Roche cobas Synergy Software User manual

cobas Synergy software

For use with cobas

®

6800/8800 Systems (software version 1.2.13) and

Microlab

®

STAR IVD

User Assistance Version 3.0

Software version 1.2

Roche Diagnostics

cobas Synergy software · Software version 1.2 · User Assistance · Version 3.0

2

Publication information

Edition notice This publication is intended for operators of the

cobas Synergy software for use with cobas

®

6800/8800

Systems (software version 1.2.13) 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

o Information added and updated for samples with high B19

titer

o Table added for minimum pool size

o Screenshots and texts updated in Configuration part

o Information about Aurora reports deleted

u What is new in publication version 1.1 (14)

2.0 1.1 December 2016 u What is new in publication version 2.0 (12)

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

y Revision history

Roche Diagnostics

cobas Synergy software · Software version 1.2 · User Assistance · Version 3.0

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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

cobas Synergy software · Software version 1.2 · User Assistance · Version 3.0

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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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cobas Synergy software · Software version 1.2 · User Assistance · Version 3.0

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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

cobas Synergy software · Software version 1.2 · User Assistance · Version 3.0

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 3.0 11

What is new in publication version 2.0 12

What is new in publication version 1.1 14

Safety

1 General safety information

Introduction 19

Safety classifications 20

Safety precautions 21

Warning messages 24

Caution messages 28

Notices 33

Safety labels on the instrument 36

Safety information for lasers 38

Safety information for disposal 39

Description of cobas Synergy solution

2 Overview of cobas Synergy solution

About the cobas Synergy solution 45

3 Overview of the hardware

Pooling instrument overview 53

Consumables 70

External PC 74

4 Overview of cobas Synergy software

About the data manager 77

About the pooling instrument manager 88

About user management 92

About the User Assistance 93

5 Description of the pooling process

Overview of pooling process 99

Primary pools 100

Secondary pools 101

Individual donor testing (IDT) 104

Aliquots 105

Exclusion lists 106

6 Specifications

List of pooling instrument specifications 109

System operation

7 Workflow overview

Workflow for PP24 and PP96 pooling runs 115

Workflow for PP6 pooling runs 116

Workflow for aliquot runs 117

8 Before operation

Starting up and logging on 121

9 Operation

Basic operational tasks 127

Pooling operations 134

Reporting in the data manager 174

10 After operation

Shutting down the system 183

11 Maintenance

Maintenance intervals 189

Periodic maintenance 190

Regular maintenance 201

Decontamination 202

12 Quick references

Creating a pool 208

Preparing aliquot plates 209

Evaluating pool results 210

Daily maintenance on the pooling

instrument 212

Weekly maintenance on the pooling

instrument 213

Troubleshooting

13 Troubleshooting

Troubleshooting on the Microlab

®

STAR

IVD 219

Troubleshooting on the data manager 233

List of data manager messages 236

Configuration

14 Configuration of pooling instrument manager

Managing users on the pooling instrument

manager 249

8 Table of contents

Roche Diagnostics

cobas Synergy software · Software version 1.2 · User Assistance · Version 3.0

15 Basic configuration of data manager

About basic configuration 257

Configuring targets 260

Configuring tests 263

Configuring primary runs 266

Assigning tests to IDT runs 268

Connecting instruments 270

Additional general settings 273

Processing results automatically 275

Backing up databases 276

Archiving databases 279

16 The Configuration environment

The Configuration environment of the data

manager 285

Configuring LIS export 288

Creating messages 294

17 The Manager environment

The Manager environment of the data

manager 301

Setting system information codes 304

Managing software access 312

Locking tests, reports, and accept methods 324

Entering laboratory details 328

Viewing log files 329

Appendix

18 Key terms

Comparison of key terms 335

19 Glossary

Index 339

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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

Search. Used on the search tab.

Table of contents. Used on the table of

contents 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.

Settings. Button used to open the settings

dialog.

Contact. Used in the User Assistance.

Functionality currently unavailable.

y Symbols used in the publication

Roche Diagnostics

cobas Synergy software · Software version 1.2 · User Assistance · Version 3.0

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Symbols used on product

Abbreviations The following abbreviations are used.

Symbol Explanation

Global Trade Item Number.

Quantity contained in the package.

y Symbols used on product

Abbreviation Definition

AD Amplification and detection

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

UL Underwriters Laboratories Inc.

UPS Uninterruptible power supply

WEEE Waste Electrical and Electronic

Equipment

y Abbreviations

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cobas Synergy software · Software version 1.2 · User Assistance · Version 3.0

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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.

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 (147)

Resending test results The software now allows the resending of already d result

on the Results for review panel. The procedure for

reviewing results was updated accordingly.

u Evaluating results for review (157)

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 (171)

Error messages Additional messages were included.

u List of data manager messages (236)

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

target. The description of configuring targets was

updated accordingly.

u Configuring targets (260)

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 (263)

Screenshots updated Screenshots that are different with the new software

version were replaced.

Roche Diagnostics

cobas Synergy software · Software version 1.2 · User Assistance · Version 3.0

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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 Sorting and filtering data in tables (86)

User management New sections about the user management have been

added.

u About user management (92)

u Managing users on the data manager (322)

Exclusion lists A new section explaining the exclusion lists has been

added.

u Exclusion lists (106)

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 (154)

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

u Searching samples (173)

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 (175)

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

reading errors has been added.

u Sample barcode reading error (220)

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cobas Synergy software · Software version 1.2 · User Assistance · Version 3.0

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

includes possible causes and recommended actions.

u List of data manager messages (236)

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

have been updated.

Archiving can be performed online now.

u Backing up databases (276)

u Archiving databases (279)

User Assistance New context links for the Administration tab have been

added to the User Assistance of the data manager.

u About basic configuration (257)

General improvements General improvements have been made throughout this

publication.

Roche Diagnostics

cobas Synergy software · Software version 1.2 · User Assistance · Version 3.0

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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 (174)

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 (169)

Workflows in case of high B19 titer The section describing workflows in case of samples with

high B19 titer was updated and extended.

Minimum pool size An overview table for the minimum pool size was added.

u Additional general settings (273)

Updates in Configuration part Screenshots and texts in the Configuration part were

updated to reflect changes in the user interface.

u The Configuration environment (283)

u The Manager environment (299)

Aurora reports The chapter describing Aurora reports was deleted

(legacy functionality only). Recommendation not to use

Aurora reports was added.

u Reporting in the data manager (174)

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Safety

1 General safety information.................................................................................. 17

1 General safety information

Roche Diagnostics

cobas Synergy software · Software version 1.2 · User Assistance · Version 3.0

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Table of contents

General safety information 1

In this chapter

1

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Safety classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Safety precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Operator qualification . . . . . . . . . . . . . . . . . . . . . . . 21

Safe and proper use of the instrument . . . . . . . . . 21

Miscellaneous safety precautions . . . . . . . . . . . . . 23

Warning messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Electrical safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Optical safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Biohazardous materials . . . . . . . . . . . . . . . . . . . . . . 25

Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Explosion and fire . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Caution messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Mechanical safety. . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Proper identification. . . . . . . . . . . . . . . . . . . . . . . . . 29

Contamination. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Collection media and other working solutions . . . 30

Fatigue due to long hours of operation . . . . . . . . . 31

Electromagnetic interference . . . . . . . . . . . . . . . . . 31

IT security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Notices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Moving parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Circuit breakers and fuses . . . . . . . . . . . . . . . . . . . 33

Pipetting channels . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Proper loading and handling . . . . . . . . . . . . . . . . . 34

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

Safety labels on the instrument . . . . . . . . . . . . . . . . . . 36

List of safety labels on the instrument. . . . . . . . . . 36

Location of safety labels on the instrument . . . . . 37

Safety information for lasers . . . . . . . . . . . . . . . . . . . . . 38

Safety information for disposal. . . . . . . . . . . . . . . . . . . 39

Disposal information . . . . . . . . . . . . . . . . . . . . . . . . 39

1 General safety information

Roche Diagnostics

cobas Synergy software · Software version 1.2 · User Assistance · Version 3.0

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Table of contents

1 General safety information

Roche Diagnostics

cobas Synergy software · Software version 1.2 · User Assistance · Version 3.0

General safety information 19

Introduction

!

General attention

To avoid serious or fatal injury, read this publication

thoroughly before you use the instrument.

r Pay particular attention to all safety precautions.

r Always follow the instructions in this publication.

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

described in this publication.

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

is not damaged and remains available for use.

This publication must always be easily accessible.

1 General safety information

Roche Diagnostics

cobas Synergy software · Software version 1.2 · User Assistance · Version 3.0

20 Safety classifications

Safety classifications

The safety precautions and important user notes are

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

Familiarize yourself with the following meanings and

icons:

!

Safety alert

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

physical injury hazards. Obey all safety messages that

follow this symbol to avoid possible damage to the

components of the cobas Synergy solution, injury, or

death.

These symbols and signal words are used for specific

hazards:

WARNING

!

Warning...

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

could result in death or serious injury.

CAUTION

!

Caution...

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

could result in minor or moderate injury.

NOTICE

Notice...

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

may result in damage to the system.

Important information that is not safety relevant is

indicated with the following icon:

q Tip...

...indicates additional information on correct use or useful

tips.

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