Manual Cobas 4800

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cobas

®

4800 system

Installation Manual

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cobas®_{4800 system}

Installation Manual Version 1.1.2 Page 3 of 175

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

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cobas®_{4800 system} _{Revision History} _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

Note added: Host Interface Test Tool 7.1.5 or higher is required 1.1.2 2-Mar-2011 13.5. New Run (WaterRun)

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1.2 Editor notice 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

Microlab®_{is a registered trademark of Hamilton Bonaduz Ltd, Switzerland}

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 6343 Rotkreuz Switzerland Web: www.roche-rotkreuz.com E-mail: [email protected]

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cobas®_{4800 system} _{Intended Use} _1.6

1.6. Intended Use

The cobas®_{4800 system is intended to be used as a diagnostic or screening system providing sample} preparation, amplification and detection of specific targets from human samples. Initial diagnostic targets are Chlamydia Trachomatis/Neisseria Gonorrhoeae (CT/NG) and human papillomavirus (HPV). It is

important that the operator read this manual thoroughly before using the system.The cobas®_{4800 system is} to be used by laboratory professionals trained in laboratory techniques and by instruction on the use of the system.

1.7. Configuration

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

1.8. About this Manual

Use always the latest version of this document with the corresponding software versions.

This manual guides through the installation of a cobas® 4800 system. Detailed technical instrument information can be found in the service documentation of cobas x 480 instrument and cobas z 480 analyzer.

GRIPS > iSDoc > cobas x 480 and GRIPS > iSDoc > cobas z 480

For operating information consult the cobas®_{4800 system Operator’s Manual.}

GRIPS > System Search > Molecular Diagnostics > cobas 4800 system > cobas z 480

Before operating the cobas® 4800 system, it is essential that the warnings, cautions, and safety requirements contained in the Installation- & Operator’s Manual cobas®

4800 system are read and understood by the user.

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1.9 Order Information 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 Used for

Numbered lists This are sequential procedures and have to be followed step by step

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

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

BOLD Used to refer to a software phrase,

BOLD Keyboard key, software button

Italic Indicates a name or expressions used software or manuals

Italic Designating another section of this manual or another manual that should be consulted. It also can refer to iSDoc. Tip

Indicates additional information on correct use of the system or useful tips

Safety alert. The safety alert symbol by itself without a signal word is used to promote awareness to hazards which are generic or to direct the reader to safety information provided elsewhere in the document.

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cobas®_{4800 system} _{Abbreviations} _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

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1.13 Safety notes cobas® _{4800 system}

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

mL Milliliter (1mL =1000μl)

uL Microliter (1mL =1000μl)

1.13. Safety notes

Following symbols are used throughout this manual to provide a ready visual reference.

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.

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cobas®_{4800 system} _{Safety notes} _1.13

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

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

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

Electromagnetic fields. Operation with an uninterruptible power supply (UPS) is

recommended. Electromagnetic fields Devices that emit electromagnetic waves may cause the instrument or analyzer to malfunction. Do not operate the following devices in the same room where the instrument or analyzer are installed such as mobile phone, transceiver, cordless phone, and other electrical devices that generate electromagnetic fields. Personal injury due hot surface

The heater/ shaker are hot while the cobas x 480 instrument is operating.

Warning potentially biohazardous material. Indicates possible biohazardous material. Universal safety precautions should be taken when handling and processing samples.

Refer to Operator's Manual cobas® 4800 system for instructions on safe operation. Instrument Ground. Located on all Power Supplies, this symbol indicates where protective ground is connected.

Disposal of control unit components

Components of your control unit (such as the computer, monitor, keyboard) which are marked with this symbol are covered by the European Directive on Waste Electrical and Electronic Equipment (WEEE, 2002/96/EC).

These items must be disposed of via designated collection facilities.For more information about disposal of your old product, please contact your city office, waste disposal service or your Roche representative.

Constraint: It is left to the responsible laboratory organization to determine whether control unit components are contaminated or not. If contaminated, treat them in the same way as the instrument and analyzer.

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1.14 Data Security 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:

• 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.

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cobas®_{4800 system} _{Safety precautions} _1.15

1.15. Safety precautions

Miscellaneous safety precautions - Power interruption

A power failure or momentary drop in voltage may damage the instrument or analyzer or lead to data loss. Perform regular backups of measurement results. Operation with an uninterruptible power supply (UPS) is recommended. Approved Part – Software

Use of non-approved parts or devices may result in malfunction of the instrument or analyzer and may render the warranty null and void. Only use parts and devices approved by Roche Diagnostics.

Personal protective equipment

Be sure to wear appropriate protective equipment, including, but not limited to

safety glasses with side shields, fluid resistant lab coat, and approved disposable gloves. Wear a face shield if there is a chance of splash or splatter.

Follow standard laboratory practices, especially when working with biohazardous material. REAGENTS - Skin inflammation or injury caused by reagents

Direct contact with reagents, detergents, or cleaning solutions may cause skin inflammation, or burns.

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

• Observe the cautions given in the package insert and observe the information the Material Safety Data Sheets available for Roche Diagnostics reagents solutions. • If a reagent or detergent comes into contact with your skin, wash it off immediately

with water and apply a disinfectant. Consult a physician immediately.

OPTICAL SAFETY - Loss of sight due to staring into laser beam

The barcode scanner on the autoloader of the cobas x 480 instrument contains a class 2 laser diode. Do not stare into the laser transmitter beam as eyesight may be severely damaged.

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1.16 Material Required 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 Installation Manual cobas z 480 analyzer Delivered with analyzer & GRIPS > _{cobas z 480 > Installation Manual} Operator’s Manual cobas® 4800 system (Language: EN, DE, ES, FR,...) 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

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 DCS Mannheim CD: cobas z 480 service software, Version 2.0.1.805 05614066001 DCS Mannheim

File: Workaround_Start_Menu_and_Shortcuts_Vx.x.zip N/A GRIPS_Manual > cobas z 480 > Installation File: Cobas4800WorkorderEditor.exe.config.zip N/A GRIPS_Manual > cobas z 480 > Installation File: cobas IT firewall Configuration Wizard 3.3 b3 N/A GRIPS_Software > cobas IT firewall > Service Host Interface Test Tool 7.1.5 or higher N/A GRIPS_{Interface Test Tool} > cobas z 480 > Host

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

1.16.3. Instrument/ Analyzer

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cobas®_{4800 system} _{Material Required} _1.16

1.16.4. Accessories & Option

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

1.16.5. Consumables

Please refer to Ordering List cobas®

4800 system available on GRIPS

1.16.6. Service Tools

Please refer to Service Tools in the according instruments iSDoc

GRIPS > iSDoc > Molecular Diagnostics > cobas 4800 > cobas x 480 >Spare Part > Service Tool

GRIPS > iSDoc > Molecular Diagnostics > cobas 4800 > cobas z 480 >Spare Part > Service Tool

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2.1 Installation Backup Restore Tool 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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cobas®_{4800 system} _{Backup Database} _2.2

3. 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.

Creating the backup may take a few minutes, depending on the size of the database. 5. Wait for the following prompt for user QUARTZ

Export Terminated successfully without Warnings

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2.3 Store Archive & Backup Files 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

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cobas®_{4800 system} _{Delivery/ Unpacking} _3.1

3. New Installation

3.1. Delivery/ Unpacking

The cobas® _{4800 system is transported in palletized boxes. The boxes should be carefully inspected for any}

visual damage. In case of damages, report to your local Roche office and the shipping agent before accepting the unit. The original shipping container must be transferred unopened to the installation site. The cobas® _{4800 system should be unpacked and installed only by authorized Roche Service personnel. No}

attempt should be made by the user to remove, set up or operate the system without Roche service personnel being present.

Each instrument of the cobas® _{4800 system is delivered with a packing list. All instrument, components,}

options, accessories and consumables are listed and should be verified against the delivered items.

3.2. Installation PART 1 cobas x 480 instrument

Unpack the cobas x 480 instrument according iSDoc.

Work according the 16.1 Installation Check List at the end of this manual and perform all PART 1 tasks. Please refer to GRIPS > iSDoc > x 480 > Installation > unpacking the instrument Set the working area, so called instrument deck in level. Check both directions X & Y. Adjust the trolley feet accordingly. Y-direction out of level might have a direct impact on reagents detected in reagent container.

Do NOT switch on the cobas x 480 instrument before all software have been installed on cobas 4800 control unit

This picture shows the options Trolley Hamilton Star with Gooseneck Display Support (A) Trolley Hamilton Star, (B) Control Unit, (C) Display Gooseneck, (D) Monitor

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3.3 Installation cobas z 480 analyzer 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} _{Delivery condition cobas 4800 control unit} _4.1

4. SW Installation control unit

4.1. Delivery condition cobas 4800 control unit

All new delivered cobas 4800 control units are preinstalled with DVD: OSXP Recovery for cobas 4800 Control Unit (IVD workflow) 1.0.0 which is also located inside the control unit.

Any Installation of the cobas 4800 1.1.0 Build 1042 software requires a cobas 4800 control unit hp rp5700.

4.2. Verification of installed BIOS

1. Power ON the cobas 4800 control unit

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

If the installed BIOS version is vE1.12 continue with the next chapter. 4.3 Verification of installed image version

If the installed BIOS version is not vE1.12 please go to chapter 16.1 Installation of BIOS settings, page 152

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4.3 Verification of installed image version cobas® _{4800 system}

4.3. Verification of installed image version

1. Wait to be automatically logged on as Operator.

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

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cobas®_{4800 system} _{Windows Time and Date Adjustments} _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

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4.5 cobas® 4800 software installation cobas® _{4800 system}

4.5. cobas

®

4800 software installation

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

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cobas®_{4800 system} _{cobas® 4800 software installation} _4.5

9. Verify that only the following components are selected to install: cobas 4800 V1.1.0.1036 ;

Start Menu Shortcuts ;

NET 3.5 ;

SamplePrepMethod ;

Additional Debug Information

PDF reader

cobas 4800 Transformer ; Click Next

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

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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

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14. cobas 4800 1.1.0.1004 SamplePrep ; Click on Install

15. Click OK

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

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17. Click Finish

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

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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

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23. Verify that only the following components are selected to install: cobas 4800 Transformer ;

Start Menu Shortcuts ; Additional Debug Information Click Next

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25. Click Finish to complete cobas 4800 Transformer installation

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4.6 cobas® 4800 oracle DB installation 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

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cobas®_{4800 system} _{cobas® 4800 oracle DB installation} _4.6

R_INT_ADMIN

is displayed, then enter PW:

LbRuwotHFP

R_INT_USER

, is displayed, then enter PW:

W8xHEQvtLC

INT_ADMIN

QhfIwXEP15

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INT_SETUP

S23WaZe66k

QUARTZ

Li5qP3n2Ab

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cobas®_{4800 system} _{cobas® 4800 oracle DB installation} _4.6

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

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

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

During this process many users are dropped.

Please wait and ignore error messages as the examples listed below: - ERROR at line 1: ORA-01918 user “BI” does not exist

- ERROR at line 1: ORA-01918 user “OE” does not exist - ERROR at line 1: ORA-01918 user “….” does not exist

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

20. Press ALT+F4 to close the first explorer window

21. Navigate to Start > Programs > cobas_4800_V1.1.0.1036 > Tools > Migration Tool Start (click) Migration Tool

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

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

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cobas®_{4800 system} _{cobas® 4800 software configuration} _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}

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4.7 cobas® 4800 software configuration cobas® _{4800 system}

4.7.2. Reporting

Navigate in the tab navigation bar to Utilities > Configuration > Reporting > Parameter Value

Enter Lab Name: xxxxxx

Enter Lab Location: xxxxxx Activate Show Lab Header ; Click Apply to take over the changes

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

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4.7.3. Test parameters

1. 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

(44)

4.7.4. Verification of cobas

®

4800 software start-up user operator

1. Power up cobas 4800 control unit

2. Wait to be logged on automatically as user Operator

3. Wait approx one more minute then start cobas_4800_V1.1.0.1036 software by double clicking on the desktop icon

After ever start up of the cobas 4800 control unit it is required to wait approx. 1 minute before starting cobas®_{4800 software to avoid the following oracle error:}

ORA-01033: ORACLE initialization or shutdown in progress

If such en error occurs close all windows and start cobas® 4800 software again.

If any other oracle database error message than ORA-01033 occurs during cobas® 4800 software start up. Shut down and start up control unit again (no restart). Start cobas® 4800 software, if error still occurs reinstall OSXP Recovery Image.

Please go to chapter 16 Appendix \ 16.2 Installation of OSXP Recovery Image, page 153 4. If no error occurs log on as user

FSE

, PW:

00rocheSRVC

and close software.

4.7.5. Verification of cobas® 4800 database size

1. Press CTRL+ALT+DEL keys, click on Log Off… and click Log Off to confirm Press & hold Shift key to interrupt auto log on

Log on as user

Install

, PW:

Instcobas48000709

2. Start cobas®_{4800 software and log on as user}

FSE

, PW:

00rocheSRVC

For more passwords please see User Access Information for cobas® 4800 system

GRIPS > Molecular Diagnostics > Systems > cobas 4800 > cobas z 480 > Installation Manual 3. Check if a database size is displayed in main working area, approx 10.5 MB

(45)

4. 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

(46)

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.

(47)

cobas®_{4800 system} _{cobas® 4800 Work Order Editor Installation} _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.

(48)

4.8 cobas® 4800 Work Order Editor Installation cobas® _{4800 system}

5. Click Install

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cobas®_{4800 system} _{Installation of cobas® 4800 Operator’s Manual} _4.9

4.9. Installation of cobas® 4800 Operator’s Manual

Please provide with a storage device (i.e. CD, USB Memory Stick) the latest Operator’s Manual cobas®

4800 system in the customer required language which can be downloaded from GRIPS

Please note there are several different version of the operator’s manual available. A CT/NG only, a HPV only and a combined manual CT/NG with HPV.

Please install the most appropriate manual for your installing site.

7. Connect or insert the storage device (i.e. usb flash drive) to cobas 4800 control unit 8. Browse to storage device F:\ and select the Operator’s Manual cobas® 4800 system.

Press CTRL+C keys (to copy the file)

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

10. Press CTRL+V keys (to paste the file)

11. Press F2 key to rename the Operator’s Manual cobas® 4800 system as UserManual.pdf 12. Browse to folder C:\Program Files\RocheDiagnosticsAG\cobas® 4800 Work Order Editor

Press SHIFT+DEL keys to permanently delete the existing file Users Manual.pdf 13. Press CTRL+V keys (to paste to file)

14. Press F2 key to rename the Operator’s Manual cobas® 4800 system as Users Manual.pdf

15. Start cobas_4800_V1.1.0.1036 software (double click on desktop icon) Log on as user FSE, PW: 00rocheSRVC, click OK to confirm log on

16. Click Info button at the right bottom corner and then click the button User Manual The Operator’s Manual (UserManual.pdf) must open now.

Verify for the correct version, if all is correct, click Exit and Yes to close cobas®_{4800 software}

17. Start cobas®_{4800 Work Order Editor (double click on desktop icon)}

18. Click Info button at the right bottom corner and then click the button User Manual. The Operator’s Manual (Users Manual.pdf) must open now.

Verify for the correct version, if all is correct close the Manual and click Exit to close cobas®₄₈₀₀

Work Order Editor

If the Operator’s manual does not open, check for correct file name UserManual.pdf and Users Manual.pdf

(50)

4.10 cobas x 480 Service Software Installation 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

(51)

cobas®_{4800 system} _{cobas x 480 instrument driver installation} _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

(52)

4.12 cobas z 480 analyzer Service Software Installation cobas® _{4800 system}

4. Wait for the pop up window New Hardware Wizard Click Next

5. Click Finish

4.12. cobas z 480 analyzer Service Software Installation

1. Insert CD: cobas z 480 service software, Version 2.0.1.0805 2. Browse to CD DRIVE E:\

3. Run (Double-click) z480_SSWSetup_2.0.1.0805.exe

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

(53)

cobas®_{4800 system} _{cobas z 480 analyzer Service Software Installation} _4.12

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 10. Press Eject CD button and remove the CD

(54)

4.13 User permission modification 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

(55)

cobas®_{4800 system} _{User permission modification} _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

(56)

4.13 User permission modification cobas® _{4800 system}

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

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

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

8. Click OK to close the window 9. Close explorer window.

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cobas®_{4800 system} _{Workaround Start Menu & Shortcuts} _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.

(58)

4.14 Workaround Start Menu & Shortcuts 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

(59)

cobas®_{4800 system} _{Windows Start Menu & Shortcuts} _4.15

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

Select icon User Manual and then press SHIFT+DEL to delete permanently. Press Yes to confirm 25. Close the explorer window

26. Skip chapter 4.15 Windows Start Menu & Shortcuts Go ahead with 4.16 Window Menu Verification

4.15. Windows Start Menu & Shortcuts

4.15.1. Create a folder to save Work Orders

1. Press CTRL+ALT+DEL keys, click on Log Off… and click Log Off to confirm 2. Wait to be logged on automatically as Operator

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

4. Select in the menu bar File > New > Folder and then rename it as Work Orders 5. Press CTRL+ALT+DEL keys

Click on Log Off… and click Log Off to confirm Press & hold Shift key to interrupt auto log on

Log on as user Install, PW: Instcobas48000709 6. Open windows explorer (Win+E)

7. Browse to C:\Documents and Settings\OPERATOR\My Documents (Administrator’s Documents) 8. Right-click the folder Work Orders, select form the context menu Create Shortcut

9. Press F2 key to rename shortcut as Work Orders as Work Orders 10. Press CTRL+X keys to cut the shortcut

11. Browse to C:\Documents and Settings\ALL USER\Start Menu and then press CTRL+V keys to paste the shortcut Work Orders

12. Select the pasted shortcut Work Orders and then press CTRL+C keys to copy the shortcut

13. Browse to C:\Documents and Settings\ALL USER\Desktop and then press CTRL+V keys to paste the shortcut Work Orders

14. Browse to C:\Documents and Settings\OPERATOR\My Documents (Administrator’s Documents)\Work Orders

Select the path in the address field of the windows explorer and then press CTRL+C keys to copy it 15. Start cobas_4800_V1.1.0.1036 and log on as user FSE, PW: 00rocheSRVC

16. Navigate to Utilities > Configuration > System Settings > Workorder import path Press CTRL+V keys to paste the path

(60)

4.15 Windows Start Menu & Shortcuts 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

Manual Cobas 4800

cobas

®

4800 system

Installation Manual

Table of Contents

1. Preface

1.1. Revision History

1.2. Editor notice

1.3. Copyrights

1.4. Trademarks

1.5. Contact addresses

1.6. Intended Use

1.7. Configuration

1.8. About this Manual

1.9. Order Information

1.10. Document Reference

1.11. Conventions used in this Manual

1.12. Abbreviations

1.13. Safety notes

1.14. Data Security

1.15. Safety precautions

1.16. Material Required

1.16.1. Documentation

1.16.2. Software

1.16.3. Instrument/ Analyzer

1.16.4. Accessories & Option

1.16.5. Consumables

1.16.6. Service Tools

2. Upgrade from version 1.0.x to 1.1.0

2.1. Installation Backup Restore Tool

2.2. Backup Database

system

4evZ352G5LRuP_a

2.3. Store Archive & Backup Files

3. New Installation

3.1. Delivery/ Unpacking

3.2. Installation PART 1 cobas x 480 instrument

3.3. Installation cobas z 480 analyzer

3.4. Installation cobas 4800 control unit

4. SW Installation control unit

4.1. Delivery condition cobas 4800 control unit

4.2. Verification of installed BIOS

4.3. Verification of installed image version

4.4. Windows Time and Date Adjustments

4.5. cobas

4800 software installation

4.6. cobas® 4800 oracle DB installation

SYSTEM

4evZ352G5LRuP_a

R_INT_ADMIN

LbRuwotHFP

R_INT_USER

W8xHEQvtLC

INT_ADMIN

QhfIwXEP15

INT_SETUP

S23WaZe66k

QUARTZ

Li5qP3n2Ab

4.7. cobas

4800 software configuration

4.7.1. cobas

4800 software start-up

4.7.2. Reporting

4.7.3. Test parameters

4.7.4. Verification of cobas

4800 software start-up user operator

FSE

00rocheSRVC

4.7.5. Verification of cobas® 4800 database size

Install

Instcobas48000709

FSE

00rocheSRVC

4.7.6. Archive Trigger and Fix Indices

INT_ADMIN

QhfIwXEP15

INT_ADMIN

QhfIwXEP15