Roche cobas Synergy Software User guide

cobas Synergy software

For use with cobas

®

6800/8800 Systems and Microlab

®

STAR IVD

User Guide Version 3.1

Software version 1.2

Roche Diagnostics

cobas Synergy software · Software version 1.2 · User Guide · Version 3.1

2

Publication information

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

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.

Publication

version

Software version Revision date Change description

1.0 1.0 December 2015 First version

1.1 1.0 May 2016 o New reports added in Operation part

o Retesting of invalid pools added

u What is new in publication version 1.1 (15)

2.0 1.1 December 2016 u What is new in publication version 2.0 (13)

3.0 1.2 August 2017 u What is new in publication version 3.0 (11)

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 (11)

y Revision history

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For test-specific information, refer to the Instructions for

Use of the respective tests.

For information about the optional pre-analytical systems,

refer to the respective user documentation.

!

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.

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.

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.

Screenshots The screenshots in this publication have been added

exclusively for illustration purposes. Configurable and

variable data, 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.

reserved.

Roche Diagnostics

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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 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 Synergy software, refer to

the electronic distribution included with this product.

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.

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 welcome and is considered during

updates. Contact your Roche representative, should you

have any such feedback.

Approvals

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.

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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.

Issued by CSA Group for Canada and the US.

'Laboratory Equipment' is the product identifier as

shown on the type plate.

CUS

Roche Diagnostics

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Contact addresses

For cobas Synergy software:

Stratec Biomedical UK Limited

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

Distributed in the EU by:

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Distributed in the US by:

Roche Diagnostics

9115 Hague Road

Indianapolis, Indiana

USA

Table of contents 7

Roche Diagnostics

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Table of contents

Publication information 2

Contact addresses 6

Table of contents 7

Intended use 9

Symbols and abbreviations 9

What is new in publication version 3.1 11

What is new in publication version 3.0 11

What is new in publication version 2.0 13

What is new in publication version 1.1 15

System operation

1 Workflow overview

Workflow for PP24 and PP96 pooling runs 21

Workflow for PP6 pooling runs 22

Workflow for PP1 pooling runs 23

Workflow for aliquot runs 24

2 Before operation

Starting up and logging on 27

3Operation

Basic operational tasks 33

Pooling operations 40

Reporting in the data manager 82

4 After operation

Shutting down the system 91

5Maintenance

Maintenance intervals 97

Periodic maintenance 98

Regular maintenance 109

Decontamination 110

6 Quick references

Creating a pool 116

Preparing aliquot plates 117

Evaluating pool results 118

Daily maintenance on the pooling

instrument 120

Weekly maintenance on the pooling

instrument 121

Appendix

7 Key terms

Comparison of key terms 127

8 Glossary

Index 131

8 Table of contents

Roche Diagnostics

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Intended use

cobas Synergy software manages samples to be

processed on pre-analytic instruments as a front-end to

the cobas

®

6800/8800 Systems. The cobas Synergy

solution collects data from pooling and analyzer

instruments which allows the user to review results

against individual samples and samples which 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 blood

establishment personnel who are trained in its operation

and are familiar with the associated tests and

instruments.

Symbols and abbreviations

Product names Except where the context clearly indicated otherwise, the

following product names and descriptors are used.

Symbols used in the publication

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

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.

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 Symbols used in the publication

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Symbols used on product

Abbreviations The following abbreviations are used.

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.

y Symbols used on product

Abbreviation Definition

AD Amplification and detection

ALR Above Linear Range

ANSI American National Standards

Institute

ASTM American Society for Testing And

Materials

DIS Donor information system

CSA Canadian Standards Association

EC European Community

EN European standard

IEC International Electrical

Commission

IDT Individual donor testing

IU International unit

IVD In vitro diagnostic

LIMS Laboratory information

management system (another

name for laboratory information

system)

LIS Laboratory information system

n/a not applicable

QC Quality control

QS Quantitation standard

SD Standard deviation

TADM Total Aspiration Dispensing

Monitoring

y Abbreviations

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What is new in publication version 3.1

Analytic system The cobas Synergy software version 1.2 can be used

together with cobas

®

6800/8800 Systems software

version 1.2.13, 1.2.14, 1.3.8, and 1.3.9.

Workflow for primary pools of 1 A workflow for primary pools of 1 (PP1) was implemented.

Use the PP1 pooling run workflow when your laboratory is

using the same sample ID on multiple sample tubes with

different sample types from the same donor. For example,

create a primary pool of 1 from the plasma sample tube to

run a plasma PP1 test whereas the other sample tubes

from the same donor are used to run a whole blood IDT

test and a plasma PP6 test.

Reactive primary pools of 1 do not need to be resolved.

The result of a primary pool of 1 is the final result.

Therefore, no secondary pools for reactive primary pools

of 1 are created.

u Refer to the section Overview of pooling process in the

User Assistance

u Refer to the section Primary pools of 1 in the User

Assistance

u Workflow for PP1 pooling runs (23)

u To force an invalid HAV result to be unresolved for an

IDT or PP1 sample p (78)

u Using sample tubes with the same sample ID for

different sample types (79)

u Refer to the section Minimum pool size in the User

Assistance

What is new in publication version 3.0

Analytic system The cobas Synergy software version 1.2 can be used

together with cobas

®

6800/8800 Systems software

version 1.2.13.

UL Underwriters Laboratories Inc.

UPS Uninterruptible power supply

WEEE Waste Electrical and Electronic

Equipment

Abbreviation Definition

y Abbreviations

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Intended use The intended-use section was updated.

u Intended use (9)

Pool details The table was updated to match the information shown in

the different panels of the software.

u List of pool details (53)

Resending test results The software now allows the resending of already

released result on the Results for review panel. The

procedure for reviewing results was updated accordingly.

u Evaluating results for review (63)

Workflows in case of high B19 titer The section was adapted to match the software version of

the analytic system.

u Handling invalid HAV results due to samples with high

B19 titer (77)

Error messages Additional messages were included.

u List of data manager messages (246)

Configuring targets The software now allows to map the result terms per

target. The description of configuring targets was

updated accordingly.

u Configuring targets (270)

Configuring tests The software now allows to configure a sample type per

test, a volume per test, and to map the result terms per

test. The description of configuring tests was updated

accordingly.

u Configuring tests (273)

Screenshots updated Screenshots that are different with the new software

version were replaced.

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What is new in publication version 2.0

Analytic system The cobas Synergy software version 1.1 can be used

together with cobas

®

6800/8800 Systems software

versions 1.1.09, 1.1.10, or 1.2.12.

Sorting and filtering of tables A new section about sorting and filtering of tables has

been added.

u For details, refer to the cobas Synergy software User

Assistance

User management New sections about the user management have been

added.

u For details, refer to the cobas Synergy software User

Assistance

Exclusion lists A new section explaining the exclusion lists has been

added.

u For details, refer to the cobas Synergy software User

Assistance

Pooling and aliquot workflows A new chapter with a summary about the pooling and

aliquot workflows has been added.

Quick references A new chapter with quick reference information has been

added.

Masking a test order The section about masking a test order has been updated

and expanded.

u About masking a test order (60)

Searching samples A new section about searching samples has been added.

u Searching samples (80)

Workflows in case of high B19 titer The section was moved to the Operation chapter. The

description was extended to differentiate between

different software versions of the analytic system.

New cobas Synergy reports Information about the new cobas Synergy reports has

been added.

• Where is my sample report

• Testing summary report

• Invalid test results report

• Pooler performance report

• Pooler performance export report

u cobas Synergy reports (83)

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Handling sample barcode errors A new section about the handling of sample barcode

reading errors has been added.

u For details, refer to the cobas Synergy software User

Assistance

Data manager messages A list of data manager messages has been added. The list

includes possible causes and recommended actions.

u For details, refer to the cobas Synergy software User

Assistance

Backing up and archiving databases The sections about backing up and archiving databases

have been updated.

Archiving can be performed online now.

u For details, refer to the cobas Synergy software User

Assistance

User Assistance New context links for the Administration tab have been

added to the User Assistance of the data manager.

u For details, refer to the cobas Synergy software User

Assistance

General improvements General improvements have been made throughout this

publication.

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What is new in publication version 1.1

cobas Synergy reports added In the Operation part, new cobas Synergy reports were

integrated in the procedures. All reporting options in the

data manager were summarized in one new section.

Descriptions of reporting in other places were shortened

and instead referenced to the new section.

u Reporting in the data manager (82)

Repeat testing on the analytic system Information was added about repeat testing on the

analytic system in case of invalid results.

u Repeat testing on the analytic system after an invalid

test result (76)

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Roche Diagnostics

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System operation

1 Workflow overview................................................................................................. 19

2 Before operation..................................................................................................... 25

3 Operation................................................................................................................... 31

4 After operation ........................................................................................................ 89

5 Maintenance ............................................................................................................ 95

6 Quick references ..................................................................................................115

1 Workflow overview

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Table of contents

Workflow overview 1

In this chapter

1

Workflow for PP24 and PP96 pooling runs . . . . . . . . . 21

Workflow for PP6 pooling runs. . . . . . . . . . . . . . . . . . . 22

Workflow for PP1 pooling runs. . . . . . . . . . . . . . . . . . . 23

Workflow for aliquot runs . . . . . . . . . . . . . . . . . . . . . . . 24

1 Workflow overview

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