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
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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 Operators 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
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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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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
13.5.6. 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
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Roche
cobas 4800 system
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
16.8.
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
Installation Manual
Version 1.1.2
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1
1.1
Preface
Revision History
Roche
cobas 4800 system
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
Page 8 of 175
Version 1.1.2
Installation Manual
Roche
cobas 4800 system
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
Installation Manual
Version 1.1.2
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1
1.2
Preface
Editor notice
Roche
cobas 4800 system
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: rotkreuz.gssmdi@roche.com
Version 1.1.2
Installation Manual
Roche
cobas 4800 system
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 Operators 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- & Operators Manual cobas 4800 system are read and
understood by the user.
Installation Manual
Version 1.1.2
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1
1.9
Preface
Order Information
Roche
cobas 4800 system
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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Version 1.1.2
Installation Manual
Roche
cobas 4800 system
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
Installation Manual
Version 1.1.2
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1
1.13
Preface
Safety notes
Roche
cobas 4800 system
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 =1000l)
uL
Microliter (1mL =1000l)
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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Version 1.1.2
Installation Manual
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.
Installation Manual
Version 1.1.2
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1
1.14
Preface
Data Security
Roche
cobas 4800 system
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:
Page 16 of 175
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
Roche
cobas 4800 system
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.
Installation Manual
Version 1.1.2
Page 17 of 175
1
1.16
Preface
Material Required
Roche
cobas 4800 system
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
Operators 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

Manual
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

Manual
File: Cobas4800WorkorderEditor.exe.config.zip
N/A

Manual
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

Page 18 of 175
Version 1.1.2
Installation Manual
Roche
cobas 4800 system
Preface
Material Required
1
1.16
1.16.4. Accessories & Option

1.16.5. Consumables
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
Installation Manual
Version 1.1.2
Page 19 of 175
2
2.1
Upgrade from version 1.0.x to 1.1.0

Installation Backup Restore Tool
Roche
cobas 4800 system
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
Page 20 of 175
Version 1.1.2
Installation Manual
Roche
cobas 4800 system
3.

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.
Installation Manual
Version 1.1.2
Page 21 of 175
2
2.3

Store Archive & Backup Files
Roche
cobas 4800 system
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
Page 22 of 175
Version 1.1.2
Installation Manual
Roche
cobas 4800 system
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
Installation Manual
Version 1.1.2
Page 23 of 175
3
3.3
New Installation
Installation cobas z 480 analyzer
Roche
cobas 4800 system
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
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.
Page 24 of 175
Version 1.1.2
Installation Manual
Roche
cobas 4800 system
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
Installation Manual
Version 1.1.2
Page 25 of 175
4
4.3

Verification of installed image version
Roche
cobas 4800 system
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

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.
Page 26 of 175
Version 1.1.2
Installation Manual
Roche
cobas 4800 system

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.
Installation Manual
Version 1.1.2
Page 27 of 175
4
4.5

cobas 4800 software installation
Roche
cobas 4800 system
4.5. cobas 4800 software installation

1.
2.
3.

on GRIPS
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
Page 28 of 175
Version 1.1.2
Installation Manual
Roche
cobas 4800 system
9.

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
Installation Manual
Version 1.1.2
Page 29 of 175
4
4.5

Roche
cobas 4800 system
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.
Page 30 of 175
Version 1.1.2
Installation Manual
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
Installation Manual
Version 1.1.2
Page 31 of 175
4
4.5

Roche
cobas 4800 system
17. Click Finish
18. Following installation screens belong to CAT SH10 IVD Model Heater/Shaker and its HW driver
Click Next
19. Click Finish
Page 32 of 175
Version 1.1.2
Installation Manual
Roche
cobas 4800 system

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
Installation Manual
Version 1.1.2
Page 33 of 175
4
4.5

Roche
cobas 4800 system
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
Page 34 of 175
Version 1.1.2
Installation Manual
Roche
cobas 4800 system

4
4.5
25. Click Finish to complete cobas 4800 Transformer installation
26. Click Finish to complete cobas 4800 software installation
Installation Manual
Version 1.1.2
Page 35 of 175
4
4.6

cobas 4800 oracle DB installation
Roche
cobas 4800 system
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
Page 36 of 175
Version 1.1.2
Installation Manual
Roche
cobas 4800 system

4
4.6
10. Verify Connect to R_INT_ADMIN is displayed, then enter PW: LbRuwotHFP

11. Verify Connect to R_INT_USER, is displayed, then enter PW: W8xHEQvtLC

12. Verify Connect to INT_ADMIN, is displayed, then enter PW: QhfIwXEP15

Installation Manual
Version 1.1.2
Page 37 of 175
4
4.6

Roche
cobas 4800 system
13. Verify Connect to INT_SETUP, is displayed, then enter PW: S23WaZe66k

14. Verify Connect to QUARTZ, is displayed, then enter PW: Li5qP3n2Ab

15. When prompted, then press any key to continue.
Page 38 of 175
Version 1.1.2
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Roche
cobas 4800 system

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
Installation Manual
Version 1.1.2
Page 39 of 175
4
4.6

Roche
cobas 4800 system
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
Page 40 of 175
Version 1.1.2
Installation Manual
Roche
cobas 4800 system

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
Installation Manual
Version 1.1.2
Page 41 of 175
4
4.7

4.7.2.
Roche
cobas 4800 system
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
Page 42 of 175
Version 1.1.2
Installation Manual
Roche
cobas 4800 system
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
Installation Manual
Version 1.1.2
Page 43 of 175
4
4.7

4.7.4.
Roche
cobas 4800 system
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
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
Page 44 of 175
Version 1.1.2
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Roche
cobas 4800 system
4.

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.
Installation Manual
Version 1.1.2
Page 45 of 175
4
4.7

Roche
cobas 4800 system
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.
Page 46 of 175
Version 1.1.2
Installation Manual
Roche
cobas 4800 system

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
Installation Manual
Version 1.1.2
Page 47 of 175
4
4.8

cobas 4800 Work Order Editor Installation
5.
Click Install
6.
Click Finish
Page 48 of 175
Version 1.1.2
Roche
cobas 4800 system
Installation Manual
Roche
cobas 4800 system

Installation of cobas 4800 Operators Manual
4
4.9
4.9. Installation of cobas 4800 Operators Manual

Please provide with a storage device (i.e. CD, USB Memory Stick) the latest Operators
Manual cobas 4800 system in the customer required language which can be
downloaded from GRIPS
Please note there are several different version of the operators 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 Operators 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 Operators 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 Operators 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 Operators 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 Operators 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 Operators manual does not open, check for correct file name UserManual.pdf and
Users Manual.pdf
19. Press Eject CD button and remove the CD
Installation Manual
Version 1.1.2
Page 49 of 175
4
4.10

cobas x 480 Service Software Installation
Roche
cobas 4800 system
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
Page 50 of 175
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cobas 4800 system

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

Installation Manual
Version 1.1.2
Page 51 of 175
4
4.12

cobas z 480 analyzer Service Software Installation
4.
Wait for the pop up window New Hardware Wizard

Click Next
5.
Click Finish
Roche
cobas 4800 system
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
Page 52 of 175
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Roche
cobas 4800 system

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
Installation Manual
Version 1.1.2
Page 53 of 175
4
4.13

User permission modification
Roche
cobas 4800 system

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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4.13.2. 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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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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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.

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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10. Press CTRL+ALT+DEL keys

Click on Log Off and click Log Off to confirm
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
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Windows Start Menu & Shortcuts
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.
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.

6.
Open windows explorer (Win+E)
7.
Browse to C:\Documents and Settings\OPERATOR\My Documents (Administrators 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 (Administrators 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.

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.
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.

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.

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:
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.

(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:
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.

Select folder cobas_4800_V1.1.0.1036 and then press CTRL+C keys to copy the folder
2.

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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4.15.7. Remove uninstall cobas 4800 Work Order Editor

1.

Select folder cobas 4800 Work Order Editor v1.1.0.1016 and then press CTRL+C keys to copy the
folder
2.

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.
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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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 Icons 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 icons 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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4.16.2. Programs Menu (OPERATOR)

1.
2.
Verify the icons 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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4.16
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.
4.
Verify Icons 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 Icons in Start Menu (b), right mouse click to open the context menu and then select Sort
by Name
6.

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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4.16.5. Programs Menu (INSTALL)

1.
2.
Verify the icons 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
Installation Manual
Version 1.1.2
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4
4.17

Workaround exchanging of Workorder Config. File
Roche
cobas 4800 system
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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Exchanging of Workorder Config. File
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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Verify Workorder Editor Display
Roche
cobas 4800 system
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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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.
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
c) cobas 4800 control unit no.3: IP: 172.20.1.142
d) cobas 4800 control unit no.4: IP: 172.20.1.143
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5
5.1
Upgrade Installation Restore Database

Installation Backup Restore Tool
Roche
cobas 4800 system
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.

on GRIPS
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.
Installation Manual
Version 1.1.2
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6
6.1
cobas x 480 instrument Installation

Stationary Carrier and Heater/Shaker Unit
Roche
cobas 4800 system
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 sidewards.
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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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

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.
Installation Manual
Version 1.1.2
Page 77 of 175
6
6.2

Liquid Waste Installation Procedure
Roche
cobas 4800 system
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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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 Operators 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 Operators Manual instruction to install the Waste Chute and Solid Waste Box
13. Switch ON cobas x 480
Installation Manual
Version 1.1.2
Page 79 of 175
6
6.3

Firmware Verification
Roche
cobas 4800 system
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 = P1P8
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.

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
Installation Manual
Version 1.1.2
Page 81 of 175
7
7.1
cobas z 480 analyzer Installation

Firmware Verification
Roche
cobas 4800 system
7. cobas z 480 analyzer Installation

The cobas z 480 analyzer must be installed according its installation manual.
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 4800 system
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
Installation Manual
Version 1.1.2
Page 83 of 175
8
8.1
Handheld Barcode Scanner

Installation
Roche
cobas 4800 system
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.
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
Reset to scanner manufacturers factory default
Select USB interface for communication
Wait for 30 seconds before proceeding

3
Set all symbologies off
Activate reading of codabar codes
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5
No Check Character Codabar
Activate reading of Code 39
No Check Character 39
Activate reading of Code 128
Activate reading of PDF417
10
Activate reading of Datamatrix
Installation Manual

Scanner Programming
Version 1.1.2
8
8.2
Page 85 of 175
8
8.3

Scanner Verification
Roche
cobas 4800 system
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
Barcode Type Codabar

Code Information 13579
Barcode Type Code 128

Code Information Code 128
Barcode Type PDF417

Code Information MicroPDF417 Test Message
Barcode Type Data Matrix

Code Information Test Symbol
Page 86 of 175
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cobas 4800 system
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)

(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.
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)
Installation Manual
Version 1.1.2
Page 87 of 175
9
9.2

Network Connection
Roche
cobas 4800 system
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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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
Installation Manual
Version 1.1.2
Page 89 of 175
9
9.3

Application Software Connection
Roche
cobas 4800 system
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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8.
Choose setup type Typical
9.
Click Install
Installation Manual

Version 1.1.2
9
9.3
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9
9.3

Roche
cobas 4800 system
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
Installation Manual
Version 1.1.2
Page 93 of 175
9
9.3

Roche
cobas 4800 system
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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5.
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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9
9.3

Roche
cobas 4800 system
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
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.
Installation Manual
Version 1.1.2
Page 97 of 175
9
9.3

Roche
cobas 4800 system
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
Page 98 of 175
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9.3.5.

9
9.3
cobas 4800 software LIS configuration
1.
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.
Installation Manual
Version 1.1.2
Page 99 of 175
9
9.4

Testing Communication Scenarios
Roche
cobas 4800 system
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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4.

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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Version 1.1.2
Page 101 of 175
9
9.4

9.4.2.
Roche
cobas 4800 system
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.
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.
Installation Manual
Version 1.1.2
Page 103 of 175
10
10.1
LIS Interface Configuration with cobas IT firewall

Physical Connection
Roche
cobas 4800 system
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.
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)
Page 104 of 175
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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
Installation Manual
Version 1.1.2
Page 105 of 175
10
10.2
3.

Network Connection
Roche
cobas 4800 system
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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3.
Select generate a new configuration
4.
Enter appropriate settings and click next.
Installation Manual

Network Connection
Version 1.1.2
10
10.2
Page 107 of 175
10
10.2

Network Connection
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
Roche
cobas 4800 system
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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7.
Click Next
8.
Select cobas 4800 and click Next
Installation Manual

Network Connection
Version 1.1.2
10
10.2
Page 109 of 175
10
10.2
9.

Network Connection
Roche
cobas 4800 system
Click Next
10. Enter LIS IP address 10.0.0.20 and port 5555
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Network Connection
10
10.2
11. Click Next
12. Click Next
Installation Manual
Version 1.1.2
Page 111 of 175
10
10.2

Network Connection
Roche
cobas 4800 system
13. Enter and confirm Password: 123456
14. Click Next
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cobas 4800 system

Network Connection
10
10.2
15. Click Next
16. Close Networking Addressing Sheet window
Installation Manual
Version 1.1.2
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10
10.2

Network Connection
Roche
cobas 4800 system
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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Network Connection
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
Installation Manual
Version 1.1.2
Page 115 of 175
10
10.2

Network Connection
Roche
cobas 4800 system
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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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
Installation Manual
Version 1.1.2
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10
10.3

Application Connection
8.
Click Next
9.
Click Change
Roche
cobas 4800 system
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
Installation Manual
Version 1.1.2
Page 119 of 175
11
11.1
Change LIS Interface Configuration

Change IP address of host computer
Roche
cobas 4800 system
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.
Page 120 of 175
Version 1.1.2
Installation Manual
Roche
cobas 4800 system

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``
Installation Manual
Version 1.1.2
Page 121 of 175
11
11.4

Additional information
Roche
cobas 4800 system
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
Page 122 of 175
Version 1.1.2
Installation Manual
Roche
cobas 4800 system
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)
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.
Installation Manual
Version 1.1.2
Page 123 of 175
12
12.2
Printer Driver Installation
Roche
cobas 4800 system
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
Page 124 of 175
Version 1.1.2
Installation Manual
Roche
cobas 4800 system
6.
In the next window Add Standard TCP/IP Printer Port Wizard

Press Next
7.
In the next window Add Port, type in the printers IP address 172.20.1.170
Press Next
8.
Select Device Type Generic Network Card

Click Next
Installation Manual
Version 1.1.2
12
12.2
Page 125 of 175
12
12.2
9.
Roche
cobas 4800 system
Click Finish
10. Click Have Disk
11. Insert manufacturers CD into CD Drive

Browse to CD Drive E:\, click OK
Page 126 of 175
Version 1.1.2
Installation Manual
Roche
cobas 4800 system
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
Installation Manual
Version 1.1.2
Page 127 of 175
12
12.2
Roche
cobas 4800 system
15. Select Yes and then click Next
16. Click Continue Anyway
17. Click OK
Page 128 of 175
Version 1.1.2
Installation Manual
Roche
cobas 4800 system
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 manufacturers support website.
12.3. Set default printer for user OPERATOR

1.
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.
Installation Manual
Version 1.1.2
Page 129 of 175
12
12.4
Printer Installation in Laboratory Network (red Network)
Roche
cobas 4800 system
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.
Page 130 of 175
Version 1.1.2
Installation Manual
Roche
cobas 4800 system
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
Roche
cobas 4800 system
13.3. Consumables
13.3.1. Requirement
Make following consumables available:
Item #
Article
Mat. No
Qty
Sample tube 13mL (SARSTEDT, Tube with cap 101*16.5mm)
11
Deepwell Plate (DWP)
05232716001
Microwell plate (MWP)
05232724001
CORE Tip Tray (tray of
04639642001
10
Reagent Reservoir 50ml
05232732001
05232759001
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
Version 1.1.2
Installation Manual
Roche
cobas 4800 system
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.

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
Roche
cobas 4800 system
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: PreservCytMedium
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
S1WaterRun
S1WaterRunU
S2WaterRun
S2WaterRunW
S3WaterRun
S3WaterRunY
S4WaterRun
S4WaterRun[
S5WaterRun
S5WaterRun]
S6WaterRun
S6WaterRun_
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
Roche
cobas 4800 system
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

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
Water Run
New Run (WaterRun)
Roche
cobas 4800 system
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)
0S0+#"BZf
Kit 24, Volume 55 mL

Storage: 15-25 C/ Load: 15-25C
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
Version 1.1.2
Installation Manual
Roche
cobas 4800 system
Water Run
New Run (WaterRun)
13
13.5

1.
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.

Item #
Barcode Information
Test Barcode
SDS Reagent
0SA+#"BZ2
Kit 24, Volume 3 mL

Reagent Carrier 2-2, track 50
0SA110302BZ

1.
2.
3.
Scan the Reagent Barcode (Lysis Buffer) provided below
4.
5.
6.

Item #
Barcode Information
Test Barcode
Lysis (LYS)
3

Storage: 15-25 C / Load: 15-25C
0S6+#"BZx
Installation Manual
Version 1.1.2
0S6110302BZ
Page 137 of 175
13
13.5
Water Run
New Run (WaterRun)
Roche
cobas 4800 system
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 #
Barcode Information
Test Barcode
Magnetic Glass Particle (MGP)
0S2+#"BZl
Kit 24, Volume 4.5 mL (vortex)

0S2110302BZ
13.5.7. Load Reagent Carrier 2-5

1.
2.
3.
Scan the Reagent Barcode (Elution Buffer) provided below
4.
5.
6.

Item #
Barcode Information
Test Barcode
Elution Buffer (EB)
0S4+#"BZr

7.
0S4110302BZ
Page 138 of 175
Version 1.1.2
Installation Manual
Roche
cobas 4800 system
Water Run
New Run (WaterRun)
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 #
Barcode Information
Test Barcode
Proteinase K (PK)
0S8+#"BZ~
Kit 24, Volume 0.9 mL

Positive Control (PC+)

7

Negative Control (NC-)

8

Master Mix (MMX)

9

Metal Ion (Mn/Mg)

10

Installation Manual
Version 1.1.2
0S8110302BZ
2H1+#"BZU
2H1110302BZ
0NC+#"BZ.
0NC110302BZ
2H4+#"BZ^
2H4110302BZ
2H3+#"BZ[
2H3110302BZ
Page 139 of 175
13
13.5
Water Run
New Run (WaterRun)
Roche
cobas 4800 system
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
Version 1.1.2
Installation Manual
Roche
cobas 4800 system
Water Run
New Run (WaterRun)
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.

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
Roche
cobas 4800 system
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 2-8C or 1515C 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
Sample tube 13mL (SARSTEDT, Tube with cap 101*16.5mm)
Deepwell Plate (DWP)
05232716001
Microwell plate (MWP)
05232724001
CORE Tip Tray
04639642001
10
05232732001
05232759001
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
Roche
cobas 4800 system
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

[A]
Temp. Storage: 15-25 C/ Load: 15-25C
SDS Reagent
Small Bottle
Temp Storage: 15-25 C/ Load: 15-25C

Temp. Storage: 2-8 C / Load: 15-25C
Lysis (LYS)
Small Bottle
Vial with Blue cap

Temp Storage: 15-25 C / Load: 15-25C
[D]

Master Mix (MMX)
Small Bottle with black cap

Vial with Yellow cap
9
[E]

Kit 96, Volume 2*1 mL
Elution Buffer (EB)
Metal Ion (Mg/Mn)
Small Bottle
Vial with Green cap
10

[C]
[D]
[C]
Vial with Red cap

Kit 96, Volume 2*1.2 mL

[B]
2
[B]
[B]
Vial with Transparent cap
Temp.Storage: 2-8 C / Load: 15-25C
[E]

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
Roche
cobas 4800 system
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: PreservCytyMedium
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
S11TestRunHPV
S11TestRunHPVs
S22TestRunHPV
S22TestRunHPVx
S33estRunHPV
S33TestRunHPV}
S44TestRunHPV
S44TestRunHPV
S55TestRunHPV
S55TestRunHPV
S66TestRunHPV
S66TestRunHPV%
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
Roche
cobas 4800 system
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

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
Test Run HPV

Roche
cobas 4800 system
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

1.
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.
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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Roche
cobas 4800 system
Test Run HPV

14
14.4

1.
2.
3.
Scan Barcode on Reagent Bottle (SDS Reagent)
4.
5.
6.
Place the Reagent Reservoir 50 mL on the Reagent Carrier pos 2

1.
2.
3.
Scan Barcode on Reagent Bottle (Lysis Buffer)
4.
5.
6.

1.
2.
3.
Scan Barcode on Reagent Bottle (Magnetic Glass Particles MGP)
4.
5.
6.

1.
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
Test Run HPV

Roche
cobas 4800 system
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
Installation Manual
Roche
cobas 4800 system
Test Run HPV

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 Operators 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
Test Run HPV

Roche
cobas 4800 system
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
Roche
cobas 4800 system
Completion of Installation
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
Roche
cobas 4800 system
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
Roche
cobas 4800 system
Appendix
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 its 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
Installation Manual
Version 1.1.2
Page 153 of 175
16
16.2
Appendix
Roche
cobas 4800 system
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.
Page 154 of 175
Version 1.1.2
Installation Manual
Roche
cobas 4800 system
Appendix
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 <C:\>
16
16.2
10. Press Y key to continue recovery

Ghost Recovery starts automatically and indicates progress. It takes approx. 5 minutes.
Installation Manual
Version 1.1.2
Page 155 of 175
16
16.2
Appendix
Roche
cobas 4800 system
11. After successful completion, the green Restore System Disk window is displayed again.
12. Press key no 3 for Full Recovery Backup Disk <D:\>
13. Press Y key to continue recovery

Ghost Recovery starts automatically and indicates progress. It takes approx. 10 seconds.
Page 156 of 175
Version 1.1.2
Installation Manual
Roche
cobas 4800 system
Appendix
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.
Installation Manual
Version 1.1.2
Page 157 of 175
16
16.2
Appendix
Roche
cobas 4800 system
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.
Page 158 of 175
Version 1.1.2
Installation Manual
Roche
cobas 4800 system
Appendix
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.
Installation Manual
Version 1.1.2
Page 159 of 175
16
16.3
Appendix
Network Overview
Roche
cobas 4800 system
16.3. Network Overview
Page 160 of 175
Version 1.1.2
Installation Manual
Roche
cobas 4800 system
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
Installation Manual
Version 1.1.2
Page 161 of 175
16
16.6
Appendix
Installation Check List cobas x 480 instrument
Roche
cobas 4800 system
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
Page 162 of 175
Version 1.1.2
Installation Manual
Roche
cobas 4800 system
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
S111TestRunHPV
S111TestRunHPVi
S112TestRunHPV
S112TestRunHPVm
S113TestRunHPV
S113TestRunHPVq
S114TestRunHPV
S114TestRunHPVu
S115TestRunHPV
S115TestRunHPVy
S116TestRunHPV
S116TestRunHPV}
S117TestRunHPV
S117TestRunHPV
S118TestRunHPV
S118TestRunHPV
S119TestRunHPV
S119TestRunHPV"
10
S120TestRunHPV
S120TestRunHPVh
Installation Manual
Version 1.1.2
Page 163 of 175
16
16.7
Appendix
Roche
cobas 4800 system
16.7.2. Reagent Loading Set #1

Rack 1
Item #
1
REAG
Barcode Information
Test Barcode
Washbuffer (WB)
0S0**5BZ*'
0S0101021BZ1000
Container 200 mL
CONS
Page 164 of 175
5`&!BZ1Hf
5640601BZ10040
Version 1.1.2
Installation Manual
Roche
cobas 4800 system
Appendix
16
16.7
Rack 2
Item #
2
Barcode Information
Test Barcode
SDS Reagent
0SA**5BZ*!g
Kit 24, Volume 3mL

REAG
Container 50mL
CONS
0SA101021BZ1001
5`&"BZ1"=
5640602BZ10200
Lysis (LYS)
Kit 24, Volume 10mL

Storage:15-25 C / Load:15-25C
REAG
Container 50mL
CONS
0S6**5BZ*"S
0S6101021BZ1002
5`&"BZ1"!I
5640602BZ10201
REAG
Kit 24, Volume 4.5mL (vortex)

Container 50mL
CONS
5
REAG
0S2101021BZ1003
5`&"BZ1""U
5640602BZ10202
Elution Buffer (EB)

Kit 24, Volume 18mL
Container 50mL
CONS
Installation Manual
0S2**5BZ*#T
0S4**5BZ*$g
0S4101021BZ1004
5`&"BZ1"#a
5640602BZ10203
Version 1.1.2
Page 165 of 175
16
16.7
Appendix
Roche
cobas 4800 system
Rack 3
Item #
10
Page 166 of 175
Barcode Information
Test Barcode
Proteinase K (PK)
Kit 24, Volume 0.9mL
0S8**5BZ*%
0S8101021BZ1005

2H1**5BZ*&d
2H1101021BZ1006

0NC**5BZ*'J
0NC101021BZ1007
Master Mix (MMX)

Storage:2-8 C / Load: 2-8C
2H4**5BZ*(
2H4101021BZ1008
Metal Ion (Mn/Mg)

2H3**5BZ*)*
2H3101021BZ1009
Version 1.1.2
Installation Manual
Roche
cobas 4800 system
Appendix
16
16.7

Pos
Barcode Information
Test Barcode
S121TestRunHPV
S121TestRunHPVl
S122TestRunHPV
S122TestRunHPVp
S123estRunHPV
S123TestRunHPVt
S124TestRunHPV
S124TestRunHPVx
S125TestRunHPV
S125TestRunHPV|
S126TestRunHPV
S126TestRunHPV
S127TestRunHPV
S127TestRunHPV
S128TestRunHPV
S128TestRunHPV!
S129TestRunHPV
S129TestRunHPV%
10
S130TestRunHPV
S130TestRunHPVk
Installation Manual
Version 1.1.2
Page 167 of 175
16
16.7
Appendix
Roche
cobas 4800 system

Rack 1
Item #
1
REAG
Barcode Information
Test Barcode
Washbuffer (WB)
Kit 24, Volume 55mL
0S0**5BZ**B
0S0101021BZ1010
Container 200mL
CONS
Page 168 of 175
5`&!BZ1Ir
5640601BZ10041
Version 1.1.2
Installation Manual
Roche
cobas 4800 system
Appendix
16
16.7
Rack 2
Item #
2
Barcode Information
Test Barcode
SDS Reagent
0SA**5BZ*+
Kit 24, Volume 3mL

REAG
Container 50mL
CONS
0SA101021BZ1011
5`&"BZ1"$m
5640602BZ10204
Lysis (LYS)
Kit 24, Volume 10mL

REAG
Container 50mL
CONS
0S6**5BZ*,n
0S6101021BZ1012
5`&"BZ1"%y
5640602BZ10205
REAG

Container 50mL
CONS
5
REAG
0S2101021BZ1013
5`&"BZ1"&
5640602BZ10206
Elution Buffer (EB)

Kit 24, Volume 18mL
Container 50mL
CONS
Installation Manual
0S2**5BZ*-o
0S4**5BZ*.
0S4101021BZ1014
5`&"BZ1"'*
5640602BZ10207
Version 1.1.2
Page 169 of 175
16
16.7
Appendix
Roche
cobas 4800 system
Rack 3
Item #
10
Page 170 of 175
Barcode Information
Test Barcode
Proteinase K (PK)
0S8**5BZ*/4
0S8101021BZ1015

2H1**5BZ*0
2H1101021BZ1016

0NC**5BZ*1e
0NC101021BZ1017
Master Mix (MMX)

2H4**5BZ*2;
2H4101021BZ1018
Metal Ion (Mn/Mg)

2H3**5BZ*3E
2H3101021BZ1019
Version 1.1.2
Installation Manual
Roche
cobas 4800 system
Appendix
16
16.7

Pos
Barcode Information
Test Barcode
S131TestRunHPV
S131TestRunHPVo
S132TestRunHPV
S132TestRunHPVs
S133estRunHPV
S133TestRunHPVw
S134TestRunHPV
S134TestRunHPV{
S135TestRunHPV
S135TestRunHPV
S136TestRunHPV
S136TestRunHPV
S137TestRunHPV
S137TestRunHPV
S138TestRunHPV
S138TestRunHPV$
S139TestRunHPV
S139TestRunHPV(
10
S140TestRunHPV
S140TestRunHPVn
Installation Manual
Version 1.1.2
Page 171 of 175
16
16.7
Appendix
Roche
cobas 4800 system

Rack 1
Item #
1
REAG
Barcode Information
Test Barcode
Washbuffer (WB)
Kit 24, Volume 55mL
0S0**5BZ*4]
0S0101021BZ1020
Container 200mL
CONS
Page 172 of 175
5`&!BZ1J~
5640601BZ10042
Version 1.1.2
Installation Manual
Roche
cobas 4800 system
Appendix
16
16.7
Rack 2
Item #
2
Barcode Information
Test Barcode
SDS Reagent
0SA**5BZ*56
Kit 24, Volume 3mL

REAG
Container 50mL
CONS
0SA101021BZ1021
5`&"BZ1"(6
5640602BZ10208
Lysis (LYS)
Kit 24, Volume 10mL

REAG
Container 50mL
CONS
0S6**5BZ*6"
0S6101021BZ1022
5`&"BZ1")B
5640602BZ10209
REAG

Container 50mL
CONS
5
REAG
0S2101021BZ1023
5`&"BZ1"*N
5640602BZ10210
Elution Buffer (EB)

Kit 24, Volume 18mL
Container 50mL
CONS
Installation Manual
0S2**5BZ*7#
0S4**5BZ*86
0S4101021BZ1024
5`&"BZ1"+Z
5640602BZ10211
Version 1.1.2
Page 173 of 175
16
16.7
Appendix
Roche
cobas 4800 system
Rack 3
Item #
10
Page 174 of 175
Barcode Information
Test Barcode
Proteinase K (PK)
0S8**5BZ*9O
0S8101021BZ1025

2H1**5BZ*:3
2H1101021BZ1026

0NC**5BZ*;
0NC101021BZ1027
Master Mix (MMX)

2H4**5BZ*<V
2H4101021BZ1028
Metal Ion (Mn/Mg)

2H3**5BZ*=`
2H3101021BZ1029
Version 1.1.2
Installation Manual
Roche
cobas 4800 system
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 Operator

Password
Type
Oprcobas48000709
User name Labmanager

Password
00labMGR
16.8.3. Admin Access Information

Software
Log in Information
User name Operator

Password
Type
Oprcobas48000709
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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Manual Cobas 4800

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cobas 4800 system

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

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

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

1.16.1. Documentation ........................................................................................................................................................ 18

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

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

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

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

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

4.8. cobas 4800 Work Order Editor Installation .................................................................................................................. 47

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

4.10.1. Service Software cobas x 480 instrument...................................................................................................... 50

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

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

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

4.13.1. cobas 4800 software log file folder................................................................................................................ 54

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

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

4.15.1. Create a folder to save Work Orders ............................................................................................................... 59

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

4.16.1. Start Menu (OPERATOR) ..................................................................................................................................... 65

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

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

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

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

5. Upgrade Installation Restore Database...................................................................................................... 74

6.4. Installation PART 2 .................................................................................................................................................................. 81

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

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

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

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

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

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

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

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

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

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

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

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

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

10.2.1. Network address configuration of cobas IT firewall ................................................................................105

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

13.3.1. Requirement ...........................................................................................................................................................132

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

13.4.1. Instrument ...............................................................................................................................................................133

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

13.5.1. Load Samples.........................................................................................................................................................135

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

14.2.1. Required Consumables ......................................................................................................................................142