Manual Cobas 4800

®

cobas 4800 system Installation Manual Version 1.1.2

Roche cobas® 4800 system

Table of Contents 1. Preface................................................................................................................................................................. 8 1.1. Revision History .......................................................................................................................................................................... 8 1.2. Editor notice............................................................................................................................................................................... 10 1.3. Copyrights .................................................................................................................................................................................. 10 1.4. Trademarks ................................................................................................................................................................................ 10 1.5. Contact addresses................................................................................................................................................................... 10 1.6. Intended Use ............................................................................................................................................................................. 11 1.7. Configuration............................................................................................................................................................................. 11 1.8. About this Manual................................................................................................................................................................... 11 1.9. Order Information .................................................................................................................................................................... 12 1.10.

Document Reference....................................................................................................................................................... 12

1.11.

Conventions used in this Manual................................................................................................................................ 12

1.12.

Abbreviations...................................................................................................................................................................... 13

1.13.

Safety notes......................................................................................................................................................................... 14

1.14.

Data Security....................................................................................................................................................................... 16

1.15.

Safety precautions ............................................................................................................................................................ 17

1.16.

Material Required ............................................................................................................................................................. 18

1.16.1. Documentation ........................................................................................................................................................ 18 1.16.2. Software ..................................................................................................................................................................... 18 1.16.3. Instrument/ Analyzer ............................................................................................................................................. 18 1.16.4. Accessories & Option............................................................................................................................................ 19 1.16.5. Consumables............................................................................................................................................................ 19 1.16.6. Service Tools............................................................................................................................................................. 19 2. Upgrade from version 1.0.x to 1.1.0............................................................................................................. 20 2.1. Installation Backup Restore Tool........................................................................................................................................ 20 2.2. Backup Database..................................................................................................................................................................... 20 2.3. Store Archive & Backup Files .............................................................................................................................................. 22 3. New Installation ............................................................................................................................................... 23 3.1. Delivery/ Unpacking ............................................................................................................................................................... 23 3.2. Installation PART 1 cobas x 480 instrument................................................................................................................... 23 3.3. Installation cobas z 480 analyzer........................................................................................................................................ 24 3.4. Installation cobas 4800 control unit .................................................................................................................................. 24 4. SW Installation control unit ........................................................................................................................... 25 4.1. Delivery condition cobas 4800 control unit .................................................................................................................... 25 4.2. Verification of installed BIOS ............................................................................................................................................... 25 4.3. Verification of installed image version ............................................................................................................................. 26 4.4. Windows Time and Date Adjustments............................................................................................................................. 27 4.5. cobas® 4800 software installation...................................................................................................................................... 28 4.6. cobas® 4800 oracle DB installation.................................................................................................................................. 36 4.7. cobas® 4800 software configuration................................................................................................................................. 41 Installation Manual

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Roche cobas® 4800 system 4.7.1.

cobas® 4800 software start-up .......................................................................................................................... 41

4.7.2.

Reporting ................................................................................................................................................................... 42

4.7.3.

Test parameters....................................................................................................................................................... 43

4.7.4.

Verification of cobas® 4800 software start-up user operator ................................................................. 44

4.7.5.

Verification of cobas® 4800 database size ................................................................................................... 44

4.7.6.

Archive Trigger and Fix Indices ......................................................................................................................... 45

4.7.7.

Delete folder ORACLE........................................................................................................................................... 46 ®

4.8. cobas 4800 Work Order Editor Installation .................................................................................................................. 47 4.9. Installation of cobas® 4800 Operator’s Manual........................................................................................................... 49 4.10.

cobas x 480 Service Software Installation ................................................................................................................ 50

4.10.1. Service Software cobas x 480 instrument...................................................................................................... 50 4.10.2. Firmware cobas x 480 instrument..................................................................................................................... 50 4.10.3. Macro cobas x 480 instrument .......................................................................................................................... 51 4.11.

cobas x 480 instrument driver installation ............................................................................................................... 51

4.12.

cobas z 480 analyzer Service Software Installation .............................................................................................. 52

4.13.

User permission modification ....................................................................................................................................... 54

4.13.1. cobas® 4800 software log file folder................................................................................................................ 54 4.13.2. Remove permissions for folder Roche_x480_ConfigFiles ........................................................................ 55 4.14.

Workaround Start Menu & Shortcuts ........................................................................................................................ 57

4.15.

Windows Start Menu & Shortcuts............................................................................................................................... 59

4.15.1. Create a folder to save Work Orders ............................................................................................................... 59 4.15.2. Relocate folder Microlab Star Service............................................................................................................. 60 4.15.3. Relocate folder Roche........................................................................................................................................... 60 4.15.4. FSE Reports (OPERATOR) ................................................................................................................................... 61 4.15.5. FSE Reports (INSTALL)......................................................................................................................................... 62 4.15.6. Remove uninstall cobas_4800_V1.1.0.1036................................................................................................... 62 4.15.7. Remove uninstall cobas® 4800 Work Order Editor..................................................................................... 63 4.15.8. Shortcut to cobas 4800 Log Files...................................................................................................................... 63 4.15.9. Shortcut to Hamilton Log Files .......................................................................................................................... 63 4.15.10. Shortcut to Balance Config file IVDVolVer.ini .............................................................................................. 64 4.15.11. Shortcut to cmd.exe............................................................................................................................................... 64 4.16.

Window Menu Verification ............................................................................................................................................ 65

4.16.1. Start Menu (OPERATOR) ..................................................................................................................................... 65 4.16.2. Programs Menu (OPERATOR) ........................................................................................................................... 66 4.16.3. Verifying permission for folder Roche_x480_ConfigFiles......................................................................... 67 4.16.4. Start Menu (INSTALL) .......................................................................................................................................... 68 4.16.5. Programs Menu (INSTALL)................................................................................................................................. 69 4.17.

Workaround exchanging of Workorder Config. File............................................................................................. 70

4.18.

Exchanging of Workorder Config. File....................................................................................................................... 71

4.19.

Verify Workorder Editor Display................................................................................................................................... 71

4.20.

LabNET settings for Printer/ Firewall ......................................................................................................................... 73

5. Upgrade Installation Restore Database...................................................................................................... 74 5.1. Installation Backup Restore Tool........................................................................................................................................ 74 Page 4 of 175

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Roche cobas® 4800 system 5.2. Restore Database..................................................................................................................................................................... 74 6. cobas x 480 instrument Installation ............................................................................................................ 76 6.1. Stationary Carrier and Heater/Shaker Unit..................................................................................................................... 76 6.2. Liquid Waste Installation Procedure ................................................................................................................................. 78 6.3. Firmware Verification.............................................................................................................................................................. 80 6.3.1.

Update Firmware..................................................................................................................................................... 81

6.4. Installation PART 2 .................................................................................................................................................................. 81 7. cobas z 480 analyzer Installation................................................................................................................. 82 7.1. Firmware Verification.............................................................................................................................................................. 82 7.2. Diagnostic Check..................................................................................................................................................................... 83 8. Handheld Barcode Scanner........................................................................................................................... 84 8.1. Installation .................................................................................................................................................................................. 84 8.2. Scanner Programming ........................................................................................................................................................... 84 8.3. Scanner Verification................................................................................................................................................................ 86 9. LIS Interface Installation ................................................................................................................................ 87 9.1. Physical Connection................................................................................................................................................................ 87 9.2. Network Connection............................................................................................................................................................... 88 9.2.1.

Network Address of Host Server....................................................................................................................... 88

9.2.2.

Network Address of cobas 4800 control unit............................................................................................... 89

9.2.3.

Check Network Communication ....................................................................................................................... 89

9.3. Application Software Connection ...................................................................................................................................... 90 9.3.1.

Installation C4800 Communication Server..................................................................................................... 90

9.3.2.

Transformer Configuration .................................................................................................................................. 93

9.3.3.

Installation of Host Interface Simulator .......................................................................................................... 94

9.3.4.

Configure HL7 Interface Simulator................................................................................................................... 95

9.3.5.

cobas 4800 software LIS configuration .......................................................................................................... 99

9.4. Testing Communication Scenarios..................................................................................................................................100 9.4.1.

Sending Results.....................................................................................................................................................100

9.4.2.

Sending an order ..................................................................................................................................................102

10. LIS Interface Configuration with cobas IT firewall .................................................................................104 10.1.

Physical Connection.......................................................................................................................................................104

10.2.

Network Connection ......................................................................................................................................................105

10.2.1. Network address configuration of cobas IT firewall ................................................................................105 10.2.2. Set IP address of host computer .....................................................................................................................116 10.2.3. Network Address of cobas 4800 control unit.............................................................................................116 10.2.4. Check Network Communication .....................................................................................................................116 10.3.

Application Connection ................................................................................................................................................117

10.4.

Testing Communication Scenarios ...........................................................................................................................119

11. Change LIS Interface Configuration ..........................................................................................................120 11.1.

Change IP address of host computer ......................................................................................................................120

11.2.

Change Port of Host Interface Simulator................................................................................................................120

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Roche cobas® 4800 system 11.3.

Change Protocol ..............................................................................................................................................................121

11.3.1. Roche.MTS Transformer.exe settings............................................................................................................121 11.4.

Additional information...................................................................................................................................................122

12. Printer Installation .........................................................................................................................................123 12.1.

Printer Network Configuration ...................................................................................................................................123

12.2.

Printer Driver Installation..............................................................................................................................................124

12.3.

Set default printer for user OPERATOR...................................................................................................................129

12.4.

Printer Installation in Laboratory Network (red Network)................................................................................130

13. Water Run........................................................................................................................................................131 13.1.

Goal ......................................................................................................................................................................................131

13.2.

Deck Layout cobas x 480 instrument.......................................................................................................................131

13.2.1. Rack Loading .........................................................................................................................................................131 13.3.

Consumables ....................................................................................................................................................................132

13.3.1. Requirement ...........................................................................................................................................................132 13.3.2. Tube Preparation...................................................................................................................................................132 13.4.

Get started .........................................................................................................................................................................133

13.4.1. Instrument ...............................................................................................................................................................133 13.4.2. TADM configuration (Recording) ...................................................................................................................133 13.4.3. Creating a new work order (Water Run)......................................................................................................134 13.5.

New Run (WaterRun) ....................................................................................................................................................135

13.5.1. Load Samples.........................................................................................................................................................135 13.5.2. Load Consumables...............................................................................................................................................136 13.5.3. Load Reagent Reservoir Carrier 1-4 ..............................................................................................................136 13.5.4. Load Reagent Reservoir Carrier 2-2 ..............................................................................................................137 13.5.5. Load Reagent Reservoir Carrier 2-3 ..............................................................................................................137 13.5.6. Load Reagent Carrier 2-4 ..................................................................................................................................138 13.5.7. Load Reagent Carrier 2-5 ..................................................................................................................................138 13.5.8. Load Reagent Vials Carrier 3-15,18,19, 23, 24 ...........................................................................................139 13.5.9. End of Sample Preparation................................................................................................................................140 13.5.10. Abort Water Run ...................................................................................................................................................140 13.5.11. TADM configuration (Monitoring)..................................................................................................................141 14. Test Run HPV ..................................................................................................................................................142 14.1.

Goal ......................................................................................................................................................................................142

14.2.

Consumables & Reagent..............................................................................................................................................142

14.2.1. Required Consumables ......................................................................................................................................142 14.2.2. Tube Preparation...................................................................................................................................................142 14.3.

Required HPV Reagent..................................................................................................................................................143

14.3.1. Creating a new work order (HPV) ..................................................................................................................144 14.4.

New Run (TestRunHPV)................................................................................................................................................145

14.4.1. Load Samples.........................................................................................................................................................145 14.4.2. Load Consumables...............................................................................................................................................146 14.4.3. Load Reagent Reservoir Carrier 1-4 ..............................................................................................................146 Page 6 of 175

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Roche cobas® 4800 system 14.4.4. Load Reagent Reservoir Carrier 2-2 ..............................................................................................................147 14.4.5. Load Reagent Reservoir Carrier 2-3 ..............................................................................................................147 14.4.6. Load Reagent Reservoir Carrier 2-4 ..............................................................................................................147 14.4.7. Load Reagent Reservoir Carrier 2-5 ..............................................................................................................147 14.4.8. Load Reagent Vials Carrier 3-15,18,19, 23, 24 ...........................................................................................148 14.4.9. End of Sample Preparation................................................................................................................................149 14.4.10. Amplification and Detection .............................................................................................................................149 14.4.11. Control Curve Analysis........................................................................................................................................150 14.4.12. Finalize HPV Run...................................................................................................................................................150 14.4.13. Clean up...................................................................................................................................................................150 15. Completion of Installation............................................................................................................................151 16. Appendix..........................................................................................................................................................152 16.1.

Installation of BIOS settings ........................................................................................................................................152

16.2.

Installation of OSXP Recovery Image.......................................................................................................................153

16.3.

Network Overview...........................................................................................................................................................160

16.4.

Installation Check List cobas 4800 control unit ...................................................................................................161

16.5.

Installation Check List cobas z 480 analyzer.........................................................................................................161

16.6.

Installation Check List cobas x 480 instrument....................................................................................................162

16.7.

Additional HPV Barcodes for WaterRun .................................................................................................................163

16.7.1. Sample Loading Set #1 ......................................................................................................................................163 16.7.2. Reagent Loading Set #1 ....................................................................................................................................164 16.7.3. Sample Loading Set #2 ......................................................................................................................................167 16.7.4. Reagent Loading Set #2 ....................................................................................................................................168 16.7.5. Sample Loading Set #3 ......................................................................................................................................171 16.7.6. Reagent Loading Set #3 ....................................................................................................................................172 16.8.

User Access Information ..............................................................................................................................................175

16.8.1. Lab Operator Access Information...................................................................................................................175 16.8.2. Lab Manger Access Information.....................................................................................................................175 16.8.3. Admin Access Information................................................................................................................................175

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1 1.1

Preface Revision History


1. Preface 1.1. Revision History Version

Revision Date

Revision Info

1.0

05-NOV-2009

First Version

1.0.1

05-FEB-2010

Modified chapter 1.16.2 CD: SW Microlab STAR Service, Version 1.1 Modified chapter 3.4 Installation cobas 4800 control unit, page 24 Modified chapter 4.7.4 Verification of cobas® 4800 software , Step 4 Modified chapter 6.3 Firmware Verification, step 5 Requested Firmware Versions Added chapter Instrument supported barcodes Modified chapter 13.3.2 Tube Preparation, step 1, sample tube reduced to 4mL

1.0.2

07-APR-2010

Modified chapter 1.16.2, CD cobas 4800 Software V1.0.2.1010Mat.No 05740681001 (Note that none of the print screens have been replaced, so all of them will appear with the previous SW version, nevertheless use the latest version listed in chapter 1.16.2) Modified chapter 1.10 Document Reference, DVS No 10330029 Modified chapter 6.3 Firmware Verification, Firmware Pip Channel changed to 3.6a Refer to Service Bulletin: Pipetting Channel Firmware Upgrade Added chapter 4.14 Workaround Start Menu & Shortcuts Following sub chapters were moved to chapter 4.15 Windows Start Menu & Shortcuts: - Create a folder to save Work Orders - Relocate folder Microlab Star Service - Relocate folder Roche Modified the following chapters to remove uninstall short cut completely from start menu: 4.15.6 Remove uninstall cobas_4800_V1.1.0.1036 4.15.7 Remove uninstall cobas® 4800 Work Order Editor 4.16.4 Start Menu (INSTALL)

1.1.0

18-Nov-2010

New chapter 2 Upgrade from version 1.0.x to 1.1.0 Backup and Restore Manual is completely integrated into the installation manual 4 SW Installation control unit Verification of installed BIOS All subchapter revised with new cobas 4800 software 1.1.0.1042 4.17 Workaround exchanging of Workorder Config. File 4.18 Exchanging of Workorder Config. File 5 Upgrade Installation Restore Database5 9 LIS Interface Installation 10 LIS Interface Configuration with cobas IT firewall 11 Change LIS Interface Configuration The Network Configuration Guide is completely implemented into the Installation manual 12.4 Printer Installation in Laboratory Network (red Network) 16.3 Network Overview 16.7 Additional HPV Barcodes for WaterRun

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Preface Revision History

1 1.1

Moved to Appendix Installation of OSXP Recovery Image Removed Chapter 3.2 Verification RAID System 3.3. RAID Array configuration 6.4 Instrument supported barcodes 3.16.1. Firmware cobas z 480 analyzer 1.1.1

8-Dez-2010

1.16.

Material Required/Software Software added: Host Interface Test Tool 7.1.5 or higher

3.4

Installation cobas 4800 control unit Overview drawing of control unit corrected

9.3.2.

Transformer Configuration Chapter added: Result Upload Configuration

9.3.3.

Installation of Host Interface Simulator

13.5.

New Run (WaterRun)

Note added: Host Interface Test Tool 7.1.5 or higher is required 1.1.2

2-Mar-2011

Created new barcodes for reagent reservoir and vials

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1 1.2

Preface Editor notice


1.2. Editor notice This documentation is strictly limited to trained Roche service personnel and authorized service engineers. Every effort has been made to ensure that all the information contained in this installation manual cobas® 4800 system is correct at the time of printing. However, Roche Diagnostics Ltd reserves the right to make any changes necessary without notice as part of ongoing product development. Any customer modification to the instrument, analyzer or control unit will render the warranty or service agreement null and void.

1.3. Copyrights Copyright 2010, Roche Molecular Systems, Inc. All rights reserved. © 2010, F. Hoffmann-La Roche Ltd. All rights reserved. Microlab® is a registered trademark of Hamilton Bonaduz Ltd, Switzerland © 2010, Hamilton Company. All rights reserved. Microsoft, Windows and Windows XP are either registered trademarks or trademarks of Microsoft Corporation in the United States and/or other countries.

1.4. Trademarks The following trademarks are acknowledged: COBAS, LightCycler and LIFE NEEDS ANSWERS is a registered trademark of F. Hoffmann-La Roche Ltd. All other trademarks are the property of their respective owners.

1.5. Contact addresses Questions or comments regarding the contents of this Manual can be directed to the address below or to your Roche representative. Roche Diagnostics Ltd. GSS Molecular Diagnostics Forrenstrasse

Page 10 of 175

6343 Rotkreuz

Web: www.roche-rotkreuz.com

Switzerland

E-mail: [email protected]

Version 1.1.2

Installation Manual


Preface Intended Use

1 1.6

1.6. Intended Use The cobas® 4800 system is intended to be used as a diagnostic or screening system providing sample preparation, amplification and detection of specific targets from human samples. Initial diagnostic targets are Chlamydia Trachomatis/Neisseria Gonorrhoeae (CT/NG) and human papillomavirus (HPV). It is important that the operator read this manual thoroughly before using the system.The cobas® 4800 system is to be used by laboratory professionals trained in laboratory techniques and by instruction on the use of the system.

1.7. Configuration This document is intended to install a complete cobas® 4800 system including the following components:

1.8. About this Manual Use always the latest version of this document with the corresponding software versions. This manual guides through the installation of a cobas® 4800 system. Detailed technical instrument information can be found in the service documentation of cobas x 480 instrument and cobas z 480 analyzer. GRIPS > iSDoc > cobas x 480 and GRIPS > iSDoc > cobas z 480 For operating information consult the cobas® 4800 system Operator’s Manual. GRIPS > System Search > Molecular Diagnostics > cobas 4800 system > cobas z 480 Before operating the cobas® 4800 system, it is essential that the warnings, cautions, and safety requirements contained in the Installation- & Operator’s Manual cobas® 4800 system are read and understood by the user.

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1 1.9

Preface Order Information


1.9. Order Information This manual is available on GRIPS > System Search > cobas 4800 > cobas z 480 > Installation Manual > Installation Manual cobas® 4800 system

1.10. Document Reference These are internal Reference Numbers. Installation Manual cobas® 4800 system, DVS No. 10330029 Installation Manual cobas® 4800 system, Mat.No. 06260691001

1.11. Conventions used in this Manual To convey information readily and consistently, certain text conventions are used throughout this manual. These text conventions are as follows:

Symbol Numbered lists

Used for This are sequential procedures and have to be followed step by step

>

Used to indicate the navigation path on WinXP, application software as the cobas® 4800 software, cobas® 4800 Work Order Editor or GRIPS > iSDoc

\

Used to indicate the browsing path in windows explorer. i.e. C:\Oracle

BOLD

Used to refer to a software phrase,

BOLD

Keyboard key, software button

Italic

Indicates a name or expressions used software or manuals

Italic

Designating another section of this manual or another manual that should be consulted. It also can refer to iSDoc. Tip Indicates additional information on correct use of the system or useful tips Safety alert. The safety alert symbol by itself without a signal word is used to promote awareness to hazards which are generic or to direct the reader to safety information provided elsewhere in the document.

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Preface Abbreviations

1 1.12

1.12. Abbreviations Acronym

Definition

cLLD

Capacitive Liquid Level Detection

CO-RE

Compression-induced O-Ring Expansion

CT

Chlamydia Trachomatis

CU

Control Unit

DB

Database

DCS

Distribution Center Spare Part

DWP

Deepwell Plate (Extraction-plate 1.6ml, REF 05232716001)

EDC

European Distribution Center

e.g.

Exempli gratia – for example

HPV

Human Papillomavirus

HDD

Hard Disk Drive

HW

Hardware

i.e.

Id est – that is to say

IQ

Installation Qualification

iSDoc

Integrated Service Documentation

iSWAP

Internal Swivel Arm Plate Handler

IVD

In Vitro Diagnostic

GRIPS

Global Repository of Information about Products and Services

LAN

Local Area Network

LIS

Laboratory Information System

MWP

Microwell Plate, Amplification/Detection plate (AD-plate 0.3ml, REF 05232724001)

n/a

Not applicable

NG

Neissera Gonorrhoeae

OQ

Operational Qualification

OS

Operation System

PC

PreservCyt®

PCB

Printed Circuit Board

PCR

Polymerase Chain Reaction

QC

Quality Control

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1 1.13

Preface Safety notes


Acronym

Definition

SP

Sure Path

STAR

Sequential Transfer Aliquoting Robot

TADM

Total Aspiration and Dispensing Monitoring

USB

Universal Serial Bus

UT

UniTrans (cobas PCR Media)

UUT

Urine UniTrans (urine stabilized with cobas PCR Media)

WEEE

Waste Electrical Electronic Equipment

XML

Extensible Markup Language

Acronym

Definition

mL

Milliliter (1mL =1000μl)

uL

Microliter (1mL =1000μl)

1.13. Safety notes Following symbols are used throughout this manual to provide a ready visual reference. Symbol

Used for Warning indicates a hazardous situation which, if not avoided, could result in death or serious injury.

Caution indicates a hazardous situation which, if not avoided, could result in minor or moderate injury.

The safety alert symbol by itself without a signal word is used to promote awareness to hazards which are generic or to direct the reader to safety information provided elsewhere in the document Notice indicates a hazardous situation which, if not avoided, may result in property damage.

Tip indicates additional information on correct use of the system or useful tips.

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Roche cobas® 4800 system Symbol

Preface Safety notes

1 1.13

Used for Warning Moving Parts indicates a possible hazardous situation. Keep hands away from moving parts.

Warning laser transmitter. Designates the presence of a laser transmitter. Do not stare into the laser transmitter.

Electrical Warning. This label indicates that there is a danger of coming into contact with electrical components when gaining access to parts of the analyzer marked with this label. Refer to Operator's Manual cobas® 4800 system for instructions on safe operation. Electrostatic sensitive devices. Observe precautions for handling electrostatic sensitive devices.

Electromagnetic fields. Operation with an uninterruptible power supply (UPS) is recommended. Electromagnetic fields Devices that emit electromagnetic waves may cause the instrument or analyzer to malfunction. Do not operate the following devices in the same room where the instrument or analyzer are installed such as mobile phone, transceiver, cordless phone, and other electrical devices that generate electromagnetic fields. Personal injury due hot surface The heater/ shaker are hot while the cobas x 480 instrument is operating.

Warning potentially biohazardous material. Indicates possible biohazardous material. Universal safety precautions should be taken when handling and processing samples. Refer to Operator's Manual cobas® 4800 system for instructions on safe operation. Instrument Ground. Located on all Power Supplies, this symbol indicates where protective ground is connected.

Disposal of control unit components

Components of your control unit (such as the computer, monitor, keyboard) which are marked with this symbol are covered by the European Directive on Waste Electrical and Electronic Equipment (WEEE, 2002/96/EC). These items must be disposed of via designated collection facilities.For more information about disposal of your old product, please contact your city office, waste disposal service or your Roche representative. Constraint: It is left to the responsible laboratory organization to determine whether control unit components are contaminated or not. If contaminated, treat them in the same way as the instrument and analyzer.

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1 1.14

Preface Data Security


1.14. Data Security Symbol

Used for Data Security Unauthorized access and data loss due to malicious software and hacker attacks

Portable storage media can be infected with and transmit computer malware, which may be used to gain unauthorized access to data or cause unwanted changes to software. The cobas® 4800 system is not protected against malicious software and hacker attacks. The customers are responsible for IT security of their IT infrastructure and for protecting it against malicious software and hacker attacks. Failure to do so may result in data loss or render the cobas® 4800 system unusable. Roche recommends the following precautions:

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•

Allow connection to authorized external devices only.

•

Ensure that all external devices are protected by appropriate security software.

•

Ensure that access to all external devices is protected by appropriate security equipment. cobas IT firewall must be used when the cobas® 4800 system is integrated into a network.

•

Do not copy or install any software on the cobas® 4800 software data station unless it is part of the system software or you are instructed to do so by this installation manual or Roche Service representative.

•

If additional software is required, contact (GSS) Global System Support to ensure validation of the software in question.

•

Do not use the USB ports to connect other storage devices unless you are instructed to do so by official user documentation or contact GSS (Global System Support)

•

Ensure the storage devices is free of any threats (trojan, virus, worm) before connecting or inserting the memory media to the cobas® 4800 control unit. Run an anti-virus program with latest virus definition file on another PC then the control unit and scan any storage devices such as USB memory stick, USB HDD, CD, DVD, etc. against harmful software before connecting it to the control unit .

•

Used dedicated storage devices for the cobas® 4800 control unit. Do not those storage device on public or home computers

•

Keep all external storage devices in a secure place and ensure that they can be accessed by authorized persons only.

Version 1.1.2

Installation Manual


Preface Safety precautions

1 1.15

1.15. Safety precautions Miscellaneous safety precautions - Power interruption A power failure or momentary drop in voltage may damage the instrument or analyzer or lead to data loss. Perform regular backups of measurement results. Operation with an uninterruptible power supply (UPS) is recommended. Approved Part – Software Use of non-approved parts or devices may result in malfunction of the instrument or analyzer and may render the warranty null and void. Only use parts and devices approved by Roche Diagnostics. Personal protective equipment Be sure to wear appropriate protective equipment, including, but not limited to safety glasses with side shields, fluid resistant lab coat, and approved disposable gloves. Wear a face shield if there is a chance of splash or splatter. Follow standard laboratory practices, especially when working with biohazardous material. REAGENTS - Skin inflammation or injury caused by reagents Direct contact with reagents, detergents, or cleaning solutions may cause skin inflammation, or burns. •

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

•

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

•

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

OPTICAL SAFETY - Loss of sight due to staring into laser beam The barcode scanner on the autoloader of the cobas x 480 instrument contains a class 2 laser diode. Do not stare into the laser transmitter beam as eyesight may be severely damaged.

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1 1.16

Preface Material Required


1.16. Material Required 1.16.1. Documentation Article

Available on

Installation Manual cobas® 4800 system

Delivered with instrument & GRIPS > cobas z 480 > Installation Manual

Operator’s Manual cobas® 4800 system (Language: EN, DE, ES, FR,...)

Delivered with analyzer & GRIPS > cobas z 480 > Installation Manual GRIPS > cobas z 480 > Operators Manual, save it on a storage device

iSDoc for cobas x 480

GRIPS > cobas x 480 > iSDoc Service Manual

iSDoc for cobas z 480

GRIPS > cobas z 480 > iSDoc Service Manual

User Access Information cobas® 4800 system

GRIPS > cobas z 480 > Installation Manual

Reagent barcode information cobas® 4800 system


Ordering List cobas® 4800 system

GRIPS > cobas z 480 > Order Checklist

Installation Manual cobas z 480 analyzer

1.16.2. Software Article

Mat.No

Available on

DVD: OSXP Recovery for cobas 4800 Control Unit (IVD workflow) 1.0.0

05831563001

DCS Mannheim

CD: cobas® 4800 software 1.1.0 Build 1042

06240402001

DCS Mannheim

CD: SW Microlab STAR Service, Version 1.2 P/N 911148/01 06531148001 05614066001 CD: cobas z 480 service software, Version 2.0.1.805

DCS Mannheim DCS Mannheim

File: Workaround_Start_Menu_and_Shortcuts_Vx.x.zip

N/A


File: Cobas4800WorkorderEditor.exe.config.zip

N/A


File: cobas IT firewall Configuration Wizard 3.3 b3

N/A

Host Interface Test Tool 7.1.5 or higher

N/A

GRIPS > cobas IT firewall > Service Software GRIPS > cobas z 480 > Host Interface Test Tool

Please refer to Ordering List cobas® 4800 system available on GRIPS

1.16.3. Instrument/ Analyzer Please refer to Ordering List cobas® 4800 system available on GRIPS

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Preface Material Required

1 1.16

1.16.4. Accessories & Option Please refer to Ordering List cobas® 4800 system available on GRIPS

1.16.5. Consumables Please refer to Ordering List cobas® 4800 system available on GRIPS

1.16.6. Service Tools Please refer to Service Tools in the according instruments iSDoc GRIPS > iSDoc > Molecular Diagnostics > cobas 4800 > cobas x 480 >Spare Part > Service Tool GRIPS > iSDoc > Molecular Diagnostics > cobas 4800 > cobas z 480 >Spare Part > Service Tool

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2 2.1

Upgrade from version 1.0.x to 1.1.0 Installation Backup Restore Tool


2. Upgrade from version 1.0.x to 1.1.0 Installation instructions for a new cobas 4800 1.1.0 Build 1042 installation start with the next chapter Please see next chapter 3.4 Installation cobas 4800 control unit, page 24 4 SW Installation control unit, page 25 This section provides information on how to upgrade an existing cobas 4800 system installation version 1.0.1 Build 0943 or 1.0.2 Build 1010 to the new version 1.1.0 Build 1042. Any upgrade to the new cobas 4800 1.1.0 Build 1042 requires a new cobas 4800 control unit hp rp5700. A Backup Restore Tool is used to transfer the database content of the existing installation to the new cobas 4800 1.1.0 Build 1042 installation. The following procedure describes how to create the database backup that will be restored later, after installing the cobas 4800 software 1.1.0 Build 1042 on the new cobas 4800 control unit hp rp5700 Upgrade installation will require an HPV Run as a final operation qualification test.

2.1. Installation Backup Restore Tool Install the Backup Restore Tool on your existing cobas 4800 system installation version 1.0.1 Build 0943 or 1.0.2 Build 1010 1.

Press CTRL+ALT+DEL keys, Click on Log Off… and click Log Off to confirm

2.

Press & hold Shift key to interrupt auto log on

3.

Log on as user Install, PW: Instcobas48000709 For more passwords please refer to User Access Information for cobas® 4800 system available on GRIPS

4.

Insert the CD cobas 4800 software 1.1.0 Build 1042.

5.

Open windows explorer (Win+E).

6.

Browse to CD drive E:\

7.

Select folder 2_ORACLE and then press CTRL+C keys to copy the folder

8.

Browse to C:\ and then press CRTL+V to paste the folder 2_ORACLE

9.

Select folder 2_ORACLE and then press F2 key to rename the folder 2_ORACLE into ORACLE

2.2. Backup Database 1.

Browse to C:\ORACLE\Dump Make sure that cobas 4800 software is not running

2.

Run the file (double-click) backup.cmd

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Roche cobas® 4800 system 3.

Upgrade from version 1.0.x to 1.1.0 Backup Database

2 2.2

Type the password for User system, Password: 4evZ352G5LRuP_a

Do not change destination folder 4.

Press the button Run to start the backup of the database.

5.

Wait for the following prompt for user QUARTZ Export Terminated successfully without Warnings

6.

Press Exit

Creating the backup may take a few minutes, depending on the size of the database.

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2 2.3

Upgrade from version 1.0.x to 1.1.0 Store Archive & Backup Files


7.

Verify the following prompt for user INT_ADMIN: Export Terminated successfully without Warnings

8.

Press Exit

2.3. Store Archive & Backup Files 1.

Browse to D:\

2.

Select the folder Archive and then press CTRL+C to copy the folder

3.

Connect or insert a storage device to cobas 4800 control unit (e.g. NTFS formatted USB 2.0 External Hard Drive) Do not use any USB flash drive for large databases (e.g USB Memory Stick). Flash drives have a very low data transfer rate. Use only NTFS files format. FAT32 has a files size limitation of 4GB

4.

Browse to storage device F:\ Press CTRL+V keys (to paste the folder)

5.

After successfully storing all back up and archive files, go ahead with installing cobas 4800 software on the new cobas 4800 control unit hp rp5700 Please see next chapter 3.4 Installation cobas 4800 control unit, page 24 followed by chapter 4 SW Installation control unit, page 25

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New Installation Delivery/ Unpacking

3 3.1

3. New Installation 3.1. Delivery/ Unpacking The cobas® 4800 system is transported in palletized boxes. The boxes should be carefully inspected for any visual damage. In case of damages, report to your local Roche office and the shipping agent before accepting the unit. The original shipping container must be transferred unopened to the installation site. The cobas® 4800 system should be unpacked and installed only by authorized Roche Service personnel. No attempt should be made by the user to remove, set up or operate the system without Roche service personnel being present. Each instrument of the cobas® 4800 system is delivered with a packing list. All instrument, components, options, accessories and consumables are listed and should be verified against the delivered items.

3.2. Installation PART 1 cobas x 480 instrument Unpack the cobas x 480 instrument according iSDoc. Work according the 16.1 Installation Check List at the end of this manual and perform all PART 1 tasks. Please refer to GRIPS > iSDoc > x 480 > Installation > unpacking the instrument Set the working area, so called instrument deck in level. Check both directions X & Y. Adjust the trolley feet accordingly. Y-direction out of level might have a direct impact on reagents detected in reagent container. Do NOT switch on the cobas x 480 instrument before all software have been installed on cobas 4800 control unit This picture shows the options Trolley Hamilton Star with Gooseneck Display Support (A) Trolley Hamilton Star, (B) Control Unit, (C) Display Gooseneck, (D) Monitor

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3 3.3

New Installation Installation cobas z 480 analyzer


3.3. Installation cobas z 480 analyzer Please refer to GRIPS > z 480 > Installation Manual > Installation Manual cobas z 480 analyzer Do NOT switch on the cobas z 480 analyzer before all software have been installed on cobas 4800 control unit

3.4. Installation cobas 4800 control unit Set the control unit up at it requested place and connect keyboard, mouse, monitor and Speakers according picture below. Position the cobas 4800 control unit at the right hand side of the cobas x 480 instrument, to have the barcode scanner handy when loading the reagents. When Gooseneck Display Support is used the control unit must be indicated with a biohazardous warning label. The label (side length 90*90 mm) is supplied with the cobas z 480 accessories box and must be stuck on top of the cobas 4800 control unit.

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SW Installation control unit Delivery condition cobas 4800 control unit

4 4.1

4. SW Installation control unit 4.1. Delivery condition cobas 4800 control unit All new delivered cobas 4800 control units are preinstalled with DVD: OSXP Recovery for cobas 4800 Control Unit (IVD workflow) 1.0.0 which is also located inside the control unit. Any Installation of the cobas 4800 1.1.0 Build 1042 software requires a cobas 4800 control unit hp rp5700.

4.2. Verification of installed BIOS 1.

Power ON the cobas 4800 control unit

2.

During start-up process (blue hp invent screen) check for the version vE1.12 in the left bottom corner

If the installed BIOS version is vE1.12 continue with the next chapter. 4.3 Verification of installed image version If the installed BIOS version is not vE1.12 please go to chapter 16.1 Installation of BIOS settings, page 152

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4 4.3

SW Installation control unit Verification of installed image version


4.3. Verification of installed image version 1.

Wait to be automatically logged on as Operator.

2.


3.


4.

Log on as user: Install, PW: Instcobas48000709 For more passwords please refer to User Access Information for cobas® 4800 system available on GRIPS

5.

Navigate to Start > Settings > Control Panel > System

6.

Open (click on) System, tab General

7.

Verify details under Computer: cobas 4800 rp5700, Image 1.0.0 Click OK

If the installed Image version is OSXP Recovery Image 1.0.0 and No error messages occurred during system startup, please continue with next chapter 4.4 Windows Time and Date Adjustments If the installed Image version is not OSXP Recovery Image 1.0.0 or an error messages occurred during system startup, please go to chapter 16.2 Installation of OSXP Recovery Image, page 153.

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SW Installation control unit Windows Time and Date Adjustments

4 4.4

4.4. Windows Time and Date Adjustments 1.

Navigate to Start > Settings > Control Panel > Date and Time Properties

2.

Set the appropriate Time Zone & Daylight Saving as well as the correct Time Press OK to apply and close the window.

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4 4.5

SW Installation control unit cobas® 4800 software installation


4.5. cobas® 4800 software installation 1.


2.


3.


4.

Insert CD cobas® 4800 software

5.

Press Win+E keys to open explorer

6.

Browse to CD c4800_1.1.0.1042 (E:) / 1_cobas4800_1.1.0.1036 Run file (double-click) Setup_cobas 4800_V1.1.0.1036.exe and wait while Setup is loading.

7.

Installation Wizard starts Click Next

8.

Click I Agree

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4 4.5

Verify that only the following components are selected to install: ; cobas 4800 V1.1.0.1036 Start Menu Shortcuts ; NET 3.5 ; SamplePrepMethod ; Additional Debug Information PDF reader cobas 4800 Transformer ; Click Next

10. Use the given default path for Destination Folder Click Install

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4 4.5



11. Following installation screens belong to MTS SamplePrep Method Installer and its HW drivers. Assistance is needed to accept and confirm settings. Click OK

12. Click on Next

13. Click I Agree.

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Roche cobas® 4800 system 14. cobas 4800 1.1.0.1004 SamplePrep Click on Install


4 4.5

;

15. Click OK

16. Following installation screen belong to Solid-Liquid Sensors and its HW driver Click Next

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4 4.5



17. Click Finish

18. Following installation screens belong to CAT SH10 IVD Model Heater/Shaker and its HW driver Click Next

19. Click Finish

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4 4.5

20. Click Finish to complete cobas 4800 Sample Prep Method installation

21. Following installation screen belong to cobas 4800 Transformer and its HW driver Click Next

22. Click I Agree

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4 4.5



23. Verify that only the following components are selected to install: ; cobas 4800 Transformer Start Menu Shortcuts ; Additional Debug Information Click Next

24. Click Install

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4 4.5

25. Click Finish to complete cobas 4800 Transformer installation

26. Click Finish to complete cobas® 4800 software installation

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4 4.6

SW Installation control unit cobas® 4800 oracle DB installation


4.6. cobas® 4800 oracle DB installation 1.


2.


3.


4.


5.

Browse to drive C:\ORACLE

6.

Run file (double-click) Install_ALL.cmd

7.

Follow closely the instruction given in the following command windows

8.

Verify Connect to SYSTEM is displayed, then enter PW: 4evZ352G5LRuP_a press ENTER followed by F6, ENTER

9.

Wait for this prompt, then press any key to continue

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4 4.6

10. Verify Connect to R_INT_ADMIN is displayed, then enter PW: LbRuwotHFP press ENTER followed by F6, ENTER

11. Verify Connect to R_INT_USER, is displayed, then enter PW: W8xHEQvtLC press ENTER followed by F6, ENTER

12. Verify Connect to INT_ADMIN, is displayed, then enter PW: QhfIwXEP15 press ENTER followed by F6, ENTER

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4 4.6



13. Verify Connect to INT_SETUP, is displayed, then enter PW: S23WaZe66k press ENTER followed by F6, ENTER

14. Verify Connect to QUARTZ, is displayed, then enter PW: Li5qP3n2Ab press ENTER followed by F6, ENTER

15. When prompted, then press any key to continue.

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4 4.6

16. Wait for this prompt, then press any key to continue

17. Wait for this prompt, then press any key to continue

18. Wait approx. for 3 minutes for this prompt, then press any key to continue

During this process many users are dropped. Please wait and ignore error messages as the examples listed below: - ERROR at line 1: ORA-01918 user “BI” does not exist - ERROR at line 1: ORA-01918 user “OE” does not exist - ERROR at line 1: ORA-01918 user “….” does not exist

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4 4.6



19. Wait approx. for 1.5 minutes for this prompt, then press any key to continue

20. Press ALT+F4 to close the first explorer window 21. Navigate to Start > Programs > cobas_4800_V1.1.0.1036 > Tools > Migration Tool Start (click) Migration Tool

22. Wait for this prompt, then press ENTER to exit

If now an error message appears (after running the Migration Tool), go back and rerun the Instal_ALL.cmd followed by the Migration Tool

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SW Installation control unit cobas® 4800 software configuration

4 4.7

4.7. cobas® 4800 software configuration 4.7.1.

cobas® 4800 software start-up

1.

Start cobas_4800_V1.1.0.1036 software (double click on desktop icon)

2.

Initial start of cobas® 4800 software takes approx. 30 seconds If now an error message appears (after starting cobas® 4800 software) go back and rerun the Instal_ALL.cmd and Migration Tool

3.

Log on to cobas® 4800 software as user FSE, PW: 00rocheSRVC

For more passwords please see User Access Information for cobas® 4800 system, available on GRIPS

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4 4.7


4.7.2.


Reporting

Navigate in the tab navigation bar to Utilities > Configuration > Reporting > Parameter Value Enter Lab Name: xxxxxx Enter Lab Location: xxxxxx Activate Show Lab Header ; Click Apply to take over the changes

Following example shows the location of Lab Name and Lab Location on the report if Show Lab Header ; is activated

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4.7.3. 1.


4 4.7

Test parameters

Navigate in the tab navigation bar to Utilities > Configuration > Test Click in column Value to activate customer required parameters CT/NG workflow CT/NG PCR only work HPV Workflow HPV PCR only workflow CT/NG Cytology workflow

; ; ; ;

Click Apply to take over the changes

2.

Click Exit on the global action bar (right) followed by a Yes click to confirm

3.

Press CTRL+ALT+DEL keys

4.

Click on Shutdown… select shutdown and then click OK to confirm Do not use function Restart

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4 4.7


4.7.4.


Verification of cobas® 4800 software start-up user operator

1.

Power up cobas 4800 control unit

2.

Wait to be logged on automatically as user Operator

3.

Wait approx one more minute then start cobas_4800_V1.1.0.1036 software by double clicking on the desktop icon After ever start up of the cobas 4800 control unit it is required to wait approx. 1 minute before starting cobas® 4800 software to avoid the following oracle error: ORA-01033: ORACLE initialization or shutdown in progress If such en error occurs close all windows and start cobas® 4800 software again.

If any other oracle database error message than ORA-01033 occurs during cobas® 4800 software start up. Shut down and start up control unit again (no restart). Start cobas® 4800 software, if error still occurs reinstall OSXP Recovery Image. Please go to chapter 16 Appendix \ 16.2 Installation of OSXP Recovery Image, page 153 4.

If no error occurs log on as user FSE, PW: 00rocheSRVC and close software.

4.7.5.

Verification of cobas® 4800 database size

1.

Press CTRL+ALT+DEL keys, click on Log Off… and click Log Off to confirm Press & hold Shift key to interrupt auto log on Log on as user Install, PW: Instcobas48000709

2.

Start cobas® 4800 software and log on as user FSE, PW: 00rocheSRVC For more passwords please see User Access Information for cobas® 4800 system GRIPS > Molecular Diagnostics > Systems > cobas 4800 > cobas z 480 > Installation Manual

3.

Check if a database size is displayed in main working area, approx 10.5 MB

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4 4.7

Press Exit on the cobas® 4800 software global action bar (right) followed by Yes click to confirm

4.7.6.

Archive Trigger and Fix Indices

1.

Open windows explorer (WIN+E)

2.

Browse to drive C:\Oracle

3.

Run file (double-click). CreateFileArchiveTrigger.cmd

4.

Type the password for oracle user INT_ADMIN, PW: QhfIwXEP15 Confirm by pressing following three keys ENTER, F6, ENTER

5.

When prompted, then press any key to continue.

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4 4.7



6.

Browse to drive C:\Oracle\FixIndices

7.

Run file (double-click). FixIndices.cmd

8.

Type the password for oracle user INT_ADMIN, PW: QhfIwXEP15 Confirm by pressing following three keys ENTER, F6, ENTER

9.

When prompted, then press any key to continue.

4.7.7.

Delete folder ORACLE

1.

Browse to drive C:\

2.

Select folder ORACLE

3.

Press SHIFT+DEL keys to permanently remove the folder Oracle with all its contents followed by a Yes click to confirm.

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SW Installation control unit cobas® 4800 Work Order Editor Installation

4 4.8

4.8. cobas® 4800 Work Order Editor Installation 1.

Insert CD cobas® 4800 software

2.

Browse to CD DRIVE E:\3_WorkOrderEditor_V1.1.0.1016 Run file (double-click) Setup_cobas_4800_WOE_v1.1.0.1016.exe

3.

Click Next.

4.

Click Next

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4 4.8

SW Installation control unit cobas® 4800 Work Order Editor Installation

5.

Click Install

6.

Click Finish

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SW Installation control unit Installation of cobas® 4800 Operator’s Manual

4 4.9

4.9. Installation of cobas® 4800 Operator’s Manual Please provide with a storage device (i.e. CD, USB Memory Stick) the latest Operator’s Manual cobas® 4800 system in the customer required language which can be downloaded from GRIPS Please note there are several different version of the operator’s manual available. A CT/NG only, a HPV only and a combined manual CT/NG with HPV. Please install the most appropriate manual for your installing site. 7.

Connect or insert the storage device (i.e. usb flash drive) to cobas 4800 control unit

8.

Browse to storage device F:\ and select the Operator’s Manual cobas® 4800 system. Press CTRL+C keys (to copy the file)

9.

Browse to folder C:\Program Files\RocheDiagnosticsAG\cobas_4800_V1.1.0.1036\Documentation Press SHIFT+DEL keys to permanently delete the existing file UserManual.pdf

10. Press CTRL+V keys (to paste the file) 11. Press F2 key to rename the Operator’s Manual cobas® 4800 system as UserManual.pdf 12. Browse to folder C:\Program Files\RocheDiagnosticsAG\cobas® 4800 Work Order Editor Press SHIFT+DEL keys to permanently delete the existing file Users Manual.pdf 13. Press CTRL+V keys (to paste to file) 14. Press F2 key to rename the Operator’s Manual cobas® 4800 system as Users Manual.pdf 15. Start cobas_4800_V1.1.0.1036 software (double click on desktop icon) Log on as user FSE, PW: 00rocheSRVC, click OK to confirm log on 16. Click Info button at the right bottom corner and then click the button User Manual The Operator’s Manual (UserManual.pdf) must open now. Verify for the correct version, if all is correct, click Exit and Yes to close cobas® 4800 software

17. Start cobas® 4800 Work Order Editor (double click on desktop icon) 18. Click Info button at the right bottom corner and then click the button User Manual. The Operator’s Manual (Users Manual.pdf) must open now. Verify for the correct version, if all is correct close the Manual and click Exit to close cobas® 4800 Work Order Editor If the Operator’s manual does not open, check for correct file name UserManual.pdf and Users Manual.pdf 19. Press Eject CD button and remove the CD

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4 4.10

SW Installation control unit cobas x 480 Service Software Installation


4.10. cobas x 480 Service Software Installation 4.10.1. Service Software cobas x 480 instrument 1.

Insert CD SW Microlab STAR Service, Version 1.2

2.

Browse to E: \Service_Software Run file (double-click) Microlab STAR Service 4_3_0_450.exe

3.

Click Next

4.

Click Finish

4.10.2. Firmware cobas x 480 instrument Open windows explorer (Win+E) 5.

Browse to CD Drive E:\Firmware\ Select and copy the folder 5.6S (CTRL+C)

6.

Browse to C:\Program Files\HAMILTON\STARService\Firmware Press CTRL+V keys to paste folder 5.6S

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SW Installation control unit cobas x 480 instrument driver installation

4 4.11

4.10.3. Macro cobas x 480 instrument 1.

Browse to CD Drive E:\ Macros Service SW 4.3.0.450 and higher\ Select and copy the folder STARline (CTRL+C)

2.

Browse to C:\Program Files\HAMILTON\STARService\Macros Press CTRL+V keys to paste the folder STARline

3.

Remove CD

4.11. cobas x 480 instrument driver installation 1.

Connect the cobas x 480 instrument to cobas 4800 control unit via USB cable A 3 meter USB cable for the connection between cobas 4800 control unit and cobas x 480 instrument is provided in the cobas x 480 accessory box. Cable length more then 5 meters may lead to signal interferences. Cable USB 2.0 high speed, gold plated connector Type A (m)–Type B (m) with 2 ferrite cores.

2.

Connect the power cable (2) according image below Do not use back channel of instrument for power cables

3.

Power up cobas x 480 instrument

Please see connectors overview of control unit in chapter 3.4 Installation cobas 4800 control unit, page 24

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4 4.12

SW Installation control unit cobas z 480 analyzer Service Software Installation

4.

Wait for the pop up window New Hardware Wizard Click Next

5.

Click Finish


4.12. cobas z 480 analyzer Service Software Installation 1.

Insert CD: cobas z 480 service software, Version 2.0.1.0805

2.

Browse to CD DRIVE E:\

3.

Run (Double-click) z480_SSWSetup_2.0.1.0805.exe

4.

The LightCycler 480/1536 - cobas z 480 analyzer Service Software – Install Shield Wizard appears and click Next

5.

Click Next

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SW Installation control unit cobas z 480 analyzer Service Software Installation

6.

On the next screen click Install

7.

The wizard will install the service software and click Finish on the following screen

8.

Close all windows.

9.

Select the shortcut named LightCycler® 480 – cobas z 480 Service Software and then press SHIFT+DEL keys to permanently delete

4 4.12

10. Press Eject CD button and remove the CD

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4 4.13

SW Installation control unit User permission modification


User permission modification 4.13.1. cobas® 4800 software log file folder Following procedure describes the user permission modification. This allows the user Operator to access the cobas 4800 software log files. 1.

Press CTRL+ALT+DEL keys to verify Logon Information. User Install is required, click Cancel

2.

Press WIN+E keys to open explorer

3.

Browse to C:\Program Files\RocheDiagnosticsAG\cobas_4800_V1.1.0.1036\bin

4.

Right Click on folder Log and then select in the context menu Properties

5.

a) Navigate to tab Security (a), Select Group Users, in Permissions for Users in column Allow click to select Full Control check box, and then click Apply followed by a click on Advanced b) Under tab Permissions (b), click to select check box Replace permission entries on all child objects with entries shown here that apply to child objects, and then click OK

6.

Click YES to confirm, followed by OK

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4 4.13

4.13.2. Remove permissions for folder Roche_x480_ConfigFiles Following procedure describes how to unlink the permissions for folder Roche_x480_ConfigFiles between users. The permissions modify and write permissions are removed for the 3 users. 1.

Browse to C:\Program Files\HAMILTON\Config

2.

Right click on folder Roche_x480_ConfigFiles and then select in the context menu Properties

3.

Navigate to tab Security (a), Select Group Administrators and then Click Advanced

4.

Under tab Permissions (b), Select Permission entries: Administrators

5.

Click to deselect check box Inherit from parent permission entries that apply to child objects. Include these with entries explicitly defined here

6.

Click COPY in the security pop up window, click OK to close the window

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4 4.13 7.



a) Navigate to tab Security (a), Select Group Lab Method Programmer, Under Allow click to deselect Modify and Write check box, and then click Apply b) Navigate to tab Security (b), Select Group Lab Operator, Under Allow click to deselect Modify and Write check box, and then click Apply c) Navigate to tab Security (c), Select Group Lab Operator 2, Under Allow click to deselect Modify and Write check box, and then click Apply

8.

Click OK to close the window

9.

Close explorer window.

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SW Installation control unit Workaround Start Menu & Shortcuts

4 4.14

4.14. Workaround Start Menu & Shortcuts Following procedure is introduced to shorten the very time consuming chapter 4.15 Windows Start Menu & Shortcuts. Relocating and arranging all these files and folders is replaced by copy and paste a predefined folder package. After performing this procedure 4.14 Workaround Start Menu & Shortcuts the chapter 4.15 Windows Start Menu & Shortcuts can be skipped. Performing this procedure is not mandatory. Skipping this procedure and continuing with 4.15 Windows Start Menu & Shortcuts will lead to the same result. Short cuts in the start menu added with the folder package do not contain the symbol ® in the short cut name, this is because such special character can not be zipped. Nevertheless this has no functional impact. 1.

Download the latest Workaround_Start_Menu_and_Shortcuts_Vx.x.zip file from GRIPS. GRIPS > cobas 4800 > cobas z 480 > Installation Manual

2.

Extract the Workaround_Start_Menu_and_Shortcuts_Vx.x.zip to a storage device (i.e. usb flash drive).

3.


4.


5.

Switch OFF the cobas x 480 instrument

6.

Start cobas_4800_V1.1.0.1036 software (Navigate to Start > Programs > cobas_4800_V1.1.0.1036 > cobas_4800_V1.1.0.1036)

7.

Log on to cobas® 4800 software as user FSE, PW: 00rocheSRVC Click OK to confirm Log on

8.

Wait for the following error messages: Processing on cobas x 480 was aborted by the instrument Error on cobas x 480

The first created problem report (FSE report) will force the system to create the folder FSEReport for user Operator. 9.

Exit cobas_4800_V1.1.0.1036 software

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4 4.14

SW Installation control unit Workaround Start Menu & Shortcuts


10. Press CTRL+ALT+DEL keys Click on Log Off… and click Log Off to confirm Press & hold Shift key to interrupt auto log on Log on as user Install, PW: Instcobas48000709 11. Connect or insert the storage device (i.e. usb flash drive) to the cobas 4800 control unit 12. Open the windows explorer (Win+E) 13. Browse to storage device F:\workaround_start_menu_and_shortcuts\ and select the folders All Users, INSTALL and OPERATOR by holding down the Shift key (multiple selection) Press CTRL+C keys (to copy the folders) 14. Browse to folder C:\Documents and Settings Press CTRL + V keys (to paste the folders) 15. Click Yes to ALL to confirm folder replace. 16. Browse to C:\Documents and Settings\OPERATOR\My Documents\Work Orders Select the path in the address field of the windows explorer and then press CTRL+C keys to copy it 17. Start cobas_4800_V1.1.0.1036. followed by a log on as user FSE, PW: 00rocheSRVC 18. Navigate to Utilities > Configuration > System Settings > Workorder import path Press CTRL+V keys to paste the path

19. Click Apply to take over the changes 20. Click Exit (a) on the global action bar (right) and then click Yes (b) to confirm

21. Browse to C:\Documents and Settings\All Users\Start Menu\Programs\HAMILTON Select folder Microlab STAR Service and press SHIFT+DEL to delete permanently. Press Yes to confirm. 22. Browse to C:\Documents and Settings\All Users\Start Menu\Programs Select folder Roche and press SHIFT+DEL to delete permanently. Press Yes to confirm. 23. Browse to C:\Documents and Settings\All Users\Start Menu\Programs\cobas_4800_V1.1.0.1036 Select folder Documentation and then press SHIFT+DEL to delete permanently. Press Yes to confirm. Select folder Tools and then press SHIFT+DEL to delete permanently. Press Yes to confirm. Select icon Uninstall cobas_4800_V1.1.0.1036 and then press SHIFT+DEL to delete permanently. Press Delete Shortcut to confirm. 24. Browse to C:\Documents and Settings\All Users\Start Menu\Programs\cobas® 4800 Work Order Editor v1.1.0.1016 Select program icon Uninstall cobas® 4800 Work Order Editor v1.1.0.1016 and then press Page 58 of 175

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4 4.15

SHIFT+DEL to delete permanently. Press Delete Shortcut to confirm. Select icon User Manual and then press SHIFT+DEL to delete permanently. Press Yes to confirm 25. Close the explorer window 26. Skip chapter 4.15 Windows Start Menu & Shortcuts Go ahead with 4.16 Window Menu Verification

4.15. Windows Start Menu & Shortcuts 4.15.1. Create a folder to save Work Orders 1.

Press CTRL+ALT+DEL keys, click on Log Off… and click Log Off to confirm

2.

Wait to be logged on automatically as Operator

3.

Browse to C:\Documents and Settings\OPERATOR\My Documents

4.

Select in the menu bar File > New > Folder and then rename it as Work Orders

5.

Press CTRL+ALT+DEL keys Click on Log Off… and click Log Off to confirm Press & hold Shift key to interrupt auto log on Log on as user Install, PW: Instcobas48000709

6.

Open windows explorer (Win+E)

7.

Browse to C:\Documents and Settings\OPERATOR\My Documents (Administrator’s Documents)

8.

Right-click the folder Work Orders, select form the context menu Create Shortcut

9.

Press F2 key to rename shortcut as Work Orders as Work Orders

10. Press CTRL+X keys to cut the shortcut 11. Browse to C:\Documents and Settings\ALL USER\Start Menu and then press CTRL+V keys to paste the shortcut Work Orders 12. Select the pasted shortcut Work Orders and then press CTRL+C keys to copy the shortcut 13. Browse to C:\Documents and Settings\ALL USER\Desktop and then press CTRL+V keys to paste the shortcut Work Orders 14. Browse to C:\Documents and Settings\OPERATOR\My Documents (Administrator’s Documents)\Work Orders Select the path in the address field of the windows explorer and then press CTRL+C keys to copy it 15. Start cobas_4800_V1.1.0.1036 and log on as user FSE, PW: 00rocheSRVC 16. Navigate to Utilities > Configuration > System Settings > Workorder import path Press CTRL+V keys to paste the path

17. Click Apply to take over the changes

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18. Click Exit (a) on the global action bar (right) and then click Yes (b) to confirm

19. Press ALT+F4 keys to close the explorer window

4.15.2. Relocate folder Microlab Star Service 1.

Browse to C:\Documents and Settings\All Users\Start Menu\Programs\HAMILTON Select folder Microlab STAR Service and then press CTRL+X keys to cut the folder

2.

Browse to C:\Documents and Settings\Install\Start Menu\Programs Create a new folder (Menu: File > New > Folder) named HAMILTON

3.

Open the folder HAMILTON Press CTRL+V keys to paste the folder Microlab STAR Service

4.

Browse to C:\Documents and Settings\Install\Start Menu\Programs\Hamilton\Microlab STAR Service Select program icon Microlab STAR Service and then press CTRL+C to copy

5.

Browse to C:\Documents and Settings\Install\Start Menu Press CTRL+V keys to paste the program icon Microlab STAR Service This creates the entries in Start Menu. See chapter 4.16.4, page 68

6.

Browse to C:\Documents and Settings\All Users\Start Menu\Programs\Hamilton\Microlab STAR Press CTRL+C keys to copy both program icons STAR Method Editor and Microlab STAR Maintenance & Verification

7.

Browse to C:\Documents and Settings\Install\Start Menu Press CTRL+V keys to paste both program icons STAR Method Editor and Microlab STAR Maintenance & Verification

8.

Close all windows

9.

Press Eject CD button and remove the CD

4.15.3. Relocate folder Roche 1.

Browse to C:\Documents and Settings\All Users\Start Menu\Programs Select folder Roche and then press CTRL+X keys to cut the folder

2.

Browse to C:\Documents and Settings\Install\Start Menu\Programs

3.

Press CTRL+V keys to paste the folder Roche

4.

Browse to C:\Documents and Settings\Install\Start Menu\Programs\Roche Select program icon LightCycler 480 - z 480 and then press CTRL+C keys to copy

5.

Browse to C:\Documents and Settings\Install\Start Menu Press CTRL+V keys to insert the program icon This creates the entries in Start Menu. See chapter 4.16.4, page 68

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4.15.4. FSE Reports (OPERATOR) 1.


2.


3.

Navigate to Start > Programs > cobas_4800_V1.1.0.1036 > cobas_4800_V1.1.0.1036 Start (click) cobas_4800_V1.1.0.1036

4.


5.

Switch OFF the cobas x 480 instrument to force the system creating the folder FSEReport for user Operator. The cobas 4800 system safes the created Error Report in this folder

6.

Exit cobas_4800_V1.1.0.1036 software

7.

Press CTRL+ALT+DEL keys Click on Log Off… and click Log Off to confirm Press & hold Shift key to interrupt auto log on Log on as user Install, PW: Instcobas48000709

8.

Press WIN+E keys to open explorer

9.

Browse to C:\Documents and Settings\OPERATOR\Application Data\Roche Diagnostics\cobas_4800_V1.1.0.1036

10. Right-click the folder FSEReport, select form the context menu Create Shortcut 11. Press F2 key to rename Shortcut to FSEReport as FSEReport 12. Select and then press CTRL+X keys to cut the shortcut 13. Browse to C:\Documments and Settings\All Users\Desktop and then press CTRL+V keys to paste the shortcut FSEReport 14. Select the shortcut FSEReport and then press CTRL+C keys to copy 15. Browse to C:\Documments and Settings\All Users\Start Menu and then press CTRL+V keys to paste shortcut FSEReport FSE Reports are stored in user specific folders according Windows Log In Procedure above creates the entries in Start Menu. See chapter 4.16.1Start Menu (OPERATOR) If the path C:\Documents and Settings\OPERATOR\ is not visible, log on as Operator Perform procedure according chapter 4.15.1 Create a folder to save Work Orders If the folder FSEReport is not displayed start cobas 4800 software, switch off cobas x 480 instrument an wait for the following error messages: Processing on cobas x 480 was aborted by the instrument Error on cobas x 480 The first created problem report (FSE report) will force the system to create the folder FSEReport for the user operator

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4.15.5. FSE Reports (INSTALL) 1.

Switch ON cobas x 480 instrument

2.

Press CTRL+ALT+DEL keys to verify Logon Information. User Install is required, click Cancel

3.

Start cobas_4800_V1.1.0.1036 software (Navigate to Start > Programs > cobas_4800_V1.1.0.1036 > cobas_4800_V1.1.0.1036)

4.


5.

Switch OFF the cobas 4800 instrument and wait for the following error messages: Processing on cobas x 480 was aborted by the instrument Error on cobas x 480 The first created problem report (FSE report) will force the system to create the folder FSEReport for the user Install

6.

Browse to C:\Documents and Settings\INSTALL\Application Data\Roche Diagnostics\cobas_4800_V1.1.0.1036

7.

Right-click the folder FSEReport, select form the context menu Create Shortcut

8.

Press F2 key to rename Shortcut to FSEReport as FSEReport (Install)

9.

Select and then press CTRL+X keys to cut the shortcut

10. Browse to C:\Documments and Settings\INSTALL\Start Menu and then press CTRL+V keys to paste shortcut FSEReport (Install)

4.15.6. Remove uninstall cobas_4800_V1.1.0.1036 1.

Browse to C:\Documents and Settings\All Users\Start Menu\Programs Select folder cobas_4800_V1.1.0.1036 and then press CTRL+C keys to copy the folder

2.

Browse to C:\Documents and Settings\Install\Start Menu\Programs Press CTRL+V keys to paste the folder cobas_4800_V1.1.0.1036

3.

Browse to C:\Documents and Settings\Install\Start Menu\Programs\cobas_4800_V1.1.0.1036 Press CTRL+X to cut program icon cobas_4800_V1.1.0.1036

4.

Browse to C:\Documents and Settings\All Users\Start Menu Press CTRL+V to paste program icon cobas_4800_V1.1.0.1036

5.

Browse to C:\Documents and Settings\All Users\Start Menu\Programs\cobas_4800_V1.1.0.1036 Select folder Documentation and then press SHIFT+DEL to delete permanently Select folder Tools and then press SHIFT+DEL to delete permanently Select icon Uninstall cobas_4800_V1.1.0.1036 and then press SHIFT+DEL to delete permanently

6.

Browse to C:\Documents and Settings\Install\Start Menu\Programs\cobas_4800_V1.1.0.1036 Select icon Uninstall cobas_4800_V1.1.0.1036 and then press SHIFT+DEL to delete permanently.

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4 4.15

4.15.7. Remove uninstall cobas® 4800 Work Order Editor 1.

Browse to C:\Documents and Settings\All Users\Start Menu\Programs Select folder cobas® 4800 Work Order Editor v1.1.0.1016 and then press CTRL+C keys to copy the folder

2.

Browse to C:\Documents and Settings\Install\Start Menu\Programs Press CTRL+V keys to paste the folder cobas® 4800 Work Order Editor v1.1.0.1016

3.

Browse to C:\Documents and Settings\Install\Start Menu\Programs\cobas® 4800 Work Order Editor v1.1.0.1016 Press CTRL+X keys to cut the program icon cobas® 4800 Work Order Editor v1.1.0.1016

4.

Browse to C:\Documents and Settings\All Users\Start Menu Press CTRL+V to paste program icon cobas® 4800 Work Order Editor v1.1.0.1016

5.

Browse to C:\Documents and Settings\All Users\Start Menu\Programs\cobas® 4800 Work Order Editor Select program icon Uninstall cobas® 4800 Work Order Editor v1.1.0.1016 and then press SHIFT+DEL to delete permanently

6.

Browse to C:\Documents and Settings\Install\Start Menu\Programs\cobas® 4800 Work Order Editor Select program icon Uninstall cobas® 4800 Work Order Editor v1.1.0.1016 and then press SHIFT+DEL to delete permanently.

4.15.8. Shortcut to cobas 4800 Log Files 1.

Browse to C:\Program Files\RocheDiagnosticsAG\cobas_4800_V1.1.0.1036\bin Select the folder Log, select form the context menu Create Shortcut

2.

Press F2 key to rename Shortcut to Log as cobas 4800 Log Files

3.

Select and Press CTRL+X keys to cut the shortcut

4.

Browse to C:\Documments and Settings\Install\Start Menu Press CTRL+V keys to paste shortcut cobas 4800 LogFiles

4.15.9. Shortcut to Hamilton Log Files 1.

Browse to C:\Program Files\Hamilton Select the folder LogFiles, select form the context menu Create Shortcut

2.

Press F2 key to rename Shortcut as Hamilton LogFiles

3.

Select and Press CTRL+X keys to cut the shortcut

4.

Browse to C:\Documments and Settings\Install\Start Menu Press CTRL+V keys to paste shortcut Hamilton LogFiles

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4.15.10. Shortcut to Balance Config file IVDVolVer.ini 1.

Browse to C:\Program Files\HAMILTON\Config Right-click on the file IVDVolVer.ini select form the context menu Create Shortcut

2.

Press F2 key to rename Shortcut to IVDVolVer.ini as Balance Configurator IVDVolVer.ini

3.

Select and then press CTRL+X keys to cut the shortcut

4.

Browse to C:\Documents and Settings\Install\Start Menu\ Press CTRL+V keys to paste the shortcut Balance Configurator IVDVolVer.ini

4.15.11. Shortcut to cmd.exe 1.

Browse to C:\WINDOWS\system32

2.

Right-click on the file cmd.exe, select form the context menu Create Shortcut

3.

Press F2 key to rename Shortcut to cmd.exe into cmd.exe

4.

Press CTRL+X keys to cut the shortcut

5.

Browse to C:\Documents and Settings\Install\Start Menu

6.

Press CTRL+V keys to paste the shortcut cmd.exe This creates the entries in Start Menu. See chapter 4.16.4 on page 68

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SW Installation control unit Window Menu Verification

4 4.16

4.16. Window Menu Verification 4.16.1. Start Menu (OPERATOR) 1.


2.

Wait to be logged on automatically as user auto log on user Operator

3.

Verify Icon’s on Desktop (a) and correct if necessary Right click on Recycle Bin and then select Empty Recycle Bin Empty Recycle Bin is grayed out if already empty

4.

Press the Win key or alternatively click Start Verify the icon’s in Start Menu (b), Right mouse click to open the context menu and then select Sort by Name

5.

Navigate to Start > Programs Verify the icons under Programs (c), Right mouse click to open the context menu and then select Sort by Name

If any correction is needed log on as user Install Go to C:\Documents and Settings\All Users\Start Menu Icons stored in this folder are accessible for both users Operator and Install

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4 4.16



4.16.2. Programs Menu (OPERATOR) 1.

Navigate to Start > Programs

2.

Verify the icon’s according pictures (a, b, c) below.

In order to correct the entries in Programs, browse to C:\Documents and Settings\All Users\Start Menu\Programs Icons stored in this folder are accessible for both users Operator and Install

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4 4.16

4.16.3. Verifying permission for folder Roche_x480_ConfigFiles This procedure is to verify that the user OPERATOR does not have permissions to modify or write in folder Roche_x480_ConfigFiles. 1.

Navigate to Start > Programs > Hamilton > Microlab STAR Start (Click) Microlab STAR Method Editor

2.

Navigate to Tools > SystemConfigurationEditor

3.

Select Microlab STAR IVD (ML_STAR) (a) Click [-] TADM settings to display the settings (b) The permissions are correct if no modification is possible

4.

Close all windows

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4.16.4. Start Menu (INSTALL) 1.


2.


3.

Log on as user Install, PW: Instcobas48000709

4.

Verify Icon’s on Desktop (a) and correct if necessary Right click on Recycle Bin and then select Empty Recycle Bin

5.

Navigate to Start > Start Menu Verify 13 Icon’s in Start Menu (b), right mouse click to open the context menu and then select Sort by Name

6.

Navigate to Start > Programs Verify the icons under Programs (c), right mouse click to open the context menu and then select Sort by Name

In order to correct the entries in start menu, browse to C:\Documents and Settings\Install\Start Menu Icons stored in this folder are accessible for user Install only

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4 4.16

4.16.5. Programs Menu (INSTALL) 1.

Navigate to Start > Programs

2.

Verify the icon’s according pictures (a, b, c, d) below.

In order to correct the entries in Programs, browse to C:\Documents and Settings\Install\Start Menu\Programs Icons are stored in the corresponding folders which are accessible for user Install only

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4 4.17

SW Installation control unit Workaround exchanging of Workorder Config. File


4.17. Workaround exchanging of Workorder Config. File Following procedure is introduced to shorten the installation time of chapter 4.18 Exchanging of Workorder Config. File Changing the settings of the Workorder Editor Display can be done by exchanging the prechanged File. After performing this procedure 4.18 Exchanging of Workorder Config. Filecan be skipped. Performing this procedure is not mandatory. Skipping this procedure and continuing with 4.18 Exchanging of Workorder Config. File will lead to the same result. 1.

Download the latest Cobas4800WorkorderEditorConfigFile.zip from GRIPS. GRIPS > cobas 4800 > cobas z 480 > Installation Manual

2.

Extract the Cobas4800WorkorderEditorConfigFile.zip to a storage device (i.e. usb flash drive).

3.

Press CTRL+ALT+DEL keys to verify logon Information. User Install is required, click Cancel.

4.

Connect or insert the storage device (i.e. usb flash drive) to the cobas 4800 control unit

5.

Open the windows explorer (Win+E)

6.

Browse to storage device F:\ and select the File Cobas4800WorkorderEditor.exe.config Press CTRL+C keys (to copy the folders)

7.

Browse to folder C:\Program Files\RocheDiagnosticsAG\cobas_4800_Work_Order_Editor_v1.1.0.1016, select the file Cobas4800WorkorderEditor.exe.config and press SHIFT+V and confirm with YES to exchange the existing File

8.

Close all Windows

9.

Skip chapter 4.18 Exchanging of Workorder Config. File Go ahead with 4.19 Verify Workorder Editor Display

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4 4.18

4.18. Exchanging of Workorder Config. File 1.

Browse to C:\Program Files\RocheDiagnosticsAG\cobas_4800_Work_Order_Editor_v1.1.0.1016 and select the Cobas4800WorkorderEditor.exe.config

2.

Double click the File, mark Select the Program from a list and choose Notepad to open the file

3.

Search for UseMediaTypeVsInCTNgCyt and change the value to False

4.

Search for UseMediaTypeVsInCTNgPcronly and change the value to False

4.19. Verify Workorder Editor Display 1.

Start cobas_4800_Workorder_Editor_v1.1.0.1016 software

2.

Choose the following parameters Run Type : Full Workflow TestType: CT/NG Cytology workflow

3.

Press Next

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SW Installation control unit Verify Workorder Editor Display


4.

Check that only PreservCyt® Medium can be selected in section Media Type

5.

Press New and confirm with ok

6.

Choose the following parameters PCR only Workflow Run Type : TestType: CT/NG workflow Plate ID: enter a dummy ID e.g. 123

7.

Press Next

8.

Check that UT, UUT and PreservCyt® Medium can be selected in section Media Type

9.

Press Exit and confirm with ok

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SW Installation control unit LabNET settings for Printer/ Firewall

4 4.20

4.20. LabNET settings for Printer/ Firewall The LabNet Address on cobas 4800 control unit is set by default on 172.20.1.140. Change this IP address to 172.20.1.141 for the second cobas 4800 control unit if more then on system get installed within the same network. The first system must have the IP 172.20.1.140 because of the cobas IT firewall wizard. There are two Network connections/ adapters: The Instrument LAN is assigned to the onboard adapter The LabNet is assigned to the PCI Intel (R) PRO/1000 PT Desktop Adapter. Please see connectors overview of control unit in chapter 3.4 Installation cobas 4800 control unit, page 24 1.

Navigate to Start > Settings > Network Connections > LabNET Click on Properties

2.

Select Internet Protocol (TCP/IP) in list This connection uses the following item Click on Properties

3.

Change the IP Address accordingly a) cobas 4800 control unit no.1: IP: 172.20.1.140 Subnet mask: 255.255.255.0, Default gateway: 172.20.1.1 b) cobas 4800 control unit no.2: IP: 172.20.1.141 Subnet mask: 255.255.255.0, Default gateway: 172.20.1.1 c) cobas 4800 control unit no.3: IP: 172.20.1.142 Subnet mask: 255.255.255.0, Default gateway: 172.20.1.1 d) cobas 4800 control unit no.4: IP: 172.20.1.143 Subnet mask: 255.255.255.0, Default gateway: 172.20.1.1

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5 5.1

Upgrade Installation Restore Database Installation Backup Restore Tool


5. Upgrade Installation Restore Database New installation, there is nothing to restore please proceed with the next chapter: 6 cobas x 480 instrument Installation, page 76 and continue to the end of the manual

5.1. Installation Backup Restore Tool 1.


2.


3.


4.

Insert the CD cobas 4800 software 1.1.0 Build 1042.

5.

Open windows explorer (Win+E).

6.


7.


8.


9.


5.2. Restore Database 1.

Browse to D:\Archive

2.

Create a new folder named MTS-Backup (Menu: File > New > Folder)

3.

Connect or insert the storage device to the cobas 4800 control unit that contains the back up files.

4.

Browse to storage device F:\ select the database backup files INT_ADMIN.dmp and QUARTZ.dmp by holding down the Shift key (multiple selection) and then press CTRL+C keys (to copy those files).

5.

Browse to D:\Archive\MTS-Backup

6.

Press CTRL+V keys to paste the folder backup files INT_ADMIN.dmp and QUARTZ.dmp

7.

Browse to C:\Oracle\Dump

8.

Run file (double-click) restore.cmd

9.

Type the password for oracle user SYSTEM, PW: 4evZ352G5LRuP_a Do not change destination folder

10. Press the Run button to start the restore process of the database.

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Upgrade Installation Restore Database Restore Database

5 5.2

11. Wait for the following prompt for user QUARTZ: Import terminated successfully without warnings.

12. Press Exit 13. Verify the following prompt for user INT_ADMIN: Import terminated successfully without warnings.

14. Press Exit 15. Start cobas® 4800 software. 16. Log on to cobas® 4800 software as user FSE, PW: 00rocheSRVC 17. Navigate to the Result tap and verify the restored results. 18. After successfully restoring the database proceed with chapter 9 LIS Interface Installation, page 87 and continue to the end of the manual. There are now hardware changes for the current software upgrade.

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6 6.1

cobas x 480 instrument Installation Stationary Carrier and Heater/Shaker Unit


6. cobas x 480 instrument Installation 6.1. Stationary Carrier and Heater/Shaker Unit There is a so called stationery carrier which needs to be installed and on the cobas x 480 instrument. It carries the Heater/Shaker Unit, the Magnet Plate, DWP Holder and MWP Holder. There are 5 predefined tracks at position 41-47 to take the Stationary Carrier on board.

1.

Unpack the stationary carrier

2.

Adjust springs of the DWP Holder (a), check the fixing lug (b) and knurled screw and then verify that the cable leaves the unit a the rear side (c) and not sideward’s.

3.

Carefully load it the stationary carrier on the platform at position 41-47 and move it to the very end

4.

Fix it at the rear side of the stationary carrier with knurled screw

5.

Lay the CAT H/S Module cable into rear instrument channel and bring it either at the left or right out of the instrument. Preferably to the right, next to the cobas 4800 control unit.

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cobas x 480 instrument Installation Stationary Carrier and Heater/Shaker Unit

6.

Place the Controller Box of the CAT H/S Unit on the top of the cobas 4800 control unit or any other suitable place. Keep in mind that the CAT H/S Unit can only be switch on and off at the Controller Box of the CAT H/S Unit and it should be easy accessible for operator/ service engineers

7.

Fix the Controller Box of the CAT H/S Unit with a large Velcro strip and bind it together with the cobas 4800 control unit

8.

Connect the CAT H/S Unit cable to controller box (Port ST)

9.

Connect the Controller Box of the CAT H/S Unit (Port RS232) with the cobas 4800 control unit port (COM1) by using the supported serial cable

6 6.1

Please see connectors overview of control unit in chapter 3.4 Installation cobas 4800 control unit, page 24 10. Place and fix the Power Supply at a suitable location 11. Connect the Power Supply Output to the Controller Box of the CAT H/S Unit 12. Take a power cable and connect it to the controller box and then to the power socket

13. Stow the cables either into the instrument cable channel or to the trolley frame. Make that cables are neatly stowed, fixed and safe against unwanted disconnection. 14. Switch ON at the controller box of the CAT H/S Module Watch init procedure for proper function. After switching on the controller box, the heater/shaker starts turning, accelerates and stops with a noticeable “click” 15. The installation of the Stationary Carrier and heater/shaker unit is complete.

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6 6.2

cobas x 480 instrument Installation Liquid Waste Installation Procedure


6.2. Liquid Waste Installation Procedure 1.

Clean the surface from any dust and grease at position (a) and (b) Stick the self-adhesive cable clamp to the waste station at position (a) and (b).

2.

Mount the liquid waste tubing assay (c) to the waste station.

3.

Cut the waste tube at 1m. This length ensures that the liquid waste container can be placed on the floor but prevents building a large siphon tube which can get clogged due to the fact of little amount of liquid lowing through this tube.

4.

Connect waste tube to the tube connector at Floating sensor Flange.

5.

Connect the cable to connector of Floating sensor Flange (d)

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cobas x 480 instrument Installation Liquid Waste Installation Procedure

6.

Attach the Floating sensor Flange to the liquid waste container

7.

Lay the Sensor cable along the waste tube, through the to cable clamps, then through the back cable channel to the instrument electronic rack at the left hand side of cobas x 480 instrument

8.

Plug the sensor cable into the DIV port on the left instrument panel:

9.

Stow the remaining cable in the cable channel.

6 6.2

10. Neatly fix the cable to the tube by using Velcro strip or cable tie 11. Install the Tip Eject Plate according Operator’s Manual Place it carefully in the notch, verify the Tip Eject Plate is in horizontal position See picture above (step 7) Misplacement leads to a run abort! 12. Install the Waste Chute and Solid Waste Box or alternatively waste bag Follow the Operator’s Manual instruction to install the Waste Chute and Solid Waste Box 13. Switch ON cobas x 480

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6 6.3

cobas x 480 instrument Installation Firmware Verification


6.3. Firmware Verification This step is to verify firmware version installed on the cobas x 480 instrument 1.

Start Microlab STAR Service Software. (start\Programs\Hamilton\Microlab STAR Service)

2.

Click Download

3.

Verify the Firmware Versions given in the screen (a) with the requested versions given in table No. 5.

4.

Requested Firmware Versions Module

Addr.

Version

File Name

Master

C0

6.0SE

GRUC0S60E.ACH

Auto load

I0

3.4S

GRUALS34.ACH

iSWAP

R0

4.0S

GRUROS40.ACH

Pip Channel Px = P1…P8

3.6Sc

GRUPXS36c.ACH

X-Drive

1.2S

GRUX0S12.ACH

X0

In case of version mismatch please update according next chapter 6.3.1 Update

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6.3.1.

cobas x 480 instrument Installation Installation PART 2

6 6.4

Update Firmware

1.

Download and reinstall firmware if any other version is displayed as the required one

2.

Navigate to the (a) Folder with download files C:\Program Files\HAMILTON\STARService\Firmware\5.6

3.

Click to select (b) instrument controller which needs to be reprogrammed ; (Pipetting channel PX = Channel 1- 8)

4.

Select the correct version in section (c)

5.

Click Start (d) to download and install the firmware on the instrument controller

6.

Verify the version with the requested version in the 6.3 Firmware Verification

7.

Reboot the control unit

8.

Power OFF the instrument for 10 seconds, the Power ON

6.4. Installation PART 2 Install the cobas x 480 according description in iSDoc Please refer to GRIPS > cobas 4800 > cobas x 480 > Installation > Instrument Installation ALL tasks MUST be performed to get a reliable cobas® 4800 system Please use the checklist at the end of this manual

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7 7.1

cobas z 480 analyzer Installation Firmware Verification


7. cobas z 480 analyzer Installation The cobas z 480 analyzer must be installed according its installation manual. Please see connectors overview of control unit in chapter 3.4 Installation cobas 4800 control unit, page 24 Please refer to Installation Manual cobas z 480 analyzer. GRIPS > System Search > Molecular Diagnostics > cobas 4800 > cobas z 480 > Installation Manual

7.1. Firmware Verification 1.

Switch ON the cobas z 480 analyzer

2.

Start LightCycler® 480 – z 480 Service Software and log on as user: LCservice PW: LCservice For more passwords please see User Access Information for cobas® 4800 system (1.16.1 Documentation)

3.

Navigate to Instrument > Configuration In the section Instrument Information, verify for the correct IC-version 1.5.4.09.01

Please compare with latest firmware versions published in iSDoc for cobas z 480 analyzer

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cobas z 480 analyzer Installation Diagnostic Check

7 7.2

7.2. Diagnostic Check Run the diagnostics check to verify the functionality of cobas z 480 analyzer. 1.

Start LightCycler® - z 480 Service Software Log in as user: LCservice PW: LCservice

2.

Navigate to Diagnostics > Checks and perform test 1.1 Perform Run (a) according description given in the software

3.

Press Reboot (b) to restart the cobas z 480 analyzer and then close the software

Whenever cobas z 480 analyzer is controlled by LightCycler® - z 480 Service Software, reboot or restart analyzer before the analyzer gets controlled by cobas_4800_V1.1.0.1036 software

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8 8.1

Handheld Barcode Scanner Installation


8. Handheld Barcode Scanner 8.1. Installation Unpack the USB handheld barcode scanner and connect it to one of the USB port on the control unit rear side. The control unit will detect and install the driver automatically while the scanner beeps several times. Please see connectors overview of control unit in chapter 3.4 Installation cobas 4800 control unit, page 24

8.2. Scanner Programming Take the handheld barcode scanner and read the program barcodes below in ascending sequence 1 to 10. Pos

Information

Program Barcode

1

Reset to scanner manufacturer’s factory default

2

Select USB interface for communication

Wait for 30 seconds before proceeding 3

Set all symbologies off

4

Activate reading of codabar codes

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Roche cobas® 4800 system 5

No Check Character Codabar

6

Activate reading of Code 39

7

No Check Character 39

8

Activate reading of Code 128

9

Activate reading of PDF417

10

Activate reading of Datamatrix

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8 8.3

Handheld Barcode Scanner Scanner Verification


8.3. Scanner Verification Verify the barcode scanner by reading the test barcodes into notepad and compare the reading with Code Information given below. Item Barcode Type, Barcode Information 1

Test Barcode

Barcode Type Code 39 Code Information BC321

2

Barcode Type Codabar Code Information 13579

3

Barcode Type Code 128 Code Information Code 128

4

Barcode Type PDF417 Code Information MicroPDF417 Test Message

5

Barcode Type Data Matrix Code Information Test Symbol

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LIS Interface Installation Physical Connection

9 9.1

9. LIS Interface Installation This chapter provides instructions on how to install and test the LIS Interface. The first installation scenario described in this chapter is realized in a point to point connection to exclude as many possible causes of error as possible. The next chapter describes the implementation of the cobas IT firewall into the test environment. Do always start with this chapter 9 LIS Interface Installation, the following chapter 10 LIS Interface Configuration with cobas IT firewall builds on this. The goal of the LIS Interface Installation and test procedure described in this chapter is to install all necessary components and to test all possible communication scenarios with the host interface simulator to ensure a proper implementation of the LIS Interface into the laboratories network. The integration into the laboratory network itself is not part of this manual, for that purpose consult the latest host interface manual which is available on GRIPS.

Host computer (e.g. Note Book)

cobas 4800 control unit (LabNet)

IP Address

172.20.1.100

172.20.1.140

Subnet Mask

255.255.255.0

255.255.255.0

172.20.1.1

172.20.1.1

Gateway

9.1. Physical Connection 1.

Connect the Computer that will host the host interface simulator (e.g. Notebook) to the LabNET network card of the cobas 4800 control unit using CAT5e Ethernet cable. Please see connectors overview of control unit in chapter 3.4 unit, page 24

2.

Verify that the red x has disappeared on the LabNET icon.

Move the cursor over the network icon to see its name. Do not proceed to the next chapter before a physical connection could be established, indicated by the network icon (no red x)

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9 9.2

LIS Interface Installation Network Connection


9.2. Network Connection 9.2.1.

Network Address of Host Server

1.

Go to the computer that will host the host interface simulator

2.

Navigate to start > Control Panel > Network Connections

3.

Open the available Local Area Connection

4.

Click on Properties

5.

Select Internet Protocol (TCP/IP) and click on Properties

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LIS Interface Installation Network Connection

6.

Select Use the following IP address, enter address listed below and click OK IP address: 172.20.1.100 Subnet mask: 255.255.255.0 Default gateway: 172.20.1.1

7.

Close all windows

9.2.2.

9 9.2

Network Address of cobas 4800 control unit

The LabNET of the cobas 4800 control unit is already set to the correct Network ID 172.20.1.xxx by default.

9.2.3.

Check Network Communication

1.

Go to the cobas 4800 control unit, log on as user Install, PW: Instcobas48000709

2.

Start cmd.exe (start>startmenu)

3.

Enter ping 172.20.1.100 and press Enter

Check for the following message: Replay from 172.20.1.100: bytes=32 time<1ms TTL=128 If the message was received four times proceed with the next chapter If the message Request timed out occurs Check the network addresses of both computers. Network addresses must have the same network ID 172.20.1.xxx Do not proceed to the next chapter before the ping request was successful

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9 9.3

LIS Interface Installation Application Software Connection


9.3. Application Software Connection 9.3.1.

Installation C4800 Communication Server

1.

Go to the cobas® 4800 software

2.

Insert CD 1.1.0 Build 1042

3.


4.

Browse to E:\4_LIS_Interface

5.

Execute the file C4800Setup.msi.

6.

Click Next

7.

Click to select check box I accept the terms in the License Agreement and press Next

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Choose setup type Typical

9.

Click Install

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9 9.3



10. Enter IP-Address: 172.20.1.100 Port-Number: 5555 Protocol: HL7 click OK

11. Click OK

12. Click OK

13. Click Finish

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9.3.2.


9 9.3

Transformer Configuration

Protocol Configuration 1.

Go to C:\Program Files\RocheDiagnosticsAG\cobas_4800_V1.1.0.1036\bin”.

2.

Open the file “Roche.MTS.Transformer.exe.config with notepad.

3.

Change Transformer Type to “HL7”, Protocol to “HL7_24” and Protocol Version to “2.4” and save

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9 9.3



Result Upload Configuration The result upload is done via cobas 4800 transformer and is always batch wise. The cobas 4800 transformer is now configurable to support two different result upload workflows. Setting: “true”, only accepted results of the batch are transmitted Setting: “false”, all results, no matter accepted or not accepted are transmitted. 1.

Open the file “Roche.MTS.Transformer.exe.config with notepad.

2.

Change the ExportAcceptedResultsOnly setting to “true” or “false”

9.3.3. 1.

Installation of Host Interface Simulator

Download the latest Host Interface Test Tool from GRIPS>cobas z 480>Host Interface Test Tool Host Interface Test Tool 7.1.5 or higher is required

2.

Unzip the file and

3.

Execute the file setup.exe on computer that will host the host interface simulator (e.g. Notebook)

4.

Click OK

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Click on Install button.

6.

Click Continue

7.

Click Ok.

9.3.4.


9 9.3

Configure HL7 Interface Simulator

The communication is always established by the cobas 4800 control unit; the cobas 4800 system is always the TCP/IP client and the LIS (Host Interface Simulator) is always the TCP/IP server. 1.

Go to START > All Programs >Host Interface Tools

2.

Open HL7 Host Simulator

3.

Select Accept on prompt message

.

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4.

Click Yes to install example trace and record files.

5.

Click OK

6.

Go to Options > Interface Settings

7.

Select TCP/IP Server, enter Local Port No: 5555 and click OK

8.

Go to Options > Common settings

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9 9.3

Select Instrument cobas 4800 and click OK

The server IP address is the address of the network card and cannot be changed for a server. It comes from the network settings of the computer hosting the simulator.

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9 9.3



10. The winsock status will immediately turn green - connected

Compared to the old communication server of cobas 4800 SW v1.0.x the connection happens immediately. (before only after every 1 min a connection was attempted) If still no connection can be established (winsock status bar remains yellow) Check Interface Settings (Port ID) and restart Control Unit Do not proceed to the next chapter before the winsock status bar turns green

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9.3.5.


9 9.3

cobas 4800 software LIS configuration

1.

Log on to cobas® 4800 software as user FSE, PW: 00rocheSRVC

2.

Go to utilities tab (1), select configuration tab (2), select System Settings (3) and enable the checkbox LIS present (4).

3.

Click apply. The cobas 4800 software is now configured for LIS communication. The workoder file workflow can be reconstituted by unchecking the LIS present check box. The change will be active after restarting the cobas 4800 software.

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9 9.4

LIS Interface Installation Testing Communication Scenarios


9.4. Testing Communication Scenarios 9.4.1.

Sending Results

In this communication scenario results are sent from the cobas 4800 system to the Host Interface Simulator.

!! Communication is only possible with the windows user Operator!! 1.

Restart control unit to be automatically logged on as windows user Operator.

2.

Open the cobas® 4800 software and log on as user FSE, PW: 00rocheSRVC

3.

Go to Results tab (1), select performed run (2), select sample (3), click Export (4).

Using the result export, all results of the selected runs are exported to the LIS. It is not possible to export individual results. No matter if just one of the results or all 94 results are selected. It is transmitted always batch wise! Results do not have to be accepted, Export works in any case.

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9 9.4

Results can be verified in the communication trace window of the HL7 Host Interface Simulator

Clear List and Clear Trace Window to clear the window

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9 9.4


9.4.2.


Sending an order

The simulator is able to reply to an order request. For this the simulator must have certain information in its database. The simulator will use its database records to respond to the instrument requests. If the instrument sends a request related to a certain Sample ID, the simulator will search its database for a matching record. If one is found, the simulator will attempt to generate an order upload, using the information stored in the simulator database record. 1.

Go to the Database tab and select 5 TestSelection.

2.

These entries can be edited by double clicking on a data field or added, duplicated via the Records tab.

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3.

Prepare a database record as follow: Received: empty TS_SampleID: 999999 or any other barcode that is available TS_PlateID: empty TS_MWPposition: empty TS_TestType: HPV TS_TestID: HPVGEN TS_RunType: Full TS_CreatedDT: empty TS_ActionCode: empty TS_ReceivedDT: empty TS_MediaType: SP TS_MediaSource: P TS_UserCreated: FSE TS_ReportType: 0

4.

Go to the cobas 4800 control unit.

5.

Start cobas_4800_V1.1.0.1036 software

6.

Log on as user FSE, PW: 00rocheSRVC

7.

Press the button New Run in the right, top corner

8.

Select Test type HPV Workflow

9.

Load a sample rack with one sample tube (tracks 17-34), having the same sampleID as entered in the simulator database

9 9.4

10. Click Load Samples at right bottom corner. 11. Now the cobas 4800 system request an order at the host computer and the communication can be seen in the communication trace window.

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10 10.1

LIS Interface Configuration with cobas IT firewall Physical Connection


10. LIS Interface Configuration with cobas IT firewall Before starting to configure the cobas IT firewall please check for the latest firmware on GRIPS

Host Server (e.g. Note Book)

cobas IT firewall External Network

cobas IT firewall Internal Network

cobas 4800 control unit (LabNet)

IP Address

10.0.0.20

10.0.0.10

172.20.1.10

172.20.1.140

Subnet Mask

255.0.0.0

255.0.0.0

255.255.255.0

255.255.255.0

Gateway

10.0.0.1

10.0.0.1

172.20.1.1

172.20.1.1

10.1. Physical Connection 1.

Connect the Computer that will host the host interface simulator (e.g. Notebook) to the red port (external network) of the cobas IT firewall and connect the green port (internal network) to the LabNet network card of the cobas 4800 control unit using 2 CAT5e Ethernet cables. Please see compare with the connection drawing above. Please see connectors overview of control unit in chapter 3.4 unit, page 24

2.

Verify that the red x has disappeared on the LabNET icon of the cobas 4800 control unit and on the Local Area Connection icon of the host computer.

Move the cursor over the network icon to see its name. Do not proceed to the next chapter before a physical connection could be established, indicated by the network icons (no red x)

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LIS Interface Configuration with cobas IT firewall Network Connection

10 10.2

10.2. Network Connection 10.2.1. Network address configuration of cobas IT firewall Reset Firewall 1.

Insert a paper-clip end or a small round pin into the reset-button access port and hold it.

2.

Simultaneously plug in the power jack into the power socket.

3.

Wait until all three led simultaneously blink four times. (After approximately 30 seconds).

4.

Release the reset button and allow 1 minute for the firewall to reboot.

Connect a computer (COE client) to the orange port 1.

Connect COE client to the Orange network of the firewall with a crossover cable.

2.

Select Obtain an IP address automatically for the Local Area Connection Properties

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10 10.2 3.



Wait until COE client has obtained an IP address for the cobas IT firewall. Check for the network icon change in the windows task bar

4.

Double Click on the network icon and check for the correctly assigned IP address 172.19.1.10

5.

Close all windows.

cobas IT firewall configuration 1.

Download the latest cobas IT firewall Configuration Wizard from GRIPS > cobas IT firewall > service software

2.

Start the configuration wizard on any COE client

Java Runtime Environment is needed to run this file which is already preinstalled on all COE clients

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Select generate a new configuration

4.

Enter appropriate settings and click next.

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10 10.2


5.

Select One fixed WAN IP address

6.

Enter settings for the external IP address 10.0.0.10 External IP address: External IP address: 255.0.0.0 Default gateway: 10.0.0.1 DNS server: 10.0.0.1


The external network setting entered in the text field above are for the so called “red interface at the cobas IT firewall” The green network is configured according the orange network with the next following number.

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Click Next

8.

Select cobas 4800 and click Next

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Click Next

10. Enter LIS IP address 10.0.0.20 and port 5555

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10 10.2

11. Click Next

12. Click Next

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13. Enter and confirm Password: 123456

14. Click Next

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10 10.2

15. Click Next

16. Close Networking Addressing Sheet window

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10 10.2



17. Select save this configuration to disk and upload it to the cobas IT firewall

18. Select Browse to choose a destination folder.

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10 10.2

19. Click Next

20. If Status Done! is displayed upload was successful Click Finish to close configuration wizard

If the following message occurred

Check all cables and make sure the firewall was reset before uploading

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10 10.2



10.2.2. Set IP address of host computer 1.

Change IP address of the computer that is hosting the host interface simulator.

2.

Close all windows.

10.2.3. Network Address of cobas 4800 control unit The LabNET of the cobas 4800 control unit is already set to the correct Network ID 172.20.1.xxx by default.

10.2.4. Check Network Communication 1.

Go to the cobas 4800 control unit, log on as user Install, PW: Instcobas48000709

2.

Start cmd.exe (start>startmenu)

3.

Ping port 10.0.0.10 and 10.0.0.20

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LIS Interface Configuration with cobas IT firewall Application Connection

10 10.3

Check for a reply of both ports Replay from 10.0.0.xx: bytes=32 time<1ms TTL=128 If the message was received four times proceed with the next chapter If the message Request timed out occurs Check the network settings of the cobas IT firewall A ping request from the host computer (red network) to the cobas 4800 control unit (green network) is not possible. Do not proceed to the next chapter before the ping request was successful

10.3. Application Connection 1.

Go to the cobas® 4800 control unit

2.

Insert CD cobas 4800 1.1.0 Build 1042

3.


4.

Browse to E:\4_LIS_Interface

5.

Execute the file C4800Setup.msi.

6.

Click Next

7.

Click Change

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10 10.3

LIS Interface Configuration with cobas IT firewall Application Connection

8.

Click Next

9.

Click Change


10. Change IP Address and click OK

11. Click OK

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10 10.4

12. Click OK

13. Click Finish

10.4. Testing Communication Scenarios After completing this chapter the LIS interface is configured to communicate over cobas IT firewall. The communication can be test with the two communication scenarios described in the previous chapter. Please see chapter 9.4.1 Sending Results, page 100 and 9.4.2 Sending an order, page 102

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11 11.1

Change LIS Interface Configuration Change IP address of host computer


11. Change LIS Interface Configuration 11.1. Change IP address of host computer If IP address of the host computer has to be changed, the security rules in cobas IT firewall have to be reconfigured with cobas IT firewall configuration wizard and in the c4800 communication server the IP address has to be changed using the installer.

Change these configurations as described in the previous chapter.

11.2. Change Port of Host Interface Simulator If Port Number of the host interface simulator has to be changed, the security rules in cobas IT firewall have to be reconfigured with cobas IT firewall configuration wizard and in the c4800 communication server the port number has to be changed using the installer.

Change these configurations as described in the instructions above.

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Change LIS Interface Configuration Change Protocol

11 11.3

11.3. Change Protocol The Protocol can be changed with the c4800 communication server installer. In addition the Roche.MTS Transformer.exe.config file has to be modified manually using notepad. The Host Interface Test Tools package does include an HL7 simulator and an ASTM simulator. Communication only works with the correct simulator.

11.3.1. Roche.MTS Transformer.exe settings ASTM Transformer Type value= ``ASTM`` Protocol value= ``ASTM`` Protocolversion value= ``1394.LIS2``

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Change LIS Interface Configuration Additional information


HL7 2.4 Transformer Type value= ``HL7`` Protocol value= ``HL7_24`` Protocolversion value= ``2.4``

HL7 2.5.1 Transformer Type value= ``HL7`` Protocol value= ``HL7_251`` Protocolversion value= ``2.5.1``

11.4. Additional information The integration of the cobas 4800 system into the Laboratories Network can be realized according the instruction given above. Please consult in addition the latest Host Interface Manual for more information which is available on GRIPS

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Printer Installation Printer Network Configuration

12 12.1

12. Printer Installation Basically any printer can be installed to cobas 4800 control unit. Due to a higher installation flexibility a network printer should be favored, i.e. HP LaserJet P2055dn. It is strongly recommended not to install the printer application software. Only standard windows driver or specific printer driver delivered with software package must be installed. In case a printer of the customer network gets connected, please contact the network administrator for its IP address. Connecting any device into customer network, a cobas IT firewall must be installed If the printer is another than HP LaserJet P2055dn, please follow the manufacturer installation instruction provide with the printer.

12.1. Printer Network Configuration This procedure describes how to install the printer via network cable by using the windows driver for basic printer features. 1.

Unpack the printer and place it to its location

2.

Power up the printer

3.

Connect the printer with a CAT5e network cable to the cobas 4800 control unit LabNET Network Adapter (PCI Network Adapter, Intel® PRO/1000PT Desktop Adapter) Please see connectors overview of control unit in chapter 3.4 Installation cobas 4800 control unit, page 24

4.

The IP address needs to be set manually according network requirements.

5.

Manual IP configuration can be done directly done at the printer according following sub procedure:

6.

On the control panel, press OK.

7.

Use the arrow buttons to select Network Config, and then press OK.

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12 12.2

Printer Installation Printer Driver Installation


8.

Use the arrow buttons to select CFG TCP/IP, and then press OK.

9.

Use the arrow buttons to select BOOTP, make sure the value is No, and

10. Use the arrow buttons to select DHCP, make sure the value is No, and 11. Use the arrow buttons to select IP BYTE 1, and then press OK. 12. Use the arrow buttons to change the value of IP BYTE 1, and then press OK. 13. Repeat steps (11) and (12) for IP BYTE 2, IP BYTE 3, and IP BYTE 4. (172.20.1.170) Also, the Subnet Mask (SM BYTE 1, SM BYTE 2, SM BYTE 3, SM BYTE 4) (255.255.255.0) and for default gateway (BYTE 1, GW BYTE 2, GW BYTE 3, GW BYTE 4). 14. Use the Back or Cancel button to leave the Network Config menu To verify the printers IP address, print the network configuration page at the printer by pressing the printer function keys, 2*OK, 6*d followed by the OK button

12.2. Printer Driver Installation 1.

Press CTRL+ALT+DEL keys to verify Logon Information. User Install is required

2.

Navigate to Start > Settings > Printer and Fax

3.

In section Printer Tasks, click Add a printer

4.

The window Add Printer Wizard opens, click Next

5.

Select a Create a new port, in the drop down menu select Standard TCP/IP Port and then press Next

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6.

In the next window Add Standard TCP/IP Printer Port Wizard Press Next

7.

In the next window Add Port, type in the printer’s IP address 172.20.1.170 Press Next

8.

Select Device Type Generic Network Card Click Next

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12 12.2 9.



Click Finish

10. Click Have Disk…

11. Insert manufacturers CD into CD Drive Browse to CD Drive E:\, click OK

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12 12.2

12. Verify the for the correct listed Printer Press Next

13. Enter any printer name for printer (i.e. HP LaserJet P2055 DN) Select Yes to use this printer as default Click Next

14. Select Do not share this printer Click Next

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15. Select Yes and then click Next

16. Click Continue Anyway

17. Click OK

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Printer Installation Set default printer for user OPERATOR

12 12.3

18. Click Finish. The printer is now installed.

19. Navigate to Start > Settings > Printer and Faxes Right mouse click on the printer, Set as default printer 20. Print a report out of cobas 4800 software and verify the header. 21. Press the Eject button and remove the CD out of drive If you encounter any problem during the setup of the printer, please refer to the troubleshooting tips on the Printer CD or refer to manufacturer’s support website.

12.3. Set default printer for user OPERATOR 1.

Press CTRL+ALT+DEL keys, click on Log Off… and click Log Off to confirm

2.

Wait to be logged on automatically as Operator

3.

Navigate to Start > Settings > Printer and Faxes Right mouse click on the printer, Set as default printer

4.

Print a report out of cobas 4800 software

5.


6.


7.

Log on as user Install, PW: Instcobas48000709

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12 12.4

Printer Installation Printer Installation in Laboratory Network (red Network)


12.4. Printer Installation in Laboratory Network (red Network) The printer can also be installed in the laboratories network (red network), for that purpose the security rules of cobas IT firewall have to be changed using cobas IT firewall configuration wizard.

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Water Run Goal

13 13.1

13. Water Run 13.1. Goal The goal to run this water run is to verify proper functions of cobas x 480 instrument. The functions as mechanical movement in X-, Y- Z- direction, pipetting tip ejection, surveillance systems (i.e. cLLD, pLLD), heater/ shaker unit get tested. A water run is a dummy HPV run. SARSTEDT tubes are filled with tap water and used as Sample tube and as Reagent vials. These tubes are not barcoded. The provided barcodes need to be scanned by the hand scanner. At the time the reagent container barcode and reagent bottle barcode are scanned, the barcodes are locked in the database and can not be used again. The barcode match (Washbuffer bottle with container) is used as threshold to start the countdown counter. The sample preparation must be started within 60 minuntes. Exceeding the 60 minuntes leads to an expired reagent status and the run is aborted even before the sample preparation started.

13.2. Deck Layout cobas x 480 instrument 13.2.1. Rack Loading The following graphic gives an overview where the consumables, sample and reagent gets loaded on the instrument deck.

Installation Manual

Version 1.1.2

Page 131 of 175

13 13.3

Water Run Consumables


13.3. Consumables 13.3.1. Requirement Make following consumables available: Item #

Article

Mat. No

Qty

1

Sample tube 13mL (SARSTEDT, Tube with cap 101*16.5mm)

-

11

2

Deepwell Plate (DWP)

05232716001

1

3

Microwell plate (MWP)

05232724001

1

4

CORE Tip Tray (tray of

04639642001

10

5

Reagent Reservoir 50ml

05232732001

4

6


05232759001

1

13.3.2. Tube Preparation 1.

Specimen Rack: Take a 24 pos. Sample Rack SMP_CAR_24_A00 and insert the empty tube in pos 1-6. Fill all 6 tubes with 2mL-10ml tap water.

2.

Reagent Vials Carrier 3: Take another 24 pos. Sample Rack SMP_CAR_24_A00 and insert the empty tube in pos 15, 18, 19, 23, 24. Fill all 5 tubes with 10.5mL tap water. This should be equal to the required level height of 80 mm (rack bottom to level).

Page 132 of 175

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Installation Manual


Water Run Get started

13 13.4

13.4. Get started 13.4.1. Instrument All instrument covers must be installed. Ensure CAT H/S unit, cobas x 480 instrument as well cobas z 480 analyzer is powered up.

13.4.2. TADM configuration (Recording) The TADM monitors the pressure curve during all aspiration/ dispensing steps and reject samples if out of range. Tap water does have a different viscosity and produces a different pressure curve. The TADM configuration needs to be changed to Record to prevent the sample rejections. 1.


2.

Press Win key to open Start Menu and then press the key d 6 times Press ENTER to start Microlab STAR Method Editor

3.


4.

Select Microlab STAR IVD (ML_STAR) (a) Click [-] TADM settings to display the settings (b) In line TADM mode click to select Recording (c)

5.

Press CTRL+S to save changes

6.

In the pop up window Enter Change Description, type in short description (i.e. Installation, water run) Click OK

7.

Press ALT+F4 keys to close HAMILTON System Configuration Editor

8.

Press ALT+F4 keys to close HAMILTON Method Editor

Installation Manual

Version 1.1.2

Page 133 of 175

13 13.4

Water Run Get started


13.4.3. Creating a new work order (Water Run) 1.

Start cobas 4800 Work Order Editor

2.

Select in section User: FSE

3.

Select File: Create New

4.

Select in section Create New Run Type: Full Test Type: HPV workflow

5.

Click on Next at bottom right corner

6.

Select in section Attributes Subtest Type: HPV High Risk Panel + Genotyping Barcode: Media Type: PreservCyt®Medium

7.

In the field Attributes set the curser into field Barcode Take the Handheld Barcode Scanner and then Scan Barcodes 1- 6 below: : Prefer to use barcoded sample tube, if so scan the barcoded sample tube instead the barcodes below. Only barcode with letters A-Z and 0-9 are supported. Do not use special characters or space Item #

Barcode Information

Test Barcode

1

S1WaterRun

ÁS1WaterRunUÈ

2

S2WaterRun

ÁS2WaterRunWÈ

3

S3WaterRun

ÁS3WaterRunYÈ

4

S4WaterRun

ÁS4WaterRun[È

5

S5WaterRun

ÁS5WaterRun]È

6

S6WaterRun

ÁS6WaterRun_È

8.

Click Save at right bottom corner

9.

Browse folder Work Orders C:\Documents and Settings\OPERATOR\Operators’ Document\Work Orders)

10. Save as WaterRun and then click OK to confirm 11. Press ALT+F4 keys to close cobas® Work Order Editor Page 134 of 175

Version 1.1.2

Installation Manual


Water Run New Run (WaterRun)

13 13.5

13.5. New Run (WaterRun) 13.5.1. Load Samples 1.

Start (Click) cobas_4800_V1.1.0.1036 software Log on as user FSE, PW: 00rocheSRVC

2.

Press the button New Run in the right, top corner

3.

Click to select in section Test type HPV Workflow

4.

Type in section Run name Installation WaterRun

5.

Insert the rack with the tube on pos 1-6 in track 20 (tracks 17-34)

6.

Click Load Samples at right bottom corner (skip step 6-12 when using Sample tube with barcodes)

7.

In window Load Carrier – Error click Barcode… (a)

8.

Cursor is now in field Enter barcode (b)

9.

Scan the S1WaterRun from the previous chapter 13.4.3 Creating a new work order

10. Press Enter (c) to confirm the message Double blind entry failed! 11. Press Tab key to set the cursor to Confirm barcode (d) and scan the same barcode again 12. The status changes to green. Barcode is entered manually 13. The curser is set in field (b) for pos 2. Scan-Enter-Tab. Repeat step 8-11 accordingly for sample pos 2-5 14. Click Execute to proceed. Please wait approx 1 minute 15. In section Work list click to the browse button WaterRun

Installation Manual

to navigate to the created Workorder file

Version 1.1.2

Page 135 of 175

13 13.5



16. Click Next at right bottom corner

13.5.2. Load Consumables 1.

Take a plate carrier P/N 185053/00, PLT_PCR_TIP_B00 Place one DWP on the DWP Holder, pos1. Barcode at right side Place one MWP on the MWP Holder, pos3. Barcode at rear side Load the plate carrier in track 1-6 as shown by the LED For further layout information see chapter 13.2.1 Rack Loading

2. 3.

Take a Tip Rack Carrier P/N 182085/02, TIP_CAR_480_A00 Set 5 CORE Tip Tray (5*96Tips) in pos1-5. Barcode at right side Load the Tip Carrier in track 11-16

4.


5.

Click Load Consumable at right bottom corner

13.5.3. Load Reagent Reservoir Carrier 1-4 1.

Take a wide metal Reagent Carrier RGT_CAR4X200_X1

2.

Load the Reagent Carrier in track 48-49

3.

Scan the Reagent Barcode (Washbuffer) provided below

4.

Take a Reagent Reservoir 200 mL and scan it by the hand scanner

5.

Pour at least 55 mL tap water into this container

6.

Place the Reagent Reservoir 200ml on the Reagent Carrier pos 4

7.

Click Load Reagents at right bottom corner Item #

Barcode Information

Test Barcode

Washbuffer (WB)

Á0S0Ä+#"ÖBZfÈ

Kit 24, Volume 55 mL Storage: 15-25 ºC/ Load: 15-25ºC

1

Reagent Carrier 1-4, track 48-49

0S0110302BZ

Apply SCAN (Reagent) – SCAN (Reservoir) – POUR - PLACE principle The first reagent vial is now matched with a container. The countdown counter for 60 min started. Within 60 min the sample preparation needs to be started or it will set to reagents to expired!

Page 136 of 175

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13 13.5


Take a small metal Reagent Carrier RGT_CAR5X50_X1

2.

Load the Reagent Carrier in track 50

3.

Scan the Reagent Barcode (SDS Reagent) provided below

4.


5.

Pour at least 3 mL Tap water into this container

6.

Place the Reagent Reservoir 50ml on the Reagent Carrier pos 2 Item #

2

Barcode Information

Test Barcode

SDS Reagent

Á0SAÄ+#"ÖBZ2È

Kit 24, Volume 3 mL Storage: 15-25 ºC/ Load: 15-25ºC Reagent Carrier 2-2, track 50

0SA110302BZ



2.


3.

Scan the Reagent Barcode (Lysis Buffer) provided below

4.


5.


6.


Barcode Information

Test Barcode

Lysis (LYS) 3

Kit 24, Volume 10 mL Storage: 15-25 ºC / Load: 15-25ºC

Á0S6Ä+#"ÖBZxÈ

Reagent Carrier 2-3, track 50

Installation Manual

Version 1.1.2

0S6110302BZ

Page 137 of 175

13 13.5



13.5.6. Load Reagent Carrier 2-4 1.


2.


3.

Scan the Reagent Barcode Magnetic Glass Particles (MGP) provided below

4.


5.

Pour at least 4.5 mL tap water into this container Item #

4

Barcode Information

Test Barcode

Magnetic Glass Particle (MGP)

Á0S2Ä+#"ÖBZlÈ

Kit 24, Volume 4.5 mL (vortex) Storage: 2-8 ºC / Load: 15-25ºC Reagent Carrier 2-4, track 50

0S2110302BZ

13.5.7. Load Reagent Carrier 2-5 1.


2.


3.

Scan the Reagent Barcode (Elution Buffer) provided below

4.


5.


6.


5

Barcode Information

Test Barcode

Elution Buffer (EB)

Á0S4Ä+#"ÖBZrÈ

Kit 24, Volume 18 mL Storage: 2-8 ºC / Load: 15-25ºC Reagent Carrier 2-5, track 50

7.

0S4110302BZ

Click Load Reagents at right bottom corner

Page 138 of 175

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Installation Manual



13 13.5

13.5.8. Load Reagent Vials Carrier 3-15,18,19, 23, 24 1.

Take the second prepared Sample Rack SMP_CAR_24_A00 with sample tube at pos 15, 18, 19, 23, 24

2.

Verify the Liquid Level in the Dummy Reagent tube is at 80 mm (equal to 10.5 mL for SARSTEDT tube)

3.


4.

Verify tubes are inserted in Pos 15, 18, 19, 23, 24

5.

Click Load Reagents

6.

Proceed as described in chapter 13.5.1 Load Samples with step 6-13 In window Load Carrier – Error click Barcode…

7.

Use the barcodes provided below Pos 15 SCAN – ENTER –TAB – SCAN Next pos Pos 18 SCAN – ENTER –TAB – SCAN Next pos, and so on Item #

6

Barcode Information

Test Barcode

Proteinase K (PK)

Á0S8Ä+#"ÖBZ~È

Kit 24, Volume 0.9 mL Storage: 15-25 ºC / Load: 15-25ºC Reagent Carrier 3-15, track 51

Positive Control (PC+) 7


Negative Control (NC-) 8


Master Mix (MMX) 9


Metal Ion (Mn/Mg) 10


Installation Manual

Version 1.1.2

0S8110302BZ

Á2H1Ä+#"ÖBZUÈ 2H1110302BZ

Á0NCÄ+#"ÖBZ.È 0NC110302BZ

Á2H4Ä+#"ÖBZ^È 2H4110302BZ

Á2H3Ä+#"ÖBZ[È 2H3110302BZ

Page 139 of 175

13 13.5



8.

Press Execute to close the window

9.

Click Start Run to start the sample preparation on cobas x 480 instrument

The barcodes can be used once per instrument Reuse of Reagent Reservoirs (barcodes) are not accepted by the cobas® 4800 software A different set of barcodes is required to repeat a water run. Please refer to GRIPS > cobas 4800 > cobas x 480

13.5.9. End of Sample Preparation The run time for the sample preparation takes approximately one hour.

At the end of the sample preparation, continue following on-screen instructions: 1.

Click Unload and wait till all racks have been unloaded by the system

2.

If no errors occurred up to here, the WaterRun is counted as successfully

13.5.10. Abort Water Run 1.

Click on Abort to cancel the run. The MWP is not transferred to cobas z 480 analyzer

2.

Click Exit to close cobas® 4800 software

3.

Reboot the cobas 4800 control unit

4.

This is the end of the WaterRun

Page 140 of 175

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13 13.5

13.5.11. TADM configuration (Monitoring) The TADM recorded pressure curves during all aspiration/ dispensing steps while performing the water run. The system does not alarm in this mode if there is a clot. The cobas x 480 instrument must not run in Recording Mode when performing sample preparation for any HPV assay, CT/NG assay, etc. The TADM configuration must be changed to Monitoring to activate the surveillances system. 1.


2.

Press Win key to open Start Menu and then press the key d 6 times Press ENTER to start Microlab STAR Method Editor

3.


4.

Select Microlab STAR IVD (ML_STAR) (a) Click [-] TADM settings to display the settings (b) In the line TADM mode click to select Monitoring (c)

5.

Press CTRL+S to save changes

6.

In the pop up window Enter Change Description, type in short description (i.e. Installation, water run) Click OK

7.

Press ALT+F4 keys to close HAMILTON System Configuration Editor

8.

Press ALT+F4 keys to close HAMILTON Method Editor

9.

Press CTRL+ALT+DEL keys, select Shutdown and select Restart to reboot the control unit.

Installation Manual

Version 1.1.2

Page 141 of 175

14 14.1

Test Run HPV Goal


14. Test Run HPV 14.1. Goal The HPV Assay is taken as final verification. It includes the sample preparation on cobas x 480 instrument as well the amplification/ detection on cobas z 480 analyzer. The HPV run is chosen due to the fact that this assay uses 4 detection channels while CT/NG run uses 3 detection channels. For the HPV Test Run a standard reagent kit is used. This is not provided with the instrument and needs to be ordered separately. There are two different kit sizes 240T (10*24 Test) or 960T (10*96 Test). To get one complete assay, 5 different kits need to be ordered. The kits are stored either at 2-8ºC or 1515ºC according specifications. Do not mix up Reagent Vials of 240T with 960T. It may have different filling volume. The best (fastest) system performance can be reached by using 8 samples or multiple of 8 samples. Therefore 6 Samples are required on the sample rack and 2 wells per MWP are automatically assigned to the Positive and Negative Control. Maximum 22 samples can be processed per batch using the 10* 24T kit size. Tap water can be used as sample.

14.2. Consumables & Reagent 14.2.1. Required Consumables Make following consumables available: Item

Article

Mat. No

Qty

1

Sample tube 13mL (SARSTEDT, Tube with cap 101*16.5mm)

-

6

2

Deepwell Plate (DWP)

05232716001

1

3

Microwell plate (MWP)

05232724001

1

4

CORE Tip Tray

04639642001

10

5


05232732001

4

6


05232759001

1

14.2.2. Tube Preparation Take a 24 pos. Sample Rack SMP_CAR_24_A00 and insert the empty tube in pos 1-6. Fill all 6 tubes with 2mL-10ml tap water.

Page 142 of 175

Version 1.1.2

Installation Manual


Test Run HPV Required HPV Reagent

14 14.3

14.3. Required HPV Reagent Use the following reagent out of cobas 4800 HPV assay for 24 reactions:

Item

Barcode Information Reagent Bottle

[Kit]

Item

Barcode Information Reagent Vial

[Kit]

Washbuffer (WB)

Proteinase K (PK)

Large Bottle

1

6

Kit 24, Volume 55 mL Kit 96, Volume 200 mL

[A]

Temp. Storage: 15-25 ºC/ Load: 15-25ºC

SDS Reagent

Positive Control (PC+)

Small Bottle

Temp Storage: 15-25 ºC/ Load: 15-25ºC

Kit 96, Volume 0.5 mL Temp. Storage: 2-8 ºC / Load: 15-25ºC Reagent Carrier 3-18, track 51

Lysis (LYS)

Negative Control (NC-)

Small Bottle

Vial with Blue cap

8

Kit 24, Volume 10 mL Temp Storage: 15-25 ºC / Load: 15-25ºC

[D]

Kit 24, Volume 0.5 mL Kit 96, Volume 0.5 mL Temp. Storage: 2-8 ºC / Load: 15-25ºC




Master Mix (MMX)

Small Bottle with black cap Kit 24, Volume 4.5 mL (vortex) Kit 96, Volume 13.5 mL (vortex) Temp. Storage: 2-8 ºC / Load: 15-25ºC

Vial with Yellow cap

9 [E]

Kit 24, Volume 0.5 mL Kit 96, Volume 2*1 mL Temp. Storage: 2-8 ºC / Load: 2-8ºC



Elution Buffer (EB)

Metal Ion (Mg/Mn)

Small Bottle

5

Vial with Green cap

10

Kit 24, Volume 18 mL Kit 96, Volume 18 mL

[C]

[D]


Kit 96, Volume 36 mL

[C]

Vial with Red cap Kit 24, Volume 0.5 mL

7

Kit 24, Volume 3.0 mL

3

4

Kit 96, Volume 2*1.2 mL Temp. Storage: 15-25 ºC / Load: 15-25ºC Reagent Carrier 3-15, track 51


[B]



2 [B]

[B]

Vial with Transparent cap

Temp.Storage: 2-8 ºC / Load: 15-25ºC

[E]


Kit 24, Volume 1.5 mL Kit 96, Volume 1.5 mL Temp. Storage: 2-8 ºC / Load: 2-8ºC Reagent Carrier 3-24, track 51

KIT [A]: Wash Buffer 240T

Mat. No 05235863190

KIT [B]: System Liquid Cytology Preparation 240T

Mat. No 05235812190

KIT [C]: Sample Preparation 240T

Mat. No 05235782190

KIT [D]: HPV Controls Kit 240T

Mat. No 05235855190

KIT [E]: HPV Amplification/Detection 240T

Mat. No 05235880190

Installation Manual

Version 1.1.2

Page 143 of 175

14 14.3

Test Run HPV Required HPV Reagent


14.3.1. Creating a new work order (HPV) 1.

Start cobas 4800 Work Order Editor

2.

Click on New at the right top corner

3.

Select in section User: FSE

4.

Select File: Create New

5.

Select in section Create New Run Type: Full Test Type: HPV workflow

6.

Click on Next at bottom right corner

7.

Select in section Attributes Subtest Type: HPV High Risk Panel + Genotyping Barcode: Media Type: PreservCyty®Medium

8.

In the field Attributes set the curser into field Barcode Take the Handheld Barcode Scanner and then Scan Barcodes 1- 6 below: Prefer to use sample tube with barcode, if so scan Sample tube barcodes instead the barcodes below

Pos

9.

Barcode Information

Test Barcode

1

S11TestRunHPV

ÁS11TestRunHPVsÈ

2

S22TestRunHPV

ÁS22TestRunHPVxÈ

3

S33estRunHPV

ÁS33TestRunHPV}È

4

S44TestRunHPV

ÁS44TestRunHPVüÈ

5

S55TestRunHPV

ÁS55TestRunHPVßÈ

6

S66TestRunHPV

ÁS66TestRunHPV%È

Click Save at right bottom corner

10. Navigate Work Orders folder C:\Documents and Settings\OPERATOR\Operators’ Document\Work Orders 11. Save as HPVTestRun and then click OK to confirm 12. Press ALT+F4 keys to close cobas® Work Order Editor

Page 144 of 175

Version 1.1.2

Installation Manual


Test Run HPV New Run (TestRunHPV)

14 14.4

14.4. New Run (TestRunHPV) 14.4.1. Load Samples 1.

Start (Click) cobas_4800_V1.1.0.1036 software Log on as user FSE, PW: 00rocheSRVC

2.

Click to select in section Test type HPV Workflow

3.

Type in section Run name Installation WaterRun

4.

Insert the rack with the tube on pos 1-6 in track 20 (tracks 17-34)

5.

Click Load Samples at right bottom corner (skip step 6-12 when using Sample tube with barcodes)

6.

In window Load Carrier – Error click Barcode… (a)

7.

Cursor is now in field Enter barcode (b)

8.

Scan the S1WaterRun from the previous chapter 13.4.3 Creating a new work order

9.

Press Enter (c) to confirm the message Double blind entry failed!

10. Press Tab key to set the cursor to Confirm barcode (d) and scan the same barcode again 11. The status changes to green. Barcode is entered manually 12. The curser is set in field (b) for pos 2. Scan-Enter-Tab. Repeat step 8-11 accordingly for sample pos 2- 5 13. Click Execute to proceed. Please wait approx 1 minute 14. In section Work list click to the browse button WaterRun

to navigate to the created Workorder file

15. Click Next at right bottom corner

Installation Manual

Version 1.1.2

Page 145 of 175

14 14.4



14.4.2. Load Consumables 1.

Take a plate carrier P/N 185053/00, PLT_PCR_TIP_B00 Place one DWP on the DWP Holder, pos1. Barcode at right side Place one MWP on the MWP Holder, pos3. Barcode at rear side Load the plate carrier in track 1-6 as shown by the LED For further layout information see chapter 13.2.1 Rack Loading

2. 3.


4.


5.

Click Load Consumable at right bottom corner


Take a wide metal Reagent Carrier RGT_CAR4X200_X1

2.

Load the Reagent Carrier in track 48-49

3.

Scan Barcode on Reagent Bottle (Washbuffer)

4.


5.

Pour the reagent into this container

6.

Place the Reagent Reservoir 200ml on the Reagent Carrier pos 4

7.


Apply SCAN – SCAN – POUR - PLACE principle The first reagent bottle is now matched with a container. The countdown counter for 60 min starts now. Within 60 min the sample preparation needs to be started or the reagents will be expired!

Page 146 of 175

Version 1.1.2

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14 14.4



2.


3.

Scan Barcode on Reagent Bottle (SDS Reagent)

4.


5.


6.

Place the Reagent Reservoir 50 mL on the Reagent Carrier pos 2



2.


3.

Scan Barcode on Reagent Bottle (Lysis Buffer)

4.


5.


6.




2.


3.

Scan Barcode on Reagent Bottle (Magnetic Glass Particles MGP)

4.


5.


6.




2.


3.

Scan Barcode on Reagent Bottle (Elution Buffer)

4.


5.


6.


7.


Installation Manual

Version 1.1.2

Page 147 of 175

14 14.4



14.4.8. Load Reagent Vials Carrier 3-15,18,19, 23, 24 1.

Take a Sample Rack SMP_CAR_24_A00

2.


3.

Take the reagent vial PK, remove the transparent cap, insert in rack pos 15

4.

Take the reagent vial PC+, remove the red cap, insert in rack pos 18

5.

Take the reagent vial NC-, remove the blue cap, insert in rack pos 19

6.

Take the reagent vial MMX, remove yellow cap, insert in rack pos 23

7.

Take the reagent vial Mg/Mn, remove green cap, insert in rack pos 24

8.

Click Load Reagents

9.

Press Execute to close the window

10. Click Start Run to start the sample preparation on cobas x 480 instrument

The barcodes can be used once per instrument Reuse of Reagent Reservoirs (barcodes) are not accepted by the cobas® 4800 software A different set of barcodes (reagents) are required to repeat a run Please refer to GRIPS > cobas 4800 > cobas x 480 > Reagent Barcode Sheet Error Message related to the Liquid Level Error will always refer to invalid positive control. This is a misleading Error Message. A run starts to pipette reagents into the DWP well position A1 (PC+). The first use for all 10 reagents is in relation to the positive control. Therefore all Liquid Error Messages are reported against the positive control. In this error case all 10 reagents should be inspected for its expected level.

Error messages related to the negative control (PC-) are correct and the cause corresponds to the error message.

Page 148 of 175

Version 1.1.2

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14 14.4

14.4.9. End of Sample Preparation The run time for the sample preparation takes approximately one hour.

At the end of the sample preparation, continue following on-screen instructions: 1.

Click Unload and wait till all racks have been unloaded by the system

2.

Take the MWP and apply the sealing film by using the applicator Follow the instruction given in the Operator’s Manual cobas® 4800 system to seal the MWP Amplification/ Detection must be started within 90 min. After this time the cobas® 4800 software changes the MWP status to expired

14.4.10. Amplification and Detection 1.

Click Next

2.

Press the Load button at cobas z 480 analyzer using instrument load button

3.

Place the sealed MWP in the plate holder of cobas z 480 analyzer

4.

Press the Load button to close the analyzer plate holder

5.

Amplification and Detection starts automatically

6.

This will take approximately 120 minutes

7.

Discard DWP and all reagent vials, reagent reservoirs of the cobas x 480 instrument

Installation Manual

Version 1.1.2

Page 149 of 175

14 14.4



14.4.11. Control Curve Analysis After the Amplification/ Detection run is performed the HPV control curves are displayed. Analyze the control curves displayed in the window:

1.

Curve HPV (+) for Channel 1-4 is expected to rise after cycle 35

(MWP well A1)

2.

Curve HPV (-) for Channel 1-4 is expected to be a flat line

(MWP well B1)

14.4.12. Finalize HPV Run Press Show Results button at the right bottom corner of the cobas® 4800 software to finalize the run data. This will close the window of the HPV control curves and the result can be seen in tab Results. Review of the control curve is at this stage not possible anymore. 1.

Print this HPVTestRun

2.

The HPVTestRun can be stated as Valid if the following requirements are fulfilled

3.

Positive Control (PC+) and Negative Control (NC-) are stated as Valid

4.

Samples 1-6 are flagged as Invalid due to the reaction limitation of water

14.4.13. Clean up Unload and discard the MWP of cobas z 480 analyzer

Page 150 of 175

Version 1.1.2

Installation Manual


Completion of Installation New Run (TestRunHPV)

15 14.4

15. Completion of Installation At the end of this manual is the User Access Information. Support the Lab Manager with this data or create the requested cobas® 4800 software user. Delete error messages and files on the control unit which are no longer used. Remove any remaining CD. Restart the cobas 4800 control unit At the end of this manual are two checklists. Make sure all this checks/ test are successfully performed. This manual is includes Log in Data. Do not leave or waste it at customer site. If this manual is no longer in use, bring it back to your office and waste it there.

Congratulation! cobas® 4800 system is now installed!

Installation Manual

Version 1.1.2

Page 151 of 175

16 16.1

Appendix Installation of BIOS settings


16. Appendix 16.1. Installation of BIOS settings 1.

Power up cobas 4800 control unit hp rp 5700

2.

Insert DVD OSXP Recovery for cobas 4800 Control Unit (IVD workflow) 1.0.0 into the DVD drive.

3.

Browse to CD DRIVE E:\ BIOS SETTINGS

4.

Copy Cpqsetup.txt to the root of a storage device (i.e. usb flash drive)

5.

Restart cobas 4800 control unit hp rp 5700

6.

Press key [F10]during boot session to enter to enter the BIOS Screen

7.

Enter BIOS Password: Biosc4k8

8.

Choose English as language

9.

Navigate to File>Replicated Setup

10. Select Restore from Removable Media, press F10 to accept the selection. 11. Select a drive USB press F10 to accept the selection. 12. Wait for this prompt and press any key to continue.

13. Select Save Changes and Exit 14. Remove the storage device.

Page 152 of 175

Version 1.1.2

Installation Manual


Appendix Installation of OSXP Recovery Image

16 16.2

16.2. Installation of OSXP Recovery Image Do not interrupt any installation process, switch off or reboot the cobas 4800 control unit unless it’s an instruction. In case of power loss or interruption restart at the beginning of this section. Do not connect any storage devices such as USB memory stick while installing the Recovery Image

1.

Power ON or restart the cobas 4800 control unit hp rp 5700

2.

Press F9 key during start-up process (blue hp invent screen) to enter the boot menu.

3.

Insert DVD OSXP Recovery for cobas 4800 Control Unit (IVD workflow) 1.0.0 into the DVD drive. Ensure the cobas 4800 control unit model is according the model labeled on the DVD. i.e. HP rp 5700

4.

Select CD-ROM and confirm with ENTER key

Starting OSXP Recovery image takes approximately 2 minutes, please wait

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16 16.2



5.

Press key no 1 to Prepare Disk and Partitions.

6.

Press Y key to confirm that System Disk will be overwritten and killed.

7.

Ghost Recovery starts automatically and indicates progress. It takes approx. 33 seconds.

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8.

After successful completion, the green Restore System Disk window is displayed again.

9.

Press key no 2 for Full Recovery OSXP on System Disk

16 16.2

10. Press Y key to continue recovery Ghost Recovery starts automatically and indicates progress. It takes approx. 5 minutes.

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16 16.2



11. After successful completion, the green Restore System Disk window is displayed again. 12. Press key no 3 for Full Recovery Backup Disk

13. Press Y key to continue recovery Ghost Recovery starts automatically and indicates progress. It takes approx. 10 seconds.

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16 16.2

14. After successful completion, the green Restore System Disk window is displayed again 15. Press key e to Exit

16. The cobas 4800 control unit reboots automatically 17. Remove the DVD. 18. After rebooting the cobas 4800 control unit peripheral devices may not work immediately. Hardware needs to be detected by the system and then suitable drivers get installed. This takes approx. 5 minutes.

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16 16.2



19. The Date and Time Properties window opens automatically. Set the appropriate Time Zone & Daylight Saving as well as the correct Time Press OK to apply and close the window

20. As Computer Name, type in the hp s/n (9-digit). See nameplate on top of the cobas 4800 control unit, press ENTER key to confirm.

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16 16.2

21. When dialog box System Settings Change appears, click NO

22. Click OK and wait for automatic reboot of cobas 4800 control unit. It takes approx. 90 seconds

23. After rebooting, the system will continue with final configuration. That takes approx. 90 seconds Just wait until the system reboots the cobas 4800 control unit one more time.

24. After this boot process the system will log on automatically as user Operator. a) No error messages appeared. Image of DVD: OSXP Recovery Image 1.0.0 is successfully installed. Go ahead with installing cobas® 4800 software. Please see next chapter 4.5 cobas® 4800 software installation, page 28 b) Error message appeared. There is an error in the installed recovery image file. Reinstall OSXP recovery image.

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16 16.3

Appendix Network Overview


16.3. Network Overview

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Appendix Installation Check List cobas 4800 control unit

16 16.4

16.4.Installation Check List cobas 4800 control unit Performed Short Description of Task

Page:

Verification of installed , Version: 1.0.0

25

Verify Start Menu (Win Operator)

65

Verify Program Menu (Win Operator)

66

Verify permissions for folder Roche_x480_ConfigFiles

67

Verify Start Menu (Win Install)

68

Verify Program Menu (Win Install)

69

Verify correct placement of the Tip Eject Plate (plate is in the notch)

78

Verify Firmware version on cobas x 480 instrument

80

Handheld Barcode Scanner programmed

84

Printer installed

123

TADM configuration set to Recording

141

WaterRun

135

TADM configuration set to Monitoring

141

Test Run HPV

142

16.5.Installation Check List cobas z 480 analyzer Performed Short Description of Task

Page:

Installation of cobas z 480 according Installation Manual for cobas z 480

24

Verify Firmware version on cobas z 480 analyzer

82

Diagnostics Check performed on cobas z 480 analyzer

83

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16 16.6

Appendix Installation Check List cobas x 480 instrument


16.6.Installation Check List cobas x 480 instrument Performed Installation PART 1 Work Place Environment Inspect workplace environment for accordance to technical specifications Inspect table or workbench for supporting the weight of the Microlab STAR IVD and providing the minimum space needed Unpacking the Instrument Inspect instrument and accessories for shipping damage or missing parts Use packing list to verify contents. If any items are missing, contact Customer Service Set up the instrument Set the instrument deck in level by adjusting the trolley feet (Y- & X-direction) Inspect iSWAP Instrument Connections Check Fuses Connect communication and power cables PART 2 Install tip waste chute and container Install Teaching Needles, Install Tip eject plate (must not be shifted or lifted) Recommended Uninterruptible Power Supply (UPS) installed? Yes

No

Instrument Check Procedure Check instrument configuration Instrument cover monitoring switched on? Yes

No

Print out instrument configuration Perform instrument check procedure Weekly Maintenance Perform Weekly Maintenance procedure Verification X-Y-Z Positioning Barcode Volume Print out verification reports

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Appendix Additional HPV Barcodes for WaterRun

16 16.7

16.7.Additional HPV Barcodes for WaterRun 16.7.1. Sample Loading Set #1 Pos

Barcode Information

Test Barcode

1

S111TestRunHPV

ÁS111TestRunHPViÈ

2

S112TestRunHPV

ÁS112TestRunHPVmÈ

3

S113TestRunHPV

ÁS113TestRunHPVqÈ

4

S114TestRunHPV

ÁS114TestRunHPVuÈ

5

S115TestRunHPV

ÁS115TestRunHPVyÈ

6

S116TestRunHPV

ÁS116TestRunHPV}È

7

S117TestRunHPV

ÁS117TestRunHPVöÈ

8

S118TestRunHPV

ÁS118TestRunHPVÜÈ

9

S119TestRunHPV

ÁS119TestRunHPV"È

10

S120TestRunHPV

ÁS120TestRunHPVhÈ

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16 16.7



16.7.2. Reagent Loading Set #1 Rack 1 Item # 1 REAG

Barcode Information

Test Barcode

Washbuffer (WB) Kit 24, Volume 55 mL Storage: 15-25 ºC/ Load: 15-25ºC

Á0S0Ä**5ÖBZÄ*ß'È


0S0101021BZ1000

1

Container 200 mL CONS

Page 164 of 175

Á5Ä`&!ÖBZ1ÄßHfÈ 5640601BZ10040

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16 16.7

Rack 2 Item # 2

Barcode Information

Test Barcode

SDS Reagent

Á0SAÄ**5ÖBZÄ*!gÈ

Kit 24, Volume 3mL Storage: 15-25 ºC/ Load: 15-25ºC

REAG


2

Container 50mL CONS

0SA101021BZ1001

Á5Ä`&"ÖBZ1Ä"ß=È 5640602BZ10200

Lysis (LYS)

3

Kit 24, Volume 10mL Storage:15-25 ºC / Load:15-25ºC

REAG


3

Container 50mL CONS

Á0S6Ä**5ÖBZÄ*"SÈ 0S6101021BZ1002

Á5Ä`&"ÖBZ1Ä"!IÈ 5640602BZ10201

4


REAG


Kit 24, Volume 4.5mL (vortex) Storage:2-8 ºC / Load:15-25ºC

4

Container 50mL CONS 5 REAG

0S2101021BZ1003

Á5Ä`&"ÖBZ1Ä""UÈ 5640602BZ10202

Elution Buffer (EB) Kit 24, Volume 18mL Storage:2-8 ºC / Load:15-25ºC Reagent Carrier 2-5, track 50

5

Container 50mL CONS

Installation Manual

Á0S2Ä**5ÖBZÄ*#TÈ

Á0S4Ä**5ÖBZÄ*$gÈ 0S4101021BZ1004

Á5Ä`&"ÖBZ1Ä"#aÈ 5640602BZ10203

Version 1.1.2

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16 16.7



Rack 3 Item #

6

7

8

9

10

Page 166 of 175

Barcode Information

Test Barcode

Proteinase K (PK) Kit 24, Volume 0.9mL Storage:15-25 ºC / Load:15-25ºC

Á0S8Ä**5ÖBZÄ*%äÈ


0S8101021BZ1005

Positive Control (PC+) Kit 24, Volume 0.5mL Storage:2-8 ºC / Load:15-25ºC

Á2H1Ä**5ÖBZÄ*&dÈ


2H1101021BZ1006

Negative Control (NC-) Kit 24, Volume 0.5mL Storage:2-8 ºC / Load:15-25ºC

Á0NCÄ**5ÖBZÄ*'JÈ


0NC101021BZ1007

Master Mix (MMX) Kit 24, Volume 0.5mL Storage:2-8 ºC / Load: 2-8ºC

Á2H4Ä**5ÖBZÄ*(ßÈ


2H4101021BZ1008

Metal Ion (Mn/Mg) Kit 24, Volume 1.5mL Storage:2-8 ºC / Load:2-8ºC

Á2H3Ä**5ÖBZÄ*)*È


2H3101021BZ1009

Version 1.1.2

Installation Manual



16 16.7

16.7.3. Sample Loading Set #2 Pos

Barcode Information

Test Barcode

1

S121TestRunHPV

ÁS121TestRunHPVlÈ

2

S122TestRunHPV

ÁS122TestRunHPVpÈ

3

S123estRunHPV

ÁS123TestRunHPVtÈ

4

S124TestRunHPV

ÁS124TestRunHPVxÈ

5

S125TestRunHPV

ÁS125TestRunHPV|È

6

S126TestRunHPV

ÁS126TestRunHPVäÈ

7

S127TestRunHPV

ÁS127TestRunHPVÖÈ

8

S128TestRunHPV

ÁS128TestRunHPV!È

9

S129TestRunHPV

ÁS129TestRunHPV%È

10

S130TestRunHPV

ÁS130TestRunHPVkÈ

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16 16.7




Barcode Information

Test Barcode

Washbuffer (WB) Kit 24, Volume 55mL Storage: 15-25 ºC/ Load: 15-25ºC

Á0S0Ä**5ÖBZÄ**BÈ


0S0101021BZ1010

1

Container 200mL CONS

Page 168 of 175

Á5Ä`&!ÖBZ1ÄßIrÈ 5640601BZ10041

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Installation Manual



16 16.7

Rack 2 Item # 2

Barcode Information

Test Barcode

SDS Reagent

Á0SAÄ**5ÖBZÄ*+üÈ


REAG


2

Container 50mL CONS

0SA101021BZ1011

Á5Ä`&"ÖBZ1Ä"$mÈ 5640602BZ10204

Lysis (LYS)

3


REAG


3

Container 50mL CONS

Á0S6Ä**5ÖBZÄ*,nÈ 0S6101021BZ1012

Á5Ä`&"ÖBZ1Ä"%yÈ 5640602BZ10205

4


REAG



4


0S2101021BZ1013

Á5Ä`&"ÖBZ1Ä"&ÜÈ 5640602BZ10206


5

Container 50mL CONS

Installation Manual

Á0S2Ä**5ÖBZÄ*-oÈ

Á0S4Ä**5ÖBZÄ*.üÈ 0S4101021BZ1014

Á5Ä`&"ÖBZ1Ä"'*È 5640602BZ10207

Version 1.1.2

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16 16.7



Rack 3 Item #

6

7

8

9

10

Page 170 of 175

Barcode Information

Test Barcode


Á0S8Ä**5ÖBZÄ*/4È


0S8101021BZ1015


Á2H1Ä**5ÖBZÄ*0´È


2H1101021BZ1016


Á0NCÄ**5ÖBZÄ*1eÈ


0NC101021BZ1017


Á2H4Ä**5ÖBZÄ*2;È


2H4101021BZ1018


Á2H3Ä**5ÖBZÄ*3EÈ


2H3101021BZ1019

Version 1.1.2

Installation Manual



16 16.7

16.7.5. Sample Loading Set #3 Pos

Barcode Information

Test Barcode

1

S131TestRunHPV

ÁS131TestRunHPVoÈ

2

S132TestRunHPV

ÁS132TestRunHPVsÈ

3

S133estRunHPV

ÁS133TestRunHPVwÈ

4

S134TestRunHPV

ÁS134TestRunHPV{È

5

S135TestRunHPV

ÁS135TestRunHPV´È

6

S136TestRunHPV

ÁS136TestRunHPVÄÈ

7

S137TestRunHPV

ÁS137TestRunHPVßÈ

8

S138TestRunHPV

ÁS138TestRunHPV$È

9

S139TestRunHPV

ÁS139TestRunHPV(È

10

S140TestRunHPV

ÁS140TestRunHPVnÈ

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16 16.7




Barcode Information

Test Barcode

Washbuffer (WB) Kit 24, Volume 55mL Storage: 15-25 ºC/ Load: 15-25ºC

Á0S0Ä**5ÖBZÄ*4]È


0S0101021BZ1020

1

Container 200mL CONS

Page 172 of 175

Á5Ä`&!ÖBZ1ÄßJ~È 5640601BZ10042

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Installation Manual



16 16.7

Rack 2 Item # 2

Barcode Information

Test Barcode

SDS Reagent

Á0SAÄ**5ÖBZÄ*56È


REAG


2

Container 50mL CONS

0SA101021BZ1021

Á5Ä`&"ÖBZ1Ä"(6È 5640602BZ10208

Lysis (LYS)

3


REAG


3

Container 50mL CONS

Á0S6Ä**5ÖBZÄ*6"È 0S6101021BZ1022

Á5Ä`&"ÖBZ1Ä")BÈ 5640602BZ10209

4


REAG



4


0S2101021BZ1023

Á5Ä`&"ÖBZ1Ä"*NÈ 5640602BZ10210


5

Container 50mL CONS

Installation Manual

Á0S2Ä**5ÖBZÄ*7#È

Á0S4Ä**5ÖBZÄ*86È 0S4101021BZ1024

Á5Ä`&"ÖBZ1Ä"+ZÈ 5640602BZ10211

Version 1.1.2

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16 16.7



Rack 3 Item #

6

7

8

9

10

Page 174 of 175

Barcode Information

Test Barcode


Á0S8Ä**5ÖBZÄ*9OÈ


0S8101021BZ1025


Á2H1Ä**5ÖBZÄ*:3È


2H1101021BZ1026


Á0NCÄ**5ÖBZÄ*;äÈ


0NC101021BZ1027


Á2H4Ä**5ÖBZÄ*

2H4101021BZ1028


Á2H3Ä**5ÖBZÄ*=`È


2H3101021BZ1029

Version 1.1.2

Installation Manual


Appendix User Access Information

16 16.8

16.8.User Access Information 16.8.1. Lab Operator Access Information Software

Log in Information

User name Operator Password Type

Oprcobas48000709 Limited account, auto logon

User name LABOPERATOR Password

00labOPR

16.8.2. Lab Manger Access Information Software

Log in Information



User name Labmanager Password

00labMGR

16.8.3. Admin Access Information Software

Log in Information



User name Admin Password Type

Installation Manual

00rocheADM For IT to switch on LIS

Version 1.1.2

Page 175 of 175

Manual Cobas 4800

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