the system scheduler. 8.

To save the assay option selections, tap Done.

9.

To save the calibration order, tap Add Order.

10. To view the calibration order, tap Order Status. Related information... Create Order screen, page 668 Install assay files, page 325 Load samples into sample racks, page 643 Initiate or resume sample processing, page 648 Calibration sample processing, page 638 Calibration procedures, page 767 Adjustment calibration (c‑series photometric), page 781 Adjustment calibration (i‑series), page 788 Prepare and load calibrator and control vials into vial racks for immediate use, page 646 Prepare and load calibrator and control vials into vial racks for onboard storage, page 624 Perform an initial user-defined assay run (c‑series), page 1603

Add a test to a specimen order Perform this procedure to add a test to a specimen order. NOTE: If a calculated assay is added and new constituent results are wanted for the calculation, add the constituent assays in addition to the calculated assay. Do not add a test to an order within a batch. If a test is added to an order that is part of a batch order, the additional test is processed instead of the batch tests. Separately order the additional test and load the sample after batch processing is completed. 1.

On the menu bar, tap Orders.

2.

On the Orders screen, tap Create Order.

3.

Under Sample Data on the Specimen tab of the Create Order screen: – Enter the SID of the original specimen. – If the original specimen was diluted manually, type the dilution factor of the specimen in the Manual Dilution: 1: box.

4.

Under Assays, tap an assay panel to run (or tap one or more of the individual assays to run). The number of selected assays is displayed. NOTE: To filter the list of available assays, tap the option for i-series, c-series, or Calculated.

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To order a calculated assay, perform one of the following steps: – Tap only the calculated assay. The system automatically orders the assays that are necessary to complete the calculation but does not release or report the results ordered by the system. Constituent assays for some calculated immunoassays that are installed from an assay file (assay numbers 3000 through 3999) cannot be ordered automatically by the system and must be ordered separately. For specific assay requirements, see the assay documentation. – Tap the calculated assay and one or more of its constituent assays. The system automatically orders the additional constituent assays that are necessary to complete the calculation but does not release or report the constituent results ordered by the system. – Tap the calculated assay and all of its constituent assays. The system releases and reports all results. 5.

Tap Assay Options.

6.

For each selected assay in the Assay Options flyout, perform the following steps if these situations occur: – If more than one processing module of the same type is configured for a system, under Module Selection, tap Module to specify a processing module, and then tap the appropriate module check boxes to override the system scheduler. – Under Dilution Protocols/Number of Replicates, if the default number of replicates for one or more dilutions is incorrect, tap the correct number of replicates for each dilution. IMPORTANT: For i‑series assays, do not order more than 10 tests for each sample loaded in sample cups. For c‑series ICT assays, do not order more than 15 tests for each sample loaded in sample cups or tubes. The total number of tests for each sample includes all assays, replicates, dilutions, and available reagent lots for the order. Ensure that the total number of tests for a c‑series sample does not exceed 220.

7.

To save the assay option selections, tap Done.

8.

To save the additional specimen order, tap Add Order.

9.

To view the additional specimen order, tap Order Status.

Related information... Create Order screen, page 668 Initiate or resume sample processing, page 648 Search for or filter data, page 757

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Descriptions of test statuses Test status information is used to determine the progress of an ordered test or to manage specimen and control results. The system tracks the test statuses for each ordered or completed test. The following list provides descriptions of the test statuses. The statuses are described in the order in which they are displayed, are sorted, and are printed: Pending

The test is ordered, but the RSM bar code reader has not scanned the corresponding sample.

Scheduled

The test is ordered and the sample is scanned by the RSM bar code reader, but the instrument has not aspirated the sample.

Running

The test is ordered, the sample is scanned, and the instrument is processing the sample.

In Process

For a calculated test, the tests that are necessary to calculate the test result are in process. For a batch order, the sample labeled with the starting SID of the batch order was scanned by the RSM bar code reader, and the batch order is in process.

Exception

The test order failed and a test result was not generated.

Complete

The test is completed.

Related information... Orders screen, page 659 Orders screen element descriptions, page 660 Sample Status screen element descriptions, page 693 Orders screen, Search flyout element descriptions, page 661 Rerun List Report element descriptions, page 1683

Descriptions of processing codes Processing code information is used to determine how samples are processed. One or more processing codes are displayed if the codes are applicable to an ordered test or test results. The following list provides descriptions of the processing codes. The codes are described in the order in which they are displayed, are sorted, and are printed: S

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The sample is ordered as a STAT sample.

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D

The test is an automated dilution with a dilution factor that is greater than 1, or the test is an automated dilution that is not the first configured dilution.

M

The sample is diluted manually.

R

The test is a rerun.

*

The test is an original result for a rerun.

B

The test is part of a batch order.

C

The test has a comment.

Related information... Orders screen, page 659 Results screen, page 706 Orders screen element descriptions, page 660 Sample Status screen element descriptions, page 693 Results screen, Unreleased tab element descriptions, page 707 Results screen, Specimen tab element descriptions, page 708 Order List Report element descriptions, page 1669 Rerun List Report element descriptions, page 1683 Result Details Report element descriptions, page 1685 Result List Report element descriptions, page 1689 Sample Laboratory Report element descriptions, page 1691

Delete a test from a sample order Prerequisite

The test status must be Pending or In Process.

Perform this procedure to delete a test or batch order that does not need to be processed. A batch order that has a status of In Process completes all tests that have a status of Scheduled or Running. No additional samples associated with the batch order are processed. NOTE: A calculated assay that has a status of In Process cannot be deleted. 1.

On the menu bar, tap Orders.

2.

In the list on the Orders screen, tap one or more tests (or tap Select All). NOTE: To filter the list, tap a tab (or tap Search).

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3.

Tap Delete.

4.

When a confirmation message is displayed, tap OK.

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Related information... Orders screen, page 659 Search for or filter data, page 757

Sample Status screen On the Sample Status screen, the operator can view the following information: • Specimen orders, control orders, and calibration orders • Unreleased results for specimens and controls • Tests that are scheduled for reruns • Test exceptions that have not been rerun, released, or deleted The operator can perform the following functions: • Find information about a specific test based on specified search criteria. • Access test information. • Add a comment to a test order. • Transmit a result. • Suspend the processing of a sample. • Rerun a test. • Print a sample status report. Related information... Specimen, calibration, and control orders, page 652 Sample Status screen element descriptions, page 693 Sample Status screen, Search flyout element descriptions, page 696 Sample Details screen, page 698 Rerun a test or an exception for a specimen or control, page 703 Release a specimen result or a control result, page 704 Suspend and access a sample that has tests in process, page 649

Sample Status screen element descriptions

All Samples tab, Specimen tab, Control tab, Calibrator tab Displays the status of the following items: • Specimen orders • Control orders, exceptions, and results • Calibrator orders and exceptions Alinity ci‑series Operations Manual

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Sample status information can be filtered by sample type by selecting the Specimen tab, Control tab, or Calibrator tab.

Elements SID Name

SID: Displays the sample identification, which can be one of the following items: • The bar code number or identification assigned to the specimen. • The control name and level. • The calibrator name and level. The SID can be sorted alphanumerically in ascending order. Name: Displays the name, which can be one of the following items: • The patient's name for specimen orders. • The control name and level for control orders. • The calibrator name and level for calibration orders. The name is displayed in green text.

R/P M/P

R/P: Displays the rack ID (R) and position (P) number. The rack/position can be sorted in ascending order, first alphanumerically by rack, and then numerically by position. M/P: Displays the module (M) number and position (P) number of the rack on the loading area. The M/P is displayed in green text. NOTE: If the system is configured for a laboratory automation system (LAS) and the specimen is run on the LAS, the R/P is displayed as LAS/1. The M/P is blank for LAS specimens and onboard vial racks.

Assay/Codes

Assay: Displays the name of the test requested for processing. Codes: Displays one or more single-character codes to indicate processing conditions. Additional information is indicated by the following colors: Black

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The test has a status of Scheduled, Pending, Running, or In Process.

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Status/Result

Green

The test has completed but is not released.

Blue

The test has completed and has been released.

Red

The test is an exception or has a flag.

Status: Displays the current status (Pending, Scheduled, Running, In Process, Exceptions, or Complete) of specimen orders, control orders, and calibration orders or displays specimen results and control results. Result: Displays the following test descriptions: • Date and time (estimated completion time when tests are processing). • Result value and result units. • Date and time (time of completion). • Message code and description (where applicable). Additional information is indicated by the following colors: Black

The test has a status of Scheduled, Pending, Running, or In Process.

Green

The test has completed but is not released.

Blue

The test has completed and has been released.

Red

The test is an exception or has a flag.

Interpretation

Displays the interpretation of the result value obtained.

Flags

Displays the flags associated with specimen results and quality control results.

Function buttons Select All

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Selects or deselects all items in a list. The button switches between Select All and Deselect All.

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Search

Displays the Search flyout.

Print

Displays the Print flyout.

Details

Navigates to the Details screen for the selected items on the current screen.

Suspend

Displays a message requesting confirmation to suspend processing on the selected module or section to access a sample.

Rerun

Displays the Rerun Options flyout.

Release

Releases the selected test results or exceptions. Test results remain on the Sample Status screen until all results for the specimen or control are released. Test exceptions that have not been rerun or released for transmission remain on the screen. Rerun or released test exceptions remain on the Sample Status screen until all results are transmitted.

Text Size

Increases or decreases the size of text displayed.

Related information... Sample Status screen, page 693 Descriptions of screen elements, page 140 Descriptions of test statuses, page 691 Descriptions of processing codes, page 691 Descriptions of specimen result flags, page 722 Descriptions of quality control result flags, page 724

Sample Status screen, Search flyout element descriptions In the Search flyout of the Sample Status screen, the operator can enter specific data that is used to filter the data on the screen.

Elements Find Sample

Used to select a location in the database to find the sample. The Search flyout has two options: Sample Status

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Used to search for the sample on the Sample Status screen.

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System Wide

Used to search for the sample on all data screens.

Module

Displays a drop-down list that is used to search for a module by the module number.

RSM Position

Used to search by a position number on the reagent and sample manager.

SID

Used to search by the bar code number or identification assigned to the sample.

PID

Used to search by the patient identification number.

Last Name

Used to search by the patient's last name.

First Name

Used to search by the patient's first name.

Rack

Used to search by the rack ID.

Position

Displays a drop-down list that is used to search by the rack position.

Start Date

Used to enter a search start date.

End Date

Used to enter a search end date.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

?

Displays Help from the operations manual for the active screen, flyout, or message code.

Related information... Sample Status screen, page 693 Search flyout, page 757 Search flyout, page 757

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Sample Details screen On the Sample Details screen, the operator can view the following information: • Details for specimen results, control results, or exceptions • Details for a specimen test order, a control test order, or a calibrator test order The operator can add a comment to an order, a result, or an exception. Related information... Sample Status screen, page 693 Sample Details (Specimen, Control, and Calibrator) screen element descriptions, page 698 Add a comment to a result or an exception, page 702

Sample Details (Specimen, Control, and Calibrator) screen element descriptions The Sample Details screen displays the sample details for specimens, controls, and calibrators.

Test Information area SID

Displays the sample identification.

Rack/Position

Displays the rack ID and position number. NOTE: If the system is configured for a laboratory automation system (LAS) and the specimen is run on the LAS, the rack ID and position number are displayed as LAS/1.

Operator ID

Displays the identification of the operator logged onto the system when the test was processed.

Sample Type

Displays the sample type for the test: • Specimen • Control • Calibrator

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Module/Position

Displays the module number and position of the rack on the loading area.

Time of Completion

Displays the date and time that the tests in process were completed.

PID

Displays the patient identification. This element is displayed only for specimens.

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Gender

Displays the gender of the patient. This element is displayed only for specimens.

Date of Birth

Displays the date of birth for the patient. This element is displayed only for specimens.

Name

Displays the name of the patient. This element is displayed only for specimens.

Transmission Status

Displays the status of the test transmission to the host. This element is not displayed for calibrators.

Released By

Displays the identification of the operator logged onto the system when the test was released. This element is not displayed for calibrators.

Control Information area This area is displayed only for controls. Control Name

Displays the name of the control.

Control Lot

Displays the lot number of the control.

Control Level

Displays the name of the control level.

Control Lot Exp.

Displays the expiration date of the control lot.

Calibrator Information area This area is displayed only for calibrators. Calibrator Name

Displays the name of the calibrator.

Calibrator Lot

Displays the lot number of the calibrator.

Calibration Method

Displays the data reduction method used for the assay.

Calibrator Level

Displays the name of the calibrator level.

Calibrator Lot Exp.

Displays the expiration date of the calibrator lot.

Calibration Type

Displays the type of assay calibration performed.

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Assay Information area Assay Name

Displays the name of the assay file.

Assay Number

Displays the number of the assay file.

Assay Version

Displays the version of the assay file.

Result

Displays the value, unit, and (where applicable) interpretation of the result.

Absorbance/mV (c‑series)

Displays the response value used to calculate the result: • Millivolt (only for ICT) • Absorbance (only for photometric assays) NOTE: This element is not displayed for sample interference index assays.

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RLU (i‑series)

Displays the response value in relative light units that is used to calculate the result.

Flag

Displays the flags associated with specimen results and quality control results.

Interpretation

Displays the interpretation of the result value obtained.

Normal Range

Displays the normal or therapeutic range for the assay. This element is displayed only for specimens.

Control Range

Displays the control range configured for the assay. If a control range is not configured, the control range that is displayed is calculated based on the configured expected mean and expected standard deviation (1 SD). This element is displayed only for controls.

Codes

Displays the processing codes associated with the test.

Dilution

Displays the type of dilution used to process the test.

Cuvette (c‑series)

Displays the number of the cuvette used to process the test. This element is not displayed for calibrators.

Module/SN

Displays the serial number of the module.

Message

Displays the message code number and description.

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Reagent Information area Reagent Lot

Displays the master lot number for the reagent.

Reagent SN

Displays the serial number of the reagent cartridge.

Reagent Lot Expiration

Displays the expiration date of the reagent cartridge.

Calibration

Displays the date and time of the reagent calibration.

Additional Information area Doctor

Displays the name of the patient's doctor. This element is displayed only for specimens.

Location

Displays the location associated with the patient. This element is displayed only for specimens.

Draw Date/Time

Displays the date and time that the sample was drawn. This element is displayed only for specimens.

Archive Status

Displays the archive status of the test: Archived or Not Archived. This element is not displayed for calibrators.

Archive Date and Time Displays the date and time that the test was archived. This element is not displayed for calibrators. Comment

Displays a text box that is used to enter a comment for the test.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Previous

Displays the previous item when multiple items are selected.

Next

Displays the next item when multiple items are selected.

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Text Size

Section 5

This function button is unavailable on this screen.

Related information... Sample Details screen, page 698 Descriptions of screen elements, page 140

Add a comment to a result or an exception Perform this procedure to add a comment to a result or an exception. This procedure can be performed from the Sample Status screen or the Results screen. 1.

To find test results that require a comment, perform the steps from one of the following screens: Sample Status screen: – On the menu bar, tap Sample Status. – Under SID Name on the All Samples tab, tap a sample. NOTE: To filter the list, tap the Specimen tab or the Control tab (or tap Search). Results screen: – On the menu bar, tap Results. The default is the Unreleased tab. – To add a comment to a released specimen, a released control, or an exception, tap the appropriate tab. NOTE: To filter the list, tap Search.

2.

In the list, tap one or more results or exceptions (or tap Select All).

3.

Tap Details.

4.

In the Comment box, type additional information that is associated with the result or exception. Comments are displayed and are printed with the result or exception. In addition, comments for samples and tests are displayed if comments were entered.

5.

If more than one result or exception was selected, tap Next or Previous to display each order, and then type a comment for each order.

6.

To save the comments, tap Done.

Related information... Sample Details screen, page 698 Results screen, page 706 Result Details screen, page 715 Search for or filter data, page 757

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Rerun a test or an exception for a specimen or control Perform this procedure to rerun a specimen test, a control test, or an exception. If additional tests are required, a new order must be created. This procedure can be performed from the Sample Status screen or the Results screen. NOTE: Only exceptions with a status of Blank can be rerun. CAUTION: Biological RISKS. This activity or area may expose you to potentially infectious material. 1.

Retrieve the original sample and verify the following conditions: – The volume is adequate. – The sample integrity is acceptable.

2.

Return the sample to the reagent and sample manager.

3.

To find the test result to rerun, perform the steps from one of the following screens: Sample Status screen: – On the menu bar, tap Sample Status. – Under SID Name on the All Samples tab, tap the sample. NOTE: To filter the list, tap the Specimen tab or the Control tab (or tap Search). Results screen: – On the menu bar, tap Results. The default is the Unreleased tab. – To rerun an exception, tap the Exception tab. NOTE: To filter the list, tap Search.

4.

In the list, tap one or more tests to rerun (or tap Select All). NOTE: To rerun a calculated assay, perform one of the following steps: – Tap only the calculated assay. The system automatically orders the assays that are necessary to complete the calculation but does not release or report the results ordered by the system. Constituent assays for some calculated immunoassays that are installed from an assay file (assay numbers 3000 through 3999) cannot be ordered automatically by the system and must be ordered separately. For specific assay requirements, see the assay documentation. – Tap the calculated assay and one or more of its constituent assays. The system automatically orders the additional constituent assays that are necessary to complete the calculation but does not release or report the constituent results ordered by the system.

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– Tap the calculated assay and all of its constituent assays. The system releases and reports all results. 5.

Tap Rerun.

6.

For each selected assay in the Rerun Options flyout, perform the following steps: – Enter the rack ID and the position number. NOTE: When bar-coded samples are used, the rack ID and the position number are not required. – If more than one processing module of the same type is configured for a system, under Module Selection, tap Module to specify a processing module, and then tap the appropriate module check boxes to override the system scheduler. – Under Dilution Protocols/Number of Replicates, if the default number of replicates for one or more dilutions is incorrect, tap the correct number of replicates for each dilution.

7.

To save the rerun option selections, tap Done. The rerun tests that are scheduled can be viewed on the Sample Status screen or the Orders screen.

Related information... Sample Status screen, page 693 Initiate or resume sample processing, page 648 Sample specifications and requirements, page 472 Results screen, page 706 Search for or filter data, page 757

Release a specimen result or a control result Perform this procedure to release manually the specimen results or control results that have been reviewed. This procedure can be performed from the Sample Status screen or the Results screen. 1.

To find test results to release, perform the steps from one of the following screens: Sample Status screen: – On the menu bar, tap Sample Status. – Under SID Name on the All Samples tab, tap a sample. NOTE: To filter the list, tap the Specimen tab or the Control tab (or tap Search). Results screen: – On the menu bar, tap Results. The default is the Unreleased tab. NOTE: To filter the list, tap Search.

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In the list, tap one or more tests to release (or tap Select All).

3.

Tap Release.

Related information... Sample Status screen, page 693 Delete a quality control, page 360 Results screen, page 706 Search for or filter data, page 757

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Results screen On the Results screen, the operator can view the following information: • Specimen and control results • Specimen and control exceptions The operator can perform the following functions: • Find information about a specific test based on specified search criteria. • Access result information. • Release or delete a result. • Rerun a test. Related information... Operating instructions, page 479 Results screen, Unreleased tab element descriptions, page 707 Results screen, Specimen tab element descriptions, page 708 Results screen, Control tab element descriptions, page 710 Results screen, Exception tab element descriptions, page 711 Results screen, Search flyout element descriptions, page 713 Result Details screen, page 715 Rerun Options (Specimen Order) flyout element descriptions, page 719 Rerun Options (Control Order) flyout element descriptions, page 720 Descriptions of specimen result flags, page 722 Descriptions of quality control result flags, page 724 Descriptions of transmission statuses, page 725 View the reaction graph and absorbance data for a result (c‑series), page 726 Delete a sample result or an exception, page 727 Transmit a result or an exception to the host, page 727 Rerun a test or an exception for a specimen or control, page 703 Release a specimen result or a control result, page 704 Descriptions of processing codes, page 691 Archive the results, page 761 Add a comment to a result or an exception, page 702

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Results screen, Unreleased tab element descriptions The Unreleased tab displays completed specimen and control results that have not been released. The Unreleased tab is not displayed if patient and control release modes are set to automatic or automatic with exceptions.

Elements Module ID

Displays the module number of the module used to process the test. The module number for specimen results of calculated assays is 6 (system control module). The module number for control results of calculated assays is the processing module used to produce the constituent results.

R/P

Displays the rack ID (R) and position (P) number. NOTE: If the system is configured for a laboratory automation system (LAS) and the specimen is run on the LAS, the R/P is displayed as LAS/1.

SID

Displays the sample identification, which can be one of the following items: • The bar code number or identification assigned to the specimen. • The control lot number and control level number. Barcoded controls include a serial number when quality controls are run in a vial rack. Bar-coded controls include the prefix QQQ followed by the control lot number and level when the controls are run in a sample rack. • The calibrator lot number and calibrator level number.

Name

Displays the name, which can be one of the following items: • The name of the specimen. • The control name and, if configured, the control level number and control level name for control orders. • The calibrator or calibrator set name, CAL (only for i‑series), and the calibrator level for calibration orders.

Assay

Displays the name of the test.

Result

Displays the value and unit of the test result.

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Interpretation

Displays the interpretation of the test result.

Flag

Displays the flags associated with specimen results and quality control results. All results with flags are displayed in red text.

Code

Displays one or more single-character codes to indicate processing conditions.

Time

Displays the date and time that the test completed processing.

Function buttons Select All

Selects or deselects all items in a list. The button switches between Select All and Deselect All.

Search

Displays the Search flyout.

Print

Displays the Print flyout.

Details

Navigates to the Details screen for the selected items on the current screen.

Rerun

Displays the Rerun Options flyout.

Release

Moves the selected test results to the Specimen tab or the Control tab.

Delete

Displays a message requesting confirmation to delete the selected items.

Text Size

Increases or decreases the size of text displayed.

Related information... Results screen, page 706 Descriptions of screen elements, page 140 Descriptions of specimen result flags, page 722 Descriptions of quality control result flags, page 724 Descriptions of processing codes, page 691

Results screen, Specimen tab element descriptions The Specimen tab displays released specimen results.

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Elements Module ID

Displays the number of the module used to process the test. The module number for results of calculated assays is 6 (the system control module).

R/P

Displays the rack ID (R) and position (P) number. NOTE: If the system is configured for a laboratory automation system (LAS) and the specimen is run on the LAS, the R/P is displayed as LAS/1.

SID

Displays the bar code number or identification assigned to the specimen.

Name

Displays the name of the specimen.

Assay

Displays the name of the test.

Result

Displays the value and unit of the test result.

Interpretation

Displays the interpretation of the test result.

Flag

Displays the flags associated with the specimen results.

Code

Displays one or more single-character codes to indicate processing conditions.

Time

Displays the date and time that the test completed processing.

Function buttons Select All

Selects or deselects all items in a list. The button switches between Select All and Deselect All.

Search

Displays the Search flyout.

Print

Displays the Print flyout.

Archive

Displays the Archive flyout.

Details

Navigates to the Details screen for the selected items on the current screen.

Transmit

Sends selected test results to the host computer.

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Delete

Displays a message requesting confirmation to delete the selected items.

Text Size

Increases or decreases the size of text displayed.

Related information... Results screen, page 706 Descriptions of screen elements, page 140 Descriptions of specimen result flags, page 722 Descriptions of processing codes, page 691

Results screen, Control tab element descriptions The Control tab displays released control results.

Elements Module ID

Displays the number of the module used to process the test. The module number for results of calculated assays is the processing module used to produce the constituent results.

R/P

Displays the rack ID (R) and position (P) number. NOTE: If the system is configured for a laboratory automation system (LAS) and the specimen is run on the LAS, the R/P is displayed as LAS/1.

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SID

Displays the bar code number or identification assigned to the control.

Control

Displays the name of the control that was processed.

Lot

Displays the lot number of the control that was processed.

Level

Displays the level of the control that was processed.

Assay

Displays the name of the test.

Result

Displays the value and unit of the test result.

Flag

Displays the flags associated with the quality control results.

Time

Displays the date and time that the test completed processing.

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Function buttons Select All

Selects or deselects all items in a list. The button switches between Select All and Deselect All.

Search

Displays the Search flyout.

Print

Displays the Print flyout.

Archive

Displays the Archive flyout.

Details

Navigates to the Details screen for the selected items on the current screen.

Transmit

Sends selected test results to the host computer.

Delete

Displays a message requesting confirmation to delete the selected items.

Text Size

Increases or decreases the size of text displayed.

Related information... Results screen, page 706 Descriptions of screen elements, page 140 Descriptions of quality control result flags, page 724

Results screen, Exception tab element descriptions The Exception tab displays rerun and unreleased test exceptions and test exceptions that have been released manually or automatically for transmission. A test exception remains on the Exception tab until the exception is deleted by an operator or is deleted automatically after 24 hours based on the completion time of the exception.

Elements Module ID

Displays the number of the module used to process the test.

R/P

Displays the rack ID (R) and position (P) number. NOTE: If the system is configured for a laboratory automation system (LAS) and the specimen is run on the LAS, the R/P is displayed as LAS/1.

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SID

Displays the bar code number or identification assigned to the specimen, control, or calibrator test order.

Name

Displays the name of the specimen, control, or calibrator.

Test Type

Displays the type of sample that was ordered: Specimen, Control, or Calibrator.

Assay

Displays the name of the test.

Status

Displays the status of the exception, which can be one of the following statuses:

Message Code

Exceptions have not been rerun or released.

Rerun

Exceptions have been rerun, but they have not been released.

Released

Exceptions have been released manually or automatically for transmission to a host computer.

Displays the numeric message code for the exception and the message text that describes the error.

Function buttons

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Select All

Selects or deselects all items in a list. The button switches between Select All and Deselect All.

Search

Displays the Search flyout.

Print

Displays the Print flyout.

Details

Navigates to the Details screen for the selected items on the current screen.

Rerun

Displays the Rerun Options flyout.

Transmit

Sends selected test results to the host computer.

Delete

Displays a message requesting confirmation to delete the selected items.

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Text Size

Increases or decreases the size of text displayed.

Related information... Results screen, page 706 Descriptions of screen elements, page 140

Results screen, Search flyout element descriptions In the Search flyout of the Results screen, the operator can enter specific data that is used to filter the data on the screen.

Elements Module

Displays check boxes that are used to search by the module. The module number for the specimen results of calculated assays is 6 (the system control module). The module number for control results of calculated assays is the processing module used to produce the constituent results.

Name

Displays a text box that is used to search by the name, which can be one of the following items: • The name of the specimen. • The control name and, if configured, the control level number and control level name for control orders.

Control Lot

Displays a text box that is used to search by the control lot.

Control Level

Displays a text box that is used to search by the control level.

SID

Displays a text box that is used to search by the bar code number or identification assigned to the sample.

PID

Displays a text box that is used to search by the patient identification number.

Rack

Displays a text box that is used to search by the rack identification number.

Position

Displays a drop-down list that is used to search by the rack position.

RSM Position

Displays a drop-down list that is used to search by a position on the reagent and sample manager.

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Assay

Displays a text box that is used to search by the assay name.

Reagent Lot

Displays a text box that is used to search by the reagent lot number.

Date From

Displays a text box that is used to enter a search start date. To enter the search start date, tap the calendar inside the box. To configure the month and year, tap the Left Arrow or Right Arrow button, and then tap the day.

To

Displays a text box that is used to enter a search end date. To enter the search end date, tap the calendar inside the box. To configure the month and year, tap the Left Arrow or Right Arrow button, and then tap the day.

Start Time

Displays a spin box that is used to enter a search start time. To enter the search start time, use the system-configured format (HH:MM) and type the time in the box or tap the Up Arrow and Down Arrow buttons. If the system is configured for the 12-hour clock format, tap the AM or PM button to configure the time of day.

End Time

Displays a spin box that is used to enter a search end time. To enter the search end time, use the system-configured format (HH:MM) and type the time in the box or tap the Up Arrow and Down Arrow buttons. If the system is configured for the 12-hour clock format, tap the AM or PM button to configure the time of day.

Operator

Displays a text box that is used to search by the operator ID.

Results with

Displays check boxes that are used to select results that have one of the following associated items: • Flags • Interpretations

Test Type

Displays check boxes that are used to select results for a specific sample type. This element is displayed only for unreleased results. The Search flyout has two test types: • Specimen • Control

Status

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Displays check boxes that are used to select result statuses. This element is not displayed for unreleased results. The Search flyout has six status types:

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• Pending Transmission • Pending Collation • Transmitted • Not Transmitted • Archived • Not Archived

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

?

Displays Help from the operations manual for the active screen, flyout, or message code.

Related information... Results screen, page 706 Descriptions of transmission statuses, page 725 Search flyout, page 757

Result Details screen On the Result Details screen, the operator can view the following information: • Details for specimen results, control results, or exceptions • Reaction graphs only for c‑series The operator can add a comment to a result or an exception. Related information... Results screen, page 706 Result Details (Specimen and Control) screen element descriptions, page 715 Add a comment to a result or an exception, page 702

Result Details (Specimen and Control) screen element descriptions The Result Details screen displays the result details for specimens and controls.

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Test Information area SID

Displays the sample identification.

Rack/Position

Displays the rack ID and position number. NOTE: If the system is configured for a laboratory automation system (LAS) and the specimen is run on the LAS, the rack ID and position number are displayed as LAS/1.

Operator ID

Displays the identification of the operator logged onto the system when the test was processed.

Sample Type

Displays one of the following sample types for the test: • Specimen • Control

Module/Position

Displays the module number and position of the rack on the loading area.

Time of Completion

Displays the date and time that the tests in process were completed.

PID

Displays the patient identification. This element is displayed only for specimens.

Gender

Displays the gender of the patient. This element is displayed only for specimens.

Date of Birth

Displays the date of birth for the patient. This element is displayed only for specimens.

Name

Displays the name of the patient. This element is displayed only for specimens.

Transmission Status

Displays the status of the test transmission to the host.

Released By

Displays the identification of the operator logged onto the system when the test was released.

Control Information area This area is displayed only for controls.

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Control Name

Displays the name of the control.

Control Lot

Displays the lot number of the control.

Control Level

Displays the name of the control level.

Control Lot Exp.

Displays the expiration date of the control lot.

Assay Information area Assay Name

Displays the name of the assay file.

Assay Number

Displays the number of the assay file.

Assay Version

Displays the version of the assay file.

Result

Displays the value, unit, and (where applicable) interpretation of the result.

Absorbance/mV (c‑series)

Displays the response value used to calculate the result: • Millivolt (only for ICT) • Absorbance (only for photometric assays) NOTE: This element is not displayed for sample interference index assays.

RLU (i‑series)

Displays the response value in relative light units that is used to calculate the result.

Flag

Displays the flags associated with specimen results and quality control results.

Interpretation

Displays the interpretation of the result value obtained.

Normal Range

Displays the normal or therapeutic range for the assay. This element is displayed only for specimens.

Control Range

Displays the control range configured for the assay. If a control range is not configured, the control range that is displayed is calculated based on the configured expected mean and expected standard deviation (1 SD). This element is displayed only for controls.

Codes

Displays the processing codes associated with the test.

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Dilution

Displays the type of dilution used to process the test.

Cuvette (c‑series)

Displays the number of the cuvette used to process the test. This element is not displayed for calibrators.

Module/SN

Displays the serial number of the module.

Message

Displays the message code number and description.

Reagent Information area Reagent Lot

Displays the master lot number for the reagent.

Reagent SN

Displays the serial number of the reagent cartridge.

Reagent Lot Expiration

Displays the expiration date of the reagent cartridge.

Calibration

Displays the date and time of the reagent calibration.

Additional Information area Doctor

Displays the name of the patient's doctor. This element is displayed only for specimens.

Location

Displays the location associated with the patient. This element is displayed only for specimens.

Draw Date/Time

Displays the date and time that the sample was drawn. This element is displayed only for specimens.

Archive Status

Displays the archive status of the test: Archived or Not Archived. This element is not displayed for calibrators.

Archive Date and Time Displays the date and time that the test was archived. This element is not displayed for calibrators. Comment

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Displays a text box that is used to enter a comment for the test.

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Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Previous

Displays the previous item when multiple items are selected.

Next

Displays the next item when multiple items are selected.

Text Size

This function button is unavailable on this screen.

Related information... Result Details screen, page 715 Descriptions of screen elements, page 140

Rerun Options (Specimen Order) flyout element descriptions In the Rerun Options flyout, the operator can order a rerun for a specimen test.

Elements Sample ID

Displays the bar code number or identification assigned to the specimen.

Assay

Displays the name of the test ordered.

Rack

Displays the rack ID if it was entered in the original order.

Position

Displays the rack position if a rack ID was entered in the original order.

SID

Displays the bar code number or identification assigned to the specimen.

Assay

Displays the name of the assay ordered.

Name

Displays the specimen name.

Result

Displays the value and unit of the test result.

Module Selection

Displays the following options:

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Auto

The system scheduler selects the processing module.

Module

Displays options that are used to select a processing module if more than one module of the same type is configured for a system.

Dilution Protocols/ Used to select the correct number of replicates for each Number of Replicates dilution protocol.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

?

Displays Help from the operations manual for the active screen, flyout, or message code.

Related information... Results screen, page 706

Rerun Options (Control Order) flyout element descriptions In the Rerun Options flyout, the operator can order a rerun on a control test.

Elements

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Sample ID

Displays the control lot number and control level number. Barcoded controls include a serial number when quality controls are run in a vial rack. Bar-coded controls include the prefix QQQ followed by the control lot number and level when the controls are run in a sample rack.

Assay

Displays the name of the test ordered.

Rack

Displays the rack ID if it was entered in the original order.

Position

Displays the rack position if a rack ID was entered in the original order.

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Control Name

Displays the control name.

Assay

Displays the name of the assay ordered.

Control Level

Displays the control level.

Result

Displays the value and unit of the test result.

Control Lot

Displays the control lot.

Reagent Selection

Displays the following options: Auto

The system scheduler selects the reagent cartridge.

Select Cartridge

Displays an option that is used to designate the reagent cartridge. When Select Cartridge is selected, the following information is available: • Module ID: Displays the number of the processing module where the reagent cartridge is located. • Position: Displays the reagent carousel position where the reagent cartridge is located. • Reagent Lot: Displays the reagent cartridge lot number. • Serial Number: Displays the reagent cartridge serial number. • Cartridge Status: Displays the reagent cartridge status.

Dilution Protocols/ Used to select the correct number of replicates for each Number of Replicates dilution protocol.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

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?

Section 5

Displays Help from the operations manual for the active screen, flyout, or message code.

Related information... Results screen, page 706

Descriptions of specimen result flags Specimen result flag information is used to provide additional information about a result and to indicate that the result may need to be reviewed. When a specimen result has a flag, the information is displayed in red text on the Results screen. One or more result flags are displayed if they are applicable to a specimen result. The following list provides descriptions of the specimen result flags. The flags are described in the order in which they are sorted: EXP*

The result was measured by using one of the following expired items: • Reagent • Supply • Onboard solution

EXPC*

The result was calculated by using an expired calibration or expired calibrators.

A#1* (c‑series)

The result was calculated by using the only reading, of all the readings in the main read time, that has measured absorbance within the defined absorbance range. This condition can occur when the result concentration is high or the sample is lipemic.

A#2* (c‑series)

The result was calculated by using the only two readings, of all the readings in the main or flex read time, that have measured absorbance within the defined absorbance range. This condition can occur when the result concentration is high or the sample is lipemic.

CNTL*

The result was calculated after the quality control failed. The flag is displayed on subsequent results until the failed quality control (QC) result is rerun for the same control name and control level and the result is within acceptable limits.

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When the control material cannot be repeated to obtain an acceptable value, the procedure to clear a control failure must be performed. When out-of-range QC results are deleted or the assay is uninstalled, the CNTL flag is not removed from patient results. NOTE: Only Westgard rules that are configured as a failure produce a CNTL flag for a patient result. < or >

The result falls outside the dynamic or linear range. NOTE: For c‑series assays, the displayed value is the result of an adjustment by the sample dilution factor. Additionally, the displayed > value reflects an adjustment by the entered correlation factor and intercept for assays that use nonlinear calibration methods when the sample absorbance exceeds the highest calibrator absorbance.

FLEX* (c‑series)

The result was calculated by using the reading data that was measured during the flex read time.

LL or HH

The result falls outside the defined extreme range. NOTE: The result is rounded to the reporting number of decimals for an assay and then is compared against the range.

PSHH* (c‑series ICT assays)

The result may be affected by the ICT sample that was measured immediately before this sample. The sample must be rerun to verify that no affects have occurred.

LOW or HIGH

The result falls outside the defined normal range. NOTE: The result is rounded to the reporting number of decimals for an assay and then is compared against the range.

CORR*

The result was produced by using a correlation version of the assay.

* These flags are carried over from a constituent assay result to a calculated assay result. Related information... Results screen, page 706 Host Setup screen element descriptions, page 225 Sample Status screen element descriptions, page 693 Results screen, Unreleased tab element descriptions, page 707

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Results screen, Specimen tab element descriptions, page 708 Clear a control failure, page 748 A#1 result flag (c‑series), page 1425 A#2 result flag (c‑series), page 1425 FLEX result flag (c‑series), page 1434 PSHH result flag (c‑series), page 1434 Result Details Report element descriptions, page 1685 Result List Report element descriptions, page 1689 Sample Laboratory Report element descriptions, page 1691

Descriptions of quality control result flags Quality control (QC) result flag information is used to provide additional information about a result and to indicate that the result may need to be reviewed. When a QC result has a flag, the information is displayed in red text on the Results screen. One or more result flags are displayed if they are applicable to a QC result. The following list provides descriptions of the QC result flags. The flags are described in the order in which they are sorted: CNTL

The QC result falls outside the minimum and maximum control level range.

Westgard rule

The QC result failed a Westgard rule.

EXP*

The result was measured by using one of the following expired items: • Reagent • Supply • Onboard solution • Control material • ICT module (only for c‑series)

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EXPC*

The result was calculated by using an expired calibration or expired calibrators.

A#1* (c‑series)

The result was calculated by using the only reading, of all the readings in the main read time, that has measured absorbance within the defined absorbance range. This condition can occur when the result concentration is high or the sample is lipemic.

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A#2* (c‑series)

The result was calculated by using the only two readings, of all the readings in the main or flex read time, that have measured absorbance within the defined absorbance range. This condition can occur when the result concentration is high or the sample is lipemic.

< or >

The result falls outside the dynamic or linear range. NOTE: For c‑series assays, the displayed value is the result of an adjustment by the sample dilution factor. Additionally, the displayed > value reflects an adjustment by the entered correlation factor and intercept for assays that use nonlinear calibration methods when the sample absorbance exceeds the highest calibrator absorbance.

FLEX* (c‑series)

The result was calculated by using the reading data that was measured during the flex read time.

PSHH* (c‑series ICT assays)

The result may be affected by the ICT sample that was measured immediately before this sample. The sample must be rerun to verify that no affects have occurred.

CORR*

The result was produced by using a correlation version of the assay.

* These flags are carried over from a constituent assay result to a calculated assay result. Related information... Results screen, page 706 Host Setup screen element descriptions, page 225 Sample Status screen element descriptions, page 693 Results screen, Unreleased tab element descriptions, page 707 Results screen, Control tab element descriptions, page 710 A#1 result flag (c‑series), page 1425 A#2 result flag (c‑series), page 1425 FLEX result flag (c‑series), page 1434 PSHH result flag (c‑series), page 1434 Result Details Report element descriptions, page 1685 Result List Report element descriptions, page 1689

Descriptions of transmission statuses Transmission status information is used to determine the progress of a result transmission to the host. The transmission status is displayed on the Result Details flyout.

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The following list provides descriptions of the transmission statuses: Transmitted

The test is completed and has been successfully transmitted to the host.

Pending Transmission The test is completed, but the test is waiting to be transmitted to the host. Pending Collation

The test is completed, but the system is waiting for one of the following actions to occur before the system transmits to the host: • All tests that are associated with the SID are completed. • All tests that are associated with the SID on a specific processing module are completed.

The test is completed, but the test is not transmitted, is not pending transmission, or is not pending collation.

Related information... Results screen, page 706 Results screen, Search flyout element descriptions, page 713 Result Details Report element descriptions, page 1685

View the reaction graph and absorbance data for a result (c‑series) Perform this procedure to view the reaction graphs and absorbance data for the released and unreleased specimen and control results for c‑series. 1.

On the menu bar, tap Results. The Unreleased tab on the Results screen is the default.

2.

To view the reaction graph or absorbance data for a released specimen or a released control, tap the appropriate tab. NOTE: To filter the list of results, tap Search.

3.

In the list on the tab, tap one or more results (or tap Select All).

4.

Tap Details.

5.

On the Result Details screen, tap Graph View to display the reaction graph and absorbance data for the first result.

6.

To edit the absorbance scale of the reaction graph, type the values in the Y Axis Scale boxes, and then tap Rescale. NOTE: Although an updated view of the reaction graph is displayed, edits to the Y axis scale are not saved.

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If more than one result was selected, tap Next or Previous to display the reaction graph and absorbance data for each result.

8.

To return to the reagent and additional information on the Result Details screen, tap Details View.

9.

To return to the Results screen, tap Done.

Related information... Results screen, page 706 Print a report, page 755 Assay Parameters screen, General tab element descriptions (c‑series photometric, user defined), page 1543

Delete a sample result or an exception Perform this procedure to complete the following tasks: • Delete a released or an unreleased sample result that is not needed on the system. • Delete a control result that is not needed on the system. • Delete an exception that is not needed for troubleshooting. 1.

On the menu bar, tap Results. The Unreleased tab on the Results screen is the default.

2.

To delete released specimens, released controls, or exceptions, tap the appropriate tab.

3.

In the list on the tab, tap one or more results or exceptions (or tap Select All). NOTE: To filter the list, tap Search.

4.

Tap Delete.

5.

When a confirmation message is displayed, tap Yes.

Related information... Results screen, page 706 Search for or filter data, page 757

Transmit a result or an exception to the host Perform this procedure to transmit a released specimen result, a released control result, or an exception to the host. 1.

On the menu bar, tap Results. The Unreleased tab on the Results screen is the default.

2.

To transmit released specimens, released controls, or exceptions, tap the appropriate tab.

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In the list on the tab, tap one or more results or exceptions (or tap Select All). NOTE: To filter the list, tap Search. NOTE: No more than 10,000 records can be transmitted (pending transmission and new selections) at one time.

4.

Tap Transmit.

Related information... Results screen, page 706 Search for or filter data, page 757 User interface (UI) computer corrective action procedures, page 1465

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Quality control analysis Quality control analysis is the process by which quality control (QC) data is monitored. QC data includes both unreleased and released control results. The Alinity ci‑series monitors QC data with Levey-Jennings graphs, Westgard rules, control range tracking, and QC data summaries. To help ensure quality results and maintain optimal system performance, comply with the following requirements: • Carefully follow all directions in the operations manual and the reagent manufacturer's assay documentation. • Do not use expired or contaminated consumables. • Perform maintenance procedures and calibration procedures as recommended. IMPORTANT: Quality control issues must be evaluated and resolved before specimens are tested. The system evaluates quality control (QC) results by assay for each control lot. If reagents are configured to be disabled when a control failure occurs, and a control failure occurs for one or more reagent cartridges, the failure prevents the use of one or more of the cartridges on the module on which the failure occurred. A system configuration parameter determines whether controls are run for an assay for each reagent lot or each reagent cartridge. If quality control is run for each reagent cartridge and any control level fails, the individual reagent cartridge is disabled. If quality control is run for each reagent lot and a tested control level fails, all reagent cartridges for that lot are disabled, including any cartridges that are subsequently loaded on the system. The system enables the reagent cartridge or the reagent lot after the failed QC result is rerun and the result is within acceptable limits. Related information... Operating instructions, page 479 Westgard rule application, page 729 Levey-Jennings (Graph) screen, page 733 Quality Control Summary screen, page 740

Westgard rule application When Westgard rules are configured, the Alinity ci‑series compares a control result at completion against the expected mean and standard deviation for the control level. Previous results, released and unreleased, for the same assay and module are considered in the analysis. Control results that are marked as excluded are not considered. Related information... Quality control analysis, page 729

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Westgard rule descriptions, page 730 Westgard rule run descriptions, page 732 Configure Westgard rules, page 366

Westgard rule descriptions Control results for an assay are evaluated at completion against all Westgard rules that are enabled for the assay. Westgard rules that are configured as a failure are evaluated first, and then the rules that are configured as a warning are evaluated. NOTE: When one-material (1M) rules are evaluated, previous control results that have the same control name, control level name, and control lot number are considered. When across-materials (xM) rules are evaluated, previous control results that have the same control name, the same control lot number, and different control level names are considered. If a control result meets the failure criteria for only one Westgard rule, the result is flagged with the corresponding rule flag. If the failure criteria for more than one Westgard rule is met, only one rule flag is applied to the control result according to the following order: 1.

1-3s

2.

2-2s 1R 1M

3.

2-2s 1R xM

4.

2-2s xR 1M

5.

R-4s

6.

4-1s 1m

7.

4-1s xM

8.

10-x 1M

9.

10-x xM

10. 1-2s When a failure is identified, no further evaluation occurs. A CNTL flag is applied to each patient result associated with an assay that has a control failure. The CNTL flag is not applied to patient results for control failures that are configured as a warning. The following list provides descriptions of the Westgard rules:

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1-2s

Control rule to test whether a control measurement exceeds the control limits of Mean (x) + 2 standard deviation (SD) or x - 2 SD.

1-3s

Control rule to test whether a control measurement exceeds the control limits of x + 3 SD or x - 3 SD.

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2-2s 1R 1M

Control rule to test whether two consecutive control measurements for the same control material within the same run exceed the same control limit of either x + 2 SD or x 2 SD. Both control results must fall on the same side of the mean.

2-2s 1R xM

Control rule to test whether two consecutive control measurements across control materials within the same run exceed the same control limit of either x + 2 SD or x - 2 SD. Both control results must fall on the same side of the mean. The two control results must have different control level names.

2-2s xR 1M

Control rule to test whether two consecutive control measurements for the same control material across two different runs exceed the same control limit of either x + 2 SD or x - 2 SD. Both control results must fall on the same side of the mean. The previous consecutive control result can be obtained during any previous run.

R-4s

Control rule to test whether the range, or difference, between control measurements that are run within 30 minutes of each other exceeds 4 SD. The two control results must have the same control name, can have the same or different control level names, and do not need to be consecutive. The current control result is compared against each control result, which is older than the current result by 30 minutes or less. Each result must be greater than 2 SD, but in opposite directions.

4-1s 1M

Control rule to test whether four consecutive control measurements for the same control material exceed the same control limit of either x + 1 SD or x - 1 SD. All four control results must fall on the same side of the mean. The previous control results can be obtained during any run.

4-1s xM

Control rule to test whether four consecutive control measurements across control materials exceed the same control limit of either x + 1 SD or x - 1 SD. All four control results must fall on the same side of the mean. The previous control results can be obtained during any run. For this rule, both control results with the same or different control level names are considered.

10-x 1M

Control rule to test whether 10 consecutive control measurements for the same control material fall on the same side of the mean. If a control result falls on the mean, the rule

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does not fail. The previous control results can be obtained during any run. 10-x xM

Control rule to test whether 10 consecutive control measurements across control materials fall on the same side of the mean. If a control result falls on the mean, the rule does not fail. The previous control results can be obtained during any run. For this rule, both control results with the same or different control level names are considered.

Related information... Westgard rule application, page 729 Westgard screen element descriptions, page 365

Westgard rule run descriptions Westgard rule run descriptions identify the options to define quality control run intervals on the Alinity ci‑series. A time-based quality control run is configured by using a start time and a time interval to define the number of hours in the run. The run period is used to evaluate the following Westgard rules: • 2-2s 1R 1M • 2-2s 1R xM • 2-2s xR 1M • 4-1s 1M • 4-1s xM The following list provides Westgard rule run descriptions: Start time for the first The quality control shift start time is defined for each c‑series run processing module and each i‑series processing module by configuring the Shift Start Time parameter on the Modules screen. The system creates quality control orders at the configured time for those controls for which the Automated and Use Module Shift Time options are enabled. The quality control shift start time is defined for a control by configuring the Start Time parameter in the Control Configuration area of the Control Create/Edit screen. The system creates quality control orders at the configured time for the control when the Automated option is enabled. Run period length

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On a control-level basis, the Time Interval (Minutes) parameter defines the time interval in minutes after the shift start time for additional control orders to be created. If the

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configured time interval cannot be divided equally into timed run periods in the 24-hour day, the last run is composed of the remaining hours. If the assay time interval is configured, the configured assay time interval supersedes the configured control level time interval if both intervals are defined for the same quality control lot number. Related information... Westgard rule application, page 729 Configure c‑series module settings, page 189 Configure i‑series module settings, page 190

Levey-Jennings (Graph) screen On the Levey-Jennings (Graph) screen, the operator can perform the following functions: • View a maximum of six Levey-Jennings graphs and the statistical data for the same control name and lot number for a specific processing module. • View the Levey-Jennings graphs for the same assay, control name, and lot number for a maximum of four processing modules of the same type in a multimodule system. • Change the criteria for a Levey-Jennings graph and its data. • Include or exclude points from a Levey-Jennings graph. • Print a Levey-Jennings report. • Recalculate the Westgard analysis for a Levey-Jennings point. • View the details of a selected Levey-Jennings point. • Add a comment to a Levey-Jennings point. Related information... Quality control analysis, page 729 Levey-Jennings (Graph) screen element descriptions, page 733 Point Details screen element descriptions, page 736 Display the value for a Levey-Jennings point, page 738 Exclude or include a Levey-Jennings point, page 738 View the details for a Levey-Jennings point, page 739 Add a comment to a Levey-Jennings point, page 739

Levey-Jennings (Graph) screen element descriptions The Levey-Jennings (Graph) screen displays the quality control graphs for the selected assay.

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Elements Assay

Displays the name of the assay selected on the Quality Control Summary screen.

Control

Displays the name of the control.

Lot Number

Displays the lot number of the control.

Exp. Date

Displays the expiration date of the control lot.

Comparison Type

Displays the source of the mean and standard deviation (SD) used to compare to the expected mean and SD. The following comparison types are available in the dropdown list: • None • Manufacturer • Module Cumulative • System Cumulative

Selected Data Range

Displays control data for the date range selected on the Quality Control Summary screen.

Displayed Data Range Displays the date range of the displayed points. As the graph is navigated, the displayed data range changes to reflect the points being viewed.

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Level

Displays the name of the control level.

Module

Displays the number of the module used to process one or more controls.

Mean

Displays the expected mean value as configured.

SD

Displays the expected SD value as configured.

Control Range

Displays the expected control range as configured.

Comparison Mean

Displays the mean used to compare to the expected control mean. Information that is displayed is determined by the comparison type selected.

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Comparison SD

Displays the SD used to compare to the expected control SD. Information that is displayed is determined by the comparison type selected.

N

Displays the number of control points covered by the selected date range.

Graph elements Mean

Represented by the center line of the graph and indicates the expected control mean.

+1 SD and -1 SD

Represented by the first line above and below the mean (green area).

+2 SD and -2 SD

Represented by the second line above and below the mean (yellow area).

+3 SD and -3 SD

Represented by the third line above and below the mean (red area).

Points

Control results that fall within the defined control range and do not fail configured Westgard rules are represented by a black dot and are graphed in the order of completion. Control points that caused a warning condition based on the Westgard analysis are represented by a yellow dot. Control points that failed Westgard analysis are represented by a red dot. Control points beyond +/- 3 SD are shown as a horizontal line. Excluded control points are represented by a white circle with a black dot.

Function buttons QC Summary

Navigates to the Quality Control Summary screen.

Point Details

Navigates to the Point Details screen.

Print

Displays the Print flyout.

Text Size

This function button is unavailable on this screen.

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Related information... Levey-Jennings (Graph) screen, page 733 Descriptions of screen elements, page 140

Point Details screen element descriptions The Point Details screen displays the details for the selected control value.

Control Information area Control Name

Displays the name of the control.

Control Lot

Displays the lot number of the control.

Operator ID

Displays the identification of the operator logged onto the system when the control result was generated or released.

Control Level

Displays the name of the control level.

Control Lot Exp.

Displays the expiration date of the control lot.

Time of Completion

Displays the date and time that the control result was generated.

Assay Name

Displays the name of the assay file.

Assay Number

Displays the number of the assay file.

Point Information area

736

Point Value

Displays the control result.

Flags

Displays the flags associated with the quality control result.

Codes

Displays the processing codes associated with the control result.

Point SD

Displays the standard deviation of the control result.

Mean

Displays the expected mean value as configured.

1 SD

Displays the expected standard deviation value as configured.

2 SD

Displays the expected standard deviation value as configured.

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3 SD

Displays the expected standard deviation value as configured.

Reagent Information area Reagent Lot

Displays the master lot number for the reagent.

Reagent SN

Displays the serial number of the reagent cartridge.

Reagent Lot Expiration

Displays the expiration date of the reagent cartridge.

Calibration

Displays the date and time of the reagent calibration.

Module/Position

Displays the module number and the position number in the reagent carousel where the cartridge is loaded. Dashes are displayed for the module and position number when the cartridge is not loaded on the system.

Additional Information area Include or Exclude Point

Used to exclude a quality control result or to include a previously excluded result.

Perform Westgard Re- Used to recalculate the Westgard analysis. evaluation System Comment

Displays the system comments.

Comment

Displays a text box that is used to enter a reason for the inclusion or exclusion of the control point.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Text Size

This function button is unavailable on this screen.

Related information... Levey-Jennings (Graph) screen, page 733 Descriptions of screen elements, page 140 Alinity ci‑series Operations Manual

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Display the value for a Levey-Jennings point Perform this procedure to display the result value and the date and time for a specific point on the Levey-Jennings (Graph) screen. 1.

Create a Levey-Jennings graph.

2.

Tap a point on the Levey-Jennings graph.

3.

Tap Point Details.

4.

On the Point Details screen, view the point value and the date and time that the control was run.

5.

To return to the Levey-Jennings (Graph) screen, tap Done.

6.

To display the value for another Levey-Jennings point, repeat steps 2, page 738 through 5, page 738.

7.

To return to the Quality Control Summary screen, tap QC Summary.

Related information... Levey-Jennings (Graph) screen, page 733 Create a Levey-Jennings graph, page 747

Exclude or include a Levey-Jennings point Perform this procedure to exclude a point, or to include a previously excluded point, from the quality control statistics. 1.

Create a Levey-Jennings graph.

2.

Tap a point on the Levey-Jennings graph.

3.

Tap Point Details.

4.

On the Point Details screen, perform one of the following steps: – Tap Include to include a previously excluded point. – Tap Exclude to exclude a point. NOTE: The system software automatically excludes a control result that exceeds a value that is six times the expected standard deviation (SD).

5.

In the Comment box, type a reason for the inclusion or exclusion of the point. NOTE: The comment replaces a previously entered comment. After a point is included or excluded, the system software recalculates the cumulative mean, SD, and sample size for the quality control (QC) data. Excluded points are not included in the recalculation.

6.

To recalculate the Westgard analysis, tap the Perform Westgard Re-evaluation check box. NOTE: The system software does not recalculate the Westgard data if more than 5000 QC data points are pending an adjustment.

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To save the edits and return to the Levey-Jennings (Graph) screen, tap Done.

8.

To include or exclude another Levey-Jennings point, repeat steps 2, page 738 through 7, page 739.

9.

To return to the Quality Control Summary screen, tap QC Summary.

Related information... Levey-Jennings (Graph) screen, page 733 Create a Levey-Jennings graph, page 747

View the details for a Levey-Jennings point Perform this procedure to view the details for a specific point on a Levey-Jennings graph. 1.

Create a Levey-Jennings graph.

2.

Tap a point on the Levey-Jennings graph to display the point value and the date and time that the control was run.

3.

Tap Point Details to display all data that is available for the selected point.

4.

On the Point Details screen, view the details for the selected point.

5.

To return to the Levey-Jennings (Graph) screen, tap Done.

6.

To view the details for another Levey-Jennings point, repeat steps 2, page 739 through 5, page 739.

7.

To return to the Quality Control Summary screen, tap QC Summary.

Related information... Levey-Jennings (Graph) screen, page 733 Create a Levey-Jennings graph, page 747

Add a comment to a Levey-Jennings point Perform this procedure to add a comment to a point on a Levey-Jennings graph. 1.

Create a Levey-Jennings graph.

2.

Tap a point on the Levey-Jennings graph.

3.

Tap Point Details.

4.

In the Comment box on the Point Details screen, type a comment. NOTE: The new comment replaces any existing comment for the point.

5.

To save the comment and return to the Levey-Jennings (Graph) screen, tap Done.

6.

To add a comment to another Levey-Jennings point, repeat steps 2, page 739 through 5, page 739.

7.

To return to the Quality Control Summary screen, tap QC Summary.

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Related information... Levey-Jennings (Graph) screen, page 733 Create a Levey-Jennings graph, page 747

Quality Control Summary screen On the Quality Control Summary screen, the operator can view the statistical data for all assay control levels. NOTE: Statistical calculations are performed for all released results, including quality control results for a specific processing module, assay, control name, lot number, and level combination. The quality control summary data is not displayed if the values for expected mean and expected standard deviation (1 SD) are not defined for the control. The operator can perform the following functions: • Find information about a specific control based on specified search criteria. • Access quality control information. • Create a Levey-Jennings graph for a selected assay control level. • Print the QC Analysis Report and the QC Summary Report. The system administrator can clear a control failure for an assay for a specific control, lot number, and level. Related information... Quality control analysis, page 729 Quality Control Summary screen element descriptions, page 740 Quality Control Summary screen, Search flyout element descriptions, page 742 Control Summary Details screen, page 743 Clear Control Failure flyout element descriptions, page 746 Create a Levey-Jennings graph, page 747 Clear a control failure, page 748 View the quality control (QC) summary data, page 749 View the control summary details, page 750

Quality Control Summary screen element descriptions

Elements Module

740

Used to select all modules or individual modules to view information.

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Date Range

Used to enter a date range to search or displays the control summary information for the selected date range.

Update button

Searches and displays data for the entered date range when a new date is selected.

Module

Displays the module number.

Assay

Displays the name of the assay.

Control Name

Displays the name of the control.

Lot Number

Displays the lot number for the control.

Level

Displays the level for the control that was processed.

N

Displays the number of control points that are available for the same level, lot, assay, and module used in the calculation.

Flagged

Displays the number of flagged control results.

Actual Mean

Displays the mean calculated for the level, lot, and assay for a processing module and the specified date range.

Actual SD

Displays the standard deviation calculated for the level, lot, and assay for a processing module and the specified date range.

%CV

Displays the percent coefficient of variation calculated for the level, lot, and assay for a processing module and the specified date range.

Expected Mean

Displays the expected mean configured for the control level.

Expected SD

Displays the expected standard deviation configured for the control level.

Expected Range

Displays the expected control range configured for the control level.

Function buttons Select All

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Selects or deselects all items in a list. The button switches between Select All and Deselect All.

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Search

Displays the Search flyout.

Print

Displays the Print flyout.

Details

Navigates to the Details screen for the selected items on the current screen.

Graph

Displays the Levey-Jennings (Graph) screen for the selected assay.

?

Displays Help from the operations manual for the active screen, flyout, or message code.

Text Size

Increases or decreases the size of text displayed.

Related information... Quality Control Summary screen, page 740 Descriptions of screen elements, page 140

Quality Control Summary screen, Search flyout element descriptions In the Search flyout of the Quality Control Summary screen, the operator can enter specific data that is used to filter the data on the screen.

Elements

742

Control Name

Displays a text box that is used to search by the control name.

Lot

Displays a text box that is used to search by the control lot number.

Level

Displays a text box that is used to search by the level of the control that was processed.

SID

Displays a text box that is used to search by the sample identification (SID) of the control. The control SID is the control lot number and control level number. Bar-coded controls include a serial number when quality controls are run in a vial rack. Bar-coded controls include the prefix QQQ followed by the control lot number and level when the controls are run in a sample rack.

Assay

Displays a text box that is used to search by the assay name.

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Results with Flags

Displays a check box that is used to search for control results that have flags.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

?

Displays Help from the operations manual for the active screen, flyout, or message code.

Related information... Quality Control Summary screen, page 740

Control Summary Details screen On the Control Summary Details screen, the operator can view the following statistical data for a selected control lot number and level: • Expected mean and expected standard deviation (SD) • Manufacturer mean and SD • Quality control data for the selected processing module and the defined date range • System control data that represents the data for all processing modules of the same type in a multimodule system for the defined date range • Module cumulative data that represents all the data for the selected processing module • System cumulative data that represents the data for all processing modules of the same type in a multimodule system Related information... Quality Control Summary screen, page 740 Control Summary Details screen element descriptions, page 743

Control Summary Details screen element descriptions The Control Summary Details screen displays the details for an assay control level.

Control Information area Assay

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Displays the name of the assay.

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Control Lot

Displays the lot number of the control.

Control Name

Displays the name of the control.

Control Level

Displays the name of the control level.

Date Range

Displays the default date range or the date range entered on the Quality Control Summary screen.

Module/Serial No.

Displays the module number and serial number of the module used to process the control. NOTE: The processing module used to produce the constituent results displays the quality control summary data for calculated assays.

Expected area Mean

Displays the configured mean for the control.

SD

Displays the configured standard deviation (SD) for the control.

Range

Displays the configured range for the control.

Manufacturer area Mean

Displays the configured manufacturer's mean for the control.

SD

Displays the configured manufacturer's SD for the control.

Module Date Range area Mean

Displays the calculated mean for the selected module and date range. NOTE: The statistical calculations in the Module Date Range area are based on all released results. These calculations also include the results in the date range for a specific combination of module, assay, control name, control lot number, and control level.

SD

744

Displays the calculated SD for the selected module and date range.

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% CV

Displays the calculated percent coefficient of variation (%CV) for the selected module and date range.

N

Displays the number of data points in the control file for the selected module and date range.

Range

Displays the range of values in the control file for the selected module and date range.

System Date Range area Mean

Displays the calculated mean for the data in the date range for all modules of the same type in a multimodule system.

SD

Displays the calculated SD for the data in the date range for all modules of the same type in a multimodule system.

% CV

Displays the calculated %CV for the data in the date range for all modules of the same type in a multimodule system.

N

Displays the number of data points in the control file in the date range for all modules of the same type in a multimodule system.

Range

Displays the range of values in the control file in the date range for all modules of the same type in a multimodule system.

Module Cumulative area Mean

Displays the cumulative calculated mean for the selected module.

SD

Displays the cumulative calculated SD for the selected module.

% CV

Displays the cumulative calculated %CV for the selected module.

N

Displays the cumulative number of data points in the control file for the selected module.

Range

Displays the range of values in the control file for the selected module.

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System Cumulative area Mean

Displays the cumulative calculated mean for the data for all modules of the same type in a multimodule system.

SD

Displays the cumulative calculated SD for the data for all modules of the same type in a multimodule system.

% CV

Displays the cumulative calculated %CV for the data for all modules of the same type in a multimodule system.

N

Displays the cumulative number of data points in the control file for all modules of the same type in a multimodule system.

Range

Displays the range of values in the control file for all modules of the same type in a multimodule system.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Previous

Displays the previous item when multiple items are selected.

Next

Displays the next item when multiple items are selected.

Text Size

This function button is unavailable on this screen.

Related information... Control Summary Details screen, page 743 Descriptions of screen elements, page 140

Clear Control Failure flyout element descriptions In the Clear Control Failure flyout, the operator can clear a control failure.

Element Comment

746

Displays a text box that is used to enter a required comment when a control failure is cleared.

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Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

?

Displays Help from the operations manual for the active screen, flyout, or message code.

Related information... Quality Control Summary screen, page 740

Create a Levey-Jennings graph Perform this procedure to create a Levey-Jennings graph to monitor quality control activity. NOTE: The Levey-Jennings graph is not displayed if the values for expected mean and expected standard deviation (1 SD) are not defined for the control. 1.

On the menu bar, tap QC. On the Quality Control Summary screen, the quality control (QC) summary data for all modules is displayed.

2.

Perform one of the following steps: – To create a Levey-Jennings graph for the same assay, control name, and lot number for a maximum of four modules of the same type in a multimodule system, proceed to step 3, page 747. – To display the QC summary data for one module, tap a Module button. NOTE: To display the QC summary data for calculated assays, tap the module number of the processing module used to produce the constituent results.

3.

To enter a date range, type a value in the Date Range box and type a value in the To box. NOTE: The default date range is composed of the last 31 days, including the current date.

4.

Tap Update. NOTE: Control results that were run between and on the entered dates are included in the QC summary data.

5.

In the list of QC summary data, tap a maximum of six assay control levels for the same assay, control name, and lot number. NOTE: To filter the list of QC summary data, tap Search. A maximum of three Levey-Jennings graphs can be viewed on the Levey-Jennings (Graph) screen at the same time for the same module, control name, and lot number. Use the scroll bar to display the remaining graphs.

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Section 5

Tap Graph. NOTE: The Graph button is unavailable if more than one assay or lot number is selected on the Quality Control Summary screen.

7.

On the Levey-Jennings (Graph) screen, tap a comparison type in the Comparison Type drop-down list: – None: A comparison method is not used. – Manufacturer: This method compares the expected mean and expected SD to the manufacturer's mean and SD that are configured for the control. NOTE: If Manufacturer is configured, the manufacturer's mean and SD are displayed as the Comparison Mean and Comparison SD elements on the left side of the LeveyJennings (Graph) screen. A dashed line indicates the manufacturer's mean on the graph. – Module Cumulative: This method compares the expected mean and expected SD to the cumulative mean and cumulative SD of the selected module. NOTE: If Module Cumulative is configured, the module cumulative mean and module cumulative SD are displayed as the Comparison Mean and Comparison SD elements on the left side of the Levey-Jennings (Graph) screen. A dashed line indicates the module cumulative mean on the graph. – System Cumulative: This method compares the expected mean and expected SD to the cumulative mean and cumulative SD of all modules in a multimodule system. NOTE: If System Cumulative is configured, the system cumulative mean and system cumulative SD are displayed as the Comparison Mean and Comparison SD elements on the left side of the Levey-Jennings (Graph) screen. A dashed line indicates the system cumulative mean on the graph.

8.

To return to the Quality Control Summary screen, tap QC Summary. NOTE: The previous selections for module, assay, control name, lot number, control level, and date range are displayed on the Quality Control Summary screen.

9.

To create a Levey-Jennings graph for another assay, repeat steps 2, page 747 through 8, page 748.

Related information... Quality Control Summary screen, page 740 Display the value for a Levey-Jennings point, page 738 Exclude or include a Levey-Jennings point, page 738 View the details for a Levey-Jennings point, page 739 Add a comment to a Levey-Jennings point, page 739

Clear a control failure Operator access level System administrator

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Perform this procedure to clear a control failure when the control material cannot be repeated to obtain an acceptable value. The control failure can occur as the result of a value that exceeds a control range or a Westgard rule failure. 1.

On the menu bar, tap QC. On the Quality Control Summary screen, the quality control (QC) summary data for all modules is displayed.

2.

To display the QC summary data for one module, tap a Module button. NOTE: To display the QC summary data for calculated assays, tap the module number of the processing module used to produce the constituent results.

3.

In the list of QC summary data, tap an assay control level that has a control failure. NOTE: An assay control level that has a control failure is displayed in red text on the Quality Control Summary screen.

4.

Tap Clear Control Failure.

5.

In the Comment box in the Clear Control Failure flyout, type a comment.

6.

To save the comment and return to the Quality Control Summary screen, tap Done. NOTE: After the control failure is cleared, Message code 1171 is logged with the comment and the text of the assay control level is displayed in black.

Related information... Quality Control Summary screen, page 740 Descriptions of specimen result flags, page 722

View the quality control (QC) summary data Perform this procedure to view the quality control (QC) summary data for a specific control level. NOTE: The QC summary data is not displayed if the values for expected mean and expected standard deviation (1 SD) are not defined for the control. 1.

On the menu bar, tap QC. On the Quality Control Summary screen, the QC summary data for all modules is displayed.

2.

Perform one of the following steps: – To view the QC summary data for the same assay, control name, and lot number for a maximum of four modules of the same type in a multimodule system, proceed to step 3, page 750. – To display the QC summary data for one module, tap a Module button. NOTE: To display the QC summary data for calculated assays, tap the module number of the processing module used to produce the constituent results.

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To enter a date range, type a value in the Date Range box and type a value in the To box. NOTE: The default date range is composed of the last 31 days, including the current date.

4.

Tap Update. NOTE: Control results that were run between and on the entered dates are included in the QC summary data.

Related information... Quality Control Summary screen, page 740

View the control summary details Perform this procedure to view the control summary details for a specific control level. NOTE: The quality control (QC) summary data is not displayed if the values for expected mean and expected standard deviation (1 SD) are not defined for the control. 1.

On the menu bar, tap QC. On the Quality Control Summary screen, the QC summary data for all modules is displayed.

2.

To display the QC summary data for one module, tap a Module button. NOTE: To display the QC summary data for calculated assays, tap the module number of the processing module used to produce the constituent results.

3.

To enter a date range, type a value in the Date Range box and type a value in the To box. NOTE: The default date range is composed of the last 31 days, including the current date.

4.

Tap Update. NOTE: Control results that were run between and on the entered dates are included in the QC summary data.

5.

In the list of QC summary data, tap one or more assay control levels.

6.

Tap Details.

7.

If more than one assay control level was selected, tap Next or Previous on the Control Summary Details screen to display each assay control level.

8.

To return to the Quality Control Summary screen, tap Done.

Related information... Quality Control Summary screen, page 740

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Print flyout Screen images, reports generated by the system, and Abbott Mail documentation can be printed or can be saved as a portable document format (PDF) file. The system can be configured to print or save the following reports automatically: • Calibration details • Result list • Sample laboratory • Maintenance Reports and Abbott Mail documentation are available from related screens. The following table provides the report availability: To print the ...

Access the ...

Abbott Mail Log Report

System Logs screen, Abbott Mail tab

Absorbance Data Report (c‑series)

Results screen

Assay Information Report

• •

Assay Parameters screen Install/Uninstall Assays screen

Assay Insert

• •

Abbott Mail Inbox screen Reagent Cartridge Details screen

Assay Installation Report

Abbott Mail Inbox screen

Assay Parameter Report

Assay Parameters screen

Calibration Details Report

Calibration Status screen

Calibration Summary Report

Calibration Status screen

Calibrator Value Sheet

•

Calibrator Set View/Edit screen

•

NOTE: A calibrator value sheet is available only for a calibrator lot that was created from an imported file. Abbott Mail Inbox screen

Configuration Log Report

System Logs screen, Configuration tab

Control Insert

Control Create/Edit screen

Diagnostic History Report

Procedures Log screen

Exception List Report

Results screen, Exceptions tab

Information Log Report

System Logs screen, Informational tab

Interfaces Log Report

System Logs screen, Interfaces tab

Inventory Log Report

System Logs screen, Inventory tab

Licenses Report

Utilities screen

Maintenance History Report

Procedures Log screen

Notifications Log Report

System Logs screen, Notifications/Alerts tab

Order List Report

Orders screen

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To print the ...

Access the ...

Print Verification Report

Printers screen

Procedure Report

Procedures screen

QC Analysis Report

Quality Control Summary screen

QC Levey-Jennings Report

Levey-Jennings (Graph) screen

QC Summary Report

Quality Control Summary screen

Reagent Status Report

Reagent screen

Rerun List Report

Orders screen

Result Details Report

Results screen

Result List Report

Results screen

Sample Laboratory Report

Sample Status screen

System Log Report

System Logs screen

System Update Details Report System Update screen, All Messages tab System Update Letter

• •

Abbott Mail Inbox screen System Update screen

System Update List Report

System Update screen

User Access Log Report

System Logs screen, User Access tab

User-Defined Maintenance Details Report

User-Defined Maintenance screen

Related information... Operating instructions, page 479 Print flyout element descriptions, page 752 Report File Location window element descriptions, page 754 Print a report, page 755 Print a screen image, page 756 View or print the Licenses Report, page 399

Print flyout element descriptions Print Options Displays the print options for report selections. Print Location

Displays a drop-down list of the following options: • Configured printer • Print to File

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Copies

Displays a drop-down list of the number of copies that can be selected to print. The default is one copy. A maximum of five copies can be selected.

Print Selection

Displays the print selection options: All Items or Selected Items. If no items were selected on the previous screen, the default is the All Items option. The Selected Items option is unavailable. If one or more items were selected on the previous screen, the default is the Selected Items option. The All Items option is available.

Report Selection

Displays a list of the reports that are available to print. A preview of the selected report is displayed before the report is printed.

PDF viewer area Displays a preview of a portable document format (PDF) file that is downloaded or imported. Rotate

Used to rotate the PDF document clockwise or counterclockwise.

Page

Displays the number of pages in the PDF document. Each page of the document can be viewed by tapping the Previous Page button or the Next Page button or by typing a page number to display to a specific page.

Zoom

Used to increase or decrease the size of the PDF document by tapping the Zoom In button or the Zoom Out button, by typing a document size, or by tapping a document size in the drop-down list.

Fit

Used to resize the PDF document to fit the window width ( ) and enable the scroll bar, or to resize the document to fit one full page in the window ( ).

Find

Used to find a word or phrase in the PDF document. The Find Previous button and the Find Next button are used to browse the document to find the word or phrase.

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Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Print

Prints the selected reports.

Previous

Navigates to the previous PDF document if more than one document was selected.

Next

Navigates to the next PDF document if more than one document was selected.

Text Size

Increases or decreases the size of text displayed. This function button is not displayed with the PDF viewer.

?

Displays Help from the operations manual for the active screen, flyout, or message code.

Related information... Print flyout, page 751

Report File Location window element descriptions The Report File Location window displays the drive and folders that are used to save a report file as a portable document format (PDF) file.

Elements button

The Previous Folder button navigates to the previously selected folder.

button

The Selected Folders button displays all previously selected folders.

Folder name button

754

Displays the currently selected folder. The Home button navigates to the hard drive folder.

Name

Displays the name of the drive or folder.

Last Update

Displays the date and time that the files in the folder were last updated.

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Function buttons OK

Saves the file and closes the window.

Cancel

Cancels the operation and closes the window.

?

Displays Help from the operations manual for the active screen, flyout, or message code.

Related information... Print flyout, page 751

Print a report Required materials

USB flash drive (Print to File option only)

Perform this procedure to print a system-generated report to a configured printer or to save the report as a portable document format (PDF) file. 1.

On a screen, tap one or more items to include in the report. NOTE: Items are printed in the order in which they are displayed on the screen. If a specific item is not selected, all items are printed.

2.

Tap Print.

3.

In the Print flyout, choose a printer or tap Print to File in the Print Location drop-down list.

4.

In the Copies drop-down list, tap the number of copies to print (printer only).

5.

Tap a Print Selection option. NOTE: If one or more items were not selected, All items is the only available option.

6.

In the Report Selection list, tap a report.

7.

Tap Print.

8.

If Print to File was selected in the Print Location drop-down list, perform the following steps to indicate the file destination:

9.

a.

Insert a USB flash drive.

b.

Tap the appropriate USB flash drive.

c.

Tap the destination folder.

d.

Tap OK.

e.

Remove the USB flash drive.

To return to the screen, tap Done.

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Related information... Print flyout, page 751 User-Defined Maintenance screen, Create/Edit tab element descriptions, page 372 Reagents screen, page 608 Abbott Mail Inbox screen, page 538 Insert and remove a USB flash drive, page 764 View the reaction graph and absorbance data for a result (c‑series), page 726

Print a screen image Required materials

USB flash drive (Print to File option only)

Perform this procedure to print a screen image to save graphical or troubleshooting information. 1.

On the screen header, tap the Abbott A button

2.

If the system is configured to save the print screen output as a file, perform the following steps to indicate the file destination:

.

a.

Tap the appropriate USB flash drive.

b.

Tap the destination folder.

c.

To save the file to the destination folder, tap OK. To cancel the save function, tap Cancel.

Related information... Print flyout, page 751 Configure the print screen file output destination, page 213 Insert and remove a USB flash drive, page 764

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Section 5

Search flyout In the Search flyout, the operator can search for specific data by entering search criteria. Related information... Operating instructions, page 479 Search for or filter data, page 757 Reagents screen, Search flyout element descriptions, page 614 Orders screen, Search flyout element descriptions, page 661 Sample Status screen, Search flyout element descriptions, page 696 Cal/QC Inventory screen, Search flyout element descriptions, page 589 Reagents screen, Search flyout element descriptions, page 614 Orders screen, Search flyout element descriptions, page 661 Sample Status screen, Search flyout element descriptions, page 696 Results screen, Search flyout element descriptions, page 713 Abbott Mail Inbox screen, Search flyout element descriptions, page 545

Search for or filter data Perform this procedure to search for specific data or to filter data on a screen. 1.

On a screen, tap Search.

2.

In the Search flyout, enter the search criteria. To limit the search results, enter more criteria. NOTE: Data is filtered based on the results that contain the criteria entered. For example, if 123 is entered in the SID box, all search results that contain 123 are displayed. The search results can include SID numbers 12345, 45123, and 41235.

3.

To search for and display the filtered data, tap Done.

4.

To display all records, tap Clear Filter.

Related information... Search flyout, page 757 Edit a user, page 176 Inactivate or activate a user, page 177 Manage user PINs, page 179 Verify vial inventory data, page 591 Reagents screen, page 608 Suspend and access a sample that has tests in process, page 649 Add a comment to an order, page 668 Alinity ci‑series Operations Manual

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Add a test to a specimen order, page 689 Delete a test from a sample order, page 692 Add a comment to a result or an exception, page 702 Rerun a test or an exception for a specimen or control, page 703 Release a specimen result or a control result, page 704 Delete a sample result or an exception, page 727 Archive the calibrations, page 762 Transmit a calibration to the host, page 806 Transmit a result or an exception to the host, page 727

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Section 5

Archive flyout In the Archive flyout, the operator can archive specimen results, control results, or calibrations. Related information... Operating instructions, page 479 Archive flyout element descriptions, page 759 Archive File Location window element descriptions, page 760 Archive the results, page 761 Archive the calibrations, page 762

Archive flyout element descriptions The Archive flyout is used to archive data.

Elements Archive Options Archive Selection

From To Archive Mode

Displays the archive options. The Archive flyout has three options: All Items

This option archives data within a defined date range.

Incremental

This option archives data that does not have a status of Archived within a defined date range.

Selected Items

This option archives selected data.

Used to enter a start date. A start date is available only for the All Items option and the Incremental option. Used to enter an end date. An end date is available only for the All Items option and the Incremental option. Displays the archive modes. The Archive flyout has two archive modes: Only Archive

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This option saves archived data to a USB flash drive.

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Archive & Delete

This option deletes data after all the selected data has been archived to a USB flash drive.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Archive

Archives data and closes the flyout.

?

Displays Help from the operations manual for the active screen, flyout, or message code.

Related information... Archive flyout, page 759

Archive File Location window element descriptions The Archive File Location window displays the drive and folders that are used to save an archive file.

Elements button

Folder name button

The Previous Folder button navigates to the previously selected folder. Displays the currently selected folder. The Home button navigates to the hard drive folder.

Name

Displays the name of the drive or folder.

Last Update

Displays the date and time that files in the folder were last updated.

Function buttons

760

OK

Saves the file and closes the window.

Cancel

Cancels the operation and closes the window.

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Section 5

Displays Help from the operations manual for the active screen, flyout, or message code.

?

Related information... Archive flyout, page 759

Archive the results Required materials

USB flash drive

Perform this procedure to archive specimen and control results on a USB flash drive. NOTE: The results are archived in an Excel file format with a digital signature and can be imported into a spreadsheet. If the spreadsheet is edited, the digital signature is removed from the Excel file. The archived results cannot be viewed on the Alinity ci‑series. 1.

Insert the USB flash drive.

2.

On the menu bar, tap Results. The Unreleased tab on the Results screen is the default.

3.

To archive released samples or released controls, tap the appropriate tab.

4.

In the list on the tab, tap one or more results (or tap Select All). NOTE: To filter the list of results, tap Search.

5.

Tap Archive.

6.

Under Archive Options in the Archive flyout, tap an Archive Selection option: – All items: This option archives all results within a defined date range. To enter a date range, tap From and enter a start date, tap To and enter an end date, or enter both a start date and an end date. – Incremental: This option archives all results that do not have a status of Archived within a defined date range. To enter a date range, tap From and enter a start date, tap To and enter an end date, or enter both a start date and an end date. – Selected items: This option is available only if results were selected in step 4, page 761.

7.

Tap an Archive Mode option: – Only Archive: This option saves archived results to a USB flash drive. – Archive & Delete: This option deletes results after all the selected results have been archived to a USB flash drive. NOTE: Results with a status of Pending Transmission or Pending Collation are not deleted.

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8.

Tap Archive.

9.

On the Archive File Location screen, tap the USB flash drive and folder to which to archive the results.

10. Tap OK. 11. When a confirmation message is displayed, tap one of the following buttons: – Tap Yes to complete the archive process. – Tap No to close the Archive flyout. 12. Remove the USB flash drive. Related information... Archive flyout, page 759 Delete a quality control, page 360 Results screen, page 706 Insert and remove a USB flash drive, page 764

Archive the calibrations Required materials

USB flash drive

Perform this procedure to archive active and inactive calibrations on a USB flash drive. NOTE: The calibrations are archived in an Excel file format with a digital signature and can be imported into a spreadsheet. If the spreadsheet is edited, the digital signature is removed from the Excel file. The archived calibrations cannot be viewed on the Alinity ci‑series. 1.

Insert the USB flash drive.

2.

On the menu bar, tap CAL. The Current tab of the Calibration Status screen displays the calibration data for all modules.

3.

On the Calibration Status screen, tap the Historical tab.

4.

On the Historical tab of the Calibration Status screen, tap one or more calibrations (or tap Select All). NOTE: To filter the list of calibrations, tap Search.

5.

Tap Archive.

6.

Under Archive Options in the Archive flyout, tap an Archive Selection option: – All items: This option archives all calibrations within a defined date range. To enter a date range, tap From and enter a start date, tap To and enter an end date, or enter both a start date and an end date.

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– Incremental: This option archives all calibrations that do not have a status of Archived within a defined date range. To enter a date range, tap From and enter a start date, tap To and enter an end date, or enter both a start date and an end date. – Selected items: This option is available only if calibrations were selected in step 4, page 762. 7.

Tap an Archive Mode option: – Only Archive: This option saves archived calibrations to a USB flash drive. – Archive & Delete: This option deletes inactive calibrations after all the selected calibrations have been archived to a USB flash drive. NOTE: If Archive & Delete is selected, only calibrations that have a status of Inactive are deleted. If calibrations that have a status of Active are selected, an informational message notifies the operator that calibrations are not deleted.

8.

Tap Archive.

9.

On the Archive File Location screen, tap the USB flash drive and folder to which to archive the calibrations.

10. Tap OK. 11. When a confirmation message is displayed, tap one of the following buttons: – Tap Yes to complete the archive process. – Tap No to close the Archive flyout. 12. Remove the USB flash drive. Related information... Archive flyout, page 759 Search for or filter data, page 757 Insert and remove a USB flash drive, page 764 Calibration review, page 795

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Section 5

Insert and remove a USB flash drive Perform this procedure to insert a USB flash drive into a USB port and to remove the USB flash drive from the USB port on the user interface computer. NOTE: USB flash drives that are software encrypted with password protection are not permitted for use on the Alinity ci‑series. 1.

Open the system control module (SCM) front door.

2.

Insert the USB flash drive into a USB port.

3.

After the procedure that uses the USB flash drive is completed, remove the USB flash drive from the USB port.

4.

Close the SCM front door.

Related information... Operating instructions, page 479 Import users, page 178

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Operating instructions Insert and remove a USB flash drive

Export users, page 179 Configure an automatic backup, page 240 Import calibrator data (c‑series), page 314 View or print a calibrator value sheet (c‑series), page 320 Install assay files, page 325 Install procedure files, page 371 Export a user-defined maintenance procedure, page 378 Perform a manual backup, page 382 Copy a backup to a USB flash drive, page 383 Retrieve a troubleshooting package, page 396 Print a 1D reagent bar code report (c‑series), page 630 Print a report, page 755 Print a screen image, page 756 Archive the results, page 761 Archive the calibrations, page 762 Export assay files (c‑series), page 331 Import assay files (c‑series), page 332

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NOTES

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Section 6

Calibration procedures

Introduction Calibration is the process used to analyze calibrators of a known concentration, to record system response values, and to plot measured values against the known concentration. Before performing sample processing, calibrate all assays. Related information... Calibration guidelines, page 768 Calibration types and methods, page 769 Calibration storage, page 793 Calibration review, page 795 Operating instructions, page 479 Create a calibration order, page 688

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Section 6

Calibration guidelines After an assay is installed that requires a calibration, an active calibration must be generated. A calibration is not required every time that an assay is run. However, a recalibration is required with certain variables. Mandatory assay calibration

A calibration must be performed when: • A new reagent lot number is used. • Assay documentation states that a calibration is required when a reagent cartridge is changed. • Documentation that accompanies a new version of an existing assay file states that a calibration is required. • A new assay file that requires a calibration is installed. • The calibration has expired.

Optional assay calibration

A calibration may need to be performed when: • Assay control values do not meet required specifications. For specific information about quality control, see the manufacturer's documentation. • Certain system maintenance procedures or component replacement procedures are performed. • Certain errors occur. To determine whether a recalibration is required when an error occurs, see assayspecific message codes.

Running all levels of appropriate controls is recommended when an assay is calibrated. Related information... Calibration procedures, page 767

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Section 6

Calibration types and methods Calibration types and methods define the system-specific processes that are used to create a calibration curve or determine a cutoff value. Related information... Calibration procedures, page 767 Calibration method (c‑series potentiometric), page 769 Calibration types and methods (c‑series photometric), page 774 Calibration types and methods (i‑series), page 784

Calibration method (c‑series potentiometric) The potentiometric calibration method is used to calculate results for the ICT assays of sodium (Na+), potassium (K+), and chloride (Cl-). Serum and urine calibrators are available for use and contain known concentrations of electrolytes. The serum calibrators are protein-based materials. The urine calibrators are aqueous-based materials that span a greater concentration range. The millivolts measured by each electrode of the ICT module are plotted against the known concentration of electrolyte in the calibrator. The slope of the calibration is expressed as a percentage of the ideal slope. Electrolyte determinations are made at 37°C. Therefore, the ideal slope of the electrode is 100% (61.5 millivolts per decade). The potentiometric calibration method is specific to these assays, is defined in the system software, and has three components: • Electromotive force measurement • Slope calculation • Sample measurement Related information... Calibration types and methods, page 769 Electromotive force measurement (c‑series potentiometric), page 769 Slope calculation (c‑series potentiometric), page 770 Sample measurement (c‑series potentiometric), page 772

Electromotive force measurement (c‑series potentiometric) The electromotive force measurement uses the potential difference between the electromotive force of an unknown sample and the electromotive force of the ICT Reference Solution, measured immediately after the sample, to determine the electrolyte concentration.

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Figure 150: Electromotive force calculation

Where: E

Electromotive force expressed in millivolts

T

Time

ΔEi

Potential difference between the sample and the ICT Reference Solution for each electrode

Ei

Potential of each electrode (i) in contact with the sample

i

Ion of interest (Na+, K+, and Cl-)

EB

Potential of each electrode (i) in contact with the ICT Reference Solution

Related information... Calibration method (c‑series potentiometric), page 769

Slope calculation (c‑series potentiometric) The slope calculation uses the potential differences between the electromotive forces of two calibrators and the electromotive force of the ICT Reference Solution and compares them to the calibrator concentrations to generate a calibration curve. When the calculation occurs, the system software generates two graphs: • A calibration graph that shows the relationship between the ion concentration and the electromotive force 770

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Section 6 • An electrode response curve during calibration

Figure 151: Relationship between the ion concentration and the electromotive force

Electromotive force is derived from the Nernst equation: E = E0 + S logCi: Where: E

Electromotive force expressed in millivolts

E0

Electromotive force under standard conditions

S

Slope (millivolts per decade) of each electrode

CL, CH

Concentration of low and high calibrators

CN

Concentration of the ICT Reference Solution

ΔEL, ΔEH

Potential difference between the ICT Reference Solution and the calibrator for each electrode

logCi

Logarithm of the concentration of the ion of interest

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Figure 152: Electrode response curve during calibration

Where: E

Electromotive force expressed in millivolts

ΔEL, ΔEH

Potential difference between the ICT Reference Solution and the calibrator for each electrode

T

Time

EL

Electromotive force of the low calibrator

EH

Electromotive force of the high calibrator

EN, EN'

Electromotive force of the ICT Reference Solution

Related information... Calibration method (c‑series potentiometric), page 769

Sample measurement (c‑series potentiometric) The sample measurement uses the following data to determine the electrolyte (ICT) concentration in an unknown sample: • The difference between the electromotive forces of the unknown sample and the ICT Reference Solution • The difference between the electromotive forces of the low calibrator and the ICT Reference Solution 772

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Section 6 • The slope of the specific ICT electrode

The electrolyte concentration is calculated by using the following equation: Ci = CL × 10 ΔEi

− ΔEL / S

Figure 153: Electrode response curve during sample measurement

Where: Ci

Concentration of the ion of interest in the sample

CL

Concentration of the ion of interest in the low calibrator (baseline for sample calculations)

ΔEi

Difference in the electrode potential when exposed to the sample and the ICT Reference Solution

ΔEL

Difference in the ICT electrode potential when exposed to the ICT Reference Solution and the low calibrator during calibration

S

Slope of the ICT electrode of interest

EN

Electromotive force of the ICT Reference Solution

Ei

Electrode potential of the sample for the ion of interest

E

Electromotive force expressed in millivolts

T

Time

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ICT index An index solution can be used to compensate for differences between ICT modules, day-to-day instrument variations, and matrix differences between calibrators and patient samples. The index solution is a sample with a known concentration and is used during calibration of an ICT analyte. After calibration is completed, sample measurements are adjusted automatically. Measured sample values are adjusted by using the following equation: Conc' = Conc - (Comp' - Comp) Where: Conc'

Adjusted ICT sample value

Conc

Measured ICT sample value (not adjusted)

Comp'

Measured value of the index solution

Comp

Nominal index concentration (known value)

(Comp' - Comp)

Adjustment value

The measured value of the index solution for the specific analyte is calculated by using the following equation: Ci = CL × 10 ΔEi

− ΔEL / S

NOTE: When the index concentration is set to zero, the index value is not calculated. Related information... Calibration method (c‑series potentiometric), page 769

Calibration types and methods (c‑series photometric) Two c‑series assay calibration types, full and adjustment, apply only to photometric assays and indicate whether a calibration curve is created or adjusted. The photometric calibration methods use measured absorbance values to plot a calibration curve or to determine a cutoff value. The system software provides six full calibration methods and three adjustment calibration types. The type and method are defined in each assay parameter file. For information about calibration types and methods for an assay, see the assay documentation. Related information... Calibration types and methods, page 769 Full calibration (c‑series photometric), page 775

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Section 6 Adjustment calibration (c‑series photometric), page 781

Full calibration (c‑series photometric) A full calibration for an assay is the measurement of a reagent blank and all specified data points. The absorbance value for each point is plotted against the known concentration and the system software generates a new calibration curve. Unknown samples are then evaluated against the calibration curve. A full calibration is necessary to update the full calibration interval. Related information... Calibration types and methods (c‑series photometric), page 774 Absorbance method (c‑series photometric), page 775 Factor method (c‑series photometric), page 775 Linear method (c‑series photometric), page 776 Logit-4 method (c‑series photometric), page 778 Spline method (c‑series photometric), page 779 Use cal factor blank method (c‑series photometric), page 781 Assay Parameters screen, Calibration tab element descriptions (c‑series photometric, user defined), page 1556

Absorbance method (c‑series photometric) The absorbance data reduction method uses the comparison between the absorbance of the sample and the absorbance of water to calculate results. For end-point assays, the data is expressed as absorbance. For rate assays, the data is expressed as the rate of absorbance change per minute. Related information... Full calibration (c‑series photometric), page 775

Factor method (c‑series photometric) The factor data reduction method uses a reagent blank and a fixed calibration factor value to calculate results. This method is applicable to assays for which the reaction is linear and stable across all reagent lots. This method is used to measure enzyme activity in a sample at a predictable and steady rate that can be determined for the chromophore, wavelengths, and processing module in use. The enzyme activity or the sample concentration is calculated by using the following equation: X = (A - Ablk) x Factor Where: X

Activity or concentration of the unknown sample

A

Absorbance or absorbance change of the unknown sample

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Ablk

Absorbance or absorbance change of the reagent blank

Factor

Calibration factor

Related information... Full calibration (c‑series photometric), page 775

Linear method (c‑series photometric) The linear data reduction method uses a reagent blank and one to six calibrators to generate a point-to-point calibration curve. The slope is calculated for each segment of the curve between calibrator levels. Figure 154: Linear calibration curve for six calibrators

Where:

776

Abs

Absorbance

Conc

Concentration

blk

Concentration of the reagent blank

C1 to C6

Concentration of the calibrator

Ablk

Absorbance or absorbance change of the reagent blank

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Section 6

Ac1 to Ac6

Absorbance or absorbance change of the calibrator

The absorbance or absorbance change that is measured for the sample determines which of the following equations are used to calculate the sample concentration. When A ≤ Ac1, X = F1 x (A - Ablk) + blk F1 =

C1 − blk Ac1 − Ablk

When Ac1 < A ≤ Ac2, X = F2 x (A - Ac1) + C1 F2 =

C2 − C1 Ac2 − Ac1

When Ac2 < A ≤ Ac3, X = F3 x (A - Ac2) + C2 F3 =

C3 − C2 Ac3 − Ac2

When Ac3 < A ≤ Ac4, X = F4 x (A - Ac3) + C3 F4 =

C4 − C3 Ac4 − Ac3

When Ac4 < A ≤ Ac5, X = F5 x (A - Ac4) + C4 F5 =

C5 − C4 Ac5 − Ac4

When Ac5 < A, X = F6 x (A - Ac5) + C5 F6 =

C6 − C5 Ac6 − Ac5

Where: A

Absorbance or absorbance change of the unknown sample

Ac1 to Ac6

Absorbance or absorbance change of the calibrator

Ablk

Absorbance or absorbance change of the reagent blank

X

Concentration of the unknown sample

C1 to C6

Concentration of the calibrator

blk

Concentration of the reagent blank

F1 to F6

Cal factor (1/slope)

Related information... Full calibration (c‑series photometric), page 775

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Logit-4 method (c‑series photometric) The logit-4 data reduction method uses a reagent blank and three to six calibrators to generate a calibration curve. This method is applicable to assays for which the absorbance or absorbance change increases as the calibrator concentration increases. Figure 155: Logit-4 calibration curve for three to six calibrators

Where: Abs

Absorbance

Conc

Concentration

blk

Concentration of the reagent blank

C1 to C(N)

Concentration of the calibrator

X

Concentration of the unknown sample

Ablk

Absorbance or absorbance change of the reagent blank

Ac1 to Ac(N)

Absorbance or absorbance change of the calibrator

A

Absorbance or absorbance change of the unknown sample

An approximation is calculated by using the following equation:

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Section 6 A =

Kc

1 +

1 e a + b × lnX

+ Ablk

Where: A

Absorbance or absorbance change of the unknown sample

Kc, a, b

Constants of the approximation expression

Ablk

Approximate value of the absorbance or absorbance change of the reagent blank

X

Concentration of the unknown sample

ln

Natural log

When the concentration is near zero, the logit-4 calibration curve converges asymptotically toward the absorbance or absorbance change of the reagent blank as the concentration approaches zero. A graph may not show this convergence if the scale is too large. The approximation expression is simple and the constant is determined through an approximation by nonlinear regression. Therefore, the curve may not consistently pass through the absorbance (or absorbance change) data points of the calibrator. A parameter is available to detect an error if the standard deviation of the absorbance or absorbance change of the calibrators exceeds a specified value. Related information... Full calibration (c‑series photometric), page 775

Spline method (c‑series photometric) The spline data reduction method uses a reagent blank and three to six calibrators to generate a calibration curve. The concentration axis of the calibration curve graph is divided into multiple sections. The sections correspond to the concentrations of the calibrators. Each section of the curve is interpolated by using a polynomial equation so that the adjoining sections are connected smoothly.

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Section 6

Figure 156: Spline calibration curve for three to six calibrators

Where: Abs

Absorbance

Conc

Concentration

blk

Concentration of the reagent blank

C1 to C(N)

Concentration of the calibrator

Ablk

Absorbance or absorbance change of the reagent blank

Ac1 to Ac(N)

Absorbance or absorbance change of the calibrator

An interpolation is calculated by using the following polynomial equation: A = a(n) + b(n) x X + c(n) x X2 + d(n) x X3 Where:

780

A

Absorbance or absorbance change of the unknown sample

a(n), b(n), c(n), d(n)

Constants of the approximation expression

X

Concentration of the unknown sample

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Section 6

Related information... Full calibration (c‑series photometric), page 775

Use cal factor blank method (c‑series photometric) The use cal factor blank calibration method uses the factor and reagent blank of a calibration curve generated for another assay (reference assay) to calculate results. This method is used when two or more assays use the same reagent and have the same sample volume to reagent volume ratios. The reference assay is defined in an assay parameter file. The unknown sample concentration is calculated by using the following equation: X =

A − Ablk′ Ac1′ − Ablk′

× C1′

Where: X

Concentration of the unknown sample

A

Absorbance or absorbance change of the unknown sample

Ac1'

Absorbance or absorbance change of the calibrator used for the reference test

Ablk'

Absorbance or absorbance change of the reagent blank used for the reference test

C1'

Concentration of the calibrator used for the reference test

Related information... Full calibration (c‑series photometric), page 775

Adjustment calibration (c‑series photometric) An adjustment calibration uses one of the following measurement options: • A new measurement of a reagent blank • A new measurement of one specific point of a full calibration curve • A new measurement of a reagent blank and one specific point of a full calibration curve The system software uses the new measurements to adjust the existing calibration data points and then generates a new calibration curve. The adjustment calibration interval is updated when either a full calibration or a designated adjustment calibration is performed. The c‑series provides the following adjustment options: • Blank adjustment • 1-point adjustment

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• 2-point adjustment Related information... Calibration types and methods (c‑series photometric), page 774 Blank adjustment (c‑series photometric), page 782 1-point adjustment (c‑series photometric), page 782 2-point adjustment (c‑series photometric), page 783 Create a calibration order, page 688 Assay Parameters screen, Calibration tab element descriptions (c‑series photometric, user defined), page 1556

Blank adjustment (c‑series photometric) In a blank adjustment, the system reanalyzes only the reagent blank. The following steps show how the calibration curve is adjusted with the new reagent blank data. The calibration curve is plotted as absorbance (Abs) versus concentration (Conc). Step

Description

1

The system software performs the new measurement (Ablk') for the reagent blank (Ablk).

2

The new reagent blank absorbance value (Ablk') replaces the previous value and the curve adjusts up or down based on the new reagent blank value.

3

The system software generates a new calibration curve.

Related information... Adjustment calibration (c‑series photometric), page 781

1-point adjustment (c‑series photometric) In a 1-point adjustment, the system reanalyzes one calibrator. The calibrator used is defined on the Calibration tab of the Assay Parameters screen. The following steps show how the

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calibration is adjusted with the new calibrator data. The calibration is plotted as absorbance (Abs) versus concentration (Conc). Step

Description

1

The system performs the new measurement (A2') for the designated adjustment calibrator (A2).

2

A ratio (R) that compares the new (A2') and previous (A2) absorbance data is calculated:

All other calibrators (A1 and A3) are adjusted by using the calculated ratio. The adjusted absorbance values are A1' and A3'. The reagent blank is not adjusted. 3

The system software uses the adjusted data points to generate a new calibration.

Related information... Adjustment calibration (c‑series photometric), page 781

2-point adjustment (c‑series photometric) In a 2-point adjustment, the system reanalyzes the reagent blank and one calibrator. The calibrator used is defined on the Calibration tab of the Assay Parameters screen. The following steps show how the calibration is adjusted with the new calibrator data. The calibration is plotted as absorbance (Abs) versus concentration (Conc). Step

Description

1

The system performs the new measurement (Ablk') for the reagent blank (Ablk).

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Section 6 Description The system performs the new measurement (A2') for the designated adjustment calibrator (A2).

2

The new reagent blank absorbance value (Ablk') replaces the previous value and the curve adjusts up or down based on the change in the reagent blank. A ratio (R) that compares the new (A2') and previous (A2) absorbance data is calculated:

All other calibrators (A1 and A3) are adjusted by using the calculated ratio. The adjusted absorbance values are A1' and A3'. 3

The system software uses the adjusted data points to generate a new calibration.

Related information... Adjustment calibration (c‑series photometric), page 781

Calibration types and methods (i‑series) A calibration type indicates whether a new calibration curve is created, a master reference curve is adjusted, or a cutoff value is created for i‑series assays on a processing module. The system software uses a specific calibration method to create each calibration. The type and method are defined in each assay parameter file and are specific to the assay. For a detailed description of assay calibrators and calibration types and methods for an assay, see the assay documentation.

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Related information... Calibration types and methods, page 769 Full calibration (i‑series), page 785 Adjustment calibration (i‑series), page 788 Index calibration (i‑series), page 792 Reference method (i‑series), page 792

Full calibration (i‑series) A full calibration is a measurement of six points specified for a quantitative assay plotted against known concentrations. The system software uses calibration data to generate a calibration curve that is specific to a processing module. A full calibration is created by using one of the three calibration (data reduction) methods that the Alinity i‑series provides. Related information... Calibration types and methods (i‑series), page 784 Point-to-point method (i‑series), page 785 Linear regression method (i‑series), page 786 4PLC methods (i‑series), page 787

Point-to-point method (i‑series) The point-to-point data reduction method uses the average relative light unit (RLU) value obtained for each calibrator compared to the calibrator concentration (Conc) to generate a calibration curve. A straight line is used to connect each point. The slope is calculated for each line segment. Concentrations of unknown samples are calculated from the line segment that brackets sample RLU values. Figure 157: Point-to-point data reduction method

For example, if a sample has an RLU value between the RLU values for calibrator B and calibrator C, the unknown sample concentration is calculated by using the following equation: Conc (X) =

Conc (C) − Conc (B) RLU (C) − RLU (B)

× RLU (X) − RLU (B) + Conc (B)

Related information... Full calibration (i‑series), page 785

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Linear regression method (i‑series) The linear regression data reduction method uses the linear relationship between the relative light unit (RLU) value and the concentration of the analyte in the sample to generate a calibration curve. The curve is calculated by using the following equation: RLU = Intercept (b) + Slope (m) x Concentration (Conc) Figure 158: Linear regression data reduction method

The unknown specimen concentration is calculated by using the following equation: Conc =

RLU − b m

Slope (m) and intercept (b) are obtained from the calibration. To calculate the slope and the intercept, the system software minimizes the sum of squares of the difference between an observed value and a predicted value (by the regression equation) for all calibrators. The following equations show the calculations: S xx × S y − S x × S xy Δ S × S xy − S x × S y m = Δ Δ = S × Sxx − S2x 1 S = Σ 2 σi xi sx = Σ 2 σi yi Sy = Σ 2 σi x 2i Sxx = Σ 2 σi xi × yi Sxy = Σ σ 2i

b =

Where:

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Standard deviation associated with a calibrator

xi

Observed calibrator concentration

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Observed calibrator RLU value

yi

Related information... Full calibration (i‑series), page 785

4PLC methods (i‑series) Data reduction methods for four-parameter logistic curve fit or four-parameter logistic calibration (4PLC) use the difference between predicted and observed calibrator concentrations (Conc) or signals to generate a calibration curve. A 4PLC curve is calculated by using the following equation: RLU = P1 +

P2

P3 + Conc P4

Four parameters (P1 through P4) control the shape of the curve. Based on the data generated, a 4PLC curve can be sigmoidal (S-shaped) or can have a shape with no second bend. The following list shows how the four parameters are used: Defines the signal at an infinite concentration

P1 P2 P3

Defines the maximum theoretical range of a relative light unit (RLU) value from zero concentration to infinity

X50 =

1 P4 P 3

Defines the concentration that yields a signal midway between the highest possible signal and the lowest possible signal Determines whether the curve is S-shaped. The curve is Sshaped when P4 is greater than 1.

P4

These parameters are calculated to find the P values that generate a curve with the lowest sum of squares: Conc =

P2 RLU − P1

− P3

1 P4

The 4PLC data reduction methods are an x residual minimization (x-weighted) method and a y residual minimization (y-weighted) method. 4PLC with x residual minimization (x-weighted) method The 4PLC with x residual minimization (x-weighted) method uses the difference between predicted and observed calibrator concentrations to generate a calibration curve. To generate a curve with the lowest possible sum of squares, the four parameters are calculated by using the following equation: Σ

xi − xi 2 σi

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Where: xi

Observed calibrator concentration

xi

Predicted calibrator concentration

σi

Standard deviation associated with a calibrator

4PLC with y residual minimization (y-weighted) method The 4PLC with y residual minimization (y-weighted) method uses the difference between predicted and observed calibrator signals to generate a calibration curve. To generate a curve with the lowest possible sum of squares, the four parameters are calculated by using the following equation: Σ =

yi − yi 2 σi

Where: yi

Observed calibrator signal (RLU value)

yi

Predicted calibrator signal (RLU value)

σi

Standard deviation associated with a calibrator

Related information... Full calibration (i‑series), page 785

Adjustment calibration (i‑series) An adjustment (adjust) calibration is a measurement of two points of a master reference curve specified for an assay. The system software uses master calibration data to generate a calibration curve that is specific to a processing module when quantitative assays are used. A two-point adjust calibration assay has master calibration data encoded within a twodimensional bar code on the reagent cartridge label. After the operator loads a reagent cartridge on a processing module, the system performs a scan and stores master calibration data in the system software. The stored data is specific for the assay, but the data must be adjusted to fit a specific processing module. Therefore, the operator must run two calibrators. The Alinity i‑series provides four methods of calibration adjustment. Related information... Calibration types and methods (i‑series), page 784 Ratio technique methods (i‑series), page 789 Linear transformation method (i‑series), page 790 Parameter method (i‑series), page 790

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Ratio technique methods (i‑series) The ratio technique adjustment methods compare the relative light unit (RLU) value of calibrators to the corresponding calibrator values from a master calibration curve. This technique is used when the lower end of the calibration curve has different characteristics than the rest of the curve, but the general behavior of the curve is still proportional and linear. Ratios are calculated for calibrator 1 and calibrator 2 by using the following equations: R1 =

C1 M1

Where: R1

Ratio 1

C1

RLU value measured for calibrator 1

M1

RLU value stored in a reagent bar code for a calibrator that corresponds to calibrator 1

R2 =

C2 M2

Where: R2

Ratio 2

C2

RLU value measured for calibrator 2

M2

RLU value stored in a reagent bar code for a calibrator that corresponds to calibrator 2

The system software uses two types of ratio techniques, A and AB. The type that is used depends on which master calibrator level is multiplied by ratio 1 and ratio 2. Both types of ratio techniques produce estimates of RLU values. The following calculations are used to determine the estimates: Ratio A technique adjustment method

The RLU value stored in the reagent bar code for calibrator A is multiplied by ratio 1. The RLU value stored in the reagent bar code for calibrators B through F is multiplied by ratio 2.

Ratio AB technique adjustment method

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The RLU value stored in the reagent bar code for calibrators A and B is multiplied by ratio 1.

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The RLU value stored in the reagent bar code for calibrators C through F is multiplied by ratio 2. The estimates of instrument-specific RLU values are used to generate the calibration curve. Related information... Adjustment calibration (i‑series), page 788

Linear transformation method (i‑series) The linear transformation adjustment method assumes a linear relationship between the calibrator relative light unit (RLU) values that are generated by the system and the master calibration information that is stored in a reagent bar code. The following equations show an example of this method. The slope and the intercept that describe the linear relationship are based on the RLU values of calibrator 1 and calibrator 2 that are generated by the system and on the corresponding RLU values that are stored in the reagent bar code. The slope (m) and the intercept (b) are calculated by using the following equations: m =

C2 − C1 M2 − M1

b = C1 − M1 ×

C2 − C1 M2 − M1

Where: C

Calibrator

M

Master

Instrument-specific RLU values for the six calibrators in the master calibration can be estimated by using the following equation: Calibrator1 = Master1 x Slope + Intercept The estimates of the instrument-specific RLU values for the six calibrators are used to generate a calibration curve by using the appropriate calibration curve model. Related information... Adjustment calibration (i‑series), page 788

Parameter method (i‑series) The parameter adjustment method uses relative light unit (RLU) values that are stored in a reagent bar code for calibrators A through F to determine the four-parameter logistic curve fit or four-parameter logistic calibration (4PLC) parameters of a master calibration. Calibrator 1 and calibrator 2 adjusters are used to provide an instrument-specific calibration curve that is based on the parameters. For this method, the residual sum of squares is calculated by using the following equation: 790

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Σ

P j − Pj 2 + σj

Σ

yi − yi 2 σi

Where: Pj

Population average parameter

Pj

System-specific parameter

σj

Standard deviation parameter

yi

Predicted calibrator signal

yi

Observed calibrator signal

σi

Standard deviation of a calibrator signal

Related information... Adjustment calibration (i‑series), page 788

Curve shape methods (i‑series) The curve shape adjustment methods use relative light unit (RLU) values that are stored in a reagent bar code for calibrators A through F to determine the four-parameter logistic curve fit or four-parameter logistic calibration (4PLC) parameters of a master calibration. Calibrator 1 and calibrator 2 adjusters are used to provide an instrument-specific calibration curve that is based on the shape of the curve. For this method, the residual sum of squares is calculated by using the following equation: Σ

Sj − Sj 2 + σj

Σ

yi − yi 2 σi

Where: Sj

Population average shape parameter

Sj

System-specific shape parameter

σj

Standard deviation shape parameter

yi

Predicted calibrator signal

yi

Observed calibrator signal

σi

Standard deviation of a calibrator signal

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Index calibration (i‑series) An index calibration is a measurement of one point or two points specified for a qualitative assay. The system software uses calibration data to generate an index (cutoff) value that is specific to a processing module. Related information... Calibration types and methods (i‑series), page 784 Cutoff assay method (i‑series), page 792

Cutoff assay method (i‑series) The cutoff assay data reduction method measures relative light unit (RLU) values and calculates a cutoff value. This method uses a one-point or two-point calibration to calculate the point (cutoff) value where reactive and nonreactive samples are differentiated. Cutoff formulas can use addition, subtraction, and multiplication, and constants can be added. After the cutoff value is calculated, the unknown sample RLU value is divided by the cutoff value to determine a cutoff ratio (index). The system software uses the following cutoff calibration methods: One-point qualitative This method uses one calibrator in the index formula. Based (index formula) on the cutoff formula, the calibrator can be either reactive or method nonreactive for an assay. The following example is a one-point cutoff formula where a and b are assay-specific constants: Cutoff = a x Calibrator RLU + b Two-point qualitative This method uses two calibrators in the index formula. The (index formula) calibrator concentrations are based on the cutoff formula. method The following example is a two-point cutoff formula where a and b are assay-specific constants: Cutoff = a x Calibrator 1 RLU + Calibrator 2 RLU - b Related information... Index calibration (i‑series), page 792

Reference method (i‑series) The reference data reduction method uses a calibration curve generated for another assay (reference assay) to calculate results. This method is used when two or more assays use the same reagent. The reference assay is defined in an assay parameter file. Related information... Calibration types and methods (i‑series), page 784

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Calibration storage The Alinity ci‑series stores active, inactive, and failed calibrations. Related information... Calibration procedures, page 767 Active calibration storage, page 793 Inactive calibration storage, page 794 Failed calibration storage, page 794

Active calibration storage The system stores active calibrations according to the following guidelines: • A calibration that is specific to a processing module is stored as the active calibration for the reagent lot. If the system is configured to require calibration by cartridge, the calibration is stored as the active calibration for the reagent lot and cartridge combination. • If the system is configured to require quality control to run after a calibration is generated, the status of the calibration is Pending QC. NOTE: A calibration that has a status of Pending QC is considered to be an active calibration that cannot be used to process tests until one level of quality control is completed. • The active calibration replaces any previous calibrations that have a status of Active, Expired, Overridden, Overridden Lot, or Pending QC. For previous calibrations that have these statuses, their statuses change to Inactive. • The system automatically uses the active calibration as the default calibration for the onboard reagent lot or the onboard reagent lot and cartridge combination. • Stored calibrations that have a status of Failed are deleted for the reagent lot, or the reagent lot and cartridge combination, that is specific to a processing module. • One active calibration is stored for a maximum of four different reagent lots, or four different reagent lot and cartridge combinations, for each assay on a processing module. • When a fifth reagent lot or a fifth reagent lot and cartridge combination is calibrated successfully, the system replaces the oldest active calibration and the status of the calibration changes to Inactive. • Stored active calibrations are deleted when the corresponding assay file is deleted. NOTE: On the Calibration Details screen, the statuses of active calibrations can be manually changed to Failed. Related information... Calibration storage, page 793

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Fail a calibration, page 806

Inactive calibration storage The system stores the previous calibration as an inactive calibration when a new calibration is generated for the reagent lot, or the reagent lot and cartridge combination, that is specific to a processing module. Inactive calibrations are stored for a maximum of 3 months. All calibrations are deleted from the system when the last cartridge of a reagent master lot is deleted. The system deletes reagents when the reagent cartridge storage capacity is exceeded. In addition, reagents are deleted when c‑series user-defined assays are deleted manually. Related information... Calibration storage, page 793

Failed calibration storage The system stores a failed calibration until an active calibration or another failed calibration is generated for the reagent lot, or the reagent lot and cartridge combination, that is specific to a processing module. Related information... Calibration storage, page 793

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Calibration review An assay calibration run must pass calibration verification before the system stores the calibration. The status of each calibration is displayed on the Current tab and the Historical tab of the Calibration Status screen. Related information... Calibration procedures, page 767 System calibration verification, page 795 Calibration Status screen, page 796 Descriptions of calibration statuses, page 804 View the assay calibration status, page 805 Transmit a calibration to the host, page 806 Fail a calibration, page 806 Archive the calibrations, page 762

System calibration verification After calibrators are processed, the system verifies the results by comparing them to the calibration parameters and calibration validity checks that are specific to an assay. If the results of a calibration fall within the specified range for the assay, the new calibration replaces any previous calibration and the status of the previous calibration changes to Inactive. If the results of a calibration fall outside the specified range for the assay, the status of the new calibration is Failed. If the assay has an existing calibration, the calibration is not replaced. Unless otherwise indicated, calibration statuses are displayed on the Current tab and the Historical tab of the Calibration Status screen, and include the following options: Active

The calibrator values fall within the assay specifications. The system software calculates patient and control test results from this calibration.

Pending QC

The calibrator values fall within the assay specifications. The system is configured to require quality control to run after a calibration is generated, and no control sample has completed. When one control level for the assay is completed, a calibration status of Active is displayed. NOTE: A completed control does not require the control result to fall within the configured specifications.

Failed

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The calibrator values fall outside the assay specifications. If a reagent lot has an existing active calibration, the system software calculates patient and control test results from the existing active calibration.

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Inactive

Section 6

This status is associated with an older, previously active calibration that was replaced by a more recent calibration. This status is displayed only on the Historical tab of the Calibration Status screen.

Related information... Calibration review, page 795

Calibration Status screen On the Calibration Status screen, the operator can view a list of the calibration statuses for assays and reagent lots that are loaded on the system. The operator can perform the following functions: • Search for specific calibrations based on specified search criteria. • Access calibration details. • Fail a calibration. • Print a calibration report. Related information... Calibration review, page 795 Calibration Status screen element descriptions, page 796 Calibration Status screen, Search flyout element descriptions, page 798 Calibration Status Details screen, page 800

Calibration Status screen element descriptions

Current tab, Historical tab The Current tab displays the current calibration information for reagents loaded on the system based on the last reagent scan. The Historical tab displays all calibration information on the system for up to 3 months.

Elements Module bar

Used to select all modules or an individual module to view information. The Module bar is available only on the Current tab. An amber badge is displayed on the module number when a calibration is within 1 hour of expiration.

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A red badge is displayed on the module number when a calibration has expired or failed. Module

Displays the module on which the calibration was ordered and processed. The module number is displayed only when the All button is selected.

Assay

Displays the name of the assay.

Calibration Method

Displays the data reduction method defined for the assay. The following c‑series methods are displayed: • Abs (Absorbance) • Factor • Linear • Logit-4 • Spline • Use Cal Factor Blank The following i‑series methods are displayed: • Point to Point • Linear Regression • 4PLC X • 4PLC Y • 4PLC X Transform • Qual 1 Point • Qual 2 Point • Reference • No Cal

Reagent Lot

Displays the lot number of the reagent.

Cal Date/Time

Displays the completion date and time of the calibration.

Status

Displays the calibration status of the reagent lot.

Expiration Date/Time Displays the expiration date and time of the full or adjustment calibration.

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Function buttons Select All

Selects or deselects all items in a list. The button switches between Select All and Deselect All.

Search

Displays the Search flyout.

Print

Displays the Print flyout.

Archive

Displays the Archive flyout. This function button is displayed only on the Historical tab.

Details

Navigates to the Details screen for the selected items on the current screen.

Transmit

Sends selected test results to the host computer.

Text Size

Increases or decreases the size of text displayed.

Related information... Calibration Status screen, page 796 Descriptions of screen elements, page 140 Descriptions of calibration statuses, page 804

Calibration Status screen, Search flyout element descriptions In the Search flyout of the Calibration Status screen, the operator can enter specific data that is used to filter the data on the screen.

Elements

798

Module

Displays check boxes that are used to search by the module. This search element is available only on the Current tab when the All button is selected and on the Historical tab.

Assay

Displays a text box that is used to search by the assay name.

Reagent Lot

Displays a text box that is used to search by the reagent lot number.

Expires (In Hours)

Displays a text box that is used to search for calibrations that will expire within a specific number of hours. The search range is from 1 hour through 24 hours.

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Calibration Status

Displays check boxes that are used to search by the calibration statuses. The Search flyout on the Current tab has eight calibration statuses: • Active • In Process • Pending QC • No Cal • Expired • Failed • Overridden • Overridden Lot The Search flyout on the Historical tab has seven calibration statuses: • Active • Inactive • Pending QC • Expired • Failed • Overridden • Overridden Lot

Archive Status

Displays check boxes that are used to search by the archive statuses. This search element is available only on the Historical tab. The Search flyout has two archive statuses: • Archived • Not Archived

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

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?

Section 6

Displays Help from the operations manual for the active screen, flyout, or message code.

Related information... Calibration Status screen, page 796 Descriptions of calibration statuses, page 804

Calibration Status Details screen On the Calibration Status Details screen, the operator can view the following information: • Details for calibrations • Calibration graphs only for c‑series The operator can fail a calibration. Related information... Calibration Status screen, page 796 Calibration Status Details screen element descriptions, page 800

Calibration Status Details screen element descriptions The Calibration Status Details screen displays the details of the assay, reagent, and calibrator information that are used to generate a calibration.

Assay and Reagent Information area Displays assay, reagent, operator, and instrument information.

800

Assay Name

Displays the name of the assay.

Assay Number

Displays the number defined for the assay. The assay number must be the same number that is used for the host.

Assay Version

Displays the version defined for the assay.

Reagent Lot

Displays the lot number of the reagent cartridge.

Reagent SN

Displays the serial number of the reagent cartridge.

Lot Expiration

Displays the lot expiration date of the reagent cartridge.

Operator ID

Displays the identification of the operator logged onto the system when the calibration was performed.

Processing Module

Displays the module used to order and process the calibration.

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Module SN

Displays the serial number of the module used to order and process the calibration.

Calibration Information area Displays the details of the calibration information. Calibration Status

Displays the calibration status of the reagent lot.

Calibration Type

Displays the calibration type for the assay.

Calibration Method

Displays the mathematical procedure used to analyze the data.

Calibration Date/Time Displays the completion date and time of the calibration. Calibrator Lot

Displays the lot number of the calibrator used to calibrate the assay. For c‑series assays that use a blank calibrator set, the calibrator lot number is displayed first, followed by the blank calibrator lot number.

Lot Expiration

Displays the lot expiration date of the calibrators used to calibrate the assay. For c‑series assays that use a blank calibrator set, the calibrator lot expiration date is displayed first, followed by the blank calibrator lot expiration date.

Full Curve Expiration Displays the expiration date and time of the full calibration. This element is available only for assays that have a defined calibration interval. Adjustment Curve Expiration

Displays the expiration date and time of the adjustment calibration. This element is available only for assays that have a defined calibration interval.

Archive Status

Displays the following status information:

Archive Date/Time

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Archived

The data has been successfully archived.

Not Archived

The data has not been successfully archived.

Displays the date and time that the data was archived.

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Transmission Status

Displays the transmission status information, which is used to determine the progress of a transmission.

Transmission Date/ Time

Displays the date and time that the archive record was transmitted.

Message Code

Displays the message code number and description.

Calibrator Results area Displays the calibration details. Calibration information that is displayed varies based on the assay type and the calibration method. Current Calibration Curve

Displays the last active calibration. This information is displayed only for c‑series.

Previous Calibration Curve

Displays the previous active calibration. This information is displayed only for c‑series. NOTE: A failed calibration will not be displayed.

Cutoff

Displays the calculated cutoff value used for assay data reduction.

Cal 1 Ratio, Cal 2 Ratio

Displays the ratios calculated for calibrator 1 and calibrator 2. This information is displayed only for i‑series.

Calibrator ID

Displays the name of the calibrator level.

Conc

Displays the concentration value for each calibrator level defined in the assay parameters. Values are displayed with the configured assay units. For c‑series assays that use the use cal factor blank calibration method and i‑series assays that use the reference calibration method, values are displayed with the configured units of the reference assay.

Fit Conc

Displays the fit curve concentration value for each calibrator level defined in the assay parameters. Values are displayed with the configured assay units. This information is displayed only for i‑series. For i‑series assays that use the reference calibration method, values are displayed with the configured units of the reference assay.

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%CV

Displays the calculated percent coefficient of variation for the calibrator.

Cal mV

Displays the median millivolt value for each calibrator level. This information is displayed only for c‑series potentiometric assays.

Absorbance

Displays the median absorbance value for the calibrator level.

Factor

Displays the calibration factor for the calibrator level.

Slope

Displays the percent response of the integrated chip technology (ICT) module for the low and high calibrators. This information is displayed only for c‑series potentiometric assays.

Mean RLU

Displays the mean relative light units (RLUs) of the calibrator replicates. This information is displayed only for i‑series.

Reference Cal RLU

Displays the reference (master calibrator) data read from the reagent bar code label. This information is displayed only for i‑series.

Fit RLU

Displays the fit curve RLU data for each calibrator. This information is displayed only for i‑series.

Rep 1, Rep 2, Rep 3

Displays the absorbance value, the millivolt value, or the RLU value for replicates 1, 2, and 3.

Rep 1 RLU, Rep 2 RLU, Rep 3 RLU

Displays the RLU value for replicates 1, 2, and 3. This information is displayed only for i‑series.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Fail

Invalidates the current calibration.

Previous

Displays the previous item when multiple items are selected.

Next

Displays the next item when multiple items are selected.

Text Size

This function button is unavailable on this screen.

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Related information... Calibration Status Details screen, page 800 Descriptions of calibration statuses, page 804 Descriptions of screen elements, page 140

Descriptions of calibration statuses The following list provides descriptions of the calibration statuses. The statuses are described in the order in which they are sorted. Unless otherwise indicated, the statuses are displayed on the Current tab and the Historical tab of the Calibration Status screen: Failed

One of the following situations occurred: • The calibration failed an assay-specific calibration parameter or assay-specific calibration validity checks. • The calibration was not completed successfully because of a hardware error. • The operator manually failed the calibration.

Expired

The calibration exceeded the full interval or the adjustment interval.

No Cal

This status is displayed only on the Current tab of the Calibration Status screen when one of the following situations occurs: • A calibration has not been run for the reagent lot, or the reagent lot and cartridge combination, that is loaded on the system. • One or more c‑series assay parameters were edited. • The c‑series parameter that designates whether to calibrate an assay by lot or cartridge was edited. • One or more calibrator concentration values were edited.

804

Pending QC

The system is configured to require quality control to run after a calibration is generated. The calibration was completed successfully and no control level has completed.

Overridden

The operator has manually overridden an expired calibration.

Overridden Lot

The system is configured to track the calibrator lot expiration date and the operator has manually overridden an expired calibrator lot.

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Calibration procedures Calibration review

Section 6

In Process

This status is displayed only on the Current tab of the Calibration Status screen and indicates that a calibration order is in process.

Active

The calibration completed successfully and is not expired.

Inactive

This status is displayed only on the Historical tab of the Calibration Status screen when one of the following situations occurs: • A previously active calibration is replaced by a more recent calibration. • The number of supported active calibrations for a specific processing module, assay, and reagent lot or reagent lot and cartridge combination has been exceeded. The oldest active calibration becomes inactive.

Related information... Calibration review, page 795 Calibration Status Details screen element descriptions, page 800 Calibration Status screen, Search flyout element descriptions, page 798 Reagents screen, Search flyout element descriptions, page 614 Calibration Status screen element descriptions, page 796 Reagent Status Report element descriptions, page 1681

View the assay calibration status Perform this procedure to view the calibration status of an assay before sample processing is initiated or when a status indicator is displayed. NOTE: When no active calibration is stored, tests that are initiated become exceptions and are not processed. 1.

On the menu bar, tap CAL. The Current tab of the Calibration Status screen displays the calibration data for all modules.

2.

To display the data for one module, tap a Module button.

3.

In the Status column, view the calibration statuses.

Related information... Calibration review, page 795

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Calibration procedures Calibration review

Section 6

Transmit a calibration to the host Perform this procedure to transmit calibration information to the host. To transmit calibration information to the host, the following conditions must be met: • On the Host Setup screen, the Host Interface option must be configured for HL7. • Under Transmission Options on the Host Setup screen, the Calibration option must be configured for On. • The calibration status is active. • The calibration result transmission status is not Pending Transmission. 1.

On the menu bar, tap CAL.

2.

On the Current tab of the Calibration Status screen, tap one or more calibrations to transmit (or tap Select All). NOTE: To filter the list, tap a Module button or tap Search.

3.

Tap Transmit.

Related information... Calibration review, page 795 Search for or filter data, page 757

Fail a calibration Required instrument status

• Processing module: Stopped, Warming, or Idle • Reagent and sample manager: Stopped or Idle

Perform this procedure to fail a calibration that has a status of Active or Pending QC and to prevent subsequent result generation from the calibration for existing control and specimen orders. NOTE: The procedure cannot be performed on assays with calibration methods of Use Cal Factor Blank (c‑series) and Reference (i‑series). The procedure can be performed from the Historical tab of the Calibration Status screen. 1.

On the menu bar, tap CAL. The Current tab of the Calibration Status screen displays the calibration data for all modules.

806

2.

To display the data for one module, tap a Module button.

3.

Tap one or more assays.

4.

Tap Details.

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Section 6 5.

On the Calibration Status Details screen, tap Fail for the selected calibration.

6.

When a confirmation message is displayed, tap Yes.

7.

If more than one calibration was selected, tap Next to go to each calibration, and then repeat steps 5, page 807 and 6, page 807 for each calibration.

8.

To return to the Calibration Status screen, tap Done.

After a calibration is failed, if a new assay calibration is ordered and specimen and control tests are included, and the new assay calibration fails, the specimen and control tests become exceptions. Related information... Calibration review, page 795 Active calibration storage, page 793

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Section 6

NOTES

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Section 7

Operational precautions and limitations

Introduction For optimal operator safety and accurate test results, comply with operational requirements, precautions, and limitations. Failure to comply can affect system performance, and may cause damage to the system or may adversely affect test results. Related information... General requirements, page 810 Precautions and requirements for system operation, page 811 Requirements for handling the consumables, page 812 Requirements for handling the specimens, page 814 Limitations of result interpretation, page 816 Operator responsibility, page 818

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Operational precautions and limitations General requirements

Section 7

General requirements For optimal system performance, comply with the following general requirements of the system: • Contact an Abbott Laboratories representative to install or relocate the system. • Do not install the system near direct sunlight, heat, drafts, and heat-generating devices. Exposure to heat and drafts can interfere with the system's ability to maintain an acceptable operating temperature. • Maintain the required space on all sides of the system. This space buffer is essential for the following conditions: – Adequate cooling of electrical components – Accurate temperature control of the system – Access for maintenance – Access to disconnect the power cord when required • Leave on the system power at all times unless instructed otherwise for a maintenance procedure or a troubleshooting procedure, or unless an emergency situation occurs. • Perform maintenance procedures as recommended later in this manual. • Do not attempt any maintenance or repairs that are not specified in documentation provided by Abbott Laboratories. Related information... Operational precautions and limitations, page 809 Service, maintenance, and diagnostics, page 837 System clearances, page 455

810

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Section 7

Precautions and requirements for system operation When operating the system, comply with the precautions and requirements for system operation. Failure to comply may cause damage to the system or may adversely affect test results. Related information... Operational precautions and limitations, page 809 Precautions and requirements before operation, page 811 Precautions during operation, page 811

Precautions and requirements before operation Before operating the system, comply with the following precautions and requirements: • Thoroughly read this manual to become familiar with the system functionality and associated hazards. • Read the sections of the product documentation that contain the following information: – Warnings and general precautions – Safety precautions – Precautions for handling • Verify that adequate supplies and reagents are loaded on the system. Related information... Precautions and requirements for system operation, page 811

Precautions during operation While operating the system, comply with the following precautions: • Close all system doors and covers unless instructed otherwise for a maintenance procedure or a troubleshooting procedure. • Do not disconnect any electrical connection during normal system operation. • Respond to system notifications that relate to waste levels during system processing. Dispose of all waste in accordance with local, state, and national regulations. • Do not replace any fuses. Fuses are not replaceable by the operator. Related information... Precautions and requirements for system operation, page 811

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Operational precautions and limitations Requirements for handling the consumables

Section 7

Requirements for handling the consumables For optimal operator safety and accurate test results, comply with the requirements for handling the consumables. For more information about handling the consumables, see the following documentation: • Product package inserts • Specific product labels • Safety Data Sheets Related information... Operational precautions and limitations, page 809 Requirements for storage, page 812 Requirements for use, page 812

Requirements for storage When storing reaction vessels, reagent cartridges, reagent replacement caps, and sample cups, comply with the following requirements: • Keep all consumables clean and dust-free. • Store all consumables in their original containers so that information such as expiration dates and lot numbers is available if necessary. When storing reagents, calibrators, controls, and bulk solutions, comply with the following requirements: • Store reagents, calibrators, controls, and bulk solutions as instructed on their labels or in the product documentation. • Store reagents in an upright position. For more information, see the product documentation. If reagents, calibrators, controls, or bulk solutions are received in a condition that is contrary to the label recommendation or the product documentation, or are damaged, contact the local representative or find country-specific contact information at abbottdiagnostics.com. Related information... Requirements for handling the consumables, page 812

Requirements for use When using reaction vessels (RVs), reagent cartridges, reagent replacement caps, and sample cups, comply with the following requirements:

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Section 7

Operational precautions and limitations Requirements for handling the consumables

• Do not reuse or substitute consumables. Abbott Laboratories cannot accept responsibility for system performance and test results when consumables are reused or have been manufactured by anyone other than Abbott Laboratories. • Use caution to prevent contamination and operator exposure when handling the RVs, reagent replacement caps, and sample cups. • Consider all used RVs, reagent cartridges, reagent replacement caps, and sample cups as potentially infectious. Follow appropriate procedures for handling the consumables. When using reagents, calibrators, controls, and bulk solutions, comply with the following requirements: • Do not substitute materials. Abbott Laboratories manufactures substances and components according to quality standards that are controlled rigidly. Substitution of materials may adversely affect system performance, test results, safety, and equipment life. • Do not excessively mix or shake liquids, minimizing the formation of foam and bubbles. • Do not pipette by mouth. • Do not smoke, eat, drink, apply cosmetics, or handle contact lenses in areas where specimens, reagents, calibrators, controls, or bulk solutions are handled. • Consider all reagents, calibrators, and controls that contain human-sourced materials as potentially infectious. • Use caution to prevent contamination and operator exposure when handling the reagents, calibrators, controls, and bulk solutions. • Wear clean gloves to prevent contamination and operator exposure when placing reagent cartridges on the system. • Do not invert used reagent cartridges since this action causes reagent leakage and may compromise test results. • Verify that reagent cartridges are within the expiration date before loading them on the system. • Do not use reagents, calibrators, controls, and bulk solutions beyond their expiration dates. • Do not use reagents on the system beyond the maximum number of cumulative days. For more information, see the product documentation. • Verify that bulk solutions are loaded in the appropriate position to ensure that test results are not adversely affected. • Do not mix reagents, calibrators, controls, and bulk solutions within a lot or between lots. Related information... Requirements for handling the consumables, page 812

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Operational precautions and limitations Requirements for handling the specimens

Section 7

Requirements for handling the specimens For information about specimen collection, preparation, and storage, see the product documentation. Consider all specimens as potentially infectious. In addition, consider all system surfaces or components that have come in contact with specimens as potentially infectious. CAUTION: Biological RISKS. This activity or area may expose you to potentially infectious material. Requirements for collection When collecting specimens, comply with the following requirements: • Comply with all precautions for blood collection by venipuncture to prevent specimen hemolysis. • Verify that the correct specimen type is used. The system does not verify the specimen type. Requirements for preparation and storage When preparing and storing specimens, comply with the following requirements: • Inspect all specimens for bubbles. Remove bubbles with a clean applicator stick before performing sample processing. Use a new applicator stick for each specimen to prevent cross contamination. • Verify that serum and plasma specimens do not contain fibrin, red blood cells, or other particulate matter. • For sample volume information, see the product documentation. • Separate serum specimens or plasma specimens from clots, serum separators, or red blood cells before freezing the specimens. • Mix and centrifuge serum specimens or plasma specimens after any freeze-thaw cycle or to remove red blood cells or other particulate matter. For information about limitations and interfering substances, see the product documentation. • Avoid multiple freeze-thaw cycles. After thawing a specimen, thoroughly mix it at a low speed or gently invert it. Mixed specimens produce consistent test results. • Remove closures from specimen tubes before loading the tubes on the reagent and sample manager. • After loading samples on the system, process the samples within the number of hours specified in the product documentation to minimize evaporation effects. Related information... Operational precautions and limitations, page 809 Sample volume requirements, page 476 814

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Section 7

Operational precautions and limitations Requirements for handling the specimens

Biological hazards, page 821

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Operational precautions and limitations Limitations of result interpretation

Section 7

Limitations of result interpretation Test results must be used with other clinical data, such as symptoms, other test results, the patient history, clinical impressions, the clinical evaluation information, and other diagnostic procedures. Consider all data for patient care management. If test results are inconsistent with the clinical evidence, additional testing is recommended to confirm the results. Errors can occur because of potential operator errors and system technology limitations. Related information... Operational precautions and limitations, page 809

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Section 8

Hazards

Introduction To minimize the potential for harm to personnel and damage to the laboratory environment, comply with the hazard and safety information. This section contains supplemental information. Do not use the supplemental information to supersede workplace safety requirements. Review any significant differences between the supplemental information and the workplace safety requirements with management or a workplace safety representative. Related information... Operator responsibility, page 818 Safety icons, page 819 Biological hazards, page 821 Chemical hazards, page 823 Waste handling and disposal, page 826 Spill cleanup, page 828 Requirements for decontamination, page 829 Electrical hazards, page 832 Mechanical hazards, page 833 Physical hazards, page 835

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817

Hazards Operator responsibility

Section 8

Operator responsibility Use the system only according to its designed purpose. Operators must be trained before operating the system. Failure to comply with safe-use instructions may cause personal injury, harm the environment, damage the system, or adversely affect test results. Any tool use to override interlocks must be controlled and distributed by the operator or the operator's management. Related information... Hazards, page 817 Operational precautions and limitations, page 809

818

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Hazards Safety icons

Section 8

Safety icons Safety icons are used on the system and in the system documentation to identify potentially dangerous conditions. Become familiar with these icons to know the type of potential hazard. Table 44: Safety icons and descriptions Icon

Description CAUTION: Biological RISKS Identifies an activity or an area where you may be exposed to potentially infectious material.

CAUTION: Possibility of electric shock Indicates the possibility of electric shock if procedural controls or engineering controls are not observed. CAUTION: Hot Surface Identifies an activity or an area where you may be exposed to hot surfaces. CAUTION: Probe Stick Hazard Identifies an activity or an area where you may be exposed to probes. CAUTION When used in this manual, this icon is accompanied by a description of the hazard and a related-information reference to safety content in this section. Examples include the following conditions: • CAUTION: Lifting Hazard Identifies an activity where you may be required to lift or move a heavy object. • CAUTION: Moving Parts Identifies an activity or an area where you may be exposed to moving parts. • CAUTION: Chemical Hazard Identifies an activity or an area where you may be exposed to hazardous chemicals. CAUTION: Disconnect Mains Plug Identifies a main electrical disconnect. Electrical and electronic equipment waste Indicates that the item needs to be disposed of in a separate waste collection for electrical and electronic equipment and must not be disposed of in the general waste or trash.

Related information... Hazards, page 817 Biological hazards, page 821 Electrical hazards, page 832

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Hazards Safety icons

Section 8

Probes and other sharps, page 835 Heavy objects, page 835 Mechanical hazards, page 833 Chemical hazards, page 823 Hot objects, page 836

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Hazards Biological hazards

Section 8

Biological hazards Exposure to potentially infectious materials may occur when the following activities are performed: • Handling of specimens, reagents, calibrators, and controls • Spill cleanup • Waste handling and disposal • System relocation • Maintenance procedures • Decontamination procedures • Component replacement procedures Comply with the precautions to help minimize the impact of this exposure. Related information... Hazards, page 817 Precautions, page 821 Required consumables, page 146 Requirements for handling the specimens, page 814 Safety icons, page 819 Requirements for decontamination, page 829 Component replacement, page 920

Precautions Consider as potentially infectious all products that are derived from human-sourced materials and all system surfaces and components that have come in contact with human-sourced materials. No known test method can offer complete assurance that products derived from human-sourced materials do not transmit infection. It is recommended that all potentially infectious materials are handled according to the OSHA Standard on Bloodborne Pathogens1. Use Biosafety Level 22 or appropriate biosafety practices3,4 for materials that contain or are suspected to contain infectious agents. Precautions include the following actions: • When handling human-sourced materials or contaminated system components: – Wear gloves, a lab coat, and protective eyewear. – Do not eat, drink, smoke, apply cosmetics, or handle contact lenses. • Do not pipette by mouth.

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Hazards Biological hazards

Section 8

• Clean spills of potentially infectious materials and contaminated system components with a quaternary ammonium detergent. Then mist or wipe the surface with 0.5% sodium hypochlorite solution. Let the disinfectant remain on the surface for a minimum of 10 minutes of contact time. • Decontaminate and dispose of all samples, reagents, and other potentially contaminated materials in accordance with local, state, and national regulations. Immediately clean an affected area if any exposure to biohazardous or potentially infectious materials occurs: Eyes

Rinse with water for 15 minutes.

Mouth

Rinse with water.

Skin

Wash the affected area with soap and water. Apply alcohol, povidone iodine, chlorhexidine, or another antiseptic.

Puncture wound

Let the wound bleed freely. Wash the affected area with soap and water.

Seek medical attention as soon as possible for appropriate follow-up. Bibliography references 1.

US Department of Labor, Occupational Safety and Health Administration, 29 CFR Part 1910.1030, Bloodborne pathogens.

2.

US Department of Health and Human Services. Biosafety in Microbiological and Biomedical Laboratories. 5th ed. Washington, DC: US Government Printing Office; December 2009.

3.

World Health Organization. Laboratory Biosafety Manual. 3rd ed. Geneva: World Health Organization; 2004.

4.

Clinical and Laboratory Standards Institute (CLSI). Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline--Fourth Edition. CLSI Document M29-A4. Wayne, PA: CLSI; 2014.

Related information... Biological hazards, page 821

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Hazards Chemical hazards

Section 8

Chemical hazards Exposure to hazardous chemicals may occur when consumables are handled. To minimize any exposure to hazardous chemicals, follow the instructions provided in the following documentation: • Product package inserts • Specific product labels • Safety Data Sheets (SDSs) When the Alinity ci‑series is installed and is used correctly, system design features further reduce exposure levels. System products are classified and labeled in accordance with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) as implemented in regional regulations. Examples of regional regulations include the U.S. OSHA Hazard Communication Standard (HCS) and the European Regulation (EC) 1272/2008 on classification, labelling, and packaging of substances and mixtures (CLP). Pictograms (red-bordered diamonds), signal words (such as Warning and Danger), hazard statements (H), and precautionary statements (P) are included on respective product labeling. Other country-specific warnings and precautions may also be included on product labeling. For SDSs, contact the local representative or find country-specific contact information at abbottdiagnostics.com. Related information... Hazards, page 817 General precautions, page 823 Sodium azide, page 824 Sensitizers, page 825 Dry ice, page 825 Required consumables, page 146 Safety icons, page 819

General precautions In general, comply with the following precautions when handling chemicals: • Consult the Safety Data Sheets for safe-use instructions and precautions. • Avoid contact with skin and eyes. If contact with material is anticipated, wear impervious gloves and protective clothing and eyewear. • Maintain good housekeeping. Do not eat, drink, or store food and beverages in areas where chemicals are used. Alinity ci‑series Operations Manual

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Hazards Chemical hazards

Section 8

• Immediately clean spilled fluids. • Seek medical attention if irritation or signs of toxicity occur after exposure. CAUTION: This product contains chemicals known to the state of California to cause cancer and birth defects or other reproductive harm. • For information related to Article 33 of the EU REACH regulation (EC 1907/2006, Registration, Evaluation, Authorisation, and Restriction of Chemicals), go to pmis.abbott.com. For website logon issues, contact Abbott Laboratories at [email protected]. • To view the China RoHS 2 Hazardous Substance tables, in accordance with the People’s Republic of China Electronic Industry Standard SJ/T 11364-2014, go to abbottdiagnostics.com/registration-ous (select Technical Library > Other Reference Documents > China RoHS Hazardous Substance Tables). Related information... Chemical hazards, page 823

Sodium azide Some products contain sodium azide. Comply with the following precautions when using products or handling waste that contains sodium azide: • Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a highly toxic gas, is released when the pH is lower than 6. Normal operation of the system uses small amounts of sodium azide with other reagent components and does not generate hydrazoic acid at levels that are harmful to the operator. • Thoroughly flush drains with water several times each day to prevent the formation of potentially explosive metal azides on lead components, copper components, brass components, or the solder in laboratory plumbing if product waste or instrument waste is released to a drain. More information about azides in laboratory drains is available in Current Intelligence Bulletin No.13: Explosive Azide Hazard (August 16, 1976), a publication issued by the U.S. National Institute for Occupational Safety and Health (NIOSH). For a copy of this bulletin, contact the local representative or go to one of the following websites: – cdc.gov/niosh Search for the bulletin title. – abbottdiagnostics.com Go to the international website or the U.S. website. Select Support/Technical Library/ Other Reference Documents. Related information... Chemical hazards, page 823

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Section 8

Hazards Chemical hazards

Sensitizers Some products contain low levels of ingredients that are reported to be sensitizers. Sensitizers can stimulate allergic reactions in some people. The allergic reactions may occur with the first exposure or only after repeated exposures. Methylisothiazolones, which are used as preservatives in some products, have been associated with the stimulation of allergic skin reactions (allergic contact dermatitis). Certain enzymatic cleansers may stimulate allergic reactions in the respiratory systems of people who are sensitive to the ingredients. To reduce the potential for exposure to sensitizers, comply with the following precautions: • Use good laboratory techniques to minimize spatters, spills, and other aerosolization of liquids and powders, particularly when pouring or transferring materials. • Wear impervious gloves and other personal protective equipment that is appropriate for biomedical laboratories. • Immediately remove gloves if they are damaged or contaminated. • Wash hands after removing gloves and immediately before putting on a fresh pair of gloves. • Handle containers at a comfortable height that is below chest level. Related information... Chemical hazards, page 823

Dry ice Some products are shipped on dry ice. Dry ice is solid carbon dioxide and is cryogenic at a temperature of -78.5°C. Wear appropriate personal protective equipment such as cold-insulating gloves and ensure appropriate ventilation when handling the dry ice. If unprotected skin comes in contact with dry ice for an extended period of time, skin cells may freeze and produce a freeze burn. Symptoms of a freeze burn are redness, blisters, and peeling skin. Symptoms can vary based on the duration of exposure. Solid carbon dioxide transitions into a gaseous state through a process known as sublimation. Carbon dioxide is a colorless, odorless gas that is approximately 1.5 times heavier than air and therefore flows downward. In closed, unventilated areas, carbon dioxide is displaced from the air and accumulates on the floor in increased concentrations as a "carbon dioxide lake." Ambient indoor air in areas with adequate ventilation contains approximately 0.03% carbon dioxide by volume. Inhalation of air with 3% to 5% carbon dioxide by volume causes headaches, respiratory disorders, and malaise. Inhalation of air with 8% to 10% carbon dioxide by volume may cause cramps, fainting, respiratory arrest, and death. Related information... Chemical hazards, page 823

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825

Hazards Waste handling and disposal

Section 8

Waste handling and disposal Each facility has the responsibility to label all waste containers and to characterize its waste stream to confirm that waste is disposed of in accordance with local, state, and national regulations. Related information... Hazards, page 817 Liquid wastes that contain (potentially) infectious materials, page 826 Batteries, page 827 Replace bulk solutions and update the inventory, page 579 Empty the high-concentration waste bottle and update the inventory (c‑series), page 583 Remove the RV waste and update the inventory (i‑series), page 584

Liquid wastes that contain (potentially) infectious materials To meet institutional or local requirements for the decontamination or disinfection of liquid wastes that contain infectious or potentially infectious materials, consider the following precautions: • Select a disinfectant that is effective against bloodborne infectious agents and against other microbial agents that may be prevalent in the local population. A disinfectant that is effective against Mycobacterium tuberculosis generally is effective against all known viruses and nonspore-forming bacteria and is suitable for most clinical laboratory situations. • Select a disinfectant and a method that do not bubble, effervesce, or generate aerosols. • Do not use any chemical or product with a pH below 6. The use of materials with a pH below 6 generates highly toxic hydrazoic acid gas if wastes from the materials contain sodium azide. • Do not use any chemical or product for disinfection that contains any metal. This precaution prevents the creation of highly explosive metal azides in wastes that may contain sodium azide. • Obtain and review the manufacturer's safety information before using any disinfectant. • Use disinfectants according to the manufacturer's directions (for example, do not use excess disinfectant). Failure to follow the manufacturer's directions may cause unexpected effects. • Do not use a disinfectant if the facility, the equipment, and other protective measures are not appropriate for safe use with the disinfectant. • Autoclaving is not recommended for materials contaminated with products that contain chemicals that are hazardous by inhalation at low concentrations (for example, cyanides). • Wear appropriate personal protective equipment (such as gloves, a lab coat, and eyewear) when performing decontamination activities.

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Section 8

Hazards Waste handling and disposal

Related information... Waste handling and disposal, page 826

Batteries The European Battery Directive requires separate collection of spent batteries to facilitate recycling and protect the environment. The system contains batteries that are not intended for the operator to service or remove. Only an Abbott Laboratories representative or a qualified individual may remove the batteries in the system at the end of the life of the system and may dispose of them in accordance with local regulations for separate collection of spent batteries. Contact the local representative or find country-specific contact information at abbottdiagnostics.com. Related information... Waste handling and disposal, page 826

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Hazards Spill cleanup

Section 8

Spill cleanup Clean spills according to established biosafety practices and follow instructions in the Safety Data Sheets. In general, safe work practices for spill cleanup include the following requirements: 1.

Wear appropriate personal protective equipment, such as gloves, a lab coat, and eyewear.

2.

Absorb the spill with an absorbent material.

3.

Wipe the spill area with a quaternary ammonium detergent.

4.

Mist or wipe the spill area with 0.5% sodium hypochlorite solution. Let the disinfectant remain on the surface for a minimum of 10 minutes of contact time.

5.

Dispose of all absorbent material and wipes according to local, state, and national regulations.

Related information... Hazards, page 817 Requirements for decontamination, page 829 Component replacement, page 920 Unscheduled cleaning, page 873

828

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Hazards Requirements for decontamination

Section 8

Requirements for decontamination Sodium hypochlorite and other disinfectants are typically hazardous chemicals that react with many chemicals, materials, and living tissues. To reduce the potential for exposure to disinfectants, comply with the following general precautions: • Obtain and review the manufacturer's safety information before using any disinfectant. • Wear appropriate personal protective equipment (such as gloves, a lab coat, and eyewear) when performing decontamination activities. Related information... Hazards, page 817 Preparation of sodium hypochlorite solutions, page 829 Sodium hypochlorite stability, page 830 System relocation, page 167 Biological hazards, page 821 Spill cleanup, page 828 Clean and decontaminate external components, page 873 Clean and decontaminate the bar code scanner, page 874 Clean and decontaminate the monitor, page 874

Preparation of sodium hypochlorite solutions To calculate the number of parts of water required to mix with one part of manufacturer-supplied sodium hypochlorite solution, use the following equation: X =

B − A A

Where: A

Percent of sodium hypochlorite solution that is wanted

B

Percent of sodium hypochlorite (active or available chlorine) in manufacturer-supplied sodium hypochlorite solution

X

Number of parts of water required to mix with one part of manufacturer-supplied sodium hypochlorite (active or available chlorine) solution

Example: A = 0.5% B = 5%

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Hazards Requirements for decontamination X =

5% − 0.5% 0.5%

Section 8

= 9

Mix one part of sodium hypochlorite with nine parts of water. To calculate the volume of sodium hypochlorite required to make a specific volume of sodium hypochlorite solution, use the following equation: V1 =

A × V2 B

Where: A

Percent of sodium hypochlorite solution that is wanted

B

Percent of sodium hypochlorite (active or available chlorine) in manufacturer-supplied sodium hypochlorite solution

V1

Volume of manufacturer-supplied sodium hypochlorite solution

V2

Total volume that is wanted

Example: A = 0.5% B = 5% V2 = 1000 mL (1 L) V1 =

0.5% × 1000 mL 5%

= 100 mL

Mix 100 mL of manufacturer-supplied sodium hypochlorite solution with 900 mL of water to make 1 L of sodium hypochlorite solution. Related information... Requirements for decontamination, page 829

Sodium hypochlorite stability Use a freshly prepared solution of sodium hypochlorite for decontamination. Sodium hypochlorite needs to be prepared fresh daily to ensure that the solution contains a sufficient quantity of active compound (for example, chlorine) to be effective. The amount of active chlorine in sodium hypochlorite solutions, for example, is reduced by the following factors: • The presence of organic matter in the water used for dilution • The temperature at which the solution is stored • The type and size of the container and closure • The frequency and nature of use

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Section 8

Hazards Requirements for decontamination

If a facility has data that demonstrates a longer shelf-life is valid under the specific conditions of solution preparation and storage in the facility, prepare solutions in advance and store them. Related information... Requirements for decontamination, page 829

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Hazards Electrical hazards

Section 8

Electrical hazards The system does not pose uncommon electrical hazards to operators if it is installed and is operated without alteration, and if it is connected to a power source that meets the required specifications. Basic electrical hazard awareness is essential to the safe operation of the system. Only qualified personnel may perform electrical servicing. Elements of electrical safety include the following requirements: • Inspect cables that connect to the system for signs of wear and damage. • Use only approved power cords and electrical accessories, such as the cords and accessories that are supplied with the system, to protect against electric shock. • Use an appropriately grounded electrical outlet of correct voltage and current-handling capability. • Do not disconnect any electrical connections or service any electrical and internal components while the system power is on. • Keep liquids away from all connectors of electrical and communication components. • Do not touch any switches or outlets with wet hands. • Keep the floor dry and clean under and near the system. • Use a ground fault circuit interrupter when working in a wet environment. • Immediately clean liquid spills. Turn off the system power and disconnect the system power cord before cleaning major liquid spills. Related information... Hazards, page 817 Electrical specifications and requirements, page 455 Safety icons, page 819

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Hazards Mechanical hazards

Section 8

Mechanical hazards The Alinity ci‑series is an automated system that operates by computer control. As with most automated equipment, the potential for injury and bodily harm from moving mechanical components is present when system operation occurs. To minimize mechanical hazards, the system provides guards to protect against accidental contact with moving components and incorporates safety features in the hardware. The system requires the operator to accurately position all specimens, reagents, calibrators, controls, sample cups, and tubes on the system. Be sure to correctly position sample cups, tubes, and reagent cartridges before any operation is initiated. Although the system is equipped with safety features to stop the lowering of probes, do not reach into the processing center during system operation. To interrupt a run, follow the operating instructions in this manual. The top of the RSM transport is equipped with white light-emitting diodes (LEDs) as visual safety indicators. The LEDs provide visibility to the RSM transport position and movement at all times. Do not reach into the path of the RSM transport at any time. Do not run the system unless at least one LED is illuminated. If neither LED is illuminated, contact Customer Service to resolve the failure. If necessary for maintenance and diagnostic procedures, interlocks can be overridden by an Abbott Laboratories representative or trained operators only by using the procedure key. Be aware that potential mechanical hazards and Biological RISK may be present. Be aware of moving parts. Do not reach into the paths of moving parts. During system operation, the operator may be exposed to the following moving components: • Pipettors and probes • Sample transport • RV loader assembly • Wash aspiration probes • Processing center • Processing module pumps Elements of mechanical safety include the following requirements: • Keep all protective covers and barriers in the appropriate positions. • Do not perform manual tasks on the work surface of the system. • Do not insert any parts of the body into an area of mechanical movement during system operation. • Do not wear articles of clothing or accessories that can catch on the system. • Empty pockets of items that can fall into the system.

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• Be aware that reflex actions can occur and cause injury in the event of a system malfunction or an unexpected sequence of movements. • Use caution when performing procedures for adjustment, maintenance, cleaning, and repair. • Use caution when loading sample racks or sample trays. • Use caution when loading reagent cartridges. • Use caution when moving full waste containers. Related information... Hazards, page 817 Operating instructions, page 479 Safety icons, page 819

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Section 8

Physical hazards Use safe practices to avoid injury when any exposure to potential physical hazards occurs. Related information... Hazards, page 817 Probes and other sharps, page 835 Heavy objects, page 835 Hot objects, page 836 Tripping hazards, page 836

Probes and other sharps Probes are sharp and may be contaminated with infectious material. Avoid contact with tips of probes. Although the system is equipped with safety features to stop the lowering of probes, do not reach into the processing center during system operation. In general, minimize the use of sharps and glassware. Use mechanical means to remove contaminated, broken glassware. Dispose of sharps in an appropriately labeled, punctureresistant, leakproof container before treatment and disposal. Related information... Physical hazards, page 835 Safety icons, page 819

Heavy objects The system is a heavy instrument. Confirm that adequate help is available before relocating the system. For information about the relocation of the system, contact an Abbott Laboratories representative. Obtain adequate help or use mechanical devices to move or lift heavy items. Use the following techniques to help reduce the risk of injury when lifting objects: • Keep the head up and the back straight. Bend at the hips and knees. • Bring the load as near to the body as possible and keep the load directly in front of the body. • Tighten the abdominal muscles, push the feet down into the ground, and straighten the knees (that is, lift with the legs, not with the back). • Do not twist and reach to the side or twist and lift. Instead, move the feet to turn the body. • Bend at the knees by using only the leg muscles and place the load in the appropriate location.

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• Try to perform lifts at waist height with the elbows near the body. Related information... Physical hazards, page 835 Safety icons, page 819

Hot objects The lamp and the lamp housing may be hot. Before replacing the lamp, power off the c‑series processing module. Wait a minimum of 5 minutes so that the lamp and the lamp housing can cool. Wear gloves if necessary. Related information... Physical hazards, page 835 Safety icons, page 819

Tripping hazards The Alinity ci‑series is equipped with a power cord for each processing module, several computer cables, and water and waste tubing for the system control module. To avoid a tripping hazard, ensure that the cords, cables, and tubing in high-traffic areas are routed safely. Related information... Physical hazards, page 835

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Section 9

Service, maintenance, and diagnostics

Introduction The appropriate service, maintenance, and diagnostics of the system are some of the most important aspects of a complete quality assurance program. A thorough service, maintenance, and diagnostic program: • Minimizes downtime. • Maintains records for inspection and accreditation. • Maintains system performance to provide optimal test results. Related information... Maintenance and diagnostics, page 838 Component replacement, page 920 Troubleshooting, page 1023 General requirements, page 810

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Maintenance and diagnostics The system software provides a user-friendly interface to perform and track maintenance and diagnostic activities. The Procedures screen displays maintenance and diagnostic procedures that can be performed. After initiating a procedure, follow step-by-step instructions through the procedure to completion. The online log indicates the date and time that the procedure is completed. The performance of the procedure is tracked in the online log. If a maintenance procedure or a diagnostic procedure requires the cover interlocks to be overridden by using the procedure key, the interlocks can be overridden only by trained operators. Be aware that potential mechanical hazards and Biological RISK may be present. Be aware of moving parts. Do not reach into the paths of moving parts. Related information... Service, maintenance, and diagnostics, page 837 Procedures screen, page 838 Procedures Log screen, page 851 Descriptions of maintenance and diagnostic procedure statuses, page 856 Maintenance procedure descriptions, page 857 Unscheduled cleaning, page 873 Diagnostic procedure descriptions, page 875

Procedures screen On the Procedures screen, the operator can view the following information: • Scheduled maintenance procedures to perform by category • Available diagnostic procedures to perform by category • In-process maintenance procedures or in-process diagnostic procedures A trained operator can perform the following functions: • Access details for a maintenance procedure or a diagnostic procedure. • Perform a maintenance procedure or a diagnostic procedure. • Print a maintenance procedure or a diagnostic procedure. • Access maintenance logs or diagnostic logs. Related information... Maintenance and diagnostics, page 838 Procedures screen element descriptions, page 839 Version Details for Procedure flyout element descriptions, page 841

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Perform Procedure screen, page 843 Perform Procedure screen element descriptions, page 843 Show Video flyout element descriptions, page 844 Show Picture flyout element descriptions, page 845 Descriptions of procedure key settings, page 845 Use a procedure key to perform a procedure, page 846 Perform a maintenance procedure or a diagnostic procedure, page 849 Return to a maintenance procedure or a diagnostic procedure in process, page 851

Procedures screen element descriptions

Maintenance tab, Diagnostics tab The Maintenance tab displays maintenance procedures that can be performed for a selected module. The Diagnostics tab displays diagnostic procedures that can be performed for a selected module. Maintenance and diagnostic procedures are grouped by categories. Category tabs are displayed on the right side of the Procedures screen.

Elements Module bar

Used to select an individual module to perform maintenance or diagnostic procedures. An amber badge is displayed on the module number when a maintenance or diagnostic procedure is in process and requires an operator response. A red badge is displayed on the module number when one or more maintenance procedures are overdue.

Procedure

Displays a list of the procedures that can be performed for the selected module. The procedures are grouped by categories. The Minus button next to each category collapses the list of procedures associated with the category. next to each category expands the list of The Plus button procedures associated with the category.

Last Performed

Displays the date and time that the procedure was last performed.

Operator ID

Displays the operator ID that is logged onto the system when the procedure was performed.

Category tabs

The following categories are displayed for maintenance procedures if applicable:

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• All • To Do • Daily • Weekly • Monthly • Quarterly • Triannual • Semiyearly • Yearly • As Needed The following categories are displayed for diagnostic procedures: • All • Optics • Pipettors • Fluidics-Wash • Temperature • RV Loader (only for i‑series) • Process Path (only for i‑series) • Sample Manager • Reagent Manager • Modules • Utilities • Reaction Mechanisms (only for c‑series) • ICT (only for c‑series)

Function buttons

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Log button

Navigates to the Procedures Log screen.

Print

Displays the Print flyout.

Details

Displays the Version Details for Procedure flyout.

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Perform

Navigates to the Perform Procedure screen.

In Process tab The In Process tab displays the maintenance or diagnostic procedure that is in process for a selected module.

Elements Module bar

Used to select an individual module to view the status of a procedure that is in process. An amber badge is displayed on the module number when a maintenance or diagnostic procedure is in process and requires an operator response.

Procedure

Displays the procedure that is in process for the selected module.

Status

Displays the status of the maintenance or diagnostic procedure.

Time Started

Displays the date and time that the procedure was started.

Function button Continue

Navigates to the Perform Procedure screen of the maintenance or diagnostic procedure that is in process.

Related information... Procedures screen, page 838 Descriptions of screen elements, page 140

Version Details for Procedure flyout element descriptions The Version Details for Procedure flyout provides the version details of the selected maintenance or diagnostic procedure.

Procedure Details area Procedure

Displays the number and name of the selected procedure.

Description

Provides a short description of the selected procedure.

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Current Version

Displays the current version of the selected procedure.

Category

Displays the category of the selected procedure.

Status to Perform Procedure

Displays the instrument status of the processing module that is necessary to perform the selected procedure.

Operator Access Level Displays the operator access level that is necessary to perform the selected procedure. Procedure Key Setting Displays the procedure key setting that is necessary to perform the selected procedure.

Last Performed Details area Version

Displays the version of the selected procedure when the procedure was last performed. If the procedure has not been performed, the element is blank.

Completion Date

Displays the date and time that the selected procedure was last performed. If the procedure has not been performed, the element is blank.

Operator ID

Displays the identification of the operator logged onto the system when the selected procedure was performed. If the procedure has not been performed, the element is blank.

Completion Status

Displays the last status of the selected procedure. If the procedure has not been performed, the element is blank.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

?

Displays Help from the operations manual for the active screen, flyout, or message code.

Related information... Procedures screen, page 838 Descriptions of maintenance and diagnostic procedure statuses, page 856

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Perform Procedure screen On the Perform Procedure screen, the operator can view the following information for a procedure in process: • Procedure category and name • Procedure status • Procedure description The operator can perform the following functions: • Continue the procedure. • Close the screen to perform a procedure on another module. • Access other screens. • Quit the procedure. Related information... Procedures screen, page 838

Perform Procedure screen element descriptions Displays information about the procedure and step-by-step instructions for performing the procedure.

Elements Type

Displays the type of procedure being performed: • Maintenance • Diagnostic

Category

Displays the maintenance or diagnostic category for the procedure.

Procedure

Displays the procedure number and name.

Status

Displays the status of the maintenance or diagnostic procedure.

Instructions

Displays step-by-step instructions to perform the maintenance or diagnostic procedure.

User Input

Displays the buttons and fields to continue the procedure or provide user input.

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Activity

Displays the activity of the module while performing the procedure.

Results

Displays the results of the procedure.

Function buttons Show Video

Displays the Show Video flyout.

Show Picture

Displays the Show Picture flyout.

Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Quit

Cancels selections or entries and displays the Done button to exit the procedure.

Print

Displays the Print flyout.

Related information... Procedures screen, page 838 Descriptions of screen elements, page 140

Show Video flyout element descriptions In the Show Video flyout, the operator can play a video that is specific for the maintenance or diagnostic procedure being performed.

Element Close button

Closes the flyout.

Function buttons

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Video slider

Advances and rewinds the video.

Play button

Starts the video.

Pause button

Pauses the video.

Stop button

Stops the video.

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Audio button

Audio is currently unavailable for the maintenance and diagnostic videos.

Volume slider

Audio is currently unavailable for the maintenance and diagnostic videos.

?

Displays Help from the operations manual for the active screen, flyout, or message code.

Related information... Procedures screen, page 838

Show Picture flyout element descriptions In the Show Picture flyout, the operator can display a picture that is specific for the maintenance or diagnostic procedure being performed.

Element Close button

Closes the flyout.

Function button ?

Displays Help from the operations manual for the active screen, flyout, or message code.

Related information... Procedures screen, page 838

Descriptions of procedure key settings The procedure key provides access to the front and rear processing center covers of the Alinity ci‑series processing modules and the reagent and sample manager (RSM) when maintenance procedures, diagnostic procedures, and component replacement procedures are in process. The procedure documentation includes the procedure key settings. NOTE: For procedures that require a processing module and the RSM, the procedure keys for the processing module and the system control module (SCM) need to be positioned at the designated procedure key settings. The following list provides descriptions of the procedure key settings: Off

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The setting is indicated by the black dot on the procedure lock. To perform a procedure, the procedure key is not required to be inserted into the procedure lock.

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Required On

The setting is indicated by the white dot on the procedure lock. To perform a procedure, the procedure key must be inserted into the procedure lock and must be positioned at the On setting.

Optional On

The procedure key is or is not inserted into the procedure lock. If the procedure key is inserted, the key can be positioned at the setting for On or Off. However, access to the front and rear processing center covers is permitted only when the procedure key is inserted and is positioned at the On setting. If the front or rear processing center cover is lifted during the procedure when the procedure key is positioned at the Off setting or when the key is not inserted, the instrument statuses of the processing module and the RSM transition to Stopped and power is removed from the following module components: • c‑series: Sample pipettor • i‑series: Sample, R1, and R2 pipettors • RSM: RSM transport

Related information... Procedures screen, page 838 Procedure key, page 58

Use a procedure key to perform a procedure Required instrument status

Stopped or Idle

Perform this procedure to adjust the procedure key setting on the Alinity c processing module, the Alinity i processing module, and the system control module (SCM). A procedure key is provided for use with a maintenance procedure, a diagnostic procedure, or a component replacement procedure. To determine the procedure key setting for a specific procedure, see the procedure documentation. When the processing module procedure key is positioned at the On setting, access to the front and rear processing center covers of the processing module is permitted when the procedure is in process. The SCM procedure key is required for procedures that use the reagent and sample manager (RSM) and require access to the front processing center cover. NOTE: When procedures are performed with the procedure key positioned at the On setting, important safety features are bypassed and the operator may be exposed to one or more of the following potential hazards: •

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CAUTION: Biological RISKS. This activity or area may expose you to potentially infectious material.

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CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.

•

CAUTION: Moving Parts. This activity or area may expose you to moving parts.

•

CAUTION: Probe Stick Hazard. This activity or area may expose you to probes.

Be aware of moving parts. Do not reach into the processing center during system operation. 1.

To access each procedure lock, perform the following steps: – Open the front electronics door of the processing module. – Open the SCM front door.

2.

Insert the procedure key into the procedure lock, and then turn the key to the On (white dot) setting. Figure 159: Procedure key for the SCM

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Figure 160: Procedure key for the Alinity c

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3.

Perform the procedure that requires the procedure key.

4.

Turn the procedure key to the Off setting (black dot), and then remove the key.

5.

Close the front electronics door of the processing module and the SCM front door.

Related information... Procedures screen, page 838 Procedure key, page 58

Perform a maintenance procedure or a diagnostic procedure Perform this procedure to perform and track maintenance and diagnostic procedures. The Maintenance tab includes scheduled procedures to perform and as-needed cleaning procedures to perform. The Diagnostics tab includes procedures that can be used to confirm the status of assemblies and mechanisms to help identify and resolve operational problems.

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CAUTION: Maintenance and diagnostic procedures may expose operators to one or more potentially hazardous conditions. Untrained operators must not perform these procedures. 1.

On the menu bar, tap Procedures. The default is the Maintenance tab. To perform diagnostic procedures, tap the Diagnostics tab. NOTE: If Procedures is not an icon on the menu bar, tap System, and then tap Procedures.

2.

On the Procedures screen, tap a Module button. The Maintenance tab displays To Do procedures. The Diagnostics tab displays All procedures.

3.

On the right side of the Procedures screen, tap a tab.

4.

Under Procedure, tap a procedure.

5.

Tap Perform. On the Perform Procedure screen, a procedure description is displayed in the Instructions box. If a procedure is selected by mistake, tap Quit to exit the procedure.

6.

To perform the procedure, tap the Proceed user input button.

7.

Follow the instructions in the Instructions box. Some procedures have pictures and videos to use as aids to perform the procedure. The Show Video button and the Show Picture button are displayed when pictures and videos are available.

8.

To leave the procedure while it is in process, tap any icon on the menu bar. The system software provides the ability to perform a procedure on a different module or to use other areas of the user interface while a procedure runs in the background. If a procedure uses the reagent and sample manager (RSM) (which is controlled by the system control module procedure key), it cannot be performed concurrently with another procedure that also uses the RSM, with the exception of 2500 Daily Maintenance. When a procedure requires an operator response, an amber badge is displayed on the Procedures icon. NOTE: The In Process tab of the Procedures screen displays procedures in process.

9.

To print a procedure report, tap Print.

10. To complete the procedure, tap Done. Related information... Procedures screen, page 838 Maintenance procedure descriptions, page 857 Diagnostic procedure descriptions, page 875 Return to a maintenance procedure or a diagnostic procedure in process, page 851

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Return to a maintenance procedure or a diagnostic procedure in process Perform this procedure to return to the Perform Procedure screen of an in-process maintenance procedure or an in-process diagnostic procedure. The operator must return to this screen to provide a response when required or to complete the procedure. 1.

On the menu bar, tap Procedures. NOTE: If a procedure requires a response, the In Process tab is displayed. If the tab is not displayed, tap the In Process tab.

2.

On the Procedures screen, tap a Module button.

3.

Under Procedure, tap an in-process procedure.

4.

Tap Continue.

5.

On the Perform Procedure screen, follow the instructions in the Instructions box.

6.

To print a procedure report, tap Print.

7.

To complete the procedure, tap Done.

Related information... Procedures screen, page 838 Perform a maintenance procedure or a diagnostic procedure, page 849

Procedures Log screen On the Procedures Log screen, the operator can view information about maintenance and diagnostic procedures that were performed. The system stores data for a maximum of 2 years. The operator can perform the following functions: • Approve a log. • Print a log. • Add a comment to a procedure. Related information... Maintenance and diagnostics, page 838 Procedures Log screen, Maintenance tab element descriptions, page 852 Procedures Log screen, Diagnostics tab element descriptions, page 853 Details for Log flyout element descriptions, page 854 Add a comment to a maintenance procedure or a diagnostic procedure, page 855 Approve a maintenance log, page 856

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Procedures Log screen, Maintenance tab element descriptions

Maintenance tab The Maintenance tab displays the maintenance logs. The following list explains the descriptive elements of the maintenance logs: • A gray box indicates that the procedure has a status of Scheduled, Pending, Canceled, Not Performed, or Failed. If the procedure is performed multiple times on the same day, the status of the last performed procedure is displayed. Tap the box to display the Details for Log flyout. • A blue box indicates that the procedure has been performed and has a status of Completed. Tap the box to display the Details for Log flyout. • An asterisk within the box indicates that a comment has been entered for the procedure in the Details for Log flyout. • A number within the box indicates that the procedure was performed multiple times on the same day. • No box indicates that the procedure was not performed or scheduled for that day.

Elements

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Module bar

Used to select an individual module to view the maintenance logs.

Procedure

Displays the name of the maintenance procedure.

Status

Displays the approval status of the selected maintenance log. The statuses are Approved and Unapproved.

Operator ID

Displays the identification of the operator who approved the log. The element is blank if the log has not been approved.

Approval Date/Time

Displays the date and time that the log was approved. The element is blank if the log has not been approved.

Activity Month

Displays the month and year for the log displayed.

Back and Forward buttons

Navigate to the previous or next maintenance log.

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Function buttons Procedures

Navigates to the Procedures screen.

Print

Displays the Print flyout.

Approve

Used to approve the maintenance log for the month displayed.

Related information... Procedures Log screen, page 851 Descriptions of screen elements, page 140

Procedures Log screen, Diagnostics tab element descriptions

Diagnostics tab The Diagnostics tab displays the diagnostic logs. The following list explains the descriptive elements of the diagnostic logs: • A gray box indicates procedures that did not complete successfully. If the procedure is performed multiple times on the same day, the status of the last performed procedure is displayed. Tap the box to display the Details for Log flyout. • A blue box indicates that the procedure has been performed and has a status of Completed. Tap the box to display the Details for Log flyout. • An asterisk within the box indicates that a comment has been entered for the procedure in the Details for Log flyout. • A number within the box indicates that the procedure was performed multiple times on the same day. • No box indicates that the procedure was not performed or scheduled for that day.

Elements Module bar

Used to select an individual module to view the diagnostic logs.

Procedure

Displays the name of the diagnostic procedure.

Activity Month

Displays the month and year for the log displayed.

Back and Forward buttons

Navigates to the previous or next diagnostic log.

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Function buttons Procedures

Navigates to the Procedures screen.

Print

Displays the Print flyout.

Related information... Procedures Log screen, page 851 Descriptions of screen elements, page 140

Details for Log flyout element descriptions The Details for Log flyout provides details of the selected maintenance or diagnostic procedure.

Elements

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Procedure

Displays the name of the selected maintenance or diagnostic procedure.

Version

Displays the version number of the procedure.

Category

Displays the category of the maintenance or diagnostic procedure.

Operator ID

Displays the identification of the operator logged onto the system when the procedure was performed. For maintenance logs, this element is blank if the procedure has a status of Scheduled, Pending, or Not Performed.

Completion Date

Displays the date and time that the procedure is completed. For maintenance logs, this element is blank if the procedure has a status of Scheduled, Pending, or Not Performed.

Completion Status

Displays the final status of the completed procedure.

Comment

Displays a text box that is used to enter comments for the selected procedure.

Results

Displays results generated for the selected procedure.

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Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

Print

Displays the Print flyout.

Previous

Displays the previously viewed details for the log. The button is displayed only when the procedure is performed multiple times on the same day.

Next

Displays the next details for the log. The button is displayed only when the procedure is performed multiple times on the same day.

?

Displays Help from the operations manual for the active screen, flyout, or message code.

Related information... Procedures Log screen, page 851

Add a comment to a maintenance procedure or a diagnostic procedure Perform this procedure to add a comment to a procedure listed in the maintenance log or the diagnostic log. Add comments as needed to document the following information: • Why a maintenance procedure was not completed when scheduled • Why a procedure failed or was repeated • Why a nonscheduled procedure was performed 1.

On the menu bar, tap Procedures. NOTE: If Procedures is not an icon on the menu bar, tap System, and then tap Procedures.

2.

On the Procedures screen, tap Log.

3.

On the Log screen, tap a Module button.

4.

In the Activity Month area, tap the Right Arrow and Left Arrow buttons to display the needed month.

5.

Under Procedure, find the needed procedure. If the procedure is not displayed on the screen, flick up and down to view more procedures.

6.

To display the procedure in the Details for Log flyout, tap a date for the procedure.

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7.

If the procedure was performed multiple times on that date, tap Next or Previous to display the details for each time that the procedure was performed.

8.

In the Comments box, type a comment.

9.

To save the comment and return to the Log screen, tap Done. To discard the comment and return to the Log screen, tap Cancel.

Related information... Procedures Log screen, page 851

Approve a maintenance log Operator access level System administrator Perform this procedure to approve a monthly maintenance log. NOTE: The maintenance log can be approved on the first day of the next month. 1.

On the menu bar, tap Procedures. NOTE: If Procedures is not an icon on the menu bar, tap System, and then tap Procedures.

2.

On the Maintenance tab of the Procedures screen, tap Log.

3.

In the Activity Month area, tap the Left Arrow and Right Arrow buttons to display the needed month.

4.

Tap Approve.

5.

When a confirmation message is displayed, tap Yes. The status of the maintenance log changes from unapproved to approved and displays the operator ID and the approval date and time.

Related information... Procedures Log screen, page 851

Descriptions of maintenance and diagnostic procedure statuses Maintenance and diagnostic procedure status refers to the completion status of a procedure. Procedures have the following completion statuses:

856

Scheduled

A maintenance procedure is scheduled for a future date.

Pending

A maintenance procedure is scheduled for the current date.

Completed

The procedure is completed. For procedures that produce results with pass-or-fail criteria, all results passed.

User Canceled

Quit is selected before the procedure is completed.

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Failed

The procedure generated an error or a failed result.

The procedure has not been performed.

Running

The procedure is in process.

Waiting user response The procedure in process requires an operator response. Not performed

The maintenance procedure was not performed on the date due.

Related information... Maintenance and diagnostics, page 838 Version Details for Procedure flyout element descriptions, page 841 Diagnostic History Report, Maintenance History Report element descriptions, page 1661 Procedure Report element descriptions, page 1671

Maintenance procedure descriptions Maintenance procedures are grouped first by module type and then by category. The type of module determines the categories and procedures that are available. Each category is represented by a tab on the right side of the Maintenance tab of the Procedures screen. The To Do tab displays scheduled procedures for the selected module. The All tab displays all procedures for the selected module. Each additional tab represents a frequency (for example, Daily or Weekly). Any procedure that is displayed can be performed even if it is not scheduled. Related information... Maintenance and diagnostics, page 838 Maintenance suggestions, page 857 Processing module maintenance procedures (c‑series), page 858 Processing module maintenance procedures (i‑series), page 868 Reagent and sample manager (RSM) maintenance procedures, page 872 Perform a maintenance procedure or a diagnostic procedure, page 849

Maintenance suggestions The appropriate maintenance of the system is important. Abbott Laboratories provides suggestions for efficient strategies to perform maintenance procedures and reduce downtime. When scheduling and performing maintenance procedures: • Schedule maintenance procedures for times when the workflow is slow.

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• Verify that adequate supplies are loaded, or are available to load, on the system before initiating a maintenance procedure. • Perform procedures within a maintenance category on different shifts or days. To avoid scheduling these procedures for the same day, perform some of them early to stagger the schedule. NOTE: All maintenance procedures must be completed on or before the due date. Related information... Maintenance procedure descriptions, page 857

Processing module maintenance procedures (c‑series) Maintenance procedures for the c‑series processing module are grouped by the module type and by frequency categories on the Maintenance tab of the Procedures screen. Related information... Maintenance procedure descriptions, page 857 Daily maintenance procedures (c‑series), page 858 Weekly maintenance procedures (c‑series), page 859 Monthly maintenance procedures (c‑series), page 860 Quarterly maintenance procedures (c‑series), page 860 Triannual maintenance procedures (c‑series), page 863 As-needed maintenance procedures (c‑series), page 865

Daily maintenance procedures (c‑series) Daily maintenance procedures are required on the c‑series processing module. Related information... Processing module maintenance procedures (c‑series), page 858 5501 Daily Maintenance (c‑series), page 858 5501 Daily Maintenance (c‑series) Perform this Daily maintenance procedure to complete the following tasks: • Flush the water lines of the sample, the reagent, and the cuvette washer. • Exchange the water in the water bath. • Add Water Bath Additive to the water bath. • Wash the ICT module with ICT Reference Solution and Cleaning Solution. • Drain and fill the ICT Reference Solution cup. • Wash the sample and reagent probes and the mixers with Acid Probe Wash and Detergent A. • Clean the sample probe, the R2 probe, and the mixers with Cleaning Solution. 858

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• Clean the sample probe exterior (only for whole blood). Estimated time

12 minutes

Required materials

• c‑series Maintenance Solutions, LN 08P9870 or LN 08P9871 (USA) • Purified water (required only for systems with whole blood applications) • Cotton swabs (required only for systems with whole blood applications)

Required instrument Warming or Idle status Procedure key setting Processing module: Required On Related information... Daily maintenance procedures (c‑series), page 858 Use a procedure key to perform a procedure, page 846 Maintenance solutions (c‑series), page 153 Solutions used in daily operations (c‑series), page 577

Weekly maintenance procedures (c‑series) Weekly maintenance procedures are required on the c‑series processing module. Related information... Processing module maintenance procedures (c‑series), page 858 5601 Clean Cuvettes with Detergent A (c‑series), page 859 5601 Clean Cuvettes with Detergent A (c‑series) Perform this Weekly maintenance procedure to wash all cuvettes and to fill them with Detergent A solution. Estimated time

30 minutes

Required materials

None

Required instrument Warming or Idle status Procedure key setting Processing module: Required On Related information... Weekly maintenance procedures (c‑series), page 859 Use a procedure key to perform a procedure, page 846

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Service, maintenance, and diagnostics Maintenance and diagnostics

Section 9

Monthly maintenance procedures (c‑series) Monthly maintenance procedures are required on the c‑series processing module. Related information... Processing module maintenance procedures (c‑series), page 858 5701 Clean ICT Drain Tip (c‑series), page 860 5701 Clean ICT Drain Tip (c‑series) Perform this Monthly maintenance procedure to clean the ICT drain tip. Estimated time

2 minutes

Required materials

• Lint-free tissue • Purified water

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Off Related information... Monthly maintenance procedures (c‑series), page 860 Use a procedure key to perform a procedure, page 846

Quarterly maintenance procedures (c‑series) Quarterly maintenance procedures are required on the c‑series processing module. Related information... Processing module maintenance procedures (c‑series), page 858 5801 Sample Syringe Maintenance (c‑series), page 860 5802 Wash Solution Syringe Maintenance (c‑series), page 861 5803 Reagent Syringe Maintenance (c‑series), page 862 5806 Change Lamp (c‑series), page 862 5808 Inspect Wash Cup Tubing (c‑series), page 863 5801 Sample Syringe Maintenance (c‑series) Perform this Quarterly maintenance procedure to replace the sample syringe O-ring and sample syringe seal tips 1 and 2.

860

Estimated time

12 minutes

Required materials

• Phillips screwdriver

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• Slotted screwdriver • 10 mm wrench • Absorbent towel • Sample and Wash Solution Syringe O-ring, LN 09D5203 • Sample and Wash Solution Syringe Seal Tip #1, LN 09D3703 • Sample and Wash Solution Syringe Seal Tip #2, LN 09D3803 • Cotton swabs Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Optional On Related information... Quarterly maintenance procedures (c‑series), page 860 Use a procedure key to perform a procedure, page 846 5802 Wash Solution Syringe Maintenance (c‑series) Perform this Quarterly maintenance procedure to replace the wash solution syringe O-ring and wash solution syringe seal tips 1 and 2. Estimated time

22 minutes

Required materials

• Phillips screwdriver • Slotted screwdriver • 10 mm wrench • Absorbent towel • Sample and Wash Solution Syringe O-ring, LN 09D5203 • Sample and Wash Solution Syringe Seal Tip #1, LN 09D3703 • Sample and Wash Solution Syringe Seal Tip #2, LN 09D3803 • Cotton swabs

Required instrument Warming or Idle status Procedure key setting Processing module: Optional On

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Section 9

Related information... Quarterly maintenance procedures (c‑series), page 860 Use a procedure key to perform a procedure, page 846 5803 Reagent Syringe Maintenance (c‑series) Perform this Quarterly maintenance procedure to replace the reagent syringe O-rings and reagent syringe seal tips 1 and 2. Estimated time

22 minutes

Required materials

• Phillips screwdriver • Slotted screwdriver • 15 mm wrench • Absorbent towel • Reagent Syringe O-ring, LN 09D5303 • Reagent Syringe Seal Tip #1, LN 09D3903 • Reagent Syringe Seal Tip #2, LN 09D4004 • Cotton swabs

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Optional On Related information... Quarterly maintenance procedures (c‑series), page 860 Use a procedure key to perform a procedure, page 846 5806 Change Lamp (c‑series) Perform this Quarterly maintenance procedure to change the lamp. Estimated time

15 minutes

Required materials

• Phillips screwdriver • Slotted screwdriver • Gloves • Source lamp, LN 09D4503 • Lint-free tissue (optional) • Ethanol (optional)

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Section 9

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Off Related information... Quarterly maintenance procedures (c‑series), page 860 Use a procedure key to perform a procedure, page 846 5808 Inspect Wash Cup Tubing (c‑series) Perform this Quarterly maintenance procedure to inspect the wash cup tubing. Estimated time

5 minutes

Required materials

• 3 mm hex wrench • Slotted screwdriver

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Off Related information... Quarterly maintenance procedures (c‑series), page 860 Use a procedure key to perform a procedure, page 846

Triannual maintenance procedures (c‑series) Triannual maintenance procedures are required on the c‑series processing module. Related information... Processing module maintenance procedures (c‑series), page 858 5833 Change 1 mL Syringes (c‑series), page 863 5834 Check and Change ICT Check Valves (c‑series), page 864 5835 Check and Clean High-Concentration Waste Sensor (c‑series), page 864 5833 Change 1 mL Syringes (c‑series) Perform this Triannual maintenance procedure to change the 1 mL syringes on the following pumps: • ICT Reference Solution pump • ICT aspiration pump • Wash solution pump Estimated time

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14 minutes

863

Service, maintenance, and diagnostics Maintenance and diagnostics Required materials

Section 9

• Seven 1 mL syringes, LN 09D4103 (If the system is not configured to use the ICT module, only three 1 mL syringes are required.) • Absorbent towels

Required instrument Warming or Idle status Procedure key setting Processing module: Optional On Related information... Triannual maintenance procedures (c‑series), page 863 Use a procedure key to perform a procedure, page 846 5834 Check and Change ICT Check Valves (c‑series) Perform this Triannual maintenance procedure to change the ICT aspiration check valve and to confirm the functionality of the ICT Reference Solution check valves. Estimated time

18 minutes

Required materials

• Absorbent towel • ICT check valve, LN 09D3503 • Beaker that is large enough to hold the 1 mL syringe and the check valve • Purified water

Required instrument Warming or Idle status Procedure key setting Processing module: Optional On Related information... Triannual maintenance procedures (c‑series), page 863 Use a procedure key to perform a procedure, page 846 5835 Check and Clean High-Concentration Waste Sensor (c‑series) Perform this Triannual maintenance procedure to test the functionality of the high-concentration waste sensor and to clean the sensor. NOTE: This procedure is required only if the high-concentration waste bottle is installed.

864

Estimated time

10 minutes

Required materials

• Absorbent towels

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• 0.5% sodium hypochlorite solution • Beaker that is large enough to hold the highconcentration waste sensor Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Off Related information... Triannual maintenance procedures (c‑series), page 863 Use a procedure key to perform a procedure, page 846

As-needed maintenance procedures (c‑series) The operator can perform as-needed maintenance procedures for the c‑series processing module to clean cuvettes and module-specific reagent and sample manager (RSM) mechanisms when messages codes and observed problems associated with the cuvettes and the modulespecific RSM are diagnosed. Related information... Processing module maintenance procedures (c‑series), page 858 5901 Clean Wash Cups (c‑series), page 865 5906 Clean Sample and Reagent Probes (c‑series), page 866 5907 Clean Mixers (c‑series), page 866 5908 Clean Cuvette Washer Nozzles (c‑series), page 867 5910 Wash Cuvettes (c‑series), page 867 5925 Manual RSM Loading Area and Positioners Cleaning (c‑series), page 867 5901 Clean Wash Cups (c‑series) Perform this As-Needed maintenance procedure to clean the processing module wash cups. Estimated time

60 minutes

Required materials

• Phillips screwdriver • 150 mL 2.5% sodium hypochlorite solution • Lint-free tissue • Two syringes that can dispense 25 mL • Cotton swabs • Purified water

Required instrument status

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Stopped, Warming, or Idle

865

Service, maintenance, and diagnostics Maintenance and diagnostics

Section 9

Procedure key setting Processing module: Required On Related information... As-needed maintenance procedures (c‑series), page 865 Use a procedure key to perform a procedure, page 846 5906 Clean Sample and Reagent Probes (c‑series) Perform this As-Needed maintenance procedure to clean the exterior surfaces of the sample probe, the R1 probe, and the R2 probe. Estimated time

5 minutes

Required materials

• Aliquot of Detergent A from a cartridge • Purified water • Cotton swabs • Absorbent tissue

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Required On Related information... As-needed maintenance procedures (c‑series), page 865 Use a procedure key to perform a procedure, page 846 5907 Clean Mixers (c‑series) Perform this As-Needed maintenance procedure to clean mixer 1 and mixer 2. Estimated time

3 minutes

Required materials

• 70% isopropyl alcohol • Cotton swabs • Purified water

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Required On Related information... As-needed maintenance procedures (c‑series), page 865 Use a procedure key to perform a procedure, page 846

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Section 9

5908 Clean Cuvette Washer Nozzles (c‑series) Perform this As-Needed maintenance procedure to clean the cuvette washer nozzles. Estimated time

3 minutes

Required materials

Nozzle cleaning wire

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Required On Related information... As-needed maintenance procedures (c‑series), page 865 Use a procedure key to perform a procedure, page 846 5910 Wash Cuvettes (c‑series) Perform this As-Needed maintenance procedure to wash all cuvettes with Alkaline Wash, Acid Wash, and water. Estimated time

16 minutes

Required materials

None

Required instrument Warming or Idle status Procedure key setting Processing module: Optional On Related information... As-needed maintenance procedures (c‑series), page 865 Use a procedure key to perform a procedure, page 846 5925 Manual RSM Loading Area and Positioners Cleaning (c‑series) Perform this As-Needed maintenance procedure to clean manually the loading area, sample positioners, and reagent positioner of the module-specific reagent and sample manager (RSM). Estimated time

4 minutes* * This time does not include the 10 minutes of contact time that is required for 0.5% sodium hypochlorite solution.

Required materials

• 0.5% sodium hypochlorite solution • Quaternary ammonium detergent • Lint-free tissue

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Service, maintenance, and diagnostics Maintenance and diagnostics

Section 9

Required instrument Stopped, Warming, or Idle status Procedure key setting • System control module: Required On • Processing module: Required On Related information... As-needed maintenance procedures (c‑series), page 865 Use a procedure key to perform a procedure, page 846

Processing module maintenance procedures (i‑series) Maintenance procedures for the i‑series processing module are grouped by the module type and by frequency categories on the Maintenance tab of the Procedures screen. Related information... Maintenance procedure descriptions, page 857 Daily maintenance procedures (i‑series), page 868 Weekly maintenance procedures (i‑series), page 869 Semiyearly maintenance procedures (i‑series), page 870 As-needed maintenance procedures (i‑series), page 871

Daily maintenance procedures (i‑series) Daily maintenance procedures are required on the i‑series processing module. Related information... Processing module maintenance procedures (i‑series), page 868 2500 Daily Maintenance (i‑series), page 868 2500 Daily Maintenance (i‑series) Perform this Daily maintenance procedure to complete the following tasks: • Clean and condition the sample pipettor probe. • Clean wash zone 1 probes and wash zone 2 probes with 0.5% sodium hypochlorite solution. • Flush and prime the Pre-Trigger Solution and the Trigger Solution. NOTE: This maintenance procedure can be performed concurrently on systems that have redundant Alinity i processing modules. Estimated time

23 minutes* * This procedure may require an additional 5 minutes to 25 minutes if a bulk solution transfer is necessary.

868

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Service, maintenance, and diagnostics Maintenance and diagnostics

Section 9 Required materials

• Maintenance Cleaning Cartridge, LN 02R52 • 0.5% sodium hypochlorite solution NOTE: The prepared solution is stable for 30 days. • Measuring device that can deliver 25 mL • Probe Conditioning Solution, LN 01R5840 (in the reagent carousel)

Required instrument Warming or Idle status Procedure key setting • System control module: Optional On • Processing module: Optional On Related information... Daily maintenance procedures (i‑series), page 868 Load cartridges on the reagent and sample manager (RSM), page 599 Load onboard vial racks or cartridges on a specific processing module, page 602

Weekly maintenance procedures (i‑series) Weekly maintenance procedures are required on the i‑series processing module. Related information... Processing module maintenance procedures (i‑series), page 868 2620 Manual Pipettor Probe Cleaning (i‑series), page 869 2625 Manual Wash Zone Probe Cleaning (i‑series), page 870 2630 Manual Wash Cup Cleaning (i‑series), page 870 2620 Manual Pipettor Probe Cleaning (i‑series) Perform this Weekly maintenance procedure to remove manually the salt buildup from the reagent 1, reagent 2, and sample pipettor probes. Estimated time

4 minutes

Required materials

• Purified water • Cotton swabs

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Required On Related information... Weekly maintenance procedures (i‑series), page 869 Alinity ci‑series Operations Manual

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Service, maintenance, and diagnostics Maintenance and diagnostics

Section 9

2625 Manual Wash Zone Probe Cleaning (i‑series) Perform this Weekly maintenance procedure to remove manually the salt buildup from the wash zone 1 and wash zone 2 probes. Estimated time

4 minutes

Required materials

• Purified water • Cotton swabs

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Required On Related information... Weekly maintenance procedures (i‑series), page 869 2630 Manual Wash Cup Cleaning (i‑series) Perform this Weekly maintenance procedure to remove manually the salt buildup from the reagent 1, reagent 2, and sample wash cups (including the induction heater wash cup where applicable) and the wash cup baffles. Estimated time

8 minutes

Required materials

• Purified water • Cotton swabs

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Required On Related information... Weekly maintenance procedures (i‑series), page 869

Semiyearly maintenance procedures (i‑series) Semiyearly maintenance procedures are required on the i‑series processing module. Related information... Processing module maintenance procedures (i‑series), page 868 2850 Air Filter Cleaning (i‑series), page 871

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Section 9

2850 Air Filter Cleaning (i‑series) Perform this Semiyearly maintenance procedure to remove manually the dust buildup from the processing module air filters. Rotating between two sets of air filters is recommended because the filters must be dry when they are reinstalled. Estimated time

10 minutes

Required materials

• Two Filters, Processing Center, LN 04S6701 • Tap water

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Off Related information... Semiyearly maintenance procedures (i‑series), page 870 Use a procedure key to perform a procedure, page 846

As-needed maintenance procedures (i‑series) The operator can perform as-needed maintenance procedures for the i‑series processing module to clean and decontaminate the processing module or module-specific reagent and sample manager (RSM) mechanisms after a spill has occurred or when message codes and observed problems associated with the processing module or the module-specific RSM are diagnosed. Related information... Processing module maintenance procedures (i‑series), page 868 2925 Manual RSM Loading Area and Positioner Cleaning (i‑series), page 871 2925 Manual RSM Loading Area and Positioner Cleaning (i‑series) Perform this As-Needed maintenance procedure to clean manually the loading area, sample positioners, and reagent positioner of the module-specific reagent and sample manager (RSM). Estimated time

4 minutes* * This time does not include the 10 minutes of contact time that is required for 0.5% sodium hypochlorite solution.

Required materials

• 0.5% sodium hypochlorite solution • Quaternary ammonium detergent • Lint-free tissue

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Service, maintenance, and diagnostics Maintenance and diagnostics

Section 9

Required instrument Stopped, Warming, or Idle status Procedure key setting • System control module: Required On • Processing module: Required On Related information... As-needed maintenance procedures (i‑series), page 871

Reagent and sample manager (RSM) maintenance procedures Maintenance procedures for the reagent and sample manager are grouped by the module type and by frequency categories on the Maintenance tab of the Procedures screen. Related information... Maintenance procedure descriptions, page 857 As-needed maintenance procedure (RSM), page 872

As-needed maintenance procedure (RSM) The operator can perform the as-needed maintenance procedure for the reagent and sample manager (RSM) to clean RSM mechanisms after a spill has occurred or when message codes and observed problems associated with the RSM are diagnosed. Related information... Reagent and sample manager (RSM) maintenance procedures, page 872 2920 Manual RSM Transport Cleaning, page 872 2920 Manual RSM Transport Cleaning Perform this As-Needed maintenance procedure to clean manually the bar code reader mirror and transport arm of the reagent and sample manager (RSM). Estimated time

4 minutes* * This time does not include the 10 minutes of contact time that is required for 0.5% sodium hypochlorite solution.

Required materials

• 0.5% sodium hypochlorite solution** • Quaternary ammonium detergent** • Isopropyl alcohol*** • Microfiber cloth*** • Lint-free tissue ** These items are only for the RSM transport arm.

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Section 9

*** These items are only for the RSM bar code reader mirror. Required instrument Stopped, Warming, or Idle status Procedure key setting System control module: Required On Related information... As-needed maintenance procedure (RSM), page 872

Unscheduled cleaning Some system components may need to be cleaned or decontaminated because of normal use from daily system operations or because of spills. Related information... Maintenance and diagnostics, page 838 Clean and decontaminate external components, page 873 Clean and decontaminate the bar code scanner, page 874 Clean and decontaminate the monitor, page 874 Spill cleanup, page 828

Clean and decontaminate external components Required materials

• Lint-free tissues • 0.5% sodium hypochlorite solution • Quaternary ammonium detergent

Perform this procedure to clean and decontaminate the following components: • Processing module external surfaces • System control module external surfaces • RV waste container (i‑series) • Sample racks • Vial racks • Trays CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.

CAUTION: Biological RISKS. This activity or area may expose you to potentially infectious material.

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Service, maintenance, and diagnostics Maintenance and diagnostics

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1.

Wipe the surface area with a quaternary ammonium detergent.

2.

Mist or wipe the surface area with 0.5% sodium hypochlorite solution. Let the disinfectant remain on the surface for a minimum of 10 minutes of contact time.

3.

Dispose of all absorbent material and wipes according to local, state, and national regulations.

Related information... Unscheduled cleaning, page 873 Requirements for decontamination, page 829

Clean and decontaminate the bar code scanner Required materials

• Lint-free tissues • 0.5% sodium hypochlorite solution • Quaternary ammonium detergent

Required instrument status

Stopped, Warming, or Idle

Perform this procedure to clean and decontaminate the bar code scanner. CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.

CAUTION: Biological RISKS. This activity or area may expose you to potentially infectious material. 1.

Wipe the surface area and scan window of the bar code scanner with a quaternary ammonium detergent.

2.

Mist or wipe the surface area and the scan window with 0.5% sodium hypochlorite solution. Let the disinfectant remain on the surface for a minimum of 10 minutes of contact time.

3.

Dispose of all absorbent material and wipes according to local, state, and national regulations.

Related information... Unscheduled cleaning, page 873 Requirements for decontamination, page 829

Clean and decontaminate the monitor Required materials

• Lint-free tissues • 0.5% sodium hypochlorite solution • Quaternary ammonium detergent

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Section 9

Perform this procedure to clean and decontaminate the monitor. NOTE: Before the procedure is performed, the monitor must be powered off. Thoroughly read the procedure and print a copy of it to use as a reference. CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.

CAUTION: Biological RISKS. This activity or area may expose you to potentially infectious material. 1.

Power off the monitor. Do not wipe the screen while the monitor is turned on.

2.

Wipe the screen with a quaternary ammonium detergent.

3.

Mist or wipe the screen with 0.5% sodium hypochlorite solution. Let the disinfectant remain on the screen for a minimum of 10 minutes of contact time.

4.

When the screen is dry, power on the monitor.

5.

Dispose of all absorbent material and wipes according to local, state, and national regulations.

Related information... Unscheduled cleaning, page 873 Requirements for decontamination, page 829 Print a topic from the operations manual, page 51

Diagnostic procedure descriptions Diagnostic procedures are grouped first by module type and then by category. The type of module determines the categories and procedures that are available. Each category is represented by a tab on the right side of the Diagnostics tab of the Procedures screen. The All tab displays all procedures for the selected module. Each additional tab represents a functional subsection of the system. Related information... Maintenance and diagnostics, page 838 Processing module diagnostic procedures (c‑series), page 875 Processing module diagnostic procedures (i‑series), page 892 Reagent and sample manager (RSM) diagnostic procedures, page 916 Perform a maintenance procedure or a diagnostic procedure, page 849

Processing module diagnostic procedures (c‑series) Diagnostic procedures for the c‑series processing module are grouped by functional categories on the Diagnostics tab of the Procedures screen.

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Service, maintenance, and diagnostics Maintenance and diagnostics

Section 9

Related information... Diagnostic procedure descriptions, page 875 Optics diagnostic procedures (c‑series), page 876 Pipettor diagnostic procedures (c‑series), page 877 Fluidics-wash diagnostic procedures (c‑series), page 882 Temperature diagnostic procedures (c‑series), page 885 Sample manager diagnostic procedures (c‑series), page 885 Reagent manager diagnostic procedures (c‑series), page 886 Module diagnostic procedures (c‑series), page 888 Reaction mechanism diagnostic procedures (c‑series), page 889 ICT diagnostic procedures (c‑series), page 891

Optics diagnostic procedures (c‑series) The operator may need to perform optics diagnostic procedures when optics components are replaced or when message codes and observed problems associated with the optics are diagnosed. Related information... Processing module diagnostic procedures (c‑series), page 875 4001 Optics Trigger Sensor Check (c‑series), page 876 4002 Absorbance Reads (c‑series), page 876 4005 Cuvette Integrity Test (c‑series), page 877 4001 Optics Trigger Sensor Check (c‑series) Perform this Optics diagnostic procedure to test the functionality of the optics trigger sensor. Estimated time

4 minutes

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Required On Related information... Optics diagnostic procedures (c‑series), page 876 Use a procedure key to perform a procedure, page 846 4002 Absorbance Reads (c‑series) Perform this Optics diagnostic procedure to measure absorbance readings and to generate a printed report for manually pipetted samples.

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Section 9

Estimated time

11 minutes for each cuvette segment that is used

Required materials

• Sample • Calibrated pipettor with disposable tips that can dispense 160 µL to 250 µL

Required instrument Idle status Procedure key setting Processing module: Required On Related information... Optics diagnostic procedures (c‑series), page 876 Use a procedure key to perform a procedure, page 846 4005 Cuvette Integrity Test (c‑series) Perform this Optics diagnostic procedure to test the condition of each one of the 187 cuvettes in the reaction carousel. Estimated time

1 minute

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Off Related information... Optics diagnostic procedures (c‑series), page 876 Use a procedure key to perform a procedure, page 846

Pipettor diagnostic procedures (c‑series) The operator may need to perform pipettor diagnostic procedures when pipettor components are replaced or when message codes and observed problems associated with the pipettor are diagnosed. Related information... Processing module diagnostic procedures (c‑series), page 875 4102 Sample Pipettor Calibration (c‑series), page 878 4103 R1 Pipettor Calibration (c‑series), page 878 4104 R2 Pipettor Calibration (c‑series), page 879 4106 Component Move (c‑series), page 879 4107 Sample Pipettor LAS Calibration (c‑series), page 879 4109 Probe Alignment Test (c‑series), page 880 Alinity ci‑series Operations Manual

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Service, maintenance, and diagnostics Maintenance and diagnostics

Section 9

4110 Crash Sensor Test (c‑series), page 881 4113 Pipettor Check (c‑series), page 881 4102 Sample Pipettor Calibration (c‑series) Perform this Pipettors diagnostic procedure to calibrate the sample pipettor. Estimated time

20 minutes

Required materials

• Cuvette Segment Alignment Tool, LN 04S70 • Tap water • Lint-free tissue • Slotted screwdriver • 16 mm x 100 mm sample tube

Required instrument Stopped, Warming, or Idle status Procedure key setting • System control module: Required On • Processing module: Required On Related information... Pipettor diagnostic procedures (c‑series), page 877 Use a procedure key to perform a procedure, page 846 4103 R1 Pipettor Calibration (c‑series) Perform this Pipettors diagnostic procedure to calibrate the R1 pipettor. Estimated time

10 minutes

Required materials

• Cuvette Segment Alignment Tool, LN 04S70 • Tap water • Lint-free tissue • Slotted screwdriver

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Required On Related information... Pipettor diagnostic procedures (c‑series), page 877 Use a procedure key to perform a procedure, page 846

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Section 9

4104 R2 Pipettor Calibration (c‑series) Perform this Pipettors diagnostic procedure to calibrate the R2 pipettor. Estimated time

10 minutes

Required materials

• Cuvette Segment Alignment Tool, LN 04S70 • Tap water • Lint-free tissue • Slotted screwdriver

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Required On Related information... Pipettor diagnostic procedures (c‑series), page 877 Use a procedure key to perform a procedure, page 846 4106 Component Move (c‑series) Perform this Pipettors diagnostic procedure to move the sample, R1, and R2 pipettors and the mixers for component replacement and troubleshooting. Estimated time

1 minute

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Required On Related information... Pipettor diagnostic procedures (c‑series), page 877 Use a procedure key to perform a procedure, page 846 4107 Sample Pipettor LAS Calibration (c‑series) Perform this Pipettors diagnostic procedure to complete the following tasks: • Confirm the current sample pipettor calibration at the laboratory automation system (LAS) aspiration position. • Calibrate the sample pipettor at the LAS aspiration position and the LAS wash cup. Estimated time

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5 minutes

879

Service, maintenance, and diagnostics Maintenance and diagnostics Required materials

Section 9

• Short calibration tool (supplied by the LAS vendor) • Tall calibration tool (supplied by the LAS vendor) • Cotton swabs • Tap water • 13 mm x 75 mm sample tube or any sample tube that meets the system specifications

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Required On Related information... Pipettor diagnostic procedures (c‑series), page 877 Use a procedure key to perform a procedure, page 846 Sample cup and tube specifications and requirements, page 473 4109 Probe Alignment Test (c‑series) Perform this Pipettors diagnostic procedure to move the sample, R1, and R2 pipettors over the aspiration, dispense, and wash positions to confirm visually the alignment. Estimated time

• 6 minutes for the sample pipettor • 4 minutes for the R1 pipettor • 2 minutes for the R2 pipettor • 15 minutes for all pipettors

Required materials

• Two sample racks • Two sample cups • Two 16 mm x 100 mm sample tubes • c‑series Reagent Cartridge, Black (Large), LN 04S1720 or LN 04S1750; or c‑series Reagent Cartridge, Clear (Large), LN 04S1740 • Phillips screwdriver • Graduated cylinder that can deliver up to 35 mL • Tap water or saline

Required instrument Warming or Idle status Procedure key setting • System control module: Required On

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• Processing module: Required On Related information... Pipettor diagnostic procedures (c‑series), page 877 Use a procedure key to perform a procedure, page 846 4110 Crash Sensor Test (c‑series) Perform this Pipettors diagnostic procedure to test the crash sensor for the sample, R1, and R2 pipettors. Estimated time

• 1 minute for one pipettor • 2 minutes for all pipettors

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Required On Related information... Pipettor diagnostic procedures (c‑series), page 877 Use a procedure key to perform a procedure, page 846 4113 Pipettor Check (c‑series) Perform this Pipettors diagnostic procedure to confirm visually the sample, R1, and R2 pipettors for precision and accuracy. Estimated time

• 14 minutes for the sample pipettor • 7 minutes for the R1 pipettor • 7 minutes for the R2 pipettor

Required materials

• Tap water or saline • c‑series Reagent Cartridge, Black (Large), LN 04S1720 or LN 04S1750; or c‑series Reagent Cartridge, Clear (Large), LN 04S1740 • 16 mm x 100 mm sample tube • Slotted screwdriver • Calibrated pipettor that can deliver 150 µL

Required instrument status

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Warming or Idle

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Procedure key setting • System control module: Required On • Processing module: Required On Related information... Pipettor diagnostic procedures (c‑series), page 877 Use a procedure key to perform a procedure, page 846

Fluidics-wash diagnostic procedures (c‑series) The operator may need to perform fluidics-wash diagnostic procedures when components from the following systems are replaced or when message codes and observed problems associated with the following systems are diagnosed: • Bulk solutions • Cuvette washer • Pumps and valves • Wash cups Related information... Processing module diagnostic procedures (c‑series), page 875 4205 Flush Water Lines (c‑series), page 882 4206 Flush Bulk Solutions (c‑series), page 883 4207 Move Cuvette Washer (c‑series), page 883 4208 Probe and Mixer Wash (c‑series), page 883 4212 Bulk Solution Sensor Test (c‑series), page 884 4213 Liquid Level Sense Test (c‑series), page 884 4205 Flush Water Lines (c‑series) Perform this Fluidics-Wash diagnostic procedure to flush the sample, reagent, and cuvette washer water lines. Estimated time

2 minutes

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Optional On Related information... Fluidics-wash diagnostic procedures (c‑series), page 882 Use a procedure key to perform a procedure, page 846

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4206 Flush Bulk Solutions (c‑series) Perform this Fluidics-Wash diagnostic procedure to flush the following bulk solutions: • Acid Wash • Alkaline Wash • ICT Reference Solution Estimated time

3 minutes

Required materials

None

Required instrument Warming or Idle status Procedure key setting Processing module: Optional On Related information... Fluidics-wash diagnostic procedures (c‑series), page 882 Use a procedure key to perform a procedure, page 846 4207 Move Cuvette Washer (c‑series) Perform this Fluidics-Wash diagnostic procedure to vertically move the cuvette washer. Estimated time

2 minutes

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Required On Related information... Fluidics-wash diagnostic procedures (c‑series), page 882 Use a procedure key to perform a procedure, page 846 4208 Probe and Mixer Wash (c‑series) Perform this Fluidics-Wash diagnostic procedure to wash mixers, sample probes, and reagent probes with water, Acid Probe Wash solution, Detergent A solution, or Detergent B solution. Estimated time

7 minutes

Required materials

Detergent B, LN 08P9780

Required instrument status

Warming or Idle

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Procedure key setting Processing module: Required On Related information... Fluidics-wash diagnostic procedures (c‑series), page 882 Use a procedure key to perform a procedure, page 846 4212 Bulk Solution Sensor Test (c‑series) Perform this Fluidics-Wash diagnostic procedure to test the functionality of the bulk solution level sensors. Estimated time

• 1 minute to obtain the current fluid level for all sensors • 4 minutes to test the functionality of each level sensor

Required materials

Absorbent towels

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Off Related information... Fluidics-wash diagnostic procedures (c‑series), page 882 Use a procedure key to perform a procedure, page 846 4213 Liquid Level Sense Test (c‑series) Perform this Fluidics-Wash diagnostic procedure to test the capability of the sample probe and reagent probes to detect liquid. Estimated time

7 minutes

Required materials

• Sample rack • Sample cup • c‑series Reagent Cartridge, Black (Large), LN 04S1720 or LN 04S1750; or c‑series Reagent Cartridge, Clear (Large), LN 04S1740 • Tap water or saline • Measuring device that can deliver 25 mL and 35 mL

Required instrument Idle status Procedure key setting • System control module: Optional On • Processing module: Optional On

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Related information... Fluidics-wash diagnostic procedures (c‑series), page 882 Use a procedure key to perform a procedure, page 846

Temperature diagnostic procedures (c‑series) The operator may need to perform temperature diagnostic procedures when temperature components are replaced or when message codes and observed problems associated with c‑series module temperatures are diagnosed. Related information... Processing module diagnostic procedures (c‑series), page 875 4301 Temperature Status (c‑series), page 885 4301 Temperature Status (c‑series) Perform this Temperature diagnostic procedure to display the temperature and status of the following module components: • Processing module interior • Reagent carousel • Water bath Estimated time

1 minute

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Off Related information... Temperature diagnostic procedures (c‑series), page 885 Use a procedure key to perform a procedure, page 846

Sample manager diagnostic procedures (c‑series) The operator may need to perform sample manager diagnostic procedures when reagent and sample manager (RSM) components are replaced or when message codes and observed problems associated with the RSM are diagnosed. These procedures are located on the Procedures screen of the c‑series processing module. Related information... Processing module diagnostic procedures (c‑series), page 875 1631 Sample Positioner Test (c‑series), page 886

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1631 Sample Positioner Test (c‑series) Perform this Sample Manager diagnostic procedure to test the functionality of the sample positioner motors. Estimated time

2 minutes

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting • System control module: Optional On • Processing module: Optional On Related information... Sample manager diagnostic procedures (c‑series), page 885 Use a procedure key to perform a procedure, page 846

Reagent manager diagnostic procedures (c‑series) The operator may need to perform reagent manager diagnostic procedures when reagent supply center components are replaced or when message codes and observed problems associated with the reagent supply center are diagnosed. Related information... Processing module diagnostic procedures (c‑series), page 875 4701 Reagent Carousel Home (c‑series), page 886 4703 Reagent Supply Center Test (c‑series), page 887 4715 Reagent Transport Calibration (c‑series), page 887 4701 Reagent Carousel Home (c‑series) Perform this Reagent Manager diagnostic procedure to rotate the reagent carousel to the home position. Estimated time

1 minute

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Optional On Related information... Reagent manager diagnostic procedures (c‑series), page 886 Use a procedure key to perform a procedure, page 846 886

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4703 Reagent Supply Center Test (c‑series) Perform this Reagent Manager diagnostic procedure to test the functionality of the following items: • Reagent positioner • Reagent transport • Reagent carousel Estimated time

6 minutes for the full-function test

Required materials

• One c‑series Reagent Cartridge, Black (Large), LN 04S1720 or LN 04S1750; or one c‑series Reagent Cartridge, Clear (Large), LN 04S1740; or one c‑series cartridge • Onboard Vial Rack, LN 04S6501

Required instrument Idle status Procedure key setting • System control module: Required On • Processing module: Required On Related information... Reagent manager diagnostic procedures (c‑series), page 886 Use a procedure key to perform a procedure, page 846 4715 Reagent Transport Calibration (c‑series) Perform this Reagent Manager diagnostic procedure to calibrate the reagent transport. Estimated time

3 minutes

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Optional On Related information... Reagent manager diagnostic procedures (c‑series), page 886 Use a procedure key to perform a procedure, page 846

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Service, maintenance, and diagnostics Maintenance and diagnostics

Section 9

Module diagnostic procedures (c‑series) The operator may need to perform module diagnostic procedures when message codes and observed problems associated with the c‑series module are diagnosed. Related information... Processing module diagnostic procedures (c‑series), page 875 4801 Module Initialization (c‑series), page 888 4803 Voltage Test (c‑series), page 888 4801 Module Initialization (c‑series) Perform this Modules diagnostic procedure to initialize the selected processing module. Estimated time

1 minute

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Optional On Related information... Module diagnostic procedures (c‑series), page 888 Use a procedure key to perform a procedure, page 846 4803 Voltage Test (c‑series) Perform this Modules diagnostic procedure to test voltages of the following power supplies: • +5 V • +11.5 V • +12 V • +15 V • -15 V • +24 V Estimated time

1 minute

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Off

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Section 9

Related information... Module diagnostic procedures (c‑series), page 888 Use a procedure key to perform a procedure, page 846

Reaction mechanism diagnostic procedures (c‑series) The operator may need to perform reaction mechanism diagnostic procedures when reaction mechanism components are replaced or when message codes and observed problems associated with reaction mechanism components are diagnosed. Related information... Processing module diagnostic procedures (c‑series), page 875 5002 Mixer Vibration Test (c‑series), page 889 5003 Clean Cuvettes - Manually (c‑series), page 889 5004 Reaction Carousel Home and Move (c‑series), page 890 5005 Exchange Water in Bath (c‑series), page 890 5006 Reaction Carousel Calibration (c‑series), page 891 5002 Mixer Vibration Test (c‑series) Perform this Reaction Mechanisms diagnostic procedure to test the vibration of mixer 1 and mixer 2 at low and high frequencies. Estimated time

2 minutes

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Required On Related information... Reaction mechanism diagnostic procedures (c‑series), page 889 Use a procedure key to perform a procedure, page 846 5003 Clean Cuvettes - Manually (c‑series) Perform this Reaction Mechanisms diagnostic procedure to clean the cuvettes manually. Estimated time

• 10 minutes for one segment • 35 minutes for all segments

Required materials

• Slotted screwdriver • Detergent A, LN 08P9670

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• Cotton swabs • Purified water • Clean, residue-free container in which to submerge the segments • Lint-free tissue • Gloves Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Required On Related information... Reaction mechanism diagnostic procedures (c‑series), page 889 Use a procedure key to perform a procedure, page 846 5004 Reaction Carousel Home and Move (c‑series) Perform this Reaction Mechanisms diagnostic procedure to rotate the reaction carousel counterclockwise by one cuvette or one cuvette segment. Estimated time

1 minute

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Optional On Related information... Reaction mechanism diagnostic procedures (c‑series), page 889 Use a procedure key to perform a procedure, page 846 5005 Exchange Water in Bath (c‑series) Perform this Reaction Mechanisms diagnostic procedure to drain and fill the water bath and to add Water Bath Additive. Estimated time

11 minutes

Required materials

c‑series Maintenance Solutions, LN 08P9870 or LN 08P9871 (USA)

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Optional On

890

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Section 9

Related information... Reaction mechanism diagnostic procedures (c‑series), page 889 Use a procedure key to perform a procedure, page 846 5006 Reaction Carousel Calibration (c‑series) Perform this Reaction Mechanisms diagnostic procedure to calibrate the reaction carousel. Estimated time

6 minutes

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Optional On Related information... Reaction mechanism diagnostic procedures (c‑series), page 889 Use a procedure key to perform a procedure, page 846

ICT diagnostic procedures (c‑series) The operator may need to perform ICT diagnostic procedures when ICT components are replaced or when message codes and observed problems associated with the ICT unit are diagnosed. Related information... Processing module diagnostic procedures (c‑series), page 875 5101 Flush ICT Reference Solution Cup (c‑series), page 891 5102 Flush ICT Module (c‑series), page 892 5101 Flush ICT Reference Solution Cup (c‑series) Perform this ICT diagnostic procedure to flush the ICT Reference Solution cup. Estimated time

2 minutes

Required materials

None

Required instrument Warming or Idle status Procedure key setting Processing module: Optional On Related information... ICT diagnostic procedures (c‑series), page 891 Use a procedure key to perform a procedure, page 846

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Section 9

5102 Flush ICT Module (c‑series) Perform this ICT diagnostic procedure to flush the ICT module with ICT Reference Solution. Estimated time

3 minutes

Required materials

None

Required instrument Warming or Idle status Procedure key setting Processing module: Required On Related information... ICT diagnostic procedures (c‑series), page 891 Use a procedure key to perform a procedure, page 846

Processing module diagnostic procedures (i‑series) Diagnostic procedures for the i‑series processing module are grouped by functional categories on the Diagnostics tab of the Procedures screen. Related information... Diagnostic procedure descriptions, page 875 Optics diagnostic procedures (i‑series), page 892 Pipettor diagnostic procedures (i‑series), page 893 Fluidics-wash diagnostic procedures (i‑series), page 901 Temperature diagnostic procedures (i‑series), page 909 RV loader diagnostic procedures (i‑series), page 910 Process path diagnostic procedures (i‑series), page 910 Sample manager diagnostic procedures (i‑series), page 913 Reagent manager diagnostic procedures (i‑series), page 914 Module diagnostic procedures (i‑series), page 915

Optics diagnostic procedures (i‑series) The operator may need to perform optics diagnostic procedures when optics components are replaced or when message codes and observed problems associated with the optics are diagnosed. Related information... Processing module diagnostic procedures (i‑series), page 892 1000 Optics Background (i‑series), page 893 1005 Shutter Test (i‑series), page 893

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1000 Optics Background (i‑series) Perform this Optics diagnostic procedure to determine optics background readings. This procedure generates the following readings: • Background with no reaction vessel (RV) • Background with an empty RV • Background with Pre-Trigger Solution in the RV For the procedure to pass, raw counts must be between 3 relative light units (RLUs) and 500 RLUs. In addition, specifications of the software background quality checks must not generate an error. Estimated time

8 minutes

Required materials

None

Required instrument Warming or Idle status Procedure key setting Processing module: Optional On Related information... Optics diagnostic procedures (i‑series), page 892 Use a procedure key to perform a procedure, page 846 1005 Shutter Test (i‑series) Perform this Optics diagnostic procedure to test the functionality of the shutter. Estimated time

1 minute

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Off Related information... Optics diagnostic procedures (i‑series), page 892 Use a procedure key to perform a procedure, page 846

Pipettor diagnostic procedures (i‑series) The operator may need to perform pipettor diagnostic procedures when pipettor components are replaced or when message codes and observed problems associated with the pipettor are diagnosed.

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Service, maintenance, and diagnostics Maintenance and diagnostics

Section 9

Related information... Processing module diagnostic procedures (i‑series), page 892 1100 Pipettor Motors Test (i‑series), page 894 1105 Pipettor Syringe and Pump Test (i‑series), page 894 1111 Sample Pipettor Check and Calibration (i‑series), page 895 1112 R1 Pipettor Check and Calibration (i‑series), page 895 1113 R2 Pipettor Check and Calibration (i‑series), page 896 1115 Sample Pipettor LAS Calibration (i‑series), page 896 1120 Sample Pipettor Syringe Precision and Accuracy (i‑series), page 897 1121 R1 Pipettor Syringe Precision and Accuracy (i‑series), page 897 1122 R2 Pipettor Syringe Precision and Accuracy (i‑series), page 898 1130 Sample Pipettor Pump Precision and Accuracy (i‑series), page 898 1131 R1 Pipettor Pump Precision and Accuracy (i‑series), page 899 1132 R2 Pipettor Pump Precision and Accuracy (i‑series), page 899 1160 Liquid Level Sense Test (i‑series), page 900 1161 Pipettor Probe Move (i‑series), page 901 1100 Pipettor Motors Test (i‑series) Perform this Pipettors diagnostic procedure to test the functionality of theta and Z motors of sample, R1, and R2 pipettors. Estimated time

• 2 minutes for each pipettor • 3 minutes for all pipettors

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Optional On Related information... Pipettor diagnostic procedures (i‑series), page 893 Use a procedure key to perform a procedure, page 846 1105 Pipettor Syringe and Pump Test (i‑series) Perform this Pipettors diagnostic procedure to test the functionality of the following components of sample, R1, and R2 pipettors: • Syringe motors • Syringe valves • 100 µL buffer pumps

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Section 9

Estimated time

1 minute

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Optional On Related information... Pipettor diagnostic procedures (i‑series), page 893 Use a procedure key to perform a procedure, page 846 1111 Sample Pipettor Check and Calibration (i‑series) Perform this Pipettors diagnostic procedure to complete the following tasks: • Set the position of the sample probes that are necessary to aspirate and dispense specimens during assay processing. • Determine the probe straightness. Estimated time

• 14 minutes for pipettor calibration • 4 minutes for probe straightness

Required materials

• Water (purified or tap) • Lint-free tissue

Required instrument Stopped, Warming, or Idle status Procedure key setting • System control module: Required On • Processing module: Required On Related information... Pipettor diagnostic procedures (i‑series), page 893 Use a procedure key to perform a procedure, page 846 1112 R1 Pipettor Check and Calibration (i‑series) Perform this Pipettors diagnostic procedure to complete the following tasks: • Set the position of the R1 probe that is necessary to aspirate and dispense reagents during assay processing. • Determine the probe straightness.

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Service, maintenance, and diagnostics Maintenance and diagnostics Estimated time

Section 9

• 14 minutes for pipettor calibration • 4 minutes for probe straightness

Required materials

• Water (purified or tap) • Lint-free tissue • Cotton swab

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Required On Related information... Pipettor diagnostic procedures (i‑series), page 893 Use a procedure key to perform a procedure, page 846 1113 R2 Pipettor Check and Calibration (i‑series) Perform this Pipettors diagnostic procedure to complete the following tasks: • Set the position of the R2 probe that is necessary to aspirate and dispense reagents during assay processing. • Determine the probe straightness. Estimated time

• 14 minutes for pipettor calibration • 4 minutes for probe straightness

Required materials

• Water (purified or tap) • Lint-free tissue • Cotton swab

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Optional On Related information... Pipettor diagnostic procedures (i‑series), page 893 Use a procedure key to perform a procedure, page 846 1115 Sample Pipettor LAS Calibration (i‑series) Perform this Pipettors diagnostic procedure to verify that the sample probe is positioned correctly at the laboratory automation system (LAS) track. The procedure allows the operator to calibrate the sample pipettor if the position is not optimal.

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Estimated time

4 minutes without adjustments to the LAS or the Alinity i

Required materials

• Tall calibration tool (supplied by the LAS vendor) • Short calibration tool (supplied by the LAS vendor)

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Required On Related information... Pipettor diagnostic procedures (i‑series), page 893 Use a procedure key to perform a procedure, page 846 1120 Sample Pipettor Syringe Precision and Accuracy (i‑series) Perform this Pipettors diagnostic procedure to confirm visually the precision and accuracy of the sample pipettor syringe aspiration and dispense. Estimated time

8 minutes* * This procedure may require an additional 5 minutes to 25 minutes if a bulk solution transfer is necessary.

Required materials

• Sample cup • Sample rack • Tap water or saline • Calibrated manual pipettor that can pipette 250 µL

Required instrument Warming or Idle status Procedure key setting Processing module: Required On Related information... Pipettor diagnostic procedures (i‑series), page 893 Use a procedure key to perform a procedure, page 846 1121 R1 Pipettor Syringe Precision and Accuracy (i‑series) Perform this Pipettors diagnostic procedure to confirm visually the precision and accuracy of the R1 pipettor syringe aspiration and dispense. Estimated time

10 minutes* * This procedure may require an additional 5 minutes to 25 minutes if a bulk solution transfer is necessary.

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Service, maintenance, and diagnostics Maintenance and diagnostics Required materials

Section 9

• Diagnostics Kit, LN 01R59 • Tap water or saline • Calibrated manual pipettor that can pipette 250 µL

Required instrument Warming or Idle status Procedure key setting Processing module: Required On Related information... Pipettor diagnostic procedures (i‑series), page 893 Use a procedure key to perform a procedure, page 846 1122 R2 Pipettor Syringe Precision and Accuracy (i‑series) Perform this Pipettors diagnostic procedure to confirm visually the precision and accuracy of the R2 pipettor syringe aspiration and dispense. Estimated time

10 minutes* * This procedure may require an additional 5 minutes to 25 minutes if a bulk solution transfer is necessary.

Required materials

• Diagnostics Kit, LN 01R59 • Tap water or saline • Calibrated manual pipettor that can pipette 250 µL

Required instrument Warming or Idle status Procedure key setting Processing module: Required On Related information... Pipettor diagnostic procedures (i‑series), page 893 Use a procedure key to perform a procedure, page 846 1130 Sample Pipettor Pump Precision and Accuracy (i‑series) Perform this Pipettors diagnostic procedure to confirm visually the precision and accuracy of the sample pipettor pump dispense. Estimated time

5 minutes* * This procedure may require an additional 5 minutes to 25 minutes if a bulk solution transfer is necessary.

Required materials

898

• Water (tap or purified)

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Section 9

• Calibrated manual pipettor that can pipette 900 µL Required instrument Warming or Idle status Procedure key setting Processing module: Required On Related information... Pipettor diagnostic procedures (i‑series), page 893 Use a procedure key to perform a procedure, page 846 1131 R1 Pipettor Pump Precision and Accuracy (i‑series) Perform this Pipettors diagnostic procedure to confirm visually the precision and accuracy of the R1 pipettor pump dispense. Estimated time

5 minutes* * This procedure may require an additional 5 minutes to 25 minutes if a bulk solution transfer is necessary.

Required materials

• Water (tap or purified) • Calibrated manual pipettor that can pipette 900 µL

Required instrument Warming or Idle status Procedure key setting Processing module: Required On Related information... Pipettor diagnostic procedures (i‑series), page 893 Use a procedure key to perform a procedure, page 846 1132 R2 Pipettor Pump Precision and Accuracy (i‑series) Perform this Pipettors diagnostic procedure to confirm visually the precision and accuracy of the R2 pipettor pump dispense. Estimated time

5 minutes* * This procedure may require an additional 5 minutes to 25 minutes if a bulk solution transfer is necessary.

Required materials

• Water (tap or purified) • Calibrated manual pipettor that can pipette 900 µL

Required instrument status

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Warming or Idle

899

Service, maintenance, and diagnostics Maintenance and diagnostics

Section 9

Procedure key setting Processing module: Required On Related information... Pipettor diagnostic procedures (i‑series), page 893 Use a procedure key to perform a procedure, page 846 1160 Liquid Level Sense Test (i‑series) Perform this Pipettors diagnostic procedure to test the capability of a probe to detect liquid in sample positioners, the process path, the pretreatment path, and the reagent carousel. For each of the following positions, tests for noise and for the liquid level sense response between air and fluid are performed: • Sample positioner inner lane • Sample positioner outer lane • Sample pretreatment RV 48 • R1 inner reagent carousel • R1 middle reagent carousel • R1 outer reagent carousel • R1 pretreatment RV 2 • R2 inner reagent carousel • R2 middle reagent carousel Estimated time

• 1 minute for each position • 7 minutes for all positions

Required materials

Materials can vary based on the option that is selected: • Diagnostics Kit, LN 01R59 • Sample rack • Sample cup • Tap water or saline

Required instrument Warming or Idle status Procedure key setting • System control module: Optional On • Processing module: Optional On Related information... Pipettor diagnostic procedures (i‑series), page 893

900

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Section 9 Use a procedure key to perform a procedure, page 846 1161 Pipettor Probe Move (i‑series)

Perform this Pipettors diagnostic procedure to move the pipettor probes to an appropriate position for component replacement. Estimated time

2 minutes* * This time does not include the time needed to replace the pipettor probe.

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Required On Related information... Pipettor diagnostic procedures (i‑series), page 893 Use a procedure key to perform a procedure, page 846

Fluidics-wash diagnostic procedures (i‑series) The operator may need to perform fluidics-wash diagnostic procedures when components from the following systems are replaced or when message codes and observed problems associated with the following systems are diagnosed: • Pre-Trigger • Trigger • Wash cup • Wash zone • Waste Related information... Processing module diagnostic procedures (i‑series), page 892 1200 Flush and Prime Fluidics (i‑series), page 902 1201 Induction Heater Test (i‑series), page 902 1202 Wash Cup Valves Test (i‑series), page 903 1205 Wash Buffer Dilution Assembly Test (i‑series), page 903 1206 Pre-Trigger and Trigger Valves and Pumps Test (i‑series), page 903 1207 Trigger Wash Cup Dispense Test (i‑series), page 904 1208 Wash Zone Valves, Pumps, and Motors Test (i‑series), page 904 1209 Empty Bulk Solution Reservoirs (i‑series), page 905 1210 Pre-Trigger Precision and Accuracy (i‑series), page 905 Alinity ci‑series Operations Manual

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Service, maintenance, and diagnostics Maintenance and diagnostics

Section 9

1211 Trigger Precision and Accuracy (i‑series), page 906 1221 Wash Zone 1 Precision and Accuracy (i‑series), page 906 1222 Wash Zone 2 Precision and Accuracy (i‑series), page 906 1231 Wash Zone 1 Residual Volume (i‑series), page 907 1232 Wash Zone 2 Residual Volume (i‑series), page 907 1261 Wash Zone 1 Wash Monitoring (i‑series), page 908 1262 Wash Zone 2 Wash Monitoring (i‑series), page 908 1270 Bulk Solutions Motors and Sensors Test (i‑series), page 909 1200 Flush and Prime Fluidics (i‑series) Perform this Fluidics-Wash diagnostic procedure to complete the following tasks: • Flush one or all pipettors, wash zones, and Pre-Trigger and Trigger systems. • Flush and prime one or all wash zones and Pre-Trigger and Trigger systems. • Prime the wash buffer dilution assembly. Estimated time

1 minute to 10 minutes based on the selected option* * This procedure may require an additional 5 minutes to 25 minutes if a bulk solution transfer is necessary.

Required materials

None

Required instrument Warming or Idle status Procedure key setting Processing module: Optional On Related information... Fluidics-wash diagnostic procedures (i‑series), page 901 Use a procedure key to perform a procedure, page 846 1201 Induction Heater Test (i‑series) Perform this Fluidics-Wash diagnostic procedure to test the functionality of the induction heater. Estimated time

1 minute to 30 minutes based on the selected option

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Required On Related information... Fluidics-wash diagnostic procedures (i‑series), page 901

902

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Section 9 Use a procedure key to perform a procedure, page 846 1202 Wash Cup Valves Test (i‑series)

Perform this Fluidics-Wash diagnostic procedure to test the functionality of sample, R1, and R2 wash cup valves. Estimated time

• 1 minute for each valve • 3 minutes for all valves

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Optional On Related information... Fluidics-wash diagnostic procedures (i‑series), page 901 Use a procedure key to perform a procedure, page 846 1205 Wash Buffer Dilution Assembly Test (i‑series) Perform this Fluidics-Wash diagnostic procedure to test the functionality of the following wash buffer dilution assembly components: • Waste valve • Water inlet valve • Wash buffer dilution pump • Conductivity sensor Estimated time

1 minute

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Off Related information... Fluidics-wash diagnostic procedures (i‑series), page 901 Use a procedure key to perform a procedure, page 846 1206 Pre-Trigger and Trigger Valves and Pumps Test (i‑series) Perform this Fluidics-Wash diagnostic procedure to test the functionality of the following PreTrigger and Trigger components:

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Service, maintenance, and diagnostics Maintenance and diagnostics

Section 9

• Dispense pumps • Dispense pump direction valves • Manifold valves Estimated time

1 minute to 2 minutes based on the selected option

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Off Related information... Fluidics-wash diagnostic procedures (i‑series), page 901 Use a procedure key to perform a procedure, page 846 1207 Trigger Wash Cup Dispense Test (i‑series) Perform this Fluidics-Wash diagnostic procedure to confirm that the Trigger Solution is adequately dispensed to the R1 and R2 wash cups. Estimated time

10 minutes

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Optional On Related information... Fluidics-wash diagnostic procedures (i‑series), page 901 Use a procedure key to perform a procedure, page 846 1208 Wash Zone Valves, Pumps, and Motors Test (i‑series) Perform this Fluidics-Wash diagnostic procedure to test the functionality of the following wash zone components: • Manifold valves • Waste valves • Dispense pump direction valves • Motors • Dispense pumps Estimated time

904

1 minute to 2 minutes based on the selected option

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Service, maintenance, and diagnostics Maintenance and diagnostics

Section 9

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Required On Related information... Fluidics-wash diagnostic procedures (i‑series), page 901 Use a procedure key to perform a procedure, page 846 1209 Empty Bulk Solution Reservoirs (i‑series) Perform this Fluidics-Wash diagnostic procedure to remove the Concentrated Wash Buffer, the diluted wash buffer, the Trigger Solution, or the Pre-Trigger Solution from the bulk solution or wash buffer reservoir. Estimated time

20 minutes to 40 minutes based on the selected options

Required materials

• Absorbent tissue • Purified water

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Optional On Related information... Fluidics-wash diagnostic procedures (i‑series), page 901 Use a procedure key to perform a procedure, page 846 1210 Pre-Trigger Precision and Accuracy (i‑series) Perform this Fluidics-Wash diagnostic procedure to confirm visually the precision and accuracy of the Pre-Trigger dispense. Estimated time

5 minutes

Required materials

• Water (tap or purified) • Calibrated manual pipettor that can pipette 300 µL

Required instrument Warming or Idle status Procedure key setting Processing module: Required On Related information... Fluidics-wash diagnostic procedures (i‑series), page 901 Use a procedure key to perform a procedure, page 846 Alinity ci‑series Operations Manual

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Service, maintenance, and diagnostics Maintenance and diagnostics

Section 9

1211 Trigger Precision and Accuracy (i‑series) Perform this Fluidics-Wash diagnostic procedure to confirm visually the precision and accuracy of the Trigger dispense. Estimated time

5 minutes

Required materials

• Water (tap or purified) • Calibrated manual pipettor that can pipette 900 µL

Required instrument Warming or Idle status Procedure key setting Processing module: Required On Related information... Fluidics-wash diagnostic procedures (i‑series), page 901 Use a procedure key to perform a procedure, page 846 1221 Wash Zone 1 Precision and Accuracy (i‑series) Perform this Fluidics-Wash diagnostic procedure to confirm visually the precision and accuracy of the wash zone 1 dispense. The system dispenses 200 µL of wash buffer into 15 reaction vessels (RVs) four times each. The operator accurately dispenses 800 µL of water (tap or purified) into a reference RV. Compare each RV that was pipetted by the system to the reference RV to determine if the correct volume was dispensed. Estimated time

8 minutes

Required materials

• Water (tap or purified) • Calibrated manual pipettor than can pipette 800 µL

Required instrument Warming or Idle status Procedure key setting Processing module: Required On Related information... Fluidics-wash diagnostic procedures (i‑series), page 901 Use a procedure key to perform a procedure, page 846 1222 Wash Zone 2 Precision and Accuracy (i‑series) Perform this Fluidics-Wash diagnostic procedure to confirm visually the precision and accuracy of the wash zone 2 dispense. The system dispenses 200 µL of wash buffer into 15 reaction vessels (RVs) four times each. The operator accurately dispenses 800 µL of water (tap or purified) into a reference RV. 906

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Service, maintenance, and diagnostics Maintenance and diagnostics

Section 9

Compare each RV that was pipetted by the system to the reference RV to determine if the correct volume was dispensed. Estimated time

8 minutes

Required materials

• Water (tap or purified) • Calibrated manual pipettor that can pipette 800 µL

Required instrument Warming or Idle status Procedure key setting Processing module: Required On Related information... Fluidics-wash diagnostic procedures (i‑series), page 901 Use a procedure key to perform a procedure, page 846 1231 Wash Zone 1 Residual Volume (i‑series) Perform this Fluidics-Wash diagnostic procedure to confirm visually the residual liquid volume that remains in a reaction vessel (RV) after a wash zone 1 dispense and aspiration. Estimated time

7 minutes

Required materials

None

Required instrument Warming or Idle status Procedure key setting Processing module: Required On Related information... Fluidics-wash diagnostic procedures (i‑series), page 901 Use a procedure key to perform a procedure, page 846 1232 Wash Zone 2 Residual Volume (i‑series) Perform this Fluidics-Wash diagnostic procedure to confirm visually the residual liquid volume that remains in a reaction vessel (RV) after a wash zone 2 dispense and aspiration. Estimated time

7 minutes

Required materials

None

Required instrument Warming or Idle status Procedure key setting Processing module: Required On

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Service, maintenance, and diagnostics Maintenance and diagnostics

Section 9

Related information... Fluidics-wash diagnostic procedures (i‑series), page 901 Use a procedure key to perform a procedure, page 846 1261 Wash Zone 1 Wash Monitoring (i‑series) Perform this Fluidics-Wash diagnostic procedure to complete the following tasks: • Calibrate the wash zone 1 wash monitoring system. • Confirm the functionality of wash zone 1 aspiration and dispense. Estimated time

14 minutes for calibration and test 9 minutes only for test

Required materials

None

Required instrument Warming or Idle status Procedure key setting Processing module: Optional On Related information... Fluidics-wash diagnostic procedures (i‑series), page 901 Use a procedure key to perform a procedure, page 846 1262 Wash Zone 2 Wash Monitoring (i‑series) Perform this Fluidics-Wash diagnostic procedure to complete the following tasks: • Calibrate the wash zone 2 wash monitoring system. • Confirm the functionality of wash zone 2 aspiration and dispense. Estimated time

14 minutes for calibration and test 10 minutes only for test

Required materials

None

Required instrument Warming or Idle status Procedure key setting Processing module: Optional On Related information... Fluidics-wash diagnostic procedures (i‑series), page 901 Use a procedure key to perform a procedure, page 846

908

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Service, maintenance, and diagnostics Maintenance and diagnostics

Section 9

1270 Bulk Solutions Motors and Sensors Test (i‑series) Perform this Fluidics-Wash diagnostic procedure to test the functionality of the bulk solution level sensors. Estimated time

• 1 minute to obtain the current fluid level for all sensors • 3 minutes to test the functionality of each level sensor

Required materials

Absorbent towel

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Off Related information... Fluidics-wash diagnostic procedures (i‑series), page 901 Use a procedure key to perform a procedure, page 846

Temperature diagnostic procedures (i‑series) The operator may need to perform temperature diagnostic procedures when temperature components are replaced or when message codes and observed problems associated with i‑series module temperatures are diagnosed. Related information... Processing module diagnostic procedures (i‑series), page 892 1300 Temperature Status (i‑series), page 909 1300 Temperature Status (i‑series) Perform this Temperature diagnostic procedure to read and display processing module temperatures and to evaluate the temperature reads at the following positions: • Process path • Pre-Trigger and Trigger manifold • Wash zones • Reagent supply center Estimated time

1 minute

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Off

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909

Service, maintenance, and diagnostics Maintenance and diagnostics

Section 9

Related information... Temperature diagnostic procedures (i‑series), page 909 Use a procedure key to perform a procedure, page 846

RV loader diagnostic procedures (i‑series) The operator may need to perform RV loader diagnostic procedures when RV loader components are replaced or when message codes and observed problems associated with the RV loader are diagnosed. Related information... Processing module diagnostic procedures (i‑series), page 892 1400 RV Loader and Sensors Test (i‑series), page 910 1400 RV Loader and Sensors Test (i‑series) Perform this RV Loader diagnostic procedure to complete the following tasks: • Home RV loader motors. • Test RV loader sensors. • Manually unload reaction vessels from the linear queue. Estimated time

8 minutes

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Required On Related information... RV loader diagnostic procedures (i‑series), page 910 Use a procedure key to perform a procedure, page 846

Process path diagnostic procedures (i‑series) The operator may need to perform process path diagnostic procedures when process path components are replaced or when message codes and observed problems associated with the process path are diagnosed. Related information... Processing module diagnostic procedures (i‑series), page 892 1505 Diverter Test (i‑series), page 911 1510 Vortexer Test (i‑series), page 911 1515 Process Path Motors Test (i‑series), page 912 1520 RV Load and Unload Test (i‑series), page 912 910

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Service, maintenance, and diagnostics Maintenance and diagnostics

Section 9 1525 Process Path Sensors Test (i‑series), page 912 1505 Diverter Test (i‑series)

Perform this Process Path diagnostic procedure to test the functionality of the following diverters: • Load diverter (LD) • STAT diverter (STD) • Wash zone diverter (WZD) • Pretreatment unload diverter (pUD) Estimated time

• 1 minute for each diverter • 4 minutes for all diverters

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Off Related information... Process path diagnostic procedures (i‑series), page 910 Use a procedure key to perform a procedure, page 846 1510 Vortexer Test (i‑series) Perform this Process Path diagnostic procedure to test the functionality of the following vortexers: • Reagent 1 pipettor vortexer (VTXR1) • Reagent 2 pipettor vortexer (VTXR2) • Pre-Trigger vortexer (VTXPT) • Pretreatment vortexer (pVTX) Estimated time

• 1 minute for each vortexer • 4 minutes for all vortexers

Required materials

None

Required instrument Warming or Idle status Procedure key setting Processing module: Off

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Service, maintenance, and diagnostics Maintenance and diagnostics

Section 9

Related information... Process path diagnostic procedures (i‑series), page 910 Use a procedure key to perform a procedure, page 846 1515 Process Path Motors Test (i‑series) Perform this Process Path diagnostic procedure to test the functionality of the process path and pretreatment path motors. Estimated time

1 minute

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Optional On Related information... Process path diagnostic procedures (i‑series), page 910 Use a procedure key to perform a procedure, page 846 1520 RV Load and Unload Test (i‑series) Perform this Process Path diagnostic procedure to load and unload reaction vessels (RVs) from the process path and pretreatment path. Estimated time

3 minutes to 7 minutes based on the selected option

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Optional On Related information... Process path diagnostic procedures (i‑series), page 910 Use a procedure key to perform a procedure, page 846 1525 Process Path Sensors Test (i‑series) Perform this Process Path diagnostic procedure to test the functionality of the following process path sensors: • RV unloader sensor • RV present sensor • Process path home sensor

912

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Service, maintenance, and diagnostics Maintenance and diagnostics

Section 9 • Pretreatment path home sensor Estimated time

1 minute to 2 minutes based on the selected option

Required materials

None

Required instrument status

Stopped, Warming, or Idle

Procedure key setting Processing module: Required On Related information... Process path diagnostic procedures (i‑series), page 910 Use a procedure key to perform a procedure, page 846

Sample manager diagnostic procedures (i‑series) The operator may need to perform sample manager diagnostic procedures when reagent and sample manager (RSM) components are replaced or when message codes and observed problems associated with the RSM are diagnosed. These procedures are located on the Procedures screen of the i‑series processing module. Related information... Processing module diagnostic procedures (i‑series), page 892 1630 Sample Positioner Test (i‑series), page 913 1630 Sample Positioner Test (i‑series) Perform this Sample Manager diagnostic procedure to test the functionality of sample positioner motors. Estimated time

2 minutes

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting • System control module: Optional On • Processing module: Optional On Related information... Sample manager diagnostic procedures (i‑series), page 913 Use a procedure key to perform a procedure, page 846

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913

Service, maintenance, and diagnostics Maintenance and diagnostics

Section 9

Reagent manager diagnostic procedures (i‑series) The operator may need to perform reagent manager diagnostic procedures when reagent supply center components are replaced or when message codes and observed problems associated with the reagent supply center are diagnosed. Related information... Processing module diagnostic procedures (i‑series), page 892 1703 Reagent Supply Center Test (i‑series), page 914 1715 Reagent Carousel and Reagent Transport Calibration (i‑series), page 914 1703 Reagent Supply Center Test (i‑series) Perform this Reagent Manager diagnostic procedure to test the functionality of the following items: • Reagent positioner • Reagent transport • Reagent carousel • Dispersion motor Estimated time

6 minutes for the full-function test

Required materials

• Diagnostics Kit, LN 01R59 (one cartridge); or one i‑series cartridge • Onboard Vial Rack, LN 04S6501

Required instrument Warming or Idle status Procedure key setting • System control module: Required On • Processing module: Required On Related information... Reagent manager diagnostic procedures (i‑series), page 914 Use a procedure key to perform a procedure, page 846 1715 Reagent Carousel and Reagent Transport Calibration (i‑series) Perform this Reagent Manager diagnostic procedure to calibrate the reagent transport to the reagent carousel to accurately load reagent cartridges and vial racks in the reagent carousel.

914

Estimated time

4 minutes

Required materials

None

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Service, maintenance, and diagnostics Maintenance and diagnostics

Section 9

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Optional On Related information... Reagent manager diagnostic procedures (i‑series), page 914 Use a procedure key to perform a procedure, page 846

Module diagnostic procedures (i‑series) The operator may need to perform module diagnostic procedures when message codes and observed problems associated with the i‑series module are diagnosed. Related information... Processing module diagnostic procedures (i‑series), page 892 1805 RV Waste Sensor Test (i‑series), page 915 1830 Buffer Run (i‑series), page 915 1890 Processing Module Initialization (i‑series), page 916 1805 RV Waste Sensor Test (i‑series) Perform this Modules diagnostic procedure to test the functionality of the RV waste sensor. Estimated time

1 minute

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Off Related information... Module diagnostic procedures (i‑series), page 915 Use a procedure key to perform a procedure, page 846 1830 Buffer Run (i‑series) Perform this Modules diagnostic procedure to run one-step and two-step assay protocols by using tap water or saline instead of reagents. When troubleshooting is performed for system failures, assay processing can be simulated without the use of reagents. Estimated time

Variable time based on the number of tests that are ordered. The minimum completion time is 30 minutes.

Required materials

• Diagnostics Kit, LN 01R59 (two cartridges)

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Service, maintenance, and diagnostics Maintenance and diagnostics

Section 9

• Tap water or saline • Sample racks • Sample cups or tubes Required instrument Warming or Idle status Procedure key setting • System control module: Off • Processing module: Off NOTE: To perform this procedure, the procedure key for the system control module and the processing module must be positioned at the Off setting. This procedure simulates assay processing and the procedure key cannot be positioned at the On setting during assay processing. Related information... Module diagnostic procedures (i‑series), page 915 Use a procedure key to perform a procedure, page 846 1890 Processing Module Initialization (i‑series) Perform this Modules diagnostic procedure to observe the i‑series processing module during an initialization. Estimated time

3 minutes

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Required On Related information... Module diagnostic procedures (i‑series), page 915 Use a procedure key to perform a procedure, page 846

Reagent and sample manager (RSM) diagnostic procedures Reagent and sample manager (RSM) diagnostic procedures are grouped in the Sample Manager category on the Diagnostics tab of the Procedures screen. The operator may need to perform sample manager diagnostic procedures when RSM components are replaced or when message codes and observed problems associated with the RSM are diagnosed. Related information... Diagnostic procedure descriptions, page 875 916

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Service, maintenance, and diagnostics Maintenance and diagnostics

Section 9

1600 RSM Transport Calibration, page 917 1610 Reagent and Sample Manager Test, page 917 1620 RSM Bar Code Reader Test, page 918 1635 RSM Transport Test, page 918 1690 Reagent and Sample Manager Initialization, page 919

1600 RSM Transport Calibration Perform this Sample Manager diagnostic procedure to calibrate the RSM transport to the following assemblies: • Sample positioner • Reagent positioner • Loading area Estimated time

Variable time based on the number of modules that are calibrated: • 12 minutes for one module • 9 minutes for each additional module

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting • System control module: Required On • Processing module: Required On Related information... Reagent and sample manager (RSM) diagnostic procedures, page 916 Use a procedure key to perform a procedure, page 846

1610 Reagent and Sample Manager Test Perform this Sample Manager diagnostic procedure to test the functionality of the following components: • RSM transport • Sample positioner (inner and outer lanes) • Reagent positioner • Loading area lights and sensors Estimated time

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• 3 minutes for the RSM transport full-function test

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Service, maintenance, and diagnostics Maintenance and diagnostics

Section 9

• 1 minute for individual tests Required materials

• Racks • Reagent cartridge

Required instrument Stopped, Warming, or Idle status Procedure key setting • System control module: Optional On • Processing module: Optional On Related information... Reagent and sample manager (RSM) diagnostic procedures, page 916 Use a procedure key to perform a procedure, page 846

1620 RSM Bar Code Reader Test Perform this Sample Manager diagnostic procedure to test the functionality of the RSM bar code reader. Estimated time

Variable time based on the number of bar codes that are scanned

Required materials

• Racks • Bar-coded tubes • Reagent cartridge

Required instrument Stopped, Warming, or Idle status Procedure key setting System control module: Optional On Related information... Reagent and sample manager (RSM) diagnostic procedures, page 916 Use a procedure key to perform a procedure, page 846

1635 RSM Transport Test Perform this Sample Manager diagnostic procedure to test the functionality of the following RSM transport components: • Motors • Rack pick sensor • Rack detect sensor

918

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Service, maintenance, and diagnostics Maintenance and diagnostics

Section 9 • Bar code reader Estimated time

2 minutes

Required materials

Sample rack or vial rack

Required instrument Stopped, Warming, or Idle status Procedure key setting System control module: Required On Related information... Reagent and sample manager (RSM) diagnostic procedures, page 916 Use a procedure key to perform a procedure, page 846

1690 Reagent and Sample Manager Initialization Perform this Sample Manager diagnostic procedure to observe the reagent and sample manager during an initialization. Estimated time

1 minute

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting System control module: Required On Related information... Reagent and sample manager (RSM) diagnostic procedures, page 916 Use a procedure key to perform a procedure, page 846

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919

Service, maintenance, and diagnostics Component replacement

Section 9

Component replacement Some system components may need to be replaced because of normal wear from daily system operation. The laboratory has a responsibility to maintain an adequate supply of replacement parts. List numbers are provided in the procedures only for guidance and are subject to change. When replacing components, comply with the following general safety precautions: • Dispose of replaced components and materials that are used during component replacement (for example, absorbent towels or lint-free tissues) according to the laboratory waste disposal procedures of the facility. • When drips or leaks occur, clean up the liquid and decontaminate the surface if necessary. Related information... Service, maintenance, and diagnostics, page 837 Processing center component replacement (c‑series), page 920 Supply and pump center component replacement (c‑series), page 957 Processing center component replacement (i‑series), page 989 Supply center component replacement (i‑series), page 1008 Optional component replacement, page 1017 Biological hazards, page 821 Spill cleanup, page 828

Processing center component replacement (c‑series) Certain processing center components may need to be replaced because of normal wear from daily system operation. The following illustration shows the location of each replaceable component. Step-by-step instructions are provided for each replaceable component.

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Service, maintenance, and diagnostics Component replacement

Section 9 Figure 162: Processing center components (c‑series)

Legend: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10.

Sample probe (S) Mixer 2 ICT module Lamp Mixer 1 Cuvette dry tip Cuvette segment Reagent probe (R1) ICT probe Reagent probe (R2)

Related information... Component replacement, page 920 Replace the sample probe (c‑series), page 922

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921

Service, maintenance, and diagnostics Component replacement

Section 9

Replace the reagent probes (c‑series), page 925 Replace the sample probe tubing (c‑series), page 930 Replace the reagent probe tubing (c‑series), page 933 Replace the lamp or the lamp plate (c‑series), page 937 Replace the cuvette segments (c‑series), page 941 Replace the cuvette dry tip (c‑series), page 945 Replace the mixers (c‑series), page 948 Replace the ICT module or the ICT probe (c‑series), page 952

Replace the sample probe (c‑series) NOTE: Recording and tracking the date of the sample probe installation is recommended to ensure that the sample probe is not used for longer than the following intervals: • Six months for systems that use whole blood assays • One year for systems that do not use whole blood assays To replace the sample probe, perform the following procedures: • Removal, page 923 – Remove the sample probe, page 923 • Replacement, page 924 – Install the sample probe, page 924 • Verification, page 925 – Calibrate the sample pipettor, page 925 Estimated time

20 minutes

Required materials

• Slotted screwdriver • Absorbent towel

Required instrument Idle status Procedure key setting Processing module: Required On Replacement parts • Sample probe, LN 04S5101 • Sample probe screw, LN 04S5301 (optional) CAUTION: Biological RISKS. This activity or area may expose you to potentially infectious material. CAUTION: Probe Stick Hazard. This activity or area may expose you to probes.

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Service, maintenance, and diagnostics Component replacement

Section 9

CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.

Removal Remove the sample probe

1.

Insert the procedure key into the processing module procedure lock and turn the key to the On setting.

2.

Lift the rear processing center cover to access the sample probe.

3.

To move the sample pipettor to the rear of the processing module, initiate Pipettors diagnostic procedure 4106 Component Move (c‑series), page 879.

4.

To remove the sample pipettor cover, gently squeeze the squeeze points to release the locking tabs and lift the cover.

5.

Place an absorbent towel under the probe tip.

6.

Use a slotted screwdriver to slightly loosen the probe screw.

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923

Service, maintenance, and diagnostics Component replacement

Section 9

7.

Loosen, but do not remove, the probe screw by hand until the probe releases from the sample pipettor.

8.

Loosen, but do not remove, the screw that secures the sample probe grounding wire.

9.

Detach the grounding wire.

10. Gently disconnect the tubing from the top of the probe.

Replacement Install the sample probe

1.

Attach the tubing to the top of the new sample probe. NOTE: Do not flare or stretch the tubing. The tubing needs to fit firmly on the sample probe but must not be pushed past the bend of the probe so that the tubing does not become too loose. If the tubing is loose or if the probe has been replaced several times by using the same tubing, replacing the sample probe tubing is recommended.

2.

924

Position the new sample probe on the alignment pins. Verify that the probe plate is flush with the plate on the sample pipettor. Alinity ci‑series Operations Manual

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Service, maintenance, and diagnostics Component replacement

Section 9 3.

Remove the probe screw from the old sample probe and insert the screw into the new sample probe. Tighten the screw by hand to secure the probe.

4.

Stabilize the pipettor and tighten the screw with the slotted screwdriver.

5.

Attach the new sample probe grounding wire and tighten the screw. NOTE: Ensure that the connector for the new sample probe grounding wire is positioned under the ring-shaped connector.

6.

Remove the absorbent towel under the probe tip.

7.

To return the sample pipettor to the home position, complete Pipettors diagnostic procedure 4106 Component Move (c‑series), page 879.

8.

Perform Fluidics-Wash diagnostic procedure 4205 Flush Water Lines (c‑series), page 882. While performing the flush, inspect the sample probe for drips and inspect the sample probe tubing and connections for leaks. If drips or leaks are observed, repeat the installation procedure.

9.

Gently replace the pipettor cover. Ensure that the tubing is not pinched or kinked below the pipettor cover.

10. Press down on the end of the cover over the pipettor shaft until the cover snaps into position. The pipettor cover must be seated completely to ensure correct liquid level sense operation.

Verification Calibrate the sample pipettor 1.

Perform Pipettors diagnostic procedure 4102 Sample Pipettor Calibration (c‑series), page 878.

2.

If the system is attached to a laboratory automation system, perform Pipettors diagnostic procedure 4107 Sample Pipettor LAS Calibration (c‑series), page 879.

3.

Close the rear processing center cover.

4.

Turn the procedure key to the Off setting and remove the key from the processing module procedure lock.

5.

Perform quality control testing to verify the system performance before reporting sample results.

Related information... Processing center component replacement (c‑series), page 920 Use a procedure key to perform a procedure, page 846

Replace the reagent probes (c‑series) To replace one or more reagent probes, perform the following procedures:

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925

Service, maintenance, and diagnostics Component replacement

Section 9

• Removal, page 927 – Remove the reagent probe, page 927 • Replacement, page 928 – Install the reagent probe, page 928 • Verification, page 929 – Calibrate the reagent pipettor, page 929 Estimated time

20 minutes

Required materials

• Slotted screwdriver • Absorbent towel

Required instrument status

• Processing module: Idle • Reagent and sample manager: Idle (only if replacing the R1 probe)

Procedure key setting Processing module: Required On Replacement parts • Reagent probe, LN 04S4901 • Reagent probe screw, LN 04S5401 (optional) CAUTION: Biological RISKS. This activity or area may expose you to potentially infectious material. CAUTION: Probe Stick Hazard. This activity or area may expose you to probes. CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.

926

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Service, maintenance, and diagnostics Component replacement

Section 9

Removal Remove the reagent probe

1.

Insert the procedure key into the processing module procedure lock and turn the key to the On setting.

2.

Lift the appropriate processing center cover: – To replace the R1 probe, lift the front processing center cover. – To replace the R2 probe, lift the rear processing center cover.

3.

To move the reagent pipettor to the reagent aspiration position, initiate Pipettors diagnostic procedure 4106 Component Move (c‑series), page 879.

4.

To remove the reagent pipettor cover, squeeze the squeeze points to release the locking tabs and lift the cover.

5.

Place an absorbent towel under the probe tip.

6.

Use a slotted screwdriver to slightly loosen the probe screw.

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927

Service, maintenance, and diagnostics Component replacement

Section 9

7.

Loosen, but do not remove, the probe screw by hand until the probe releases from the reagent pipettor.

8.

Loosen, but do not remove, the screw that secures the reagent probe grounding wire.

9.

Detach the grounding wire.

10. Gently disconnect the tubing from the top of the probe.

Replacement Install the reagent probe

1.

Attach the tubing to the top of the new reagent probe. NOTE: Do not flare or stretch the tubing. The tubing needs to fit firmly on the reagent probe but must not be pushed past the bend of the probe so that the tubing does not become too loose. If the tubing is loose or if the probe has been replaced several times by using the same tubing, replacing the reagent probe tubing is recommended.

2.

928

Position the new reagent probe on the alignment pins. Verify that the probe plate is flush with the plate on the reagent pipettor. Alinity ci‑series Operations Manual

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Service, maintenance, and diagnostics Component replacement

Section 9 3.

Remove the probe screw from the old reagent probe and insert the screw into the new reagent probe. Tighten the screw by hand to secure the probe.

4.

Stabilize the pipettor and tighten the screw with the slotted screwdriver.

5.

Attach the new reagent probe grounding wire and tighten the screw. NOTE: Ensure that the connector for the new reagent probe grounding wire is positioned under the ring-shaped connector.

6.

Remove the absorbent towel under the probe tip.

7.

To return the reagent pipettor to the home position, complete Pipettors diagnostic procedure 4106 Component Move (c‑series), page 879.

8.

Perform Fluidics-Wash diagnostic procedure 4205 Flush Water Lines (c‑series), page 882. While performing the flush, inspect the reagent probe for drips and inspect the reagent probe tubing and connections for leaks. If drips or leaks are observed, repeat the installation procedure.

9.

Gently replace the pipettor cover: – Insert the rear of the pipettor cover into the pipettor and press backward to fully seat the tabs. – Align the tabs at the front end of the pipettor cover and press down until the tabs snap into position. – Ensure that the tubing is not pinched or kinked below the pipettor cover.

10. Stabilize the pipettor so that it does not drop and damage the probe. Press down on the middle of the pipettor cover to confirm that it is seated completely. The pipettor cover must be seated completely to ensure correct liquid level sense operation.

Verification Calibrate the reagent pipettor 1.

Perform the appropriate Pipettors diagnostic procedure: – 4103 R1 Pipettor Calibration (c‑series), page 878 – 4104 R2 Pipettor Calibration (c‑series), page 879

2.

Close the appropriate processing center cover: – For the R1 probe, close the front processing center cover. – For the R2 probe, close the rear processing center cover.

3.

Turn the procedure key to the Off setting and remove the key from the processing module procedure lock.

4.

Perform quality control testing to verify the system performance before reporting sample results.

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Service, maintenance, and diagnostics Component replacement

Section 9

Related information... Processing center component replacement (c‑series), page 920 Use a procedure key to perform a procedure, page 846

Replace the sample probe tubing (c‑series) To replace the sample probe tubing, perform the following procedures: • Removal, page 931 – Remove the sample probe tubing, page 931 • Replacement, page 932 – Install the sample probe tubing, page 932 • Verification, page 933 – Run quality control samples, page 933 Estimated time

15 minutes

Required materials

Absorbent towel

Required instrument Idle status Procedure key setting Processing module: Required On Replacement parts

Sample probe tubing

CAUTION: Biological RISKS. This activity or area may expose you to potentially infectious material. CAUTION: Probe Stick Hazard. This activity or area may expose you to probes. CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.

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Section 9

Removal Remove the sample probe tubing

1.

Insert the procedure key into the processing module procedure lock and turn the key to the On setting.

2.

Lift the rear processing center cover to access the sample probe.

3.

To remove the sample pipettor cover, gently squeeze the squeeze points to release the locking tabs and lift the cover.

4.

Unscrew the tubing from the probe tubing connector. Ensure that the black O-ring inside the tubing connector remains in position.

5.

Gently disconnect the tubing from the top of the probe. Use the absorbent towel to absorb any water from the end of the probe tubing.

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Service, maintenance, and diagnostics Component replacement

Section 9

Replacement Install the sample probe tubing

1.

Attach the end of the new tubing to the top of the sample probe. NOTE: Do not flare or stretch the tubing. The tubing needs to fit firmly on the sample probe but must not be pushed past the bend of the probe so that the tubing does not become too loose.

2.

Verify that the black O-ring is inside the probe tubing connector.

3.

Screw the opposite end of the tubing into the tubing connector.

4.

Perform Fluidics-Wash diagnostic procedure 4205 Flush Water Lines (c‑series), page 882. While performing the flush, inspect the sample probe for drips and inspect the sample probe tubing and connections for leaks. If drips or leaks are observed, repeat the installation procedure.

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Section 9 5.

Gently replace the pipettor cover. Ensure that the tubing is not pinched or kinked below the pipettor cover.

6.

Press down on the end of the cover over the pipettor shaft until the cover snaps into position. The pipettor cover must be seated completely to ensure correct liquid level sense operation.

7.

Close the rear processing center cover.

8.

Turn the procedure key to the Off setting and remove the key from the processing module procedure lock.

Verification Run quality control samples Perform quality control testing to verify the system performance before reporting sample results. Related information... Processing center component replacement (c‑series), page 920 Use a procedure key to perform a procedure, page 846

Replace the reagent probe tubing (c‑series) To replace the reagent probe tubing, perform the following procedures: • Removal, page 934 – Remove the reagent probe tubing, page 934 • Replacement, page 935 – Install the reagent probe tubing, page 935 • Verification, page 936 – Run quality control samples, page 936 Estimated time

15 minutes

Required materials

Absorbent towel

Required instrument status

• Processing module: Idle • Reagent and sample manager: Idle (only if replacing the R1 probe tubing)

Procedure key setting Processing module: Required On Replacement parts

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Reagent probe tubing, LN 04S5001

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Service, maintenance, and diagnostics Component replacement

Section 9

CAUTION: Biological RISKS. This activity or area may expose you to potentially infectious material. CAUTION: Probe Stick Hazard. This activity or area may expose you to probes. CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.

Removal Remove the reagent probe tubing

1.

Insert the procedure key into the processing module procedure lock and turn the key to the On setting.

2.

Lift the appropriate processing center cover: – To replace the R1 probe tubing, lift the front processing center cover.

934

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Service, maintenance, and diagnostics Component replacement

Section 9

– To replace the R2 probe tubing, lift the rear processing center cover. 3.

To move the reagent pipettor to the reagent aspiration position, initiate Pipettors diagnostic procedure 4106 Component Move (c‑series), page 879.

4.

Place an absorbent towel under the probe tip.

5.

To remove the reagent pipettor cover, squeeze the squeeze points to release the locking tabs and lift the cover.

6.

Observe the position of the tubing in the routing guides.

7.

Gently disconnect the tubing from the top of the probe.

8.

Gently disconnect the metal connector from the reagent pipettor tubing. Ensure that the protective sleeve remains on the reagent pipettor tubing.

Replacement Install the reagent probe tubing

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Service, maintenance, and diagnostics Component replacement

Section 9

1.

Attach the end of the new tubing with the metal connector to the reagent pipettor tubing. Verify that the metal connector is inserted into the reagent pipettor tubing and the protective sleeve.

2.

Position the tubing in the routing guides.

3.

Attach the other end of new tubing to the reagent probe. NOTE: Do not flare or stretch the tubing. The tubing needs to fit firmly on the reagent probe but must not be pushed past the bend of the probe so that the tubing does not become too loose.

4.

Remove the absorbent towel under the probe tip.

5.

To return the reagent pipettor to the home position, complete Pipettors diagnostic procedure 4106 Component Move (c‑series), page 879.

6.

Perform Fluidics-Wash diagnostic procedure 4205 Flush Water Lines (c‑series), page 882. While performing the flush, inspect the reagent probe for drips and inspect the reagent probe tubing and connections for leaks. If drips or leaks are observed, repeat the installation procedure.

7.

Gently replace the pipettor cover: – Insert the rear of the pipettor cover into the pipettor and press backward to fully seat the tabs. – Align the tabs at the front end of the pipettor cover and press down until the tabs snap into position. – Ensure that the tubing is not pinched or kinked below the pipettor cover.

8.

Stabilize the pipettor so that it does not drop and damage the probe. Press down on the middle of the pipettor cover to confirm that it is seated completely. The pipettor cover must be seated completely to ensure correct liquid level sense operation.

9.

Close the appropriate processing center cover: – For the R1 probe tubing, close the front processing center cover. – For the R2 probe tubing, close the rear processing center cover.

10. Turn the procedure key to the Off setting and remove the key from the processing module procedure lock.

Verification Run quality control samples Perform quality control testing to verify the system performance before reporting sample results. Related information... Processing center component replacement (c‑series), page 920 Use a procedure key to perform a procedure, page 846

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Section 9

Replace the lamp or the lamp plate (c‑series) To replace the lamp or the lamp plate, perform the following procedures: • Removal, page 938 – Remove the lamp or lamp plate, page 938 • Replacement, page 940 – Install the lamp and the lamp plate, page 940 • Verification, page 941 – Run quality control samples, page 941 Estimated time

15 minutes* * This time does not include the 30-minute lamp warm-up period that is required after replacement.

Required materials

• Phillips screwdriver • Slotted screwdriver • 3 mm hex wrench • Gloves • Lint-free tissue (optional) • Ethanol (optional)

Required instrument Stopped or Idle status Procedure key setting Processing module: Off Replacement parts

Source lamp, LN 09D4503

To document the lamp change in the maintenance log, perform Quarterly maintenance procedure 5806 Change Lamp (c‑series), page 862. CAUTION: Possibility of electric shock. This activity or area may expose you to electrical shock. CAUTION: Hot Surface. This activity or area may expose you to hot surfaces.

CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.

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Service, maintenance, and diagnostics Component replacement

Section 9

Removal Remove the lamp or lamp plate

1.

Power off the processing module by using the main power breaker that is located at the rear of the module. NOTE: Do not remove the lamp or the lamp plate when the processing module is powered on.

2.

After turning off the power, wait a minimum of 5 minutes so that the lamp and the lamp housing can cool.

3.

Lift the rear processing center cover.

4.

Remove the two screw covers from the rear access panel.

5.

Perform one of the following steps to loosen the screws to remove the rear access panel: – Use the 3 mm hex wrench to loosen the captive hex screws. – Use the slotted screwdriver to loosen the captive screws.

938

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Service, maintenance, and diagnostics Component replacement

Section 9 6.

Remove the rear access panel.

7.

Use the slotted screwdriver to loosen the slotted screw on the lamp cover to remove the cover.

8.

Remove the lamp cables from the plastic clamp.

9.

Locate the lamp terminal block and lift up both ends of the transparent cover to remove the cover.

10. Use the Phillips screwdriver to completely loosen the two captive screws that secure the lamp cables to the lamp terminal block. 11. Raise the screws and lower the lamp cables completely to disengage the cables from the bottom of the screws. 12. Locate the lamp housing and ensure that it is cool before proceeding to the next step. 13. Completely loosen the tall thumbscrew on the lamp plate. If necessary, use the slotted screwdriver. 14. Lift the lamp plate out of the lamp housing. 15. Use the slotted screwdriver to loosen the thumbscrew so that the lamp can be removed from the lamp plate. 16. Remove the lamp and cable from the lamp plate.

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Service, maintenance, and diagnostics Component replacement

Section 9

Replacement Install the lamp and the lamp plate

IMPORTANT: Wear gloves to perform the following steps. Residual oil from an ungloved hand on the glass surface of the lamp shortens the lamp life. If the glass surface needs to be cleaned, use lint-free tissue and ethanol.

940

1.

To install the lamp on the lamp plate, align the pins on the lamp plate with the holes on the new lamp. Ensure that the lamp filament is perpendicular to the lamp plate.

2.

With the lamp seated completely on the pins, use the slotted screwdriver to tighten the screw on the lamp plate.

3.

To insert the lamp assembly into the lamp housing, press the assembly against the leaf spring, and then lower the assembly into the housing. Ensure that the lamp assembly is seated completely in the lamp housing.

4.

Verify that the lamp cables exit the lamp housing through the slot behind the lamp and that the cables are not pinched by the lamp plate.

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Section 9 5.

Press down on the lamp plate and tighten the thumbscrew to secure the plate to the lamp housing.

6.

On the terminal block, lift the Phillips screws and insert the cables under the screws.

7.

Use the Phillips screwdriver to tighten the two captive screws and to secure the two lamp cables to the terminal block.

8.

Replace the transparent cover on the terminal block.

9.

Replace the lamp cables in the plastic clamp.

10. Replace the lamp cover and tighten the slotted screw. 11. Install the rear access panel. 12. Perform one of the following steps to secure the rear access panel: – Use the 3 mm hex wrench to tighten the captive hex screws. – Use the slotted screwdriver to tighten the captive screws. 13. Replace the two screw covers. 14. Close the rear processing center cover. 15. Power on the processing module. NOTE: To ensure the appropriate initialization of the processing module, the system control module power must be turned on before the processing module power is turned on. 16. Let the lamp warm up for 30 minutes before performing assay processing.

Verification Run quality control samples Perform quality control testing to verify the system performance before reporting sample results. Related information... Processing center component replacement (c‑series), page 920 Use a procedure key to perform a procedure, page 846

Replace the cuvette segments (c‑series) To replace one or more cuvette segments, perform the following procedures: • Removal, page 943 – Remove the cuvette segment, page 943 • Replacement, page 944 – Clean and install the cuvette segment, page 944 • Verification, page 945 – Verify that the cuvette segment is installed correctly, page 945

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Service, maintenance, and diagnostics Component replacement

Estimated time

15 minutes

Required materials

• Detergent A, LN 08P9670

Section 9

• Lint-free, absorbent towel • Cotton swabs • Slotted screwdriver • Purified water • Clean, residue-free container in which to submerge the cuvette segments • Gloves Required instrument Idle status Procedure key setting Processing module: Required On Replacement parts

Cuvette segment, LN 04S4701

CAUTION: Biological RISKS. This activity or area may expose you to potentially infectious material. CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.

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Service, maintenance, and diagnostics Component replacement

Section 9

Removal Remove the cuvette segment

1.

Insert the procedure key into the processing module procedure lock and turn the key to the On setting.

2.

Lift the rear processing center cover to access the reaction carousel.

3.

Identify the location of the first cuvette segment to replace in the reaction carousel.

4.

To rotate the reaction carousel so that the appropriate cuvette segment is located at the rear of the processing module, perform Reaction Mechanisms diagnostic procedure 5004 Reaction Carousel Home and Move (c‑series), page 890.

5.

Use the slotted screwdriver to loosen the slotted screw on the top of the cuvette segment to remove the segment from the reaction carousel.

6.

Dispose of the used cuvette segment.

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Service, maintenance, and diagnostics Component replacement 7.

Section 9

Repeat steps 4, page 943 through 6, page 943 until all the cuvette segments to replace are removed.

Replacement Clean and install the cuvette segment

IMPORTANT: Wear gloves to perform the following steps. Residual oil from an ungloved hand can cause imprecise optical readings.

944

1.

Remove the new cuvette segment from the shipping container and place the segment on a lint-free, absorbent towel.

2.

Wet a cotton swab with Detergent A and clean the inside and outside of all the cuvettes in the cuvette segment.

3.

Fill a clean, residue-free container with enough purified water to completely submerge the cuvette segment.

4.

Rinse the cuvette segment in the purified water to remove the Detergent A. Drain any excess purified water from the cuvettes.

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Section 9 5.

Dry the top of the cuvette segment, especially the slotted edges, to remove any remaining purified water.

6.

Position the cuvette segment on the reaction carousel alignment pins. NOTE: To ensure optimal performance throughout the life span of the c‑series processing module, the cuvettes need to be replaced after 12 years of use.

7.

Tighten the slotted screw by hand on the cuvette segment.

8.

Gently tighten the slotted screw with a slotted screwdriver.

9.

Repeat steps 1, page 944 through 8, page 945 until all the cuvette segments to replace are cleaned and are installed.

10. Close the rear processing center cover. 11. Turn the procedure key to the Off setting and remove the key from the processing module procedure lock.

Verification Verify that the cuvette segment is installed correctly Perform Reaction Mechanisms diagnostic procedure 5004 Reaction Carousel Home and Move (c‑series), page 890. Related information... Processing center component replacement (c‑series), page 920 Use a procedure key to perform a procedure, page 846

Replace the cuvette dry tip (c‑series) To replace the cuvette dry tip, perform the following procedures: • Removal, page 946 – Remove the cuvette dry tip, page 946 • Replacement, page 947 – Install the cuvette dry tip, page 947 • Verification, page 948 – Wash the cuvettes, page 948 Estimated time

15 minutes

Required materials

• Metric ruler • Gloves

Required instrument status

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• Processing module: Idle

945

Service, maintenance, and diagnostics Component replacement

Section 9

• Reagent and sample manager: Idle Procedure key setting Processing module: Required On Replacement parts

Cuvette dry tip, LN 04S5201

IMPORTANT: Wear gloves to perform the following steps. Residual oil from an ungloved hand interferes with the appropriate drying function of the cuvette dry tip. CAUTION: Biological RISKS. This activity or area may expose you to potentially infectious material. CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.

Removal Remove the cuvette dry tip

946

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Section 9 1.

Insert the procedure key into the processing module procedure lock and turn the key to the On setting.

2.

Lift the front processing center cover.

3.

Loosen the black knurled knob at the left side of the cuvette washer until the cuvette washer assembly can be lifted from the mounting bracket.

4.

Lift the cuvette washer assembly and rotate it so that the white cuvette dry tip can be accessed easily. NOTE: The cuvette washer nozzles are attached to the nozzle mounting plate. The screws that secure the cuvette washer nozzles to the mounting plate do not need to be removed.

5.

To remove the cuvette dry tip, pull the tip off the metal nozzle.

6.

Dispose of the used cuvette dry tip.

Replacement Install the cuvette dry tip

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Service, maintenance, and diagnostics Component replacement 1.

Section 9

Gently install the new cuvette dry tip. Carefully and appropriately orient the cuvette dry tip. NOTE: The cuvette dry tip and the cuvette are both rectangular in shape. Install the cuvette dry tip so that it fits into the cuvette.

2.

Position the bottom of the cuvette dry tip 61 mm ± 0.5 mm from the underside of the cuvette washer assembly.

3.

Position the cuvette washer assembly on the alignment pins, and then tighten the black knurled knob.

4.

To return the cuvette washer assembly and the reaction carousel to the home position, perform Fluidics-Wash diagnostic procedure 4207 Move Cuvette Washer (c‑series), page 883.

5.

Verify the rectangular orientation and alignment of the cuvette dry tip with the cuvette. NOTE: If the cuvette dry tip needs to be adjusted, wear gloves. Residual oil from an ungloved hand interferes with the appropriate drying function of the cuvette dry tip.

6.

On the Perform Procedure screen, tap Down to move the cuvette washer assembly downward.

7.

Verify that the cuvette dry tip is correctly aligned and that it moves smoothly into the cuvettes.

8.

To move the cuvette washer assembly upward, tap Up.

9.

To end the procedure, tap End Procedure.

10. To complete the procedure, tap Done on the Perform Procedure screen. 11. Close the front processing center cover. 12. Turn the procedure key to the Off setting and remove the key from the processing module procedure lock.

Verification Wash the cuvettes 1.

Perform As-Needed maintenance procedure 5910 Wash Cuvettes (c‑series), page 867.

2.

Perform quality control testing to verify the system performance before reporting sample results.

Related information... Processing center component replacement (c‑series), page 920 Use a procedure key to perform a procedure, page 846

Replace the mixers (c‑series) To replace one or both mixers, perform the following procedures: • Removal, page 950

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Section 9 – Remove the mixer, page 950 • Replacement, page 951 – Install the mixer, page 951 • Verification, page 951 – Verify the mixer function, page 951 Estimated time

5 minutes

Required instrument status

• Processing module: Idle • Reagent and sample manager: Idle (only if replacing mixer 1)

Procedure key setting Processing module: Required On Replacement parts

Mixer, LN 09D5903

CAUTION: Biological RISKS. This activity or area may expose you to potentially infectious material. CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.

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Service, maintenance, and diagnostics Component replacement

Section 9

Removal Remove the mixer

1.

Insert the procedure key into the processing module procedure lock and turn the key to the On setting.

2.

Lift the appropriate processing center cover: – To replace mixer 1, lift the front processing center cover. – To replace mixer 2, lift the rear processing center cover.

950

3.

To unplug the mixer cable, pinch the white connector.

4.

Loosen the thumbscrew on the top of the mixer assembly.

5.

Remove the mixer.

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Section 9

Replacement Install the mixer

1.

Align the new mixer so that the flat side faces away from the mixer arm.

2.

Align the positioning pins on the top of the mixer with the holes on the mixer arm. Tighten the thumbscrew until the top of the mixer is flush with the mixer arm.

3.

Attach the mixer cable connector to the white connector on the mixer assembly. NOTE: The mixer cable connector is keyed and can be inserted only one way.

Verification Verify the mixer function 1.

Perform Reaction Mechanisms diagnostic procedure 5002 Mixer Vibration Test (c‑series), page 889.

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Service, maintenance, and diagnostics Component replacement 2.

Section 9

Close the appropriate processing center cover: – For mixer 1, close the front processing center cover. – For mixer 2, close the rear processing center cover.

3.

Turn the procedure key to the Off setting and remove the key from the processing module procedure lock.

4.

Perform quality control testing to verify the system performance before reporting sample results.

Related information... Processing center component replacement (c‑series), page 920 Use a procedure key to perform a procedure, page 846

Replace the ICT module or the ICT probe (c‑series) To replace the ICT module or the ICT probe, perform the following procedures: • Removal, page 953 – Remove the ICT module or the ICT probe, page 953 • Replacement, page 955 – Install the ICT module and the ICT probe, page 955 • Verification, page 956 – Calibrate the ICT assays, page 956 Estimated time

15 minutes

Required materials

Absorbent towel

Required instrument Processing module: Idle status Procedure key setting Processing module: Off Replacement parts • ICT Module, LN 09D2804 • ICT Probe, LN 09D6304 CAUTION: Biological RISKS. This activity or area may expose you to potentially infectious material. CAUTION: Probe Stick Hazard. This activity or area may expose you to probes.

952

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Section 9

Removal Remove the ICT module or the ICT probe

1.

To replace the ICT probe, proceed to step 7, page 954.

2.

To replace the ICT module, verify that the new ICT module is within the expiration date on the ICT module box. Do not use an expired ICT module. NOTE: When the ICT module is replaced, the c‑series processing module tracks and maintains a record of the serial number, the expiration date, the warranty sample count, and the warranty days on the system. The warranty for the ICT module is 20,000 samples or 3 months after installation, whichever occurs first.

3.

On the menu bar, tap Supplies.

4.

On the Supplies screen, tap a Module button.

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Service, maintenance, and diagnostics Component replacement 5.

Section 9

Use the bar code scanner to scan the two-dimensional (2D) bar code on the Alinity c label of the new ICT module box. Under Supply Details in the ICT Module flyout, the system automatically updates the ICT module with the serial number and expiration date of the new module. To enter manually the lot number and the expiration date, perform the following steps: a.

Tap Update for the ICT module.

b.

Under Supply Details in the ICT Module flyout, enter the serial number and the expiration date. NOTE: Entry of the expiration date is optional. If the expiration date is not provided, expiration tracking for the module is disabled.

c. 6.

Tap Replace.

When a confirmation message is displayed, perform one of the following steps: – Tap Yes to continue and confirm that calibrations for all ICT assays are inactivated. Instructions to replace the ICT module are displayed. – Tap No to continue without saving the changes. Tap Done to return to the Supplies screen.

7.

Lift the rear processing center cover to access the ICT unit.

8.

Loosen the two captive thumbscrews that secure the black plate on the top of the unit.

9.

Remove the black plate.

10. Place an absorbent towel under the probe tip. 11. Loosen the thumbscrew on the side of the ICT holder until the ICT module can be lifted upward. 12. To disconnect the black electrical connector from the side of the module, pull the connector straight out of the module. 13. Verify that the black electrical connector is disconnected completely from the ICT module. 14. Lift the ICT module until the connectors on the side of the ICT module clear the ICT holder. IMPORTANT: To avoid damage to the ICT probe, do not lift the ICT module and the probe all the way out of the ICT holder. 15. Gently unscrew the ICT module to disconnect it from the top connector. 16. Lift the ICT module and the ICT probe straight upward and out of the ICT holder. 17. Unscrew the ICT probe holder from the ICT module. 18. Inspect the ports on the ICT module. The yellow O-rings must be present. IMPORTANT: If the c‑series processing module is run without the yellow O-rings in the appropriate position, sample results may be adversely affected. 19. If the ICT module will be replaced, dispose of the used module. If the ICT module will not be replaced, set aside the module for use with the new ICT probe.

954

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Section 9 20. Remove the ICT probe from the probe holder.

21. If the ICT probe will be replaced, dispose of the used probe. If the ICT probe will not be replaced, set aside the probe for use with the new ICT module.

Replacement Install the ICT module and the ICT probe

1.

To replace the ICT module, remove the new ICT module from the box.

2.

Disconnect and discard the plastic tubing that is attached to both ends of the ICT module.

3.

Inspect the ports on the ICT module. The yellow O-rings must be present. IMPORTANT: If the system is run without the yellow O-rings in the appropriate position, sample results may be adversely affected.

4.

Align the ICT module so that the gap between the side connectors is on top of the module and the module label is facing upward and is legible.

5.

Place the ICT probe into the ICT probe holder.

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Service, maintenance, and diagnostics Component replacement

Section 9

6.

If an O-ring from the previous ICT module is attached to the ICT probe, remove the O-ring.

7.

Attach the ICT probe holder and ICT probe to the bottom of the ICT module. Do not overtighten the ICT probe holder. IMPORTANT: The O-rings may twist and obstruct the flow through the ICT module if the ICT probe holder connection is overtightened.

8.

Insert the ICT module with the ICT probe into the ICT probe holder until the connectors on the side of the module are located above the top of the holder.

9.

Rotate the ICT module to reattach the module to the top port and to the connector. Do not overtighten the ICT module.

10. If an O-ring from a previous ICT module is attached to the connector, remove the O-ring before attaching the ICT module. 11. Lower the ICT module until the module is seated completely and the module connectors are aligned with the slot in the ICT holder. 12. Gently reconnect the black electrical connector to the ICT module connectors. Ensure that the ICT module is plugged completely into the connector. 13. Press down on the ICT module and simultaneously tighten the side thumbscrew until the module is secure. Do not overtighten the thumbscrew to prevent damage to the ICT module. 14. Remove the absorbent towel under the probe tip. 15. To flush the ICT module, perform one of the following steps: – If the ICT module was replaced, tap Flush ICT in the ICT Module flyout. – If the ICT probe was replaced, perform ICT diagnostic procedure 5102 Flush ICT Module (c‑series), page 892. 16. During the flush, perform the following steps: – Inspect the tubing from the ICT module for bubbles. – Inspect the ICT probe to ensure that it does not drip. NOTE: If bubbles or drips are observed, see Processing module observed problems (c‑series), page 1418. 17. Replace the black plate and tighten the two captive thumbscrews. 18. If the ICT module was replaced, tap Done in the ICT Module flyout. 19. Close the rear processing center cover.

Verification Calibrate the ICT assays

956

1.

Perform a calibration for the ICT assays.

2.

Perform quality control testing to verify the calibration.

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Section 9

Related information... Processing center component replacement (c‑series), page 920 Supplies screen element descriptions (c‑series), page 562 Supplies screen, page 561 Supplies screen, Supply Details flyout for ICT Module element descriptions (c‑series), page 569 Use a procedure key to perform a procedure, page 846

Supply and pump center component replacement (c‑series) Certain supply and pump center components may need to be replaced because of normal wear from daily system operation. The following illustration shows the location of each replaceable component. Step-by-step instructions are provided for each replaceable component. Figure 163: Supply and pump center components (c‑series)

Legend: 1. 2.

Sample syringe Reagent syringes

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Service, maintenance, and diagnostics Component replacement 3. 4. 5. 6.

Section 9

Wash solution syringes Wash solution pump syringes (1 mL) and check valves ICT Reference Solution pump syringes (1 mL) and check valves ICT aspiration pump syringes (1 mL) and check valve

Related information... Component replacement, page 920 Replace the 1 mL syringes (c‑series), page 958 Replace the check valves (c‑series), page 961 Replace the wash solution syringe O-ring and seal tips 1 and 2 (c‑series), page 965 Replace the reagent syringe O-ring and seal tips 1 and 2 (c‑series), page 972 Replace the sample syringe O-ring and seal tips 1 and 2 (c‑series) , page 979 Replace the bulk solution level sensor (c‑series), page 986

Replace the 1 mL syringes (c‑series) To replace the 1 mL syringes on the ICT Reference Solution pump, the ICT aspiration pump, and the wash solution pump, perform the following procedures: • Removal, page 959 – Remove the 1 mL syringe, page 959 • Replacement, page 960 – Install the 1 mL syringe, page 960 • Verification, page 961 – Run quality control samples, page 961 Estimated time

14 minutes

Required materials

Absorbent towel

Required instrument status

Idle

Procedure key setting Processing module: Optional On NOTE: The procedure key setting depends on the location of the 1 mL syringe to be replaced. See step 3 of Remove the 1 mL syringe, page 959. Replacement parts

1 mL syringe, LN 09D4103

To replace all 1 mL syringes and to document the procedure in the maintenance log, perform Triannual maintenance procedure 5833 Change 1 mL Syringes (c‑series), page 863.

958

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Section 9

CAUTION: Biological RISKS. This activity or area may expose you to potentially infectious material. CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.

Removal Remove the 1 mL syringe

1.

Open the bulk solution door.

2.

Identify the 1 mL syringe to replace: – ICT Reference Solution pump – ICT aspiration pump – Wash solution pump

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Service, maintenance, and diagnostics Component replacement

Section 9

3.

If the 1 mL syringe to replace is located on the ICT Reference Solution pump or the ICT aspiration pump, insert the procedure key into the processing module procedure lock and turn the key to the On setting.

4.

To remove the clear plunger shield from the pump, remove the two black knobs.

5.

Pull the 1 mL syringe forward to remove it from the syringe holder.

6.

Place an absorbent towel under the pump area to absorb any liquid.

7.

Unscrew the syringe assembly from the check valve.

Replacement Install the 1 mL syringe

960

1.

Screw the new syringe assembly onto the check valve.

2.

Install the 1 mL syringe. Ensure that the plunger flange and the bottom of the syringe barrel are aligned in the syringe holder.

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Section 9 3.

Reinstall the clear plunger shield and secure it with the black knobs. Tighten the black knobs by hand.

4.

Remove the absorbent towel from the pump area.

5.

Perform the following diagnostic procedures to remove any air that may be present: – For the ICT Reference Solution pump and the ICT aspiration pump, perform ICT diagnostic procedure 5102 Flush ICT Module (c‑series), page 892. – For the wash solution pump, perform Fluidics-Wash diagnostic procedure 4206 Flush Bulk Solutions (c‑series), page 883.

6.

Inspect the syringe tubing and connections for drips and leaks during the flush. If drips or leaks are observed, repeat the installation procedure.

7.

If the procedure key was turned on, turn the key to the Off setting and remove the key from the processing module procedure lock.

8.

Close the bulk solution door.

Verification Run quality control samples Perform quality control testing to verify the system performance before reporting sample results. Related information... Supply and pump center component replacement (c‑series), page 957 Use a procedure key to perform a procedure, page 846

Replace the check valves (c‑series) To replace the check valves on the ICT Reference Solution pump, the ICT aspiration pump, or the wash solution pump, perform the following procedures: • Removal, page 963 – Remove the check valve, page 963 • Replacement, page 964 – Install the check valve, page 964 • Verification, page 965 – Run quality control samples, page 965 Estimated time

15 minutes

Required materials

Absorbent towel

Required instrument status

Idle

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Service, maintenance, and diagnostics Component replacement

Section 9

Procedure key setting Processing module: Optional On NOTE: The procedure key setting depends on the location of the check valve to be replaced. See step 3 of Remove the check valve, page 963. Replacement parts

• ICT Check Valve, LN 09D3503 • Wash Solution Check Valve, LN 09D3403

To replace the ICT check valves and to document the procedure in the maintenance log, perform Triannual maintenance procedure 5834 Check and Change ICT Check Valves (c‑series), page 864. CAUTION: Biological RISKS. This activity or area may expose you to potentially infectious material. CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.

962

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Section 9

Removal Remove the check valve

1.

Open the bulk solution door.

2.

Identify the check valve to replace: – ICT Reference Solution check valve – ICT aspiration check valve – Wash solution check valve

3.

To replace one of the ICT check valves, insert the procedure key into the processing module procedure lock and turn the key to the On setting.

4.

To remove the clear plunger shield from the pump, remove the two black knobs.

5.

Pull the 1 mL syringe forward to remove it from the syringe holder.

6.

Place an absorbent towel under the pump area to absorb any liquid.

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Service, maintenance, and diagnostics Component replacement 7.

Disconnect the top and side tubing from the check valve.

8.

Unscrew the check valve from the syringe.

Section 9

Replacement Install the check valve

964

1.

Install the new check valve onto the syringe and tighten the valve by hand.

2.

Reattach the tubing to the side and top ports on the check valve and tighten the tubing by hand.

3.

Install the syringe. Ensure that the plunger flange and the bottom of the syringe barrel are aligned in the syringe holder.

4.

Remove the absorbent towel from the pump area.

5.

Reinstall the clear plunger shield and secure it with the black knobs. Tighten the black knobs by hand.

6.

Perform the following diagnostic procedures to remove any air that may be present:

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Section 9

– For the ICT Reference Solution pump and the ICT aspiration pump, perform ICT diagnostic procedure 5102 Flush ICT Module (c‑series), page 892. – For the wash solution pump, perform Fluidics-Wash diagnostic procedure 4206 Flush Bulk Solutions (c‑series), page 883. 7.

Inspect the syringe tubing and check valve connections for drips and leaks during the flush. If drips or leaks are observed, repeat the installation procedure.

8.

If the procedure key was turned on, turn the key to the Off setting and remove the key from the processing module procedure lock.

9.

Close the bulk solution door.

Verification Run quality control samples Perform quality control testing to verify the system performance before reporting sample results. Related information... Supply and pump center component replacement (c‑series), page 957 Use a procedure key to perform a procedure, page 846

Replace the wash solution syringe O-ring and seal tips 1 and 2 (c‑series) To replace the wash solution syringe O-ring and seal tips 1 and 2, perform the following procedures: • Removal, page 967 – Remove the wash solution syringe, page 967 – Remove the seal tips and the O-ring, page 968 • Replacement, page 970 – Install the seal tips and the O-ring, page 970 – Install the wash solution syringe, page 971 • Verification, page 972 – Run quality control samples, page 972 Estimated time

22 minutes

Required materials

• Phillips screwdriver • Slotted screwdriver • 10 mm wrench • Absorbent towels

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Service, maintenance, and diagnostics Component replacement

Section 9

• Cotton swabs Required instrument Processing module: Idle status Procedure key setting Processing module: Off Replacement parts • Sample and Wash Solution Syringe O-ring, LN 09D5203 • Sample and Wash Solution Syringe Seal Tip #1, LN 09D3703 • Sample and Wash Solution Syringe Seal Tip #2, LN 09D3803 To replace the O-rings and seal tips for both wash solution syringes and to document the procedure in the maintenance log, perform Quarterly maintenance procedure 5802 Wash Solution Syringe Maintenance (c‑series), page 861. CAUTION: Biological RISKS. This activity or area may expose you to potentially infectious material. CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.

966

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Section 9

Removal Remove the wash solution syringe

1.

Open the bulk solution door and locate the wash solution pump.

2.

Unscrew the two black knobs to remove the clear plastic plunger shield.

3.

Pull the three 1 mL syringes forward to remove them from the white syringe holder. Do not disconnect the tubing from the syringes.

4.

Place the three 1 mL syringes to the left side of the white syringe holder.

5.

Use the Phillips screwdriver to unscrew the two Phillips screws to remove the white syringe holder.

6.

Use the slotted screwdriver to loosen the slotted screw that secures the clear syringe block. NOTE: The screw is captive and cannot be removed completely.

7.

Pull the clear syringe block forward to remove it from the syringe drive.

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Service, maintenance, and diagnostics Component replacement

Section 9

8.

Place absorbent towels under the clear syringe block to absorb any liquid when the tubing is disconnected.

9.

Disconnect the tubing labeled 2 and labeled 3 from the top and front of the clear syringe block. NOTE: Ensure that the black O-rings remain in the clear syringe block after the tubing is disconnected.

10. Identify the wash solution syringe for which the O-ring and seal tips will be replaced. Remove the seal tips and the O-ring

1.

Use the 10 mm wrench to loosen the nut that secures the syringe plunger to the bottom of the clear syringe block.

2.

Turn the nut by hand until the syringe plunger can be removed from the clear syringe block. The plunger assembly includes the following parts in order:

968

a.

O-ring

b.

Seal tip 2

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Section 9 c.

Spacer

d.

Seal tip 1

e.

Spring

f.

Nut

g.

Plunger with the plunger flange

The O-ring can remain in the syringe when the plunger assembly is removed. 3.

Remove and discard the following items: – O-ring – Seal tip 2 – Seal tip 1 NOTE: Do not discard the spacer. Set aside the spacer and the remainder of the plunger assembly parts. Do not remove the spring from the nut.

4.

Dry the interior of the syringe barrel with a cotton swab. Dry the plunger completely with an absorbent towel if liquid is present.

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Service, maintenance, and diagnostics Component replacement

Section 9

Replacement Install the seal tips and the O-ring

970

1.

Install seal tip 1 on the plunger so that the seal tip sits above the spring with the open side away from the spring.

2.

Install the spacer so that it fits into the open side of seal tip 1.

3.

Install seal tip 2 on top of the spacer with the open side toward the spacer.

4.

Install the O-ring so that it fits into the groove of seal tip 2. Do not push the O-ring out of alignment. The O-ring must sit flat against the inside of the clear syringe block.

5.

Press lightly to push all the components together.

6.

Install the plunger assembly into the clear syringe block.

7.

Tighten by hand the nut that holds the plunger assembly in the clear syringe block until the nut is tight.

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Section 9

NOTE: The nut must be flush with the clear syringe block. If the nut binds when tightening it, do not apply excessive force. Back out the nut one turn. Then, push in the nut to apply pressure against the spring and continue to tighten the nut. 8.

Use the 10 mm wrench to further tighten the nut, but do not overtighten it.

Install the wash solution syringe

1.

Ensure that the black O-rings remain in the clear syringe block.

2.

Reattach the knurled connection for the tubing labeled 2 to the top left opening of the clear syringe block.

3.

Reattach the knurled connection for the tubing labeled 3 to the top right opening of the clear syringe block.

4.

Reattach the knurled connection for the tubing labeled 2 from the 1 mL syringe to the front left opening of the clear syringe block.

5.

Reattach the knurled connection for the tubing labeled 3 from the 1 mL syringe to the front right opening of the clear syringe block.

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Service, maintenance, and diagnostics Component replacement

Section 9

6.

Remove the absorbent towels under the clear syringe block.

7.

Place the wash solution syringe block on the alignment pins and tighten the slotted screw by hand until the screw is tight.

8.

Further tighten the slotted screw with the slotted screwdriver.

9.

Ensure that the plunger flanges are seated on the metal block beneath the syringes.

10. Replace the white syringe holder and tighten the two Phillips screws with the Phillips screwdriver. 11. Verify that the 1 mL syringe tubing connections did not loosen during the removal and replacement procedure. 12. Reinstall the 1 mL syringes into the syringe holder in the following order: a.

Place the 1 mL syringe with tubing labeled 2 in the left syringe holder position.

b.

Place the 1 mL syringe with no tubing label in the center syringe holder position.

c.

Place the 1 mL syringe with tubing labeled 3 in the right syringe holder position.

13. Ensure that the 1 mL syringe plunger flanges and the bottom of the syringe barrels are aligned in the syringe holder. 14. Attach the clear plastic plunger shield and tighten the two black knobs by hand. 15. To remove any air that may be present, perform Fluidics-Wash diagnostic procedure 4205 Flush Water Lines (c‑series), page 882. 16. Inspect the syringe tubing and connections for drips and leaks during the flush. If drips or leaks are observed, repeat the installation procedure. 17. Close the bulk solution door.

Verification Run quality control samples Perform quality control testing to verify the system performance before reporting sample results. Related information... Supply and pump center component replacement (c‑series), page 957 Use a procedure key to perform a procedure, page 846

Replace the reagent syringe O-ring and seal tips 1 and 2 (c‑series) To replace the reagent syringe O-ring and seal tips 1 and 2, perform the following procedures: • Removal, page 974 – Remove the reagent syringe, page 974 – Remove the seal tips and the O-ring, page 975 • Replacement, page 977

972

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Section 9 – Install the seal tips and the O-ring, page 977 – Install the reagent syringe, page 978 • Verification, page 979 – Run quality control samples, page 979 Estimated time

22 minutes

Required materials

• Phillips screwdriver • Slotted screwdriver • 15 mm wrench • Absorbent towels • Cotton swabs

Required instrument Processing module: Idle status Procedure key setting Processing module: Off Replacement parts • Reagent syringe O-ring, LN 09D5303 • Reagent Syringe Seal Tip #1, LN 09D3903 • Reagent Syringe Seal Tip #2, LN 09D4004 To replace the O-rings and seal tips for both the R1 and R2 reagent syringes and to document the procedure in the maintenance log, perform Quarterly maintenance procedure 5803 Reagent Syringe Maintenance (c‑series), page 862. CAUTION: Biological RISKS. This activity or area may expose you to potentially infectious material. CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.

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Service, maintenance, and diagnostics Component replacement

Section 9

Removal Remove the reagent syringe

974

1.

Open the bulk solution door and locate the syringe cover for the sample and reagent syringes.

2.

Remove the sample and reagent syringe tubing from the clamps on the syringe cover.

3.

Use the Phillips screwdriver to loosen the two Phillips screws enough to pull the cover away from the syringes.

4.

Identify the reagent syringe for which the O-rings and seal tips will be replaced.

5.

Use the slotted screwdriver to loosen the slotted screw that secures the syringe block. Do not attempt to remove the syringe block.

6.

Use the slotted screwdriver to loosen the slotted screw that holds the syringe bracket over the syringe plunger. Do not remove the screw or the syringe bracket.

7.

Pull the reagent syringe away from the syringe drive and the syringe bracket.

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Section 9 8.

Place an absorbent towel under the reagent syringe to absorb any liquid.

9.

Unscrew the knurled connections at the top and side of the syringe block to disconnect the tubing. NOTE: Ensure that the black O-rings remain in the syringe block after the tubing is disconnected.

Remove the seal tips and the O-ring

1.

Use the 15 mm wrench to loosen the nut that secures the syringe plunger to the bottom of the syringe block.

2.

Turn the nut by hand until the syringe plunger can be removed from the syringe block. The plunger assembly includes the following parts in order: a.

O-ring

b.

Seal tip 2

c.

Spacer

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975

Service, maintenance, and diagnostics Component replacement d.

Seal tip 1

e.

Spring

f.

Nut

g.

Plunger with the plunger flange

Section 9

The O-ring can remain in the syringe when the plunger assembly is removed. 3.

Remove and discard the following items: – O-ring – Seal tip 2 – Seal tip 1 NOTE: Do not discard the spacer. Set aside the spacer and the remainder of the plunger assembly parts. Do not remove the spring from the nut.

4.

976

Dry the interior of the syringe barrel with a cotton swab. Dry the plunger completely with an absorbent towel if liquid is present.

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Section 9

Replacement Install the seal tips and the O-ring

1.

Install seal tip 1 on the plunger so that the seal tip sits above the spring with the open side away from the spring.

2.

Install the spacer so that it fits into the open side of seal tip 1.

3.

Install seal tip 2 on top of the spacer with the open side toward the spacer.

4.

Install the O-ring so that it fits into the groove of seal tip 2. Do not push the O-ring out of alignment. The O-ring must sit flat against the inside of the syringe block.

5.

Press lightly to push all the components together.

6.

Install the plunger assembly into the syringe block.

7.

Tighten by hand the nut that holds the plunger assembly in the syringe block until the nut is tight.

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Service, maintenance, and diagnostics Component replacement

Section 9

NOTE: The nut must be flush with the syringe block. If the nut binds when tightening it, do not apply excessive force. Back out the nut one turn. Then, push in the nut to apply pressure against the spring and continue to tighten the nut. 8.

Use the 15 mm wrench to further tighten the nut, but do not overtighten it.

Install the reagent syringe

978

1.

Ensure that the black O-rings remain in the syringe block.

2.

Reattach the knurled connections at the top and side of the syringe block to connect the tubing.

3.

Remove the absorbent towel from the syringe drive area.

4.

Insert the plunger flange into the syringe bracket. Align the reagent syringe block with the pin on the syringe drive.

5.

Push the reagent syringe block onto the syringe drive. Ensure that the syringe plunger is pushed back into the U-shape of the syringe bracket.

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Section 9 6.

Place the syringe block on the alignment pin and tighten the slotted screw by hand until the screw is tight.

7.

Further tighten the slotted screw with the slotted screwdriver.

8.

Use the slotted screwdriver to tighten the slotted screw that holds the syringe bracket to the syringe drive.

9.

Replace the syringe cover and tighten the two Phillips screws with the Phillips screwdriver.

10. Replace the sample and reagent syringe tubing in the clamps on the syringe cover. 11. To remove any air that may be present, perform Fluidics-Wash diagnostic procedure 4205 Flush Water Lines (c‑series), page 882. 12. Inspect the syringe tubing and connections for drips and leaks during the flush. If drips or leaks are observed, repeat the installation procedure. 13. Close the bulk solution door.

Verification Run quality control samples Perform quality control testing to verify the system performance before reporting sample results. Related information... Supply and pump center component replacement (c‑series), page 957 Use a procedure key to perform a procedure, page 846

Replace the sample syringe O-ring and seal tips 1 and 2 (c‑series) To replace the sample syringe O-ring and seal tips 1 and 2, perform the following procedures: • Removal, page 981 – Remove the sample syringe, page 981 – Remove the seal tips and the O-ring, page 982 • Replacement, page 984 – Install the seal tips and the O-ring, page 984 – Install the sample syringe, page 985 • Verification, page 986 – Run quality control samples, page 986 Estimated time

12 minutes

Required materials

• Phillips screwdriver • Slotted screwdriver

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Service, maintenance, and diagnostics Component replacement

Section 9

• 10 mm wrench • Absorbent towels • Cotton swabs Required instrument Processing module: Idle status Procedure key setting Processing module: Off Replacement parts • Sample and Wash Solution Syringe O-ring, LN 09D5203 • Sample and Wash Solution Syringe Seal Tip #1, LN 09D3703 • Sample and Wash Solution Syringe Seal Tip #2, LN 09D3803 To replace the O-ring and seal tips for the sample syringe and to document the procedure in the maintenance log, perform Quarterly maintenance procedure 5801 Sample Syringe Maintenance (c‑series), page 860. CAUTION: Biological RISKS. This activity or area may expose you to potentially infectious material. CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.

980

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Section 9

Removal Remove the sample syringe

1.

Open the bulk solution door and locate the syringe cover for the sample and reagent syringes.

2.

Remove the sample and reagent syringe tubing from the clamps on the syringe cover.

3.

Use the Phillips screwdriver to loosen the two Phillips screws enough to pull the cover away from the syringes.

4.

Identify the sample syringe.

5.

Use the slotted screwdriver to loosen the slotted screw that secures the syringe block. Do not attempt to remove the syringe block.

6.

Use the slotted screwdriver to loosen the slotted screw that holds the syringe bracket over the syringe plunger. Do not remove the screw or the syringe bracket.

7.

Pull the sample syringe away from the syringe drive and the syringe bracket.

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Service, maintenance, and diagnostics Component replacement

Section 9

8.

Place an absorbent towel under the sample syringe to absorb any liquid.

9.

Unscrew the knurled connections at the top and side of the syringe block to disconnect the tubing. NOTE: Ensure that the black O-rings remain in the syringe block after the tubing is disconnected.

Remove the seal tips and the O-ring

1.

Use the 10 mm wrench to loosen the nut that secures the syringe plunger to the bottom of the syringe block.

2.

Turn the nut by hand until the syringe plunger can be removed from the syringe block. The plunger assembly includes the following parts in order:

982

a.

O-ring

b.

Seal tip 2

c.

Spacer

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Section 9 d.

Seal tip 1

e.

Spring

f.

Nut

g.

Plunger with the plunger flange

The O-ring can remain in the syringe when the plunger assembly is removed. 3.

Remove and discard the following items: – O-ring – Seal tip 2 – Seal tip 1 NOTE: Do not discard the spacer. Set aside the spacer and the remainder of the plunger assembly parts. Do not remove the spring from the nut.

4.

Dry the interior of the syringe barrel with a cotton swab. Dry the plunger completely with an absorbent towel if liquid is present.

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Service, maintenance, and diagnostics Component replacement

Section 9

Replacement Install the seal tips and the O-ring

984

1.

Install seal tip 1 on the plunger so that the seal tip sits above the spring with the open side away from the spring.

2.

Install the spacer so that it fits into the open side of seal tip 1.

3.

Install seal tip 2 on top of the spacer with the open side toward the spacer.

4.

Install the O-ring so that it fits into the groove of seal tip 2. Do not push the O-ring out of alignment. The O-ring must sit flat against the inside of the syringe block.

5.

Press lightly to push all the components together.

6.

Install the plunger assembly into the syringe block.

7.

Tighten by hand the nut that holds the plunger assembly in the syringe block until the nut is tight.

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Section 9

NOTE: The nut must be flush with the syringe block. If the nut binds when tightening it, do not apply excessive force. Back out the nut one turn. Then, push in the nut to apply pressure against the spring and continue to tighten the nut. 8.

Use the 10 mm wrench to further tighten the nut, but do not overtighten it.

Install the sample syringe

1.

Ensure that the black O-rings remain in the syringe block.

2.

Reattach the knurled connections at the top and side of the syringe block to connect the tubing.

3.

Remove the absorbent towel from the syringe drive area.

4.

Insert the plunger flange into the syringe bracket. Align the sample syringe block with the pin on the syringe drive.

5.

Push the sample syringe block onto the syringe drive. Ensure that the syringe plunger is pushed back into the U-shape of the bracket.

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Service, maintenance, and diagnostics Component replacement

Section 9

6.

Place the syringe block on the alignment pin and tighten the slotted screw by hand until the screw is tight.

7.

Further tighten the slotted screw with the slotted screwdriver.

8.

Use the slotted screwdriver to tighten the slotted screw that holds the syringe bracket to the syringe drive.

9.

Replace the syringe cover and tighten the two Phillips screws with the Phillips screwdriver.

10. Replace the sample and reagent syringe tubing in the clamps on the syringe cover. 11. To remove any air that may be present, perform Fluidics-Wash diagnostic procedure 4205 Flush Water Lines (c‑series), page 882. 12. Inspect the syringe tubing and connections for drips and leaks during the flush. If drips or leaks are observed, repeat the installation procedure. 13. Close the bulk solution door.

Verification Run quality control samples Perform quality control testing to verify the system performance before reporting sample results. Related information... Supply and pump center component replacement (c‑series), page 957 Use a procedure key to perform a procedure, page 846

Replace the bulk solution level sensor (c‑series) To replace the level sensor for Acid Wash, Alkaline Wash or ICT Reference Solution, perform the following procedures: • Removal, page 987 – Remove the bulk solution level sensor, page 987 • Replacement, page 988 – Install the bulk solution level sensor, page 988 • Verification, page 989 – Verify the functionality of the bulk solution level sensors, page 989 Estimated time

15 minutes

Required materials

Absorbent towels

Required instrument Warming or Idle status Procedure key setting Processing module: Off

986

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Section 9

Replacement parts

Level sensor, bulk solution, LN 04S6801

CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.

IMPORTANT: To ensure that the correct tubing and connections are used for the bulk solution level sensors, replace one level sensor at a time.

Removal Remove the bulk solution level sensor

1.

Open the bulk solution door and pull out the reservoir tray. NOTE: Use caution when handling the bulk solution level sensors. Avoid applying stress on the wiring and connector.

2.

Disconnect the electrical connector from the appropriate bulk solution level sensor.

3.

Use an absorbent towel to absorb any spills.

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Service, maintenance, and diagnostics Component replacement

Section 9

4.

Unscrew the two tubing fittings from the bulk solution level sensor.

5.

Unscrew the bulk solution level sensor cap.

6.

Remove the bulk solution level sensor from the reservoir.

Replacement Install the bulk solution level sensor

988

1.

Place the bulk solution level sensor into the container.

2.

Tighten the bulk solution level sensor cap.

3.

Connect the tubing from the bulk solution transfer pump to the input connector (labeled with an arrow that points toward the connector) on the bulk solution level sensor.

4.

Connect the tubing from the syringe pump to the output connector (labeled with an arrow that points away from the connector) on the bulk solution level sensor.

5.

Verify that both tubing connectors are tightened completely.

6.

Connect the electrical connector of the bulk solution level sensor.

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Section 9 7.

Start the processing module.

8.

To remove any air that may be present, perform Fluidics-Wash diagnostic procedure 4206 Flush Bulk Solutions (c‑series), page 883. While performing the flush, inspect the tubing and connections of the bulk solution level sensor for drips and leaks. If drips or leaks are observed, repeat the installation procedure.

9.

Slide the reservoir bottle tray into the bulk solution reservoir area and close the bulk solution door.

Verification Verify the functionality of the bulk solution level sensors Perform Fluidics-Wash diagnostic procedure 4212 Bulk Solution Sensor Test (c‑series), page 884. Related information... Supply and pump center component replacement (c‑series), page 957 Use a procedure key to perform a procedure, page 846

Processing center component replacement (i‑series) Certain processing center components may need to be replaced because of normal wear from daily system operation. The following illustration shows the location of each replaceable component. Step-by-step instructions are provided for each replaceable components.

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Service, maintenance, and diagnostics Component replacement

Section 9

Figure 164: Processing center components (i‑series)

Legend: 1. 2. 3. 4. 5. 6.

Sample pipettor probe (S) Reagent pipettor probe (R2) Wash zone 1 probes (WZ1) Liquid waste arm probe Reagent pipettor probe (R1) Wash zone 2 probes (WZ2)

Related information... Component replacement, page 920 Removal and replacement of the process path light cover (i‑series), page 991 Replace a sample or reagent pipettor probe (i‑series), page 998 Replace the wash zone probes (i‑series), page 1001 Replace the liquid waste arm probe (i‑series), page 1005

990

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Section 9

Removal and replacement of the process path light cover (i‑series) The process path light cover on the process path prevents external light interference with the diverter sensors and the optics. The cover must be removed to access the RV unloader and the waste aspirate probe. One of two configurations will be installed on the system. Determine the configuration that is installed on the Alinity i. Then, refer to the appropriate removal and replacement procedure. Figure 165: Process path light cover configurations (i‑series)

Legend: 1. 2.

One-piece process path light cover Two-piece process path light cover

Related information... Processing center component replacement (i‑series), page 989 Remove and replace the one-piece process path light cover (i‑series), page 992 Remove and replace the two-piece process path light cover (i‑series), page 995

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Service, maintenance, and diagnostics Component replacement

Section 9

Remove and replace the one-piece process path light cover (i‑series) To remove and replace the one-piece process path light cover, perform the following procedures: • Removal, page 993 – Remove the process path light cover, page 993 • Replacement, page 994 – Install the process path light cover, page 994 • Verification, page 995 – Initialize the processing module, page 995 Estimated time

1 minute

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Required On CAUTION: Biological RISKS. This activity or area may expose you to potentially infectious material. CAUTION: Probe Stick Hazard. This activity or area may expose you to probes. CAUTION: Moving Parts. This activity or area may expose you to moving parts.

992

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Section 9

Removal Remove the process path light cover

1.

Open the front processing center cover to access the process path light cover.

2.

Gently pull the process path light cover straight up and out of the processing center. Be sure to clear the waste aspirate probe.

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993

Service, maintenance, and diagnostics Component replacement

Section 9

Replacement Install the process path light cover

994

1.

Place the front right corner of the process path light cover directly in front of the knurled screw, near the STAT diverter (STD), on the process path.

2.

Align the cables and tubing with the small notches at the bottom of the process path light cover.

3.

Open the rear processing center cover.

4.

Verify that the process path light cover is seated completely on the process path.

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Section 9

Verification Initialize the processing module 1.

Perform Modules diagnostic procedure 1890 Processing Module Initialization (i‑series), page 916.

2.

While the processing module initializes, verify that the waste aspirate probe does not interfere with the process path light cover.

3.

Close the front and rear processing center covers.

Related information... Removal and replacement of the process path light cover (i‑series), page 991 Replace the liquid waste arm probe (i‑series), page 1005

Remove and replace the two-piece process path light cover (i‑series) To remove and replace the RV unloader access piece of the two-piece process path light cover, perform the following procedures: • Removal, page 996 – Remove the RV unloader access piece of the process path light cover, page 996 • Replacement, page 997 – Install the RV unloader access piece of the process path light cover, page 997 • Verification, page 997 – Initialize the processing module, page 997 Estimated time

1 minute

Required materials

None

Required instrument Stopped, Warming, or Idle status Procedure key setting Processing module: Required On CAUTION: Biological RISKS. This activity or area may expose you to potentially infectious material. CAUTION: Probe Stick Hazard. This activity or area may expose you to probes. CAUTION: Moving Parts. This activity or area may expose you to moving parts.

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Service, maintenance, and diagnostics Component replacement

Section 9

Removal Remove the RV unloader access piece of the process path light cover

1.

Open the rear or front processing center cover to access the process path light cover.

2.

Gently pull the RV unloader access piece of the process path light cover upward to remove the RV unloader access piece. Set aside the RV unloader access piece. NOTE: To access the RV unloader or the waste aspirate probe, the unload access sensor does not need to be disconnected.

996

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Section 9

Replacement Install the RV unloader access piece of the process path light cover

1.

Place the guides on the right and left sides of the RV unloader access piece of the process path light cover into the slots on the second piece of the cover, which is secured to the process path.

2.

Verify that the RV unloader access piece is seated completely on the second piece of the process path light cover.

Verification Initialize the processing module 1.

Perform Modules diagnostic procedure 1890 Processing Module Initialization (i‑series), page 916.

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Section 9

2.

While the processing module initializes, verify that the RV unloader access piece does not interfere with the waste aspirate probe.

3.

Close the rear processing center cover.

Related information... Removal and replacement of the process path light cover (i‑series), page 991

Replace a sample or reagent pipettor probe (i‑series) To replace a sample or reagent pipettor probe, perform the following procedures: • Removal, page 999 – Remove the pipettor probe, page 999 • Replacement, page 1000 – Install the pipettor probe, page 1000 • Verification, page 1001 – Perform a pipettor probe calibration, page 1001 Estimated time

20 minutes

Required materials

Absorbent towels

Required instrument Warming or Idle status Procedure key setting Processing module: Required On Replacement parts

Pipettor Probe, LN 03R9601

CAUTION: Biological RISKS. This activity or area may expose you to potentially infectious material. CAUTION: Probe Stick Hazard. This activity or area may expose you to probes. CAUTION: Moving Parts. This activity or area may expose you to moving parts.

998

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Section 9

Removal Remove the pipettor probe

1.

Insert the procedure key into the processing module procedure lock and turn the key to the On setting.

2.

Lift the rear processing center cover to access the pipettor probe.

3.

Initiate Pipettors diagnostic procedure 1161 Pipettor Probe Move (i‑series), page 901 to move the pipettor probes to an appropriate position for component replacement.

4.

If replacing the sample pipettor probe, place an absorbent towel on the process path under the probe.

5.

Place an absorbent towel under the probe tubing connection.

6.

Loosen the metal fitting on the probe and remove the probe tubing from the probe.

7.

Rotate the probe retainer counterclockwise until it clears the probe.

8.

Lift the probe and remove it from the boom arm.

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999

Service, maintenance, and diagnostics Component replacement

Section 9

Replacement Install the pipettor probe

1.

Slide the pipettor probe into the boom arm.

2.

Rotate the probe retainer clockwise until the probe is secured.

3.

Align the probe tubing with the probe and tighten the probe fitting by hand.

4.

Remove the absorbent towels.

5.

Complete Pipettors diagnostic procedure 1161 Pipettor Probe Move (i‑series), page 901.

6.

To remove any air that may be present, perform Fluidics-Wash diagnostic procedure 1200 Flush and Prime Fluidics (i‑series), page 902, Flush Wash Buffer, All option. While performing the flush, inspect the probe for drips and inspect the probe tubing and connections for leaks. If drips or leaks are observed, repeat the installation procedure.

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Section 9

Verification Perform a pipettor probe calibration 1.

Perform the appropriate Pipettors diagnostic procedure: – 1111 Sample Pipettor Check and Calibration (i‑series), page 895 – 1112 R1 Pipettor Check and Calibration (i‑series), page 895 – 1113 R2 Pipettor Check and Calibration (i‑series), page 896

2.

If the system is attached to a laboratory automation system and the sample pipettor probe was replaced, perform Pipettors diagnostic procedure 1115 Sample Pipettor LAS Calibration (i‑series), page 896.

3.

Close the rear processing center cover.

4.

Turn the procedure key to the Off setting and remove the key from the processing module procedure lock.

Related information... Processing center component replacement (i‑series), page 989 Use a procedure key to perform a procedure, page 846

Replace the wash zone probes (i‑series) To replace one or more wash zone probes, perform the following procedures: • Removal, page 1002 – Remove the wash zone probe, page 1002 • Replacement, page 1004 – Install the wash zone probe, page 1004 • Verification, page 1005 – Calibrate and test the wash monitoring, page 1005 Estimated time

20 minutes

Required materials

None

Required instrument Warming or Idle status Procedure key setting Processing module: Required On Replacement parts

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Wash Zone Probe, LN 08C9436

1001

Service, maintenance, and diagnostics Component replacement

Section 9

CAUTION: Biological RISKS. This activity or area may expose you to potentially infectious material. CAUTION: Probe Stick Hazard. This activity or area may expose you to probes. CAUTION: Moving Parts. This activity or area may expose you to moving parts.

Removal Remove the wash zone probe

1002

1.

Insert the procedure key into the processing module procedure lock and turn the key to the On setting.

2.

Lift the rear processing center cover to access the wash zone probes.

3.

Locate the wash zone probe to replace on the appropriate wash zone.

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Section 9 4.

To disconnect the electrical connector from the WZ ASP cable, press the connector tab and pull apart the electrical connector and the connector tab.

5.

Unscrew the thumbscrew that secures the probe block assembly to the wash zone elevator assembly.

6.

Lift the probe block assembly to access the wash zone probe tubing.

7.

To disconnect the wash zone probe tubing from the wash zone probes, gently pull the tubing and slide it off each probe.

8.

Invert the probe block assembly so that the wash zone probes are facing upward.

9.

Unscrew the two thumbscrews that secure the wash zone monitor housing (black) to the probe housing (blue). Do not disconnect the two assemblies.

10. With the wash zone monitor housing and the probe housing still connected, invert the probe block assembly so that the wash zone probes are facing downward. 11. Disconnect the wash zone monitor housing from the probe housing. 12. Remove the wash zone probe.

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Service, maintenance, and diagnostics Component replacement

Section 9

Replacement Install the wash zone probe

1.

Slide the wash zone probe into the probe housing (blue).

2.

Align the L-shaped cutout of the wash zone monitor housing (black) with the L-shaped cutout of the probe housing. Guide the wash zone probes into the probe channel in the wash zone monitor housing.

3.

With the wash zone monitor housing and the probe housing connected, invert the probe block assembly so that the wash zone probes are facing upward.

4.

Tighten the two thumbscrews that secure the wash zone monitor housing to the probe housing.

5.

Push the wash zone probe tubing onto the wash zone probe until the tubing passes the ridge on the probe. NOTE: Position the tubing halfway between the bend and the ridge of the probe.

1004

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Section 9 6.

To install the probe block assembly on the wash zone elevator assembly, align the holes on the probe block assembly with the pins on the wash zone elevator assembly.

7.

Tighten the thumbscrew that secures the probe block assembly to the wash zone elevator assembly.

8.

To reconnect the electrical connector to the WZ ASP cable, align the notch on the electrical connector with the connector tab.

Verification Calibrate and test the wash monitoring Perform the appropriate Fluidics-Wash diagnostic procedure: • 1261 Wash Zone 1 Wash Monitoring (i‑series), page 908, Calibrate and Test option • 1262 Wash Zone 2 Wash Monitoring (i‑series), page 908, Calibrate and Test option Related information... Processing center component replacement (i‑series), page 989 Use a procedure key to perform a procedure, page 846

Replace the liquid waste arm probe (i‑series) To replace the waste arm probe, perform the following procedures: • Removal, page 1006 – Remove the liquid waste arm probe, page 1006 • Replacement, page 1007 – Install the liquid waste arm probe, page 1007 • Verification, page 1008 – Perform a wash zone prime, page 1008 Estimated time

10 minutes

Required materials

None

Required instrument Warming or Idle status Procedure key setting Processing module: Required On Replacement parts

Wash Zone Probe, LN 08C9436

CAUTION: Biological RISKS. This activity or area may expose you to potentially infectious material.

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1005

Service, maintenance, and diagnostics Component replacement

Section 9

CAUTION: Probe Stick Hazard. This activity or area may expose you to probes. CAUTION: Moving Parts. This activity or area may expose you to moving parts.

Removal Remove the liquid waste arm probe

1006

1.

Insert the procedure key into the processing module procedure lock and turn the key to the On setting.

2.

Lift the front processing center cover to access the liquid waste arm probe.

3.

Remove the process path light cover.

4.

Remove the liquid waste arm probe tubing from the tubing clip on the liquid waste arm.

5.

Lift the probe and remove it from the front of the liquid waste arm.

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Section 9 6.

To disconnect the liquid waste arm probe tubing from the probe, gently pull the tubing and slide it off the probe.

Replacement Install the liquid waste arm probe

1.

Push the liquid waste arm probe tubing onto the liquid waste arm probe until the tubing passes the ridge on the probe. NOTE: Position the tubing halfway between the bend and the ridge of the probe.

2.

Slide the probe into the front of the liquid waste arm until the probe is seated completely.

3.

Insert the liquid waste arm probe tubing into the tubing clip on the liquid waste arm.

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Service, maintenance, and diagnostics Component replacement

Section 9

Verification Perform a wash zone prime 1.

Perform Fluidics-Wash diagnostic procedure 1200 Flush and Prime Fluidics (i‑series), page 902, Flush and Prime Manifolds, Wash Zone 1 option. While performing the prime, observe the liquid waste arm probe tubing and confirm that liquid is dispensed through the tubing.

2.

Replace the process path light cover.

3.

Close the front processing center cover.

4.

Turn the procedure key to the Off setting and remove the key from the processing module procedure lock.

Related information... Processing center component replacement (i‑series), page 989 Remove and replace the one-piece process path light cover (i‑series), page 992 Use a procedure key to perform a procedure, page 846

Supply center component replacement (i‑series) Certain supply center components may need to be replaced because of normal wear from daily system operation. The following illustration shows the location of each replaceable component. Step-by-step instructions are provided for each replaceable component.

1008

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Section 9

Figure 166: Bulk solution reservoir components (i‑series)

Legend: 1. 2. 3.

Concentrated Wash Buffer level sensor Trigger Solution level sensor Pre-Trigger Solution level sensor

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Service, maintenance, and diagnostics Component replacement

Section 9

Figure 167: Pump drawer component (i‑series)

Legend: 1.

Diluted wash buffer level sensor

Related information... Component replacement, page 920 Replace the level sensor for Pre-Trigger Solution, Trigger Solution, or Concentrated Wash Buffer (i‑series), page 1010 Replace the diluted wash buffer level sensor (i‑series), page 1014

Replace the level sensor for Pre-Trigger Solution, Trigger Solution, or Concentrated Wash Buffer (i‑series) To replace the level sensor for Pre-Trigger Solution, Trigger Solution, or Concentrated Wash Buffer, perform the following procedures: • Removal, page 1012 – Remove the bulk solution level sensor, page 1012

1010

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Section 9 • Replacement, page 1013 – Install the bulk solution level sensor, page 1013 • Verification, page 1014

– Verify the functionality of the bulk solution level sensors, page 1014 Estimated time

15 minutes

Required materials

Absorbent towel

Required instrument Warming or Idle status Procedure key setting Processing module: Off Replacement parts

Level sensor, bulk solution, LN 04S6801

CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.

IMPORTANT: To ensure that the correct tubing and connections are used for the bulk solution level sensors, replace one level sensor at a time.

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Service, maintenance, and diagnostics Component replacement

Section 9

Removal Remove the bulk solution level sensor

1.

Open the bulk solution door and pull out the reservoir tray. NOTE: Use caution when handling the bulk solution level sensors. Avoid applying stress on the wiring and connector.

1012

2.

Disconnect the electrical connector from the appropriate bulk solution level sensor.

3.

Use an absorbent towel to absorb any spills.

4.

Unscrew the two tubing fittings from the bulk solution level sensor.

5.

Unscrew the bulk solution level sensor cap.

6.

Remove the bulk solution level sensor from the reservoir.

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Section 9

Replacement Install the bulk solution level sensor

1.

Place the bulk solution level sensor into the container.

2.

Tighten the bulk solution level sensor cap.

3.

Connect the tubing from the bulk solution transfer pump to the input connector (labeled with an arrow that points toward the connector) on the bulk solution level sensor.

4.

Connect the tubing from the syringe pump to the output connector (labeled with an arrow that points away from the connector) on the bulk solution level sensor.

5.

Verify that both tubing connectors are tightened completely.

6.

Connect the electrical connector of the bulk solution level sensor.

7.

Start the processing module.

8.

To remove any air that may be present, perform Fluidics-Wash diagnostic procedure 1200 Flush and Prime Fluidics (i‑series), page 902 for the appropriate bulk solution.

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Service, maintenance, and diagnostics Component replacement

Section 9

Perform one of the following procedure options: – Flush Pre-Trigger and Trigger – Prime Dilution Assembly While performing the flush, inspect the tubing and connections of the bulk solution level sensor for drips and leaks. If drips or leaks are observed, repeat the installation procedure. 9.

Slide the reservoir bottle tray into the bulk solution reservoir area and close the bulk solution door.

Verification Verify the functionality of the bulk solution level sensors Perform Fluidics-Wash diagnostic procedure 1270 Bulk Solutions Motors and Sensors Test (i‑series), page 909, Read All Sensors option. Related information... Supply center component replacement (i‑series), page 1008 Start the processing module and the reagent and sample manager (RSM), page 500

Replace the diluted wash buffer level sensor (i‑series) To replace the level sensor for the diluted wash buffer, perform the following procedures: • Removal, page 1015 – Remove the diluted wash buffer level sensor, page 1015 • Replacement, page 1016 – Install the diluted wash buffer level sensor, page 1016 • Verification, page 1017 – Verify the functionality of the diluted wash buffer level sensor, page 1017 Estimated time

15 minutes

Required materials

• Absorbent tissue • Lock ring release tool

Required instrument Warming or Idle status Procedure key setting Processing module: Off Replacement parts

1014

Level Sensor, Diluted Wash Buffer, LN 04S6901

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Section 9

CAUTION: Biological RISKS. This activity or area may expose you to potentially infectious material. CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.

Removal Remove the diluted wash buffer level sensor

1.

Remove the rear fluidics panel and pull out the pump drawer. NOTE: Use caution when handling the diluted wash buffer level sensor. Avoid applying stress on the wiring and connector.

2.

Disconnect the electrical connector from the diluted wash buffer level sensor.

3.

Use absorbent tissue to absorb any spills.

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Service, maintenance, and diagnostics Component replacement

Section 9

4.

Insert the lock ring release tool between the tube fitting and the diluted wash buffer level sensor.

5.

Press the lock ring release tool toward the diluted wash buffer level sensor and pull the tubing straight out of the level sensor.

6.

Repeat steps 4, page 1016 and 5, page 1016 to remove the remaining tubing.

7.

Unscrew the diluted wash buffer level sensor cap.

8.

Remove the diluted wash buffer level sensor from the reservoir.

Replacement Install the diluted wash buffer level sensor

1016

1.

Place the diluted wash buffer level sensor into the container.

2.

Tighten the diluted wash buffer level sensor cap.

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Section 9 3.

Connect the tubing from the buffer waste valve (located at the top of the dilution assembly tray) to the input connector (labeled with an arrow that points toward the connector) on the diluted wash buffer level sensor.

4.

Align the tubing connector with the fitting and press the connector straight into the fitting.

5.

Connect the tubing from the manifold in the pump drawer to the output connector (labeled with an arrow that points away from the connector) on the diluted wash buffer level sensor.

6.

Align the tubing connector with the fitting and press the connector straight into the fitting.

7.

Slightly pull the connector to confirm that it is connected completely.

8.

Connect the electrical connector of the diluted wash buffer level sensor.

9.

Start the processing module.

10. To remove any air that may be present, perform Fluidics-Wash diagnostic procedure 1200 Flush and Prime Fluidics (i‑series), page 902, Flush Wash Buffer option. While performing the flush, inspect the tubing and connections of the diluted wash buffer level sensor for drips and leaks. If drips or leaks are observed, repeat the installation procedure. 11. Slide the pump drawer into the rear fluidics area and replace the rear fluidics panel.

Verification Verify the functionality of the diluted wash buffer level sensor Perform Fluidics-Wash diagnostic procedure 1270 Bulk Solutions Motors and Sensors Test (i‑series), page 909, Read All Sensors option. Related information... Supply center component replacement (i‑series), page 1008 Start the processing module and the reagent and sample manager (RSM), page 500

Optional component replacement Certain optional components may need to be replaced because of normal wear from daily system operation. Step-by-step instructions are provided for each replaceable component. Related information... Component replacement, page 920 Replace the external waste pump, page 1017

Replace the external waste pump To replace the external waste pump, perform the following procedures:

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Service, maintenance, and diagnostics Component replacement

Section 9

• Removal, page 1019 – Remove the external waste pump, page 1019 • Replacement, page 1020 – Install the external waste pump, page 1020 • Verification, page 1021 – Perform a flush procedure, page 1021 Estimated time

20 minutes

Required materials

None

Required instrument Warming or Idle status Procedure key setting Processing module: Off Replacement parts

External Waste Pump, LN 04S7401

CAUTION: Biological RISKS. This activity or area may expose you to potentially infectious material.

1018

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Section 9

Removal Remove the external waste pump

1.

Power off the external waste pump.

2.

Unplug the power cord from the external waste pump.

3.

Disconnect the waste outlet quick disconnect.

4.

Disconnect the inlet quick disconnect.

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Service, maintenance, and diagnostics Component replacement

Section 9

Replacement Install the external waste pump

1020

1.

Move the voltage switch on the external waste pump assembly to the correct position (115 V or 230 V) according to the voltage requirements of the country.

2.

Attach the power cord.

3.

Connect the inlet lines.

4.

Connect the outlet waste line.

5.

Power on the external waste pump.

6.

Press and hold the manual operation switch until the pump turns on.

7.

Release the manual operation switch to leave the pump in Automatic mode.

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Section 9

Service, maintenance, and diagnostics Component replacement

Verification Perform a flush procedure Perform the appropriate Fluidics-Wash diagnostic procedure consecutive times to verify that the external waste pump turns on and transports the waste fluid to the drain: • 4205 Flush Water Lines (c‑series), page 882 • 1200 Flush and Prime Fluidics (i‑series), page 902, Flush Wash Buffer, All option Related information... Optional component replacement, page 1017

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1021

Service, maintenance, and diagnostics Component replacement

Section 9

NOTES

1022

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Section 10

Troubleshooting

Introduction Problems with the Alinity ci‑series are characterized by symptoms. Troubleshooting tools, references, and suggested techniques help to trace the symptom to one or more root causes. After determining the root cause, perform the corrective actions to resolve the problem. Related information... Approach to troubleshooting, page 1024 Alert Center flyout, page 1033 System Logs screen, page 1036 Message codes, page 1051 Observed problems, page 1417 Miscellaneous corrective action procedures, page 1449 Service, maintenance, and diagnostics, page 837

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Approach to troubleshooting To identify and resolve operational problems, become thoroughly familiar with normal system operation. Effective troubleshooting requires a logical, step-by-step approach to resolve problems. This approach focuses on the following activities: • Observation, recognition, and categorization of symptoms • Identification of the probable cause • Systematic elimination of each potential problem (from the most likely problem to the least likely problem) The following troubleshooting model describes a five-step approach to define symptoms, identify problems, and implement solutions. To troubleshoot the system, include considerations that are appropriate to the laboratory environment. 1.

Observe and recognize symptoms. To analyze and resolve a problem, investigate what is incorrect and observe what is correct. Symptoms help to identify the problem area and to eliminate areas that operate correctly. Examples of symptoms include: – Message codes. – Observed problems such as a noise, a fluid leak, a monitor that flickers, or a trend in controls.

2.

Categorize symptoms. To eliminate symptoms automatically as probable causes, classify symptoms by categories. Categories of symptoms include: – System – Reagents – Operator – Environmental

3.

Isolate the root cause and create a plan of action. Based on the probable causes that are identified, devise a plan that first addresses the most likely cause and then progresses to the least likely cause. Address one probable cause at a time to isolate the resolution, and then apply the resolution to a specific problem. Diagnostic resources and tools include: – Message codes and messages. – System logs. – Control information. – Maintenance and diagnostic procedures.

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– This manual or the Help. Specific reference topics include the following sections in this manual: • Troubleshooting • Service, maintenance, and diagnostics • Performance characteristics and specifications • Principles of operation – The product documentation such as reagent and consumable information. 4.

Resolve the problem. Carefully perform the required steps to resolve the problem. Problems can be resolved by the following actions: – Make adjustments, such as tighten connections. – Perform a calibration. – Replace or repair system components. – Run new controls.

5.

Verify that the resolution worked. Verify that symptoms do not occur: – Perform the appropriate verification procedure. – Confirm control values if appropriate.

If symptoms continue to occur, perform the steps to resolve the next most likely problem. Repeat this process until the problem is resolved. Related information... Troubleshooting, page 1023 System troubleshooting variables (c‑series), page 1025 System troubleshooting variables (i‑series), page 1027 Reagent troubleshooting variables (c‑series), page 1029 Reagent troubleshooting variables (i‑series), page 1030 Operator troubleshooting variables, page 1031 Environmental troubleshooting variables, page 1032

System troubleshooting variables (c‑series) The system category is a high-level group of symptoms that relate to system performance. This category contains more specific subcategories or variables. Trace an error or a problem to one of these variables to begin to isolate the probable cause.

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Fluidics subsystems Fluidics subsystems are hardware components that control the precision and accuracy of liquid level sensing, aspiration, and dispense. In addition, these components distribute the fluids used to wash the probes: Examples

• Pipettors and probes • Pressure monitors • Syringes and valves • Tubing • Processing module circuit boards • Pumps • ICT unit

Symptoms

• LLS and fluidics message codes (3000-3999) • Imprecise results or erratic results

Optical subsystem The optical subsystem has hardware components that control concise and accurate optical readings: Examples

• Lamp • Heat absorbing filter • Lenses • Cuvettes • Water bath • Optics

Symptoms

• Optical read message codes (4000-4999) • Shift in values

Hardware The hardware has mechanical components that move consumables and samples through the system and distribute power and electrical signals: Examples

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• Reagent carousel

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• Reaction carousel • Sensors • RSM bar code reader Symptoms

• Robotics and sensor message codes (5000-5999) • Bar code read message codes (4000-4999) • Homing failures, jams, and step losses

Software The software has computer instructions that interpret the system and assay information, calculate results, and provide the interface to control the system hardware: Examples

System, assay, maintenance, and diagnostic software

Symptoms

• Software message codes (9000-9999) • Inability to power on the system control module

Consumables Consumables are supplies that are necessary to run assays: Examples

• Sample cups • Bulk solutions • Reagent cartridges • Onboard solutions

Symptoms

Imprecise results or erratic results

Related information... Approach to troubleshooting, page 1024

System troubleshooting variables (i‑series) The system category is a high-level group of symptoms that relate to system performance. This category contains more specific subcategories or variables. Trace an error or a problem to one of these variables to begin to isolate the probable cause.

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Fluidics subsystems Fluidics subsystems are hardware components that control the precision and accuracy of liquid level sensing, aspiration, and dispense. In addition, these components distribute the fluids used to wash the probes: Examples

• Pipettors and probes • Liquid level sense (LLS) antennae • Syringes and valves • Pumps

Symptoms

• LLS and fluidics message codes (3000-3999) • Imprecise results or erratic results

Optical subsystem The optical subsystem has hardware components that control concise and accurate optical readings: Examples

• Optics • Shutter • Read magnet

Symptoms

• Optical read message codes (4000-4999) • Shift in values

Hardware The hardware has mechanical components that move consumables and samples through the system and distribute power and electrical signals: Examples

• Reagent carousel • Sensors • RV loader • RSM bar code reader

Symptoms

• Robotics and sensor message codes (5000-5999) • Bar code read message codes (4000-4999)

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• Homing failures, jams, and step losses

Software The software has computer instructions that interpret the system and assay information, calculate results, and provide the interface to control the system hardware: Examples

System, assay, maintenance, and diagnostic software

Symptoms

• Software message codes (9000-9999) • Inability to power on the system control module

Consumables Consumables are supplies that are necessary to run assays: Examples

• Sample cups • Bulk solutions • Reaction vessels

Symptoms

Imprecise results or erratic results

Related information... Approach to troubleshooting, page 1024

Reagent troubleshooting variables (c‑series) The reagent category is a high-level group of symptoms that relate to the processing of results. This category contains more specific subcategories or variables. Trace an error or a problem to one of these variables to begin to isolate the probable cause. Reagent kits Reagent kits contain consumables that detect and measure the specific analyte presence or concentration in samples: Examples

• Reagents • Sample diluents • Pretreatments

Symptoms

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• Controls that fall outside the range

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• Trends and shifts in control results or patient results

Calibrators Calibrators are samples with known concentrations of analytes that are used to create the calibration against which samples are measured: Examples

Analyte-specific and multiconstituent calibrators

Symptoms

Shifts in control results and patient results

Controls Controls are samples with known concentrations of analytes that are used for performance monitoring within a clinical range: Examples

Analyte-specific and multiconstituent controls

Symptoms

• Controls that fall outside the range • Imprecise control results • Trends and shifts in control results or patient results

Related information... Approach to troubleshooting, page 1024

Reagent troubleshooting variables (i‑series) The reagent category is a high-level group of symptoms that relate to the processing of results. This category contains more specific subcategories or variables. Trace an error or a problem to one of these variables to begin to isolate the probable cause. Reagent cartridges Reagent cartridges contain consumables that detect and measure the specific analyte presence or concentration in samples: Examples

• Antibody-coated microparticles • Conjugate • Assay-specific diluent

Symptoms

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• Controls that fall outside the range

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• Trends and shifts in control results or patient results

Calibrators Calibrators are samples with known concentrations of analytes that are used to create the calibration against which samples are measured: Examples

Analyte-specific calibrators

Symptoms

Shifts in control results and patient results

Controls Controls are samples with known concentrations of analytes that are used for performance monitoring within a clinical range: Examples

Analyte-specific and multiconstituent controls

Symptoms

• Controls that fall outside the range • Imprecise control results • Trends and shifts in control results or patient results

Related information... Approach to troubleshooting, page 1024

Operator troubleshooting variables The operator category is a group of symptoms that relate to correct system operation and maintenance. Within this category, the actions of one operator or multiple operators can result in a variety of symptoms: Examples

A new user and a trained operator

Symptoms

• Bubbles in reagents or samples • Particulate matter or fibrin in samples • General message codes (0001-0999) • Assay-specific message codes (1000-1999) • Message codes that are generated because of incorrect maintenance or incorrect component replacement

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Related information... Approach to troubleshooting, page 1024

Environmental troubleshooting variables The environmental category is a high-level group of symptoms that relate to the processing of results. This category contains more specific subcategories or variables. Trace an error or a problem to one of these variables to begin to isolate the probable cause. Physical requirements Physical requirements identify the environmental conditions that are needed for optimal system performance: Examples

• Room temperature and humidity • Location and instrument clearances • Water quality

Symptoms

• Temperature message codes (7000-7999) • Inadequate airflow

Electrical requirements Electrical requirements identify the power requirements that are needed for optimal system performance and optical readings: Examples

Power outlet, voltages, and dedicated line

Symptom

Loss of power to the system

Host interface components Host interface components enable communication between the host interface and the Alinity ci‑series: Examples

Ports, cables, and connections

Symptoms

Communication message codes (8000-8999)

Related information... Approach to troubleshooting, page 1024

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Troubleshooting Alert Center flyout

Section 10

Alert Center flyout In the Alert Center flyout, the operator can view the following information: • The last 25 alerts and notifications. • The probable cause and corrective action for a message. The operator can clear all messages in the Alert Center flyout. Related information... Troubleshooting, page 1023 Alert Center flyout element descriptions, page 1033 View the probable cause and corrective action for a message, page 1034 View additional messages that are associated with a message, page 1034 Delete a message from the Alert Center, page 1035 Clear all messages, page 1035

Alert Center flyout element descriptions The Alert Center flyout displays alert and notification messages for system problems that require attention. The Alert Center stores a maximum of 25 messages that are sorted based on newest to oldest. Messages are displayed in the Alert Center until they are cleared.

Elements All tab

Displays all alert and notification messages generated.

Alerts tab

Displays all alert messages generated.

Notifications tab

Displays all notification messages generated.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Clear All

Displays a message requesting confirmation to clear all messages in the Alert Center. Individual messages can be cleared by tapping the X in the upper-right corner of the message. Cleared messages are retained in system logs.

Show Logs

Navigates to the System Logs screen.

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? Message

Displays Help from the operations manual for the selected message code.

?

Displays Help from the operations manual for the active screen, flyout, or message code.

Related information... Alert Center flyout, page 1033

View the probable cause and corrective action for a message Perform this procedure to view the probable cause and corrective action for a message. 1.

On the menu bar, tap Alert Center.

2.

In the Alert Center flyout, tap a message to view. NOTE: To display older messages, slide the horizontal scroll bar to the right side of the flyout. To filter the list of messages, tap the Alerts tab or the Notifications tab.

3.

Tap ? Message. The probable cause and corrective action in the operations manual is displayed for the selected message.

Related information... Alert Center flyout, page 1033

View additional messages that are associated with a message Perform this procedure to view additional messages that are associated with a message that is displayed in the Alert Center. 1.

On the menu bar, tap Alert Center.

2.

In the Alert Center flyout, tap a message to view. NOTE: To display older messages, slide the horizontal scroll bar to the right side of the flyout. To filter the list of messages, tap the Alerts tab or the Notifications tab.

3.

Tap Show Logs. On the System Logs screen, the selected message is displayed. If additional messages are associated with the selected message, a Plus button is displayed at the left side of the Date/Time column.

4.

Tap

to display the additional messages.

Related information... Alert Center flyout, page 1033

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Delete a message from the Alert Center Perform this procedure to delete a message from the Alert Center. 1.

On the menu bar, tap Alert Center.

2.

In the Alert Center flyout, tap a message to delete. NOTE: To display older messages, slide the horizontal scroll bar to the right side of the flyout. To filter the list of messages, tap the Alerts tab or the Notifications tab.

3.

To delete the message, tap the Close button box.

in the upper-right corner of the message

Related information... Alert Center flyout, page 1033

Clear all messages Perform this procedure to delete all messages from the Alert Center. 1.

On the menu bar, tap Alert Center.

2.

In the Alert Center flyout, tap Clear All.

3.

When a confirmation message is displayed, tap Yes.

4.

To close the Alert Center flyout, tap the Close button

in the upper-right corner.

Related information... Alert Center flyout, page 1033

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System Logs screen On the System Logs screen, the operator can view a record of all system messages that can be used to troubleshoot problems associated with system performance and results reporting. On the screen, the messages are filtered by the following categories: • Alerts and notifications: A record of critical messages, alert messages, and notification messages • Informational: A record of informational messages • Inventory: A record of supply-related messages • User access: A record of new users that have been created, edits to user data, and logon and logoff events • Configuration: A record of changes to configuration • Interfaces: A record of host interface communication messages, laboratory automation system messages, and Alinity PRO messages • Abbott Mail: A record of Abbott Mail activities and status messages • All messages: A record of all system messages The operator can perform the following functions: • Print a log. • Search for specific log data. Related information... Troubleshooting, page 1023 System Logs screen, Notifications/Alerts tab element descriptions, page 1036 System Logs screen, Informational tab element descriptions, page 1038 System Logs screen, Inventory tab element descriptions, page 1039 System Logs screen, User Access tab element descriptions, page 1040 System Logs screen, Configuration tab element descriptions, page 1041 System Logs screen, Interfaces tab element descriptions, page 1042 System Logs screen, Abbott Mail tab element descriptions, page 1043 System Logs screen, All Messages tab element descriptions, page 1044 System Logs screen, Search flyout element descriptions, page 1046 Message Details For flyout element descriptions, page 1049 Descriptions of message types, page 1049

System Logs screen, Notifications/Alerts tab element descriptions The Notifications/Alerts tab displays alert, critical, and notification message codes.

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Elements button

Displays the Message Details For flyout.

Date/Time

Displays the date and time that the message code was generated.

Module

Displays the number of the module that generated the message code. The module number for messages associated with the system control module is 6.

Message

Displays the message code number and description. In the first column, a Plus button associated with the message code indicates that related message codes with additional details are available.

Message Type

Displays the type of message code generated. The Notifications/Alerts tab has three message types: • Alert • Critical • Notification

Category

Displays the related message category. The Notifications/ Alerts tab has seven message categories: • Abbott Mail • Alinity PRO • Configuration • Host • Inventory • LAS • User Access

Function buttons Print

Displays the Print flyout.

Search

Displays the Search flyout.

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Message Help

Displays Help from the operations manual for the selected message code.

Text Size

Increases or decreases the size of text displayed.

Related information... System Logs screen, page 1036 Descriptions of screen elements, page 140

System Logs screen, Informational tab element descriptions The Informational tab displays informational message codes.

Elements button

Displays the Message Details For flyout.

Date/Time

Displays the date and time that the message code was generated.

Module

Displays the number of the module that generated the message code. The module number for messages associated with the system control module is 6.

Message

Displays the message code number and description. In the first column, a Plus button associated with the message code indicates that related message codes with additional details are available.

Category

Displays the related message category. The Informational tab has seven message categories: • Abbott Mail • Alinity PRO • Configuration • Host • Inventory • LAS • User Access

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Function buttons Print

Displays the Print flyout.

Search

Displays the Search flyout.

Message Help

Displays Help from the operations manual for the selected message code.

Text Size

Increases or decreases the size of text displayed.

Related information... System Logs screen, page 1036 Descriptions of screen elements, page 140

System Logs screen, Inventory tab element descriptions The Inventory tab displays message codes related to inventory.

Elements button

Displays the Message Details For flyout.

Date/Time

Displays the date and time that the message code was generated.

Module

Displays the number of the module that generated the message code. The module number for messages associated with the system control module is 6.

Message

Displays the message code number and description. In the first column, a Plus button associated with the message code indicates that related message codes with additional details are available.

Message Type

Displays the type of message code generated. The Inventory tab has four message types: • Alert • Critical • Informational • Notification

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Supply Name

Displays the name of the supply item associated with the message code.

Operator ID

Displays the identification of the operator logged onto the system when the message code was generated.

Function buttons Print

Displays the Print flyout.

Search

Displays the Search flyout.

Message Help

Displays Help from the operations manual for the selected message code.

Text Size

Increases or decreases the size of text displayed.

Related information... System Logs screen, page 1036 Descriptions of screen elements, page 140

System Logs screen, User Access tab element descriptions The User Access tab displays message codes related to user access.

Elements button

Displays the Message Details For flyout.

Date/Time

Displays the date and time that the message code was generated.

Message

Displays the message code number and description. In the first column, a Plus button associated with the message code indicates that related message codes with additional details are available.

Message Type

Displays the type of message code generated. The User Access tab has four message types: • Alert • Critical

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• Informational • Notification

Function buttons Print

Displays the Print flyout.

Search

Displays the Search flyout.

Message Help

Displays Help from the operations manual for the selected message code.

Text Size

Increases or decreases the size of text displayed.

Related information... System Logs screen, page 1036 Descriptions of screen elements, page 140

System Logs screen, Configuration tab element descriptions The Configuration tab displays message codes related to configuration.

Elements button

Displays the Message Details For flyout.

Date/Time

Displays the date and time that the message code was generated.

Module

Displays the number of the module that generated the message code. The module number for messages associated with the system control module is 6.

Message

Displays the message code number and description. In the first column, a Plus button associated with the message code indicates that related message codes with additional details are available.

Message Type

Displays the type of message code generated. The Configuration tab has four message types: • Alert

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• Critical • Informational • Notification Operator ID

Displays the identification of the operator logged onto the system when the message code was generated.

Function buttons Print

Displays the Print flyout.

Search

Displays the Search flyout.

Message Help

Displays Help from the operations manual for the selected message code.

Text Size

Increases or decreases the size of text displayed.

Related information... System Logs screen, page 1036 Descriptions of screen elements, page 140

System Logs screen, Interfaces tab element descriptions The Interfaces tab displays message codes related to host communications.

Elements button

Displays the Message Details For flyout.

Date/Time

Displays the date and time that the message code was generated.

Message

Displays the message code number and description. In the first column, a Plus button associated with the message code indicates that related message codes with additional details are available.

Message Type

Displays the type of message code generated. The Interfaces tab has four message types: • Alert

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• Critical • Informational • Notification Category

Displays the related message category. The Interfaces tab has three message categories: • Alinity PRO • Host • LAS

Function buttons Print

Displays the Print flyout.

Search

Displays the Search flyout.

Message Help

Displays Help from the operations manual for the selected message code.

Text Size

Increases or decreases the size of text displayed.

Related information... System Logs screen, page 1036 Descriptions of screen elements, page 140

System Logs screen, Abbott Mail tab element descriptions The Abbott Mail tab displays message codes related to Abbott Mail.

Elements button

Displays the Message Details For flyout.

Date/Time

Displays the date and time that the message code was generated.

Message

Displays the message code number and description. In the first column, a Plus button associated with the message code indicates that related message codes with additional details are available.

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Message Type

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Displays the type of message code generated. The Abbott Mail tab has four message types: • Alert • Critical • Informational • Notification

Mail Category

Displays the type of Abbott Mail item associated with the message code. The Abbott Mail tab has four mail categories: • Assay File • Assay Insert • System Update • Calibrator Data

Operator ID

Displays the identification of the operator logged onto the system when the message code was generated.

Function buttons Print

Displays the Print flyout.

Search

Displays the Search flyout.

Message Help

Displays Help from the operations manual for the selected message code.

Text Size

Increases or decreases the size of text displayed.

Related information... System Logs screen, page 1036 Descriptions of screen elements, page 140

System Logs screen, All Messages tab element descriptions The All Messages tab displays all message codes generated by the system. Message codes can be filtered by message types and message categories by selecting the appropriate tab.

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Elements button

Displays the Message Details For flyout.

Date/Time

Displays the date and time that the message code was generated.

Module

Displays the number of the module that generated the message code. The module number for messages associated with the system control module is 6.

Message

Displays the message code number and description. In the first column, a Plus button associated with the message code indicates that related message codes with additional details are available.

Message Type

Displays the type of message code generated. The All Messages tab has four message types: • Alert • Critical • Informational • Notification

Category

Displays the related message category. The All Messages tab has seven message categories: • Abbott Mail • Alinity PRO • Configuration • Host • Inventory • LAS • User Access

Function buttons Print

Displays the Print flyout.

Search

Displays the Search flyout.

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Message Help

Displays Help from the operations manual for the selected message code.

Text Size

Increases or decreases the size of text displayed.

Related information... System Logs screen, page 1036 Descriptions of screen elements, page 140

System Logs screen, Search flyout element descriptions In the Search flyout of the System Logs screen, the operator can enter specific data that is used to filter the data on the screen. The search criteria differ based on the specific tab of the System Logs screen. Thus, not all the following criteria (elements) are displayed on all tabs on the System Logs screen.

Elements Module

Displays a check box for each module in the system. Module 0 indicates the reagent and sample manager messages. Module 6 indicates the system control module.

Message Code

Displays a text box that is used to enter the message code number.

Message Type

Displays a check box for each message type. The following message type check boxes may be displayed: • Alert • Critical • Informational • Notification

Supply Name

Displays a drop-down list that is used to select a supply name. NOTE: This element is displayed only on the Inventory tab.

Mail Category

Displays a drop-down list that is used to select a mail category. The following mail category items may be provided in the drop-down list: • Assay File

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• Assay Insert • Calibrator Data • System Update NOTE: This element is displayed only on the Abbott Mail tab. Operator ID

Displays the identification of the operator logged onto the system when the message was generated.

Message Category

Displays a check box for each message category. The following message category check boxes may be displayed: • Abbott Mail • Alinity PRO • Configuration • Host • Inventory • LAS • User Access

Message Text

Displays a text box that is used to enter the message code text.

Message Class

Displays a check box for each message class. The following message class check boxes may be displayed:

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0001-0999

General message codes

1000-1999

Assay-specific message codes

2000-2999

Maintenance and diagnostic message codes

3000-3999

Level sense and fluidics message codes

4000-4999

Optics and bar code reader message codes

5000-5999

Robotics and sensor message codes

6000-6999

Support system message codes

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7000-7999

Temperature message codes

8000-8999

Computer hardware peripheral message codes

9000-9999

Software message codes

Date From

Displays a text box that is used to enter a search start date. To enter the search start date, tap the calendar inside the box. To configure the month and year, tap the Left Arrow or Right Arrow button, and then tap the day.

To

Displays a text box that is used to enter a search end date. To enter the search end date, tap the calendar inside the box. To configure the month and year, tap the Left Arrow or Right Arrow button, and then tap the day.

Time From

Displays a spin box that is used to enter a search start time. To enter the search start time, use the system-configured format (HH:MM) and type the time in the box or tap the Up Arrow and Down Arrow buttons. If the system is configured for the 12-hour clock format, tap the AM or PM button to configure the time of day.

To

Displays a spin box that is used to enter a search end time. To enter the search end time, use the system-configured format (HH:MM) and type the time in the box or tap the Up Arrow and Down Arrow buttons. If the system is configured for the 12-hour clock format, tap the AM or PM button to configure the time of day.

Function buttons Done

Saves changes and either displays the previously viewed screen or closes the flyout.

Cancel

Cancels selections or entries and displays the previously viewed screen or flyout.

?

Displays Help from the operations manual for the active screen, flyout, or message code.

Related information... System Logs screen, page 1036 Descriptions of message types, page 1049 1048

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Message Details For flyout element descriptions The Message Details For flyout displays additional message codes that provide detailed information related to the primary message code.

Elements Date/Time

Displays the date and time that the message code was generated.

Message Type

Displays the type of message code generated. The Message Details For flyout has four message types: • Alert • Critical • Informational • Notification

Message

Displays the message code number and description.

Function buttons ?

Displays Help from the operations manual for the active screen, flyout, or message code.

Related information... System Logs screen, page 1036

Descriptions of message types Message type information is used to determine the severity of a message code. The following list provides descriptions of the message types. The message types are described in the order in which they are sorted: Alert

The message is displayed in the Alert Center flyout and indicates a condition that affects the system's ability to generate results.

Critical

The message is displayed in a pop-up window and indicates a critical condition that requires immediate corrective action.

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Informational

The message is displayed only in system logs and indicates an additional message associated with an alert message or information that is tracked but does not require corrective action.

Notification

The message is displayed in the Alert Center flyout and indicates a condition that can affect the system's ability to generate results if the condition is not resolved.

Related information... System Logs screen, page 1036 System Logs screen, Search flyout element descriptions, page 1046 Log Report element descriptions, page 1666

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Section 10

Message codes Message codes are divided into 10 sections that reflect the major categories in which errors may occur. Probable causes and associated corrective actions are provided for each message code. If the corrective actions for a message code do not resolve the problem, contact the local representative or find country-specific contact information at abbottdiagnostics.com. NOTE: Corrective actions may involve hazardous activity. Use caution to minimize operator exposure and to prevent personal injury or system damage. Examples of hazardous activities include: • The replacement of system probes. • The use of reagents, calibrators, controls, and specimens. • The removal of physical obstructions. • The removal of system waste. Related information... Troubleshooting, page 1023 General message codes (0001-0999), page 1051 Assay-specific message codes (1000-1999), page 1108 Maintenance and diagnostic message codes (2000-2999), page 1173 Level sense and fluidics message codes (3000-3999), page 1199 Optics and bar code reader message codes (4000-4999), page 1259 Robotics and sensor message codes (5000-5999), page 1269 Support system message codes (6000-6999), page 1346 Temperature message codes (7000-7999), page 1346 Computer hardware peripheral message codes (8000-8999), page 1353 Software message codes (9000-9999), page 1378

General message codes (0001-0999) The general message code category includes message codes from 0001 through 0999. Related information... Message codes, page 1051 0106, page 1056 0108, page 1056 0109, page 1056 0110, page 1057 0117, page 1057

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0118, page 1057 0139, page 1057 0145, page 1058 0147, page 1058 0148, page 1058 0149, page 1059 0150, page 1059 0151, page 1059 0153, page 1060 0154, page 1060 0155, page 1060 0156, page 1061 0157, page 1061 0158, page 1061 0161, page 1062 0169, page 1062 0172, page 1062 0173, page 1063 0177, page 1063 0178, page 1063 0197, page 1063 0200, page 1064 0201, page 1064 0202, page 1064 0203, page 1064 0204, page 1065 0206, page 1065 0207, page 1066 0209, page 1066 0210, page 1066 0211, page 1066 0212, page 1067 0213, page 1067 0214, page 1067 0215, page 1067 0217, page 1068 0218, page 1068 0220, page 1068 0221, page 1069 1052

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0222, page 1069 0223, page 1069 0224, page 1069 0225, page 1070 0226, page 1070 0228, page 1070 0229, page 1071 0230, page 1071 0231, page 1071 0232, page 1071 0233, page 1072 0234, page 1072 0235, page 1072 0236, page 1072 0237, page 1073 0238, page 1073 0248, page 1073 0250, page 1074 0251, page 1074 0252, page 1074 0253, page 1074 0254, page 1075 0255, page 1075 0256, page 1075 0257, page 1075 0258, page 1076 0259, page 1076 0260, page 1076 0261, page 1077 0262, page 1077 0263, page 1077 0264, page 1077 0265, page 1078 0266, page 1078 0267, page 1078 0268, page 1079 0269, page 1079 0270, page 1079 0271, page 1080 Alinity ci‑series Operations Manual

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0272, page 1080 0273, page 1081 0274, page 1081 0300, page 1081 0301, page 1082 0302, page 1082 0303, page 1082 0304, page 1083 0305, page 1083 0306, page 1083 0307, page 1084 0308, page 1084 0309, page 1084 0310, page 1084 0321, page 1085 0328, page 1086 0331, page 1086 0335, page 1086 0336, page 1086 0337, page 1087 0338, page 1087 0339, page 1088 0340, page 1088 0341, page 1088 0342, page 1089 0343, page 1089 0344, page 1089 0348, page 1090 0357, page 1090 0358, page 1090 0600, page 1090 0601, page 1091 0602, page 1091 0603, page 1091 0604, page 1091 0605, page 1092 0606, page 1092 0607, page 1092 0608, page 1092 1054

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Troubleshooting Message codes

0622, page 1093 0623, page 1093 0626, page 1093 0627, page 1093 0628, page 1094 0656, page 1094 0657, page 1094 0658, page 1094 0659, page 1095 0660, page 1095 0661, page 1095 0662, page 1095 0663, page 1096 0664, page 1096 0665, page 1096 0666, page 1097 0667, page 1097 0679, page 1097 0680, page 1097 0681, page 1098 0682, page 1098 0683, page 1099 0684, page 1099 0685, page 1099 0686, page 1099 0689, page 1099 0690, page 1100 0691, page 1100 0692, page 1100 0693, page 1101 0694, page 1101 0695, page 1101 0696, page 1102 0697, page 1102 0698, page 1102 0699, page 1102 0700, page 1103 0701, page 1103 0702, page 1103 Alinity ci‑series Operations Manual

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0703, page 1103 0704, page 1104 0705, page 1104 0706, page 1104 0707, page 1104 0708, page 1104 0709, page 1105 0710, page 1105 0711, page 1105 0712, page 1106 0713, page 1106 0714, page 1106 0749, page 1107 0750, page 1107 0758, page 1107 0759, page 1107 0760, page 1108

Message code: 0106 Authentication failed. Operator ID (0) inactive. 0 = Operator ID Probable cause

Corrective action

An inactive operator ID was entered.

Status message. No corrective action is required.

Related information... General message codes (0001-0999), page 1051

Message code: 0108 Authentication failed. Operator ID (0) invalid. 0 = Operator ID Probable cause

Corrective action

An invalid operator ID was entered.

Enter the correct operator ID.

Related information... General message codes (0001-0999), page 1051

Message code: 0109 An unexpected error (0) occurred while exporting user data. 0 = Error description

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Section 10 Probable cause

Corrective action

User export failed because of an unexpected error. A specific error description is provided where available.

Review the specific message text. Perform the corrective action for the specific message text.

Related information... General message codes (0001-0999), page 1051

Message code: 0110 An unexpected error (0) occurred while importing user data. 0 = Error Probable cause

Corrective action

The data file is damaged or corrupted.

Repeat the data import procedure with a new file.

Software error.

Contact Customer Service. Provide information about the operation that was attempted when the error occurred.

Related information... General message codes (0001-0999), page 1051

Message code: 0117 Unable to retrieve log. Invalid log file type (0) or invalid log name (1). 0 = File type 1 = Log name Probable cause

Corrective action

The requested log file cannot be retrieved by Abbottlink. Contact Customer Service. Provide information about the operation that was attempted when the error occurred.

Related information... General message codes (0001-0999), page 1051

Message code: 0118 Authentication failed. (0) for operator ID (1) invalid. 0 = PIN or password 1 = Operator ID Probable cause

Corrective action

The authentication failed. The supplied credential was invalid.

Status message. No corrective action is required.

Related information... General message codes (0001-0999), page 1051

Message code: 0139 Unable to perform automatic system backup. Instrument is not in the correct status. Alinity ci‑series Operations Manual

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Probable cause

Corrective action

The instrument was not in the correct status for the automatic backup to be performed.

Perform a manual backup, page 382 or wait until the next scheduled automatic backup.

Related information... General message codes (0001-0999), page 1051

Message code: 0145 Unable to perform requested operation. Cuvette segment alignment tool detected in cuvette (0). 0 = Cuvette Probable cause

Corrective action

The cuvette segment alignment tool was not removed from the reaction carousel after a pipettor calibration procedure was performed.

1.

Remove the cuvette segment alignment tool from the reaction carousel.

2.

Place the cuvette segment into the position.

Water is present on the slotted edges of a cuvette segment.

Dry the slotted edge of the cuvette segment.

The cuvette tab is broken.

Replace the cuvette segments (c‑series), page 941.

Hardware failure.

Contact Customer Service to resolve any hardware failure.

Related information... General message codes (0001-0999), page 1051

Message code: 0147 Unable to perform requested operation. Remove racks from sample positioners on module (0). 0 = Module Probable cause

Corrective action

The initialization of the reagent and sample manager (RSM) failed.

Remove racks from the sample positioners, page 1464.

A physical interference is blocking the movement of the Locate and remove any physical obstruction. RSM. The module was unable to pick racks at the sample positioners.

Perform Sample Manager diagnostic procedure 1600 RSM Transport Calibration, page 917.

Hardware failure.

Contact Customer Service to resolve any hardware failure.

Related information... General message codes (0001-0999), page 1051

Message code: 0148 Run initialization failed.

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Section 10 Probable cause

Corrective action

Hardware failure.

Additional messages that are associated with this message can be used to determine the appropriate corrective action. View additional messages that are associated with a message, page 1034.

Related information... General message codes (0001-0999), page 1051

Message code: 0149 Unable to process test. Reagent cartridge unavailable. Probable cause

Corrective action

A reagent cartridge that was selected to be unloaded had scheduled tests in process.

1.

Load the required reagent cartridge. Perform Load cartridges on the reagent and sample manager (RSM), page 599.

2.

Rerun the test. Perform Rerun a test or an exception for a specimen or control, page 703.

Related information... General message codes (0001-0999), page 1051

Message code: 0150 Unable to process test. Previous processing module error. Probable cause

Corrective action

A processing module error occurred.

1.

Review the message log for messages that occurred at the same time as this message. Perform the corrective action.

2.

Rerun the test. Perform Rerun a test or an exception for a specimen or control, page 703.

Related information... General message codes (0001-0999), page 1051

Message code: 0151 Duplicate rack detected on module (0) position (1). 0 = Module 1 = Position Probable cause

Corrective action

A rack with a duplicate rack ID is already loaded on the system.

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Remove the second rack with the duplicate rack ID. After the first rack on the instrument with the duplicate rack ID is completed processing and is unloaded, the second rack can be reloaded.

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Section 10 Corrective action •

Load the samples from the rack with the duplicate rack ID into a rack with a different rack ID, and then load the rack on the reagent and sample manager.

Related information... General message codes (0001-0999), page 1051

Message code: 0153 Unable to process test. ICT Reference Solution empty. Probable cause

Corrective action

The ICT Reference Solution bottle is empty.

Load a new bottle and update the inventory. Perform Replace bulk solutions and update the inventory, page 579.

The Supplies screen was not updated when the ICT Reference Solution bottle was replaced.

Update the inventory. Perform Replace bulk solutions and update the inventory, page 579.

Hardware failure.

Contact Customer Service to resolve any hardware failure.

Related information... General message codes (0001-0999), page 1051

Message code: 0154 Unable to process test. Rack removed from RSM before access granted. Probable cause

Corrective action

The rack was removed from the reagent and sample manager (RSM).

1.

Rerun the test. Perform Rerun a test or an exception for a specimen or control, page 703.

2.

Reload the rack into the RSM.

Related information... General message codes (0001-0999), page 1051

Message code: 0155 Unable to load reagent cartridge in RSM position (0). No assay installed. 0 = RSM position Probable cause

Corrective action

The assay file is not installed on the system.

Install the assay. Perform Install assay files, page 325. NOTE: Assay files are available at abbottdiagnostics.com or can be requested through Abbott Mail.

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Related information... General message codes (0001-0999), page 1051

Message code: 0156 Unable to load reagent cartridge in RSM position (0). All reagent carousel positions are full. 0 = RSM position Probable cause

Corrective action

The reagent carousel is full.

1.

Unload a reagent cartridge before new reagent cartridges are loaded. Perform Unload racks and cartridges from a reagent carousel to the RSM, page 631.

2.

Load a new reagent cartridge. Perform Load cartridges on the reagent and sample manager (RSM), page 599.

Hardware failure.

Contact Customer Service to resolve any hardware failure.

Related information... General message codes (0001-0999), page 1051

Message code: 0157 Unable to load reagent cartridge in RSM position (0). Reagent cartridge empty. 0 = RSM position Probable cause

Corrective action

No tests or volume remain for the indicated reagent cartridge.

Load a new reagent cartridge or load a reagent cartridge that has tests or volume remaining. Perform Load cartridges on the reagent and sample manager (RSM), page 599.

Related information... General message codes (0001-0999), page 1051

Message code: 0158 Unable to perform requested operation. Remove rack from reagent positioner. Probable cause

Corrective action

A rack was found on the reagent positioner.

1.

Remove the rack from the reagent positioner.

2.

Reinitialize the reagent and sample manager. Perform Start the processing module and the reagent and sample manager (RSM), page 500.

Hardware failure.

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Contact Customer Service to resolve any hardware failure.

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Related information... General message codes (0001-0999), page 1051

Message code: 0161 Unable to process test. Water bath level low or temperature out of range. Probable cause

Corrective action

A water bath level or temperature error occurred while the test was being processed.

1.

Additional messages that are associated with this message can be used to determine the appropriate corrective action. View additional messages that are associated with a message, page 1034.

2.

Rerun the test. Perform Rerun a test or an exception for a specimen or control, page 703.

Related information... General message codes (0001-0999), page 1051

Message code: 0169 Reagent access cover removed. Probable cause

Corrective action

The reagent access cover was removed.

Replace the reagent access cover.

Reagent access cover sensor failure.

Contact Customer Service to resolve any hardware failure.

Related information... General message codes (0001-0999), page 1051

Message code: 0172 Unable to process test. Processing module not in Running status. Probable cause

Corrective action

The operator stopped the processing module before processing began.

Reinitialize the processing module. Perform Start the processing module and the reagent and sample manager (RSM), page 500.

Hardware failure.

1.

Review the message log for messages that occurred at the same time as this message. Perform the corrective action.

2.

Rerun the test. Perform Rerun a test or an exception for a specimen or control, page 703.

Related information... General message codes (0001-0999), page 1051

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Message code: 0173 Unable to process test. Reagent sample manager not in Running status. Probable cause

Corrective action

The operator stopped the reagent and sample manager Reinitialize the RSM. Perform Start the processing (RSM) before processing began. module and the reagent and sample manager (RSM), page 500. Hardware failure.

1.

Review the message log for messages that occurred at the same time as this message. Perform the corrective action.

2.

Rerun the test. Perform Rerun a test or an exception for a specimen or control, page 703.

Related information... General message codes (0001-0999), page 1051

Message code: 0177 Unable to perform automatic system backup. Automatic backup disabled. Probable cause

Corrective action

The automatic backup is disabled.

Enable the automatic backup. Perform Configure an automatic backup, page 240.

Related information... General message codes (0001-0999), page 1051

Message code: 0178 Invalid order for SID (0). Rack/position (1/2) already contains order for SID (3). 0 = SID 1 = Rack ID 2 = Position 3 = SID Probable cause

Corrective action

An order exists for the indicated rack and position.

Create an order that uses a different rack and position.

Related information... General message codes (0001-0999), page 1051

Message code: 0197 FSE logon required to complete initial system configuration settings. Probable cause

Corrective action

An FSE logon is required to change the module configuration.

Contact Customer Service.

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Related information... General message codes (0001-0999), page 1051

Message code: 0200 Unable to process test. Rack transport error. Probable cause

Corrective action

An error occurred with the RSM transport when a rack was transported.

Rerun the test. Perform Rerun a test or an exception for a specimen or control, page 703.

The rack is damaged.

Replace the damaged rack.

The RSM transport is out of alignment.

Perform Sample Manager diagnostic procedure 1600 RSM Transport Calibration, page 917.

Hardware failure.

Contact Customer Service to resolve any hardware failure.

Related information... General message codes (0001-0999), page 1051

Message code: 0201 Run request denied. Module is not in the correct status. Probable cause

Corrective action

An attempt was made to run the module when the system was in an incorrect instrument status.

Repeat the request to run the module when the system is in a status of Stopped, Idle, or Pausing.

Related information... General message codes (0001-0999), page 1051

Message code: 0202 Unable to process test. Process path disabled. Probable cause

Corrective action

An error occurred on the process path or pretreatment path.

1.

Review the message log for messages that occurred at the same time as this message. Perform the corrective action.

2.

Rerun the test. Perform Rerun a test or an exception for a specimen or control, page 703.

Related information... General message codes (0001-0999), page 1051

Message code: 0203 Processing module initialization failed. The unload access sensor is not detected.

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Section 10 Probable cause

Corrective action

The RV unloader was not detected during initialization.

The RV unloader is not installed. See Process path (Alinity i), page 107 to locate the RV unloader.

The RV unloader is not seated correctly.

Verify that the RV unloader is in the correct position. See Process path (Alinity i), page 107 to locate the RV unloader.

For the two-piece process path light cover, the RV Replace the RV unloader access piece of the process unloader access piece of the process path light cover is path light cover. Perform Remove and replace the twomissing. piece process path light cover (i‑series), page 995. For the two-piece process path light cover, the RV Verify that the RV unloader access piece of the process unloader access piece of the process path light cover is path light cover is in the correct position. Perform not seated correctly. Remove and replace the two-piece process path light cover (i‑series), page 995. Hardware failure.

Contact Customer Service to resolve any hardware failure.

Related information... General message codes (0001-0999), page 1051

Message code: 0204 Reagent access cover removed. Probable cause

Corrective action

The reagent access cover was removed.

Status message. Reagents in the reagent carousel are removed, scanned, and replaced.

Related information... General message codes (0001-0999), page 1051

Message code: 0206 Unable to execute command. Operator requested Stop or hardware error. Probable cause

Corrective action

The operator transitioned the instrument to the Stopped 1. status. 2.

Resolve the reason the instrument was transitioned to the Stopped status. Start the processing module and the reagent and sample manager (RSM), page 500.

Communication error.

Review the message log for messages that occurred at the same time as this message. Perform the corrective action.

Hardware failure.

Contact Customer Service to resolve any hardware failure.

Related information... General message codes (0001-0999), page 1051

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Message code: 0207 Start initialization failed. Probable cause

Corrective action

Hardware failure.

Additional messages that are associated with this message can be used to determine the appropriate corrective action. View additional messages that are associated with a message, page 1034.

Related information... General message codes (0001-0999), page 1051

Message code: 0209 Start or Run initialization failed. Probable cause

Corrective action

Hardware failure.

Additional messages that are associated with this message can be used to determine the appropriate corrective action. View additional messages that are associated with a message, page 1034.

Related information... General message codes (0001-0999), page 1051

Message code: 0210 Module transitioning to Pausing status. (0) failed. 0 = Mechanism Probable cause Hardware failure.

Corrective action • •

Review the specific message text. Perform the corrective action for the specific message text. Contact Customer Service to resolve any hardware failure.

Related information... General message codes (0001-0999), page 1051

Message code: 0211 Rack detected at module (1) position (0). Remove rack. This position is not available. 0 = Position 1 = Module Probable cause

Corrective action

A rack was loaded in a position that is already in use.

Remove the rack that was loaded in a position that is already in use.

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Section 10

Related information... General message codes (0001-0999), page 1051

Message code: 0212 Rack ID (0) removed from module (2) position (1) before access granted. 0 = Rack ID 1 = Position 2 = Module Probable cause

Corrective action

The rack was removed before access was granted.

Tests with a scheduled status become exceptions. Reorder the tests.

Related information... General message codes (0001-0999), page 1051

Message code: 0213 Unable to load reagent cartridge in RSM position (0). Reagent cartridge is for the (1) processing module. 0 = RSM position 1 = Module Probable cause

Corrective action

No processing module is available for the reagent type.

Load a new reagent cartridge for the correct module type.

Related information... General message codes (0001-0999), page 1051

Message code: 0214 Unable to process test. Sample diluent insufficient or not available. Probable cause

Corrective action

The required sample diluent is empty or expired.

Load a new onboard solution cartridge. Perform Load onboard solutions and sample diluents on the reagent and sample manager (RSM) (c‑series), page 604.

Related information... General message codes (0001-0999), page 1051

Message code: 0215 Unable to process test. Reagent cartridge for assay number (0) version (1) has insufficient volume or is unusable. 0 = Assay number 1 = Assay version

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Probable cause

Corrective action

The indicated reagent cartridge is empty or expired.

Load a new reagent cartridge. Perform Load cartridges on the reagent and sample manager (RSM), page 599.

The calibration has exceeded the expiration date for the Calibrate the reagent lot again. assay.

Related information... General message codes (0001-0999), page 1051

Message code: 0217 Unable to create order for sample in rack ID (0). Position ordered (2) does not match position scanned (1). 0 = Rack ID 1 = Position scanned 2 = Position ordered Probable cause

Corrective action

The control sample was found in a different position in the rack.

Verify that the control sample is in the correct position in the rack.

Related information... General message codes (0001-0999), page 1051

Message code: 0218 Unable to process test. Module (0) not available. 0 = Module Probable cause

Corrective action

The processing module transitioned to a status of Offline or Stopped when tests were in process.

Start the processing module and the reagent and sample manager (RSM), page 500.

Related information... General message codes (0001-0999), page 1051

Message code: 0220 No pending orders found for SID (0) in rack ID (1) position (2). 0 = SID 1 = Rack ID 2 = Position Probable cause

Corrective action

No orders were found for a bar-coded sample.

Create an order for the bar-coded sample.

Related information... General message codes (0001-0999), page 1051

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Message code: 0221 Priority order for SID (0) in rack ID (1) position (2) loaded in RSM routine position. SID will not be processed as priority sample. 0 = SID 1 = Rack ID 2 = Position Probable cause

Corrective action

Samples that are designated as STAT must be priority loaded to be processed as STAT samples.

Load STAT samples in a priority position of the reagent and sample manager.

Related information... General message codes (0001-0999), page 1051

Message code: 0222 Module initialization failed after fault condition detected. Probable cause

Corrective action

The initialization failed.

Cycle power to the processing module and the reagent and sample manager (RSM), page 484.

Hardware failure.

Contact Customer Service to resolve any hardware failure.

Related information... General message codes (0001-0999), page 1051

Message code: 0223 Unable to process test. Instrument status is not Running or Processing. Probable cause

Corrective action

The processing module is no longer in the Running status or the Processing status.

To transition the instrument status of the processing module to Running, perform Initiate or resume sample processing, page 648 for the appropriate module.

Related information... General message codes (0001-0999), page 1051

Message code: 0224 Run request denied. RV waste container not present. Probable cause

Corrective action

The RV waste container is not present in a processing module.

Replace the RV waste container.

Related information... General message codes (0001-0999), page 1051

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Message code: 0225 Unable to process test. Hardware error or operator requested Stop. Probable cause

Corrective action

The operator transitioned the instrument status to Stopped.

1.

Resolve the reason that the instrument status was transitioned to Stopped.

2.

Start the processing module and the reagent and sample manager (RSM), page 500.

3.

Rerun a test or an exception for a specimen or control, page 703.

1.

Review the message log for messages that occurred at the same time as this message. Perform the corrective action.

2.

Rerun a test or an exception for a specimen or control, page 703.

Hardware failure.

Related information... General message codes (0001-0999), page 1051

Message code: 0226 Reagent access cover removed. Probable cause

Corrective action

The reagent access cover is missing.

1.

Replace the reagent access cover.

2.

Start the processing module and the reagent and sample manager (RSM), page 500.

The reagent access cover sensor failed.

Contact Customer Service to resolve any hardware failure.

Related information... General message codes (0001-0999), page 1051

Message code: 0228 Rack or cartridge detected on module (0) RSM position (1) without a tray. 0 = Module 1 = RSM position Probable cause

Corrective action

A rack or cartridge was detected on the loading area without a tray.

Remove the rack or cartridge from the loading area. Place the rack or cartridge in a tray, and then load the tray on the reagent and sample manager of the processing module.

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Section 10

Related information... General message codes (0001-0999), page 1051

Message code: 0229 Tray on module (0) bay (1) removed before access was granted. 0 = Module 1 = RSM bay Probable cause

Corrective action

The tray was removed from the loading area of the processing module before access was granted.

Load the tray into the bay indicated on the processing module. Do not remove trays before access is granted.

Related information... General message codes (0001-0999), page 1051

Message code: 0230 Unable to process test. Control lot expired. Probable cause

Corrective action

The control is expired.

Load a new control.

Related information... General message codes (0001-0999), page 1051

Message code: 0231 Number of unreleased results reached limit. New orders will not be accepted. Probable cause

Corrective action

The limit of the number of unreleased results has been reached.

Delete or release results, controls, or exceptions before new orders are created. Perform Delete a sample result or an exception, page 727 and Transmit a result or an exception to the host, page 727.

Related information... General message codes (0001-0999), page 1051

Message code: 0232 Unable to process test. Sample removed from system. Probable cause

Corrective action

The rack or tray was removed from the reagent and 1. sample manager (RSM) before the access indicator was activated. 2.

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Load the rack on the RSM. Perform Load racks on the reagent and sample manager (RSM), page 595. Rerun the exception. Perform Rerun a test or an exception for a specimen or control, page 703.

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Section 10

Related information... General message codes (0001-0999), page 1051

Message code: 0233 Unable to process test. Reagent onboard solution cartridge empty. Probable cause

Corrective action

The R1 onboard solution cartridge is empty.

Load a new onboard solution cartridge. Perform Prepare onboard solutions (c‑series), page 625 or Load onboard solutions and sample diluents on the reagent and sample manager (RSM) (c‑series), page 604.

Related information... General message codes (0001-0999), page 1051

Message code: 0234 Unable to process test. Reagent onboard solution cartridge empty. Probable cause

Corrective action

The R2 onboard solution cartridge is empty.

Load a new onboard solution cartridge. Perform Prepare onboard solutions (c‑series), page 625 or Load onboard solutions and sample diluents on the reagent and sample manager (RSM) (c‑series), page 604.

Related information... General message codes (0001-0999), page 1051

Message code: 0235 RSM load error for a two-cartridge reagent set. Unload reagent cartridges in RSM positions (0) and (1). 0 = RSM position 1 = RSM position Probable cause

Corrective action

A two-cartridge reagent set did not load successfully.

Unload and reload the reagent cartridges from the reagent and sample manager. Perform Load cartridges on the reagent and sample manager (RSM), page 599.

A reagent cartridge is damaged.

Load a new reagent cartridge. Perform Load cartridges on the reagent and sample manager (RSM), page 599.

Hardware failure.

Contact Customer Service to resolve any hardware failure.

Related information... General message codes (0001-0999), page 1051

Message code: 0236 Number of unreleased results reached 90% of the allowable limit.

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Corrective action

The number of unreleased results reached 90% capacity.

Release or delete unreleased specimen results, control results, or exceptions on the system. Perform Delete a sample result or an exception, page 727.

Related information... General message codes (0001-0999), page 1051

Message code: 0237 Unable to process test. Reagent cartridge unavailable. Probable cause

Corrective action

A reagent cartridge was scheduled to be unloaded when 1. tests were in process. 2.

3.

Prepare reagent cartridges, page 622. Load a new reagent cartridge for the assay. Perform Load cartridges on the reagent and sample manager (RSM), page 599. Rerun the exception. Perform Rerun a test or an exception for a specimen or control, page 703.

Related information... General message codes (0001-0999), page 1051

Message code: 0238 Unable to perform requested operation. Remove rack from reagent positioner. Probable cause

Corrective action

A rack was found on the reagent positioner.

Remove the rack from the reagent positioner. Perform Start the processing module and the reagent and sample manager (RSM), page 500.

Hardware failure.

Contact Customer Service to resolve any hardware failure.

Related information... General message codes (0001-0999), page 1051

Message code: 0248 Unable to add order. SID (0) exists with different sample type. 0 = SID Probable cause

Corrective action

An order exists for the SID that uses a different sample type (calibrator, control, or specimen).

Create a new order that uses the correct sample type. Perform Create a single specimen order, page 682.

Related information... General message codes (0001-0999), page 1051

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Message code: 0250 Unable to update order for SID (1). Manual dilution factor (0) is different than manual dilution factor for pending order. 0 = Manual dilution 1 = SID Probable cause

Corrective action

The manual dilution that was entered for the current order is different from the manual dilution that was entered for the pending order.

Enter the same manual dilution that was entered for the pending order. Perform Create a single specimen order, page 682.

Related information... General message codes (0001-0999), page 1051

Message code: 0251 Invalid order. Calibration order already exists for SID (0) in rack ID/position (1/2). 0 = SID 1 = Rack ID 2 = Position Probable cause

Corrective action

A calibration order already exists for the rack ID and position.

Create the calibration order using a different rack ID and position. Perform Create a calibration order, page 688.

Related information... General message codes (0001-0999), page 1051

Message code: 0252 Invalid order. SID (0) exists for previously ordered sample. 0 = SID Probable cause

Corrective action

An attempt was made to create a new order for an SID without a rack ID and position. An order already exists for the SID.

Create the new order for the SID with a different rack ID and position. Perform Create a single specimen order, page 682.

The system received an order from the host for an SID that is the starting SID for an existing batch order. The host order is ignored by the system.

1.

Wait until the batch order is completed.

2.

Load the sample rack with the SID for the host order.

Related information... General message codes (0001-0999), page 1051

Message code: 0253 Unable to create order. HIL replicate or calculated assay (0) already exists for sample. 0 = HIL or calculated assay

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Section 10 Probable cause

Corrective action

An attempt was made to order a replicate for HIL or a calculated assay when an order already exists.

Complete the test for the existing order before the replicate is ordered.

Related information... General message codes (0001-0999), page 1051

Message code: 0254 Duplicate rack ID (0) detected. 0 = Rack ID Probable cause

Corrective action

The rack ID is already loaded on the reagent and sample manager (RSM).

Load the samples in a rack with a different rack ID and load the rack on the RSM.

Related information... General message codes (0001-0999), page 1051

Message code: 0255 Sample with pending priority order loaded in rack ID (0) position (1). 0 = Rack ID 1 = Position Probable cause

Corrective action

Samples that are designated as STAT must be priority loaded to be processed as STAT samples.

Load STAT samples in a priority position of the reagent and sample manager.

Related information... General message codes (0001-0999), page 1051

Message code: 0256 A tray has been removed from the RSM on module (0) that is needed to place the rack back in RSM position (1). 0 = Module 1 = RSM position Probable cause

Corrective action

A tray with racks in process has been removed from the Load trays on the reagent and sample manager (RSM), reagent and sample manager (RSM). page 594.

Related information... General message codes (0001-0999), page 1051

Message code: 0257 (0) cover opened when module status is Running or Processing. 0 = Processing center cover

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Probable cause

Corrective action

A processing center cover was opened.

1.

Close the processing center cover.

2.

Perform Start the processing module and the reagent and sample manager (RSM), page 500.

Hardware failure.

Contact Customer Service to resolve any hardware failure.

Related information... General message codes (0001-0999), page 1051

Message code: 0258 RSM stopped. Front processing center cover opened. Probable cause

Corrective action

A front processing center cover was opened while the reagent and sample manager was in a Running status.

1.

Close the processing center cover.

2.

Perform Start the processing module and the reagent and sample manager (RSM), page 500.

Hardware failure.

Contact Customer Service to resolve any hardware failure.

Related information... General message codes (0001-0999), page 1051

Message code: 0259 Unable to delete all selected results. Result is either a constituent of a calculated assay or pending transmission to the host. Probable cause

Corrective action

An attempt was made to delete an assay that is a constituent assay for a calculated assay.

• •

Delete or edit the calculated assay before the constituent assay is deleted. Wait until the results have been transmitted to the host before the results are deleted.

Related information... General message codes (0001-0999), page 1051

Message code: 0260 Unable to process test. Calculated result exceeds limits. Probable cause

Corrective action

A calculated result cannot be computed. The result exceeds the numerical limit of the software.

Modify the calculated result formula or the constituent assay ranges. Perform Create a calculated assay, page 302.

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Related information... General message codes (0001-0999), page 1051

Message code: 0261 Tray in bay (1) on module (0) has been unexpectedly removed. 0 = Module 1 = Bay Probable cause

Corrective action

A tray with racks in process was removed from the reagent and sample manager (RSM) before the access indicator was activated.

1.

Restart the RSM. Perform Start the processing module and the reagent and sample manager (RSM), page 500.

2.

Load trays on the reagent and sample manager (RSM), page 594.

A tray is defective.

Replace the tray.

Related information... General message codes (0001-0999), page 1051

Message code: 0262 A retest rule with the same name is already defined. Probable cause

Corrective action

The name of the retest rule already exists.

Use a different name for the retest rule.

Related information... General message codes (0001-0999), page 1051

Message code: 0263 Operator ID (0) changed one or more module configuration parameters for module (1). 0 = Operator ID 1 = Module Probable cause

Corrective action

A change was made to the module configuration.

Status message. No corrective action is required.

Related information... General message codes (0001-0999), page 1051

Message code: 0264 Unable to create retest order. Assay not longer available on system. Probable cause

Corrective action

An assay that is required for a retest is not loaded on the system.

Install the assay. Perform Install assay files, page 325.

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Section 10 Corrective action NOTE: Assay files are available at abbottdiagnostics.com or can be requested through Abbott Mail.

Related information... General message codes (0001-0999), page 1051

Message code: 0265 Unable to add order. Insufficient positions in rack ID (0) for all calibrators. 0 = Rack ID Probable cause

Corrective action

The number of positions required for the calibration exceeds the number of available positions in the rack.

Create the calibration order using a rack with the required number of available positions. Perform Create a calibration order, page 688.

Related information... General message codes (0001-0999), page 1051

Message code: 0266 Run request denied. Reagent cartridges or racks are currently being loaded or unloaded from the reagent carousel. Probable cause

Corrective action

Reagent cartridges or