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

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

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


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

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

9.2.2.

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

9.2.3.

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

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


9.3.1.

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

9.3.2.

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

9.3.3.

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

9.3.4.

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

9.3.5.

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

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


9.4.1.

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

9.4.2.

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

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


10.1.

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

10.2.

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

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


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

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

10.4.

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

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


11.1.

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

11.2.

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

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cobas 4800 system
11.3.

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

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


11.4.

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

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


12.1.

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

12.2.

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

12.3.

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

12.4.

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

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


13.1.

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

13.2.

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

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


13.3.

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

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


13.3.2. Tube Preparation...................................................................................................................................................132
13.4.

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

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


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

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

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


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

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

14.2.

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

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


14.2.2. Tube Preparation...................................................................................................................................................142
14.3.

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

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


14.4.

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

14.4.1. Load Samples.........................................................................................................................................................145


14.4.2. Load Consumables...............................................................................................................................................146
14.4.3. Load Reagent Reservoir Carrier 1-4 ..............................................................................................................146
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cobas 4800 system
14.4.4. Load Reagent Reservoir Carrier 2-2 ..............................................................................................................147
14.4.5. Load Reagent Reservoir Carrier 2-3 ..............................................................................................................147
14.4.6. Load Reagent Reservoir Carrier 2-4 ..............................................................................................................147
14.4.7. Load Reagent Reservoir Carrier 2-5 ..............................................................................................................147
14.4.8. Load Reagent Vials Carrier 3-15,18,19, 23, 24 ...........................................................................................148
14.4.9. End of Sample Preparation................................................................................................................................149
14.4.10. Amplification and Detection .............................................................................................................................149
14.4.11. Control Curve Analysis........................................................................................................................................150
14.4.12. Finalize HPV Run...................................................................................................................................................150
14.4.13. Clean up...................................................................................................................................................................150
15. Completion of Installation............................................................................................................................151
16. Appendix..........................................................................................................................................................152
16.1.

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

16.2.

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

16.3.

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

16.4.

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

16.5.

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

16.6.

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

16.7.

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

16.7.1. Sample Loading Set #1 ......................................................................................................................................163


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

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

16.8.1. Lab Operator Access Information...................................................................................................................175


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

Installation Manual

Version 1.1.2

Page 7 of 175

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

Page 9 of 175

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

Page 11 of 175

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.

Page 12 of 175

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

Page 13 of 175

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.

Page 14 of 175

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

Page 15 of 175

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

GRIPS > cobas z 480 > Installation


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

GRIPS > cobas z 480 > Installation


Manual

File: Cobas4800WorkorderEditor.exe.config.zip

N/A

GRIPS > cobas z 480 > Installation


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


Please refer to Ordering List cobas 4800 system available on GRIPS

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


Please refer to Ordering List cobas 4800 system available on GRIPS

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

1.16.6. Service Tools


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

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

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Version 1.1.2

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cobas 4800 system
3.

Upgrade from version 1.0.x to 1.1.0


Backup Database

2
2.2

Type the password for User system, Password: 4evZ352G5LRuP_a

Do not change destination folder


4.

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

5.

Wait for the following prompt for user QUARTZ


Export Terminated successfully without Warnings

6.

Press Exit

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

Installation Manual

Version 1.1.2

Page 21 of 175

2
2.3

Upgrade from version 1.0.x to 1.1.0


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
cobas 4800 control unit

3.4. Installation cobas 4800 control unit


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

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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

SW Installation control unit


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.

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

3.

Press & hold Shift key to interrupt auto log on

4.

Log on as user: Install, PW: Instcobas48000709


For more passwords please refer to User Access Information for cobas 4800 system available
on GRIPS

5.

Navigate to Start > Settings > Control Panel > System

6.

Open (click on) System, tab General

7.

Verify details under Computer: cobas 4800 rp5700, Image 1.0.0


Click OK

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

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Version 1.1.2

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Roche
cobas 4800 system

SW Installation control unit


Windows Time and Date Adjustments

4
4.4

4.4. Windows Time and Date Adjustments


1.

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

2.

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

Installation Manual

Version 1.1.2

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4
4.5

SW Installation control unit


cobas 4800 software installation

Roche
cobas 4800 system

4.5. cobas 4800 software installation


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 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.

SW Installation control unit


cobas 4800 software installation

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

SW Installation control unit


cobas 4800 software installation

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

SW Installation control unit


cobas 4800 software installation

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

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4.5

SW Installation control unit


cobas 4800 software installation

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

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cobas 4800 system

SW Installation control unit


cobas 4800 software installation

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

SW Installation control unit


cobas 4800 software installation

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

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cobas 4800 system

SW Installation control unit


cobas 4800 software installation

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

SW Installation control unit


cobas 4800 oracle DB installation

Roche
cobas 4800 system

4.6. cobas 4800 oracle DB installation


1.

Browse to CD drive E:\

2.

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

3.

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

4.

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

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

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cobas 4800 system

SW Installation control unit


cobas 4800 oracle DB installation

4
4.6

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


press ENTER followed by F6, ENTER

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


press ENTER followed by F6, ENTER

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


press ENTER followed by F6, ENTER

Installation Manual

Version 1.1.2

Page 37 of 175

4
4.6

SW Installation control unit


cobas 4800 oracle DB installation

Roche
cobas 4800 system

13. Verify Connect to INT_SETUP, is displayed, then enter PW: S23WaZe66k


press ENTER followed by F6, ENTER

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


press ENTER followed by F6, ENTER

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

Page 38 of 175

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cobas 4800 system

SW Installation control unit


cobas 4800 oracle DB installation

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

SW Installation control unit


cobas 4800 oracle DB installation

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

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cobas 4800 system

SW Installation control unit


cobas 4800 software configuration

4
4.7

4.7. cobas 4800 software configuration


4.7.1.

cobas 4800 software start-up

1.

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

2.

Initial start of cobas 4800 software takes approx. 30 seconds


If now an error message appears (after starting cobas 4800 software)
go back and rerun the Instal_ALL.cmd and Migration Tool

3.

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

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

Installation Manual

Version 1.1.2

Page 41 of 175

4
4.7

SW Installation control unit


cobas 4800 software configuration

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

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cobas 4800 system

4.7.3.
1.

SW Installation control unit


cobas 4800 software configuration

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

SW Installation control unit


cobas 4800 software configuration

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
Press & hold Shift key to interrupt auto log on
Log on as user Install, PW: Instcobas48000709

2.

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

3.

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

Page 44 of 175

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cobas 4800 system
4.

SW Installation control unit


cobas 4800 software configuration

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

SW Installation control unit


cobas 4800 software configuration

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

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cobas 4800 system

SW Installation control unit


cobas 4800 Work Order Editor Installation

4
4.8

4.8. cobas 4800 Work Order Editor Installation


1.

Insert CD cobas 4800 software

2.

Browse to CD DRIVE E:\3_WorkOrderEditor_V1.1.0.1016


Run file (double-click) Setup_cobas_4800_WOE_v1.1.0.1016.exe

3.

Click Next.

4.

Click Next

Installation Manual

Version 1.1.2

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4
4.8

SW Installation control unit


cobas 4800 Work Order Editor Installation

5.

Click Install

6.

Click Finish

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cobas 4800 system

Installation Manual

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cobas 4800 system

SW Installation control unit


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

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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

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4
4.11

4.10.3. Macro cobas x 480 instrument


1.

Browse to CD Drive E:\ Macros Service SW 4.3.0.450 and higher\


Select and copy the folder STARline (CTRL+C)

2.

Browse to C:\Program Files\HAMILTON\STARService\Macros


Press CTRL+V keys to paste the folder STARline

3.

Remove CD

4.11. cobas x 480 instrument driver installation


1.

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

2.

Connect the power cable (2) according image below


Do not use back channel of instrument for power cables

3.

Power up cobas x 480 instrument

Please see connectors overview of control unit in chapter


3.4 Installation cobas 4800 control unit, page 24

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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

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cobas z 480 analyzer Service Software Installation

6.

On the next screen click Install

7.

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

8.

Close all windows.

9.

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

4
4.12

10. Press Eject CD button and remove the CD

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User permission modification

Roche
cobas 4800 system

User permission modification


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

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

2.

Press WIN+E keys to open explorer

3.

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

4.

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

5.

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

6.

Click YES to confirm, followed by OK

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4.13

4.13.2. Remove permissions for folder Roche_x480_ConfigFiles


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

Browse to C:\Program Files\HAMILTON\Config

2.

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

3.

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

4.

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

5.

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

6.

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

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User permission modification

Roche
cobas 4800 system

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.

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

4.

Wait to be logged on automatically as user Operator

5.

Switch OFF the cobas x 480 instrument

6.

Start cobas_4800_V1.1.0.1036 software


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

7.

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


Click OK to confirm Log on

8.

Wait for the following error messages:


Processing on cobas x 480 was aborted by the instrument
Error on cobas x 480

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

Exit cobas_4800_V1.1.0.1036 software

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Workaround Start Menu & Shortcuts

Roche
cobas 4800 system

10. Press CTRL+ALT+DEL keys


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

19. Click Apply to take over the changes


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

21. Browse to C:\Documents and Settings\All Users\Start Menu\Programs\HAMILTON


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

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4.15

SHIFT+DEL to delete permanently. Press Delete Shortcut to confirm.


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

4.15. Windows Start Menu & Shortcuts


4.15.1. Create a folder to save Work Orders
1.

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

2.

Wait to be logged on automatically as Operator

3.

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

4.

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

5.

Press CTRL+ALT+DEL keys


Click on Log Off and click Log Off to confirm
Press & hold Shift key to interrupt auto log on
Log on as user Install, PW: Instcobas48000709

6.

Open windows explorer (Win+E)

7.

Browse to C:\Documents and Settings\OPERATOR\My Documents (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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cobas 4800 system

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

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

4.15.2. Relocate folder Microlab Star Service


1.

Browse to C:\Documents and Settings\All Users\Start Menu\Programs\HAMILTON


Select folder Microlab STAR Service and then press CTRL+X keys to cut the folder

2.

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


Create a new folder (Menu: File > New > Folder) named HAMILTON

3.

Open the folder HAMILTON


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

4.

Browse to C:\Documents and Settings\Install\Start Menu\Programs\Hamilton\Microlab STAR Service


Select program icon Microlab STAR Service and then press CTRL+C to copy

5.

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


Press CTRL+V keys to paste the program icon Microlab STAR Service
This creates the entries in Start Menu. See chapter 4.16.4, page 68

6.

Browse to C:\Documents and Settings\All Users\Start Menu\Programs\Hamilton\Microlab STAR


Press CTRL+C keys to copy both program icons STAR Method Editor and Microlab STAR
Maintenance & Verification

7.

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


Press CTRL+V keys to paste both program icons STAR Method Editor and Microlab STAR
Maintenance & Verification

8.

Close all windows

9.

Press Eject CD button and remove the CD

4.15.3. Relocate folder Roche


1.

Browse to C:\Documents and Settings\All Users\Start Menu\Programs


Select folder Roche and then press CTRL+X keys to cut the folder

2.

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

3.

Press CTRL+V keys to paste the folder Roche

4.

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


Select program icon LightCycler 480 - z 480 and then press CTRL+C keys to copy

5.

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


Press CTRL+V keys to insert the program icon
This creates the entries in Start Menu. See chapter 4.16.4, page 68

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4.15.4. FSE Reports (OPERATOR)


1.

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

2.

Wait to be logged on automatically as user Operator

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.

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


Click OK to confirm Log on

5.

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

6.

Exit cobas_4800_V1.1.0.1036 software

7.

Press CTRL+ALT+DEL keys


Click on Log Off and click Log Off to confirm
Press & hold Shift key to interrupt auto log on
Log on as user Install, PW: Instcobas48000709

8.

Press WIN+E keys to open explorer

9.

Browse to C:\Documents and Settings\OPERATOR\Application Data\Roche


Diagnostics\cobas_4800_V1.1.0.1036

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

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Windows Start Menu & Shortcuts

Roche
cobas 4800 system

4.15.5. FSE Reports (INSTALL)


1.

Switch ON cobas x 480 instrument

2.

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

3.

Start cobas_4800_V1.1.0.1036 software


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

4.

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


Click OK to confirm Log on

5.

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

6.

Browse to C:\Documents and Settings\INSTALL\Application Data\Roche


Diagnostics\cobas_4800_V1.1.0.1036

7.

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

8.

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

9.

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

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

4.15.6. Remove uninstall cobas_4800_V1.1.0.1036


1.

Browse to C:\Documents and Settings\All Users\Start Menu\Programs


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

2.

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


Press CTRL+V keys to paste the folder cobas_4800_V1.1.0.1036

3.

Browse to C:\Documents and Settings\Install\Start Menu\Programs\cobas_4800_V1.1.0.1036


Press CTRL+X to cut program icon cobas_4800_V1.1.0.1036

4.

Browse to C:\Documents and Settings\All Users\Start Menu


Press CTRL+V to paste program icon cobas_4800_V1.1.0.1036

5.

Browse to C:\Documents and Settings\All Users\Start Menu\Programs\cobas_4800_V1.1.0.1036


Select folder Documentation and then press SHIFT+DEL to delete permanently
Select folder Tools and then press SHIFT+DEL to delete permanently
Select icon Uninstall cobas_4800_V1.1.0.1036 and then press SHIFT+DEL to delete permanently

6.

Browse to C:\Documents and Settings\Install\Start Menu\Programs\cobas_4800_V1.1.0.1036


Select icon Uninstall cobas_4800_V1.1.0.1036 and then press SHIFT+DEL to delete permanently.

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4.15

4.15.7. Remove uninstall cobas 4800 Work Order Editor


1.

Browse to C:\Documents and Settings\All Users\Start Menu\Programs


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

2.

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


Press CTRL+V keys to paste the folder cobas 4800 Work Order Editor v1.1.0.1016

3.

Browse to C:\Documents and Settings\Install\Start Menu\Programs\cobas 4800 Work Order


Editor v1.1.0.1016
Press CTRL+X keys to cut the program icon cobas 4800 Work Order Editor v1.1.0.1016

4.

Browse to C:\Documents and Settings\All Users\Start Menu


Press CTRL+V to paste program icon cobas 4800 Work Order Editor v1.1.0.1016

5.

Browse to C:\Documents and Settings\All Users\Start Menu\Programs\cobas 4800 Work Order


Editor
Select program icon Uninstall cobas 4800 Work Order Editor v1.1.0.1016 and then press SHIFT+DEL
to delete permanently

6.

Browse to C:\Documents and Settings\Install\Start Menu\Programs\cobas 4800 Work Order Editor


Select program icon Uninstall cobas 4800 Work Order Editor v1.1.0.1016 and then press SHIFT+DEL
to delete permanently.

4.15.8. Shortcut to cobas 4800 Log Files


1.

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


Select the folder Log, select form the context menu Create Shortcut

2.

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

3.

Select and Press CTRL+X keys to cut the shortcut

4.

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


Press CTRL+V keys to paste shortcut cobas 4800 LogFiles

4.15.9. Shortcut to Hamilton Log Files


1.

Browse to C:\Program Files\Hamilton


Select the folder LogFiles, select form the context menu Create Shortcut

2.

Press F2 key to rename Shortcut as Hamilton LogFiles

3.

Select and Press CTRL+X keys to cut the shortcut

4.

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


Press CTRL+V keys to paste shortcut Hamilton LogFiles

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Windows Start Menu & Shortcuts

Roche
cobas 4800 system

4.15.10. Shortcut to Balance Config file IVDVolVer.ini


1.

Browse to C:\Program Files\HAMILTON\Config


Right-click on the file IVDVolVer.ini select form the context menu Create Shortcut

2.

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

3.

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

4.

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


Press CTRL+V keys to paste the shortcut Balance Configurator IVDVolVer.ini

4.15.11. Shortcut to cmd.exe


1.

Browse to C:\WINDOWS\system32

2.

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

3.

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

4.

Press CTRL+X keys to cut the shortcut

5.

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

6.

Press CTRL+V keys to paste the shortcut cmd.exe


This creates the entries in Start Menu. See chapter 4.16.4 on page 68

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4.16

4.16. Window Menu Verification


4.16.1. Start Menu (OPERATOR)
1.

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

2.

Wait to be logged on automatically as 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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Window Menu Verification

Roche
cobas 4800 system

4.16.2. Programs Menu (OPERATOR)


1.

Navigate to Start > Programs

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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Version 1.1.2

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Window Menu Verification

Roche
cobas 4800 system

4.16.4. Start Menu (INSTALL)


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

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.

Navigate to Start > Programs


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

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

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4.16

4.16.5. Programs Menu (INSTALL)


1.

Navigate to Start > Programs

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

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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

Page 70 of 175

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cobas 4800 system

SW Installation control unit


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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Version 1.1.2

Page 71 of 175

4
4.19

SW Installation control unit


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

Page 72 of 175

Version 1.1.2

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Roche
cobas 4800 system

SW Installation control unit


LabNET settings for Printer/ Firewall

4
4.20

4.20. LabNET settings for Printer/ Firewall


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

Navigate to Start > Settings > Network Connections > LabNET


Click on Properties

2.

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

3.

Change the IP Address accordingly


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

Installation Manual

Version 1.1.2

Page 73 of 175

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.

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

5.2. Restore Database


1.

Browse to D:\Archive

2.

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

3.

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

4.

Browse to storage device F:\


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

5.

Browse to D:\Archive\MTS-Backup

6.

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

7.

Browse to C:\Oracle\Dump

8.

Run file (double-click) restore.cmd

9.

Type the password for oracle user SYSTEM, PW: 4evZ352G5LRuP_a


Do not change destination folder

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

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Upgrade Installation Restore Database


Restore Database

5
5.2

11. Wait for the following prompt for user QUARTZ:


Import terminated successfully without warnings.

12. Press Exit


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

14. Press Exit


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

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Version 1.1.2

Page 75 of 175

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.

Page 76 of 175

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cobas 4800 system

cobas x 480 instrument Installation


Stationary Carrier and Heater/Shaker Unit

6.

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

7.

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

8.

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

9.

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

6
6.1

Please see connectors overview of control unit in chapter


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

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

Installation Manual

Version 1.1.2

Page 77 of 175

6
6.2

cobas x 480 instrument Installation


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)

Page 78 of 175

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cobas 4800 system

cobas x 480 instrument Installation


Liquid Waste Installation Procedure

6.

Attach the Floating sensor Flange to the liquid waste container

7.

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

8.

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

9.

Stow the remaining cable in the cable channel.

6
6.2

10. Neatly fix the cable to the tube by using Velcro strip or cable tie
11. Install the Tip Eject Plate according 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

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Version 1.1.2

Page 79 of 175

6
6.3

cobas x 480 instrument Installation


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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cobas 4800 system

6.3.1.

cobas x 480 instrument Installation


Installation PART 2

6
6.4

Update Firmware

1.

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

2.

Navigate to the (a) Folder with download files


C:\Program Files\HAMILTON\STARService\Firmware\5.6

3.

Click to select (b) instrument controller which needs to be reprogrammed ;


(Pipetting channel PX = Channel 1- 8)

4.

Select the correct version in section (c)

5.

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

6.

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

7.

Reboot the control unit

8.

Power OFF the instrument for 10 seconds, the Power ON

6.4. Installation PART 2


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

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 see connectors overview of control unit in chapter
3.4 Installation cobas 4800 control unit, page 24
Please refer to Installation Manual cobas z 480 analyzer.
GRIPS > System Search > Molecular Diagnostics > cobas 4800 > cobas z 480 > Installation Manual

7.1. Firmware Verification


1.

Switch ON the cobas z 480 analyzer

2.

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

3.

Navigate to Instrument > Configuration


In the section Instrument Information, verify for the correct IC-version 1.5.4.09.01

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

Page 82 of 175

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

8.2. Scanner Programming


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

Information

Program Barcode

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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cobas 4800 system
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

Handheld Barcode Scanner


Scanner Programming

Version 1.1.2

8
8.2

Page 85 of 175

8
8.3

Handheld Barcode Scanner


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

Version 1.1.2

Installation Manual

Roche
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)

cobas 4800 control unit


(LabNet)

IP Address

172.20.1.100

172.20.1.140

Subnet Mask

255.255.255.0

255.255.255.0

172.20.1.1

172.20.1.1

Gateway

9.1. Physical Connection


1.

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

2.

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

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

Installation Manual

Version 1.1.2

Page 87 of 175

9
9.2

LIS Interface Installation


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

Page 88 of 175

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cobas 4800 system

LIS Interface Installation


Network Connection

6.

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

7.

Close all windows

9.2.2.

9
9.2

Network Address of cobas 4800 control unit

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

9.2.3.

Check Network Communication

1.

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

2.

Start cmd.exe (start>startmenu)

3.

Enter ping 172.20.1.100 and press Enter

Check for the following message:


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

Installation Manual

Version 1.1.2

Page 89 of 175

9
9.3

LIS Interface Installation


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.

Press Win+E keys to open explorer

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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cobas 4800 system
8.

Choose setup type Typical

9.

Click Install

Installation Manual

LIS Interface Installation


Application Software Connection

Version 1.1.2

9
9.3

Page 91 of 175

9
9.3

LIS Interface Installation


Application Software Connection

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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cobas 4800 system

9.3.2.

LIS Interface Installation


Application Software Connection

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

LIS Interface Installation


Application Software Connection

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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cobas 4800 system
5.

Click on Install button.

6.

Click Continue

7.

Click Ok.

9.3.4.

LIS Interface Installation


Application Software Connection

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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Version 1.1.2

Page 95 of 175

9
9.3

LIS Interface Installation


Application Software Connection

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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cobas 4800 system
9.

LIS Interface Installation


Application Software Connection

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

LIS Interface Installation


Application Software Connection

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

Version 1.1.2

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Roche
cobas 4800 system

9.3.5.

LIS Interface Installation


Application Software Connection

9
9.3

cobas 4800 software LIS configuration

1.

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

2.

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

3.

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

Installation Manual

Version 1.1.2

Page 99 of 175

9
9.4

LIS Interface Installation


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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cobas 4800 system
4.

LIS Interface Installation


Testing Communication Scenarios

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

Installation Manual

Version 1.1.2

Page 101 of 175

9
9.4

LIS Interface Installation


Testing Communication Scenarios

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.

Page 102 of 175

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cobas 4800 system

LIS Interface Installation


Testing Communication Scenarios

3.

Prepare a database record as follow:


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

4.

Go to the cobas 4800 control unit.

5.

Start cobas_4800_V1.1.0.1036 software

6.

Log on as user FSE, PW: 00rocheSRVC

7.

Press the button New Run in the right, top corner

8.

Select Test type HPV Workflow

9.

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

9
9.4

10. Click Load Samples at right bottom corner.


11. Now the cobas 4800 system request an order at the host computer and the communication can be
seen in the communication trace window.

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10
10.1

LIS Interface Configuration with cobas IT firewall


Physical Connection

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.
Please see connectors overview of control unit in chapter
3.4 unit, page 24

2.

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

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

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cobas 4800 system

LIS Interface Configuration with cobas IT firewall


Network Connection

10
10.2

10.2. Network Connection


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

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

2.

Simultaneously plug in the power jack into the power socket.

3.

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

4.

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

Connect a computer (COE client) to the orange port


1.

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

2.

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

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10
10.2
3.

LIS Interface Configuration with cobas IT firewall


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

LIS Interface Configuration with cobas IT firewall


Network Connection

Version 1.1.2

10
10.2

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10
10.2

LIS Interface Configuration with cobas IT firewall


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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cobas 4800 system
7.

Click Next

8.

Select cobas 4800 and click Next

Installation Manual

LIS Interface Configuration with cobas IT firewall


Network Connection

Version 1.1.2

10
10.2

Page 109 of 175

10
10.2
9.

LIS Interface Configuration with cobas IT firewall


Network Connection

Roche
cobas 4800 system

Click Next

10. Enter LIS IP address 10.0.0.20 and port 5555

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cobas 4800 system

LIS Interface Configuration with cobas IT firewall


Network Connection

10
10.2

11. Click Next

12. Click Next

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10.2

LIS Interface Configuration with cobas IT firewall


Network Connection

Roche
cobas 4800 system

13. Enter and confirm Password: 123456

14. Click Next

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cobas 4800 system

LIS Interface Configuration with cobas IT firewall


Network Connection

10
10.2

15. Click Next

16. Close Networking Addressing Sheet window

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10.2

LIS Interface Configuration with cobas IT firewall


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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cobas 4800 system

LIS Interface Configuration with cobas IT firewall


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

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10
10.2

LIS Interface Configuration with cobas IT firewall


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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cobas 4800 system

LIS Interface Configuration with cobas IT firewall


Application Connection

10
10.3

Check for a reply of both ports


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

10.3. Application Connection


1.

Go to the cobas 4800 control unit

2.

Insert CD cobas 4800 1.1.0 Build 1042

3.

Press Win+E keys to open explorer

4.

Browse to E:\4_LIS_Interface

5.

Execute the file C4800Setup.msi.

6.

Click Next

7.

Click Change

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10.3

LIS Interface Configuration with cobas IT firewall


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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cobas 4800 system

LIS Interface Configuration with cobas IT firewall


Testing Communication Scenarios

10
10.4

12. Click OK

13. Click Finish

10.4. Testing Communication Scenarios


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

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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.

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cobas 4800 system

Change LIS Interface Configuration


Change Protocol

11
11.3

11.3. Change Protocol


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

11.3.1. Roche.MTS Transformer.exe settings


ASTM
Transformer Type value= ``ASTM``
Protocol value= ``ASTM``
Protocolversion value= ``1394.LIS2``

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Version 1.1.2

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11
11.4

Change LIS Interface Configuration


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

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

4.

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

5.

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

6.

On the control panel, press OK.

7.

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

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12
12.2

Printer Installation
Printer Driver Installation

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

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Printer Installation
Printer Driver Installation

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.

Printer Installation
Printer Driver Installation

Roche
cobas 4800 system

Click Finish

10. Click Have Disk

11. Insert manufacturers CD into CD Drive


Browse to CD Drive E:\, click OK

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Printer Installation
Printer Driver Installation

12
12.2

12. Verify the for the correct listed Printer


Press Next

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

14. Select Do not share this printer


Click Next

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12
12.2

Printer Installation
Printer Driver Installation

Roche
cobas 4800 system

15. Select Yes and then click Next

16. Click Continue Anyway

17. Click OK

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cobas 4800 system

Printer Installation
Set default printer for user OPERATOR

12
12.3

18. Click Finish. The printer is now installed.

19. Navigate to Start > Settings > Printer and Faxes


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

12.3. Set default printer for user OPERATOR


1.

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

2.

Wait to be logged on automatically as Operator

3.

Navigate to Start > Settings > Printer and Faxes


Right mouse click on the printer, Set as default printer

4.

Print a report out of cobas 4800 software

5.

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

6.

Press & hold Shift key to interrupt auto log on

7.

Log on as user Install, PW: Instcobas48000709

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12
12.4

Printer Installation
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.

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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.

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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

Reagent Reservoir 200ml

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).

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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.

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

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.

Navigate to Tools > SystemConfigurationEditor

4.

Select Microlab STAR IVD (ML_STAR) (a)


Click [-] TADM settings to display the settings (b)
In line TADM mode click to select Recording (c)

5.

Press CTRL+S to save changes

6.

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

7.

Press ALT+F4 keys to close HAMILTON System Configuration Editor

8.

Press ALT+F4 keys to close HAMILTON Method Editor

Installation Manual

Version 1.1.2

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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
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Water Run
New Run (WaterRun)

13
13.5

13.5. New Run (WaterRun)


13.5.1. Load Samples
1.

Start (Click) cobas_4800_V1.1.0.1036 software


Log on as user FSE, PW: 00rocheSRVC

2.

Press the button New Run in the right, top corner

3.

Click to select in section Test type HPV Workflow

4.

Type in section Run name Installation WaterRun

5.

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

6.

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

7.

In window Load Carrier Error click Barcode (a)

8.

Cursor is now in field Enter barcode (b)

9.

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

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

Installation Manual

to navigate to the created Workorder file

Version 1.1.2

Page 135 of 175

13
13.5

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.

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 35-40

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!

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cobas 4800 system

Water Run
New Run (WaterRun)

13
13.5

13.5.4. Load Reagent Reservoir Carrier 2-2


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.

Take a Reagent Reservoir 50 mL and scan it by the hand scanner

5.

Pour at least 3 mL Tap water into this container

6.

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


Item #

Barcode Information

Test Barcode

SDS Reagent

0SA+#"BZ2

Kit 24, Volume 3 mL


Storage: 15-25 C/ Load: 15-25C
Reagent Carrier 2-2, track 50

0SA110302BZ

13.5.5. Load Reagent Reservoir Carrier 2-3


1.

Take a small metal Reagent Carrier RGT_CAR5X50_X1

2.

Load the Reagent Carrier in track 50

3.

Scan the Reagent Barcode (Lysis Buffer) provided below

4.

Take a Reagent Reservoir 50 mL and scan it by the hand scanner

5.

Pour at least 10 mL tap water into this container

6.

Place the Reagent Reservoir 50ml on the Reagent Carrier pos 3


Item #

Barcode Information

Test Barcode

Lysis (LYS)
3

Kit 24, Volume 10 mL


Storage: 15-25 C / Load: 15-25C

0S6+#"BZx

Reagent Carrier 2-3, track 50

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.

Take a small metal Reagent Carrier RGT_CAR5X50_X1

2.

Load the Reagent Carrier in track 50

3.

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

4.

Take a Reagent Reservoir 50 mL and scan it by the hand scanner

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)


Storage: 2-8 C / Load: 15-25C
Reagent Carrier 2-4, track 50

0S2110302BZ

13.5.7. Load Reagent Carrier 2-5


1.

Take a small metal Reagent Carrier RGT_CAR5X50_X1

2.

Load the Reagent Carrier in track 50

3.

Scan the Reagent Barcode (Elution Buffer) provided below

4.

Take a Reagent Reservoir 50 mL and scan it by the hand scanner

5.

Pour at least 18 mL tap water into this container

6.

Place the Reagent Reservoir 50ml on the Reagent Carrier pos 5


Item #

Barcode Information

Test Barcode

Elution Buffer (EB)

0S4+#"BZr

Kit 24, Volume 18 mL


Storage: 2-8 C / Load: 15-25C
Reagent Carrier 2-5, track 50

7.

0S4110302BZ

Click Load Reagents at right bottom corner

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.

Load the Reagent Carrier in track 51

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


Storage: 15-25 C / Load: 15-25C
Reagent Carrier 3-15, track 51

Positive Control (PC+)


7

Kit 24, Volume 0.5 mL


Storage: 2-8 C / Load: 15-25C
Reagent Carrier 3-18, track 51

Negative Control (NC-)


8

Kit 24, Volume 0.5 mL


Storage: 2-8 C / Load: 15-25C
Reagent Carrier 3-19, track 51

Master Mix (MMX)


9

Kit 24, Volume 0.5 mL


Storage: 2-8 C / Load: 2-8C
Reagent Carrier 3-23, track 51

Metal Ion (Mn/Mg)


10

Kit 24, Volume 1.5 mL


Storage: 2-8 C / Load: 2-8C
Reagent Carrier 3-24, track 51

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.

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

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.

Navigate to Tools > SystemConfigurationEditor

4.

Select Microlab STAR IVD (ML_STAR) (a)


Click [-] TADM settings to display the settings (b)
In the line TADM mode click to select Monitoring (c)

5.

Press CTRL+S to save changes

6.

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

7.

Press ALT+F4 keys to close HAMILTON System Configuration Editor

8.

Press ALT+F4 keys to close HAMILTON Method Editor

9.

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

Installation Manual

Version 1.1.2

Page 141 of 175

14
14.1

Test Run HPV


Goal

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

Reagent Reservoir 50ml

05232732001

Reagent Reservoir 200ml

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

Kit 24, Volume 55 mL


Kit 96, Volume 200 mL

[A]

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

SDS Reagent

Positive Control (PC+)

Small Bottle

Temp Storage: 15-25 C/ Load: 15-25C

Kit 96, Volume 0.5 mL


Temp. Storage: 2-8 C / Load: 15-25C
Reagent Carrier 3-18, track 51

Lysis (LYS)

Negative Control (NC-)

Small Bottle

Vial with Blue cap

Kit 24, Volume 10 mL


Temp Storage: 15-25 C / Load: 15-25C

[D]

Kit 24, Volume 0.5 mL


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

Reagent Carrier 2-3, track 50

Reagent Carrier 3-19, track 51

Magnetic Glass Particle (MGP)

Master Mix (MMX)

Small Bottle with black cap


Kit 24, Volume 4.5 mL (vortex)
Kit 96, Volume 13.5 mL (vortex)
Temp. Storage: 2-8 C / Load: 15-25C

Vial with Yellow cap

9
[E]

Kit 24, Volume 0.5 mL


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

Reagent Carrier 2-4, track 50

Reagent Carrier 3-23, track 51

Elution Buffer (EB)

Metal Ion (Mg/Mn)

Small Bottle

Vial with Green cap

10

Kit 24, Volume 18 mL


Kit 96, Volume 18 mL

[C]

[D]

Reagent Carrier 2-2, track 50

Kit 96, Volume 36 mL

[C]

Vial with Red cap


Kit 24, Volume 0.5 mL

Kit 24, Volume 3.0 mL

Kit 96, Volume 2*1.2 mL


Temp. Storage: 15-25 C / Load: 15-25C
Reagent Carrier 3-15, track 51

Kit 96, Volume 9.0 mL

[B]

Kit 24, Volume 0.9 mL

Reagent Carrier 1-4, track 48-49

2
[B]

[B]

Vial with Transparent cap

Temp.Storage: 2-8 C / Load: 15-25C

[E]

Reagent Carrier 2-5, track 50

Kit 24, Volume 1.5 mL


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

KIT [A]: Wash Buffer 240T

Mat. No 05235863190

KIT [B]: System Liquid Cytology Preparation 240T

Mat. No 05235812190

KIT [C]: Sample Preparation 240T

Mat. No 05235782190

KIT [D]: HPV Controls Kit 240T

Mat. No 05235855190

KIT [E]: HPV Amplification/Detection 240T

Mat. No 05235880190

Installation Manual

Version 1.1.2

Page 143 of 175

14
14.3

Test Run HPV


Required HPV Reagent

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


Log on as user FSE, PW: 00rocheSRVC

2.

Click to select in section Test type HPV Workflow

3.

Type in section Run name Installation WaterRun

4.

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

5.

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

6.

In window Load Carrier Error click Barcode (a)

7.

Cursor is now in field Enter barcode (b)

8.

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

9.

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

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

to navigate to the created Workorder file

15. Click Next at right bottom corner

Installation Manual

Version 1.1.2

Page 145 of 175

14
14.4

Test Run HPV


New Run (TestRunHPV)

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.

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.

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 35-40

5.

Click Load Consumable at right bottom corner

14.4.3. 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 Barcode on Reagent Bottle (Washbuffer)

4.

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

5.

Pour the reagent into this container

6.

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

7.

Click Load Reagents at right bottom corner

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

Installation Manual

Roche
cobas 4800 system

Test Run HPV


New Run (TestRunHPV)

14
14.4

14.4.4. Load Reagent Reservoir Carrier 2-2


1.

Take a small metal Reagent Carrier RGT_CAR5X50_X1

2.

Load the Reagent Carrier in track 50

3.

Scan Barcode on Reagent Bottle (SDS Reagent)

4.

Take a Reagent Reservoir 50 mL and scan it by the hand scanner

5.

Pour the reagent into this container

6.

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

14.4.5. Load Reagent Reservoir Carrier 2-3


1.

Take a small metal Reagent Carrier RGT_CAR5X50_X1

2.

Load the Reagent Carrier in track 50

3.

Scan Barcode on Reagent Bottle (Lysis Buffer)

4.

Take a Reagent Reservoir 50 mL and scan it by the hand scanner

5.

Pour the reagent into this container

6.

Place the Reagent Reservoir 50 mL on the Reagent Carrier pos 3

14.4.6. Load Reagent Reservoir Carrier 2-4


1.

Take a small metal Reagent Carrier RGT_CAR5X50_X1

2.

Load the Reagent Carrier in track 50

3.

Scan Barcode on Reagent Bottle (Magnetic Glass Particles MGP)

4.

Take a Reagent Reservoir 50 mL and scan it by the hand scanner

5.

Pour the reagent into this container

6.

Place the Reagent Reservoir 50 mL on the Reagent Carrier pos 4

14.4.7. Load Reagent Reservoir Carrier 2-5


1.

Take a small metal Reagent Carrier RGT_CAR5X50_X1

2.

Load the Reagent Carrier in track 50

3.

Scan Barcode on Reagent Bottle (Elution Buffer)

4.

Take a Reagent Reservoir 50 mL and scan it by the hand scanner

5.

Pour the reagent into this container

6.

Place the Reagent Reservoir 50 mL on the Reagent Carrier pos 5

7.

Click Load Reagents at right bottom corner

Installation Manual

Version 1.1.2

Page 147 of 175

14
14.4

Test Run HPV


New Run (TestRunHPV)

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.

Load the Reagent Carrier in track 51

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


New Run (TestRunHPV)

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


New Run (TestRunHPV)

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
New Run (TestRunHPV)

15
14.4

15. Completion of Installation


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

Congratulation! cobas 4800 system is now installed!

Installation Manual

Version 1.1.2

Page 151 of 175

16
16.1

Appendix
Installation of BIOS settings

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
Installation of OSXP Recovery Image

16
16.2

16.2. Installation of OSXP Recovery Image


Do not interrupt any installation process, switch off or reboot the cobas 4800 control unit unless 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
Installation of OSXP Recovery Image

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
Installation of OSXP Recovery Image

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
Installation of OSXP Recovery Image

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
Installation of OSXP Recovery Image

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
Installation of OSXP Recovery Image

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
Installation of OSXP Recovery Image

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
Additional HPV Barcodes for WaterRun

Roche
cobas 4800 system

16.7.2. Reagent Loading Set #1


Rack 1
Item #
1
REAG

Barcode Information

Test Barcode

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

0S0**5BZ*'

Reagent Carrier 1-4, track 48-49

0S0101021BZ1000

Container 200 mL
CONS

Page 164 of 175

5`&!BZ1Hf
5640601BZ10040

Version 1.1.2

Installation Manual

Roche
cobas 4800 system

Appendix
Additional HPV Barcodes for WaterRun

16
16.7

Rack 2
Item #
2

Barcode Information

Test Barcode

SDS Reagent

0SA**5BZ*!g

Kit 24, Volume 3mL


Storage: 15-25 C/ Load: 15-25C

REAG

Reagent Carrier 2-2, track 50

Container 50mL
CONS

0SA101021BZ1001

5`&"BZ1"=
5640602BZ10200

Lysis (LYS)

Kit 24, Volume 10mL


Storage:15-25 C / Load:15-25C

REAG

Reagent Carrier 2-3, track 50

Container 50mL
CONS

0S6**5BZ*"S
0S6101021BZ1002

5`&"BZ1"!I
5640602BZ10201

Magnetic Glass Particle (MGP)

REAG

Reagent Carrier 2-4, track 50

Kit 24, Volume 4.5mL (vortex)


Storage:2-8 C / Load:15-25C

Container 50mL
CONS
5
REAG

0S2101021BZ1003

5`&"BZ1""U
5640602BZ10202

Elution Buffer (EB)


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

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
Additional HPV Barcodes for WaterRun

Roche
cobas 4800 system

Rack 3
Item #

10

Page 166 of 175

Barcode Information

Test Barcode

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

0S8**5BZ*%

Reagent Carrier 3-15, track 51

0S8101021BZ1005

Positive Control (PC+)


Kit 24, Volume 0.5mL
Storage:2-8 C / Load:15-25C

2H1**5BZ*&d

Reagent Carrier 3-18, track 51

2H1101021BZ1006

Negative Control (NC-)


Kit 24, Volume 0.5mL
Storage:2-8 C / Load:15-25C

0NC**5BZ*'J

Reagent Carrier 3-19, track 51

0NC101021BZ1007

Master Mix (MMX)


Kit 24, Volume 0.5mL
Storage:2-8 C / Load: 2-8C

2H4**5BZ*(

Reagent Carrier 3-23, track 51

2H4101021BZ1008

Metal Ion (Mn/Mg)


Kit 24, Volume 1.5mL
Storage:2-8 C / Load:2-8C

2H3**5BZ*)*

Reagent Carrier 3-24, track 51

2H3101021BZ1009

Version 1.1.2

Installation Manual

Roche
cobas 4800 system

Appendix
Additional HPV Barcodes for WaterRun

16
16.7

16.7.3. Sample Loading Set #2


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
Additional HPV Barcodes for WaterRun

Roche
cobas 4800 system

16.7.4. Reagent Loading Set #2


Rack 1
Item #
1
REAG

Barcode Information

Test Barcode

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

0S0**5BZ**B

Reagent Carrier 1-4, track 48-49

0S0101021BZ1010

Container 200mL
CONS

Page 168 of 175

5`&!BZ1Ir
5640601BZ10041

Version 1.1.2

Installation Manual

Roche
cobas 4800 system

Appendix
Additional HPV Barcodes for WaterRun

16
16.7

Rack 2
Item #
2

Barcode Information

Test Barcode

SDS Reagent

0SA**5BZ*+

Kit 24, Volume 3mL


Storage: 15-25 C/ Load: 15-25C

REAG

Reagent Carrier 2-2, track 50

Container 50mL
CONS

0SA101021BZ1011

5`&"BZ1"$m
5640602BZ10204

Lysis (LYS)

Kit 24, Volume 10mL


Storage:15-25 C / Load:15-25C

REAG

Reagent Carrier 2-3, track 50

Container 50mL
CONS

0S6**5BZ*,n
0S6101021BZ1012

5`&"BZ1"%y
5640602BZ10205

Magnetic Glass Particle (MGP)

REAG

Reagent Carrier 2-4, track 50

Kit 24, Volume 4.5mL (vortex)


Storage:2-8 C / Load:15-25C

Container 50mL
CONS
5
REAG

0S2101021BZ1013

5`&"BZ1"&
5640602BZ10206

Elution Buffer (EB)


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

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
Additional HPV Barcodes for WaterRun

Roche
cobas 4800 system

Rack 3
Item #

10

Page 170 of 175

Barcode Information

Test Barcode

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

0S8**5BZ*/4

Reagent Carrier 3-15, track 51

0S8101021BZ1015

Positive Control (PC+)


Kit 24, Volume 0.5mL
Storage:2-8 C / Load:15-25C

2H1**5BZ*0

Reagent Carrier 3-18, track 51

2H1101021BZ1016

Negative Control (NC-)


Kit 24, Volume 0.5mL
Storage:2-8 C / Load:15-25C

0NC**5BZ*1e

Reagent Carrier 3-19, track 51

0NC101021BZ1017

Master Mix (MMX)


Kit 24, Volume 0.5mL
Storage:2-8 C / Load: 2-8C

2H4**5BZ*2;

Reagent Carrier 3-23, track 51

2H4101021BZ1018

Metal Ion (Mn/Mg)


Kit 24, Volume 1.5mL
Storage:2-8 C / Load:2-8C

2H3**5BZ*3E

Reagent Carrier 3-24, track 51

2H3101021BZ1019

Version 1.1.2

Installation Manual

Roche
cobas 4800 system

Appendix
Additional HPV Barcodes for WaterRun

16
16.7

16.7.5. Sample Loading Set #3


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
Additional HPV Barcodes for WaterRun

Roche
cobas 4800 system

16.7.6. Reagent Loading Set #3


Rack 1
Item #
1
REAG

Barcode Information

Test Barcode

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

0S0**5BZ*4]

Reagent Carrier 1-4, track 48-49

0S0101021BZ1020

Container 200mL
CONS

Page 172 of 175

5`&!BZ1J~
5640601BZ10042

Version 1.1.2

Installation Manual

Roche
cobas 4800 system

Appendix
Additional HPV Barcodes for WaterRun

16
16.7

Rack 2
Item #
2

Barcode Information

Test Barcode

SDS Reagent

0SA**5BZ*56

Kit 24, Volume 3mL


Storage: 15-25 C/ Load: 15-25C

REAG

Reagent Carrier 2-2, track 50

Container 50mL
CONS

0SA101021BZ1021

5`&"BZ1"(6
5640602BZ10208

Lysis (LYS)

Kit 24, Volume 10mL


Storage:15-25 C / Load:15-25C

REAG

Reagent Carrier 2-3, track 50

Container 50mL
CONS

0S6**5BZ*6"
0S6101021BZ1022

5`&"BZ1")B
5640602BZ10209

Magnetic Glass Particle (MGP)

REAG

Reagent Carrier 2-4, track 50

Kit 24, Volume 4.5mL (vortex)


Storage:2-8 C / Load:15-25C

Container 50mL
CONS
5
REAG

0S2101021BZ1023

5`&"BZ1"*N
5640602BZ10210

Elution Buffer (EB)


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

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
Additional HPV Barcodes for WaterRun

Roche
cobas 4800 system

Rack 3
Item #

10

Page 174 of 175

Barcode Information

Test Barcode

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

0S8**5BZ*9O

Reagent Carrier 3-15, track 51

0S8101021BZ1025

Positive Control (PC+)


Kit 24, Volume 0.5mL
Storage:2-8 C / Load:15-25C

2H1**5BZ*:3

Reagent Carrier 3-18, track 51

2H1101021BZ1026

Negative Control (NC-)


Kit 24, Volume 0.5mL
Storage:2-8 C / Load:15-25C

0NC**5BZ*;

Reagent Carrier 3-19, track 51

0NC101021BZ1027

Master Mix (MMX)


Kit 24, Volume 0.5mL
Storage:2-8 C / Load: 2-8C

2H4**5BZ*<V

Reagent Carrier 3-23, track 51

2H4101021BZ1028

Metal Ion (Mn/Mg)


Kit 24, Volume 1.5mL
Storage:2-8 C / Load:2-8C

2H3**5BZ*=`

Reagent Carrier 3-24, track 51

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
Limited account, auto logon

User name Labmanager


Password

00labMGR

16.8.3. Admin Access Information


Software

Log in Information

User name Operator


Password
Type

Oprcobas48000709
Limited account, auto logon

User name Admin


Password
Type

Installation Manual

00rocheADM
For IT to switch on LIS

Version 1.1.2

Page 175 of 175