Roche cobas 5800 User guide

cobas

®

6800/8800 Systems

User Guide

Publication version 4.2

Software version 1.3

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.3 · User Guide · Publication version 4.2

2

Publication information

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

delete archived data maintenance action

removed.

Section Defining the interval to delete

archived data added.

Section About the automatic IG server

cleanup removed.

Section Defining automatic IG server

cleanup added.

2.1 1.1.10 January 2016 Publication title Operator’s Manual changed

to User Guide.

Section Cleaning up the instrument during

startup updated.

Section Canceling a run updated.

3.0 1.2 September 2016 Added new section about the minimum

volumes for gel separator tubes.

Updated the list of supported sample tubes

and the procedure to replace the liquid

waste container.

u What is new in publication version

3.0 (19)

3.1 1.2 August 2017 Intended use updated. New instrument

approval. New radio equipment

specifications.

Update about repeat test.

Updated maintenance tasks to clean

processing module from front and to clean

covers. New maintenance task to

decontaminate rack trays.

u What is new in publication version

3.1 (18)

3.2 1.2 July 2018 Details about cleaning solutions updated.

Message codes 1061 and 1072 updated.

Unloading amplification plate updated.

Consumable reuse information updated.

Information about loading sample tubes

with swabs added. Update about repeat

testing. Weekly system restart

recommendation added. Decontamination

procedures updated.

u What is new in publication version

3.2 (16)

y Revision history

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.3 · User Guide · Publication version 4.2

3

Edition notice This publication is intended for users of the

cobas

®

6800/8800 Systems.

Every effort has been made to ensure that all the

information contained in this publication is correct at the

time of publishing. However, the manufacturer of this

product may need to update the publication information

as output of product surveillance activities, leading to a

new version of this publication.

Where to find information The User Assistance contains all information about the

product, including the following:

• Routine operation

• Maintenance

• Safety

• Troubleshooting information

• Configuration information

• Background information

4.0 1.3 October 2017 Added new tasks from the global

information area, a task to restart after a

shutdown longer than 3 months,

information about non-Roche external

controls and history calculation, new

maintenance task to clean the tube rotator,

and minor text and image updates.

u What is new in publication version

4.0 (15)

4.1 1.3 March 2018 Additional information related to tubes with

swabs and to non-Roche external controls

based on alcohol.

u What is new in publication version

4.1 (15)

4.2 1.3 August 2018 Using the User Assistance on the

instrument software updated.

Environmental conditions updated. Details

about cleaning solutions updated. Message

codes 0305, 1061 and 1072 updated.

Unloading amplification plate updated.

Consumable reuse information updated.

Update of the list of flags. Update about

repeat testing. Weekly system restart

recommendation added. Decontamination

procedures updated.

u What is new in publication version

4.2 (13)

Publication version Software version Revision date Change description

y Revision history

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.3 · User Guide · Publication version 4.2

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The Safety Guide contains important safety information.

You must read the Safety Guide before operating the

instrument.

The User Guide focuses on routine operation and

maintenance. The chapters are organized according to

the normal operation workflow.

!

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.

Images The screenshots and hardware images in this publication

have been added exclusively for illustration purposes.

Configurable and variable data in screenshots, such as

tests, results, or path names 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.

License information

cobas

®

6800/8800 Systems software is protected by

contract law, copyright law, and international treaties.

cobas

®

6800/8800 Systems contains a user license

between F. Hoffmann-La Roche Ltd. and a license holder,

and only authorized users may access the software and

use it. Unauthorized use and distribution may result in

civil and criminal penalties.

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.3 · User Guide · Publication version 4.2

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Open-source and commercial software

cobas

®

6800/8800 Systems may include components or

modules of commercial or open-source software. For

further information on the intellectual property and other

warnings, as well as licenses pertaining to the software

programs included in cobas

®

6800/8800 Systems, refer

to the electronic distribution included with this product.

This open-source and commercial software and

cobas

®

6800/8800 Systems as a whole can constitute a

device regulated in accordance with applicable law. For

more detailed information, refer to the User Guide and

labeling.

Note that the respective authorization is no longer valid

according to the corresponding legislation should any

unauthorized changes be made to cobas

®

6800/8800

Systems.

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 use. All feedback on any aspect of

this publication is welcome and is considered during

updates. Contact your Roche representative, should you

have any such feedback.

Instrument approvals

The cobas

®

6800/8800 Systems meet the requirements

laid down in:

Directive 98/79/EC of the European Parliament and of the

Council of 27 October 1998 on in vitro diagnostic medical

devices.

Directive 2011/65/EU of the European Parliament and of

the Council of 8 June 2011 on the restriction of the use of

certain hazardous substances in electrical and electronic

equipment.

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.3 · User Guide · Publication version 4.2

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Directive 2014/53/EU of the European Parliament and of

the Council of 16 April 2014 on the harmonization of the

laws of the Member States relating to the making

available on the market of radio equipment and repealing

Directive 1999/5/EC.

To view the full text of the 2014/53/EU declaration of

conformity, go to the Roche DiaLog Global Web Site

(https://dialog1.roche.com/) and choose the eLabDoc

link.

If you are unable to access Roche DiaLog, contact a

Roche Service representative.

Compliance with the applicable directive(s) is provided by

means of the Declaration of Conformity.

The following marks demonstrate compliance:

Contact addresses

Complies with the provisions of the applicable EU

directives.

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.

'Laboratory Equipment' is the product identifier as

shown on the type plate.

CUS

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.3 · User Guide · Publication version 4.2

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Distributed in the United States by

Roche Diagnostics

9115 Hague Road

Indianapolis

Indiana, USA

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.3 · User Guide · Publication version 4.2

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Table of contents 9

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.3 · User Guide · Publication version 4.2

Table of contents

Publication information 2

Contact addresses 6

Table of contents 9

Intended use 11

Symbols and abbreviations 11

What is new in publication version 4.2 13

What is new in publication version 4.1 15

What is new in publication version 4.0 15

What is new in publication version 3.2 16

What is new in publication version 3.1 18

What is new in publication version 3.0 19

What is new in publication version 2.1 20

What is new in publication version 2.0 22

What is new in publication version 1.2 23

Operation

1 Overview of the system

About the cobas

®

6800/8800 Systems 29

Overview of the sample supply module 32

Overview of the transfer module 35

Overview of the processing module 37

Overview of the analytic module 40

Buttons and power switches on the system 41

2 Overview of operation

Overview of the software 47

Overview of the main workflow 63

Quick start guide 66

3 Before operation

Starting up the system 71

System alarm concept 84

4 Reagents and consumables

Overview of the reagents and consumables 97

Unloading the amplification plates 98

Handling the wash/waste drawer 100

Loading the bulk reagent drawer 119

Loading the consumables drawer 124

Loading and unloading the reagent cassette

drawer 131

5 Sample processing

Setting the system to Ready status 141

Handling test orders 142

Overview of loading/unloading procedures 146

Handling racks for clotted tips 151

Loading samples 156

Unloading sample racks 165

Starting a run 170

Canceling a run 173

Masking/unmasking a module or magazine 174

Reviewing test results 176

Test result reports 197

Releasing test results 203

Releasing test results via remote

connection 204

Downloading files from the IG server 205

Viewing audit trail entries 206

Exporting test results 207

Priming the instrument 208

6 After operation

Pausing and resuming the system 211

Setting the system to Hibernate status 212

Shutting down the system 214

Restarting by power switch 217

Shutting down the IG server 219

Starting the IG server 220

Setting the system to powerless status 221

Shut down for more than 10 days 224

7 Maintenance

List of maintenance intervals 227

Periodic maintenance 228

Regular maintenance 259

Automatic maintenance actions 264

Decontamination 269

Moving the movable platform 280

Appendix

8 Specifications

List of system specifications 289

Supported material 292

9 Glossary

Index 299

10 Table of contents

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.3 · User Guide · Publication version 4.2

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.3 · User Guide · Publication version 4.2

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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).

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 descriptors are used.

Symbols used in the publication The following symbols are used:

Product name Descriptor

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.

u Related topics containing further information.

q

Tip. Extra information on correct use or useful

hints.

r Start of a task.

I Extra information within a task.

f Result of an action within a task.

c Frequency of a task.

n Duration of a task.

y Symbols used in the publication

Roche Diagnostics

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Symbols used on the product

Abbreviations The following abbreviations are used:

d Materials that are required for a task.

j Prerequisites of a task.

u Topic. Used in cross-references to topics.

p Task. Used in cross-references to tasks.

w

Figure. Used in figure titles and cross-

references to figures.

y

Table. Used in table titles and cross-references

to tables.

z

Equation. Used in cross-references to

equations.

k

Code example. Used in code titles and cross-

references to codes.

Symbol Explanation

y Symbols used in the publication

Symbol Explanation

Global Trade Item Number

Quantity contained in the package.

Hardware coding of the cobas omni

Amplification Plate

Hardware coding of the cobas omni Pipette

Tips

Hardware coding of the cobas omni

Processing Plate

y Symbols used on the product

Abbreviation Definition

AD Amplification and detection

ANSI American National Standards Institute

CFR Code of Federal Regulations

CISPR Comité International Spécial des

Pertubations Radioélectriques

CSA Canadian Standards Association

EC European Community

EN European standard

FCC Federal Communications Commission

y Abbreviations

Roche Diagnostics

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What is new in publication version 4.2

Using the User Assistance on the instrument

software

The User Assistance is accessible from the instrument

software.

u Refer to the section Using the User Assistance on the

instrument software in the User Assistance

u Refer to the section Displaying the User Assistance

within the work area in the User Assistance

Environmental conditions Environmental conditions (ambient temperature and

humidity) have been updated.

u Environmental conditions (289)

List of supported sample tubes Contact details were added where to get information

about validated tubes and tubes that are not supported

by the system.

u List of supported sample tubes (292)

List of allowed cleaning solutions

Further details about the use of neodisher MediClean

®

were added.

u List of allowed cleaning solutions (295)

Pausing and resuming the system Information about pausing and resuming the system was

updated.

u Starting the system from Paused status (73)

u List of system statuses (92)

u Pausing and resuming the system (211)

IEC International Electrical Commission

ISO International Organization for

Standardization

LIS Laboratory information system

MGP Magnetic glass particles

n/a not applicable

NAT Nucleic acid testing

PCR Polymerase chain reaction

SOP Standard Operating Procedure

UL Underwriters Laboratories Inc.

UPS Uninterruptible power supply

WEEE Waste Electrical and Electronic Equipment

Abbreviation Definition

y Abbreviations

Roche Diagnostics

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List of sample supply module message codes Measure for the message codes 0305, 1061, and 1072

was updated.

u List of sample supply module message codes (89)

Unloading the amplification plates Information about unloading the amplification plates was

updated.

u Unloading the amplification plates (98)

Consumable reuse Information about the consumable reuse was updated.

Manually removed consumables that were already used

must be discarded. Never reload used consumables.

An additional warning statement about the risk of

contamination was added.

u Unloading/loading the consumables drawer (124)

u Loading tip racks, reagent, and control cassettes (131)

u Refer to the section Cleaning up the instrument during

startup in the User Assistance

u Refer to the section Cleaning up the transfer module in

the User Assistance

u Refer to the section Cleaning up the processing

module in the User Assistance

Loading samples Preconditions for sample loading were updated. Ensure

that all sample tubes are decapped when loading

samples.

u Loading samples (157)

List of flags Flag details were added to the list of flags.

u List of flags (182)

Ordering a repeat test Information about ordering a repeat test was updated.

u Ordering a repeat test (192)

System shutdown and restart A recommendation to weekly shut down and restart the

system was added.

u Shutting down the system (214)

u Periodic maintenance action (227)

Maintenance actions Precondition to start maintenance actions was updated

for two maintenance actions. The instrument must be in

Standby status to start a maintenance action.

u Starting the periodic maintenance wizard to open the

covers (6 of 8) (249)

u Starting sample pipetter tightness check

manually (266)

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Automatic maintenance actions Introduction to the automatic maintenance action was

updated. Information about the responsible user for

automatic maintenance actions was added.

u Automatic maintenance actions (264)

Decontamination procedures Procedures to decontaminate solid and liquid waste

containers were updated.

u Decontaminating solid and liquid waste

containers (278)

Barcode types EAN-8 and EAN-13 Information about the use of barcode types EAN-8 and

EAN-13 was updated. Barcodes starting with prefix 378

and 379 are not supported.

u Refer to the section About barcodes in the User

Assistance

New option for LIS connection Information about the new Include rack ID and rack

position of loaded samples option was added.

u Refer to the section Defining the connection to the LIS

in the User Assistance

Unloading consumables drawer in powerless

or Error status

Information to discard the reagent cassettes after removal

from the interim reagent storage was added.

u Refer to the section Unloading consumables drawer

and MGP cassettes in the User Assistance

What is new in publication version 4.1

Non-Roche external controls based on

alcohol

New safety information about loading non-Roche

external controls based on alcohol.

u Supported sample types (157)

Sample tubes with swabs Additional information added about loading sample tubes

with swabs.

u To load samples (157)

What is new in publication version 4.0

New tasks from the global information area New tasks to configure language and other settings, to

lock the system, and to restart the user interface.

u Editing personal settings (50)

u Locking the system (51)

u Restarting the user interface (51)

Roche Diagnostics

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Restarting after long shutdowns Additional task for systems that have been shut down for

more than 3 months and update of task to restart the

system after a shutdown longer than 10 days.

u Restarting after a shutdown longer than 10 days (79)

u Restarting after a shutdown longer than 3 months (82)

Non-Roche external controls Result formatting of non-Roche external controls.

u Refer to the section About test result formatting in the

User Assistance

Cleaning the tube rotator New maintenance task to clean the tube rotator and

improve barcode reading.

u Cleaning the tube rotator (261)

What is new in publication version 3.2

List of supported sample tubes Contact details were added where to get information

about validated tubes and tubes that are not supported

by the system.

u List of supported sample tubes (292)

List of allowed cleaning solutions

Further details about the use of neodisher MediClean

®

were added.

u List of allowed cleaning solutions (295)

Pausing and resuming the system Information about pausing and resuming the system was

updated.

u Starting the system from Paused status (73)

u List of system statuses (92)

u Pausing and resuming the system (211)

List of sample supply module message codes Measure for the message codes 1061 and 1072 was

updated.

u List of sample supply module message codes (89)

Unloading the amplification plates Information about unloading the amplification plates was

updated.

u Unloading the amplification plates (98)

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.3 · User Guide · Publication version 4.2

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Consumable reuse Information about the consumable reuse was updated.

Manually removed consumables that were already used

must be discarded. Never reload used consumables.

An additional warning statement about the risk of

contamination was added.

u Unloading/loading the consumables drawer (124)

u Loading tip racks, reagent, and control cassettes (131)

u Refer to the section Cleaning up the instrument during

startup in the User Assistance

u Refer to the section Cleaning up the transfer module in

the User Assistance

u Refer to the section Cleaning up the processing

module in the User Assistance

Loading samples Preconditions for sample loading were updated. Ensure

that all sample tubes are decapped when loading

samples.

u Loading samples (157)

Sample tubes with swabs Additional information about loading sample tubes with

swabs was added.

u Loading samples (157)

Ordering a repeat test Information about ordering a repeat test was updated.

u Ordering a repeat test (192)

System shutdown and restart A recommendation to weekly shut down and restart the

system was added.

u Shutting down the system (214)

u Periodic maintenance action (227)

Maintenance actions Precondition to start maintenance actions was updated

for two maintenance actions. The instrument must be in

Standby status to start a maintenance action.

u Starting the periodic maintenance wizard to open the

covers (6 of 8) (249)

u Starting sample pipetter tightness check

manually (266)

Automatic maintenance actions Introduction to the automatic maintenance action was

updated. Information about the responsible user for

automatic maintenance actions was added.

u Automatic maintenance actions (264)

Roche Diagnostics

cobas® 6800/8800 Systems · Software version 1.3 · User Guide · Publication version 4.2

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Decontamination procedures Procedures to decontaminate sample racks and solid and

liquid waste containers were updated.

u Decontaminating sample racks (276)

u Decontaminating solid and liquid waste

containers (278)

Barcode types EAN-8 and EAN-13 Information about the use of barcode types EAN-8 and

EAN-13 was updated. Barcodes starting with prefix 378

and 379 are not supported.

u Refer to the section About barcodes in the User

Assistance

New option for LIS connection Information about the new Include rack ID and tube

position of loaded samples in host query option was

added.

u Refer to the section Defining the connection to the LIS

in the User Assistance

Unloading consumables drawer in powerless

or Error status

Information to discard the reagent cassettes after removal

from the interim reagent storage was added.

u Refer to the section Unloading consumables drawer

and MGP cassettes in the User Assistance

Recovering the system after detecting a

dispense clot

A new troubleshooting procedure about recovering the

system after detecting a dispense clot was added.

u Refer to the section Recovering the system after

detecting dispense clot in the User Assistance

What is new in publication version 3.1

Intended use The intended use statement was updated.

u Intended use (11)

Additional directive New directive added to instrument approvals.

u Instrument approvals (5)

Radio equipment specifications Specifications for radio equipment were added.

u Radio equipment specifications (291)

Repeat test Tip added how to retest invalid individual sample. Further

reason added why no repeat test is possible. Information

added about repeat test with history calculation.

u Reviewing test results (176)

u Repeat test with history calculation (192)

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General decontamination procedure The general decontamination procedure was updated to

include lint-free cotton swabs.

u General decontamination procedures (270)

Cleaning of blue acrylic surfaces Information was added not to clean the blue acrylic

surfaces with ethanol.

u Cleaning the covers and doors (259)

Decontaminating rack trays Decontamination of rack trays was separated from

decontamination of sample racks. A maintenance task to

decontaminate rack trays was added.

u Decontaminating sample racks (276)

u Decontaminating rack trays (276)

Cleaning of processing module The maintenance procedure for cleaning the processing

module from the front was updated.

u To clean the processing module from the front p (255)

Cleaning up of processing module for

troubleshooting

The troubleshooting procedure to clean up the

processing module from the front was updated.

u Refer to the section To clean up the processing

module from the front in the User Assistance.

What is new in publication version 3.0

Strong magnetic field label Information added about this new safety label.

u Refer to the section List of safety labels on the system

in the User Assistance

List of supported sample tubes Update of the sample tube types and dimensions

supported by the system.

u List of supported sample tubes (292)

Minimum volumes for gel separator tubes New section listing the minimum sample volumes

required for gel separator tubes.

u Minimum sample volumes for gel separator

tubes (292)

Replacing the liquid waste container Previous task (Emptying the liquid waste container)

updated.

u Replacing the liquid waste container (111)

Barcode settings The minimum number of characters supported in

barcodes was updated.

u Refer to the section Barcode settings in the User

Assistance

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Automatic hibernation and startup Section for the new feature to set up a time to hibernate

or start up the system automatically.

u Refer to the section Automatic system hibernation and

startup processes in the User Assistance

New options to configure the LIS connection Steps added to include the new settings available for the

LIS connection.

u Refer to the section Defining the connection to the LIS

in the User Assistance

Defining regional settings Section for the new feature that allows configuring

default language and regional settings.

u Refer to the section Defining regional settings in the

User Assistance

Defining print and report settings Section for the new feature that allows configuring print

and report options.

u Refer to the section Defining print and report settings

in the User Assistance

Troubleshooting of open reagent cassette

drawer

What to do if you fin the reagent cassette drawer open

after restarting the system.

u Refer to the section Reagent cassette drawer open in

the User Assistance

What is new in publication version 2.1

User Assistance The section describing installation and use of the User

Assistance has been updated. The topic has also been

moved to a more prominent position within the

publication.

u Refer to the section User Assistance in the User

Assistance.

Starting up the system from off status A step explaining how to manually start up the IG server if

power switch 2 was set to "0" was added.

u Starting up the system from Off status (71)

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