Roche cobas 6800 User manual

cobas

®

6800/8800 Systems

User Assistance

Version 2.0

Software version 1.1

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.1 · User Assistance · Version 2.0

2

Publication information

Edition notice This publication is intended for operators of the

cobas

®

6800/8800 Systems.

Every effort has been made to ensure that all the

information is correct at the time of publishing. However,

Roche Diagnostics International Ltd. reserves the right to

make any changes necessary without notice as part of

ongoing product development.

Keep this publication in a safe place to ensure that it is

not damaged. This document should be easily accessible

at all times.

Where to find information The Safety Manual contains important safety

information. You must read the Safety Manual before

operating the instrument.

The Operator’s Manual focuses on routine operation

and maintenance. The chapters are organized according

to the normal operation workflow.

The User Assistance includes the content of the

Operator’s Manual, Safety Manual. Additionally, the User

Assistance includes the following information:

• Troubleshooting information

• Configuration information

• Additional information in the system description

Publication version Software version Revision date Change description

1.0 1.0 August 2014 First version

1.1 1.0 August 2014 Added videos and utility films to the User

Assistance.

1.2 1.0 October 2014 Added information on how to create

reports, implemented information related to

findings from usability tests, changed

procedure on how to empty solid waste.

2.0 1.1 July 2015 Section About the interval of the automatic

purge archived data maintenance action

removed. Section Defining the interval to

purge archived data added. Section About

the automatic IG server cleanup removed.

Section Defining automatic IG server

cleanup added.

y Revision history

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.1 · User Assistance · Version 2.0

3

!

General attention

To avoid serious or fatal injury, ensure that you are

familiar with the instructions and safety information

before you use the system.

r Pay particular attention to all safety precautions.

r Always follow the instructions in this publication.

r Do not use the system in a way that is not described in

this publication.

r Store all publications in a safe and easily retrievable

place.

Training Do not carry out operation tasks or maintenance actions

unless you have received training from Roche

Diagnostics. Leave tasks that are not described in the

user documentation to trained Roche Service

representatives.

Screenshots The screenshots in this publication have been added

exclusively for the purpose of illustration. Configurable

and variable data such as parameters, test results, path

names etc. visible therein must not be used for laboratory

purposes.

Warranty Any customer modification to the system will render the

warranty or service agreement null and void.

For conditions of warranty, please contact your local sales

representative or refer to your warranty contract partner.

Software updates must be performed by or with the

assistance of a Roche Service representative.

reserved.

Trademarks The following trademarks are acknowledged:

COBAS, COBAS OMNI, COBAS P, and LIFE NEEDS

ANSWERS are trademarks of Roche.

All other trademarks are the property of their respective

owners.

Feedback Every effort has been made to ensure that this publication

fulfills the intended purpose as mentioned above. All

feedback on any aspect of this publication is welcome

and will be considered during updates. Please contact

your Roche representative, should you have any such

feedback.

Instrument approvals

The cobas

®

6800/8800 Systems meet the requirements

of the Directive 98/79/EC.

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.1 · User Assistance · Version 2.0

4

Compliance is demonstrated by the following marks:

Contact addresses

Complies with the IVD directive 98/79/EC.

For in vitro diagnostic use.

Issued by Underwriters Laboratories, Inc. (UL) for Canada and

the US.

Issued by CSA Group for Canada and the US.

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

Table of contents 5

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.1 · User Assistance · Version 2.0

Table of contents

Publication information 2

Contact addresses 4

Table of contents 5

Intended use 7

Symbols and abbreviations 7

What is new in document version 2.0 8

What is new in document version 1.2 10

About using the User Assistance 10

Safety

1 General safety information

Introduction 15

Safety classifications 16

Safety precautions 17

Warning messages 21

Caution messages 25

Notices 34

Safety labels on the system 37

Safety information for lasers 44

Safety information for disposal 45

System description

2 Overview of the system

About the cobas

®

6800/8800

Systems 51

Monitor 53

Start button 54

Open/close covers button 55

Middle and rear covers 56

Overview of the sample supply module 57

Overview of the transfer module 61

Overview of the processing module 67

Overview of the analytic module 74

Buttons and power switches on the system 77

3 Specifications

List of system specifications 83

Supported material 86

Operation

4 Overview of operation

Overview of the software 95

User Assistance 108

Overview of the main workflow 112

Quick start guide 115

5 Before operation

Starting up the system 121

System alarm concept 131

6 Reagents and consumables

Overview of the reagents and consumables 145

Unloading the amplification plates 146

Handling the wash/waste drawer 148

Loading the bulk reagent drawer 162

Loading the consumable drawer 166

Unloading control cassettes 173

Loading the reagent cassette drawer 176

7 Sample processing

Setting the system to Ready status 183

Handling test orders 184

Overview of loading/unloading procedures 188

Handling racks for clotted tips 193

Loading samples 198

Unloading sample racks 207

Starting a run 212

Canceling a run 216

Masking/unmasking a module or magazine 218

Reviewing test results 220

Test result reports 232

Releasing test results 238

Releasing test results via remote

connection 239

Downloading files from the IG server 240

Viewing audit trail entries 241

Exporting test results 243

Priming the instrument 244

8 After operation

Pausing the system 247

Setting the system to Hibernate status 248

Shutting down the instrument 250

Restarting by power switch 253

Shutting down the IG server 255

Restarting the IG server 256

Setting the system to powerless status 257

Shut down for more than 10 days 260

9 Maintenance

List of maintenance intervals 263

Periodic maintenance 264

Moving the movable platform 293

Regular maintenance 297

Automatic maintenance actions 299

Decontamination 304

6 Table of contents

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.1 · User Assistance · Version 2.0

10 Configuration

Description of the software 315

About electronic signature 318

Barcode settings 319

System data management 324

Defining address and paper size of reports 331

Problem reports 332

About process step data tracking 334

User management 335

Defining the connection to the LIS 342

Test order settings 343

Test specific settings 348

Installing temperature sensors 349

11 Troubleshooting

Cleaning up the instrument during startup 357

Enabling/disabling screen sharing 368

Troubleshooting the sample supply module 369

Unloading in powerless status 381

Glossary

12 Glossary

Index 399

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.1 · User Assistance · Version 2.0

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Intended use

The cobas

®

6800/8800 Systems support an automated

and integrated workflow to run Polymerase Chain

Reaction (PCR) based Nucleic Acid Testing (NAT) to be

applied in diagnostic and blood screening laboratories.

The cobas

®

6800/8800 Systems combine the

functionalities of instrumentation, consumables, reagents,

and data management to provide an efficient workflow

from sample processing to result interpretation.

Symbols and abbreviations

Product names Except where the context clearly indicates otherwise, the

following product names and abbreviations are used:

Symbols The following symbols are used:

Product name Abbreviation

cobas

®

6800 System

system

cobas

®

6800/8800 Systems

system

cobas

®

6800/8800 Systems

software

cobas

®

8800 System

system

cobas omni Amplification Plate amplification plate

cobas omni Liquid Waste

Container

liquid waste container

cobas omni Lysis Reagent lysis reagent

cobas omni MGP Reagent MGP reagent

cobas omni Pipette Tips tip rack

cobas omni Processing Plate processing plate

cobas omni Solid Waste

Container

solid waste container

cobas omni Specimen Diluent diluent

cobas omni Wash Reagent wash reagent

y Product names and abbreviation

Symbol Explanation

o List item

Search. Used on the search tab.

Table of content. Used on the table of content

tab.

History. Used on the history tab to show

previously viewed topics.

Favorites. Used on the favorites tab and on the

content panel.

y Symbols

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.1 · User Assistance · Version 2.0

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GTIN icon used on the instrument

Abbreviations The following abbreviations are used:

What is new in document version 2.0

Hardware explorers A new tab in the User Assistance allowing graphical

navigation through the system.

u About using the User Assistance (10)

Emptying solid waste A new procedure describing how to empty the solid

waste was added. It is also possible to empty solid waste

by replacing the solid waste container.

u Replacing the solid waste container (151)

Enlarge. Button used on images.

Settings. Button used to open the settings

dialog.

Frequency of a task

Duration of a task

Materials that are required for a task

Prerequisites of a task

Symbol Explanation

y Symbols

Symbol Explanation

Global Trade Item Number

y GTIN icon used on the instrument

Abbreviation Definition

ANSI American National Standards Institute

EC European Community

EN European standard

IEC International Electrical Commission

LIS Laboratory information system

MGP Magnetic glass particles

NAT Nucleic acid testing

n/a not applicable

PCR Polymerase chain reaction

y Abbreviations

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.1 · User Assistance · Version 2.0

9

Canceling a run A new procedure describing how you can cancel all runs

that are not yet being processed by stopping the analytic

system.

u Canceling a run (216)

Test result formatting Reactive test results are now highlighted in red in test

result views and reports.

u About test result formatting (220)

Control batch report This section was added to describe how to create a

control batch report.

u To create a control batch report p (235)

Software description This new section provides a software tree of the system

software.

u Description of the software (315)

Data management recommendations A summary of recommendations for data management

maintenance actions is provided.

u List of data management recommendations (324)

Automatic purge archived data maintenance

action

Section About the interval of the automatic purge

archived data maintenance action was replaced by

Defining the interval to purge archived data.

u Defining archiving settings and interval (327)

Automatic IG server cleanup Section About the automatic IG server cleanup was

replaced by Defining automatic IG server cleanup.

u Defining automatic IG server cleanup (329)

False bottom tubes False bottom tubes are now supported with software

version 1.1.

u Using false bottom tubes (345)

Repeat tests of valid reactive results A new procedure to configure tests to automatically

perform a repeat test for valid reactive results.

u Configuring repeat tests of valid reactive results (348)

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.1 · User Assistance · Version 2.0

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What is new in document version 1.2

This update is related to documentation updates only. No

changes were done in the software of the system.

Moved component descriptions to User

Assistance

The descriptions of the components (such as sample

pipetter, heating station) were removed from the

Operator’s Manual and moved to the User Assistance.

Archive and IG server cleanup Added information that the Archive and IG server cleanup

maintenance actions must not be performed.

Creating test result reports A procedure describing how to create test result reports

was added.

u Test result reports (232)

Emptying solid waste The procedure describing how to empty the solid waste

was updated. As sharp objects may pierce the solid waste

bags, additional caution is required. It is necessary to

perform a visual check of the solid waste bags and the

solid waste container. Also, it is necessary to

decontaminate the solid waste container if a leakage was

detected.

u Emptying the solid waste container (148)

u Cleaning the solid waste container (271)

Cleaning up the instrument The troubleshooting procedures describing how to clean

up the instrument during startup was updated. All

references to the cleanup wizard were removed. The

procedures describe how the instrument can be cleaned

up without using the cleanup wizard.

u Cleaning up the instrument during startup (357)

Weight specification The specification of the weight of the instrument was

updated.

u Dimensions and weight (84)

About using the User Assistance

This video provides an introduction on how to use the

User Assistance.

u Related topics

• Using the User Assistance in a browser (108)

• Using the User Assistance on an offline PC (109)

• Using the User Assistance on the instrument

software (108)

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.1 · User Assistance · Version 2.0

Safety

1 General safety information.................................................................................. 13

1 General safety information

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.1 · User Assistance · Version 2.0

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Table of contents

General safety information 1

In this chapter

1

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Safety classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

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

About operator qualification . . . . . . . . . . . . . . . . . . 17

About safe and proper use of the system . . . . . . . 17

Miscellaneous safety precautions overview . . . . . 19

Warning messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Electrical safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Biohazardous materials . . . . . . . . . . . . . . . . . . . . . . 22

Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Caution messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Burns due to hot surfaces . . . . . . . . . . . . . . . . . . . . 25

Mechanical safety. . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Reagents and other working solutions . . . . . . . . . 27

Fatigue due to long hours of operation . . . . . . . . . 29

Electromagnetic interference . . . . . . . . . . . . . . . . . 29

Data security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Emergency stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Reagent storage service door . . . . . . . . . . . . . . . . . 33

Reaching into the transfer module from the

sample supply module . . . . . . . . . . . . . . . . . . . . . . . 33

Notices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Circuit breakers and fuses . . . . . . . . . . . . . . . . . . . 34

Electromagnetic compatibility. . . . . . . . . . . . . . . . . 34

Mechanical stress. . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Heat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Spillage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Safety labels on the system. . . . . . . . . . . . . . . . . . . . . . 37

List of safety labels on the system . . . . . . . . . . . . . 37

1 General safety information

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.1 · User Assistance · Version 2.0

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Table of contents

Location of safety labels on the system. . . . . . . . . 38

Safety information for lasers . . . . . . . . . . . . . . . . . . . . . 44

Laser presence detector and barcode reader . . . 44

Safety information for disposal. . . . . . . . . . . . . . . . . . . 45

Disposal information . . . . . . . . . . . . . . . . . . . . . . . . 45

1 General safety information

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.1 · User Assistance · Version 2.0

General safety information 15

Introduction

!

General attention

To avoid serious or fatal injury, read this publication

thoroughly before you use the instrument.

r Pay particular attention to all safety precautions.

r Always follow the instructions in this publication.

r Do not use the instrument in a way that is not

described in this publication.

r Keep this publication in a safe place to ensure that it

is not damaged and remains available for use.

This publication must always be easily accessible.

1 General safety information

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.1 · User Assistance · Version 2.0

16 Safety classifications

Safety classifications

The safety precautions and important user notes are

classified according to the ANSI Z535.6-2011 standard.

Familiarize yourself with the following meanings and

icons:

!

Safety alert

r The safety alert symbol is used to alert you to potential

physical injury hazards. Obey all safety messages that

follow this symbol to avoid possible damage to the

system, injury, or death.

These symbols and signal words are used for specific

hazards:

WARNING

!

Warning...

r ...indicates a hazardous situation which, if not avoided,

could result in death or serious injury.

CAUTION

!

Caution...

r ...indicates a hazardous situation which, if not avoided,

could result in minor or moderate injury.

NOTICE

Notice...

r ...indicates a hazardous situation that, if not avoided,

may result in damage to the system.

Important information that is not safety relevant is

indicated with the following icon:

q Tip...

...indicates additional information on correct use or useful

tips.

1 General safety information

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.1 · User Assistance · Version 2.0

General safety information 17

Safety precautions

!

To avoid serious or fatal injury, read and

comply with the following safety precautions.

u

• About operator qualification (17)

• About safe and proper use of the system (17)

• Miscellaneous safety precautions overview (19)

About operator qualification

Insufficient knowledge and skills As an operator, ensure that you know the relevant safety

precaution guidelines and standards and the information

and procedures contained in these instructions.

r Do not carry out operation and maintenance unless

Roche Diagnostics has trained you to do so.

r Leave maintenance, installation, or service that is not

described to trained Roche Service representatives.

r Carefully follow the procedures specified in the

instructions for operation and maintenance.

r Follow good laboratory practices, especially when you

work with biohazardous material.

About safe and proper use of the system

Missing personal protective equipment Working without personal protective equipment means

danger to life or health.

r Wear appropriate personal protective equipment,

including, but not limited to, the following items:

o Eye protection with side shields

o Fluid-resistant laboratory coat

o Approved lab gloves

o Face shield if there is a chance of splashing or

splattering

r Follow good laboratory practices and regularly change

lab gloves to minimize the risk of infection and

contamination (especially after contact with waste or

sample material).

1 General safety information

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.1 · User Assistance · Version 2.0

18 Safety precautions

Exposure to chemicals r Avoid exposure to chemicals.

Exposure to infectious waste Failure to place an appropriate waste container beneath

the pooling instrument can lead to exposure to infectious

waste material.

r Always place a waste container below the pooling

instrument during operation.

r Follow good laboratory practices and regularly change

lab gloves to minimize the risk of infection and

contamination (especially after contact with waste or

sample material).

Regular cleaning To prevent inaccurate results and unsafe operation of the

system:

r Regularly clean and/or decontaminate the instrument

as required. Follow good laboratory practices for

cleaning and decontamination.

r Ensure that the laboratory is regularly cleaned and is

maintained in an orderly manner.

Approved cleaning solutions

r Use only approved cleaning solutions for cleaning.

Errors in installation Only trained Roche Service representatives may install

the system.

r Leave installation that is not described to trained

Roche Service representatives.

Exchange or removal of parts Unauthorized exchange or removal of system parts can

damage the system or stop it from functioning correctly.

r Do not exchange or remove any part of the

instrument.

r Leave replacement of instrument parts to trained

Roche Service representatives.

1 General safety information

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.1 · User Assistance · Version 2.0

General safety information 19

Unsuitable environmental conditions Operation outside of the specified ranges may lead to

incorrect results or malfunction of the system.

r Use the system indoors only, and avoid heat and

humidity outside of the specified range.

r Make sure that the system's ventilation openings

always remain unobstructed.

r To maintain the environmental conditions of the

system, perform maintenance in accordance with the

specified intervals.

r Keep the operating instructions undamaged and

available for use. Operating instructions must be

easily accessible for all users.

u For the allowable environmental conditions, see

Non-approved spare parts Use of non-approved spare parts or devices may result in

malfunction of the system and may render the warranty

null and void.

r Use only spare parts and devices approved by Roche

Diagnostics.

Non-specified third-party software Installation of third-party software is not approved by

Roche Diagnostics and may result in malfunction.

r Do not install third-party software.

Non-specified consumables Use of non-specified consumables can lead to incorrect

results.

r Do not use consumables that are not intended for use

with the cobas

®

6800/8800 Systems or the

cobas p 680 instrument.

u For a list of supported materials, see

Miscellaneous safety precautions overview

Power interruption A power failure or momentary drop in voltage may

damage the system or lead to data loss.

r It is recommended to use an uninterruptible power

supply (UPS).

r Ensure regular maintenance of the UPS.

r Perform regular backup of results.

1 General safety information

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.1 · User Assistance · Version 2.0

20 Safety precautions

Electromagnetic compatibility

The cobas

®

6800/8800 Systems comply with the

emission and immunity requirements described in this

part of the IEC 61326:2012 series.

The systems comply with the emission requirements

described in this part of the FCC CFR 47, Part 15 Class A.

u Electromagnetic compatibility (34)

System not used for an extended period r Follow the decommissioning procedure.

r Set the power switch to OFF if you do not use the

system for an extended period.

r Remove and refrigerate any remaining reagents and

controls.

r For further information, call your Roche Service

representative.

u See the Decommissioning Procedure.

Damage in transit r Do not attempt to relocate or transport the system.

r Leave relocation and transportation to Roche Service

representatives.

q Relocating the cobas

®

6800 System using the

movable platform is permissible.

u Related topics

• Disposal information (45)

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