Roche cobas 8800 User guide

cobas

®

6800/8800 Systems

User Guide

Publication version 5.0

Software version 1.4

2

Roche Diagnostics

cobas

®

6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0

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.

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.

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.

y Revision history

3

Roche Diagnostics

cobas

®

6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0

Publication version Software version Revision date Change description

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

(19)

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

(19)

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

(16)

5.0 1.4 December 2019

u What is new in publication version 5.0

(13)

y Revision history

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 information

• Troubleshooting information

• Configuration information

• Background information

4

Roche Diagnostics

cobas

®

6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0

The Safety Guide contains important safety information.

This information is also included in the User Assistance.

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. This information is also

included in the User Assistance.

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.

Copyright

reserved.

5

Roche Diagnostics

cobas

®

6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0

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.

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.

6

Roche Diagnostics

cobas

®

6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0

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.

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://dialog.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:

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.

Contact addresses

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

7

Roche Diagnostics

cobas

®

6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0

Distributed in the United States by

Roche Diagnostics

9115 Hague Road

Indianapolis

Indiana, USA

8

Roche Diagnostics

cobas

®

6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0

9Table of contents

Roche Diagnostics

cobas

®

6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0

Table of contents

Publication information 2

Contact addresses 6

Intended use 11

Symbols and abbreviations 11

What is new in publication version 5.0 13

What is new in publication version 4.2 16

What is new in publication version 4.1 19

What is new in publication version 4.0 19

Operation

1 Overview of the system

About the cobas

®

6800/8800 Systems

25

Monitor 27

Start button 28

Open/close covers button 29

Middle and rear covers 30

Overview of the sample supply module 31

Overview of the transfer module 35

Overview of the processing module 41

Overview of the analytic module 49

Buttons and power switches on the system 52

2 Overview of operation

Overview of the software 59

Overview of the main workflow 73

Quick start guide 76

3 Before operation

Starting up the system 83

System alarm concept 95

4 Reagents and consumables

Overview of the reagents and consumables 109

Unloading the amplification plates 110

Handling the wash/waste drawer 112

Loading the bulk reagent drawer 131

Unloading and loading the consumables

drawer

136

Loading and unloading the reagent cassette

drawer

143

5 Sample processing

Setting the system to Ready status 155

Handling test orders 156

Overview of loading/unloading procedures 160

Handling racks for clotted tips 166

Loading samples 172

Unloading sample racks 181

Starting a run 186

Canceling a run 189

Masking/unmasking a module or magazine 190

Reviewing test results 192

Test result reports 214

Releasing test results 219

Releasing test results via remote access 220

Downloading files from the IG server 221

Viewing audit trail entries 222

Exporting test results 223

Priming the instrument 224

6 After operation

Pausing and resuming the system 227

Setting the system to Hibernate status 228

Shutting down the system 230

Restarting by power switch 233

Shutting down the IG server 235

Starting the IG server 236

Setting the system to powerless status 237

Shut down for more than 10 days 240

Maintenance

7 Maintenance

List of maintenance intervals 245

Viewing maintenance logs 247

Periodic maintenance 248

Regular maintenance 281

Automatic maintenance actions 286

Decontamination 293

Moving the movable platform 304

System description

8 Specifications

List of system specifications 313

Supported material 316

Glossary

Index

10

Roche Diagnostics

cobas

®

6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0

11

Roche Diagnostics

cobas

®

6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0

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.

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

Symbols used in the publication

The following symbols are used:

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.

y Symbols used in the publication

12

Roche Diagnostics

cobas

®

6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0

Symbol Explanation

I

Extra information within a task.

f

Result of an action within a task.

c

Frequency of a task.

n

Duration of a task.

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.

Context search. Used on the context search

tab.

Search. Used on the search tab.

Table of contents. Used on the table of

contents tab.

Hardware explorer. Used on the hardware

explorer tab.

History. Used on the history tab to show

previously viewed topics.

Favorites. Used on the favorites tab and on the

content panel.

Enlarge. Button used on images.

y Symbols used in the publication

Symbols used on the product

Symbol Explanation

Global Trade Item Number

Quantity contained in the package.

y Symbols used on the product

13

Roche Diagnostics

cobas

®

6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0

Symbol Explanation

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

Abbreviations

The following abbreviations are used:

Abbreviation Definition

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

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

RFID Radio frequency identification

SOP Standard Operating Procedure

UL Underwriters Laboratories Inc.

UPS Uninterruptible power supply

WEEE Waste Electrical and Electronic Equipment

y Abbreviations

What is new in publication version 5.0

Maintenance

Maintenance functions for the instruments and IG server

have been redesigned. The main changes are:

14

Roche Diagnostics

cobas

®

6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0

• Each instrument has its own maintenance settings.

Maintenance actions can be performed individually

for each instrument from the Monitoring tab.

• Scheduled instrument maintenance is performed

during the daily maintenance window. For each

instrument, you can define an individual daily

maintenance window.

• The maintenance actions are scheduled based on

their schedule plan (Daily, Weekly, and On

demand)

• To add more flexibility to the periodic maintenance

execution, you can define a lead period and grace

period for each maintenance action.

• The launch type defines whether the maintenance

action is launched automatically or has to be started

manually when due.

• Each maintenance action has default values.

• Instrument maintenance settings are configured in

Administration > Settings > Processing settings

> Instrument maintenance settings.

• IG server maintenance actions are configured in

Administration > Settings > Processing settings

> IG server maintenance settings.

• A new instrument maintenance action Sample

pipetters teaching was introduced.

u Refer to the section List of data management maintenance

actions in the User Assistance

u Refer to the section Instrument maintenance settings in

the User Assistance

u Starting the Sample pipetters teaching maintenance

action manually (291)

User Assistance

The description of the User Assistance was reworked.

u Refer to the section Using User Assistance in the User

Assistance

Message confirmation

It is possible to select and confirm several messages in

one step.

u Monitoring statuses and messages (97)

Solid waste compartment

The solid waste compartment and solid waste bag with

insert is now the default waste option. The solid waste

container for waste bags without an insert is available

only on request.

u About the options for solid waste (112)

15

Roche Diagnostics

cobas

®

6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0

Reagent cassette allocation

A new section about reagent cassette allocation was

added.

u Reagent cassette allocation (150)

Handling error sample racks on sample

supply module

Configuration of the error sample rack unloading settings

can be assigned for either unidirectional or bidirectional

modes in the sample supply module.

u About the unidirectional mode (162)

u About the bidirectional mode (164)

u Refer to the section Defining conveyor settings in the User

Assistance

Handling racks for clotted tips on sample

supply module

The racks for clotted tips are unloaded to the output

buffer when the sample supply module is set to

bidirectional mode and connected to a conveyor belt.

u Handling racks for clotted tips (166)

High-target test results

Results of high-target tests are displayed in a separate

High-target test results view.

u Reviewing test results (193)

Results detail panel

The results detail panel was changed. Results and flags

are displayed on separate tabs.

u Reviewing test results (193)

Cleaning processing modules

The cleaning procedure for the processing modules was

expanded with additional steps to clean the teach block

and the wash station, if necessary.

u Cleaning transfer and processing modules (7 of 8)

(273)

Barcode masking for secondary tubes

Barcode masking is not supported for secondary tubes

that are used for pooling.

u Refer to the section About barcode masking in the User

Assistance

Result upload to LIS

Results can be automatically uploaded to the LIS. The

result upload is configurable.

u Refer to the section Defining the connection to the LIS in

the User Assistance

16

Roche Diagnostics

cobas

®

6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0

Test order settings

Two new test order settings have been added.

• Repeat test button: The Repeat test button can be

disabled.

• Delete test orders for unprocessed samples after

system stopping.: Unprocessed test orders are

deleted during sample unloading.

u Refer to the section Defining test order settings in the

User Assistance

Screen sharing on IG server

Screen sharing on the IG server is done using the IG

server remote service access option.

u Refer to the section To enable and disable screen sharing

in the IG server in the User Assistance

Troubleshooting

The following new troubleshooting topics have been

added:

u Refer to the section Recovering the instrument after error -

including pre- and postactions in the User Assistance

u Refer to the section Guided troubleshooting for pipetting

issues on the transfer module in the User Assistance

u Refer to the section Finding pipetting issues in the

message list in the User Assistance

u Refer to the section Finding unprocessed samples in the

message list in the User Assistance

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.

Environmental conditions

Environmental conditions (ambient temperature and

humidity) have been updated.

u Environmental conditions (313)

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 (316)

17

Roche Diagnostics

cobas

®

6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0

List of allowed cleaning solutions

Further details about the use of neodisher MediClean

®

were added.

u List of allowed cleaning solutions (318)

Pausing and resuming the system

Information about pausing and resuming the system was

updated.

u Starting the system from Paused status (85)

u List of system statuses (103)

u Pausing and resuming the system (227)

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 (101)

Unloading the amplification plates

Information about unloading the amplification plates was

updated.

u Unloading the amplification plates (110)

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 and loading the consumables drawer (136)

u Loading tip racks, reagent, and control cassettes (143)

u Refer to the section Recovering the instrument after error

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 (173)

List of flags

Flag details were added to the list of flags.

u List of flags (196)

18

Roche Diagnostics

cobas

®

6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0

Ordering a repeat test

Information about ordering a repeat test was updated.

u Ordering a repeat test (209)

System shutdown and restart

A recommendation to weekly shut down and restart the

system was added.

u Shutting down the system (230)

u Periodic maintenance action (245)

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) (272)

u Starting the Sample pipetter tightness check

maintenance action manually (289)

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 (286)

Decontamination procedures

Procedures to decontaminate solid and liquid waste

containers were updated.

u Decontaminating solid and liquid waste containers

(302)

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

19

Roche Diagnostics

cobas

®

6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0

What is new in publication version 4.1

Non-Roche controls based on alcohol

New safety information about loading non-Roche

controls based on alcohol.

Sample tubes with swabs

Additional information added about loading sample

tubes with swabs.

u To load samples (173)

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 (62)

u Locking the system (63)

u Restarting the user interface (64)

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

(91)

u Restarting after a shutdown longer than 3months

(92)

Non-Roche controls

Result formatting of non-Roche controls.

u About test result formatting (192)

Cleaning the tube rotator

New maintenance task to clean the tube rotator and

improve barcode reading.

u Cleaning the tube rotator (283)

New LIS connection options

Task to configure LIS connection updated.

u Refer to the section Defining the connection to the LIS in

the User Assistance

Troubleshooting after dispense clot

Task to follow in case of having the system stopped after

dispense clot.

20

Roche Diagnostics

cobas

®

6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0

u Refer to the section Recovering the system after detecting

a clot during dispensing in the User Assistance

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