Roche cobas Synergy Software User guide

cobas

®

Synergy software

For use with cobas

®

6800/8800 Systems and Microlab

®

STAR IVD

User Guide

Publication version 5.1

Software version 1.4

2

Roche Diagnostics

cobas

®

Synergy software · Software version 1.4 · User Guide · Publication version 5.1

Publication information

Publication version Software version Revision date Change description

1.0 1.0 December 2015 First version

1.1 1.0 May 2016

• New reports added in Operation part

• Retesting of invalid pools added

u What is new in publication version 1.1 (26)

2.0 1.1 December 2016

u What is new in publication version 2.0 (24)

3.0 1.2 August 2017

u What is new in publication version 3.0 (23)

3.1 1.2 August 2018

Update done for cobas

®

Synergy software patch 5.

This publication is in accordance with analytic software

versions 1.2.13, 1.2.14, 1.3.8, and 1.3.9.

u What is new in publication version 3.1 (22)

4.0 1.3 January 2019

Update for cobas

®

Synergy software version 1.3 to be used

together with analytic software versions 1.2.14 and 1.3.9.

u What is new in publication version 4.0 (17)

5.0 1.4 December 2019

Update for cobas

®

Synergy software version 1.4 to be used

together with analytic software versions 1.3.9 and 1.4.

u What is new in publication version 5.0 (15)

5.1 1.4 November 2020

Update for cobas

®

Synergy software version 1.4 patch1 to be

used together with analytic software versions 1.3.9 and 1.4.7.

u What is new in publication version 5.1 (13)

y Revision history

Edition notice

This publication is intended for operators of the

cobas

®

Synergy software for use with

cobas

®

6800/8800 Systems and Microlab

®

STAR IVD.

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

• A software reference

• Configuration information

• Background information

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Roche Diagnostics

cobas

®

Synergy software · Software version 1.4 · User Guide · Publication version 5.1

The Safety Guide contains important safety information.

You must read the Safety Guide before operating the

Microlab

®

STAR IVD.

The User Guide focuses on routine operation and

maintenance. The chapters are organized according to

the normal operation workflow.

For information about the cobas

®

6800/8800 Systems,

refer to the respective User Assistance.

For test-specific information, refer to the Instructions

for Use of the respective tests.

Privacy notice

When you use User Assistance online, viewing events

(topics viewed and searches performed) and IP

addresses are logged.

The data collected is for Roche internal use only and is

never forwarded to third parties. It is anonymized, and

after one year it is automatically deleted.

Viewing events are analyzed to improve User Assistance

content and search functionality. IP addresses are used

to classify regional behavior.

General attention

To avoid serious or fatal injury and to avoid incorrect

results, ensure that you are familiar with the system, the

instructions, and safety information before you use the

system.

r Pay particular attention to all safety precautions and

safety notices.

r Always follow the instructions in this publication.

r Do not use the Microlab

®

STAR IVD in a way that is

not described in this publication.

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

in this publication.

r Store all publications in a safe and easily retrievable

place.

Incident reporting

r Inform your Roche representative and your local

competent authority about any serious incidents

which may occur when using this product.

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.

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Roche Diagnostics

cobas

®

Synergy software · Software version 1.4 · User Guide · Publication version 5.1

Disclaimer

Not every software version applies to all markets. Some

content in this publication is related to products,

configurations, or tests which are not available in all

markets.

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 renders the

warranty or service agreement null and void.

For conditions of warranty, contact your local sales

representative or refer to your warranty contract partner.

Always leave software updates to a Roche Service

representative, or perform such updates with their

assistance.

Copyright

reserved.

License information

cobas

®

Synergy software is protected by contract law,

copyright law, and international treaties.

cobas

®

Synergy software 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

®

Synergy software might contain components or

modules that are open source or commercial software

programs. For copyright and other notices and licensing

information regarding such software programs included

with cobas

®

Synergy software please see the Copyright

and licensing file deployed on the client desktop.

This open source and commercial software and

cobas

®

Synergy software as a whole can constitute a

device regulated in accordance with applicable law. For

more detailed information, refer to the user manual and

labeling.

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Roche Diagnostics

cobas

®

Synergy software · Software version 1.4 · User Guide · Publication version 5.1

Please note that the respective authorization is no longer

valid according to the corresponding legislation should

any unauthorized changes be made to

cobas

®

Synergy software.

Trademarks

The following trademarks are acknowledged:

Microlab is a registered trademark of Hamilton Bonaduz

AG.

COBAS, COBAS P, COBAS SYNERGY, 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 welcomed and is considered

during updates. Contact your Roche representative,

should you have any such feedback.

Approvals for the Microlab

®

STAR IVD

The Microlab

®

STAR IVD meets 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.

Compliance with the applicable directive(s) is provided

by means of the Declaration of Conformity.

The following marks demonstrate compliance:

For in vitro diagnostic use.

Complies with the provisions of the applicable EU

directives.

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Roche Diagnostics

cobas

®

Synergy software · Software version 1.4 · User Guide · Publication version 5.1

Issued by CSA Group for Canada and the US.

'Laboratory Equipment' is the product identifier as

shown on the type plate.

Approvals for cobas

®

Synergy software

The cobas

®

Synergy software meets the requirements

laid down in:

Regulation (EU) 2017/746 of the European Parliament

and of the Council of 5 April 2017 on in vitro diagnostic

medical devices and repealing Directive 98/79/EC and

Commission Decision 2010/227/EU.

Compliance with the applicable directive(s) is provided

by means of the Declaration of Conformity.

The following marks demonstrate compliance:

For in vitro diagnostic use.

Complies with the provisions of the applicable EU

regulations.

Contact adresses

For cobas

®

Synergy software:

Biomedical Data Solutions

Centrum Point

Third Avenue

Centrum 100

Burton upon Trent

DE14 2WD

United Kingdom

For Microlab

®

STAR IVD:

HAMILTON Bonaduz AG

Via Crusch 8

CH-7402 Bonaduz

Switzerland

Made in Switzerland

7

Roche Diagnostics

cobas

®

Synergy software · Software version 1.4 · User Guide · Publication version 5.1

Distributed in the United States by:

Roche Diagnostics

9115 Hague Road

Indianapolis, IN 46256

USA

Roche affiliates

A list of all Roche affiliates can be found at:

www.roche.com/about/business/roche_worldwide.htm

eLabDoc

Electronic user documentation can be downloaded using

the eLabDoc e-service on Roche Dialog:

www.dialog.roche.com

For more information, contact your local affiliate or

Roche Service representative.

8

Roche Diagnostics

cobas

®

Synergy software · Software version 1.4 · User Guide · Publication version 5.1

9Table of contents

Roche Diagnostics

cobas

®

Synergy software · Software version 1.4 · User Guide · Publication version 5.1

Table of contents

Publication information 2

Contact adresses 6

Intended use 11

Symbols and abbreviations 11

What is new in publication version 5.1 13

What is new in publication version 5.0 15

What is new in publication version 4.0 17

What is new in publication version 3.1 22

What is new in publication version 3.0 23

What is new in publication version 2.0 24

What is new in publication version 1.1 26

System operation

1 Workflow overview

Workflow for PP24 and PP96 pooling runs 31

Workflow for PP6 pooling runs 32

Workflow for PP1 pooling runs 33

Workflow for aliquot runs 34

2 Before operation

Starting up and logging on 37

3 Operation

Basic operational tasks 43

Pooling operations 49

Reporting in the data manager 90

Changing the database in the data manager 96

4 After operation

Shutting down the system 101

5 Maintenance

Maintenance intervals 107

Periodic maintenance 108

Regular maintenance 118

Decontamination 120

6 Quick references

Creating a pool 127

Preparing aliquot plates 128

Evaluating pool results 129

Daily maintenance on the pooling

instrument

132

Weekly maintenance on the pooling

instrument

133

Appendix

7 Key terms

Comparison of key terms 139

Glossary

Index

10

Roche Diagnostics

cobas

®

Synergy software · Software version 1.4 · User Guide · Publication version 5.1

11

Roche Diagnostics

cobas

®

Synergy software · Software version 1.4 · User Guide · Publication version 5.1

Intended use

The cobas

®

Synergy software is intended to be used for

the management of data regarding samples to be

processed for individual testing and pooling. The

software collects data for samples that have been pooled

and analyzed, which allows the user to review results

against individual samples and samples that have been

pooled, creating output files from the data that can be

sent to a laboratory information system.

cobas

®

Synergy software is intended for use by

laboratory staff who are trained in its use and are familiar

with the associated test and instruments.

Symbols and abbreviations

Product names

Except where the context clearly indicates otherwise, the

following product names and descriptors are used.

Product name Descriptor

cobas

®

Synergy solution

solution

cobas

®

Synergy core

core

cobas

®

Synergy software

software

Microlab

®

STAR IVD pooling instrument

cobas

®

6800/8800 Systems

analytic system

y Product names

Symbols used in the publication

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

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Roche Diagnostics

cobas

®

Synergy software · Software version 1.4 · User Guide · Publication version 5.1

Symbol Explanation

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.

y Symbols used in the publication

Symbols used on product

Symbol Explanation

Global Trade Item Number.

Quantity contained in the package.

Date of manufacture.

Manufacturer.

y Symbols used on product

Abbreviations

The following abbreviations are used.

Abbreviation Definition

ANSI American National Standards Institute

ASTM American Society for Testing And

Materials

CSA Canadian Standards Association

Ct Threshold cycle

EC European Community

EN European standard

IC Internal control

y Abbreviations

13

Roche Diagnostics

cobas

®

Synergy software · Software version 1.4 · User Guide · Publication version 5.1

Abbreviation Definition

IEC International Electrical Commission

IDT Individual donor testing

IDT RBO IDT rack-based ordering (on the

cobas

®

Synergy software)

IU International unit

IVD In vitro diagnostic

LIS Laboratory information system

n/a not applicable

QS Quantitation standard

RBO Rack-based ordering (on the

cobas

®

6800/8800 Systems)

SD Standard deviation

UPS Uninterruptible power supply

WEEE Waste Electrical and Electronic

Equipment

y Abbreviations

What is new in publication version 5.1

Analytic system

The cobas

®

Synergy software version 1.4 patch1 can

be used together with cobas

®

6800/8800 Systems

software versions 1.3.9 and 1.4.7.

Pre-analytical systems

The optional pre-analytical systems are not supported

any more by the cobas

®

Synergy solution.

Approvals for cobas

®

Synergy software

Approvals for the cobas

®

Synergy software were added.

u Approvals for cobas

®

Synergy software (6)

Contact addresses

The contact addresses were updated.

Information where to find a list of Roche affiliates and

how to access electronic user documentation was added.

u Contact adresses (6)

Intended use

The intended use was updated.

u Intended use (11)

Pipetting overview

The information was updated:

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Roche Diagnostics

cobas

®

Synergy software · Software version 1.4 · User Guide · Publication version 5.1

• The information for primary pools was updated for the

different sample types and the number of tests that

can be ordered.

• Information for secondary pools was added.

• Aliquoting is only possible for plasma samples.

u Pipetting overview (49)

Confirmation of sample type

Confirmation of sample type during loading of the

pooling instrument is only required if more than 1 sample

type is configured in the pooling instrument manager.

u Creating a pool (51)

Mixing status of PP1 and SP1

On the Pending tests panel, PP1 and SP1 have mixing

status = 1 because they are not mixed.

For PP1 and SP1, this does not indicate that mixing failed.

u List of pool details (61)

Pending pooling orders for invalid pooling

orders

If a pooling order for a sample is invalidated while

creating a pool, it depends on when the invalidation

happens if a new pending pooling order with the same

run settings is created automatically.

u Evaluating pending pools (66)

Masking of test orders

The rules were generalized when masking of test orders

is not possible.

u Evaluating pending tests (68)

Results for review

A result is final if it can be validated in the Results for

review panel in the data manager.

Information was added that manual validation and/or

release of results is only necessary if automatic validation

and/or release is not configured.

When a test result for PP6 is rejected, a SP6 pending

pooling order is created.

Manual validation and manual release of results require

entering of comment, user name, and password.

u Evaluating results for review (73)

Reports

The templates for the cobas

®

Synergy reports were

updated.

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Roche Diagnostics

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®

Synergy software · Software version 1.4 · User Guide · Publication version 5.1

The following cobas

®

Synergy reports include now up

to 4 targets:

• Donor result report

• Testing summary report

• Invalid test result report

• Sample audit report

• Control batch summary report

u cobas

®

Synergy reports (91)

What is new in publication version 5.0

Lysed whole blood

Support for the new sample type lysed whole blood was

added.

u For details, refer to the cobas

®

Synergy software

User Assistance

Analytic system

The cobas

®

Synergy software version 1.4 can be used

together with cobas

®

6800/8800 Systems software

versions 1.3.9 and 1.4.

User Assistance

The section about the User Assistance was reworked.

u For details, refer to the cobas

®

Synergy software

User Assistance

WNV exclusion list and default IDT

The functions for WNV exclusion list and default IDT

tests have been removed from the software.

SP1 resolution workflow

A new resolution workflow using secondary pools of 1

(SP1) was introduced. This workflow is an alternative to

the existing IDT resolution and is used when working

with both sample types plasma and lysed whole blood on

the system.

u For details, refer to the cobas

®

Synergy software

User Assistance

Filtering data in tables

The usability of the filter function in tables was adapted.

When you type a filter value in a column header, it

becomes active only after you have pressed enter.

u For details, refer to the cobas

®

Synergy software

User Assistance

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Roche Diagnostics

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®

Synergy software · Software version 1.4 · User Guide · Publication version 5.1

cobasomni utility channel test

Support for cobasomni utility channel tests was added.

Four predefined PP6 pooling protocols, three predefined

PP1 pooling protocols, and the required secondary

pooling protocols are assigned to cobasomni utility

channel tests.

u For details, refer to the cobas

®

Synergy software

User Assistance

Pool tube confirmation

The pooling instrument checks the pool tube barcodes

during loading and rejects pool tubes that were used

previously.

u Creating a pool (51)

Force unresolved result function

On the Pending pools panel, the Force unresolved

result button was added. Use this button to force

unresolved PP1 or SP1 pooling orders.

u Evaluating pending pools (66)

Rejecting pools

On the Pending tests panel, the functionality of the

Reject pool button was expanded.

Multi-test pool tubes that have a final and an invalid

result assigned (for example MPX-N.R. and DPX-Invalid),

the pool is not invalidated and a repeat pooling order is

only created for the invalid test (for example PP24_DPX).

u Evaluating pending tests (68)

Search function on the Sample history panel

On the Sample history panel, a new search function

was introduced.

u Evaluating sample history (76)

Control batch summary report

The control batch summary report was added. The report

provides an overview of all results associated with

specific control batches of an analytic system, including

reagent and consumable information

u Operation reports (92)

Data manager messages

The list of data manager messages was updated.

Messages now include instructions on the next steps to

be performed.

u For details, refer to the cobas

®

Synergy software

User Assistance

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Roche Diagnostics

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®

Synergy software · Software version 1.4 · User Guide · Publication version 5.1

Administration panels on client workstation

All administration panels are now also accessible from

the client workstation. When entering a file path or folder

location on a client workstation, be aware that the path is

interpreted as related to the server.

Pool resolution method

It is possible to select the pool resolution method for the

sample types plasma and lysed whole blood (IDT or SP1).

This option is only related to systems that run both

sample types.

u For details, refer to the cobas

®

Synergy software

User Assistance

User access rights

A new section about user access rights was introduced.

u For details, refer to the cobas

®

Synergy software

User Assistance

What is new in publication version 4.0

Analytic system

The cobas

®

Synergy software version 1.3 can be used

together with cobas

®

6800/8800 Systems software

versions 1.2.14 and 1.3.9.

User Assistance

The information about the digital User Assistance was

updated and moved to a separate chapter.

u For details, refer to the cobas

®

Synergy software

User Assistance

Track positions

The track positions on the pooling instrument for 24-

positions sample carriers was updated for pooling runs

and aliquot runs.

u For details, refer to the cobas

®

Synergy software

User Assistance

Screenshot function

You can take screenshots of the currently displayed

panel.

u For details, refer to the cobas

®

Synergy software

User Assistance

Data in tables

Information was added how to refresh data in tables. The

information how to sort data in tables was updated.

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Roche Diagnostics

cobas

®

Synergy software · Software version 1.4 · User Guide · Publication version 5.1

u For details, refer to the cobas

®

Synergy software

User Assistance

Exclusion lists

The information on exclusion lists was updated and

expanded.

u For details, refer to the cobas

®

Synergy software

User Assistance

Loading sample tubes

Only leave empty positions at the end of the first carrier

loaded onto the pooling instrument.

u To load sample tubes (45)

Loading pool tubes

Start loading in the leftmost track and do not leave gaps

between pool tube carriers.

u To load pool tubes (45)

Tip rack carriers

Always place 5 tip racks on a tip rack carrier.

u Preparing a tip rack carrier (47)

Analytic system

Information how the analytic system must be configured

was added.

Information how to load the analytic system was added.

u Configuration of the cobas

®

6800/8800 Systems

(50)

u Loading the cobas

®

6800/8800 Systems (50)

IDT RBO

It is now possible to use IDT RBO. Recommendations

were added for the ordering concept and the loading

concept when using IDT RBO.

The IDT rack-based order settings are configured on the

cobas

®

Synergy software.

u RBO on the cobas

®

6800/8800 Systems (50)

u For details about IDT rack-based order settings, refer

to the cobas

®

Synergy software User Assistance

Invalid pools

If there was a clot detected during dispensing, the

affected pool is invalidated.

u To create a pool (52)

Information in the data manager

The descriptions for the information available in the data

manager was updated.

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Roche Diagnostics

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®

Synergy software · Software version 1.4 · User Guide · Publication version 5.1

u List of pool details (61)

Pending pools

The information how to evaluate pending pooling orders

was updated and expanded.

u Evaluating pending pools (66)

Pending tests

The information how to evaluate pending test orders was

updated and expanded.

Masking of test orders allows you to choose which tests

are performed on the analytic system.

The description how to proceed after a run abort on the

analytic system was updated.

u Evaluating pending tests (68)

Results for review

The information how to evaluate results for review was

updated and expanded.

Control, reagent, and consumable information are

displayed on the Results for review panel.

For IDT samples, rejecting a test result creates a new

pending test order.

u Evaluating results for review

Sample history

The information how to evaluate the sample history was

updated and expanded.

u Evaluating sample history (76)

Unconfirmed samples

Samples that were already tested for the same test are

unconfirmed for a pooling run.

Do not use the repeat loading option for unconfirmed

samples.

Unconfirmed samples are displayed in the Pending

pools panel.

u Handling a pool when not all samples were

confirmed (78)

Invalid pools

The procedure how to handle invalid pools was updated.

u To handle invalid pools (81)

Repeat testing after invalid test result

IDT samples with an invalid test result from IDT RBO

must be reloaded in the same rack range on the analytic

system for repeat testing.

The information how to release invalid test results from

the analytic system was updated.

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®

Synergy software · Software version 1.4 · User Guide · Publication version 5.1

u Repeat testing on the analytic system after an invalid

test result (85)

Using sample tubes with the same sample ID

for different sample types

When using sample tubes with the same sample ID for

different sample types, always use IDT RBO.

u Using sample tubes with the same sample ID for

different sample types (88)

Changing the database

A description how to change to a previously restored

archive database was added.

u Changing the database in the data manager

Restarting the workstation

Restart the data manager workstation weekly was added

to the regular maintenance.

u Restarting the workstation (118)

Quick reference

The quick reference for evaluating pool results was

updated and expanded.

To mask a test order and to force an unresolved result

was added to the quick reference.

u Evaluating pool results (129)

Barcode reading errors

In case of barcode reading errors, enter the barcode ID

either by using the hand-held barcode reader or

manually using the keyboard.

u For details, refer to the cobas

®

Synergy software

User Assistance

Consumable identification error

The information how to resolve a consumable

identification error was updated.

u For details, refer to the cobas

®

Synergy software

User Assistance

Pipette tip pickup error

If you cancel the run after a pipette tip pickup error, the

samples from the run get a new pending pooling order

with the same run settings.

u For details, refer to the cobas

®

Synergy software

User Assistance

Switching off control unit

Always switch off the control unit before switching off

the pooling instrument.

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Roche cobas Synergy Software User guide

Roche cobas Synergy Software User guide

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