Maual de Operare Cobas 411 PDF [PDF]

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cobas e 411 analyzer Operator’s Manual Software Version 02-02 & 02-03

cobas e 411 analyzer

Revision history

Edition notice

Document

Software

Revision

Version

Version

date

1.0

01-01

31.11.2006

1.1

01-01

01.06.2007

Template Updated Changes from Addendum incorporated

2.0

02-01

01.06.2008

Added new software and analyzer functions. Collated Direct Drain descriptions in Appendix

2.1

02-02 & 02-03

11.06.2010

New error information storage feature; updates to reflect changes to screens; added addenda and RD; updated templates and presentation of safety information.

Language

Order Number

English

0490 5148 018

French

0490 5148 080

German

0490 5148 001

Italian

0490 5148 050

Portuguese

0490 5148 046

Spanish

0490 5148 036

Changes

cobas e 411 analyzer Operator’s Manual This document is for users of the cobas e 411 analyzer. Every effort has been made to ensure that all the information contained in this manual is correct at the time of printing. However, Roche Diagnostics GmbH reserves the right to make any changes necessary without notice as part of ongoing product development. Any customer modification to the instrument will render the warranty or service agreement null and void. For warranty conditions, refer to the analyzer purchase agreement. Contact your local Roche Diagnostics representative for further information. Software updates are done by Roche Diagnostics representatives.

Intended use

Copyrights Trademarks

The cobas e 411 analyzer is an automated, random-access, multichannel analyzer for immunological analysis. It is designed for both quantitative and qualitative in vitro determination of a wide range of analytes by use of electrochemiluminescence (ECL) technology. © 2001-2010, Roche Diagnostics GmbH. All rights reserved. COBAS, COBAS C, COBAS E, ELECSYS, and LIFE NEEDS ANSWERS are trademarks of Roche. All other trademarks are the property of their respective owners.

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Instrument approvals

The cobas e 411 analyzer meets the requirements of Directive 98/79/EC of the European Parliament and the Council of the European Union (EU) on in vitro diagnostic medical devices. Furthermore, the cobas e 411 analyzer is manufactured and tested according to International Standard IEC 61010-1, 2nd edition, “Safety requirements for electrical equipment for measurement, control and laboratory use, Part 1: General requirements”. This International Standard is equivalent to the national standards Underwriters Laboratories (UL) 61010-1 2nd edition for the USA, and CAN/CSA C22.2 No. 61010-1:2004 for Canada. Compliance is demonstrated by the following marks: Complies with the IVD directive 98/79/EC.

Issued by Underwriters Laboratories, Inc. (UL) for Canada and the US.

C

®

US

The analyzer complies with the emission and immunity requirements described in the following standard: IEC 61326-2-6:2005 (Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment)

Contact addresses Manufacturer

Hitachi High-Technologies Corporation 24-14. Nishi-shimbashi. 1-chome. Minato-ku Tokyo. 105-8717 JAPAN

Authorized representative

Roche Diagnostics GmbH Sandhofer Strasse 116 D-68305 Mannheim Germany

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Table of contents Revision history Contact addresses Table of contents Preface

System description

2 3 5 7

Part A

1 General safety information

Safety classifications Safety precautions Safety summary Safety labels on the system 2 System overview Overview of the cobas e 411 analyzer

System components System specifications

A-5 A-6 A-8 A-15

A-23 A-25 A-33

3 Control unit

Components Software basics

A-51 A-56

4 Analyzer components

Overview of the analyzer components Sample/reagent area components Consumables area components Measuring area components

A-67 A-68 A-84 A-90

How to change the sample disk mode How to add a new operator ID How to change documentation settings How to program calculated tests How to define a reagent level How to define a new profile How to install Roche calibrators How to install and define Roche controls How to install and define non-Roche controls How to edit control target values and ranges How to request stand-by bottle QC How to assign calibrator and control positions How to upload results manually How to print two or more samples in Data Review How to export data manually How to rerun a sample manually How to delete a single open request How to print reports, lists and traces How to back up and restore the database How to reset the system How to shut down the analyzer

Maintenance

B-103 B-104 B-105 B-106 B-107 B-108 B-109 B-111 B-113 B-115 B-116 B-117 B-119 B-120 B-121 B-122 B-123 B-124 B-127 B-129 B-130

Part C

8 Safety information for maintenance 9 Maintenance

Operation

Part B

5 Safety information for operation 6 Daily operation

Overview Pre-start inspection Startup procedures Pre-routine operation Routine operation Results Post-operation data management Daily maintenance Switch off the analyzer

B-9 B-11 B-11 B-16 B-30 B-82 B-87 B-88 B-88

7 Special operation: How to…

Introduction B-93 How to apply barcode labels to tubes and vials B-93 How to change test settings B-95 How to change QC violation settings B-97 How to activate and apply auto masking B-98 How to define rack ranges B-100 How to use sample reception mode B-101

Introduction Maintenance schedule Maintenance log Daily maintenance Weekly maintenance Every two weeks maintenance Every two months maintenance As needed maintenance

Troubleshooting

C-7 C-11 C-13 C-16 C-18 C-22 C-28 C-34

Part D

10 Troubleshooting

Introduction Alarms Problem categories Contacting Technical Support Basic troubleshooting flow chart Immunoassay troubleshooting Instrument troubleshooting Chemistry troubleshooting

D-5 D-5 D-5 D-8 D-10 D-11 D-15 D-23

11 Data alarms

Introduction

D-33

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List of data alarms Data alarms Data problems without an alarm Instrument problems without an alarm

Appendix

D-34 D-35 D-46 D-48

Part E

12 Direct drain

Safety information Overview Pre-routine operation Maintenance Troubleshooting

E-5 E-6 E-8 E-9 E-12

13 Technical support information form

Glossary Glossary

Index Index

Notes

Part F F-3

Part G G-3

Part H

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Preface The Roche Diagnostics cobas e 411 analyzer is a fully automated, random-access, software controlled system for immunoassay analysis. It is available as both a disk system and a rack system. The differences between the two configurations are detailed throughout this document. The cobas e 411 analyzer was designed for both quantitative and qualitative in vitro determination of analytes in body fluids using a wide variety of tests. Both disk and rack systems have a throughput of approximately 85 tests per hour. The cobas e 411 analyzer can be placed on a bench top, so saving space in the laboratory environment. Handling of the system is easy; potential for manual errors is reduced to a minimum. All assay reagent, calibrator, and control information is automatically entered into the software through the use of barcodes and e-barcodes. The system consists of the analyzer, which performs all functions required for fully automated sample and assay processing, and a control unit, which controls the analyzer through the user software. This entirely automated process begins with the recording of patient samples—provided that they are in barcode labeled tubes—up to the electrochemiluminescence detection and results transmission. Data transmission to and from the analyzer, results evaluation, documentation, and quality control are performed automatically by the software. Also, the software is responsible for the management of data between a connected an LIS/PSM (PreAnalytic Systems Manager) and the cobas e 411 analyzer. Several cobas e 411 analyzers can be centrally controlled when integrated with PSM. Pre-Analytic Systems Manager is not available in the United States of America.

This document has detailed descriptions of cobas e 411 analyzer features and general operational concepts, specification functions and use of controls, operating techniques, emergency procedures, product labeling, and maintenance procedures. Keep this manual in a safe place to ensure that it is not damaged and remains available for use.

Where to find information The information you need to operate the cobas e 411 analyzer is supplied in several printed or online publications. Operator’s Manual

The Operator’s Manual contains information about safety, hardware, and operating the system, as well as maintenance and troubleshooting. A table of contents at the beginning of the book and each chapter, and an index at the end of this book help you to find information quickly.

Online Help

The online Help contains a detailed description of the software of the cobas e 411 analyzer. The contents of the Operator’s Manual is also included in the online Help.

Short guide

The short guide is designed to complement your Operator’s Manual. It tells you exactly what is necessary to operate the analyzer without the level of detail found in the Operator’s Manual.

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COBI-CD

The COBI-CD (Compendium of Background Information) provides you with background information about the technologies, test principles, their theory, and the calibration methods used by the cobas e 411 analyzer. The information can be read and printed using Adobe Acrobat Reader. You cannot use the COBI-CD on the cobas e 411 analyzer because the COBI-CD requires Adobe Acrobat Reader to be viewed correctly. Adobe Acrobat Reader is not installed on the control unit and such third-party software must not be installed. For essential safety information, see Third-party software on page A-7.

Online Help system The cobas e 411 analyzer has a context-sensitive online Help to aid in operating the analyzer. “Context-sensitive” means that wherever you are located in the software, choosing the Help feature displays Help text or a screen picture relating to that area of the software. The online Help offers a quick and convenient way to find information, such as explanations of screens and windows and how to perform particular processes. a To display the online Help 1 You can display Help from any screen. However, if you wish to see Help information about a particular screen, display that screen on the monitor first. 2 Choose ? Help at the bottom left of the screen. The Help window opens displaying information concerning the current software screen or window. 3 If the Help information displayed initially does not answer your questions, use the contents, index, or search tab to locate more appropriate information.

Customer information Customer training

Contact your local Roche service representative for any questions or information regarding cobas e 411 analyzer training and training material.

Customer service

Contact your local Roche service representative for further information regarding the cobas e 411 analyzer service agreement.

Ordering information

Replacement parts, consumable materials, reagents, calibrators, and controls should be ordered from Roche Diagnostics. When ordering, please use the Roche Diagnostics catalog number and reference name for each item. Contact your local Roche service representative for the detailed ordering list.

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Conventions used Visual cues help you to locate and interpret information in this document. This section explains the formatting conventions used. Symbols

The following symbols are used: Symbol

Used for

a

Start of procedure

o

List item

e

Cross-reference

h

Call-up (software reference) Tip Safety alert

Electrical and electronic equipment marked with this symbol are covered by the European directive WEEE. The symbol denotes that the equipment must not be disposed of in the municipal waste system. Disk system-specific

Rack system-specific

Abbreviations

The following abbreviations are used: Abbreviation

Definition

A

ANSI

American National Standards Institute

C

CCITT

Comité consultatif international téléphonique et télégraphique (Consultative Committee on International Telegraph and Telephone)

CE

Conformité Européenne

CLIA

Clinical Laboratory Improvement Amendments

CLSI

Clinical and Laboratory Standards Institute

COBI-CD

Compendium of Background Information

CSA

Canadian Standards Association

D

dBA

decibel weighted against the A-frequency response curve. This curve approximates the audible range of the human ear.

DIL

diluent

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Abbreviation

Definition

E

EC

european Community

ECL

electrochemiluminescence

EMC

electromagnetic compatibility

EN

european standard

F

FIFO

first in first out

H

HCFA

Health Care Financing Administration

I

IEC

International Electrical Commission

IVD

in vitro diagnostic directive

K

KVA

kilovolt-Ampere. Unit for expressing the power rating of AC electrical machinery.

L

LDL

lower detection limit see analytical sensitivity

LIS

laboratory information system

LLD

liquid level detection

M

MSDS

material safety data sheet

P

PC/CC

ProCell/CleanCell

PSM

Pre-Analytic Systems Manager

Q

QC

quality control

S

SD

standard deviation

S/R

sample/reagent

STAT

Short Turn Around Time

SVGA

Super Video Graphics Adapter

T

TPA

tripropylamine

TSN

TeleService-Net

U

UL

Underwriters Laboratories Inc.

V

VDE

Use of example screens

Verband Deutscher Elektrotechniker (association of German electrical engineers)

This document includes examples of screens from the cobas e 411 analyzer software. The equivalent screens might be different on your analyzer because the appearance of a screen depends on the specific configuration of an instrument and on the access level of the person operating it.

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A

1

General safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . A–3

2

System overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A–21

3

Control unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A–49

4

Analyzer components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A–65

cobas e 411 analyzer

1 General safety information Table of contents

General safety information

Before operating the cobas e 411 analyzer, it is essential that you read and understand the warnings, cautions, and safety requirements contained in this document. The following safety precautions and instructions are intended for operators and also for anyone responsible for the management of the analyzer.

In this chapter

Chapter

1

Safety classifications ........................................................................................................ A–5 Safety precautions ........................................................................................................... A–6 Operator qualification .............................................................................................. A–6 Safe and proper use of the analyzer ........................................................................ A–6 Miscellaneous safety precautions ............................................................................ A–7 Safety summary ............................................................................................................... A–8 Warning messages .................................................................................................... A–8 Caution messages .................................................................................................... A–11 Notices ...................................................................................................................... A–14 Safety labels on the system ........................................................................................... A–15 Analyzer unit ........................................................................................................... A–15 Power supply ........................................................................................................... A–18 Electromagnetic compatibility (EMC) ................................................................ A–20 Peripheral device connections .............................................................................. A–20 Disposal of the analyzer ......................................................................................... A–20

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Table of contents

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1 General safety information Safety classifications

Safety classifications This section explains how precautionary information is presented in this document. The safety precautions and important user notes are classified according to the ANSI Z535.6 Standard. Familiarize yourself with the following meanings and icons: The safety alert symbol by itself without a signal word is used to promote awareness to hazards which are generic or to direct the reader to safety information provided elsewhere in the document.

These symbols and signal words are used for specific hazards: WARNING WARNING

Indicates a hazardous situation which, if not avoided, could result in death or serious injury. CAUTION

CAUTION NOTICE

Indicates a hazardous situation which, if not avoided, could result in minor or moderate injury. NOTICE Indicates a hazardous situation which, if not avoided, could result in damage to equipment. e For more information about the product safety labels, see

Safety labels on the system on page A-15

Important information which is not safety relevant is indicated by the following symbol: Tip Indicates additional information on correct use of the analyzer or useful tips.

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Safety precautions

Safety precautions

Particular attention must be paid to the following safety precautions. If these safety precautions are ignored, the operator may suffer serious or fatal injury. Each precaution is important.

Operator qualification Operators are required to have a sound knowledge of relevant guidelines and standards as well as the information and procedures contained in the Operator’s Manual. o

Do not carry out operation and maintenance unless you have been trained by Roche Diagnostics.

o

Carefully follow the procedures specified in the Operator’s Manual for the operation and maintenance of the analyzer.

o

Leave maintenance, installation or service that is not described in the Operator’s Manual to trained Roche service personnel.

o

Follow standard laboratory practices, especially when working with biohazardous material.

Safe and proper use of the analyzer Personal protective equipment

Accuracy/precision of measured results

Installation

Operating conditions

o

Be sure to wear appropriate protective equipment, including, but not limited to, safety glasses with side shields, fluid resistant lab coat, and approved disposable gloves.

o

Wear a face shield if there is a chance of splash or splatter.

o

An incorrect measuring result may lead to an error in diagnosis, therefore posing danger to the patient.

o

For proper use of the instrument, measure control samples and monitor the instrument during operation.

o

Do not use reagents that have exceeded their expiration date, otherwise inaccurate data may be obtained.

o

For diagnostic purposes always assess the results in conjunction with the patient’s medical history, clinical examination, and other findings.

o

Installation must be performed by trained Roche service personnel only.

o

Leave installation that is not described in the Operator’s Manual to trained Roche service personnel. Follow the described installation instructions carefully.

o

Operation outside of the specified ranges may lead to incorrect results or malfunction of the instrument (see System specifications on page A-33).

o

Use the instrument indoors only and avoid heat and humidity.

o

Make sure that the analyzer's ventilation openings remain unobstructed at all times.

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1 General safety information Safety precautions

Approved parts

Third-party software

o

Perform maintenance according to the specified intervals to maintain the operating conditions of the instrument.

o

Keep the Operator’s Manual in a safe place to ensure that it is not damaged and remains available for use. This manual must be easily accessible at all times.

Use of non-approved parts or devices may result in malfunction and may render the warranty null and void. Only use parts and devices approved by Roche Diagnostics. Installation of any third-party software that is not approved by Roche Diagnostics may result in incorrect behavior of the analyzer. Do not install any non-approved software.

Miscellaneous safety precautions Power interruption

A power failure or momentary drop in voltage may damage the analyzer or lead to data loss. Perform regularly backups of measurement results. Operate only with an uninterruptible power supply. Do not switch off power while the control unit accesses its memory or connected storage device.

Electromagnetic fields

Devices that emit electromagnetic waves may cause the instrument to malfunction. Do not operate the following devices in the same room where the analyzer is installed: o

Mobile phone

o

Transceiver

o

Cordless phone

Other electrical devices that generate electromagnetic fields. Instrument unused for an extended period of time

Relocation and transportation

If the instrument is not used for an extended period of time, the main circuit breaker switch must be set to OFF. Remove and refrigerate any remaining reagents. For further information, call technical support. Do not attempt to relocate or transport the analyzer. Leave relocation and transportation to personnel trained or authorized by Roche. e For information about disposal of the analyzer, see:

Disposal of the analyzer on page A-20

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Safety summary

Safety summary This safety summary contains the most important and general warning and caution messages. Additionally, you will find specific safety information at the beginning of Part Operation and Part Maintenance.

Warning messages List of warning messages WARNING

Before operating the analyzer, read the warning messages contained in this summary carefully. Failure to observe them may result in death or serious injury.

Electrical safety Electrical shock by electronic equipment Removing the covers of electronic equipment can cause electric shock, as there are high voltage parts inside. In addition, opening the top cover and touching the microbead mixer during operation can also cause electrical shock. o

Do not attempt to work in any electronic compartment.

o

Do not remove any cover of the instrument other than those specified in this Operator’s Manual.

o

Do not open the top cover and touch the microbead mixer during operation or when the analyzer performs maintenance.

o

Installation, service, and repair must only be performed by personnel authorized and qualified by Roche.

o

Observe the system safety labels illustrated on pages A-15 to A-19.

Disconnecting the power supply To disconnect the analyzer from the supply source, the circuit breaker must be in the O (off) position and the power cord must be removed. Rack systems are provided with more than one power supply cord. All power supply cords must be removed to disconnect the equipment from the mains power supply.

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Biohazardous materials Infection by samples and associated materials Contact with samples containing material of human origin may result in infection. All materials and mechanical components associated with samples of human origin are potentially biohazardous. o

Follow standard laboratory practices, especially when working with biohazardous material.

o

Keep the top cover and the front cover closed and in place during operation.

o

When working with open top cover while the instrument is powered on (for example, for cleaning or maintenance), always put the analyzer in Maintenance mode or in Sleep mode first.

o

Be sure to wear appropriate protective equipment, including, but not limited to, safety glasses with side shields, fluid resistant lab coat, and approved disposable gloves.

o

Wear a face shield if there is a chance of splash or splatter.

o

If any biohazardous material is spilled, wipe it up immediately and apply disinfectant.

o

If sample or waste solution comes into contact with your skin, wash it off immediately with soap and water and apply a disinfectant. Consult a physician.

The following materials must be treated as potentially biohazardous materials and handled accordingly: o

All in vitro diagnostic equipment, pretreatment systems, patient samples, serum-based calibrators, quality control (QC) products, and waste materials.

o

Everything that comes into contact with these potentially biohazardous materials, such as syringes, tubes, waste containers, reservoirs, S/R probe, sipper probe, rinse stations, and sample disk protective cover.

Infection and injury due to sharp objects When wiping probes, use several layers of gauze and wipe from the top down. o

Be careful to not puncture yourself.

o

Be sure to wear appropriate protective equipment, for example gloves. Take extra care when working with protective gloves; these can easily be pierced or cut, which can lead to infection.

Waste Infection by waste solution Contact with waste solution may result in infection. All materials and mechanical components associated with the waste systems are potentially biohazardous. o

Be sure to wear protective equipment. Take extra care when working with protective gloves; these can easily be pierced or cut which can lead to infection.

o

If any biohazardous material is spilled, wipe it up immediately and apply disinfectant.

o

If waste solution comes into contact with your skin, wash it off immediately with water and apply a disinfectant. Consult a physician.

o

Observe the system safety labels illustrated on pages A-15 to A-17.

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Safety summary

Contamination of the environment by liquid and solid waste The waste of the analyzer is potentially biohazardous. The analyzer discharges two kinds of waste solutions: o

Concentrated waste solution that contains highly concentrated reaction solution. This waste must be treated as infectious waste.

o

Dilute waste: Rinsing water from cell wash or water from the incubation bath.

o

Take special care when disposing ProCell and CleanCell, as these may produce toxic gases. When pouring waste down the drain, run the faucet (tap) continuously to ensure the waste is diluted with plenty of water.

o

Always refer to the package inserts for details on particular warnings.

o

Consult the reagent manufacturer for information on the concentrations of heavy metals and other toxic constituents in each reagent.

When disposing of any waste, do so according to the appropriate local regulations. e For information about disposal of the instrument, see

Disposal of the analyzer on page A-20

Flammables Flammables Keep flammables away from the instrument when conducting maintenance or checks using alcohol. When using isopropyl alcohol or ethanol on or around the instrument, use no more than 20 mL at a time. Isopropyl alcohol and ethanol (70%) are flammable substances, and there is a danger of fire, explosion, or burns.

Application Application This instrument is designed for clinical immunological test analysis using water-soluble samples and reagents. Other analyses may not be applicable to this instrument. For clinical tests, the instrument should be used under the management of a doctor or clinical inspector.

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1 General safety information Safety summary

Caution messages List of caution messages CAUTION

Before operating, read the caution messages contained in this summary carefully. Failure to observe them may result in minor or moderate injury.

Mechanical safety Personal injury due to contact with moving parts o

Keep the top cover closed and in place while the instrument is operating.

o

When working with open top cover while the analyzer is powered on (for example, for cleaning or maintenance), always put the analyzer in Maintenance mode or in Shutdown status first.

o

Only trained personnel should have access to the keys to the protective covers of the instrument.

o

Do not touch any parts of the instrument other than those specified. Keep away from moving parts during operation.

o

Do not wear loose garments or jewelry that could catch in moving mechanisms.

o

When you close the rack sample cover, take care not to pinch your fingers or hand.

o

During operation and maintenance proceed according to the instructions.

o

Observe the system safety labels illustrated from page A-15 to A-16.

Loading and unloading racks and trays Verify that the light on the rack sampler is green before you add a new rack or tray to the A-Line or remove a tray of processed samples from the C-Line while the analyzer is in operation. Otherwise, the instrument may be damaged or operation may stop. Do not add or remove single AssayCups and AssayTips to a tray when it is on the analyzer. Loading and unloading the sample disk Verify that sampling has stopped before you load additional samples on the sample disk, remove processed samples from the sample disk, or replace the sample disk while the analyzer is in operation. When sampling has stopped, raise the sample disk cover before changing samples. Otherwise, personal injury may result or the instrument may be damaged or operation may stop. Rack line cover Do not detach the rack line cover. Because racks are moving at a high speed beneath the cover, you may be injured if you touch racks in the A-line and C-line during operation. Cooling fan Avoid touching the cooling fan of the detection unit while the analyzer is operating. Otherwise, personal injury may result. Do not touch the fan unless the analyzer circuit breaker is turned Off.

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Safety summary

Reagents and other working solutions Skin inflammation or injury caused by reagents and other working solutions Direct contact with reagents, detergents, cleaning solutions, or other working solutions may cause skin irritation, inflammation, or burns. o

When handling reagents, exercise the precautions required for handling laboratory reagents. Be sure to wear protective equipment (such as goggles, gloves).

o

Observe the cautions given in the package insert and observe the information given in the Material Safety Data Sheets available for Roche Diagnostics reagents and cleaning solutions.

o

If a reagent, detergent or other working solution comes into contact with your skin, wash it off immediately with water and apply a disinfectant. Consult a physician.

Incorrect results due to incorrect reagent volume Application faults may cause an undetectable loss of reagent. o

Store reagents always according to specified storage conditions.

o

Do not reuse a reagent whose reagent has been spilled.

Damage from organic solvents o

Do not use organic solvents on the AssayCups, AssayTips, and waste solution flow path, as these parts are not guaranteed to be chemically resistant against organic solvents.

o

Do not use organic solvents, other than isopropyl alcohol or ethanol, for maintenance and checkup.

Handling of cleaning solutions (detergents) Always wear protective (chemical-resistant) gloves and safety glasses when handling cleaning solutions. Roche Diagnostics cleaning solutions have corrosive properties. The handling of cleaning solutions with bare hands may result in injury to your skin, and failure to wear suitable eye protection may result in injury to your eyes. Handling of reagents o

Avoid direct contact with reagents. Direct contact may result in irritation or injury to the skin.

o

Refer to the labels on the reagent boxes for specific handling instructions.

o

Avoid direct contact with CleanCell. Direct contact may result in irritation or injury to the skin. Refer to the CleanCell box label for specific handling instructions.

o

Do not store reagents at a temperature of less than 2°C as the microbeads should not be frozen.

o

Before loading reagents on the analyzer, ensure that they contain no bubbles, foam, or films as these may cause pipetting volume shortage and deterioration in measurement accuracy.

Insoluble contaminants in samples Incorrect results and interruption of analysis due to contaminated samples Insoluble contaminants in samples and bubbles or films inside a sample container may cause clogging or pipetting volume shortage and lead to a deterioration in measurement accuracy. Make sure that samples contain no insoluble contaminants such as fibrin or dust. Roche Diagnostics A-12

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1 General safety information Safety summary

Evaporation of samples or reagents Incorrect results due to evaporation of samples or reagents Evaporation of samples or reagents may lead to incorrect results. o

Do not leave samples, calibrators, or quality controls that have been pipetted into a sample container for any length of time.

o

Do not use expired reagents. Do not leave reagents on the analyzer for an extended period.

Cross contamination of samples Incorrect results due to carryover Traces of analytes or reagents may be carried over from one test to the next. Take adequate measures to safeguard additional testing and to avoid potentially false results.

Fatigue due to long hours of operation Fatigue due to long hours of operation Looking at the monitor screen over an extended period of time may lead to eye strain or body fatigue. o

Take a break for 10 to 15 minutes every hour to relax.

o

Avoid spending more than 6 hours per day looking at the monitor screen.

Malfunction due to interfering electromagnetic fields Malfunction of instrument and incorrect results due to interfering electromagnetic fields This instrument has been designed and tested to CISPR 11 Class A. In a domestic environment it may cause radio interference, in which case, you may need to take measures to mitigate the interference. o

The electromagnetic environment should be evaluated prior to operation of the device.

o

Do not operate this instrument in close proximity to sources of strong electromagnetic fields (for example unshielded intentional RF sources), as these may interfere with the proper operation.

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Safety summary

Notices NOTICE

List of notices Before operating, read the notices contained in this summary carefully. Failure to observe them may result in damage to equipment.

Moving parts Damage to the analyzer due to contact with moving parts Contact with moving parts may bend the probes or damage some other component. If the analyzer detects a collision, an alarm will be issued and operation will be stopped immediately. o

Keep all covers closed and in place during operation.

o

Do not touch any parts of the instrument other than those specified. Keep away from moving parts during operation.

Avoid damage to motorized components Switch off the analyzer power before manually moving any motorized components. If power is on, the motors are engaged and attempted movement may damage them.

Circuit breakers and fuses Damage to the analyzer due to improper use Should one of the circuit breakers or fuses blow, do not attempt to operate the analyzer before contacting either your Roche service representative or technical support.

Spillage Malfunction due to spilled liquid Any liquid spilled on the instrument may result in malfunction or damage. o

Do not place samples, reagents, or any other liquid on the surface of the analyzer.

o

If liquid does spill on the instrument, wipe it up immediately and apply disinfectant. Be sure to wear protective equipment.

Measuring cell unit Damage to the measuring cell unit Do not open the detection unit cover or service cover while the main circuit breaker is On. Otherwise, damage to the photomultiplier may result.

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Safety labels on the system Warning labels have been placed on the system to draw your attention to areas of potential hazards. The labels and their definitions are listed below, according to the area of the system where they are located. If the labels are damaged, they must be replaced by Roche service personnel. Contact your local Roche service representative for replacement labels. Some of the photos of the label may differ from those on your system, if they have changed since the photographs were taken for this manual.

Analyzer unit Warning

The presence of this label on part of the analyzer indicates that there is a danger of hazardous situations nearby which may result in death or serious injury. Biohazard warning

The presence of this label on part of the analyzer indicates that there are potential biohazards nearby. The relevant laboratory procedures on safe use must be observed. Moving parts

This label identifies moving parts of the analyzer that you must not touch if you are to avoid injuring yourself or damaging the equipment. Corrosive materials

This label indicates protective goggles and gloves should be worn when working within the vicinity of this label as there is a danger of coming into contact with corrosive or caustic material. STAT rack orientation

CAUTION: When setting the STAT rack, confirm the direction of rack. This label provides a caution that racks must be must be placed in the STAT (Short Turn Around Time) position with the correct orientation. Placing the rack the wrong way round may cause damage to the instrument. Use SysWash

This label indicates that SysWash must be added to the distilled water with a SysWash to water dilution ratio of 100+1 when refilling the system water container.

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Safety labels on the system

Positions of safety labels on the analyzer unit (disk system) Warning labels are attached to the instrument at the following positions:

Figure A-1

Safety label location: analyzer unit (disk system)

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Positions of safety labels on the analyzer unit (rack system) Warning labels are attached to the instrument at the following positions:

Figure A-2

Safety label location: analyzer unit (rack system)

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Safety labels on the system

Positions of safety labels on the solid waste tray and Clean-Liner Warning labels are attached to the solid waste tray and Clean-Liner at the following positions.

Figure A-3

Safety label location: solid waste tray and Clean-Liner

Power supply Electrical safety precautions WARNING

As with any electronic equipment, electric shock can occur. Installation, service, and repair must only be performed by authorized and qualified personnel. Disconnecting the power supply To disconnect the analyzer from the supply source, the circuit breaker must be in the O (off) position and the power cord must be removed. Rack systems are provided with more than one power supply cord. All power supply cords must be removed to disconnect the equipment from the mains power supply.

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Circuit breaker The following figure shows the circuit breaker and power cord.

Figure A-4

Safety label location: circuit breaker

Rack sampler circuit breaker The following figure shows the rack sampler circuit breaker and power cord. A label warns that rack systems are provided with more than one power supply cord, because the rack sampler has a separate power supply. All power supply cords must be removed to disconnect the equipment from the mains power supply.

Figure A-5

Safety label location: rack sampler circuit breaker

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Safety labels on the system

Electromagnetic compatibility (EMC) The cobas e 411 analyzer fulfils the electromagnetic compatibility (EMC) requirements of EN 61326: 1997, +A1:1998, +A2:2001.

Peripheral device connections All peripheral devices that are connected to the cobas e 411 analyzer must comply with safety standard IEC 60950 (UL 1950) for information technology equipment or with IEC 61010 (UL 3101) for laboratory instruments.

Disposal of the analyzer Infection by a potentially biohazardous instrument The instrument must be treated as potentially biohazardous waste. Decontamination (that is, a combination of processes including cleaning, disinfection and/or sterilization) is required before reuse, recycling, or disposal of the instrument. Dispose of the instrument according to the appropriate local regulations. For more information, contact your Roche representative. Disposal of control unit components Components of your control unit which are marked with this symbol are covered by the European Directive on Waste Electrical and Electronic Equipment (WEEE, 2002/96/EC). These items must be disposed of via designated collection facilities appointed by government or local authorities. For more information about disposal of your old product, please contact your city office, waste disposal service or your Roche representative. Constraint: It is left to the responsible laboratory organization to determine whether control unit components are contaminated or not. If contaminated, treat them in the same way as the instrument.

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System overview

This chapter provides an overview of the cobas e 411 analyzer, system specifications, and product labeling.

In this chapter

Chapter

2

Overview of the cobas e 411 analyzer ........................................................................ A–23 Disk and rack systems ............................................................................................ A–24 Disk system .............................................................................................................. A–24 Rack system .............................................................................................................. A–25 System components ...................................................................................................... A–25 Analyzer unit ........................................................................................................... A–25 Control unit ............................................................................................................. A–28 Power components ................................................................................................. A–29 cobas® link platform ............................................................................................. A–31 System specifications .................................................................................................... A–33 Technical data ......................................................................................................... A–33 Instrument dimensions .......................................................................................... A–33 Electrical ................................................................................................................... A–34 Environmental conditions ..................................................................................... A–35 Noise level ................................................................................................................ A–35 Water supply ............................................................................................................ A–36 Liquid waste ............................................................................................................. A–36 Solid waste ................................................................................................................ A–36 Throughput rate ...................................................................................................... A–36 Sampling system ...................................................................................................... A–37 Residual volume (disk system) .............................................................................. A–38 Residual volume (rack system) ............................................................................. A–39 Reagent system ........................................................................................................ A–40 Incubation system ................................................................................................... A–40 Measuring system ................................................................................................... A–40 Control unit ............................................................................................................. A–41 Reagent kit box labels ............................................................................................. A–41 Reagent packs .......................................................................................................... A–42 Roche Diagnostics Operator’s Manual · Version 2.1

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Reagent barcode label ............................................................................................. A–43 Package inserts ........................................................................................................ A–43 Calibrator kits .......................................................................................................... A–44 Calibrator barcode cards ........................................................................................ A–45 Control kits .............................................................................................................. A–45 Control barcode cards ............................................................................................ A–47

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Overview of the cobas e 411 analyzer The Roche Diagnostics cobas e 411 analyzer is an automated, random-access, multichannel analyzer for immunological analysis. It is designed for both quantitative and qualitative in vitro determination of a wide range of analytes by use of electrochemiluminescence (ECL) technology. The cobas e 411 analyzer can be placed on a bench top, thereby saving space in the laboratory environment. All assay reagent, calibrator, and control information is automatically entered into the software by using barcodes, or downloaded over the cobas® link connection (if installed). The system consists of the analyzer, which performs all functions required for fully automated sample and assay processing, and a control unit, which controls the analyzer through the user software. The process includes the recording of patient samples, the ECL detection, and the transmission of results. The software controls data transmission to and from the analyzer, evaluates results, produces documentation, and implements quality control. Also, the software manages data between a connected LIS/PSM (Pre-Analytic Systems Manager) and the cobas e 411 analyzer. Several cobas e 411 analyzers can be centrally controlled when integrated with PSM. Pre-Analytic Systems Manager is not available in the United States of America.

The advantages of the system include the following: o

Easy operation by means of a color touchscreen. Very few manual entries are required.

o

An integrated-barcode concept improves convenience and work flow. You do not have to identify individual samples manually if you use barcode-labeled tubes. Racks (on rack systems), reagent packs, and calibrator and control vials are barcode-labeled and are also read automatically.

o

Automatic entry of test applications. Transfer of test parameters to the system using the reagent barcode label speeds the installation of new assays.

o

Real-time monitoring of the analyzer allows the system to run unattended. Alarm messages notify the operator of any problems.

o

Continuous access to samples avoids interruption of routine testing while ensuring that results will be available as quickly as possible.

o

STAT (Short Turn Around Time) samples are prioritized and processed as soon as possible as the first priority, once the current operation has been completed.

o

Reagents are kept at a constant temperature (20 ± 3°C) on the analyzer, allowing on-analyzer storage.

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Overview of the cobas e 411 analyzer

Disk and rack systems The cobas e 411 analyzer is available as a disk system and as a rack system. The differences between the two configurations are detailed throughout this document. Both systems have a throughput of approximately 86 tests per hour. To assist you in quickly identifying information that is specific to either the disk or rack system, one of the following symbols is present to the left of the text. Applies to disk system only.

Applies to rack system only.

Disk system The following figure shows a cobas e 411 analyzer disk system:

Figure A-6

cobas e 411 analyzer (disk system)

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Rack system The following figure shows a cobas e 411 analyzer rack system:

Figure A-7

cobas e 411 analyzer (rack system)

System components This chapter provides an overview of the following main components and functional areas: o

Analyzer unit

o

Control unit

o

Power components

o

cobas® link platform

Analyzer unit The analyzer unit on the disk system consists of the: o

Sample/reagent area

o

Consumables area

o

Measuring area

o

Operation switch

e See Analyzer components on page A-65

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Analyzer unit: disk system The only difference on the disk system is in the sample area. The rack sampler is replaced by the sample disk, as shown in the following figure:

E

A

C

B

D

A

Operation switch

C

Measuring area

B

Sample/reagent area

D

Consumables and liquid waste area

Figure A-8

E

Main circuit breaker (hidden)

Analyzer unit (disk system)

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Analyzer unit: rack system The only difference on the rack system is in the sample area. The sample disk is replaced by a rack sampler, as shown in the following figure:

G

A

B

C

A

Rack sampler circuit breaker (hidden) C

B

Rack sampler

Figure A-9

D

D

E

Operation switch

E

Measuring area

Reagent area

F

Consumables and liquid waste area

F G

Main circuit breaker (hidden)

Analyzer unit (rack system)

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A B

C

D

E

A

Rack sampler circuit breaker

B

C-Line

C

B-Line (hidden)

D

A-Line

E

STAT (Short Turn Around Time) position

Figure A-10

Rack sampler

Control unit The control unit is located at the top left of the analyzer and consists of the following components: o

Touchscreen monitor

o

Connections located on the left side for data storage, an external printer, and a host interface.

e See Control unit on page A-49

A

A

Monitor power button

Figure A-11

Control unit

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Power components The power components include the following: o

Operation switch

o

Circuit breaker

o

Rack sampler circuit breaker

Operation switch The operation switch is located on the lower left front side of the analyzer. When you set the operation switch to on, the analyzer software reboots. Use the operation switch to switch off the analyzer to perform certain maintenance procedures or when the system is not in use for extended periods of time (for example, overnight while reagents are kept on the instrument). The operation switch also switches off the power to the touchscreen. If the circuit breaker is on, the reagent rotor and system reagent compartment temperatures are maintained while the operation switch is off.

A

A

Operation switch

Figure A-12

Operation switch

e See Switch off the analyzer on page B-88

Circuit breaker The circuit breaker is located on the right side panel of the analyzer, above the power supply cord. The circuit breaker controls the power supplied to the temperature controlled reagent compartments when the operation switch is off. When connecting or disconnecting the host cable, power the analyzer off at the circuit breaker only. For essential safety information, see Disconnecting the power supply on page A-8. WARNING Roche Diagnostics Operator’s Manual · Version 2.1

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A

B

A

B

Circuit breaker

Figure A-13

Power cord

Circuit breaker

e See How to shut down the analyzer on page B-130

Rack sampler circuit breaker There is a circuit breaker located on the left side of the rack sampler, above the rack sampler power cord. This controls power to the sampler unit. The circuit breaker should be kept in the I (on) position at all times. Use the operation switch to switch the rack system on and off. For essential safety information, see Disconnecting the power supply on page A-8. WARNING

A

B

A

Rack sampler circuit breaker

Figure A-14

B

Rack sampler power cord

Rack sampler circuit breaker

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cobas® link platform The cobas® link platform is the gateway for retrieving and distributing information from Roche TeleService-Net to cobas® analyzers in the laboratory. Information such as instructions for use, value sheets, important notes, as well as test- and lot-specific analyzer settings are made available through cobas® link.

A

C

D

B A B

TeleService-Net ®

cobas analyzers

Figure A-15

C

cobas® link data station

D

cobas e 411 analyzer (rack system)

cobas® link platform

A number of applications and other information, for example, controls and calibrators, are available on cobas® link that automate manual tasks improving efficiency and reducing errors. NOTICE

No patient demographic data is transferred to or stored within TeleService-Net.

TeleService-Net TeleService-Net (TNS) is the technical infrastructure to provide cobas® analyzers and operators with important product information from Roche Diagnostics. TeleService-Net offers several applications to manage and display data and information for remotely connected instruments. cobas® e-library The cobas® e-library (e-library) application runs on the cobas® link platform and is available via a dedicated desktop computer: the cobas® link data station. The e-library is updated daily using an automatic download if connected to a network or phone line. It receives data from TeleService-Net about assay parameters as well as labeling information for the assays, controls and calibrators used on cobas® analyzers. This data is then made available to the connected analyzers, ensuring that the analyzers always have the current data when it is required. Laboratory staff can also view and print this data as required from the e-library. The e-library replaces the need for laboratory staff to store and scan barcode cards, thereby allowing staff to perform more valuable tasks. Roche Diagnostics Operator’s Manual · Version 2.1

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NOTICE

Regular Updates It is important to update the e-library regularly to ensure you receive all important information as it becomes available. e For more information, refer to the cobas® e-library Operator’s Manual

Main functions From the operator’s point of view, the main functions of cobas® link are: o

e-package inserts The e-library stores many documents (e-package inserts) such as instructions for use for applications, announcements as well as control and calibration information.

o

e-barcodes cobas® link provides e-barcodes (e-BC), which provide information such as calibrator lot information. e See How to install and define Roche controls on page B-111

How to install Roche calibrators on page B-109 Parameter Download on page B-22

o

Backup function Analyzer data is automatically backed up to cobas® link.

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System specifications This section details the system specifications.

Technical data A plate located on the right side of the analyzer displays the part number, serial number, and power requirements. The following figure shows an example of the analyzer plate.

Figure A-16

Analyzer plate example

Instrument dimensions The following table lists the dimensions of the cobas e 411 analyzer, for both the disk and rack systems: Analyzer

Height

Depth

Width

Weight

31.4 in(a)

28.7 in

47.2 in

397 lbs

80 cm(a)

73 cm

120 cm

180 kg

31.4 in(a)

37.4 in(b)

67 in

551 lbs

80 cm(a)

95 cm(b)

170 cm

250 kg

(43 in or 109 cm with top cover opened)

(43 in or 109 cm with top cover opened) (a) The height includes the touchscreen (b) The depth includes the STAT position Table A-1

Instrument dimensions

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Electrical The following table lists the power requirements and heat output of the cobas e 411 analyzer: Installation requirements:

The instrument complies with the safety requirements of IEC 61010-1, 2nd edition; IEC 61010-2-081, 1st edition; IEC 61010-2-101, 1st edition; UL 61010-1, 2nd edition; CAN/CSA C22.2 No. 61010-1:2004. Pollution degree: 2 (IEC 61010-1) Overvoltage category: II (IEC 664) The instrument complies with the electromagnetic compatibility (EMC) requirements of EN 61326: 1997, +A1:1998, +A2:2001. The cobas e 411 analyzer must be connected to a threewire power supply cord with a safety ground.

AC Cord Set ratings: Countries requiring UL and CSA: 115 V 208 or 240 V Temperature rate Whole length Safety standard

AC125V-15A /SJT type 3×14AWG AC250V-10A /SJT type 3×16AWG Minimum 60°C 2500 ± 50 mm UL817 / CSA C22.2 No.21

Europe

The AC Cord must be marked "HAR".

220 to 240 V Temperature rate Whole length Safety standard

AC250V-10A /3×1.16AWG Minimum 60°C 2500 ± 50 mm CENELEC HD21

Connector type to e411 inlet

IEC320 / EN60320 type

Supply voltage/frequency:

100 - 240 V AC, 50/60 Hz single phase The power supply voltage is automatically detected by the system.

Main supply voltage fluctuation:

± 10% of nominal voltage (90 VAC to 264VAC)

Power consumption: 1000 VA

1250 VA (Analyzer unit: 1000 VA; rack sampler unit: 250 VA) Heat generation (approximate): 2879 kJ/hresp. 688 kcal/hresp. 2730 Btu/hr 3778 kJ/hresp. (Rack sampler unit: 899 kJ/hr resp.) 903 kcal/hresp. (Rack sampler unit: 215 kcal/hr resp.) 3583 Btu/hr (Rack sampler unit: 853 Btu/hr) Table A-2

Electrical specifications

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Environmental conditions The cobas e 411 analyzer is designed for indoor use only. The following table lists the range of acceptable environmental conditions under which cobas e 411 analyzers will reliably and accurately operate: Temperature:

Operation: 18 to 32°C Storage and transport: -20 to 75°C

Temperature variation:

Maximum ± 2°C/h

Humidity (indoor use only):

Operation: 20 to 80% (non-condensing) Storage and transport: 5 to 95% (non-condensing, 0.1 megohm, bacteria-free (SysWash is added, with a dilution 100+1)

Water consumption (approximate):

3 L for 250 tests 12 mL/cycle

Table A-5

Water supply

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Liquid waste Liquid waste container: Table A-6

Capacity: 4 L, with overflow detection.

Liquid waste

The liquid waste container is not installed if the direct drain option is used. e See Specifications on page E-8

Solid waste Disposable solid waste container: Table A-7

Capacity: 420 AssayCups and 680 AssayTips, or 1100 items.

Solid waste

Throughput rate Assay measurements: Table A-8

Up to 86 tests/hour

Throughput rate

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Sampling system The following table lists the specifications for the sampling system. Certain capacities vary between the disk and rack systems. Sample/reagent pipetter principle:

Conductive disposable AssayTip handling

Sample volume per test:

10 to 50 μL

Sample/reagent pipetter precision:

For 10 μL volumes, the coefficient of variance is < 1.2% at an ambient temperature of 18 to 25°C and < 2.4% at an ambient temperature of 25 to 32°C. < 0.8% CV for 50 μL volumes

Sample detection:

Liquid level detection and clot detection

Sample loading capacity: 30 positions for samples, controls, and calibrators

Rack tray: 15 racks with five positions each = 75 positions Input buffer: 5 racks with five positions each = 25 positions Total: 100 positions for samples, controls, and calibrators STAT capacity: Any unoccupied position on the sample disk

STAT rack position at the front of the analyzer

Barcode symbologies:

The barcode symbologies that can be read include the following: o o o o o

PDF417 NW7 (Codabar) Code 39 Code 128 Interleaved 2 of 5

Assay tips:

360 AssayTips (3 trays, with 120 AssayTips/tray)

Assay cups:

180 AssayCups (3 trays, with 60 AssayCups/tray)

Sample cups:

2 mL (Standard) Hitachi cup; NO micro cups

Primary sample tubes: (external diameter x height)

13 x 75 mm

16 x 75 mm

13 x 100 mm

16 x 100 mm

Table A-9

Sampling system

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For essential safety information, see Check digits in barcodes on page B-4 CAUTION

Residual volume (disk system) The following table lists the residual volumes for the various sample container options. These figures apply to the disk system only. Sample Container

Tube height “Normal”

“Reduced”

residual volume residual volume

Standard Hitachi cup directly on the sample disk:

—

200 μL

100 μL

Standard Hitachi cup on top of a primary sample tube (16 mm diameter):

75 mm

200 μL

150 μL

Standard Hitachi cup on top of a primary sample tube (16 mm diameter):

100 mm

200 μL

150 μL

Primary sample tube (13 mm diameter):

75 mm

600 μL

—

Primary sample tube (13 mm diameter):

100 mm

600 μL

—

Primary sample tube (16 mm diameter):

75 mm

1000 μL

—

Primary sample tube (16 mm diameter):

100 mm

1000 μL

—

Calibrator/control vial: Table A-10

—

(a)

150 μL

—

Sample container residual volume (disk system)

(a) The distinction "Normal" or "Reduced" does not apply for the residual volumes of calibrator or control vials.

For essential safety information, see Reduced sample volume on page B-5. CAUTION NOTICE

Working with reduced sample volume A reduced dead volume may only be used with Hitachi standard cups. A reduced volume may not be used with primary or secondary tubes You cannot use 13 mm diameter false bottom tubes on disk systems. Disk systems cannot accept cup adapters.

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Residual volume (rack system) The following table lists the residual volumes for the various sample container options. These figures apply to the rack system only. Sample Container

Tube height “Normal”

“Reduced”

residual volume residual volume

Standard Hitachi cup directly on the sample rack:

—

200 μL

100 μL

Standard Hitachi cup on top of a primary sample tube (16 mm diameter):

75 mm

200 μL

100 μL

Standard Hitachi cup on top of a primary sample tube (16 mm diameter):

100 mm

150 μL

100 μL

Primary sample tube (13 mm diameter):

75 mm

600 μL

—

Primary sample tube (13 mm diameter):

100 mm

600 μL

—

Primary sample tube (16 mm diameter):

75 mm

1000 μL

—

Primary sample tube (16 mm diameter):

100 mm

1000 μL

—

Calibrator/control vial:

—

150 μL(a)

—

—

200 μL

200 μL

False bottom tube (from Roche Diagnostics for cobas® Table A-11

systems)

(b)

Sample container residual volume (rack system)

(a) The distinction "Normal" or "Reduced" does not apply for the residual volumes of calibrator or control vials. (b) False bottom tube are only for use with cup adapters for Roche Diagnostics standard racks.

For essential safety information, see Reduced sample volume on page B-5. CAUTION NOTICE

Working with reduced sample volume A reduced dead volume may only be used with Hitachi standard cups. A reduced volume may not be used with primary or secondary tubes.

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Reagent system Assay reagents

The following table lists the specifications for the assay reagents: Reagent rotor temperature:

20°C ± 3°C

Reagent capacity:

Up to 18 assays, 9 pretreatments, or 8 diluents in 18 reagent positions

R1/R2 consumption:

50 to 80 μL per reagent, dependent upon the assay

Microbead consumption:

30 to 50 μL dependent upon the assay

Reagent detection:

Liquid level detection

Positive reagent identification:

Two-dimensional barcode (PDF417)

Automatic dilution:

Available up to 1:400 (for applicable assays)

Evaporation protection:

Reagent lids are automatically opened and closed

Table A-12

System reagents

Assay reagent system

The following table lists the specifications for the system reagents: Temperature:

28°C ± 2°C

Inventory control:

Automatic based on counting (reagent rotor) or liquid level detection (ProCell/CleanCell)

ProCell consumption:

Approximately 2 mL per cycle

CleanCell consumption:

Approximately 2 mL per cycle

Table A-13

System reagent system

Incubation system The following table lists the specifications for the incubation system: Incubator capacity:

32 AssayCups

Volume of AssayCups:

200 μL

Incubation temperature:

37.0°C ± 0.3°C

Table A-14

Incubation system

Measuring system The following table lists the specifications for the measuring system: Measuring method:

Integral measuring of an electrochemiluminescence signal

Calibration mode:

2-point calibration

ProCell consumption:

Approximately 2 mL per cycle

CleanCell consumption:

Approximately 2 mL per cycle

Cycle time:

42 s

Temperature:

28.0°C ± 0.3°C

Table A-15

Measuring system

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Control unit The following table lists the specifications for the control unit: Type:

Integral PC unit with touchscreen monitor

Data storage:

Compact flash card

System interfaces:

Standard PC ports (USB, ethernet, and serial) for other communication devices (remote access, cobas® link)

Host interface:

CCITT V. 24/RS-232-C (bidirectional) The host should comply with the requirements of IEC (60950)

External printer:

Connection through a USB port e For further information and a list of recommended printer

models, see External printer on page A-54 Touchscreen monitor:

39 cm (15 in) color TFT-LCD, XGA

Operating system

Microsoft Windows XP (embedded version)

Table A-16

Control system

e See Control unit on page A-49

Reagent kit box labels The reagent pack comes as part of a reagent kit. On each reagent kit box, a large label shows the intended use, storage temperature, contents, and catalog number of the kit. A smaller side box label shows the lot and expiration date of the reagent pack, as well as a barcode number. A

B A

Kit catalog number

Figure A-17

B

Reagent Pack lot number

Reagent box labels

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Reagent packs The following figure shows an example of a reagent pack (e-pack) used on the cobas e 411 analyzer.

Figure A-18

Reagent pack

Each reagent pack is a single ready-to use unit that consists of three bottles: o

A transparent bottle (with a transparent lid) containing suspended paramagnetic microbeads (M).

o

A black bottle (with a gray lid) containing reagent 1 (R1)

o

A black bottle (with a black lid) containing reagent 2 (R2)

The reagent pack and reagent rotor are keyed to prevent you from placing reagents on the analyzer incorrectly.

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Reagent barcode label Reagent packs have a barcode label that contains information required to run the assay on the analyzer. This information includes, but is not limited to: o

Test number

o

Lot number

o

Master calibration curve parameters (for example, Rodbard parameters)

o

Instrument settings

o

Calibrator lot numbers and assigned values

o

Expiration date

o

Calibration frequency

The following information can be identified on each reagent barcode label:

A B C D E F G H I

A

Test code

B

Kit catalog number

C

Reagent volume within the package

D

Reagent pack number

E

Storage temperature

F

Abbreviation for in vitro diagnostics

G

Reagent pack lot number

H

Expiration date

I

Reagent barcode number

Figure A-19

T4 reagent barcode label

Package inserts Each reagent kit comes with a package insert, which provides detailed information required to perform the assay. This information includes, but is not limited to: o

Intended use

o

Test principle

o

Reagent handling and stability

o

Calibration and QC information

o

Measuring range

o

Dilution

o

Expected values

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Calibrator kits For most tests, calibrators for the Elecsys reagents can be ordered separately (for example, Elecsys FT3 or Troponin-T CalSet). Each kit contains barcoded calibrator vials. Some calibrators are in a ready to use liquid form and require no further action other than to place them on the sample disk or rack when a calibration is necessary. A few of the calibrators are lyophilized in glass bottles and must be reconstituted before being transferred into plastic barcode-labeled vials. (Empty barcode-labeled vials are packaged in kits with lyophilized calibrators.) You can store reconstituted calibrators in the plastic vials after transfer. Calibrators also have color-coded caps to assist you in identification. A level 1 calibrator has a white cap, and a level 2 calibrator has a black cap.

C A D B E

A

Empty calibrator vials to be filled

B

Bottles containing calibrators to be reconstituted according to the package inserts

C

Calibrator barcode card

E

Extra labels for calibrator aliquots that should

D

Package inserts

be kept separately Figure A-20

Calibrator kit

Each calibrator bottle has a traditional linear barcode label that contains an identifier to link it to information encoded in the reagent barcode label and the calibrator barcode card. Each calibrator kit contains a calibrator barcode card. e See Calibrator barcode cards on page A-45

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Calibrator barcode cards Each calibrator kit comes with a barcode card. This card is in the PDF417 format and must be used with the corresponding calibrators. Information encoded in the calibrator barcode cards includes, but is not limited to: o

Test number

o

Calibrator lot number

o

Lot identifier to calibrator barcode labels

o

What calibrators are to be used and their number of determinations

o

Target or assigned values

o

Expiration date

Roche Diagnostics produces a factory master calibration for each calibration lot. The results are encoded into the corresponding reagent barcode. Scan the new barcode card when you use a new lot or download it from cobas® link. e See Perform calibration and QC on page B-30

For more information, refer to Reagent concept on the COBI-CD

Control kits For most tests, controls for the Elecsys reagents come packaged separately (for example, Elecsys PreciControl Universal). Each kit contains barcoded control vials for use on the analyzer. Most of the controls are lyophilized in glass bottles and must be reconstituted before being transferred into plastic barcode-labeled vials. (Empty barcode-labeled vials are packaged in these kits with lyophilized controls.) You can store reconstituted controls in the plastic vials after transfer. Controls also have color-coded caps to assist you in identification. A level 1 control has a light brown cap and a level 2 control normally has a dark brown cap. Read the package insert to check the color of the caps on the level 1 and level 2 controls. Each control bottle has a traditional linear barcode label that contains an identifier to link it to information encoded in the reagent barcode label and the control barcode card. Control barcode cards come packed in each control kit. These cards are described in more detail in the next section.

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A B

E

C D

F G

A

Empty control vials to be filled with level 2

B

controls C

Empty control vials to be filled with level 1 controls

Bottles containing level 2 controls to be

D

reconstituted according to the package

Bottles containing level 1 controls to be reconstituted according to the package

inserts

inserts

E

Control barcode cards

G

Extra labels for control aliquots that should

F

Package inserts

be kept separately Figure A-21

PreciControl Universal kit

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Control barcode cards Each control kit comes with barcode cards. These cards are also in the PDF417 format and must be used with the corresponding controls. Information encoded in the control barcode cards includes, but is not limited to: o

Test number

o

Control lot number

o

Control code (for example, PC U1)

o

Lot identifier to control barcode labels

o

Target or assigned values

o

Control ranges

o

Expiration date

Scan the new barcode cards when you use a new control lot or download the information from cobas® link.

Figure A-22

PC Universal barcode cards

e See Perform calibration and QC on page B-30

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Control unit

This chapter provides a detailed description of the control unit and its components and an overview of the system software.

In this chapter

Chapter

3

Components ................................................................................................................... A–51 Touchscreen monitor ............................................................................................. A–51 Software keyboard .................................................................................................. A–52 Data storage ............................................................................................................. A–53 External printer ....................................................................................................... A–54 Service interface ...................................................................................................... A–55 Host interface .......................................................................................................... A–55 Software basics ............................................................................................................... A–56 Status line ................................................................................................................. A–57 Guidance prompt .................................................................................................... A–58 Main menu screens ................................................................................................. A–59 Menu tabs ................................................................................................................. A–60 List boxes .................................................................................................................. A–60 Text boxes ................................................................................................................ A–60 Options buttons ...................................................................................................... A–61 Buttons ..................................................................................................................... A–61 Windows .................................................................................................................. A–62 Selection menu for multiple items ........................................................................ A–63 Screen access levels ................................................................................................. A–63 Online Help system ................................................................................................ A–64

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Components The control unit consists of the following components: o

Touchscreen monitor

o

Software keyboard

o

Data storage

o

External printer

o

Service interface

o

Host interface

Touchscreen monitor The 39 cm (15 in) color touchscreen monitor is located on the top left of the analyzer and is used to: o

Display information

o

Navigate through the software

o

Initiate instrument functions

You can tilt the touchscreen to provide the best viewing angle. To use the touchscreen, choose the item you want to request or change on the screen by lightly touching it with a finger or stylus. When touching the touchscreen, do not press hard as this could cause damage. Instead, tap the screen lightly and then remove your finger or stylus. If no one touches the screen for 30 minutes, the back light turns off. Touch the screen to reactivate the monitor and return to the last-viewed software screen. You can access all items within the software by using the touchscreen. Choose the required item (such as a menu bar, list box, text box, or button) to complete your task. For example, to display the Data Review screen in the Workplace menu, choose Workplace and then choose the Data Review tab.

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Figure A-23

Touchscreen monitor

Software keyboard The cobas e 411 software has an on-screen keyboard function. When you touch a text box, a software keyboard pops up around the text box. The required input determines whether the display is a full keyboard or numeric only. Numeric keyboard A

A

B

Full keyboard mode button

Figure A-24

B

Transparency button

Numeric software keyboard

Use the numeric keyboard to type numeric values, touching each field in turn to enter the required values. When all the numeric entries are complete, choose Close to return to the previous screen. Choose the full keyboard mode button (A) to switch from the numeric keyboard to the full keyboard mode.

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Full keyboard A

A

Transparency button

Figure A-25

B

B

Numeric keyboard mode button

Full (alphanumeric) software keyboard

Use the full keyboard to type alphabetical or numeric values, either touching the Tab key or touching each field in turn to move between fields. You can either: o

Choose Close to return to the previous screen.

o

Move to the next text box either by choosing Tab or by touching the required box. The software keyboard moves aside automatically from the selected text box.

Choose the numeric keyboard mode button to switch from the full keyboard to the numeric keyboard mode. Keyboard transparency You can control the transparency of the software keyboards by choosing the Transparency button. This enables you to see what is behind the keyboard without having to move or close it. There are three transparency states: o

No transparency (default)

o

Normal transparency

o

Increased transparency

Each time you choose the transparency button, the transparency button will move to the next transparency state.

Data storage The system uses flash memory, memory cards, and DVD-RAMs for data storage. There is no mechanical hard drive; the Windows XP operating system is embedded. The memory contains a number of data files necessary for the analyzer and the software to work together. These files include the following: o

Reagent data O

o

Sample data O

o

Up to 2000 test records (for routine samples, STAT samples, and controls)

Calibration data O

o

Up to 300 reagent packs

Up to 160 calibrators

QC data O

Up to 100 controls

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o

o

Parameter data O

Sixty parameters for assays and an additional five parameters for calculated tests

O

Up to 20 operator IDs

O

Analyzer serial number (entered by Roche Diagnostics service personnel during software installation)

Log data O

Up to 20 000 daily alarm blocks

O

Up to 1000 operator ID logs

O

Up to 180 logs for each maintenance item

O

Up to 5 MB host communication log

The data DVD-RAM contains read-only data, including assay reference tables containing information that is linked to data encoded in the reagent barcode, for example, test number, test code, available units, and unit conversion factors.

External printer The instrument is designed to be used with one of the following printers: o

HP LaserJet 1320

o

HP LaserJet P2015n

o

HP LaserJet 2035

Your Roche service representative will inform you if Roche approves additional printers in the future. NOTICE

Unapproved printers The printers in the list above have been tested for use with the cobas e 411 analyzer and are supported by Roche Diagnostics. You may be able to use an alternative USB printer that is not on this list. However, Roche Diagnostics would be unable to provide support for use of any printer that is not recommended for use with the cobas e 411 analyzer.

Connect the printer to the USB port marked PRINTER on the left side of the analyzer. See the following figure for the location of this port.

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Figure A-26

Location of the USB ports and host interface

e For more information on Reports, refer to Reports in the online Help

Service interface The service port is used to connect an external DVD-RAM drive. Contact Roche Technical Support for information or assistance concerning the use of this port.

Host interface The instrument can be bidirectionally interfaced with a host. Contact Roche Technical Support for information or assistance concerning the interfacing of the cobas e 411 analyzer to the host.

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Software basics This section provides an overview of the system software, with a brief description of the following screen elements: o

Status line

o

Guidance prompt

o

Main menu screens

o

Menu tabs

o

List boxes

o

Text boxes

o

Option buttons

o

Buttons

o

Windows

The main menus and online Help system are also described. e For more information, refer to the Software description in the online Help NOTICE

Screen representations The screen representations shown in this chapter and throughout this manual are for illustrative purposes only. The screens do not necessarily show valid results. Also, the availability and appearance of any specific screen depends on the ‘access level’ assigned to the operator.

The screen is divided into various areas. Some of these areas do not change, and some differ according to the currently active function. Following is an example of a screen showing the various areas. A

D

B C A

Status line

B

Online Help

C

Guidance prompt (no message displayed)

D

Global buttons

Figure A-27

Screen configuration

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Status line The status line is displayed across the top of each screen.

Figure A-28

Status line

The status line displays the current operational mode, sample reception mode remaining time, operator ID, date, and time. e See How to use sample reception mode on page B-101

The double System Overview icon on the left changes colors to reflect the current operational status of the system. The color codes, listed from lowest to highest priority, are: Icon

Color

Meaning.

Host

Blue

Host communication is Off.

E

Green

Host communication is On.

Blue

The analyzer is in Initialization, Operation, or Maintenance mode.

Green

The analyzer is in Stand By mode.

Yellow

An instrument alarm has been raised with a caution level. This could mean the number of tests remaining for a reagent is less than the caution level specified on the Reagent Level Check window.

Red

An instrument alarm of Stop, S.Stop, or E.Stop has been raised.

Table A-17

System Overview icon color codes

Choose the System Overview icon at any time to display the System Overview screen. The operational mode is displayed to the right of the System Overview icon. Start up

Follows power-on. During start up, the analyzer prepares itself for operation.

Stand By

During stand by, the power is on but no sample analysis or maintenance procedures are performed.

Initialization

During initialization, the analyzer prepares itself for operation.

Operation

During operation, the analyzer processes samples.

Maintenance

During maintenance, the analyzer performs maintenance procedures.

Reset

During reset, the analyzer sets and aligns all mechanical parts to their home positions.

R.Stop

During R.stop/S.stop, no new samples are pipetted. Samples already pipetted will be completed without interruption or loss. In sample reception mode the analyzer remains in R.stop/S.stop until the time interval has elapsed or the operator restarts the analyzer.

(Rack)/S.Stop (Disk) CF Access

During CF access, the analyzer reads data from the internal CF card.

Media Write

During media write, the analyzer writes data to a storage device.

Scan BC Card

During scan BC card, the analyzer scans a barcode card.

Reagent Scan

During reagent scan, the analyzer scans the reagent in the reagent rotor.

Sleep

During sleep, no immediate processing can be initiated by the operator.

Table A-18

Operational modes

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Guidance prompt The guidance prompt is shown in the lower left of each screen. A

A

Guidance prompt

Figure A-29

Guidance prompt screen area

In this area, the software explains how you can use a specific text box. When you select a text box, the guidance prompt defines the information that you can enter. It may also give an action to take, such as choosing a button or pressing a key.

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Main menu screens The graphical user interface used by the control unit consists of six main menu screens: o

System Overview

o

Workplace

o

Reagent

o

Calibration

o

QC

o

Utility

Through these screens all instrument functions are controlled. Access to some screens, especially those of the Utility menu, is restricted by the access level of the user. e For more information, refer to User access levels in the online Help

System Overview The System Overview screen is the central screen used for performing daily operation. From here you can view the status of reagents, calibrations, and quality control. You can also check the quantities of consumables available on the analyzer. The System Overview screen consists of the following areas: o

Work Flow Guide

o

Inventory area

o

Menu buttons

o

Main screen buttons

e For more information, refer to the System Overview screen in the online Help

Workplace The Workplace menu screen consists of two main tabs: o

Test Selection is used to enter and review test selections for a sample, and

o

Data Review is used to search, review, export, delete, and send data to the host.

e For more information, refer to Workplace menu in the online Help

Reagent The Reagent menu screen is used to view detailed reagent and consumables information. e For more information, refer to Reagent menu in the online Help

Calibration The Calibration menu screen consists of three tabs: Status, Calibrator, and Install. They are used to request calibrations, define calibrators, and view calibration results. e For more information, refer to Calibration menu in the online Help

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QC The QC menu screen consists of six tabs: Status, Run Status, Individual, Cumulative, Control, and Install. Use these screens to install, view, request and edit controls, and to evaluate and accumulate quality control results. e For more information, refer to QC menu in the online Help

Utility The Utility menu screen consists of four tabs: System, Maintenance, Application, and Calculated Test. These screens are used to enter system settings, application parameters, and access maintenance and service functions. e For more information, refer to Utility menu in the online Help

Menu tabs You can use the menu tabs to select screens and windows that are grouped together and used to perform related tasks. The menu tabs are accessible from every screen (but not from popup windows). This makes the software navigation within the menus, and between menus, very easy. The menu tabs are for the five menus: Workplace, Reagent, Calibration, QC, and Utility.

List boxes List boxes display a list of choices. If there are more choices than can fit in the box, a scroll bar is displayed. Touchscreen: Choose the item within the list box on the screen by touching it. If a scroll bar is displayed next to the list box, you can touch the scroll bar above or below the current display position, or touch the arrows on the scroll bar, to move up or down the list to view the available item choices. Software Keyboard: You can use the arrow keys to move quickly through the list by pressing the arrow key that points in the required direction. The currently selected choice is indicated by the selection cursor, which appears as a highlight. You can also use the Home, End, Page Up, and Page Down keys of the full software keyboard to move through the list. When the required item is highlighted, choose Enter (ENT).

Text boxes A text box provides a place for you to type information on a screen. However, some text boxes are read-only. Select a text box by touching it on the screen. The full or numerical software keyboard will be displayed, depending on the entry field. After you have typed in a text box, choose Enter or Tab, or just touch the next field, for your information to be accepted. Choose Tab (full keyboard only) or touch the required field to move the cursor to the next text box or option button.

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Options buttons Option buttons are used to select a particular function. Sometimes when an option is selected, other option buttons or text boxes become available. Select an option by touching it on the screen. An option is selected when the corresponding option button is colored light blue. If it is dark blue, the option is not selected.

Buttons Buttons are used to start functions, confirm entries and selections, and display windows. The available buttons depend on the menu or tab that is active. A black triangle in the upper right-hand corner of a button indicates that choosing this button displays another window. A black triangle in the lower left corner of a button indicates that choosing this button performs the specified function and closes the window. Choose a button by touching it on the touchscreen. Standard buttons Standard buttons are used throughout the software. These buttons are explained below, and will not be explained again with individual screens in the online help. OK

Choose this button to accept the changes and entries made in a window and to close the window.

Cancel

Choose this button to close the window without saving the changes and entries made in a window.

Yes

Choose this button to accept the changes made in a window, perform the action of the window and close the window.

No

Choose this button to close the window without saving the changes made in a window or without executing the function of the window.

Close

Choose this button to close the window.

Save

Choose this button to save any changes made to the screen or window currently displayed. When changes have been made, this button turns yellow.

Update

Choose this button to update any changes made to the screen/window currently displayed. When changes have been made, this button turns yellow.

Page buttons

Because space on screens is limited, it is not always possible to display all buttons on a screen. In this situation, you can access the additional buttons using the page button. These page buttons are numbered (for example, x/3) to indicate the page that you are on. The page buttons only change the displayed buttons and not the entire appearance of the screen.

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Global buttons Use the global buttons to open screens that are used for specific functions. The global buttons are accessible from every screen and are located on the right side of the screen; except for the Help button, which is located in the lower left corner of the screen. The global buttons include: Stop, Logoff, S. Stop, Stat Mode, Alarm, Print, Start, and Help. The Stop, S. Stop, Stat Mode, and Start buttons are also the system control buttons. You can select the global buttons using the touchscreen.

A

A

Global buttons

Figure A-30

Global buttons

Stop

Stops the analyzer at the end of the current mechanical cycle

Logoff

Log off, change operator or shutdown the analyzer

S.Stop

Performs a sample stop

Stat mode

Puts the analyzer in STAT mode

Alarm

Opens the Alarm screen

Print

Opens the Print screen

Start

Starts processing samples from the Start Conditions screen

Help

Opens the online Help system

Windows Windows containing additional information are displayed, overlaying part of currently displayed screens or windows. Windows function in a similar way to screens. Information in a window can be entered or edited through list boxes, text boxes, and option buttons. Action buttons are also available. Confirmation Window

Many functions require confirmation before they are performed (for example, Delete). Confirmation windows are used to confirm these functions. Choose OK to confirm the function and to close the confirmation window, or choose Cancel to close the confirmation window without carrying out the function.

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Selection menu for multiple items The Sample Range Start and Select Sample buttons on the Workplace > Data Review screen are used to select consecutive or non-consecutive samples in the sample list. a To select multiple non-consecutive samples 1 Select the first sample from the list. The selected sample is highlighted with a blue background and the results of the tests performed on this sample are displayed in the test results list. 2 Choose Select Sample. The Select Sample button changes to white. 3 Select the next sample. Use the scroll bar to display samples that are further down on the list. 4 Repeat steps 2 and 3 until you have selected all the required samples. The selected samples are all highlighted with a blue background.

a To select a range of consecutive samples 1 Select the first sample in the required range from the sample list on the left of the screen. 2 Choose Sample Range Start. The button title changes to Sample Range End and the color turns white. 3 Select the last sample in the range from the list on the left of the screen. Use the scroll bar to display samples that are further down on the list. 4 Choose Sample Range End. The selected samples are highlighted with a blue background.

Screen access levels Access to some screens, especially those of the Utility menu, is restricted by the access level of the user. Some screens are not accessible with the operator level logon, or can not be edited. Some boxes can only be viewed at the administrator level logon. e For more information, refer to User access levels in the online Help

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Online Help system The cobas e 411 analyzer has a context-sensitive online Help to aid in operating the analyzer. The online Help offers a quick and convenient way to find information, such as explanations of screens and windows and how to perform particular processes. A

A

? Help button

Figure A-31

Online Help button

e See Online Help system on page 8

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Analyzer components

This chapter provides a detailed description of the components to be found in each of the areas of the analyzer.

In this chapter

Chapter

4

Overview of the analyzer components ....................................................................... A–67 Sample/reagent area components ............................................................................... A–68 Sample disk .............................................................................................................. A–69 Rack sampler ............................................................................................................ A–70 Sample/reagent (S/R) probe .................................................................................. A–75 Sample disk protective cover ................................................................................. A–76 Barcode readers ....................................................................................................... A–76 Reagent rotor ........................................................................................................... A–80 Reagent cap open/close mechanism ..................................................................... A–81 Microbead mixer ..................................................................................................... A–82 Probe/mixer rinse station ...................................................................................... A–82 Sample/reagent (S/R) pipetter ............................................................................... A–83 Consumables area components .................................................................................. A–84 Gripper unit ............................................................................................................. A–85 Pipetting station ...................................................................................................... A–86 System water container .......................................................................................... A–87 Liquid waste container ........................................................................................... A–88 Solid waste tray and Clean-Liner .......................................................................... A–89 Measuring area components ....................................................................................... A–90 Incubator .................................................................................................................. A–90 Sipper probe and rinse station .............................................................................. A–91 Sipper pipetter ......................................................................................................... A–92 System reagents (ProCell and CleanCell) ............................................................ A–93 Detector unit ............................................................................................................ A–94

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Overview of the analyzer components The cobas e 411 analyzer components are located in the following areas: o

o

o

Sample/reagent area components, comprising: o

Sample disk

o

Rack sampler

o

Sample/reagent (S/R) probe

o

Barcode reader

o

Barcode card reading station

o

Reagent rotor

o

Reagent cap open/close mechanism

o

Microbead mixer

o

Probe/mixer rinse station

o

Sample/reagent (S/R) pipetter

Consumables area components, comprising: o

Gripper unit

o

AssayCup disposal opening

o

Pipetting station

o

System water container

o

Liquid waste container

o

Solid waste tray and Clean-Liner

Measuring area components, comprising: o

Incubator

o

Sipper probe

o

Sipper pipetter

o

System reagents (ProCell and CleanCell)

o

Detection unit

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Sample/reagent area components The sample/reagent area, occupying the left half of the analyzer, consists of the following components: o

Sample disk or rack sampler (rack system)

o

Rack barcode reader (rack system)

o

Sample/reagent (S/R) probe

o

Barcode reader

o

Barcode card reading station

o

Reagent rotor

o

Reagent cap open/close mechanism

o

Microbead mixer

o

Probe/mixer rinse station

o

Sample/reagent (S/R) pipetter

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Sample disk The sample disk has 30 positions for samples, calibrators, and controls. You may place patient samples in either primary sample tubes or sample cups. Built-in adapters allow intermixing of different-sized primary sample tubes. e See Sampling system on page A-37

You may place sample cups [2 mL (Standard) Hitachi cups only] directly on the sample disk or on top of 16 mm primary sample tubes. For essential safety information, see Use of microcups on page B-6. CAUTION

Figure A-32

Sample disk

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Rack sampler The rack sampler consists of an A-Line, B-Line, C-Line, and STAT (Short Turn Around Time) rack position. e See Racks on page A-74

A-Line Specimens are placed in five-position racks and are loaded onto a tray. Once a tray has been loaded, you can add additional racks to the tray one at a time during operation, provided the tray indication light is green (on). If the light is out (off), the pusher arm is preparing to move. The pusher arm, which is located at the far left of the A-Line, pushes the racks forward and onto the B-Line. The A-Line, shown in the following figure, holds a tray that accommodates 15 racks at one time. Tray Part 1 Output buffer

C-Line

tray indication light

5 racks

5 racks

A-Line

5 racks

5 racks Input buffer

STAT

tray indication light

Tray Part 2

B-LINE

Tray Part 3

A

C

B A

Tray indication light

Figure A-33

B

Rack pusher arm

C

Input buffer (hidden)

A-Line of the rack sampler

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Input buffer The input buffer, shown in the following figure, has space for an additional five racks. Therefore, added to the 15 racks on the A-Line, you can have a total of 20 racks holding 100 specimens on board at any one time. Tray Part 2

Tray Part 1 Output buffer

C-Line

tray indication light

5 racks

5 racks

5 racks

Input buffer

A-Line

STAT

tray indication light

5 racks

B-LINE

Tray Part 3

Figure A-34

Input buffer of the rack sampler

B-Line The B-Line transports the racks to the rack barcode reader. Here each position in the rack is scanned for a sample barcode. After the last position is scanned, the barcode reader scans the rack ID. After the last specimen is sampled, the rack is transferred through the output buffer onto the tray on the C-Line. Tray Part 1 Output buffer

C-Line

tray indication light

5 racks

5 racks

A-Line

5 racks

5 racks Input buffer

STAT

tray indication light

Tray Part 2

B-LINE

Tray Part 3

A B

A

Rack barcode reader

Figure A-35

B

Rack in B-Line

B-Line of the rack sample

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Output buffer Racks are off-loaded from the B-Line into the output buffer, shown in the following figure. If there is no tray, up to five racks can enter the output buffer. At this point the sampling procedure stops. Tray Part 2

Tray Part 1 Output buffer

C-Line

tray indication light

5 racks

5 racks

5 racks

Input buffer

A-Line

STAT

tray indication light

5 racks

B-LINE

Tray Part 3

Figure A-36

Output buffer with racks

C-Line Racks are pushed onto the tray on the C-Line, shown in the following figure. You can remove the tray from the C-Line any time the tray indication light is green (on). If the light is out (off), the system is preparing to push a rack onto the C-Line tray. Tray Part 1 Output buffer

C-Line

tray indication light

5 racks

5 racks

A-Line

5 racks

5 racks Input buffer

STAT

tray indication light

Tray Part 2

B-LINE

Tray Part 3

A A

Output buffer

Figure A-37

C-Line of the rack sampler

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You cannot remove single racks from the C-Line; you must remove an entire tray at one time. If you remove the tray, the system continues to push racks into the output buffer. If the buffer fills and there is no tray, the analyzer issues an alarm and stops sampling racks. STAT rack position The STAT (Short Turn Around Time) rack position is located at the front of the analyzer and feeds directly onto the B-Line. Place a rack in the position as directed on the label and choose the Stat mode button. When the rack currently being sampled is completed, the STAT rack is pushed onto the B-Line and is sent on to the rack barcode reader and sampling position. Tray Part 1 Output buffer

C-Line

tray indication light

5 racks

5 racks

A-Line

5 racks

5 racks Input buffer

STAT

tray indication light

Tray Part 2

B-LINE

Tray Part 3

A A

STAT position

Figure A-38

STAT rack position of the rack sampler

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Racks Sample cups, primary sample tubes, calibrator vials, or control vials are placed in racks. Each rack holds a maximum of five samples. For small primary sample tube sizes an adapter must be used. Each rack has a unique ID found on the barcode label on the back end of the rack. This rack ID is read by the barcode reader and transferred to the system. It appears both on the screens and on the reports.

A A

Rack ID barcode

C

Slot for tube

Figure A-39

B

C B

Tray guide

Racks

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Sample/reagent (S/R) probe The sample/reagent probe is located on the back left wall of the analyzer and is mounted on an arm (S/R arm) that moves horizontally between the sample disk or rack and the pipetting station. The probe uses disposable AssayTips to avoid sample carryover and has liquid level and clot detection for accurate pipetting. Liquid level detection is accomplished by capacitance measurement. Clot detection is accomplished by a pressure transducer. Every new pipetting sequence uses a new AssayTip. For example, a TSH assay uses one AssayTip for R1, R2, and the sample, and an additional new AssayTip for the microbeads. The AssayTip is washed externally at the rinse station between each aspiration step. Additional AssayTips are used for sample dilutions or pretreatment.

A

A

AssayTip

Figure A-40

S/R probe with AssayTip NOTICE

Surface foam Ensure that there is no foam on the surface of the sample or reagent.

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Sample disk protective cover The sample disk protective cover is located on the left at the back of the analyzer, behind the sample disk. The protective cover prevents cross contamination from the sample/reagent probe as it moves to and from the sample disk.

A

A

Sample disk protective cover

Figure A-41

Sample disk protective cover

Lift the protective cover to access the sample disk. The protective cover has a stand on a ratchet to hold it open. To lower the protective cover, lift it fully before lowering it. For essential safety information, see Sample disk protective cover on page B-5. CAUTION

Barcode readers This section provides a description of the system’s barcode readers. Sample barcode reader The sample barcode reader is located toward the back wall of the analyzer. During a sample scan, the barcode reader scans the information on the barcodelabeled primary sample tubes, calibrators, or controls and transmits it to the software. During a reagent scan, the barcode reader rotates to the reagent rotor side to read the two-dimensional barcode labels on the reagent packs. e See Reagent barcode label on page A-43

The barcode reader is auto-discriminating, allowing the use of various types of barcodes during operation. This barcode reader also reads PDF417 barcodes. e For more information, refer to Reagent concept on the COBI-CD

You can see the barcode reader on a rack system when the reagent rotor is removed. To read barcode labels, the barcode reader rotates between the reagent rotor and the barcode card reading station. e See Barcode card reading station on page A-79 Roche Diagnostics A-76

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A second barcode reader scans sample barcodes and rack ID barcodes. e See Rack barcode reader and sample sensor on page A-78

You can see the barcode reader on a disk system when either the sample disk or reagent rotor is removed. e For the location of the barcode reader on a disk system, see Figure A-42 (viewed from the

sample disk side) and Figure A-43 (viewed from the reagent rotor side)

To read barcode labels, the barcode reader rotates between the sample disk and reagent rotor and the barcode card reading station. e See Barcode card reading station on page A-79

A

B

A

Slot for calibrator or control barcode card

Figure A-42

B

Barcode reader slot

Barcode reader (sample disk side)

A

A

Barcode reader slot

Figure A-43

Barcode reader (reagent rotor side)

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Rack barcode reader and sample sensor The rack barcode reader reads both sample barcode labels and the rack barcode label. The barcode reader is auto-discriminating, allowing the use of various types of barcodes during operation. The barcode symbologies that can be read include: o

NW7 (Codabar)

o

Code 39

o

Code 128

o

Interleaved 2 of 5

In addition to the barcode reader, there is also a sample sensor, which detects whether there is a tube available in the rack position.

A

B

A

Barcode reader slot

Figure A-44

B

Sample sensor window

Rack sample barcode reader

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Barcode card reading station At this station, the barcode reader scans calibrator and control information from the calibrator or control barcode card. These cards are packed in calibrator and control kits. When the barcode card is inserted, the barcode must face toward the back of the analyzer. e See Calibrator barcode cards on page A-45

Control barcode cards on page A-47

On a disk system, the barcode card reading station is located between the sample disk and reagent rotor.

Figure A-45

Barcode card reading station (disk system)

On a rack system, the barcode card reading station is located to the back left of the reagent rotor.

Figure A-46

Barcode card reading station (rack system)

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Reagent rotor The reagent rotor contains 18 positions for assay, diluent, or pretreatment reagents. These 18 positions can be used in any combination. There are restrictions on the maximum number of each type of reagent that can be placed on the rotor. The reagent rotor is temperature controlled at 20 ± 3°C. You can place diluent or pretreatment reagent in any position on the reagent rotor and load more than one reagent pack on the reagent rotor for each test.

Figure A-47

Reagent rotor

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Reagent cap open/close mechanism To prevent reagents from evaporating, and to promote ease of use, the reagent rotor uses a reagent cap open/close mechanism during reagent pipetting. The mechanism is located on the back wall of the reagent rotor compartment and emerges when reagents need to be opened or closed. Caps are opened before reagent pipetting or mixing and are closed when pipetting or mixing is completed.

Figure A-48

Reagent cap open/close mechanism

The reagent cap open/close mechanism is normally hidden beneath the cover of the reagent rotor and cannot be seen in use.

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Microbead mixer The mixer is used to mix the microbeads to ensure a homogeneous suspension before aspiration. The mixer is located to the right of the reagent rotor. In its home position, it occupies the space directly to the left of the S/R probe.

Figure A-49

Microbead mixer

Probe/mixer rinse station The rinse station rinses the AssayTip or mixer externally with system water between aspirations or before and after microbead mixing. The rinse station is located below the S/R probe and mixer when the probe is in its standby position and the mixer is in its home position.

A B

A

S/R probe rinse station

Figure A-50

B

Microbead mixer rinse station

Rinse station

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Sample/reagent (S/R) pipetter The S/R pipetter is located on the back right of the analyzer. The pipetter is filled with system water and uses positive displacement to aspirate and dispense from the S/R probe.

A

A

Sample/reagent pipetter

Figure A-51

Sample/reagent (S/R) pipetter

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Consumables area components

Consumables area components The consumables area is on the right of the analyzer and consists of the following components: o

Three AssayTip trays

o

Three AssayCup trays

o

Gripper unit

o

AssayCup disposal opening

o

Liquid waste container

o

Solid waste tray and Clean-Liner

o

System water container

One AssayTip tray holds up to 120 AssayTips, and one AssayCup tray holds up to 60 AssayCups. Therefore, a total of 360 AssayTips and 180 AssayCups can be placed on the analyzer.

Figure A-52

AssayTip tray and AssayCup tray

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Gripper unit The gripper can move in three directions: o

X (left and right)

o

Y (forward and back)

o

Z (up and down)

It is equipped with gripping fingers for gripping AssayTips or AssayCups. The gripper takes an AssayTip from the AssayTip tray, or an AssayCup from the AssayCup tray, and delivers it to the pipetting station. The gripper then moves the AssayCup to the incubator, then to the aspiration station, and finally to the AssayCup disposal opening. During operation, if all trays are full, the analyzer starts using AssayTips and AssayCups from tray 1, position 1. As soon as tray 1 is empty, the analyzer starts using tray 2. As soon as tray 2 is empty, the analyzer continues with tray 3. e See To replace AssayCup and AssayTip trays on page B-29

z axis

B

C

A

D y axis

E

x axis A

Position 1

B

Position 2

C

Tray 3

D

Tray 2

E

Tray 1

Figure A-53

Gripper and trays

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Pipetting station A five-position pipetting station is located to the back left of the incubator. AssayCups and AssayTips are moved by the gripper to this location for sample pipetting, reagent pipetting, sample dilution, and sample pretreatment. Positions 1 and 2 are used for AssayTips, and positions 3 and 4 are used to hold AssayCups for dilution or pretreatment. The S/R probe pipettes samples and reagents at position 5. The AssayTips are discarded at the AssayTip eject station at the far right of the station. A

B

C

D A

AssayTip positions 1-2

B

AssayCup positions 3-5

C

AssayTip eject station

D

AssayCup disposal opening

Figure A-54

Pipetting station

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System water container The system water container is located in front of the pipetters. It holds deionized or distilled water plus SysWash, which should be added to prevent bacterial growth and avoid reagent carryover. An alarm is issued when the system water container is empty. A float mechanism sensor, located beneath the aspiration inlet, triggers the alarm on the Reagent screen. e See Checking the liquid waste container on page B-26

Figure A-55

System water container

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Liquid waste container The liquid waste container is located in front of the ProCell and CleanCell reagents. It holds four liters of waste and issues an alarm when it is approximately three-quarters full. The alarm is triggered by a weight-sensitive mechanism that activates a photosensor located in the compartment holding the container. An alarm is also issued when the container is improperly positioned. This alarm is triggered by a plate mechanism that activates a photosensor located at the front of the compartment. NOTICE

Removing liquid container Removing the liquid waste container during operation or an improperly positioned container causes the analyzer to enter E. Stop status.

Figure A-56

Liquid waste container

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Solid waste tray and Clean-Liner The solid waste tray and Clean-Liner is located behind the front access door on the analyzer. Used AssayCups and AssayTips are discarded into the waste tray during operation. A disposable Clean-Liner is placed inside the solid waste tray. The Clean-Liner has a sliding cover to reduce potential splashing and to prevent AssayTips and AssayCups from falling out of the tray upon removal from the analyzer. The sliding cover must be open during operation. The tray shakes periodically during operation so that used AssayTips and AssayCups do not accumulate at one end of the tray. An alarm is issued if the solid waste tray is full (a maximum of 1100 AssayTips and AssayCups) or if the solid waste tray and Clean-Liner are missing. A photosensor monitors the presence of a tray. The amount of solid waste in the tray is displayed in the Inventory area of the System Overview screen. e See Empty the solid waste on page C-49 NOTICE

Removing solid waste tray Removing the solid waste tray during operation causes the analyzer to enter E. Stop mode.

Figure A-57

Solid waste tray and Clean-Liner

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Measuring area components

Measuring area components The measuring area consists of the following components: o

Incubator

o

Sipper probe and rinse station

o

Sipper pipetter

o

System reagents (ProCell and CleanCell)

o

Detector unit

The sipper probe aspirates the incubated reaction mixture into the detector unit for the determination of results.

Incubator The incubator is maintained at a specific temperature (37.0°C ± 0.3°C) for the reaction of the sample and the reagents that have been dispensed into an AssayCup. The incubator has 32 positions. When an assay is ready for measurement, the AssayCup is transferred by the gripper to the aspiration station, and the sipper probe aspirates the reaction mixture for measurement. The aspiration station, located in the lower right corner of the incubator, is not temperature controlled.

B

A A

Incubator positions

Figure A-58

B

Aspiration station

Incubator

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Sipper probe and rinse station The sipper probe aspirates the reaction mixture into the measuring cell, and also aspirates ProCell and CleanCell. It is located to the right of the incubator. The sipper rinse station externally washes the sipper probe with system water between measurements. When the sipper probe is in its Standby position, it is located directly above the rinse station.

Figure A-59

Sipper probe and rinse station

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Sipper pipetter The sipper pipetter is located directly to the right of the sample/reagent pipetter, behind the liquid waste container. It uses positive displacement of system water to aspirate and dispense from the sipper probe.

A

A

Sipper pipetter location

Figure A-60

Sipper pipetter

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System reagents (ProCell and CleanCell) ProCell and CleanCell are located in bottles in the pipetter area, behind the liquid waste container. o

ProCell is the buffer solution containing tripropylamine (TPA). ProCell bottles are identified by white caps.

o

CleanCell is the cleaning solution used to clean the measuring cell after measurement. CleanCell bottles are identified by black caps.

Two bottles of each reagent are stored on the analyzer, temperature controlled at 28.0°C ± 2.0°C. The keyed shape of the reagent compartment ensures that the reagent bottles can only be placed in the proper position. A transparent sipper shield is fitted to the pipetter area. The sipper shield must be opened to gain access to the system reagent bottles. It is opened and closed by applying pressure to the white metal area at the top until the latch is released or engaged. The sipper shield should not be opened during operation or during maintenance programmed through the software, otherwise the analyzer will immediately stop processing and an alarm will be issued. For essential safety information, see Sipper shield on page B-6. CAUTION A

B

C

D

E

F G

H

I

A

Sipper shield latch

B

Bottle set 2

C

Bottle set 1

D

Sipper shield (in the open position)

E

Position 1 (ProCell position) of bottle set 2

F

Photosensor

— shown with bottle removed G

Position 2 (CleanCell position) of bottle set 2 H

Position 1 (ProCell position) of bottle set 1

— shown with bottle removed I

Position 2 (CleanCell position) of bottle set 1

Figure A-61

ProCell (PC) and CleanCell (CC)

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For essential safety information, see Photosensors on page C-4. CAUTION

When starting from Standby, the sipper probe always attempts to first use ProCell and CleanCell from bottle set 1. If the quantity is insufficient, bottle set 2 is used. When starting from S. Stop or R. Stop, the bottle set in use when the analyzer was previously in operation is pipetted. The analyzer can operate with just one bottle of ProCell and one bottle of CleanCell reagent, but they must be placed together either as bottle set 1 or as bottle set 2.

Detector unit The detector unit receives the incubated reaction mixture aspirated from the sipper probe. e For more information on the detector unit measuring cell, refer to the COBI-CD

This is the last page of Part A

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Safety information for operation . . . . . . . . . . . . . . . . . . . . . . . B–3

6

Daily operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B–7

7

Special operation: How to… . . . . . . . . . . . . . . . . . . . . . . . . . . . B–91

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5 Safety information for operation

Safety information for operation Make sure that you have read and understood Chapter 1 General safety information. The following safety messages in particular are relevant: Warning messages: o

Electrical shock by electronic equipment on page A-8

o

Infection by samples and associated materials on page A-9

o

Infection and injury due to sharp objects on page A-9

o

Skin inflammation or injury caused by reagents and other working solutions on page A-12

o

Infection by waste solution on page A-9

o

Contamination of the environment by liquid and solid waste on page A-10

Caution messages: o

Personal injury due to contact with moving parts on page A-11

o

Incorrect results due to incorrect reagent volume on page A-12

o

Incorrect results and interruption of analysis due to contaminated samples on page A-12

o

Incorrect results due to evaporation of samples or reagents on page A-13

o

Incorrect results due to carryover on page A-13

o

Fatigue due to long hours of operation on page A-13

o

Malfunction due to spilled liquid on page A-14

Observe the system safety labels illustrated and described starting on page A-15.

Before starting to work with the instrument, read the following safety messages carefully. If you ignore these safety messages, you may suffer serious or fatal injury. Air bubbles or films in system reagents WARNING

Perform a reagent prime after replacing the ProCell and CleanCell bottles back on the analyzer to ensure that there are no air bubbles or films in the fluid system.

Instrument problems without alarms Certain instrument problems may arise that the system does not monitor. If this is the case, no alarm is issued to alert the operator. Erroneous control measurements provide an important indicator of analyzer problems even when no alarms are issued. Such problems may include worn parts, air leaks in the syringe system, or reagent contamination. When you encounter these types of problems, you must decide whether to continue to process samples or to terminate the operation, depending on the possibility of causing damage to the system or reporting erroneous test results.

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Manual assignment of sample containers WARNING

It is sometimes necessary to manually assign a vial or other sample or calibrator container to a rack or a specific sample disk position, for example, due to an unreadable barcode or non-barcoded container. o

Ensure that the position is not already assigned before manually assigning a position.

o

Do not manually assign calibrator vials with barcodes to racks or sample disks.

Refer to the Operator’s Manual or online Help for more details on making manual assignments. Quality control measurement An incorrectly measured result may lead to an error in diagnosis, therefore posing danger to the patient. o

Check that quality control measurements are within the specified range before accepting the sample results. The frequency of quality control depends upon the system settings and your local legal requirements.

o

Do not use reagents, calibrators, or controls that are expired. Otherwise, inaccurate data may be obtained.

o

Refer to package inserts for example assigned values and sample/control stability.

Replacing reagent packs o

The instrument must be in Standby before you perform this operation.

o

If you open the reagent rotor cover during operation, your fingers may be injured.

Replacing system reagents The instrument must be in Standby before you perform this operation. Avoidance of foam with all reagent and sample types CAUTION

Avoid the formation of foam with all reagent and sample types (specimens, calibrators, and controls). Barcode read error If the barcode read error option is disabled, the system will not issue an alarm when it is unable to read a sample barcode, or when it detects a sample with no barcode. Therefore, the operator must pay particular attention to ensure correct sample handling when operating with the barcode read error option disabled. Barcode reader window Take care not to scratch or smear the barcode reader window. Check digits in barcodes Use only barcodes with check digits. Barcode scanning errors could potentially go undetected when a check digit is not used. Continuous sample loading on sample disks When loading additional samples on the sample disk after testing has begun, do not place a new sample in a position where measurement has not been completed for the sample previously assigned there. Otherwise, the new sample will be measured rather than the registered sample.

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Data backup CAUTION

If a momentary drop in power voltage occurs due to a power interruption or lightning, the control unit of the instrument may become faulty or the system software, application software, or data may be damaged. In addition, instrument malfunctions or operating errors may cause damage to result data or assay parameters. To prevent such losses, be sure to back up result data and assay parameters periodically. Loading samples and reagents Be sure to load samples and reagents only into the specified positions on the instrument. Loading STAT racks When loading racks on the system from the STAT rack position, ensure the rack is inserted the right way around. Memory problems If any message from the operating system indicates a problem with the Flash memory, contact your Roche service representative. Non-Roche controls When measuring a non-Roche control, use only recommended sample tubes, cup-ontube, or cup-on-rack. Do not use the Roche control vials, as the system would register this as cup-on-tube and would not be able to pipette the control material. Reagent rotor o

Do not touch the reagent rotor or the reagent cover during operation. Otherwise, the instrument may be damaged, or may stop running.

o

Do not insert your fingers into the openings in the reagent rotor cover or into the opening of the reagent cap open/close mechanism. Otherwise, personal injury may result.

o

Never unlock or open the reagent rotor cover during operation unless the analyzer is in Standby mode. If the cover is kept open, the cooling efficiency and temperature control may be compromised and the reagents may deteriorate. Opening the cover during analysis also causes an instrument alarm but does not stop the analyzer from operating.

Reduced sample volume A reduced residual volume may only be used with Hitachi standard cups (not with primary or secondary tubes). Reduced sample volume should not be used routinely and only when the operator can verify appropriate sampling. Restrictions on samples Do not use sample and cleaning or disinfectant solutions that are likely to adhere to the sample probe, reagent probes, or measuring channel. Sample disk protective cover Make sure that you lay down the sample disk protective cover before you start operation.

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Sipper shield o

To open the sipper shield, push the white metal area at the top to release the latch. Do not pull the sipper shield without releasing the latch in this way, otherwise the latch may be damaged.

o

Do not open the sipper shield while the analyzer is in operation, otherwise the analyzer will immediately stop processing and an alarm will be issued.

o

Close the sipper shield after replacing a system reagent or performing maintenance, otherwise the instrument will not operate.

CAUTION

Stop processing Choosing the Stop button causes all sampling and sample processing to be stopped. Results from samples currently being processed are lost. Switching on the instrument After switching off the analyzer, wait for at least ten seconds before switching on again. Use of microcups Microcups must not be used on the cobas e 411 analyzer. Where to use Roche cup adapter inserts Roche Diagnostics recommends the use of Roche cup adapter inserts to improve the vertical alignment of 13 mm primary tubes in five-position standard racks.

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6 Daily operation Table of contents

Daily operation

This chapter describes the everyday tasks that are required for running the cobas e 411 analyzer. Common procedures that are performed as part of the daily work flow are also described here.

In this chapter

Chapter

6

Overview ............................................................................................................................B–9 Work flow of daily operation ...................................................................................B–9 Check list for daily operation .................................................................................B–10 Pre-start inspection ........................................................................................................B–11 Startup procedures .........................................................................................................B–11 Switch the printer on ...............................................................................................B–11 Switch the analyzer on .............................................................................................B–11 Check system alarms ...............................................................................................B–15 Pre-routine operation ....................................................................................................B–16 System Overview screen ..........................................................................................B–16 Color scheme of the System Overview screen .....................................................B–17 Reagent overview .....................................................................................................B–17 Work Flow Guide ....................................................................................................B–20 Replacing required reagents and consumables ....................................................B–23 Routine operation ..........................................................................................................B–32 Perform calibration and QC ...................................................................................B–32 Validate calibration and control results ................................................................B–40 Correct placement of sample tubes on a sample disk .........................................B–43 Correct placement of sample tubes on a rack ......................................................B–44 Correct insertion of Roche Cup-Adapters ...........................................................B–45 Routine sample measurements: disk system ........................................................B–46 Routine sample measurements: rack system ........................................................B–56 Measurement of additional routine samples .......................................................B–63 STAT test selections: disk system ..........................................................................B–66 STAT test selections: rack system ..........................................................................B–70 Dilution .....................................................................................................................B–77 Sample tracking: disk system ..................................................................................B–79 Roche Diagnostics Operator’s Manual · Version 2.1

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Table of contents

Sample tracking: rack system .................................................................................B–80 Loading consumables during operation ...............................................................B–82 Results ..............................................................................................................................B–85 View patient results .................................................................................................B–86 Filter patient results .................................................................................................B–88 Print or upload patient results ...............................................................................B–88 Print a Result Report ...............................................................................................B–90 Post-operation data management ................................................................................B–91 Review results ...........................................................................................................B–91 Delete documented samples ...................................................................................B–91 Daily maintenance .........................................................................................................B–93 Switch off the analyzer ...................................................................................................B–93 Prevent evaporation of the system reagents .........................................................B–94 Final power off checks .............................................................................................B–95

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6 Daily operation Overview

Overview Daily operation encompasses the routine tasks that are required to prepare the system, analyze samples, and maintain the system. The layout of the System Overview screen gives you an intuitive guide for the tasks required for routine operation. The sections in this chapter contain detailed descriptions explaining how to accomplish various daily operational tasks.

Work flow of daily operation The following diagram gives an overview of the daily operation process. Pre-start inspection

Startup procedure • Switch on (Initialization and Standby) • Check alarm button

Pre-routine operation

Routine operation • Calibration and control

Rerun

• Routine or STAT(a) sampling

Assigned

-----------------------------------------------------Results

Sampling Stop (Finalization, Stop, and Standby)

Maintenance

Switch off

Additional maintenance (a)

Short Turn Around Time

Figure B-1

Work flow diagram

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Overview

Check list for daily operation Procedure

Software tab or screen

Pre-start inspection

Startup procedures

m Switch on

(None)

m Log on

Logon screen

m Open the lids on the ProCell and CleanCell bottles

(None)

m Check system alarms

Alarm screen

m Perform troubleshooting on any alarms (if necessary)

(None)

Pre-routine operation

m Clear sample data

System Overview screen > Sample Data Clear window

m Print a reagent load list

System Overview screen > Reagent Load List

m Replace required reagents packs

(None)

m Replace system reagents (ProCell and CleanCell), if necessary

(None)

m Replace AssayCup and AssayTip trays (if necessary)

(None)

m Fill system water container with distilled water and SysWash

(None)

m Empty waste containers (if necessary)

(None)

Instrument calibration/quality control

m Check if calibration or QC is requested by the system.

System Overview screen > Calib/QC Load List

m Check if calibration renewal is due on each reagent pack

System Overview screen

m Request non-Roche controls

System Overview screen > Calib/QC Load List

m Prepare calibrator and control material (if needed)

(None)

m Load required calibrators and controls

(None)

m Measure calibrators and controls

Start Conditions screen

m Validate calibration and control results

(None)

Sample processing

m Program patient samples (if needed)

Performed at the host or manually via Workplace tab >Test Selection screen

m Load patient samples

(None)

m Start processing

Start Conditions screen

m Track sample processing

System Overview screen > Sample Tracking window

Result evaluation

m Print reports

Data Review screen

m Review results

Data Review screen

m Delete documented samples

Data Review screen

Table B-1

Daily operation check list

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Procedure

Software tab or screen

Daily maintenance

m Perform Finalization maintenance (if needed)

Utility > Maintenance > Finalization window

m Switch off at Operation switch

(None)

m Clean the S/R probe

(None)

Table B-1

Daily operation check list (continued)

Pre-start inspection Before switching on, check the following aspects of the system: o

All surfaces are clean and clear of loose articles or debris.

o

Probes and microbead mixer paddle are in good condition and not bent.

o

No tubing is pinched or bent.

o

Pipetter syringes and associated tubing are free of bubbles and are not leaking system water.

If any problems arise, refer to the Maintenance and Troubleshooting chapters. e See Maintenance on page C-5

Troubleshooting on page D-3

Startup procedures Once you have completed the pre-start inspections, you can switch on the analyzer.

Switch the printer on If the printer is not already on, switch it on. Check that the printer paper supply is adequate. e Refer to the appropriate printer documentation for details, as the analyzer may be used

with several printer models. For further information, and a list of recommended printers, see External printer on page A-54

Switch the analyzer on When the analyzer is in service, leave the circuit breakers set to On so that the analyzer continues to regulate the temperature of the reagent rotor. Use only the operation switch to switch on or off the analyzer at the start and end of the day. However, if you have had to shut down the analyzer completely, you need to switch the circuit breakers back on before switching on the analyzer.

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Startup procedures

NOTICE

Use of the screen saver In normal operation, the monitor will remain powered for prolonged periods. To preserve the image quality of the monitor, Roche Diagnostics recommends that you enable the screen saver. Use the Utility > System screen to activate the screen saver.

When the system is switched on, it performs initialization before entering Standby mode. a To switch on the circuit breakers 1 Switch on the circuit breaker, located on the right side of the analyzer, if it is not already switched on. 2 Switch on the rack transport system circuit breaker located on the left side of the analyzer (rack systems only). If the rack transport system circuit breaker is not turned on then a yellow pop-up window appears on the screen with the message: ‘Line main power off’. Always keep the analyzer switched on at the circuit breaker. Power from the circuit breaker keeps the reagent rotor temperature controlled.

a To switch the analyzer on 1 Switch the analyzer on at the operation switch located on the front panel.

Figure B-2

Operation on/off switch location

A small green light on the switch lights when the system is on and the Logon screen is displayed while the system performs initialization. During initialization, the mechanisms are reset to their home positions. Roche Diagnostics B-12

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2 After initialization is complete, ensure that the screen displays a Standby mode.

a To open the lids of the system reagents Before performing the following actions, observe these safety precautions: o

Sipper shield on page B-6

1 Open the sipper shield by pressing the white metal area at the top, as shown in the following figure, until the latch is released.

A

A

Press here to open or close the sipper shield

Figure B-3

Open the sipper shield

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2 Open the lids on the ProCell and CleanCell bottles.

Figure B-4

Open lids of ProCell/CleanCell

3 Close the sipper shield by applying pressure to the white metal area at the top until the latch is engaged and you hear a click. NOTICE

Sipper shield Do not open the sipper shield during a run as the action will interrupt the run.

a To log on to the system 1 When the system has started and the Logon window appears, type your Operator ID and password. If the screen is black, check the monitor is on.

Figure B-5

Logon window

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2 Choose Logon to log on and gain access to the software. Your Operator ID will be shown next to the date at the top of all screens and on the analyzer printouts.

Check system alarms If an alarm has been issued, there is an audible warning and the Alarm global button shows red or yellow. The Alarm button is always accessible even prior to log on. Choose Alarm to open the Alarm screen, which displays any system alarm conditions. You can sort the list of alarms according to the criteria shown in the headers that appear above the list. For example, if you choose Level, the system sorts the list according to the severity of the alarms.

Figure B-6

Alarm screen

a To review the Alarm screen 1 Choose the Alarm global button to open the Alarm screen. 2 Select each alarm to view the description and remedy (displayed in the lower half of the screen). 3 Correct any alarm conditions by following the remedies outlined in the system software. e See Troubleshooting on page D-3

4 Choose Close to close the Alarm screen. When the Logon screen appears, continue with the logon procedure. e See To switch on the circuit breakers on page B-12

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Pre-routine operation

Pre-routine operation Before you can start routine operation you must first prepare the system.

System Overview screen

Figure B-7

System Overview screen

The System Overview screen has a central role within the cobas e 411 analyzer software. From here you have an overview of the whole system at any time. This screen displays the status of each reagent, the details of the reagents loaded, and details of the inventory. You can access other windows by choosing the corresponding button or area of the screen. You can use the Work Flow Guide to prepare the system for routine operation. You can open the System Overview screen from any screen by choosing the double System Overview icon in the top left corner of the screen. The colors of the two halves of this icon show you the status of the host communication and the analyzer. Icon

Color

Meaning

Host

Blue

Host communication on the cobas e 411 analyzer side is set to Off (independently of the availability of host communication).

Green

Host communication on the cobas e 411 analyzer side is set to On (independently of the availability of host communication).

Blue

The analyzer is in Initialization, Operation, or Maintenance mode.

Green

The analyzer is in Standby mode.

Yellow

An instrument alarm has been raised with a caution level. This could mean the number of tests remaining for a reagent is less than the caution level specified on the Reagent Level Check window.

Red

An instrument alarm of Stop, S.Stop, or E.Stop has been raised.

E

Table B-2

System Overview screen icons

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Color scheme of the System Overview screen The System Overview screen uses color to display the system status. The following table gives the meaning of the color for each button in the Work Flow Guide area. Button in Work Flow Guide area

Color

Meaning

Maintenance

Blue

System ready (active)

Yellow

Remaining time is below the yellow alarm caution level

Red

Caution. Maintenance action is required. A mechanical problem may have occurred that requires a manual reset.

Sample Data Clear

Reagent Load List

Calib/QC Load List

Blue

System ready (active)

Yellow

80-90% of the database capacity is reached. It is recommended that you delete the results.

Red

The database is full. You should delete the results.

Blue

System ready (active)

Yellow

At least one parameter falls below the limit for the reagent level check

Red

A reagent or consumable for one test is unavailable (missing or empty)

Blue

System ready (active)

Yellow

A request for calibration and QC has been made

Red

Failed calibration or QC violation

Parameter Download

Blue

System ready (active)

Sample Tracking

Blue

System ready (active)

Table B-3

Color scheme for the Work Flow Guide area

Reagent overview

Figure B-8

Reagent Overview area

Use the Reagent Overview area of the System Overview screen to view the status of the consumables on board. The Reagent Overview area consists of two sections: the reagent rotor graphic and the Inventory area.

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Reagent rotor graphic Choosing a position segment of the reagent rotor graphic displays the Reagent Detail window, with details of the reagent loaded in the chosen position. The color of the segments of the reagent rotor graphic indicates the status of reagents, calibrators, and controls. Inner block: reagent pack

Active

Reagent pack currently in use for this test.

Warning

Remaining tests in this reagent pack below yellow alarm level (Utility > System (Page 2/3) > Reagent Level Check).

Caution

No more reagent is available for this assay on the analyzer, or no diluent, or pretreatment available.

Stand-by

This is a standby reagent pack.

Zero tests, Used up The reagent pack has been used and is empty. There is still

reagent available in another reagent pack on the analyzer.

Middle block: calibrator

Outer block: QC

Free Pos.

There is no reagent pack in this position.

Expired.

The reagent pack has passed its expiration date.

Valid

A calibration has been successfully generated.

Requested

A calibration has been requested.

Failed

Calibration of the reagent has failed.

Valid

QC result is within the confidence limits.

Requested

Requested for QC measurement.

Violated

QC result is not within the confidence limits.

N.A.

Not applicable.

Inventory area This area displays the amount of system reagents, AssayCups, AssayTips, and solid waste on the analyzer by means of seven bar charts. PC1/PC2

The blue bar indicates the amount of ProCell (PC) remaining, with a % figure below. The PC1 column represents bottle 1 and PC2 bottle 2.

CC1/CC2

The blue bar indicates the amount of CleanCell (CC) remaining, with a % figure below. The CC1 column represents bottle 1 and CC2 bottle 2.

Solid waste

The blue bar indicates the amount of solid waste present in the solid waste container, with the quantity displayed below (0=empty).

Cup

The blue bar indicates the proportion of AssayCups remaining in each tray, with the quantity displayed below.

Tip

The blue bar indicates the proportion of AssayTips remaining in each tray, with the quantity displayed below.

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Reagent Detail window f

System Overview > any position on the reagent rotor graphic

Figure B-9

Reagent Detail window

Use this window to view detailed information about the reagent loaded in the position selected in the Reagent area of the System Overview screen. Test Position Reagent Type Reagent Lot No. Reagent Pack No. First Registration Date and Time Lot Expiration Date Determinations Last Calib Date (L-Calib) recommended at Last Calib Date (R-Calib) recommended at

The short name of the test for which the reagent pack is used. The position the reagent pack occupies in the reagent rotor. The type of reagent used (for example, ASSAY). The lot number of the current reagent pack. The sequence number of the current reagent pack. The date and time that the current reagent pack was first registered by the system.

The expiration date of the current reagent pack lot. The number of determinations remaining for the corresponding reagent. The date of the last lot calibration of the current reagent pack. The recommended date for the next lot calibration. The date of the last reagent pack calibration of the current reagent pack. The recommended date for the next reagent pack calibration.

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Pre-routine operation

Work Flow Guide The Work Flow Guide area at the top of the System Overview screen is a step-bystep guide through the preventive action.

Figure B-10

Work Flow Guide area

The Work Flow Guide area consists of six buttons: Maintenance, Sample Data Clear, Reagent Load List, Calib/QC Load List, Parameter Download, and Sample Tracking. The color of each button varies, depending on the status. Choosing these buttons displays screens and windows that enable you to take actions appropriate to the situation. Maintenance Choose Maintenance to display the Utility > Maintenance screen. From this screen you can select and start maintenance actions. Sample Data Clear Choose Sample Data Clear when the button is red or yellow to open the Sample Data Clear window.

Figure B-11

Sample Data Clear window

Select Clear to perform a sample data clear. A sample data clear deletes all records of the samples and moves QC data to the QC view. Regular backing up is recommended. If your system is connected to a host, make sure that all data has been uploaded before performing a sample data clear. Information exported using the Export and Clear function cannot be read back onto the system. However, the exported data can be viewed on an external PC using a suitable program. e See How to export data manually on page B-121 NOTICE

Delete sample results regularly Roche strongly recommends that you delete sample results daily after uploading data to the host, or performing an export to maintain system performance.

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Reagent Load List f

The Reagent Load List displays the reagents packs, reagent bottle sets, and other consumables that need to be replenished on the system.

a To print and use a Reagent Load List 1 Choose Reagent Load List on the System Overview screen. A confirmation window opens. 2 Choose OK to print the Reagent Load List. 3 Replace any required reagent, diluent, ProCell, CleanCell, or pretreatment reagent. Ensure that reagent packs have not exceeded their expiration dates. You can also print a Reagent Load List from the Reagent tab of the Print global screen.

Calib/QC Load List The Calib/QC Load List report describes in detail the calibrators that are ordered and should be loaded and displays information about the requested measurement for each control. A calibration can be requested for the following reasons: o

A new assay is installed

o

The lot number is changed

o

Calibration has failed

o

Controls are outside the confidence limits

o

A calibration has been requested manually by the operator

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a To print a Calib/QC Load List 1 Choose Calib/QC Load List on the System Overview screen. A confirmation window opens. 2 Choose OK to print the Calib/QC Load List. You can also print a Calib/QC Load List from the Calibration and QC tab of the Print global screen.

Parameter Download Choose Parameter Download to open the Parameter Download window, where you can select from calibrator and control data that are available for download from cobas® link. Sample Tracking Choose Sample Tracking to monitor the progress of sample processing. e See Sample tracking: disk system on page B-76

Sample tracking: rack system on page B-77

Replacing required reagents and consumables Replace all required reagent packs and system reagents as indicated by the Reagent Load List. Ensure that reagent packs have not exceeded their expiration dates. Before performing the following actions, observe these safety precautions: o

Handling of reagents on page A-12

Replacing reagent packs Load reagents on the reagent rotor as directed by the Reagent Load List. NOTICE

Manual reagent pack registration When you manually register a reagent pack, you must confirm that you have placed it in the correct position. Before performing the following actions, observe these safety precautions: o

Replacing reagent packs on page B-4

e See Reagent Load List on page B-21

Reagent rotor on page A-80 for more information, see the online Help

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a To replace reagent packs 1 Open the reagent rotor cover by rotating it to the left until it reaches the stop and then lift it clear.

Figure B-13

Open/close the reagent rotor cover

2 Place the required reagents in the reagent rotor, ensuring that the reagent packs are correctly oriented in the rotor. NOTICE

Reagent temperature Reagents on the reagent rotor are stored in temperature controlled conditions. If you plan to run assays that currently are not stored on the analyzer, you must allow them to reach reagent rotor temperature (20 ± 3°C) before starting analysis.

Figure B-14

Load new reagents, if necessary

3 Close the reagent rotor cover. If you try to operate the analyzer without first closing the cover, the analyzer generates an alarm. Closing reagent rotor cover The reagent rotor cover is keyed. Before you can close the cover, you must orientate it properly so that the cover fits into the key. Roche Diagnostics Operator’s Manual · Version 2.1

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4 Choose Scan Reagent on the System Overview screen to activate a reagent scan. When the reagent scan is complete, the reagent rotor indicator on the System Overview screen is updated to display the status of each reagent pack placed on the reagent rotor.

Replacing system reagents You must always replace ProCell and CleanCell bottles as sets. You cannot exchange them during a run due to the sipper shield. If you attempt to replace the bottles, the run is aborted. e See System reagents (ProCell and CleanCell) on page A-93

Before performing the following actions, observe these safety precautions: o

Air bubbles or films in system reagents on page B-3

o

Replacing system reagents on page B-4

o

Photosensors on page C-4

o

Sipper shield on page B-6

a To replace system reagents 1 Lift the instrument cover. 2 Open the sipper shield by applying pressure to the white metal area at the top, until the latch is released. e See Figure B-3 on page B-13 NOTICE

The reagent rotor cover is keyed. Before you can close the cover, you must orientate it properly so that the cover fits into the key. Always replace ProCell and CleanCell bottles as sets. If you remove and replace a full (100% volume) bottle from one of the system reagent compartment positions containing a photosensor, the analyzer assumes that you have loaded a new bottle set, even if the bottle has been on the analyzer for several hours or days. The analyzer consequently waits 15 minutes for temperature equilibration, as is normal for a new bottle set. If you need to load two new bottle sets of ProCell/CleanCell, load these new bottles as your first inventory check. By the time you are ready to operate, the system reagents should be at the correct temperature. If they are not, you will receive ProCell/CleanCell reagent temperature alarms. e See Data alarms on page D-31

The bottles on the right (Set 1) are consumed first. If replacing the bottles on the right, move the bottles from the left (Set 2) to the right. Then load the new bottles in the correct positions of Set 2.

3 Remove the empty ProCell and CleanCell bottles, indicated in the inventory area on the System Overview screen, and replace them with a set of full bottles. Ensure that each bottle is firmly in place in the correct position with the correct orientation. Place ProCell only in the left hand position of each bottle set and CleanCell in the right hand position. The keyed shapes of the reagent compartment and reagent bottles ensure that the reagents are placed in the proper position. Roche Diagnostics B-24

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NOTICE

Open bottle lids Open the lids of all PC and CC bottles on board prior to starting operation or programmed maintenance functions. A

C

B

D

E

F

A

Bottle set 2

B

Bottle set 1

C

ProCell position (bottle set 2)

D

CleanCell position (bottle set 2)

E

ProCell position (bottle set 1)

F

CleanCell position (bottle set 1)

Figure B-15

System reagent positions

4 Close the sipper shield by applying pressure to the white metal area at the top until the latch is engaged and you hear a click. 5 Close the instrument cover. 6 If a ProCell bottle with a new lot number was loaded, select Reagent and choose Inventory Set. The Inventory Set window is opens. Type the lot number for each of the ProCell bottle.

Checking the system water container If the system water container is empty, it needs to be refilled with a 100+1 solution of SysWash in distilled water.

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a To check the system water container 1 Check that the analyzer is in Standby mode. 2 Raise and remove the system water container.

A

B

A

Cap and valve (not visible)

Figure B-16

B

System water container

Remove the system water container

3 Remove the cap and discard any water remaining inside. 4 Clean the container if it appears to be dirty or contaminated. e See Clean the system water container on page C-36

5 Fill the container with distilled or deionized water up to the upper level mark. 6 Add 35 mL of SysWash to the distilled or deionized water, pouring carefully to avoid creating air bubbles. This creates a 100+1 dilution. The upper level mark on the system water bottle denotes a volume of 3 liters plus a dead volume of 500 mL.

7 Dry the outside of the container with paper towels, attach the cap to the container, and return the container to the analyzer.

Checking the liquid waste container Treat the waste from the waste container as potentially infectious. You may add an appropriate volume of a germicidal agent (as directed in its product labeling) to the empty liquid waste container before processing samples. e If your system has a direct drain installed, see To check the external direct drain system on

page E-8

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Before performing the following actions, observe these safety precautions: o

Infection by samples and associated materials on page A-9

o

Avoid use of bleach on page C-3

a To check the liquid waste container 1 Check that the analyzer is in Standby mode. 2 Pull the liquid waste container toward you and cap it. 3 Raise the container carefully while avoiding the liquid waste outlet. At the same time, place a paper towel directly under the waste outlet to catch any drips.

Figure B-17

Remove the liquid waste container

4 Empty the container and rinse it thoroughly with water. 5 If the inside of the container appears to be dirty, use 70% isopropyl alcohol to rinse the container. Follow with a thorough water rinse. 6 Wipe the outside of the container with a paper towel. 7 Use a paper towel to wipe the compartment where the container is to be placed. 8 Optional step: Add the appropriate volume of a germicidal agent of pH 9 (as directed in its product labeling) to the liquid waste container. 9 Remove the paper towel under the waste outlet and replace the liquid waste container. 10 Remove the cap from the container and store it nearby for the next container removal. 11 Push the container forward so that the container opening is under the liquid waste outlet.

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Emptying the solid waste tray The solid waste tray is located behind the solid waste door, beneath the AssayTip and AssayCup trays. If the tray is full, you will need to remove the Clean-Liner and replace it with a new one. e See Solid waste tray and Clean-Liner on page A-89

Before performing the following actions, observe these safety precautions: o

Infection by samples and associated materials on page A-9

o

Infection by waste solution on page A-9

o

Contamination of the environment by liquid and solid waste on page A-10

o

Changing the Clean-Liner on page C-3

a To empty the solid waste tray 1 Check that the analyzer is in Standby mode. 2 Open the solid waste door and pull out the tray. The Clean-Liner has a clear sliding lid. 3 Slide the lid forward to close the Clean-Liner.

A

B

C

A

Sliding lid

C

Waste tray

Figure B-18

B

Solid waste compartment door

Remove the Clean-Liner

4 Remove the Clean-Liner from the tray and dispose of it according to the waste procedures that apply in your laboratory for potentially biohazardous material. 5 Place a fresh Clean-Liner in the tray. Verify that the sliding door is open and that the opening is located at the back of the tray. 6 Insert the tray into the analyzer and close the door. The counter for the solid waste, which is located on the System Overview screen, automatically resets to zero (0) when the tray is removed. Roche Diagnostics B-28

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NOTICE

Removing solid waste tray If you remove the solid waste tray for any reason, you should discard the solid waste or replace the Clean-Liner at the same time. The software counts the AssayTips and AssayCups used during operation. When the analyzer senses that the solid waste tray is removed, the counter resets to 0 (zero) and starts counting as if the tray is empty.

Replacing AssayCup and AssayTip trays During operation, if all trays are full, the analyzer starts using AssayTips and AssayCups from tray 1. When tray 1 is empty the analyzer starts using tray 2, and then tray 3. When tray 3 is empty, the analyzer returns to tray 1 if a new tray has been loaded. e For an explanation of the locations of the numbered trays, see Figure A-53 on page A-85

a To replace AssayCup and AssayTip trays 1 Replace any empty AssayCup or AssayTip trays with full ones as required. Do not add or remove single AssayTips or AssayCups. 2 Make sure that the trays are seated properly with the correct orientation. Trays are keyed for proper placement.

Figure B-19

Load new AssayCup or AssayTip trays

e See Loading consumables during operation on page B-79

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Routine operation After completing pre-routine tasks, you are ready to start routine operation. Routine operation involves procedures related to the following areas: o

Perform calibration and QC

o

Validate calibration and control results

o

Correct placement of sample tubes on a sample disk

o

Correct placement of sample tubes on a rack

o

Routine sample measurements: disk system

o

Routine sample measurements: rack system

o

Measurement of additional routine samples

o

STAT test selections: disk system

o

STAT test selections: rack system

o

Dilution

o

Sample tracking: disk system

o

Sample tracking: rack system

o

Loading consumables during operation

Sample preparation When preparing samples, always ensure that the preanalytical requirements are fulfilled according to good laboratory practice and tube manufacturer recommendations.

Perform calibration and QC Calibration and controls are normally processed at the beginning of routine operation (before sample processing begins), but this can be done at any time during routine operation. Calibration and QC involves two steps: o

Measuring the calibrators and controls

o

Validating the results

Prepare calibrators and controls Prepare calibrators as necessary, based on the Reagent Overview screen information updated at the last reagent scan. Most are supplied ready to use, but some require reconstitution. Refer to the specific calibrator package insert. Prepare controls, if necessary, following the instructions on their package inserts. You do not need to scan barcode cards or e-barcodes for in-pack calibrators (provided as part of the reagent kits).

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Load calibrators and controls Before performing the following actions, observe these safety precautions: o

Manual assignment of sample containers on page B-4

o

Non-Roche controls on page B-5

a To load calibrators and controls onto the sample disk 1 Prepare all required calibrator and control materials according to the manufacturer's instructions, using the Calib/QC Load List as a guide. e See Calib/QC Load List on page B-21

2 Use QC materials to verify calibration as well as the precision and accuracy of the instrument. Follow the regulatory requirements for your local area to establish additional control runs for your laboratory. 3 Load calibrators and controls onto the sample disk so that the barcodes face out (see Figure B-20). NOTICE

QC after calibration If you load control vials in positions that directly follow a calibrator set (with no samples or empty positions in between), the system uses the controls for that calibration only. The controls are only used for that calibration set if they are assigned to the same test. If the controls are assigned to a different test, no control measurement takes place. If you wish to use the controls for all the activated and available tests, leave an empty position between the calibrator vials and control vials. e See How to assign calibrator and control positions on page B-117

a To load calibrators and controls onto a rack 1 Prepare all required calibrator and control materials according to the manufacturer's instructions, using the Calib/QC Load List as a guide. e See Calib/QC Load List on page B-21

2 Use QC materials to verify calibration as well as the precision and accuracy of the instrument. Follow the regulatory requirements for your local area to establish additional control runs for your laboratory. 3 Load calibrators and controls onto the racks so that the opened lid is toward the back of the rack (see Figure B-21) and place the racks on the loader. NOTICE

QC after calibration If you load control vials in positions that directly follow a calibrator set (with no samples or empty positions in between), the system uses the controls for that calibration only. The controls are only used for that calibration set if they are assigned to the same test. If the controls are assigned to a different test, no control measurement takes place. If you wish to use the controls for all the activated and available tests, leave an empty position between the calibrator vials and control vials. e See How to assign calibrator and control positions on page B-117

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Routine operation

Scan calibrator and control barcode cards You should perform a barcode card scan if a new lot of calibrators or controls has been loaded. You require administration level access to perform this task. If you have cobas® link, you can download calibrator or control barcode information.

a To scan calibrator barcode cards 1 Choose Calibration > Install. 2 Insert the calibrator barcode card into the card reading station, with the barcode facing the back of the analyzer. Push the card as far down as it will go into the station. 3 Choose Scan BC Card to initiate a scan of the calibrator barcodes. When the confirmation window opens, choose OK. Once the barcode card has been successfully scanned, the barcode reader makes an audible beep. Do not remove the card until the analyzer returns to Standby mode. 4 Repeat steps 2 to 3 for each card to be scanned.

a To scan control barcode cards 1 Choose QC > Install. 2 Insert the control barcode card into the card reading station, with the barcode facing the back of the analyzer. Push the card as far down as it will go into the station. 3 Choose Scan BC Card to initiate a scan of the control barcodes. When the confirmation window opens, choose OK. Once the barcode card has been successfully scanned, the barcode reader makes an audible beep. Do not remove the card until the analyzer returns to Standby mode. 4 Repeat steps 2 to 3 for each card to be scanned.

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Load the sample disk and request calibration a To load the sample disk 1 Place one CalSet (vials Cal1 and Cal2) of open, barcode-labeled calibrator vials on the sample disk. Ensure that both levels of calibrators are next to each other on the sample disk. When the calibrator barcode is scanned by the barcode reader, calibration is automatically requested for the assay. 2 Place the CalSet vials and control vials correctly in their keyed positions on the sample disk, as shown in the following figure, with the barcode facing outward.

A

B

A

Keyed vial

Figure B-20

B

Keyed disk

Keyed vial loaded on the sample disk

3 Open each CalSet vial lid to the vertical position.

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Load the racks and request calibration a To load a rack 1 Place one CalSet (vials Cal1 and Cal2) of open, barcode-labeled calibrator vials on the rack. Ensure that both levels of calibrators are next to each other on the rack. When the calibrator barcode is scanned by the barcode reader, calibration is automatically requested for the assay. 2 Place the CalSet vials and control vials correctly in their keyed positions on the rack, with the barcode facing outward as shown in the following figure.

A B

A

B

Keyed vial

Figure B-21

Keyed rack

Keyed vial loaded on the rack

3 Open each CalSet vial lid to the vertical position as shown above.

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Activate QC test If a new control lot is loaded, you may need to activate the required tests. a To activate or deactivate tests 1 Choose QC > Install.

Figure B-22

QC > Install screen

2 Select the required control from the control list. 3 Select the test that you wish to activate from the control list. 4 Choose Activate Test to activate the selected test. 5 The Activate Test button changes to Inactivate Test if an active test is selected. To deactivate an active test, select the test and choose Inactivate Test.

Measure calibrators and controls When the calibrators and controls have been placed on the sample disk or rack, the calibrations and controls can be measured. NOTICE

Expired calibrators Expired calibrators are not processed and no calibration is performed with them.

When validating control results, check for any anomalies. Unusually high or low readings might indicate a problem that does not cause the analyzer to raise alarms. Before performing the following actions, observe these safety precautions: o

Air bubbles or films in system reagents on page B-3

o

Instrument problems without alarms on page B-3

o

Manual assignment of sample containers on page B-4

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a To measure calibrators and controls (disk system) 1 Choose Start (global button).

Figure B-23

Start Conditions screen (disk system)

2 Check the settings on the Start Conditions screen. If these settings are not as required, make the necessary adjustments. If the analyzer is running in the multiple sample disk mode, make sure that the number in the Disk No. box matches the sample disk currently loaded. When the calibrator barcode is scanned by the barcode reader, calibration is automatically requested for the assay. To assign positions to non-Roche controls, use the QC > Control screen. To perform measurements, you must also assign and activate tests on the Control > Install screen. For more information, refer to: e How to assign calibrator and control positions on page B-117

If you need to measure stand-by bottle QC, refer to: e How to request stand-by bottle QC on page B-116

How to install and define non-Roche controls on page B-113

3 Choose Start. The monitor displays the previous screen and the calibration and control run begins. If automatic printout has been selected at Utility > System (Page 2/3) > Documentation Setup, the Calibration Result report will be printed automatically when calibration is complete. Only one result is printed per page. If automatic printout is not selected the calibration report may be printed by selecting the calibration and select print screen.

4 Remove calibrators and controls from the sample disk when sampling is complete. Promptly close the lids of the calibrator and control vials and return them to the refrigerator.

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a To measure calibrators and controls (rack system) 1 Choose Start (global button).

Figure B-24

Start Conditions screen (rack system)

2 Check the settings on the Start Conditions screen. If these settings are not as required, make the necessary adjustments. When the calibrator barcode is scanned by the barcode reader, calibration is automatically requested for the assay. To assign positions to non-Roche controls, use the QC > Control screen. To perform measurements, you must also assign and activate tests on the Control > Install screen. For information on positioning controls, refer to: e How to install and define non-Roche controls on page B-113

How to request stand-by bottle QC on page B-116 How to assign calibrator and control positions on page B-117

3 Choose Start. The monitor displays the previous screen and the calibration and control run begins. If automatic printout has been selected at Utility > System (Page 2/3) > Documentation Setup, the Calibration Result report will be printed automatically when calibration is complete. Only one result is printed per page. If automatic printout is not selected the calibration report may be printed by selecting the calibration and select print screen.

4 Remove calibrators and controls from the sample rack when sampling is complete. Promptly close the lids of the calibrator and control vials and return them to the refrigerator.

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Validate calibration and control results After calibrators and controls have been measured, it is necessary to check the results are valid. Expired calibrators

NOTICE

Expired calibrators are not processed and no calibration is performed with them.

If automatic printout has been selected for calibration and control samples on the Documentation and Printer Setting window, the results will be printed automatically when each calibration is complete. Only one result is printed per page.

Roche Diagnostics

Immunoanalyzer

Calibration Result

cobas e 411

Operator-ID: admin

S/N 04/21/2008, 16:09

L-Calib. could not be generated! Released as R-Calib. by System Test Unit Reagent pack Lot no. Reagent pack number Reagent pack expiration date

: : : : :

TSH 0 uIU/ml 00178806 058812 02/2008

Data latest successful calibration L Calibration L calibration date Reagent pack no. for L Calib. Calibrator Lot no. Expiration date calibrator Recalibration recommended at

: : : : :

08/24/2007 058812 00179992 02/2008 09/21/2007

RP Calibration RP calibration date Reagent pack no. for RP Calib. Calibrator Lot no. Expiration date calibrator Recalibration recommended at

: : : : :

08/28/2007 058812 00179454 12/2007 09/04/2007

: : : : : : : : : :

00179454 12/2007 08/28/2007 -------------0.930 ----------------------

Data current measurement Calibration Quality Criteria Calibrator Lot no. Expiration date calibrat Calibration date Missing values Monotony of curve Calibration factor Minimum signal Min. acceptable difference Deviation of duplicates System errors Calibrators 1 2

Figure B-25

1. signal : 880.4 : 30049

2. signal 843.9 29702

Target value 0.000 uIU/ml 1.78 uIU/ml

Calibration Result report (quantitative assays)

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a Validate calibration and control results 1 Choose Calibration > Status. Use this screen to review tests for failed, changeover, or manual calibrations.

Figure B-26

Calibration Status screen

The background display color on the Calibration > Status screen identifies the calibration status of the test, as in the following table: Color

Calibration status.

None

Calibration is available or was successful.

Red

No calibration available or calibration failed. If no calibration is available then it is not possible to calculate using a previous curve. If the calibration failed then repeat the calibration for the test.

Blue (in Select Calibration is selected. column) Table B-4

Calibration status screen color codes

Cause

Occurrence

Changeover

A changeover is triggered when a new test or a new reagent pack is added to the system that has no lot calibration.

Daily

When calibration has been defined as required daily.

Failed

When a calibration has failed and needs to be repeated.

Manual

When calibration is manually requested by the operator.

QC Violation

When the test is configured for QC-triggered calibration and a QC result falls out of the confidence range specified for this test.

Table B-5

Calibration causes

If there are no failed calibrations, continue with routine sample measurement. e See Routine sample measurements: disk system on page B-44

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2 Select a failed calibration from the Status list, if you want to view more information about that calibration, then: o

Choose Calibration Result to view more details on the Calibration Result window.

o

Choose Calibration Trace to check the calibration trace in the Calibration Trace window.

3 Select a failed calibration from the Status list and choose Reject to reject the calibration request, if necessary. The check mark and blue background are removed from the Select column. 4 Choose the Print global button. The Calibration Print screen opens. 5 Select Calib/QC Load List from the Calibration Items list and choose Print. A Calib/QC load list is sent to the printer. 6 Repeat calibration and QC measurement following the Calib/QC Load List. e Perform calibration and QC on page B-30

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Correct placement of sample tubes on a sample disk Take special care to place sample tubes correctly on the sample disk. This is especially important for 13 mm tubes, which are narrower and more likely to tilt if placed incorrectly. If the tubes are not correctly seated in an upright position on the sample disk, the sample/reagent probe may attempt to sample outside the tube, causing errors and incorrect results. The following figure illustrates correct and incorrect placement of a sample tube on the sample disk. The tube should be seated correctly in the grommet at the base of the sample disk so that the tube is vertical.

A

B

D C

A C

Correctly placed tube (bottom of tube seated B

Incorrectly placed tube (bottom of tube not

in the grommet)

seated in the grommet)

Correctly placed tube (overhead view)

Figure B-27

D

Incorrectly placed tube (overhead view)

Correct placement of a sample tube on the sample disk

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Correct placement of sample tubes on a rack Take special care to place sample tubes correctly on the rack. This is especially important for 13 mm tubes, which are narrower and more likely to tilt if placed incorrectly. If the tubes are not correctly seated in an upright position on the rack, the sample/reagent probe may attempt to sample outside the tube, causing errors and incorrect results. The following figure illustrates correct and incorrect placement of a sample tube on the rack. The tube should be seated correctly in the rack so that the tube is vertical.

A

B

D

C

A

Correctly placed tube

B

Incorrectly placed tube

C

Correctly placed tube (overhead view)

D

Incorrectly placed tube (overhead view)

Figure B-28

Correct placement of a sample tube on the rack

To improve the alignment of 13 mm tubes on the rack, Roche Diagnostics recommends that the Roche Cup-Adapters (part name: CUPADAPTER FOR STANDARD RACK) are used. Cup-Adapters are placed as an insert to the standard rack. e See Correct insertion of Roche Cup-Adapters on page B-43

System specifications on page A-33

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Correct insertion of Roche Cup-Adapters Take special care to insert Roche Cup-Adapters into racks. If a Cup-Adapter is not correctly inserted into the rack, the sample/reagent probe may not sample correctly causing errors and incorrect results. The Roche Cup-Adapters should be used only for the sample tubes specified for use with the cobas e 411 analyzer. Tubes with an outer diameter greater than 13mm should not be used in combination with Cup-Adapters because the barcode label might be damaged.

A

B

A

Cup-Adapters

Figure B-29

B

Roche standard rack

Roche Cup-Adapter

The following figure illustrates how to correctly insert a Cup-Adapter into a standard rack.

A B

D

C

A

Insert Cup-Adapter pushing down gently

B

Stop when finger touches top of rack

C

Push Cup-Adapter to bottom of rack

D

Stop when depth-stop touches rack body

Figure B-30

Correct insertion of Cup-Adapter in a rack

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Routine sample measurements: disk system You can make patient test selections at any time during operation. Patient programming for interfaced, barcoded samples NOTICE

Invalid test number If the host system sends an invalid test number to the analyzer, pipetting of the sample concerned is interrupted and all further test requests for that sample are ignored. The system continues pipetting with the next sample.

a To perform sample programming 1 Perform sample programming from the host.

a To load patient samples 1 Place the barcoded samples on the sample disk. Make sure the barcodes are facing out so the barcode reader scans them properly. For essential safety information, see Loading and unloading the sample disk on page A-11. CAUTION

Figure B-31

Load barcoded samples

2 Place a Stop barcode in the next open position on the disk. NOTICE

Stop barcode If you forget the Stop barcode when running in single disk mode, the disk turns continuously. If calibrators or controls are present, they will be pipetted. If you forget the Stop barcode when running in multiple disk mode, the disk stops at position 30.

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a To start processing Before starting a run, ensure that all necessary samples are on board and test selections made. 1 Choose Start (global button).

Figure B-32

Start Conditions screen

2 Verify the settings on the Start Conditions screen. If the settings are not as required, make the necessary adjustments. Check the following: o

The disk number displayed in the window is correct.

o

The Host Communication setting is On (if a host connection is being used).

3 Choose Start (on the Start Conditions screen). The system performs an initial preparation process, and begins to process patient samples. NOTICE

Host communication If the host does not answer within 15 seconds, the position is skipped and the disk advances to the next position. If you are using the batch mode for the analyzer-host communication, make sure that all requests are loaded from the host to the analyzer.

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Patient programming for interfaced, non-barcoded samples NOTICE

Invalid test number If the host system sends an invalid test number to the analyzer, pipetting of the sample concerned is interrupted and all further test requests for that sample are ignored. The system continues pipetting with the next sample.

a To perform sample programming 1 Perform sample programming at the host. 2 Download sample IDs, test selections, disk number, and position to the analyzer from your host. A sequence number is assigned to each sample ID during the download. 3 Choose Workplace > Test Selection > Routine. 4 Print a Work List report. e See How to print reports, lists and traces on page B-124

a To load patient samples 1 Load samples onto the sample disk according to the Work List report printed out at the end of sample programming. For essential safety information, see Loading and unloading the sample disk on page A-11. CAUTION

2 Place a Stop barcode in the next open position on the disk. NOTICE

Stop barcode If you forget the Stop barcode when running in single disk mode, the disk turns continuously. If calibrators or controls are present, they will be pipetted. If you forget the Stop barcode when running in multiple disk mode, the disk stops at position 30.

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a To start processing Before starting a run, ensure that all necessary samples, calibrators and controls are on board and test selections made. 1 Choose Start (global button).

Figure B-33

Start Conditions screen

2 Verify the settings on the Start Conditions screen. If the settings are not as required, make the necessary adjustments. 3 Choose Start (on the Start Conditions screen). The system performs an initial preparation process, and begins to process patient samples.

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Patient programming for non-interfaced, barcoded samples a To perform sample programming 1 Choose Sample Tracking. 2 Choose Sample Scan. Wait for the system to go to Standby mode. 3 Choose Workplace > Test Selection.

Figure B-34

Test Selection screen (disk system)

4 Select the Routine option from the Sample area on the top left of the screen. 5 Choose the Sample ID field to open the software keyboard. Type in the sample ID of the sample in the Sample ID text box. A sequence number is assigned automatically. 6 Select the Pre-dilution On button if the sample has already been diluted manually. 7 Select the Normal or Reduced button for Sample Cup. 8 Select the required dilution, if any, for the sample in the Sample Volume/Dilution list box. Resetting dilution factor CAUTION

The selected dilution factor remains after a test selection has been made and will be applied to the next test selected. Set the dilution factor to the correct level before making a test selection.

9 Select the test, combination of tests or test profiles for the sample in the test key matrix. Selected tests and profile keys appear white. 10 Choose Save to save the test selection.

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a To load patient samples 1 Place the barcoded samples on the sample disk. Make sure the barcodes are facing out so the barcode reader scans them properly. For essential safety information, see Loading and unloading the sample disk on page A-11. CAUTION

Figure B-35

Load barcoded samples

2 Place a Stop barcode in the next open position on the disk. NOTICE

Stop barcode If you forget the Stop barcode when running in single disk mode, the disk turns continuously. If calibrators or controls are present, they will be pipetted. If you forget the Stop barcode when running in multiple disk mode, the disk stops at position 30.

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a To start processing 1 Choose Start (global button).

Figure B-36

Start Conditions screen

2 Verify the setting on the Start Conditions screen. If the settings are not as required, make the necessary adjustments. Check the following: o

The disk number displayed in the window is correct.

o

The Host Communication setting is Off.

3 Choose Start (on the Start Conditions screen). The system performs an initial preparation process, and begins to process patient samples.

Patient programming for non-interfaced, non-barcoded samples Use the Tab key on the full software keyboard or touch the required field to move the cursor to appropriate fields. When not using sample barcodes, you can either use a numeric sample ID or alternatively type in characters using the software keyboard.

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a To perform sample programming 1 Choose Workplace > Test Selection.

Figure B-37

Test Selection screen (disk system)

2 Select the Routine option from the Sample area on the top left of the screen. A sequence number is assigned automatically. 3 Type the disk number in the Disk No. text box. 4 Type the position number for the sample in the Pos. text box. 5 Type the sample ID in the Sample ID text box if necessary. 6 Select the Pre-dilution button if the sample has already been diluted. 7 Select the Normal or Reduced Sample Cup button. 8 Select the required dilution, if any, for the sample in the Sample Volume/Dilution list box. Refer to the package insert of the test for the recommended dilutions. Resetting dilution factor CAUTION

The selected dilution factor remains after a test selection has been made and will be applied to the next test selected. Set the dilution factor to the correct level before making a test selection.

9 Select the test, combination of tests or test profiles for the sample in the test key matrix. Selected tests and profile keys appear white. Dilutions are also displayed in a key if requested. 10 Choose Save to save the test selection. 11 Place a stop barcode in the next open position on the disk.

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NOTICE

Stop barcode If you forget the Stop barcode when running in single disk mode, the disk turns continuously. If calibrators or controls are present, they will be pipetted. If you forget the Stop barcode when running in multiple disk mode, the disk stops at position 30.

12 Print a Work List report (optional). e How to print reports, lists and traces on page B-124

a To load patient samples 1 Load samples on the sample disk according to the Work List report printed out at the end of sample programming. For essential safety information, see Loading and unloading the sample disk on page A-11. CAUTION

Figure B-38

Load non-barcoded samples

2 Place a Stop barcode in the next open position on the disk. NOTICE

Stop barcode If you forget the Stop barcode when running in single disk mode, the disk turns continuously. If calibrators or controls are present, they will be pipetted. If you forget the Stop barcode when running in multiple disk mode, the disk stops at position 30.

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a To start processing Before starting a run, ensure that all necessary samples, calibrators and controls are on board and test selections made. 1 Choose Start (global button).

Figure B-39

Start Conditions screen

2 Verify the settings on the Start Conditions screen. If the settings are not as required, make the necessary adjustments. 3 Choose Start (on the Start Conditions screen). The system performs an initial preparation process, and begins to process patient samples.

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Routine sample measurements: rack system You can make patient test selections at any time during operation. Patient programming for interfaced, barcoded samples NOTICE

Invalid test number If the host system sends an invalid test number to the analyzer, pipetting of the sample concerned is interrupted and all further samples on the rack are ignored. The system continues pipetting with the first sample on the following rack.

a To perform sample programming 1 Perform sample programming at the host. a To load patient samples 1 Place the barcoded samples on the rack. Make sure the barcodes are visible through the openings on the rack so the barcode reader scans them properly. 2 Load the racks on a tray and place the tray on the A-Line (supply). At the same time, verify there is a tray on the C-Line (output buffer). If necessary, place a tray on the C-Line.

Figure B-40

Load barcoded samples on the A-Line

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a To start processing Before starting a run, ensure that all necessary samples are on board and test selections made. 1 Choose Start (global button).

Figure B-41

Start Conditions screen (rack system)

2 Verify the settings on the Start Conditions screen. If the settings are not as required, make the necessary adjustments. 3 Choose Start (on the Start Conditions screen). The system performs an initial preparation process, and begins to process patient samples. As each barcode is scanned, the analyzer queries the host and receives test requests for the sample. The sequence number, rack ID, and rack position are assigned automatically during this process.

Patient programming for interfaced, non-barcoded samples NOTICE

Invalid test number If the host system sends an invalid test number to the analyzer, pipetting of the sample concerned is interrupted and all further sample s on the rack are ignored. The system continues pipetting with the first sample on the following rack.

a To perform sample programming 1 Perform sample programming at the host. Make sure to program the rack ID and position number at the host. 2 Print a Work List report at the host. e How to print reports, lists and traces on page B-124

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a To load patient samples 1 Load samples on the racks according to the Work List report printed out at the end of sample programming. 2 Load the racks on a tray and place the tray on the A-Line (supply). At the same time, verify there is a tray on the C-Line (output buffer). If necessary, place a tray on the C-Line.

Figure B-42

Load non-barcoded samples on the A-Line

a To start processing Before starting a run, ensure that all necessary samples, calibrators and controls are on board and test selections made. 1 Choose Start (global button).

Figure B-43

Start Conditions screen (rack system)

2 Verify the settings on the Start Conditions screen. If the settings are not as required, make the necessary adjustments. 3 Choose Start (on the Start Conditions screen). The system performs an initial preparation process, and begins to process patient samples. As each rack position is encountered, the host is queried to download the sample ID and test selections to the analyzer.

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Patient programming for non-interfaced, barcoded samples Use the Tab key on the full software keyboard or touch the required field to move the cursor to appropriate fields. a To perform sample programming 1 Choose Workplace > Test Selection.

Figure B-44

Test Selection screen (rack system)

2 Select the Routine option from the Sample area on the top left of the screen. A sequence number is assigned automatically. NOTICE

Programming rack ID and position It is not necessary to program a rack ID and position when the sample is barcoded.

3 Select the sample type using the Type drop-down list. 4 Choose the Sample ID field to open the software keyboard. Type in the sample ID of the sample in the Sample ID text box. 5 Select the Pre-dilution On option if the sample has already been diluted manually. 6 Select the Normal or Reduced option for Sample Cup. 7 Select the required dilution, if any, for the sample in the Sample Volume/Dilution drop-down list box. Refer to the package insert of the test for the recommended dilutions. Resetting dilution factor CAUTION

The selected dilution factor remains after a test selection has been made and will be applied to the next test selected. Set the dilution factor to the correct level before making a test selection.

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8 Select the test, combination of tests or test profiles for the sample in the test key matrix. Selected tests and profile keys appear white. Dilutions are also displayed in a key if requested. 9 Choose Save to save the test selection.

a To load patient samples 1 Place the barcoded samples on the racks. Make sure the barcodes are visible through the openings on the rack so the barcode reader scans them properly. 2 Load the racks on a tray and place the tray on the A-Line (supply). At the same time, verify there is a tray on the C-Line (output buffer). If necessary, place a tray on the C-Line.

a To start processing Before starting a run, ensure that all necessary samples are on board and test selections made. 1 Choose Start (global button).

Figure B-45

Start Conditions screen (rack system)

2 Verify the settings on the Start Conditions screen. If the settings are not as required, make the necessary adjustments. 3 Choose Start (on the Start Conditions screen). The system performs an initial preparation process and begins to process patient samples. The sequence number, rack ID, and rack position are assigned automatically during this process.

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Patient programming for non-interfaced, non-barcoded samples a To perform sample programming Use the Tab key on the full software keyboard or touch the required field to move the cursor to appropriate fields. 1 Choose Workplace > Test Selection.

Figure B-46

Test Selection screen (rack system)

2 Select the Routine option from the Sample area on the top left of the screen. A sequence number is assigned automatically. 3 Select the sample type using the Type drop-down list. 4 Type the rack number in the Rack No. text box. 5 Type the position number for the sample in the Pos. text box. 6 Type the sample ID in the Sample ID text box, if necessary. 7 Select the Pre-dilution On option if the sample has already been diluted. 8 Select the Normal or Reduced option for Sample Cup. 9 Select the required dilution, if any, for the sample in the Sample Volume/Dilution drop-down list box. Refer to the package insert of the test for the recommended dilutions. Resetting dilution factor CAUTION

The selected dilution factor remains after a test selection has been made and will be applied to the next test selected. Set the dilution factor to the correct level before making a test selection.

10 Select the test, combination of tests or test profiles for the sample in the test key matrix. Selected tests and profile keys appear white. 11 Choose Save to save the test selection.

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a To load patient samples 1 Load the racks on a tray. 2 Place the tray on the A-Line (supply). At the same time, verify there is a tray on the C-Line (output buffer). If necessary, place a tray on the C-Line.

Figure B-47

Load non-barcoded samples on the A-line

a To start processing Before starting a run, ensure that all necessary samples are on board and test selections made. 1 Choose Start (global button).

Figure B-48

Start Conditions screen (rack system)

2 Verify the settings on the Start Conditions screen. If the settings are not as required, make the necessary adjustments. 3 Choose Start (on the Start Conditions screen). The system performs an initial preparation process, and begins to process patient samples.

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(Short Turn Around Time) patient sample, proceed to one of the following sections: Sample tracking: rack system on page B-77 Measurement of additional routine samples on page B-61 STAT test selections: rack system on page B-68.

Measurement of additional routine samples The procedure for measuring additional routine samples varies, depending on whether you are using a disk or rack system. Continuous loading using the single disk mode You can program additional routine samples at any time. When the analyzer starts from Standby mode, the system always begins at position 1 on the disk and stops at the position of the Stop barcode. When the analyzer starts from Sampling Stop, the system remembers the last position where the Stop barcode was and starts at that position. Before performing the following actions, observe these safety precautions: o

Continuous sample loading on sample disks on page B-4

o

Loading and unloading the sample disk on page A-11

If you forget to place the Stop barcode on the disk, the disk turns continuously. If calibrators or controls are present, they will be pipetted again.

The following example is a graphical representation of continuous loading. a To program additional routine samples using the single disk mode 1 Load seven samples on the disk. Place the Stop barcode in position 8. 1 2 3

4 5 6 7

STOP

8

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2 When the sample in position 4 is complete, add seven more samples to the disk. Move the Stop barcode to position 15. 1 2 3

X X X

4 5

X

6 7 8 9 10 11

STOP 14

15

13

12

All 14 samples have been pipetted. The analyzer goes into Sampling Stop when it reaches the Stop barcode in position 15. 1 2 3

X X X

STOP

X

X

15

X 14

4 5 X

6 X X 7 X 8 X 9 X 10 X 11 X 13

12

3 Add samples starting at position 15 (the previous position of the Stop barcode). After choosing Start the system continues sampling past position 30 until it sees the Stop barcode again (here in position 6). 28

29

30

1

2 3

4 5

27 26

6

25

STOP

24 23 22 21 20 19

18 17 16 15

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Continuous loading using the multiple disk mode When the analyzer starts from Standby mode, the system always begins at position 1 on the disk and stops at the position of the Stop barcode. The analyzer enters the sampling stop mode when it recognizes the Stop barcode or reaches position 30 on the sample disk. When the analyzer starts from sampling stop and the system has reached position 30, the analyzer will begin again at position 1. If using multiple disks, you should change the disk and type the new disk number on the Start Conditions screen before choosing Start. Before performing the following actions, observe these safety precautions: o

Continuous sample loading on sample disks on page B-4

o

Loading and unloading the sample disk on page A-11

If you forget to place the Stop barcode on the disk, the disk stops at position 30.

Continuous loading using the rack system There are two ways to load continuously on the rack system: o

Add single racks to the A-Line. Refer to the photograph below.

o

Add a loaded tray to the A-Line.

A

A

Tray indication light

Figure B-49

Loading a rack on the A-Line during operation

Loading/unloading of racks CAUTION

You can add single racks or loaded trays to the A-Line only when the tray indication light is green. When the light is out, do not load racks or loaded trays onto the analyzer.

You can add racks during operation. When the rack system is in sampling stop mode, choose Start to continue sampling.

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STAT test selections: disk system You can make STAT (Short Turn Around Time) patient test selections when the analyzer is in Operation, S. Stop, or Standby. During STAT processing, the current sample finishes pipetting. The STAT samples are pipetted next. When the STAT sampling is complete, the analyzer proceeds to the next sample (the sample directly after where it had previously stopped) and resumes pipetting routine samples. STAT patient programming for interfaced, barcoded or non-barcoded samples Test selections must be made at the host system before a sample query from the analyzer. NOTICE

Invalid test numbers If the host system sends an invalid test number to the analyzer, pipetting of the sample concerned is interrupted and all further test requests for that sample are ignored. The system continues pipetting with the next sample.

a To program STAT samples 1 Perform sample programming at the host. 2 Choose Workplace > Test Selection. 3 Select the Stat option from the Sample area at the top left of the screen. 4 Type the disk number and the position number in the Disk No. and Pos. text boxes to specify the vacant position, after the Stop barcode, where you will place the STAT sample. 5 If you are not using barcodes, type the relevant sample ID in the Sample ID text box.

a To load STAT samples 1 Choose S.Stop if the system is in operation. The system enters sample stop. 2 Load samples on the sample disk at the previously specified position after the Stop barcode.

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a To start processing STAT samples 1 Choose Stat Mode (global button). If the analyzer is in operation, S.Stop, or initialization, the button changes to a yellow color. 2 Choose Start (global button).

Figure B-50

Start Conditions screen

3 Verify the settings on the Start Conditions screen. If the settings are not as required, make the necessary adjustments. 4 Choose Start (on the Start Conditions screen). The analyzer continues processing any open requests for the current routine sample before it begins to process STAT samples.

STAT patient programming for non-interfaced, barcoded or non-barcoded samples In the STAT mode, when the Test Selection screen is opened, an available disk position is suggested by the software. You can override the position suggested by the system. Before performing the following actions, observe these safety precautions: o

Manual assignment of sample containers on page B-4

o

Loading samples and reagents on page B-5

o

Use of microcups on page B-6

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a To program STAT samples 1 Choose Workplace > Test Selection.

Figure B-51

Test Selection screen (disk system)

2 Select the Stat option from the Sample area on the top left of the screen. 3 Type the disk number and the position number in the Disk No. and Pos. text boxes to specify the vacant position, after the Stop barcode, where you will place the STAT sample. 4 Type in the sample ID of the sample in the Sample ID text box. 5 Select the Predilution On button if the sample has already been diluted. 6 Select the Sample Cup Normal or Reduced button. 7 Select the required dilution, if any, for the sample from the Sample Volume/Dilution list box. Refer to the package insert of the test for the recommended dilutions. Resetting dilution factor CAUTION

The selected dilution factor remains after a test selection has been made and will be applied to the next test selected. Set the dilution factor to the correct level before making a test selection.

8 Select the test, combination of tests or test profiles for the sample from the test key matrix. Selected tests and profile keys appear white. Dilutions are also displayed in a key if requested. 9 Choose Save to save the test selection.

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a To load STAT samples 1 Choose S.Stop if the system is in operation. The system enters sample stop. 2 Load samples on to the sample disk at the previously defined position after the Stop barcode.

a To start processing STAT samples 1 Choose Stat Mode (global button). If the analyzer is in operation, S.Stop, or initialization, the button changes to a yellow color. 2 Choose Start (global button).

Figure B-52

Start Conditions screen

3 Verify the settings on the Start Conditions screen. If the settings are not as required, make the necessary adjustments. 4 Choose Start (on the Start Conditions screen). The analyzer continues processing any open requests for the current routine sample before it begins to process STAT samples.

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STAT test selections: rack system You can make STAT (Short Turn Around Time) patient test selections when the analyzer is in Operation, R. Stop, or Standby. During STAT processing, the analyzer first finishes pipetting the current rack. The samples in the STAT rack are pipetted next. When the STAT sampling is complete, the analyzer proceeds to the next rack on the A-Line and resumes pipetting routine samples. NOTICE

Invalid test numbers If the host system sends an invalid test number to the analyzer, pipetting of the sample concerned is interrupted and all further samples on the rack are ignored. The system continues pipetting with the first sample on the following rack.

STAT patient programming for interfaced, barcoded samples Before performing the following actions, observe these safety precautions: o

Loading STAT racks on page B-5

a To program STAT samples 1 Perform sample programming at the host.

a To load STAT samples 1 Place the barcoded STAT samples on a rack. Make sure the barcodes are visible through the openings on the rack so the barcode reader scans them properly. 2 Load the rack in the STAT rack position.

Figure B-53

Load barcoded samples at STAT rack position

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a To start processing STAT samples 1 If the analyzer is not in operation, choose Start (global button). If the analyzer is in operation, begin at step 4. 2 Verify the settings on the Start Conditions screen. If the settings are not as required, make the necessary adjustments.

Figure B-54

Start Conditions screen (rack system)

3 Choose Start (on the Start Conditions screen). The system performs an initial preparation process. 4 Choose Stat Mode (global button). The button changes to a yellow color and the STAT rack is taken into the analyzer. As each barcode is scanned, the analyzer queries the host and receives test selections for the sample. The sequence number, rack ID, and rack position are assigned automatically during this process. If multiple STAT racks are necessary, you must choose Stat Mode each time a STAT rack is loaded in the STAT rack position.

STAT patient programming for interfaced, non-barcoded samples Before performing the following actions, observe these safety precautions: o

Loading STAT racks on page B-5

a To program STAT samples 1 Perform sample programming at the host. 2 Print a work list at the host. The list assigns sample positions.

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a To load STAT samples 1 Load the STAT non-barcoded sample on the rack according to the host work list. 2 Load the rack in the STAT rack position.

Figure B-55

Load non-barcoded samples at STAT rack position

a To start processing STAT samples 1 If the analyzer is not in operation, choose Start (global button). If the analyzer is in operation, begin at step 4.

Figure B-56

Start Conditions screen (rack system)

2 Verify the settings on the Start Conditions screen. If the settings are not as required, make the necessary adjustments.

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3 Choose Start (on the Start Conditions screen). The system performs an initial preparation process. 4 Choose Stat Mode. The button changes to a yellow color and the STAT rack in taken in to the analyzer. As each STAT rack position is encountered, the analyzer queries the host and receives test selections for the sample. The sequence number, rack ID, and rack position are assigned automatically during this process. If multiple STAT racks are necessary, you must choose Stat Mode each time a STAT rack is loaded in the STAT rack position.

STAT patient programming for non-interfaced, barcoded or non-barcoded samples Before performing the following actions, observe these safety precautions: o

Manual assignment of sample containers on page B-4

o

Loading samples and reagents on page B-5

o

Use of microcups on page B-6

a To program STAT samples 1 Choose Workplace > Test Selection.

Figure B-57

Test Selection screen - STAT samples (rack system)

2 Select the Stat option from the Sample area on the top left of the screen. 3 Select the sample type using the Type drop-down list. 4 Type in the rack ID and position number of the sample in the Rack No. and Pos. text boxes for non-barcoded samples. 5 Type in the sample ID of the sample in the Sample ID text box. 6 Select the Pre-dilution On option if the sample has already been diluted. 7 Select Normal or Reduced option for Sample Cup.

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8 Select the required dilution, if any, for the sample in the Sample Volume/Dilution drop-down list box. Refer to the package insert of the test for the recommended dilutions Resetting dilution factor CAUTION

The selected dilution factor remains after a test selection has been made and will be applied to the next test selected. Set the dilution factor to the correct level before making a test selection.

9 Select the test, combination of tests or test profiles for the sample in the test key matrix. Selected tests and profile keys appear white. Dilutions are also displayed in a key if requested. 10 Choose Save to save the test selection.

a To load STAT samples 1 Load the samples in the rack. If using barcoded samples, make sure the barcodes are visible through the openings on the rack so the barcode reader scans them properly. 2 Load the rack in the STAT rack position.

Figure B-58

Load barcoded samples at STAT rack position

a To start processing STAT samples 1 If the analyzer is not in operation, choose Start (global button). If the analyzer is in operation, begin at step 4.

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Figure B-59

Start Conditions screen (rack system)

2 Verify the settings on the Start Conditions screen. If the settings are not as required, make the necessary adjustments. 3 Choose Start (on the Start Conditions screen). The analyzer performs an initial preparation process. 4 Choose Stat Mode (global button). The button changes to a yellow color and the STAT rack is taken into the analyzer. If multiple STAT racks are necessary, you must choose Stat Mode each time a STAT rack is loaded in the STAT rack position.

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Dilution Sample results that exceed the measuring range of the assay must be diluted and measured again. Dilutions can be requested from the Workplace > Test Selection screen and are performed automatically by the analyzer.

Figure B-60

Test Selection screen (disk system)

Sample Volume/Dilution menu

NOTICE

The Sample Volume/Dilution menu is activated only when both the following apply: o

The assays are encoded in the reagent barcode as being suitable for dilution.

o

A bottle of suitable diluent is on the analyzer.

The diluent must be in the reagent rotor: this is an essential condition. To select dilution: choose the sample volume dilution factor from the list box, following the recommendations in the package insert, and choose the test for dilution. The sample result is recalculated based on the selected dilution factor. e For more information on dilutions, refer to Mechanical theory on the COBI-CD

Manual predilution of samples If a sample is manually prediluted before analysis, you can set the instrument to flag the corresponding sample ID on the reports and on the Workplace > Data Review screen. a To identify a sample as manually prediluted 1 Choose Workplace > Test Selection to open the Test Selection screen, used to enter test selections and information for a sample. 2 Choose On (because the sample is already prediluted).

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3 Program your sample as usual. e See Routine sample measurements: disk system on page B-44

Routine sample measurements: rack system on page B-54

After changes have been made on the Test Selection screen, the Save button turns yellow. 4 Choose Save to save the entries. After measurement, the target sample is flagged “Prediluted” on the Test Review screen and on the result report. NOTICE

Calculating prediluted samples The results for prediluted samples are not calculated using the predilution factor. You must calculate the final results for manually prediluted samples.

Automatic dilution by the analyzer Follow the instructions below to dilute a patient sample by the analyzer. The process is the same for both the disk and rack systems. a To set automatic dilution for a sample 1 Choose Workplace > Test Selection to open the Test Selection screen, used to enter test selections and information for a sample. 2 Program your sample as usual. e See Routine sample measurements: disk system on page B-44

Routine sample measurements: rack system on page B-54

3 Select the required dilution factor from the Sample Volume/Dilution menu. e For recommended dilutions, refer to the dilution section of the package insert

4 Choose the key button for the test on which to set automatic dilution. After changes have been made on the Test Selection screen, the Save button turns yellow. Resetting dilution factor CAUTION

The selected dilution factor remains after a test selection has been made and will be applied to the next test selected. Set the dilution factor to the correct level before making a test selection.

5 Choose Save. The test key button appears with the dilution factor you have just specified. If the dilution factor is not displayed, either the diluent is not on board or the test cannot be diluted.

When measurement starts, the sample is automatically diluted by the analyzer. When calculating the final sample concentration, the software calculates the result based on the selected dilution factor.

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Sample tracking: disk system Use the Sample Tracking window to monitor the progress of sample processing. a To track a sample on the system 1 Choose the graphical icon representing the system in the status line (top left of the screen) to open the System Overview screen. 2 Choose Sample Tracking to open the Sample Tracking window.

Figure B-61

Sample Tracking window (multiple disk)

The status conditions are as follows: Routine

A routine sample is loaded in this position.

Stat

A STAT sample is loaded in this position.

Control

A control is loaded in this position.

Calibrator

A calibrator is loaded in this position.

Empty (E)

This sample position is empty (the sample position is light gray).

Processing (P)

The sample, control or calibrator in this position is in process, but results are not yet ready. The sample position is green.

Incomplete (I)

At least one ordered request for the sample has a missing value. The sample position is red.

Occupied (O)

The sample in this position is not being processed. The sample position is blue.

Completed (C)

The processing of the sample in this position has been completed satisfactorily. The sample position is white.

Stop BC (S)

This sample position contains a stop barcode. The sample position is yellow.

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3 To obtain more detailed information on the result of a specific sample, select the sample from the sample disk information area on the right side, and then choose Show Result. The Test Review window opens.

Figure B-62

Test Review window (disk system)

Sample tracking: rack system Use the Sample Tracking window to monitor the progress of sample processing. a To track a sample on the system 1 Choose the graphical icon representing the system in the status line (top left of the screen) to open the System Overview screen. 2 Choose Sample Tracking to open the Sample Tracking window.

Figure B-63

Sample Tracking window (rack system)

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This screen displays the output tray and buffer, each row represents a rack. To the left of each rack is the rack ID number. The selected rack is displayed in the upper right corner of the screen. The selected rack is highlighted with a blue border. Each position also lists a status. Each time a tray is replaced at the output buffer, the information about the replaced racks disappears from the screen but is not deleted.

The status conditions are as follows: Routine

A routine sample is loaded in this position.

Stat

A STAT sample is loaded in this position.

Control

A control is loaded in this position.

Calibrator

A calibrator is loaded in this position.

Empty (E)

This sample position is empty (the sample position is light gray).

Processing (P)

The sample, control or calibrator in this position is in process, but results are not yet ready. The sample position is green.

Incomplete (I)

At least one ordered request for the sample has a missing value. The sample position is red.

Occupied (O)

The sample in this position is not being processed. The sample position is blue.

Completed (C)

The processing of the sample in this position has been completed satisfactorily. The sample position is white.

3 Obtain more detailed information on the result of a specific sample by selecting the sample from the rack information area on the right side and choosing Show Result. The Test Review window opens.

Figure B-64

Test Review window (rack system)

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Loading consumables during operation You can reload AssayCup and AssayTip trays during operation if you take suitable precautions.

A B

C

A

Tray 3

C

Tray 1

Figure B-65

B

Tray 2

Tray areas in consumables compartment

When the AssayCup and AssayTip compartments are fully loaded, the analyzer begins by using AssayCups and AssayTips from tray 1. When tray 1 is empty, the analyzer starts using tray 2, followed by tray 3. When tray 3 is empty, the analyzer returns to tray position 1 to check if a new tray has been loaded.

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The analyzer indicates the current gripper position for AssayCups (Cup) and AssayTips (Tip) on the System Overview screen.

Figure B-66

System Overview screen showing the available consumables

When the AssayCup and AssayTip compartments are only partly loaded, the analyzer starts using AssayCups and AssayTips from the positions last in use during the previous run. The AssayCup position may be different from the AssayTip position in this case. The table below shows how you can use the Cup and Tip symbols in the System Overview screen to determine when you can safely load additional consumables at the tray positions. System Overview symbols

Loading options

(Cup/Tip)

Do not load consumables at any position.

You may load AssayCups and AssayTips at tray position 1.

You may load AssayCups and AssayTips at tray positions 1 and 2.

Table B-6

Examples of loading options at different gripper positions

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System Overview symbols

Loading options

(Cup/Tip)

Do not load consumables at any position.

You may load AssayCups and AssayTips at position 1. Do not load consumables at position 2.

You may load AssayCups and AssayTips at position 1. Do not load consumables at position 2.

Table B-6

Examples of loading options at different gripper positions (continued)

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Results

Results You can evaluate control and patient results on printed reports or on the Workplace > Data Review screen. All samples can be viewed, deleted, printed, or uploaded from this screen. As results are generated on the instrument, they are saved in the database located on the control unit. The database stores up to 2000 results depending upon the number of orders in the system. Once this limit is reached, the system automatically deletes the oldest documented result. You can manually delete any results, documented or undocumented, from the database to free additional space. NOTICE

Delete sample results regularly Roche strongly recommends that to maintain system performance, you delete sample results daily, after uploading data to the host, or after performing a data export. e See Delete documented samples on page B-87

As soon as results are printed, uploaded or printed/uploaded, they are considered to be documented (the documentation mode is defined in the Utility > System > Documentation Setup window). After documentation, an “H” appears at the top of the row. Partial sample results can be viewed from this screen as soon they are made available by the system. e See How to reset the system on page B-129

How to export data manually on page B-121

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View patient results All samples can be viewed from the Data Review screen. a To view patient results 1 Choose Workplace > Data Review to open the Data Review screen, used to perform tasks related to reviewing routine, STAT and QC results.

Figure B-67

Data Review screen (disk system)

Figure B-68

Data Review screen (rack system)

2 Choose Search to open the Sample Search window, used to search for a sample in the database.

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Figure B-69

Search Sample window

3 Select either the Sequence No. option to search for a sample by sequence number, or the Sample ID option to search by sample ID. 4 Type the sequence or sample ID, depending on the option selected in the previous step. 5 Choose Down to search the sample list of the Data Review screen downward from the currently selected sample, or Up to search upward from the currently selected sample, until you find the required sample. 6 Choose Cancel to close the Sample Search window and return to the Data Review screen. The chosen sample is highlighted.

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Filter patient results Use this function to filter the type of samples you want to view, document or print. The default filter setting is Off. a To filter patient results 1 Choose Filter to open the Filter window, used to define the criteria for filtering the information displayed in the sample selection list of the Data Review screen.

Figure B-70

Filter window

2 Enter filter criteria as required, and choose OK to save the selected filter criteria, close the Filter window, and return to the Data Review Screen. 3 Select On in the Filter area of the Data Review screen to activate the filter. The results are filtered according to the filter criteria you selected.

Print or upload patient results The Documentation and Printer Setting window enables you to select the desired documentation output option and the items to print out automatically. If you choose Upload, or Print/Upload, when the host communication set to Off on the Start Conditions screen, an alarm is issued.

a To print or upload patient results 1 Choose Utility > System. 2 Choose Documentation Setup, The Documentation and Printer Setting window opens. 3 Select one of the following options from the Completion Conditions area. o

Printout: Send reports to the printer.

o

Upload: Upload results to the host.

o

Print/Upload: Send reports to the printer and also upload results to the host.

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Results

4 Select one of the following options from the Printer Connection area. o

Connected: A printer is connected to the system.

o

Not connected: A printer is not connected to the system; reports will not be sent to the printer.

5 Select one of the following options from the Automatic Printout area. o

Calibration Sample: Select On to enable, or Off to disable automatic printing of the results from calibration samples.

o

Control Sample: Select On to enable, or Off to disable automatic printing of the results from quality controls.

o

STAT Sample: Select On to enable, or Off to disable automatic printing of the results from STAT samples.

o

Routine Sample: Select On to enable, or Off to disable automatic printing of the results from routine samples.

6 Choose OK to save the selected settings and to close the Documentation and Setting window.

Print a Result Report Results can be printed out from the Workplace > Data Review screen. a To print a Result Report 1 Select the required data on Workplace > Data Review before printing or viewing this report. 2 Select a single sample, a range of samples, or non-consecutive samples to be printed from the sample selection list on the left side of the screen. 3 Choose Print (global button) > Workplace to open the Workplace Print screen.

Figure B-71

Workplace print screen

4 Choose Result Report from the Workplace Items list. 5 Select the required print format, Monitor or Report, from the Print Format area. 6 Choose Print to print the report. Roche Diagnostics B-86

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7 Choose Close to close the Print screen.

e See Results on page B-82

Post-operation data management To ensure the cobas e 411 analyzer is operating optimally, it is important to manage the amount of data in the database.

Review results You should review the results as they become available using the printout or on the Workplace > Data Review screen. Use the Test Review window to check results in more detail. e See Results on page B-82

Repeat any questionable results, or those with an incomplete status, as necessary. e See Dilution on page B-74

Delete documented samples Samples are considered documented once they are printed out or uploaded to the host. Delete documented samples to free up additional space in the database. Filter settings have no effect on this function. a To delete all documented samples 1 Choose System Overview > Sample Data Clear. 2 Choose Clear to delete all sample records. Sample results are deleted and control results moved to the Data Review > QC View. e See Sample Data Clear on page B-20

a To delete control results 1 Choose Workplace > Data Review > QC View. 2 Choose Delete All to delete all control results. Control results are deleted from the QC View but remain in the QC Individual screen. 3 Choose QC > Individual. 4 Select each line of assay/control-combinations for the controls to be deleted and choose Delete. The selected control results are deleted from the QC Individual screen. e See Selection menu for multiple items on page A-63

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Daily maintenance

Daily maintenance Before the end of routine operation, it is important to ensure that all required maintenance is performed. In addition to the routine daily maintenance, this could also include other scheduled maintenance, for example, weekly and monthly maintenance. Perform the following tasks each day: o

Clean the sample/reagent probe

o

Check for condensation inside compartments

e For information about daily maintenance items to be performed, refer to your laboratory

maintenance schedule, Maintenance schedule on page C-11 and Daily maintenance on page C-16.

Switch off the analyzer After routine operation is finished and you have performed all the required maintenance, you can switch off the analyzer. Under normal circumstances it is not necessary to shut down the analyzer. Keep the circuit breaker on the right of the analyzer on to maintain the temperatures in the reagent rotor and system reagent compartments. e See How to shut down the analyzer on page B-130

a To switch off the analyzer 1 Set the operation switch to Off. The analyzer goes into Sleep mode and the Sleep window opens.

Figure B-72

Sleep window

In sleep mode the analyzer remains powered, and the temperatures in the reagent rotor and system reagent compartments are maintained. The monitor screen goes blank after a few minutes.

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Prevent evaporation of the system reagents After switching off the analyzer, close the lids on the ProCell and CleanCell bottles to prevent evaporation of their contents. Before performing the following actions, observe these safety precautions: o

Sipper shield on page B-6

a To close the lids of the system reagent bottles 1 Open the sipper shield by applying pressure to the white metal area at the top, as shown in the following figure, until the latch is released.

A

A

Press here to open or close the sipper shield

Figure B-73

Open the sipper shield

2 Close the lids on the ProCell and CleanCell bottles.

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Switch off the analyzer

Figure B-74

Close lids of ProCell/CleanCell

3 Close the sipper shield by applying pressure to the white metal area at the top until you hear the click of the latch engaging.

Final power off checks If the analyzer will remain switched off for longer than seven days, it is important to prepare the system properly and to perform the correct shutdown maintenance. Failure to observe these recommendations may result in damage to the measuring cell. e See How to shut down the analyzer on page B-130

Protect the measuring cell during extended shutdown on page C-51

a To complete final power off checks 1 Check individual parts of the instrument. 2 If the analyzer is to be switched off at the circuit breaker, move any reagent packs from the analyzer to the refrigerator as temperature control to the reagent rotor will be off. Make sure that the reagent pack lids are tightly closed.

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Special operation: How to…

This chapter describes special tasks that are not usually part of the daily work flow. It complements the Daily Operation chapter, which describes everyday tasks and common procedures for running the cobas e 411 analyzer.

In this chapter

Chapter

7

Introduction ....................................................................................................................B–93 How to apply barcode labels to tubes and vials .........................................................B–93 How to change test settings ..........................................................................................B–95 How to change QC violation settings ..........................................................................B–97 How to activate and apply auto masking ....................................................................B–98 How to define rack ranges ..........................................................................................B–100 How to use sample reception mode ..........................................................................B–101 How to change the sample disk mode .......................................................................B–103 How to add a new operator ID ...................................................................................B–104 How to change documentation settings ...................................................................B–105 How to program calculated tests ................................................................................B–106 How to define a reagent level .....................................................................................B–107 How to define a new profile ........................................................................................B–108 How to install Roche calibrators ................................................................................B–109 How to install and define Roche controls .................................................................B–111 How to install and define non-Roche controls ........................................................B–113 How to edit control target values and ranges ...........................................................B–115 How to request stand-by bottle QC ...........................................................................B–116 How to assign calibrator and control positions .......................................................B–117 How to upload results manually ................................................................................B–119 How to print two or more samples in Data Review ................................................B–120 How to export data manually .....................................................................................B–121 How to rerun a sample manually ...............................................................................B–122 How to delete a single open request ..........................................................................B–123 How to print reports, lists and traces ........................................................................B–124 How to back up and restore the database .................................................................B–127 How to reset the system ..............................................................................................B–129 How to shut down the analyzer .................................................................................B–130 Roche Diagnostics Operator’s Manual · Version 2.1

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Table of contents

Roche Diagnostics B-92

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7 Special operation: How to… Introduction

Introduction The sections in this chapter contain detailed descriptions explaining how to accomplish specific non-routine tasks.

How to apply barcode labels to tubes and vials The size and placement of barcode labels on sample, calibrator, and control containers must comply with certain specifications. The sample barcode reader may fail to read any labels that do not conform to these restrictions. a To apply barcode labels to sample tubes and calibrator and control vials 1 Ensure that the barcode label dimensions comply with Figure B-75. E

D

C

A

B

A

Label width (16 mm minimum)

B

Barcode width (12 mm minimum)

C

Quiet zone (5 mm minimum)

D

Barcode zone (50 mm maximum for 100 mm tubes; 38 mm maximum for 75 mm tubes)

E

Quiet zone (5 mm minimum)

Figure B-75

Dimensions for barcode labels for tubes and vials

2 For sample tubes, position your barcode labels according to the restriction shown in Figure B-76. For calibrator and control vials, position your barcode labels according to the restriction shown in Figure B-77.

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How to apply barcode labels to tubes and vials

A

A

A

Upper margin: 12 mm minimum (for both 100 mm and 75mm sample tubes)

Figure B-76

Required position for barcode labels on sample tubes

A

A

Minimum margin 2.5 ± 1 mm

Figure B-77

Required position for barcode labels on vials

3 Press and smooth the labels to ensure that all the label edges adhere to the tubes or vials. NOTICE

Positioning sample tubes Place all sample tubes upright and settled in their positions, with the barcode labels fully visible to the barcode reader.

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7 Special operation: How to… How to change test settings

How to change test settings The following procedure describes how you can change various parameters that the system records for a test. a To change test settings 1 Choose Utility > Application. 2 Select the test to be changed from the Test list on the left of the screen. 3 Choose Utility > Application > Analyze.

Figure B-78

Utility Application Analyze screen

4 Select a default dilution ratio from the list box if it is available. Refer to the reagent package insert for the recommended dilution ratio. NOTICE

Default dilution ratio Changing the Default Dilution Ratio setting to any value other than 1 causes all samples to be diluted and may affect patient recovery.

5 Choose Save to confirm the dilution change. 6 Choose Utility > Application > Range.

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How to change test settings

Figure B-79

Utility Application Range screen

7 Change the User Test No., the Unit, and the Expected Values as required. The User Test No defines the order of the test keys in Workplace > Test Selection and is the test number used by the host. Changing these settings will affect host communication.

8 Choose Save to confirm the parameter changes at the previous step.

Roche Diagnostics B-96

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7 Special operation: How to… How to change QC violation settings

How to change QC violation settings If you want to change the method of calibration when controls are out of range, use the following procedure. a To change QC violation settings 1 Choose Utility > Application > Calib.

Figure B-80

Utility Application Calib. screen

2 Select a test from the Test list. 3 Set QC Violation to On. The QC Violation Setting area becomes active. 4 Select the Full method to trigger a calibration request in case of QC violation. 5 Select the SD Rule to apply (1S, 2S, or 3S). 6 Select the controls from those listed for Control1, Control2, and Control3. Only controls activated for the chosen test are listed. 7 Choose Save to confirm the settings. This button will change color from yellow to blue when the setting is successfully saved. NOTICE

Control out of range If one of the controls is out of range, the system suggests QC Violation as a cause for calibration showing blue in the Select column of the Status window (Calibration > Status). If the control is repeated and the result is within range, the suggestion is removed.

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How to activate and apply auto masking

How to activate and apply auto masking If you apply auto masking for a test, the analyzer masks that particular test in either of the following situations: o

If no valid calibration is available and the test requires calibration

o

If an attempt at calibration renewal has failed

However, before you can apply auto masking to a test, this function must first be activated on the analyzer. a To activate calibration auto masking 1 Choose Utility > System. 2 Choose Calib. Mask Setting. The Calibration Mask Setting window opens.

Figure B-81

Calibration Mask Setting window

3 Choose On to activate or Off to deactivate calibration auto masking. 4 Choose OK to save the setting and close the window.

a To apply auto masking to a test 1 Choose Utility > Application > Calib. 2 Select the test from the Test list.

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Figure B-82

Application: Calibration screen

3 In the Auto Masking area, select On. 4 Choose Save. 5 Repeat steps 2 and 3 if you wish to apply auto masking to other tests also. 6 Choose Save.

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How to define rack ranges

How to define rack ranges Rack ranges need to be defined to enable position assignment for calibrators and controls. e See How to assign calibrator and control positions on page B-117

a To define rack ranges 1 Choose Utility > System. 2 Choose Change in the Range for Position Assignment area. The Range for Position Assignment window opens.

Figure B-83 NOTICE

Range for Position Assignment window

Rack ID digit The Rack ID Digit must be set to 5 (default) otherwise the rack ID will not be recognized correctly.

3 Enter the lower rack ID in the left text boxes and the upper rack ID in the right text boxes. If you enter overlapping ranges, the system gives an "Input Error" and will not allow you to save the ranges. 4 Choose OK to save your changes and close the window.

Roche Diagnostics B-100

Operator’s Manual · Version 2.1

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7 Special operation: How to… How to use sample reception mode

How to use sample reception mode When Sample Reception Mode is activated, the system remains in operation mode after the last available sample is processed and until one of the following occurs: Event

Result

Elapse of specified interval

System goes into Standby

Stop button chosen

System goes into Standby

Red alarm issued

System goes into Standby

Table B-7

Stopping the system in sample reception mode

a To configure sample reception mode Changes to the sample reception mode settings can be made only in Standby mode.

1 Choose Utility > System.

Figure B-84

Utility System screen (disk system)

2 Choose the sample reception time interval (1, 2, 4, or 8 hours) from the Sample Reception Mode area. 3 Choose OK to save the setting.

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How to use sample reception mode

a To activate sample reception mode 1 Choose the Start global button. The Start Conditions screen opens.

Figure B-85

Start Conditions screen (disk system)

2 Choose On in the Sample Reception Mode Setting area. 3 Choose OK to save the setting.

Roche Diagnostics B-102

Operator’s Manual · Version 2.1

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7 Special operation: How to… How to change the sample disk mode

How to change the sample disk mode Change the sample disk mode only when the analyzer is in Standby and all data has been deleted from Data Review. Complete all open requests before making the change, as data related to uncompleted requests will be deleted during the process. a To change the sample disk mode 1 Choose Utility > System. 2 Choose Change in the Sample Disk Mode area. The Sample Disk Mode window opens.

Figure B-86

Sample Disk Mode window (disk system)

3 Select Single or Multiple to change the mode, and choose OK. A Confirmation window appears. 4 Choose OK to change the mode. The Confirmation window will close. The OK button in the Utility > System screen changes to yellow. 5 Choose OK to save the mode setting. The OK button changes to blue. NOTICE

To change the disk number, choose Start (global button) to open the Start Conditions screen. Correct the displayed number if necessary.

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How to add a new operator ID

How to add a new operator ID When password protection mode is activated, operators must log on to operate the analyzer. Operators must be defined in the system before they can log on. Each operator is assigned an access level to provide access to necessary parts of the software. e See User access levels in the Software description section of the online Help

a To add a new user 1 Choose Utility > System. 2 Choose Operator ID (Page 2/3). The Operator ID window opens.

Figure B-87

Operator ID window

3 Select a blank line and choose Add. The Add Operator ID window opens. 4 Enter the new operator ID in the Operator ID text box. 5 Select the appropriate access level from the Level drop-down list. 6 Choose OK to save the settings and close the window. The new operator ID is displayed in the Operator ID window. After the operator ID is established, the password entered the first time the operator ID is used becomes the permanent password for this operator ID. You can log off during operation to change operator. The system remains switched on after you have logged off.

Roche Diagnostics B-104

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7 Special operation: How to… How to change documentation settings

How to change documentation settings If the communication link with the host breaks down, the system displays a Host Communication error and the host cannot receive the results. In this event you can change the settings to print out the results without uploading. When Automatic printout is selected only one result per page is printed

a To change documentation settings 1 Choose Utility > System. 2 Choose Documentation Setup (Page 2/3). The Documentation and Printer Setting window opens.

Figure B-88

Documentation and Printer Setting window

3 Set the Completion Conditions to Printout. 4 Choose OK to save the new settings to the system. The Documentation and Printer Setting window closes.

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How to program calculated tests

How to program calculated tests You can configure the system to divide the result of one test by the result of another test to derive a third parameter of diagnostic significance. Before programming ensure that the tests required for the calculation are registered on the system. a To program calculated tests 1 Choose Utility > Calc. Test.

Figure B-89

Calc. Test (Calculated Test) Screen

2 Select an empty field in the Calculate Test list. 3 Enter a value for the User Test No. 4 Enter a value (such as ‘calc1’) for the Test Name. 5 Select test names from the Numerator and Denominator list boxes to provide the primary results for calculating the derived result. 6 Enter a unit if one is appropriate. If the primary tests used in the calculation use the same units, the derived result is a ratio and has no units. 7 Choose the material for the test (Serum/Plasma, Urine, or Other). 8 Enter the range of the derived result. 9 Choose Save. The entries move to the Calculated Test list. NOTICE

Calculation failure If one of the tests used for the calculation fails, the calculation will fail.

Roche Diagnostics B-106

Operator’s Manual · Version 2.1

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7 Special operation: How to… How to define a reagent level

How to define a reagent level To ensure the analyzer does not run out of reagents during operation, the analyzer issues a reagent level alarm when a reagent is running low. You can set the number of determinations at which the alarm is issued but only for assay reagents, not for diluent or pre-treatment reagent packs. a To define a reagent level 1 Choose Utility > System. 2 Choose Reagent Level Check. The Reagent Level Check window opens.

Figure B-90

Reagent Level Check window

3 Select a test from the Test list. The cursor moves to the Tests text box. 4 Type the number of remaining tests (0-200) at which a caution alarm will be triggered. 5 Choose Check Update. The new level is displayed in the Determinations column of the Test list. 6 Choose OK to save your changes and close the window.

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How to define a new profile

How to define a new profile Profiles are predefined groups of tests that can speed up manual test selections. Once defined, a profile is automatically assigned to a test key in the test matrix on the Workplace > Test Selection screen. a To define a new profile 1 Choose Utility > System. 2 Choose Profile Setting. The Profile Setting window opens.

Figure B-91

Profile Setting window

3 Select a blank line in the Profile Name list and choose Name Setting. The Profile Name Setting window opens. 4 Enter the name of the new profile and choose Update. The window closes and the profile name is displayed in the Profile Name list. 5 Assign the required tests to the profile: select a test from the Available Tests list and choose Assign. 6 Choose OK to save the profile and close the window.

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7 Special operation: How to… How to install Roche calibrators

How to install Roche calibrators Calibrators can be either installed from a barcode card provided or downloaded from cobas® link. In-pack calibrators do not required installation. a To install calibrators using a barcode card 1 Choose Calibration > Install. 2 Insert the calibrator barcode card in the barcode card reader station, to the left of the reagent rotor. 3 Choose Scan BC Card. 4 Choose OK on the Scan BC Card window to confirm the scan.

Figure B-92

Scan Calibrator BC Card window

During the reading process the operational mode changes from Standby to BC card scan. When scanning is complete, the calibrator and its lot number are displayed in the list on the left of the Calibration > Install screen and the operational mode returns to Standby. NOTICE

One calibrator lot per test Only one calibrator lot can be installed per test for quantitative tests. Installing a calibrator lot will overwrite the previous lot installed.

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How to install Roche calibrators

a To download calibrator data from cobas® link 1 Choose Calibration > Install. 2 Choose Download. The Download window opens.

Figure B-93

Download window - Calibrators

3 Select one of the available search conditions (required item, calibrator name, lot number, or release date). o

The Release Date option refers to the date when the calibration was released by the QA department.

o

The Required Item option refers to calibrator information that has not been found on the system.

4 Choose Search. A list of items that meet the given search conditions is displayed. To change the order of the list, select either the Calibrator Name or Release Date option in the Sort By area. 5 Select the check box for each item in the list you want to download. 6 Choose Download. A confirmation dialog opens. Choose OK to confirm and close the dialog. 7 Choose Close to return to the Calibration > Install screen. When downloading is complete, the calibrator and its lot number are displayed in the list on the left of the Calibration > Install screen. NOTICE

One calibrator lot per test Only one calibrator lot can be installed per test for quantitative tests. Installing a calibrator lot will overwrite the previous lot installed.

Roche Diagnostics B-110

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7 Special operation: How to… How to install and define Roche controls

How to install and define Roche controls Controls can be either installed from a barcode card provided or downloaded from cobas® link. Once installed, the control must be activated for a test before it is used. e See Activate QC test on page B-35

a To install and define Roche controls 1 Choose QC > Install. 2 Insert the control barcode card in the barcode card reader station, to the left of the reagent rotor, with the barcode facing to the back of the analyzer. 3 Choose Scan BC Card. 4 Choose OK on the Scan BC Card window to confirm the scan.

Figure B-94

Scan Control BC Card window

During the reading process the operational mode changes from Standby to BC card scan. When scanning is complete, the list on the left of the QC > Install > Individual screen shows the control and its lot number, and the operational mode returns to Standby. The right of the screen displays the tests that are on board and encoded in the control barcode, together with the Reagent Lot No., T.Mean, and T.SD. The Active Test button color is blue. 5 Select a test you wish to activate, and choose Active Test. The selected test name displays a green highlight, the caption of Active Test button changes to Inactive Test, and the button color changes to blue. 6 Repeat step 5 for every test you wish to activate.

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How to install and define Roche controls

a To download control data from cobas® link 1 Choose QC > Install. 2 Select a free position in the Controls list and choose Download. The Download window opens.

Figure B-95

Download window - Controls

3 Select one of the available search conditions (required item, control name, lot number, or release date). o

The Release Date option refers to the date when the control was released by the QA department.

o

The Required Item option refers to control information that has not been found on the system.

4 Choose Search. A list of items that meet the given search conditions is displayed. To change the order of the list, select either the Control Name or Release Date option in the Sort By area. 5 Select the check box for each item in the list you want to download. 6 Choose Download. A confirmation dialog opens. Choose OK to confirm and close the dialog. 7 Choose Close to return to the QC > Install screen. When downloading is complete, the control and its lot number are displayed in the list on the left of the QC > Install > Individual screen, and the operational mode returns to Standby. The right of the screen displays the tests that are on board and encoded in the control data, together with the Reagent Lot No., T.Mean, and T.SD. The Active Test button color is green. 8 Select a test you wish to activate and choose Active Test. The selected test name displays a blue highlight, the caption of Active Test button changes to Inactive Test, and the button color changes to blue. 9 Repeat step 8 for every test you wish to activate.

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7 Special operation: How to… How to install and define non-Roche controls

How to install and define non-Roche controls a To install and define non-Roche controls 1 Choose QC > Install. 2 Select a vacant row on the left of the screen. 3 Choose Add to open the Add Control window.

Figure B-96

Add Control window

4 Enter the control information into the fields by using the software keyboard. The control code for non-Roche controls must be in the range 64-78. 5 Choose OK to confirm the entries. The Add Control window closes. 6 Select the non-Roche control on the left of the screen. 7 Choose Edit. The Edit Control window opens. 8 Choose Test Assign. The Test Assign window opens.

Figure B-97

Test Assign window

9 Select a test on the left of the screen. 10 Choose Assign to copy the selected test to the list of assigned tests on the right of the screen. 11 Repeat steps 9 and 10 to assign other tests if required. 12 Choose OK to confirm the assignments. The Test Assign window closes. 13 Select a test, and enter the T.Mean and T.SD values (Individual and Cumulative) into the required fields by using the software keyboard. Roche Diagnostics Operator’s Manual · Version 2.1

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How to install and define non-Roche controls

14 Choose Update to transfer the entries to the list. The Calculate button is only active for tests that are set for QC violation. 15 Repeat steps 13 and 14 for every assigned test. 16 Choose OK to confirm the entries. The Edit Control window closes. 17 Select the defined non-Roche control in the QC > Install > Individual window. 18 Select a test to be activated for the defined non-Roche control, and choose Active Test. The selected test name displays a blue highlight, the Active Test button caption changes to Inactive Test, and the button color changes to blue. 19 Repeat step 18 for any other test to be activated for the non-Roche control.

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7 Special operation: How to… How to edit control target values and ranges

How to edit control target values and ranges a To edit control target values and ranges 1 Choose QC > Install.

Figure B-98

QC Install Individual screen

2 Select the required control on the left of the screen. 3 Choose Edit. The Edit Control window opens.

Figure B-99

Edit Control window

4 Select the test to be edited, and enter the values given in the package into the Individual and Cumulative T.Mean and T.SD fields. 5 Choose Calculate to transfer the entries to the list of tests. The Calculate button is only active for tests that are set for QC violation. 6 Choose OK to confirm the changes to the control values. The Edit Control window closes.

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How to request stand-by bottle QC

How to request stand-by bottle QC Stand-by reagent packs currently on the analyzer require QC processing. All stand-by bottle sets and reagent packs for tests currently loaded on the analyzer are displayed in the Stand By Bottle QC window. Stand-by bottle QC data are handled as excluded and therefore not used in QC calculations. Stand-by bottle QC data are only displayed on the Individual QC Chart and Run Status screen.

a To request stand-by bottle QC 1 Choose QC >Status. 2 Choose Stand By Bottle QC. The Stand By Bottle QC window opens.

Figure B-100

Stand By Bottle QC window

3 Choose the required Reagent Position from the list. The chosen line is highlighted. 4 Choose Select. A check mark and a change of background in the Selection column identify the selected test. 5 Repeat steps 3 and 4 for any other selections required. 6 Choose OK to confirm the selection. The Stand By Bottle QC window closes. If a stand-by bottle QC is selected, the current reagent pack will not be measured unless also selected on the QC > Status screen.

Selections can be changed whenever necessary, even during Operation, S.Stop or R.Stop and will be performed as described above.

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7 Special operation: How to… How to assign calibrator and control positions

How to assign calibrator and control positions Use the following procedure to assign a position to a calibrator or control if you are using cups without a barcode, or if the system cannot read the barcode. If the system reads a barcode at a position that has a manual assignment, the barcode takes precedence and the manual assignment is ignored. The procedure is the same on both disk and rack systems. The calibrator or control to be assigned must already be installed and the racks must be assigned as calibrator or control ranges in the Utility > System screen. e See How to define rack ranges on page B-100

How to change the sample disk mode on page B-103 Calibrator and control position assignments are lost when the calibrator or control is deleted.

a To assign calibrators to positions 1 Choose Calibration > Calibrator. 2 Select from the list the calibrator to be assigned. 3 Choose Position Assignment. The Position Assignment window opens.

Figure B-101

Position Assignment window for calibrators (disk system)

4 Select a calibrator from the list on the left of the screen, and a position for the calibrator from the list on the right. 5 Choose Assign to assign the selected calibrator to the position selected. The calibrator and the corresponding lot number appear on the right of the screen, and Assign becomes inactive. The OK button turns yellow and remains yellow until you save the changes in step 7. You can assign a calibrator to one position only. 6 Repeat steps 4 to 5 to assign further calibrators. 7 Choose OK to save the changes when each of the desired calibrators has an assigned position. The Position Assignment window closes. Roche Diagnostics Operator’s Manual · Version 2.1

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NOTICE

Calibrator position assignment Calibrator vials must be assigned to consecutive positions on disks or racks. The position assignments are stored until they are manually removed.

a To assign controls to positions 1 Choose QC > Control. 2 Choose Position Assignment. The Position Assignment window opens.

Figure B-102

Position Assignment window for controls (rack system)

3 Select a control from the left hand list, and a position for the control from the right-hand list. 4 Choose Assign to assign the selected control to the position selected. The control and the corresponding lot number appear on the right of the screen, and the Assign button becomes inactive. The OK button turns yellow and remains yellow until you save the changes in step 6. You can assign a control to one position only. 5 Repeat steps 3 to 4 to assign further controls. 6 Choose OK to save the changes when each of the desired controls has an assigned position. The Position Assignment window closes. NOTICE

Control position assignment Control position assignments are stored until they are manually removed.

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7 Special operation: How to… How to upload results manually

How to upload results manually If automatic uploading is switched off and the analyzer is connected to a host, you must upload sample results manually. You can upload a single result or multiple results at any time, and you can upload results more than once if necessary. If automatic upload is activated, and the Utility > System > Review by Exception window shows alarms listed as Exception Alarms on the right of the screen, you must upload manually the results flagged with exception alarms. The procedure is the same for both disk and rack systems. e See Sample tracking: disk system on page B-76

Sample tracking: rack system on page B-77

a To upload a single result or multiple results Multiple results should be uploaded only when the analyzer is in stand by mode. Single result can be uploaded during operation. 1 Choose Workplace > Data Review.

Figure B-103

Data Review screen (rack system)

2 Select an individual sample to upload. e See How to print two or more samples in Data Review on page B-120

3 Choose Send to Host. The Send to Host window opens. 4 Choose Send in the Send to Host window to confirm upload. A confirmation dialog opens when the operation is complete. Choose Close to return to the Workplace Data Review window. The sample status changes to ‘H’ (documented/sent to host) if all results are sent to the host. NOTICE

Automatic Upload If you wish to validate the result before uploading, switch off Automatic Upload.

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How to print two or more samples in Data Review

How to print two or more samples in Data Review The sample data displayed on the Data Review screen can be selected, for example, when a printout of all sample results is required. The following procedure describes the selection of some sample results for printing. The procedure is the same for both disk and rack systems. a To print a list of samples 1 Choose Workplace > Data Review.

Figure B-104

Data Review screen (rack system)

2 Choose Routine View to display all the sample results. 3 Select the sample(s) you wish to print from the list on the left of the screen. The selected sample(s) is highlighted in blue. e See To select multiple non-consecutive samples on page A-63

4 Choose the Print global button. The Workplace Print screen opens. 5 Choose Print in the Print screen to print the sample results. To deselect a complete selection, select any sample previously selected. The highlight will disappear from all the samples.

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7 Special operation: How to… How to export data manually

How to export data manually The cobas e 411 analyzer can only use DVD-RAM disks. If another type of disk is used the following message is displayed: "Export media drive is just getting started, please wait until it gets stable and please try again."

a To export sample data manually 1 Choose Workplace > Data Review. 2 Choose Routine View. QC View is an option, but this view displays only QC data.

3 Select samples for which data is to be exported, from the list on the left of the screen. e See Selection menu for multiple items on page A-63

4 Choose Export Data. The Export Data window opens.

Figure B-105

Data Review - Export Data window

5 Choose with or without in the Double quotation marks area. 6 Choose OK. The selected data is saved to the external drive as a CSV file in the folder "X:\e411_CSV" with the name format "backup-YYYY-MM-DD-HHMM.csv". Information exported using the Export and Clear function cannot be read back onto the system. However, the CSV file can be viewed on an external PC using a suitable program.

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How to rerun a sample manually

How to rerun a sample manually If you wish to rerun a sample, you must program it manually. The analyzer does not record any link between the original run and any subsequent reruns. a To rerun a sample 1 Process a routine sample as usual. e See Routine sample measurements: disk system on page B-44

Routine sample measurements: rack system on page B-54

2 Choose Workplace > Test Selection. 3 Choose New Sequence and select Rerun. 4 Specify the sample in the Sample ID text box. You can use the same sample ID more than once. 5 Select the applicable test or tests from the test matrix. 6 Choose Save.

Figure B-106

Test Selection screen - Rerun sample (disk system)

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7 Special operation: How to… How to delete a single open request

How to delete a single open request You can delete single open requests from the Data Review screen. The procedure is the same for disk and rack systems. a To delete a single open request 1 Choose Workplace > Data Review. 2 Select the request to be deleted from the open requests (status ‘O’) on the left of the screen. 3 Choose Delete Record.

Figure B-107

Delete Record window

4 Confirm the deletion in the Delete Record window. The window closes automatically and the selected sample is no longer listed in the Data Review screen.

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How to print reports, lists and traces

How to print reports, lists and traces Use the Print screen to select the report to be printed or viewed. The software is context-sensitive and automatically displays the Print screen corresponding to the software area currently displayed. If no printer is connected to the analyzer, the report is sent to the print buffer and displayed in the Preview List window. a To print a result report 1 Choose Workplace > Data Review. 2 Select the samples and/or controls for which you want a printout of the result. Selected items are highlighted in blue. e See Selection menu for multiple items on page A-63

3 Choose the Print (global button). The Data Review Print window opens.

Figure B-108

Result Report print window

4 Select Result Report from the Workplace Items list if it is not already selected. 5 Choose the print format required. Monitor produces a condensed format, and Report a more complete format. e Refer to the online Help for more information on reports

6 Choose Print. The report is sent to the printer.

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7 Special operation: How to… How to print reports, lists and traces

a To print a daily Alarm Trace report 1 Choose Print (global button) to open the Print window. 2 Choose Utility. 3 Select Alarm Trace from the Utility Items list.

Figure B-109

Print Utility Alarm Trace window

4 Choose Daily for the Alarm Trace option. 5 Choose Print for the Alarm Information option. 6 Choose Date Range for the Data Selection option to specify a date range, or All to print all data. Enter the Start and End dates and times (mm/dd/yyyy/hh/mm) of the alarms required in Date Range. 7 Choose OK. The data is sent to the preview list. 8 Choose View. The Preview List window opens. 9 Select the most recent Daily Alarm Trace from the list and choose Print. The report is printed out.

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How to print reports, lists and traces

a To print a System Communication Trace report 1 Choose Print (global button) to open the Print window. 2 Choose Utility. 3 Select Communication Trace from the Utility Items list.

Figure B-110

Print Utility Communication Trace window

4 Choose Print for the Communication Information option. 5 Choose OK. The data is sent to the preview list. 6 Choose View. The Preview List window opens. 7 Select the most recent Communication Trace from the list and choose Print. The report is printed out.

a To cancel a print job After you have requested the printout of a report from the analyzer, you might decide that you wish to cancel your request. The cobas e 411 analyzer software does not provide an option for canceling print jobs. Instead, you must cancel the print job by using the options available on your printer. Consult your printer’s documentation to choose the most appropriate procedure.

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7 Special operation: How to… How to back up and restore the database

How to back up and restore the database The cobas e 411 analyzer can only use DVD-RAM disks. If the DVD-RAM is not ready to be read or if you try to use another type of disk, the monitor displays an error message:

Figure B-111

The error message when the DVD-RAM storage media is not available

a To back up the database 1 Choose Utility > System > Storage Utility.

Figure B-112

Storage Utility window

2 Choose Write. 3 Choose Internal to back up the database to the internal storage device or External to back up to the external storage device. Only two backups can be saved on the internal storage device. The oldest backup will be deleted first.

4 Choose Execute. The back up is saved to the folder "X:\e411\backup-YYYY-MMDD-hh-mm\" where X is the drive letter.

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How to back up and restore the database

a To restore the database 1 Choose Utility > System > Storage Utility.

Figure B-113

Storage Utility window

2 Choose Read. 3 Choose Internal to restore the database from the internal storage device or External to restore from the external storage device. Data loss CAUTION

All data currently stored on the device will be lost when data is read in from the target storage device.

4 Choose Execute. The database is restored and the system reboots.

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7 Special operation: How to… How to reset the system

How to reset the system System reset is necessary following system alarm events that put the analyzer into P. Stop or Stop status. Examples are: o

Interference with the gripper action.

o

Malfunction of the cap open/close mechanism.

o

Any movement of the pipetter shield away from the fully closed position during operation.

Resetting the system returns mechanical parts to their home or standby positions. It does not reset any of the line mechanisms on a rack system. a To reset the system 1 Choose Utility > Maintenance.

Figure B-114

Utility Maintenance screen (rack system)

2 Select System Reset from the Maintenance Items list. 3 Choose Select. The System Reset window opens.

Figure B-115

System Reset window

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How to shut down the analyzer

4 Choose Start. The system reset begins and the System Reset window closes.

How to shut down the analyzer Under normal circumstances it is not necessary to shut down the analyzer. e See Switch off the analyzer on page B-88

Before performing the following actions, observe these safety precautions: o

Handling of reagents on page A-12

a To shut down the analyzer 1 Choose Logoff (global button). The Logoff screen opens.

Figure B-116

Logoff screen

2 Select Shutdown and choose OK. The system shuts down. 3 Set the circuit breaker located on the right side of the analyzer to Off. If you have a rack system, switch off the circuit breaker on the left side of the rack sampler. e See Rack sampler circuit breaker on page A-30

When the analyzer is powered off, the temperatures in the reagent rotor and system reagent compartments are no longer maintained. This is the last page of Part B

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C

8

Safety information for maintenance . . . . . . . . . . . . . . . . . . . . . C–3

9

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C–5

cobas e 411 analyzer

8 Safety information for maintenance

Safety information for maintenance Make sure that you have read and understood the Chapter 1 General safety information. The following safety messages in particular are relevant: Warning messages: o

Electrical shock by electronic equipment on page A-8

o

Infection by samples and associated materials on page A-9

o

Infection and injury due to sharp objects on page A-9

o

Skin inflammation or injury caused by reagents and other working solutions on page A-12

o

Infection by waste solution on page A-9

o

Contamination of the environment by liquid and solid waste on page A-10

Caution messages: o

Personal injury due to contact with moving parts on page A-11

Observe the system safety labels illustrated and described starting on page A-15.

Before performing any maintenance, read the following safety messages carefully. If you ignore these safety messages, you may suffer serious or fatal injury. Importance of maintenance WARNING

Provide the system with proper maintenance and care to ensure consistent and accurate functioning. Modifying or omitting the maintenance procedures may result in the loss of performance or reliability of the system, which are the responsibility of the operator. Avoid use of bleach Do not use bleach, SysClean, or alkaline disinfectant (pH > 9.5) to clean the liquid waste container. If such solutions are mixed with the contents of the liquid waste container, this could cause potentially harmful fumes. Bent or damaged microbead mixer paddle Do not bend the microbead mixer during cleaning. If the microbead mixer is damaged, it will have to be replaced because incorrect mixing may cause incorrect results. Changing the Clean-Liner o

The system must be in Standby or switched off before continuing with this operation.

o

Do not touch the System Reset or Reagent Scan buttons, or switch on the analyzer, while changing the Clean-Liner.

Contact with sample/reagent probe Do not touch the sample/reagent probe until the analyzer enters S.Stop status as damage to the probe may result. Take care not to damage the lower end of the sample/reagent probe during cleaning.

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Residual liquid in pinch valve tubing WARNING

When you replace the pinch valve tubing, take care to avoid contact with any residual liquid remaining in the old tubing. The liquid that flows through this tubing comes from the measuring cell and so is potentially biohazardous. Wear approved disposable gloves. If you get any of the liquid on your skin, wash it off immediately, apply disinfectant according to your own laboratory practices, and consult a physician. Aluminum parts

CAUTION

Do not use an acidic or an alkaline solution to clean the system reagent compartment or incubator. The compartment is made of aluminum and these solutions degrade the metal. Avoid damage to the probes Do not bend probes during cleaning, as this can crimp them. Be careful not to damage the tip of a probe. If the probe is damaged, it will have to be replaced. Photosensors o

Take care not to scratch or smear the photosensors in compartment positions 2 and 3.

o

If the sensors become wet, use a cotton swab to dry them.

The sensors are rectangular windows located at the back of the compartment, just below the top edge. These sensors check for the presence of a ProCell/CleanCell bottle set.

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9 Maintenance Table of contents

Maintenance

This chapter provides step-by-step instructions for performing essential maintenance procedures on the cobas e 411 analyzer and a maintenance schedule. As the operator, you are responsible for providing the proper care and maintenance to ensure consistent and accurate functioning. The following procedures are written for trained operators with a working knowledge of all mechanical functions and software functions of the cobas e 411 analyzer.

In this chapter

Chapter

9

Introduction ......................................................................................................................C–7 Maintenance procedures ...........................................................................................C–7 Performing maintenance ..........................................................................................C–8 Maintenance items .....................................................................................................C–8 Maintenance schedule .................................................................................................. C–11 Daily .......................................................................................................................... C–11 Weekly ...................................................................................................................... C–11 Every two weeks ...................................................................................................... C–11 Every two months ................................................................................................... C–11 As needed ................................................................................................................. C–12 Maintenance log ............................................................................................................ C–13 Daily maintenance ........................................................................................................ C–16 Clean the sample/reagent probe ........................................................................... C–16 Check for condensation inside compartments ................................................... C–17 Weekly maintenance .................................................................................................... C–18 Clean the sipper probe ........................................................................................... C–18 Clean the incubator and aspiration station ......................................................... C–20 Every two weeks maintenance ..................................................................................... C–22 Clean the rinse stations .......................................................................................... C–22 Liquid flow cleaning ............................................................................................... C–25 Every two months maintenance .................................................................................. C–28 Replace the pinch valve tubing ............................................................................. C–28 As needed maintenance ............................................................................................... C–34 Perform finalization maintenance ........................................................................ C–34 Roche Diagnostics Operator’s Manual · Version 2.1

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Table of contents

Replace the valve on the system water container ............................................... C–34 Clean the system water container ......................................................................... C–36 Clean the liquid waste container ........................................................................... C–38 Clean the microbead mixer ................................................................................... C–40 Clean the ProCell and CleanCell compartments ................................................ C–42 Clean the reagent rotor and compartment .......................................................... C–45 Clean the analyzer surfaces .................................................................................... C–48 Empty the solid waste ............................................................................................. C–49 Protect the measuring cell during extended shutdown ..................................... C–51

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9 Maintenance Introduction

Introduction This chapter contains an overview of maintenance on the system including the following topics: o

Types of required cleaning solutions

o

Types of maintenance

All of the software screens shown are examples only. Your screens may vary depending on your system setup. The maintenance procedures are listed in order of descending frequency. Each procedure is presented in the same way, with planning information at the beginning, followed by the procedure.

Maintenance procedures Each maintenance task section is divided into two parts: Introduction and Procedure. The introduction provides important information about the procedure including the following matters: o

Materials required

o

Time required

o

Precautions

The procedures provide step-by-step directions for performing the required maintenance. Some maintenance tasks are divided into several procedures. You must perform each procedure in the order specified, as well as following each step in the correct order. Specific notes, precautions, warnings, and cautions are included in the procedures when appropriate. These maintenance recommendations are based on using the system eight hours per day, five days per week. You may adjust your maintenance frequency based on your laboratory's actual use. Scheduled maintenance follows the Recommended Scheduled Maintenance table. e See Maintenance log on page C-13

Replacement parts may be needed for a specific maintenance procedure. Materials required are listed in the Introduction section of the procedure. For essential safety information, see: o

Infection by samples and associated materials on page A-9.

o

Personal injury due to contact with moving parts on page A-11

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Introduction

Performing maintenance There are two types of maintenance on the system: o

Operator-controlled maintenance, performed primarily by the operator, such as cleaning (for example, Clean the sample/reagent probe) or replacement (for example, Replace the pinch valve tubing). There may be limited interaction with system-controlled actions when performing some operator-controlled maintenance procedures (for example, Liquid flow path cleaning).

o

System-controlled maintenance, performed by selecting a maintenance item (for example, Perform finalization) from the Maintenance Items list on the Maintenance screen and choosing the Select button. The system then independently performs the function.

After performing maintenance, measure control samples to ensure that the instrument operates properly. Inaccurate results may cause a wrong diagnosis. Operator-controlled maintenance items can also be set up in the Maintenance screen. If this option is selected, the user performs the item and chooses Select. The item is updated by date and time.

Maintenance items Applies to disk system only

Figure C-1

Maintenance - Maintenance items screen (disk systems)

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9 Maintenance Introduction

Applies to rack system only

Figure C-2

Maintenance - Maintenance items screen (rack systems)

This section lists all system-controlled maintenance items and a brief description of their function. System Reset Resets mechanical parts to their home or Standby positions. A system reset is often necessary if the analyzer is in a P. Stop or Stop status due to an alarm condition. This button does not reset any of the line mechanisms on a rack system. The system will stop during reagent scan or after a start if the PC/CC bottles have not been manually opened. A reset must then be done because the sipper needle path is blocked over the bottles. Close the sipper shield, select System Reset and choose Start. Liquid Flow Cleaning Washes the sipper flow paths and the measuring cell with SysClean. L. and A. Reset All (rack system only) Initiates a complete system and line reset for the rack analyzer A-, B-, and C-lines, and returns all analyzer mechanisms to their home or Standby positions. An L. and A. Reset All is often necessary if the analyzer is in a Stop or P. Stop status due to an alarm condition. Rack Clear (rack system only) Clears the B-line of any racks and transfers them to the C-line. Sipper Pipetter Prime Primes sipper flow paths with system water to purge them of air, for the specified number of cycles. Roche Diagnostics Operator’s Manual · Version 2.1

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Introduction

S/R Pipetter Prime Purges the sample/reagent pipetter flow path of air for the specified number of cycles. Measuring Cell Exchange Purges tubing. Also used by Roche service representatives. Measuring Cell Preparation Conditions the measuring cell for the specified number of cycles. Finalization Maintenance Primes the system with water, and fills the measuring cell with ProCell. This allows the analyzer to stand unused for several hours, such as when left overnight. Media Write Opens the Media Write window to select the internal or external target device for data storage. Error Information Storage Stores data files and records of error statuses to provide information for Roche service representatives to analyze when they investigate software problems. If you run this item, the analyzer compresses the relevant data and copies them to a specific folder on the local memory. If the Error Information Storage item is not available because the software screen has locked, reboot the system and then run Error Information Storage. If the cobas e 411 analyzer software stops running, you can start the data storage by double-clicking the Error Information Gathering icon on the Windows XP desktop.

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Maintenance schedule It is important that you keep to the recommended schedule for all maintenance actions. You can find detailed descriptions of the maintenance tasks later in this chapter. If you have a direct drain installed, please refer to the appendix. e See Direct drain on page E-3

For essential safety information, see Importance of maintenance on page C-3. WARNING

Daily Maintenance task

Operator

System

time (min)

time (min)

Clean the sample/reagent probe

1

0

C-16

Clean the direct drain flow path (if fitted)

5

0

E-9

Check for condensation inside compartments

5

0

C-17

Page

Table C-1

Page

Maintenance schedule: Daily

Weekly Maintenance task

Operator

System

time (min)

time (min)

Clean the sipper probe

1

0

C-18

Clean the incubator and aspiration station

5

0

C-20

Page

Table C-2

Maintenance schedule: Weekly

Every two weeks Maintenance task

Operator

System

time (min)

time (min)

Clean the rinse stations

7

0

C-22

Liquid flow cleaning

4

17

C-25

Page

Table C-3

Maintenance schedule: Every two weeks

Every two months Maintenance task

Replace the pinch valve tubing Table C-4

Operator

System

time (min)

time (min)

5

15

C-28

Maintenance schedule: Every two months

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Maintenance schedule

As needed Maintenance task

Perform finalization maintenance

Operator

System

time (min)

time (min)

0.5

4

Page

C-34

Replace the valve on the system water container

10

0

C-34

Clean the system water container

10

0

C-36

Clean the liquid waste container

5

0

C-38

Clean the direct drain waste container (if fitted)

5

0

E-10

Clean the microbead mixer

2

0

C-40

Clean the ProCell and CleanCell compartments

5

0

C-42

Clean the reagent rotor and compartment

15

0

C-45

Clean the analyzer surfaces

5

0

C-45

Empty the solid waste

2

0

C-49

Protect the measuring cell during extended shutdown

0-10

0

C-51

Table C-5

Maintenance schedule: As needed

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Maintenance log Use the maintenance log to record the dates when the maintenance tasks were performed and the initials of the person who performed them. For convenience, the cobas e 411 analyzer maintenance log is printed on two sheets. You can make photocopies of both parts of the maintenance schedule sheet provided on the following pages for your own records.

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Maintenance log

cobas e 411 analyzer monthly maintenance log (days 1 to 16) Serial Number______________Month______________Year__________ Daily

Clean:

1

2

3

4

5

6

7

8

9

10 11 12 13 14 15 16

1

2

3

4

5

6

7

8

9

10 11 12 13 14 15 16

1

2

3

4

5

6

7

8

9

10 11 12 13 14 15 16

1

2

3

4

5

6

7

8

9

10 11 12 13 14 15 16

1

2

3

4

5

6

7

8

9

10 11 12 13 14 15 16

Sample/reagent probe Direct drain flow path (if fitted)

Check:

Condensation inside compartments Operator

Weekly

Clean:

Sipper probe Incubator and aspiration stations Operator

Every two weeks

Clean:

Rinse stations

Perform: Liquid flow cleaning * Operator Every two months

Replace:

Pinch valve tubing Operator

As needed

Perform: Finalization maintenance Replace: Clean:

Valve on the system water container System water container Liquid waste container Microbead mixer ProCell and CleanCell compartments Reagent rotor and compartments Reagent compartment Analyzer surfaces

Perform: Empty solid waste tray Protect the measuring cell (extended shutdown) Operator

* Every two weeks or 2500-3000 cycles, whichever comes first

For information about safety precautions and a detailed description of each maintenance action, see the cobas e 411 analyzer Operator’s Manual Version 2.1.

© 2010 Roche Diagnostics

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9 Maintenance Maintenance log

cobas e 411 analyzer monthly maintenance log (days 17 to 31) Serial Number______________Month______________Year__________ Daily

Clean:

17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

Sample/reagent probe Direct drain flow path (if fitted)

Check:

Condensation inside compartments Operator

Weekly

Clean:

17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

Sipper probe Incubator and aspiration stations Operator

Every two weeks

Clean:

17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

Rinse stations

Perform: Liquid flow cleaning * Operator Every two months

Replace:

17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

Pinch valve tubing Operator

As needed

17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

Perform: Finalization maintenance Replace: Clean:

Valve on the system water container System water container Liquid waste container Microbead mixer ProCell and CleanCell compartments Reagent rotor and compartments Reagent compartment Analyzer surfaces

Perform: Empty solid waste tray Protect the measuring cell (extended shutdown) Operator

* Every two weeks or 2500-3000 cycles, whichever comes first

For information about safety precautions and a detailed description of each maintenance action, see the cobas e 411 analyzer Operator’s Manual Version 2.1. © 2010 Roche Diagnostics

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Daily maintenance

Daily maintenance Record in the maintenance log the dates when the maintenance tasks were carried out and the initials of the person who performed them.

Clean the sample/reagent probe Dirt on the sample/reagent (S/R) probe may cause contamination and carryover, and affect results. Clean this part daily to prevent contamination. Planning

Recommended frequency:

Daily

Operator time:

Approximately one minute

System time:

None

Precautions:

The operation switch must be off. Wear suitable protective gloves. Take care not to bend the probe during cleaning.

Table C-6

Materials

Planning considerations

Item

Lint-free gauze squares Distilled or deionized water 70% alcohol (isopropyl alcohol or ethanol) Table C-7

Required materials

Before performing this maintenance action, observe the following safety precautions: o

Infection by samples and associated materials on page A-9

o

Infection and injury due to sharp objects on page A-9

o

Avoid damage to motorized components on page A-14

o

Avoid damage to the probes on page C-4

a To clean the sample/reagent probe 1 Switch off the analyzer at the operation switch. 2 Move the sample/reagent probe to an area where you can readily access it. 3 Wipe the outer surfaces of the sample/reagent probe with a gauze square soaked in distilled or deionized water.

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A

B

A

B

Sample/reagent probe

Figure C-3

Sample/reagent probe tip

Clean the sample/reagent probe

4 Inspect the probe. If any dirt is visible, wipe the outer surfaces with a gauze soaked in 70% alcohol and a second wipe with a gauze soaked in distilled or deionized water. 5 Switch on the analyzer at the operation switch. The analyzer performs a start-up reset operation and each mechanism returns to its home or Standby position.

Check for condensation inside compartments Condensation inside the reagent rotor compartment or system reagent compartments may cause corrosion or malfunction. Inspect these compartments daily and wipe off any condensation with dry gauze squares. e See Clean the ProCell and CleanCell compartments on page C-42

Clean the reagent rotor and compartment on page C-45

Planning

Recommended frequency: Operator time:

Approximately five minutes

System time:

None

Precautions:

The analyzer must be switched off at the operation switch. Wear protective gloves.

Table C-8

Materials

Daily

Planning considerations

Item

Lint-free gauze squares Table C-9

Required materials

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Weekly maintenance

Weekly maintenance Record in the Maintenance log the dates when the maintenance tasks were carried out and the initials of the person who performed them.

Clean the sipper probe Dirt on the sipper probe may cause contamination and carryover, thereby affecting results. Clean this part weekly to prevent contamination. Planning

Recommended frequency:

Weekly

Operator time:

Approximately one minute

System time:

None

Precautions:

The operation switch must be off. Take care not to bend the probe during cleaning.

Table C-10

Materials

Planning considerations

Item

Lint-free gauze squares Cotton swabs 70% alcohol (isopropyl alcohol or ethanol) Table C-11

Required materials

Before performing this maintenance action, observe the following safety precautions: o

Infection by samples and associated materials on page A-9

o

Infection and injury due to sharp objects on page A-9

o

Avoid damage to motorized components on page A-14

o

Avoid damage to the probes on page C-4

o

Sipper shield on page B-6

a To clean the sipper probe 1 Switch off the analyzer at the operation switch. 2 Lift the instrument cover. 3 Open the sipper shield by applying pressure to the white metal area at the top, until the latch is released.

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Figure C-4

Sipper shield

4 Move the sipper probe to an area where you can readily access it. 5 Wipe the outer surfaces of the sipper probe with a gauze square soaked in 70% alcohol, followed by a wipe with a gauze square soaked in distilled or deionized water.

A B

A

Sipper probe

Figure C-5

B

Sipper probe rinse station

Sipper probe and rinse station

6 Close the sipper shield by applying pressure to the white metal area at the top until the latch is engaged and you hear a click. 7 Switch on the analyzer at the operation switch. The analyzer performs a start-up reset operation and each mechanism automatically returns to its home or Standby position.

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Weekly maintenance

Clean the incubator and aspiration station Spills on the incubator may cause gripper movement alarms. The incubator and aspiration station should be cleaned regularly. Planning

Recommended frequency: Operator time:

Approximately five minutes

System time:

None

Precautions:

The operation switch must be off. Wear suitable protective gloves.

Table C-12

Materials

Weekly

Planning considerations

Item

Lint-free gauze squares Cotton swabs Distilled or deionized water Table C-13

Required materials

Before performing this maintenance action, observe the following safety precautions: o

Infection by samples and associated materials on page A-9

o

Avoid damage to motorized components on page A-14

o

Aluminum parts on page C-4

a To clean the incubator and aspiration station 1 Switch off the analyzer at the operation switch. 2 Move the sample/reagent probe arm to the far left. 3 Move the gripper towards the front of the analyzer. 4 Open the sipper shield by applying pressure to the white metal area at the top, until the latch is released, and then move the sipper arm to the far right. 5 Clean the top of the incubator and aspiration station with gauze squares dampened with distilled or deionized water. 6 Inspect the incubator and the aspiration station. Remove any residual dirt by using a light scrubbing motion with the water-soaked gauze squares. 7 Wet a cotton swab with distilled or deionized water and swab each of the 32 positions on the incubator, as well as the aspiration station.

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A A

Wipe incubator surface

C

Aspiration station

Figure C-6

B B

C

Swab incubator positions

Clean the incubator surface and incubation positions

8 Use a dry gauze square to dry the incubator when you have finished cleaning. Dry the incubator surface CAUTION

Make sure that the incubator surface and its positions are dry or you may experience gripper problems when you resume operation.

9 Switch on the analyzer at the operation switch. The analyzer performs a start-up reset operation and each mechanism automatically returns to its home or Standby position.

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Every two weeks maintenance

Every two weeks maintenance Record in the Maintenance log the dates when the maintenance tasks were carried out and the initials of the person who performed them.

Clean the rinse stations The analyzer has one rinse station for the sample/reagent (S/R) probe and the microbead mixer, and another for the sipper probe. Contamination of the rinse stations can be responsible for carryover. To prevent contamination, clean the rinse stations at least every two weeks. Planning

Recommended frequency: Operator time:

Approximately seven minutes

System time:

None

Precautions:

The operation switch must be off. Wear suitable protective gloves.

Table C-14

Materials

Every two weeks

Planning considerations

Item

Cotton swabs Distilled or deionized water (approx 300 mL) Syringe with attached tubing 70% alcohol (isopropyl alcohol or ethanol) Table C-15

Required materials

Before performing this maintenance action, observe the following safety precautions: o

Infection by samples and associated materials on page A-9

o

Avoid damage to motorized components on page A-14

o

Avoid damage to the probes on page C-4

You may find it easier to use two syringes for this procedure; use one for aspirating liquid and the other for refilling the rinse stations.

a To clean the rinse stations 1 Switch off the analyzer at the operation switch. 2 Move the sample/reagent probe, the microbead mixer, and the sipper probe to an area away from the rinse stations.

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9 Maintenance Every two weeks maintenance

A

C

B

A

Microbead mixer arm (being moved)

C

Sample/reagent probe (moved)

Figure C-7

B

Rinse station

Move components from the rinse stations

3 Aspirate the water out of the microbead mixer rinse station using a syringe with tubing attached.

A

B

D

C

A

Microbead mixer

B

Microbead mixer rinse station

C

Attached tube

D

Syringe

Figure C-8

Aspirating and refilling the rinse station

4 Use a cotton swab soaked in 70% alcohol to clean thoroughly the microbead mixer rinse station and the sipper rinse stations.

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A B

A

B

Swab

Figure C-9

Rinse station

Swabbing the rinse station

5 Wipe the microbead mixer rinse station and the sipper rinse station again using a fresh cotton swab soaked in distilled or deionized water. 6 Fill the syringe with distilled or deionized water, and refill the microbead mixer rinse station. This should take approximately 50-100 mL of water. 7 Flush the sample/reagent probe and sipper rinse stations with water (50-100 mL). 8 Aspirate the water out of the microbead mixer rinse station again, by using the syringe. 9 Refill the microbead mixer rinse station, and flush all the rinse stations with distilled or deionized water again. 10 Switch on the analyzer at the operation switch. The analyzer performs a start-up reset operation, and each mechanism automatically returns to its home or Standby position.

Roche Diagnostics C-24

Operator’s Manual · Version 2.1

cobas e 411 analyzer

9 Maintenance Every two weeks maintenance

Liquid flow cleaning Contamination in the sipper system may degrade sample accuracy and precision, or possibly block the measuring cell flow. To keep the sipper liquid flow clean and maintain the integrity of the measuring cell, perform the following liquid flow cleaning procedural steps in the correct order. Planning

Recommended frequency:

Every two weeks or after 2500-3000 tests, whichever comes first.

Operator time:

Approximately 4 minutes.

System time:

Approximately 17 minutes.

Precautions:

Wear suitable protective gloves, plus eye and face protection.

Table C-16

Materials

Planning considerations

Item

SysClean SysClean adapter Distilled or deionized water Table C-17

Required materials

Before performing this maintenance action, observe the following safety precautions: o

Avoid use of bleach on page C-3

o

Skin inflammation or injury caused by reagents and other working solutions on page A-12

o

Handling of cleaning solutions (detergents) on page A-12

o

Malfunction due to spilled liquid on page A-14

a To perform liquid flow cleaning 1 Open the sipper shield. 2 Remove the ProCell bottle from bottle set 1 in the system reagent compartment. 3 Fill the 'USER' compartment (the smaller compartment) of the SysClean adapter to the ledge of the compartment with SysClean reagent. The compartment holds approximately 9 mL of fluid. 4 Carefully insert the filled SysClean adapter into the ProCell position of bottle set 1 in the system reagent compartment, with the edge marked 'USER' facing the back of the analyzer.

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Every two weeks maintenance

B

A

A

USER compartment of the SysClean adapter

Figure C-10

B

Ledge of the USER compartment

SysClean adapter in the ProCell position of bottle set 1 (system reagent compartment)

5 Remove the liquid waste container and clean it thoroughly with distilled or deionized water. Replace the empty liquid waste container. e See Clean the liquid waste container on page C-38

6 Verify that ProCell and CleanCell bottles are correctly located in the other three positions with the lids open and adequate ProCell and CleanCell in the bottles. 7 Close the sipper shield. 8 Choose Utility > Maintenance. 9 Select Maintenance from the Maintenance Type list. 10 Select Liquid Flow Cleaning from the Maintenance Items list. 11 Choose Select to open the Liquid Flow Cleaning window.

Figure C-11

Liquid Flow Cleaning window

12 Type 1 in the Cycles text box and choose Start. Wait for the analyzer to return to Standby. Roche Diagnostics C-26

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9 Maintenance Every two weeks maintenance

13 Remove the liquid waste container and rinse it thoroughly with distilled or deionized water. Return the liquid waste container to the analyzer. e See Clean the liquid waste container on page C-38

14 Open the sipper shield and remove the SysClean adapter. 15 Dispose of any remaining SysClean in an appropriate manner and rinse the SysClean adapter thoroughly. 16 Return the ProCell bottle to its correct position in bottle set 1 in the system reagent compartment. 17 Close the sipper shield.

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Every two months maintenance

Every two months maintenance Record in the Maintenance log the dates when the maintenance tasks were carried out and the initials of the person who performed them.

Replace the pinch valve tubing Worn pinch valve tubing can allow liquid to leak out. Leakage will affect both the accuracy of the pipetting volumes and the ability of the analyzer to properly clean the measuring cell. This maintenance task is divided into the following procedures: o

Procedure 1: To purge the tubing of liquid

o

Procedure 2: To remove the tubing from the fittings

o

Procedure 3 (optional): To replace a broken fitting

o

Procedure 4: To prime the sipper

o

Procedure 5: To prepare the measuring cell

Perform these procedures in the correct order. Planning

Recommended frequency: Operator time:

Approximately five minutes

System time:

Approximately 15 minutes

Precautions:

The operation switch must be off while changing the tubing. Wear suitable protective gloves.

Table C-18

Materials

Every two months

Planning considerations

Item

Pinch valve tubing Tube joint B Disposable cloth or paper towels Lint-free gauze squares Table C-19

Required materials

Before performing this maintenance action, observe the following safety precautions: o

Residual liquid in pinch valve tubing on page C-4

o

Infection by samples and associated materials on page A-9

o

Malfunction due to spilled liquid on page A-14

Care when handling tubing and fittings Do not crimp the replacement pinch tubing or damage the fittings during this operation. CAUTION NOTICE

Tube joint B It is highly recommended that you keep a spare tube joint B on-site. There is a risk that this part may be damaged during replacement of the pinch valve tubing.

Roche Diagnostics C-28

Operator’s Manual · Version 2.1

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9 Maintenance Every two months maintenance

a Procedure 1: To purge the tubing of liquid 1 Choose Utility > Maintenance > Maintenance. 2 Select Measuring Cell Exchange and choose Select to open the Measuring Cell Exchange window. 3 Choose Start. The tubing is purged of liquid. 4 When the analyzer returns to Standby, switch the power off at the Operation switch.

a Procedure 2: To remove the tubing from the fittings The pinch valve tubing and fittings are located above the sample/reagent and sipper pipetters.

A

E

B

F

C

G

D

H

A

Pinch valve (left side, sample/reagent probe) B

Tubing (left side, sample/reagent probe)

C

Fitting (sample/reagent probe)

D

Fitting (sample/reagent probe)

E

Pinch valve (right side, sipper probe)

F

Tubing (right side, sipper probe)

G

Fitting (sipper probe)

H

Fitting (sipper probe)

Figure C-12

Pinch value tubing and fittings

1 Switch off the analyzer at the operation switch. 2 Remove the system water container. 3 Cover the area beneath the pipetters with disposable towels to prevent spillages and potential contamination.

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Figure C-13

Place disposable towels under the pipetters

4 Carefully remove the tubing from the fittings on the metal plate and discard. There may still be some liquid in the tubing. The liquid that flows through this tubing comes from the measuring cell and is potentially biohazardous. Use gauze squares and disposable towels to prevent spillage.

Figure C-14

Absorb liquid as it drains from the tubing

5 Remove the tubing from the pinch valve and discard. 6 Take a new piece of tubing and verify that the tubing length is 180 mm. If it is not, discard and use the correct tubings as detailed in the list of materials. 7 Insert the tubing through the pinch valve.

Roche Diagnostics C-30

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9 Maintenance Every two months maintenance

A

A

B

B

Pinch valve

Figure C-15

Tubing

Insert new tubing through the pinch valve

8 Carefully slide the ends of the tubing over each of the fittings in turn. A B

A

Fitting

Figure C-16

B

Tubing

Fit new tubing on to the fitting

9 Repeat the procedure for the other pinch valve tubing. e For more information on fitting the pinch valve tubing, see Figure C-12 on page C-29

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a Procedure 3 (optional): To replace a broken fitting It is only necessary to perform this procedure if any of the fittings are broken.

1 Turn the fitting counterclockwise from the valve block.

A B C

A

Fitting

C

Valve block

Figure C-17

B

O-ring

Replacing a fitting

2 Insert the new fitting (tube joint B) and turn clockwise. 3 Repeat steps 1 to 2 if any other fittings are broken. 4 Continue with the pinch valve tubing replacement procedure.

a Procedure 4: To prime the sipper 1 Place the system water container back on the analyzer. 2 Switch on the analyzer at the operation switch. Wait for initialization to complete. 3 Choose Utility > Maintenance. The Maintenance screen opens. 4 Select Maintenance on the Maintenance Type list. 5 Select Sipper Pipetter Prime and choose Select. The Sipper Pipetter Prime window opens. 6 Type 10 in the Sipper Pipetter Prime Count text box in the Sipper Pipetter Prime window. 7 Choose Start to purge air from the sipper system. 8 Check for leaks at the fittings and on the tubing while the system is priming. Priming is complete when the system returns to Standby.

Roche Diagnostics C-32

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9 Maintenance Every two months maintenance

a Procedure 5: To prepare the measuring cell 1 Select Measuring Cell Preparation from the Maintenance Items list and choose Select. The Measuring Cell Preparation window opens. 2 Type 10 in the Measuring Cell Preparation Count text box in the Measuring Cell Preparation window. 3 Choose Start. The window closes and the system begins purging the measuring cell with ProCell. Preparation is complete when the system returns to Standby.

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As needed maintenance

As needed maintenance Record in the Maintenance log the dates when the maintenance tasks were carried out and the initials of the person who performed them.

Perform finalization maintenance Finalization allows the module to stand unused for several hours (for example, overnight). The system is primed with water and the measuring cells are filled with ProCell. Before going into Standby mode, the system automatically performs finalization maintenance. Finalization must be manually initiated if it was not performed automatically (for example, due to an emergency stop), did not complete (for example, when an alarm is issued), or if the system stands unused for several hours. If you choose S. Stop (Sample stop), finalization is bypassed and the analyzer goes directly into Standby mode. Planning

Recommended frequency:

Daily (if the analyzer does not automatically enter finalization during the course of the day)

Operator time:

Approximately 30 seconds

System time:

Approximately four minutes

Precautions:

None

Table C-20

Materials

Planning considerations

None

a To perform finalization maintenance 1 Choose Utility > Maintenance and select Finalization Maintenance in the Maintenance Items list. 2 Choose Select to open the Finalization Maintenance window. 3 Choose Start to perform the Finalization Maintenance process. Once the process has been completed, the system goes into Standby mode.

Replace the valve on the system water container Over time, the valve that is located on the underside of the system water container may become worn or damaged through maintenance or extended use. Check the valve periodically and replace it if you see signs of wear or damage, for example cracks or water leakage.

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Causes of damage might include the following possibilities:

Planning

o

Accumulated stress caused by the daily removal and reinstallation of system water container during refilling

o

Damaged caused by dropping the system water container during a cleaning procedure

o

Over-tightening of the valve when it is replaced

Recommended frequency:

As needed

Operator time:

Approximately 10 minutes

System time:

None

Precautions:

The analyzer must be in Standby or switched off at the operation switch. Wear suitable protective gloves.

Table C-21

Materials

Planning considerations

Item

Disposable cloth or paper towels Complete valve (including its internal components) Table C-22

Required materials

A

B

C

A

Cap

C

Valve

Figure C-18

B

Location of the fitted valve

Remove the system water container

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a To replace the valve on the system water container 1 Lift the system water container and remove it from the analyzer. 2 Look at the underside of the container and inspect the valve for leaks or cracks. If you see evidence of wear or damage, go to the next step; if you see no evidence of wear of damage, continue at step 9. 3 Remove the cap from the container and discard any system water. 4 Place the empty container upside down, or on its side, on a cloth or paper towel. 5 Grasp the valve and turn it counterclockwise until you can remove it from the container. 6 Connect a new replacement valve. Turn the valve clockwise to attach it firmly to the container. Damage to the bottle valve due to over-tightening

NOTICE

When you attach a valve, turn it only until you meet a moderate resistance. At this point, you have created an adequate seal. If you exert excessive force, you may cause the valve to crack.

7 Refill the system water container and check for any leaks. 8 Screw the cap back on to the container. 9 Return the system water container to its place on the analyzer.

Clean the system water container A contaminated system water container can adversely affect analyzer performance. Clean the system water container as needed. Planning

Recommended frequency:

As needed

Operator time:

Approximately 10 minutes

System time:

None

Precautions:

The analyzer must be in Standby or switched off at the operation switch. Wear suitable protective gloves.

Table C-23

Materials

Planning considerations

Item

Lint-free gauze squares Cleaning brush Distilled or deionized water Disposable cloth or paper towels 70% alcohol (isopropyl alcohol or ethanol) Table C-24

Required materials

Roche Diagnostics C-36

Operator’s Manual · Version 2.1

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9 Maintenance As needed maintenance

a To clean the system water container 1 Put the analyzer into Standby. 2 Raise and remove the system water container.

A

B

A

Cap and valve (not visible)

Figure C-19

B

System water container

Remove the system water container

3 Remove the cap and discard any water remaining inside. 4 Rinse the container with water and then rinse with distilled or deionized water. 5 Inspect the inside of the container and scrub away any visible dirt or contamination by using a large cleaning brush immersed in 70% alcohol. Rinse thoroughly with distilled or deionized water. 6 Remove the valve on the bottom of the system water container.

Figure C-20

Remove the valve from the system water container valve

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7 Clean the valve with a wet brush then rinse with distilled or deionized water. If the valve appears to be dirty, use a brush immersed in 70% alcohol to clean the valve. Then rinse thoroughly with distilled or deionized water. 8 Use a gauze square to wipe and clean the aspiration inlet for the distilled or deionized water supply. 9 Connect the valve to the container bottom and fill the container with distilled or deionized water. 10 Add 35 mL of SysWash to the distilled or deionized water pouring carefully to avoid creating air bubbles. This gives a SysWash dilution of 1+100. 11 Dry the outside of the container with disposable towels, attach the cap to the container, and return the container to the analyzer.

A

A

Aspiration inlet

Figure C-21

Clean the aspiration inlet

Clean the liquid waste container The liquid waste container must be checked and emptied as necessary. A full liquid waste container causes an alarm and interrupts the operation of the analyzer. This applies to the internal liquid waste container and also to any external liquid waste tank in cases where the optional direct drain arrangement is used. e See Clean the direct drain waste container on page E-10

Planning

Recommended frequency:

As needed

Operator time:

Approximately five minutes

System time:

None

Precautions:

The analyzer must be in Standby or switched off at the operation switch.

Table C-25

Planning considerations

Roche Diagnostics C-38

Operator’s Manual · Version 2.1

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9 Maintenance As needed maintenance

Materials

Item

70% alcohol (isopropyl alcohol or ethanol) Disposable cloth or paper towels Germicidal agent, pH 9 (optional) Table C-26

Required materials

Before performing this maintenance action, observe the following safety precautions: o

Avoid use of bleach on page C-3

o

Infection by samples and associated materials on page A-9

a To clean the liquid waste container 1 Put the analyzer into Standby mode. 2 Pull the liquid waste container toward you, cap it, and raise it carefully while avoiding the liquid waste outlet.

Figure C-22

Remove the liquid waste container

3 Place a disposable towel under the liquid waste outlet to absorb any drips that may fall during this procedure. 4 Empty the container and rinse it thoroughly with water. 5 If the inside of the container appears to be dirty, use 70% isopropyl alcohol to rinse the container. Follow with a thorough water rinse. 6 Wipe the outside of the container with a disposable towel. 7 Use a disposable towel to wipe the compartment where the container is to be placed. 8 Optional step: Add the appropriate volume of a germicidal agent of pH 9 (as directed in its product labeling) to the liquid waste container. 9 Remove the disposable towel under the waste outlet and replace the liquid waste container.

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10 Push the container forward so that the container opening is under the liquid waste outlet. Be sure to remove the cap.

Clean the microbead mixer Clean the microbead mixer when necessary. Check the microbead mixer periodically and remove visible dirt (for example, red dots on the mixer arm or the paddle). Impurities on the microbead mixer may cause problems and affect results. Planning

Recommended frequency:

As needed

Operator time:

Approximately two minutes

System time:

None

Precautions:

The analyzer must be in Standby or switched off at the operation switch. Wear protective gloves. Do not bend the mixer.

Table C-27

Materials

Planning considerations

Item

Lint-free gauze squares Distilled or deionized water 70% alcohol (isopropyl alcohol or ethanol) Table C-28

Required materials

Before performing this maintenance action, observe the following safety precautions: o

Bent or damaged microbead mixer paddle on page C-3

o

Infection by samples and associated materials on page A-9

o

Avoid damage to motorized components on page A-14

Roche Diagnostics C-40

Operator’s Manual · Version 2.1

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9 Maintenance As needed maintenance

a To clean the microbead mixer 1 Put the analyzer into Standby mode. 2 Move the microbead mixer arm to a readily accessible position.

A

A

Mixer paddle

Figure C-23

Move the mixer paddle for cleaning

3 Wipe the outer surface of the microbead mixer paddle carefully, using a gauze square soaked in 70% alcohol. Repeat with a new gauze square soaked in distilled water. Take care not to bend the mixer paddle during cleaning.

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As needed maintenance

Clean the ProCell and CleanCell compartments Clean the system reagent compartment whenever necessary to remove any liquid or residue spilled from the ProCell and CleanCell reagents. Planning

Recommended frequency: Operator time:

Approximately five minutes

System time:

None

Precautions:

The analyzer must be in Standby or switched off at the operation switch. Wear protective gloves.

Table C-29

Materials

As needed

Planning considerations

Item

Lint-free gauze squares Cotton swabs Distilled or deionized water 70% alcohol (isopropyl alcohol or ethanol) Table C-30

Required materials

Before performing this maintenance action, observe the following safety precautions: o

Aluminum parts on page C-4

o

Avoid damage to motorized components on page A-14

o

Photosensors on page C-4

o

Malfunction due to spilled liquid on page A-14

o

Sipper shield on page B-6

a To clean the ProCell and CleanCell compartments 1 Put the analyzer into Standby mode. 2 Lift the instrument cover. 3 Open the sipper shield by applying pressure to the white metal area at the top, until the latch is released. e For the location of the sipper shield, see Figure C-4 on page C-19

4 Move the sipper arm manually as far to the left as the arm will allow. 5 Remove all four ProCell and CleanCell reagent bottles from their compartments. 6 Wipe the sipper shield with a damp gauze square and repeat with a dry gauze square.

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9 Maintenance As needed maintenance

A

B

A

Sipper shield latch

Figure C-24

B

Sipper shield (in the open position)

Clean the sipper shield

7 Wipe the inside of the compartments with damp (not wet) gauze squares. Do not allow water to pool in the bottom of the compartments. Avoid the photosensors in the two inside compartments that check for the presence of ProCell/CleanCell bottle sets. Each sensor is in a rectangular window at the back of its compartment, just below the top edge. If you wet the sensors, dry them with a cotton swab.

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As needed maintenance

A

B A

Photosensor locations (visible when bottle removed) B

C

Bottle set 1, ProCell position

Figure C-25

C Bottle set 2, CleanCell position

Clean the ProCell and CleanCell compartments

8 Wipe the compartment with a dry gauze square. 9 Return the ProCell and CleanCell reagents to their respective system reagent compartments. 10 Close the sipper shield by applying pressure to the white metal area at the top until the latch is engaged and you hear a click. 11 Close the instrument cover.

Roche Diagnostics C-44

Operator’s Manual · Version 2.1

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9 Maintenance As needed maintenance

Clean the reagent rotor and compartment To maintain the efficiency of the analyzer, the reagent rotor and compartment must be cleaned as soon as any signs of dirt or contamination appear. Any reagent spills must be cleaned up as they occur. Planning

Recommended frequency: Operator time:

Approximately 15 minutes

System time:

None

Precautions:

The analyzer must be switched off at the operation switch. Wear protective gloves.

Table C-31

Materials

As needed

Planning considerations

Item

Lint-free gauze squares Distilled or deionized water 70% alcohol (isopropyl alcohol or ethanol) Disposable cloth or lint-free paper towels Table C-32

Required materials

Before performing this maintenance action, observe the following safety precautions: o

Infection by samples and associated materials on page A-9

o

Avoid damage to motorized components on page A-14

o

Barcode reader window on page B-4

o

Malfunction due to spilled liquid on page A-14

a To clean the reagent rotor and compartment 1 Switch off the analyzer at the operation switch. 2 Remove the cover from the reagent rotor. 3 Close completely all the reagent pack caps, and remove all the reagent packs from the reagent rotor. 4 Loosen and remove the black thumbscrews on the center of the reagent rotor.

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As needed maintenance

A

B A

B

Thumbscrews

Figure C-26

Alignment pin

Loosen and remove thumbscrews

5 Remove the reagent rotor from the compartment. 6 Remove any visible dirt or contamination by using gauze squares soaked with 70% alcohol. Then wipe the cleaned rotor with gauze squares soaked with distilled or deionized water.

A B

A

B

Compartment

Figure C-27

Body of the disk

Wipe the reagent rotor

7 Dry the reagent rotor with a disposable towel and set it to one side.

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Operator’s Manual · Version 2.1

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8 Inspect the reagent rotor compartment and remove any visible dirt or contamination by using gauze squares soaked with 70% alcohol. Then wipe the compartment and barcode reader window with gauze squares soaked with distilled or deionized water. If there is any condensation inside the compartment, first wipe it off with dry gauze squares.

A

A

Barcode Reader Window

Figure C-28

Cleaning the reagent rotor compartment

9 Dry the reagent rotor compartment and the barcode reader window with a disposable towel. 10 Return the reagent rotor to the compartment then replace and secure the thumbscrews. The rotor is keyed; make sure that the alignment pin on the center plate is aligned with the hole on the rotor. 11 Place the reagent packs back into the reagent rotor and replace the reagent rotor cover. 12 Switch on the analyzer at the operation switch. The analyzer performs a start-up reset operation and each mechanism automatically returns to its home position.

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As needed maintenance

Clean the analyzer surfaces Spills on the analyzer surfaces could be potentially biohazardous or damage the surfaces. Planning

Recommended frequency: Operator time:

Approximately 5 minutes

System time:

None

Precautions:

The analyzer must be in Standby or switched off at the operation switch. Wear protective gloves.

Table C-33

Materials

As needed

Planning considerations

Item

Disposable cloth or lint-free paper towels Laboratory disinfectant (no bleach) Table C-34

Required materials

Before performing this maintenance action, observe the following safety precautions:

NOTICE

o

Infection by samples and associated materials on page A-9

o

Infection by waste solution on page A-9

o

Personal injury due to contact with moving parts on page A-11

o

Skin inflammation or injury caused by reagents and other working solutions on page A-12

Damage to the analyzer surfaces Do not use alcohol or bleach to clean the analyzer surfaces because these substances may damage the finish.

a To clean the analyzer surfaces 1 Put the analyzer in Standby or switch it off at the operation switch. 2 Clean the soiled surfaces using a cloth or paper towel moistened with disinfectant. Clean up all spills immediately. If necessary, move the probes or microbead mixer arm manually to clean the surfaces.

Roche Diagnostics C-48

Operator’s Manual · Version 2.1

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9 Maintenance As needed maintenance

Empty the solid waste During operation, the solid waste tray is filled with disposed tips and cups. Check the solid waste tray regularly, and empty as needed. Planning

Recommended frequency: Operator time:

Approximately two minutes

System time:

None

Precautions:

The analyzer must be in Standby or switched off at the operation switch. Wear protective gloves.

Table C-35

Materials

As needed

Planning considerations

Item

Clean-Liner Table C-36

Required materials

Before performing this maintenance action, observe the following safety precautions: o

Changing the Clean-Liner on page C-3

o

Infection by samples and associated materials on page A-9

o

Infection by waste solution on page A-9

o

Contamination of the environment by liquid and solid waste on page A-10

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As needed maintenance

a To empty the solid waste 1 Put the analyzer into Standby mode. 2 Open the solid waste door and pull out the tray. 3 Slide the clear lid forward to close the Clean-Liner.

A

B

C

A

Sliding lid

C

Waste tray

Figure C-29

B

Solid waste compartment door

Remove the Clean-Liner

4 Remove the Clean-Liner from the tray and dispose of it according to the waste handling and disposal procedures that apply in your laboratory. 5 Place a fresh Clean-Liner into the tray. 6 Verify that the sliding door is open and that the opening is located at the back of the tray. 7 Insert the tray into the analyzer and close the door. On the System Overview screen, the solid waste counter automatically resets to 0 (zero) when the solid waste tray is removed. 8 Dispose of the Clean-Liner appropriately, as it contains potentially biohazardous material. NOTICE

Solid waste tray If you remove the solid waste tray for any reason you should also discard the solid waste or replace the Clean-Liner at the same time. The software counts the AssayTips and AssayCups used during operation. When the analyzer senses that the solid waste tray was removed, the counter resets to 0 (zero).

Roche Diagnostics C-50

Operator’s Manual · Version 2.1

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9 Maintenance As needed maintenance

Protect the measuring cell during extended shutdown If the analyzer is not going to be used for more than seven days, it is important to prepare the system properly and perform the correct shutdown maintenance. Failure to observe these recommendations may result in damage to the measuring cell. Different shutdown procedures are recommended depending upon the duration of inactivity. Certain procedures may require the assistance of a Roche Diagnostics service representative. Shutdown period

Shutdown procedure

Startup process

One week

No special action necessary after operation

No special action

One to four weeks After operation, perform a sipper prime (5 times) Perform measuring cell preparation (30 to fill the measuring cell with system water. The times). measuring cell will remain in the instrument. Four weeks and longer

Table C-37

After operation, perform a sipper prime (5 times) Perform measuring cell preparation (30 to fill the measuring cell with system water. Seal times). the sipper probe by using flexible tubing. The measuring cell will still remain in the instrument. Measuring cell protection measures for different shutdown periods

This is the last page of Part C

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Roche Diagnostics C-52

Operator’s Manual · Version 2.1

Troubleshooting

D

10

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D–3

11

Data alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D–31

cobas e 411 analyzer

10 Troubleshooting Table of contents

Troubleshooting

This chapter provides general information about troubleshooting problems on the cobas e 411 analyzer.

In this chapter

Chapter

10

Introduction ..................................................................................................................... D–5 Alarms ............................................................................................................................... D–5 Problem categories .......................................................................................................... D–5 Sample/reagent problems ........................................................................................ D–6 Instrument/hardware problems ............................................................................. D–6 Computer/software problems ................................................................................ D–7 Facility problems ...................................................................................................... D–7 Operator's primary responsibility ........................................................................... D–7 Contacting Technical Support ..................................................................................... D–8 Basic troubleshooting flow chart ................................................................................ D–10 Immunoassay troubleshooting .................................................................................... D–11 Reagents, calibrators, and controls ....................................................................... D–11 Instrument troubleshooting ........................................................................................ D–15 Troubleshooting at power up ................................................................................ D–15 General mechanical problem isolation ................................................................ D–15 The instrument does not power up ...................................................................... D–16 Cannot access another software screen ............................................................... D–16 The touchscreen does not switch on .................................................................... D–16 The touchscreen is difficult to see ........................................................................ D–17 The solid waste tray does not come out or produces unusual sounds ............ D–17 The reagent rotor cover does not open or close ................................................. D–17 The sample disk does not move ............................................................................ D–18 Trouble placing a reagent pack on the reagent rotor ......................................... D–18 Trouble replacing an AssayTip or AssayCup tray .............................................. D–19 Trouble replacing a system reagent (ProCell or CleanCell) ............................. D–19 Trouble replacing the system water container .................................................... D–20 Trouble replacing the solid waste tray ................................................................. D–20 Empty liquid waste container causes an alarm ................................................... D–21 Roche Diagnostics Operator’s Manual · Version 2.1

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Table of contents

Probes do not descend to the liquid surface ....................................................... D–21 Results do not print automatically ....................................................................... D–22 Bubbles in syringes ................................................................................................. D–22 Chemistry troubleshooting .......................................................................................... D–23 False measurements ................................................................................................ D–23 Drift ........................................................................................................................... D–23 Erratic test results .................................................................................................... D–24 Assay calibration ..................................................................................................... D–24 Recovery of controls ............................................................................................... D–27 Intra assay precision ............................................................................................... D–27 Inter assay precision ............................................................................................... D–28 System to system variance ..................................................................................... D–28 Method comparison ............................................................................................... D–28 Auto dilution not possible ..................................................................................... D–29

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10 Troubleshooting Introduction

Introduction To identify and isolate problems effectively, you must understand the theory of operation, operating procedures, emergency procedures, and test reaction descriptions covered in this manual. The information in this chapter will help you to recognize the causes of various operational problems, find information to resolve operational problems, and minimize the potential for operator-induced problems. e If you are unable to resolve the problem and you need support, see Contacting Technical

Support on page D-8 for a list of information that Roche might request if you call for assistance.

Alarms If any abnormality occurs while the system is switched on, the system notifies you of the potential problem by issuing an alarm. There are two types of alarm: o

Instrument alarms These are displayed alarms that indicate abnormal instrument conditions, such as reagent rotor temperature, and mechanical malfunctions.

o

Data alarms These are printed or displayed alarms or flags that indicate unusual reaction conditions, such as insufficient sample or reagent, or measured values outside the limits. e See Data alarms on page D-31

Problem categories The problems that may be encountered can be separated into the following categories: o

Sample/reagent problems

o

Instrument/hardware problems

o

Computer/software problems

o

Facility problems

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Problem categories

Sample/reagent problems o

Insufficient sample volumes of: O

Sample cups

O

Sample tubes

e See Residual volume (disk system) on page A-38

Residual volume (rack system) on page A-39

o

Reagent packs not loaded correctly with the white bottle furthest from the center of the reagent rotor

o

Diluent bottles not loaded with the correct barcode label facing outwards

o

Incorrect sample preparation

o

O

Proper reconstitution

O

Aliquoting/labeling

Incorrect sample storage O

Refrigerating

O

Freezing

O

Thawing

O

Labeling after use

o

Manually assigned calibrators

o

Operator error

Instrument/hardware problems o

Electrical/electronic

o

Mechanical:

o

O

Pinch valve tubing leaking

O

AssayCup/AssayTip jammed

O

Problem with solid waste tray removal

Operator error: O

Incorrect size of sample tubes or cups used

O

Incorrect replacement of AssayCup/AssayTip

O

Incorrect or insufficient maintenance

O

Caps not removed from liquid waste containers

O

Caps not opened on ProCell/CleanCell bottles

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Computer/software problems o

Incorrect system parameters

o

Faulty barcode card or software settings

o

Disk system: O

Single disk mode

O

Multiple disk mode

O

Starting from Standby compared with starting from S. Stop

o

Orders/result database capacity exceeded (up to 2000 results can be stored, for routine samples, STAT (Short Turn Around Time) samples, and controls)

o

Alarms

o

Operator error

o

Temperature

o

Humidity

o

Power supply

o

Water supply

o

Drain

Facility problems

e See System specifications on page A-33

Operator's primary responsibility Your primary responsibility lies in the following areas: o

Reagent, calibrator, and control preparation and storage

o

Sample and sample container preparation

o

Computer parameters and general computer input/output operations

o

Basic operator technique, including instrument and computer operation

o

Basic component replacement

o

Maintenance

For essential safety information, see Electrical shock by electronic equipment on page A-8. WARNING

e See General safety information on page A-3

When troubleshooting, review the alarms and isolate the problem to the area denoted by the alarms. In many cases, you may be able to find the problem, correct it, and resume test processing. The remainder of this section provides you with instructions and guidelines to assist you in isolating problems. If there is a problem with barcode reading, first check the position of the barcode label.

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Contacting Technical Support

Contacting Technical Support If it becomes necessary to consult Technical Support to troubleshoot a test or instrument problem, you should be prepared with the following information. The information that is needed depends upon whether you have encountered a chemistry problem, immunoassay problem, or instrument problem. Use the Technical support information form on page E-13 to record the necessary information before calling Technical Support. General information The following general information is required for all problems: o

Account number or customer ID number

o

Contact name and telephone number

o

Instrument serial number

o

The version of software installed

o

Description of the problem, including relevant alarm(s) and alarm code numbers

o

When the problem first occurred (for example, after reagent pack lot change)

o

Whether the problem was observed with just one system or with all systems

o

Copies of the original instrument printouts (send by fax or e-mail)

o

Perform backup function using Utility > Maintenance > Media Write window

Immunoassay problems The following general information is required for immunoassay problems: o

Whether the problem was observed with just one assay or with all assays

o

Whether the problem was observed with just one sample type or with all sample types

o

Control results and ranges from the last few controls performed

o

Sample type used (serum, plasma, urine, or saliva)

o

Sample tube used (manufacturer, diameter, primary or secondary tube)

o

Elapsed time between specimen collection and measurement

o

Patient results (with correlation results, if relevant)

o

Test(s) affected and other tests on board

o

Whether SysWash was added to the system water container

o

Catalog number, lot numbers, and expiration dates of reagents

o

Catalog number, lot numbers, and expiration dates of calibrators and controls

o

Calibration signals (HetIA) from the last few calibrations performed

o

Details of reagent/calibrator/control handling (such as calibration frequency, stability, ambient temperature, foam, and evaporation)

o

When the reagent was loaded onto the system

o

When liquid flow cleaning was last performed

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Software problems The following general information is required for software problems: o

The lot and sequence numbers of the reagent packs

o

The language currently installed

o

Software version number and date of installation

o

The date the instrument was initially installed

o

Version number of the reference data file

o

Version number of internationalization CD

o

A complete set of back up files

o

Any other illustrative details (for example, screen captures, pictures of screens, printed data, or a description of exactly how the analyzer was being operated when the problem occurred)

To find the version numbers for the reference data file and the internationalization CD, open the online Help. In the Contents panel, go to cobas e 411 analyzer > System information. The System information topic identifies the relevant version numbers.

Instrument problems The following general information is required for instrument problems: o

Rack or disk system

o

Instrument maintenance and service history

o

Whether a host or a Pre-Analytic Systems Manager (PSM) was connected

o

Number of tests performed

o

Other instrument or maintenance related information

o

Error code and error description

o

Print out of the alarm trace report e See To print a daily Alarm Trace report on page B-125

PSM is not available in the United States of America.

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Basic troubleshooting flow chart

Basic troubleshooting flow chart The following flow chart details the basic decisions to be made when performing troubleshooting on the cobas e 411 analyzer. Problem detected

Was an instrument alarm generated?

Yes

Follow the remedy displayed on screen

No

Follow appropriate remedy in Data alarms chapter

Yes

No

Was a data alarm generated?

Does the alarm recur?

Continue normal operation Does the alarm recur?

Yes No No Continue normal operation

Yes

Check the Troubleshooting chapter for a description of this problem

Was a description of this problem found?

Yes

Follow the remedy

No

Does the problem recur?

Print out relevant data, ready to send to Technical Support

No

Yes

Identify the type of problem: Immunoassay problem? Software problem? Instrument problem?

Continue normal operation

Copy the Technical Support information form in the Appendix and record the information for the type of problem encountered

Call Technical Support

Figure D-1

Basic troubleshooting flow chart

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10 Troubleshooting Immunoassay troubleshooting

Immunoassay troubleshooting Mechanical problems are evident when the analyzer displays an alarm message. A chemistry problem may display a data alarm, or may only become evident with an unexpected result. Deciding that a problem exists is the first step in the process. The following situations may require troubleshooting: o

Error codes on calibration documentation.

o

Data alarms on control or patient samples.

o

Quality control sample results outside established range.

o

Patient tests with unexpected results.

When troubleshooting a problem, open the Print screen (using the Print global button), choose Utility tab, and print an alarm list. Use this list to assist you with troubleshooting. To troubleshoot effectively, eliminate extraneous information and pinpoint the problem. Use the calibration documentation, quality control results, or patient results to decide which of the following conditions apply, and perform the associated checks outlined in the following sections: e See For problems with a single sample on page D-13

For problems with a single assay on page D-14

Reagents, calibrators, and controls Sometimes conditions arise that cannot be detected by the analyzer. These conditions do not generate alarms and therefore must be detected by the operator. When one or more of these conditions are present, test results can be extremely high, low or erratic. To identify the cause of high, low or erratic test results, first verify the handling of reagents, calibrators and controls by considering the following lists of checks. Before working with reagents and other working solutions, observe the following safety precautions: o

Handling of reagents on page A-12.

o

Skin inflammation or injury caused by reagents and other working solutions on page A-12.

e See General safety information on page A-3

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Immunoassay troubleshooting

When handling reagents o

Has the catalog number changed?

o

Have the lot numbers changed? Do they match the lot numbers in the Reagent Detail window?

o

Was the reagent stored appropriately?

o

Was the reagent kit stored in an upright position and at the correct temperature (2-8°C)?

o

Was the reagent allowed to reach the correct temperature on board before starting the instrument?

o

Were the reagent packs within the allowed stability after opening and the expiration dates not exceeded?

o

Were the system reagent bottles closed overnight?

o

Were the partly used ProCell/CleanCell bottles replaced from the left to right side?

o

Was any foam observed on the surface of the reagents?

o

Were any bubbles observed in the pipetters or syringes?

When reconstituting/handling calibrators o

Has the lot number changed?

o

What is the correct reconstitution volume?

o

Was the correct amount of time allowed for reconstitution?

o

What is the recommended storage?

o

What is the expiration date of the calibrator lot?

o

What is the expiration date of the reconstituted material?

o

Was fresh, bacteria-free, deionized water used in reconstitution?

o

Were volumetric pipettes used (where appropriate)?

o

Were the calibrators brought to room temperature before starting the instrument?

o

Were the reconstituted calibrators brought to room temperature and allowed to stand closed for 15 minutes after 1 mL of distilled water was added?

o

Were the calibrators carefully mixed, avoiding the formation of foam?

o

Were the lyophilized calibrators carefully dissolved?

o

Were the calibrators transferred to the correct barcoded vials?

o

Was the calibrator on board the analyzer for longer than the time recommended in the package insert?

o

Were the calibrators checked and found to be within the allowed stability after opening?

o

Were drops observed hanging on the CalSet cap?

o

Was crystallized material observed on the CalSet cap? (If so, discard the CalSet vial)

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When reconstituting/handling controls o

Has the lot number changed?

o

What is the correct reconstitution volume?

o

Was the correct amount of time allowed for reconstitution?

o

What is the recommended storage?

o

What is the expiration date of the control lot?

o

What is the expiration date of the reconstituted material?

o

Was fresh, bacteria-free, deionized water used in reconstitution?

o

Were volumetric pipettes used (where appropriate)?

o

Were the lyophilized controls carefully reconstituted with, for example, 3 mL for PreciControl Universal and PreciControl Tumor Marker (stand closed for 30 minutes), and 2 mL for PreciControl Cardiac (stand closed for 15 minutes)?

o

Were the controls transferred to the correct barcoded vials?

o

Were the controls checked and found to be within the allowed stability after opening, and the expiration date not exceeded?

o

Was any foam observed on the surface of the controls?

o

Were drops observed hanging on the control vial cap? (You need to clean the control caps carefully with a paper tissue.)

o

Was crystallized material observed on the control vial cap? (If so, discard the control vial.)

o

Were the controls aliquoted and frozen? (This is recommended for controls such as PreciControl Universal, Cardiac, and Tumor Marker.)

For problems with a single sample Check for: o

Sufficient sample volume, including adequate sample container residual volume.

o

Sample integrity (fibrin, hemolysis, icterus, and lipemia).

o

Appropriate type of sample (serum, plasma, urine, and saliva).

o

Bubbles in the sample cup or tube.

o

Sample reproducibility.

o

Recommended sample containers used.

o

Air bubbles or foam on the surface of the samples.

o

Sample stability within the specified range (refer to package inserts).

o

Correct preparation of the sample material (allow 30 minutes waiting time for clotting, and centrifuge the samples before putting them on the analyzer).

o

Presence of precipitates in the sample. Samples containing precipitates must be centrifuged before testing at a minimum of 2500 rpm for 10 minutes (primary and normal cups).

o

Correct placement of sample cups in sample disk or rack.

o

Residual volume within the specified range. e See Residual volume (disk system) on page A-38

Residual volume (rack system) on page A-39

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Immunoassay troubleshooting

For problems with a single assay Check for: o

Calibrators not at room temperature before operation.

o

Incorrectly prepared calibrators.

o

Expired reagent(s).

o

Expired calibrators.

o

Calibrators’ on-board stability exceeded.

o

Correct lot number in the Reagent Detail window.

When handling system water o

Was distilled water used according to the specification (conductivity Sound), and the alarm indicator on the global Alarm button lights, alerting you to the problem. Choose the Alarm global button to open the Alarm screen, which displays the specific alarm code, date and time the alarm occurred and a description of the alarm. Select a specific alarm to display the alarm details and appropriate remedy. For certain problems affecting the instrument's performance, the system terminates the operation mode and enters the sampling stop or stop mode. In the sampling stop mode, the system allows completion of the samples in process unaffected by the failure. If the problem affects all samples in process, the computer immediately terminates the operation mode with a stop or emergency stop. For essential safety information, see Instrument problems without alarms on page B-3. WARNING

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Instrument troubleshooting

The instrument does not power up If you are having problems switching the analyzer on, follow the steps below: 1 Are the operation on/off switch and analyzer circuit breaker turned off? o

If yes, go to step 2.

o

If no, go to step 3.

2 Switch on both the analyzer circuit breaker and power switches. 3 Is the power cable plug disconnected at either the instrument or the outlet? o

If yes, go to step 4.

o

If no, go to step 5.

4 Firmly connect the power cable. 5 Is the outlet working? o

If yes, go to step 7.

o

If no, go to step 6.

6 Check the circuit breaker in the laboratory distribution box. 7 If the instrument still does not power up, call Technical Support.

Cannot access another software screen If you are unable to access another software screen, follow the steps below: 1 Check the instrument status in the Status line. If the analyzer is not in stand by, wait until it enters stand by. 2 Switch the analyzer off at the circuit breaker. 3 Switch the analyzer on at the circuit breaker. If you are still unable to access another screen, then call Technical Support.

The touchscreen does not switch on If you are having problems with the touchscreen, follow the steps below: 1 Is the operation on/off switch on the front of the analyzer switched off? o

If yes, go to step 2.

o

If no, go to step 3.

2 Switch the operation switch on. Does the touchscreen switch on? o

If no, go to step 3.

3 Firmly connect the cable. 4 Call Technical Support.

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The touchscreen is difficult to see If the touchscreen is difficult to see, follow the steps below: 1 Is the touchscreen dirty? o

If yes, go to step 2.

o

If no, go to step 3.

2 Gently wipe the surface with a dry cloth. 3 Is the ambient lighting too bright? o

If yes, go to step 4.

o

If no, go to step 5.

4 Either reduce the brightness of the ambient lighting or change the direction of the adjustable monitor face. 5 Call Technical Support.

The solid waste tray does not come out or produces unusual sounds If you are having problems removing the solid waste tray or unusual sounds are coming from the solid waste tray area, follow the steps below: 1 Are the tray and Clean-Liner seated correctly? o

If yes, go to step 3.

o

If no, go to step 2.

2 Reseat the tray and Clean-Liner. 3 Are there stray cups or tips behind the tray? o

If yes, go to step 4.

o

If no, go to step 5.

4 Remove the stray cups and tips and replace the tray and Clean-Liner. 5 Call Technical Support.

The reagent rotor cover does not open or close If you are having problems opening or closing the reagent rotor cover, follow the steps below: 1 The reagent rotor cover is keyed. Is the reagent rotor cover correctly oriented for placement? o

If yes, go to step 3.

o

If no, go to step 2.

2 Make sure that the reagent rotor cover fits into the key, which is there to prevent the cover being placed in the wrong orientation. 3 Is there an obstacle around the cover? o

If yes, go to step 4.

o

If no, go to step 5.

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4 Remove the obstacle. 5 Call Technical Support.

The sample disk does not move If the sample disk does not move properly, follow the steps below: 1 Is the sample disk seated correctly? o

If yes, go to step 3.

o

If no, go to step 2.

2 Remove and reseat the sample disk. 3 Is there an obstacle around the sample disk? o

If yes, go to step 4.

o

If no, go to step 5.

4 Remove the obstacle. 5 Call Technical Support.

Trouble placing a reagent pack on the reagent rotor If you are having problems placing a reagent pack on the reagent rotor, follow the steps below: 1 Reagent packs are keyed for correct placement. Is the reagent pack correctly oriented? o

If yes, go to step 3.

o

If no, go to step 2.

2 Reorient the reagent pack (the transparent cap and the barcode should face the outside of the reagent rotor). 3 Is there an obstacle beneath the reagent rotor? o

If yes, go to step 4.

o

If no, go to step 5.

4 Remove the obstacle. 5 Is the reagent pack damaged? o

If yes, go to step 6.

o

If no, go to step 7.

6 Replace the reagent pack. 7 Call Technical Support.

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Trouble replacing an AssayTip or AssayCup tray If you are having problems replacing an AssayTip or AssayCup tray, follow the steps below: 1 AssayTip and AssayCup trays are keyed for correct placement. Is the AssayTip or AssayCup tray correctly oriented? o

If yes, go to step 3.

o

If no, go to step 2.

2 Remove and reseat the AssayTip or AssayCup tray. 3 Is there an obstacle around the tray? o

If yes, go to step 4.

o

If no, go to step 5.

4 Remove the obstacle. 5 Is the tray damaged or deformed? o

If yes, go to step 6.

o

If no, go to step 7.

6 Replace the tray. 7 Call Technical Support.

Trouble replacing a system reagent (ProCell or CleanCell) If you are having problems replacing a ProCell or CleanCell reagent bottle, follow the steps below: 1 The system reagent bottles are keyed for correct placement. Is the bottle in its correct position? o

If yes, go to step 3.

o

If no, go to step 2.

2 Remove the bottle and check the position before placing the reagent into its correct position. ProCell must only be placed in positions 1 and 3, and CleanCell in positions 2 and 4. NOTICE

Replacing Procell and CleanCell The analyzer can operate with just one bottle set of ProCell and CleanCell reagent, but they must be placed either in positions 1 (ProCell) and 2 (CleanCell), or in positions 3 (ProCell) and 4 (CleanCell).

3 Is there an obstacle beneath the system reagent bottle? o

If yes, go to step 4.

o

If no, go to step 5.

4 Remove the obstacle.

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5 Is the system reagent bottle damaged or deformed? Sometimes the system reagent bottle appears to bulge until the cap is opened. You may be able to fit the bottle in the compartment after opening the cap.

o

If yes, go to step 6.

o

If no, go to step 7.

6 Replace the system reagent bottle. 7 Call Technical Support.

Trouble replacing the system water container If you are having problems replacing the system water container, follow the steps below: 1 The system water container must be correctly oriented for placement. Verify that the cap is closest to the rear of the analyzer. Is the container facing the right way? o

If yes, go to step 3.

o

If no, go to step 2.

2 Reseat the container and gently push down until you feel a snap indicating that the bottle is connected. 3 Is there an obstacle around the system water container? o

If yes, go to step 4.

o

If no, go to step 5.

4 Remove the obstacle. 5 Is the system water container damaged or deformed? o

If yes, go to step 6.

o

If no, go to step 7.

6 Replace the system water container. 7 Call Technical Support.

Trouble replacing the solid waste tray If you are having problems replacing the solid waste tray, follow the steps below: 1 Does the Clean-Liner fit properly (the opening in the sliding door must point to the rear of the analyzer) and is not damaged or bent? o

If yes, go to step 3.

o

If no, go to step 2.

2 Try a different Clean-Liner. 3 Is there an obstacle around the solid waste tray? o

If yes, go to step 4.

o

If no, go to step 5.

4 Remove the obstacle. 5 Is the solid waste tray damaged or deformed? Roche Diagnostics D-20

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o

If yes, go to step 6.

o

If no, go to step 7.

6 Replace the solid waste tray. 7 Call Technical Support.

Empty liquid waste container causes an alarm If your empty liquid waste container gives an alarm stating that the container is full, follow the steps below: 1 Is there an obstacle causing the tray on which the container rests, to remain in the down position (that is, is it still activating the sensor)? o

If yes, go to step 2.

o

If no, go to step 3.

2 Remove the obstacle. 3 Call Technical Support.

Probes do not descend to the liquid surface If the S/R probe or sipper probe tip does not descend to the liquid surface, follow the steps below: 1 Are there bubbles on the liquid surface? o

If yes, go to step 2.

o

If no, go to step 3.

2 Eliminate the bubbles in the sample container with an applicator stick. 3 Did the probe tip touch something during descent? o

If yes, go to step 4.

o

If no, go to step 5.

4 Remove the obstacle. 5 Is the sample cup upright? o

If yes, go to step 7.

o

If no, go to step 6.

6 Position the sample cup correctly in the upright position. 7 If the S/R probe or sipper probe tip still does not descend to the liquid surface, call Technical Support.

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Instrument troubleshooting

Results do not print automatically If results do not print automatically, follow the steps below: 1 Is the printer switched on and online? o

If yes, go to step 3.

o

If no, go to step 2.

2 Switch the printer on. 3 Is the Connected selected in the Utility > Document Setting window? o

If yes, go to step 5.

o

If no, go to step 4.

4 Select Connected in the Utility > Document Setting window. 5 Is automatic printing selected on the Automatic Printout Setting window? (automatic printout can be set for Calibration Data, Control Results, STAT Samples, and Routine Samples) o

If yes, go to step 7.

o

If no, go to step 6.

6 Specify the correct automatic printing settings. 7 Call Technical Support.

Bubbles in syringes If you see bubbles in either the S/R syringe or sipper syringe, follow the steps below: 1 Perform S/R pipetter prime (item 7 on the Maintenance Items list) or sipper pipetter prime (item 6 on the Maintenance Items list), or both primes if bubbles are seen in both syringes, from Utility > Maintenance. Choose Parameter and type 10 in the Prime Cycles text box. 2 If there are still bubbles in the syringe, repeat this process for the appropriate syringe. 3 If bubbles remain in the syringe after the second pipetter prime, call Technical Support.

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Chemistry troubleshooting When troubleshooting a problem, open the Print screen (using the Print global button), choose Utility tab, and print an alarm list. Use this list to assist you with troubleshooting.

False measurements This section suggests the actions to take in the following situation: o

Values out of measuring range

Values out of measuring range Problem

Possible causes

Actions/Prevention

Values out of measuring range (values below the lower detection limit or values above the measuring range). o

Foam on sample.

o

Foam on assay or system reagents.

o

Foam on controls.

o

Reagent pack stressed (storage or transport conditions not as recommended, for example, temperature and upright position).

o

Air bubbles in the system water container.

o

Dirty gripper (deposits contaminate the reaction mixture in the vessels).

o

Unstable system table.

o

Incorrect sample container used.

o

Have you handled the reagents, calibrators, and controls according to the package inserts?

o

Empty the system water container and refill with fresh distilled or deionized water and 35 mL of SysWash, pouring carefully to avoid creating air bubbles.

o

Have you performed recommended maintenance?

o

If you are still experiencing problems, contact Technical Support.

Drift Problem Possible causes

The control or sample shows drift over a period of time. o

Evaporation or incorrect storage conditions of reagent packs, ProCell, CleanCell, and controls.

o

Reagent packs are not at the correct temperature.

o

Recommended calibration frequency not followed.

o

Recommended handling of controls or samples not followed (for example, stability and evaporation).

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Chemistry troubleshooting

Actions/Prevention

o

Have you handled the reagents, calibrators, and controls according to the package inserts?

o

Have you performed recommended maintenance?

o

If you are still experiencing problems, contact Technical Support.

Erratic test results Problem Possible causes

Actions/Prevention

The test results obtained are erratic. o

Foam on sample or controls.

o

Foam on assay or system reagents.

o

Reagent pack stressed (storage or transport conditions not as recommended, for example, temperature and upright position).

o

Incorrect sample container used.

o

Have you handled the reagents, samples and controls according to package inserts?

o

Have you performed the recommended maintenance?

o

If you are still experiencing problems, contact Technical Support.

Assay calibration This section suggests the actions to take in the following situations: o

Calibration cannot be performed

o

Duplicates are out of limits

o

Monotony or minimum acceptable difference are not fulfilled

o

Missing values

o

Values are out of limits

o

Calibration factor is out of limits

Calibration cannot be performed Problem Possible causes

Actions/Prevention

The calibration cannot be performed. o

Calibration not selected in the software.

o

Reagent pack or calibrator not on board.

o

Calibrator expiration date exceeded.

o

Calibrator vial barcode or calibrator lot-specific barcode card not read, or wrong calibrator barcode card is used.

o

The calibration data link is not available for the current reagent pack and CalSet combination.

o

Vials Cal1 and Cal2 not on same rack, or empty space between calibrator vials.

o

Diluent not on board (for example, CA15-3).

o

Check the barcodes of calibrator vial, calibrator barcode card, and reagent pack. Is the barcode damaged, or not in the correct position?

o

Wipe off the dust on the surface of the barcode reader.

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o

Dry the calibrator vial if it is wet.

o

Check calibrator position for manually assigned positions.

o

Check if calibrator lot installed.

o

If you are still experiencing problems, contact Technical Support.

Duplicates are out of limits Problem Possible causes

Actions/Prevention

The calibration is not released because duplicates are out of limits. o

Possible causes in connection with calibrator or reagent handling: O

Foam on calibrator or assay reagents.

O

Calibrator handling not as recommended.

o

Air bubbles in the system water container.

o

Have you handled the reagents, calibrators, and controls according to the package inserts?

o

Empty the system water container and refill with fresh distilled or deionized water and 35 mL of SysWash, pouring carefully to avoid creating air bubbles.

o

Perform a new assay calibration (new CalSet).

o

Have you performed recommended maintenance?

o

If you are still experiencing problems, contact Technical Support.

Monotony or minimum acceptable difference are not fulfilled Problem Possible causes

Actions/Prevention

The calibration is not released because the monotony has not been fulfilled. o

Calibrator not transferred to the correct barcoded calibrator vials (for example, content of bottle Cal1 transferred to vials Cal1 and Cal2).

o

Non-barcoded vials were incorrectly placed on the sample rotor or rack.

o

Have you handled the reagents, calibrators, and controls according to the package inserts?

o

Perform a new assay calibration (new CalSet).

Missing values Problem Possible causes

Actions/Prevention

The calibration is not released because of missing values. o

Possible causes in connection with calibrator handling: O

Foam on calibrator

O

Empty calibrator

O

Insufficient volume of calibrator or calibrators

o

Second calibrator level is missing.

o

Calibrators are not in consecutive positions.

o

Have you handled the reagents, calibrators, and controls according to the package inserts?

o

Perform a new assay calibration (new CalSet).

o

If you are still experiencing problems, contact Technical Support.

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Values are out of limits Problem

Possible causes

The calibration is not released because of values below the minimum signal (valid for quantitative and qualitative assays), or the signal difference between vials Cal1 and Cal2 or the maximum signal is out of limits (valid for qualitative assays only). o

o

Actions/Prevention

Possible causes in connection with reagent handling: O

Reagent pack not within allowed stability after opening.

O

Reagent pack expiration date exceeded.

O

Reagent pack stressed (storage or transport conditions not as recommended, for example, temperature and upright position).

O

Reagent pack not at correct temperature.

O

Foam on assay or system reagents.

Possible causes in connection with calibrator handling: O

Calibrators not within allowed stability after opening or reconstitution.

O

Calibrator expiration date exceeded.

O

Calibrator handling not as recommended.

O

Calibrator not transferred to the correct barcoded calibrator vials (for example, content of bottle Cal1 transferred to vials Cal1 and Cal2).

O

Calibrator not at correct temperature.

O

Foam on calibrator.

o

Have you handled the reagents, calibrators, and controls according to the package inserts?

o

Perform a new assay calibration (new reagent pack or new CalSet).

o

Have you performed recommended maintenance?

o

If you are still experiencing problems, contact Technical Support.

Calibration factor is out of limits Problem

The calibration is not released because the calibration factor is out of limits. This problem is only valid for quantitative assays, and applies to reagent pack calibration only.

Possible causes

o

o

Possible causes in connection with reagent handling: O

Reagent pack not within allowed stability after opening.

O

Reagent pack expiration date exceeded. (Only for non-barcoded vials. Usually the system does not process expired calibrators.)

O

Reagent pack stressed (storage or transport conditions not as recommended, for example, temperature and upright position).

O

Reagent pack not at correct temperature.

O

Foam on assay or system reagents.

Possible causes in connection with calibrator handling: O

Calibrators not within allowed stability after opening or reconstitution.

O

Calibrator expiration date exceeded.

O

Calibrator handling not as recommended (stability and evaporation).

O

Calibrator not transferred to the correct barcoded calibrator vials (for example, content of bottle Cal1 transferred to vials Cal1 and Cal2).

O

Calibrator not at correct temperature.

O

Foam on calibrator.

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Actions/Prevention

o

Have you handled the reagents, calibrators, and controls according to the package inserts?

o

Perform a new assay calibration (new reagent pack or new CalSet).

o

Perform a new lot calibration.

o

Have you performed recommended maintenance?

If you are still experiencing problems, contact Technical Support.

Recovery of controls Problem Possible causes

The control values are out of range. o

o

o

Actions/Prevention

Possible causes in connection with control handling: O

Controls not at correct temperature.

O

Control not within allowed stability after opening or reconstitution.

O

Control expiration date exceeded.

O

Foam on controls.

O

Control handling not as recommended (for example, incorrect deionized water volume for reconstitution).

Possible causes in connection with reagent handling: O

Reagent packs not at correct temperature.

O

Reagent packs not within allowed stability after opening.

O

Reagent pack expiration date exceeded.

O

Reagent packs stressed (storage or transport conditions not as recommended, for example, temperature and upright position).

O

Foam on assay reagents or system reagents.

Possible causes in connection with calibrator handling: O

Recommended calibration frequency not followed.

O

Calibration not performed correctly.

o

Have you handled the reagents, calibrators, and controls according to the package inserts?

o

Use another control vial.

o

Perform a new reagent pack calibration (new reagent pack and CalSet).

o

Have you performed recommended maintenance?

o

If you are still experiencing problems, contact Technical Support.

Intra assay precision Problem Possible causes

Actions/Prevention

The intra assay precision is outside the expected range. o

Reagent packs or sample not at correct temperature.

o

Foam on assay or system reagents.

o

Air bubbles in the system water container.

o

Have you handled the reagents, calibrators, and controls according to the package inserts?

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o

Empty the system water container and refill with fresh distilled or deionized water and 35 mL of SysWash, pouring carefully to avoid creating air bubbles.

o

Have you performed recommended maintenance?

o

If you are still experiencing problems, contact Technical Support.

Inter assay precision Problem Possible causes

Actions/Prevention

The inter assay precision is outside the expected range. o

Reagent packs or sample not at correct temperature.

o

Foam on assay reagents.

o

Reagent pack stressed (storage or transport conditions not as recommended, for example, temperature and upright position).

o

Calibration not carefully performed.

o

Recommended calibration frequency not followed.

o

Air bubbles in the system water container.

o

Have you handled the reagents, calibrators, and controls according to the package inserts?

o

Empty the system water container and refill with fresh distilled or deionized water and 35 mL of SysWash, pouring carefully to avoid creating air bubbles.

o

Have you performed recommended maintenance?

o

If you are still experiencing problems, contact Technical Support.

System to system variance Problem Possible causes

Actions/Prevention

There is a deviation of control and samples when measured with different systems. o

Recommended handling of assay, system reagents, calibrators, or controls not followed (for example, stability and evaporation).

o

Calibration not carefully performed.

o

Have you handled the reagents, system reagents, calibrators, and controls according to the package inserts?

o

Have you performed recommended maintenance?

o

If you are still experiencing problems, contact Technical Support.

Method comparison Problem

Possible causes

There is a deviation of method comparison when compared with competitors (internal, external). o

Different standardizations (reference material).

o

Different antibodies (for example, HCG on Elecsys).

o

Different methods (such as RIA or ELISA).

o

Different units (conversion factor between units sometimes different from competitor to competitor).

o

Different sample material ± anticoagulants.

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Actions/Prevention

o

Recommended calibration frequency not followed.

o

Calibration handling not as recommended.

o

The number of samples is too small, or all results are within a very limited range compared to the measuring range of the assay.

o

Reagent lot to reagent lot variance.

o

System to system variance.

o

Have you handled the reagents, calibrators, and samples according to the package inserts?

o

Have you performed recommended maintenance?

o

If you are still experiencing problems, contact Technical Support.

Auto dilution not possible Problem

Possible causes

An auto dilution is no longer possible, even though corresponding diluent is on board. The Elecsys Universal Diluent bottle may have been incorrectly placed on the reagent rotor. If this happens, the MODULAR ANALYTICS barcode is read instead of the cobas e 411 analyzer (Elecsys) barcode. This is because the barcode reader is outside the reagent rotor on the cobas e 411 analyzer, whereas it is inside the reagent rotor on the MODULAR ANALYTICS. If the wrong barcode is read, it will not be possible to use this diluent for auto dilution on the cobas e 411 analyzer. The reason for this is that if the same lot number is scanned again by the barcode reader, it will not be accepted by the system because the information will already be in the database.

Actions/Prevention

Take care to position the Elecsys Universal Diluent or Elecsys Diluent MultiAssay Reagent Pack carefully, so that the cobas e 411 analyzer (Elecsys) barcode is read, and not the one for the MODULAR ANALYTICS.

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11 Data alarms Table of contents

Data alarms

This chapter describes the data alarms generated by the cobas e 411 analyzer, the cause of each alarm and suggested remedies.

In this chapter

Chapter

11

Introduction ................................................................................................................... D–33 List of data alarms ......................................................................................................... D–34 Data alarms .................................................................................................................... D–35 >AB .......................................................................................................................... D–35 >Curr ....................................................................................................................... D–35 Test ........................................................................................................................ D–36 Data Review screen, on the Test Review window (Workplace > Data Review > Test Review), and on printed reports. If a data alarm occurs, a symbol (also referred to as flag) is attached to the measurement result. These flags are strings of three to six characters which are all explained in this chapter. Instrument alarms are indicated by the Alarm button (global button) on the System Overview screen as well as by an audible alarm. If an alarm occurs, the Alarm button lights up. Its color indicates the alarm level: yellow indicates warning level, red indicates emergency stop. In case of an alarm, choose the Alarm button to open the Alarm window. This window provides an alarm list and descriptions and remedies for each listed alarm.

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List of data alarms

List of data alarms The following table displays the data alarms and their presentation (flag) on screens and reports.

Flag

Alarm

>AB

AB level range over

>Curr

Measuring cell current range over

Test

Measurement range (upper)

AB Alarm Description

Cause Remedy

AB level range over During run preparation, the ProCell count level was out of range (the ProCell signal was 400 counts). The ProCell has evaporated or may be contaminated. 1 Check for bubbles in the ProCell bottle. 2 Try a new bottle of ProCell. 3 Rerun all flagged samples. 4 If the error recurs, call Technical Support.

>Curr Alarm Description Cause Remedy

Measuring cell current range over The measuring cell current was out of range when checked during run preparation. Abnormal measuring cell condition. 1 Choose Utility > Maintenance > Maintenance and perform the Liquid Flow Cleaning maintenance item (1 cycle). e See Liquid Flow Cleaning on page C-9

2 Rerun all flagged samples. 3 If the alarm recurs, call Technical Support.

Test Alarm Description

Cause

Remedy

Measurement range (upper) The measured value is above the upper limit of the measuring range encoded on the reagent pack barcode. The sample concentration is above the upper limit of the measuring (reportable) range. Rerun using the recommended dilution and check the measured value.

Maintenance > Maintenance and perform the System Reset maintenance item. 3 If the alarm recurs call Technical Support.

Cal.E Alarm Description

Calibration result abnormal There is no valid calibration data in the system for this reagent pack (that is, a new assay on the analyzer). Cal.E appears on each control and patient sample for the affected test until the problem is resolved.

Cause

Remedy

o

There is no valid calibration stored in the system.

o

Previous calibration data was used to calculate this result.

o

The attempted calibration failed.

1 Check the calibrators and reagents and repeat the calibration. 2 Set new calibrators and a reagent pack if necessary, and repeat the calibration. 3 Rerun the samples after a successful calibration is obtained.

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Data alarms

Calc.? Alarm Description Cause Remedy

Calculation not possible The denominator becomes zero in calculation. Internal calculation error occurred. Rerun the sample.

Cancel [Power Fail/Power Off Cancel] Alarm Description Cause

Remedy

Power failure - operation stopped. The test concerned was cancelled by power fail or power off. Test cancelled due to power failure or power off. Sample(s) may be excluded; refer to printout. Correct condition and rerun any excluded samples.

Cancel [E.STOP Cancel] Alarm Description Cause Remedy

E.STOP - operation stopped. The test concerned was cancelled by E.Stop. Test cancelled due to E.Stop. Sample(s) may be excluded; refer to printout. Correct alarm condition and rerun any excluded samples.

Cancel [STOP Cancel] Alarm Description Cause Remedy

Stop - operation stopped by operator. Operation stopped by operator or the test concerned was cancelled by Stop. Operation stopped by operator. Sample(s) may be excluded; refer to printout. Correct alarm condition and rerun any excluded samples.

Cancel [P.STOP/A.STOP Cancel] Alarm Description Cause Remedy

P.STOP/A.STOP - operation stopped. The test concerned was cancelled by P.Stop. Test cancelled due to P.Stop or A.Stop. Sample(s) may be excluded; refer to printout. Correct alarm condition and rerun any excluded samples.

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Cancel [S.STOP Cancel] Alarm Description Cause Remedy

S.STOP - operation stopped. Operation stopped by operator or the test concerned was cancelled by S.Stop. Sampling stopped due to S.Stop. Sample(s) in process will be completed. Correct alarm condition and continue with samples to be processed.

Cancel [Recovery Cancel] Alarm Description Cause

Remedy

Instrument handling error - determination not performed. Determination not performed. Test cancelled due to instrument handling error. Sample(s) may be excluded; refer to printout. Rerun any excluded samples.

Cancel [Sample ID Error Cancel] Alarm Description Cause

Remedy

Sample ID Error Cancel. Sample ID scanning was not successful. The sample ID that was scanned just before pipetting is different from the ID scanned during the sample scan. All tests for the sample were cancelled. Verify that sample tubes are not removed until the Status screen reads “Proc” or “Complete”.

CarOvr Alarm Description Cause Remedy

Potential microparticle carry over The signal level of this sample is low. Carryover from the previous sample may have occurred. Rerun the sample. Exception: Do not rerun the sample if either qualitative assays are negative or quantitative assays are below the lower limit of the clinical decision.

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Data alarms

ClcT.E Alarm Description Cause

Remedy

Calc Test Error. Data flag is attached if one or both of two calculated tests are flagged "no result". A data alarm has occurred for a test needed in the calculation. It is not valid for the alarm “Calculation not possible” (Calc.?). 1 Correct the data alarms for the test used in the calculation. 2 Rerun the samples after a successful calibration has been obtained.

Cell.T Alarm Description

Cause

Remedy

Abnormal measuring cell temperature Measuring cell temperature is out of range. The system performs an initial check 30 minutes after start-up and checks the temperature continuously thereafter. o

Radiation of heat does not work normally.

o

The room temperature is out of range.

1 Check the fans at the rear are operating normally and are free of obstructions. 2 Check that room temperature is between 18°C and 32°C. 3 If the alarm recurs, call Technical Support.

Curr.E Alarm Description Cause

Remedy

Measuring cell current check The measuring cell current check failed. ProCell liquid level check failed. The ProCell volume is inadequate for run preparation. 1 Replace the low volume bottle with a new bottle. 2 Rerun all flagged samples. 3 If the error recurs, call Technical Support.

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FacA Alarm Description Cause Remedy

Instrument factor A reset The instrument factor A was set to 1.0 by the system. For information only. Repeat BlankCell calibration.

H Alarm Description

Outside of expected value (upper) For patient samples, the calculated concentration is greater than the upper limit of the expected value range. For control samples, a concentration exceeded the 3 SD values specified on QC > Install.

Cause

Remedy

o

The sample concentration is higher than the expected value.

o

A proper expected value range is not specified.

1 Follow laboratory protocol for high samples. 2 Specify a proper range under Expected Values in Utility > Application > Range.

Sample status alarm

NOTICE

This alarm DOES NOT cause an incomplete sample status alarm.

Inc.T Alarm Description

Cause

Remedy

Incubator temperature Incubator temperature is out of range. The system performs an initial check 30 minutes after start-up and checks the temperature continuously thereafter. o

Radiation of heat does not work normally.

o

The room temperature is out of range

1 Check the fans at the rear are operating normally and are free of obstructions. 2 Check that room temperature is between 18°C and 32°C. 3 If the error recurs, call Technical Support.

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Data alarms

L Alarm Description

Outside of expected value (lower) For patient samples, the calculated concentration is less than the lower limit of the expected value range. For control samples, a concentration was less than the 3 SD values entered on QC > Install.

Cause

Remedy

o

The sample concentration is lower than the expected value.

o

A proper expected value range is not specified.

1 Follow laboratory protocol for low samples. 2 Specify a proper range under Expected Values in Utility > Application > Range.

Sample status alarm

NOTICE

This alarm DOES NOT cause an incomplete sample status alarm.

ReagEx Alarm Description Cause Remedy

Reagent expired An expired reagent was used for the measurement. For information only. Not applicable

Reag.F Alarm Description Cause

Remedy

Assay reagent film detected; Diluent film detected; Pretreatment film detected Foam or film was detected above reagent. o

Foam or film was detected above reagent.

o

Foam or film was detected above diluent.

o

Foam or film was detected above pretreatment reagent.

o

Foam or film was detected above ProCell or CleanCell.

Remove foam or air bubbles with an applicator stick and rerun the affected sample.

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Reag.H Alarm Description Cause

Remedy

Assay reagent hovering; Diluent hovering; Pretreatment hovering. The reagent probe hovers over the reagent rotor. A premature LLD signal was detected during reagent pipetting, causing the S/R probe to hover over the reagent pack. 1 Dry the lids on the affected reagent pack. 2 Check for bubbles in the affected reagent pack. If bubbles are present, remove with an applicator stick. 3 Choose Utility > Maintenance > Maintenance and perform the System Reset maintenance item. 4 If the error recurs, call Technical Support.

Reag.S Alarm Description Cause

Remedy

Assay reagent short; Diluent short; Pretreatment reagent short. The liquid level cannot be detected in the reagent pack. o

There is no reagent in the reagent pack, the assay reagent volume is insufficient.

o

The diluent volume is insufficient.

o

The pretreatment volume is insufficient.

1 Verify that reagent, diluent, and pretreatment volumes are adequate. Replace the low reagent, if necessary, and perform a reagent scan after the replacement. 2 If adequate reagent volumes are present, verify volumes on the Reagent screen. 3 Resume operation and rerun the sample. 4 If the alarm recurs, call Technical Support.

Reag.T Alarm Description

Cause

Remedy

Abnormal reagent rotor temperature Reagent rotor temperature is out of range. The system performs an initial check 30 minutes after start-up and checks the temperature continuously thereafter. o

Radiation of heat does not work normally.

o

The room temperature is out of range.

1 Verify that the reagent rotor cover is securely in place. 2 Check the fans at the rear are operating normally and are free of obstructions. 3 Check that room temperature is between 18°C and 32°C.

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Data alarms

4 If the alarm recurs, call Technical Support.

Samp.C Alarm Description Cause

Remedy

Sample clot A sample clot is detected during aspiration. o

The sample volume is insufficient.

o

There are clots in the sample.

1 Check sample volume, and fill the required volume in the sample container as necessary. 2 Check the sample for fibrin. Remove any clots. 3 Rerun the sample.

Samp.S Alarm

Sample short e See Samp.C on page D-44

Description Cause

Remedy

The sample volume is insufficient or missing. o

The sample is missing from the sample disk.

o

The sample volume is insufficient.

1 Load the sample if it is not already on board. 2 Check sample volume, and fill the required volume in the sample container as necessary. If the sample appears to be sufficient, contact Technical Support. 3 Rerun the sample.

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SLLD.E Alarm Description Cause Remedy

Sample LLD abnormal The S/R probe does not start liquid level detection (LLD) or LLD is not completed. o

The S/R probe is dirty or wet.

1 Clean and dry the S/R probe, and resume measurement. 2 If the alarm recurs, call Technical Support.

SLLD.N Alarm Description Cause Remedy

Sample LLD noise The S/R probe detects noise. There are bubbles in the sample container. 1 Remove the bubbles with an applicator stick. 2 Rerun the sample.

SysR.S Alarm

System reagent short

Description

Liquid short signal is detected, or the liquid level cannot be detected in the ProCell reservoir.

Cause

The volumes in the system reagent bottles (ProCell and CleanCell) are insufficient.

Remedy

1 Check levels in ProCell and CleanCell bottles, and replace as necessary. 2 Resume operation and rerun the sample. 3 If the alarm recurs, call Technical Support.

SysR.T Alarm Description

Cause

System reagent temperature ProCell/CleanCell temperature is out of range. The system performs an initial check 30 minutes after start-up and checks the temperature continuously thereafter. o

Radiation of heat does not work normally.

o

The room temperature is out of range.

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Data problems without an alarm

Remedy

1 Check the fans at the rear are operating normally and are free of obstructions. 2 Check that room temperature is between 18°C and 32°C. 3 If the alarm recurs, call Technical Support.

SysR.U Alarm Description Cause Remedy

System reagent temperature unstable. System reagent temperature is unstable. ProCell/CleanCell temperature was unstable. ProCell and CleanCell must be at 28°C before operation. Either bring the reagent to temperature, or place it on the analyzer approximately 15 minutes before operation.

Data problems without an alarm This section outlines issues which may occur, but that do not generate an alarm.

Drift of result data Cause

Remedy

o

Concentration or deterioration of sample

o

The standard solution is concentrated or has deteriorated.

Avoid leaving the sample in the sample cup for a long time.

Erroneous operation Cause

Remedy

o

Neglect of preliminary or periodical check.

o

Fibrin contained in sample or dust contained in reagent.

o

The sample container that was used was not of a recommended type.

1 Carry out preliminary or periodical check according to the specified procedure. 2 Eliminate fibrin or dust. Be sure to check the sample and reagent before setting them. 3 Use the recommended sample container.

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Poor reproducibility Cause

Remedy

o

A maintenance item is overdue.

o

Deterioration of reagent or precipitation of insoluble matter.

o

Deterioration of ProCell or CleanCell.

o

Poor distilled water quality.

o

Reagent handling was not done as recommended.

1 Carry out daily checks and periodic maintenance according to the specified maintenance procedure. 2 Set a new reagent pack. 3 Set new ProCell or CleanCell bottles. 4 The water quality must be 10 μS/cm (microsiemens per cm) or less. 5 Use the recommended reagent handling.

Result data at high level Cause

Remedy

o

Concentration of control or sample.

o

Deterioration of ProCell or CleanCell.

o

The reagent, control, and standard handling was not done as recommended.

1 If the sample has been loaded for more than two hours, repeat the analysis with a fresh sample. 2 Set a new ProCell/CleanCell bottle. 3 Use the recommended reagent, control and standard handling.

Result data at low level Cause

Remedy

o

Reagent handling was not done as recommended.

o

Deterioration of ProCell or CleanCell.

1 Use the recommended reagent handling. 2 Set a new ProCell or CleanCell bottle.

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Instrument problems without an alarm

Trouble for each test Cause Remedy

Improper preparation or management of a control (high value, low value). 1 Prepare a new control. 2 Set a new reagent pack.

Trouble for all tests Cause

Remedy

o

Intrusion of air bubbles into S/R or sipper syringe (poor reproducibility).

o

Liquid leakage from the sample or reagent syringe coupling (poor reproducibility).

o

Deterioration of ProCell or CleanCell.

o

The electrode of the measuring cell is contaminated or has deteriorated (high value or low value).

1 Carry out maintenance. 2 Set a new ProCell or CleanCell bottle. 3 Choose Utility > Maintenance > Maintenance and perform the Liquid Flow Cleaning maintenance item. e See Liquid Flow Cleaning on page C-9

4 Call Technical Support.

Instrument problems without an alarm In the case of an instrument problem but no alarm, call Technical Support. This is the last page of Part D

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Appendix

E

12

Direct drain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E–3

13

Technical support information form . . . . . . . . . . . . . . . . . . . . E–13

cobas e 411 analyzer

12 Direct drain Table of contents

Direct drain

The direct drain is an optional system that routes the flow of the waste solution directly into a prepared container or the facility drainage. The liquid waste container is not installed if the direct drain option is used.

In this chapter

Chapter

12

Safety information ............................................................................................................ E–5 Overview ............................................................................................................................ E–6 Drain tube ................................................................................................................... E–7 Specifications .............................................................................................................. E–8 Pre-routine operation ...................................................................................................... E–8 Maintenance ..................................................................................................................... E–9 Clean the direct drain flow path .............................................................................. E–9 Clean the direct drain waste container .................................................................E–10 Troubleshooting .............................................................................................................E–12 The direct drain reserve tank is full .......................................................................E–12

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Table of contents

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12 Direct drain Safety information

Safety information Before operating the direct drain, it is essential that you read and understand the warnings, cautions, and safety requirements contained in this section and the General safety information chapter of the cobas e 411 analyzer documentation. e See General safety information on page A-3

Figure E-1

Safety label location: Direct drain reserve tank

For essential safety information, see Infection by waste solution on page A-9 Contamination of the environment by liquid and solid waste on page A-10.

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Overview

Overview The direct drain is an optional system that routes the flow of the waste solution directly into a prepared container or the facility drainage. A reserve tank is provided in front of the ProCell and CleanCell reagents to store the waste solution temporarily if a problem arises with the flow. The liquid waste container is not installed if the direct drain option is used. Installing the direct drain option or any container size change must be undertaken by Roche service personnel.

A

B

A

Tank inlet

Figure E-2

B

Reserve tank

Direct drain reserve tank

The reserve tank can hold up to one liter of waste solution. The analyzer will enter S. Stop mode and issue an alarm when the liquid reaches a predetermined level (approximately 500 mL). A tube, the drain tube, extends from the right side of the analyzer to an external waste tank.

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12 Direct drain Overview

Drain tube The drain tube must be placed as shown in the examples in Figure E-3. The examples show correctly installed drain tubes, running horizontally or sloping downwards. The tube must not be bent, pinched, placed above the level of the drain port, or form a U-bend along any part of its course.

A A

Drain port

Figure E-3

Correct drain tube placement

Figure E-4 shows incorrectly installed drain tubes. The tube on the left runs upward from the drain port. The tube on the right is forming a U-bend. In both cases, flow stagnation will occur. NOTICE

Flow stagnation Flow stagnation or leaks may occur if the drain tube is bent or pinched. Check the condition of the drain tube every day. Do not connect any extension to the drain tube as this may cause flow stagnation.

NOTICE

Drain tube blockage If the reserve tank gets full, the analyzer will enter S. Stop mode. Check if the drain tube is bent or pinched and ensure that it is correctly placed. If you cannot find the cause, or if the tube is clogged, contact a Roche service representative. Do not try to unclog the drain tube.

Figure E-4 NOTICE

Incorrect drain tube placement

Use approved disposable gloves Hands shown in photos and illustrations in the Operator’s Manual and online Help are to be considered as hands covered with approved disposable gloves.

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Pre-routine operation

Make sure that the end of the tube does not touch the liquid surface in the external waste tank, as this may stop the flow (Figure E-5).

B

A A

Figure E-5 NOTICE

B

Incorrect

Correct

Incorrect and correct placement of drain tube end in the external waste tank

Prevent clogging To prevent clogging in the flow path, pour approximately 100 mL distilled or deionized water into the reserve tank inlet after each day's operation.

Specifications Liquid waste: Table E-1 NOTICE

Rate: 1.0 L/hr (1.2 L/100 tests) Liquid waste

Liquid waste capacity Ensure the external waste tank or plant have sufficient capacity for your operational requirements.

Pre-routine operation The following procedures must be carried out as part of the pre-routine operation if a direct drain is installed. e See Pre-routine operation on page B-16

a To check the external direct drain system 1 Inspect the level of the external waste tank. 2 Empty and rinse the external waste tank if there is a possibility of insufficient capacity to hold the effluent from the next processing session. 3 Inspect the drain tubing to ensure that no part of it slopes upward or forms a U-bend.

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12 Direct drain Maintenance

Maintenance This section provides step-by-step instructions for performing essential maintenance procedures on the direct drain system. e See Maintenance on page C-5

Clean the direct drain flow path If your analyzer is equipped with the direct drain system, crystallization from waste solution in the flow path could cause clogging. To prevent crystallization, clean the flow path after each day's operation. Planning

Recommended frequency: Operator time:

Approximately five minutes

System time:

None

Precautions:

The operation switch must be off. Wear suitable protective gloves.

Table E-2

Materials

Daily, at the end of operations

Planning considerations

Item

Syringe (minimum capacity 100 mL) with attached tubing Distilled or deionized water (approximately 100 mL) Table E-3

Required materials

Before performing this maintenance action, observe the following safety precautions: o

Infection by samples and associated materials on page A-9

o

Infection by waste solution on page A-9

o

Contamination of the environment by liquid and solid waste on page A-10

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Maintenance

a To clean the direct drain flow path 1 Introduce approximately 100 mL of distilled or deionized water into the reserve tank inlet by using a syringe with attached tubing. 2 Check that the water flows freely through the drain tube. If the flow stagnates, check the condition of the drain tube.

A

B

A

B

Tank inlet

Figure E-6

Reserve tank

Checking the direct drain flow path

Direct drain tube clogged

NOTICE

If the tube is clogged, contact your Roche service representative. Do not try to unclog the tube yourself.

Clean the direct drain waste container The direct drain waste container must be checked and emptied as necessary. Planning

Recommended frequency:

As needed

Operator time:

Approximately five minutes

System time:

None

Precautions:

The analyzer must be in Standby or switched off at the operation switch.

Table E-4

Materials

Planning considerations

Item

70% isopropyl alcohol Paper towels Germicidal agent, pH 9 (optional) Table E-5

Required materials

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12 Direct drain Maintenance

Avoid using bleach. WARNING

Do not add bleach or strong alkaline disinfectants (pH > 9.5) to the liquid waste container. Disinfectants combined with the contents of the liquid waste could cause potentially harmful fumes. Before performing this maintenance action, observe the following safety precautions: o

Infection by samples and associated materials on page A-9

a To clean the liquid waste container for direct drain (if fitted) 1 Put the analyzer into Standby mode. 2 Remove the window plate (4 screws) to gain access to the container. 3 Empty the container and rinse it thoroughly with water. Keep paper towels at hand to mop up any drips or spillages. 4 If the inside of the container appears to be dirty, rinse it with 70% isopropyl alcohol. Follow with a thorough water rinse. 5 Wipe the outside of the container with a paper towel. 6 Use a paper towel to wipe the area around the container. 7 Optional step: Add the appropriate volume of a germicidal agent of pH 9 (as directed in its product labeling) to the container. 8 Position the drain tubing with no upwards slope or U-bend. e See Direct drain on page E-3

9 Replace the container window plate.

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Troubleshooting

Troubleshooting This section provides general information about troubleshooting problems with the direct drain system.

The direct drain reserve tank is full If the direct drain reserve tank is full, as indicated by the corresponding alarm, and operation has stopped, follow the steps below: 1 Is the drain tube placement correct? For correct placement of the tube, see Drain tube on page E-7. o

If yes, go to step 4.

o

If no, go to step 2.

2 Place the tube correctly. 3 Check for an overflow of liquid waste solution on the instrument. 4 Call Technical Support.

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Technical support information form Day______________Month______________Year__________ Customer information

Account number or customer ID number Contact name and telephone number General information

Instrument serial number Version number of the reference data file Version number of internationalization CD Description of the problem, including relevant alarm(s) and alarm code numbers When the problem first occurred (for example, after reagent pack lot change) Whether the problem was observed with just one system or with all systems Copies of the original instrument printouts (send by fax or e-mail) Perform backup function using Utility > Maintenance > Media Write window Problem category (check box)

Immunoassay problems

m Complete the details below for Immunoassay problems

Software problems

m Complete the details below for Software problems

Instrument problems

m Complete the details below for Instrument problems

Immunoassay problems

Details

Whether the problem was observed with just one assay or with all assays Whether the problem was observed with just one sample type or with all sample types Control results and ranges from the last few controls performed Sample type used (serum, plasma, urine, or saliva) Sample tube used (manufacturer, diameter, primary or secondary tube) Elapsed time between specimen collection and measurement Patient results (with correlation results, if relevant) Test(s) affected and other tests on board Whether SysWash was added to the system water container Table E-6

Technical support information form

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Catalog number, lot numbers, and expiration dates of reagents Catalog number, lot numbers, and expiration dates of calibrators and controls Calibration signals (HetIA) from the last few calibrations performed Details of reagent/calibrator/control handling (such as calibration frequency, stability, ambient temperature, foam, and evaporation) When the reagent was loaded onto the system When liquid flow cleaning was last performed Software problems

Details

The version of software installed The lot and sequence numbers of the reagent packs The language currently installed Software version number and date of installation The date the instrument was initially installed Instrument problems

Details

Instrument serial number Rack or disk system Instrument maintenance and service history Whether a host or a Pre-Analytic Systems Manager (PSM) was connected Number of tests performed Other instrument or maintenance related information Error code and error description Print out of the alarm trace report Table E-6

Technical support information form (continued)

This is the last page of Part E

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F

Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F–3

cobas e 411 analyzer

Glossary 2-dimensional barcode - AssayCup disposal opening

Glossary This glossary is a compendium you can use to look up the meaning of technical terms related to the cobas e 411 analyzer.

Numbers 2-dimensional barcode A type of barcode on reagent packs, calibrators, and control barcode cards or sheets. These matrix barcodes, which use PDF417 symbology, contain more information than traditional linear barcodes.

A accuracy The absolute deviation of a result from a predefined target value in percent or absolute units. action key A key, on the keyboard, that has a predefined function. For example, START, STAT, or ALARM. adequate sample volume A starting sample volume that exceeds the combination of the volume of sample that will be required for assays and the residual volume specified for the container that holds the sample. air purge The removal of air from the hydraulic tubing between the probes (reagent or sample) and their respective pipetters. alarm A visual or audible operator notification of any system irregularity. alarm code The classification number for an alarm. Each alarm has a major classification code and a minor classification code. ALARM global button A button used to display the Alarms global menu. Detailed information is displayed in the Detail window. alarm level A level that identifies the source and severity of a problem. There are five levels: data alarm, warning, sampling stop, stop, and emergency stop. A system uses the alarm levels to determine how to respond to any problem that generates alarms. A-Line A section of the input buffer where samples or racks are placed for processing.

aliquot Portion of sample material pipetted into any secondary cup. alphanumeric sorting The listing of information, in a printout or on a screen, in a pre-defined order by letters or numbers. analyte The constituent in the sample that is to be determined. analytical instrument A device or a combination of devices used to carry out an analytical process. analytical sensitivity The lowest analyte concentration that can be distinguished from zero. It is calculated as the concentration of two or three standard deviations above the lowest standard used in the master calibration. Roche Diagnostics uses master calibrators to determine the lower detection limit (LDL). analytical unit The hardware unit containing the sampling, reagent, incubator, gripper, and measuring cell components. application sheet A document that lists all the information necessary to perform a specific assay or test on an instrument. arbitrary units A result classification using 1+, 2+, and 3+ classes instead of numerical concentration results. ASCII Abbreviation for American Standard Code for Information Interchange. A character code used by most computers. aspiration station A position located next to the incubator where an AssayCup containing the reaction mixture is placed for aspiration into the measuring cell by the sipper probe. assay 1. A specific test. 2. The process of measuring a substance. AssayCup A plastic vessel that is used to hold the assay reaction mixture. An alternative term is reaction vessel. AssayCup disposal opening The opening to the left of the incubator where used AssayCups are disposed into the solid waste tray.

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cobas e 411 analyzer

AssayTip - BCR

AssayTip A disposable pipette tip made of black, conductive plastic. AssayTips are used by the sample/reagent (S/R) probe. assigned value (Roche-defined) Roche-defined concentration for calibrator material that is encoded on the calibrator barcode card or transfer sheet. See also target value. ASTM Abbreviation for American Society for Testing and Materials, a US organization that develops and proposes industry standards. ASTM protocol A host interface protocol according to the American Society for Testing Materials standard. automatic calibration 1. Automatic time-out calibration. A calibration of a parameter performed if a specified time interval expires. The calibration can be defined for each method separately. 2. Automatic calibration after bottle or lot exchange. A calibration performed if a new bottle or lot is registered. The calibration can be defined for each method separately. 3. Automatic calibration on QC failure. A calibration request is generated by the system if a QC value is outside a pre-defined range. The calibration can be defined for each method separately. automatic QC A quality-control function that takes sample measurements by moving the dedicated QC rack to the sample line from the rack rotor. Automated Download (ADL) A service that provides the information necessary for analysis, for example analytical parameters or concentration information from the data center. ADL is a cobas TeleService application. See also TeleService. automatic start-up The automatic start of instrument or system initialization and priming functions without operator intervention. See also maintenance pipe.

B backup 1. The saving of data onto supplementary storage media such as disks or tape. If such data is required again but is no longer available from the main storage (instrument hard disk), it can be restored from a backup copy. 2. An internal instrument-specific process to establish the data for a backup; only used in a case of routine instrument break down. See also restore.

backup operation A function that performs measurement by using only analysis unit when a trouble occurs in the rack sampler and a rack cannot be conveyed. bandwidth 1. A network's capacity to carry data. 2. Also used in optics to characterize a photometer. barcode A numeric or alphanumeric code used on sample tubes, racks, and reagent packs to identify the samples, racks, and reagents. Different barcode standards are available. See also barcode type. barcode card A card bearing a barcode that encodes either assigned values (calibrator card) or target values and ranges (control card) for assays. barcode labeler A pre-analytical instrument or module for the automatic labeling of sample tubes. barcode reader The device that reads the code from sample or reagent barcode labels or reagent pack barcodes. This term also applies to handheld barcode readers. barcode scan The process of reading barcode information into the memory of an instrument. barcode type Typical sample barcode types used in the IVD industry are Code39, NW7 (Codabar), ITF, and Code 128. batch mode/operation 1. A computing technique in which a number of data transactions are collected over a period of time and aggregated for sequential processing at a given time. 2. The operation of an analytical instrument in such a way that one or more analytical processes must be completed for a sequence of samples before the next sequence can be started. batch registration A function to register the testselection information of the same combination as the sample ID of the specified realm in registration of routine samples. baud A unit of transmission speed equal to the number of discrete conditions or signal events per second. BC Abbreviation for barcode. BC card scan A scan to read the information from the two-dimensional calibrator barcode card or control barcode card. BCR Abbreviation for barcode reader.

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Glossary biohazardous - calibration trace

biohazardous A classification used to identify material that poses a health threat, for example something contaminated with biological material. bit The smallest addressable unit of computer memory. blank cell Calibration procedure for ECL instruments performed by Roche Diagnostics service staff.

C calculated result See calculated test. calculated test A test result calculated from different individual analytical methods with a given formula such as ratio A/B.

B-line The transport line that moves racks from the STAT port, or A-line to the sample barcode reader and then to the sampling position.

calibration The set of operations that establish, under specified conditions, the relationship between values indicated by the analytical instrument and the corresponding known values of an analyte.

blocked result A result can be blocked by the operator (B) or the system (S). A blocked result is printed or uploaded to the host with the respective flag (B or S).

calibration curve A plot of known concentrations of calibrators against their signals established during calibration.

boot Also booting-up. The process that causes computer software to start performing programmed instructions, usually from ROM.

bottle set 1 The set of ProCell/CleanCell bottles that occupies positions 1 and 2 (position on the right) in the system reagent compartment.

calibration factor 1. In electrochemiluminescence: one of the six calibration quality criteria used to verify the validity of a calibration. This criterion is only used for reagent pack calibrations. It is derived by comparing two different calibrations. A factor of 1.0 is achieved when two calibrations are equal. A successful calibration has a factor of 0.8-1.2. 2. In clinical chemistry: the slope of a calibration curve (only applicable to linear calibrations). One of the factors used to create a calibration curve (S1Abs, K, A, B, C).

bottle set 2 The set of ProCell/CleanCell bottles that occupies positions 3 and 4 (position on the left) in the system reagent compartment.

calibration frequency A specified interval at which an assay should be calibrated. Typically found on reagent package inserts.

bound/free separation The physical separation of reagent or sample that is bound to a solid phase (the microbeads) from free reagent or sample.

calibration function Also known as calibration mode. The type of calibration (for example, Rodbard function, linear function, or cutoff function). A mathematical model that describes the relationship between a signal and a concentration in the calibration curve. See calibration curve.

bottle A glass or plastic container with a lid used for liquids. Some bottles may be used directly on systems.

Bracketing A mode of operation in which patient results have to be surrounded by successful control results before they are released. bridging principle One of three test principles that can be applied to ECL immunoassays. It is used to detect antibodies (such as IgG, IgM, or IgA) in the sample. See also competitive principle, sandwich principle. buffer The temporary storage of data by any software in a defined section of the computer memory. button A button is found on a screen or pop-up window. It can be touched either to initiate an action or to move to a different screen.

calibration monitor A function that prints the measured absorbance of the standard solution and the calibration factors, at the time of calibration, for every measurement item. calibration quality criteria Criteria applied to the auto-validation of every calibration on the analyzer. calibration trace A function for checking day-to-day changes by saving calibration results for the same item.

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cobas e 411 analyzer ®

calibration type - cobas link data station

calibration type 1. The kind of standard solution used in calibration including 1-point, 2-point, span, and full. The factors updated differ depending on which type of calibration is performed. 2. In electrochemiluminescence: lot calibration (L-Cal) or reagent pack calibration (R-Cal). 3. In clinical chemistry: bottle or cassette calibration. calibration validation Analysis, performed by software, to check a calibration data set against specific criteria encoded in a reagent barcode. Calibration validation results are: successful or failed. calibration verification A procedure required by HCFA and CLIA. Calibration verification is the assaying of calibration materials in the same manner as patient samples to confirm that the calibration of the instrument kit or test system has remained stable throughout the laboratory's reportable range for patient test results (for example, Elecsys CalChecks). calibrator 1. A material of known composition or properties that can be presented to the analytical instrument for calibration purposes. 2. The test portion or test solution used for calibration of an analytical procedure. calibrator code The identification number of the standard solution in calibration measurement. capacitance The property of an electrical nonconductor that provides the basis for liquid level detection in the S/R (sample/reagent) probe and sipper probes. The probes carry a high-frequency, low-voltage electrical charge. Frequency and electrical charge characteristics are altered and sensed when the probe touches liquid. CapTwist An opener to aid the manual removal of ProCell and CleanCell bottle caps. carryover A process by which materials are carried into a reaction mixture where they do not belong. CC Abbreviation for clinical chemistry and for CleanCell cell holder A container holding the electrode in the electrode measurement unit. channel 1. The number of reagent positions on an analytical instrument. 2. A specific reagent position.

check sum The result of a mathematical procedure to validate the integrity of a set of data. circuit breaker 1. The main power switch on the instrument. It controls the power to the Peltier elements and, consequently, controls the temperature in the reagent rotor, incubator, and measuring detection unit. 2. A switch that controls power to the Peltier elements, thereby controlling the temperature in the reagent rotor, incubator, system reagent compartment, and measuring cell CleanCell An auxiliary reagent used to rinse the tubing system and measuring cell after each measurement and condition the electrodes in the measuring cell. cleaning solution See wash solution. Clean-Liner A disposable liner used in the solid waste tray of Elecsys 2010/cobas e411. client/server A network in which computer processing is distributed among many individual PCs (clients) and a more powerful, central computer (server). C-line The transport line that receives racks from the B-Line via the output buffer. clot detection 1. A device built into the pipetting system to detect clots and to avoid false pipetting. 2. The procedure of detecting a clot. cobas® A modular range of in vitro diagnostics analyzers from Roche Diagnostics/Hitachi HighTechnologies. cobas e pack The name given to a reagent cassette used on cobas e systems and Elecsys systems. cobas® link The infrastructure of network connections that enables cobas TeleService to exchange information between the Roche service network and a customer's laboratory. cobas® link data station A specific desktop computer, located in the laboratory, that has been configured to act as a gateway between Roche systems and the Internet. As well as providing a communication link, the data station also stores data and documentation for assay processing and can provide a data archive.

check digit A verification number used in barcodes and software. Roche Diagnostics F-6

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Glossary ®

cobas TeleService - data alarm

cobas® TeleService The set of software applications that use cobas® link to exchange service information between Roche service network and a customer's laboratory. cobas TeleService provides remote monitoring and diagnosis, hotline support, and software and documentation updates.

control material A material used to assess the performance of an analytical procedure or part of an analytical procedure. Also called the control sample.

Code39 A barcode type for sample tubes that can be read by the barcode reader.

control SD value The acceptable variation SD value of a quality control sample.

coefficient of variation A statistical measure used to describe imprecision. Often abbreviated to CV.

control unit An external PC or printer by which an analytical system is controlled. The control unit also serves as the user interface.

communication The exchange of data between different computers. compensated test A test that has the result modified by a formula that takes account of known or defined interference factors. competitive principle One of three test principles that can be applied to ECL immunoassays. It is used to detect analytes of low molecular weight (for example, FT3). See also bridging principle, sandwich principle. Complete A sample status found on several screens indicating that all requested determinations have been completed. conditioning The process of letting serum-type liquid flow through the flow path before electrolyte measurement. consumables A generic term for items that are used during test processing and must be replaced on a regular basis by the operator. Examples of consumables include AssayCups, printer paper, and reaction cells. consumables area The area of an analyzer where the consumables, such as AssayCups and AssayTips, are stored.

control name The name of a control material, for example PreciControl Universal.

correction item A function that corrects the measurement result of one item by using figures or the measurement result of other tests. CPU The Central Processing Unit of the system or computer. cross-reactivity The reaction of an antibody with an antigen other than the one that elicited its formation as a result of shared, similar, or identical antigenic determinants. CSF Abbreviation for cerebral spinal fluid. A sample type for clinical analysis. cumulative QC The accumulated data and associated statistics of individual QC data. cup-on-tube The placement of a smaller secondary sample container (for example a Hitachi Cup) on top of a primary sample tube. CV See coefficient of variation. cycle The instrument time interval during which pipetting or measurement can be carried out. cyclic QC Controls run at fixed intervals.

container See sample container.

D

continuous access The instrument function that enables an operator to permanently access the sample loading area of an analyzer.

DAT Abbreviation for Drugs of Abuse Testing. The abbreviation DAU is also used.

continuous loading/access The ability to load (or unload) sample or reagents at any time.

data alarm An alarm that occurs if a measurement result or calibration result is abnormal.

control ID The abbreviated name for a control material, for example PC U1 or PC TSH. Control IDs are used on software screens and windows where limited space prevents the use of longer names. Roche Diagnostics Operator’s Manual · Version 2.1

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data disk - duplicate limit

data disk 1. The floppy disk or Zip Disk used to store patient data. 2. The floppy disk contains files that enable communication between the analyzer and the user software. The files might include analyzer-specific adjustment files, assay reference tables, or calibration data. data entry field A field on the software screen where a user can enter or edit data. data field A field on the software screen that contains information. There is no user access to this type of field. data flags Printed or displayed alarms or flags that indicate unusual reaction or instrument conditions, for example insufficient sample or reagent or substrate depletion database A defined section of the computer memory where all instrument, assay, and patient-relevant data are processed and stored. database management system A software system that provides the necessary procedures and programs to collect, create, organize, store, retrieve, and maintain databases or data files with security and integrity. DAU Drug of Abuse in Urine. The old term for DAT or Drugs of Abuse Testing. DB Abbreviation for database. DBMS Abbreviation for database management system. default value A set value registered in advance (initial setting). deionized water supply A device that produces purified water. demographics Patient-related data such as name, date of birth, and gender. detection unit A hardware unit comprising a photomultiplier tube, Peltier elements, flow-through measuring cell, magnet drive assembly, and an amplifier circuit board. determination The process of quantifying analytes. deviation A value minus its reference value. deviation of duplicate measurements See duplicate limit.

Diagnostics The status that is required to perform system diagnostics and hardware error tracking actions. The field service engineer may request a system to go to Diagnostics mode to perform such procedures. The system may require initialization afterwards to resume normal operation. diluent (DIL) A liquid agent used to reduce the concentration of a sample. dilute waste solution A waste solution resulting after rinsing with water. dilution factor A software preset or manually assigned dilution ratio that is used by the analyzer to perform a requested dilution. disk position A dedicated position on the reagent or sample disk. dispense The process of adding sample material or reagents by the pipetter probe into a reaction vessel or cell dispenser technology A technique in which a rinsed probe transfers reagents into a reaction vessel and the reagent container is directly connected with the pipetter probe. disposable Typically a plastic tip, vessel, or cuvette that is discarded after a single use. DMS Abbreviation for data management system. document (to ...) The process of printing or uploading a result report to a LIS. down time The period of non-operation between an instrument failure and the resumption of operation. download The process of receiving data from Roche by a network link. dual value method A mode of expression of the control chart in real-time quality control. For X-axis and Y-axis, measure simultaneously the average and the standard deviation of control of a low value and a high value, and display them by X and Y coordinates, respectively. duplicate limit A calibration quality criterion. For a successful calibration, duplicate measurements must be within a specified limit.

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Glossary dynamic range - GUI

dynamic range The reportable range of an assay. This range extends from the lower detection limit to the limit of linearity.

E e-barcode (e-BC) An electronic barcode received via cobas® link. ECL Abbreviation for electrochemiluminescence, the detection technology used on immunoassay analyzers. electromotive force (EMF) The physical principle that provides the basis for electrolyte measurement. emergency stop An instrument alarm level that immediately stops all instrument functions. endpoint assay An analytical technique taking measurements after a reaction is completed or has been halted. error handling A process during which the analyzer attempts to recover from an error condition (for example, an AssayTip is not picked up from the magazine). If the analyzer cannot successfully recover from error, an alarm is issued and the instrument is halted. E-stopped A status indicating that the system has performed an emergency stop (E. Stop). This could be due to hardware failure or because any of the safety devices have requested an emergency stop. The system requires either complete power off, or at least initialization, to resume normal operation. expected range The pre-defined range of test result values expected for a defined group of healthy patients or materials. Also known as normal range or reference range.

F FDA Abbreviation for Food and Drug Administration. A US government-controlled agency responsible for regulating diagnostic and pharmaceutical products. FIFO Abbreviation for first in, first out. A logistic process for handling goods or data. filter A process that sorts data for viewing, documenting, or printing according to pre-defined criteria first registration The date and time when a reagent pack or sample was successfully recognized by the barcode reader for the very first time fixing knob A screw lid that fixes the reaction disk. flag An identifier used to call an operator's attention to a result. float sensor A sensor that detects the surface of solutions. The sensor position moves up and down depending on the surface level. front access panel A door behind which the floppy disk drive and solid waste tray are located. function key 1. An analyzer button that an operator can use to control various analyzer actions (for example, moving specific items), depending on the current operational mode. 2. Any one of a set of keys (F1 to F12), located along the top of the keyboard, used to enter a specific command. functional sensitivity The concentration of an analyte at which a pre-defined level of imprecision is obtained.

G

expected value A value for a test result that can be considered as a normal result.

global action key A keyboard key that remains active on all screens

expiration date Also called the expiry date. The end of a period until which Roche Diagnostics guarantees product claims for its reagents, calibrators, and controls.

global button A button that allows access to the global software screens and that can be used at any time.

extended dynamic range The measuring range for an assay at its highest dilution.

gripper A technical device that transports AssayCups and AssayTips to their required destination on the analyzer (for example, to the incubator). The gripper moves in three directions (X, Y, and Z). GUI Abbreviation for graphical user interface.

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hardware (HW) - IVDD

H hardware (HW) The mechanical and electrical components of a computer and its peripheral devices. Het IA Abbreviation for heterogeneous immunoassay. HIA Abbreviation for homogeneous immunoassay. HIS Abbreviation for Hospital Information System. A computer system that manages the hospital's overall information processing. Sometimes also (incorrectly) referred to as LIS (Laboratory Information System). Hitergent 1. A detergent, with antibacterial properties, that can be added to the reaction bath where it acts as a surfactant, reducing the formation of foam. 2. A surfactant diluted for use in some cleaning procedures. home position The position to which a certain part of the instrument returns on reset. The start position of a mechanism. homogeneous immuno assay (HIA) An analytical technique employing antigens and antibodies. An HIA uses assay protocols similar to clinical chemistry without a bound-free separation (for example, latex assays). host communication Data exchange with a clinical laboratory information system (LIS). host computer 1. A computer used for overall management and control of the computer network. 2. A clinical laboratory computer that stores and processes patient requests and results. A host is able to communicate with analytical instruments. host interface protocol A technical description that defines data transfer between a host computer and an analytical system. See also ASTM protocol.

I

in vitro qualitative assay A determination outside the living body of constituents of a substance without regard to quantity. in vitro quantitative assay A determination outside the living body of constituents of a substance with regard to a specified number or amount. incubator A temperature controlled aluminum block for AssayCups on cobas and Elecsys instruments. initial BlankCell procedure The calibration procedure for ECL instruments performed by Roche Diagnostics service staff when setting up an ECL-based analyzer for the first time. Initialization Also known as Initializing. The operational mode of an analyzer that occurs immediately after switching on and during which the instrument prepares itself for operation. input buffer A section of an analyzer where samples are loaded by using a rack or rack tray. See also rack loader. instrument alarm A displayed alarm that indicates an unusual instrument condition such as an abnormal reaction bath temperature or a mechanical malfunction. Instrument Manager Typically, PC-based software that controls or supervises one or more analytical instruments. interface See parallel interface, user interface. Internet A publicly available, internationally interconnected system of computers. intranet An access-restricted network used internally in an organization. inventory control The real-time monitoring of the quantities of all consumable items (liquid and solid) on an analyzer.

IC Abbreviation for immunochemistry.

IVD Abbreviation for in vitro diagnostics. A diagnostic procedure performed outside the living body with specimen body fluid.

ID A unique alphanumerical set of data that clearly identifies a patient sample or rack. Also known as an ID no.

IVDD Abbreviation for In Vitro Diagnostics Directive. A set of rules and regulations laid out by the EU commission to ensure the safety of IVD products.

IA Abbreviation for immunoassay.

In-pack calibrator A calibrator provided with the associated reagent pack. Roche Diagnostics F-10

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Glossary lab automation - mean

lab automation The process of managing the entire analytical process with minimal operator intervention.

log on The procedure of gaining access to a system by entering a user name and, if required, a password. Also known as log in or logon. The reverse procedure is known as log out or log off.

LDL Abbreviation for lower detection limit. See analytical sensitivity.

Log on button A button used to gain access to a system. See also log on.

level detection A check for the availability of sufficient liquid in a container.

lot calibration (L-cal) A mandatory calibration when a new lot of reagents is introduced to an analytical instrument.

L

LIMS Abbreviation for Laboratory Information Management System. See LIS. linear barcode A conventional one-dimensional barcode with limited data capacity. liquid level detection (LLD) The ability of an analytical instrument to sense liquid by using the sample or reagent probes. liquid waste container A reservoir for liquid waste generated by an analyzer; its size and location vary between instruments. LIS Abbreviation for Laboratory Information System. A clinical laboratory computer system for the management and storage of patient data and results. An LIS communicates with analytical instruments. list box On a screen, a type of box that lists available choices: for example, a list of available tests from which the operator can choose. loader A section of an analyzer that hold trays and racks waiting to be processed. Also known as the input buffer or the A-line. loading capacity The maximum number of samples that can be loaded onto the input buffer. local area network (LAN) A computer network covering a limited area, such as an office or a home. log file A set of data, typically stored in the control unit, that traces instrument-related or operator-related activities such as maintenance. log off The procedure of terminating access to a system. Also known as log out or logoff. The reverse procedure is known as log on or log in. Log off button A button used to terminate access to a system. See also log off.

M maintenance item A maintenance procedure performed by the system or the operator. maintenance key A button for position movement, used for a probe position check. maintenance procedure A procedure that must be performed on a regular basis (for example daily, weekly, monthly, or every three months) to secure reliable operation of the analyzer. manual dilution An off-system, pre-analytical step performed by laboratory staff to reduce the analyte concentration in a sample. master calibration A reference standardization that uses master test kit reagents and certified reference standard material (for example, World Health Organization reference material) measured at Roche Diagnostics. The resulting reference standard curve, typically using 10 to 12 points, is the basis for the production of in-house master calibrators. master curve A lot-specific master calibration curve (n=5 or 6) measured at Roche Diagnostics using lotspecific test-kit reagents and master calibrators. The shape of the lot-specific master curve is characterized by a four-parameter Rodbard function. The data characterizing this curve is stored in the lot-specific reagent barcode. Lot-specific, calibrator-assigned values (CalSet-assigned values) are read from the lot-specific master calibration curve and encoded in the CalSet calibrator barcode transfer sheet. Material Safety Data Sheets (MSDS) Documents that list components of chemical solutions and precautions for the handling and disposal of the solutions. mean The sum of values divided by the number of values.

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measure point - order

measure point Time at which absorbance reading is taken and used to calculate results.

nozzle A pipe or tube of varying diameter that is used to direct or modify the flow of a liquid or gas.

measuring cell A flow-through device that is used to generate light during the ECL detection process.

nozzle head The cover of the device holding multiple rinse nozzles.

measuring range See reportable range.

nozzle seal A seal placed between the tube and the probe to connect them.

message In computing, a defined set of alphanumeric data that transfers information from computer to computer or from an analytical instrument to the operator. microbead mixer A paddle that thoroughly mixes the microbead reagent to ensure resuspension before use. microbeads Paramagnetic streptavidin-coated microparticles used as the solid phase for heterogeneous immunoassays in the Elecsys format. Microcup A secondary sample cup made by Hitachi with a small dead (residual) volume microparticle See microbead. minimum sample volume The smallest volume of sample required to ensure faultless sample aspiration. In practice this is the sum of the residual volume plus the volume required to assay all requested tests. minimum signal In ECL assays, a calibration quality criterion. A pre-defined, assay-specific signal level that must be achieved to establish a valid calibration. missing value In ECL assays, a calibration quality criterion. All calibrator values must be available for a successful calibration. mode Defined states of operation of an analyzer. monochromatic Absorbance measurement at one (primary) wavelength. monotony of curve A calibration quality criterion. All measured calibrator values must fall in either ascending (sandwich or bridging principle) or descending (competition principle) order for a successful calibration.

N nipple A part for connecting a syringe and the flow path.

nozzle tip A tip attached to the end of the nozzle that sucks up rinse water remaining after a reaction cuvette has been washed.

O onboard 1. A technical device or function that is part of the analytical instrument and can be used by the instrument at any time. 2. The availability of reagents and consumables on an analytical instrument for use at any time. one-way serial processing The sample flow and processing along a single, serial process lane that allows no bypass function and no rerun. online help On-screen documentation that a user can request in a context-sensitive manner and search for any given term. online support A service that supports the preparation for analysis and maintenance management by exchanging information over networks. See also TeleService. open request See pending requests. Operate The operational mode during which the instrument processes samples. operating system A software program that controls all basic functions of a computer (for example, Windows, Linux, and Palm OS). operator The person who uses and controls the analytical instrument or a computer system. operator ID An alphanumeric ID that a system uses to identify a particular operator. Access levels differ for operators, administrators, and service personnel. order Also called a request. A test selected for a specific sample or control.

normal range See expected values. Roche Diagnostics F-12

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Glossary order date/time - PreClean

order date/time A field used to maintain the arrival date and time of an order in the laboratory. The date/time data may be entered manually or transmitted by LIS protocols. order ID The sample order identification refers to a number of sample tubes (one or more specimen types) of a given patient collected for a panel of different tests. Typically, the sample order identification is printed on order sheets. output buffer A section of an analyzer to which samples are moved on completion of the analytical process and from which they can be unloaded. See also rack unloader.

P parallel interface The interface (Centronics type) through which the analyzer can be connected to an external printer. paramagnetic A property of microbeads that do not exhibit magnetic forces themselves but are capable of becoming magnetic in the presence of a magnet or magnetic field used with ECL technology. parameters A set of criteria or definitions used to establish how an assay is performed. Examples of parameters include sample and reagent volumes and incubation times and temperatures. Such information is typically encoded on reagent barcode labels and cannot be changed by the operator. password A form of authentication that uses secret data to control access to a resource. patient ID A set of alphanumeric data that unmistakably identifies a particular patient. For example, a social security number and a sample ID. PC Abbreviation for personal computer. pending requests Also known as open requests. The results for a sample are partially available; other tests have not yet been performed or completed. photomultiplier A light-sensitive tube that collects and amplifies emitted photons from the ECL reaction and converts them into an electric signal. photon A quantum of electromagnetic energy, having both particle and wave behavior, that carries the light emitted from the ECL reaction.

pinch valve A valve that pinches the suction tube and switches the flow path. pipette (to …) The process of aspirating and dispensing sample and reagents performed by an appropriate probe. pipetter A device used for pipetting a fixed amount of sample or reagent. pipetter technology A technique used to transfer reagents into a reaction vessel by using a rinsed probe or a disposable tip. Reagents are aspirated from cassettes, bottles, or reagent packs. pipetting station The part of the analytical unit that performs all pipetting-related functions. See also pipetter. plunger A rod that connects with the drive arm and moves up or down, depending on the pipetting amount. pop-up window A small screen window that contains additional information or additional options required for making entries or decisions. positive displacement Water in the pipetter that is displaced by the plunger during an aspirate/dispense cycle. The positive displacement is equal to the amount of sample or reagent that is aspirated or dispensed by the probe. post-analytical The sample management process, typically storage and archiving, after results have been reported. potentiometric assay An assay in which analytes (for example Na, K, or Cl) are measured in millivolts by ionselective electrodes. Power Up The system status while it is loading programs, performing self-checks, and so on. PPID Abbreviation for Positive Patient Identification. pre-analytical The sample management process before the analytical phase. Pre-analytical processing typically involves actions such as sorting and aliquoting. precision The closeness of agreement between independent test results obtained under prescribed conditions. PreClean A phosphate buffer used to wash and resuspend the microbeads during the pre-wash step.

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pre-dilution - reaction mixture

pre-dilution A dilution step performed before samples are analytically processed on the analyzer. PRID Abbreviation for Positive Reagent Identification. primary tube The original tube containing the sample that has been drawn from the patient. ProCell An auxiliary reagent that transports the reaction mixture from an AssayCup into the measuring cell and aids the ECL detection technology. profile A user-defined set of test requests. protocol 1. A convention or standard that controls or enables the connection, communication, and data transfer between two computing end points. Protocols can be implemented by hardware, software, or a combination of the two. 2. A set of rules that guides how an activity should be performed. PSD Abbreviation for Primary Sample Distribution. PSID Abbreviation for Positive Sample Identification. PSM Abbreviation for Pre-Analytic Systems Manager, which is PC-based software in a laboratory environment connected to one or more pre-analytic or analytical devices. A PSM controls the sample flow and offers extended data management. PSM is not available in the United States of America. pushing spring A part that presses down a seal piece.

Q

qualitative measurement The determination of a substance without calculating and reporting the concentration with a qualitative assay. quantitative assay An assay that allows the determination of the concentration of an analyte. quantitative measurement The determination of a substance by calculating and reporting the concentration with a quantitative assay. query download A communication process between instrument PC and LIS by which a pre-defined data set is transmitted upon request of the analytical instrument.

R RA Abbreviation for random access. rack A sample carrier device that holds sample cups or primary sample tubes (including those for routine samples, standard and washing solutions, quality control, STAT, and rerun samples). The rack enables easy transportation on analytical systems and modules. Different rack types can be distinguished by their differing colors. rack circuit breaker A technical device controlling the power to the rack sampler unit. rack ID A barcode (one-dimensional or binary) at the end of the rack that unmistakably identifies the rack. rack loader Area where the racks to be measured are set. Fifteen racks can be placed on the rack tray and 15 racks on the input buffer.

QA Abbreviation for quality assurance. All the planned and systematic activities implemented within the quality system and demonstrated as needed to provide adequate confidence that an entity will fulfill requirements for quality.

rack pusher arm An arm, located on the A-line, for pushing racks.

QC Abbreviation for quality control. The operational techniques and activities that are used to fulfill requirements for quality.

rack tray A device for carrying many racks and setting them in a rack sampler.

QC error An alarm generated in real-time when either a low value or a high value exceeds the limit of 3SD (QC error 1) or 2.5 SD (QC error 2). qualitative assay An assay that does not allow the determination of the concentration of an analyte, only a classification of the analyte (for example, positive or negative).

rack sampler A sample-handling device that presents sample tubes in racks to the analytical unit.

RAM Abbreviation for random access memory. Semiconductor memory devices used in computers. RAM content gets lost when a computer is switched off. random access The ability of an analytical instrument to process requests from a patient sample in any order. reaction mixture The mixture of reagents and sample material.

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Glossary reagent - ruthenium complex

reagent A composition of chemicals used to determine the concentration of substances in body fluid. reagent cap open/close mechanism A mechanism that prevents evaporation by automatically opening and closing the reagent pack caps before and after reagent pipetting or operation. reagent compartment A temperature controlled section on an analyzer that holds reagents and diluents. reagent pack A complete set of physically combined and ready-to-use reagent bottles for Elecsys assays. The components of a reagent pack cannot be interchanged with another reagent pack. See also cobas e pack. reagent pack calibration (R-cal) The calibration performed when a reagent has been onboard the analyzer more than 25 hours. A reagent pack calibration is valid for one specific reagent pack. reagent pack number A unique number on the reagent bottle label that identifies each reagent pack. reagent probe The probe used to transfer or pipette reagents from the reagent bottles to the reaction cells. reagent probe rinse station The area located between the reagent rotors and reaction disk where reagent probes are rinsed both internally and externally with water. reagent rotor The device in the reagent compartment into which the reagent bottles are placed. reagent rotor cover The cover that closes the reagent compartment. reagent rotor position One of the multiple positions on the reagent rotor. reagent scan A scan of the reagent rotor to read information from the reagent barcode into the analyzer and to update the inventory. real time The display of information on the monitor at the very moment a change to such information occurs. recalibration The repetition of a calibration. repeat The performance of the same test on a sample again under unchanged conditions.

reportable range The range of results that can be reported for the assay. It stretches from the lower detection limit to the high end of the calibration curve. request See order. Reset The operational mode during which the analyzer sets and aligns all mechanical parts to their home positions. residual volume The volume at the bottom of the sample tube that cannot be aspirated by the sample probe. restore The command for reloading data from a storage device onto the hard disk of the analyzer PC. See also backup. result The value reported by an analytical device during or after the assay of a sample or control. Result Date/Time The instrument fills the result date and time after the result calculation is finished. It may be maintained by work area management systems for information purpose. rinse bath See reagent probe rinse station. rinse nozzle A nozzle that supplies or drains the detergent or water used for rinsing a reaction cell. rinse station A technical device that cleans disposable tips or probes with deionized water or cleaning solutions to avoid contamination and carryover. Rodbard function A mathematical algorithm used to convert measured signals into concentrations. It uses four parameters to define the shape and the position of the calibration curve. ROM Abbreviation for read-only memory. Semiconductor memory devices used in computers. ROM content remains when a computer is switched off. ruthenium A rare metallic chemical element of the platinum group that is employed in electrochemiluminescent (ECL) reactions. ruthenium complex [Ru(byp)32+] Nhydroxysuccinimide (NHS) ester. This chemical complex is employed in the ECL detection technology.

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S. Stop button - signal

S S. Stop button Abbreviation for sampling stop. A button used to stop the pipetting of samples but process already scheduled activities without interruption or loss. S.Stop Abbreviation for sampling stop. A system operating mode in which no new samples are pipetted, but samples already pipetted will be completed without interruption or loss. S/R arm See sample/reagent arm. S/R pipetter See sample/reagent pipetter. S/R probe See sample/reagent probe. S1Abs The absorbance of standard solution 1. The displayed value is 10 000 times greater than the actual measured absorbance. sample blank A control solution used to determine the background measurements (such as turbidity or color) of test samples. sample container A device in which sample material is transported or stored, typically made from glass or plastic. Also referred to as sample tube. sample cup A small container that is used for samples and also for calibrator and control material. A sample cup can be placed either on specific racks, other inserts, or on sample tubes. Compared to a sample tube, a sample cup allows the use of smaller liquid volumes and so reduces the residual volume. sample disk A rotor into which sample containers are placed. sample ID A set of alphanumeric data that unmistakably identifies a particular sample. See also patient ID. sample probe The rinsed probe used to transfer sample material from the sample disks to the reaction cells. sample scan A scan of the sample disk to read the information from the primary sample tubes into the analyzer. sample splitting The act of making one or more aliquots from a primary or secondary specimen. sample tube A glass or plastic container for liquid samples to be used with the system. It may or may not

have a barcode label, which may be used for positive sample identification. A sample tube contains sample of one specific specimen (sample) type. sample type One of four types of sample that can be analyzed: serum, plasma, cerebrospinal fluid, or urine. The sample volume and normal value are settable for each type. sampling stop An instrument alarm level that indicates a problem with the sampling system. See also S.Stop. sandwich principle One of three test principles that can be applied to ECL immunoassays. It is used to detect higher molecular weight analytes, such as TSH. See also bridging principle, competitive principle. scan See barcode scan. scroll The action of moving through text or graphics (up, down, left, or right) to see parts of the file or list that cannot fit on the screen. scroll arrow An arrow on either end of a scroll bar that you use to scroll through the contents of the window or list box. scroll bar A bar that appears at the bottom or right edge of a window whose contents are not entirely visible. Each scroll bar contains a scroll box and two scroll arrows. scroll box In a scroll bar, the small box that shows the position of information currently in the window or list box relative to the contents of the entire window. SD Abbreviation for standard deviation. secondary tube A sample container of variable size into which aliquots are transferred sequence number A number automatically assigned to each sample by the analyzer and used to track samples and orders. Service The status that is required to perform a maintenance action. See maintenance item, maintenance procedure. shutdown The process of powering off an instrument. signal The emission of light converted into an electrical signal that is subsequently converted into an analyte concentration.

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Glossary sipper arm - target value

sipper arm A horizontally moving arm that holds the sipper probe. sipper pipetter A device, filled with deionized water, that uses positive displacement to aspirate and dispense from the sipper probe. sipper probe The probe that aspirates reaction mixture out of the AssayCup into the measuring cell. This probe also aspirates ProCell and CleanCell.

STAT application A special test application (for example, reduced incubation time) for STAT or emergency samples to achieve faster result reporting. See also STAT. STAT port Special entry area for STAT samples, which will be processed with priority. STAT sample Emergency sample. Results should be available within shortest possible time. See also STAT.

Sleep mode Also called sleeping. A mechanical and electrical status of an analytical instrument during which no immediate processing can be initiated by the operator.

status A general term used to refer to the current status of the system. Explicit terminology may be used to address sub-parts of the system status (such as analyzer status and printer status).

software A computer-operated program that processes data in a defined manner. Software is usually intellectual property of the software supplier or its licensee.

stop barcode A special barcode used on disk systems to halt sample scanning.

solid waste compartment A metal waste container holding a liner that collects discarded solid waste. solid waste tray A metal waste container holding a liner that collects discarded solid waste.

STOP button A button used to immediately stop all system operations, including test processing functions. The system may need special attention to resume its normal operation state. SW Abbreviation for software.

standard Traceable reference material used to create the master calibration curve.

SysClean An auxiliary reagent used for the periodic cleaning of the measuring cell.

standard deviation A statistic used as a measure of the dispersion or variation in a distribution of data.

system cleaning solution See wash solution.

standard rack A standardized transportation device for a maximum of five sample containers on Roche Diagnostics/Hitachi High-Technologies instruments. standard tray A metal device that holds and carries multiple standard racks and that can be placed directly in the sample reception area of an analyzer. Standby An operational mode of the analyzer during which power is on but no sample analysis or maintenance procedures are being performed. Start button A button used to start system operation (Operating status) and begin the pipetting of samples, measurement, and the result calculation process. Startup An operational mode of an analyzer, following power-on, during which the instrument prepares itself for operation. STAT Abbreviation for Short Turn Around Time. Terminology used by the medical clinical professionals to prioritize the processing of a sample in a laboratory.

system error 1. A calibration quality criterion that originates from a hardware failure while a calibration measurement is performed. 2. The general term for a case of instrument-related problems. system reagent A non-test specific reagent that is needed to perform testing on an analyzer. systematic error An error that is generated by a cause giving deviation to measured values. An alarm generated when control of a low value or a high value is changed in the same direction in real-time quality control. SysWash A system-specific agent used to avoid reagent carryover. It also prevents bacterial growth.

T target range The allowed range of recovery for an analyte in a control material. target value The mean of all participant responses after removal of outlying values.

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TDM - web tunnel

TDM Abbreviation for Therapeutic Drug Monitoring. technical limit The dynamic range of an assay. test code The abbreviated name for a test. This code is displayed on test buttons shown on software screens or windows. test principle A technique that serves as the basis for designing an assay to detect or quantify analytes. test protocol The sequence of test steps used to perform an assay (for example, volumes and timings). text box A box, on a screen, where a user can type information or a command. time-out calibration An instrument mode that automatically generates a calibration request after a predefined interval. tip See AssayTip. tip eject station An opening in the instrument housing through which AssayCups and AssayTips are discarded. touch screen An input device that allows the user to interact with the computer by touching the display screen. transaction The smallest unit of interaction between the two computers. One computer (a host computer or Instrument Manager) sends a message and a receiving computer returns a reply. tray indication light A light, at the left side of both the A-Line and C-Lines, that indicates the mode of operation.

U unit A chosen reference quantity of an analyte used to compare quantities of the same dimension (for example, mol/L, g/L, or U/L). upload The process of sending data to Roche by a network link. user See operator. user interface The part of a system exposed to a user. In a computer system, the user typically interacts with an operating system or with application software. With these the user interacts by using menus, icons, keystrokes, mouse clicks, and similar means.

V validation The process of checking results or data against defined rules or ranges in clinical laboratories. Validation can be against technical or clinical criteria. vessel See AssayCup. vial A small sample container with flip-top lid, mainly used for calibrator and control material.

W WAM Workarea management: PC-based software that controls and monitors sample tracking and offers extended data management for a defined workarea in a clinical laboratory environment. waste Anything discarded by the analyzer; waste can be liquid or solid.

trend An upward or downward tendency in data values after the exclusion of the random error and cyclic effects.

waste solution reservoir Container that collects reaction waste.

tripropylamine (TPA) One of two electrochemically active substances used in the ECL reaction.

water level sensor A sensor that monitors the water level of temperature controlled water.

turn-around-time 1. The time between the decision to perform a test and the time when the doctor receives the result and can act on it. 2. Inside the laboratory (Lab-TAT): Time between receiving a sample and sending out the validated result.

water supply tank A tank used to store ionexchanged water.

two-way processing A type of sample flow allowing two directions, typically a main lane to feed analytical modules with samples and a return line to handle rerun and reflex testing.

web tunnel A web service that transports encrypted data from a company network to a dedicated server application outside of the network.

water supply tube A tube for connecting a water supply tank and an analyzer.

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Glossary window - workarea consolidation

window An object displayed on a monitor. By using several windows, a user can handle multiple functions on a PC in parallel. A user can overlap, resize, or reposition windows. work list A report generated by an analytical instrument. A work list aids a user by listing calibrators, controls, and samples currently loaded on the sample disk. workarea consolidation The combination of separate workstations to produce one physical or logical workarea in a laboratory. This combination can be achieved through mechanics (a conveyor, for example), facilitated sample transfer (racks or trays), and data management. This is the last page of Part F

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G

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . G-3

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Index

Index Symbol Curr (data alarm), D-35 >Test (data alarm), D-36

A AB level check error (data alarm), D-36 AB level range over (data alarm), D-35 AB.E (data alarm), D-36 Abbreviations, 9 Abnormal reagent disk temperature (data alarm), D-43 Access levels – software screens, A-63 Activating sample reception mode, B-102 ADC abnormal (data alarm), D-37 ADC.E (data alarm), D-37 Alarm screen – reviewing, B-15 Alarms – system alarms, B-15 – types, D-5 A-Line (of rack sampler), A-70 Analyzer – components, A-67 – dimensions, A-33 – switching off, B-88 – unit, A-25 Analyzer compartments – cleaning, C-42, C-45 – removing condensation, C-17 Analyzers, A-31 Approvals – instrument, 3 Assay calibration – See calibration Assay reagent film detected (data alarm), D-42 Assay reagent hovering (data alarm), D-43 Assay reagent short (data alarm), D-43 AssayCup trays – replacing, B-29 – troubleshooting, D-19 AssayCups – disposal opening, A-86 – inventory, B-18 – tray positions, A-85 AssayTip trays – replacing, B-29

– troubleshooting, D-19 AssayTips – inventory, B-18 – tray positions, A-85 Assigning – calibrator positions, B-117 – control positions, B-117 Auto masking – activation, B-98 – apply to a test, B-98 Automatic Printout area options, B-86

B Barcode card – calibrator, A-45 – reading station, A-79 – scanning, B-32 Barcode labels – applying correctly, B-93 – calibrator, A-45 – control, A-45 – reagent, A-43 Barcode readers – rack, A-78 – sample, A-76 Barcodes – supported symbologies, A-37 – use of check digits, B-4 B-Line (of rack sampler), A-71 Boxes – list, A-60 – text, A-60 Bubbles in syringes, D-22 Buttons – global, A-62 – options, A-61 – standard, A-61 – types, A-61

C Cal.E (data alarm), D-37 Calc.? (data alarm), D-38 Calc.Test Error (data alarm), D-40 Calculated test – programming, B-106 Calculation not possible (data alarm), D-38 Calibration – assay troubleshooting, D-24

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Index

– auto masking, B-98 – measuring, B-35 – performing, B-30 – requesting, B-33 – validating results, B-38 Calibration result abnormal (data alarm), D-37 Calibration/QC Load List – daily operation, B-21 – loading calibrators, B-31 – loading controls, B-31 – printing, B-22 Calibrators – assigning positions, B-117 – barcode cards, A-45 – installing, B-109 – kits, A-44 – loading, B-31 – preparing, B-30 – scanning barcode card, B-32 – troubleshooting, D-11 Cancel [E.STOP Cancel] (data alarm), D-38 Cancel [P.STOP/A.STOP Cancel] (data alarm), D-38 Cancel [Power Fail/Power Off Cancel] (data alarm), D-38 Cancel [Recovery Cancel] (data alarm), D-39 Cancel [S.STOP Cancel] (data alarm), D-39 Cancel [Sample ID Error Cancel] (data alarm), D-39 Cancel [STOP Cancel] (data alarm), D-38 Canceling print jobs, B-126 Cap open/close mechanism, A-81 CarOvr (data alarm), D-39 Cell temperature (data alarm), D-40 Cell.T (data alarm), D-40 Changing – documentation settings, B-105 – QC violation settings, B-97 – sample disk mode, B-103 – test settings, B-95 Check – system alarms, B-15 Checking – liquid waste container, B-26 – system alarms, B-15 – system water container, B-25 Checks – power off, B-90 Circuit breaker – main, A-29 – rack sampler, A-30 ClcT.E (data alarm), D-40 Clean, C-42 CleanCell – cleaning compartments, C-42 – inventory, B-18 – preventing evaporation, B-89 – use, A-93

cobas e 411 analyzer

Cleaning – analyzer surfaces, C-48 – CleanCell compartments, C-42 – liquid flow path, C-25 – liquid waste container, C-38, E-10 – microbead mixer, C-40 – ProCell compartments, C-42 – reagent rotor and compartment, C-45 – rinse stations, C-22 – sample/reagent probe, C-16 – sipper probe, C-18 – system water container, C-36 Clean-Liner – solid waste, A-89 C-Line (of rack sampler), A-72 cobas© link – analyzers, A-31 – platform, A-31 – TeleService-Net, A-31 Color scheme – Work Flow Guide, B-17 Compartments – See analyzer compartments Components – measuring area, A-90 Configuring – sample reception mode, B-101 Consumables – loading during operation, B-79 – replacing, B-22 Consumables area, A-84 Contact addresses, 3 Containers – direct drain, E-3 – liquid waste, A-88 – solid waste, A-89 – system water, A-87 Continuous loading – multiple disk, B-63 – rack, B-63 – single disk, B-61 Control – kits, A-45 Control unit, A-49 – components, A-51 – specifications, A-41 Control values, editing, B-115 Controls – assigning positions, B-117 – loading, B-31 – measuring, B-35 – preparing, B-30 – scanning barcode card, B-32 – troubleshooting, D-11 Conventions used, 9 Copyrights, 2

Roche Diagnostics G-4

Operator’s Manual · Version 2.1

cobas e 411 analyzer

Cup adapters – see Roche Cup-Adapters Cups – See AssayCups Curr.E (data alarm), D-40

D Daily alarm trace report – printing, B-125 Daily maintenance, C-16 Daily Maintenance button – operation, B-20 Daily operation – daily maintenance, B-88 – overview, B-9 – post-operation data management, B-87 – pre-routine operation, B-16 – pre-start inspection, B-11 – results, B-82 – routine operation, B-30 – startup procedures, B-11 – Switch off the analyzer, B-88 Data – post-operation management, B-87 – storage, A-53 Data alarms – Curr, D-35 – >Test, D-36 – AB level check error, D-36 – AB level range over, D-35 – AB.E, D-36 – abnormal reagent disk temperature, D-43 – ADC abnormal, D-37 – ADC.E, D-37 – assay reagent film detected, D-42 – assay reagent hovering, D-43 – assay reagent short, D-43 – Cal.E, D-37 – Calc.?, D-38 – Calc.Test Error, D-40 – calculation not possible, D-38 – calibration result abnormal, D-37 – Cancel [E.STOP Cancel], D-38 – Cancel [P.STOP/A.STOP Cancel], D-38 – Cancel [Power Fail/Power Off Cancel], D-38 – Cancel [Recovery Cancel], D-39 – Cancel [S.STOP Cancel], D-39 – Cancel [Sample ID Error Cancel], D-39 – Cancel [STOP Cancel], D-38 – CarOvr, D-39 – Cell.T, D-40

Index

– ClcT.E, D-40 – Curr.E, D-40 – diluent film detected, D-42 – diluent hovering, D-43 – diluent short, D-43 – FacA, D-41 – H, D-41 – Inc.T, D-41 – incubator temperature, D-41 – instrument factor A reset, D-41 – L, D-42 – list of all alarms, D-34 – low signal level, D-35 – measurement range, lower, D-36 – measurement range, upper, D-36 – measuring cell current check, D-40 – measuring cell current range over, D-35 – measuring cell temperature, D-40 – outside expected higher value, D-41 – outside expected lower value, D-42 – potential microparticle carry over, D-39 – pretreatment film detected, D-42 – pretreatment hovering, D-43 – pretreatment reagent short, D-43 – Reag.F, D-42 – Reag.H, D-43 – Reag.S, D-43 – Reag.T, D-43 – reagent expired, D-42 – ReagEx, D-42 – Samp.C, D-44 – Samp.S, D-44 – sample clot, D-44 – sample LLD abnormal, D-45 – sample LLD noise, D-45 – sample short, D-44 – SLLD.E, D-45 – SLLD.N, D-45 – SysR.S, D-45 – SysR.T, D-45 – SysR.U, D-46 – system reagent short, D-45 – system reagent temperature, D-45 – system reagent temperature unstable, D-46 Data drifting, D-46 Data problems without alarms, D-46 Data Review screen – printing samples, B-120 Dead volume – See residual volume Defining – non-Roche controls, B-113 – password, B-104 – Roche controls, B-111

Roche Diagnostics Operator’s Manual · Version 2.1

G-5

Index

Deleting – results, B-87 – single open requests, B-123 Diluent film detected (data alarm), D-42 Diluent hovering (data alarm), D-43 Diluent short (data alarm), D-43 Dilution – automatic dilution, B-75 – manual predilution, B-74 – sample, B-74 Dimensions – analyzer, A-33 Direct drain – checking waste level, E-8 – drain tube, E-7 – liquid waste, E-3 – maintenance, E-9 – overview, E-6 – pre-routine operation, E-8 – specifications, E-8 – troubleshooting, E-12 Disk – sample disk, A-69 – system, A-24 Disposal opening – AssayCups, A-86 Distilled water container – See system water container Documentation settings – changing, B-105 Drain tube – direct drain, E-7

E Editing control values, B-115 Electrical specifications, A-34 Electromagnetic compatibility, A-20 EMC – See electromagnetic compatibility Emptying – liquid waste, B-26 – solid waste, B-28 – solid waste tray, C-49 Environmental conditions, A-35 Erroneous operation, D-46 Evaporation of system reagents – preventing, B-89 Example screens, 10 Exporting data, B-121 Extended shutdown, C-51

cobas e 411 analyzer

F FacA (data alarm), D-41 False measurements – troubleshooting, D-23 Filtering – results, B-85 Final power off – See power off Finalization maintenance – performing, C-34 Flash memory, A-53 Full keyboard, A-53

G Global buttons, A-62 Gripper unit, A-85 Guidance prompt, A-58

H H (data alarm), D-41 Help – See Online Help Host interface, A-55

I IEC 61010 (noise levels), A-35 Immunoassay – troubleshooting, D-11 Inc.T (data alarm), D-41 Incubator – description, A-90 – specifications, A-40 – temperature (data alarm), D-41 Input buffer (of rack sampler), A-71 Inserts – package, A-43 Installing – calibrators, B-109 – non-Roche controls, B-113 – Roche controls, B-111 Instrument – approvals, 3 – troubleshooting, D-15 – See analyzer Instrument factor A reset (data alarm), D-41 Intended use, 2 Interface – host, A-55 – USB, A-54

Roche Diagnostics G-6

Operator’s Manual · Version 2.1

cobas e 411 analyzer

Inventory – AssayCups, B-18 – AssayTips, B-18 – CleanCell, B-18 – ProCell, B-18 – solid waste, B-18 Inventory area, B-18

K Kits – calibrator, A-44 – control, A-45 – reagent, A-42

L L (data alarm), D-42 Labels – reagent barcode, A-43 Liner – See Clean-Liner Liquid flow path cleaning, C-25 Liquid waste – checking container, B-26 – cleaning container, C-38 – container, A-88 – direct drain, E-3 – emptying container, B-26 – specifications, A-36 Liquid waste container – cleaning, E-10 List boxes, A-60 Load list – reagents, B-21 Loading – calibrators, B-31 – consumables during operation, B-79 – continuous (multiple disk), B-63 – continuous (rack), B-63 – continuous (single disk), B-61 – controls, B-31 – sample disk, B-33 Logging on, B-14 Low signal level (data alarm), D-35

M

Index

– cleaning reagent rotor and compartment, C-45 – cleaning the CleanCell compartments, C-42 – cleaning the microbead mixer, C-40 – cleaning the ProCell compartments, C-42 – cleaning the rinse stations, C-22 – cleaning the sample/reagent probe, C-16 – cleaning the sipper probe, C-18 – daily, B-88, C-16 – direct drain, E-9 – emptying solid waste tray, C-49 – every two months, C-28 – every two weeks, C-22 – finalization maintenance, C-34 – items, C-8 – liquid flow path cleaning, C-25 – log, C-13 – performing, C-8 – procedures, C-7 – protecting the measuring cell, C-51 – replacing the pinch valve tubing, C-28 – schedule, C-11 – weekly, C-18 Measurement range – lower (data alarm), D-36 – upper (data alarm), D-36 Measurements – troubleshooting false values, D-23 Measuring – additional routine samples, B-61 – calibrators, B-35 – controls, B-35 Measuring area – components, A-90 Measuring cell – current check (data alarm), D-40 – current range over (data alarm), D-35 – protecting during extended shutdown, C-51 Measuring system – specifications, A-40 Memory – cards, A-53 – saving space, B-20 Menu tabs, A-60 Microbead mixer – cleaning, C-40 – description, A-82 – rinse station, A-82 Mixer – See microbead mixer Monitor – See touchscreen monitor

Main circuit breaker, A-29 Maintenance, C-5 – as needed, C-34 – caution messages, C-3 – cleaning liquid waste container, C-38, E-10 Roche Diagnostics Operator’s Manual · Version 2.1

G-7

Index

N Noise levels (IEC 61010-1), A-35 Non-Roche controls – installing and defining, B-113 Numeric keyboard, A-52

O Online Help – system, A-64 Operation – safety information, B-3 – System Overview screen, B-16 Operation switch, A-29 Operator – responsibility for troubleshooting, D-7 Operator’s Manual – conventions used, 9 – finding information, 7 Option buttons, A-61 Organic solvents – safety precautions, A-12 Output buffer – rack sampler, A-72 Outside expected higher value (data alarm), D-41 Outside expected lower value (data alarm), D-42

P Package inserts, A-43 Parameter Download – daily operation, B-22 Password – defining, B-104 Patient programming – calculated test, B-106 – interfaced, barcoded samples (disk systems), B-44 – interfaced, barcoded samples (rack systems), B-54 – interfaced, non-barcoded samples (disk systems), B-46 – interfaced, non-barcoded samples (rack systems), B-55 – non-interfaced, barcoded samples (disk systems), B-48 – non-interfaced, barcoded samples (rack systems), B-57 – non-interfaced, non-barcoded samples (disk systems), B-50 – non-interfaced, non-barcoded samples (rack systems), B-59 – See STAT patient programming Patient results – See results

cobas e 411 analyzer

Peripheral devices – safety precautions, A-20 Pinch valve tubing – replacing, C-28 Pipetter – sample/reagent, A-83 – sipper, A-92 Pipetting station, A-86 Platform – cobas© link, A-31 – TeleService-Net, A-31 Port – See Interface Position Assignment – calibrators, B-117 – controls, B-117 Potential hazards, A-6 Potential microparticle carry over (data alarm), D-39 Power off – checks, B-90 – See switching off Power on – See switching on Power requirements, A-34 Power supply – safety labels, A-18 Pre-Analytic Systems Manager (PSM), A-23 Precision – inter assay troubleshooting, D-28 – intra assay troubleshooting, D-27 Predilution – manual, B-74 Pre-routine operation – daily operation, B-16 – direct drain, E-8 Pre-start inspection, B-11 Pretreatment film detected (data alarm), D-42 Pretreatment hovering (data alarm), D-43 Pretreatment reagent short (data alarm), D-43 Preventive action – Work Flow Guide, B-20 Printer – approved models, A-54 – connection port, A-54 – switching on, B-11 Printing – a report, B-124 – canceling, B-126 – daily alarm trace report, B-125 – results, B-85 – two or more samples, B-120 Probe – rinse station, A-82 – sample/reagent, A-75 – sipper, A-91 ProCell

Roche Diagnostics G-8

Operator’s Manual · Version 2.1

cobas e 411 analyzer

– cleaning compartments, C-42 – inventory, B-18 – preventing evaporation, B-89 – use, A-93 Programming – See patient programming Prompt, guidance, A-58 Protect, C-51

Q QC – activating a test, B-35 – measuring, B-35 – performing, B-30 – validating results, B-38 QC violation settings – changing, B-97

R Rack – barcode reader, A-78 – Roche Cup-Adapter, B-43 – system, A-24 Rack sampler – A-Line, A-70 – B-Line, A-71 – C-Line, A-72 – input buffer, A-71 – output buffer, A-72 – STAT rack position, A-73 Rack sampler circuit breaker, A-30 Reading station – barcode card, A-79 Reag.F (data alarm), D-42 Reag.H (data alarm), D-43 Reag.S (data alarm), D-43 Reag.T (data alarm), D-43 Reagent – area, A-68 – barcode labels, A-43 – cap open/close mechanism, A-81 – pipetter, A-83 – rotor, A-80 Reagent Detail window – System Overview screen, B-19 Reagent disk – See reagent rotor Reagent expired (data alarm), D-42 Reagent kits – See reagent packs Reagent Load List – daily operation, B-21

Index

– printing, B-21 Reagent overview area, B-17 Reagent packs – description, A-42 – replacing, B-22 Reagent probe – See Sample/reagent probe, A-75 Reagent rotor and compartment – cleaning, C-45 Reagent system – specifications, A-40 Reagents – replacing, B-22 – system, A-93 – troubleshooting, D-11 ReagEx (data alarm), D-42 Replacing – AssayCup trays, B-29 – AssayTip trays, B-29 – consumables, B-22 – pinch valve tubing, C-28 – reagent packs, B-22 – reagents, B-22 – system reagents, B-24 – valve on the system water container, C-34 Reports – canceling print job, B-126 – printing, B-124 Reproducibility, poor (of results), D-47 Requesting – calibration, B-33 – stand-by bottle QC, B-116 Rerunning samples, B-122 Resetting system, B-129 Residual volume – disk system, A-38 – rack system, A-39 Result data – at high level, D-47 – at low level, D-47 – drifting, D-46 Result report – printing, B-86 Results – deleting, B-87 – filtering, B-85 – printing, B-85 – reviewing, B-87 – sample, B-82 – uploading, B-85 – uploading manually, B-119 – viewing, B-83 Reviewing – results, B-87 Reviewing Alarm screen, B-15 Rinse station

Roche Diagnostics Operator’s Manual · Version 2.1

G-9

Index

– microbead mixer, A-82 – S/R probe, A-82 – sipper probe, A-91 Rinse stations – cleaning, C-22 Roche controls – installing and defining, B-111 Roche Cup-Adapter, B-43 Rotor – reagent, A-80 Routine, B-44 Routine operation, B-30

S S/R probe – See Sample/reagent probe Safety – classifications, A-5 – information, A-3 – precautions, A-6 Safety information – for maintenance, C-3 – for operation, B-3 Safety labels – power supply, A-18 Samp.C (data alarm), D-44 Samp.S (data alarm), D-44 Sample – area, A-68 – barcode reader, A-76 – containers (disk), A-38 – containers (rack), A-39 – pipetter, A-83 – sensor, A-78 Sample clot (data alarm), D-44 Sample data – exporting, B-121 – printing two or more samples, B-120 Sample Data Clear – pre-routine operation, B-20 Sample disk – description, A-69 – loading, B-33 Sample disk mode – changing, B-103 Sample LLD – abnormal (data alarms), D-45 – noise (data alarm), D-45 Sample measurements – disk systems, B-44 – rack systems, B-54 Sample programming – See patient programming Sample racks

cobas e 411 analyzer

– See rack Sample reception mode – activating, B-102 – configuring, B-101 Sample short (data alarm), D-44 Sample Tracking – daily operation, B-22 Sample tracking – disk system, B-76 – rack system, B-77 Sample tubes – applying barcode labels, B-93 Sample/reagent probe, A-75 – cleaning, C-16 Samples – automatic dilution, B-75 – dilution, B-74 – measuring additional, B-61 – rerunning, B-122 – residual volume (disk), A-38 – residual volume (rack), A-39 – results, B-82 Sampling system – specifications, A-37 Screen – access levels, A-63 – See touchscreen monitor Short Turn Around Time (STAT) – rack position, A-73 – test selections (disk systems), B-64 – test selections (rack systems), B-68 Shutdown – extended, C-51 Single open requests – deleting, B-123 Sipper pipetter, A-92 Sipper probe, A-91 – cleaning, C-18 Sipper shield, C-19 SLLD.E (data alarm), D-45 SLLD.N (data alarm), D-45 Software – basics, A-56 – buttons, A-61 – guidance prompt, A-58 – list boxes, A-60 – logging on, B-14 – main menu screens, A-59 – menu tabs, A-60 – online Help, A-64 – option buttons, A-61 – screen access levels, A-63 – selecting multiple items, A-63 – status line, A-57 – text boxes, A-60 – version, 2

Roche Diagnostics G-10

Operator’s Manual · Version 2.1

cobas e 411 analyzer

Software keyboard – full, A-53 – numeric, A-52 Solid waste – emptying, B-28 – inventory, B-18 – specifications, A-36 Solid waste tray – Clean-Liner, A-89 – emptying, C-49 – replacing, D-20 Solvents – See organic solvents Specifications – control unit, A-41 – direct drain, E-8 – electrical, A-34 – environmental, A-35 – incubation system, A-40 – liquid waste, A-36 – measuring system, A-40 – noise levels, A-35 – reagent system, A-40 – sampling system, A-37 – solid waste, A-36 – throughput, A-36 – water supply, A-35 Spillage, cleaning procedure, C-48 Stand-by bottle QC – requesting, B-116 STAT – See Short Turn Around Time STAT patient programming – interfaced, barcoded or non-barcoded samples (disk), B-64 – interfaced, barcoded samples (rack), B-68 – interfaced, non-barcoded samples (rack), B-69 – non-interfaced, barcoded or non-barcoded samples (disk), B-65 – non-interfaced, barcoded or non-barcoded samples (rack), B-71 Status line, A-57 Switch, operation, A-29 Switching off – analyzer, B-88 Switching on – analyzer, B-11 – printer, B-11 Symbols, 9 Syringe – problems with bubbles, D-22 SysR.S (data alarm), D-45 SysR.T (data alarm), D-45 SysR.U (data alarm), D-46 System, A-93 System alarms

Index

– checking, B-15 System Communication Trace – printing report, B-126 System Overview screen – inventory area, B-18 – operation, B-16 – reagent overview area, B-17 – Work Flow Guide, B-17 System reagent short (data alarm), D-45 System reagent temperature (data alarm), D-45 System reagent temperature unstable (data alarm), D-46 System reagents – opening lids, B-13 – preventing evaporation, B-89 – ProCell and CleanCell, A-93 – replacing, B-24 System resetting, B-129 System water container, A-87 – checking, B-25 – cleaning, C-36 – replacing, D-20 – valve replacement, C-34 Systems – disk, A-24 – rack, A-24

T Tabs – See menu tabs Technical data – system, A-33 Technical Support – contacting, D-8 – information required, D-8 TeleService-Net, A-31 Test settings – changing, B-95 Text boxes, A-60 Throughput rate, A-36 Tips – See AssayTips Touchscreen monitor, A-51 TPA (Tripropylamine), A-93 Trademarks, 2 Trays – solid waste, A-89 – See AssayCup trays – See AssayTip trays Tripropylamine (TPA), A-93 Troubleshooting – assay calibration, D-24 – auto dilution not possible, D-29 – bubbles in syringes, D-22 – calibrator problems, D-11

Roche Diagnostics Operator’s Manual · Version 2.1

G-11

Index

– chemistry problems, D-23 – computer problems, D-7 – contacting Technical Support, D-8 – control problems, D-11 – control unit problems, D-7 – direct drain, E-12 – drift, D-23 – emptying liquid waste container, D-21 – erratic test results, D-24 – facility problems, D-7 – false measurements, D-23 – flowchart, D-10 – hardware problems, D-6 – immunoassay problems, D-11 – instrument, D-15 – instrument problems, D-6 – inter assay precision, D-28 – intra assay precision, D-27 – method comparison, D-28 – operator’s responsibility, D-7 – probes, D-21 – problem categories, D-5 – reagent problems, D-6, D-11 – recovery of controls, D-27 – replacing AssayCup trays, D-19 – replacing AssayTip trays, D-19 – replacing solid waste tray, D-20 – replacing system water container, D-20 – result data, D-47 – results do not print automatically, D-22 – sample problems, D-6 – software problems, D-7 – trouble for all tests, D-48 – trouble for each test, D-48 – types of alarm, D-5 – variance between systems, D-28 Tubes – See sample tubes

cobas e 411 analyzer

Vessels – See AssayCups Viewing – results, B-83

W Waste containers – direct drain, E-3 – liquid waste, A-88 – solid waste, A-89 Water container – See system water container Water supply requirements, A-35 WEEE, disposal of components, A-20 Weekly maintenance, C-18 Windows – confirmation type, A-62 – description, A-62 Work Flow Guide – color scheme, B-17 – preventive action, B-20

U Uploading – results, B-85 Uploading results manually, B-119 USB interface, A-54 User access levels – See access levels User interface – See, Software basics

V Validating – QC and calibration results, B-38 Roche Diagnostics G-12

Operator’s Manual · Version 2.1

Notes

H