Cobas E411 ServiceManual v1.0 [PDF]

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Roche Diagnostics / Hitachi cobas e 411

Service Manual Version 1.0 May 2006

Service Manual for cobas e411 Immunoassay System

Revision Record Date Number

Version

January 2006

Draft

May 2006

1.0

New Chapter

Note Part No. and Part name are different depending on the manufacturing time. Please refer to Parts List for details.

RD/Hitachi Immunoassay System cobas e411 Service Manual 1.

Application/Introduction

1.1 1.2 1.3 1.4 1.5

Instrument Specifications Operating Precautions and Hazards Service Concept Rack Sampler/Rack Conveyor System

2.

Installation / Set Up

2.1 2.2 2.3 2.4 2.5 2.6

Site Requirements Inventory Analyzer Installation Software Installation Rack Sampler Connected to CLAS 1 System Installation Check/Adjustment During Installation

3.

Fludics

3.1 3.2 3.3 3.4

Description of Flow Path System Volume Cleaning Procedures SysWash

4.

Mechanics

4.1 4.2 4.3 4.4 4.5 4.6

Overview Location of Mechanisms List of Motors, Sensors and Other Mechanisms Detailed Explanation of Each Mechanism Mechanical Adjustment Rack Sampler System

5.

Electronics

5.1 5.2 5.3 5.4 5.5 5.6

Boards Power Source Electronic Modules Printed Circuit Boards Cross Wiring Diagrams How to Check Photo Interrupters

6.

Service Software

6.1 Overview

1

7.

Troubleshooting

7.1. 7.2 7.3 7.4 7.5

Alarms List Data Alarms Troubleshooting List Data File Load Errors Quality Control Check

8.

Spare Parts/Recommended Parts

8.1 Special Service Tools 8.2 Complete Recommended Parts List 8.3 Printed Circuit Boards List

9.

Host Interface (not applicable)

10. Maintenance 10.1 Operator Maintenance 10.2 Preventive Maintenance 10.3 Maintenance Material

Appendix Timing Chart Tables Assay Timetable

2

System Description

Chapter 1 System Description 1.1 INSTRUMENT ..............................................................................................................................................1 - 1 1.1.1 System Configuration ........................................................................................................................ 1 - 1 1.1.2 System Introduction........................................................................................................................... 1 - 2 1.1.3 Control Unit Components ................................................................................................................. 1 - 5 1.1.4 Sample/Reagent Area Components ................................................................................................... 1 - 7 1.1.5 Consumables Area Components...................................................................................................... 1 - 22 1.1.6 Measuring Area Components.......................................................................................................... 1 - 27 1.1.7 Power Components ......................................................................................................................... 1 - 33 1.1.8 Mechanical Theory.......................................................................................................................... 1 - 35 1.1.9 Detailed Assay Sequence................................................................................................................. 1 - 38 1.1.10 Dilution Steps ................................................................................................................................ 1 - 47 1.1.11 Analyzer Status Conditions ........................................................................................................... 1 - 48 1.2 TECHNICAL DATA ....................................................................................................................................1 - 52 1.2.1 Technical Data for Operation of Instrument................................................................................... 1 - 52 1.3 POTENTIAL HAZARD AND SAFETY PRECAUTIONS ....................................................................................1 - 61 1.3.1 Safety Classifications ...................................................................................................................... 1 - 61 1.3.2 Safety Information........................................................................................................................... 1 - 62 1.3.3 Safety Labels on the cobas e411...................................................................................................... 1 - 68 1.3.4 Approvals ........................................................................................................................................ 1 - 70 1.4 SYSTEM LABEL ........................................................................................................................................1 - 71 1.4.1 Disk System ..................................................................................................................................... 1 - 71 1.4.2 Rack System..................................................................................................................................... 1 - 73

Contents - 1

Installation / Set Up

Chapter 2 Installation / Set Up 2.1 SITE REQUIREMENTS ..................................................................................................................................2 - 1 2.1.1 Delivery Space Requirements............................................................................................................ 2 - 1 2.1.2 Physical Space and weighs Requirements......................................................................................... 2 - 1 2.1.3 Ambient Condition Requirements...................................................................................................... 2 - 3 2.1.4 Electrical Requirements .................................................................................................................... 2 - 3 2.1.5 Water Requirements .......................................................................................................................... 2 - 3 2.2 INVENTORY ................................................................................................................................................2 - 4 2.3 ANALYZER INSTALLATION .........................................................................................................................2 - 7 2.3.1 Unpacking ......................................................................................................................................... 2 - 7 2.3.2 Explanation of Packaging Position in the System ........................................................................... 2 - 14 2.3.3 Panel PC Installation and confirmation of AC Power Supply ........................................................ 2 - 21 2.3.4 Setup................................................................................................................................................ 2 - 25 2.3.5 Mounting a Measuring Cell ............................................................................................................ 2 - 25 2.3.6 Installation of System Software ....................................................................................................... 2 - 26 2.3.7 Fill Liquid System ........................................................................................................................... 2 - 26 2.3.8 Adjustments to be Checked During Installation and After Replacement......................................... 2 - 26 2.3.9 Measuring Cell Preparation ........................................................................................................... 2 - 27 2.3.10 System Volume Check.................................................................................................................... 2 - 28 2.3.11 High Voltage Check/Adjustment ................................................................................................... 2 - 28 2.3.12 Initial BlankCell Calibrations ....................................................................................................... 2 - 35 2.3.13 Instrument Checks......................................................................................................................... 2 - 39 2.3.14 Assay Calibration.......................................................................................................................... 2 - 51 2.3.15 Installation Procedures Overview / Checklist ............................................................................... 2 - 51 2.3.16 Procedure for Multiple Installations............................................................................................. 2 - 51 2.4 SOFTWARE INSTALLATION .......................................................................................................................2 - 53 2.4.1 Application Instruction.................................................................................................................... 2 - 53 2.4.2 Printer Driver Instruction ............................................................................................................... 2 - 58 2.4.3 System Parameter Setup.................................................................................................................. 2 - 69 2.5 RACK SAMPLER SYSTEM INSTALLATION..................................................................................................2 - 70 2.5.1 Rack Sampler System Installation ................................................................................................... 2 - 70 2.6 CHECKS/ADJUSTMENTS DURING INSTALLATION .....................................................................................2 - 84 2.6.1 Bead Mixer ...................................................................................................................................... 2 - 84 2.6.2 Pipetter Adjustment......................................................................................................................... 2 - 86 2.6.3 Sipper adjustment............................................................................................................................ 2 - 86 2.6.4 Electronic adjustments .................................................................................................................... 2 - 86 2.6.5 Rack Sampler adjustments .............................................................................................................. 2 - 86 2.7 TABLE OF CONTENTS ...............................................................................................................................2 - 92 2.7.1 Method to detach the external covers.............................................................................................. 2 - 92 2.7.2 Method to attach the external covers .............................................................................................. 2 - 99 2.7.3 Mmethod to detach the PC Unit .................................................................................................... 2 - 107 2.7.4 Method to attach the PC Unit ....................................................................................................... 2 - 109

Contents - 1

Fluidics

Chapter 3 Fluidics 3.1 DESCRIPTION OF FLOW PATH .....................................................................................................................3 - 1 3.1.1 Overall Piping Diagram.................................................................................................................... 3 - 2 3.1.2 List of Parts ....................................................................................................................................... 3 - 3 3.2 SYSTEM VOLUME .......................................................................................................................................3 - 3 3.2.1 Definition of System Volume ............................................................................................................. 3 - 3 3.2.2 Determination of System Volume ...................................................................................................... 3 - 3 3.2.3 Storage of the System Volume Value / Data Handling...................................................................... 3 - 4 3.3 CLEANING PROCEDURES ............................................................................................................................3 - 5 3.3.1 Liquid Flow Cleaning ....................................................................................................................... 3 - 5 3.3.2 Cleaning Procedure for Fluidics System........................................................................................... 3 - 6 3.4 SYSWASH ..................................................................................................................................................3 - 8 3.4.1 Introduction....................................................................................................................................... 3 - 8 3.4.2 SysWash Rinsing Procedure.............................................................................................................. 3 - 8

Contents - 1

Mechanics

Chapter 4 Mechanics 4.1 OVERVIEW .................................................................................................................................................4 - 1 4.1.1 Location ............................................................................................................................................ 4 - 1 4.1.2 Outline of Mechanical Units ............................................................................................................. 4 - 1 4.2 LOCATION OF MECHANISMS ......................................................................................................................4 - 3 4.2.1 Analyzer ............................................................................................................................................ 4 - 3 4.2.2 Rack Sampler System ........................................................................................................................ 4 - 6 4.3 LIST OF MOTORS, SENSORS, AND OTHER MECHANISMS ..........................................................................4 - 10 4.3.1 List of Motors .................................................................................................................................. 4 - 10 4.3.2 Motor Reference List....................................................................................................................... 4 - 10 4.3.3 List of Sensors ................................................................................................................................. 4 - 10 4.3.4 List of Peltier, Heater and Fan Motor ............................................................................................ 4 - 11 4.3.5 List of Motors for Rack Sampler System ......................................................................................... 4 - 12 4.3.6 List of Sensors for Rack Sampler System ........................................................................................ 4 - 12 4.3.7 List of LEDs and Fan Motor for Rack Sampler System .................................................................. 4 - 12 4.4 DETAILED EXPLANATION OF EACH MECHANISM .....................................................................................4 - 13 4.4.1 Sample Disk Drive Mechanism ....................................................................................................... 4 - 13 4.4.2 Reagent Disk Drive Mechanism ...................................................................................................... 4 - 19 4.4.3 Cap Open/Close Mechanism........................................................................................................... 4 - 28 4.4.4 Beads Mixer Mechanism ................................................................................................................. 4 - 33 4.4.5 Pipetter Mechanism ........................................................................................................................ 4 - 40 4.4.6 Gripper Mechanism ........................................................................................................................ 4 - 52 4.4.7 Sipper Mechanism........................................................................................................................... 4 - 66 4.4.8 System Reagent Mechanism ............................................................................................................ 4 - 74 4.4.9 Syringe Mechanism ......................................................................................................................... 4 - 77 4.4.10 System Water Container (Float SW) Mechanism / Pump Assembly.............................................. 4 - 81 4.4.11 Liquid Waste Container Mechanism ............................................................................................. 4 - 87 4.4.12 Solid Waste Mechanism ................................................................................................................ 4 - 91 4.4.13 Detection Unit ............................................................................................................................... 4 - 94 4.4.14 Magnet Drive Mechanism ........................................................................................................... 4 - 105 4.4.15 Matrix BCR Mechanism .............................................................................................................. 4 - 110 4.4.16 SIPPER SAFETY COVER (INTER ROCK Mechanism).............................................................. 4 - 121 4.5 MECHANICAL ADJUSTMENT ...................................................................................................................4 - 123 4.5.1 Overview ....................................................................................................................................... 4 - 123 4.5.2 Mechanical Adjustment Procedure ............................................................................................... 4 - 123 4.5.3 Mechanical Adjustment Procedure for Rack Sampler .................................................................. 4 - 129 4.6 RACK SAMPLER SYSTEM ........................................................................................................................4 - 132 4.6.1 Overview ....................................................................................................................................... 4 - 132 4.6.2 Rack Sampler Movement............................................................................................................... 4 - 132 4.6.3 A Line ............................................................................................................................................ 4 - 133 4.6.4 B Line ............................................................................................................................................ 4 - 134 4.6.5 C Line............................................................................................................................................ 4 - 137

Contents - 1

Electronics

Chapter 5 Electronics 5.1 BOARDS .....................................................................................................................................................5 - 1 5.1.1 System Overview ............................................................................................................................... 5 - 1 5.1.2 Location of Boards............................................................................................................................ 5 - 2 5.2 POWER SOURCE .......................................................................................................................................5 - 10 5.2.1 AC Power ........................................................................................................................................ 5 - 10 5.2.2 DC Power Supply............................................................................................................................ 5 - 11 5.3 ELECTRONIC MODULES / ELECTRONIC ADJUSTMENTS .............................................................................5 - 17 5.3.1 Principle of Temperature Control................................................................................................... 5 - 17 5.3.2 Principle of LLD ............................................................................................................................. 5 - 18 5.3.3 Principle of Clot Detection ............................................................................................................. 5 - 20 5.3.4 Adjustment / Check Procedure of LLD/Clot Detection ................................................................... 5 - 20 5.3.5 Functional Details of FRONT SW (Operation Switch) ................................................................... 5 - 27 5.3.6 Details of Temperature Control / Troubleshooting of Temp. Units ................................................ 5 - 28 5.3.7 Serial Data Communication............................................................................................................ 5 - 31 5.3.8 Adjustment of Mixer Speed.............................................................................................................. 5 - 32 5.4 PRINTED CIRCUIT BOARDS .......................................................................................................................5 - 33 5.4.1 ECPU550 Board ............................................................................................................................. 5 - 33 5.4.2 EECL300 Board .............................................................................................................................. 5 - 36 5.4.3 EMOT300 Board............................................................................................................................. 5 - 38 5.4.4 EIO3 Board ..................................................................................................................................... 5 - 42 5.4.5 DO1 Board...................................................................................................................................... 5 - 44 5.4.6 DO2 Board...................................................................................................................................... 5 - 47 5.4.7 DO3 Board...................................................................................................................................... 5 - 48 5.4.8 DIST-PA Board ............................................................................................................................... 5 - 50 5.4.9 DIST-SA Board................................................................................................................................ 5 - 51 5.4.10 DIST-TVA Board........................................................................................................................... 5 - 52 5.4.11 DIST-F Board................................................................................................................................ 5 - 52 5.4.12 DIST-F3 Board.............................................................................................................................. 5 - 54 5.4.13 DIST232C Board........................................................................................................................... 5 - 55 5.4.14 ANG-EP2 Board............................................................................................................................ 5 - 56 5.4.15 PMT-SHV2 Board ......................................................................................................................... 5 - 59 5.4.16 L-AMP(3) Board ........................................................................................................................... 5 - 60 5.4.17 LLD-SA Board............................................................................................................................... 5 - 62 5.4.18 LLD-P3 Board............................................................................................................................... 5 - 63 5.4.19 UIRS-C Board ............................................................................................................................... 5 - 64 5.4.20 MVLB110 Board ........................................................................................................................... 5 - 65 5.4.21 S.AB-CE Board ............................................................................................................................. 5 - 66 5.4.22 DET-A Board ................................................................................................................................ 5 - 67 5.4.23 DET-B Board ................................................................................................................................ 5 - 68 5.4.24 DET-C Board ................................................................................................................................ 5 - 68 5.4.25 DETECT1 Board........................................................................................................................... 5 - 69 5.4.26 RS CONTD Doard......................................................................................................................... 5 - 69 5.4.27 PS CONTA Board ......................................................................................................................... 5 - 71 5.4.28 DO4A Board ................................................................................................................................. 5 - 73 5.4.29 BCR Board .................................................................................................................................... 5 - 75 5.4.30 PH-D Board .................................................................................................................................. 5 - 76 5.4.31 PH-T Board................................................................................................................................... 5 - 76 5.5 CROSS WIRING DIAGRAMS ......................................................................................................................5 - 77 5.5.1 Cross Wiring Diagrams for Rack Sampler System.......................................................................... 5 - 77 5.5.2 Cross Wiring Diagrams for Rack Sampler...................................................................................... 5 - 77 5.6 HOW TO CHECK PHOTO INTERRUPTERS ...................................................................................................5 - 78 5.6.1 Photo Interrupters........................................................................................................................... 5 - 78 5.6.2 How to check the PCPs ................................................................................................................... 5 - 80

Contents - 1

Service Software

Chapter 6 Service Software 6.1 OVERVIEW .................................................................................................................................................6 - 1 6.1.1 Utility Screen of Print ....................................................................................................................... 6 - 4 6.1.2 Interface Setup ................................................................................................................................ 6 - 10 6.1.3 System Setup.................................................................................................................................... 6 - 13 6.1.4 Storage Utility ................................................................................................................................. 6 - 15 6.1.5 Documentation and Printer Setting................................................................................................. 6 - 18 6.1.6 Keep Function Setup ....................................................................................................................... 6 - 20 6.1.7 Retry Function Setup....................................................................................................................... 6 - 20 6.1.8 Sample Reception Mode .................................................................................................................. 6 - 21 6.2 MAINTENANCE .........................................................................................................................................6 - 22 6.2.1 Detailed Description of Each Maintenance Function..................................................................... 6 - 24 6.3 MECHANISM CHECK ................................................................................................................................6 - 27 6.3.1 System Volume Check...................................................................................................................... 6 - 31 6.3.2 Assay Performance Check............................................................................................................... 6 - 31 6.3.3 Voltage Monitor .............................................................................................................................. 6 - 39 6.3.4 Temperature Monitor ...................................................................................................................... 6 - 40 6.3.5 Sensor Monitor................................................................................................................................ 6 - 41 6.4 SERVICE ...................................................................................................................................................6 - 43 6.4.1 Manual Adjustment ......................................................................................................................... 6 - 44 6.4.2 Adjustment Rack.............................................................................................................................. 6 - 47 6.4.3 BCR Setup ....................................................................................................................................... 6 - 49 6.4.4 Service Setup ................................................................................................................................... 6 - 52 6.4.5 Service Maintenance ....................................................................................................................... 6 - 53 6.4.6 Alarm Setting................................................................................................................................... 6 - 55 6.4.7 Initial Blank Cell ............................................................................................................................. 6 - 56 6.4.8 Automatic Adjustment ..................................................................................................................... 6 - 59

Contents - 1

Troubleshooting

Chapter 7 Troubleshooting 7.1 ALARM LIST ...............................................................................................................................................7 - 1 7.2 DATA ALARM LIST ....................................................................................................................................7 - 2 7.3 TROUBLESHOOTING LIST ............................................................................................................................7 - 4 7.3.1 Reagent Disk ..................................................................................................................................... 7 - 4 7.3.2 Cap Opener ....................................................................................................................................... 7 - 5 7.3.3 Beads Mixer ...................................................................................................................................... 7 - 6 7.3.4 Barcode Reader Mechanism ............................................................................................................. 7 - 8 7.3.5 Sample Disk Mechanism ................................................................................................................... 7 - 8 7.3.6 Pipetter Mechanism .......................................................................................................................... 7 - 9 7.3.7 Pipetter / Sipper Syringe ................................................................................................................. 7 - 11 7.3.8 Gripper Mechanism ........................................................................................................................ 7 - 12 7.3.9 Solid Waste...................................................................................................................................... 7 - 15 7.3.10 Sipper Mechanism......................................................................................................................... 7 - 16 7.3.11 Magnet Drive Mechanism ............................................................................................................. 7 - 17 7.3.12 Pipetter Buffer............................................................................................................................... 7 - 18 7.3.13 Distilled Water Float Switch ......................................................................................................... 7 - 18 7.3.14 System Reagent Unit ..................................................................................................................... 7 - 19 7.3.15 Liquid Waste Mechanism .............................................................................................................. 7 - 19 7.3.16 Rack Sampler System .................................................................................................................... 7 - 21 7.3.17 CF card problem ........................................................................................................................... 7 - 22 7.4 QUALITY CONTROL CHECK......................................................................................................................7 - 26 7.4.1 Covers ............................................................................................................................................. 7 - 26 7.4.2 Sample/Assay Reagent Rotation Mechanism................................................................................... 7 - 26 7.4.3 Cap Open/Close Mechanism........................................................................................................... 7 - 26 7.4.4 Beads Mixer Mechanism ................................................................................................................. 7 - 26 7.4.5 Barcode Reader Mechanism ........................................................................................................... 7 - 26 7.4.6 Pipetter, Sipper Mechanism ............................................................................................................ 7 - 27 7.4.7 Syringes Mechanism (after exchange); ........................................................................................... 7 - 27 7.4.8 Gripper Mechanism ........................................................................................................................ 7 - 27 7.4.9 solid Waste Mechanism................................................................................................................... 7 - 27 7.4.10 1Incubation Unit ........................................................................................................................... 7 - 27 7.4.11 1Detection Unit ............................................................................................................................. 7 - 28 7.4.12 1Pump Module (after exchange);.................................................................................................. 7 - 28

Contents - 1

Spare Parts/Recommended Parts

Chapter 8 Spare Parts/Recommended Parts 8.1 SPECIAL SERVICE TOOLS ...........................................................................................................................8 - 1 8.2 COMPLETE PARTS LIST ..............................................................................................................................8 - 2

Contents - 1

Host Interface

Chapter 9 Host Interface 9.1 HOST INTERFACE .......................................................................................................................................9 - 1

Contents - 1

Maintenance

Chapter 10 Maintenance 10.1 MAINTENANCE PROCEDURE OVERVIEW ................................................................................................10 - 6 10.1.1 Replace pipettor tube 510 ............................................................................................................. 10 - 8 10.1.2 Replace pipettor tube 465 with nozzle seal ................................................................................. 10 - 10 10.1.3 Replace Pinch Valve Tubing ....................................................................................................... 10 - 13 10.1.4 Replace Pipettor Seals ................................................................................................................ 10 - 15 10.1.5 Exchange packings for sipper & pipettor syringe ....................................................................... 10 - 22 10.1.6 Clean Rinse Stations for S/R Probe, Mixer and Sipper Probe .................................................... 10 - 24 10.1.7 Clean Sipper and S/R probe ........................................................................................................ 10 - 26 10.1.8 Clean water filter main pump...................................................................................................... 10 - 29 10.1.9 Clean System Water Container ................................................................................................... 10 - 31 10.1.10 Clean Liquid Waste Container .................................................................................................. 10 - 33 10.1.11 Clean ProCell/CleanCell Compartments .................................................................................. 10 - 34 10.1.12 Clean Reagent Disk and Compartment ..................................................................................... 10 - 35 10.1.13 Check drain tubes for contamination and exchange if necessary ............................................. 10 - 37 10.1.14 Drain the outlet pipettor wash station and waste pipe.............................................................. 10 - 39 10.1.15 Perform Liquid Flow Cleaning ................................................................................................. 10 - 39 10.1.16 Perform system volume check ................................................................................................... 10 - 41 10.1.17 Exchange mixer belt S ............................................................................................................... 10 - 41 10.1.18 Clean mixer paddle ................................................................................................................... 10 - 42 10.1.19 Check mixer speed; adjust if necessary..................................................................................... 10 - 43 10.1.20 Check / Clean gripper finger..................................................................................................... 10 - 44 10.1.21 Clean light barriers and mechanic parts................................................................................... 10 - 45 10.1.22 Clean Incubator and Aspiration Station.................................................................................... 10 - 45 10.1.23 Check LLD voltage pipettor ...................................................................................................... 10 - 47 10.1.24 Check LLD voltage sipper......................................................................................................... 10 - 47 10.1.25 Check clot voltage ..................................................................................................................... 10 - 47 10.1.26 Check Temperature Monitor for Detection unit ........................................................................ 10 - 47 10.1.27 Check Temperature Monitor for Incubator............................................................................... 10 - 47 10.1.28 Check Temperature Monitor for Reagent.................................................................................. 10 - 47 10.1.29 Check Temperature Monitor for PC / CC ................................................................................. 10 - 47 10.1.30 Clean peltier elements from dust if necessary ........................................................................... 10 - 47 10.1.31 Clean BCR window and window reagent disk .......................................................................... 10 - 49 10.1.32 Perform artificial media check.................................................................................................. 10 - 50 10.1.33 Perform TSH assay test ............................................................................................................. 10 - 50 10.1.34 Perform initial blank cell .......................................................................................................... 10 - 50 10.1.35 Perform assay calibration......................................................................................................... 10 - 50 10.1.36 Perform assay control ............................................................................................................... 10 - 50 10.1.37 Exchange measuring cell .......................................................................................................... 10 - 51 10.1.38 Exchange tube B for MC ........................................................................................................... 10 - 52 10.1.39 Exchange tube B for sipper with nozzle seal ............................................................................. 10 - 54 10.1.40 Exchange tube B for sipper syringe .......................................................................................... 10 - 56 10.1.41 Clean the valve body on the system water container................................................................. 10 - 58 10.1.42 Exchange O-ring SV 1 / 2 / 5 / 6 / 7 .......................................................................................... 10 - 59 10.1.43 Exchange sipper wash station ................................................................................................... 10 - 61 10.1.44 Exchange the spring at the gripper finger................................................................................. 10 - 64 10.2 OPERATOR MAINTENANCE...................................................................................................................10 - 66 10.3 MAINTENANCE MATERIALS .................................................................................................................10 - 67

Contents - 1

RD/Hitachi cobas e411

Service Manual

1.1 Instrument 1.1.1 System Configuration

Figure 1.1-1 cobas e411 disk system

Figure 1.1-2 cobas e411 rack system

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1.1.2 System Introduction The Roche Diagnostics cobas e411 Immunoassay System is a fully automated, software-controlled system for immunoassay analysis. It is designed for both quantitative and qualitative in vitro determinations using a large variety of tests for analysis. To assist you in quickly identifying which component is specific to either the disk or rack system, one of the following graphics appears to the right of the subsection header. If no graphic appears next to the header, then that component is common to both systems.

Figure 1.1-3 Disk

Figure 1.1-4 Rack

1.1.2.1 The Control Unit The control unit of the e411 analyzer is a touchscreen, no-keyboard type computer, which is located on the left-center of the analyzer unit. This monitor unit contains the controlling software and also has an on-screen keyboard function.

Figure 1.1-5 Control unit

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1.1.2.2 The Analyzer Unit

Figure 1.1-6 The analyzer unit on the disk system consists of the: • • • •

sample/reagent area consumables area measuring area operation switch

The only difference on the rack system is in the sample area. The sample disk is replaced by a rack sampling unit. Refer to the photo below.

Figure 1.1-7

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1.1.2.3 Sample/Reagent Area The sample/reagent area comprises the left half of the analyzer and consists of a sample disk or rack sampler (rack system), rack bar code reader (rack system), sample/reagent (S/R) probe, bar code reader, bar code card reading station, reagent disk, a cap open/close mechanism, a microparticle mixer, probe/ mixer rinse station and sample/reagent (S/R) pipettor. The sample disk accommodates up to 30 samples. The A-Line of the rack sampler accommodates 75 samples on a single tray (15 racks at a time; each rack with five positions) and 25 samples in the input buffer for a total capacity of 100 samples. The reagent disk, temperature controlled at 20 ± 3 °C, accommodates up to 18 reagent packs.

1.1.2.4 Consumables Area The consumables area is on the right of the analyzer, consisting of three tip trays, three AssayCup trays, a gripper unit, cup disposal opening, liquid waste container, solid waste tray and liner and system water container.

1.1.2.5 Measuring Area The measuring area includes the incubator, the sipper probe, sipper rinse station, system reagents (ProCell and CleanCell), an aspiration station, sipper pipettor and the detection unit. The sipper probe aspirates the incubated reaction mixture into the detection unit for result determination.

1.1.2.6 Operation Switch The operation ON/OFF switch is located on the front left of the analyzer. In addition, there is a circuit breaker for the analyzer located on the right side panel and a rack sampler circuit breaker located on the left side of the rack sampler.

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1.1.3 Control Unit Components The control unit consists of a color touchscreen monitor, host interface and external printer.

1.1.3.1 Touchscreen Monitor The touchscreen monitor is located on the left-center of the analyzer and displays the software. For details on the cobas e411 software, refer to the Software Guide.

Figure 1.1-8 Touchscreen monitor

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1.1.3.2 On-screen Keyboard The e411 software has an on-screen keyboard. For details refer to the Software Guide.

Figure 1.1-9 On-screen keyboard

1.1.3.3 External Printer The instrument uses an 80-column, graphics-capable, dot matrix printer. The printer is connected to the analyzer via a USB port. The analyzer has two USB ports on its left side.

Figure 1.1-10 Location of the USB ports and Host port

1.1.3.4 Host Interface The instrument can be bidirectionally interfaced with a host computer. Please refer the Host Interface manual in detail.

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1.1.4 Sample/Reagent Area Components The sample/reagent area consists of a sample disk or rack sampler (rack system), rack ID bar code reader (rack system), sample/reagent (S/R) probe, bar code reader, bar code card reading station, reagent disk, cap open/close mechanism, microparticle mixer, probe/mixer rinse station and sample/reagent (S/R) pipettor.

Figure 1.1-11 Sample Disk The sample disk has 30 positions for samples, calibrators and controls. Patient samples may be placed in either primary sample tubes or sample cups. Built-in adapters allow intermixing of different size primary sample tubes. Sample tubes that may be used are listed in chapter 2.7 Technical Data. Sample cups [2 mL (Standard) Hitachi cups only] may be placed directly on the sample disk or on top of 16 mm primary sample tubes.

Figure 1.1-12 Sample disk

CAUTION Micro cups cannot be used on the e411 analyzer!

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Note: How to raise the sample disk protective cover To take out the sample disk, first you must raise the sample disk protective cover. The cover can be held at a certain angle. To lay the cover down, release the hold by raising the cover up to its limit angle. Be sure to lay it down before you start operation.

Figure 1.1-13 Sample disk protective cover

Figure 1.1-14 n Raising the sample disk protective cover

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Figure 1.1-15 Standing angle

Figure 1.1-16 Limit angle

CAUTION Be sure to lay down the sample disk protective cover before you start operation.

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Figure 1.1-17

Rack Sampler The rack sampler consists of an A-Line, B-Line, C-Line and STAT position.

1.1.4.1 A-Line Specimens are placed in 5-position sample racks and are loaded onto a tray. Once a tray is loaded, additional racks can be added 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 is located at the far left of the A-Line and pushes the sample racks forward and onto the B-Line. The A-Line holds a tray that accommodates 15 racks at one time. Another five racks can be in the input buffer. Therefore, you can have a total of 100 specimens loaded at any one time. Refer to the photo and graphic below.

Figure 1.1-18

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Figure 1.1-19

1.1.4.2 B-Line The B-Line transports the sample racks, single file, first to the rack bar code reader. Here each position in the rack is scanned for a sample bar code. After the last position is scanned, the bar code reader scans the rack ID. After the last specimen is sampled, the rack is transferred via the output buffer onto the tray on the C-Line. Refer to the photo and graphic below.

Figure 1.1-20

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Figure 1.1-21 B-Line of the rack sampler

1.1.4.3 Rack Bar Code Reader The rack bar code reader reads both sample bar code labels and the rack bar code label. The bar code reader is auto-discriminating, allowing the use of various types of bar codes during operation. Bar code symbologies read include: • • • •

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

Figure 1.1-22 Rack bar code reader

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1.1.4.4 C-Line Racks are off-loaded from the B-Line into the output buffer. If there is no tray, up to 5 racks can enter the output buffer, thereafter the sampling procedure is stopped. When the sixth rack is moved into the output buffer, a rack is pushed onto the tray on the C-Line. 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. You cannot remove single racks from the C-Line. You must remove an entire tray at one time.

Figure 1.1-23

Figure 1.1-24 C-Line of the rack sampler If the tray is removed, 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.

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Figure 1.1-25 Output buffer with racks

1.1.4.5 STAT Position The STAT position is located at the front of the analyzer and is in line to feed directly onto the B-Line. Place a rack in the position as directed on the label and press the STAT key. When the rack currently being sampled is completed, the STAT rack is pushed onto the B-Line and is sent on to the rack bar code reader and sampling position.

Figure 1.1-26

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Figure 1.1-27 STAT position of the rack sampler

1.1.4.6 Sample Rack Sample cups, primary sample tubes, calibrator or control vials are placed in sample racks shown below. Each sample rack holds a maximum of five samples. Each tube slot contains adapters that allow the rack to hold different sizes of primary sample tubes. Each rack has a unique ID found on the bar code label on the back end of the rack. This rack ID is read by the bar code reader and transferred to the system. This ID appears on the screens in the software and on the reports.

Figure 1.1-28 Sample rack

1.1.4.7 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 and reagent disk. The probe uses disposable tips 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. A new AssayTip is utilized with every new pipetting sequence. For example, TSH = 1 tip for R1, R2 and sample, then one new tip for microparticles. The tip is washed externally at the rinse station between each aspiration. Additional tips are used for sample dilutions or pretreatment.

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Figure 1.1-29 S/R probe with tip

Note: Ensure that there is no foam on the surface of the sample.

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1.1.4.8 Bar Code Reader During a sample scan, the bar code reader scans the information on the bar code-labeled primary sample tubes, calibrators or controls, and transmits it to the software. During a reagent scan, the reader rotates to the reagent disk side to read the 2-dimensional bar code labels on the reagent packs. The bar code reader is located toward the back wall of the analyzer.

Figure 1.1-30 On the disk system: • •

it can be seen when either the sample disk or reagent disk is removed. to read bar code labels, the bar code reader rotates between the sample and reagent disks, and the card reading station.

Figure 1.1-31

On the rack system: • • •

it can only be seen when the reagent disk is removed. to read bar code labels, the bar code reader rotates between the reagent disk and the card reading station. A second bar code reader scans sample bar codes and rack ID bar codes.

The bar code reader is auto-discriminating, allowing the use of various types of bar codes during operation. In addition, this bar code reader also reads PDF417.

Note: PDF417 can only be used for reagent bar codes and bar code cards.

Figure 1.1-32 Bar code reader (sample disk side)

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Figure 1.1-33 Bar code reader (reagent disk side)

1.1.4.9 Bar Code Card Reading Station At this station, the bar code reader scans calibrator and control information from the calibrator or control bar code card. These cards are packed in calibrator or control kits.

Figure 1.1-34

On the disk system: •

it is located between the sample disk and reagent disk.

Figure 1.1-35

On the rack system: •

it is located to the back left of the reagent disk.

Figure 1.1-36 Bar code card reading station

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1.1.4.10 Reagent Disk The reagent disk contains 18 positions for assays, diluent or pretreatment reagent. These 18 positions can be used in any combination, with the following restrictions: max. 18 assays, max. 8 diluents, max. 9 pretreatments. The reagent disk is temperature controlled at 20 ± 3 °C.

Note: Diluents or pretreatment reagents can be placed in ANY position on the reagent disk. More than one reagent pack can be loaded on the reagent disk for each test.

Figure 1.1-37 Reagent disk

1.1.4.11 Reagent Cap Open/Close Mechanism To prevent reagents from evaporating, and to promote ease of use for the operator, the reagent disk utilizes a reagent cap open/close mechanism during reagent pipetting. The mechanism is located on the back wall of the reagent disk compartment and emerges when reagents need to be opened or closed. Caps are opened prior to pipetting or mixing the specific reagent (e.g., M, R1 or R2) and are closed when pipetting or mixing for the specific reagent (e.g., M, R1 or R2) is completed.

Figure 1.1-38 Reagent cap open/close mechanism

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1.1.4.12 Microparticle Mixer The mixer is utilized to mix the microparticles to ensure a homogeneous suspension before aspiration. The mixer is located to the right of the reagent disk. In its home position, it occupies the space directly to the left of the S/R probe.

Figure 1.1-39 Microparticle mixer

1.1.4.13 Probe/Mixer Rinse Station The rinse station rinses the AssayTip or mixer externally with system water between aspirations, or before and after microparticle mixing. The rinse station is located below the S/R probe and mixer when the probe is in its Stand-by position and the mixer is in its home position.

Figure 1.1-40 Rinse station

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

Figure 1.1-41 Sample/reagent pipettor

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1.1.5 Consumables Area Components The consumables area consists of three AssayCup trays, three tip trays, gripper, incubator, cup disposal opening, pipetting station, liquid waste container, system water container and solid waste tray and liner. One tip tray holds up to 120 tips, and one cup tray holds up to 60 cups. Therefore, a total of 360 tips and 180 cups can be placed on the analyzer.

Figure 1.1-42 Tip tray and cup tray

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1.1.5.1 Gripper The gripper can move in three directions: • • •

X (left and right) Y (forward and back) Z (up and down)

It is also equipped with gripping fingers for gripping a tip or AssayCup. The gripping fingers grip a tip from the tip tray, or a cup from the cup tray and deliver it to the pipetting station. Then, at the appropriate time, the gripper moves the AssayCup to the incubator, then to the aspiration station, and finally to the cup disposal opening. During operation, the analyzer starts utilizing tips and cups 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. When tray 3 is empty, the analyzer returns to tray 1, if a new tray has been reloaded.

Figure 1.1-43 Gripper and trays

1.1.5.2 Cup Disposal Opening AssayCups are discarded through a cup opening located directly to the left of the incubator.

Figure 1.1-44 Cup disposal opening

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1.1.5.3 Pipetting Station A five position pipetting station is located to the upper left of the incubator. AssayCups and tips are moved by the gripper to this location for sample and reagent pipetting, sample dilution and sample pretreatment. The AssayTips are discarded at the tip eject station at the far right of the station. Positions 1 and 2 are used for tips and positions 3 and 4 are used to hold cups for dilution or pretreatment. Position 5 is the position where the S/R probe pipettes sample and reagent.

Figure 1.1-45 Pipetting station

1.1.5.4 System Water Container The system water container is located in front of the pipettors and to the right of the liquid waste container. It holds three liters of system water. 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 System Overview screen.

Note: Removing the system water container while the analyzer is in Operation causes the analyzer to enter P. Stop status.

Figure 1.1-46 System water container

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1.1.5.5 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 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.

Note: Removing the liquid waste container while the analyzer is in Operation or an improperly positioned container causes the analyzer to enter E. Stop status.

Figure 1.1-47 Liquid waste container

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1.1.5.6 Solid Waste Tray and Liner The solid waste tray and liner is located behind the front access door on the analyzer. Used AssayCups and tips are discarded into the waste tray during operation. A disposable liner (Clean-Liner) made of polystyrene is placed inside the solid waste tray. The CleanLiner has a sliding cover to reduce potential splashing and to prevent tips and cups from falling out of the tray upon removal from the analyzer. During operation, the sliding cover must be open. The tray shakes periodically during operation so that used tips and cups do not accumulate at one end of the tray. An alarm is issued when either the tray is full (max. 1100 tips and cups) or if the tray and liner are missing. The presence of a tray is monitored by a photosensor.

Note: Removing the solid waste tray while the analyzer is in Operation causes the analyzer to enter E. Stop status.

Figure 1.1-48 Solid waste tray and liner

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1.1.6 Measuring Area Components The measuring area includes the incubator, aspiration station, sipper probe, sipper rinse station, sipper pipettor, system reagents (ProCell and CleanCell) and the detection unit.

1.1.6.1 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 a cup. The incubator is equipped with 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.

Figure 1.1-49 Incubator

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1.1.6.2 Sipper Probe The sipper probe aspirates the reaction mixture into the measuring cell. ProCell and CleanCell are also aspirated by the sipper probe. The sipper probe 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 Stand-by position, the probe is located directly above the rinse station.

Figure 1.1-50 Sipper probe and rinse station

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1.1.6.3 Sipper Pipettor The sipper pipettor is located directly to the right of the sample/reagent syringe. They use positive displacement of water to aspirate and dispense from the sipper probe.

Figure 1.1-51 Sipper pipettor

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1.1.6.4 System Reagents (ProCell and CleanCell) ProCell and CleanCell are located behind the liquid waste container. ProCell is the buffer solution containing tripropylamine (TPA). These bottles are identified with white caps. CleanCell is the cleaning solution used to clean the measuring cell after measurement. CleanCell bottles are identified with black caps. The reagent compartment is keyed to ensure the correct reagent is placed in the proper position. Two bottles of each reagent are stored on the analyzer, temperature controlled at 28.0 °C ± 2.0 °C.

Figure 1.1-52 ProCell (PC) and CleanCell (CC) When starting from Stand-by, the sipper probe always attempts to first use ProCell and CleanCell from bottle set 2. If the quantity is insufficient, bottle set 1 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 one bottle set of ProCell and CleanCell reagent, but they must be placed in positions 1 & 2 or 3 & 4. Refer to the photograph above.

Note: To have access to system reagent bottles, you must open the sipper safety cover. To open

this cover, push the cover’s metal part as shown in the picture below to release the hold. To close the cover, push the same part until a click is heard.

Note: How to open the sipper safety cover

Figure 1.1-53 Opening/closing the sipper safety cover (Push the circled point)

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Figure 1.1-54 Sipper safety cover (when opened)

CAUTION •

Do not open the sipper safety cover while the analyzer is in Operation. Otherwise, the operation will stop.

•

Be sure to close the cover after you placed/replaced system reagents, or performed maintenance. Otherwise, the instrument will not operate.

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1.1.6.5 Detection Unit The detection unit is the core of the cobas e411 system. The detection unit contains the photomultiplier tube, peltier, flow-through measuring cell, magnet drive assembly and an amplifier circuit board. The temperature is maintained at 28.0 °C ± 0.3 ° C.

Figure 1.1-55 Measuring cell of the detection unit

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1.1.7 Power Components 1.1.7.1 Operation Switch The operation switch is located on the lower left front side of the analyzer. Use this switch to turn OFF the analyzer to perform certain maintenance procedures or when the system is not in use for extended periods of time (e.g., overnight). Provided the circuit breaker is ON, the reagent disk and system reagent compartment temperatures are maintained while the operation switch is OFF.

Figure 1.1-56 Operation ON/OFF switch

1.1.7.2 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. The circuit breaker must be in the I (ON) position whenever reagents are stored on the analyzer and to maintain liquid in the measuring cell. When connecting or disconnecting the host cable, power the analyzer off at the circuit breaker only

Note: 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.

Figure 1.1-57 Circuit breaker

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Figure 1.1-58

1.1.7.3 Rack Circuit Breaker There is a circuit breaker located on the left side of the rack sampler. 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 power ON and OFF the rack system.

Note: 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.

Figure 1.1-59 Rack circuit breaker

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1.1.8 Mechanical Theory 1.1.8.1 Introduction The cobas e411 analyzer automates the immunoassay reactions utilizing electrochemiluminescence (ECL). These reaction methods are described in detail in Chapter 4, ECL Technology. The individual test steps and how the system performs the necessary procedures are discussed here.

1.1.8.2 Test Protocols There are 28 test protocols or test steps that can be used on the analyzer. These protocols are predefined by Roche Diagnostics for each test and cannot be changed by the operator.

1.1.8.3 General Assay Sequence An immunological ECL test is made up of various pipetting steps, at least one incubation period and a measurement step. Generally at least three test components (sample, reagent and microparticles) are pipetted into an AssayCup. After the appropriate incubation period, the reaction mixture is aspirated into the measuring cell where the measurement process takes place. Each of the required pipetting cycles is performed within a defined period (42 seconds). The number of pipetting steps, as well as the make up of the reaction mixture are dependent on the test method (1 or 2 step test). For some methods, predilution with diluent and/or pretreatment with a special reagent is necessary. Thus the number of pipetting steps is increased. After each pipetting step the sample/reagent (S/R) probe tip is cleaned and, if necessary, the microparticle mixer and sipper probe are also cleaned. The following steps apply in principle to all methods. The sequence of the individual processes differ from test to test.

1.1.8.4 Preparative Operations Once the analyzer's power is switched ON, the initialization process is started. During initialization, the mechanisms are reset to their home positions.

1.1.8.5 Run Operation After the appropriate test selections are made in the software for patient samples, operation is started according to the predetermined test protocol for each assay selected. Initially, at least one reagent (R1 or R2) and the sample or microparticles (M) are aspirated one after another by the S/R probe. After each aspiration, the outside of the S/R probe tip is cleaned at the rinse station. The sample and reagents are dispensed into a new AssayCup and the AssayTip is ejected into the solid waste tray. For some tests that require sample dilution or pretreatment, diluent or pretreatment reagent is pipetted together with sample into an AssayCup. An aliquot of the diluted/pretreated sample is then dispensed with reagent into a second AssayCup. Therefore, certain tests with predilution/pretreatment may require two or more AssayCups.

1.1.8.6 First Incubation at 37 °C The incubation times are 4.5 or 9 minutes long, depending on the test. Some tests require only two incubation periods, whereas tests with pretreatment tests can require three incubation periods. During the incubation step(s) the immune complex products are formed.

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1.1.8.7 Additional Reagent Pipetting Some assays (usually those with multiple incubation steps) require additional reagent pipetting. As in the initial reagent pipetting step, a new pipette tip is picked up prior to reagent aspiration. The S/R probe tip is washed at the rinse station after each liquid aspiration. The liquid is then dispensed into the corresponding AssayCup where the sample and other liquids were dispensed in the first pipetting step. The probe rises while dispensing the reaction mixture back into the cup, thereby mixing the solution and accelerating the reaction in the cup. The pipette tip is ejected into the solid waste tray when pipetting is complete.

1.1.8.8 Second Incubation at 37 °C If necessary, a second incubation step (4.5 or 9 minutes) occurs. If using a pretreatment assay, the second incubation is similar to that described above for "First Incubation at 37 °C".

1.1.8.9 Additional Reagent Pipetting (Pretreatment assays) For pretreatment assays, reagent pipetting similar to that described above for “Additional Reagent Pipetting” occurs.

1.1.8.10 Third Incubation at 37 °C (Pretreatment assays) If necessary, a third incubation step (9 minutes) occurs for pretreatment assays.

1.1.8.11 Reaction Mixture Aspiration and Measurement In this process the sipper probe first aspirates ProCell (tripropylamine solution, TPA) to prepare the measuring cell. Then, the sipper probe aspirates the reaction mixture from the AssayCup and transfers it to the measuring cell. The sipper probe is washed at the rinse station and ProCell is aspirated again to rinse away the unbound reagent and sample constituents. Next, the ECL reaction in the measuring cell occurs.

1.1.8.12 Measuring Cell Cleaning Once the measurement is complete, the measuring cell is cleaned with CleanCell and prepared for a new measurement process. It takes 42 seconds (one pipetting cycle) from the aspiration of the reaction mixture by the sipper probe until the measuring cell is filled with ProCell and ready for the next sample.

1.1.8.13 Finalization 30 Minutes after documentation of the last result, the sipper pipettor flushes system water through the sipper probe, and then fills the measuring cell with ProCell before the analyzer returns to Stand-by. After this procedure periodically all 30 minutes the waste pump of the S/R rinse station is running for 2 seconds (waste consumption approx. 12 mL). This procedure will be stopped after you switch off the operation switch.

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1.1.8.14 Operation Flow in Analysis An operational flow chart is shown below.

Figure 1.1-60 Operational flow chart

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1.1.9 Detailed Assay Sequence The mechanical process of the instrument is described below using a sandwich test, TSH, as an example. This example assumes that the reagent pack was already registered by the analyzer and does not need calibration. All results are calculated based on an existing lot calibration.

1.1.9.1 Preoperation Steps When START (the Start Conditions screen) is pressed from Stand-by, the following preoperative steps occur. A. The analyzer resets all mechanisms to their respective home positions. Next, the S/R pipettor primes the S/R probe. B. The gripper checks for a tip in position number 1 of the tip trays. If this position is empty, the gripper remembers where it last left off and checks that position. If this position is empty, the gripper considers the whole tray empty and the System Overview screen is updated accordingly.

Note: If the analyzer is in S. Stop, the gripper remembers where it last left off and checks for a tip in that position.

1. During the tip check, the S/R probe is checked for the presence of a tip. The probe moves to the tip eject station and performs the movements to eject a tip. If a tip is present it is ejected. 2. After the tip check is complete, the AssayCups are checked in the same manner. During the cup check, the analyzer finishes priming the probes. 3. Next, the gripper checks the last three of the five positions on the pipetting station. If a cup is present, the analyzer goes through the steps of a cup disposal. The gripper places a tip in position 1 of the pipetting station. Then, the S/R probe picks up the tip in position 1 of the pipetting station. The S/R probe descends into the AssayCup and attempts to aspirate any possible liquid from the cup. The gripper picks up the cup and discards it into the cup disposal opening. As the cup is disposed, the S/R probe moves to the rinse station and dispenses any aspirated liquid. The tip is then washed and discarded. 4. The gripper moves to the incubator where it checks all 32 incubator positions. If a cup is present, the gripper moves the cup to position 5 on the pipetting station and uses the same procedure listed in step 3 to discard the cup. 5. The S/R probe tip is ejected after all the incubator positions are checked.

Figure 1.1-61

Dispense Reagent 1, Reagent 2 and Sample A TSH sample is present on position 1 of the sample disk. 1. After preoperation functions are complete, the gripper takes a tip from the tip tray and transports it to position 1 of the pipetting station. The gripper returns to its Stand-by position. 2. The sample disk rotates until position 1 is in the sampling position. 3. The S/R probe moves to position 1 of the pipetting station, descends to obtain the tip, rises and returns to its Stand-by position. 4. During this time, the reagent disk rotates until the TSH reagent pack is at the cap open/close mechanism. The mechanism moves forward and opens the caps on the reagent pack. The disk rotates again to move the TSH reagent to the R1 position. 5. The S/R probe moves from its Stand-by position to the R1 aspiration position. While activating liquid level detection, the probe descends until it is 2 mm below the reagent surface and aspirates 60 µL of R1. Version 1.0 – May 2006

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Note: The lowest allowable point the S/R probe can descend to is 1.3 mm above the bottom of the reagent pack.

Figure 1.1-62 While aspirating R1, the gripper puts another tip in position 1 of the pipetting station. 6. If the S/R probe does not detect liquid during descent, no reagent aspiration can occur, an alarm is generated. 7. After R1 aspiration, the S/R probe rises and moves to the rinse station. To prevent the aspirated R1 from contacting the water in the rinse station, the probe aspirates 10 µL of air. The rinse station externally washes the tip. 8. During step 7, the reagent disk rotates until the TSH reagent pack is in the R2 position. 9. The S/R probe moves from the rinse station to the R2 position while aspirating another 10 µL of air. This air layer prevents R1 from mixing with R2. While activating liquid level detection, the probe descends until it is 2 mm below the reagent surface and aspirates 50 µL of R2. While aspirating R2 the gripper moves an AssayCup to position 5 of the pipetting station. 10. Upon completion of R2 aspiration, the S/R probe rises and moves to the rinse station. To prevent the aspirated R2 from contacting the water in the rinse station, the probe aspirates another 10 µL of air. The rinse station externally washes the tip. 11. After R2 aspiration, the reagent disk rotates until the TSH reagent pack is at the cap open/close mechanism. The mechanism moves out and closes the caps. 12. The S/R probe moves from the rinse station to the sampling position while aspirating another 10 µL of air. While activating liquid level detection, the probe descends until it is 2 mm below the sample surface and aspirates 50 µL of sample. During sample aspiration, clot detection is activated.

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Figure 1.1-63

Figure 1.1-64

Note: Depending on the sample volumes and the type of vials used (e.g. primary sample tube or sample cup), the sample/reagent (S/R) probe can, when necessary, be lowered further to prevent air being aspirated. With some low capacity vials, the inside diameter is relatively small, which means the level of the liquid sinks when the liquid is being aspirated.

13. The S/R probe moves from the sampling position to position 5 of the pipetting station. The probe descends until the tip reaches 2 mm below where the calculated level of the reaction mixture surface should be and dispenses the sample, R2 and R1. The probe's downward displacement is determined by calculating the reaction mixture volume for the sample and utilizing downward displacement tables in the software. The probe does not rise during dispense. 14. After dispense, the S/R probe moves to the tip eject position and ejects the tip.

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Figure 1.1-65

Dispense Reagent 1, Reagent 2 and Sample A TSH sample is present on position 1 of the sample rack. 1. After preoperation functions are complete, the gripper takes a tip from the tip tray and transports it to position 1 of the pipetting station. The gripper returns to its Stand-by position. 2. The pusher arm pushes the racks in the A-Line forward to the B-Line. The arm returns to its home position. The first rack loads on the B-Line. 3. As the rack incrementally moves on the B-Line, the rack bar code reader scans all five rack positions and rack ID. When scanning is complete, position 1 of the rack is in the sampling position. 4. The S/R probe moves to position 1 of the pipetting station, descends to obtain the tip, rises and returns to its Stand-by position. 5. During this time, the reagent disk rotates until the TSH reagent pack is at the cap open/close mechanism. The mechanism moves forward and opens the caps on the reagent pack. The disk rotates again to move the TSH reagent to the R1 position. 6. The S/R probe moves from its Stand-by position to the R1 aspiration position. While activating liquid level detection, the probe descends until it is 2 mm below the reagent surface and aspirates 60 µL of R1.

Figure 1.1-66

Note: The lowest allowable point the S/R probe can descend to is 1.3 mm above the bottom of the reagent pack.

While aspirating R1, the gripper puts another tip in position 1 of the pipetting station. 7. If the S/R probe does not detect liquid during descent, no reagent aspiration can occur, an alarm is generated. 8. After R1 aspiration, the S/R probe rises and moves to the rinse station. To prevent the aspirated R1 from contacting the water in the rinse station, the probe aspirates 10 µL of air. The rinse station externally washes the tip. 9. During step 8, the reagent disk rotates until the TSH reagent pack is in the R2 position. 10. The S/R probe moves from the rinse station to the R2 position while aspirating another 10 µL of air. This air layer prevents R1 from mixing with R2. While activating liquid level detection, the probe descends until it is 2 mm below the reagent surface and aspirates 50 µL of R2. While aspirating R2 the gripper moves an AssayCup to position 5 of the pipetting station. Version 1.0 – May 2006

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Figure 1.1-67 11. Upon completion of R2 aspiration, the S/R probe rises and moves to the rinse station. To prevent the aspirated R2 from contacting the water in the rinse station, the probe aspirates another 10 µL of air. The rinse station externally washes the tip. 12. After R2 aspiration, the reagent disk rotates until the TSH reagent pack is at the cap open/close mechanism. The mechanism moves out and closes the caps. 13. The S/R probe moves from the rinse station to the sampling position while aspirating another 10 µL of air. While activating liquid level detection, the probe descends until it is 2 mm below the sample surface and aspirates 50 µL of sample. During sample aspiration, clot detection is activated.

Figure 1.1-68

Note: Depending on the sample volumes and the type of vials used (e.g. primary sample tube or sample cup), the sample/reagent (S/R) probe can, when necessary, be lowered further to prevent air being aspirated. With some low capacity vials, the inside diameter is relatively small, which means the level of the liquid sinks when the liquid is being aspirated.

14. The S/R probe moves from the sampling position to position 5 of the pipetting station. The probe descends until the tip reaches 2 mm below where the calculated level of the reaction mixture surface should be and dispenses the sample, R2 and R1. The probe's downward displacement is determined by calculating the reaction mixture volume for the sample and utilizing downward displacement tables in the software. The probe does not rise during dispense. 15. After dispense, the S/R probe moves to the tip eject position and ejects the tip.

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1.1.9.2 First Incubation 1. The gripper grasps and transports the cup containing the reaction mixture from the pipetting station to the incubator. 2. The cup is incubated at 37 °C for 9 minutes. 3. During incubation, the analyzer continues to perform operations for other test(s) or sample(s), if necessary.

1.1.9.3 Microparticle Preparation Before the first incubation is completed, the TSH microparticles are mixed to facilitate microparticle aspiration and dispense. 1. The reagent disk rotates until the TSH reagent pack is at the reagent cap open/close mechanism. The mechanism moves out and opens the cap. The disk moves the reagent pack to the mixing position. 2. The mixer moves over the reagent disk and descends into the microparticles to a level 1.4 mm above the bottom of the bottle.

Figure 1.1-69

Note: The mixer descends to this level regardless of the volume of microparticles in the bottle. 3. The mixer stirs the microparticles for approximately 4 seconds to obtain a homogeneous suspension. During the mixing, the gripper obtains a fresh AssayTip and transports it to position 2 of the pipetting station. 4. When mixing is complete, the mixer rises and returns to the rinse station where it descends and rotates in the rinse station for washing. 5. At the same time, the reagent disk rotates the TSH reagent pack to the microparticle pipetting position.

1.1.9.4 Microparticle Aspiration and Dispense 1. The gripper grasps the incubating cup and transports it to position 5 of the pipetting station. 2. The S/R probe moves to the pipetting station and obtains the fresh tip and moves to the microparticle pipetting position. 3. While activating the liquid level detection, the S/R probe descends to 2 mm below the reagent surface and aspirates 40 µL of microparticles. 4. After reagent aspiration, the S/R probe rises, moves to position 5 of the pipetting station and descends to dispense the microparticles. 5. After dispense, the S/R probe descends further until it is 0.8 mm above the bottom of the cup and aspirates the entire volume of reaction mixture. The probe rises while dispensing the reaction mixture back into the cup, thereby mixing the solution and accelerating the reaction in the cup. This mixing takes place only once. Version 1.0 – May 2006

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6. The S/R probe moves to the tip eject position and discards the tip.

Figure 1.1-70

1.1.9.5 Second Incubation 1. The gripper grasps the cup containing the mixed reaction mixture and returns it to the incubator. 2. The cup is incubated at 37 °C for 9 minutes. 3. During incubation, the analyzer continues to perform operations for other test(s) or sample(s), if necessary.

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1.1.9.6 Measurement Process Preparations Before the second incubation is completed, the sipper probe aspirates ProCell into the measuring cell to facilitate measurement. 1. The sipper probe moves from its home position to a ProCell bottle and descends to 2 mm below the solution level and aspirates ProCell into the measuring cell. During descent, liquid level detection is activated.

Note: The sipper probe can descend as low as 1.3 mm above the bottom of the ProCell bottle. 2. The sipper probe rises.

1.1.9.7 Measurement Process 1. The gripper grasps and transports the cup that has completed its second incubation from the incubator to the aspiration station. 2. The sipper probe moves to the aspiration station and descends into the cup until it is 0.8 mm above the cup bottom. This descent is independent of the reaction mixture volume. 3. When the sipper probe detects the reaction mixture in the cup, it aspirates 150 µL. 4. After aspiration, the sipper probe rises, aspirates 10 µL of air and moves to the sipper rinse station to descend for rinsing. 5. The gripper grasps the cup from the aspiration station, transports it to the cup disposal opening and discards the cup. 6. The sipper probe is rinsed. 7. The sipper probe rises and moves to the ProCell position, descends into the bottle and aspirates ProCell in a set aspiration/dispense sequence. The immune complex is captured by the magnet onto the electrode of the measuring cell. The ProCell washes away all unbound reagent and serum constituents. 8. After the bound-free separation, a voltage is applied between the working electrode and the counter electrode. The ECL reaction is initiated and measured by the photomultiplier. 9. After measurement, the sipper probe rises and moves to the CleanCell position and aspirates 20 µL of air. The probe then descends into the CleanCell bottle and aspirates reagent. This procedure is repeated eight times. The alternate flow of air and cleaning solution washes the measuring cell. During this washing process, a voltage is applied between the electrodes, which aids in the cleaning process. 10. The sipper probe moves to the sipper rinse station, aspirates 20 µL of air and descends into the rinse station for washing. 11. Finally, the sipper probe rises and moves to the ProCell bottle. The probe descends into the bottle and aspirates 500 µL of ProCell. Next, the probe aspirates 90 µL of ProCell and moves to the rinse station. At the rinse station, the probe dispenses 35 µL to flush the probe and prepare it for the next sample. During the aspirations of the ProCell, a sequence of voltages is applied three times to prepare the electrodes for the next measurement. One cycle of the measurement process consumes approximately 2 mL each of ProCell and CleanCell.

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1.1.9.8 Signal Detection and Conversion The measuring cell is kept at a constant 28 °C throughout the measurement process. The photomultiplier tube detects and converts the ECL signal into an electric signal from which the e411 calculates assay results. For details on this process, refer to Chapter 4, ECL Technology.

1.1.9.9 Automatic Analyzer Cycles There are certain analyzer functions that occur automatically while the analyzer is powered ON. • • • • •

While in Operation, the solid waste tray periodically shakes for 1.5 seconds. While in Stand-by, the reagent disk turns 90° every 30 minutes. While in Stand-by, the rinse stations for the S/R probe and sipper probe are switched on for 3 seconds every 30 minutes. Microparticles undergo a long mix when starting from Stand-by and then every 90 minutes, when pipetting not yet started. Microparticles undergo a short mix (approx. 4 seconds) and then a short mix every 60 minutes for each reagent pack.

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1.1.10 Dilution Steps The following is a description of how an assay with a dilution is performed, including the number of AssayTips and AssayCups used in the process.

1.1.10.1 Assay With One Step Dilution (1:2, 1:5, 1:10, 1:20) Tip 1 -> diluent (wash)* + sample

-> cup 1

Tip 2 -> R1 (wash)* + R2 (wash)* + diluted sample from cup 1

-> cup 2 ... 1st incubation

Tip 3 -> M (wash)*

-> cup 2 ... 2nd incubation

Detection * (wash) = the outside of the AssayTip is washed. R1 = Reagent 1 R2 = Reagent 2 M = Microparticles

1.1.10.2 Assay With Two Step Dilution (1:20, 1:50, 1:100, 1:400) Tip 1 -> diluent (wash)* + sample Tip 2 -> R1 (wash)* + diluted sample from cup 1 Tip 3 -> R1 (wash)* + R2 (wash)* + diluted sample from cup 2 Tip 4 -> M (wash)*

-> cup 1 -> cup 2 -> cup 3 … 1st incubation -> cup 3 … 2nd incubation

Detection * (wash) = the outside of the AssayTip is washed. R1 = Reagent 1 R2 = Reagent 2 M = Microparticles

1.1.10.3 Pretreatment Steps In certain test protocols, pretreatment reagent is added prior to R1, R2 or M.

Pretreatment Assay (3 tips and 1 cup) Tip 1 -> PT1 (wash)* + PT2 (wash)* + sample Tip 2 -> R1 + pretreated sample in cup 1 Tip 3 -> M (wash)* + R2 + reaction mixture in cup 1

-> cup 1 -> cup 1 -> cup 1

1st incubation 2nd incubation 3rd incubation

Detection * (wash) = the outside of the AssayTip is washed. PT1 = Pretreatment 1 PT2 = Pretreatment 2 R1 = Reagent 1 R2 = Reagent 2 M = Microparticles

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1.1.11 Analyzer Status Conditions 1.1.11.1 Introduction The e411 analyzer can occupy a number of status conditions. A table of the status conditions you normally see during routine operation or maintenance procedures is listed below. There are several other conditions that exist; however, most of these status conditions are seen during various adjustment or maintenance procedures performed by a Roche Diagnostics representative. These additional status conditions are not included in the table below.

Figure 1.1-71

1.1.11.2 A. Stop (Analyzer Stop) The analyzer is no longer able to continue operation. An alarm was issued. Take the appropriate measures to resolve the problem. For further details on A. Stop, refer to Chapter 7, Instrument Alarms - List.

Figure 1.1-72

1.1.11.3 A. Stop/L. Stop (Analyzer Stop/Line Stop) The analyzer is already in A. Stop status when the lines stop operation. For further details on A. Stop and L. Stop, refer to Chapter 7, Instrument Alarms – List.

Figure 1.1-73

1.1.11.4 A. Stop/R. Stop (Analyzer Stop/Rack Stop) The analyzer is already in A. Stop status when the A-Line stops supplying racks to the B-Line. For further details on A. Stop and R. Stop, refer to Chapter 7, Instrument Alarms - List

1.1.11.5 BC card scan This status is seen when a bar code card scan is initiated from the BC Read pop-up window (QC/Calibration -> Install -> touch the Scan BC Card button).

1.1.11.6 E. Stop (Emergency Stop) An emergency stop condition exists. An alarm was issued. Take the appropriate measures to resolve the problem. For further details on E. Stop, refer to Chapter 7, Instrument Alarms - List.

1.1.11.7 Finalization The status of the analyzer when it is between the status conditions S. Stop and Stand-by.

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1.1.11.8 Finalization maint. This status occurs when Finalization Maintenance is initiated from the Finalization Maintenance popup window (Utility -> Maintenance -> select “Maintenance” from the maintenance type list -> select “Finalization Maintenance” from the maintenance items list -> then touch the Select button).

1.1.11.9 Initialization This status is seen when the e411 is powered ON or when START is pressed from Stand-by.

Figure 1.1-74

1.1.11.10 L. & A. reset all (Line & Analyzer) L. and A. reset all status occurs when the corresponding function is initiated from the L. and A. Rest All pop-up window (Utility -> Maintenance -> select “Maintenance” from the maintenance type list -> select “L. And A. Reset All” from the maintenance items list -> then touch the Select button). This function resets the analyzer and the lines.

Figure 1.1-75

1.1.11.11 L. Stop (Line Stop) All lines stop operation. An alarm was issued. Take the appropriate measures to resolve the problem. For further details on L. Stop, refer to Chapter 7, Instrument Alarms – List.

1.1.11.12 Liquid flow cleaning Liquid flow cleaning occurs when this function is initiated from the Liquid Flow Cleaning pop-up window (Utility -> Maintenance -> select “Maintenance” from the maintenance type list -> select “Liquid Flow Cleaning” from the maintenance items list -> then touch the Select button).

1.1.11.13 M. Cell preparation Measuring cell (M. Cell) preparation occurs when this function is initiated from the Measuring Cell Preparation pop-up window (Utility -> Maintenance -> select “Maintenance” from the maintenance type list -> select “Measuring Cell Preparation” from the maintenance items list -> then touch the Select button).

1.1.11.14 Operation This is the status during which the e411 performs its routine operations.

1.1.11.15 P. Stop (Partial Stop) A partial stop condition exists. An alarm was issued. Take the appropriate measures to resolve the problem. For further details on P. Stop, refer to Chapter 7, Instrument Alarms - List.

Figure 1.1-76

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1.1.11.16 R. Stop (Rack Stop) This status occurs when there are no more racks to process on the A-Line or B-Line.

Figure 1.1-77

1.1.11.17 Rack clear Rack clear status occurs when the corresponding function is initiated from the Rack Clear pop-up window (Utility -> Maintenance -> select “Maintenance” from the maintenance type list -> select “Rack Clear” from the maintenance items list -> then touch the Select button). This function clears any remaining racks on the A-, B- or C-Lines.

1.1.11.18 Reagent scan This status is seen when a reagent scan is initiated from the RScan pop-up window (Reagent -> Setting -> RScan button).

1.1.11.19 S/R pipettor prime This status occurs when the S/R pipettor prime is initiated from the S/R Pipettor Prime pop-up window (Utility -> Maintenance -> select “Maintenance” from the maintenance type list -> select “S/R Pipettor Prime” from the maintenance items list -> then touch the Select button).

1.1.11.20 S/R probe LLD volt. This status is seen when the analyzer is monitoring the liquid level detection voltage of the S/R probe. The check is initiated from the S/R Probe LLD Check pop-up window (Utility -> Maintenance -> select “Check” from the maintenance type list -> select “S/R Probe LLD Check” from the maintenance items list -> then touch the Select button).

Figure 1.1-78

1.1.11.21 S. Stop (Sampling Stop) This status occurs when the S. Stop global button is pressed or when sampling is complete.

Figure 1.1-79

1.1.11.22 S. Stop-S. Scan The analyzer is in S. Stop and a sample scan is requested from the Sample Tracking screen.

Figure 1.1-80

1.1.11.23 Sample scan This status occurs when a sample scan is initiated from the Sample Tracking screen. Version 1.0 – May 2006

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1.1.11.24 Sipper LLD volt. The analyzer is monitoring the liquid level detection voltage of the sipper probe. The check is initiated from the Voltage Monitor pop-up window (Utility -> Maintenance -> select “Maintenance” from the maintenance type list -> select “Voltage Monitor” from the maintenance items list -> then touch the Select button).

1.1.11.25 Sipper pipet. prime This status occurs when the sipper prime is initiated from the Sipper Pipettor Prime pop-up window (Utility -> Maintenance -> select “Maintenance” from the maintenance type list -> select “Sipper Pipettor Prime” from the maintenance items list -> then touch the Select button).

1.1.11.26 Stand-by The analyzer is not performing any operations.

1.1.11.27 Stop This status occurs when the Stop global button is pressed or when a Stop alarm condition exists. If an alarm exists, take the appropriate measures to resolve the problem. For further details on Stop, refer to Chapter 7, Instrument Alarms - List.

1.1.11.28 System reset A system reset is initiated from the System Reset pop-up window (Utility -> Maintenance -> select “Maintenance” from the maintenance type list -> select “System Reset” from the maintenance items list -> then touch the Select button).

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1.2 Technical Data 1.2.1 Technical Data for Operation of Instrument 1.2.1.1 Instrument Dimensions Analyzer

Height 31.4 in 80 cm [43 in, 109 cm with top cover opened] [24.2 in, 61.5 cm without control unit]

Depth 29.4 in 74.5 cm

Width 47.2 in 120 cm

Weight 375 lbs 170 kg

31.4 in 80 cm [43 in, 109 cm with top cover opened] [24.2 in, 61.5 cm without control unit]

37.4 in 95 cm

67 in 170 cm

529 lbs 240 kg

1.2.1.2 Electrical Installation requirements

AC Cord For countries which require UL and CSA compliance Recommended rate Supply voltage : 115 V Supply voltage : 208 or 240 V Temperature rate Whole length Safety Standard For European countries Recommended rate Supply voltage : 220 to 240 V Temperature rate Whole length Safety Standard Connector Type connected to e411 inlet Supply voltage/frequency

Power consumption Heat generation Version 1.0 – May 2006

Pollution degree: 2 (IEC 61010-1) Overvoltage category: II (IEC 664) The cobas e411 analyzer must be connected to a three-wire power supply cord with a safety ground. A UL-listed and CSA-certified AC cord set must be used. (A cord with a plug and a connector) AC125V-15A / SJT type 3×14AWG AC250V-10A / SJT type 3×16AWG Min 60°C 2500±50mm UL817 / CSA C22.2 No.21 An HAR-certified AC cord must be used. (A cord with a plug and a connector) AC250V-10A / 3×1.0 mm2 Min 60°C 2500±50mm CENELEC HD21 IEC320 / EN60320 type

100-240 VAC 50/60 Hz Single-phase The ratings of the AC cord set to be used must be consistent with the ratings of the customer equipment. Disk system: 1000VA Rack system: 1250VA (Rack sampler unit: 250VA) Analyzer unit: approx. 2,879 kJ/hr resp. 1 - 52

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Main supply voltage fluctuation

688 kcal/hr resp. 2,730 Btu/hr Rack sampler unit: approx. 899 kJ/hr resp. 215 kcal/hr resp. 853 Btu/hr ±10% of nominal voltage (90 VAC to 264 VAC)

1.2.1.3 Environmental Conditions Temperature

Temperature variation Humidity Indoor use only Altitude up to 2000m

During measurement 18 °C to 32 °C (64.4 °F to 89.6 °F) Max. ± 2 °C/hour (Max. ± 3.6 °F/hour) 20% to 80%

During transportation and storage -20 °C to 75 °C (-4 °F to 167 °F) 5% to 95%

1.2.1.4 Noise Level (DIN 43635) Stand-by level Operation level (average) Operation level (maximum)

60 dBA 63 dBA 70 dBA

1.2.1.5 Water Supply Water container Water requirements Water consumption

3 Liters < 10 µS/cm or > 0.1 megohm, bacteria-free approx. 3 L for 250 tests approx. 12 mL/cycle

1.2.1.6 Liquid Waste Liquid waste container

4 Liters

1.2.1.7 Throughput Rate Assay measurements

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1.2.1.8 Sampling System Sample/Reagent pipettor principle Sample volume per test Sample detection Sample loading capacity

conductive disposable tip handling 10 µL to 50 µL Liquid level detection and clot detection

Figure 1.2-1 30 positions for samples, controls and calibrators Figure 1.2-2 tray - 15 racks with 5 positions each for samples, controls and calibrators = 75 tray with input buffer - 20 racks with 5 positions each = 100 STAT capacity

Figure 1.2-3 any unoccupied position on the sample disk Figure 1.2-4 Bar code symbologies

AssayTips AssayCups Sample cups Primary sample tubes (external diameter x height):

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STAT position at the front of the analyzer PDF417 NW7 (Codabar) Code 39 Code 128 Interleaved 2 of 5 360 tips (3 trays; 120 tips/tray) 180 cups (3 trays; 60 cups/tray) 2 mL (Standard) Hitachi cup; NO micro cups 13 x 75 mm 16 x 75 mm 13 x 100 mm 16 x 100 mm

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1.2.1.9 Sample Barcode Specification Table 1.2-1 No. of ID digits Code symbol NW7:

No. of ID digits 3 to 13 digits (w/o check digit) 6 digits + 1 digit (with check digit)

Code 39:

3 to 13 digits (w/o check digit) 3 to 13 digits + 1 digit (with check digit) 4 to 12 digits (w/o check digit) 3 to 13 digits + 1 digit (with check digit) Set C; 4 to 12 digits + 2 digits (with check digit)

Interleaved2 to 5: Code 128:

Check character format Modulus 16, Modulus 11, Weight Modulus 11, Modulus 10/2 Weight, Modulus 10/2 Weight-A, Modulus 10/3 Weight and 7 check DR;Configurable via software. Modulus 43 Modulus 10 alternate 1, 3 weight Modulus 103

“NW 7” allows the use of 6 digits + 1 digit with check digit. In case of “Interleaved 2 to 5”, the number of ID digit is fixed (at an even number of digit). For “Code 128”, the check digit should be always given. With or w/o check digit has to be chosen. Mixed use is not available. Table 1.2-2 Character usable for ID NW7:

0 to 9 (w/o check digit) 0 to 9, -, /, ., $, :, + (with check digit) 0 to 9, A to Z, -, /, ., +, [space], $, % 0 to 9 Alphanumeric characters, excluding Non-data function characters and code set selection characters.

Code 39: Interleaved 2 to 5: Code 128: Label size

The label size when attaching it with reference to the uppermost edge of the test tube mouth is shown in Figure 1.2-6. A quiet zone of more than 5mm should be provided at both ends of the symbol as shown in Figure 1.2-5. However, for RD calibrator/control vials, a quiet zone of more than 3mm should be provided at both ends of the symbol as shown in Figure 1.2-6.

Bar and Space Minimum bar (space) width: Ratio of narrow bar (space) to wide bar (space):

>0.19mm 1 : 2.5 to 3

Reference and PCS value (The values comply with the ANSI X3.182:Bar Code Quality Guideline) Reference of space: PCS value:

70% or higher 0.7 or more

Color Bar: Space:

Black White

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Figure 1.2-5 Bar code label

Figure 1.2-6 Bar code read zone

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The bar code label must be attached to each test tube in bar code zone as shown in Figure 1.2-7.

Figure 1.2-7 Attachment of Bar code label to Test Tube and vial 1 2 3 4

Test tube Bar code zone Vial Bar code label

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Sample ID, when using the secondary tube for sample vessel, is by putting sample cup on the test tube with bar code label (Cup on Tube) as shown in Figure 1.2-8, Figure 1.2-9. Setting Procedure 1 Sample Cup + Test Tube

Method Assembly

Setting Procedure 2 Test Tube alone

Figure 1.2-9 Sample ID by Cup on Tube

Figure 1.2-8 Sample ID by Cup on Tube 1

Sample cup

2

Test Tube

3

Bar code label

1

Test tube

Figure 1.2-10

Sample Disk dead volume Sample Container

"Normal" dead volume

Tube height

"Reduced" dead volume

standard Hitachi cup directly on the sample disk standard Hitachi cup on top of a primary sample tube (o = 16 mm) standard Hitachi cup on top of a primary sample tube (o = 16 mm) primary sample tube (o = 13 mm)

--

200 µL

100 µL

75 mm

200 µL

150 µL

100 mm

200 µL

150 µL

75 mm

600 µL

--

primary sample tube (o = 13 mm)

100 mm

600 µL

--

primary sample tube (o = 16 mm)

75 mm

1000 µL

--

primary sample tube (o = 16 mm)

100 mm

1000 µL

--

calibrator/control vial

--

150 µL

∗

1: There is no assignation of “Normal” or “Reduced (Others)” for the dead volume of RD Calibrator/Control vial.

CAUTION A reduced dead volume may only be used with Hitachi standard cups (not with primary or secondary cups).

Figure 1.2-11 Table 1.2-3 Sample Rack dead volume Version 1.0 – May 2006

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Sample Container

Tube height

"Normal" dead volume

"Reduced" dead volume

standard Hitachi cup directly on the sample rack standard Hitachi cup on top of a primary sample tube (o = 16 mm) standard Hitachi cup on top of a primary sample tube (o = 16 mm) primary sample tube (o = 13 mm)

--

200 µL

100 µL

75 mm

200 µL

100 µL

100 mm

150 µL

100 µL

75 mm

600 µL

--

primary sample tube (o = 13 mm)

100 mm

600 µ

--

primary sample tube (o = 16 mm)

75 mm

1000 µL

--

primary sample tube (o = 16 mm)

100 mm

1000 µL

--

calibrator/control vial

--

150 µL

∗

1: There is no assignation of “Normal” or “Reduced (Others)” for the dead volume of RD Calibrator/Control vial.

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Reagent System Reagent disk temperature Reagent capacity

R1/R2 consumption Microparticle consumption Reagent detection Positive reagent identification Automatic dilution Evaporation protection Inventory control

20 °C ± 3 °C (68 °F ± 5.4 °F) in any combinations in 18 reagent positions with the exception of the following restrictions: At the same time not more than 18 tests, 9 pretreatments or 8 diluents. 50 to 80 µL per reagent dependent upon the assay 30 to 50 µL dependent upon the assay liquid level detection 2-dimensional bar code (PDF417) available up to 1:400 reagents are automatically opened and closed automatic based on counting (reagent disk) or liquid level detection (ProCell/CleanCell)

Incubation System Incubator capacity Volume of AssayCups Incubation temperature

32 AssayCups 200 µL 37.0 °C ± 0.3 °C (98.6 °F ± 0.5 °F)

Measuring System Measuring method Calibration mode Test protocols ProCell consumption CleanCell consumption Cycle time

integral measuring of an electrochemiluminescence signal 2-point calibration 28 test methods approx. 2 mL per cycle approx. 2 mL per cycle 42 sec.

Control Unit Compact flash card Host interface

External printer Optional module Touchscreen monitor

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CCITT V. 24/RS-232-C (bidirectional) The host computer should comply with the requirements of IEC (60950). Connected via the USB port Laboratory System Manager (LSM) 38 cm (15 in) color TFT-LCD, XGA

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1.3 Potential Hazard and Safety Precautions 1.3.1 Safety Classifications Before operating with the cobas e411, it is essential that the warnings, cautions, and safety requirements contained in this manual, as well as the explanation of warning and biohazard symbols marked on the analyzer are read and understood by the service engineer. This section explains how precautionary information is formatted in this manual. See 1.3.3 “Safety Labels of the System” in this chapter. The safety precautions and important user notes are classified according to ANSI Z535 standards. Familiarize yourself with the following meanings and icons:

WARNING Indicates a possibly hazardous situation which, if not avoided, may result in death or serious injury. Indicates documentation must be consulted in all cases where this symbol is marked.

WARNING Indicates that samples containing material of human origin must be treated as potentially infectious. The relevant laboratory guidelines on safe use must be observed.

CAUTION Indicates a possibly hazardous situation which, if not avoided, may result in slight or minor injuries, damage to equipment, inaccurate results or loss of result data. “Minor injury” refers to injuries that may require medical assistance. “Equipment” refers to extended damage to buildings, furniture, and so on.

Note: Notes contain information about a topic in the text.

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1.3.2 Safety Information Make sure that you follow the safety precautions and instructions described in this manual. Otherwise, personal injuries, damage to the instrument or malfunctions may result. For corresponding labels and their positions, see Safety Labels on the cobas e411. •

DO NOT open the back cover and service cover with the power switch or circuit breaker turned on. Otherwise, you may receive an electrical shock.

•

DO NOT open the Detection unit cover with the power switch or circuit breaker turned on. Otherwise, you may receive an electrical shock. Corresponding label: L

•

DO NOT open the cover of the PMT high voltage supply circuit board with the power switch or circuit breaker turned on. Touching the board may cause death or severe injury. Corresponding label: K

•

Before starting operation or after maintenance/checks, be sure that all analyzer covers are closed. DO NOT open the analyzer covers while the analyzer is in operation.

•

Avoid touching the A-, B-, or C-Lines, sample/reagent probe mechanism, sipper probe mechanism, gripper (tip/cup carrier) mechanism, beads mixing mechanism, cap opener mechanism, and other moving parts while the analyzer is operating. therwise, personal injury may result. Corresponding label: C (for the cap opener mechanism)

•

Make sure the analyzer is in S. Stop status when you load additional samples onto the sample disk or remove processed samples from the sample disk while the analyzer is operating. Otherwise, personal injury may result.

•

Verify there is no rack movement and rack indication light is green when you load additional sample racks on the A-Line or remove processed sample racks from the C-Line while the analyzer is operating. Otherwise, personal injury may result.

•

DO NOT wear loose garments or jewelry that could catch in moving mechanisms and cause you to hit other mechanisms.

•

Before placing additional samples onto the sample disk, or replacing the sample disk during operation, make sure that the analyzer is in S. Stop status. And then be sure to raise the sample disk protective cover before placing the samples or taking out the disk.

•

Avoid touching the cooling fan of the detection unit while the analyzer is operating. Otherwise, personal injury may result. To clean the fan, be sure to turn OFF the analyzer.

•

DO NOT insert your finger into the openings on the reagent disk cover. Otherwise, personal injury may result.

•

Open/close the analyzer top cover quietly. Otherwise, personal injury may result.

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•

Use the personal protective equipment (such as rubber gloves, lab coat, safety glasses, etc.) recommended by your facility when handling biohazardous materials.

•

Be sure to wear personal protective equipment (such as rubber gloves, lab coat, safety glasses, etc.) before performing any maintenance/checks, and follow the procedure described in this manual.

•

Avoid direct contact with samples, which may be biohazardous materials. If sample spills on the analyzer, wear protective equipment and wipe it off immediately and apply disinfectant.

•

Avoid direct contact with the sample/reagent probe, sample disk protective cover, sipper probe, and rinse stations. Treat these components as potentially biohazardous area. Corresponding label: A, B and E

•

Avoid direct contact with waste solution and/or solid waste. Both should be handled as potentially biohazardous materials. Corresponding label: H and I

•

Before any maintenance/checks, be sure to wear protective equipment (such as rubber gloves, lab coat, safety glasses, etc.) and follow the instruction specified in this operational manual.

•

Direct contact with sample may result in infection. Be sure to wear protective equipment and follow the instruction specified in this operational manual.

•

If sample or reagent contacts your skin, wash it off immediately with water and apply a disinfectant. Consult a physician.

•

DO NOT wear loose garments or jewelry that could catch in moving mechanisms and cause you to make contact with the sipper or S/R probe and lead you to infection. Corresponding label: A and E

•

Avoid direct contact with CleanCell. Direct contact with the reagent may result in skin irritation or damage. Refer to the CleanCell box label for specific instructions. Corresponding label: G

•

Avoid direct contact with reagents. Direct contact with reagents may result irritation or damage in the skin. Refer to the reagent kit box labels for instructions.

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.

Avoid using dangerous flammables around the instrument. Fire or explosion may be caused by ignition.

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Isopropyl alcohol is a highly flammable material. When performing maintenance using isopropyl alcohol, make sure there are no open flames around. Otherwise, a fire and severe burns may result.

•

Dispose of waste solution and/or solid wastes according to the relevant governmental regulations

•

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

•

Avoid all kinds of liquid spillage on the instrument.

Power must be off to move mechanical components. If power is on, the motors are engaged and attempted movement may damage these components.

•

DO NOT touch the sampling, sipper, gripper, or microparticle mixer mechanisms until the analyzer enters S. Stop status. Instrument malfunctions or damage may result.

•

Be careful not to damage the lower end of the S/R probe during cleaning.

Make sure the analyzer is in S. Stop status when you load additional samples onto the sample disk or remove processed samples from the sample disk while the analyzer is operating. Otherwise, the instrument may be damaged or operation may be stopped.

•

DO NOT touch the reagent disk while the analyzer is in operation. Otherwise, the instrument may be damaged, or operation may be stopped.

•

DO NOT open the reagent disk cover, except for replacement of reagents. Otherwise, this may compromise the cooling efficiency or cause deterioration of the reagents. Opening of the cover during analysis also causes an instrument alarm.

•

Be sure to put the cover on the reagent disk before you start operation or after you placed/replaced reagents. Otherwise, operation will not start.

Verify that the lights on the rack sampler is green, prior to adding a new rack or tray to the A-Line or removing a tray of processed samples from the C-Line while the analyzer is in Operation. Otherwise, the instrument may be damaged or operation may be stopped.

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Be careful not to bend the microparticle mixer. A bent mixer could lead to inaccurate results.

Be careful not to damage the lower end of the sipper probe during cleaning.

•

Do not open the sipper safety cover while the analyzer is in operation. Otherwise, the operation will stop. DO NOT open the sipper safety cover unless the analyzer is in Stand-by.Corresponding label: F

•

Be sure to close the cover after you placed/replaced system reagents, or performed maintenance. Otherwise, the analyzer will not operate. Corresponding label: F

•

To open/close the sipper safety cover, press the proper spot that is indicated in this manual. See 1.1.6 Measuring Area Component.

Insoluble contaminants such as fibrin and dust in samples may cause probe clogging and thus lead to pipetting volume shortage and deterioration in measurement accuracy. When loading samples on the analyzer, make sure that samples contain no insoluble contaminants such as fibrin or dust.

On occurrence of momentary power voltage drop due to power interruption or lightning, the control unit of the instrument may become faulty, or the system software, application software or data may 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. Sample or reagent spillage on the instrument surface may cause instrument malfunctions. DO NOT place samples or reagents on the instrument unless otherwise indicated.

If a malfunction occurs in the touch screen monitor and you cannot use it, contact a Roche Diagnostics service representative. And in such cases, please use the auxiliary USB mouse to operate the instrument until the service representative arrives.

•

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

•

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

•

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

•

Films or bubbles in sample or reagent may cause pipetting volume shortages and thus lead to inaccurate measurement results. Before you set samples or reagents, check if there are films or bubbles in them.

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•

This instrument is designed for clinical immunological test analysis using water-soluble samples and reagents.

•

Please note that other analyses may not be applicable to this instrument.

•

Operation should be conducted under the management of a technician who has undergone training at the facility specified by the sales agent. ( For clinical tests, the instrument should be used under the management of a doctor or clinical inspector.

•

During operation and maintenance of the instrument, proceed according to the instructions and do not touch any parts of the instrument other than those specified.

•

Carefully follow the procedures specified in the operator’s manual and this manual for maintenance of the analyzer.

•

AssayCups, AssayTips, the detection unit and liquid waste container or solid waste tray and liner are not guaranteed to be chemically resistant against organic solvents. Therefore, do not use organic solvents on these parts.

•

Avoid using samples and reagent solutions that are likely to adhere to AssayTips, AssayCups, the liquid waste container or detection unit.

Never switch on the power within one second of switching it off.

If the instrument will not be used for a long period of time (i.e., > 7 days), Different shutdown procedures are recommended depending upon the duration of inactivity.

Devices that emit electromagnetic waves may affect measured data, or cause the instrument to malfunction. DO NOT operate the following devices in the same room where the instrument is installed: Mobile phones, cordless phones, other electrical devices that generate electromagnetic waves. •

Only trained Roche Support personnel, or similarly qualified personnel supervised by authorized service agents of Roche Diagnostics, are qualified to install, transport, and dispose of the cobas e411.

•

At least two persons must carry the instrument, by holding the base plates on the left side and right side of the analyzer. Be careful not to hurt your hands or fingers when putting the instrument in place.

•

Follow the specified installation conditions carefully. Otherwise, inaccurate results or damage to the analyzer may occur.

•

The cobas e411 is provided with more than one power supply cords. Make

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A reduced dead volume may only be used with Hitachi standard cups (not with primary or secondary cups).

Micro cups cannot be used on the e411 analyzer!

Be sure to lay down the sample disk protective cover before you start operation.

If you load additional AssayTip/Cup trays onto the analyzer while the analyzer is in operation, be sure to place them only in the positions indicated by the software screen as accessible.

When loading a rack into the STAT position, check the orientation of the rack. An improperly oriented rack may cause instrument damage. Corresponding label: J

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1.3.3 Safety Labels on the cobas e411

Figure 1.3-1

Figure 1.3-2

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Figure 1.3-3 Table 1.3-1 Symbol

Validity S/R Probe

Position A

Sample Disk Protective Cover Sipper Probe

E

Liquid Waste Tank

H

Solid Waste Tray

I

Cap Opener

C

STAT position

J

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Validity Sipper Safety Cover

Position F

S/R Probe, Sipper Probe Cover of the PMT high voltage supply circuit board Cover of Detection Unit

D

Liquid Waste Tank

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1.3.4 Approvals The cobas e411 analyzer meets the requirements stated in 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 e411 analyzer is manufactured and tested according to International Standard IEC 61010-1, "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 for the USA, CSA CSA 22.2 No. 61010-1-4 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 USA.

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1.4 System Label 1.4.1 Disk System

Figure 1.4-1

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Figure 1.4-2

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1.4.2 Rack System

Figure 1.4-3

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Figure 1.4-4

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2.1 Site Requirements 2.1.1 Delivery Space Requirements 2.1.1.1 Receiving A loading dock or other suitable facility is needed to allow the analyzer to be safely unloaded.

2.1.1.2 Routing It is necessary to move the analyzer safely from the unloading point to the proposed point of operation. Following spaces are required: • • •

Minimum door width is 91 cm or more (36 in. or more). Loading size & capacity of elevator, if required, are 135 cm x 91 cm (54 in x 36 in) or more and 207 kg (595 lbs). Minimum turning radius is 163 cm (65 in).

Note: The size and weight in the packing of e411 are as following Table 2.1-1 Packed e411(main body only) Packed Rack Sampler

LxWxH 135 x 91 x 86 cm (54 x 36 x 34 in) 110 x 82 x 60 cm (44 x 33 x 24 in)

Weight 207 kg (595 lbs) 69 kg (152 lbs)

2.1.2 Physical Space and weighs Requirements To install the cobas e411 analyzer, you are required to provide: •

A firm table and floor that is level and solid enough to bear the weight of the instrument. The disk system weighs approximately 180 kg (397 lbs). The rack system weighs approximately 250 kg (551 lbs).

•

Adequate space around the instrument for ventilation, maintenance and easy access to power inlets:

For the disk system, allow at least 100 cm (39.3 in) on the front, 10 cm (3.9 in) on the rear 50 cm (19.6 in) on the right side, and 10 cm (3.9 in) on the left side of the instrument. For the rack system, allow at least 100 cm (39.3 in) on the front, 10 cm (3.9 in) on the rear, 50 cm (19.6 in) on the right side, and 50 cm (19.6 in) on the left side of the instrument.

Note: Please refer to Figure 2.1-1.

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2.1.2.1 Installation diagram

Figure 2.1-1

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An appropriate grounding system

The installation site must have a grounding system with less than 10 ohms of resistance.

Grounding

Figure 2.1-2

2.1.3 Ambient Condition Requirements See Chapter 1.2.1 Technical Data for Operation of Instrument

2.1.4 Electrical Requirements See Chapter 1.2.1 Technical Data for Operation of Instrument

2.1.5 Water Requirements See Chapter 1.2.1 Technical Data for Operation of Instrument

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2.2 Inventory Note: The current Inventory List is packed with the instrument. Please check the parts according to this list when unpacking the instrument.

Please see the list below as example. 741-0050 : IMMUNOASSY SYSTEM cobas e411(FOR RDG/RDC) 741-0051 : IMMUNOASSY SYSTEM cobas e411(R/S SYSTEM FOR RDG/RDC) 741-8650 : e411ACCESSORY PARTS

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Figure 2.2-2

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Figure 2.2-3

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2.3 Analyzer Installation General Installation is performed by an engineer of Roche Diagnostics representative. When installing the cobas e411 we highly recommend that you follow the instructions in this Chapter.

2.3.1 Unpacking • • • • • •

Make sure that the counter on which you will set the instrument satisfies the set up requirements. Refer to Chapter 2.1. Unpack the cobas e411, and make sure that all accessories are in the box. Refer to the Inventory list packed with the instrument. After complete unpacking of the instrument, remove all the safety devices from bead mixer, pipetter, gripper, sipper, magnet drive and liquid waste container. See Figure 2.3-13 to Figure 2.320. Check if there is any transport damage and please report details in case of transport damaged via Roche Diagnostics GmbH to Hitachi High-Technologies Corporation.. Place the plate (P/N 741-1770) on the counter top under the cobas e411 and verify that all the feet of the cobas e411 are on the plate. Please refer the notice sheet to install the system that attached in the box. (See the next page)

Figure 2.3-1

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Figure 2.3-2 Notice Sheet

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Figure 2.3-3 Notice Sheet

Note: We offer a special table (Systable) on which to place the system, on stock. Note: A side extension can also be ordered for Rack instruments.

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When you move or lift up the instrument by using your hands, lift it by using the 4 points hand positions indicated in following position.

Figure 2.3-4 General view of the instrument

Figure 2.3-5 Expansion of a part

Figure 2.3-6 Hand positions

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Place the two rubber plates (P/N 741-1760) under the front two leveling feet.

Figure 2.3-7 • •

Please match stability with a level. Please confirm that an analyzer is stable enough.

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When you move or lift up the Rack system by using your hands, lift it by using the 4 points hand positions indicated in following position.

Figure 2.3-8 General view of the Rack system

Figure 2.3-9 left side from the front

Figure 2.3-10 right side from the front

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Figure 2.3-11 Expansion of a part

Figure 2.3-12 • •

Please match stability with a level. Please confirm that a rack syastem is stable enough.

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2.3.2 Explanation of Packaging Position in the System The arrangement of the parts and packaging is shown in the following figures

Figure 2.3-13 1 2 3 4 5

741-0119 BEADS MIXER ASSY 741-0302 WATER RESERVOIR ASSY 741-1510 L WATER TANK 741-0627 R DISK ASSY 741-0117 S DISK ASSY

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2.3.2.1 Packing of S Disk Assy The S Disk Assy is held with a cushion and fixed with a tape at one position.

Figure 2.3-14 1 2 3

741-0117 S Disk Assy Cushion Tape

Figure 2.3-15 1 2 3

Tape Cushion 741-0117 S Disk Assy

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2.3.2.2 Packing of R Disk Assy The R Disk Assy is fixed with tapes at two positions.

Figure 2.3-16 1 2

Tape 741-0627 R Disk Assay

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2.3.2.3 Packing of L Waste Tank The L Waste Tank is held with a cushion and fixed with a tape at one position.

Figure 2.3-17 1 2 3

741-1510 L Waste Tank Cushion Tape

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2.3.2.4 Packing of Water Reservoir Assy The connection part of Buffer Tank Assy and Water Reservoir Assy is covered with a vinyl resin bag. A cushion is placed on the Buffer Tank Assy, and the Water Reservoir Assy is placed on it; they are fixed with a tape at one position. Water Reservoir Assy is placed so that the lid is on the front side.

Figure 2.3-18 1 2 3 4 5

Lid Tape 741-0302 Water Reservoir Assy Vinyl resin bag 741-0561 Buffer Tank Assy

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2.3.2.5 Packing of Beads Mixer Assy The Beads Mixer Assy is held with a cushion, and fixed with tapes at two positions.

Figure 2.3-19 1 2 3 4

741-0119 Beads Mixer Assy Cushion Tapes Tape

Note: The mixing paddle (P/N741-0516) is detached from the head of beads mixer and is packed with two (2) hex screws in a box together with the accessory parts.

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2.3.2.6 Packing of R/S Cover

Figure 2.3-20 1

Tape

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2.3.3 Panel PC Installation and confirmation of AC Power Supply Please follow this procedure to attach the Panel PC to the instrument.. Follow this procedure to attach the Panel PC to the instrument. 1 ►

Take out the main instrument body and Panel PC from the packing box.

Figure 2.3-21 Mooting position for PC

Figure 2.3-22 Front view of the panel PC 2 ►

Attach the Panel PC to the instrument as shown in Figure 3 and 4. First, fold the BASE PLATE and insert the Hook part to the main unit body and then, using three screws, fix the PC in the three points indicated in the figure below.

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Figure 2.3-23 General view of the installment

Figure 2.3-24 Screw positions

Figure 2.3-25 Cap positions

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As shown in Figure 2.3-25, route the PC wires through the cramp on the back of the Panel PC. Finally, connect the wires to the Panel PC as shown in Figure 2.3-26.

Figure 2.3-26 Wiring through cramp

Figure 2.3-27 Wire connection 4 ► ο ο ο ο ο

Connect AC power cable Make sure that the AC power voltage is between 100 and 240 V. Make sure capacity of AC breaker at customer. Refer to chapter 1.2.1 Technical Data for Operation of Instrument in detail. Please follow this procedure to connect power cables. Refer to chapter 1.1.7 Power Components.

Circuit Breaker • •

Make sure that circuit breaker is “OFF” as shown in below. Please connect AC cable as shown in below.

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Figure 2.3-28

Rack Circuit Breaker • •

Make sure that circuit breaker is “OFF” as shown in below. Please connect AC cable as shown in below.

Figure 2.3-29

Attention When PLUG / UNPLUG Connector for HOST, turn off the Circuit Breaker of instrument. If PLUG / UNPLUG Connector for HOST with turn on the Circuit Breaker, not only e411 main unit but also External Host may be damaged.

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2.3.4 Setup For Rack system, first refer to Chapter 2.5.1.

Mount the following items on the instrument. • • • • • •

Reagent disk, sample disk Liquid waste container (empty) System water container filled with system water (Max. 3.0 L). Solid Waste Tray with a CleanLiner. Two sets of system reagent ProCell/CleanCell bottles. Three tip trays and three Assaycup trays on a magazine tray.

Check the following items before you switch the instrument on. • • • • • •

S/R probe and Sipper probe are attached straight and vertically. Mixer paddle is attached straight and tightly to the part of Bead Mixer. Please never put an irrelevant thing on a instrument. Sample disk, reagent disk, Assay cup trays/Tip trays and system reagents. Solid Waste Tray with a CleanLiner is attached correctly to the container. Liquid waste container is mounted correctly.

2.3.5 Mounting a Measuring Cell • • • • • • • • •

Unpack Reference Electrode (RE) and Cell Body. Uncap the reference electrode and verify that there are the O ring at the junction of MC. Soak a reference electrode in distilled water during about 30 minutes Shake the reference electrode vigorously about 10 times to wet the ceramic junction. Tap the reference electrode gently on a hard surface. Attach the reference electrode into the cell body by screwing firmly. Mount the measuring cell (for mechanical details and mounting description refer to Chapter 4.4.13.3, using the two screws that taped to the bottom of the Detection unit. Attach the inlet/outlet tube for MC. Connect a connector (J610). Make sure that the cable cannot be jammed between the MC body and the magnet arm by placing the cable across the reference electrode.

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2.3.6 Installation of System Software Install current system software (use only original software package, released by Roche Diagnostics GmbH) even if a software version has already been installed on the system. Refer to Chapter 2.4 Software Installation.

2.3.7 Fill Liquid System Note: If water is not rinsed after the start of the priming function, the pump may run in air. To

remove this air, detach the pipe from the main pump (located on the right side below drain cover). Make sure that no bubbles are left in the syringes or tube after priming function.

2.3.7.1 Pipetter/Sipper Priming Make sure that the instrument is in standby status. Concerning pipetter priming/sipper priming, refer to Chapter 6.2 Maintenance. Carry out pipetter priming until water comes out of the pipetter probe. Carry out sipper priming until water comes out of the sipper probe.

2.3.7.2 Beads Mixing Make sure that the instrument is in standby status. Concerning beads mixing, refer to Chapter 6.3 Mechanism Check. Carry out beads mixing mechanism check until the bead mixer wash station fills with water.

2.3.8 Adjustments to be Checked During Installation and After Replacement Refer to Chapter 2.6 for adjustments to be checked during installation for Disk and Rack System and confirm the positions described.

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2.3.9 Measuring Cell Preparation Introduction of MC All measuring cells (MC) have been checked by HHT. For storage and transportation, the MCs are dried again after having been checked at HHT. The reference electrodes (RE) are packed with the MCs. To prepare the measuring cell the two components have to be treated as follows to ensure good measuring results.

2.3.9.1 Preparation Place the system reagent bottles in the appropriate positions. Place two sets of system reagent ProCell/CleanCell bottles filled with ProCell/CleanCell at Position 1 and Position 2. Make sure the liquid waste container is empty. Fill the system water container with system water (max. 3.0 liters).

2.3.9.2 Procedure of MC Preparation Make sure that the instrument is in standby status. Touch the [Utility] [Maintenance] [Measuring Cell Preparation] button in the Main screen. Having touched the button in the screen, you will see a popup. Input the number of repetitions in the screen. The number of cycles depends on the type of MC. Input 30 under the present conditions, and please carry out. Touch the START button in the screen.

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2.3.10 System Volume Check 2.3.10.1 Preparation • • • •

Place the system reagent bottles in the appropriate positions. Place two sets of system reagent ProCell/CleanCell bottles filled with ProCell/CleanCell at Position 1 and Position 2. Make sure the liquid waste container is empty. Fill the system water container with system water (max. 3.0 liters).

2.3.10.2 Procedure • • •

Make sure that the instrument is in standby status. Touch the [Utility] [Maintenance] [Check] [System Volume Check] button in the Main screen. Touch the START button in the screen.

The system volume will be determined (for details refer to Chapter 3.4).

Note: After the procedure has been finished successfully, the status of instrument returns to StandBy. When alarm message occurred, check the liquid flow path (sipper side) for possible leakage.

2.3.11 High Voltage Check/Adjustment Introduction Each MC in combination with a PMT represents a complete detection unit, which has to be adjusted correctly. The high voltage adjustment should be carried out after measuring cell preparation to obtain initial information about the instrument signal level. The high voltage value has been adjusted initially in the quality control department at Hitachi in the course of checks on the instrument, but not for some MC/PMT combinations. With the high voltage adjustment (check) the field engineer should make sure that the combination of instrument (photomultiplier tube, electronic components) and measuring cell work in the expected signal range. If the signal is not in the required range, the photomultiplier tube (PMT) voltage has to be adjusted to make the signal levels comparable between the different instruments. BlankCell reagent is used to check the signal level (refer also to Chapter 6, Assay performance explanation, for more details).

Note: The [PMT high voltage adjustment] run only checks the current signal level of instrument

Calibrator BlankCell reagent. The high voltage adjustment to the correct signal range then has to be carried out manually by the field engineer.

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Figure 2.3-31 Assay Performance Check screen

2.3.11.1 Preparations 1 ► 2 ►

Place system reagent bottles in the appropriate positions. Place the BlankCell reagent pack as shown below: Table 2.3-1

Reagent rotor Pos. No. 2 3 ►

RackPack BlankCell set

Beads BCR1

R1 BCR2

R2 -

Sample arrangement Table 2.3-2 For Disk System: Run

PMT High Voltage Adjustment

Cup in rotor pos. Stop BC in Pos. 4

Liquid –

Table 2.3-3 For Rack Sampler (R/S): Racks in A line

Run PMT High Voltage Adjustment

1

Cup in rack pos. 1, 2, 3

Liquid –

► Use Hitachi normal sample cups. ► Remove all tips and cups from the incubator and the buffer plate. ► Place a full magazine with tips and cups in the front position on the tray.

2.3.11.2 Check Procedure •

Select [PMT HV adjustment] in the [Assay Performance Check] screen (Figure 2.3-32).

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Start the measurement by pressing the start button in the popup.

Figure 2.3-32 Popup screen of PMT High Voltage Adjustment

2.3.11.3 Evaluation of the PMT HV Adjustment Run •

Check the result in the [PMT High Voltage adjustment] popup after the run has finished (Figure 2.3-33).

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Figure 2.3-33 Result screen of PMT High Voltage Adjustment • • •

Calculate the mean value of the BCR2 effective signals from the Result screen. Note the target value from the package insert of the BlankCell lot used. Compare the mean value of the BCR2 counts with the target. It should be in the range of ± 5% of the target value.

Over time, the BCR2 level should be in the range of ± 10% (refer to Maintenance). •

If the current mean is outside the range, you may readjust the high voltage (refer to 2.3.11.5).

Note: We highly recommend that the high voltage is not changed in the first step if the signal level of the BCR2 mean is outside the range of ± 7% of the target value.

First of all, the measuring cell preparation should be extended by another 30 or 50 measuring cell preparation cycles (refer to Chapter 2.3.9). In the second step make sure that the measuring cell is mounted properly and that the BlankCell reagent is O.K. Refer also to Chapters Troubleshooting of Assay Performance Check ƒ

The second row of values in the Result popup shows the dark level of the photomultiplier tube. The dark level should be between 625 and 635 counts.

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2.3.11.4 Restore Parameter Carry out "RESTORE PARAMETER" after you have performed or even selected any assay performance check (APC). Select the [Restore Parameter] button in the [Assay Performance] check screen if you have finished the assay performance section. You do not need to restore if you want to perform another APC run.

2.3.11.5 Adjustment of High Voltage • •

Note the current high voltage by measuring the control voltage signal (CVS) between TP1 (GND) and TP2 (CVS) on the PMT-SHV PCB (refer to Chapter 5.4.13 for details). Calculate the corresponding high voltage using the formula:

Figure 2.3-34 •

Calculate the new PMT HV voltage using the following formula.

Figure 2.3-35 Vnew: Vold: BCR2 Target: •

PMT HV voltage that will be applied after measurement. PMT HV voltage that was applied previously. (See the PMT HV record label on the PMT SHV cover). BCR2 value specified by RD.

Calculate the new control voltage relative to the PMT HV voltage using the following formula.

Figure 2.3-36 •

• •

Adjust the voltage between TP1 (GND) and TP2 (control voltage signal) by changing the resistance of the corresponding variable resistor (VR1, VR2 or VR3) according to the calculated control voltage. The resistor is chosen by the jumper setting of JP1 (Pos.1, 2 or 3; refer to Chapter 5.4.13 for details). If the new high voltage value is outside the selected range you have to change the setting of JP1then repeat the procedure, return to 2.3.11.2 If the new high voltage value is the O.K., change the PMT HV record (the label is on the PMT SHV cover).

Note: In case of problems make sure that LED1 located on the PMT-SHV2 PCB is lit. Check connection J400.

Hint: A simplified calculation for determining the new High Voltage is shown in the example below. Comment:On the high voltage side (HV voltage) 1 V ≈ 1000 counts On the low voltage side (control voltage)

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0.005 V ≈ 1000 counts Example: To change the BRC2 count result from 100,000 to 105,000 counts (ca. 5000 counts difference), the HV voltage has to be increased by 5 V (+5 V ≈ 5000 counts difference). To adjust the value, change the control voltage by + 0.025 V ≈ 5000 counts.

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2.3.11.6 Adjustment of HV in Practice • • • • • • •

Select [PMT HV adjustment] in the [Assay Performance Check] screen. Start the program by pressing the [start] button in the popup window. Select the [Data Review] screen, the values of 20 determinations is shown in real time. Increase the sequence No. after 7 determination to display the next results. Carry out the adjustment by turning the corresponding variable resistor during the run. Turn clockwise for decreasing and counter clockwise for increasing the signal. The values (BCR2) should be in the range of ± 5% of the target value. The target value from the BlankCell is written on the package insert. After the determination press the [Stop] button to switch the instrument from the Operation to the Stand by mode. Carry out [Restore Parameter] after you have performed the HV adjustment.

Figure 2.3-37 Test Review Screen

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2.3.12 Initial BlankCell Calibrations Introduction After the measuring cell has been prepared and it has been checked that the signal level is in the expected signal range by means of the high voltage adjustment, the initial BlankCell calibration has to be performed. The instruments are calibrated to give the same homogeneous signal level. The initial BlankCell measurement is the first calibration done on the instrument before other assays can be calibrated. Each measured signal will first be BlankCell-corrected (parameters a (intercept) and b (slope)). The corresponding concentration is then read from the specific assay calibration. •

Initial Calibration

Determine factors (a) and (b)

Figure 2.3-38

2.3.12.1 Concept of BlankCell Calibration • • •

Target values of BlankCell R1 and R2, measured in the standardization department, are stored in the barcode. Three determinations of BlankCell R1 and R2 are measured and the medians of BlankCell R1 and R2 are calculated. Calculation of the BlankCell correction parameters

Calculation of BlankCell correction parameters - factors a and b:

Figure 2.3-39 Each calibrator, control and sample signal measured is corrected by the BlankCell correction parameters as shown below.

Figure 2.3-40 Version 1.0 – May 2006

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2.3.12.2 Preparation 1 ►

Place BlankCell reagent pack in reagent rotor . Table 2.3-4

Reagent rotor Pos. no. in any position 2 ►

RackPac k BlankCell set

Beads BCR1

R1 BCR2

R2 -

Sample arrangement

Note: Samples need not be placed to perform Initial BlankCell. 2.3.12.3 Check Procedure 1 ►

After boot up the e411 or Logoff the e411, a pop-up window appears as shown in Figure 2.3-41. The Operation ID and Password are following.

Operator ID Password

: bmserv : nakakojo

Figure 2.3-41 Logon window 2 ► 3 ►

Select Initial Blank Cell Calibration item in the Service screen Set to “ON” on Blank Set Option

Note: if you want to measure “Initial Blank Cell Calibration”, you must set the ”ON” button. Otherwise e411 will measure “Blank Cell Calibration”

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Figure 2.3-42 Initial Blank Cell Calibration screen 4 5 6 7

► ► ► ►

Start Reagent Scan (Reagent Screen ) After the scan the BLANK CELL is requested by the instrument. Press the Start button. After the Blank Cell procedure has finished, check the printout of the results carefully. The quality criteria should look the same as in the specimen printout. See attached printout of successful Initial Blank Cell (specimen).

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Figure 2.3-43 Example for printout : 8 ► 9 ► 10 ►

It is very important that the Initial Blank Cell is successful. If not, repeat the process until it is successful, otherwise all results may not be corrected properly. Refer to Chapter 2.3.12.3 for current result targets. (If necessary start procedure once more. Go back to point 3.) If the Initial Blank Cell was successful, remove the BLANK CELL RackPack. This is very important, otherwise the instrument will do the periodic blank cell automatically. Start Reagent scan.

2.3.12.4 Evaluation of Initial BlankCell • • •

Compare the mean value of the BCR1 (all values are on the printout) counts with the target. It should be : BCR1 Target range 120 to 400 counts Check the slope value from Initial BlankCell screen: BCR2 Slope should be 1.0 ± 0.05 (= parameter (b)). If one of the targets is outside these limits refer to the recommendations given and repeat the procedure until the targets are reached.

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2.3.13 Instrument Checks Finally, we recommend that the Artificial Media Test and the TSH assay test are performed to check the instrument performance. To perform the runs you need the Elecsys check reagents.

2.3.13.1 Artificial Media Test (AM Test) Introduction The Artificial Media Test is a button in the menu [Assay Performance Check] in the [Utility] screen. It is a short instrument check and principally measures the same criteria as the RD internal instrument check. Homogeneous Determination With homogeneous determination magnetic separation is not used. A solution of free label is transported inside the measuring cell and the performance of the detection unit (MC/PMT) can be analyzed. With equal height of BCR2 1:20, the performance of the pipetter side can be analyzed. Heterogeneous Determination The heterogeneous determination simulates an assay. The iSAP test uses beads and a biotinylated and ruthenium-labeled antibody. An immuno-independent bead/antibody complex is generated to analyze the detection unit, measuring cell and magnet function. If all performance data for the homogenous determination are in order, then disturbance in the heterogeneous determination can only be caused by the liquid flow system (tubing/fittings, connectors, sipper),the magnet or the MC BCR1, BCR2 and BCR2 1:20 are homogeneous, ProCell, iSAP and TSH are heterogeneous. The test takes about 45 min. Table 2.3-5 Materials Required RackPack name BlankCell CellCheck SAP

Amount 2 2 1

Material No. 1729306-122 1820451-122 1820435-122

Table 2.3-6 Samples Required Sample name ProCell BCR2

Amount 7 ml 1 ml

Preparations Place system reagent bottles in the appropriate positions. Set reagent rack packs in reagent disk positions 1 to 5 as follows: Table 2.3-7 Pos. No. 1 2 3

RackPack BlankCell set BlankCell set CellCheck

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Beads BCR1 BCR1 ProCell

R1 BCR2 BCR2 ProCell

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Service Manual

RackPack CellCheck SAP test

Beads ProCell Beads

R1 ProCell Buffer

R2 ProCell FC

Sample arrangement For Disk System: Table 2.3-8 Run

Cup in Rotor pos.

Artificial Media Check.

Liquid

3

BCR2 (1 ml)

4 to 10

ProCell (1 ml)

Use Hitachi normal sample cups. Pipette 1 ml of BCR2 into sample disk position 3 and 1 ml of ProCell into each sample disk position from 4 to 10. Place a stop Bar code in Pos. 11. Remove all tips and cups from the incubator and the buffer plate. Place a full magazine with tips and cups in the front position on the tray. For Rack Sampler: To perform the AM test with the R/S you need at least two racks. Table 2.3-9 Run Artificial Media Check

Rack in A line No. 1

2

Cup in rack pos.

Liquid

1, 2

Empty cups

3

BCR2 (1 ml)

4, 5

ProCell (1 ml)

1 to 5

ProCell (1 ml)

Use Hitachi normal sample cups. Pipette 1 ml of BCR2 into rack no. 1 position and 3, 1 ml of ProCell into rack 1 positions 4 and 5 and rack 2 positions 1 to 5. Remove all tips and cups from the incubator and the buffer plate. Place a full magazine with tips and cups in the front position on the tray.

Check Procedure For Disk System: After touching the [Artificial Media Test] button in the [Assay Performance Check] screen, start the measurement by pressing the start button. For Rack Sampler: On the rack sampler simply place rack 1 and rack 2 in the A line and start the [Artificial media test] button in the [Assay Performance Check] screen.

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Artificial Media (AM) Test parameters Table 2.3-10 R. Disk Pos. No. 1

Reagent BlankCell

Assay BCR1

Assay parameters Assay protocol Incubation time [cycles]

i1 i2 R1 R2 B S

Pipetting volume [µL]

BlankCell

2

BCR2

Detection Cycle Assay protocol Incubation time [cycles]

i1 i2 R1 R2 B S

Pipetting volume [µL]

CellCheck

3

BCR2-D

Detection Cycle Assay protocol Incubation time [cycles]

i1 i2 R1 R2 B S

Pipetting volume [µL]

CellCheck

4

AB3

Detection Cycle Assay protocol Incubation time [cycles]

i1 i2 R1 R2 B S

Pipetting volume [µL]

iSAP

5

iSAP

Detection Cycle Assay protocol Incubation time [cycles]

i1 i2 R1 R2 B S

Pipetting volume [µL]

Detection Cycle

24 1 1 200 0 0 0 Check 26 1 1 0 200 0 0 Check 0 1 1 95 95 0 10 Check 2 1 13 100 100 0 0 Normal 2 1 13 105 60 35 0 Normal

Test items performed by the artificial media check

Rack Rack 1 2

Table 2.3-11 For Rack Pos. No. 1 2 3

For Disk Pos. No. 1 2 3

Sampl e BCR2

4 5 1

4 5 6

ProCell ProCell ProCell

Version 1.0 – May 2006

Item 1

Item 2

Item 3

Item 4

Item 5

Item 6

Item 7

Item 8

Item 9

Item 10

BCR1 BCR2 BCR2 -D AB3 iSAP AB3 (CO)

BCR1 BCR2 BCR2 -D AB3

BCR1 BCR2 BCR2 -D AB3

BCR1 BCR2 BCR2 -D AB3

BCR1 BCR2 BCR2 -D AB3

BCR2 BCR2 -D

BCR2 BCR2 -D

BCR2 BCR2 -D

BCR2 BCR2 -D

BCR2 BCR2 -D

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For Rack 2 3

For Disk 7 8

ProCell ProCell

4 5

9 10

ProCell ProCell

iSAP AB3 (CO) iSAP AB3 (CO)

Evaluation of the AM Test The instrument can automatically calculate the results. Press the [Print result] button in the [Assay performance] screen. To evaluate the results use the parameters and acceptable ranges for the artificial media test given in the table. (For target values refer to table Table 2.3-13 “APC test; Targets, AM test”). If troubleshooting is necessary refer to the charts given in 2.3.13.3.

Note: If a result is missing, the mean and CV are calculated wrongly. In such cases calculate the corresponding result manually with the formulas given in Calculation Formulas

•

The BCR (BlankCell reagent) target value should be reached; this is used for the instrument calibration. The determination of BCR1 means the lower, BCR2 the higher calibration value. This reflects the recovery and the variance of the target value.

Note: None of the measured counts with tests from the Assay Performance Checks are connected with the instrument calibration factor.

• • • • •

BCR2 is used to adjust the PMT-HV and indicates problems with the PMT and excitation. BCR2-D is a dilution of BCR2 with BCR1 and shows the functionality of the pipetter, the pipetter precision and general problems with the liquid handling. AB3(CO) is determined using the measuring cycle for heterogeneous assays. These values are the basic values used for calculating carryover. iSAP is a model assay based on streptavidin beads. iSAP facilitates the evaluation of the complete LFS (liquid flow, magnet, capturing, detection) in a routine assay. Carryover is the measurable influence on the assay performance and is the consequence of carryover of beads into the measuring cell in this case.

Calculation Formulas cobas e411 instrument in which all items listed in list below meet the criteria passes Assay Performance Check. •

The normalization of items is carried out with BCR2 measured value

Figure 2.3-44 • •

BCR2 target value, concentration values for TSH Cal1and Cal2, and LO factor (LOF) are provided for each lot by RD. LOF is defined as ratio: (tangent new rackpack lot) / (tangent frozen reference lot) That factor is corrected by the typical coefficient of reagent aging on a monthly base. That typical coefficient of reagent aging is calculated as the median monthly decay over several lots. LOF and its aging forecast are transferred from RD. Table 2.3-12 Please Enter a Table Caption

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Item

Calculation

BCR1/ BCR2N

Average

BCR2

Average CV CV Average

BCR2(1:20) iSAP/ BCR2N

average of 10 values of BCR2 [counts] CV of 10 values of BCR2 CV of 10 values of BCR2-D

Figure 2.3-45 Carry over (CO)

Figure 2.3-46

Restore Parameter Carry out "RESTORE PARAMETER" after you have performed or even selected any assay performance check (APC). Select the [Restore Parameter] button in the [Assay Performance Check] screen if you have finished the Assay performance section. You do not need to restore if you want to perform another APC run. Table 2.3-13 APC Tests; Targets (AM test) 1 2

No.

Parameter BCR1 signal average BCR2 signal average

Unit [ counts ] [ counts ]

Range 120 - 400

3

BCR2 precision

[ CV ]

≤ 2.0%

4

BCR2 –Dil (1:20) precision

[ CV ]

5 6

iSAP/BCR2N Carry over ( CO )

[ counts ] [ ppm ]

≤ 2.5% 0.85 to 1,3 Mio

Target ± 10% cobas e411

≤ 90

Instrument released, if all values are in the range.

2.3.13.2 TSH Assay Test TSH assay (heterogeneous determination) is a button in the menu [assay performance check]. Unlike to the artificial media test, the customer as a matter of routine performs this immunoassay. The TSH assay is a necessary service tool as it reveals problems in the assay performance that occur in determinations where high dynamic, very low LDL (lower detection limit) and very high precision are required. For instrument/instrument performance criteria we have to use more detailed checks. There, the calibration also plays a role. The test takes about 45 min. Table 2.3-14 Materials required Rack pack name TSH CellCheck

Amount 1 1

Material No. 1731459-122 1820451-122

Table 2.3-15 Required samples: Sample name ProCell TSH Cal 1 TSH Cal 2 Version 1.0 – May 2006

Amount 1 ml 650 µl 400 µl

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Preparations: Place system reagent bottles in the appropriate positions. Set reagent racks for TSH assay test in reagent disk positions 6 and 7. Table 2.3-16 Pos. No.

RackPack CellCheck TSH

6 7

Beads ProCell Beads

Reagent 1 ProCell R01

Reagent 2 ProCell R02

Sample arrangement For Disk-System: Table 2.3-17 Run

Cup in rotor pos.

TSH assay test

Liquid

15

ProCell (1 ml)

16

TSH Cal1

17

TSH Cal2

Use Hitachi normal cups and RD calibrator vials. For Rack Sampler: Table 2.3-18 Run TSH assay test

Rack in A line No. 1

Cup in rack pos.

Liquid

1

ProCell (1 ml)

2

TSH Cal1

3

TSH Cal2

Use Hitachi normal cups and RD calibrator vials. Remove all tips and cups from the incubator and the buffer plate. Place a full magazine with tips and cups in the front position on the tray.

Check Procedure For Disk System: After touching the [TSH assay test] button in the [Assay Performance Check] screen, start the measurement by pressing the start button For Rack Sampler: On the rack sampler simply place rack 1 in the A line and start the TSH test by pressing the [TSH assay test] button in the [Assay Performance Check] screen.

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TSH Assay Test parameters Table 2.3-19 R. Disk Pos. No. 6

Reagent CellCheck

Assay AB2

Assay parameters Assay protocol Incubation time [cycles] Pipetting volume [µL]

7

TSH

TSH

2 12 12 60 50 40 50 Normal 2 12 12 60 50 40 50 Normal

i1 i2 R1 R2 B S

Detection Cycle Assay protocol Incubation time [cycles]

i1 i2 R1 R2 B S

Pipetting volume [µL]

Detection Cycle

Test items performed by the TSH assay test Table 2.3-20 Pos. No. 1/15 2/16 3/17

Sample ProCell TSH Cal1 TSH Cal2

Item 1

Item 2

Item 3

Item 4

Item 5

Item 6

Item 7

Item 8

Item 9

AB2 TSH

AB2 TSH

AB2 TSH

TSH

TSH

TSH

TSH

TSH

TSH

TSH

TSH

TSH

TSH

TSH

Item 10 TSH

2.3.13.3 Evaluation of the TSH Assay Test The instrument can automatically calculate the results. Press the [Print result] button in the [Assay performance check] screen. To evaluate the results use the parameters and acceptable ranges for the TSH assay test given in Table 2.3-21 on the next page (APC tests; Targets, TSH test) If troubleshooting is necessary refer to the charts in 2.3.13.3.

Note: If a result is missing, the mean and CV are calculated wrongly. In such cases calculate the

corresponding result manually using the formulas given in Test items performed by the TSH assay test

ƒ ƒ ƒ ƒ

The tangent (TSH Cal2) describes concentration-independent dynamics. A tangent value outside target indicates problems with the measuring cell, LFS and MC or the magnet. The LDL (lower detection limit) is the lowest value that differs significantly from the concentration of 0 µU/ml. Dynamics and precision in the lower range influence the LDL. Apart from problems with the measuring cell, the pipetter or the magnet, problems with the sipper, liquid handling and liquid flow ( tubing, foam, bubbles ) and temperature influences increase the LDL, i.e. give poorer assay performance. An increased first value of the TSH Cal1 (TSH Cal1 1st value high) is seen in the event of a preceding homogeneous determination (e.g. ProCell, Prepare, Idle). In most cases it is related to the performance of the measuring cell. A high first value is only observed if a ProCell/Prepare cycle is run before a very low signal in a heterogeneous determination.

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2.3.13.4 Calculation Formulas Cal1/ BCR2 N

Average Figure 2.3-47

CV Cal2 CV Tangent

CV of 10 values of TSH Cal1 CV of 5 values of TSH Cal2

Figure 2.3-48 Cal1 first value high (FVH) Figure 2.3-49 Low Detection Limit (LDL) Figure 2.3-50

2.3.13.5 Restore Parameter Carry out "RESTORE PARAMETER" after you have performed or even selected any assay performance check (APC). Select the [Restore Parameter] button in the [Assay Performance check] screen if you have finished the Assay performance section. You do not need to restore if you want to perform another APC run. Table 2.3-21 APC tests, Targets (TSH test) 1

No.

Parameter Cal1/BCR2N

Unit [counts]

≤ 1300

Range

2

TSH Cal 1 precision

[CV]

≤ 4.0%

3

TSH Cal 2 precision

[CV]

≤ 2.0%

4

Lower detection limit (LDL)

≤ 0.005

5

Tangent TSH Cal2

[µU/ml] [counts]

6

Cal 1 first value high

[counts]

≤ +8.0%

cobas e411

≥ 12 000

Instrument released, if all values are in the range.

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2.3.13.6 Assay Performance Check Troubleshooting Flow Diagram

Figure 2.3-51

Legend CV = Coefficient of Variation MC = Measuring Cell RE = Reference Electrode HV = High Voltage LFS = Liquid Flow System

Version 1.0 – May 2006

HW = Hardware BCR = BlankCell Reagent PMT = Photomultiplier Tube LF(C) = Liquid Flow (Cleaning) LH = Liquid Handling

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Figure 2.3-52

Legend SAP = Special service reagent CV = Coefficient of Variation MC = Measuring Cell PMT = Photomultiplier Tube LF(C) = Liquid Flow (Cleaning) LH = Liquid Handling

Version 1.0 – May 2006

TSH = Thyroid-specific Hormone HW = Hardware RE = Reference Electrode HV = High Voltage LFS = Liquid Flow System BCR = Blank Cell Reagent

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Figure 2.3-53

Legend SAP = Special service reagent CV = Coefficient of Variation MC = Measuring Cell LFC = Liquid Flow Cleaning LH = Liquid Handling

TSH = Thyroid-specific Hormone HW = Hardware BCR = Blank Cell Reagent LFS = Liquid Flow System

Troubleshooting of Assay Performance Check Table 2.3-22 Check items PMT HV adjustment

Phenomenon Signal≅0, DL=625

Possible cause 1. HV connector is not connected 2.PMT connector is not connected.

3.Connector of L-Amp. board is not connected. 4.Shield plug is not connected. 5.PMT or L-Amp board is to be defected. 6.Shield cable is opencircuited.

Signal≅0,

1.Measuring cell is not

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Remedy 1.Confirm the following connections: •

between P400 and J400 on PMT-SHV board.

•

between P401 and J401 on PMT-SHV board.

•

between P610 and J610 in Detection Unit.

2.Others, refer to the Cross Wiring Diagrams for details. Confirm the following connections: •

between P430 and J430 on L-AMP board.

•

P/J431 on L-AMP board or P/J119 on EECL board.

Replace the PMT or L-Amp board.

Confirm the following connection. •

between P430 and J430 on L-AMP board.

•

P/J431 on L-AMP board or P/J119 on EECL board.

1.Confirm no ADC alarm 31-02-01 or 31-02-02 takes

Chapter 2.3

RD/Hitachi cobas e411 Check items

Phenomenon DL>625

Signal625

PMT HV adjustment

Signal is not stable.

Service Manual Possible cause mounted. 2.Connector of measuring cell is not connected.

Remedy place. 2. Confirm the following connection:

3.Liquid leakage occurs in sipper flow system. 4.Liquid leakage occurs in pipetter flow system. 1.Wrong reagent or reagent position.

Check the sipper flow system.

2.Measuring cell is not mounted correctly. 3.PMT is not mounted correctly. 4.Liquid leakage occurs in sipper flow system. 5.Liquid leakage occurs in pipetter flow system. 1.Shading to the detection unit is not sufficient. 2.Shield plug is not connected correctly.

AM test

Normalized BCR1>400

BCR2 CV% >2%

BCR2(1:20) CV% >5%,

Carryover >100 ppm

Sensitivity >6E15W

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3.Liquid leakage occurs in sipper flow system. 4.Temperature control of the detection unit is not sufficient. 1.Wrong reagent or reagent position. 2. L-AMP board is defective. 3. Active bleeder is defective. 1. System volume check not done. 2. Liquid leakage occurs in sipper flow system. 3. Number of MC preparations is not sufficient. 4. Measuring cell is defective. 1. Liquid leakage occurs in pipetter flow system. 2.Dust on pipetter probe end. 3.Height of pipetter probe, Z axis position is not correct. 1. Liquid leakage occurs in sipper flow system. 2.Position of magnet relative to the Measuring cell is not sufficient. 3. Measuring cell is defective. 1. Anode dark current of PMT is bigger than usual value. 2.Shading to the detection unit is not sufficient. 3. Number of MC

2 - 50

•

between P610 and J610 in detection unit.

Check the pipetter flow system. 1.Confirm that the Reagent Lot is valid. 2.Replace the reagent. Confirm position of the measuring cell relative to PMT.

Check the sipper flow system. Check the pipetter flow system. 1.Confirm the dark level value is lower than 640. 2.Confirm that the sponge lid between PMT and the plug P401 has not become detached. 1.Confirm the connection between P430 and J430 on LAMP board. 2. P/J431 on L-AMP Board or P/J119 on EECL board. Check the sipper flow system. Confirm temperature of the detection unit on the temperature monitor screen, refer to Chapter 6. 1.Confirm that the Reagent Lot is valid. 2.Replace the reagent. Replace the L-AMP board. Replace the PMT. Perform system volume check. Check of the sipper flow system. Repeat MC preparation again at least 30 times as described in Chapter 2. Replace the measuring cell as described in Chapter 4. Check the pipetter flow system.

Use gauze moistened with distilled water to clean the end of the pipetter probe. Adjust the Z axis position of pipetter according to Chapter 4. Check the sipper flow system. Use the magnet drive tool, adjust the position by referring to Chapter 4. Replace the measuring cell as described in Chapter 4. 1.Confirm the dark level value. If the value is more than 640, leave the PMT in instrument standby status overnight. 2. Confirm that the sponge lid between PMT and the plug P401 has not become detached. Repeat MC preparation again at least 30 times as

Chapter 2.3

RD/Hitachi cobas e411 Check items

TSH assay test

Phenomenon

Tangent 0.005

CAL 1 signal >1200 1st value >8%

Service Manual Possible cause preparations is not sufficient. 4.Measuring cell is defective. 1.Magnet itself is defective. 2.Temperature control of the detection unit is not sufficient. 3.Measuring cell is defective. 4.L-AMP board is defective. 1. Liquid leakage occurs in pipetter flow system. 2.Dust on pipetter probe end. 3.Height of pipetter probe, Z axis position is not correct. Measuring cell is defective.

Remedy described in Chapter 2. Replace the measuring cell as described in Chapter 4. Confirm iSAP signal value. If the value is lower than 1.2E 6, replace the magnet or check position of magnet relative to the measuring cell. Confirm temperature of the detection unit on the temperature monitor screen, refer to Chapter 6. Replace the measuring cell as described in Chapter 4. Replace the L-AMP board. Check the pipetter flow system.

Use gauze moistened with distilled water to clean the end of the pipetter probe. Adjust the Z axis position of pipetter according to Chapter 4. Replace the measuring cell as described in Chapter 4.

2.3.14 Assay Calibration After the procedures described above have been finished successfully, we recommend that the field engineer carries out at least one or two assay calibrations. To check the installation in routine some controls should be performed finally. We recommend running PCU1/PCU2 for the TSH assay.

2.3.15 Installation Procedures Overview / Checklist Note: You may copy the following table and use it as an installation checklist Table 2.3-23 Step 1 2 3 4 5 6 7 8 9 10 11

12 13

Procedure Unpacking PC installation and AC power supply confirmation Setup Mounting a measuring cell Installation of system software Fill liquid system Check important adjustments Measuring cell preparation System volume check High voltage check/adjustment Instrument checks -Artificial media check -TSH assay test Initial BlankCell calibration Assay calibration

Refer to chapter

DONE

2.3.1 2.3.3 2.3.4 2.3.5 2.3.6; 2.4 2.3.7 2.6 2.3.9 2.3.10 2.3.11 2.3.13, 2.3.13.1 2.3.13.2 2.3.12 2.3.14

2.3.16 Procedure for Multiple Installations In the event of multiple instrument installations, the following results should be compared. Precondition: Individual results for AM, TSH and PCU1/PCU2 must be determined on the instruments. Version 1.0 – May 2006

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Step 14

15

Procedure Instrument checks -TSH assay test •

Targets as described in this chapter (Targets/Ranges of APC Tests).

•

SAP signals and or Calset 1 and 2-signal difference should be max. 10% between systems. ο

Change measuring cell and restart with point 8 if the signal difference is not within the limits.

ο

Change system and restart with point 1 if the signal difference is not within limits after exchanging the measuring cell.

Refer to chapter 2.3.13

Carry out Assay Calibration for TSH and measure Precicontrol Universal as sample. •

Control concentration difference should be max. 5% between systems ο

Change measuring cell and restart with point 8 if the concentration difference is not within the limits.

ο

Change system and restart with point 1 if the concentration difference is not within the limits after exchanging the measuring cell.

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2.4 Software Installation 2.4.1 Application Instruction It is described the specification of the installer that install a cobas e 411 system software to the instrument. The installer is offered by installation CD and copies a cobas e 411 system software file to a fixed directory (CF memory).

Figure 2.4-1

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2.4.1.1 Install function The installation function executes the processing of the following each item one by one. However, it can be executed by selecting the installation of a cobas e 411 application and the installation of the multi national language file with the external definition file.

Figure 2.4-2 1 ►

Logoff of e411 application. Push Logoff button and display Logoff dialog screen, then push Shutdown button.

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Figure 2.4-3 2 ► 3 ►

Switch on the Main Power Close the cmd.exe when e411 system boot up. Push close button on cmd.exe screen.

Figure 2.4-4 4 ► 4.1 ► 4.2 ► 5 ►

Extracting the Application File Connect the external media to a USB port on the left side of the analyzer. Set CD include e411 application program in external media. Select “Start -> My Computer”

Figure 2.4-5

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Installation of e411 application program

This installation program doesn't have the difference between a new installation and the update. 6.1 ► 6.2 ►

Connect the DVD drive with the USB port. Insert installation CD in the DVD drive, then the following screens are displayed.

Figure 2.4-6 When installing, it displays the dialog whether to initialize data. If select “YES”, it initializes data. If select “NO”, the file in the data directory is not changed. When you select Yes or No and push “NEXT”, the go to next screen. If you push “Cancel”, the installer is ended without processing anything. Note) If you insert CD, and the above screen doesn't display, double-click E:\setup.exe from “My Computer”(see “5)”). 6.3 ►

Push “NEXT”, then the following screens are displayed.

Figure 2.4-7 You select whether to copy it to the directory for which the system software is specified with the external definition file. When you select Yes or No and push “NEXT”, the go to next screen. If you push “Cancel”, the installer is ended without processing anything. 6.4 ►

Push “NEXT”, then the following screens are displayed.

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Figure 2.4-8 You finally confirm the installation. When you copy the selected file to the preceding clause, push the “OK” button. If you push “Cancel”, the installer is ended without processing anything. 6.5 ►

Push “OK” and the installation ends, and then the following screens are displayed.

Figure 2.4-9 If the installation fails, the installation failure message is displayed and the installer is ended.

Figure 2.4-10 If you failed in the installation of the application, it is necessary to do over again from procedure 6.2 ►. 7 ► 7.1 ► 8 ► 9 ► 9.1 ►

Shut down of PC and Main Power Select Shut Down from Start menu and Switch off the Main Power Switch on the Main Power System Setup Confirm the following items.

1. Confirm the Date and Time 2. Confirm the Software Version Version 1.0 – May 2006

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3. Confirm the Check Sum of AU and PC

Figure 2.4-11 Refer to Chapter 6.1.3 System Setup for details.

2.4.2 Printer Driver Instruction 1 ► 2 ► 2.1 ►

Switch on the Main Power Close the cmd.exe when e411 system boot up Push close button on cmd.exe screen.

Figure 2.4-12 3 ► 3.1 ►

Disabling the Write Protection Select ControlPanel

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Figure 2.4-13 3.2 ►

Run “Drive Protect” (double click)

Figure 2.4-14 3.3 ►

Select Setting tab and set password “1234” and uncheck “Protect ON”

Figure 2.4-15 3.4 ►

Reboot

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Figure 2.4-16 3.5 ►

Select “No” after reboot.

Figure 2.4-17 4 ► 4.1 ►

Deleting Already-installed Printer Settings Select Start -> Printers and Faxes.

Figure 2.4-18 4.2 ►

If there are already-installed printers, select the file and then right-click on it, and select “Delete” from the pop-up menu (or select File -> Delete).

Figure 2.4-19 4.3 ►

When the following dialogs appear, touch the Yes button, and then the OK button.

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Figure 2.4-20

Figure 2.4-21 5 ► 5.1 ► 5.2 ► 5.3 ►

Extracting the Driver File Connect the external media to a USB port on the left side of the analyzer. Start Explorer and see the contents of the external media. And double-touch the obtained file, “lj1320PCL6win2kxp2003-en.exe”. Follow the steps below to extract the contents to a default folder.

Figure 2.4-22

Figure 2.4-23 6 ► 6.1 ►

Installing the HP1320 Printer Driver Connect the printer and turn the power on. And install the printer driver according to the following procedure.

Note: This is a procedure for the HP1320 Printer Driver. If you use other Printer Driver defined by the e411, the procedure will be shown in other Printer Driver.

6.2 ►

When the following dialog appears, check the “Install from a list or specific location (Advanced)” radio button. Then touch the Next button.

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Figure 2.4-24 6.3 ►

When the following dialog appears, check the “Don’t search. I will choose the driver to install” radio button. Then touch the Next button.

Figure 2.4-25 6.4 ►

Touch the Have Disk… button.

Touch

6.5 ►

Figure 2.4-26

When the following dialog appears, touch the Browse… button.

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Figure 2.4-27 6.6 ►

Select “C:/Program Files/Hewlett-Packard/LaserJet 1320 Drivers”, and touch the Open button.

Select

Figure 2.4-28 6.7 ►

Select “hpc1320c.inf”, and touch the Open button.

Figure 2.4-29 6.8 ►

Touch the OK button.

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Touch the Next button.

Figure 2.4-31 6.10 ► When the following dialog appears, touch the Browse… button.

Touch

Figure 2.4-32 6.11 ► Select “C:/WINDOWS/system32”, and touch the Open button.

Figure 2.4-33 6.12 ► Touch the OK button.

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6.13 ► Select “C:/Program Files/Hewlett-Packard/LaserJet 1320 Drivers”, and touch the Open button.

Figure 2.4-35 6.14 ► Touch the OK button.

Figure 2.4-36 6.15 ► Touch the Finish button. 6.16 ► When the following dialog appears, touch the Browse… button.

Figure 2.4-37 6.17 ► Select “C:/WINDOWS/system32” and touch the Open button.

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Figure 2.4-38 6.18 ► Touch the OK button.

Figure 2.4-39 6.19 ► If the following dialog appears, touch the Browse…” button.

Figure 2.4-40 6.20 ► Select “C:/Program Files/Hewlett-Packard/LaserJet 1320 Drivers” and touch the Open button.

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Select

Figure 2.4-41 6.21 ► Touch the OK button.

Figure 2.4-42 6.22 ► Select Start -> Printers and Faxes, and check if the installation went successful.

Figure 2.4-43 This ends the procedure for installing the printer driver. 7 ► 7.1 ►

Enabling the Write Protection Select ControlPanel

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Figure 2.4-44 7.2 ►

Run “Drive Protect”

Figure 2.4-45 7.3 ►

Select Setting tab, and check “Protect ON”

Figure 2.4-46 7.4 ►

Select “OK” after reboot.

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Figure 2.4-47 8 ► 8.1 ► 9 ► 10 ► 10.1 ►

Shut down of PC and Main Power Select Shut Down from Start menu and Switch off the Main Power Switch on the Main Power Push “Print Screen” button Confirm whether the device can be printed.

2.4.3 System Parameter Setup After install, you need to set up the system parameter. See Chapter 6.1.4.

Figure 2.4-48 Storage Utility Screen

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2.5 Rack Sampler System Installation 2.5.1 Rack Sampler System Installation ∗

Procedures 3 to 5 are required for upgrading from the Disk System to the Rack Sampler When install the Rack Sampler System, Procedures 3 to 5 are not required

1. Setting Up cobas e411 1) Preparing cobas e411 main unit: Figure 2.5-1 • • • • • • • • •

Remove the rear cover. Remove the cover for gripper. Remove the R. lid. Remove the table cover L. Remove the front cover. Remove the S jacket assembly with the ground wire. Remove the S disk driving unit. Remove the side base. Connect a dummy connector to the connector from which the S disk driving unit has been removed. (P510, P511)

2. Setting Up the Rack Sampler Unit • • • • • •

Set the rack sampler unit in the position to be installed. Remove the loader cover (2 screws M4, top surface,2 screws M4, left side) : Figure 2.5-2 Remove the sampler rear cover (2 screws M4, front surface, 2 screws M4, left side) Remove 3 bushes for fixing slide unit. Slide the base to the left by 160 mm, and fix it with 1 bush. : Figure 2.5-3 ο ! When sliding the base, be sure to hold the handle of the base to slide. ο ! When mounting the bush, take care not to catch the wire. Remove the coupling plate. (2 screws M6, pan-head screws)

3. Adding PC Board, and Setting DIP Switches • • • • • •

Remove the cover for PCB rack (P/N 741-4541). Remove all the connectors at the upper part of PCB rack. Remove the cover for circuit board (P/N 741-1583). Remove the EIO3 PC board (P/N 741-5080) from the PCB rack. Connect the RS CONT D PC board (P/N 741-5074) through spacer. : Figure 2.5-4 Set the DIP switches on the RS CONT D PC board. Set all the DSW2 to Off.

• •

Attach the EIO 3 PC board to which the RS CONT D PC board is attached to the PCB rack. Attach the cover for circuit board (P/N 741-1583).

4. Connecting Communication Cable: Figure 2.5-5 • • • • • • • •

Remove the DIST-F PC board (P/N 741-5028). Connect the communication cable to the J900 connector on the RS CONT D PC board. Change the nylon clamp (HP-5N ⇒ HP-10N), bundle the communication cable with the existing cable. Connect the BRC cable to the J343 connector on the UIRS-C PC board (P/N741-5081) : Figure 2.5-5 Pass the communication cable through the side hole of the cobas e411 main unit. Attach the connector of the upper part of PCB rack. Attach the cover for PCB rack (P/N 741-4541). Attach the DIST-F PC board.

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5. Attaching BCR Assembly, and Connecting BCR Cable: Figure 2.5-5 • • • •

Attach the BCR assembly to the cobas e411 main unit. Attach the ground wire. Connect the BCR cable to the connector on the BCR PI PC board (P/N 741-5056). Refer to chapter 2.6.5.3 for the BCR adjustment.

6. Connecting Rack Sampler Unit to Main Unit • • •

Attach the coupling plate to the aluminum base of the cobas e411 main unit. (3 screws M5, pan head screws). Put the communication cable between the main unit and the coupling plate. Connect the rack sampler unit to the cobas e411 main unit. : Figure 2.5-6 ο ! When connecting, make sure that the couple blocks meet each other so that there is no gap between the “A” plane and “B” plane, and fix them with screws.

7. Wiring between Units Connect the communication cable from the cobas e411 to the J908 connector on the rack sampler PC board. Arrange wiring as shown in the figure, fasten the cable with clamps at five positions. : Figure 2.5-7 8. Fixing Rack Sampler Unit • •

Remove the bush attached in procedure 2-5, slide the rack sampler unit onto the cobas e411 main unit. Attach the 3 bushes removed in procedure 2-4, fix the unit.

9. Height Adjustment • •

Loosen the lock nut of the adjuster (×2). Then, while checking levelness using a level gauge, turn the adjuster to adjust the height as shown in Figure 2.5-8. When good levelness is obtained, tighten the lock nut to fix the adjuster.

10. Attaching Cover: Figure 2.5-7 • • • • • •

Attach the front cover and rear cover to the cobas e411 main unit. Attach the cover for rack sampler unit by following the procedure for removal in reverse (refer to Procedure 2). Attach the Stat cover. (2 screws M4, top surface) Attach the screw lids to the rack sampler unit and cobas e411 main unit. Attach label. (Only if the cobas e411 main unit has a molded base.) Figure 2.5-9 shows dimensions.

Note: Be careful not to detach the photocoupler PI213 located at the Stat position from the plate of the B line.

11. Adjusting Sampling Position (refer also to Chapter 2.6.5.2) After turning on the power of the instrument, wait until it goes into Stand-by and perform the sampling position adjustment by following the following procedures. 1 ► 2 ► 3 ► 4 ►

Fix the test tube guide with tape so that it stays open. Press the B line Sampling Pos key on the adjustment rack.(Put 13mm diameter test tubes onto the rack, and attach tip to P nozzle.) Check roughly how far the tip of the Tip is from the center position of the container. : Figure 2.5-10 Loosen the sensor fixing screws (2 screws M4, 1 screw M3), shift the sensor fixing plate by about the same distance as checked in 2 ►, and fix the plate. : Figure 2.5-10 Perform 2 ► again.

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If the tip of the tip shifts by a large amount from the center position of the container, perform 3. again. Press the [Service] [Adjustment S/R Probe, R.Disk, Mix] [S/R Probe-X Rack Sampling] key to perform fine adjustment in the moving direction of pipetter. (The same as sampling position adjustment of the main unit). When the tip of the tip has been adjusted to be roughly in the center of the container by procedures 1 - 6, perform 2 ►. again to adjust finely the flow direction of the rack. (If fine adjustment is not required, you do not need to perform 7 ► and 8 ►..) Press the Front key or Back key on Panel PC screen to perform fine adjustment of rack stop position. (Moving forward and backward for 5 pulses can be performed, resolution: 0.15 mm/pulse) After completion, press the OK key to finish adjustment. Remove the fixing of the test tube guide performed in 1 ►.. Perform 2 ►again. Loosen the test tube guide fixing screws (4 screws, M4) and adjust the fixing position so that all 4 resin rollers of the test tube guide can touch the test tube. : Figure 2.5-11 Attach the table cover L2. (3 screws M4, top surface).

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Figure 2.5-1 Setting up the cobas e411 1 2 3 4 5 6 7 8 9

Cover for Gripper R.Lid S.Disk Front Cover Assy Rear Cover Side Base S Jacket Assy S Disk Drive Assy Table Cover L

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Figure 2.5-2 Remove Three Bushes 1 2 3

Bush Rear Cover for Sampler Loader Cover

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Figure 2.5-3 Removing the Coupling Plate 1 2 3 4

Pull Bush M6 Screw Coupling Plate

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Figure 2.5-4 Setting up the PCB and DSW 1 2 3 4 5 6 7 8 9 10

Cover for PCB Rack (P/N 741-4541) PCB Rack Assy PCB Rack Assy Cover for Circuit Board (P/N 741-1583) Spacer Nut M3 Spring Washer 3 Screw M3×6 Washer 3 Spring Washer DIP Switch RS CONT DCircuit Board Assy (P/N 741-5074) PCB Rack Assy

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Figure 2.5-5 Connection of the Cable 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

BCR Cable Earth BCR BCR Circuit Board Assy P510, P511 Connector M5 Screw Coupling Plate Cable J900 Clamp(HP-10N) DIST-F Circuit Board (P/N:741-5028) Coupling Plate UIRS-C Circuit Board Assy (P/N:741-5081) J343 Connector J342

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Figure 2.5-6 Connection to the Instrument 1 2 3

Screw Couple Block 2 Couple Block 1

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Figure 2.5-7 Installation of Covers 1 2 3 4 5 6 7 8 9 10 11

Acryl Cover Assy J908 Rear Cover for Sampler Clamp The Communication Cable Label Rear Cover Front Cover Assy Table Cover L2 Stat Cover Loader Cover

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Figure 2.5-8 Height Adjustment 1 2 3

Adjuster Water Level Lock Nut

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Figure 2.5-9 Rack Sampler System

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Figure 2.5-10 B Line (Top View) 1 2 3 4 5 6

Test Tube Guide Open/Close direction Test Tube Guide Sensor fixing screw (M3) Sampling position Sensor fixing plate B line A line

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Figure 2.5-11 B Line (Side View) 1 2

Test Tube Guide Fixing Screw (M4) (Opposite side, too) Roller made of resin (Opposite side, too)

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2.6 Checks/Adjustments During Installation The following adjustments should be checked during analyzer installation because they are very import for good instrument performance. The instrument should always be observed during the initial operations. Refer to Chapter 4.5.2 with regard to any other positions that need to be adjusted.

2.6.1 Bead Mixer 2.6.1.1 Check Mixer Speed (see also Chapter 5.3.8) To check the mixer speed, use one of the following procedures: Place reagent packs in positions 1 to N . Start the Mixing Check ( [Maintenance][Check][Mixing Check] ) and enter < N > repititions.

Confirm the following mixer speeds using an rpm meter : Table 2.6-1 In air 2050 rpm ± 100 rpm

In liquid 2000 rpm ± 100 rpm

2.6.1.2 Mixer Adjustment Table 2.6-2 1

2

3

Adjusted item Beads Mixer Rinse Station

Beads Mixer-R Mix

Beads Mixer Up/Down

Item to be confirmed 1 ►

Make sure that the mixing paddle is straight.

2 ►

Confirm visually that when the beads mixer is in the horizontal home position, there is a distance of 2 mm or more between the mixing arm and the end of the U-shaped cut of the table cover and that the mixing arm is located approximately in the middle of the Ushaped cut. If not, adjust the beads mixer and/or relevant units referring to the procedures described in the latter half of 3 ►.

3 ►

Confirm visually that the mixing paddle is adjusted as concentrically as possible with the washing station Note:. If not, adjust the beads mixer and/or relevant units by applying one or more of the following three options.

3.2 ►

Adjust the table cover mechanically.

3.3 ►

Carry out the " Mixer-Horiz.Rinse " function in the " Adjustment S/R Probe R.Disk Mixer " screen.

3.4 ►

Adjust mechanically the beads mixer head rotational angle around the arm.

4 ►

Make sure that the mixing arm in home pos. does not interfere with the pipetter.

1 ►

Attach the reagent disk cover.

1.2 ►

Confirm visually that the mixing paddle is adjusted as concentrically as possible with the reagent disk cover hole.

•

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Detach the reagent disk cover.

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How to adjust Carry out the “Mixer-Horiz.Rinse” function in the “Adjustment S/R Probe R.Disk Mixer” screen. (See Chapter 4.4.4. Service Manual )

Carry out the “MixerHoriz.Reag.Mix” function in the “ Adjustment S/R Probe R.Disk Mixer ” screen.

Carry out the “Mixer Up/Down” function in the “Adjustment S/R Probe R. Disk Mixer”

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Adjusted item

Item to be confirmed • 1 ►

Place a RackPack in pos. 1 of the reagent disk.

How to adjust screen.

Confirm visually that the mixing paddle lower end is just level with the upper edge of the opening of the RackPack Note:.

Note: You may manually push down the mixing arm to allow easier confirmation. Note: You may put a thin sheet of paper on the RackPack opening to allow easier confirmation (paddle top should touch the paper).

2.6.1.3 Mixer Paddle Shape Examination of Paddle Shape 1 ► 2 ► 3 ►

To examine the mixing effect, a new or used RackPack (not mixed for at least 20 hours) should be placed in reagent rotor pos. 1. Start the Running Test from [Assay performance check] screen because the RackPack will be mixed initially (15 s). The initial mixing should create a homogeneous solution of microparticles. Stop the running test after mixing and check the bead solution: No foam should be visible on the reagent surface (only valid for 3 to 5 ml filling volume). No bead sediment should be visible at the bottom of the bottle (check from below, see Figure 2.6-1 and Figure 2.6-2)

Note: Perform restore parameter after running test has been stopped

Figure 2.6-1 No bead sediments visible at the bottom of the bottle (seen from below): PADDLE OK

Figure 2.6-2 Bead sediments visible at the bottom of the bottle (seen from below): PADDLE NOT OK

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2.6.2 Pipetter Adjustment Table 2.6-3 1

Adjusted item Pipetter-Z C/T Buffer

2

Pipetter-Z C/T Buffer Bottom

3

Pipetter-Z Beads Bottom

4

Pipetter-Z S.Cup Bottom

Procedure Detach the tip, if any from the pipetter probe. Confirm visually that pipetter probe end with no tip is pretty level with the buffer station surface at the tip eject position. Detach the tip, if any from the pipetter probe. Place a tip in Tip Pos. 1 of the buffer station. Confirm visually that the pipetter probe end with no tip is pretty level with the buffer station surface at the tip eject position. Attach a tip to the pipetter probe. Place an empty RackPack in pos. 1 of the reagent disk. Automatically checked ! Attach a tip to the pipetter probe. Place a Hitachi sample cup in Pos. 1 of the sample disk or Pos. 1 of a rack in STAT pos. Automatically checked !

How to adjust Carry out the "S/R Probe-Z C/T Buffer" function in the "Adjustment S/R Probe R Disk Mixer" screen. Carry out the "S/R Probe-Z C/T Buffer Bottom" function in the " Adjustment S/R Probe R Disk Mixer " screen. Carry out the "S/R Probe-Z Beads Bottom" function in the " Adjustment S/R Probe R Disk Mixer " screen. Carry out the "S/R Probe –Z S.Cup Bottom" function in the " Adjustment S/R Probe R Disk Mixer " screen.

2.6.3 Sipper adjustment Table 2.6-4

1

2

Adjusted item Sipper Z adjustment Sipper-Z Incubator

Sipper-Z Inc. Bottom Sipper-Z PC1 Bottom Sipper-Z CC2 Bottom

Procedure How to adjust The sipper Z adjustment has to be done without a bottle in place. Confirm visually that the sipper probe Carry out the “Sipper-Z Incubator” function in the end is just level with the upper surface of “Adjustment Sipper Cap O/C the holder in the sipping position. BCR” screen. Take PC1 bottle and CC2 bottle off. Carry out one of the following functions in the “Adjustment Automatically checked ! Sipper Cap O/C BCR ”. 1.

Sipper-Z Inc. Bottom

2.

Sipper-Z PC1 Bottom

3.

Sipper-Z CC2 Bottom

2.6.4 Electronic adjustments The following electronic checks should be done: Table 2.6-5 1 2 3

Unit Pipettor LLD Sipper LLD Pressure sensor

How to Adjust Refer to chapter 5.3 for adjustment procedure of Pipettor LLD, Sipper LLD and Clot.

2.6.5 Rack Sampler adjustments 2.6.5.1 Adjustment table In case of Rack Sampler installation we recommend that all positions are checked. Refer also to Chapter 4.5.2.2. Table 2.6-6 Unit

Adjusted Item

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1

2

3

Unit A Line

B Line

C Line

Adjusted Item

Service Manual Item to be Confirmed Not applicable

How to Adjust ---

1.

Belt tension.

2.

Mounting position of the rack feed arm.

3.

Position of the rack guide at the buffer base.

4.

Position of the rack feed end.

1.

Belt tension.

2.

Sampling position.

3.

Position of the rack feed end.

4.

BCR Reading Position.

1.

Belt tension

2.

Mounting position of the rack feed arm.

The rack guide and the rack feed arm on the rack tray must be at right angles (within ±1 mm).

Mechanical adjustment

3.

Position of rack guide at the buffer base.

The center of the rack guide on the rack tray must correspond with the center of the rack guide on the buffer base (within ±5 mm).

Mechanical adjustment

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The rack guide and the rack feed arm on the rack tray must be at right angles.

Mechanical adjustment

The center of the rack guide on the rack tray must correspond with the center of the rack guide on the buffer base.

Mechanical adjustment

The space between the rack feed arm and the rack must be 1 to 2 mm when the rack is pressed against the rack rail on the B Line.

Carry out the “A Line Loading Pos.” function in the “Adjustment Rack” Screen.

Not applicable

---

The tip must be in the center of the tubes (within ±1 mm).

Carry out the “B Line Sampling Pos.” function in the “Adjustment Rack” Screen. Carry out the “B Line Unloading” function in the “Adjustment Rack” Screen.

The center of the notch to prevent the rack from toppling must correspond with the center of the rack guide on the buffer base of the C Line (within ±1mm). Automatically determines the reading position.

Not applicable.

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Carry out the “B Line B.C.R. Auto” function in the “Adjustment Rack” Screen. ---

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2.6.5.2 Explanation Adjustment Sample Position Place a rack with a primary tube (diameter 10 or 13 mm) in rack position one at the STAT position of rack sampler unit. Carry out "B line sampling pos." from the screen "Adjustment Rack". Check the current sample position adjustment! If the pipetter needs correction to left/right (x-axis, see Figure 2.6-3), quit the current screen with "Cancel" key, change to the "Adjustment S/R Probe R.Disk Mixer" screen and carry out "S/R Probe-X Rack Sampling" from the screen.

B line sample position

Figure 2.6-3 If the pipetter needs correction in up/down direction (y-axis, see Figure 2.6-3), change the rack position with "Forward" or "Backward" key.

Note: The hook will only move the rack backwards (see Figure 2.6-3). For forward hook

movement, you have to push the rack by hand to get the actual position.The range of software adjustment for B line sample pos. is only ± 5 steps because of the design of the racks (Figure 2.6-4).

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cobas e411 rack

Figure 2.6-4 If the range of software adjustment for B line sample pos. is not sufficient, change the sample position manually. To adjust manually, move the whole sample detector B assembly (see Figure 2.6-5) in the corresponding direction. The detector B assembly is fastened with two screws on the left and one screw on the right. After changing the position manually, optimize again with the software (as described above).

B line sample position, adjustment possibilities

Figure 2.6-5

2.6.5.3 Adjustment the Barcode Reader Position Adjusting the Barcode Reader Base Position Adjust the BCR base position according to Figure 2.6-6. Detail:

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Adjust the position of BASE (P/N741-7641) so that the distance between Surface A of the notch located on BASE and Surface B of the readout window becomes 38.5 ± 1mm.

Figure 2.6-6 Adjusting BASE position

Figure 2.6-7 How to adjust the BCR position – Reference 1

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Figure 2.6-8 How to adjust the BCR position – Reference 2

Automatic Adjustment of BCR Readout Position Perform automatic adjustment of BCR readout position according to the following. 1 2 3 4

► ► ► ►

Attach all COVER ASSY on the analyzer body. Attach COVER on the rack sampler body. Open Front top COVER on the analyzer body and on the rack sampler body. Perform automatic adjustment of the BCR readout position. Use calibrator and control vials to perform the adjustment.

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2.7 Table of Contents 2.7.1 Method to detach the external covers 1. Detaching the REAR COVER (P/N: 741-8065) 1 ►

Detach the REAR COVER by removing the two SCREWS (M641007: M4×6 TP screw) that fix it.

Figure 2.7-1 2. Detaching the PC Unit (P/N: 741-0231) 1 ►

Remove the two SCREW COVERS (E)(P/N 741-8080).

Figure 2.7-2 2 ►

Detach the WIRE COVER (1) by unfastening the two SCREWS (M641051: M4×6 Terminal screw) that fix it and then shifting it leftward.

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Figure 2.7-3 3 ►

Unlock each of the eight CRAMPS (P/N: 731-1415, J839403, J839411) and release the PC wires

Figure 2.7-4 4 ►

Pull out the PC wires from the Wire-fix of the FRONT COVER S1 (P/N: 741-8051) to slacken them.

Figure 2.7-5 5 ►

Remove the three HEXAGON SOCKET HEAD CAP BOLTS (M330621: M4×16) that fix the PC unit and then remove the PC unit shifting it in the direction indicated in the figure below.

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Figure 2.7-6 6 ►

Place the PC UNIT temporarily on the left area of the instrument. When doging this, keep the base part of the UNIT opened.

Figure 2.7-7 3. Detaching the TOP COVER (P/N: 741-8053) 1 ►

Open the TOP COVER, and unfasten the two SCREWS (M641009: M4×8 TP screw) that fix the left part of the GUIDE COVER (P/N: 741-8070)

Figure 2.7-8 2 ►

Remove the two SCREWS (M641009: M4×8 TP screw) that fix the right part of the GUIDE COVER.

Figure 2.7-9 3 ►

Detach the GUIDE COVER by shifting it rightward.

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Figure 2.7-10 4 ►

Fix the SCREWS unfastened in 1 ►(Figure 2.7-8) and also the SCREWS detached in 2 ►(Figure 2.7-9), to the TOP COVER

Figure 2.7-11 5 ►

Remove the eight SCREWS (M641136: M4×10 SCREW WITH SPRING WASHER, M871105: SCREW WITH WASHER) that fix the TOP COVER.

Figure 2.7-12 6 ►

Lift the TOP COVER upward to disconnect it from HINGE PLATES (P/N: 741-8074)

Figure 2.7-13 4. Detaching the FRONT COVER S3 (P/N: 741-8064) 1 ►

Remove the two SCREW CAPS (E)(P/N: 741-8080)

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Figure 2.7-14 2 ►

Remove the two SCREWS (M641009: M4×8 TP screw) that fix the FRONT COVER S3 and detach it by lifting it upward.

Figure 2.7-15 5. Detaching the FRONT COVER S2 (P/N: 741-8052) 1 ►

Remove the three SCREW COVERS (E)(P/N: 741-8080).

Figure 2.7-16 2 ►

Remove the three SCREWS (M641009: M4×8 TP screw, M641056: M4×16 Terminal screw) that fix the FRONT COVER S2. And remove the FRONT COVER S2 by pulling it frontward.

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Figure 2.7-17

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6. Detaching the FRONT COVER S1 (P/N: 741-8051) 1 ►

Remove the three SCREWS (M641052: M4×8 Terminal screw, M641054: M4×12 Terminal screw, M641056: M4×16 Terminal screw) that fix the FRONT COVER S1. And remove the FRONT COVER S1 by lifting it upward. When doing this, be careful not to hurt the inside surface of the FRONT COVER S1.

Figure 2.7-18

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2.7.2 Method to attach the external covers 1. Attaching the FRONT COVER S1 (P/N: 741-8051) 1 ►

Bring the FRONT COVER S1 above the mounting position, and lower it carefully paying attention to its alignment. When doing this, be careful not to hurt the inside surface of the FRONT COVER S1. After placing it on the main unit base, temporarily fix the FRONT COVER S1 to the main unit base using three SCREWS (M641052: M4×8 Terminal screw, M641054: M4×12 Terminal screw, and M641056:M4×16 Terminal screw)

Figure 2.7-19

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2. Attaching the FRONT COVER S2 (P/N: 741-8052) 1 ►

Shift the FRONT COVER S2 in the direction indicated in the figure below. After inserting the pins of the FRONT COVER S2 into the receptive holes on FRONT COVER S2 (on both right and left sides), fix the FRONT COVER S2 to the main unit base using three SCREWS (M641009: M4×8 TP screw, M641056: M4×16 Terminal screw). When doing this, keep the FRONT COVER S2 pressed in the direction indicated in the figure below.

Figure 2.7-20 2 ►

Attach the three SCREW COVERS (E)(P/N: 741-8080).

Figure 2.7-21

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3. Adjusting the Mounting Position of the FRONT COVER S1 1 ►

Keeping the FRONT COVER S1 pressed to the FRONT COVER S2, fasten tightly the three SCREWS that were fastened temporarily in 1 ► (Figure 2.7-19), to fix the FRONT COVER S1 to the main unit base. When doing this, pay attention to minimize the gap between the mating faces of the FRONT COVER S1 and FRONT COVER S2 (on both right and left sides).

Figure 2.7-22 4. Attaching the FRONT COVER S3 (P/N: 741-8064) 1 ►

Place the FRONT COVER S3 in the mounting position and fix it to the FRONT COVER S2 using two SCREWS (M641009: M4×8 TP screw).

Figure 2.7-23 2 ►

Attach the two SCREW COVERS(E)(P/N: 741-8080).

Figure 2.7-24

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5. Attaching the TOP COVER (P/N: 741-8053) 1 ►

Using your hand, raise the two HINGE PLATES (P/N: 741-8074) so that they stand vertical to the Side A (see the figure below) of the FRONT COVER S1.

Figure 2.7-25 2 ►

Insert the two HINGE PLATES into the TOP COVER’s receptive holes and fix it temporarily by using eight SCREWS (M641136: M4×10 SCREW WITH SPRING WASHER, M871105: SCREW WITH WASHER).

Figure 2.7-26

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Adjust the position of the TOP COVER as follows: Adjust the position of the TOP COVER so that Side B of the FRONT COVER S1 does not interfere with Side C of the TOP COVER. (i.e., Match Side D of the FRONT COVER with Side E of the TOP COVER)

Figure 2.7-27 3.3 ► 4 ►

Fasten tightly the SCREWS that were fasten temporarily in 2 ►(Figure 2.7-25) to fix the TOP COVER to the main unit base. Open the TOP COVER, and unfasten the two SCREWS (M641009: M4×8 TP screw) that fix the left part of the HINGE GUIDE 1 (P/N: 741-8061)

Figure 2.7-28

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Remove the two SCREWS (M641009: M4×8 TP screw) that fix the right part of the HINGE GUIDE 1.

Figure 2.7-29 6 ►

Shift the GUIDE COVER (P/N: 741-8070) in the direction indicated in the figure below. Using the SCREWS you have removed in 5 ►(Figure 2.7-29), fix the GUIDE COVER to the TOP COVER.

Figure 2.7-30

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6. Attaching the PC Unit (P/N: 741-0231) 1 ►

Shift the PC unit with its base part closed in the direction indicated in the figure below, and place it on the FRONT COVER S1. Using three HEXAGON SOCKET HEAD CAP BOLTS (M330621: M4×16), fix the PC unit to the FRONT COVER S1.

Figure 2.7-31 2 ►

Properly route the PC wires through the eight CRAMPS and the Wire-fix of the FRONT COVER S1 to secure them.

Figure 2.7-32

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Shift the WIRE COVER (1) (P/N: 741-8069) in the direction indicated in the figure below and place it on the FRONT COVER S1. Using two SCREWS (M641051: M4×6 Terminal screw), fix the WIRE COVER (1) to the FRONT COVER S1.

Figure 2.7-33 4 ►

Attach the two SCREW COVERS (E)(P/N: 741-8080).

Figure 2.7-34 7. Attaching the REAR COVER (P/N: 741-8065) 1 ►

Place the REAR COVER in the mounting position and fix it to the main base unit using two SCREWS (M641007: M4×6 TP screw). When doing this, be careful no to sandwitch the PC wires you have routed in 2 ► (Figure 2.7-32).

Figure 2.7-35

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2.7.3 Mmethod to detach the PC Unit 1. Detaching the REAR COVER (P/N: 741-8065) 1 ►

Detach the REAR COVER by removing the two SCREWS (M641007: M4×6 TP screw) that fix it.

Figure 2.7-36 2. Detaching the PC Unit (P/N: 741-0231) 1 ►

Remove the two SCREW COVERS (E)(P/N: 741-8080).

2 ►

Detach the WIRE COVER (1) (P/N: 741-8069) by removing the two SCREWS (M641051: M4×6 Terminal screw) and then shift it leftward.

Figure 2.7-37

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Unlock each of the eight CRAMPS (P/N: 731-1415, J839403, J839411) and release the wires that run through them.

Figure 2.7-38 4 ►

Pull out the PC wires from the Wire-fix of the FRONT COVER S1 (P/N: 741-8051) to slacken them.

Figure 2.7-39 5 ►

Remove the three HEXAGON SOCKET HEAD CAP BOLTS (M330621: M4×16) and detach the PC Unit by shifting it in the direction indicated in the figure below.

Figure 2.7-40

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Place the PC unit temporarily on the left of the instrument keeping the base part of the unit opened.

Figure 2.7-41

2.7.4 Method to attach the PC Unit 1. Attaching the PC Unit (P/N: 741-0231) 1 ►

Shif the PC unit in the direction indicated in the figure below and place it on the FRONT COVER S1. Fix the PC unit to the FRONT COVER S1 using three HEXAGON SOCKET HEAD CAP BOLTS (M330621:M4×16)

Figure 2.7-42

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Properly route the PC wires through the eight CRAMPS and the Wire-fix of the FRONT COVER S1 to secure them.

Figure 2.7-43 3 ►

Shift the WIRE COVER (1) (P/N: 741-8069) and place it on the FRONT COVER S1. After that, fix them using two SCREWS (M641051: M4×6 Terminal screw)

Figure 2.7-44 4 ►

Attach the two SCREW CAPS (E)(P/N: 741-8080)

Figure 2.7-45 2. Attaching the REAR COVER (P/N: 741-8065) 1 ►

Place the REAR COVER on the mouting position and fix it to the main unit base using two SCREWS (M641007: M4×6 TP). When doing this, be careful no to sandwitch the PC wires you have routed in 2 ►(Figure 2.7-43).

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Figure 2.7-46

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3.1 Description of Flow Path • • • •

• •

System water is supplied by the water supply bottle (capacity: 3.5 liters) and the water level is monitored by a float switch. Water is pumped by a magnet pump and distributed to the pipetter and sipper inside/outside wash and also to the mixing paddle wash via a branch pipe and the solenoid valves (SV). The pipetter line has clot detection (Refer to Chapter 5.3.4 for principle of clot detection), and checks for blood clots and serum gel separator clots, etc. Reacted solution is sipped into the measuring cell in the detection unit by means of the sipper probe; waste is transferred to the waste solution bottle after measuring. All system water that is used for washing (P) & (S) probes and paddle is collected in the waste solution bottle via the cleaning path (P), & (S). The waste bottle has a capacity of 4 liters. A mechanical switching unit detects whether the bottle is full and causes the instrument to go into sampling stop. System water quality requires less than 10µS/cm conductivity. If water conductivity is higher, liquid level detection fails will occur because the detection method relies on a capacitance principle. Refer to the overall piping diagram for details of the flow path.

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3.1.1 Overall Piping Diagram See

pdf\OverallPipingDiagram.pdf for more details

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3.1.2 List of Parts Table 3.1-1 List of Valves and Pumps SV/Pump No. SV1 SV2

Part Name

Type

Voltage

Application

Part No.

Solenoid Valve UDV Assy

UDV-2-M6C

24VDC

↑ Pinch Valve 2 Assy

↑ AP-2602-13-HA

↑

For Pipetter Syringe For Sipper Syringe

↑

For Sipper Line Probe

741-0833

↑ UDV-2-M6C

↑

For Sipper line Drain

741-0833

SV5

↑ Solenoid Valve UDV Assy

↑

741-0830

SV6

↑

↑

↑

SV7

↑

↑

↑

Pump

DC Magnet Pump Assy

MD-6Z-DC-7

↑

For External Washing of Pipetter Tip For Washing Beads Mixing Paddle For External Washing of Sipper Probe Water Supply

SV3 SV4

741-0830 741-0830

741-0830 741-0830 741-0832

Table 3.1-2 List of Tubes No. 0

Part Name Tube B for Sipper Syringe

Material, Length

Part No. 741-0821

1

Tube 1

741-0807

2

Tube 2

741-0808

3

Sipper Drain Tube

4 5

Drain Tube Cleaning Bath (S) Tube for Tip Wash

Tygon Tube R3603 3.17ID x 3.35OD L=750 SR Tube 8x12 FB L=150 L=930

T3604-23-1

6

Tube for Mixer Bath

L=760

T3604-23-1

7

Tube 7

741-0809

8

Tube 8

741-0543

9

Tube 9

741-0803

10

Water Return Tube

11

Water Supply Tube

12

G153177

Pump Out Tube

G153171

13

Joint Tube

L=80

G153171

14

Ventilation Tube

SR Tube 4x8 FB L=300

G153176

15

Tube B for Measuring Cell

741-0822

16

Tube B for Sipper

741-0820

17 18

Tube Set IH (Pinch Tube) Tube 510

19

Tube 465

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T3604-23-1

SR Tube 4x8 FB L=350 Silastic Tube 8ID x 3T L=150 L=50

L=180 ( 2 PCS )

Roche ID

G153176 G153171

741-0941 741-1778 741-1775

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Part Name Heat pipe (Line heater)

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Part No. 741-0967

Roche ID

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3.2 System Volume Introduction The system volume value is needed by the system to ensure that the sample is transported to the measuring cell working electrode surface. If the system volume is wrong the results may vary. (Bad CV´s )

Note: Whenever a part on the sipper line (excluding the measuring cell ) is exchanged the system volume has to be determined.

3.2.1 Definition of System Volume The volume between the sipper needle top and the measuring cell outlet. The mean system volume of the e411 is 460 µl ± 30 µl. The measuring cell itself has a volume of 60 µl ± 5 µl.

3.2.2 Determination of System Volume Preparation Place 1 (one) set of system reagent ProCell/CleanCell bottles filled with ProCell/CleanCell at Position 1, right side in the system reagent container.

3.2.2.1 Procedure ► ► ► ► ► ►

Make sure that the instrument is in standby status. Touch the [Utility] button. Touch the [Maintenance] button. Touch the [Service] button. Touch the [System Volume Check] button and Touch the [Select] button. Touch the START button in the screen.

The system volume is determined as follows: The sipper line is first filled with ProCell. An air bubble of 100 µl is set. The air bubble is transported to the measuring cell. Before the bubble arrives at the cell the measuring cell voltage is switched on. The bubble separates the reference electrode (RE) from the counter electrode (CE) and working electrode (WE). When the bubble leaves the cell a current peak is created, and this peak is measured to calculate the volume (refer to Figure 3.2-1 and Figure 3.2-2).

Note: After the procedure has been finished successfully the instrument returns to Standby. If an

error message appears, refer to troubleshooting. The system volume value is not displayed.

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Figure 3.2-1

Figure 3.2-2

3.2.3 Storage of the System Volume Value / Data Handling The determined system volume is stored as a value between 1 to 7 in the static SRAM of the CPU. The value is also stored on the database file. When the instrument is switched on (main switch), the value is loaded from the static SRAM (like adjustment data) and CF.

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3.3 Cleaning Procedures Introduction Two cleaning procedures are recommended for the e411 flowpath. Liquid flow cleaning (see Chapter 3.3.1) This cleaning procedure is also part of the customer maintenance (see Operator’s Manual) and should be carried out frequently. Service liquid flow cleaning (equivalent to 3 customer cleanings) should only be performed in the event of high grade contamination problems (e.g. heat pipe blockage) Cleaning for Fluidics System (see Chapter 3.3.2) This procedure cleans tubings and the washing stations, but not the sipper line.

3.3.1 Liquid Flow Cleaning

Introduction Contamination in the sipper system could potentially degrade sample accuracy and precision, or possibly block the measuring cell flow path. Liquid flow cleaning keeps the sipper liquid flow path clean and maintains the integrity of the measuring cell. The customer should perform LFC on a frequent basis. Please train all your customers according to the procedure described below and inform them about the importance of keeping the liquid flow path clean and the measuring cell at the best performance level. If operators perform this procedure frequently it will lead to fewer customer complaints. Required materials:

SysClean adapter Ident. SysClean Solution Recommended frequency*: ∗

No.: 1933159.910 Ident. No.: 1298500 Every two weeks or after 2500 - 3000 cycles

If customer maintenance has been done as recommended, it is only necessary to carry out an additional customer cleaning at the PM visit. The service LFC is only necessary during PM if the sipper line is highly contaminated or if LFC has not been carried out regularly by the customer.

Operator time: Analyzer time:

Approx. 3 minutes User LFC: Approx. 16 minutes (user) Service LFC: Approx. 32 min + time for MC prepare cycles The cleaning solution is corrosive. Wear protective gloves and glasses when handling this solution.

Precautions:

Procedure for Customer / Service 1.

User

Replace the PC bottle at position 3 by the SysClean adapter (keep the CC bottle in position).

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3.

User /Service User Service

4. 5.

Service Manual

Insert the adapter with the marking "USER" in direction towards the back of the instrument. Fill the SysClean solution to the edge of the fill mark on the adapter (approx. 9 ml). PC/CC bottle has to be placed at the left side. Same procedure as for customers but using the Service position of the adapter. Touch the Liquid Flow Cleaning button on the screen (Screen: Util / Maintenance). The number of LFCs should be 1 for User maintenance. The number of LFCs should be 3 for service. Take out the SysClean adapter and place ProCell and CleanCell bottles in all positions. Perform Measuring Cell Preparation cycles. [Press ”MC Preparation” in Maintenance screen; select number of cycles]

Start the LFC procedure shortly after filling up the SysClean solution. After the instrument returns to Stand by remove the SysClean adapter and discard the remaining ISE solution. To avoid an unpleasant odor, please empty the waste container at the end of the liquid flow cleaning procedure. After a Service LFC has been performed customers should check all controls and carry out a calibration if necessary. This is not necessary for normal routine with customer LFC.

3.3.2 Cleaning Procedure for Fluidics System The fluidics system consists of the tubing system, the pipettor, all wash stations except the part between the sipper probe and SV3) The cleaning procedure is a function to be carried out when frequent high water conductivity errors happen and if the system is contaminated with bacteria, algae, etc. Contamination can lead to problems with the pipetting or washing processes, thereby degrading the sample accuracy and precision.

Note: This is not a part of the routine maintenance for the e411. This procedure should only be used if contamination has occurred.

3.3.2.1 Required materials - 30 % Perhydrol-Solution; Fa. Merck Cat. No.: 1.07209.1000

Procedure 1 ►

Remove the system water container. Fill with 3% Perhydrol solution and empty the liquid waste container.(Put about 100 ml 30 % Perhydrol solution in the tank, and fill up with purified water to the 3 L mark. (3.5L volume). Mix carefully. Replace the system water container.

2 ►

Touch the Maintenance button on the screen.

3 ►

Touch the Service Cleaning button on the screen.

4 ►

Start. The procedure takes 50 min and consumes about 2.8 L. When cleaning is finished the status changes to Stand-by. Allow the solution to react for 20 min.

5 ►

Empty the liquid waste container.

6 ►

Clean the system water container and refill with system water. Replace the container on system.

7 ►

Touch the Cleaning button again. Rinsing with system water starts (50 min).

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8 ►

Repeat points 5 to 7 twice to guarantee that the whole system is filled with system water.

9 ►

After finishing, the top of the screen changes to Stand-by. Please empty the liquid waste container and refill the system water container with system water. The system is now ready for the normal routine.

In case of frequent high water conductivity errors, check that the pipettor LLD voltage is 1.5 V or lower. Otherwise, repeat the cleaning process with system water until the voltage is reduced to 1.5 V. In case of strong contamination repeat the whole cleaning procedure again.

Note: There are some instruments that generate the alarm "Distilled Water: 25-01-01" during Cleaning and the status shifts to Stand-by. However there is no problem with the performance of cleaning function if enough system liquid (around 3 L) has run.

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3.4 SysWash 3.4.1 Introduction SysWash is used as an additive to the wash water in the e411. SysWash increases the rinsing efficiency between pipetting steps. SysWash also contains a preservative to protect the system from contamination (e.g. by bacteria). The detergent solution is particularly necessary when performing analyses using e411 infectious disease assays, but can also be used for the other parameters. Before SysWash is regularly used on the instrument, service has to carry out the Rinsing procedure (see below). After the rinsing procedure has been finished, SysWash has to be used in the system water in the recommended concentration (prepared working solution contains 0.075% detergent).

Note: The SysWash is recommended for use in all e411 systems. For further details refer to “Product Information” inside the SysWash package. SysWash Cat No. 1930346 1 x 500mL

3.4.2 SysWash Rinsing Procedure 1 ► 1.1 ►

Preparing the Mixture in the System Water Container Take 35 mL of SysWash and pour it into the empty e411 wash water container. Fill the container with distilled water to the highest mark (dilution ratio is now 1 + 100).

Note: When pouring in the water make sure that it flows quickly enough, but avoid the formation of foam. This ensures that the additive will be dispersed evenly in the wash water, so no additional mixing will be necessary.

2 ► 2.1 ►

2.2 ►

Analyzer Rinsing Procedure Proceed as follows to ensure that the active component is present in the tip wash station for the first determination: Start CLEANING-function ([Util] [Maintenance] [Service Cleaning] [Start]) Run the CLEANING-function 2-3 times. Make sure that the total rinse volume is ≥ 5 L *.*This amount is necessary to replace the volume in the buffer container below the system water container.

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4.1 Overview 4.1.1 Location See Chapter 4.2.

4.1.2 Outline of Mechanical Units 4.1.2.1 Sample Disk Mechanism The sample disk mechanism rotates the sample disk to position the sample in the pipetting position.

4.1.2.2 Reagent Disk Mechanism The reagent disk mechanism consists of the following two units: 1. Reagent Disk Mechanism: The reagent disk mechanism causes the rotation of the reagent disk to bring the reagent in the pipetting position. 2. Reagent Cooling Unit: The reagent cooling unit is a Peltier-element temperature controller that controls the reagent temperature.

4.1.2.3 Cap Open/Close Mechanism The cap open/close mechanism has three separate hooks. Using these hooks, the mechanism opens and closes the snap-in cap of the rack pack, coinciding with pipetting the reagent or stirring by the beads.

4.1.2.4 Beads Mixer Mechanism The beads mixer stirs the beads in the reagent rack pack right before pipetting the reagent.

4.1.2.5 Pipetter Mechanism The pipetter is a unit that picks up the disposable tip using the X-Z mechanism, aspirates a sample, calibrator, reagent (beads, R1, and R2), and diluent, and injects the material into the reaction vessel.

4.1.2.6 Buffer Station The buffer station is a picking-up position of tips for the pipetter and an injection position for sample and reagent into the reaction vessel.

4.1.2.7 Gripper Mechanism The gripper consists of the following three units. It carries the tip/vessel from the container to buffer station and from the buffer station to the incubator. 1. Tip/Vessel Carrier - Transports the tip/vessel by using the X/Y/Z/Grip mechanism. 2. Container Station - Capable to carry up to three tip containers and three vessel containers. 3. Incubator Station - On its heat blocks are 32 incubator stations and 1 sipping station.

4.1.2.8 Sipper Mechanism The sipper carries the probe that is connected to the syringe with a tube to each station throught the measuring cell. Version 1.0 – May 2006

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4.1.2.9 System Reagent Mechanism The system reagent mechanism is a unit that keeps the liquid temperature constant inside the AB and CC bottles. It has a case that has grooves for an AB bottle and a CC bottle. By setting an AB bottle and a CC bottle, one at a time, it adjusts the case temperature by using a Peltier temperature controller.

4.1.2.10 Syringe Mechanism The syringe consists of the two systems below. It moves the liquid by pumping it up with the force driven by the plunger’s up-and-down movement and by the shift of the position of the probe in each system. 1. Pipetter Syringe (on the left side) - Aspirates and pipettes a specified amount of each sample, reagent, or beads using the pipetter probe and tube. 2. Sipper Syringe (on the right side) - Aspirates the reaction mixture through the sipper probe, tube, and measuring cell.

4.1.2.11 System Water Container (Float SW) The system water container consists of the following two units. Driven by the pump and valve, it provides system water to each wash bath and syringe. 1. System Water Container - Capacity: 3 liters 2. Buffer Tank - Capacity: 1 liter, with float SW.

4.1.2.12 Liquid Waste Container The liquid waste container consists of the following two units. It collects the wash solution and reaction mixture. 1. Liquid Waste Container - Capacity 4 liters. 2. Container Station (with a fill-level detector with a detection level: 3.5 liters)

4.1.2.13 Solid Waste Mechanism The solid waste mechanism vibrates the waste box to smooth the used tips and vessels piled up in the waste box so that the space to collect the tips and vessels is maximized.

4.1.2.14 Magnet Drive Mechanism The magnet drive mechanism is located in the detection unit below the measuring cell. In the analyzer, it is used for positioning the magnet in the detection point of the measuring cell and for taking the magnet away from the cell.

4.1.2.15 Matrix BCR Mechanism The matrix BCR mechanism is a unit that contains a rotating mechanism that is used for scanning barcoded data with a bar-code reader. The bar-code reader scans a bar code attached to a sample tube, or a reagent rack pack, or scans a bar-code card that carries the information of these three in combination

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4.2 Location of Mechanisms 4.2.1 Analyzer

Figure 4.2-1 1 2 3 4 5 6 7 8 9 10

Pipetter Mechanism Cap Open/Close Mechanism Beads Mixer Mechanism System Reagent Mechanism Sipper Mechanism Sipper Safety Cover Syringe Mechanism Gripper Mechanism Solid Waste Mechanism Reagent Disk Mechanism

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Figure 4.2-2 1 2 3 4

BCR Mechanism Cap Open/Close Mechanism Reagent Disk Mechanism Sample Disk Mechanism

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Figure 4.2-3 1

Detection Mechanism

Figure 4.2-4 1 2

System Water Container Liquid Waste Mechanism

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4.2.2 Rack Sampler System

Figure 4.2-5 Rack Sampler Unit 1 2 3 4 5

C Line BCR & BCR Board(P/N741-5056) in the Analyzer STAT Sample Position B Line A Line

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Figure 4.2-6 Overview of the A Line 1 2 3 4 5

LED201 PI202 (A Line Rack Feed End Position) PI201 (A Line HOME Position) PI200 (A Line Tray Detection) Motor SM200

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Figure 4.2-7 Overview of the B Line 1 2 3 4 5 6 7

PI213 (B Line STAT Position) PI210 (B Line HOME Position) PI216 (B Line BCR Read Position) PI211 (B Line Rack Feed End Position) PI212 (B Line Rack Detection) PI217(B Line cup Detection) PI215 (B Line Sampling Position)

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Figure 4.2-8 Overview of the C Line 1 2 3 4 5 6 7 8

LED202 PI224 (C Line Tray Detection) PI226 (C Line Tray Full 2 Detection) PI225(C Line Tray Full 1 Detection) PI223 (C Line Rack Full Detection) Rack Feed Arm PI222(C Line Rack Feed End Position) PI221(C Line HOME Position)

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4.3 List of Motors, Sensors, and Other Mechanisms 4.3.1 List of Motors Table 4.3-1 No. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

Unit Sample Disk Reagent Disk Cap Open Close Mecha. (F/B) Cap Open Close Mecha (O/C) Beads Mixer (Rotation) Beads Mixer (U/D) Beads Mixer (Mix.) Pipetter (X-axis) Pipetter (U/D) Gripper (X-axis) Gripper (Y-axis) Gripper (U/D) Gripper Solenoid Pipetter Syringe Sipper Syringe Sipper (X-axis) Sipper (U/D) D Unit (Mag. Drive) Solid Waste BCR Rotate

Type KP56KM1-014 KH56LM2-027 KH56HM2-016 PH264-01-C97 PX244M-02A KH42HM2-052 16CL-2524 KH56LM2-027 KH42HM2-052 KH42JM2-011 KH56LM2-049 PF25-48D4 2ER45-33x3x9 PH265M-33-C3 KH56KM2-016 KH56LM2-027 KH42HM2-052 KH42HM2-052 KH56HM2-016 KH42HM2-052

Part No. 741-0550 741-0551 741-4257 741-4255 741-0601 741-0603 741-0725 741-4244 741-4245 741-4320 741-4319 741-4321 741-4322 741-0804 741-0806 741-4248 741-4249 741-8551 741-0581 741-0600

Drive PCB DO1 DO2 DO1 DO1 DO1 DO1 EIO3 DO1 DO1 DO1 DO1 DO1 EIO3 DO1 DO2 DO1 DO2 DO2 DO1 DO2

Control PCB GPCONT1 GPCONT1 GPCONT2 GPCONT2 GPCONT3 GPCONT3 GMCONT GPCONT5 GPCONT5 GPCONT7 GPCONT8 GPCONT7 GMCONT GPCONT9 GPCONT9 GPCONT6 GPCONT6 GPCONT8 GPCONT4 GPCONT4

4.3.2 Motor Reference List This is a cross-reference list for motors used in the cobas e411 instrument. The part numbers in the current pasts list mainly include motors with connected wires. Due to the fact that we only stock single motors, the part numbers cannot be used for ordering purposes. Table 4.3-2 Page of Parts List

Part number (motor with lead wires)

8 11 13 20 24 26 28 29 32 37 41 43 44

741-0551 741-4244 741-4247 741-4320 741-4319 741-4257 741-4248 741-4251 741-0806 741-8551 741-0603 741-0600 741-0581

Part number (motor itself, without lead wires) 741-1120 741-1120 741-1049 K591137 741-3132 741-1048 741-1120 741-1049 741-1560 741-1049 741-1049 741-1049 741-1048

Part name (motor itself, without lead wires) Pulse Motor KH56LM2-027 Pulse Motor KH56LM2-027 Pulse Motor KH42HM2-052 Pulse Motor KH42JM2-011 Pulse Motor KH56LM2-049 Pulse Motor KH56HM2-016 Pulse Motor KH56LM2-027 Pulse Motor KH42HM2-052 Pulse Motor KH56KM2-016 Pulse Motor KH42HM2-052 Pulse Motor KH42HM2-052 Pulse Motor KH42HM2-052 Pulse Motor KH56HM2-016

4.3.3 List of Sensors Table 4.3-3 No. 1 2

Item Photo-Coupler Photo-Coupler

Description S.Disk Home P S.Disk Stop P

Version 1.0 – May 2006

Type GP1A34LC GP1A34LC

4 - 10

Part No. J339165 ↑

Bright/Dark Dark Bright

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Item Photo-Coupler

Service Manual

Description R.Disk Home P

Type GP1A34LC

↑

Part No.

Bright/Dark Dark

4

Photo-Coupler

R.Disk Stop P

GP1A34LC

↑

Bright

5

Photo-Coupler

BCR Home P

GP1A34LC

↑

Dark

6

Photo-Coupler

Cap Opener F/B Home.P

GP1A34LC

↑

Dark

7

Photo-Coupler

Cap Opener F/B Stop.P

GP1A34LC

↑

Dark

8

Photo-Coupler

Cap Opener O/C Home P

GP1A34LC

↑

Dark

9

Photo-Coupler

Pipetter U/D UDP

GP1A34LC

↑

Dark

10

Photo-Coupler

Pipetter X-axis Home P

GP1A34LC

↑

Dark

11

Photo-Coupler

Pipetter X-axis End P

GP1A34LC

12 13 14

Photo-Coupler Photo-Coupler Photo-Coupler

Pipetter Z-axis Abnormal D Beads Mixer Arm Home P Beads Mixer Arm End P

TLP830 GP1A34LC GP1A34LC

↑ J339168 J339165 ↑

Bright Dark Dark

15

Photo-Coupler

Beads Mixer U/D UDP

GP1A34LC

↑

Dark

16

Photo-Coupler

Solid Waste Home P

GP1A34LC

17 18 19

Photo-Coupler Photo-Coupler Photo-Coupler

Solid Waste Box Det. Sipper U/D UDP Sipper X-axis Home P

DET-C GP1A34LC GP1A34LC

↑ 741-5026 J339165

20

Photo-Coupler

Sipper X-axis End P

GP1A34LC

21 22 23 24

Photo-Coupler Photo-Coupler Photo-Coupler Photo-Coupler

Sipper Z-axis Abnormal D Magnet Drive Home P Pip. Syringe UDP Sip Syringe UDP

TLP830 GP1A34LC DETECT1 DETECT1

25 26

Photo-Coupler Photo-Coupler

Gripper U/D UDP Gripper X-axis Home P

TLP830 TLP830

27

Photo-Coupler

Gripper Y-axis Home P

28

Photo-Coupler

Gripper Y-axis End P

29

Photo-Coupler

Gripper Y-axis Rest P

30

Photo-Coupler

31

↑ ↑ J339168 J339165 741-0810 ↑ J339168

Dark

Dark Dark Dark Dark Dark Dark Dark Dark Dark

↑

Dark Dark

TLP830

↑

Dark

TLP830

↑

Dark

TLP830

↑

Dark

Gripper Solenoid Abnormal D

TLP830

↑

Dark

Photo-Coupler

Gripper Solenoid Grip D

TLP830

Bright

32 33

Photo-Coupler Photo-Coupler

Waste Tank Detection Waste Tank Full

GP1A34LC GP1A34LC

↑ J339165

34 35 36

Float Switch Photo-Coupler Photo-Coupler

Distilled Water Level Tip Buffer 1 Tip Buffer 2

OLV-5-1 PLI-523 PLI-523

37 38 39 40 41 42

Photo-sensor Thermistor Thermistor Thermistor Thermistor Photo-Coupler

System Reagent Bottle R.Disk Temp. Control Incubator Temp Control D.Unit Temp. Control S.Reagent Temp Control Sipper Safety Cover

EE-Spy412 DET-C

↑ 741-0563 741-4318 ↑ 741-1385 741-0554 741-0582 741-8551 741-0548 741-5026

Bright Bright Dark Dark Presence Dark

4.3.4 List of Peltier, Heater and Fan Motor Table 4.3-4 No. 1

Item Peltier

Application Reagent Disk Jacket

Type EC-50FH

Parts No. 741-1216

±15V

Voltage

↑ 741-1202

↑

↑ 741-1216

↑ 12V

↑ 741-1202

↑

↑

2

Peltier

Reagent Disk Jacket

EC-50FH

3

Peltier

System Reagent

EC-50FL

4

Peltier

Detection Unit

EC-50FL

5 6

Fan Motor Fan Motor

Reagent Disk Jacket Reagent Disk Jacket

109P0912H402 109P0912H402

7

Fan Motor

System Reagent

0915-12

8

Fan Motor

Detection Unit

0915-12

9

Fan Motor

PCB Rack

109P1212H402

↑ L542164

↑

10

Fan Motor

Cooling of Instrument

109P1212H402

↑

↑

11

Fan Motor

Cooling of Instrument

109P1212H402

12

Heater

Incubator

SD-124--520

↑ J864036

↑

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4.3.5 List of Motors for Rack Sampler System No. 1 2 3

Unit A Line B Line C Line

Type C7640-9212K KP56KM1-014 A3339-9212

Part No. 741-7258 K591127 K591271

Drive PCB DO4A DO4A DO4A

Control PCB GPCONT12 GPCONT13 GPCONT12

4.3.6 List of Sensors for Rack Sampler System No. 1 2 3

Item Photo-Coupler PI200 Photo-Coupler PI201 Photo-Coupler PI202

Description A Line Tray Detection A Line Home Pos. A Line Rack Feed End Pos.

Type PM2-LF10HH GP1A34LC GP1A34LC

Parts No. J684019 J339165 ↑

Bright/Dark Dark Dark Dark

4

Photo-Coupler PI210

B Line Home Pos.

GP1A34LC

↑

Bright

5

Photo-Coupler PI211

B Line Rack Feed End Pos.

GP1A34LC

Dark

6 7 8

Photo-Coupler PI212 Photo-Coupler PI213 Photo-Coupler PI215

B Line Rack Detection B Line STAT Pos. B Line Sampling Pos.

9 10 11 12

Photo-Coupler PI216 Photo-Coupler PI217 Photo-Coupler PI221 Photo-Coupler PI222

B Line BCR Read Pos. B Line Cup Detection C Line Home Pos. C Line Rack Feed End Pos.

PM2-LF10HH GP1A34LC PH-D PH-T GP1A34LC PM2-LF10HH GP1A34LC GP1A34LC

↑ J684019 J339165 741-5053 741-5054 J339165 J684019 J339165

13 14

Photo-Coupler PI223 Photo-Coupler PI224

C Line Rack Full Detection C Line Tray Detection

PM2-LF10HH PM2-LF10HH

15

Photo-Coupler PI225

C Line Tray Full(1) Detection

16

Photo-Coupler PI226

C Line Tray Full(2) Detection

↑ J684019

Dark Dark Bright Dark Dark Dark Dark

↑

Dark Dark

PM2-LF10HH

↑

Dark

PM2-LF10HH

↑

Dark

4.3.7 List of LEDs and Fan Motor for Rack Sampler System No. 1 2

LED201 LED202

Item

Description A Line Tray Exchange C Line Tray Exchange

Type BD-703G BD-703G

3

Fan Motor

Cooling of DC Power Supply

MD825BM-24

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Parts No. J853635 ↑ L542069

Voltage 5V 5V 24V

Chapter 4.3

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Service Manual

4.4 Detailed Explanation of Each Mechanism Note: Part No. and Part name of each mechanism are different depending on the manufacturing time. Please refer to Parts List for details.

4.4.1 Sample Disk Drive Mechanism 4.4.1.1 Overview The sample disk drive mechanism is a unit that activates the rotation movement of sample disk and transfers samples to the pipetting position.

4.4.1.2 Location See Chapter 4.2.

4.4.1.3 Function Explanation Details This unit consists of the following parts: •

Sample Disk

•

Rotation Mechanism

Sample Disk The sample disk can have positions for thirty (30) samples and controls and be removed from the device in a single operation. Upon delivery, the Sample Disk is wrapped independently from the main body as an accessory. Suitable test tubes for the sample disk:

•

Φ13mm x 75 mm

•

Φ13mm x 100 mm

•

Φ16mm x 75 mm

•

Φ16mm x 100 mm

Suitable sample cups for the sample disk:

•

HITACHI sample cup

The 2~3 ml calibrator bottle can be used for the sample disk. Table diameter: Φ219 mm,Table height: 100 mm

Rotation Mechanism

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The rotation mechanism is a mechanism activated by the timing belt and the motor that activates the rotation movement of the sample disk. •

Speed reduction comparison: 1:10

•

Step angle after speed reduction: 0.045º

4.4.1.4 Explanatory Diagram

Figure 4.4-1

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Figure 4.4-2

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Figure 4.4-3

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4.4.1.5 Parts List Table 4.4-1 Pos. No.

Part Name

Part No.

1

MOTOR S ASSY

741-0550

2

SPRING S ASSY

741-0556

3

PULLEY ASSY

741-0639

4

BASE

741-1185

5

TIMING BELT SR

741-1211

6

HOLDER 2

741-2158

7

GND RING R

741-2159

8

SPRING

741-2166

9

CORD J511

741-4300

10

SENSOR GP1A34LC

J339165

11

WIRE BINDER TY-23M

J839050

12

WIRE BINDER TY-24M

J839051

13

BALL BEARING 6002ZZ

L111060

14

PULLEY

L237010

4.4.1.6 Disassembly and Assembly Procedures Removing the units Remove the parts in the following order: 1 ►

Remove waste tank and water supply tank.

2 ►

Take out the R lid, reagent disk, and sample disk.

3 ►

Take out cover Y (side cover of the gripper).

4 ►

Take out rear cover.

5 ►

Take out front cover.

6 ►

Take out table cover.

7 ►

Unscrew the M4 screw that press-fixes the GND stopper (S) assembly.

8 ►

Remove the sample jacket.

9 ►

Remove the connectors (J510 and J511) and the GND wire.

10 ►

Pull out the sample disk drive unit.

Disassembly and Assembly of Unit Rotation Motor

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Disassembly 1 ► •

Remove the motor

Unscrew the M4 Screw that secures the motor.

Assembly 1 ►

Temporarily fix the motor with the M4 screw, and put the timing belt on the small pulley for the motor.

2 ►

Put the timing belt SR on the big pulley, then rotate the pulley by a small amount (2 or 3 teeth) in either direction to ensure a solid fit.

3 ►

Adjust the belt tension. The belt tension is indicated in the figure below.

Figure 4.4-4 Big Pulley

Disassembly When removing the big pulley, remove it before dismounting the unit from the main body. 1 ►

Remove the sample jacket.

2 ►

Detach the center holder 2.

3 ►

Take out the GND ring and GND spring 1.

4 ►

Remove the timing belt SR.

5 ►

Pull out the big pulley (the small bearing does not need to be removed.).

•

Support the outer circumference by hand

Assembly Assemble after dismounting the motor for rotation. 1 ►

Put the big pulley horizontally on the bearing, and push firmly to set.

2 ►

Insert the small bearing, GND spring, GND ring, and center holder 2 sequentially and fix with the screw.

3 ►

Install the rotation motor.

4 ►

Adjust the belt tension as described above.

Home Position Sensor and Position Sensor

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Disassembly 1 ►

Pull out the big pulley.

2 ►

Unhook the hook of the sensor from the back of the unit.

3 ►

Pull out the connector of the sensor.

Assembly 1 ►

Insert the sensor and install the connector.

2 ►

Install the big pulley.

3 ►

Mount the rotation motor.

4.4.1.7 The Motion and Motion Check Method Check the motion via Reset Motion and confirm that Position No. 1 stops at the sampling position.

4.4.2 Reagent Disk Drive Mechanism 4.4.2.1 Overview The reagent disk drive mechanism is a unit that activates the rotation movement of reagent disk and transfers reagents to the pipetting positions.

4.4.2.2 Location See Chapter 4.2.

4.4.2.3 Functional Details This unit consists of the following parts: •

Reagent Disk

•

Rotation Mechanism

1. Reagent Disk The reagent disk can be used to set more than eighteen (18) reagent rack packs on the circumference. On delivery, the reagent disk is packaged independently from the main body as an accessory. 2. Rotation Mechanism The rotation mechanism is activated by the timing belt and the motor that activates the rotation movement of the reagent disk. •

Speed reduction comparison: 1:10

•

Step angle after speed reduction: 0.18° / step (during operation), 0.0225° / step (during initialization)

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4.4.2.4 Explanatory Diagram

Figure 4.4-5

Figure 4.4-6 Version 1.0 – May 2006

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4.4.2.5 Parts List Pos. No.

Part Name

Part No.

1

Base

741-1185

2

Pulley Assy

741-0639

3

Holder 1

741-1193

4

Ring

741-1197

5

Spring 1

741-1195

6

Spring R Assy

741-0557

7

Ball Bearing 6002ZZ

L111060

8

Timing Belt SR

741-1211

9

Pulley

L237010

10

Sensor GP1A34LC

J339165

11

Motor R Assy

741-0551

12

Cord J521

741-4301

13

Rubber Washer

707-2007

14

Washer R

741-1217

15

Clamp CKS-05-H

J839408

16

Set Plate

741-0598

17

R Disk Assy

741-0627

18

Lock Knob

741-1199

4.4.2.6 Disassembly and Assembly Procedures Removing the Units Remove the parts in the following order: 1 ►

Remove waste tank and water supply tank.

2 ►

Take out the R lid, reagent disk, and sample disk.

3 ►

Take out cover Y (side cover of the gripper).

4 ►

Take out rear cover.

5 ►

Take out front cover.

6 ►

Take out table cover L and table cover R.

7 ►

Remove the set plate.

8 ►

Remove the reagent cooler unit.

•

Take out connectors J520, J521, and the GND wire.

9 ►

Dismount the reagent disk drive unit.

Disassembly and Assembly of Unit

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4.4 Detailed Explanation of Each Mechanism Note: Part No. and Part name of each mechanism are different depending on the manufacturing time. Please refer to Parts List for details.

4.4.1 Sample Disk Drive Mechanism 4.4.1.1 Overview The sample disk drive mechanism is a unit that activates the rotation movement of sample disk and transfers samples to the pipetting position.

4.4.1.2 Location See Chapter 4.2.

4.4.1.3 Function Explanation Details This unit consists of the following parts: •

Sample Disk

•

Rotation Mechanism

Sample Disk The sample disk can have positions for thirty (30) samples and controls and be removed from the device in a single operation. Upon delivery, the Sample Disk is wrapped independently from the main body as an accessory. Suitable test tubes for the sample disk:

•

Φ13mm x 75 mm

•

Φ13mm x 100 mm

•

Φ16mm x 75 mm

•

Φ16mm x 100 mm

Suitable sample cups for the sample disk:

•

HITACHI sample cup

The 2~3 ml calibrator bottle can be used for the sample disk. Table diameter: Φ219 mm,Table height: 100 mm

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Rotation Mechanism The rotation mechanism is a mechanism activated by the timing belt and the motor that activates the rotation movement of the sample disk. •

Speed reduction comparison: 1:10

•

Step angle after speed reduction: 0.045º

4.4.1.4 Explanatory Diagram

Figure 4.4-1

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Service Manual

Figure 4.4-2

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Figure 4.4-3

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4.4.1.5 Parts List Table 4.4-1 Pos. No.

Part Name

Part No.

1

MOTOR S ASSY

741-0550

2

SPRING S ASSY

741-0556

3

PULLEY ASSY

741-0639

4

BASE

741-1185

5

TIMING BELT SR

741-1211

6

HOLDER 2

741-2158

7

GND RING R

741-2159

8

SPRING

741-2166

9

CORD J511

741-4300

10

SENSOR GP1A34LC

J339165

11

WIRE BINDER TY-23M

J839050

12

WIRE BINDER TY-24M

J839051

13

BALL BEARING 6002ZZ

L111060

14

PULLEY

L237010

4.4.1.6 Disassembly and Assembly Procedures Removing the units Remove the parts in the following order: 1 ►

Remove waste tank and water supply tank.

2 ►

Take out the R lid, reagent disk, and sample disk.

3 ►

Take out cover Y (side cover of the gripper).

4 ►

Take out rear cover.

5 ►

Take out front cover.

6 ►

Take out table cover.

7 ►

Unscrew the M4 screw that press-fixes the GND stopper (S) assembly.

8 ►

Remove the sample jacket.

9 ►

Remove the connectors (J510 and J511) and the GND wire.

10 ►

Pull out the sample disk drive unit.

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Disassembly and Assembly of Unit Rotation Motor

Disassembly 1 ► •

Remove the motor

Unscrew the M4 Screw that secures the motor.

Assembly 1 ►

Temporarily fix the motor with the M4 screw, and put the timing belt on the small pulley for the motor.

2 ►

Put the timing belt SR on the big pulley, then rotate the pulley by a small amount (2 or 3 teeth) in either direction to ensure a solid fit.

3 ►

Adjust the belt tension. The belt tension is indicated in the figure below.

Figure 4.4-4 Big Pulley

Disassembly When removing the big pulley, remove it before dismounting the unit from the main body. 1 ►

Remove the sample jacket.

2 ►

Detach the center holder 2.

3 ►

Take out the GND ring and GND spring 1.

4 ►

Remove the timing belt SR.

5 ►

Pull out the big pulley (the small bearing does not need to be removed.).

•

Support the outer circumference by hand

Assembly Assemble after dismounting the motor for rotation. 1 ►

Put the big pulley horizontally on the bearing, and push firmly to set.

2 ►

Insert the small bearing, GND spring, GND ring, and center holder 2 sequentially and fix with the screw.

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3 ►

Install the rotation motor.

4 ►

Adjust the belt tension as described above.

Home Position Sensor and Position Sensor

Disassembly 1 ►

Pull out the big pulley.

2 ►

Unhook the hook of the sensor from the back of the unit.

3 ►

Pull out the connector of the sensor.

Assembly 1 ►

Insert the sensor and install the connector.

2 ►

Install the big pulley.

3 ►

Mount the rotation motor.

4.4.1.7 The Motion and Motion Check Method Check the motion via Reset Motion and confirm that Position No. 1 stops at the sampling position.

4.4.2 Reagent Disk Drive Mechanism 4.4.2.1 Overview The reagent disk drive mechanism is a unit that activates the rotation movement of reagent disk and transfers reagents to the pipetting positions.

4.4.2.2 Location See Chapter 4.2.

4.4.2.3 Functional Details This unit consists of the following parts: •

Reagent Disk

•

Rotation Mechanism

1. Reagent Disk The reagent disk can be used to set more than eighteen (18) reagent rack packs on the circumference. On delivery, the reagent disk is packaged independently from the main body as an accessory. 2. Rotation Mechanism The rotation mechanism is activated by the timing belt and the motor that activates the rotation movement of the reagent disk. Version 1.0 – May 2006

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•

Speed reduction comparison: 1:10

•

Step angle after speed reduction: 0.18° / step (during operation), 0.0225° / step (during initialization)

4.4.2.4 Explanatory Diagram

Figure 4.4-5

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Figure 4.4-6

4.4.2.5 Parts List Pos. No.

Part Name

Part No.

1

Base

741-1185

2

Pulley Assy

741-0639

3

Holder 1

741-1193

4

Ring

741-1197

5

Spring 1

741-1195

6

Spring R Assy

741-0557

7

Ball Bearing 6002ZZ

L111060

8

Timing Belt SR

741-1211

9

Pulley

L237010

10

Sensor GP1A34LC

J339165

11

Motor R Assy

741-0551

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Pos. No.

Part Name

Part No.

12

Cord J521

741-4301

13

Rubber Washer

707-2007

14

Washer R

741-1217

15

Clamp CKS-05-H

J839408

16

Set Plate

741-0598

17

R Disk Assy

741-0627

18

Lock Knob

741-1199

4.4.2.6 Disassembly and Assembly Procedures Removing the Units Remove the parts in the following order: 1 ►

Remove waste tank and water supply tank.

2 ►

Take out the R lid, reagent disk, and sample disk.

3 ►

Take out cover Y (side cover of the gripper).

4 ►

Take out rear cover.

5 ►

Take out front cover.

6 ►

Take out table cover L and table cover R.

7 ►

Remove the set plate.

8 ►

Remove the reagent cooler unit.

•

Take out connectors J520, J521, and the GND wire.

9 ►

Dismount the reagent disk drive unit.

Disassembly and Assembly of Unit Rotation Motor

Disassembly 1 ► •

Remove the motor

Unscrew the M4 screw that secures the motor.

Assembly 1 ►

Temporarily fix the motor with the M4 screw, and put the timing belt on the small pulley for the motor.

2 ►

Put the timing belt SR on the big pulley, and turn the pulley a small amount (2 or 3 teeth) in either direction to ensure a solid fit .

3 ►

Adjust the belt tension. The belt tension is indicated in the figure below.

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Figure 4.4-7 Big Pulley

Disassembly When removing the big pulley, remove it before dismounting the unit from the main body. 1 ►

Remove center holder 1.

2 ►

Take out the GND ring and GND spring 1.

3 ►

Remove the timing belt SR.

4 ►

Pull out the big pulley.

•

Support the outer edge by hand. (The small bearing does not need to be removed.)

Assembly Assemble after dismounting the rotation motor. 1 ►

Put the big pulley horizontally on the bearing and insert it firmly.

2 ►

Insert the small bearing, GND spring, GND ring, and center holder 2 sequentially and fix with the screw.

3 ►

Install the rotation motor.

4 ►

Adjust the belt tension.

Home Position Sensor and Position Sensor

Disassembly 1 ►

Pull out the big pulley.

2 ►

Unhook the hook of the sensor from the back of the unit.

3 ►

Pull out the connector of the sensor.

Assembly 1 ►

Insert the sensor and install the connector.

2 ►

Install the big pulley.

3 ►

Mount the rotation motor.

4.4.2.7 The Motion and Motion Check Method Check the motion via Reset Motion and confirm that Position No.1 stops at the Cap O/C position. Version 1.0 – May 2006

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4.4.2.8 Reagent Cooler Unit Overview The reagent cooler unit is a reagent-temperature control unit by Peltier element.

Location See Chapter 4.2.

Functional Details This unit consists of the following parts: •

Peltier cooling unit

•

Copper jacket part

•

R. lid (cover at the top part)

•

Window section to read bar code

•

R. lid O/C sensor part

1. Peltier Cooling Unit The Peltier cooling unit consists of a Peltier element, cooling fin, and DC fan. It maintains the reagent temperature at 20°C ± 3°C using two (2)sets. 2. Copper Jacket Part The copper jacket part consists of a pot-shaped copper jacket and insulating material that covers the round copper plate (THK: 5mm) and maintains a constant internal temperature. 3. R. Lid The R. lid prevents temperature increases via the top of the reagent cooler unit. 4. Window Section to Read Bar Code This window allows the labels on reagent bottles to be read by the two-dimensional bar-code reader. The heater prevents condensation. 5. R. Lid O/C Sensor Part The R. lid O/C Sensor part detects opening/closing of the R lid via a microswitch.

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Explanatory Diagram

Figure 4.4-8

Parts List Pos. No.

Part Name

Part No

1

THERMISTOR R ASSY

741-0554

2

COVER SW ASSY

741-0555

3

MICRO-COOLER S3 ASSY

741-0750

4

INNER RING

741-1188

5

CUP

741-1190

6

TEMP JACKET

741-1200

7

PACKING

741-1210

8

PLATE

741-1219

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Pos. No.

Part Name

Part No

9

BUSH B

741-1383

10

OUTER RING

741-8507

11

PACKING S

768-3116

12

WIRE BINDER TY-23M

J839050

Disassembly and Assembly Procedures Removing the Units

Remove the parts in the following order (start with covers): 1 ►

Remove waste tank and water supply tank.

2 ►

Take out the R lid, reagent disk, and sample disk.

3 ►

Take out cover Y (side cover of the gripper).

4 ►

Take out rear cover.

5 ►

Take out front cover.

6 ►

Take out table cover L and table cover R.

7 ►

Remove P plate cover.

8 ►

Take out the following connectors: J523, J524, and J525.

9 ►

Remove set plate.

10 ►

Dismount reagent cooler unit.

Disassembly and Assembly of Units

•

Microcooler assembly

•

Thermistor R assembly

•

Outer ring, inner ring

•

Window heater

•

R. lid

1. Microcooler Assembly Disassembly 1 ►

Take out the two (2) packing S.

2 ►

Unscrew the two (2) screws of the thermostat.

3 ►

Remove the J523 connector.

4 ►

Pull out #3 and #6 pins (for window heater) of J523 connector.

•

Use tweezers to pull out the pins.

5 ►

Release two (2) microcoolers.

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Assembly 1 ►

Apply a thin coat of silicone grease (heat-conducting) to the cooling surface of the microcooler.

2 ►

Fix the two (2) microcoolers evenly using screws.

3 ►

Push the pins for window heater to #3 and #6 of J523 connector (no polarity in the window heater).

4 ►

Assemble the thermostat, packing S, and J523 connector.

2. Thermistor R. Assembly Disassembly 1 ►

Remove the microcooler assembly.

2 ►

Take out insulation cup.

3 ►

Remove thermistor R assembly.

Assembly To assemble the thermistor R assembly, re-install the parts removed during disassembly procedures (see above) in the reverse order. 3. Outer Ring, Inner Ring Disassembly 1 ►

Dismount the microcooler assembly.

2 ►

Take out insulation cup.

3 ►

Remove thermistor R assembly.

4 ►

Remove outer ring and inner ring.

Assembly To assemble the outer ring and inner ring, re-install the parts removed during disassembly procedures (see above) in the reverse order. 4. Window Heater Disassembly 1 ►

Remove the microcooler assembly.

2 ►

Take out insulation cup.

3 ►

Remove thermistor R. assembly.

4 ►

Remove outer ring.

5 ►

Remove the heater holder.

6 ►

Remove window heater.

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Assembly To assemble the window heater, re-install the parts removed during disassembly procedures (see above) in the reverse order. 5. R. Lid Disassembly 1 ►

Pull out the lock knob.

Assembly 1 ►

Apply a very thin coat of silicone grease (heat-conducting) to the tip of the lock knob.

2 ►

Push and insert the hold rubber in the R. lid.

3 ►

Turn the lock knob to insert it into the R. lid.

4.4.3 Cap Open/Close Mechanism 4.4.3.1 Overview The cap open/close mechanism is a unit that opens/closes the snap cap of RackPacks according to the timing of beads stirring or reagent pipetting by means of three (3) independent hooks.

4.4.3.2 Location See Chapter 4.2.

4.4.3.3 Functional Details This unit consists of the following parts: •

Rotation mechanism

•

Front-rear mechanism

•

RackPack stopper

Rotation Mechanism The rotation mechanism activates three (3) hooks to start rotation movement to open the cap. The rotation mechanism constitutes the crank mechanism with the fork link that rotates around the center of a spinning fulcrum of hook and the drive link installed to the motor shaft with speed reduction control. The three (3) hooks are installed in a special manner: 1. The hooks are attached to the hook plate by a coil spring. 2. Each hook can independently work on the hook-plate that moves following the motion of fork link. Speed reduction comparison: Version 1.0 – May 2006

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Step angle after speed reduction:

0.18° / step

Stroke:

51.1° / step

Front-Rear Mechanism The front-rear mechanism activates the rotation mechanism in a front-rear movement. It constitutes the straight-line movement mechanism by the timing belt and the stepping motor installed at the base of the unit. Step angle:

0.9°

Stroke:

113 mm

RackPack Stopper The RackPack stopper is a rod-shaped mechanism that initiates front-rear movement at the same time as the rotation mechanism part executes front-rear movement. Upon opening the cap, the RackPack stopper prevents the rack pack from rising. Stroke:

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4.4.3.4 Explanatory Diagram

Figure 4.4-9

4.4.3.5 Parts List Pos. No.

Part Name

Part No.

1

Pulse Motor Assy

741-4257

2

Pulse Motor PH264-C97 Assy

741-4255

3

Gear Head H0051-122

741-1262

4

Pulley 5M

741-1121

5

Timing Belt

741-1267

6

Sensor GP1A34LC

J339165

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4.4.3.6 Disassembly and Assembly Procedures Removing and Mounting of Unit If removing from the front cover. Removal:

1 ►

Remove the following covers:

•

Rear cover

•

R. lid

•

Y cover

•

Front cover assembly

•

Table cover R

•

Table cover L

2 ► •

See 4.4.2.

3 ► •

Dismount the unit with base sheet assembly.

Unscrew the two (2) M4 x 6 screws.

4 ► •

Take out R. disk.

Remove the unit from the base sheet assembly.

Unscrew the two (2) M4 x 6 screws.

Mounting

Mount the units by re-installing the parts removed during the removal procedures (see above) in the reverse order. If removing from the rear cover Removal 1 ►

Remove the rear cover.

2 ►

Dismount the unit.

•

Unscrew the M4 x 6 screw.

Mounting Assemble the units by re-installing the parts removed during the removal procedures (see above) in the reverse order.

Disassembly and Assembly of Units •

Rotation mechanism

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•

Service Manual

Front-rear mechanism

1. Rotation mechanism (link mechanism assembly) Disassembly 1 ►

Unscrew the M4 x 6 screws that fix the clamp on the plug (J532) side.

2 ►

Remove the tie wraps that fix the CAP O/C cord assembly and the J532 cord assembly.

3 ►

Take out the P532 socket.

4 ►

Dismount the photo interrupter (PI033) and the cord together.

•

You can replace the photo interrupter (PI033) by removing the connector.

5 ►

Detach the E-type fix ring 4 located at the tip of the rear part of the RackPack stopper assembly.

6 ►

Pull out the RackPack stopper assembly. Do not misplace the dumping spring.

7 ►

Detach the E-type fix ring 6 attached to the inside of the cap open/close mechanism base from the two (2) slick shafts.

8 ►

Support the link mechanism assembly and pull out the two (2) slick shafts.

9 ►

Remove the timing belt from the motor bracket.

10 ►

Unscrew the two (2) M4 x 4 point screws that fix the link pin assembly.

11 ►

Pull out the J532 cord assembly.

•

Unscrew four (4) M4 x 40 screws.

12 ►

Remove speed reduction control H0051.

Assembly 1 ►

Assemble the unit by re-installing the parts removed during the disassembly procedure (see above) in the reverse order.

2 ►

Fix the link assembly by adjusting bearing to fork link assembly.

2. Front-Rear Mechanism Disassembly 1 ►

Unscrew the two (2) M4 x 6 screws that fix the pulley base.

2 ►

Remove the timing belt from the motor bracket.

3 ►

Detach one (1) E-type fix ring 4 from the pulley shaft (See Figure**), and remove pulley S5M and timing belt.

4 ► •

Remove the photo interrupters (PI031, PI032) and the cord together.

You can replace the photo Interrupters (PI031, PI032) by removing the connector.

5 ►

Unplug plugs (J530, J531) from the cap open/close mechanism base.

6 ►

Unscrew the two (2) M4 x 6 screws that fix the clamp.

7 ►

Take out the tie wraps that fix the CAP O/C cord assembly and the J532 cord assembly.

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8 ►

Remove P532 socket.

9 ►

Remove the photo interrupter (PI033) and the cord together.

•

You can replace the photo interrupter (PI033) by removing the connector.

10 ►

Pull out the cord from the clamp that fixes the cord.

11 ►

Unscrew the two (2) M4 x 16 screws that fix stepping motor KH56.

12 ►

Unscrew two (2) M4 x 4 W point screws, and remove pulley S5M.

Location of PCP

Figure 4.4-10 1

Open/Close HOME PCP

2

F/B HOME PCP

3

F/B STOP PCP

4.4.4 Beads Mixer Mechanism 4.4.4.1 Overview The beads mixer mechanism is a mechanism that stirs the beads inside the reagent rack pack immediately before the pipetting of the reagent.

4.4.4.2 Location See Chapter 4.2.

4.4.4.3 Functional Details The beads mixer mechanism consists of the following components: •

Stirrer head vertical movement mechanism

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•

Stirrer head rotating mechanism

•

Stirring paddle rotating mechanism

Service Manual

Stirrer Head Vertical Movement Mechanism The Stirrer Head Vertical Movement Mechanism moves the stirring paddle up and down over the RackPack with its cap open and over the wash bath. The stirrer head that supports the stirring paddle and the vertical movement mechanism are vertically connected with an arm pipe. A nut holder and slide guide that are installed on the inner and outer rings of the ball bearings are installed in the vertical movement mechanism. A spline nut is inserted in the nut holder. The slide guide and the nut holder shift up and down guided by the spline shaft and guide shaft; the slide guide stops the rotation and the vertical movement, and the nut holder controls the rotation triggered by the rotation of the spline shaft and makes vertical movement. Pulleys are positioned above and below the moving parts keeping a sufficient axle distance from the stirring paddle so that they will not contact with each other when the stirring paddle makes strokes. The slide guide, which is hooked up to the timing belt, is moved vertically, driven by the stepping motor. Slow down rate

1:1

Motor step angle

0.9°/step

Shift range

0.1 mm/step

Stirrer Head Rotating Mechanism A nut holder is fixed on the inner ring of the ball bearings and a slide guide on the outer ring. An arm pipe that secures the stirrer head is fixed to the nut holder. The ball bearings guide the arm pipe and nut holder to swing together within a range limited by the stopper that is installed on the slide guide. Driven by the stepping motor, the moving parts cause rotation of the pulley that is attached to the bottom of the spline shaft. The rotating force is conveyed to the pulley via the timing belt. Slow down rate

1:1

Motor stepping angle

0.45°/step

Shift range

0.235 mm/step

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Stirring Paddle Rotating Mechanism The stirring paddle rotating mechanism is driven by a DC motor and its pulley causes the rotation of the pulley that is attached to one end of the stirring paddle. The rotating force is conveyed to the rotation pulley via the rectangular elastic belt connected to it. Slow down rate

1:1

Applied voltage

4.8 V (adjustable)

Rotation

2050 ± 100 rpm in air 2000 ± 100 rpm in liquid (refer to Chapter 5.3.8 for details)

Figure 4.4-11

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4.4.4.4 Parts List Pos. No.

Part Name

Part No.

1

Frame

741-1220

2

Guide

741-1221

3

Holder

741-1222

4

Arm

741-0576

5

Ball Bearing 6804ZZ

741-1244

6

Spline

L142042

7

Guide Shaft

741-1224

8

Timing Belt M

741-1243

9

Pulley S

741-0549

10

Motor Z Assy

741-0603

11

Motor M Assy

741-0601

12

Timing Belt S(Z)

741-1338

13

Arm Head 2

741-8552

14

Arm Cover 2

741-8554

15

Pulley 2

741-1461

16

Shaft A

741-1234

17

Ball Bearing DDRFW-830ZZ

L111270

18

Joint 2

741-3050

19

Belt

741-2244

20

Mixing Motor

741-0725

21

Dish

741-1230

22

Mixing Paddle With Screw

741-0934

23

W Point Screw

M731021

24

Snap Ring E IN 2 SUS304

M883003

25

CordJ541*

*Refer

to

Chapter

10,

741-4303

Maintenance

4.4.4.5 Disassembly and Assembly Procedures Removing the Beads Mixer Unit First remove the reagent disk mechanism (see Chapter 4.4.2.6). After removing the reagent disk, unscrew three (3) screws, two (2) connectors (P540 and P541), and one (1) grounding terminal set screw to remove the beads mixer unit from the main unit base.

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Disassembly and Assembly of the Beads Mixer Unit

•

Stirrer head vertical movement / rotating mechanism

•

Moving parts

•

Stirring arm head

1. Stirrer Head Vertical Movement / Rotating Mechanism Disassembly Procedure 1 ►

Remove the stirrer arm head from the arm pipe. ► Take out the head cover and pull out the DC motor wiring connector pin inside. ► Unscrew two (2) W point screws on the side of the stirrer arm head.

2 ►

Pull out the guide shaft. ► Remove two (2) E rings.

3 ►

Remove the mechanism that is installed in the spline hut and the ball spline shaft together. ► Remove two (2) E rings. ► Unscrew two (2) W point screws on the timing pulley. ► Unhook the belt off the belt hook of the slide guide. ► Lift the spline shaft with the bearings on its top by about 20 mm and remove the spline shaft from the timing pulley. ► Remove the spline shaft and spline nut mechanism by pulling them downward. Note: Be careful not to pull the spline nut mechanism off the shaft.

4 ►

Remove the slide guide. ► Remove the C ring.

5 ►

Remove the nut holder. ► Remove the four (4) screws from the spline nut.

6 ►

Remove the lead wire and grounding wire from the DC motor. ► To remove the lead wire from the DC motor, disconnect the connector terminal from connector J541 and pull the wire through the arm pipe. ► To remove the grounding wire, remove the screw from the terminal attached to the hut holder and remove the wire from the O ring.

Assembly Procedure Assemble the mechanism by re-installing the parts removed during the disassembly procedure (see above) in the reverse order.

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2. Moving Parts (Vertical, Rotating) Disassembly Procedure 1 ►

Remove the stepping motor. ► Remove the two (2) screws.

2 ►

Remove the timing belt.

Assembly Procedure Assemble the moving parts by re-installing the parts removed during the disassembly procedure (see above) in the reverse order. Adjusting the Belt Tension ► Adjust the belt by sliding the stepping motor (see Figure 4.4-12, Adjustment of Belt Tension). 3. Stirrer Arm Head Disassembly Procedure 1 ►

Remove the stirrer belt (a rectangular elastic belt) from the pulley.

2 ►

Remove the mixing motor assembly. ► Unscrew the two screws that secure the motor plate.

3 ►

Remove the stirring paddle. ► Loosen the bottom parts of the two W point screws of the joint.

4 ►

Pull out the stirrer pulley and shaft from the bearings. ► Loosen the top parts of the two W point screws of the joint and remove them. ► Remove the E ring.

Assembly Procedure Assemble the stirrer arm head by re-installing the parts removed during the disassembly procedure (see above) in the reverse order.

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Figure 4.4-12 Adjustment of Belt Tension Location of PCP

Figure 4.4-13

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4.4.5 Pipetter Mechanism 4.4.5.1 Overview The pipetter mechanism is a mechanism that picks up disposable tips and pipettes sample, calibrator, reagent (beads, R1, R2 and diluent, etc.) into the reaction vessel by means of an X-Z moving mechanism.

4.4.5.2 Location See Chapter 4.2.

4.4.5.3 Functional Details The pipetter mechanism consists of the following components: •

X-Axis movement mechanism

•

Z-Axis movement mechanism

•

Tip/Vessel buffer

•

Pressure (clot) sensor

X-Axis Movement Mechanism The X-axis movement mechanism moves the pipetter probe to each sampling position and replaces the disposable tip. The X-axis movement mechanism drives Z-axis mechanism that is mounted on the timing belt with a stepping motor.

Z-Axis Movement Mechanism The Z-axis movement mechanism moves the pipetter probe and disposable tip to each sampling height position, and drives the nozzle head that is mounted on the timing belt with a stepping motor via the LM guide.

Tip/Vessel Buffer •

The tip/vessel buffer is the area where the gripper places the disposable tips and the reaction vessels so that the pipetter probe has access to them.

•

There are sensors in the first two positions to detect the presence of a tip; the gripper mechanism also checks the tip and vessel placement

•

The tip eject position is at the edge of tip/vessel buffer.

Pressure (Clot) Sensor This detects clots in sample, calibrator, reagent or diluent during piping by monitoring pressure changes inside the tube.

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4.4.5.4 Explanatory Diagram

Figure 4.4-14

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Figure 4.4-15

4.4.5.5 Parts List Table 4.4-2 Pos. No.

Part Name

Part No.

1

Cord FPC P

741-4503

2

Motor X Assy

741-4244

3

Cord P557

741-4247

4

Circuit Board Assy LLD-P3

741-5048

5

Timing Belt P (X)

741-1062

6

Timing Belt P (Z)

741-1063

7

P Nozzle Box 3 Assy

741-8820

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Pos. No.

Part Name

Part No.

8

Circuit Board Assy DIST-PA

741-5045

9

Sensor GP1A34LC

J339165

10

Sensor GP1A34LC

J339165

11

Tube 510

741-1778

12

Tube 465

741-1775

13

P-Sensor 2 Assy

741-2267

14

Twin Detector Assy

741-4318

Note: Shape of the tip of P.Nozzle is different between E2010 and e411. In addition, shape of the tip of e411 P.Nozzel is similar to E170 P.Nozzle. But internal structure is different

Figure 4.4-16

4.4.5.6 Disassembly and Assembly Procedures 1. Removing the Pipetter Mechanism ► Remove the rear cover. ► Remove cover Y from gripper. ► Remove the reagent disk cover. ► Remove the table cover L. ► Remove the front cover. ► Remove the connector of the pressure sensor. ► Remove the syringe tube of pressure detecting part. ► Unscrew the screw fixing the pipetter mechanism. 2. Disassembly and Assembly of each Unit 1) X-axis movement mechanism 2) Z-axis movement mechanism 3) FPC cable 4) Tube 5) Photo interrupter 6) Pressure (clot) sensor Version 1.0 – May 2006

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7) Tip/vessel buffer

X-Axis Movement Mechanism- - - - - - -Replacement of Motor and Timing Belt Disassembly Procedure

► Remove the fixing screw which is located on the right side of center cover. ► Remove the motor bracket and X pulley from P side base. ► Remove the timing belt. Assembly Procedure

► Assemble in reverse order of disassembly procedure (see above). ► Adjust the timing belt tension. Tension : Press middle of the timing belt with a vertical force of 2±0.5 N, then adjust pulley position by loosening the X pulley screw as shown in the diagram below.

Figure 4.4-17

Z-Axis Movement Mechanism - - - - - - -Replacement of Motor and Timing Belt. Disassembly Procedure

► Remove the P carrier cover. ► Remove the Z-axis stepping motor. Assembly Procedure

► Adjust the timing belt tension. Tension: Push middle of the timing belt with a vertical force of 1.5±0.3 N, then adjust motor position by loosening the motor fixing screw as shown in the diagram below.

Figure 4.4-18 Version 1.0 – May 2006

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Disassembly Procedure for Z-Axis Photo Interrupter

► Remove the photo interrupter from the bracket of the Z-axis movement unit, and pull out to the side. Assembly Procedure

► Assemble in reverse order of disassembly procedure (see above). Disassembly Procedure of Probe Abnormal Descent Photo Interrupter

► Refer to FPC cable disassembly procedure. Assembling Procedure

► Refer to FPC Cable assembly procedure.

Pressure (Clot) Sensor (X Axis, Z Axis, Probe Abnormal Detection) Disassembly Procedure

► Loosen the screw of the driver base. ► Remove the pressure sensor cable from ANG-EP PCB and the rear cover of the pipetter mechanism. ► Remove the rear cover of the pipetter mechanism. ► Disconnect the pressure sensor from the tube joint, and put cap or cover on the top.

Note: Do not touch the top of the screw part of the pressure sensor with your fingers. Assembly Procedure

► Attach about 70mm spiral tube onto the pressure sensor cable. ► Remove cap or cover from top of the pressure sensor. ► Put seal packing on the screw part of the pressure sensor, and attach to the tube joint. ► Mount the rear cover of the pipetter mechanism. ► Fix the spiral tube part of the pressure sensor cable taking care not to catch the cable in the open close mechanism. ► Fix the pressure sensor cable to the rear cover. ► Connect the cable to ANG-EP PCB. ► Tighten the screw of the driver base.

FPC Cable Disassembly Procedure

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► Remove the FPC cable from PCB. ► Pull out the FPC cable from the Z-axis movement unit. ► Remove the P arm cover. ► Pull out FPC holder. ► Remove PCB from the P arm, and pull out the FPC cable from the PCB. Assembly Procedure

► Assemble in reverse order of disassembly procedure (see above).

Tube (L1=465, L2=510) Disassembly Procedure for L1

► Remove the P arm cover. ► Disconnect the tube nipple from the probe. Assembly Procedure

► Attach the tube nipple to the probe. (tightening torque is 2.5 kgf·cm). ► Tubing as original. ► Confirm that P arm moves smoothly without catching. Disassembly Procedure for L2

► Remove P plate. ► Cut the tie-wrap tube clamping. ► Disconnect the tube nipple the tube joint. Assembly Procedure

► Attach the tube nipple to the tube joint. ► Fix the tube with tie-wrap. ► Move the Z-axis movement unit to the left and right and confirm that the tube does not come out from between the tube guide and the rear cover.

Photo Interrupter (X Axis, Z Axis, Probe Abnormal Detection) Disassembly Procedure for X-Axis Photo Interrupter

► Remove the bracket of the photo interrupter from left and right of pipetter mechanism side frame. ► Disconnect the connector. ► Remove the photo interrupter from bracket.

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Assembly Procedure

► Assemble in reverse order of disassembly procedure (see above). Disassembly Procedure for Z-Axis Photo Interrupter

► Remove the photo interrupter from the bracket of the Z-axis movement unit, and pull out to the side. Assembly Procedure

► Assemble in reverse order of disassembly procedure (see above). Disassembly Procedure of Probe Abnormal Descent Photo Interrupter

► Refer to FPC cable disassembly procedure. Assembling Procedure

► Refer to FPC Cable assembly procedure.

Pressure (Clot) Sensor (X Axis, Z Axis, Probe Abnormal Detection) Disassembly Procedure

► Loosen the screw of the driver base. ► Remove the pressure sensor cable from ANG-EP PCB and the rear cover of the pipetter mechanism. ► Remove the rear cover of the pipetter mechanism. ► Disconnect the pressure sensor from the tube joint, and put cap or cover on the top.

Note: Do not touch the top of the screw part of the pressure sensor with your fingers. Assembly Procedure

► Attach about 70mm spiral tube onto the pressure sensor cable. ► Remove cap or cover from top of the pressure sensor. ► Put seal packing on the screw part of the pressure sensor, and attach to the tube joint. ► Mount the rear cover of the pipetter mechanism. ► Fix the spiral tube part of the pressure sensor cable taking care not to catch the cable in the open close mechanism. ► Fix the pressure sensor cable to the rear cover. ► Connect the cable to ANG-EP PCB. ► Tighten the screw of the driver base.

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4.4.5.7 Procedure for exchanging TUBE 465 TUBE 465 How to remove TUBE 465

1 ►

Remove two (2) screws A from PR cover (refer to Figure 4.4-20).

2 ►

Move P carrier to the left end, and remove TUBE 465 from tube joint 2 (refer to Figure 4.4-23).

3 ►

Remove the P arm cover, and remove tube holder from both the P arm cover and the P arm internal cover (refer to Figure 4.4-25).

4 ►

Remove TUBE 465 from P nozzle (refer to Figure 4.4-25). Be careful not to lose the nozzle seal between the nipple and the P nozzle.

How to attach TUBE 465

1 ►

Insert TUBE 465 into the P nozzle. Make sure that there is a nozzle seal between TUBE 465 and the P nozzle. Note that the torque of screwing the nipple should be 0.25 Nm.

2 ►

Set the tube holder into both the P arm internal cover and the P arm cover, and attach the P arm cover.

3 ►

Arrange TUBE 465 as shown in Figure 4.4-24, and insert into tube joint 2 (refer to Figure 4.4-25). Note that the torque of screwing the nipple should be 0.25 Nm.

4 ►

Attach screw A of the PR cover.

5 ►

Make sure that the tube moves smoothly when the P arm is moved vertically.

TUBE 510 How to remove TUBE 510

1 ►

Remove the tube guide assembly (refer to Figure 4.4-19).

2 ►

Remove two (2) screws A from the PR cover (refer to Figure 4.4-20).

3 ►

Move the P Carrier to the left end, and cut the two (2) tie wraps that fix TUBE 510.

4 ►

Remove TUBE 510 from the tube joint (refer to Figure 4.4-21 and Figure 4.4-22).

5 ►

Remove TUBE 510 from tube joint 2 (refer to Figure 4.4-23).

How to attach TUBE 510

1 ►

Insert TUBE 510 into both tube joint and tube joint 2. Note that the torque of screwing the nipple should be 0.25Nm.

2 ►

Fix TUBE 510 with two (2) tie wraps (Refer to Figure 4.4-21, Figure 4.4-22 and Figure 4.4-23). Ensure that the direction of the nail of the tie wrap is the same as in the figures. Be careful not to twist the tube.

3 ►

Attach the tube guide assembly. Be careful not to nip the GNP line.

4 ►

Attach screw A of the PR cover.

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Figure 4.4-19 Pipetter Unit

Figure 4.4-20 Pipetter Unit 1

PR cover

2

M4 screws

3

Tube Joint

4

Pressure Sensor

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Figure 4.4-21 Back 1

Guide (P/N: 741-0895)

2

PR cover

3

Tube 510

4

Tube Joint

Figure 4.4-22 Tube510 1

Wrap tie

2

Tube510

3

Nipple

4

Inner Tube

5

Outer Tube

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Figure 4.4-23 Tube Joint 1

Railbase

2

Tube Joint 2

3

Tube 465

4

Ty-rap

5

Tube 510

6

Nipple

Figure 4.4-24 TUBE 465 Version 1.0 – May 2006

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1

P Arm Cover

2

P Arm Inside Cover

3

Tube holder

4

Nozzle seal

5

P Nozzle

6

Nipple

7

Tube 465

Service Manual

Figure 4.4-25 P Carrier left side 1

Tube Joint 2

2

Tube 465

3

P Arm Cover

4.4.6 Gripper Mechanism 4.4.6.1 Overview The gripper mechanism consists of the following 3 components and transfers tips/vessels between the container station, buffer station, and incubator. 1. Gripper --- transfers tips/vessels via X/Y/Z grip mechanism. 2. Container station --- can hold 3 tip containers and 3 vessel containers. 3. Incubation station --- There are 32 incubator stations and one sipping station on the heat block. Version 1.0 – May 2006

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4.4.6.2 Location See Chapter 4.2.

4.4.6.3 Detailed Function This unit consists of the following components: •

Base frame

•

Y carriage

•

X carriage

•

Grip part

•

Container station

•

Incubator station

Base Frame Base frame is fixed on the four (4) pillars that are secured to the main base. The carrier mechanisms such as the Y carriage, container station, and incubator station, are attached to the base frame.

Y Carriage The Y carriage contains the X carriage (mentioned below). It is driven in the Y direction (back and forth movement) and placed (at 0.25 mm/step) via the stepping motor and the pulley belt mechanism. The Y carriage is supported by the following bearings: •

On the right side: Two (2) linear bearings that are guided by a shaft

•

On the left side: One (1) radial bearing that is guided by the channel

A shielding plate on the right of the Y carriage passes via three (3) photo interrupters fixed on the base frame and detects home position, rest position, and end position (the order starts from the front).

X Carriage The X carriage contains the grip parts described below. It is driven in the X direction (left and right movement) and placed (at 0.125 mm/step) via the stepping motor and the pulley belt mechanism. A shielding plate on right of the X carriage passes via 3 photo interrupters on the right side of the Y Carriage and detects home position.

Grip Part The grip part consists of the Z-driving part and the grip-driving part. The grip-driving part consists of a rack gear driven in the Z direction (up and down shift) and placed (at 0.2 mm/step) via the stepping motor and the Z-drive part of the rack/pinion mechanism. The grip-drive part is Version 1.0 – May 2006

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supported by a linear guide fixed to the X carriage and is pulled up via a spring. A shielding plate secured on the upper side of the grip-drive part passes via 3 photo interrupters at the upper side of the X carriage and detects home position. The grip-drive part is driven to open/close via a cam rotated by a rotary solenoid and a pair of arms with a grip nail positioned to catch the cam. The tip/vessel is gripped at the nail by the power of pull-spring attached to close a pair of arms and is positioned on X & Y where the back arm is pushed by the cam. A shielding plate located at the tip of the front arm passes via Photo Interrupter under the condition w/o tip/vessel and detects “None.” Also, a pair of arms are supported and guided to up and down shift as well as holder which retains the arms above and below and positioned to the lower edge by two (2) push-springs. If Grip-drive part is lowered to abnormal positions on XY, the head part of tip/vessel halts the down movement of a grip nail, arms, and a holder. A shielding plate located at the bottom side of Grip-drive part passes via Photo Interrupter secured to the holder and detects “Abnormal Down Position.”

Container Station The container station has a partition to hold three (3) tip containers and three (3) vessel containers and is positioned at the base frame via two (2) pins located at the bottom side and secured by four (4) screws.

Incubator Station Incubator Station consists of the heat block with thirty-two (32) storage holes for vessel incubation with one (1) vessel storage hole sipping, heater, and thermistor. It is secured to the base frame by two (2) screws.

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4.4.6.4 Explanatory Figures

Figure 4.4-26

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Figure 4.4-27

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Figure 4.4-28

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4.4.6.5 Parts List Table 4.4-3 Position No.

Short Name

1

Part

name

Comment T/V

CARRIER

Material number

Part number 741-0409

ASSY 2

PM062

Motor

Y

assy

Motor

Y

assy;

741-4319

motor & cable & pully & dumper 3

PI063

CORD P563 Y-

741-4306

HP; PI 063 4

PI064 PI065

CORD P5634 YEP-RP;

741-4307

PI

064/65 5

Circuit

Board

741-5047

Assy DIST-TVA 6

PM061

Motor

Assy

741-4320

PULSE

K591137

C

with MOTOR

KH42JM2-011 Motor

C

assy,

motor x-move 7

Motor Cover X

741-8530

8

Holder C

741-1139

9

PM063

Pulse

Motor

741-4321

PF25-48D4 Assy Gripper-Z; DOWN

UP PF25;

motor 10

Cover Z

741-8534

11

Carrier Z assy /

741-0412 / 741-

Plate

8533

12

SOL

Rotary

solenoid

741-4322

2ER45-33 assy 13

FPC-C1

Version 1.0 – May 2006

Cord

FPC 4 - 58

C1

741-4323 Chapter 4.4

RD/Hitachi cobas e411

Position No.

Short Name

Service Manual

Part

name

Comment

Material number

Part number

From Dist-TVA to Gripper-Z 14

FPC-C2

Cord

FPC

C2

741-4324

From Dist-TVA to carrier x-motor 15

FPC-C11

Cord FPC C11

741-4325

Gripper-Z; open/close PI068;

Abn.

PI067 16

FPC-C21

Cord FPC C21 Gripper-Z;

741-4326

UP

DOWN

PF25;

PI066 17

Thermostat

INC

741-0761

Assy 18

Thermistor I

741-0582

19

Timing Belt C(X)

741-1143

Gripper X-belt 20

Timing Belt C(Y)

741-1124

Gripper Y-belt Sensor TLP830

PCB

ASSY

DETECT

J339168

3

TLP830 Signal

photo

coupler used in Gripper see

assy; list

Sensors

of SM

chapter 4.3.2 Tool

gripper

741-1471

adjustment Gripper

sensor

741-2022

tool

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Position No.

Short Name

Service Manual

Part

name

Comment Tool

Material number

transport

Part number 741-2154

module adjustment For

automatic

adjust

4.4.6.6 Disassembly and Assembly Procedures Note: Do not damage the FPC cable, handle with care. Note: When removing the FPC cable from the connector, move the slide lock of the connector towards the cable and take out the cable.

Note: When mounting the FPC cable, mount it in the right direction and lock it. Note: When peeling double-sided tape from the FPC cable, hold the cable so that no extra tension is placed on the corner and peel slowly.

Removing the Units Remove the following covers: •

Rear cover

•

Gripper Y cover

•

Front cover

•

Table cover R

•

Sipper front cover

•

Container station

•

S guide plate/board cover (at the right side of solid waste)

•

Unscrew four (4) screws and four (4) connectors to remove the unit from the main base pillars.

•

Assemble the units by re-installing the units removed during the disassembly procedure (see above) in the reverse order.

•

However, position-teaching adjustment is required after assembly. See Adjustment Operation.

Disassembly and Assembly of the Units 1. Y motor assembly 2. P563, P564 cord assembly (Y-axis photo interrupter board) 3. DIST-TV board assembly 4. X motor assembly 5. Z motor assembly 6. Solenoid assembly Version 1.0 – May 2006

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7. FPC cable C1, C2, C11, C21 assemblies (including X axis, Z axis, and photo interrupter at grip). 8. X carriage assembly 9. Heater I assembly (including thermostat). 10. Thermistor I assembly Y Motor Assembly

Disassembly Procedure 1 ►

Remove the Y motor.

1.1 ►

Unscrew two (2) screws.

2 ►

Pull out cords.

2.1 ►

Remove two (2) clamps, FPC holder, FPC connector, DIST-TV board connector.

Assembly: 1 ►

Assemble the motor by re-installing the parts removed during the disassembly procedure (see above) in the reverse order.

2 ►

Fix the belt at the position where the tension of the belt satisfies the conditions shown in the following figure.

3 ►

The cable should be straight.

Figure 4.4-29 P563, P564 Cord Assembly (Photo Interrupter Board for Y Axis)

Disassembly 1 ►

Remove DET-A (Y-HP), DET-B (Y-RP/EP) board.

1.1 ►

Unscrew two (2) screws from each.

2 ►

Pull out the cord.

2.1 ►

Release four (4) tie wraps, three (3) clamps.

2.2 ►

Unscrew the DIST-TV board connector.

Assembly ► Assemble the cord assembly by re-installing the parts removed during the disassembly procedure (see above) in the reverse order. DIST-TVA Board Assembly

Disassembly 1 ►

Remove the DIST-TVA board assembly

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1.1 ►

Service Manual

Unscrew two (2) screws and five (5) connectors.

Assembly 1 ►

Assemble the DIST-TVA board assembly by re-installing the parts removed during the disassembly procedure (see above) in the reverse order.

X Motor Assembly

Disassembly 1 ►

Take out the X motor cover.

1.1 ►

Unscrew two (2) screws.

2 ►

Remove the X motor holder.

2.1 ►

Unscrew two (2) screws.

Assembly 1 ►

Assemble the X motor assembly by re-installing the parts removed during the disassembly procedure (see above) in the reverse order.

2 ►

Fix the belt at the position where the belt tension satisfies the following conditions.

Figure 4.4-30 Z Motor Assembly

Disassembly 1 ►

Take out the Z cover.

1.1 ►

Unscrew two (2) screws.

2 ►

Take out blind plate.

2.1 ►

Unscrew two (2) screws.

3 ►

Remove the Z motor assembly.

3.1 ►

Unscrew two (2) screws and a connector.

Assembly 1 ►

Assemble the Z motor assembly by re-installing the parts removed during the disassembly procedure (see above) in the reverse order.

2 ►

Fix the Z motor and the opponent rack where backlash of the rack gear and pinion of the motor is 0.1 ~ 0.2 mm.

3 ►

Hold the pinion with fingers, and confirm the backlash.

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Solenoid Assembly

Disassembly 1 ►

Take out the Z cover .

1.1 ►

Unscrew two (2) screws.

2 ►

Remove lead wire from the solenoid.

2.1 ►

Release two (2) tie wraps and two (2) ‘1P’ connectors.

3 ►

Remove grip/trouble detect board of FPC cable C11 assembly.

3.1 ►

Unscrew two (2) screws.

4 ►

Dismount grip-drive assembly.

4.1 ►

Unscrew two (2) screws.

4.2 ►

Unhook lower hook of spring.

5 ►

Rotate half and remove solenoid assembly.

5.1 ►

Unscrew two (2) nuts.

Assembly 1 ►

Assemble the solenoid assembly by re-installing the parts removed during the disassembly procedure (see above) in the reverse order.

2 ►

Fix grip/trouble detect board at the position where the shielding plate is centered in photo interrupter.

FPC cable C1, C2, C11, C21 assemblies (including X axis, Z axis, and photo interrupter at grip. (See Handling Note for FPC Cable)

Disassembly 1 ►

Take out the X motor cover.

1.1 ►

Unscrew two (2) screws.

2 ►

Take out the X Cover

2.1 ►

Unscrew two (2) screws.

3 ►

Take out the Z Cover

3.1 ►

Unscrew two (2) screws.

4 ►

Remove the cable (Y driving part) between the Y carriage and the DIST-TV board.

4.1 ►

Remove two (2) FPC holders, two (2) board connectors, and tape-glued part.

5 ►

Dismount the X motor connector board

5.1 ►

Unscrew two (2) screws and a connector.

5.2 ►

Release tie wrap.

5.3 ►

Remove a board connector and tape-glued part.

6 ►

Remove the X motor holder.

6.1 ►

Unscrew two (2) screws.

6.2 ►

the See section on X motor assembly.

7 ►

Remove FPC holders located at the upper right side of Y carriage.

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7.1 ►

Unscrew four (4) screws.

8 ►

Dismount the relay connector board.

8.1 ►

Unscrew each screw and a connector.

8.2 ►

Then remove FPC cable C1, C2 assembly.

9 ►

Remove the cable (X-driving part) between relay connector and X carriage.

9.1 ►

Release 2 saucer screws and FPC holder fixtures,.

9.2 ►

Pull out the cable.

10 ►

Take out the FPC holder at the upper part of the Z motor.

10.1 ► Unscrew one (1) screw. 11 ►

Dismount the Z motor connector board.

11.1 ► Unscrew two (2) screws. 12 ►

Remove the Z-HP photo interrupter board.

12.1 ► Unscrew one (1) screw. 13 ►

Take out the grip/trouble detect board.

13.1 ► Unscrew two (2) screws. 13.2 ► Release tie wrap and connector. 13.3 ► See the section on solenoid assembly. Assembly ► Assemble the FPC Cable C1, C2, C11, C21 Assemblies by re-installing the parts removed during the disassembly procedure (see above) in the reverse order. X Carriage Assembly

Disassembly 1 ►

Take out the X cover.

1.1 ►

Unscrew two (2) screws.

2 ►

Release FPC cable C11, C21 assemblies from relay connector and FPC holder

2.1 ►

Unscrew two (2) saucer screws.

2.2 ►

Pull out the cable.

3 ►

Remove X carriage assembly.

3.1 ►

Unscrew two (2) back-lower screws.

3.2 ►

Release gear of the belt.

Assembly 1 ►

Assemble the X carriage assembly by re-installing the parts removed during the disassembly procedure (see above) in the reverse order.

2 ►

Fix the X carriage assembly on the tip container in the position where the left surface of the X carriage assembly and the top side of the tip container satisfy the perpendicular angle 0.2 mm/100mm.

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Heater I Assembly (including thermostat)

Disassembly 1 ►

Dismount the incubator station from the base frame.

1.1 ►

Unscrew two (2) screws.

2 ►

Remove the J570 connector.

2.1 ►

Take out tie wrap and clamps.

3 ►

Remove heater and thermostat.

3.1 ►

Unscrew two (2) screws from each.

Assembly 1 ►

Assemble the heater I assembly by re-installing the parts removed during the disassembly procedure (see above) in the reverse order.

2 ►

Apply sufficient Amicon epoxy resin to the heater part.

Thermistor I Assembly

Disassembly 1 ►

Dismount the incubator station from the base frame.

1.1 ►

Unscrew two (2) screws.

2 ►

Take out the J571 connector.

2.1 ►

Remove tie wrap and clamps.

3 ►

Remove the heat block from the base.

3.1 ►

Unscrew three (3) bottom screws.

4 ►

Peel off insulation packing.

5 ►

Peel off aluminum tape.

6 ►

Remove the thermistor I assembly.

Assembly 1 ►

Assemble the thermistor I assembly by re-installing the parts removed during the disassembly procedure (see above) in the reverse order.

2 ►

Apply sufficient Amicon epoxy resin to the heater part.

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Detail of incubator

Figure 4.4-31 1

Heater

2

Thermistor

3

Incubator Thermostat

4.4.7 Sipper Mechanism 4.4.7.1 Overview The sipper transports the probe that is connected to the syringe with tubes from one station to another via the measuring cell.

4.4.7.2 Location See Chapter 4.2.

4.4.7.3 Functional Details The sipper unit consists of the following: •

Base Frame

•

X Carriage

•

Z Carriage

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Base Frame The base frame is fixed on the platform that is secured on the top part of the main unit base. The X carriage and Z carriage are installed on the base frame.

X Carriage The X carriage contains the Z carriage, which is explained below. The X carriage shifts horizontally at a speed of 0.3 mm/step to its position, and is driven by the stepping motor and pulley / belt mechanism. At its top, the X carriage is held up by two linear bearings that are supported by the shaft, and at the bottom the X carriage is supported by two radial bearings. There are two photo interrupters on the base frame. The home position sensor is on the right and the end position sensor is on the left (as viewed from the front of the cobas e411). The X carriage stops in six positions: CC2, AB2, CC1, AB1, Washing Pos., and Sipping Pos. in a normal operation.

Z Carriage The Z carriage shifts vertically at a speed of 0.1 mm/step (during the aspiration of the reaction agent at 0.025 mm/step) to its position, and is driven by the stepping motor and the pulley / belt mechanism. The Z carriage is supported by the linear guide that is installed on the X carriage. The shielding plate that is installed on the right side of the Z carriage passes the photo interrupter above the top of the X carriage and detects the home position. The probe inside the Z carriage is moved vertically and is positioned to the bottom end by a spring. If the Z carriage descends from an abnormal position, the mechanism interrupts the descent of the probe and the shielding plate interrupts the beam from the photo interrupter that is installed on the Z carriage. This leads to an error, “Abnormal Descending.”

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4.4.7.4 Detailed Diagrams

Figure 4.4-32

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Figure 4.4-33

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Figure 4.4-34

4.4.7.5 Parts List Table 4.4-4 Pos. No.

Part Name

Part No.

1

Sipper Z Assy

741-0416

2

X Motor Assey

741-4248*

3

Sensor GP1A34LC

J339165

4

Front Cover

741-8547

5

Suppot S

741-8182

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Pos. No.

Part Name

Part No.

6

Cover S

741-8181

7

Cord P587 Assy With Motor

741-4251*

8

Cover R

741-8542

9

Cover L

741-8543

10

Bracket

741-1474

11

S Nozzle Box Assy

741-0933

12

Cover

741-8541

13

Circuit Board Assy DIST-SA

741-5046

14

Cord FPC S

741-4253

15

Fixing Plate

741-1481

16

Base

741-8540

17

SS COVER ASSY

741-0350

∗

Refer to Motor Reference List, Chapter 4.3.1

4.4.7.6 Disassembly and Assembly Procedures Removing the Sipper Unit First remove the following covers: •

Rear cover

•

Gripper Y cover

•

Front cover

Then remove the following parts from the sipper unit and take out the sipper from the main unit platform: •

Four screws

•

One tube

•

Three connectors

•

One grounding wire

To reassemble the sipper unit, you can re-install the parts removed in the above procedure in the reverse order. Be sure to position the unit so that the tip of the probe passes the center of the sipper position vessel and the reagent container cap. Also, adjust its position by tapping, following the procedure in the adjustment procedure that is described separately. Disassembly and Assembly Procedures

•

X Motor Assembly & Photo Interrupter

•

Z Motor Assembly & Photo Interrupter

•

Probe Assembly

•

DIST-S PCB Assembly

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•

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FPC Cable S Assembly

1. X Motor Assembly and Photo Interrupter Disassembly 1 ►

Remove the front cover by unscrewing three (3) screws.

2 ►

Remove the FPC holder by unscrewing three (3) screws.

3 ►

Remove the top cover by unscrewing one (1) screw.

4 ►

Remove the X motor assembly by removing two (2) screws and connector P585.

5 ►

Remove the photo interrupter by removing the connector and pushing the hook on its back.

Assembly Re-install all the parts removed in the disassembly procedure in the reverse order. When installing the X motor assembly, secure the part at the position where the belt tension satisfies the specifications below.

Figure 4.4-35 2. Z Motor Assembly and Photo Interrupter Disassembly 1 ►

Remove X carriage covers (R), (L) by unscrewing two (2) screws each.

2 ►

Remove the Z motor assembly by removing two (2) screws, motor connector, and tiewraps.

3 ►

Remove the photo interrupter holder by removing two (2) screws.

4 ►

Remove the photo interrupter by removing the connector and pushing the hook on its back.

Assembly Re-install all the parts removed in the disassembly procedure in the reverse order. When reinstalling the Z motor assembly, be sure that the belt tension meets the specifications described in the figure above.

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3. Probe Assembly Disassembly 1 ►

Remove the Z carriage cover by pushing the hook on the bottom.

2 ►

Take out the probe assembly by removing the 1P connector.

Assembly Re-install the parts removed in the disassembly procedure in the reverse order. 4. DIST-S Board Assembly Disassembly Remove the DIST-S PCB assembly by unscrewing by two (2) screws and four (4) connectors and then release the sliding lock of the connector to the cable side, and taking out the DIST-S board. Assembly Re-install all the parts removed in the disassembly procedure in the reverse order. 5. FPC Cable 3 Assembly

CAUTION Be careful not to damage the cable.

Disassembly 1 ►

Remove the FPC holder by unscrewing three (3) screws.

2 ►

Remove the top cover by unscrewing three (3) screws.

3 ►

Release the sliding lock and disconnect the cable from the DIST-S board connector.

4 ►

Remove the connector which side of Z motor cord.

5 ►

Remove the holder from the relay board by unscrewing two (2) screws.

6 ►

Remove the double-sided tape and the cable from the left side of the holder.

7 ►

Remove the FPC holder of the Z carriage (by unscrewing one (1) screw) and take out the Z carriage.

8 ►

Slide out the failure-detection photo interrupter board.

9 ►

Remove the 1P connector from the Z carriage base by pushing it up from the bottom with tweezers.

Assembly Re-install all the parts removed in the disassembly procedure in the reverse order. Make sure that none of the cables are entangled.

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4.4.8 System Reagent Mechanism 4.4.8.1 Overview The system reagent mechanism is a unit that keeps the liquid temperature constant inside the AB and CC bottles. The case of the system reagent mechanism has grooves for an AB bottle and a CC bottle. By setting an AB bottle and a CC bottle, one at a time, it adjusts the case temperature by means of a Peltier temperature controller.

4.4.8.2 Location See Chapter 4.2.

4.4.8.3 Functional Details The System Reagent Mechanism consists of the following components: •

Bottle Heating Unit

•

Case Heating Unit

•

Thermostat

Bottle Heating Unit The bottle heating unit is a die-cast product made of flat aluminum (5mm thick). Its function is to keep the liquid temperature inside the AB and CC bottles at 28

C. This aluminum case detects

the signals from the sipper probe when the sipper probe detects the liquid level in the bottle, and is therefore insulated from other parts and the main unit base.

Case Heating Unit Insulating material is attached to the bottom and sides of the aluminum case and, in addition, the case is enclosed in a steel case frame so that the bottles inside the case are not be subject to the ambient temperature. In order to secure the thermostat, the case frame is installed on the main unit base and is fixed to the cooling unit holder. The case frame is also used as a holder for the sipper probe wash bath.

Thermostat A Peltier element thermostat is installed on the outside bottom of the aluminum case. A thermistor is installed in the space between the case surface and the side of the case. It measures the difference between the ambient temperature and the case temperature, and the thermostat regulates the case temperature.

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4.4.8.4 Detailed Diagram

Figure 4.4-36

4.4.8.5 Parts List Table 4.4-5 Pos. No.

Part Name

Part No.

1

Case

741-1379

2

Holder R

741-8659

3

Case S

741-8153

4

Cover

741-1387

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Pos. No.

Part Name

Part No.

5

Bush A

741-1382

6

Bush B

741-1383

7

Micro-Cooler SR Assy

741-0756

8

Thermistor Assy

741-0548

9

Wave Washer WW-5

M874001

10

Sensor SR Assy

741-0663

4.4.8.6 Disassembly and Assembly Procedures Removing the System Reagent Unit To remove the system reagent unit, first remove the following covers: •

Rear Cover

•

Gripper Y Cover

•

Front Cover

•

SR Cover

Then, remove two (2) screws and three (3) connectors (P660, P661, and P662). Also, pull out the fixtures of the cooling unit holder from the case table installed on the main unit base.

Disassembly and Assembly of the System Reagent Unit Disassembly Procedure

1 ►

Remove the steel plate around the case cover assembly and case frame assembly.

1.1 ►

Remove the sockets from connectors J660, J661, and J662.

1.2 ►

Remove the four (4) screws from each.

2 ►

Turn the unit upside down.

3 ►

Remove the thermostat.

3.1 ►

Remove the four (4) screws.

4 ►

Remove the cooling unit holder.

Assembly Procedure

Assemble the system reagent unit by re-installing parts removed during the disassembly procedure (see above) in the reverse order. When installing the thermostat, apply heatconducting grease to the surface that is contact with the aluminum case. Since the unit is installed through the cooling unit holder, install bush A, bush B, and washer in this order as shown in the figure below:

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Figure 4.4-37

4.4.9 Syringe Mechanism 4.4.9.1 Overview The syringes consist of the two systems described below. The syringes transport liquid, driven by the pumping force generated by the up and down movement of the plunger and by the movement of the probe of each system. 1. Pipetter Syringe (Left): Aspirates and pipettes specified amounts of the sample, reagent, and beads via the pipetter probe and tube. 2. Sipper Syringe (Right): Aspirates specified amounts of the reaction mixture via the sipper probe, tube, and measuring cell.

4.4.9.2 Location See Chapter 4.2.

4.4.9.3 Functional Details Each syringe consists of the following components: •

Base Frame

•

Syringe Motor

•

Flow Route Switch

Base Frame The base frame is fixed to the main unit base. The syringe motor and the flow route switch are installed on the base frame.

Syringe Motor In the syringe motor, the slider that moves the syringe plunger moves in the vertical direction is driven by the stepping motor and pulley / belt mechanism to a specified position. The slider is supported by two linear bearings that are guided by the shaft. A shielding plate is installed on the back of the slider, and when the slit passes by the photo interrupter that is located above it the home position is detected. On the slider is the plunger assembly, which is supported by the sealing inside the sealing body, the O ring, and the syringe, mounted in this order. These parts Version 1.0 – May 2006

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are secured at the top with a nut and connected with each other by tubing. The plunger assembly, O ring, and syringe are different in the two syringe systems. The parts for the sipper syringe (on the right side) have larger diameters.

Flow Route Switch The sipper syringe system is connected with pinch valves SV3 (at the measuring cell) and SV4 (at the liquid waste container) by tubing.

4.4.9.4 Detailed Diagrams

Figure 4.4-38

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4.4.9.5 Parts List The parts for the pipetter syringe system are installed on the left side of the unit, those for the sipper syringe system on the right side. Table 4.4-6 Pos. No.

Part Name

Part No.

1

Base N

741-8037

2

Syringe PS Assy

741-0418

3

Pulse Motor PH265M33 Assy

741-0804

(Pip, PH265M-33-C3) 4

Motor S Assy (Sip, KH56KM2-

741-0806*

016) 5

Detect 3 PCB 130T Assy

741-0810

6

Syringe P Assy (Pip)

741-0801

7

Syringe S Assy (Sip)

741-0802

8

Syringe (Pip)

G825045

9

Syringe S (Sip)

741-1313

10

Pinch Valve 2 Assy

741-0833

∗

Refer to Motor Reference List, Chapter 4.3.1.

4.4.9.6 Disassembly and Assembly Procedures CAUTION Before removing the flow route tubing, prepare a beaker, a syringe, and a cloth wiper. Drain water from the tubing, and wipe up any spillage.

Removing the Syringes First remove the following covers: •

Rear cover

•

Gripper Y cover

•

Front cover

•

Sipper FPC holder (secured with 3 screws)

•

Sipper top cover (secured with 1 screw)

•

Sipper bottom cover (secured with 2 screws)

Then, remove the three (3) screws, four (4) tubes (two small tubes, one small black tube, and one big tube), five (5) connectors (P622, P591, P592, P593, J630), and finally remove the syringes from the main unit base. Version 1.0 – May 2006

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Disassembly and Assembly of Syringes •

Syringe Motor Assembly, Motor Assembly, Photo Interrupter Assembly

•

Syringe Plunger Assembly

•

Pinch Valve Assembly

Syringe Motor Assembly, Motor Assembly, and Photo Interrupter Assembly

Disassembly Procedure 1 ►

Remove the syringe motor assembly by unscrewing the upper and lower screws and removing the tube and lead wire from the clamp.

2 ►

Remove the motor assembly by unscrewing two (2) screws, removing the lead wire from the clamp, and removing the connector and contact.

3 ►

Remove the photo interrupter assembly by unscrewing one (1) screw, removing the lead wire from the clamp, and removing the connector and contact.

Assembly Procedure Reassemble the unit by following the disassembly procedure in the reverse order.

Note: If you have loosened the belt, readjust the belt tension by (1) loosening the tension bolt, (2) adjusting the tension axle phase, and (3) securing the tension bolt again. (See the figure below.)

Figure 4.4-39 1

Timing Belt

2

Tension Belt

3

Tension Axle

4

Tension Gauge (a tension of 1.67N)

5

Red mark

Adjusting the Timing Belt Tension As shown in the above figure, press the gauge against the belt, adjust the tension axle until the gauge shaft is aligned with the red marking, and tighten the tension bolt to secure the belt. Version 1.0 – May 2006

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Syringe Plunger Assembly

Disassembly Procedure 1 ►

Remove the two (2) tubes, one upper and one lower.

2 ►

Loosen the clamp nut on the top of the unit.

3 ►

Remove the syringe plunger assembly.

Assembly Procedure Reassemble the unit by re-installing the parts removed in the disassembly procedure in the reverse order. Pinch Valve Assembly

Disassembly Procedure ► Remove pinch valves SV3 and SV4 by removing two (2) screws, a tube, a connector, and a contact. Assembly Procedure ► Reassemble the unit by re-installing the parts removed in the disassembly procedure in the reverse order.

4.4.10 System Water Container (Float SW) Mechanism / Pump Assembly 4.4.10.1 Overview The system water container contains system water for each wash bath and syringe. It consists of the following two parts. 1. System Water Container (capacity: 3 liters) 2. Buffer Tank (capacity: 200 mL, with float SW)

4.4.10.2 Location See Chapter 4.2.

4.4.10.3 Functional Details The system water container consists of the following components: •

System Water Container

•

Buffer Tank

System Water Container The system water container has a handle and a cap on its upper part and a plug in its bottom part. It is filled with system water and is connected to the piping when positioned as specified. Version 1.0 – May 2006

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Buffer Tank The buffer tank is installed on the main unit base. It has a guide for container installation and a plug that faces the plug of the system water container. It also has a float SW and a degassing tube in its inside upper corner. A tube for connection to the pump and a tube for connection to the valve are connected on the back of the tank.

4.4.10.4 Detailed Diagrams

Figure 4.4-40

4.4.10.5 Parts List Table 4.4-7 Pos. No.

Part Name

Part No.

1

Water Reservoir Assy

741-0302

2

Buffer Tank Assy

741-0561

3

Cap D Assy

741-0560

4

Buffer Tank Cover

741-1502

5

Float Switch Assy

741-0563

6

Filter Cup

741-1505

7

Filter

L472061

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4.4.10.6 Disassembly and Assembly Procedures CAUTION Before removing the flow route tubing, prepare a beaker, a syringe, and a wiper. Drain water from the tubing, and wipe up any spillage.

Removing the System Water Container Unit First remove the following covers: •

Rear cover

•

Gripper Y cover

•

Front cover

Then remove the three (3) screws, three (3) tubes. Finally, remove the system water container unit from the main unit base.

Disassembly and Assembly of the Unit •

Ball sealing assembly of system water container

•

Buffer tank assembly, ball sealing assembly, and float SW

Ball sealing assembly of system water container

Disassembly Procedure ► Remove the ball sealing assembly that is secured with a closed nut. When you remove the inner closed nut, you will find a filter, a spring, ball, and an O ring installed over the nut and packing outside the nut. Assembly Procedure ► Reassemble the unit by re-installing the parts removed in the disassembly procedure (see above) in the reverse order. Buffer tank assembly, ball sealing assembly, float SW

Disassembly Procedure 1 ►

Remove the tank lid by unscrewing the seven (7) screws. When you turn the tank upside down and remove the closed nut of the ball sealing assembly, you will find a filter, a spring, ball, and an O ring installed over the nut.

2 ►

Remove the float SW that is secured with a nut.

Assembly Procedure ► Reassemble the unit by re-installing the parts removed in the disassembly procedure (see above) in the reverse order. Version 1.0 – May 2006

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4.4.10.7 Pump Assembly Overview The pump assembly supplies system water from the system water container to the wash baths and syringes via the valve block.

Functional Details The pump assembly consists of the following components. •

Drain pipe

•

DC magnet pump

•

Valve block

For further details, refer to Chapter 3, Fluidics.

Detailed Diagram / Parts List 741-2171

Filter ( Water pump )

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Figure 4.4-41

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Figure 4.4-42

4.4.10.8 Parts List Table 4.4-8 Pos. No.

Part Name

Part No.

1

CHOKE PIECE S10

714-1257

2

SOLENOID VALVE UDV ASSY

741-0830

3

DC MAGNET PUMP ASSY

741-0832

4

JOINT

741-1602

5

PIPING BLOCK

741-1603

6

NIPPLE

741-1606

7

PIPE M2

741-2190

8

BASE R

741-8654

9

SUPPORT R

741-8661

10

PLATE R

741-8669

11

TYGON TUBE R3603 3.17IDX6.35OD

G153001

12

SILASTIC TUBE 8IDX14OD

G153171

13

SOCKET CONTACT DF1BA-4DEP-2.5RC

J830575

14

PLUG DF1BA-10DEP-2.5RC

J830577

15

WIRE BINDER TY-23M

J839050

16

WIRE BINDER TY-24M

J839051

17

ELBOW JOINT 198-19-23-05E

L369125

18

O-RING NBR P4

L456001

19

O-RING NBR P5

L456002

20

MARK BAND KL-1 5

L991365

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Pos. No.

Part Name

Part No.

21

MARK BAND KL-1 6

L991366

4.4.11 Liquid Waste Container Mechanism 4.4.11.1 Overview The liquid waste container consists of the following two units. It collects wash liquid and reaction waste. 1. Liquid waste container (capacity: 4 liters) 2. Container station (capacity: 3.5 liters, with fill level detector; also detects whether or not the container is installed.)

4.4.11.2 Location See Chapter 4.2.

4.4.11.3 Functional Details The liquid waste container consists of the following components: •

Liquid waste container

•

Container station

Liquid Waste Container The liquid waste container has a handle and a cap on its upper part. Remove the cap and position the liquid waste container in the specified position.

Container Station The container is located in the inner station of the container station. The inner station is attached to the outer station that is installed in the main unit base and is pushed up by a shaft on the back and by a spring in the front. A shielding plate is installed in the inner station. This shielding plate is depressed as the waste liquid level increases. When it is depressed, it passes the beam from the photo interrupter installed in the outer station and thus indicates when the waste liquid container is full. A pressure plate with a shaft and coil spring is attached to the front of the inner station. This pressure plate is installed so that it pushes in the container. A shielding plate is installed on one end of the pressure plate. If a container is not installed, the pressure plate will cause the photo interrupter beam to come through the shielding plate and the “no container” state is detected.

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4.4.11.4 Detailed Diagrams

Figure 4.4-43

4.4.11.5 Parts List Table 4.4-9 Pos. No.

Part Name

Part No.

1

Liquid Waste Tank

741-1510

2

Liquid Waste Base Assy

741-0438

3

Cord J631

741-4310

4

Sensor GP1A34LC

J339165

5

Bottle Sensor Assy

741-0566

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Pos. No.

Part Name

Part No.

6

Support

741-1513

7

Shaft L2

741-1526

8

Spring L

741-1523

9

Waterproof Cover S1

741-8180

4.4.11.6 Disassembly and Assembly Procedures Removing the Liquid Waste Container Unit First remove the following covers: •

Rear cover

•

Gripper Y cover

•

Front cover

Then remove the three (3) screws, and then the liquid waste container unit from the main unit base.

Disassembly and Assembly of the Unit •

Photo Interrupter

•

Inner Station and Pressure Plate Assembly

Photo Interrupter

Disassembly Procedure 1 ►

Remove the cord assembly (J631).

2 ►

Remove the photo interrupter (P1132: container detector; P1133: fill level detector)

Assembly Procedure ► Reassemble the unit by re-installing the parts removed in the disassembly procedure (see above) in the reverse order. Inner Station and Pressure Plate Assembly

Disassembly Procedure 1 ►

Remove the pressure plate assembly by unscrewing two (2) screws.

2 ►

Remove the inner station, a shaft, and a spring. Remove the E ring to remove the shaft.

Assembly Procedure ► Reassemble the unit by re-installing the parts removed in the disassembly procedure (see above) in the reverse order.

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4.4.11.7 Adjustment Procedure regarding Liquid Waste Full after few cycles during installation Check that Waste Full Error takes place correctly as follows;

Check Procedure 1 ►

Make sure that the instrument is in Stand-by status by checking that Stand-by appears on the screen.

2 ►

Fill with distilled water ta depth of 115 mm from the bottom of waste tank (equal to 3.4 liters).

3 ►

Make sure that a Waste Full Error is not shown in Reset status. If a Waste Full Error is shown, adjust according to the adjustment procedure.

4 ►

Add a further 200 ml of distilled water to the tank.

Make sure that a Waste Full Error is shown in Reset status. If a Waste Full Error is shown, the setting is OK. If not, adjust according to the adjustment procedure.

Adjustment Procedure 1 ►

Remove the rear cover and front cover.

2 ►

Switch on the instrument.

3 ►

Make sure that the instrument is in Stand-by status by checking that Stand-by appears on the screen.

4 ►

Fill with distilled water to a depth of 120mm from the bottom of the waste tank (equal to 3.5 liters).

5 ►

Unfasten the hex nut shown in Figure 4.4-44.

Figure 4.4-44 Side view of liquid waste container 6 ►

Find a border point where the voltage changes between high (ca. 5V) and low (ca. 0V) by turning the minus screw located at the top of support S (P/N741-8621) with a minus screwdriver. Measure the voltage between Pin #5 and Pin #6 on connector J631.

7 ►

Fasten the hex nut at the border point.

8 ►

Check the function again according to the check procedure.

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4.4.12 Solid Waste Mechanism 4.4.12.1 Overview The solid waste mechanism is designed to efficiently collect tips and vessels used by the analyzer. It levels the used tips and vessels collected by vibrating the waste box periodically.

4.4.12.2 Location See Chapter 4.2.

4.4.12.3 Functional Details The mechanism of this unit is shown below.

Mechanism of Solid Waste The solid waste mechanism generates vibration towards the long dimension of the waste box set in the unit. The crank mechanism consists of the assembly, lever and roller bearing that are fixed to the stepping motor and motor shaft as well as the drive tray that holds a tray to settle waste in the box. The solid waste mechanism generates straight-line forward & reverse movement referenced to the long dimension. Step angle

1.8°/step

Stroke

30 mm

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4.4.12.4 Detailed Diagrams

Figure 4.4-45

4.4.12.5 Parts List Table 4.4-10 Pos.

Part Name

Part No.

1

Motor S Assy

741-0581*

2

Cord J641

741-4311

3

SW Retainer

741-1369

4

Sensor GP1A34LC

J339165

5

Clamp CKS-05-L

J839400

6

Clamp CKS-10-L

J839402

7

Wire Binder TY-23M

J839050

8

Fixture

741-1361

9

Tray

741-0534

No.

∗

Refer to Motor Reference List, Chapter 4.3.1.

4.4.12.6 Procedures for Disassembly/Assembly Removal of the unit 1 ►

Confirm that the disposable tray assembly (waste box) is not left in the equipment. Remove if still present.

2 ►

Remove the gripper of each cover (see 4.4.8.6).

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3 ►

Remove FDD base S, FDD base L, MC latch, FDD guard, and floppy disk.

4 ►

Unscrew four (4) screws and two (2) connectors. Then remove the unit from the main base.

To assembly the unit re-install the parts removed during the removal procedure (see above) in the reverse order (4~1). Position adjustment is not required.

Disassembly/Assembly of the Unit •

Motor S assembly

•

J641 cord assembly

•

Photo Interrupter GP1A34LC

Motor S Assembly

Disassembly 1 ►

Remove the motor.

1.1 ►

Unscrew four (4) screws.

2 ►

Remove the motor S assembly.

2.1 ►

Release clamps in two (2) places.

Assembly ► Assemble the motor S assembly by re-installing the parts removed during the disassembly procedure (see above) in the reverse order. J641 Cord Assembly

Disassembly 1 ►

Remove the sensor holder from SW base.

1.1 ►

Unscrew two (2) screws.

2 ►

Remove the J641 cord assembly.

2.1 ►

Replace tie wraps in three (3) places, clamps in four (4) places

2.2 ►

Unscrew two (2) screws for sensor holder.

2.3 ►

Remove photointerrupter GP1A34LC connector.

Assembly ► Assemble the J641 cord assembly by re-installing the parts removed during the disassembly procedure (see above) in the reverse order. Photo Interrupter GP1A34LC

Disassembly 1 ►

Replace photo interrupter GPA.

1.1 ►

Release connector.

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Assembly ► Assemble photo interrupter GP1A43LC by re-installing the parts removed during the disassembly procedure (see above) in the reverse order. Disassembly 2 (without removing unit) 1 ►

Confirm that the disposal tray assembly (waste box) is not left in the equipment. Remove if still present.

2 ►

Dismount the container station of the gripper unit.

2.1 ►

Unscrew four (4) screws.

3 ►

Move drive-tray forwards manually.

4 ►

Remove photo interrupter GP1A34LC.

4.1 ►

Remove the connector of the J641 cord assembly.

Assembly 2 ► Assemble photo interrupter GP1A34LC by re-installing the parts removed during the disassembly procedure (see above) in the reverse order.

4.4.13 Detection Unit 4.4.13.1 Overview The detection unit of cobas e411 has the following major components. 1. Photomultiplier and its housing 2. Circuit boards for PMT and amplifier 3. Peltier heat exchanger 4. Magnet driver 5. Measuring cell 6. Heat insulating casing

4.4.13.2 Location See Chapter 4.2. The figures below show the principal components and the parts in the detection unit as each number. Table 4.4-11 Components Pos. No.

Component

1

PMT assembly

2

PMT HV circuit assembly

3

Peltier heat exchanger

4

Magnet driver

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Pos. No.

Component

5

Amplifier assembly for PMT signals

6

Measuring cell Table 4.4-12 Parts

Pos. No.

Part Name

Part No.

7

Cord P119

741-4232

8

Tube for sipper

741-0820

9

Label PMT-HV

741-1954

10

Circuit board assy PMT-SHV

741-5024

11

Holder

741-1805

12

Support

741-1803

13

Front cover

741-0618

14

Heat-Insulating case

741-0617

15

Tube B for measuring cell

741-0822

16

Cord P600 with micro-cooler

741-4400

17

Cord J600 assy with motor

741-8551, 741-4317

Cord J601 18

Cover

741-0619

19

Cord J601

741-4317

20

Photomultiplier tube

741-1827

Figure 4.4-46 Detection unit cross-sectional view with slanted PMT housing

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Figure 4.4-47 Details of Measuring Cell Mounting (PMT Holder) MC fixing 1

CELL FRAME (P/N:741-1832)

2

FLOW CELL ASSY (P/N:741-0461)

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Figure 4.4-48 Details of Measuring Cell Mounting (PMT Holder) Support Fixing 1

SUPPORT (P/N:741-1803)

2

CELL FRAME (P/N:741-1832)

3

FLOW CELL ASSY (P/N:741-0461)

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Figure 4.4-49 Top view of detection unit

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Figure 4.4-50 Rear view of detection unit

4.4.13.3 Measuring Cell The measuring cell has 2 (two) separable components as shown in Figure 4.4-51. 1. Cell body 2. Reference electrode (RE)

Preparation of the Measuring Cell •

RE is originally covered with a cap. On use, it should be detached by unscrewing.

•

Attach the RE into the cell body by screwing firmly.

•

Connect the plug into the RE terminal.

•

The ECL signals are obtained through PMMA window (see Figure 4.4-51).

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Figure 4.4-51 Assembled measuring cell 1

PMMA Window

2

Cell Body

3

RE (Reference Electrode)

4

Connector J610

Replacement of Measuring Cell 1 ►

Make sure that the instrument is switched off.

2 ►

Remove the lid of the detection unit by unscrewing the 2 (two) M3 screws located on the rear cover.

3 ►

Remove the detection unit cover by unscrewing the 6 (six) M3 screws.

4 ►

Detach the inlet/outlet tubes from the measuring cell by unfastening their nipples.

5 ►

Detach connector J610 from connector P610.

6 ►

Unfasten 2 (two) M3 screws.

7 ►

Slide the measuring cell base forwards and then downwards.

8 ►

Detach the measuring cell itself by unfastening 2 (two) M3 screws located on the base.

9 ►

Replace the measuring cell by a new one.

10 ►

Slide the measuring cell base upwards and then backwards into the detection unit.

11 ►

Replace the 2 (two) M3 screws.

12 ►

Replace the inlet/outlet tubes and the connector.

13 ►

Replace the covers.

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14 ►

Switch the instrument on.

15 ►

Refer to Chapter 2.3.9 for details concerning conditioning of the measuring cell.

When to replace the measuring cell 1 ►

The measuring cell should be replaced if the measuring cell position relative to the PMT and magnet is correct and the BSR2 mean value is lower than an acceptable limit specified by RD/Hitachi

2 ►

After six (6) months or 50,000 cycles if TSH values are out of the acceptable range as specified by RD/Hitachi.

3 ►

If there is no mechanical/electrical trouble but the result of the Performance Check shows abnormal behavior within the warranty term according to the specification between RD and Hitachi.

4.4.13.4 PMT (Photomultiplier Tube) •

The PMT in the cobas e411 has the following specifications.

•

The figures below show side views of the PMT and PMT socket.

•

The PMT is very sensitive to environmental lighting and magnetic fields, and must be treated with great care. Whenever you open the cover of the detection unit, be sure to avoid direct irradiation by light and sunshine.

•

Be sure not to touch the window of the PMT with your bare fingers.

Specification of PMT R1617-05 Table 4.4-13 Description

Specifications

Photosensitive window

Head-on type

Photocathode material

Multialkali

Spectral response range

300-850 nm

Peak wavelength

420 nm

Anode-to-cathode

supply

1250 Vdc

(Max.) Anode-to-last dinode voltage

250 Vdc

(Max.) Average anode current

0.1 mA

Storing

-80 ~ +50°C

environmental

temperature Cathode sensitivity (Sk)

≥120µA/lm

Anode sensitivity (Sp)

≥200 A/lm

Equivalent

dark

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Specifications

(Sp=200A/lm) Red/white ratio (R/W)

150 X 10-3

Figure 4.4-52 Side view of PMT

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Figure 4.4-53 Side view of PMT socket assembly

Replacement of PMT 1 ►

Make sure that the instrument is switched off.

2 ►

Remove the lid of the detection unit by unscrewing the 2 (two) M3 screws located on the rear cover.

3 ►

Remove the detection unit cover by unscrewing 6 (six) M3 screws.

4 ►

Detach the inlet/outlet tubes from the measuring cell by unfastening their nipples.

5 ►

Detach the connector J610 from the connector P610.

6 ►

Unfasten 2 (two) M3 screws.

7 ►

Slide the measuring cell base forwards and then downwards.

8 ►

Detach the fixing frame from the PMT socket by unfastening the screw.

9 ►

Detach the PMT holder with the PMT and the PMT socket.

10 ►

Remove the PMT and the PMT socket from the PMT holder.

11 ►

Remove the PMT from the PMT socket.

12 ►

Insert a new PMT.

13 ►

Attach the PMT, the PMT socket, and the PMT holder as before.

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Attach the PMT holder to the measuring cell base.

Note: Push the PMT socket tail lightly to ensure sufficient fixing f the PMT window, and

attach

the fixing frame of the PMT socket by fastening the screw.

15 ►

Slide the measuring cell base upwards and then backwards into the detection unit.

16 ►

Replace the 2 (two) M3 screws.

17 ►

Replace the inlet/outlet tubes and the connector.

18 ►

Replace the covers.

19 ►

Switch the instrument on.

CAUTION •

PMT replacement must be carried out in subdued lighting.

•

The PMT window must be cleaned.

•

Use clean gloves when you handle the PMT.

•

Allow 1 (one) hour stabilization time.

4.4.13.5 Replacement of Sipper Tubing 1 ►

Make sure that the instrument is switched off.

2 ►

Remove the rear cover by unscrewing the 2 (two) M3 screws.

3 ►

Remove the detection unit cover by unscrewing the 6 (six) M3 screws.

4 ►

Detach the inlet/outlet tubs from the measuring cell by unfastening their nipples.

5 ►

Detach the other side of the inlet/outlet tubs by unfastening their nipples.

6 ►

Attach the new tubs firmly by fastening their nipples as before.

CAUTION •

In order to avoid liquid leakage from the nipples, the tubes must be inserted straight and firmly.

•

Check that none of the nipple screws are damaged.

4.4.13.6 Replacement of Detection Unit 1 ►

Make sure that the instrument is switched off.

2 ►

Remove the rear cover by unscrewing the 2 (two) M3 screws.

3 ►

Unfasten the four (4) screws locate at the feet of the detection unit itself.

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4 ►

Detach the inlet tubing from the sipper probe by unfastening the nipple.

5 ►

Detach the outlet tubing from branch block located on the syringe unit by unfastening the nipple.

6 ►

Disconnect wires and cables attached to the outside connector.

7 ►

Replace the detection unit by a new one.

8 ►

Replace the four (4) screws.

9 ►

Replace the inlet/outlet tubs and the connectors.

4.4.13.7 Housing Disassembly/ reassembly of detection unit Disassembly

•

Similar to the procedure described in 4.4.14.6.

•

Each component will be separated during disassembly procedure.

Reassembly

•

Follow the disassembly procedure in reverse.

Casing The detection unit is equipped with heat insulating casing for temperature control. White polymer foam sheets are glued to the outer surface of the unit casing. Black polymer sheets are also applied around the unit cover and the service window to shield from light. The entire casing must be replaced if the polymer sheets are damaged or come off the casing over a wide area.

PMT stabilization time Following disassembly/reassembly, of the Detection Unit, one hour is needed for stabilization of the PMT,

4.4.14 Magnet Drive Mechanism 4.4.14.1 Overview The magnet drive mechanism is used to position the magnet at the detection point of the measuring cell and to take the magnet away from the cell.

4.4.14.2 Location The magnet drive mechanism is located in the detection unit below the measuring cell. See Chapter 4.2.

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4.4.14.3 Functional Details The magnet drive mechanism consists of the following components: Magnet Drive Mechanism is driven by a stepping motor which rotates in 2W, 1-2 phase, bipolar microsteps, the magnet driving mechanism rotates the arm fixed to the magnet by 90 ° from the home position to move it to and from the detection point of the measuring cell. Step angle

0.225°/step

Rotation angle

90 °

4.4.14.4 Detailed Diagram

Figure 4.4-54

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4.4.14.5 Parts List Table 4.4-14 Pos. No.

Part Name

Part No.

1

HEAT-INSULATING

741-0617

CASE 2

FRONT COVER

741-0618

3

COVER

741-0619

4

HEATING PIPE

741-0669

5

BUSH B

741-1383

6

SHIELD CASE

741-1808

7

PC COVER

741-1810

8

PACKING

741-1814

9

RETAINER

741-1820

10

BUSH HV

741-1822

11

PHOTOMULTIPLIER

741-1827

TUBE 12

GASKET

741-1835

13

BASE

741-1842

14

BASE 2

741-1843

15

CORD GND (HV)

741-4329

16

CIRCUIT BOARD ASSY

741-5024

PMT-SHV 17

FRAME ASSY

741-8549

18

PMT SUPPORT R

741-8679

19

TRAY R

741-8680

20

EPOXIDE RESIN 910-50

F440079

21

SOCKET

J831873

22

WIRE BINDER TY-23M

J839050

23

BUSH NB-400 (BLACK)

L938317

24

COLLAR NA407 (BLACK)

L938319

25

COLLAR

L938322

NA-420

(BLACK) 26

CIRCUIT

BOARD

L-

R629243

With

741-8551

AMP(3) 27

Cord

J600

Assy

Motor (Thermistor) 28

Sensor GP1A34LC

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4.4.14.6 Assembly and Disassembly Procedure Removing the Unit 1 ►

Remove the rear cover.

2 ►

Remove the detection unit from the main unit (base (00) assembly) by taking out three (3) nipples, three (3) connectors, four (4) screws, and four (4) spacer DEs.

Reassemble the unit by re-installing the parts disassembled in steps 1 and 2 in the reverse order. Adjustment of the position is not necessary

Disassembly and Assembly of the Unit 1. Magnet Drive Assembly 2. J600 Cord Assembly 3. Photo Interrupter (GP1A34LC) Magnet Drive Assembly

Disassembly Procedure 1 ►

Remove the main cover assembly by removing six (6) screws from it and then remove the service cover assembly by removing four (4) screws from it.

2 ►

Take out the L-AMP PI assembly together with the shield case LOG by removing the three (3) connectors and one (1) screw.

3 ►

Remove the cell holder, PC cover, and PMT-HV PI assembly in this order. (You need to remove three (3) screws from the cell holder, one (1) screw from the PC cover, and four (4) screws and one (1) connector from the PMT-HV PI assembly.)

4 ►

Remove the PC base and PC base (2) by unscrewing two (2) screws from each.

5 ►

Remove the P600 cord assembly by taking out two (2) M2.6 screws and one (1) cramp.

6 ►

Remove the micro cooling unit and then the P601 cord assembly by unscrewing four (4) screws and two (2) M2.6 screws.

7 ►

Remove the four (4) screws (screw a) that secure the main frame assembly to the case insulation assembly.

8 ►

Slide the main frame assembly, support frame, cell frame, and pipe assembly together with the lead wire of the photo multiplier out of the case insulation assembly. (Unscrew two (2) M4 screws and two (2) M3 screws.) Be careful not to expose the photomultiplier to light.

9 ►

Remove the magnet drive assembly by unscrewing two (2) screws.

10 ►

Remove the J600 cord assembly by removing two (2) locking fixtures, two (2) tie wraps, and one (1) screw.

Assembly Procedure

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Reassemble the unit by re-installing the component removed during the disassembly procedure in the reverse order.

Note: When reassembling the unit, generously apply Amicon epoxy resin (F440079) to the bottom (b) of the micro cooling unit. Also, thickly apply Amicon epoxy resin in groove (c) of the main frame where the pipe assembly is to be mounted.

Note: After removing the magnet drive assembly from the unit, adjust the positions of the magnet drive and the measuring cell position. Refer to Chapter 5.2.1, Replacement of Measuring Cell. J600 Cord Assembly

Disassembly Procedure Replace the J600 cord assembly. Assembly Procedure Re-install the parts removed in the disassembly procedure in the reverse order. Photo Interrupter (GP1A34LC)

Disassembly Procedure ► Replace the photo interrupter (GP1A34LC). Assembly Procedure ► Re-install the parts removed in the disassembly procedure in the reverse order.

4.4.14.7 Adjustment Procedure for Magnet Position 1 ►

Switch off the instrument.

2 ►

Take out measuring cell from the cell plate as described above.

3 ►

Attach the positioning tool to the cell plate in the same manner as for the measuring cell.

4 ►

Loosen two (2) screws for magnet driver in rear part of cell plate.

5 ►

Move magnet arm upwards and insert the magnet part of magnet arm in the hole of positioning tool.

6 ►

Tighten the two (2) screws for magnet driver.

7 ►

Take out the positioning tool.

8 ►

Attach measuring cell to cell plate.

9 ►

Follow the procedure for cell replacement and close the cover and lid of the detection unit.

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4.4.15 Matrix BCR Mechanism 4.4.15.1 Overview The matrix BCR mechanism is a unit that contains a rotating mechanism that is used for scanning bar-coded data with a bar-code reader. The bar-code reader scans a bar code attached to a sample tube, or a reagent rack pack, or scans a bar-code card that carries the information of these three in combination.

4.4.15.2 Location See Chapter 4.2.

4.4.15.3 Functional Details The matrix BCR mechanism consists of the following components: •

Rotating Unit

•

Bar-code Reader

•

Bar-code Card Holder

Rotating Unit The rotating unit rotates and shifts the bar-code reader to the scanning point on either the sample disk or the reagent disk. This unit conveys the movement of the stepping motor via a flat gear to the bar-code reader so that the bar-code reader will rotate slowly when scanning a bar-code card. Slow Down Rate

1: 8.438

Motor Stepping Angle

0.225 °/step to 0.9 °/step

Shifting Angle

0.027 °/step to 0.107 °/step

Bar-code Reader The bar-code reader is installed onto a molded bracket at a gear fixed to the bracket with a screw. The gear controls the rotation of the bar-code reader. The bracket is supported by a rotating axle which is inserted into ball bearings.

Bar-code Card Holder The bar-code card holder supports the table cover L and also guides a card into the appropriate card position.

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4.4.15.4 Detailed Diagrams

Figure 4.4-55

Figure 4.4-56 bracket（P/N：741-1321） Version 1.0 – May 2006

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Figure 4.4-57 barcode reader Assy（P/N：741-0133） 1

WIDE BCR

2

741-1321: bracket

4.4.15.5 Parts List Table 4.4-15 Pos. No.

Part Name

Part No.

1

Base BCR

741-1320

2

Bracket

741-1321

3

Holder

741-1322

4

Motor Base Assy

741-0600

5

Motor Gear

741-1323

6

Shaft

741-1324

4.4.15.6 Disassembly and Assembly Procedures Removing the Matrix BCR Unit Before removing the matrix BCR unit, remove the following covers: •

Rear cover

•

Gripper Y cover

•

Front cover

•

R lid

•

Table cover L

•

Table cover R

•

P plate assembly (at the front bottom of the pipetter unit)

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Then, remove three (3) screws, two (2) connectors (P650 and P651), and the bar-code reader cable connector from the relay board (UI-RS) and remove the unit from the main unit base.

Disassembly and Assembly of the Matrix BCR Unit Disassembly Procedure 1 ►

Remove the bar-code reader.

1.1 ►

Remove four (4) screws.

2 ►

Remove the motor.

2.1 ►

Remove two (2) screws.

3 ►

Remove the rotating axle from the BCR bracket.

3.1 ►

Remove one (1) screw.

4 ►

Pull out the rotating axle from the BCR base.

Assembly Procedure Assemble the Matrix BCR Unit by re-installing the parts removed disassembly procedure in the reverse order. If you have removed the motor, re-adjust the backlash of the gear, referring to the diagram below. Adjustment of Backlash. First, make the BCR bracket rotate and shift to the stopper positions at both ends to fix the stopper for the motor gear rotation. Then, adjust the backlash of the BCR bracket in the direction of its circumference to 0.1 to 0.2 by shifting the motor position.

Figure 4.4-58

4.4.15.7 Adjustment Procedure for BCR Overview •

The BCR base positions itself. It is not necessary to adjust it mechanically because there is enough tolerance.

•

If you replace the BCR itself, first you just make sure whether it is possible to read a label according to the Check Procedure.

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Check Procedure Check that the BCR functions well as follows. Refer to attached flow diagrams. Sample BC Scanning

•

Place a Sample Rack with primary tubes to all of which BCR labels are attached.

•

Make sure that the instrument is in Stand-by status by checking that Stand-by appears on the screen.

•

Perform Sample BC Scanning by touching the button in the Mechanism check screen. Refer to Chapter 6.3.

•

Confirm whether you hear a beep at each position during scanning.

If everything is OK, the BCR reader is ready for further checks, e.g. Barcode Card Reading and Reagent Pack BC Scanning. See Comment 1. If not OK, begin BCR adjustment as described in the Adjustment Procedure. •

Stop Sample BC Scanning by pressing the STOP button.

Barcode Card Reading

•

Place a Barcode Card into the Barcode Card Holder.

•

Make sure that the instrument is in Stand-by status by checking that Stand-by appears on the screen.

•

Perform Barcode Card Reading by touching the button in the Mechanism check screen. Refer to Chapter 6.3.

•

Confirm whether you hear a beep during reading.

If everything is OK, the BCR reader is ready for further checks like Reagent Pack BC Scanning. If not OK, begin BCR adjustment as described in the Adjustment Procedure. •

Stop Barcode Card Reading by pressing the STOP button.

Reagent Pack BC Scanning

•

Place a Reagent Rack with RackPacks to all of which BCR labels are attached.

•

Make sure that the instrument is in Stand-by status by checking that Stand-by appears on the screen.

•

Perform Reagent Pack BC Scanning by touching the button in the Mechanism check screen. Refer to Chapter 6.1.10. See Comment 2.

•

Confirm whether you hear a beep at each position during scanning.

If everything is OK, the BCR reader is ready for operation. If not OK, begin BCR adjustment as described in the Adjustment Procedure. •

Stop the Reagent Pack BC Scanning by pressing the STOP button.

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Adjustment Procedure Sample ID

This procedure adjusts the angle of BCR itself relative to slit of the Sample Disk at Sample position. The BCR angle moves one (1) pulse by touching the button once in the popup screen (Figure 4.4-59). In the meantime, find a beep area within ca. ± five (5) pulses of the zero (0) value. In principle, you do not have to adjust the angle of the Sample Disk rotation, even though the function is available. ∗

Make sure that the instrument is in Stand-by status by checking that Stand-by appears on the screen.

∗

Touch the Utility button.

∗

Touch the Adjustment Sipper, Cap Open/Close BCR button.

∗

Touch the BCR Sample DIsk button.

1 ►

Perform the BCR adjustment as follows.

2 ►

Having touched the button, a popup appears (Figure 4.4-59).

Figure 4.4-59 Popup screen of BCR & S.disk 3 ►

In the meantime, the BCR continuously scans at half (0.5) second intervals. If everything is OK, the BCR beeps. It is now ready for further checks like those in item4 ►. If not OK, the BCR does not beep; adjust the BCR as described in items 5 ► to 6 ►.

4 ►

Check whether the BCR can be read when you move the Sample Rack by hand by about 2 mm to the left or right. See Comment 3.

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Adjust the BCR angle to find a beep area within ca. ± five (5) pulses of the zero (0) value by touching the following buttons.

Note: If you touch the BCR Right + button once, the BCR moves one (1) step to the right. Note: If you touch the BCR Left - button once, the BCR moves one (1) step to the left. See Comment 4. 6 ►

Confirm that the BCR beep is stable. If it is stable beep, touch the OK button. In the meantime, the BCR returns to the HOME position (in reset status) once and it moves to an updated position, the BCR scans again.

If everything is OK, the BCR beeps. It is now ready for operation. See Comment 5. In not everything is OK, the BCR does not beep; repeat from items 5 ► to 6 ►. Check Procedure of Retry function of Sample ID—See Comment 6

•

There is a BCR Retry function during Sample BC Scanning in operation.

•

If the BCR is not readable at first, S. Disk rotates ca. 2mm to the right (CW) and it performs a second reading.

1 ►

Check the Retry function by setting up a BCR position equivalent to the position of the second reading as follows. ► Make sure that the instrument is in Stand-by status. ► Touch the BCR S. Disk button. ► Touch the button, then a popup appears (Figure 4.4-59). ► Touch the BCR Left - button ten (10) times. ► Confirm that the BCR beep is stable.

In case of all: If it is stable beep, touch the Cancel button. Perform the Sample Scan. In case of all: If it is not OK, touch the Cancel button and repeat from items 5 ► to 6 ► of Sample ID. 2 ►

Confirm that the Retry function works well as follows. ► Perform a Sample Scan by touching the Sample Scan button in the Orders screen. ► Momentarily block the first Sample Scan with paper; remove the paper and check that the second Sample Scan is performed.

See Comment 7. See Comment 8 Reagent ID

•

The BCR has a sufficiently wide angle of readable area. Therefore, in principle, it is not necessary to adjust even though an adjustment function is available.

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The adjustment value is to set zero (0) during production. See Comment 9.

Attachment 1 Comment 1

Some customers are using narrow width barcodes (out of specification) and primary tubes (diameter 13mm) that rotate with rotation of the sample disk. Therefore, please check sample BC Scanning by using the adjustment procedure for Sample ID. Comment 2

Before you perform Reagent Pack BC Scanning, check that the window of the Reagent Jacket is clean. If you find any stains, clean the window. Comment 3

(4)’ Check whether the BCR can be read when you touch the BCR Right +button three (3) times and touch the BCR Left - button three (3) times. Comment 4

(5)’ If you cannot find a beep area within ca. ± five (5) pulses of the zero (0) value, adjust the sample disk position by touching the following buttons.

Note: If you touch the Sample Disk Right + button once, the sample disk moves one (1) step to the right (CW).

Note: If you touch the Sample Disk Left - button once, the sample disk moves one (1) step to the left (CCW). Comment 5

Return to (4) and (4)’ (comment 3) for checking. Comment 6

You need to set up function status of barcode reading on the Data Disk if you want to use the Retry function. Comment 7

If everything is OK, the BCR beeps and it is now ready for operation. If not OK, the BCR does not beep; repeat Sample ID adjustment after checking for stains on the Barcode label itself. Comment 8

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The BCR has a sufficiently wide angle of readable area. In principle, it is not necessary to adjust.

1 ►

Change angle of the barcode holder.

2 ►

Confirm whether you hear a beep by using the check procedure for Barcode Card Reading.

Comment 9 ∗

Make sure that the instrument is in Stand-by status by checking that Stand-by appears on the screen.

∗

Touch the Utility button.

∗

Touch the Adjustment Sipper, Cap Open/Close BCR button.

∗

Touch the BCR Reagent DIsk button.

1 ►

Perform the BCR adjustment as follows.

2 ►

Having touched the button, a popup appears (Figure 4.4-60).

Figure 4.4-60 Popup screen of BCR & R. disk 3 ►

In the meantime, the R. Disk rotates continuously and the BCR scans.

If everything is OK, the BCR beeps; it is now ready for further checks like the Retry function for Reagent ID. Touch the Cancel button. In not everything is OK, the BCR does not beep; adjust the BCR angle as described in item (4). 4 ►

Adjust the BCR angle to find a beep area by touching the following buttons.

If you touch the BCR Right + button once, the BCR moves one (1) step to the right. If you touch the BCR Left - button once, the BCR moves one (1) step to the left. Version 1.0 – May 2006

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Confirm that the BCR beep is stable.

If everything is OK, the BCR beeps; it is now ready for further checks like the Retry function for Reagent ID. Touch the OK button. If not OK, the BCR does not beep; return to item (4).

Check Procedure for Retry function of Reagent ID •

You need to set up function status of barcode reading on the Data Disk if you want to use the retry function.

•

The BCR Retry function is in operation during Reagent BC Scanning.

•

If the bar code is not readable at first, the R. Disk rotates again and a second reading is performed.

1 ►

Confirm that the Retry function works well as follows. ► Perform the Reagent Scan by touching the Reagent Scan button in Inventory screen. ► Momentarily block the first Sample Scan with paper; remove the paper and check that the second Sample Scan is performed.

If everything is OK, the BCR beeps. It is now ready for operation. In not OK, the BCR does not beep; repeat Reagent ID adjustment, after checking for stains on the window and on the Barcode Label itself.

Attachment 2 Flow Diagram for BCR Adjustment

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Figure 4.4-61 Sample ID Adjustment

Figure 4.4-62 Version 1.0 – May 2006

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Note: In principle, you do not have to adjust the angle of the S.Disk rotation. Bar code Card Adjustment

Figure 4.4-63 Reagent ID Adjustment

Figure 4.4-64

4.4.16 SIPPER SAFETY COVER (INTER ROCK Mechanism) 4.4.16.1 Overview The INTER ROCK Mechanism is a function that stops the device by opening the cover when the operation and resetting it and does safely.

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4.4.16.2 Location See Chapter 4.2.

4.4.16.3 Function Explanation Details •

If you open the cover, instrument status changes to STOP by the detector.

•

It stops the motor of Sopper X at the same time (by Switch)

4.4.16.4 Explanatory Diagram

Figure 4.4-65

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4.5 Mechanical Adjustment 4.5.1 Overview The following is detailed procedures for adjusting the mechanical positions. The procedures are described in the order in which you can carry out the adjustments most conveniently. 1 ►

2 ► 3 ►

Make sure that the mechanical positions of the unit which you have just replaced or adjusted are well adjusted relative to those units that share the same working areas with the unit. For instance, when you replace the reagent disk, you should make sure that it is well adjusted relative to the cap opener, pipetter and beads mixer. The belt tension must always be adjusted prior to the position adjustment by means of the software because you have to take the units out when you adjust their belt tension. Refer to Chapter 6.4.1 for general procedures on how to operate the mechanical adjustment software.

4.5.2 Mechanical Adjustment Procedure See

pdf\4.5_MechanicalAdjustmentProcedure.pdf for more details

4.5.2.1 Adjustment of Gripper Head This procedure describes how to adjust Carrier ZE ASSY (P/N:741-0412) to align perpendicularly to the analyzer. 1. The following jigs are used (Figure 4.5-1 and Figure 4.5-2).

Figure 4.5-1 JIG-1 (P/N:741-8219)

Figure 4.5-2 JIG-2 (P/N:741-8218) 2. As shown in Figure 4.5-3, place the JIG-1 in the magazine container. Then, by using the JIG-2, check visually that the gripper cover stands perpendicularly to the magazine container. If it is not, perform an adjustment by unfastening the two screws (Screws-A) shown in Figure 4.5-4.

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Figure 4.5-3 Visual checking (1)

Figure 4.5-4 Position adjustment (1) 3. As shown in Figure 4.5-5, place the JIG-1 in the magazine container. Then, by using the JIG-2, check visually that the gripper cover stands perpendicularly to the magazine container. If it is not, perform an adjustment by unfastening the two screws (Screw-B) shown in Figure 4.5-6, and if necessary, the two screws (Screws-C) shown in Figure 4.5-7. If you have performed an adjustment by unfastening the Screws-C, open the inspection hole cover and check if the gears are engaged smoothly; the Gripper Assy(Figure 4.5-7) must returns to its original height by the action of the spring when you press it down from above. If the gears are not engaged smoothly, perform an adjustment by unfastening the screws that secure the motor (Figure 4.5-7).

Figure 4.5-5 Visual checking (2)

Figure 4.5-6 Position adjustment (2)

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Figure 4.5-7 Position adjustment (2)

4.5.2.2 Adjustment of Vessel Waste Pos. 1. A Vessel Waste Guide (P/N 741-8835) is added to TABLE COVER R (P/N 7410-8586). 2. The screw holes of TABLE COVER R are enlarged and the TABLE COVER R position adjustable.

Figure 4.5-8 3. Adjustment procedure of TABLE COVER R 1 ►

Prepare the TABLE COVER ADJUSTMENT TOOL (P/N 741-8813).

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Figure 4.5-9 TABLE COVER ADJUSTMENT TOOL (P/N 741-8813) 2 ►

Remove COVER Z (P/N 741-8534).

Figure 4.5-10 3 ►

Prepare the 1 tip, 2 vessels, 3 tip magazines, and 3 vessel magazines. Set them as shown in the pictures below.

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Figure 4.5-12 4 ► 5 ► 6 ►

Touch the [START] button and the instrument starts the initialization. About 1 minute later, the vessel on CB Pos. will be discarded by the gripper. The moment the gripper is over the vessel waste hole, open the SS cover in order to stop the gripper movement right on the spot. Be careful NOT to be late. Remove the vessel and set the TABLE COVER ADJUSTMENT TOOL (P/N 741-8813) to the gripper as shown in the picture below.

(*Instrument status is Stand-by) (** Smaller side should be placed upward) (*** Never moves the X-Y position of gripper when remove the vessel or set the tool)

Figure 4.5-13 7 ►

Push the gripper down toward the vessel waste hole by your finger, and check if the adjustment tool does NOT come into contact with the inner wall of the Vessel Waste Guide. Adjust Vessel Waste Guide so that Tool may become the center of Vessel Waste Guide as much as possible. If it is in contact, adjust the position of TABLE COVER R and Vessel Waste Guide. Then check it in the same way.

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Figure 4.5-14 8 ►

Check for interference between TABLE COVER R and the following. 1. 2. 3. 4.

FRONT COVER S2 (P/N 741-8052) MAGAZINE TRAY (P/N 741-1130) P CARRIER ASSY (P/N 741-0407) Gripper Y mechanism

► Especially, does not come in contact with the TABLE COVER R when you operate Gripper Y mechanism and P CARRIER ASSY by the hand.

Figure 4.5-15 9 ► 10 ►

After completing the adjustment of TABLE COVER R and Vessel Waste Guide, attach COVER Z. Pepare the 1 tip for buffer station, 33 vessels for incubator (include the Sipping Pos.), 3 tip magazines, and 3 vessel magazines. ► Set them at the each position. ► Touch the [START] button and the instrument starts the initialization. ► Adjust it again when the following alarms are generated after disposal operates.

Alarm Code: 18-04-01 Gripper finger didn't close See

pdf\4.5_MechanicalAdjustmentProcedure_2.pdf for more details

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4.5.3 Mechanical Adjustment Procedure for Rack Sampler 4.5.3.1 Position of the Adjustment

Figure 4.5-16 Rack Sampler’s Range of Adjustment

4.5.3.2 Mechanical Adjustment Procedures for the Rack Sampler System See

pdf\4.5_3_MechanicalAdjustmentProcedure.pdf for more details

Explanation Adjustment Sample Position Place a rack with a primary tube (diameter 10 or 13 mm) in rack position one at the STAT position of rack sampler unit. Carry out "B line sampling pos." from the screen "Adjustment rack sampler". Check the current sample position adjustment! If the pipetter needs correction to left/right (x-axis, see Figure 4.5-17), quit the current screen with "Cancel" key, change to the "Adjustment pipetter R.Disk" screen and carry out "Pipetter-X S.Disk" from the screen .

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B line sample position

Figure 4.5-17 If the pipetter needs correction in up/down direction (y-axis, see Figure 4.5-17), change the rack position with "Forward" or "Backward" key.

Note: Note: The hook will only move the rack backwards (see Figure 4.5-17). For forward hook movement, you have to push the rack by hand to get the actual position.

Note: Note: The range of software adjustment for B line sample pos. is only ± 5 steps because of the design of the racks (Figure 4.5-18).

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cobas e411 rack

Figure 4.5-18 If the range of software adjustment for B line sample pos. is not sufficient, change the sample position manually. To adjust manually, move the whole sample detector B assembly (see Figure 4.5-19) in the corresponding direction. The detector B assembly is fasten with two screws on the left and one screw on the right. After changing the position manually, optimize again with the software (as described above).

B line sample position, adjustment possibilities

Figure 4.5-19

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4.6 Rack Sampler System

Figure 4.6-1 Rack Sampler System 1 2

Rack Sampler Unit Analyzer

4.6.1 Overview For details of Photo Sensor and Photo Interrupter indicated by PIxxx, see Chapter 4.3.5.

Figure 4.6-2

4.6.2 Rack Sampler Movement 4.6.2.1 A Line This line sets the rack in which the samples (maximum 15) are placed to the tray and conveys it to the B line.

4.6.2.2 B Line This line accurately conveys the rack that has the samples that have been received from the A line to the bar code reading position and the pipetting position. After reading the sample bar code and the rack bar code and after pipetting, the rack is conveyed to the C line (storage unit) or the D line.

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4.6.2.3 C Line This line unloads the rack that has the samples that have been conveyed by the C line to the tray with the arm used for rack conveying.

4.6.3 A Line 4.6.3.1 Composition (Stroke : 441 mm Delay : 2 mm Sensor to Sensor : 437 mm, 2778P)

Figure 4.6-3 1. Motor used SM200 : A3339-9212 • • •

2 phase motor, step angle: 0.9o / full step Rated current 1.2A Use with 1-2 phase

2. Tray used • •

Tray for Rack Sampler (space for 15 racks: 75 samples) Construct buffer downstream from Tray (space for 5 racks: 25 samples)

3. (3) Rack Feed Speed • •

High-speed feeding: 849.2 PPS (134.8 mm/s) Low-speed feeding: 445.2 PPS (70.7 mm/s)

4.6.3.2 Overview of Operation This line sets the rack in which the samples (maximum 15) are placed to the tray and conveys it to the B line.

4.6.3.3 Rack Feed Operation The rack is conveyed when the following requirements are fulfilled on operation: • • • • •

That the Rack Feeding Detection (PI212: dark) is not on. That STAT samples do not exist and the STAT SW is not on. That the Rack that has the samples is not on the tray, Home Detection (PI201:dark) is not on. That the Rack Detection for rotation machines are not on, for rack conveyors only. That Rack Full detection (PI223: dark) for the C line buffer is not in, for rack samples only.

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When the rack that has the samples is not on the tray and Home Detection is not on, the rack feed arm returns to the Home Position. When the rack that has the samples is on the tray and Home Detection is on, the rack feed arm leaves the Home Position and then returns to the Home Position.

4.6.2.4

Explanation of Operation

1. Home detection (PI201 detection: dark) interrupts and stops the Home position. 2. Rack feed to the B-Line is interrupted and stopped by the Rack Feed Detection (PI212:dark) or the Rack Feed End Detection. The rack feed arm returns to the Home Position every time after the Rack Feed End Detection or the Rack Feed Detection. 3. When a STAT sample (STAT input/output) is received, the STAT sample rack is given priority and the A line rack feed operation is not executed after moving the B line rack. 4. If Rack Feed End Detection (PI202:dark) enters, it returns to the Home Position and executes the rack feed operation once more in the next cycle. • •

If the Rack Feed Detection enters anew, the operation is continued. If the Rack Feed End Detection enters, the alarm (S. STOP) for the Rack Feed End is outputted, and sampling stops.

5. The LED (green) lights up when addition of trays is possible.

4.6.4 B Line 4.6.4.1 Composition (Stroke:364 mm+153 mm including 2 mm delay)

Figure 4.6-4

Figure 4.6-5

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1. Motor used SM210 P: PH265M-31B-A5 • •

2 phase motor, step angle 0.9o / 2 phase Use 0.45o / P with 1-2 phase

2. Rack Feed speed: overmoderated pulse 250P (0.237S) • •

High-speed feeding: 1917 PPS (304.4mm/s) Low-speed feeding: 191 PPS (30.3mm/s)

4.6.4.2 Overview of Operation This line accurately conveys the rack that has the samples that have been received from the A line to the bar code reading position and the pipetting position. After reading the sample bar code and the rack bar code and after pipetting, the rack is conveyed to the C line (storage unit) or the D line.

4.6.4.3 Rack Feeding Operation 1. The rack is conveyed when the following requirements are fulfilled during the operation: •

When the Rack Detection (PI212:dark) or the STAT SW is inputted. However, when there is a detection at the same time, the Rack Detection(PI212) is given priority.

2. The rack is conveyed when the following requirements are fulfilled during reset: • •

• •

Home removal is done when Home Detection (PI210: dark) is on When Home Detection (PI210: dark) remains on, if there is SW recognition it remains in standby after moving to STAT rack position (Interrupt half as a result of STAT Detection (PI213:dark by H.P).If there is no recognition of the STAT SW, Rack Feeding is done when the C line and the D line are in a condition to carry. After that, it returns to home and then goes into standby. If Home Detection (PI210: dark) is not attached; it goes into standby after returning to home. If Home Detection (PI210: dark) is not attached, Rack Feeding is done when the C line and the D line are in a condition to convey. After that, it returns to home and then goes into standby. The rack prior to reading the bar code should not be a reset rack.

3. The rack is conveyed to the pipetting position when the following requirements are fulfilled. When the Rack Full Detection (PI223) for the C line buffer is on and when the rack detection for the rotation mechanism (PI241, P1244) is on, a series of analyses is continued and after the final sample pipetting of the rack that has been loaded, and until the above detections are canceled, it will be in a standby mode in that position.

4.6.4.4 Explanation of Operation 1. In the Home position, it will interrupt and stop when Home is detected (PI260: dark). 2. The bar code reading position detection will interrupt and stop the movement of the bar code reading position (PI216: dark). The same is true for the movement between samples but from the 5th sample to the bar code position shall be a fixed pulse feed. 3. The Sampling Position Detection (PI215: dark → bright) will interrupt and stop the movement from the bar code reading position to the pipetting position. Also, the Sampling Position Detection (PI215: dark → bright) shall interrupt and stop the movement between the samples. Skip processing shall be done for samples that have no analysis requests and if there are empty positions. For empty racks, one machine cycle shall be used to process. 4. the Rack Feed End Detection (PI211: dark) will interrupt and stop the movement from the 5th position to the storage position. 5. By pressing the STAT SW after placing the rack in the STAT rack position, the STAT rack processing makes the machine recognize that there is a STAT rack. The STAT detection (P1211) from H.P will interrupt and stop the movement to the STAT rack position. If the STAT SW is pressed, it will give priority from the rack feed of the A-Line after analysis of all of the samples in the rack that are currently being processed and will convey the STAT rack. Version 1.0 – May 2006

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6. If the STAT SW is pressed when Rack Detection (PI212) is on, the regular rack conveyor rather than the STAT Rack will be given priority.

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4.6.5 C Line 4.6.5.1 Composition (Stroke : 139 mm Delay : 2 mm Including 2 mm delay)

Figure 4.6-6 1. Motor used SM200 : A3339-9212 • • •

2 phase motor, step angle: 0.9o / full step Rated current: 1.2A Use with 1-2 phase

2. Tray used • •

Tray for Rack Sampler (space for 15 racks: 75 samples) Construct buffer upstream from tray (space for 5 racks:25 samples)

3. Rack Feed Speed • •

High-speed feeding: 955.7 PPS (151.7 mm/s) Low-speed feeding: 183.1 PPS (29.1 mm/s)

4.6.5.2 Overview of Operation This line unloads the rack that has the samples that have been conveyed by the B line to the tray with the arm used for rack conveying.

4.6.5.3 Rack Feed Operation 1. The rack is conveyed when the following requirements are fulfilled at operation: • • • •

When the C line is in the Home Position (PI221 detection: dark) When the Tray Full detection 1 (PI225 detection: dark) is OFF, the Tray Full detection 2 (PI296 detection: dark) is OFF, the tray detection (PI224 detection: dark) is ON, and the Rack Full detection (PI292 detection: dark) is OFF. (Feed to tray: Stroke 139 mm) When the Tray Full detection 1 (PI225 detection: dark) is OFF, the Tray Full detection 2 (PI226 detection: dark) is OFF, the tray detection (PI224 detection: dark) is OFF, and the Rack Full detection (PI223 detection: dark) is OFF. (Feed to buffer: Stroke 27 mm) When the Tray Full detection 1 (P1225 detection: dark) is ON, the Tray Full detection 2 (P1226 detection: dark) is OFF, the tray detection (P1224 detection: dark) is ON, and the Rack Full

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detection (P1223 detection: dark) is OFF. Feed to the tray if the previous unloading operation is sent to the tray. If the previous unloading operation is sent it to the buffer, then send to the buffer. When the Tray Full detection 1 (PI225 detection: dark) is ON, the Tray Full detection 2 (PI226 detection: dark) is ON, the tray detection (PI224 detection: dark) is ON, and the Rack Full detection (PI223 detection: dark) is OFF. (Feed to buffer: Stroke 27 mm) Cannot feed when the Tray Full detection 1 (PI225 detection: dark) is ON, the Tray Full detection 2 (PI226 detection: dark) is OFF, the Tray detection (PI224 detection: dark) is ON, and the Rack Full detection (PI223 detection: dark) is ON. Table 4.6-1

No. 1 2 3 4 5 6 7 8

Tray detection PI293 ON OFF ON ON ON OFF ON ON

Rack Full Detection 1 PI292 OFF OFF OFF OFF ON ON ON ON

Tray Full Detection 1 PI294 OFF OFF ON ON ON OFF ON OFF

Tray Full Detection 2 PI296 OFF OFF OFF ON OFF OFF ON ON

Discriminant Can feed (to tray) Can feed (to buffer) Can feed (to tray or buffer) Can feed (to buffer) Cannot feed Cannot feed Cannot feed Cannot feed

2. The rack is conveyed when the following requirements are fulfilled at reset: • •

When the C line is in the Home Position (PI221 detection: dark), the rack is conveyed in the same manner as (1). When the C line is not in the Home Position , the rack is conveyed in the same manner as (1) after H.P return is performed.

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4.6.5.4 Explanation of Operation 1. Movement from the 5th position to the storage position(PI221 detection: dark). 2. For regular rack feeding, interrupt stop by the rack feed end detection (PI222 detection: dark) from H.P. (1 rack shall be fed to the tray.) Returns to Home Position after feeding. However, at the end of feeding, when both the Rack Full detection 1 and Rack Full detection 2 (PI296 detection: dark) has entered, a ‘Warning’ alarm goes off. Also, after that, until the Rack Full detection (PI296 detection: dark) goes in, it continues a 1 pitch feed. 3. When both the Tray Full detections are resolved, all of the racks that are in the buffer are fed to a batch of trays. (feeds a maximum of 5) 4. When both the Tray Full detection and the Rack Full detection (PI223 detection: dark) both go in, a ‘Warning’ alarm goes off. 5. After that, when both the Tray Full detections have been cleared, analysis automatically starts up again. 6. When returning to Home after 1 rack is fed, (1 pitch feed) a check on the remaining pulse is done and checks whether the 1 rack feeding is being performed normally or not. 7. When the Rack Full detection (PI223: dark) for the Buffer is on, rack feeding of the A line is not done.

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5.1 Boards 5.1.1 System Overview 5.1.1.1 General Wiring Diagram See the next diagram. Location of boards in the PCB. Rack

Figure 5.1-1 Location

Note: RS CONTD (P/N 741-5074) mounted with EIO3 PCB for Rack Sampler System. Note: DIST232C (P/N 741-5075) mounted with EIO3 PCB for Disk System. 5.1.1.2 General Wiring Diagram See

pdf\GeneralWiringDiagram.docfor more details

5.1.1.3 Wiring Diagram for Rack Sampler System See

pdf\WiringDiagramforRackSamplerSystem.pdffor more details

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5.1.2 Location of Boards Table 5.1-1 PCB list PCB Name ECPU550

Part No. 271-5818

Location PCB rack

EECL300

275-0716

PCB rack

EMOT300 EIO3

275-0710 741-5080

PCB rack PCB rack

DO1 DO2

741-5031 741-5032

PCB rack PCB placement plate at rear of the instrument

DO3

741-5033

Front/side of the PCB rack

DIST-PA

741-5045

In the pipetter unit

DIST-SA

741-5046

In the sipper unit

DIST-TVA

741-5047

In the gripper unit

DIST-F

741-5028

DIST-F3

741-5077

Left side of the instrument In the DC power supply unit

USB-F

741-5078

DIST232C ANG-EP2

741-5075 741-5068

PMT-SHV2

741-5025

L-AMP(3) LLD-SA

741-4806 741-5044

LLD-P3

741-5048

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Left side of the instrument PCB rack PCB placement plate at rear of the instrument On the detection unit In the detection unit PCB placement plate at rear of the instrument In the pipetter head

Primary Function 1. CPU board for system control. 2. RS232C x 4 channel equipped. 1. Temperature control. 2. LLD signal control. 3. ADC function for log amp (DI). 4. Reading current & volt of potentio circuit. 1. Motor control function (PPMC) 1. Solenoid driver. 2. Photo interrupter buffer. 3. DC power failure detection. Pulse motor driver for 2 or 1-2 phase control. Pulse motor driver for W1-2 or 2W1-2 phase control energized method Reagent disk : 2 or W1-2 phase Sample disk : 1-2 or 2W1-2 phase Magnet drive : 1-2 or 2W1-2 phase Barcode reader : 1-2 or 2W1-2 phase 1. Peltier control driver for temperature of reagent disk, incubator, system reagent. 2. Heater control driver for detection unit. 3. DC fan motor driver Distribution of photo interrupter signal and pulse motor signal for pipetter. Distribution of photo interrupter signal and pulse motor signal for sipper Distribution of photo interrupter signal and pulse motor signal for gripper unit. Fuse and LED for DC+5V, +12V and +24V 1. +12VDC fuse for DC Power Supply 2. +5VDC fuse for EIO board power down monitor 3. +5VDC fuse for DIST-232C or RSCONTD board RS232C control power. 4. +12VDC fuse for PC unit. Fuse for current limit at USB power supply of PC Changes TTL level for communication of ECPU to RS232C level 1. Potentiostat voltage generated 2. Conversion of pressure sensor signal 3. +12VDC for PMT-SHV board 1. High voltage generator for PMT 1. Log conversion of PMT electric current to voltage 1. Liquid level detection of sipper.

1. Liquid level detection of pipetter

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Table 5.1-2 PCB Name UIRS-C

Part No. 741-5081

Location Left/rear side of the instrument Under the PCB rack In the AC power unit In the gripper In the gripper In the solid waste box In the SYRINGE PCB rack(On the EIO Pcb)

MVLB110 S.AB-CE DET-A DET-B DET-C DETECT1 RS CONTD (for R/S)

271-3907 725-5029 741-5016 741-5017 741-5026 736-0824 741-5074

PS CONTA (for R/S) DO4A (for R/S)

741-5058 741-5071

In the R/S (Under the DO4A Pcb) In the R/S

BCR (for R/S) PH-D (for R/S) PH-T (for R/S)

741-5056 741-5053 741-5054

In the B line In the B line In the B line

Primary Function Connection of RS232C signal for 2-set of BCR, HOST. Mother board for PCB rack Surge absorber circuit Photo interrupter equipped (gripper Y-axis) Photo interrupter equipped (gripper Y-axis) Photo interrupter equipped (solid waste boxpresence/absence) Photo interrupter equipped (syringe) 1. Motor control function 2. Conversion from parallel signals to serial signals Conversion from serial signals to parallel signals 1. Pulse motor driver for 2 or 1-2 phase control 2. Photo interrupter buffer Connection of RS232C signal for BCR Photo transistor equipped Photo diode equipped

Note: Part No. and PCB name are different depending on the manufacturing time. Please refer to Parts List for details.

5.1.2.1 Analyzer

Figure 5.1-2

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Figure 5.1-3

Figure 5.1-4

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Figure 5.1-5

Figure 5.1-6

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Figure 5.1-7

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Figure 5.1-8

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5.1.2.2 Rack Sampler System

Figure 5.1-9

Note: PS CONTA board (P/N741-5058) is located just behind the DO4A board(P/N741-5071) as shown in the picture above.

Note: BCR Board (P/N741-5056) and BCR are located at the BCR reading position on the B line in the analyzer.

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Figure 5.1-10

Note: PH-D Board (P/N741-5053) should be mounted with PH-T Board (P/N741-5054) as a pair at the sampling position in the B-line.

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5.2 Power Source 5.2.1 AC Power • •

AC lines are only connected to the DC power supply through main switch and noise filter. The surge absorber provides protection from electrical surges of more than 600V and is connected between the main switch and the noise filter.

Figure 5.2-1 Power Supply System Diagram

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5.2.2 DC Power Supply 5.2.2.1 Specification of DC Power Supply (For e411) Range of Input Voltage: Tolerance of AC frequency change: Inrush Current: Efficiency: Safety Regulations: Hold-up time: Power Factor:

Single phase 100VAC～240VAC(85 ∼ 264VAC) 47 ∼ 63 Hz 15A/30 A (TYP,at 100VAC),30A/30A(TYP,at 200VAC) 77% (TYP, at 100VAC,600W)/80% (TYP,at 200VAC,650W) UL60950, C-UL(CSA60950), EN60950, EN50178 20 ms (TYP, at 100VAC) 0.99 (at 100VAC,600W)/0.95(at 200VAC,650W)

Dimensions:

Figure 5.2-2 DC Power Supply for e411

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5.2.2.2 Specification of DC Power Supply(For R/S) Single phase 100VAC~240VAC(85 ∼ 264VAC) 47 ∼ 63 Hz 15 A (TYP,at 100VAC)/30A(TYP,at 200VAC) 81% (TYP, at 100VAC)/83%(TYP,at 200VAC) UL1950, C-UL(CSA950), EN60950, VDE0160 40 ms (TYP, at 5VDC), 20 ms (TYP, at 24VDC), 0.99 (at 100VAC)/0.93(at 200VAC) 5V:120mVp-p(MAX,at Ta=0~40°C), 160mVp-p(MAX,at Ta=-10~0°C)24V:150mVpp(MAX,at Ta=0～40℃), 180mVp-p(MAX,at Ta=-10~0°C) (Measured by 20MHz Oscilloscope or Ripple-Noise meter (Equivalent to KEISOKU-GIKEN:RM101)) Overvoltage protection: 5V:5.75V(MIN) 24V:27.60V(MIN)～33.60V(MAX) Overcurrent protection: 5V:5.25A(MIN) 24V:14.14A(MIN)

Range of Input Voltage: Tolerance of AC frequency change: Inrush Current: Efficiency: Agency Approved: Hold-up time: Power Factor: Ripple Noise:

Dimensions:

Figure 5.2-3 DC Power Supply for R/S

5.2.2.3 Specification of DC Power Supply(For PC) Single phase 100VAC～240VAC(85 ∼ 264VAC) Tolerance of AC frequency change: 47 ∼ 63 Hz Inrush Current: 20 A (TYP,at 100VAC)/40A(TYP,at 200VAC) Efficiency: 85% (TYP, at 100VAC)/88%(TYP,at 200VAC) Safety Regulations: UL60950-1, C-UL(CSA60950-1), EN60950-1, EN50178 Hold-up time: 10 ms (TYP, at 100VAC) Power Factor: 0.99 (at 100VAC)/0.93(at 200VAC) Ripple Noise: 250mVp-p(MAX,at Ta=0～50℃), 300mVp-p(MAX,at Ta=10～0°C) (Measured by 20MHz Oscilloscope or Ripple-Noise meter(Equivalent to KEISOKU-GIKEN:RM101)) Overcurrent protection: Works over 105% of rated Range of Input Voltage:

Dimensions:

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Figure 5.2-4 DC Power Supply for PC

5.2.2.4 Output Voltage & Adjustment •

The output voltage of the DC power source is preset to the values in the table below. Table 5.2-1 Preset of DC Power output voltage

Voltage +5 V

+5.35V±1.0% ( +5.29 ～ +5.40V)

Check Pin No. Between DIST-F Board TP1 and TP4

Part e411

+12 V(1)

+12.30V±1.0% (+12.17 ～ +12.42V)

Between DIST-F Board TP1 and TP5

e411

+15 V

+16.00V±1.0% (+15.84 ～ +16.16V)

Between DO3 Board TP4 and TP5

e411

-15 V

-16.00V±1.0% (-15.84 ～ -16.16V)

Between DO3 Board TP6 and TP5

e411

+24 V

+24.45V±1.0% (+24.20 ～ +24.69V)

Between DIST-F Board TP3 and TP6

e411

+5 V

+5.30V±5.0% ( +5.04 ～ +5.57V)

Between PS CONTA Board TP11 and TP12

R/S

+24V

+24.30V±10.0% (+21.90 ～ +26.70V)

Between DO4A Board TP1 and TP2

R/S

+ 12V(2)

+12.24V±2.0% (+12.00 ～ +12.48V)

Between DC Power Supply +V and -V

PC

•

Preset Voltage

To adjust or inspect the voltage turn the variable resistors (shown in the figure below) on the terminal side of the power supply unit without an electric load. (DC output has sensing line and voltage is maintained even if the electric load is changed.) Table 5.2-2 Adjustment of DC Power output voltage

Voltage +5 V

+5.35V±1.0% ( +5.29 ～ +5.40V)

Adjustment Voltage Tolerance at Terminal

Adjust Position VR between +5V and GND terminal

Part e411

+12 V(1)

+12.30V±1.0% (+12.17 ～ +12.42V)

VR between +12V and GND terminal

e411

+15 V

+16.00V±1.0% (+15.84 ～ +16.16V)

VR between +15V and GND terminal

e411

-15 V

-16.00V±1.0% (-15.84 ～ -16.16V)

VR between -15V and GND terminal

e411

+24 V

+24.45V±1.0% (+24.20 ～ +24.69V)

VR between +24V and GND terminal

e411

+5 V

+5.30V±5.0% ( +5.04 ～ +5.57V)

Refer to Figure 5.2-3

R/S

+24V

+24.30V±10.0% (+21.90 ～ +26.70V)

Refer to Figure 5.2-3

R/S

+ 12V(2)

+12.24V±2.0% (+12.00 ～ +12.48V)

Between DC Power Supply +V and -V

PC

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Figure 5.2-5 Output Terminal Side of the Power Supply Unit ∗

Refer toFigure 5.2-4 for the locations of power source adjustment for R/S

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Figure 5.2-6 Side View of the Power Supply Unit

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Figure 5.2-7 Wiring Diagram of the Power Supply Unit

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5.3 Electronic Modules / Electronic Adjustments 5.3.1 Principle of Temperature Control The temperature control is performed by the microprocessor ANGCNT on the EECL300 board. Temperature is controlled by four units by one of the following two methods.

5.3.1.1 Incubator, System Reagent Unit The unit calculates the control signal using the deviation between the target temperature given by the CPU and the actual temperature measured at the control point and outputs the signal on the DO3 board. The signal is augmented on the DO3 board, and the system runs electricity to the Peltier or the heater. The fan is used to maximize the heat release efficiency. As the voltage applied to the Peltier increases, the fan turns on. No fan is used in the incubator.

Figure 5.3-1 Temperature Control Block Diagram (Incubator, System Reagent)

5.3.1.2 Reagent Disk, Detection Unit The reagent disk determines the target temperature from the ambient temperature of the reagent disk unit. The detection unit determines the target temperature from the ambient temperature of the system reagent unit. The system calculates the control signal using the deviation between the target temperature and the actual temperature measured at the control point and outputs the signal to the DO3 board. The DO3 board augments the signal and the system runs the electricity to the Peltier or the heater. The fan is used to maximize the heat release efficiency and turns on as the voltage applied to the Peltier increases.

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Figure 5.3-2 Temperature Control Block Diagram (Incubator, System Reagent)

5.3.2 Principle of LLD • •

•

The liquid level detector of the cobas e411 detects the change of the static electricity capacity between the detection electrode and GND before and after its contact with the liquid. The structure of the liquid level detector is shown in Figure 5.3-3. The detection electrodes used for the pipetter are a nozzle tip and a disposable tip made of a conductive material. The sample disk and reagent disk are also made of a conductive material and are grounded. The detection electrode used for the sipper is the system reagent unit, and is grounded via the sipper nozzle. The outer wall of the system reagent unit is shielded. When the CPU sends a command to the GPCNT (motor controller) to lower the pipetter (or the sipper), it also sends a command to the LLD CNT (liquid level detection controller) to start the liquid level detection. Upon receiving the start command, LLD CNT starts monitoring the signal output from the LLD-P3 board (or the LLD-SA board for the sipper). LLD CNT processes the received signal and when the signal is for the liquid surface, it sends a "motor stop" command to GPCNT. The output and "motor stop" signals from the LLD-P3 board (or the LLD-SA) are described in Figure 5.3-4 (Figure 5.3-5for the LLD-SA).

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Figure 5.3-3 LLD Composition

Figure 5.3-4 Pipetter LLD Signal

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Figure 5.3-5 Sipper LLD Signal

5.3.3 Principle of Clot Detection • • •

Clot detection is a monitoring function of liquid pressure in the pipetter tube when sampling to detect abnormal situations as a result of a blood clot, fibrin, etc. Liquid pressure is detected by a semiconductor pressure sensor and a half bridge circuit on ANGEP2 PCB, and this signal is also amplified on ANG-EP2 PCB. Then, the pressure signal (range 0 5 volts) is converted to a digital signal by EECL PCB and sent to ECPU 550 PCB. The clot detection algorithm is fixed by software parameters in the Data FD.

5.3.4 Adjustment / Check Procedure of LLD/Clot Detection This describes an adjustment procedure if the following items are replaced or checked. • • •

Pipetter Probe/LLD-P3 Board LLD-SA Board/System Reagent Unit Pressure Sensor/Tubing of Pipetter System/ANG-EP Board

Figure 5.3-6

5.3.4.1 Pipetter Probe/LLD-P3 Board Adjustment of Pipetter LLD Voltage • •

Concerning the pipetter LLD voltage monitoring, see Chapter 6.1.8. Remove the pipetter head cover as illustrated in Figure 5.3-7.

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Figure 5.3-7 How to Remove the Cover from the Pipetter Head Precondition:

1 ► 2 ►

Ensure that the pipetter tube is primed Use a plastic screwdriver to adjust the variable capacitor on the LLD-P3 PCB as shown in Figure 5.3-12. When monitoring the voltage, keep your hands off the pipetter arm.

After “Reset”, select “Voltage Monitor” and execute “Pipetter LLD”. Adjust the voltage to the minimum value while the pipetter head is at the highest position. ► The voltage without tip has to be below 1.5V (see Figure 5.3-9 for testing position) and the principle LLD curve (check pos. 1) should be in the recommended range (see also Figure 5.3-8).

3 ►

Put a tip onto the pipetter nozzle. ► The voltage with tip should be increased by 0.1 V to 1.5 V (check pos. 2, see Figure 5.3-8). If the voltage decreases, re-adjust the trimmer so that the voltage increases with a tip.

4 ► 5 ► 6 ► 7 ►

Take out the RackPack from positions 1, 17 and 18 on reagent disk. Move the pipetter to reagent position 18 by hand. The pipetter should be in the position of R2 aspiration (see Figure 5.3-10) Move the pipetter down to position “A” by hand, see Figure 5.3-10 and Figure 5.3-11 for detailed position. The tip should not touch any plastic. Memorize the monitoring voltage. Move the pipetter down to position “B” by hand, see Figure 5.3-10. ► Make sure that the monitoring voltage increases between 0.3 V and 0.7 V (see Figure 5.3-8).

Figure 5.3-8 Principle LLD Curve , Check Positions

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Explanation: 1. Recommended adjustment range ο ο

Pipettor in upper dead point No Tip attached

2. Pipettor in upper dead point ο

Tip attached

3. Pipettor in pos. A ο

Tip attached

4. Pipettor in pos. B (lower dead point) ο

Tip attached

Figure 5.3-9

Figure 5.3-10

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Figure 5.3-11 •

If the voltage is OK, touch the Monitoring Stop button in the Voltage Monitor screen.

Figure 5.3-12 Location of the variable capacitor

Adjustment of Pipetter Z Abnormal Detection range Check the crash sensor signal output by measuring the voltage between the connector pin#A3 of J552 and TP2 (AG) on DIST-PA Board as follows. • •

Detach the Pipetter head cover as shown in Figure 5.3-7. Make sure that the voltage is 0.5 V or lower (ca.35 mV) under normal conditions, i.e. no crash is detected.

Note: Keep the current height of the pipetter head. This means that only pipetter probe itself should go up and down during the next measurements.

• • • • •

Make sure that the voltage is 0.5 V or lower (ca.35 mV) when the thickness tool (0.8), which is 0.8 mm in thickness, is inserted into the gap between the pipetter probe and the flat place as shown in Figure 5.3-7. Also make sure that the voltage increases up to ca.4.5 V or more (ca.5V) when the tool is replaced by the 1.2mm thickness tool under the same conditions. If the increase is not sufficient, bend the detection plate on the pipetter probe upwards or downwards with pliers (see Figure 5.3-13). Repeat the above procedure until the specification is met. Replace the pipetter head cover as before.

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Figure 5.3-13 Pipettor Z abnormal detection adjustment

Adjustment of Pipetter Y Direction • •

Check the pipetter probe position relative to Tip pos.1 on buffer station, washing station, reagent disk, sample disk and vessel buffer. All positions should be at the center of the hole in each. In particular, if the Y-direction pos. of the pipetter probe is not sufficient on the buffer station when viewed from the side, adjust the pipetter probe Pos. at the center of Tip pos.1 and the vessel buffer by unfastening and fastening two (2) screws shown by the arrows in Figure 5.3-14.

Figure 5.3-14 Side View of Pipetter

5.3.4.2 LLD-SA Board/System Reagent Unit Adjust the LLD-SA only when the LLD-SA board or the system reagent unit is replaced. The LLD-P3 PCB must not be adjusted in any other circumstances.

Adjustment of Sipper LLD Voltage • • • •

Concerning the Sipper LLD Voltage Monitoring, see Chapter 6.1.8. Lift the sipper probe up to the upper home position. It is not important where you place the sipper head between the two horizontal ends as long as the tubing is not detached from the sipper probe. Adjust the variable capacitor TC2 on the LLD-SA PCB (Figure 5.3-15) with a plastic or ceramic tool so that the minimum voltage displayed is 3.50 V or lower. If the voltage is OK, touch the Monitoring Stop button in the Voltage Monitor screen.

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Figure 5.3-15 LLD-SA PCB

Insulation Resistance between the Aluminum Block and the Shield Plate • • • • •

Remove the system reagent unit. Disconnect the connector J662. Measure the insulation resistance between the aluminum block and the shield plate (outer cover of the system reagent unit) with a multimeter. If the resistance is normal, it goes up beyond the measurable limit of the multimeter. If it is low, it will indicate a value below 1,000 kΩ. If low, replace the nozzle or replace the system reagent unit.

Note: The resistance cannot be measured if connector J662 is connected. Also, damaged wiring and damaged FPC will cause an abnormality of the sipper LLD function.

5.3.4.3 Pressure Sensor / Tubing of Pipetter System / ANG-EP2 Board When the installation and pressure sensor or tubing in the pipetter system is replaced, please check the pressure sensor voltage. It is not necessary for the P-Sensor 2 Assy to be Adjusted the trimmer resistance on the ANG-EP2 PCB

Check of Pressure Sensor Voltage • • • • • • •

Touch the Pipetter Prime button in the Maintenance screen to start pipetter priming. See Chapter 6. Press the Stop key when the Pipetter System has filled with water. Concerning the Pressure Sensor Voltage Monitoring, See Chapter 6. Leave the instrument for 2 minutes or longer. Touch the pressure sensor button in the voltage monitor screen. Confirm the pressure sensor voltage to 1.8 ± 1.3 V . If the voltage is OK, touch the Monitoring Stop button in the Voltage Monitor screen.

1

Sensor and ANG-EP PCB

2

Adjustment / Check the voltage of the pressure sensor

P-Sensor 2 Assy ANG-EP2 PCB 1.8 ± 1.3 V After pipetter prime, leave for 2 min. or more. ( No adjustment available )

5.3.4.4 Troubleshooting of LLD function The LLD may be malfunctioning if it shows any of the following problems:

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1. It stops before it reaches the liquid surface. 2. It does not stop at the liquid surface, but goes deep in the liquid. 3. It starts descending from an incorrect position.

Pipetter Abnormality of the liquid level detection for the pipetter may be caused by one of the following problems. Use the following procedures for troubleshooting. •

•

The insulation resistance of the probe is low. ο Detach the two (2) wires from the probe. ο Measure the insulation resistance with a voltage multimeter or any similar device. ο If the resistance is normal, the resistance goes up beyond the measurable limit of the multimeter. ο If the resistance is low, it will be shown by a value below 1,000 kΩ. In this case replace the pipetter probe. The electrical conductivity of the water inside the pipetter tube is too high. ο Measure the output voltage of the LLD-P3 board twice as follows. a) With the tubing located inside of the pipetter head connected. b) With the tubing disconnected. ο

•

• • •

If there is a difference in the output voltage between the former and the latter, the conductivity of the water could be increased. ο With the tube connected, move the pipetter horizontally and check the voltage. If the output voltage varies depending on where the pipetter is located on the horizontal axis, the conductivity of the water could be increased. ο If high conductivity is detected, replace the water in the water supply tank by water with conductivity meeting the specification. Repeat the pipetter prime to clean the flow path. The spring of the pipetter nozzle holder is mispositioned. ο If the spring of the pipetter nozzle holder, which is installed in the upper cover of the pipetter case, is mispositioned, the inner pipe (detection electrode) and the outer pipe (shield) of the pipetter become mutually conductive. In such a case, the voltage output from the LLD-P3 board goes up by ca. 10 V. ο If the output voltage is normal when the cover is open, but it is not when the cover is closed, mispositioning of the spring may be the cause. In this case, return the spring to the normal position. The board is damaged due to liquid leakage. The liquid level is too low or there is no liquid in the container. Damaged wiring and damaged FPC will cause abnormal liquid level detection with the pipetter.

Sipper Abnormality of the liquid level detector for the sipper may be caused by one of the following problems. •

The insulation resistance of the system reagent unit is low.

See Chapter 5.3.4.2.

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5.3.5 Functional Details of FRONT SW (Operation Switch) 5.3.5.1 Function of the Front SW Table 5.3-1 Analyzer Status

1 2

Operation Stand By ∗

Function of the Switch SW ON/OFF is ignored. With SW OFF, status changes to sleep (+24 V off). With SW ON, status recovers from sleep and the system is reset.

If the switch is turned off during operation and kept off, the analyzer shifts to the sleep status as the operation is completed and the status changes to stand-by.

To switch off the analyzer Turn off the front switch. The Sleep window is displayed

Figure 5.3-16

NOTICE Do not touch Shutdown unless there is a particular reason to shutdown the analyzer. Otherwise all the analyzer functions and components will be shutdown. In case you have mistakenly touched the button, turn off the circuit breaker once, and then turn it on to revive the analyzer.

NOTICE It is highly recommended that you enable the screensaver. To enable, select Utility -> System and in the Screen Saver area, touch the On button and set the activation time by typing in a value within the range of 1-60. For details, refer to Utility menu, Screen Saver area.

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5.3.6 Details of Temperature Control / Troubleshooting of Temp. Units 5.3.6.1 Principle of temperature control • •

Temperature control is based on PI control. ANG CNT determines the control parameter for the peltier or heater by calculating every 100 ms as follows. It first calculates the difference (En) between the current temperature of the control point (Tn), which is the temperature n ∗100ms after temperature control started, and the target temperature (Ttrg).

(a) En = Tn - Ttrg •

It then sums up Ens to the Esumn .

(b) Esumn = En + Esum(n-1) •

Finally, it determines the control parameter (Vout).

(c) Vout = K1*(K2*En + K3*Esumn) (K1, K2 and K3 are coefficients) • •

The voltage of the incubator is limited from 0 V to 5 V, the voltages of other unit are limited within ±5 V. The temperature of the reagent disk and the detection unit is influenced by the ambient temperature around the units. So the target temperatures (Ttrg) for the two units are calculated according to the formula below. The Ttrg of the R.Disk refers to the temperature around the reagent disk, and the Ttrg of the detection unit refers to the temperature around the system reagent unit.

Ttrg = A*Tamb + B (A and B are control coefficients) Table 5.3-2 Coefficients of Temperature Control

Detection Unit Reagent Disk •

A

B

-0.02 -0.57

28.6 30.0

Tamb (Ambient Temp) System Reagent unit R.Disk

The fans of the peltier rotate when the voltages (Vout) are more than ca.+1.0 V or less than ca.1.0 V.

Note: You can see the temperatures of the control points (Tn), the ambient temperatures (Tamb), the target temperatures (Ttrg) and the control parameters (Vout) on the Temperature Monitor Screen.

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Figure 5.3-17 Temperature Monitor Screen

Note: The Peltier works as a heater when the control parameter is positive and as a cooler when the control parameter is negative.

Note: The control parameters (Vout) are multiplied by +1 at the EIO3 board and by -2.6 at the DO3 board. Voltages are limited within ± 12 V on the DO3 board.

Note: The control parameter for the detection unit turns over when it comes to ANGCNT.On the

Temperature Monitor Screen you can see the voltage which does not turn over. It turns over by the cable (P/N 741-4237) between the DO3 board and the detection unit

5.3.6.2 Troubleshooting •

If temperature below 4.6 degrees C is displayed

1. If temperature control is being normally operated, the temperature displayed in the screen should be 13 to 15 degree C at the lowest. 2. Therefore, if the screen displays a temperature below 4.6 degrees C, this may be due to the thermistor wire or the cable between the EECL300 board and the thermistor breaking. 3. What is displayed is identical to that which is displayed if the thermistor resistance were infinite. •

If temperature higher than 80.0 degrees C is displayed

1. If temperature control is normal, the thermostat breaks the input for peltier or heater at around 60 degrees C. 2. Therefore if the temperature is displayed higher than 80.0 degrees C, this may be due to the thermistor or the cable between the EECL300 board and the thermistor being shortcircuited. 3. This phenomenon is identical to that which takes place if the resistance of the thermistor were zero (0) ohm. •

If temperature does not meet the specification

1. Check whether covers the are closed or not. For example, temperature control of the R. Disk does not work well without the R. Disk cover. 2. Check that there was not a steep temperature gradient. The specification of the temperature gradient is ± 2 degrees C /h. Direct wind from air conditioners, etc., must be avoided. 3. Check the relation between the indication temperature and the ambient temperature of the thermistor. 1) Check the peltier or the heater if the two temperatures are nearly the same. 2) Check the thermistor if the two temperatures are significantly different.

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Because of the thermometer accuracy might be within ± 0.5 degrees C, only a rough comparison is possible. •

How to check the peltier and heater. 1. Check the resistance between the wires of the peltier or heater to detect any abnormalities in the element. 2. Measure the resistance at Table 5.3.6-2 shows the check pins of the peltier or heater. Table 5.3-3 Check pins of peltier or heater Eleme nt peltier peltier

Unit Detection R.Disk System Reagent Incubator •

peltier

Pins to measure J603 5pin-6pin J523 2pin-5pin J523 8pin-11pin J660 4pin-6pin

heater

J570 3pin-4pin

Resistance Ca. 2.7Ω Ca. 2.7Ω Ca. 2.7Ω Ca. 7.2Ω

How to check the thermistor

1. Check the resistance between the wirings of the thermistor to determine whether or not the thermistor is normal. 2. Thermistor errors are usually caused by moisture. 3. With the usual ambient humidity, the thermistor never absorbs moisture. However, if the thermistor gets wet as a result of condensation, the resistance of the thermistor goes down significantly. Therefore, there are no circumstances in which the thermistor only slightly defective, and so the error is quick to find. 4. Table 5.3-4 shows the check pins of the thermistor. 5. Table 5.3-5 Table 5.3.6-4 shows the outline of the resistances of thermistor. 6. Details are shown in the data sheet for the thermistor. Table 5.3-4 Check pins for thermistor Unit

Thermistor

Pins to measure

Detection

Control point

J603 4pin-12pin

R.Disk

Control point

J524 1pin-2pin

Ambient

J524 3pin-4pin

Control point

J661 1pin-2pin

Ambient

J661 3pin-4pin

Control point

J571 1pin-2pin

System Reagent

Incubator

Table 5.3-5 Pl Relation between thermistor resistance and temperature Temperature (degrees C)

10

15

20

25

30

35

40

45

50

Resistance (kΩ)

9.9 5

7.8 6

6.2 5

5.0 0

4.0 3

3.2 7

2.6 6

2.1 8

1.8 0

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5.3.7 Serial Data Communication 5.3.7.1 General Description Use a 26 bit parallel data, a shift register and convert for a serial data and transmit/receive it at a speed of 1250[Kbps].

5.3.7.2 Functional Description Block Diagram

Figure 5.3-18

Parallel - Serial Conversion Latch the parallel data, and with the shift register convert to parallel → serial.

Figure 5.3-19

Serial-Parallel Conversion With the shift register convert the serial data from serial → parallel, and latch the parallel data.

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Figure 5.3-20

5.3.8 Adjustment of Mixer Speed The mixer speed should be measured with a tachometer (Ident No. 1903152) or stroboscope during each maintenance and whenever the assay performance is insufficient. Refer to Chapter 2.6.1 for the complete mixer adjustment procedure. To check the mixer speed, use one of the following procedures: 1 ► 2 ►

Place a reagent pack in positions 1 to n. Start the Bead Mixer Check ( Mechanism Check ) and enter < n > repititions. Adujst the speed by the VR ( CW for encreasing the speed ) ► Confirm the following mixer speeds using an rpm meter : Table 5.3-6

In air 2050 rpm ± 100 rpm

In liquid 2000 rpm ± 100 rpm

The figure below shows the location of the resistor to be adjusted on the EIO3 PCB (see also Chapter 5.4.4).

Figure 5.3-21

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5.4 Printed Circuit Boards 5.4.1 ECPU550 Board 5.4.1.1 General Description • • •

ECPU550 PCB has SH4 as main CPU and does the central processing of the instrument. RS-232C controller (8 channels) also are mounted on the board. (As for e411, RS-232C controller uses 4 channels at maximum.) Main memories are 64MByte-DRAM, and 128KByte-SRAM which are backed up with a battery (Electric double layer capacitor) for memorizing the instrument’s parameters.

Block Diagram

Figure 5.4-1

Note: This block Diagram is Disk System Note: Note for EIO3 PCB ∗ ∗

Disk System : EIO3 + DIST232C PCB Rack System : EIO3 + RSCONTD PCB

5.4.1.2 Location

Figure 5.4-2 Location in the PCB Rack

5.4.1.3 Functional Description RS-232C Controller This controller communicates with the following units via UIRS-C PCB. • •

Host Computer to receive the Test Order and send back the Measured Results. Barcode Reader to Read Rack Pack information and Sample ID.

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Battery •

The specifications of the battery (Electric double layer capacitor)are as follows. Table 5.4-1 No.

1 2 3

•

Description

Specification

Data holding time during Power off Recharging time from empty status Life time

7 days (with full charge) 24 hours 7 years

Power Supply of SRAM on the board is provided by a re-chargeable battery during Main Switch off.

LED Description Table 5.4-2 Silk-print display

Name

Color

Meaning

RUN

RUN

Green

FAIL

FAIL

Red

DMA

DMA

Green

INT

INT

Green

MBS

MBSY

Green

MER

MERR

Red

DIG

DIAG

Red

During Reset

After Reset is released

Lights-on : Reset is released. Also, Double Bus Error is not generated. Lights-out : During Reset, or, Double Bus Error was generated. Lights-on : Due to Double Bus Error, MPU stopped. Or, Watchdog Timeup was generatead. Lights-out : Double Bus Error is not generated. And Watchdog Timeup is not genrated.

Lights-out

Lights-on/Lights-out

Lights-out

Lights-on : DMA is being transffered. Lights-out : DMA is not being transffered. Lights-on : The order is changeable depending on the priority. Lights-out : The order is not changeable depending on the priority. Lights-on : Memory is accessed. Lights-out : Memory is not accessed. Lights-on : 2 bit ECC Error was generated. Lights-out : 2 bit ECC Error is not generated.

Lights-out

Light is out until the new phenomenon (Due to Double Bus Eror, CPU stopped. Or, Watchdog Timeup was generated.) occurs. Lights-on/Lights-out

Lights-out

Lights-on/Lights-out

Lights-out

Lights-on/Lights-out

Lights-out

Lights-on (For approx. one Second) : Self-diagnosing. Lights-on (Every 0.5 second) : Self-diagnose error was generated. Consecutive lights-on : Boot error was genrated. Lights-out : Not self-diagnosing. And Self-diagnose error is not generated. And Boot error is not generated. ∗ For the error code, LED registor D31

Lights-out

Light is out until the new Phenomenon (2 bit ECC Erros was generated in Main Memory) occurs. Lights-on/Lights-out

Remarks

Dip Switch Setting (SW3: see next page)

Figure 5.4-3 Version 1.0 – May 2006

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5.4.1.4 Parts Mounting Diagram The parts mounting diagram for the ECPU550 board is shown below.

Figure 5.4-4

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5.4.2 EECL300 Board 5.4.2.1 General Description This circuit board consists of the following functions. • •

Analog Data Controller(H8 ADCCNT) LLD Controller(H8 LLDCNT)

Block Diagram

Figure 5.4-5

5.4.2.2 Location

Figure 5.4-6 Location in the PCB Rack

5.4.2.3 Functional Description Analog Controller (ANGCNT) Potentiostat •

The ANGCNT sends the potentiostat voltage twice as high as the order according to the timing chart for potentiostat which comes from the CPU.

Data Collection • •

The luminescence data are converted to logarithmic values in the L-AMP(3) circuit board, then ANGCNTcarries out analog-to-digital conversion and transmits the data to the CPU. GMCNT converts the current running through the cell and voltage between CE and WE from analog to digital and transmits the data to the CPU.

Temperature Control •

The ANGCNT determines the output voltage to the Peltier and the heater according to the temperature measured by the thermistor thermometers, and it controls ON/OFF of the fans.

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LLD Controller (LLDCNT) Liquid Level Detection •

LLDCNT determines the liquid level according to the signal from LLD-P3 or LLD-SA circuit board, sends the interruption signal to GPCNT on the EMOT300 circuit board and stops the motor.

Clot Detection •

LLDCNT takes in the pressure sensor signal from ANG-EP circuit board and transmits the data to CPU. CPU decides whether or not a clot is detected.

•

LED Description Table 5.4-3 LED No. RUN

Supplied Voltage 5V

INT

5V

CRT

5V

ADC

5V

Version 1.0 – May 2006

Purpose

Remark

CPU running monitor is lit when CPU is running, other than in HALT status. MPU interruption DC bus busy

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5.4.2.4 Parts Mounting Diagram The parts mounting diagram for the EECL300 board is shown below.

Figure 5.4-7

5.4.3 EMOT300 Board 5.4.3.1 General Description This circuit board consists of the following controllers and memory. • •

GPCNT Motor Controller x ten (10) GMCNT DI/DO controller x one (1)

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Block Diagram

Figure 5.4-8

5.4.3.2 Location

Figure 5.4-9 Location in the PCB Rack

5.4.3.3 Functional Description Motor Control • •

GPCNT generates pulse signal, and sends it to DO1 or DO2 circuit board when it receives the order of drive pattern of motor and pulses from the CPU. GPCNT stops a motor when it finishes the pulses ordered from the CPU or it receives the signal from photo interrupter or the signal of LLD.

DI/DO control DI function • •

The status information from EIO3 circuit board about the power supply watching, fuse detection, tip detection, R. Disk cover detection, water level watching in the distilled water tank, etc. are written on GMCNT. CPU scans DI at regular intervals, and gets these statuses.

DO function • •

CPU writes the status of switching of micro step and static current drive and ON/OFF of SV, beads mixer, HV, potentiostat and +24V on GMCNT. Each driver on EIO3 circuit board or other boards drives them.

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Dip Switch Setting

Figure 5.4-10

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5.4.3.4 Parts Mounting Diagram The parts mounting diagram for the EMOT300 board is shown below.

Figure 5.4-11

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5.4.4 EIO3 Board 5.4.4.1 General Description This circuit board has many functions like wave shaping of sensor signal, driving SV, switching ON/OFF for HV, detection of fuse blowing on DO circuit board and other boards, signal buffer, driving a motor for beads mixing, power supply for circuit boards and modules, watching the power supply and generating the signal for system reset.

Block Diagram

Figure 5.4-12

5.4.4.2 Location

Figure 5.4-13 Location in the PCB Rack

5.4.4.3 Functional Description 1. Wave shaping and power supply for the sensors • •

EIO3 shapes the wave from photointerrupter into TTL level and transmits it to EMOT300 Board. The main chips for this function are MDIR1 - 6.

2. Driving SV etc. • •

EIO3 drives SV1 - 8, ON/OFF of the pump and the solenoid for gripping mechanism of T/V carrier. The main chip is for this function is MP4501 (transistor array).

3. Switching ON/OFF for HV etc. • •

EIO3 switches ON/OFF HV, potentiostat, +24V power supply and power supply for DO3 board. EIO3 stores the ON/OFF status of GMCNT on the EMOT300 board in the buffer memory and switches each function.

4. Detection of fuse burning out and abnormal temperature on the DO3 board • •

A circuit on the EIO3 board detects that a fuse that is mounted on DO1, DO2, DO3 or EIO3 board is burned out, and it informs GMCNT on EMOT300 board of the issue. A circuit on the EIO3 board also detects an abnormal temperature of a fan on DO3 board, and it informs GMCNT on EMOT300 board of the issue.

5. Buffer for signals A circuit on the EIO3 board stores the output signal of peltier and fan from EECL board into the buffer memory ,and it transmits them to DO3 board. 6. Driving a motor for beads mixing Version 1.0 – May 2006

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A circuit on the EIO3 board supplies the power to a DC motor for beads mixing. 7. Power supply for the following printed circuit boards and electronic modules. • • • •

±12V for LLD - P3 board via DIST - PA board ±12V for LLD - SA board ±15V for ANG – EP2 board ±12V for L - AMP (3) board via ANG – EP2 board

8. Watching the power supply A circuit on the EIO3 board compares the supplied voltage (V) with the reference voltage (Vref) ,and it puts LOW level signal out to the EMOT300 board if the supplied voltage (V) is lower than the reference voltage (Vref). 9. Generating the signal for SYSTEM RESET • •

A circuit on the EIO3 board generates the VACFAIL signal according to the ACFAIL signal from DC power supply and 5V power watch IC (IC17 : MAX791), and it transmits SYSRESET signal to the ECPU board. Following switching on of the instrument, the main CPU is informed by VACFAIL signal,and the main CPU is reset by SYSRESET signal. When the instrument is switched off, VACFAIL signal cuts in on main CPU just before DC power supply is off.

Fuses/LEDs Description Table 5.4-4 Fuse No. F1

F2

Rated Current 5.0 A

Ditto

Rated voltage 48 V

ditto

Supplied voltage

LED No. LED1

5V

LED2

5 V(1)

LED3

12 V(1)

LED4

5 V(2) 24 V(1) 24 V(2) 5 V(3) +15 V(1) -15 V(1)

F3 F4

Ditto Ditto

ditto ditto

F5

Ditto

ditto

LED5 LED6 LED7 LED8

F6

Ditto

ditto

LED9

Purpose Power supply for the wave shaping circuit Power supply for photocoupler on SV driving circuit For driving HV, potentiostat, beads mixer, +24V ON/OFF For controlling HV, potentiostat, beads mixer, +24V ON/OFF For driving SV5 - SV8 For driving SV1 - SV4 and pump For controlling SV1 - SV8 and pump Power supply for LLD-P3, LLD-SA and L-AMP(3) Power supply for ANG-EP2 and EECL300

Dip Switch Setting Table 5.4-5 JP number JP1

Jumper Pin Arrangement

Figure 5.4-14 2-3pin Jumper JP2

Figure 5.4-15 1-8, 2-7, 4-5pin Jumper JP3

Figure 5.4-16 2-7, 4-5pin Jumper

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Service Manual Jumper Pin Arrangement

Figure 5.4-17 1-8, 2-7pin Jumper

5.4.4.4 Parts Mounting Diagram The parts mounting diagram for the EIO3 board is shown below.

Figure 5.4-18

5.4.5 DO1 Board 5.4.5.1 General Description The DO1 board has fourteen (14) constant current motor drivers and two (2) constant voltage motor drivers for the stepping motor and supply current to each motor.

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Block Diagram

Figure 5.4-19

5.4.5.2 Location

Figure 5.4-20 Location in the PCB Rack

5.4.5.3 Functional Description The motor driving signals from GPCNT on the EMOT300 board are converted to motor driving current on the DO1 board for the following stepping motors. Table 5.4-6 No . 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

Motor No. SM011 SM031 SM032 SM041 SM042 SM141 SM051 SM052 SM081 SM061 SM063 SM062 SM091 -

Drive method

Function

Constant Current 1-2 phase Constant Current 1-2 phase Constant Current 2 phase Constant Current 1-2 phase Constant Current 1-2 phase Constant Current 1-2 phase Constant Current 1-2 phase Constant Current 1-2 phase Constant Current 1-2 phase Constant Current 1-2 phase Constant Current 1-2 phase Constant Current 1-2 phase Constant Voltage 1-2 phase -

Version 1.0 – May 2006

S.DISK rotation Cap Open / Close (Forward / Back) Cap Open / Close (Open / Close) Beads Mixer (Arm Rotate) Beads Mixer (Up/Down) Solid Waste Pipetter Pipetter Sipper Gripper Gripper Gripper Pipetter Syringe -

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Fuses/LEDs Description Table 5.4-7

F1

Rated current 3.2 A

Rated voltage 48 V

F2

Ditto

F3

Fuse No.

LED No.

Supplied voltage

LED1 LED2

5 V(1) 24 V(1)

Ditto

LED3

24 V(2)

Ditto

Ditto

LED4

24 V(3)

F4 F5 F6 F7

Ditto Ditto Ditto Ditto

Ditto Ditto Ditto Ditto

LED5 LED6 LED7 LED8

24 V(4) 24 V(5) 24 V(6) 24 V(7)

F8

Ditto

Ditto

LED9

24 V(8)

Purpose DC power after photo coupler (PCP) Driving power for S.Disk, and Cap Open/Close (Forward/Backward) Driving power for Cap Open/Close (Open/Close) and Beads Mixer Rotation. Driving power for Cap Open/Close (Up/Down), S.WASTE Driving power for Pipetter X axis / Z axis Driving power for Sipper X axis, and Gripper X axis Driving power for Gripper Z axis / Y axis Spare × 2 Pipetter Syringe & Spare

5.4.5.4 Parts Mounting Diagram The parts mounting diagram for the DO1 board is shown below.

Figure 5.4-21

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5.4.6 DO2 Board 5.4.6.1 General Description The board has five (5) micro step driver circuits for the stepping motor and supplies current to the following motors.

Block Diagram

Figure 5.4-22

5.4.6.2 Location See Chapter 5.1.2.

5.4.6.3 Functional Description •

The motor driving signals from GMCNT on the EMOT300 board are converted to motor driving current on the DO2 board. Micro step driving (2W1-2 phase or W1-2 phase) and constant current drive will be switched by control signal from GMCNT on EMOT300 the board.

•

Table 5.4-8 No. 1 2 3 4 5

Motor SM021 SM151 SM082 SM111 SM101

Drive method W1-2/2 2W1-2/1-2 2W1-2/1-2 2W1-2/1-2 2W1-2/1-2

Function R.DISK Rotation Barcode Reader Rotation Sipper Up/Down Magnet Drive Sipper Syringe

Fuses/LEDs Description Table 5.4-9

F1

Rated current 3.2 A

Rated voltage 48 V

F2 F3

Ditto Ditto

Ditto Ditto

Fuse No.

Version 1.0 – May 2006

LED No. LED1 LED2 LED3 LED4

Voltage 5 V1 24 V1 24 V2 24 V3

Purpose DC power for after photo coupler R.Disk rotation ,BCR rotation Sipper Up/Down, Magnet Drive Syringe (Sipper) Drive

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5.4.6.4 Parts Mounting Diagram The parts mounting diagram for the DO2 board is shown below.

Figure 5.4-23

5.4.7 DO3 Board 5.4.7.1 General Description The DO3 board is a current driver for the peltier and heater.

Block Diagram

Figure 5.4-24

5.4.7.2 Location See Chapter 5.1.2

5.4.7.3 Functional Description • •

Control parameter (value is indicated on PC) from ANGCNT on EECL Board is amplified 2.6 times by EIO3 board & this PCB, and converted to current by the driver circuit for peltier or heater. Also, the fan motor for the peltier is driven by this board with ANGCNT signal.

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Fuses/LEDs Description Table 5.4-10

F1

Rated current 5.0 V

Rated voltage 48 V

F2 F3 F4 F5 F6 F7 F8 F9 F10 F11

Ditto Ditto Ditto Ditto Ditto Ditto Ditto Ditto Ditto Ditto

Ditto Ditto Ditto Ditto Ditto Ditto Ditto Ditto Ditto Ditto

Fuse No.

LED No.

Voltage

LED1 LED2 LED3 LED4 LED5 LED6 LED7 LED8 LED9 LED10 LED11 LED12

5 V1 12 V +15 V1 +15 V2 +15 V3 +15 V4 +15 V5 -15 V1 -15 V2 -15 V3 -15 V4 -15 V5

Purpose DC power for photocoupler Fan motor Peltier for R. disk Ditto Peltier for measuring unit Peltier for system reagent unit Heater for incubator Peltier for R. disk Ditto Peltier for measuring unit Peltier for system reagent unit Heater for incubator

5.4.7.4 Parts Mounting Diagram The parts mounting diagram for the DO3 board is shown below.

Figure 5.4-25

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5.4.8 DIST-PA Board 5.4.8.1 General Description •

This board distributes DO1 output signal to the pipetter assembly and connects detector signal including LLD signal from the pipetter assembly to the EIO3 board.

Block Diagram

Figure 5.4-26

5.4.8.2 Location See Chapter 5.1.2

5.4.8.3 Parts Mounting Diagram The parts mounting diagram for the DIST-PA board is shown below.

Figure 5.4-27

5.4.8.4 Check Procedure Pipetter Z Abnormal Detection Check the voltage between Pin# A3( Z-ABN) of J552 and TP2(A.G) with a voltage multimeter.

Pipetter LLD Check the voltage between TP1(LLD Sig.) and TP2(A.G) with a voltage multimeter.

Supplied Voltage + 5 V on Board Check the voltage between TP3(5V) and TP2(A.G) with a voltage multimeter.

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5.4.9 DIST-SA Board 5.4.9.1 General Description This board distributes DO1 & DO2 output signal to the sipper assembly and connects detector signal from the sipper assembly to the EIO3 board.

Block Diagram

Figure 5.4-28

5.4.9.2 Location See Chapter 5.1.2

5.4.9.3 Parts Mounting Diagram The parts mounting diagram for the DIST-SA board is shown below.

Figure 5.4-29

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5.4.10 DIST-TVA Board 5.4.10.1 General Description This board distributes DO1 output signal to following devices, gathers detection signal from the following devices and connects to the EIO3 board.

Block Diagram

Figure 5.4-30

5.4.10.2 Location See Chapter 5.1.2.

5.4.10.3 Parts Mounting Diagram The parts mounting diagram for the DIST-TVA board is shown below.

Figure 5.4-31

5.4.11 DIST-F Board 5.4.11.1 General Description This board distributes DC power from DC power supply to MVLB and protects it from the DC power line.

Block Diagram

Figure 5.4-32 Version 1.0 – May 2006

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5.4.11.2 Location See Chapter 5.1.2.

5.4.11.3 Functional Description Fuses/LEDs Description Table 5.4-11 Fuse No. F1 F2 F3 F4 F5 -

Rated current 3.2 A 5.0 A 5.0 A 5.0 A 3.2 A -

Rated voltage 48 V ditto ditto ditto ditto -

LED No. LED1 LED2 LED3 LED4 LED5 LED6 LED7

Corresponding power +5 V(1) +5 V(2) +5 V(3) +5 V(4) +5 V(5) +12 V +24 V

Purpose For ECPU board For EECL board For EMOT300 board For EIO3 board For DO1 board +12 V for MVLB board +24 V for MVLB board

5.4.11.4 Parts Mounting Diagram The parts mounting diagram for the DIST-F board is shown below.

Figure 5.4-33

Note: Fuse F4 should be mounted with a rated current of 5.0 A.

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5.4.11.5 Check Procedure Check the supplied voltage with a voltage multimeter as follows. Table 5.4-12 Fuse No. F1 F2 F3 F4 F5 -

LED No. LED1 LED2 LED3 LED4 LED5 LED6

Corresponding power +5 V(1) +5 V(2) +5 V(3) +5 V(4) +5 V(5) +12 V

-

LED7

+24 V

Check point Voltage between TP1 and TP4.

Voltage between TP2 and TP5. Voltage between TP3 and TP6.

Voltage ca. 5 V

ca. 12 V ca. 24 V

5.4.12 DIST-F3 Board 5.4.12.1 Overview

Figure 5.4-34

5.4.12.2 Location See Chapter 5.1.2.

5.4.12.3 Block Diagram

Figure 5.4-35

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Fuse Description Table 5.4-13 Fuse No. F1 F2 F3 F4

Rated current 0.5 A 1.0 A 5.0A 5.0A

Rated voltage 48 V ditto ditto ditto

Supplied voltage 5V ditto ditto ditto

Purpose +5 VDC Fuse for EIO3 board power down monitor +5 VDC Fuse for DIST232C or RSCONTD board +12VDC Fuse for DC FAN unit (DC Power supply 1) +12VDC Fuse for PC unit (DC Power supply 2)

5.4.13 DIST232C Board 5.4.13.1 General Description Make ECPU550 TTL Signal RS232C voltage.

Block Diagram

Figure 5.4-36

5.4.13.2 Location See Chapter 5.1.2.

5.4.13.3 Functional Description Controlling circuit board for the 2D BCR, BCR, and the HOST.

5.4.13.4 Parts Mounting Diagram The parts mounting diagram for the DIST232C board is shown below.

Figure 5.4-37

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5.4.14 ANG-EP2 Board 5.4.14.1 General Description This printed circuit PCB acts as a potentiostat for the measuring cell, amplifier of pressure sensor, ON/OFF of PMT high voltage and power supply for L-AMP(3) PCB.

5.4.14.2 Functional Description Potentiostat • •

This circuit has the function of applying constant voltage between RE-WE of the measuring cell by regulating the current. The voltage is switched by the software. With relay the voltage will be cut off when the software is not activated. Also, there is a function for sending voltage between CE and WE and current for the measuring cell to the EECL board.

Block Diagram

Figure 5.4-38 Vref : order voltage of potentiostat voltage × (-2) Vol : voltage between CE and WE Cur : current for Cell +12(3) : DC driving power for relay

Amplifier of Pressure Sensor • •

The pressure sensor signal is picked up by half of the bridge circuit in the pressure sensor and half of the bridge circuit on this board, and this signal is amplified and sent to EECL PCB. For the adjustment procedure for the bridge circuit see the ANG-EP PCB adjustment procedure.

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Block Diagram

Figure 5.4-39

ON/OFF function of PMT-High Voltage DC power for PMT-SHV PCB and drive signal for relay of PMT High Voltage ON / OFF. Block Diagram

Figure 5.4-40 +12 V(1) : HV input voltage +12 V(2) : DC driving power for PMT-SHV PCB.

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DC Power Supply for L-AMP(3) PCB ±15V from EIO3 PCB is filtered on this PCB and connected to L-AMP(1) PCB. Block Diagram

Figure 5.4-41 Fuses/LEDs Description Table 5.4-14

F1

Rated current 0.5 A

Rated voltage 48 V

F2 F3

0.5 A 1.0 A

ditto ditto

Fuse No.

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Corresponding power

LED No. LED4 LED5 LED3 LED1

15 V -15 V 12 V 15 V

LED2

-15 V

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Purpose LOG-AMP board LOG-AMP board PMT-SHV board +15V in PCB for potentiostat circuit -15V in PCB for potentiostat circuit

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5.4.14.3 Parts Mounting Diagram The parts mounting diagram for the ANG-EP2 board is shown below.

Figure 5.4-42

5.4.15 PMT-SHV2 Board 5.4.15.1 General Description This PCB converts DC+12V to DC-1000V and applies the voltage to PMT.

Block Diagram

Figure 5.4-43 +12 V(1): input voltage for HV +12 V(2): driving power for PMT-SHV PCB

5.4.15.2 Functional Description • • •

When High Voltage ON command is issued by software, the relay will be switched on and DC+12V will be applied to DDC (DC-DC converter). DDC will convert to High Voltage around DC-1000V and it will be applied to the PMT. GAIN Adjuster consists of voltage generator (DC+10V), three (3) variable resistors VR1,VR2,VR3 and three (3) jumper sockets J1, J2, J3 that are changeable.

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LED Description Table 5.4-15 LED No. LED1

Supplied Voltage +12 V

Purpose

Remarks

Confirmation of HV ON/OFF

5.4.15.3 Parts Mounting Diagram The parts mounting diagram for the PMT-SHV2 board is shown below.

Figure 5.4-44

5.4.15.4 Adjustment of PMT-SHV2 Board • •

Refer to Chapter 2.3.8 concerning calculation of control voltage. Control Voltage (CV) between TP2 (VCON-IN) and TP1(GND) is to be adjusted instead of the high voltage by turning the necessary variable resistor and setting a jumper socket according to the calculated Control Voltage (CV) relative to the high voltage as shown in the following table. Table 5.4-16

1 2 3

High Voltage Output 1100 (V) to 940 (V) 1020 (V) to 810 (V) 850 (V) to 660 (V)

JP1 Setting / Variable Resistor JP1 / VR1 JP2 / VR2 JP3 / VR3

Control Voltage (CV) 6.45 (V) to 5.13 (V) 5.57 (V) to 4.43 (V) 4.66 (V) to 3.29 (V)

5.4.16 L-AMP(3) Board 5.4.16.1 General Description Luminescence from the cell is converted to current signal by the PMT. Then, the current signal is converted by the logarithmic function on this board and is sent to the EECL300 board.

Block Diagram See the figure below.

5.4.16.2 Location See Chapter 5.1.2.

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5.4.16.3 Functional Description The output voltage of the L-AMP (3) board is calculated as follows.

Figure 5.4-45

5.4.16.4 Parts Mounting Diagram The parts mounting diagram for the L-AMP(3) board is shown below.

Figure 5.4-46

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CAUTION Be careful not to touch the variable resistors on the board.

•

L-AMP(3) board is preadjusted in production. Any changes made in the field by the service engineer will have a significant effect on measured data. The warranty is no longer valid in this case

5.4.17 LLD-SA Board 5.4.17.1 General Description This board has the function of detecting and amplifying the liquid surface signal from the sipper and sending it to the EECL300 board.

Block Diagram

Figure 5.4-47

5.4.17.2 Location See Chapter 5.1.2.

5.4.17.3 Functional Description • •

Variation of static capacity between sipper and system reagent unit is converted to unbalance the signal of the bridge circuit, then amplified and sent to the EECL300 board. Refer to Chapter 5.3.2 Principle of Liquid Level Detection for details.

5.4.17.4 Parts Mounting Diagram The parts mounting diagram for the LLD-SA board is shown below.

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Figure 5.4-48

5.4.17.5 Check Procedure Sipper LLD Voltage Output (refer to Chapter 5.3.4.2)

5.4.18 LLD-P3 Board 5.4.18.1 General Description This PCB has the function of detecting and amplifying the liquid surface signal from the pipetter and sending it to the EECL300 board.

Block Diagram

Figure 5.4-49

5.4.18.2 Location See Chapter 5.1.2.

5.4.18.3 Functional Description • •

Variation of pipetter’s static capacity is converted to unbalance the signal of the bridge circuit, then amplified and sent to the EECL300 PCB via DIST-PA PCB. Refer to Chapter 5.3.2 Principle of Liquid Level Detection.

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5.4.18.4 Parts Mounting Diagram The parts mounting diagram for the LLD-P3 board is shown below.

Figure 5.4-50

5.4.18.5 Check Procedure Pipetter LLD Voltage Output (refer to Chapter 5.3.4.1)

5.4.19 UIRS-C Board 5.4.19.1 General Description This is a connection board between ECPU550, EECL300 board, and it also connects RS232 communication for BCR and host.

Block Diagram

Figure 5.4-51 Version 1.0 – May 2006

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Note: This block Diagram is Disk System Note: Note for EIO3 PCB ∗ ∗

Disk System : EIO3 + DIST232C PCB Rack System : EIO3 + RSCONTD PCB

5.4.19.2 Location See Chapter 5.1.2.

5.4.19.3 Parts Mounting Diagram The parts mounting diagram for the UIRS-C board is shown below.

Figure 5.4-52

5.4.20 MVLB110 Board 5.4.20.1 General Description This is the mother board for the following PCBs.

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Block Diagram

Figure 5.4-53

5.4.20.2 Location This board is located under the PCB rack.

5.4.20.3 Parts Mounting Diagram The parts mounting diagram for the MVLB110 board is shown below.

Figure 5.4-54

5.4.21 S.AB-CE Board 5.4.21.1 General Description This is a surge absorber circuit board.

Block Diagram

Figure 5.4-55

5.4.21.2 Location See Chapter 5.1.2.

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5.4.21.3 Parts Mounting Diagram The parts mounting diagram of the S.AB-CE board is shown below.

Figure 5.4-56

5.4.22 DET-A Board 5.4.22.1 Overview

Figure 5.4-57

Block Diagram

Figure 5.4-58

5.4.22.2 Location See Chapter 5.1.2.

5.4.22.3 PCP Description See Chapter 5.6 for details.

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5.4.23 DET-B Board 5.4.23.1 Overview

Figure 5.4-59

Block Diagram

Figure 5.4-60

5.4.23.2 Location See Chapter 5.1.2.

5.4.23.3 PCP Description See Chapter 5.6 for details.

5.4.24 DET-C Board 5.4.24.1 Overview

Figure 5.4-61

5.4.24.2 Location See Chapter 5.1.2.

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5.4.24.3 PCP Description See Chapter 5.6 for details.

5.4.25 DETECT1 Board 5.4.25.1 Overview

Figure 5.4-62

5.4.25.2 Location See Chapter 5.1.2.

5.4.25.3 PCP Description See Chapter 5.6 for details.

5.4.26 RS CONTD Doard 5.4.26.1 General Description Five (5) motor controllers GPCNT, a DI/DO buffer controller and serial transmit/receive signal controller are located on this board.

Block Diagram

Figure 5.4-63

5.4.26.2 Location See Chapter 5.1.2.

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5.4.26.3 Function Description Motor Controller When a drive pattern of the motor and the command for the number of pulses are received from the CPU, the GPCNT will output a magnetization signal and a pulse and transmits to the PS CONTA board. The GPCNT sends the number of pulses that were ordered or stops the motor if it receives a photo-interrupter signal.

DI/DO Buffer Controller 1. DI Status information such as power supply surveillance, fuse detection, rack detection, cup detection and tray full detection are received from the PS CONTA board.By READING each DI address, the CPU knows the status of the above-mentioned items. 2. DO The CPU will WRITE the ON/OFF condition of the +24 V power supply, the tray exchange indicator, the cup detection timing, etc., into each address. This is then WRITTEN into each latch within the RS CONTD board and transmitted to the PS CONTA board. 3. Serial Transmit/Receive Signal Controller Executes the transmit/receive signal between the device itself and the rack unit with 16bit serial data. Executes the parallel serial data exchange and the serial parity data exchange such as motor control signal and DI/DO signal. Location of DIP SW

Figure 5.4-64 DIP SW Description (DSW1)

Figure 5.4-65 Table 5.4-17

DSW 1

bit 1 ON ON OFF OFF OFF OFF others

bit 2 OFF OFF ON ON ON ON

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bit 3 OFF OFF ON ON OFF OFF

bit 4 ON OFF ON OFF ON OFF

RS CONTD Board address $D06000 to $D06FFF $D07000 to $D07FFF $D08000 to $D08FFF (Initialize) $D09000 to $D09FFF $D0A000 to $D0AFFF $D0B000 to $D0BFFF not used

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5.4.26.4 Parts Mounting Diagram The parts mounting diagram for the RS CONTD board is shown below.

Figure 5.4-66

5.4.27 PS CONTA Board 5.4.27.1 General Description Loaded on this board are a serial transmit/receive signal controller and a serial communication command circuit with the RS CONTD board.

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Block Diagram

Figure 5.4-67

5.4.27.2 Location See Chapter 5.1.2.

5.4.27.3 Functional Description Serial Transmit/Receive Signal Controller Executes the transmit/receive signal between the device itself and the rack unit with 16bit serial data.Executes the parallel → serial data exchange and the serial → parity data exchange such as motor control signal and DI/DO signal.

Serial Communication Command Circuit Commands the CLK signal of the serial communication; if a malfunction occurs within the communication, an ERR occurs in the RS CONTD board.

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5.4.27.4 Parts Mounting Diagram The parts mounting diagram for the PS CONTA board is shown below.

Figure 5.4-68

5.4.28 DO4A Board 5.4.28.1 General Description This board loads the constant-current drive motor driver of the stepping motor, then supplies the current to the motor. It also performs the waveform shape of the sensor, the ON/OFF fuse disconnect detection of the DC+24V power supply and the voltage command.

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Block Diagram

Figure 5.4-69

5.4.28.2 Location See Chapter 5.1.2.

5.4.28.3 Functional Description Stepping Motor Drive Using the drive waveform from the GPCNT of the RS CONTD board, supplies the current that drives the motors. Table 5.4-18 CH-No. 1 2 3

Drive method Constant Current 1-2 phase Constant Current 1-2 phase Constant Current 1-2 phase

Function (Sampler)

Motor SM200

A-Line

SM220

C-Line

SM210

B-Line

Sensor Waveform Shape Signal waveform (e.g. from photo-interrupters) is shaped in the TTL level and sent to the RS CONTD board. The main element is MDI-R1 to 3.

DC+24V Power Supply ON/OFF Buffers the ON & OFF signal from the RS CONTD board and turns the DC+24V power supply ON & OFF. The main element is MP4501 (transistor array)

Fuse Disconnect Detection and Voltage Command Detects disconnected fuses within the DO4A board and sends a detection signal to the RS CONTD board. Also, if the DC+24V voltage within the DO4A board is low, it sends a detection signal of the low voltage condition to the RS CONTD board.

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Fuse/LED Description Table 5.4-19

F1

3.2 A

48 V

LED No. LED6

F2

ditto

ditto

LED1

24 V1

F3

ditto

ditto

LED2

24 V2

LED7

5 V1

Fuse No.

Rated current

Rated voltage

Supplied voltage 5V

Purpose Logic drive use power supply within the board Power supply for the stepping motor drive (1) Power supply for the stepping motor drive (2) Power supply for the latter part of the photo-coupler

Remarks

CH-1,2 CH-3

DIP SW Description Table 5.4-20 JP number JP1

Jumper Pin Arrangement

Figure 5.4-70 1-5, 4-8pin Jumper JP2

Figure 5.4-71 1-5, 2-6pin Jumper

5.4.28.4 Parts Mounting Diagram The parts mounting diagram for the DO4A board is shown below.

Figure 5.4-72

5.4.29 BCR Board 5.4.29.1 General Description This is the BCR board which connects the RS232C signal between the UIRS-C board and the BCR for Rack System. Version 1.0 – May 2006

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Block Diagram

Figure 5.4-73

Note: This block Diagram is Rack System 5.4.29.2 Location See Chapter 5.1.2.

5.4.29.3 Parts Mounting Diagram The parts mounting diagram for the BCR board is shown below.

Figure 5.4-74

5.4.30 PH-D Board 5.4.31 PH-T Board Location See Chapter 5.1.2.

Parts Mounting Diagrams The parts mounting diagrams for the PH-D and PH-T boards are shown below.

Figure 5.4-75

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5.5 Cross Wiring Diagrams See

pdf\SM5_5_Wire_Analyzer1_1.pdf for more details

See

pdf\SM5_5_Wire_Analyzer1_2.pdf for more details

5.5.1 Cross Wiring Diagrams for Rack Sampler System See

pdf\5.5_RackSamplerSystem.pdf for more details

5.5.2 Cross Wiring Diagrams for Rack Sampler See

pdf\5.5_RackSampler.pdf for more details

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5.6 How to Check Photo Interrupters 5.6.1 Photo Interrupters The following Photo Interrupters (hereafter referred to as PCPs or PCP) are mounted in e411. See sketch in Figure 5.6-1. Table 5.6-1 No . 1. 2. 3. 4. 5. 6. 7.

PCP Name

Appearance

Position in e411

GP1A34LC OJ-HT04 OJ-HT02 TLP830

PCP with a connector Smallish PCP with a circuit board Largish PCP with a circuit board Small PCP

TWIN-DETECT PLI-523 PM2-LF10HH (for R/S) PH-D and PH-T boards (for R/S)

PCP attached to a plastic base

All the other positions described in the rows below Home position for syringes Solid waste container present/absent detection On FPC for pipetter/gripper home (HP), end (EP) and rest(RP) position for gripper Y movement On buffer station for tip present/absent detection

Reflection PCP

Rack tray and rack detection for A line, B line, C line

Through PCP

Sampling position for B line unit

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Figure 5.6-1

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5.6.2 How to check the PCPs Voltage and current at the PCP terminals are to be checked according to the following instructions. Table 5.6-2 N o . 1 .

2 .

PCP Name GP1A34 LC

OJHT04

How to check the voltage and the current •

Check the voltage at Pin#3(Sig.) against Pin#2(GND).

•

Your voltage multimeter should show the right voltage

•

Check the voltage at Pin#1(Sig.) against Pin#3(R.GND).

•

Your voltage multimeter should show the right voltage if the PCP is functioning properly.

Light path

Voltage

Close: Reflection is interrupted Open: Reflection is uninterrupted

ca. 5 V ca. 0 V

Close: Light path is interrupted Open: Light shines across the gap

ca. 0 V ca. 5 V

Close: Light path is interrupted Open: Light shines across the gap

ca. 0 V ca. 5 V

Close: Light path is interrupted Open: Light shines across the gap

ca. 0 V ca. 5 V

Close: Light path is interrupted by a tip Open: Light shines across the gap without a tip

ca. 0 V

Be careful not to short-circuit Pin#2(5V) and Pin#3(R.GND). This PCP breaks readily in the event of a short circuit. 3 .

OJHT02

•

Same as OJ-HT04. The only difference is the gap width.

Be careful not to short-circuit Pin#2(5V) and Pin#3(R.GND). This PCP breaks readily in the event of a short circuit. 4 .

TLP830

•

Check the voltage at Pin#4(Sig.) against Pin#2(R.GND).

•

Your voltage multimeter should show the right voltage if the PCP is functioning properly.

•

Find a short-circuit on FPC when you try to find the Pin location.

•

Short-circuited on FPC are Pin#1(R.GND) and Pin#3(5V).

•

Check the voltage at the other two (2) Pins against Pin#1 or Pin#3 (5V) to find other Pin location.

Be careful not to short-circuit Pin#1 or #3(5V) and Pin#2 (R.GND). This PCP breaks readily in the event of a short circuit. 5 .

PLI-523

•

Check the voltage at Pin#5(Sig.1) against Pin#2 or #3(R.GND) with and without a tip in Tip Pos. 1.

•

Check the voltage at Pin#6(Sig.2) against Pin#2 or #3(R.GND) with and without a tip in Tip Pos. 2.

•

Your voltage multimeter should show the right voltage if the PCP is functioning properly.

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Table 5.6-3 N o . 6 .

7 .

PCP Name PM2LF10

PH-D /PHTboards

How to check the voltage and the current •

Check the voltage at Pin#2(Sig.) against Pin#3(GND).

•

Your voltage multimeter should show the right voltage if the PCP is functioning properly.

•

Check the voltage at Pin#3(Sig) against Pin#1(5V).

•

Your voltage multimeter should show the right voltage if the PCP is functioning properly.

Light path

Voltage

Close: Light path is interrupted Open: Light shines across the gap

ca. 0 V ca. 5 V

Close: Light path is interrupted Open: Light shines across the gap

ca. 0 V ca. 5 V

Be careful not to short-circuit Pin#1(5V) and Pin#3(Sig). This PCP breaks readily in the event of a short circuit.

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6.1 Overview The service software is part of the system software that which provides you with tools with which you can carry out programs for the instrument and measuring cell maintenance, check and adjust mechanical units, monitor temperature, unit temperature and LLD voltage, etc. All functions with which service engineers should be acquainted are described in the following chapter. Screens that are not described in Chapter 6 are discussed in detail in the Software Guide of the Operator’s Manual.

Figure 6.1-1 System Overview Screen If you started e 411 without the password protecting, the maintenance screen is as follows.

Figure 6.1-2 Utility-Maintenance Screen without the password protecting: Disk System Version 1.0 – May 2006

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You cannot select “Service” item in this screen (only Maintenance and Check). You should start the device in the service mode before service begins. It is according to the following procedures. 1 ► 2 ►

Start e 411. Push Operator ID button in system screen. Then following screen is shown.

Figure 6.1-3 Input Operator ID Screen 3 ►

Input the following information and push OK button, then following screen is shown. Operator ID: bmserv Password: nakakojo

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Figure 6.1-4 Pasword Protection Setting Screen 4 ►

Push On button and OK button, then Logon screen is shown.

Figure 6.1-5 Logon Screen 5 ►

Input the following information and push Logon button, then Overview screen is shown. Operator ID: bmserv Password: nakakojo

6 ►

Open Maintenance screen. You can select “Service” item in Maintenance screen.

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Figure 6.1-6 Utility-Maintenance Screen with the password protecting: Disk System

6.1.1 Utility Screen of Print 6.1.1.1 Alarm Trace Output the alarm Trace from e411 and delete the Alarm information. In case of output the alarm Trace • •

Utility Screen - Alarm Trace “Daily” – Alarm Information “Print” – Data Selection “All” or “Data Range” (Input the Start and End) – Press the “OK” button Utility Screen - Alarm Trace “Cumulative” – Alarm Information “Print” – Data Selection “All” or “Data Range” (Input the Start and End date) - Press the “OK” button

In case of delete the alarm Trace • •

Utility Screen - Alarm Trace “Daily” – Alarm Information “Delete” - Press the “OK” button Utility Screen - Alarm Trace “Cumulative” – Alarm Information “Delete” - Press the “OK” button

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Figure 6.1-7 Print-Alarm Trace screen (Daily)

Figure 6.1-8 Print-Alarm Trace screen（Comulative）

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Figure 6.1-9 Daily Alarm Trace

Figure 6.1-10 Comulative Alarm Trace

6.1.1.2 Communication Trace Output the Communication tarce between e411 and Host system and delet the Communication Trace. In case of output the Communication Trace •

Utility Screen - Communication Information “Print” – Press the “OK” button

In case of delete the Communication Trace •

Utility Screen – Communication Trace “Delete” - Press the “OK” button

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Figure 6.1-11 Print- Communication Trace screen

Figure 6.1-12 Print- System Communication Trace

6.1.1.3 Operator ID Trace Output the Operator ID information of Logon / Logoff. •

Utility Screen – Data Selection “All” or “Data Range” (Input the Start and End) – Press the “Print” button

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Figure 6.1-13 Print-Operator ID Trace screen（All）

Figure 6.1-14 Print-Operator ID Trace screen （Data Range）

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Figure 6.1-15 Print- Oprator ID Trace

6.1.1.4 Application Parameters Output the Application Parameters. •

Utility Screen – Press the “Print” button

Figure 6.1-16 Print-Application Parameters screen

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Figure 6.1-17 Print-Application Parameters

6.1.2 Interface Setup 6.1.2.1 Start Conditions Change the Host Setting “On“ or “Off“ of Host Communication. In case of Host Communication “On” •

Start Conditions – Host Communication “On” – Press the OK button

Figure 6.1-18 Host Setting Screen

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6.1.2.2 Host Communication Setting Set the parameters of Host Communication.

Figure 6.1-19 Host Communication Setting Screen

Protocol Type Elecsys / cobas : When selecting [Elecsys], it communicates with HOST by Elecsys type. When selecting [cobas], it communicates with HOST by cobas type. You can select the baud rate only when communication is OFF.

RS232C setting (Speed) The baud rate choices are: 4800, 9600 and 19200. You can select the baud rate only when communication is OFF.

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Figure 6.1-20 Host Communication Setting Screen (Frame) Character Configuration is selected from Table 6.1-1. The setting is Changeable when “Host Communication” is off. Table 6.1-1 Character Configurations No. 1 2 3 4 5 6 7 8

Data bit 7bit 7bit 7bit 7bit 8bit 8bit 8bit 8bit

Parity bit EVEN ODD EVEN ODD NONE NONE EVEN ODD

Stop bit 2Stopbit 2Stopbit 1Stopbit 1Stopbit 2Stopbit 1Stopbit 1Stopbit 1Stopbit

Automatic Result Upload Yes/No : When [YES] is selected, result data of a sample is sent to HOST in real time as far as all such data is collected.

Communication Trace Yes/No : When [YES] is selected, communication detail with HOST is traced in e411

cobas Type Setting When Protocol Type is [cobas], parameters are as follows. Automatic Recovery of Session Yes/No : This is an automatic reconnection function in case of communication is disconnected, (HOST Communication Off) under error described ASTM1381-91 has occurred. When [Yes] is selected, the erroneous message and a message sent from HOST before the reconnection process completed are rejected.

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Send Comment Yes/No : When [Yes] is selected, enabled to register test selection information from HOST as well as patients comment. It also enables to transfer to HOST the patient comment registered to the analyzer along with result data. If not selected, the patient comment is not transferred. QC Additional Information ControlName/LotNo. : When [ControlName] is selected, name of control is sent as sample ID. When [LotNo.] is selected, lot No. is sent as sample ID. Send Result Only Mode Yes/No : Only result data is sent. Inquiry for order is not conducted. This function is not applied to Batch transfer. HOST Test Code Push “HOST Test Code” button, then following screen is shown.

Figure 6.1-21 Host Test Code Setting Screen (Frame) You can set Test Code used by the communication(Host Code) besides it used instrument.Select Test Code in list, input Host Code, then push OK button.

6.1.3 System Setup The System Setup screen allows you to check the analyzer information, including the software version, and set the current date and time (see Figure 6.1-22).

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Figure 6.1-22 System Screen

Date and Time Setting Date Format : “dd/mm/yyyy“ “mm/dd/yyyy“ “yyyy/dd/mm“ “yy/mm/dd“

Set Date / Time Input the current date and Time.

Figure 6.1-23 Special Function Setting Screen

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Serial No. The serial number of the analyzer.

Install Date The software installation date.

Software Version The version of software currently loaded in the system.

Check Sum Check Sum of AU and PC

Last LFC Date Date of the last Liquid Flow Cleaning ( LFC ) procedure.

Total Test Counter The total cumulative number of tests that have been performed on the analyzer. There is no user access to this field. This number is not reset by reloading software.

Cell Test counter This field tracks the number of assays performed on the measuring cell currently on the analyzer. This number must be reset to “0” if a new measuring cell is installed.

Effective Signal Output This function is to print out an Effective Signal[count] to the test result.

Test Generation Printout This function is to print out an Test Generation to the test result. Test Generation ON : TSH 0 Test Generation OFF: TSH

6.1.4 Storage Utility The Storage Utility Setup screen allows to read some specific data and to write backup data from CF or DVD.

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Figure 6.1-24 Strage Utility Screen

6.1.4.1 In case of the Read System Specific Data from CD. 1 2 3 4 5 6

► ► ► ► ► ►

Connect the external media to a USB port on the left side of the analyzer. Set CD that can be written. Open the Storage Utility screen. Select “Read System Specific Data” button. Select “External” button. Push “Execute” button, then read the system specific data from CD.

6.1.4.2 In case of the Back up Data from CF. 1 2 3 4

► ► ► ►

Open the Storage Utility screen. Select “Back up Data” button. Select “Internal” button. Push “Execute” button, then write the backup data to CF.

Other function are as following. Table 6.1-2 Strage Utility Functions No. 1

Button name Read System Specific Data

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Read /Write Read

Data All (including APC data)

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Note When the file for APC is changed, and when the file for new APC is copied onto data F/D that you had used up to now, uses this function. 1 ►

Set data F/D with the file for new APC.

2 ►

Push “Read System Specific Data”.

3 ►

Set data F/D that has been used up to now.

4 ►

Push “Backup”.

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2

Read Reference Data

Read /Write Read

3

Read Adjustment Data

Read

Adjustment file

4

Read Rack Adjustment Data

Read

Rack Adjustment file

5

Back up Data

Write

All

No.

Button name

Data Reference data

Note Reads refer.dat in which test item information etc. are defined and param.dat in which various parameters(Common parameter that doesn't depend on per-device) are defined. Reads a peculiar adjustment value (adjust.dat) to the e 411 and parameter (analysis.dat) necessary for the measurement. When the reading processing is executed, it checks Serial No. in data FD and Serial No. in the device. If the check is OK, it executes reading. If NG, It outputs the alarm. Reads only the adjustment value of line part peculiar adjust.dat to the e 411. No check the Serial No. When you ship only the “line part”, and the “line part” is connected with the analysis part in the locale, uses this function. When the file for APC is read, the file for APC is written. When is not read, the file for APC is not written.

Back up Write(Internal) Data files will be stored in d:\e411\backup\data_YYYYMMDD Max two folder. The older one will be overwritten first. Files except APC files like SETUP00.dat, … , SEUP08.dat will be stored.

Back up Write (External) Data files will be stored in e:\e411\data_YYYYMMDD (e: DVD-RAM drive)

Backup Read (Internal) Folders in d:\e411\backup are shown. Data files in d:\e411\data will be overwritten with the files in the selected folder.

Figure 6.1-25

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Backup Read (External) Folders in e:\e411 are shown. Data files in d:\e411\data will be overwritten with the files in the selected folder.

Figure 6.1-26

Read (Internal)

Figure 6.1-27 Data files in d:\e411\data will be overwritten with the files in the selected folder

Read (External) Data files in d:\e411\data will be overwritten with the files in the selected folder in the e:\

6.1.5 Documentation and Printer Setting Set the external output method and information in this screen.

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Figure 6.1-28 Documentation and Printer Setting The meaning of a set each value is as follows.

6.1.5.1 Completion Conditions You can define the external output method. Table 6.1-3 Button Printout Upload Printout/Upload

Mean When the measurement result outputs it, the result is printed. When the measurement result outputs it, the result is uploading to HOST. When the measurement result outputs it, the result is printed and uploading to HOST.

6.1.5.2 Printer Condition You can define whether to print. Table 6.1-4 Button Connected Not connected

Mean Can print. Even if the printer is connected, it is not printed.

6.1.5.3 Automatic Printout "ON" means the function is selected. Otherwise not be selected. And you can select two or more. Table 6.1-5 Button Calibration Sample Control Sample Stat Sample Routine Sample

Mean The calibration result is automatically output. The control result is automatically output. The Stat result is automatically output. The routine result is automatically output.

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6.1.6 Keep Function Setup The Keep Function Setup screen allows you to choose different “Keep” functions – the sample type and the default sample Cup.

Figure 6.1-29 Keep Function Setup Keep Sample Type: You can decide to keep sample type or not. Default Sample Cup: You can decide keep the default sample cup (Normal or Reduced).

6.1.7 Retry Function Setup The Retry Function Setup screen allows you to choose “retry aliquot” functions – Sample Premature LLD and Sample short.

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Figure 6.1-30 Retry Function Setup When Sample Premature LLD: When Sample Premature LLD occurs, you can decide to retry aliquot(On) or not(Off). When Sample short: When Sample short occurs, you can decide to retry aliquot(On) or not(Off).

6.1.8 Sample Reception Mode The Sample Reception Function allows you to choose Sample Reception Mode. When you want to begin analyzing at once, this function is effective.

Figure 6.1-31 Sample Reception Mode Off: When the e 411 ends the analysis, it will change to Stand-by in 30 minutes. 1 – 12 Hours: When the e 411 ends the analysis, it will change to Stand-by in 1–12 hours.

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6.2 Maintenance How to select a maintenance function in the Maintenance screen There are 10(Disk for 8 items) maintenance functions available. Each of them corresponds to a button in the Check screen. Touch the Check button in the Maintenance screen in order to display the Maintenance items. After touching a button in the Maintenance Items, a pop-up window appears in the screen.

Figure 6.2-1 Maintenance screen for Rack System

Figure 6.2-2 Maintenance screen for Disk System Version 1.0 – May 2006

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To start a maintenance function, touch the respective button. The general functions of each button and the input area are as follows. Start button : Close button : Input area :

To start the maintenance function corresponding to the button To close the pop-up window and return to the Maintenance screen without carrying out any maintenance functions To define how many times the maintenance function is to be carried out

There is no Stop button in the pop-up window. Instead, the Stop key can be used to stop the maintenance function. The following table shows a summary of the maintenance functions. Table 6.2-1 Summary of the maintenance functions No. 1. 2. 3. 4. 5. 6. 7.

Name System Reset Liquid Flow Cleaning L.And A. Reset All* Rack Clear* Sipper Pipetter Prime S/R Pipetter Prime Measuring Cell Exchange Measuring Cell Preparation Finalization Maintenance Media Write

8. 9. 10.

Function Resetting all the mechanical units and priming the pipetter system A function that decontaminates the liquid flow system Resetting all the mechanical units including Rack Sampler Carrying all racks in the line to the output area (C line) Priming the sipper system with system water Priming the pipetter system with system water Priming the sipper system three times and draining the measuring cell. Conditioning the measuring cell A function that carries out the finalization cycle Output to external Media

Note: these maintenance functions are only available for rack systems Initial conditions for the maintenance functions When you start each maintenance function, make sure that the instrument is put in the condition corresponding to the function described in Table 6.2-2. Table 6.2-2 Initial conditions for the maintenance functions 1.

No.

Function Name System Reset

2. 3.

Liquid Flow Cleaning L.And A. Reset All

4. 5.

Rack Clear Sipper Pipetter Prime

6.

S/R Pipetter Prime

7.

Measuring Cell Exchange Measuring Cell Preparation

8.

9. 10.

Finalization Maintenance Media Write

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Initial Condition Water container contains at least 1L system water. The water consumption is about 20 ml per cycle. See 6.2.1.2 Water container contains at least 1L system water. The water consumption is about 20 ml per cycle Water container contains at least 1L system water. The water consumption is about 5 ml per cycle. Water container contains at least 1L system water. The water consumption is about 6 ml per cycle. Water container contains at least 1L system water. The water consumption is about 15 ml per cycle. 1)Water container contains at least 1L system water. The water consumption is 150ml + n × 5 ml. 2)Mount PC and CC bottles in system reagent position 2. The consumption of each system reagents is n × 2ml. See Chapter 6.2.1.9 External Media

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6.2.1 Detailed Description of Each Maintenance Function 6.2.1.1 System Reset System Reset is a maintenance function that resets all the mechanical units and primes the pipetter system. This function is to be carried out when an operation is aborted due to an error and takes all the mechanical units to their original positions. The reset function in the Service software is identical to the reset that is carried out at the beginning of each run. Only Start and Close are available in the System Reset pop-up window. About 20 ml water are needed each time System Reset is carried out.

6.2.1.2 Liquid Flow Cleaning Contamination in the sipper system could potentially degrade sample accuracy and precision, or possibly block the measuring cell flowpath. Liquid flow cleaning keeps the sipper liquid flowpath clean and maintains the integrity of the measuring cell. The customer should perform LFC on a frequent basis. Please train all your customers according to the procedure described below and inform them about the importance of keeping the liquid flow path clean and the measuring cell at the best performance level. If operators perform this procedure frequently it will lead to fewer customer complaints. Required materials: Recommended frequency *: ∗

SysClean adapter Ident. No.: 1933159.910 ISE Cleaning Solution Ident. No.: 1298500 Every two weeks or after 2500 - 3000 cycles

If customer maintenance has been done as recommended, it is only necessary to carry out an additional customer cleaning at the PM visit. The service LFC is only necessary during PM if the sipper line is highly contaminated or if LFC has not been carried out regularly by the customer.

Operator time: Analyzer time:

Approx. 3 minutes User LFC: Approx. 16 minutes (user), Service LFC: Approx. 32 min + time for MC prepare cycles The cleaning solution is corrosive. Wear protective gloves and glasses when handling this solution.

Precautions:

Procedure 1.

User

Replace the PC bottle in position 3 by the SysClean adapter (keep the CC bottle in position).

Figure 6.2-3

2.

Service

3.

User /Service User

4.

Insert the adapter with the marking "USER" in direction towards the back of the instrument. Fill the ISE cleaning solution to the edge of the fill mark on the adapter (approx. 9 ml). PC/CC bottle has to be placed at the left side. Same procedure as for customers but using the Service position of the adapter. Touch the Liquid Flow Cleaning button on the screen (Screen: Util / Maintenance). The number of LFCs should be 1 for User maintenance.

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The number of LFCs should be 3 for service. Take out the SysClean adapter and place ProCell and CleanCell bottles in all positions. Perform Measuring Cell Preparation cycles. [Press ”MC Preparation” in Maintenance screen; select number of cycles]

Start the LFC procedure shortly after filling up the ISE solution. After the instrument returns to Stand by remove the SysClean adapter and discard the remaining ISE solution. To avoid an unpleasant odor, please empty the waste container at the end of the liquid flow cleaning procedure. After a Service LFC has been performed customers should check all controls and carry out a calibration if necessary. This is not necessary for normal routine with customer LFC.

When Liquid Flow Cleaning is completed the Liquid Flow system is set in the usual condition in which the system is set when a run is completed in the normal manner. The function takes about quarter of an hour.

6.2.1.3 L.And A. Reset All* ∗

*This function is available only for Rack Sampler.

L&A All Reset is a maintenance function that carries racks whose barcode has already been read to the unloader, resets all the mechanical units and primes the pipetter system. This function is to be carried out when an operation is aborted due to an error to take all the mechanical units in the original position and the operation should be restarted from the condition before the error occurred. The reset function in the Service software is identical to the reset which is carried out at the beginning of each run. About 20 ml water are needed to carry out the Reset function once.

6.2.1.4 Rack Clear* ∗

*This function is available only for Rack Sampler.

Rack Clear is a maintenance function that carries all racks in the line to the output line (C line). Only Start and Close are available in the reset pop-up window.

6.2.1.5 Sipper Pipetter Prime Sipper Pipetter Prime is a maintenance function that primes the sipper system with system water. This function is to be carried out when the tubing in the sipper system is drained due for reason such as replacing the tubing. However, this function should not be carried out unless it is followed by measuring cell preparation. This is because the measuring cell is filled with water after the Sipper Prime, and this might cause the luminescence signal to drift at the beginning of the following run. In addition to Start and Close buttons in the pop-up window, the iteration number can be set in the input area. The maximum iteration number is 100. It takes ca. 10 s to carry out the Sipper Prime function once, and the process consumes ca. 5 ml water.

6.2.1.6 S/R Pipetter Prime S/R Pipetter Prime is a maintenance function that primes the pipetter system with system water. This function is to be carried out when the tubing in the pipetter system is drained for some reason such as replacing the tubing, although the Pipetter Prime is always carried out when the system is reset or a run is started. In addition to Start and Close buttons in the pop-up, the iteration number can be set in the input area. The maximum iteration number is 100. It takes ca. 11 s to carry out the Pipetter Prime function once, and the process consumes ca. 6 ml water.

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6.2.1.7 Measuring Cell Exchange Measuring Cell Exchange is a maintenance function that primes the sipper system three times and drains the measuring cell. This ftunction is to be carried out before you replace or take out the measuring cell mounted in the detection unit. Only Start and Close buttons are available in the pop-up window. About 15 ml water are needed to carry out the Measuring Cell Exchange function once

6.2.1.8 Measuring Cell Preparation Measuring Cell Preparation is a maintenance function that carries out preparation cycles in order to condition a newly mounted measuring cell or measuring cells which have undergone maintenance (refer to Installation and Maintenance). In addition, this function can be used just to initialize the sipper system, especially just after the sipper prime to fill the MC with assay buffer. In addition to Start and Close buttons in the pop-up window, the iteration number of the preparation cycles can be set in the input area. The maximum iteration number is 100. Place ProCell and CleanCell bottles in system reagent position 1 when you start this function. The consumption of water and system reagents to carry out Measuring Cell Preparation are as follows: Water: 150ml + iteration number × 5 ml System reagents: iteration number × 2 ml The following functions are to be carried out sequentially when Measuring Cell Preparation is started. 1. 2. 3. 4. 5. 6. 7.

Reset Priming the sipper system between the sipper syringe and the waste via SV4 (ca. 20 s) Checking the system reagent inventory Preparation 1 cycle (once without potential application) Preparation 2 cycles according to the iteration number with the potential application Preparation 3 cycle (once with the potential application) Sipper finalization

When Measuring Cell Preparation is completed the sipper system is set in the usual condition in which the system is set when a run is completed in the normal manner.

6.2.1.9 Finalization Maintenance The Finalization Maintenance initiates the daily maintenance procedure of finalization maintenance. Finalization is the analyzer status that occurs between the time when the analyzer stops pipetting samples (S. Stop or R. Stop) and Stand-by. Finalization allows the analyzer to stand unused for several hours (e.g. overnight). The system is primed with water, the measuring cell is filled with ProCell and the sipper probe is cleaned with water. The function takes about three (3) minutes.

6.2.1.10 Media Write Output to external Media

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6.3 Mechanism Check How to select a mechanical unit check function in the Mechanism Check screen There are 18(Disk for 18 items) mechanical unit check functions available. Each of them corresponds to a button in the Check screen. Touch the Check button in the Maintenance screen in order to display the Maintenance items. After touching a button in the Maintenance Items, a pop-up window appears in the screen.

Figure 6.3-1 Mechanism Check screen for Rack System

Figure 6.3-2 Mechanism Check screen for Disk System Version 1.0 – May 2006

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Some functions can also be activated by touching a button in one of the screens for the mechanical unit adjustment. There are some buttons in each pop-up window; some pop-up windows also have an input area. The general functions of each button and the input area are as follows. Start button : Close : Input area :

To start the maintenance function corresponding to the button To close the pop-up and return to the Maintenance screen without carrying out any maintenance functions To define how many times the maintenance function is to be carried out

There is no Stop button in the pop-up window. Instead, the Stop key can be used to stop the maintenance function. While a mechanical unit check function is in process, the remaining iteration number is displayed in the corresponding button. The number is reset to 1 when the Stop key is pressed and to 0 when the function is completed. The following table shows a summary of the mechanical unit check functions. Table 6.3-1 Summary of the mechanical unit check functions No. 1.

Name System Volume Check

2.

Assay Performance Check

3.

Voltage Monitor

4.

Temperature Monitor

5.

Sensor Monitor

6.

Cap Open/Close Check

7.

Mixing Check

8.

Magnet Up/Down

9.

Waste Tray Shaking

10.

Sample BC Scanning (for disk system only)

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Function System Volume Check is a maintenance function that measures the system volume and updates the flag corresponding to the system volume in the database. Carries out following functions. “Running Test”, “PMT High Volt. Adjustment” , “Artificial Media Test” , “TSH Assay Test” , “AM & TSH Test” Please Refer 6.3.2. LLD voltages of the S/R probe, the pressure sensor for clot detection and the sipper probe. Voltages can only be checked while the analyzer is in Stand-by. Temperature, Target Temperature and Control parameters are measured for Detection Unit and Incubator. Ambient temperature, Temperature, Target Temperature and Control parameters are measured for Reagent Disk and PC/CC (System reagent). Select the sensor you want to check by touching the corrosponding button. Check whether colour of the button changes when the sensor detects. Repeats the RackPack cap opening/closing from the RackPack in position 1 counterclockwise as many times as entered in the input area. The maximum repetition number is 180. This function is also activated by touching the button in the screens for the mechanical position adjustment. Repeats the bead mixing from the RackPack in position 1 counterclockwise as many times as entered in the input area. The maximum repetition number is 180. This function is also activated by touching the button in the screen for the mechanical position adjustment. Repeats the magnet drive upward and downward movement as many times as entered in the input area. The maximum repetition number is 180. Repeats the solid waste shaking as many minutes as entered in the input area. The maximum repetition number is 180. Carries out S. Scan once including the database update and the transmission to HOST. This function is also activated by touching the button in the screen for the mechanical position adjustment.

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Table 6.3-2 No. 11.

Name Bar Code Card Reading

12.

Reagent Pack BC Scanning

13.

Gripper Quick Check

14.

Gripper Repetition Check

Function Carries out Barcode Card Scan once including the database update and the transmission to HOST. This function is also activated by touching the button in the screen for the mechanical position adjustment. Carries out R. Scan once including the database update and the transmission to HOST. This function is also activated by touching the button in the screen for the mechanical position adjustment. Carries out a mock operation with tips and vessels mounted on each corner of each magazine. Only the gripper and the pipetter move according to the AP 2, whereas the pipetter carries out only picking up a tip and discarding it moving between the pipetter buffer and the pipetter washing station. This function is also activated by touching the buttons in the screen for the mechanical position adjustment.

Figure 6.3-3 Carries out a mock operation with all full magazines. Only the gripper moves according to the AP 2 although no tip/vessel discarding takes place. Instead, all tips and vessels are to be returned back to their original positions. This function is also activated by touching the button in the screen for the mechanical position adjustment.

Figure 6.3-4

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Table 6.3-3 No. 15.

Name S/R Probe Check

Function Carries out mock pipetter, reagent disk and cap opener cycles as many times as entered in the input area with no liquid handling except for the LLD. The maximum repetition number is 180. The gripper carries a vessel to the vessel buffer (VB) at the beginning of the function and discards it at the end. This function is also activated by touching the button in the screen for the mechanical position adjustment.

Figure 6.3-5 16.

Gripper S/R Probe Check

Carries out mock cycles except for the sipper as many times as entered in the input area with no liquid handling except for the LLD. The maximum repetition number is 180. This function is also activated by touching the button in the screens for the mechanical position adjustment.

Figure 6.3-6

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Table 6.3-4 No. 17.

Name Sipper Check

Function Carries out mock sipper cycles as many times as entered in the input area. The current position is switched alternately every cycle. The gripper carries a vessel to the sipping position at the beginning of the function and discards it at the end. The maximum repetition number is 180. This function is also activated by touching the button in the screen for the mechanical position adjustment.

Figure 6.3-7 18.

S/R Probe LLD Check

Checks the pipetter LLD function by moving the pipetter down to the sample disk and the RackPack at position No. 1 of the sample disk and the middle bottle at position No.1 of the reagent disk, respectively.

Figure 6.3-8 19.

Sampler Check (only for Rack Sampler)

Carries out a mock operation with all racks on rack loader after reset action, checks the BC reading function on the rack sampler, and prints out the result. Only the rack sampler moves in the same manner as in the operation.

6.3.1 System Volume Check System Volume Check is a maintenance function that measures the system volume and updates the flag corresponding to the system volume in the database. Only Start and Close buttons are available in the pop-up window. The function must always be carried out when a part of the sipper line (sipper probe, tubing, heat pipe or measuring cell) is replaced. Place ProCell and CleanCell bottles in system reagent position 1 when you start this function. About 140 ml water and 5 ml assay buffer are needed to carry out the System Volume Check function once. For further details refer to Chapter 3.2.2.

6.3.2 Assay Performance Check Screen of the Assay Performance Check is shown below.

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Figure 6.3-9 Assay Performance Check Screen

6.3.2.1 Running Test Introduction This test is carried out to check the mechanical movements of the system.

Materials Required Table 6.3-5 RackPack name CellCheck

Amount 6

Material No. 1820451-122

Samples Required: Disk Table 6.3-6 Sample name ProCell

Cups in Rotor Pos. 1-30

Amount 1 ml per test

Samples Required: Rack Table 6.3-7 Sample name ProCell Version 1.0 – May 2006

No. of racks 6

Cups in Pos. 1-5 6 - 32

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1. Preparation 1 ► 2 ► 3 ► 4 ► 5 ►

Place six (6) sets of RackPacks filled with CellCheck in positions 1 to 6 on the reagent disk. Load thirty (30) Hitachi sample cups filled with ProCell on 6 racks for Rack System, or into positions 1 to 30 on the sample disk for Disk System. Make sure the liquid waste container is empty. Fill the system water container with system water (max. 3.0 liters). Place a CleanLiner in the solid waste tray.

Note: Reset the waster number counter mechanically by detaching the solid waste tray. 6 ► 7 ► 8 ►

Place 2 (two) sets of system reagent ProCell/CleanCell bottles filled with ProCell/CleanCell in the system reagent container. Place three magazines filled with tips and three (3) magazines filled with assay cups on a magazine tray. Remove all tips and cups from the incubator and the buffer plate

2. Check Procedure 1 ► 2 ►

Make sure that the instrument is in standby status. First perform Reset (Maintenance Screen)

Note: Make sure that no mechanical problem takes place by carrying out the “RESET” in reset status.

3 4 5 6 7 8

► ► ► ► ► ►

Touch the Utility screen. Touch the Check button in the screen Touch the Assay Performance Check button. Touch the Running Test button in the Assay Performance Check screen. Having touched the button in the screen, you will see a popup shown below. Start the Running Test by touching the Start button in the screen. 180 determinations according to the Assay Protocol 2 are carried out on the instrument. This procedure lasts 2.5 hours.

3. Evaluation 1 ► 2 ► 3 ►

At the beginning, check whether all mechanical positions (especially position relative to pipetter, sipper, beads mixer) are sufficient within a tolerance limit; refer to Chapter 4.5 Mechanical Adjustment. Observe the mechanical functions during the Running Test. Mechanical errors should not take place.If you observe irregular movements, refer to Chapter 4.5 and carry out Mechanical Adjustment. Confirm that pipetter LLD functions properly.

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Figure 6.3-10 Popup screen of Running Test

6.3.2.2 PMT High Voltage Adjustment The PMT High Voltage Adjustment is already described in the installation part of the Service Manual. Please Refer Chapter 2.3.11

6.3.2.3 Artificial Media Test (AM Test) The AM Test is already described in the installation part of the Service Manual. Please Refer Chapter 2.3.13.1

6.3.2.4 TSH Assay Test The TSH Test is already described in the installation part of the Service Manual. Please Refer Chapter 2.3.13.2

6.3.2.5 MC CO Check Introduction The MC CO (measuring cell carryover) Check is part of the AM Test and is carried out if only MC carryover is to be checked. In the event of a general test of the system (e.g. when installing the instrument, replacing the measuring cell or carrying out a performance check during maintenance) both the complete AM test and the TSH assay test should be carried out. The following measurements are carried out: • • •

5 x BCR1 (homogeneous measurement) 5 x ProCell (heterogeneous measurement) 3 x iSAP (heterogeneous measurement)

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3 x Carry Over (heterogeneous measurement)

The test takes about 30 minutes.

Materials Required Table 6.3-8 Pos. No. 1 2 3 4 5

Name BlankCell set CellCheck SAP test

Beads

R1

BCR1 ProCell iSAP

R2

BCR2 ProCell Beads Buffer

ProCell FC

Samples Required Disk System Place 1 ml ProCell in positions 2 to 8 and an empty Hitachi cup in Pos. 1. Rack Sampler Place 1 ml ProCell in positions 2 to 5 of a rack and an empty Hitachi cup in Pos. 1. In a second rack, pipette 1 ml of ProCell in positions 1 to 3. The further procedure is as described for the AM Test in Chapter 6.3.2.3.

6.3.2.6 LH Check Introduction The LH (liquid handling) Check is part of the AM Test and is carried out if only liquid handling is to be checked. In the event of a general test of the system (e.g. when installing the instrument, replacing the measuring cell or carrying out a performance check during maintenance) both the complete AM test and the TSH assay test should be carried out. The following measurement is carried out: 10 x BCR2 (homogeneous measurement) The test takes about 18 minutes.

Materials Required Table 6.3-9 Pos. No. 1 2 3 4 5

Name CellCheck -

Beads ProCell -

R1 ProCell -

R2 ProCell -

Samples Required Disk System Place 1 ml BCR2 in Pos. 1. Version 1.0 – May 2006

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Rack Sampler Place 1 ml BCR2 in Pos. 1 of a rack. The further procedure is as described for the AM Test in Chapter 6.3.2.3.

6.3.2.7 AM & TSH Test Performed with pressing one button in APC screen. The Test takes about 45 min.

Preparartions Place system reagent bottles in the appropriate positions. Set reagent rack packs in reagent disk positions 1 to 7 as follows Table 6.3-10 Pos. No. 1 2 3 4 5 6 7

Rack Pack BlankCell set BlankCell set CellCheck CellCheck SAP test CellCheck TSH Test

Beads BCR1 BCR1 ProCell ProCell Beads ProCell Beads

R1

R2

BCR2 BCR2 ProCell ProCell Buffer ProCell R1

ProCell ProCell FC ProCell R2

Sample arrangement For Disk System: Table 6.3-11 Run AM & TSH Test

Cup in Rotor pos. 3 4 to 10 15 16 17

Liquid BCR2 (1 ml) ProCell (1 ml) ProCell (1 ml) TSH Cal 1 TSH Cal 2

Use Hitachi normal sample cups and RD calibrator vials. Place a stop Bar code in Pos. 18. Remove all tips and cups from the incubator and the buffer plate. Place a full magazine with tips and cups in the front position on the tray. For Rack Sampler : Table 6.3-12 Rack in A line No.

Run AM & TSH Test

1

2 3

Cup in rack pos. 1, 2 3 4, 5 1 to 5 1 2 3

Liquid Empty cups BCR2 (1 ml) ProCell (1 ml) ProCell (1 ml) ProCell (1 ml) TSH Cal 1 TSH Cal 2

Use Hitachi normal sample cups and RD calibrator vials. Remove all tips and cups from the incubator and the buffer plate. Place a full magazine with tips and cups in the front position on the tray. Version 1.0 – May 2006

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Start the test by pressing the AM & TSH Test in the APC screen. Evaluation of the AM&TSH Test For evaluation of the AM and TSH Test refer please chapter 2.3.13.1. and 2.3.13.3

6.3.2.8 Print Result This function is to print out the results of the artificial media test, MC CO test, LH test and the TSH assay test. • • • •

Select the [Print Results] button in the [Assay Performance] check screen after you finish each test of Assay the Performance Check. Having touched the button in the screen, you will see a popup . Touch the [print out] button on the popup if the instrument has APC results. Input “Date”, “Operator name”, “Instrument No.”, “BCR1 target value” and “BCR2 target value” on the printed results sheet, and compare the results for each item with the criteria and evaluate whether the results are acceptable or not.

Carry out “Print Results” after you finish each “AM test”, “TSH test”, “MC CO test”, “LH test” of the Assay Performance Check, and before you touch the [Restore Parameter] button or start any Assay Performance Check (APC).

Example for printout : AM Test

Figure 6.3-11

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Example for printout : TSH Test

Figure 6.3-12

6.3.2.9 Restore Parameter Carry out “RESTORE PARAMETER” after you have performed or even selected any Assay Performance Check (APC). Select the [Restore Parameter] button in the [Assay Performance] check screen if you have finished the Assay performance section. You do not need to restore if you have performed another APC run.

When and what • • • •

You must check the instrument according to the procedures in the following cases. The detailed checking procedures and acceptable ranges are described in the preceding sections. Some checking procedures are necessary as shown in the following table when some parts or assemblies are replaced. The Running Test is to be performed if you make adjustments to the instrument to check the reliability of the hardware. Table 6.3-13 When and what has to be performed (see below for further details)

X X X

System Volume check X X -

-

X X

MC Prepare

Case Instrument Installation Detection Unit Replacement Measuring Cell Replacement PMT Replacement ANG-EP Replacement L-AMP Replacement Magnet Drive Replacement Sipper Probe Replacement Sipper Tubing Replacement

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PMT-HV Check

Initial BlankCell

Artificial Media Test

TSH Assay Test

X X X X

X X X X

X X X X

X X X X

-

X X

X -

X -

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Pipetter Probe Replacement Pipetter Tubing Replacement Long-term Rest

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12.

System Volume check

MC Prepare

Case -

-

PMT-HV Check -

Initial BlankCell

Artificial Media Test

X X

X X

TSH Assay Test -

Installation of instrument . Refer to Chapter 2 for details. Replacement of detection unit Replacement of measuring cell Replacement of PMT Replacement of ANG-EP Replacement of L-AMP Replacement of magnet driver The same procedures to check instrument / MC performance as recommended for installation: refer to Chapter 2.3.9 and following. Replacement of sipper probe Replacement of sipper tubing In case of changing a tube or any other part in the sipper flow path, a system volume check must be performed. In addition, system performance should be checked after exchange (AM, TSH assay test) in the same way as during PM exchange. Replacement of pipetter probe Replacement of pipetter tubing In case of changing any part in the pipetter liquid handling path, we recommend checking liquid handling precision. At least the LH check (refer to Chapter 6.3.2.6) should be performed (or, alternatively, the AM test). Long-term rest Depending on the condition of the instrument, at least LFC and system performance check should be performed.

Note: If the system appears to be contaminated we recommend performing the System Cleaning function (refer to Maintenance) or exchanging the affected parts (tubings, etc.). For instruments not used for more than 6 months, the 12 month PM procedure should also be carried out (refer to Chapter 10).

General note If any major performance shift is detected, assay calibration must be performed.

6.3.2.10 Assay Performance Check Troubleshooting The Assay Performance Check Troubleshooting is already described in the installation part . Please Refer Chapter 2.3.13.3

6.3.3 Voltage Monitor Check the output voltages of the Pipetter LLD sensor, the Pressure sensor and the Sipper LLD sensor on the Voltage Monitor Screen when the instrument is in Stand-by status according to the following steps. 1 ► 2 ► 3 ► 4 ►

Touch the Voltage Monitor button in the Utility - Maintenance screen. Touch the Voltage Button in which you want to see the voltage. If the instrument is not in Stand-by status there will be no response. If you want to see another voltage, touch the Monitoring Stop button followed by the Voltage button. If you do not touch the Monitoring Stop button, touching other buttons is not possible. If you want to switch to another screen, touch the Monitoring Stop button and the Close the Voltage Monitor Screen.

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Figure 6.3-13 Voltage Monitor screen The following table shows the tolerance limits for each voltage and the Head Line Monitor. Table 6.3-14 * Voltage Monitor function Description Pipetter LLD sensor

Tolerance Limit 1.5 V or less when no Tip attached to the Pipetter Probe

Pipetter Pressure sensor

1.80 ± 1.30 V after Pipetter priming and leave for 2 minutes.

Sipper LLD sensor

3.5 V or less

∗

Head Line Monitor Pipetter LLD Output Voltage Clot Detection Output Voltage Sipper LLD Output Voltage

*For details, refer to Chapter 5.3.4

6.3.4 Temperature Monitor You can see the Temperatures of the control points, the Ambient temperatures, the Target temperatures, and the Control Parameter in the Temperature Monitor screen.

Figure 6.3-14 Temperature Monitor screen For details refer to Chapter 5.3.1 and 5.3.6: Version 1.0 – May 2006

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Principle of temperature control Troubleshooting of temperature units

6.3.5 Sensor Monitor This function is available for the Disk / Rack Sampler System.

6.3.5.1 How to select the Sensors Monitor function • • • • •

Touch the Sensors Monitor button in the Check screen. Select the Monitoring Start / Stop button. ( Toggle switch ) Select the sensor you want to check by touching the corrosponding button. Check whether colour of the button changes when the sensor detects. Finish the Monitoring by pressing the Monitoring tart / Stop button.

Figure 6.3-15 Sensor Monitor screen for Disk Table 6.3-15 Sensors corresponding to the buttons Unit R/S Pipetter Tip Buffer Gripper S.Water Tank Liquid Waste

Sensor No. PI055 PS051 PS051 PI068 PI131 PI133

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Button name Pipettor Abnormal Descend Tip Buffer 1 Tip Buffer 2 Gripper Finger Distilled Water Lower Limit Liquid Waste Container Level

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Remarks Crash Sensor

Grip Detection Float Switch

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Figure 6.3-16 Sensor Monitor screen for Rack Sampler System Table 6.3-16 Sensors corresponding to the buttons Unit A Line

B Line

C Line

R/S Pipetter Tip Buffer Gripper S.Water Tank Liquid Waste

Sensor No. PI200 PI201 PI202 PI210 PI211 PI212 PI213 PI215 PI216 PI217 PI221 PI222 PI223 PI224 PI225 PI226 PI055 PS051 PS051 PI068 PI131 PI133

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A Line

B Line

C Line

Button name Tray Home Loading End Home Loading End Rack Stat Sampling B.C.R Cup Home Loading End Rack Full Tray Tray Full 1 Tray Full 2 Pipettor Abnormal Descend Tip Buffer 1 Tip Buffer 2 Gripper Finger System Water Lower Limit Liquid Waste Container Level

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Remarks Tray Detection Home Pos. Detection Rack Feed End Pos. Detection Home Pos. Detection Rack Feed End Pos. Detection Rack Detection STAT Pos. Detection Sampling Pos. Detection BCR Read Pos. Detection Cup Detection Home Pos. Detection Rack Feed End Pos. Detection Rack Full Detection Tray Detection Tray Full 1 Detection Tray Full 2 Detection Crash Sensor

Grip Detection Float Switch

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6.4 Service How to select a Service function • •

After boot up the e411 or Logoff the e411, a pop-up window appears as shown in Figure 6.4-1. The Operation ID and Password are following. Operator ID: bmserv Password: nakakojo

•

There are 15(Disk for 14 items) service functions available. Each of them corresponds to a button in the Check screen. Touch the Check button in the Maintenance screen in order to display the Maintenance items. After touching a button in the Maintenance Items, a pop-up window appears in the screen.

Figure 6.4-1 Logon window

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Figure 6.4-2 Service screen (for rack sampler)

Figure 6.4-3 Service screen (for disk)

6.4.1 Manual Adjustment The three manual adjustment screens are shown below (Figure 6.4-4 to Figure 6.4-8). For details of the adjustment (adjustment items, what is to be confirmed), refer to the table in Chapter 4.5.2 “Mechanical Adjustment”.

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6.4.1.1 How to select a unit to be adjusted in the Manual Adjustment screens Manual adjustment functions are available on three screens together with mechanical unit check functions for some units. Each of them corresponds to a button in the manual adjustment screens. Touch one of the manual adjustment buttons in the Service screen in order to display the screen. After touching a button in one of the manual adjustment screens, a pop-up window appears in the screen.

Figure 6.4-4 Manual adjustment screen 1（for rack sampler）

Figure 6.4-5 Manual adjustment screen 1（for disk）

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Figure 6.4-6 Manual Adjustment screen 2（for rack sampler）

Figure 6.4-7 Manual Adjustment screen 2（for disk）

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Figure 6.4-8 Manual adjustment screen 3 In principle, the manual adjustment is carried out according to the following steps. 1 ► 2 ► 3 ► 4 ► 5 ► 6 ► 7 ►

Touch a button corresponding to the unit and the position to be adjusted. A pop-up window appears in which there are a maximum of most six buttons: OK, Cancel and two or four buttons for the horizontal or vertical movement. At the same time the unit moves to the position where the adjustment should take place. Adjust the mechanical unit position by pressing buttons for the horizontal or vertical movement. After adjusting so that the gripper seems to stay in the best position, additionally move the unit according to the offset value described in the Table in Chapter 4.5.1 for the positions for which the offset values are defined (only some gripper positions). Press the OK button when you are sure you have completed the adjustment successfully. If not, press Cancel. The pop-up window closes and the unit moves to the adjusted position when you touch the OK button.

The adjustment parameters are updated when you close an adjustment by pressing the OK button. This update is carried out even if an error takes place while the mechanical unit is moving after the OK button has been touched. The adjustment parameters are displayed in the buttons in the three screens for the adjustment. By the time that the unit arrives at the position where the adjustment takes place, touching the buttons is no longer effective. If the initial movement or the movement triggered by touching one of the buttons for the movement is suspended for some reason, e.g. an error, the pop-up window can only be closed using the Cancel button. Usually the database update takes place in both the RAM and CF.

6.4.2 Adjustment Rack 6.4.2.1 How to select a unit to be adjusted in the Adjustment Rack screen Touch the Adjustment Rack button in the Service screen to display the screen. After touching a button in the Adjustment Rack screen, a pop-up window appears in the screen. In principle, the Adjustment Rack is carried out in the same manner as described in Chapter 6.4.1. For details of the adjustment, refer to the Table in Chapter 4.5.3. Version 1.0 – May 2006

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Figure 6.4-9 Adjustment Rack Sampler screen The following table summarizes the Adjustment Rack. Table 6.4-1 Summary of the Adjustment Rack A Line

Unit

Position Loading Pos.

B Line

Sampling Pos.

Unloading Pos.

BCR Reading Pos.

Sample & Rack ID Position

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Preparation 1.

Set a tray with a rack on the A line.

1.

If there is a rack on the line, remove it.

2.

Set a rack with a tube in the position 1 of the rack at the STAT position.

1.

If there is a rack on the line, remove it.

2.

Set a rack with a tube in the position 1 of the rack at the STAT position.

1.

If there is a rack on the line, remove it

2.

Set a rack with five tubes with BC labels at the STAT position.

No Preperation required

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Adjustment Right + /Left Front - /Back +

Front - /Back +

Automatic Adjustment

Manual Input

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Figure 6.4-10 Pop-up Screen for B Line Manual Input

6.4.3 BCR Setup 6.4.3.1 Initialization The BCR Initialize function is to be carried out as follows when you replace the BCR. • • •

Touch the Service button in the Maintenance Screen (see Figure 6.4-2,Figure 6.4-3). After touching the button in the BCR Initialization, a pop-up window appears as in Figure 6.4-11. Touch the OK button to complete the BCR Initialize function.

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Figure 6.4-11 Pop-up window for Initialize

Note: The FLASH memory in the BCR has a lifetime of up to 1000 storage times. Therefore, the Initialize and Check Digit functions should not be carried out too often.

Note: The above items are stored into the FLASH memory of the BCR even if you switch the instrument off.

6.4.3.2 Check Digit Four Sample BCR decode functions are available. Code39, Interleaved 2 of 5, and Codabar (NW-7) correspond to a button in the Check Digit screen. Code128 is automatically available. 1 ► 2 ► 3 ► 4 ►

Touch the Check Digit button in the System Screen. After touching the button in the System screen, a Check Digit pop-up window appears as shown in Figure 6.4-12. Select a Check Digit according to the Barcode label required by the customer by touching the appropriate button. Touch the Send button if OK.

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Figure 6.4-12 Check Digit Popup screen

Note: The user is recommended to use a bar code label that contains a check digit in order to ensure reliable bar code reading.

6.4.3.3 Rack-Id Read Digit This function is not available for the disk version. 1 ► 2 ► 3 ► 4 ►

Touch the Rack Assignment button in the System screen as shown in Figure 6.4-13. After touching the Rack Assignment button in the System screen, a Rack-Id Digit setup popup window appears as shown in Figure 6.4-14. Select a digit number for Rack-Id reading. Touch the OK button after selecting the number.

Figure 6.4-13 Rack Assignment screen (for rack sampler)

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Figure 6.4-14 Digit Pop-up window

6.4.4 Service Setup There are three functions available for service activities as follows.

Figure 6.4-15 Special Function Setting screen

6.4.4.1 Total Test counter Reset This function resets the Test Counter by touching the button. After resetting the Test Counter, confirm the action in the Instrument Setup screen. Version 1.0 – May 2006

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The counter should not normally be reset, since it allows the total number of cycles performed on the instrument to be checked.

6.4.4.2 Cell Test counter Reset This function resets the Measuring Cell Test Counter by touching the button. The cell test counter should be reset if the measuring cell is exchanged. After resetting the Measuring Cell Test Counter, confirm the action in the Instrument Setup screen.

6.4.4.3 Effective signal This function prints out an Effective Signal [count] for the test result by touching the button when you want to know the count for detailed service activities.

Note: This function should only be used for service activities. The number of total results to be stored in the database is lower when this function is activated.

6.4.5 Service Maintenance 6.4.5.1 Instrument Information Printout Instrument Information Printout is a maintenance function that provides several technical information like System Volume, Last LFC Date, Test Counter, Cell Exchange Counter and Adjustment Values via printout. Refer the example on the next page.

Figure 6.4-16 Instrument Information Printout screen

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Example for Printout of Instrument Information:

Figure 6.4-17

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Figure 6.4-18 Instrument information(Print View)

6.4.6 Alarm Setting This function is Rack system only. If you need the alarm when Rack Supply is completed, set “ON”. Otherwise set “OFF”.

Figure 6.4-19 Alarm Setting screen

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6.4.7 Initial Blank Cell 6.4.7.1 Introduction After the measuring cell has been prepared and it has been checked that the signal level is in the expected signal range by means of the high voltage adjustment, the initial BlankCell calibration has to be performed. The instruments are calibrated to give the same homogeneous signal level. The initial BlankCell measurement is the first calibration done on the instrument before other assays can be calibrated. Each measured signal will first be BlankCell-corrected (parameters a (intercept) and b (slope)). The corresponding concentration is then read from the specific assay calibration. For further details refer to Chapter 2.3.12. 1 ►

Set to “ON” on BlankSet Option.

Figure 6.4-20 Initial Blank Cell Calibration screen 2 3 4 5

► ► ► ►

Start Reagent Scan (Reagent Screen ) After the scan the BLANK CELL is requested by the instrument. Press the Start button. After the Blank Cell procedure has finished, check the printout of the results carefully. The quality criteria should look the same as in the specimen printout. See attached printout of successful Initial Blank Cell (specimen).

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Figure 6.4-21 6 ► 7 ► 8 ►

It is very important that the Initial Blank Cell is successful. If not, repeat the process until it is successful, otherwise all results may not be corrected properly. Refer to Chapter 2.3.12.3 for current result targets. (If necessary start procedure once more. Go back to point 3.) If the Initial Blank Cell was successful, remove the BLANK CELL RackPack. This is very important, otherwise the instrument will do the periodic blank cell automatically. Start reagent scan.

6.4.7.2 Evaluation of Initial BlankCell • • •

Compare the mean value of the BCR1 (all values are on the printout) counts with the target. It should be: BCR1 Target range 120 to 400 counts. Check the slope value from [Initial BlankCell] screen: BCR2 Slope should be 1.0 ± 0.05 (= parameter (b)). If one of the targets is outside these limits refer to the recommendations given and repeat the procedure until the targets are reached.

6.4.7.3 Further Explanation of the Results Printed Out Headline messages and interpretations two messages are possible: •

BlankCell calibration was generated. This message means that the procedure was successful; all quality criteria were met. No need for further action.

•

BlankCell calibration can’t be generated.

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This means that the procedure failed; one or more of the quality criteria failed. The detailed quality messages and the data groups below have to be studied to determine the cause.

Quality messages and interpretations Three messages are possible, each depending on the results of the quality checks with status ok / not ok. In case of Öok no further action is needed. In case of any Önot ok the following interpretations are possible: Missing values This field displays six dashes representing the six single measurements of the procedure. In case of problems the data are not complete. The instrument was not able to perform the six measurements. If a number appears instead of a dash, there was a problem with this measurement, and this may indicate a mechanical problem.Problems with missing values cause further messages as achievement of targets and deviations of replicates Önot ok. Deviation of replicate measurements This field reads Öok if the replicate measurements are within the replicate limits listed in the columns below. Ö In case of any Önot ok a new BlankCell request has to be set and a new initial BlankCell has to be performed : Achievement of targets This field reads Ö ok if all values of the replicate measurements are within the corresponding ranges Lower and Upper around the targets. If the field reads Ö not ok, it indicates abnormal signal levels. It is possible that only one single measurement has failed. In this case the means seem to be Öok but the achievement of targets and probably the deviation of replicates are Önot ok. Comparison to last valid BlankCell This quality message was only designed for user´s periodical BlankCell. Therefore, it is ignored in case of the Initial BlankCell.

Data groups and interpretations mean target lower

upper

The median (not mean) of the replicate measurements. The value is given in PMT counts. The target value in PMT counts. The value is encoded on the BlankCell reagent barcode. The lower acceptable limit in PMT counts. The limit was formerly designed as the limit for a working range for the user’s periodical BlankCell. For initial BlankCell it detects only extreme problems (< 200 counts for BCR1 / - 7% for BCR2). A better criterion for signal levels are parameters a and b in the screen (-79 for a, 0.93 for b). The upper acceptable limit in PMT counts. The limit was formerly designed as the limit for a working range for the user’s periodical BlankCell. For initial BlankCell it detects only extreme problems (> 400 counts for BCR1 / + 7% for BCR2). A better criterion for signal levels are parameters a and b in the screen (79 for a, 1.07 for

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b). The maximum acceptable deviation of replicates to their median in percent.

Upper group shows data for measurements with BlankCell Reagent BCR1. Lower group shows data for measurements with BlankCell Reagent BCR2. Left column shows data for BlankCell measurements of last valid BlankCell procedure. This column was only designed for the user’s periodical BlankCell. Right column shows data for actual BlankCell measurements.

6.4.8 Automatic Adjustment Gripper automatic adjustment is used to adjust the gripper instead of manual adjustment.

6.4.8.1 Functions of the automatic adjustment This automatic adjustment has six functions. The following table shows the purpose of each adjustment function and the adjustment area corresponding to each adjustment function. Figure 6.422 shows how to mount tips and assay cups for automatic adjustment. Table 6.4-2 N o. 1

2 3 4 5 6

Adjustment Function Gripper All Positions Preparation Gripper All Positions Magazine Cup / Tip Sipping – Inc C / T Buffer Gripper – Z

Purpose

Adjustment Area

To adjust all positions when adjustment has never been performed.

Magazine, Incubator, Buffer

To adjust all positions when adjustment has been performed.

Magazine, Incubator, Buffer

To adjust positions on magazines.

Magazine

To adjust positions on the incubator. To adjust positions on the buffer. To adjust the height direction.

Incubator Buffer plate Magazine, Incubator, Buffer

The following table shows the adjustment positions in each adjustment area that are described in Figure 6.4-22. Table 6.4-3 No. 1 2 3

Adjustment Area Magazine Incubator Buffer

Version 1.0 – May 2006

Adjustment Positions TM1_12, TM12_29, CM1_1, CM29_1 Inc1_1, Inc4_1, Inc4_8, Sipping Tip Pos.1, CB

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Figure 6.4-22 How to mount tips and vessels for automatic adjustment

Note: Adjustment Tool for buffer area should be placed on buffer plate. 6.4.8.2 How to operate the automatic adjustment Touch the Automatic Adjustment button in the Utility screen.

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Figure 6.4-23 Automatic Adjustment screen Touch the Gripper All Position button in the Automatic screen.

Figure 6.4-24 Pop-up screen of Gripper All Positions 3. Gripper All Positions Preparation At first, all adjustment values are set to zero (0) internally and the Preparation movement is performed. All areas are continuously adjusted. Preparation is a movement to find roughly a position that can pick up Tips or Cups at each adjustment position. Adjustment of all areas is performed in two (2) or three (3) cycles. Whether or not the third cycle is performed is decided automatically on the basis of the results of the first and second cycles, but height adjustment is performed in three cycles. Adjustment values in the memory and on the FD Version 1.0 – May 2006

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are overwritten when each adjustment cycle is finished. The color Note: of the display windows for adjustment value(s) depends on the adjustment situation. 4. Gripper All Positions Adjustment of all areas is performed using the adjustment values in the memory. See Point (1) for details of the adjustment process. 5. Magazine Cup / Tip Adjustment of the magazine area is performed using the adjustment values in the memory. See Point (1) for details of the adjustment process. 6. Sipping - Incubator Adjustment of the incubator area is performed using the adjustment values in the memory. See Point (1) for details of the adjustment process. 7. C / T Buffer Adjustment of the buffer area is performed using the adjustment values in the memory. See Point (1) for details of the adjustment process. 8. Gripper - Z The height adjustment is performed in three cycles in the order of Sipping position and CB position. Adjustment values in the memory and on the FD are overwritten when each adjustment cycle is finished. The color Note: of the display windows for adjustment value(s) depends on the adjustment situation. 9. Gripper Adjust Write Media The function is to write down the gripper adjust data ( ADJSTLOG.TXT) onto a CF card. 10. Gripper Adjustment Printout The function is to print out the gripper adjust data.

Note: The display window is green, yellow or red. Refer to Chapter 6.4.5.6 for details of the meanings of the three colors.

6.4.8.3 Adjustment procedure CAUTION Do not execute System Reset when the adjustment tool is on the buffer plate because the pipetter probe will be damaged..

1 2 3 4 5

► ► ► ► ►

6 ► 7 ►

Place Tips and Cups as shown in Figure 6.4-22according to purpose. Place the adjustment tool on the buffer plate as shown in Figure 6.4-22. Touch the Automatic Adjustment button in the Util screen. Touch one of the adjustment item buttons in the Automatic Adjustment screen. If an alarm occurs during the adjustment, perform automatic adjustment again after troubleshooting. After finishing the automatic adjustment, repeat the procedure if the display windows for adjustment value(s) is red. Refer to Chapter 6.4.8.2. In order to confirm that the automatic adjustment has been completed successfully, perform the gripper / S/R Probe check.

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6.4.8.4 Display of Adjustment Values and the Displayed Colors Display of Adjustment Values Adjustment values are displayed in the display windows for adjustment value(s) in the manual adjustment screen. These displayed adjustment values are calculated from the value(s) obtained from adjustment position(s) as shown in the following table. Table 6.4-4 Adjustment Area

The Display Windows of Adjustment Value

Magazine

TM Front

Incubator

TM Back CM Left Sipping

Buffer

Incubator Tip Pos.1

X Y X Y X Y Y X Y X Y Z Z

CB Pos. Incubator Buffer

Sipping CB.Pos.

Adjustment Position Using for Calculation TM12_29(X) and CM29_1(X) TM1_12(Y) and TM12_29(Y) TM1_12(X) and CM1_1(X) CM1_1(Y) and CM29_1(Y) Inc4_1(X) and Inc4_8(X) Inc4_8(Y) Inc1_1(Y) and Inc4_1(Y) TP1(X) TP(Y) CB(X) VB(Y) Sipping(Z) CB(Z)

Meaning of the Displayed Colors The color of the display window for adjustment value(s) changes depending on the situation of adjustment. However, if the instrument is switched off and on, all display windows change to green. The following table shows the meaning of the displayed colors. Table 6.4-5 Displayed Color Green Yellow

Red

Description Adjustment finished successfully. Corresponds to alarm code 51_01_02. The Gripper could pick up a Tip or Cup at the adjustment limit of the adjustment position(s) that is (are) used to calculate the adjustment value. Therefore, there is the possibility that the automatic adjustment was not finished successfully. Corresponds to alarm code 51_01_01. The Gripper could not pick up a Tip or Cup at the adjustment position(s) that is (are) used to calculate the adjustment value on at least one occasion. Therefore, the automatic adjustment failed.

Note: If the displayed color is red, the adjustment value does not change. However, if the

adjustment values for X and Y are displayed in the same display window, one of the adjustment values may be overwritten because the adjustment values for X and Y are calculated separately.

What to do for each color of the display window The following table shows what is to be done for each color of the display window of adjustment value(s). Table 6.4-6 Displayed color Green

Yellow

What to do > No need to adjust again because the automatic adjustment was finished successfully. If any alarms occur during operation, check the cause of alarm, e.g. cups floating on the incubator, or tips and cups leaning to the side on the magazine. > Basically, no need to adjust again.

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RD/Hitachi cobas e411 Displayed color

Red

Service Manual

What to do If any alarms occur during operation, take the following measures. 1.

If the area for which the display window of adjustment value(s) has changed to yellow and the area in which alarm has happened are the same, perform automatic adjustment in the same area or adjust manually.

2.

If the area for which the display window of adjustment value(s) has changed to yellow and the area in which alarm has happened are different, check the cause of the alarm, e.g. cups floating on the incubator or tips and cups leaning to the side on the magazine.

> Readjustment is necessary because automatic adjustment failed. 1.

After performing manual adjustment of the affected position roughly, carry out automatic adjustment of the area.

2.

After checking mechanical position etc., carry out automatic adjustment of the affected area or adjust manually.

Check the Gripper X/Y Tip Pos. 1 • • •

Attach a Tip between the gripper fingers. Touch the Gripper X/Y Tip Pos.1 button in the screen as shown in Figure 6.4-18. Having attached a Tip, adjust the position so that the Tip end remains at the center of the hole.

Carry out the Gripper S/R Probe Check In order to confirm that the automatic adjustment has been completed successfully, carry out the Gripper S/R Probe Check by touching the corresponding button. • • • • •

Load three (3) magazines filled with Tips and three (3) magazines filled with Cups. Mount the System Water Container fill with system water (max. 3.5 Liters). Make sure that the Waste Box Tray is mounted correctly. Carry out mechanical reset of the waste number counter by detaching the Waste Box Tray. Make sure that the Liquid Waste Container is mounted correctly. System Reagent PC/CC bottles are not to be mounted.

NOTICE If you ignore a Pipetter LLD function which means LLD functions, but no liquid handling functions during the Gripper S/R Probe Check, the following need not be prepared. If an LLD error takes place in normal condition. •

Thirty (30) Hitachi Sample Cups filled with tap water.

•

Eighteen (18) RackPacks filled with tap water.

• • • • • • •

Make sure that the instrument is in Stand-by status. Touch the RESET button in the Maintenance screen. Touch the Gripper S/R Probe Check button in the screen. After touching the button in the screen, a pop-up window appears. Input a number of repetitions up to 180 and touch the OK button. Press the START button. Then confirm the mechanical reliability of the gripper movement.

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7.1 Alarm List See

pdf\SM7_1.pdf for more details

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Service Manual

7.2 Data Alarm List Table 7.2-1 e411 Data Alarm List

Power Fail/Power Off Cancel

Cancel

Host No (E2010 mode). 1

E.STOP Cancel

Cancel

2

-

2

STOP Cancel

Cancel

3

-

3

P.STOP/A.STOP Cancel

Cancel

4

-

4

S.STOP Cancel

Cancel

5

-

4

Recovery Cancel

Cancel

6

-

5

Data Alarm

Screen/ Printer

Host No (cobas mode).

Level

-

1

Description The test concerned was canceled by power fail or power off. The test concerned was canceled by E.Stop. Operation stopped by operator or the test concerned was canceled by Stop. The test concerned was canceled by P.Stop. Sampling stopped by operator or the test concerned was canceled by S.Stop. Determination not performed.

Sample Short

Samp.S

7

3

6

Sample short detected.

Assay Reagent Short

Reag.S

8

4

6

Reagent short detected.

Diluent Short

Reag.S

9

4

6

Diluent short detected.

Pretreatment Reagent Short

Reag.S

10

4

6

Abnormal Reagent Disk Temperature Abnormal Incubator Temperature Abnormal Measuring Cell Temperature Abnormal System Reagent Temperature System Reagent Short

Reag.T

12

74

7

Pretreatment reagent short detected. Temperature of reagent disk above permitted range.

Inc.T

13

75

7

Temperature of incubator is above permitted range.

Cell.T

14

77

7

Temperature of measuring unit is out of permitted range.

SysR.T

15

76

7

Temperature of System Reagent is above permitted range.

SysR.S

16

62

6

System Reagent short detected.

ADC abnormal

ADC.E

17

1

6

ADC data is abnormal.

Calculation Error

Calc.?

24

39

6

No Calibration Data

Cal.E

25

43

6

Previous Calibration Data

Cal.E

26

43

8

Assay Reagent Hovering

Reag.H

31

69

6

Diluent Hovering

Reag.H

32

69

6

Pretreatment Hovering

Reag.H

33

69

6

Calculation not possible. Only “No Value” may be shown and printed out . No calibration data, result calculation not possible. The measured data were calculated by using previous calibration data. Premature LLD R.disk : Assay Reagent Premature LLD R.disk : Diluent Premature LLD R.disk : Pretreatment

Assay Reagent Film Detected

Reag.F

35

70

6

Diluent Film Detected

Reag.F

36

70

6

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Film detected on assay reagent surface. Film detected on diluent surface.

Chapter 7.2

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Service Manual

Table 7.2-2

Pretreatment Film Detected

Reag.F

Host No (E2010 mode). 37

System Reagent Film Detected

Reag.F

38

70

6

AB Level Range Over

>AB

40

63

6

AB Level Check Error

AB.E

41

64

6

Current Range Over

>Curr

42

65

6

Screen/ Printer

Data Alarm

Host No (cobas mode).

Level

70

6

Description Film detected on pretreatment surface. Film detected System Reagent surface. AB signal level is out of range during “Pre-Operation” cycle. ( < 120 or > 400 counts ) AB liquid level check failed during “Pre-Operation” cycle. MC current out of range during “PreOperation” cycle. MC current check failed.

Current Range Check Error

Curr.E

43

66

6

System Reagent Temperature Unstable Sample Clot Detected

SysR.U

44

120

6

System Reagent temperature is unstable

Samp.C

45

72

6

Low Signal Sample

CarOvr

46

71

6

Sample ID Error Cancel

Cancel

47

121

6

Below normal(expected)range

L

48

41

6

Above normal(expected)range

H

49

40

6

Below measuring range

Test

51

26

6

Expired RackPack

ReagEx

52

101

7

No Sample

Samp.S

53

3

6

Clot detected when pipetter aspirates sample. Carryover from the previous sample may have occurred. Sample ID scanning was not successful. Final concentration is below expected range, less than lower limit. Final concentration is above expected range, more than upper limit. Concentration (not including diluent ratio) is below measured range, less than lower limit. Concentration (not including diluent ratio) is above measured range, more than upper limit. Result generated with expired reagent pack. No sample has been detected.

Sample LLD Inexecution

SLLD.E

54

86

6

Sample LLD Noise

SLLD.N

55

87

6

Current Range Over(Operation)

>Curr

56

99

6

Instrument Factor A

FacA

57

122

6

Signal level below limit

9.5) to the liquid waste container. Disinfectants combined with the contents of the liquid waste could cause potentially harmful fumes.

CAUTION Section 10.1.11 Clean ProCell/CleanCell Compartments DO NOT use an acid solution or an alkaline solution to clean the system reagent compartment. The compartment is made of aluminum and these solutions degrade the metal.

CAUTION Section 10.1.12 Clean Reagent Disk and Compartment Any component that comes into contact with sample fluids is potentially biohazardous and should be handled in an appropriate manner. Wear protective gloves when handling these materials.

CAUTION Section 10.1.12 Clean Reagent Disk and Compartment Take care not to scratch or smear the bar code reader window.

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CAUTION Section 10.1.3 Replace Pinch Valve Tubing Section 10.1.37 Exchange Measuring Cell Section 10.1.38 Exchange Tube B for MC Section 10.1.39 Exchange Tube B for Sipper with Nozzle seal Section 10.1.40 Exchange Tube B for Sipper Syringe Section 10.1.43 Exchange sipper wash station Any component that comes into contact with sample fluids is potentially biohazardous and should be handled in an appropriate manner. Wear clean, protective gloves when changing pinch valve tubing.

WARNING Section 10.1.3 Replace Pinch Valve Tubing Section 10.1.3710.1-37 Exchange Measuring Cell Section 10.1.38 Exchange Tube B for MC Section 10.1.39 Exchange Tube B for Sipper with Nozzle seal Section 10.1.40 Exchange Tube B for Sipper Syringe Section 10.1.43 Exchange sipper wash station 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. Wear gloves.

CAUTION Section 10.1.3 Replace Pinch Valve Tubing Make sure that you do not damage the fitting when replacing the tubing.

CAUTION Section 10.1.4 Replace Pipettor Seals For the S/R and sipper pipettor - loosen and REMOVE the locking screw to prevent damage to the glass barrel.

CAUTION Section 10.1.4 Replace Pipettor Seals Section 10.1.5 Exchange packing fo sipper & pipetter syringe Do not overtighten the pipettor retaining screw.

CAUTION Section 10.1.4 Replace Pipettor Seals If the pipettor holder is not properly seated in its mounting block recess, damage to the pipettor assembly may occur.

CAUTION Section 10.1.4 Replace Pipettor Seals Section 10.1.5 Exchange packing fo sipper & pipetter syringe The top and side tubing retaining nuts can be damaged if excessive force is applied when replacing them. Take care not to cross-thread these nuts.

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CAUTION Section 10.1.9Check mixer speed; adjust if necessary Before starting operation or after maintenance/checks, be sure that all analyzer covers are closed. DO NOT open the analyzer covers while the analyzer is in operation. Do not open the Reagent Disk cover while the analyzer is in operation.

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Service Manual

10.1 Maintenance Procedure Overview The following procedures are written for trained service engineer with a working knowledge of all instrument mechanical functions, software displays and software functions. The instrument must be provided with proper care and maintenance to ensure consistent and accurate functioning.

How to Use this Chapter All maintenance procedures are listed in descending frequency. Each maintenance procedure is divided into two parts: the Introduction and the Procedure. The Introduction provides important information about the procedure, which includes: • • • •

recommended frequency materials required time required precautions.

The recommended frequency is based on using the analyzer 8 hours per day, 5 days per week. The materials required provides you with a list of all materials needed to perform each procedure. The time required includes both operator time and analyzer time, when appropriate. Precautions are included for your protection. The Procedure gives step-by-step directions for performing the required maintenance function. This part frequently is divided into smaller procedure blocks to help you organize your approach to maintenance.

Replacement Parts A replacement part may be needed for a specific maintenance procedure. That part's description and catalog number are included in the Materials Required table of each procedures' Introduction. Please use the catalog number when ordering replacement parts. Remember, you are responsible for maintaining an adequate spare parts inventory. For most efficient use of time, gather all required materials before starting the maintenance procedure.

Maintenance Schedule Detailed descriptions of the maintenance procedures listed below are found later in this chapter. Table 10.1-1 Every 6 Months

Liquid System

Maintenance procedure every 6 months 1. Replace pipettor tube 510 2. Replace pipettor tube 465 with nozzle seal 3. Replace Pinch Valve Tubing 4. Replace Pipettor Seals (S/R and sipper) 5.Exchange packings for sipper & pipettor syringe 6. Clean Rinse Station for S/R probe ,Mixer and Sipper Probe 7. Clean Sipper and S/R probe

Remarks

Exchange the pinch tubes every 2months by coustomer.

Clean sipper probe and S/R probe tip with 70% isopropyl alcohol. S/R probe only with distilled or deionised water.

8. Clean water filter main pump 9. Clean System Water Container

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Liquid System

Service Manual

Maintenance procedure every 6 months 10. Clean Liquid Waste Container 11. Clean ProCell/CleanCell Compartments 12. Clean Reagent Disk and Compartment 13. Check drain tubes for contamination and exchange if necessary

14. Drain the outlet pipettor wash station and waste pipe 15. Perform Liquid Flow Cleaning with new tubings

16. Perform system volume check 17. Exchange mixer belt S 18. Clean mixer paddle 19. Check mixer speed; adjust if necessary Transport Unit

20. Check / Clean gripper finger

Voltage monitor

21. Clean light barriers and mechanic parts 22. Clean incubator and aspiration satation 23. Check LLD voltage pipettor 24. Check LLD voltage sipper 25. Check clot voltage

Temperatur monitor

26. Detection unit 27. Incubator 28. Reagent

Barcode reader System performance check

29. PC / CC 30. Clean peltier elements from dust if necessary 31. Clean BCR window and window reagent disk 32. Perform artificial media check 33. Perform TSH assay test 34. Perform initial blank cell 35. Perform assay calibration 36. Perform assay control

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Remarks

In case whole tubing system (except Sipper side) seems to be contaminated perform cleaning procedure with Perhydrol-solution. Refer to chapter 3.3.2. use SysClean solution The Service LFC is only necessary during PM visits if the Sipper line is highly contaminated or if LFC has not been carried out regularly by the customer.

Change if the paddle is bent 2000 rpm ± 100 in liquid 2050 ± 100 in air clean gripper finger with soaked (distilled or deionised water. ) cotton stick

pipettor in upper dead point without Tip < 1.5V sipper in upper dead point < 3.5V after S/R prime 1.8V ± 1.3 ( P-sensor 2 ) approx. 28°C; Target influenced by ambient temperature 37°C approx. 18°C; Target influenced by ambient temperature 28°C

Refer to Chapter 6.3.2.3 and 2.3.13.1. Refer to Chapter 6.3.2.4 and 2.3.13.2. Refer to Chapter 6.4.7 and 2.3.12. Refer to Chapter 2.3.14 and Operator’s manual. Refer to Chapter 2.3.14 and Operator’s manual.

Chapter 10.1

RD/Hitachi cobas e411

Service Manual

Table 10.1-2 Every 12 Months

Measuring Unit

Liquid system

Transport Unit

Maintenance procedure every 12 months 37. Exchange measuring cell

38. Exchange tube B for MC 39. Exchange tube B for sipper with nozzle seal 40. Exchange tube B for sipper syringe 41. Clean the valve body on the system water container 42. Exchange O-ring SV 1 / 2 / 5 / 6 / 7 43. Exchange sipper wash station 44. Exchange the spring at the gripper finger

Remarks Exchange the measuring cell every 12 months or after measuring 50,000 tests whichever comes first. For installation refer to chapter 2.3.9. Together with the measuring cell.

Solenoid valves above the magnet pump.

10.1.1 Replace pipettor tube 510 Note: Read Safety Information Recommended frequency: Operator time: Analyzer time: Precautions: Materials Required Gauze squares Distilled or deionized water 70% isopropyl alcohol

6 Months at PM visits Approximately 15 minute. Approximately 15 minute. The operation switch must be OFF. Catalog Number obtain locally -------------

10.1.1.1 Procedure Exchange Tube 510 1 ►

Remove the cover until entering the following condition.

Figure 10.1-1 Removing the front cover 2 ►

Remove GUIDE as shown in Figure 10.1-2.

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Figure 10.1-2 Removing GUIDE 3 ►

Remove COVER as shown in Figure 10.1-3.

Figure 10.1-3 Removing COVER 4 ► 5 ► 6 ►

Draw out the Tube 510. Remove Tube 510 on the side of P-SENSOR2 ASSY. Use gauze etc. so that the drop of water might leak from the tube.

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Figure 10.1-4 Removing Tube510 on the side of P-SENSOR2 ASSY 7 ►

Remove Tube 510 on the side of JOINT 2.

Figure 10.1-5 Removing Tube 510 on the side of JOINT 2 8 ► 9 ►

Follow the reverse procedure of removing for installation. After exchange Tube 510, operate the S/R Pipettor right and left. Because to take care about drawing tube.

Prime the Pipettors 1 ► 2 ► 3 ►

Open the Utility/Maintenance tab screen after initialization is complete. Select “Maintenance” in the maintenance type list and then “S/R Pipettor Prime” in the maintenance item list. The S/R Pipettor Prime pop-up window opens. Type “10” in the text box and touch Start. The liquid system is purged of air. During priming, check the pipettor and tubing connections for leaks. The plunger should be in the correct position and must be moving up and down continuously.

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10.1.2 Replace pipettor tube 465 with nozzle seal Note: Read Safety Information Recommended frequency: Operator time: Analyzer time: Precautions: Materials Required Gauze squares Distilled or deionized water 70% isopropyl alcohol

6 Months at PM visits Approximately 15 minute. Approximately 15 minute. The operation switch must be OFF. Catalog Number obtain locally -------------

Procedure Exchange Tube 465 1 ►

Remove the cover until entering the following condition.

Figure 10.1-6 Outline view of the pipettor 2 ►

Remove the pipettor cover.

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Figure 10.1-7 Removing the pipettor cover 3 ► 4 ►

Remove the tube 465 on the side of a nozzle. Use gauze etc. so that the drop of water might leak from the tube.

Figure 10.1-8 Removing of the tube 465 on the side of a nozzle 5 ►

Remove the tube 465 from PULLEY and PULLEY 1.

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Figure 10.1-9 Removing the tube 465 6 ►

Remove the tube 465 on the side of JOINT 2.

Figure 10.1-10 Removing the tube 465 on the side of JOINT 2 7 ► 8 ►

Follow the reverse procedure of removing for installation. After exchange Tube 465, move the tube up and down. Confirm the tube doesn't come off from PULLEY.

Prime the Pipettors 1 ► 2 ► 3 ►

Open the Utility/Maintenance tab screen after initialization is complete. Select “Maintenance” in the maintenance type list and then “S/R Pipettor Prime” in the maintenance item list. The S/R Pipettor Prime pop-up window opens. Type “10” in the text box and touch Start. The liquid system is purged of air. During priming, check the pipettor and tubing connections for leaks. The plunger should be in the correct position and must be moving up and down continuously.

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10.1.3 Replace Pinch Valve Tubing NOTICE Read Safety Information

Worn pinch valve tubing allows liquid to leak, thereby affecting the accuracy of the pipetting volumes and the ability to properly clean the measuring cell. Recommended frequency: Operator time: Analyzer time: Precautions: Materials Required Pinch valve tubing

6 Months at PM visits. Approximately 2 minutes. Approximately 15 minutes. The operation switch must be OFF while changing the tubing. Catalog Number 741-0941

Purge the Tubing of Liquid 1 ► 2 ► 3 ► 4 ► 5 ►

Select Utility -> Maintenance. Select “Maintenance” in the maintenance type list box (left). In the maintenance items list box (right), select “Measuring Cell Exchange“ and touch the Select button.The Measuring Cell Exchange pop-up window opens. Touch Start. The tubing is purged of liquid. When the analyzer returns to Stand-by, power it OFF.

Remove the Tubing from the Fittings The pinch valve tubing and fittings are located above the S/R and sipper pipettors. Refer to the reference point photograph at the right and then to the enlarged view of the area in the photograph below.

Figure 10.1-11 Reference point for pinch valve tubing

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Figure 10.1-12 Enlarged view of pinch value tubing and fittings 1 ► 2 ► 3 ► 4 ► 5 ► 6 ►

Remove the distilled water container and cover around the foot area of the pipettor unit with paper towels Carefully remove the pinch valve tubing from the fittings on the metal plate while holding a dry gauze square around the tubing. Use the gauze square to absorb liquid comes out of the released tubing. Remove the tubing from the pinch valve and discard it. Take a new piece of tubing and insert it through the pinch valve. Verify the tubing length is 180 mm. If not, cut the tubing to that length. Carefully slide the ends of the tubing over each of the fittings. In the photo on the previous page, one set of fittings is shown with solid red circles and the other pair of fittings is shown with dotted red circles. Verify that each tubing end is connected to the appropriate fitting according to the diagram shown below.

Figure 10.1-13 pinch valve tubing 7 ►

Repeat the procedure for the other pinch valve tubing.

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Prime the Sipper Pipettor 1 2 3 4 5 6 7

► ► ► ► ► ► ►

Power ON the analyzer. Select Utility -> Maintenance. Select “Maintenance” in the maintenance type list (left). Select “Sipper Pipettor Prime” in the maintenance items list (right). Touch Select. The Sipper Pipettor Prime pop-up window opens. Type "10" in the text box. Touch Start. The pop-up window closes and the system begins purging air out of the pipettor system. While the system is priming, check for leaks at the fittings and on the tubing.

Prime the Measuring Cell 1 2 3 4 5 6

► ► ► ► ► ►

Select Utility -> Maintenance. Select “Maintenance” in the maintenance type list (left). Select “Measuring Cell Preparation” in the maintenance items list (right). Touch Select. The Measuring Cell Preparation pop-up window opens. Type "10" in the text box. Touch Start. The pop-up window closes and the system begins priming the measuring cell with ProCell. While the system is priming, check for leaks at the fittings and on the tubing.

NOTICE If a fitting breaks while exchanging a pinch valve tube, exchange it with a new one by following the procedure described below . 1. Remove the broken fitting by turning it counterclockwise. 2. Attach a new fitting on the valve block by turning it clockwise. 3. Proceed with the pinch valve tubing maintenance.

10.1.4 Replace Pipettor Seals NOTICE Read Safety Information

A worn seal piece allows liquid to leak, thereby affecting the accuracy of the pipetting volumes However, should the seals require replacement between visits, instructions are provided below. Recommended frequency: Operator time: Analyzer time: Precautions: Materials Required S/R pipettor seal Sipper pipettor seal Spanner wrench Absorbent towels Gauze squares Distilled or deionized water 70% isopropyl alcohol

6 Months at PM visits. Approximately 15 minutes. Approximately 5 minutes. The operation switch must be OFF while changing the seals. Catalog Number 741-1302 741-1303 741-0919 obtain locally obtain locally ------obtain locally

Disassemble Pipettor 1 ►

Disconnect the tubing at the top of the pipettor assembly by turning its retaining nut counterclockwise.

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Figure 10.1-14 Loosen pipettor retaining nut 2 ►

Hold a dry gauze square or other absorbent material next to the side tubing of the pipettor; disconnect this tubing by turning its retaining nut counterclockwise. Use the gauze square to absorb water as it drains from the tubing.

Figure 10.1-15 Disconnect tubing 3 ►

Loosen the knurled locking screw from the top of the pipettor assembly by turning it counterclockwise.

Figure 10.1-16 Loosen knurled locking screw

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Service Manual

Carefully pull the pipettor assembly out of its mounting block. With one hand, support the glass barrel. With the other hand, grasp the pipettor holder and lift up, then out to remove the assembly. Make sure the plunger is removed from the U-shaped slot.

Note: Avoid touching the top of the glass barrel. Note: For sipper pipettor - pull the plunger down far enough so that you can lift out the glass barrel. Then remove the remaining pipettor assembly.

Figure 10.1-17 Remove pipettor assembly 5 ►

Remove the glass pipettor barrel. Set it aside in a safe place. Remove the o-ring that fits below the pipettor barrel and set in a safe place.

Figure 10.1-18 Remove o-ring

Expose Pipettor Seal 1 ► 2 ► 3 ►

Turn the pipettor holder upside down and expose the plunger retaining screw. Apply the spanner wrench to the plunger retaining screw and turn the screw counterclockwise until it is loose. Turn the pipettor holder right side up and carefully lift the pipettor holder off of the plunger. Leave all parts on the plunger.

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Figure 10.1-19 Remove pipettor holder

Replace Pipettor Seal 1 ► 2 ►

Remove the seal piece, press piece, spring and retaining screw from the plunger. Dispose of the seal piece. Wipe the plunger with a gauze square soaked in 70% isopropyl alcohol to remove any debris. Follow with a gauze square soaked with distilled or deionized water.

Figure 10.1-20 Remove S/R pipettor seal piece

Figure 10.1-21 Remove sipper pipettor seal piece

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Service Manual

Ensure that the retaining screw, spring and press piece are properly positioned on the plunger. Place the new seal on the plunger, verifying the rounded end is down. Refer to the graphic on the right for the correct order of the individual parts. Although the actual components of the sipper pipettor may not be the same size as those of the S/R pipettor, they are assembled in the same order.

Figure 10.1-22 Pipettor assembly order 4 ►

Place the plunger back in the pipettor holder with the pipettor vertically oriented. Tighten the retaining screw with the spanner wrench until the screw is snug with the pipettor holder.

Figure 10.1-23 Tighten retaining screw

Reassemble Pipettor 1 ► 2 ►

Place the pipettor holder o-ring into the pipettor holder. If the o-ring appears damaged or worn, replace it. Inspect the glass pipettor barrel for chips or cracks at the top and bottom. If the pipettor barrel is etched or damaged in any way, replace it. Place the pipettor barrel over the plunger and onto the pipettor holder. It is easier to place the barrel back on if the barrel and pipettor holder are dry.

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Service Manual

Return the pipettor holder onto its mounting block by tilting the top of the pipettor toward the instrument. Ensure that the pipettor holder is in the recess on the top surface of the mounting block. The notched (bottom) end of the plunger must be secured within the U-shaped notch of the stepper motor. Rotate the pipettor holder until the side tube port is positioned to accept the pipettor tubing. Finger-tighten the top knurled locking screw. Ensure that the pipettor assembly is seated correctly (not loose or crooked) and the glass barrel o-ring is properly positioned.

Figure 10.1-24 Secure plunger in notch

Figure 10.1-25 Replace retaining nut 7 ► 8 ► 9 ►

Reconnect the pipettor's top tubing and finger-tighten its retaining nut. Reconnect the side tubing and finger-tighten its retaining nut. Turn the analyzer power ON.

Prime the Pipettors 1 ► 2 ► 3 ►

Open the Utility/Maintenance tab screen after initialization is complete. Select “Maintenance” in the maintenance type list and then “S/R Pipettor Prime” in the maintenance item list. The S/R Pipettor Prime pop-up window opens. Type “10” in the text box and touch Start. The liquid system is purged of air. During priming, check the pipettor and tubing connections for leaks. The plunger should be in the correct position and must be moving up and down continuously.

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Service Manual

If air bubbles are found on the plunger, gently tap on the glass barrel to remove the air bubbles. If this is not successful, remove the pipettor and thoroughly clean the plunger again with a gauze square soaked in 70% isopropyl alcohol. Repeat steps 1 ► - 4 ►, if necessary. When you change the sipper pipettor seal, repeat steps 1 ► - 5 ►, but select “Sipper Pipettor Prime” instead of “S/R Pipettor Prime” in the maintenance items list.

Note: The sipper pipettor plunger does not move up and down during a sipper prime. Prime the Measuring Cell 1 2 3 4 5 6 7

► ► ► ► ► ► ►

Power ON the analyzer. Select Utility -> Maintenance. Select “Maintenance” in the maintenance type list (left). Select “Measuring Cell Preparation” in the maintenance items list (right). Touch Select. The Measuring Cell Preparation pop-up window opens. Type "5" in the text box. Touch Start. The pop-up window closes and the system begins priming the measuring cell with ProCell.

10.1.5 Exchange packings for sipper & pipettor syringe NOTICE Read Safety Information

Recommended frequency: Operator time: Analyzer time: Precautions: Materials Required Gauze squares Distilled or deionized water 70% isopropyl alcohol Tweezers

6 Months at PM visits Approximately 10 minute. Approximately 15 minute. The operation switch must be OFF. Catalog Number obtain locally ------------obtain locally

Procedure Exchange packings for sipper & pipettor syringe 1 ► 2 ► 3 ►

Remove the cover until entering the following condition. Remove the nipple on the side of a syringe. Use gauze etc. so that the drop of water might leak from the tube.

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Figure 10.1-26 Removing the nipple on the side of a syringe 4 ►

The following Figure 10.1-27 is the top view after following the step 1.

Figure 10.1-27 Top view of the syringe with the nipple removed. 5 ► 6 ►

Remove packings with tweezers. Must not damage the tube etc., by using tweezers.

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Figure 10.1-28 Removing packings 7 ►

Follow the reverse procedure of removing for installation.

Prime the Pipettors 1 ► 2 ► 3 ►

Open the Utility/Maintenance tab screen after initialization is complete. Select “Maintenance” in the maintenance type list and then “S/R Pipettor Prime” and “Sipper Pipettor Prime” in the maintenance item list. The S/R Pipettor Prime and Sipper Pipettor Prime pop-up window opens. Type “10” in the text box and touch Start. The liquid system is purged of air. During priming, check the pipettor and tubing connections for leaks. The plunger should be in the correct position and must be moving up and down continuously.

10.1.6 Clean Rinse Stations for S/R Probe, Mixer and Sipper Probe NOTICE Read Safety Information

Contamination in the rinse stations for the S/R probe, the mixer and the sipper probe can be responsible for carryover. To prevent contamination, clean the rinse stations every 6 Months at PM visit. Recommended frequency: Operator time: Analyzer time: Precautions: Materials Required Cotton swabs 70% isopropyl alcohol Syringe with attached tubing Distilled or deionized water (approximately 300 mL)

6 Months at PM visits. Approximately 10 minutes. None. The operation switch must be OFF. Catalog Number obtain locally obtain locally obtain locally ----------

Procedure 1 ►

Move the S/R probe and the mixer to an area away from the rinse stations. Also, open the sipper safety cover and move the sipper probe to an area away from the rinse stations.

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Figure 10.1-29 Move component away from rinse station 2 ► 3 ► 4 ► 5 ► 6 ► 7 ► 8 ►

Take a syringe with tubing attached to its end (as in the photo on the right) and aspirate the water out of the mixer rinse station. Use a cotton swab soaked in 70% isopropyl alcohol to thoroughly clean the S/R probe, mixer and sipper rinse stations. Take another cotton swab soaked in distilled or deionized water and wipe the rinse stations again. Fill the syringe with distilled or deionized water and refill the mixer rinse station. This should take approximately 50-100 mL of water. Also, flush the S/R probe and sipper rinse stations with water (50-100 mL). Aspirate the water out of the mixer rinse station again using the syringe. Refill the mixer rinse station and flush all the rinse stations with distilled or deionized water one final time. When you power ON the analyzer, it performs the start-up reset operation, and each mechanism returns to its home or Stand-by position.

Note: You may want to use two syringes for this procedure - one for aspirating liquid and the other for refilling the rinse stations.

Figure 10.1-30 Aspirate/refill the rinse stations

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Figure 10.1-31 Swab mixer rinse station

10.1.7 Clean Sipper and S/R probe 10.1.7.1 Clean Sipper Probe NOTICE Read Safety Information

Dirt on the sipper probe may cause contamination and carryover, and affect results. Clean this part at PM visits to prevent contamination. Recommended frequency: Operator time: Analyzer time: Precautions: Materials Required Gauze squares Distilled or deionized water 70% isopropyl alcohol

6 Months at PM visits. Approximately 1 minutes. None. The operation switch must be OFF. Catalog Number obtain locally obtain locally obtain locally

Procedure 1 ►

Open the sipper safety cover.

Note: How to open the sipper safety cover

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Figure 10.1-32 Opening/closing the sipper safety cover (Push the circled point)

Figure 10.1-33 Sipper safety cover (when opened) 2 ► 3 ► 4 ►

Move the sipper probe to an area where you can readily access it. Wipe the outer surfaces of the sipper probe with a gauze square soaked in 70% isopropyl alcohol. Follow with a gauze square soaked in distilled or deionized water. When completed, close the sipper safety cover.

Figure 10.1-34 Sipper probe 5 ►

When you power ON the analyzer, it performs the start-up reset operation, and each mechanism returns to its home or Stand-by position.

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10.1.7.2 Clean S/R Probe NOTICE Read Safety Information

Dirt on the sample/reagent (S/R) probe may cause contamination and carryover, and affect results. Clean this part to prevent contamination. Recommended frequency: Operator time: Analyzer time: Precautions: Materials Required Gauze squares Distilled or deionized water 70% isopropyl alcohol

6 Months at PM visits Approximately 1 minute. None. The operation switch must be OFF. Catalog Number obtain locally obtain locally obtain locally

Procedure 1 ► 2 ►

Move the S/R probe to an area where you can readily access it. Wipe the outer surfaces of the S/R probe and probe tip with a gauze square soaked in distilled or deionized water.

Figure 10.1-35 Wipe S/R probe

Figure 10.1-36 S/R probe tip

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If the probe appears dirty, wipe the outer surfaces with a gauze square soaked in 70% isopropyl alcohol. Follow with a gauze square soaked in distilled or deionized water. When you power ON the analyzer, it performs the start-up reset operation, and each mechanism returns to its home or Stand-by position.

10.1.8 Clean water filter main pump NOTICE Read Safety Information

Recommended frequency: Operator time: Analyzer time: Precautions: Materials Required Gauze squares Distilled or deionized water 70% isopropyl alcohol Drainage container

6 Months at PM visits Approximately 10 minute. None. The operation switch must be OFF. Catalog Number obtain locally ------------obtain locally

Procedure 1 ► 2 ► 3 ►

Remove the System Water Container. Open the cover for main pump part. Shows the main pump part.

Figure 10.1-37 Main pump part 4 ► 5 ►

Prepare the drainage container. Rotate the water filter to drain water by using a drainage container as shown in Figure 10.1-38

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Figure 10.1-38 How to drain water 6 ► 7 ►

Remove the water filter. Figure 10.1-39 shows the water filter.

Figure 10.1-39 Water filter 8 ►

Dismanel the water filter.

Figure 10.1-40 Dismantling the water filter 9 ►

Take FILTER NOZZLE part out from the water filter as shown in Figure 10.1-41 and clean it.

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Figure 10.1-41 Taking out FILTER NOZZLE part 10 ►

Follow the reverse procedure of removing for installation.

10.1.9 Clean System Water Container A contaminated system water container can adversely affect analyzer performance. Clean the system water container at PM visits. Recommended frequency: Operator time: Analyzer time: Precautions: Precautions: Materials Required Gauze squares Cleaning brush Paper towels 70% isopropyl alcohol

6 Months at PM visits. As needed. Approximately 10 minutes. None. The analyzer must be in Stand-by or turn OFF the operation switch. Catalog Number obtain locally obtain locally obtain locally obtain locally

Procedure 1 2 3 4

► ► ► ►

Raise and remove the system water container. Remove the cap and discard any water remaining inside. Rinse the container with water, then follow with distilled or deionized water. If the inside of the container appears dirty or contaminated use a large cleaning brush immersed in 70% isopropyl alcohol to scrub the interior of the container. Rinse thoroughly with distilled or deionized water.

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Figure 10.1-42 Remove system water container 5 ► 6 ►

Remove the valve on the bottom of the system water container. Clean the valve with a wet brush, then rinse with distilled or deionized water. If the valve appears dirty, use a brush immersed in 70% isopropyl alcohol to clean the valve. Then, rinse thoroughly with distilled or deionized water.

Figure 10.1-43 Valve body on the System Water Container 7 ► 8 ►

Use a gauze square to wipe and clean the aspiration inlet for distilled or deionized water supply, located on the analyzer. Connect the valve on the container bottom and fill the container with distilled or deionized water. Then, dry the outside of the container with paper towels, attach the cap to the container and return the container to the analyzer.

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Figure 10.1-44 Aspiration inlet

10.1.10 Clean Liquid Waste Container NOTICE Read Safety Information

A full liquid waste container causes an alarm and interrupts operation. The liquid waste container must be checked and emptied as needed. Recommended frequency: Operator time: Analyzer time: Precautions:

6 Months at PM visits. Approximately 5 minutes. None. The analyzer must be in Stand-by or turn OFF the operation switch. Do not execute System Reset or Reagent Scan, or power ON the analyzer while cleaning the liquid waste container. Materials Required Catalog Number 70% isopropyl alcohol obtain locally Paper towels obtain locally optional - germicidal agent (pH obtain locally 9)

Procedure 1 ► 2 ► 3 ► 4 ► 5 ► 6 ► 7 ►

Pull the liquid waste container toward you, cap it and raise it carefully, while avoiding the liquid waste outlet. Place a folded paper towel under the waste outlet to catch any waste droplets that may fall. Empty the container and rinse it thoroughly with water. If the inside of the container appears dirty, use 70% isopropyl alcohol to rinse the container. Follow with a thorough water rinse. Wipe the outside of the container with a paper towel. Use a paper towel to wipe the compartment where the container is to be placed. OPTIONAL - Add the appropriate volume of a germicidal agent with a pH - 9 (as directed in its product labeling) to the liquid waste container.

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Figure 10.1-45 Remove liquid waste container 8 ►

Remove the paper towel under the waste outlet and replace the liquid waste container. Push the container forward so that the container opening is under the liquid waste outlet. Be sure to remove the cap.

10.1.11 Clean ProCell/CleanCell Compartments NOTICE Read Safety Information

The system reagent compartment should be cleaned as needed to eliminate spills from the ProCell and CleanCell reagents. Recommended frequency: Operator time: Analyzer time: Precautions: Materials Required Gauze squares Distilled or deionized water

6 Months at PM visits. Approximately 5 minutes. None. The operation switch must be OFF. Catalog Number obtain locally ------

Procedure 1 ►

Open the sipper safety cover. Push on the part indicated in the picture below.

Figure 10.1-46 Open the sipper safety cover Version 1.0 – May 2006

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Move the sipper arm as far to the left as the arm will allow. Remove the ProCell and CleanCell reagent bottles. Wipe the inside of the compartments with damp, not wet, gauze squares. DO NOT allow water to pool in the bottom of the compartments. Take care to avoid the photosensors in compartment positions 2 and 3. These sensors check for the presence of the ProCell/CleanCell bottle sets. They appear as rectangular windows located at the back of the compartment, just below the top edge. If you should get the sensors wet, use a cotton swab to dry them.

Figure 10.1-47 Wipe ProCell/CleanCell compartments 5 6 7 8

► ► ► ►

Wipe the compartment with a dry gauze square. Return the ProCell and CleanCell reagents to their respective system reagent compartments. Close the sipper safety cover. When you power ON the analyzer, it performs the start-up reset operation, and each mechanism returns to its home or Stand-by position.

10.1.12 Clean Reagent Disk and Compartment NOTICE Read Safety Information

Reagent spills should be cleaned up as they occur. The reagent disk and compartment must be cleaned every 6 Months at PM visits. Recommended frequency: Operator time: Analyzer time: Precautions: Materials Required Gauze squares Distilled or deionized water 70% isopropyl alcohol Cloth or lint-free towels

6 Months at PM visits. Approximately 15 minutes. None. The operation switch must be OFF. Catalog Number obtain locally -----obtain locally obtain locally

Clean the Reagent Disk 1 ► 2 ► 3 ► 4 ►

Remove the cover from the reagent disk. Loosen and remove the black thumbscrews on the center of the reagent disk. Completely close the reagent pack caps and remove all the reagent packs from the reagent disk. Remove the reagent disk from the compartment.

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Figure 10.1-48 Loosen and remove thumbscrews 5 ► 6 ► 7 ►

Wipe the inside and outside of the reagent disk with gauze squares soaked with distilled or deionized water. If the disk appears dirty, use gauze squares soaked with 70% isopropyl alcohol to clean the disk. Follow with gauze squares soaked with distilled or deionized water. Dry the reagent disk with a cloth or lint-free towels. Set the reagent disk aside.

Figure 10.1-49Clean the inside of the reagent disk

Clean the Reagent Disk Compartment 1 ► 2 ► 3 ► 4 ► 5 ► 6 ► 7 ►

Wipe the reagent disk compartment with gauze squares soaked with distilled or deionized water. If the compartment appears dirty, use gauze squares soaked with 70% isopropyl alcohol to clean the compartment. Follow with gauze squares soaked with distilled or deionized water. Dry the reagent disk compartment with a cloth or lint-free towels. Return the reagent disk to the compartment. The disk is keyed; make sure that the alignment pin on the center plate (refer to photo above) is aligned with the hole on the disk. Securely reinstall the thumbscrews. Place the reagent packs back into the reagent disk. Replace the reagent disk cover and lock.

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Figure 10.1-50 Clean the reagent disk compartment

10.1.13 Check drain tubes for contamination and exchange if necessary NOTICE Read Safety Information

Recommended frequency: Operator time: Analyzer time: Precautions: Materials Required Gauze squares Distilled or deionized water 70% isopropyl alcohol

6 Months at PM visits Approximately 10 minute. None. The operation switch must be OFF. Catalog Number obtain locally -------------

Procedure 1 ► 2 ►

Remove the cover until entering the following condition. Remove the drain tube shown in Figure 10.1-51.

Figure 10.1-51 Removing the drain tube

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Figure 10.1-52 COVER 3 ► 4 ►

Remove COVER. Show the drain tube as shown Figure 10.1-53.

Figure 10.1-53 Drain tube at COVER 5 ► 6 ►

Remove the drain tube of RINSE STATION P2 part as shown Figure 10.1-54. Use gauze etc. so that the drop of water might leak from the tube.

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Figure 10.1-54 Drain tube of RINSE STATION P2 part 7 ►

Follow the reverse procedure of removing for installation.

10.1.14 Drain the outlet pipettor wash station and waste pipe NOTICE Read Safety Information

Recommended frequency: Operator time: Analyzer time: Precautions: Materials Required Gauze squares Distilled or deionized water 70% isopropyl alcohol SysClean

6 Months at PM visits Approximately 5 minute. None. The operation switch must be OFF. Catalog Number obtain locally obtain locally ------obtain locally

Procedure 1 ►

If the inside of the container appears dirty, use SysClean to rinse the drain the pipetter wash station. Follow with a thorough water rinse.

10.1.15 Perform Liquid Flow Cleaning NOTICE Read Safety Information

Contamination in the sipper system could potentially degrade sample accuracy and precision, or possibly block the measuring cell flowpath. To keep the sipper liquid flowpath clean and maintain the integrity of the measuring cell, perform a liquid flow cleaning every 6 Months at PM visits. High volume analyzers may require more frequent cleaning. If customer maintenance has been done as recommended, it is only necessary to carry out an additional customer cleaning at the PM visit. The service LFC is only necessary during PM if the sipper line is highly contaminated or if LFC has not been carried out regularly by the customer. Recommended frequency: Operator time:

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6 Months at PM visits. Approximately 12 minutes.

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Service Manual Approximately 16 minutes for User Approximately 32 min + MC preparation cycles for Service

Precautions: Materials Required SysClean SysClean adapter

Catalog Number obtain locally obtain locally

Pre-Cleaning Steps 1 ► 2 ► 3 ►

Open the sipper safety cover. Remove the ProCell bottle from position 3 of the system reagent compartment. Fill the "USER" or “SERVICE” compartment of the SysClean adapter to the ledge of the compartment with SysClean reagent.

Figure 10.1-55 Location of ledge in "USER" compartment of adapter 4 ►

Carefully, insert the filled SysClean adapter into position 3 of the system reagent compartment.

Figure 10.1-56 SysClean adapter in position 3 5 ► 6 ► 7 ►

Remove the liquid waste container and thoroughly clean it with distilled or deionized water. Verify ProCell/CleanCell bottles are in positions 1, 2 and 4. Also, verify the bottle lids are open and that there is adequate liquid in the bottles in positions 1 and 2. Close the sipper safety cover.

Initiate Cleaning 1 ► 2 ►

Select Utility -> Maintenance. Select “Maintenance” in the maintenance type list box (left).

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In the maintenance items list box (right), select “Liquid Flow Cleaning” and touch the Select button. The Liquid Flow Cleaning pop-up window opens. Type "1" for User / Type “3” for Service in the text box and press Start. The system begins cleaning the sipper liquid flowpath. Perform Measuring Cell Preparation cycles in case of Service LFC.[Press ”MC Preparation” in Maintenance screen; select number of cycles]

Post-Cleaning Steps 1 ► 2 ► 3 ► 4 ►

When the analyzer returns to Stand-by, remove the liquid waste container and thoroughly rinse it with distilled or deionized water. Return the liquid waste container to the analyzer. Open the sipper safety cover. Remove the SysClean adapter and properly discard any remaining SysClean. Thoroughly rinse the adapter. Return the ProCell bottle to position 3 of the system reagent compartment. Close the sipper safety cover.

10.1.16 Perform system volume check Refer to Chapter 6.3.1.

10.1.17 Exchange mixer belt S NOTICE Read Safety Information

Recommended frequency: Operator time: Analyzer time: Precautions: Materials Required Gauze squares Distilled or deionized water 70% isopropyl alcohol

6 Months at PM visits Approximately 5 minute. None. The operation switch must be OFF. Catalog Number -------------------

Procedure 1 ► 2 ►

Remove the cover until entering the following condition. Remove the mixer cover.

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Figure 10.1-57 Removing the mixer cover 3 ►

Remove the mixer belt S as shown in Figure 10.1-58.

Figure 10.1-58 Removing the mixer belt S 4 ► 5 ►

Follow the reverse procedure of removing for installation. Execute “Check mixer speed” (See 10.1.19; adjust if necessary).

10.1.18 Clean mixer paddle NOTICE Read Safety Information

Recommended frequency: Operator time: Analyzer time: Precautions: Materials Required Gauze squares Distilled or deionized water 70% isopropyl alcohol

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6 Months at PM visits Approximately 1 minute. None. The operation switch must be OFF. Catalog Number obtain locally -------------

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Procedure 1 ► 2 ►

Remove the cover until entering the following condition. Wipe the mixer paddle with gauze as shown in Figure 10.1-59.

Figure 10.1-59 Cleaning the mixer paddle 3 ►

Confirm the mixer paddle is not curved.

10.1.19 Check mixer speed; adjust if necessary NOTICE Read Safety Information

Recommended frequency: Operator time: Analyzer time: Precautions: Materials Required Gauze squares Distilled or deionized water

6 Months at PM visits Approximately 1 minute. None. The operation switch must be ON Catalog Number -------------

Procedure 1 ► 2 ►

Remove the cover until entering the following condition. As shown in Figure 10.1-60, put a white paper on the top of the mixer paddle and measure it with the rotation meter.

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Figure 10.1-60 Measuring the mixer speed 3 ►

For the adjusting method, refer to the chapter 2.6.1 and 5.3.8.

10.1.20 Check / Clean gripper finger NOTICE Read Safety Information

Recommended frequency: Operator time: Analyzer time: Precautions: Materials Required Gauze squares Distilled or deionized water 70% isopropyl alcohol

6 Months at PM visits Approximately 5 minute. Approximately 10 minute. The operation switch must be OFF Catalog Number obtain locally obtain locally -------

Procedure 1 ► 2 ►

Remove the cover until entering the following condition. Figure 10.1-61 shows the gripper part.

Figure 10.1-61 Gripper part

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Remove the gripper cover.

Figure 10.1-62 Removing the gripper cover 4 ► 5 ►

Shows the gripper fingers part. Wipe it with a cotton swab with distilled or demonized water if it is dirty.

Figure 10.1-63 Gripper finges 6 ►

Adjust the Gripper according to Chapter 4.5.1. If positioning shifts, must execute the adjustment.

10.1.21 Clean light barriers and mechanic parts NOTICE Read Safety Information

Wipe the each light barrier and mechanic parts if it is dirty.

10.1.22 Clean Incubator and Aspiration Station NOTICE Read Safety Information

Spills on the incubator could cause gripper movement alarms. The incubator and aspiration station should be cleaned at PM visits. Recommended frequency: 6 Months at PM visits Version 1.0 – May 2006

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RD/Hitachi cobas e411 Operator time: Analyzer time: Precautions: Materials Required Gauze squares Cotton swabs Distilled or deionized water

Service Manual Approximately 5 minutes. None. The operation switch must be OFF. Catalog Number obtain locally obtain locally -------

Procedure 1 ► 2 ► 3 ►

Move the S/R arm to the far left and the gripper toward the front of the analyzer. Open the sipper safety cover and move the sipper arm to the far right. Clean the top of the incubator with gauze squares dampened with distilled or deionized water. If the incubator appears dirty, use a slight scrubbing motion with the water-soaked gauze squares. DO NOT use an acid solution or an alkaline solution to clean the incubator. The incubator is made of aluminum and these solutions degrade the metal.

Figure 10.1-64 Wipe incubator surface 4 ► 5 ►

Next, 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. Use a dry gauze square to dry the incubator when you are finished cleaning.

Figure 10.1-65 Swab incubator positions 6 ►

When you power ON the analyzer, it performs the start-up reset operation, and each mechanism returns to its home or Stand-by position.

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10.1.23 Check LLD voltage pipettor NOTICE Read Safety Information

Refer to Chapter 5.3.4 and 6.3.3 Voltage Monitor

10.1.24 Check LLD voltage sipper NOTICE Read Safety Information

Refer to Chapter 5.3.4 and 6.3.3 Voltage Monitor

10.1.25 Check clot voltage NOTICE Read Safety Information

Refer to Chapter 5.3.4 and 6.3.3 Voltage Monitor

10.1.26 Check Temperature Monitor for Detection unit NOTICE Read Safety Information

Refer to Chapter 5.3.1, 5.3.6 and 6.3.4.

10.1.27 Check Temperature Monitor for Incubator NOTICE Read Safety Information

Refer to Chapter 5.3.1, 5.3.6 and 6.3.4.

10.1.28 Check Temperature Monitor for Reagent NOTICE Read Safety Information

Refer to Chapter 5.3.1, 5.3.6 and 6.3.4.

10.1.29 Check Temperature Monitor for PC / CC NOTICE Read Safety Information

Refer to Chapter 5.3.1, 5.3.6 and 6.3.4.

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10.1.30 Clean peltier elements from dust if necessary NOTICE Read Safety Information

Recommended frequency: Operator time: Analyzer time: Precautions: Materials Required Gauze squares Distilled or deionized water 70% isopropyl alcohol

6 Months at PM visits Approximately 20 minute. None. The operation switch must be OFF. Catalog Number obtain locally obtain locally -------

Procedure 1 ► 2 ►

Remove the cover until entering the following condition. Remove the reagent disk shown in Figure 10.1-66.

Figure 10.1-66 Reagent disk 3 ► 4 ► 5 ►

Remove the Reagent Jacket Assay Puts Reagent Jacket Assay as shown like Figure 10.1-66. Clean peltier elements with a gauze square soaked in distilled or deionized water If duty.

Figure 10.1-67 Reagent Jacket Assay

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10.1.31 Clean BCR window and window reagent disk NOTICE Read Safety Information

Recommended frequency: Operator time: Analyzer time: Precautions: Materials Required Gauze squares Distilled or deionized water 70% isopropyl alcohol

6 Months at PM visits Approximately 1 minute. None. The operation switch must be OFF. Catalog Number obtain locally -------------

Procedure 1 ► 2 ►

Remove the cover until entering the following condition. Figure 10.1-68 shows BCR window and window reagent disk.

Figure 10.1-68 BCR window and window reagent disk 3 ►

Wipe BCR window with gauze.

Figure 10.1-69 Wiping BCR window

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Wipe window of reagent disk with gauze.

Figure 10.1-70 Wiping window of reagent disk 5 ►

In case of Rack Sampler, wipe BCR window for Sampler with gauze also.

10.1.32 Perform artificial media check NOTICE Read Safety Information

Refer to Chapter 6.3.2.3 and 2.3.13.1.

10.1.33 Perform TSH assay test NOTICE Read Safety Information

Refer to Chapter 6.3.2.4 and 2.3.13.2.

10.1.34 Perform initial blank cell NOTICE Read Safety Information

Refer to Chapter 6.4.7 and 2.3.12.

10.1.35 Perform assay calibration NOTICE Read Safety Information

Refer to Chapter 2.3.14 and Operator’s manual.

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10.1.36 Perform assay control NOTICE Read Safety Information

Refer to Chapter 2.3.14 and Operator’s manual.

10.1.37 Exchange measuring cell NOTICE Read Safety Information

Recommended frequency: 12 Months at PM visits(Exchange the measuring cell every 12 months or after measuring 50,000 tests whichever comes first.) Operator time: Approximately 10 minute. Analyzer time: Approximately 30 minute. Precautions: The operation switch must be OFF. Materials Required Catalog Number Gauze squares ------Distilled or deionized water ------70% isopropyl alcohol -------

Procedure 1 ► 2 ►

Remove the cover until entering the following condition. Figure 10.1-71 shows CELL FRAME mounted inside Detection Unit.

Note: Do not need to remove the Rear Cover, usually.

Figure 10.1-71 CELL FRAME 3 ►

Remove the measuring cell from CELL FRAME by removing the screw of the cell in two places..

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Figure 10.1-72 Removing measuring cell 4 ►

Figure 10.1-73 shows the measuring cell removed from CELL FRAME

Figure 10.1-73 Measuring cell 5 ► 6 ►

Follow the reverse procedure of removing for installation. Please follow the procedure since chapter 2.3.9.

10.1.38 Exchange tube B for MC NOTICE Read Safety Information

Recommended frequency: Operator time: Analyzer time: Precautions: Materials Required Gauze squares Distilled or deionized water 70% isopropyl alcohol

Version 1.0 – May 2006

12 Months at PM visits Approximately 10 minute. Approximately 30 minute. The operation switch must be OFF. Catalog Number -------------------

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Procedure 1 ► 2 ►

Remove the cover until entering the following condition. Figure 10.1-74 shows the inside of Detection Unit.

Figure 10.1-74 Inside of Detection Unit 3 ►

Remove TUBE B FOR MEASURING CELL as shown in Figure 10.1-75.

Figure 10.1-75 Removing TUBE B FOR MEASURING CELL 4 ►

Remove TUBE B FOR MEASURING CELL as shown in Figure 10.1-76.

Figure 10.1-76 Removing TUBE B FOR MEASURING CELL

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Follow the reverse procedure of removing for installation. Please follow the procedure since chapter 2.3.9.

10.1.39 Exchange tube B for sipper with nozzle seal NOTICE Read Safety Information

Recommended frequency: Operator time: Analyzer time: Precautions:

12 Months at PM visits Approximately 10 minute. Approximately 30 minute. The operation switch must be OFF.

Materials Required Gauze squares Distilled or deionized water 70% isopropyl alcohol

Catalog Number obtain locally -------------

Procedure 1 ► 2 ►

Remove the cover until entering the following condition. Figure 10.1-77 shows tube B on the side of Sipper.

Figure 10.1-77 Tube B on Sipper side 3 ►

Remove tube B on the side of Sipper as shown in Figure 10.1-78.

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Figure 10.1-78 Tube B on Sipper side 4 ►

Figure 10.1-79 shows tube B on the side of DETECTION UNIT

Figure 10.1-79 Tube B on DETECTION UNIT side 5 ►

Remove tube B on the side of DETECTION UNIT as shown in Figure 10.1-80.

Figure 10.1-80 Removing tube B on DETECTION UNIT side

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Follow the reverse procedure of removing for installation. Please follow the procedure since chapter 2.3.9.

10.1.40 Exchange tube B for sipper syringe NOTICE Read Safety Information

Recommended frequency: Operator time: Analyzer time: Precautions: Materials Required Gauze squares Distilled or deionized water 70% isopropyl alcohol

12 Months at PM visits Approximately 10 minute. Approximately 30 minute. The operation switch must be OFF. Catalog Number obtain locally -------------

Procedure 1 ► 2 ►

Remove the cover until entering the following condition. Figure 10.1-81 shows tube B on the side of measuring cell.

Figure 10.1-81 Tube B on measuring cell side 3 ►

Remove tube B on the side of measuring cell as shown in Figure 10.1-82.

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Figure 10.1-82 Removing tube B on measuring cell side 4 ►

Remove TUBE B FOR SIPPER SYRINGE as shown in Figure 10.1-83.

Figure 10.1-83 Removing TUBE B FOR SIPPER SYRINGE 5 ►

Figure 10.1-84 shows tube B on the side of DISPENSER SYRINGE ASSY

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Figure 10.1-84 Tube B on DISPENSER SYRINGE ASSY side 6 ►

Remove tube B on the side of DISPENSER SYRINGE ASSY as shown in Figure 10.1-85.

Figure 10.1-85 Removing tube B on DISPENSER SYRINGE ASSY side 7 ► 8 ►

Follow the reverse procedure of removing for installation. Please follow the procedure since chapter 2.3.9.

10.1.41 Clean the valve body on the system water container NOTICE Read Safety Information

Recommended frequency: Operator time: Analyzer time: Precautions: Materials Required Gauze squares Distilled or deionized water 70% isopropyl alcohol

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12 Months at PM visits Approximately 3 minute. None. The operation switch must be OFF. Catalog Number obtain locally ------obtain locally

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Procedure 1 ► 2 ►

Raise and remove the system water container. Remove the cap and discard any water remaining inside.

Figure 10.1-86 Valve body on the System Water Container 3 ► 4 ►

Remove the valve on the bottom of the system water container if necessary. Follow the reverse procedure of removing for installation.

10.1.42 Exchange O-ring SV 1 / 2 / 5 / 6 / 7 NOTICE Read Safety Information

Recommended frequency: Operator time: Analyzer time: Precautions: Materials Required Gauze squares Distilled or deionized water 70% isopropyl alcohol

12 Months at PM visits Approximately 10 minute. None. The operation switch must be OFF. Catalog Number -------------------

Procedure 1 ► 2 ►

Remove the cover until entering the following condition. Figure 10.1-87 shows SV 1 / 2 / 5 / 6 / 7.

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Figure 10.1-87 SV 1 / 2 / 5 / 6 / 7 3 ►

Remove the nipples attached to each SV’s as shown in Figure 10.1-88.

Figure 10.1-88 Removing the nipple 4 ►

Remove the cover (SUPPORT R part) as shown in Figure 10.1-89.

Figure 10.1-89 Removing the cover

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Remove PIPING BLOCK from each SV’s and O-ring’s shown in Figure 10.1-90.

Figure 10.1-90 O-ring 6 ►

Follow the reverse procedure of removing for installation.

10.1.43 Exchange sipper wash station NOTICE Read Safety Information

Recommended frequency: Operator time: Analyzer time: Precautions: Materials Required Gauze squares Distilled or deionized water 70% isopropyl alcohol

12 Months at PM visits Approximately 10 minute. None. The operation switch must be OFF. Catalog Number obtain locally -------------

Procedure 1 ► 2 ►

Remove the cover until entering the following condition. Figure 10.1-91 shows the surrounding part of sipper wash station.

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Figure 10.1-91 Surrounding part of sipper wash station 3 ►

Remove the screws putting sipper wash station and PLATE R together as shown in Figure 10.1-92.

Figure 10.1-92 Removing screws 4 ►

Remove the screws of COVER and PLATE R as shown in Figure 10.1-93.

Figure 10.1-93 Removing screws of COVER and PLATE R 5 ►

Remove the screws of WASHING STATION S(M) ASSY as shown in Figure 10.1-94.

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Figure 10.1-94 Removing screws of WASHING STATION S(M) ASSY 6 ►

Remove PIPE 1 shown in Figure 10.1-95.

Figure 10.1-95 PIPE 1 7 ►

Remove the nipple shown in Figure 10.1-96.

Figure 10.1-96 Removing nipples 8 ►

Remove sipper wash station as shown in Figure 10.1-97.

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Figure 10.1-97 Removing sipper wash station 9 ►

Follow the reverse procedure of removing for installation.

10.1.44 Exchange the spring at the gripper finger NOTICE Read Safety Information

Recommended frequency: Operator time: Analyzer time: Precautions: Materials Required Gauze squares Distilled or deionized water 70% isopropyl alcohol

12 Months at PM visits Approximately 30 minute. Approximately 10 minute. The operation switch must be OFF. Catalog Number obtain locally -------------

Procedure 1 ►

Figure 10.1-98 shows CARRIER Z ASSY.

Figure 10.1-98 CARRIER Z ASSY

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Remove COVER Z as shown in Figure 10.1-99.

Figure 10.1-99 Removing COVER Z 3 ► 4 ►

Exchange the spring. If you cannot exchange the spring, then remove the Gripper Head for safety and recommended it. Adjust the Gripper according to Chapter 4.5.1. If positioning shifts, must execute the adjustment.

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10.2 Operator Maintenance Refer to the Operator’s Manual.

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10.3 Maintenance Materials Table 10.3-1 Contents of Preventive Maintenance Kit P/N : 741-0925 Name : 2010/e411 Service Kit No 1 2 3 4 5 6 7 8 9 10 11 12 13

Part name Tube 465 Tube 510 TUBE B FOR SIPPER TUBE B FOR MEASURING CELL SIPPER NOZZLE SEAL SET MIXING BELT 3 P NOZZLE SEAL SET SPRING GRP SEAL PIECE S SEAL PIECE P TUBE B FOR SIPPER SYRINGE TUBE SET IH PACKING

P/N 741-1175 741-1778 741-0820 741-0822 741-0910 741-2244 741-0903 741-1168 741-1303 741-1302 741-0821 741-0941 L443085

Qty. 1 1 1 1 1 (total 2) 1 1 (total 2) 1 1 1 1 1 (total 2) 2 (total 2)

Table 10.3-2 Contents of Preventive Maintenance Kit P/N : 741-0926 Name : 2010/e411 2010 PM KIT No 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Part name

P/N

Tube 465 S NOZZLE SEAL MIXING BELT 3 NOZZLE SEAL SPRING GRP SEAL PIECE S SEAL PIECE P WASHING STATION S O-RING NBR P9 O-RING NBR P16 VALVE BODY TUBE JOINT B2 Tube Joint C TUBE SET IH PACKING

741-1175 741-2065 741-2244 F729051 741-1168 741-1303 741-1302 741-1380 L456006 L456013 741-1503 741-1591 741-1609 741-0941 L443085

Qty. 1 1 1 1 1 2 (total 2) 2 (total 2) 1 2 (total 2) 2 (total 2) 1 4 (total 4) 1 4 (total 8) 4

Table 10.3-3 Additional Parts which has to be ordered for Preventive Maintenance ( Every 12 month ) No 1 2 3 4 5

Part name

P/N

MEASURING CELL VALVE BODY RINSE STATION P2 O-RING NBR P4 O-RING NBR P5

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741-0461 741-1503 741-0997 L456001 L456002

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Qty. 1 1 1 5 5

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