Roche cobas 8000 Data Manager User manual

cobas

®

8000 data manager

Operator's Manual

Version 14

Software version 1.06.09

(01)07613336172728(8012)1.06.09

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14

2

Document information

Revision history

Manual version Software version Revision date Main changes

1.0 1.0 Jun-2009 First version of this Operator’s Manual.

1.01 1.01 Jan-2010 E-module support

1.02 1.02 Oct-2010 Terminology: "Technical validation" changed to

"Validation", "Instrument data alarm" changed to

"data alarm".

User Interface: New information window system

message for software update package, buttons

changed.

Rounding rules for immunology test rounding

implemented.

Pass-through mode: new chapter in operator

manual.

TraceDoc chapter enhanced and renamed to "Data

cleanup and archiving".

1.03 (Revision 1) 1.03 Jul-2012 Creation of standalone version of data manager

operator’s manual.

Integration of software update installer chapter.

Integration of Online Help content into print version.

New glossary for standalone manual.

Update of TraceDoc chapter.

Added description of sequence mode.

Added workflows in chapter pass-through mode

and software update installer.

Version 5 1.04 Feb-2014 Restructured manual.

Added workplace overview chart in chapter

Introduction.

Updated procedures on software update, creating a

calculated test, setting up a non-Roche QC material.

Data alarms chapter added.

Version 6 1.05 Aug-2014 Updated procedures on software update, creating a

calculated test.

Forward instrument status

TSN agent upload data points for all heterogeneous

immunoassays

TSN agent split result upload for ISE, CC, and HET-

IA

Version 7 1.06 May-2016 Restructured manual.

Added images to task steps, concepts, and

references.

Added cobas e 801 module with cobas e flow test.

Update QC type for asymmetric QC range.

Version 8 1.06.01 Jan-2017 Calculated QC result validation

Host code assignment for cobas e flow test

Data cleanup options

Sample life time option

Version 9 1.06.05 Nov-2017 Additional information related to cobas e flow tests

New workflow for host code assignment

New options for sending omitted results to the host

New cobas e flow test upload options

y Revision history

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14

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Edition notice

This publication is intended for users of the cobas

®

8000

data manager software.

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 For information on the individual components of the

cobas

®

8000 modular analyzer series see:

The Safety Manual contains important safety

information. You must read the Safety Manual before

operating the instrument.

The Operator’s Manual focuses on routine operation

and maintenance. The chapters are organized according

to the normal operation workflow.

The Online Help contains the content of the Operator’s

Manual, Safety Manual and additionally:

• Troubleshooting information

• A software reference

• Configuration information

• Information about basic analytical principles

The PC manufacturer’s manual contains all information

about the hardware.

Version 10 1.06.06 Mar-2018 o Removal of QC standby bottles component

from the cobas 8000 data manager QC

Routine workplace

u What is new in manual version 10? (16)

Version 11 1.06.07 Nov-2018

Version 12 1.06.08 Mar-2019 Data archiving to network storage

u What is new in manual version 12? (16)

Version 13 1.06.09 Mar-2021 Changing expired password.

Automated third party QC materials.

Default profiles for routine and STAT samples

without test orders.

Panels updated related to cobas e flow tests.

Details on some user interface options and functions

added

Screenshots updated

u What is new in manual version 13? (14)

Version 14 1.06.09 May-2021 u What is new in publication version 14? (14)

Manual version Software version Revision date Main changes

y Revision history

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14

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!

General attention

To avoid incorrect results, ensure that you are familiar

with the instructions and safety information.

r Pay particular attention to all safety notices.

r Always follow the instructions 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.

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.

reserved.

License information

cobas

®

8000 data manager software is protected by

contract law, copyright law, and international treaties.

cobas

®

8000 data manager contains a user license

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

and only authorized users may access the software and

use it. Unauthorized use and distribution may result in

civil and criminal penalties.

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14

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License agreement for UltraVNC software UltraVNC is a piece of free software for all commercial

uses. It is installed on the control unit PC of the

cobas

®

8000 modular analyzer series.

You can redistribute the software and/or modify it under

the terms of the GNU General Public License (version 2 or

later), as published by the Free Software Foundation. A

copy of the GNU General Public License (version 2) is

stored on the control unit PC and on the data manager

server. The path for the license is C:\Program Files\uvnc

bvba\UltraVNC.

The software is distributed without warranty. There is no

implied warranty of merchantability or fitness for a

particular purpose. For more information, see the GNU

General Public License at http://www.gnu.org/licenses.

The source code for the software is stored on the control

unit PC. The path for the source code is

C:\DriversAndTools\UltraVNC.

Open source and commercial software

cobas

®

8000 data manager 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

®

8000 data manager, refer

to the electronic distribution included with this product.

This open source and commercial software and

cobas

®

8000 data manager as a whole can constitute a

device regulated in accordance with applicable law. For

more detailed information, refer to the corresponding

user documentation and labeling.

Note that the respective authorization is no longer valid

according to the corresponding legislation should any

unauthorized changes be made to cobas

®

8000 data

manager.

Trademarks The following trademarks are acknowledged:

COBAS, COBAS C, COBAS E, 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.

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14

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Approvals

The cobas

®

8000 data manager 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.

The following marks demonstrate compliance:

For in vitro diagnostic use.

Complies with the provisions of the applicable EU

regulations.

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14

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Contact addresses

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 Dialog:

www.dialog.roche.com

For more information, contact your local affiliate or Roche

Service representative.

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14

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Table of contents 9

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14

Table of contents

Document information 2

Contact addresses 7

Table of contents 9

Intended use 11

Symbols and abbreviations 12

What is new in publication version 14? 14

What is new in manual version 13? 14

What is new in manual version 12? 16

What is new in manual version 10? 16

What is new in the manual version 9? 17

What is new in the manual version 8? 18

What is new in the manual version 7? 19

Safety

1 General safety information

Introduction 25

Safety classifications 26

Safety precautions 27

Warning messages 29

Caution messages 30

Notices 33

Disposal of the equipment 34

Operation

2 Introduction

Introduction to the cobas

®

8000 data

manager 39

The cobas

®

8000 data manager and

associated workflows 40

Starting the data manager 45

Working with the interface 46

Features accessed via Sidebar 52

Working with tables 60

About searching for data 65

Searching for Value Sheets 68

Using the Online Help 70

3 Routine tasks

Quick reference: Main workflow 75

About cobas e flow tests 78

Working with samples 85

Working with tests 117

Validating test results 137

Reporting test results 150

Masking and unmasking tests 154

Reviewing system status 164

Viewing system alarm details 165

QC tasks 166

4 Data cleanup and archiving

Data cleanup 197

About the Interface options tab 213

About uploading data to Roche or to the

host 216

Data archiving 217

About deleting data 223

Browsing data using the TraceDocViewer 224

List of TraceDocViewer interface elements 231

5 Software update installer (SUI)

Software update 247

Update procedures 255

Troubleshooting 266

Glossary

6 Glossary

Index 275

10 Table of contents

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14

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Intended use

Intended use statement for US only

The cobas

®

8000 data manager provides data and

workflow management for the in vitro diagnostic medical

device cobas

®

8000 modular analyzer series.

Intended use statement for EU/EFTA and

outside US

The cobas

®

8000 data manager provides data and

workflow management for the in vitro diagnostic medical

device cobas

®

8000 modular analyzer series.

For cobas e flow tests, measured on cobas e 801

modules, the cobas

®

8000 data manager provides

predefined workflow management and performs result

calculation and reporting.

List of available accessories and

consumables

For a list of globally available accessories and

consumables, refer to the cobas

®

8000 modular analyzer

series Operator’s Manual.

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14

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Symbols and abbreviations

Visual cues are used to help locate and interpret

information in this document quickly. This section

explains formatting conventions used in this document.

Symbols used in the publication

Symbols used on product

Abbreviations The following abbreviations are used:

Symbol Explanation

o List item.

u Cross-reference to another topic.

q

Tip. Extra information on correct use or useful

hints.

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.

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

Symbol Explanation

Global Trade Item Number.

Catalog number.

Unique device identifier.

Caution. Consult the instructions for use.

Consult instructions for use on this website:

www.dialog.roche.com.

y Symbols used on product

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cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14

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Abbreviation Definition

ACN Application Code Number. Unique

reference number to identify and to

manage downloaded files across the

whole system, e.g. parameter files for

applications, QC materials,

calibrators, etc.

ANSI American National Standards

Institute

AU1, AU2, … Analytical Unit 1, 2, … (used in the

user interface only)

c module Photometric module (e.g. c 702,

c 701, or c 502)

c 502 cobas c 502 module for clinical

chemistry

c 701 cobas c 701 module for clinical

chemistry

c 702 cobas c 702 module for clinical

chemistry

c7-1, c7-2, c7-3 First, second, third module of the

instrument (e.g. c 702, c 701, or

c 502)

Cal., CAL Calibration

Cfas Calibrator For Automated Systems

ClinChem Clinical chemistry

CV Coefficient of Variation (%)

CU Control unit

DM Data manager

e module Heterogeneous immunoassay

modules (e.g. e 602 or e 801)

e 602 cobas e 602 module for

heterogeneous immunoassay analysis

e 801 cobas e 801 module for

heterogeneous immunoassay analysis

e6-1, e6-2, e6-3 First, second, third module of the

instrument (e.g. e 602 or e 801)

e.g. Exempli gratia – for example

HIS Hospital information system

ID Identification

i.e. Id est – that is to say

ISE Ion Selective Electrode; also used for

ISE module

ISO International Organization for

Standardization

IVD In Vitro Diagnostic

IVDR In Vitro Diagnostic Directive

LIS Laboratory information system

n/a Not applicable

PC/CC ProCell/CleanCell, system reagents

used on the e 602 and e 801 module

y Abbreviations

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14

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What is new in publication version 14?

Regulatory adaptations The following information was added as part of the

adaptation to the EU regulation 2017/746 on in vitro

diagnostic medical devices:

• Information about incident reporting

• Link to the worldwide list of Roche affiliates

• Download information about electronic user

documentation

What is new in manual version 13?

An overview of the changes compared to the previous

version of the manual is provided below.

Changing expired password On the Sidebar. a new button allows you to change an

expired password or to set the password at first login.

u Changing an expired password (58)

Automated third party QC materials Automated third party QC materials are non-Roche QC

materials where the parameter file is downloaded from

cobas® link. The analyzer handles automated third party

QC results in the same way as QC results from Roche QC

materials providing you observe specific rules for rack

loading and container type.

PCCC1 PreciControl ClinChem Multi 1, a

Roche QC material

PCCC2 PreciControl ClinChem Multi 2, a

Roche QC material

QC Quality control

SB Standby

SD Standard deviation

sFTP Secure File Transfer Protocol

SPR Special Reagent

STAT Short turnaround time

Std Standard, commonly used for

calibrator

SU Rack Sampler Unit, the rack

loader/unloader

(SU is used on the Overview menu)

WEEE European Waste Electrical and

Electronic Equipment Directive

Abbreviation Definition

y Abbreviations

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14

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cobas e flow tests The following panels related to cobas e flow tests have

been updated:

u About the Sample overview component (97)

u About the Day list component (103)

u About the Validation component (118)

Details on some user interface options and

functions added

Details have been added for the following options and

functions:

• Show all tests for this sample check box on the

Day list component

• Masking and unmasking of ISE tests

• Refresh button on the QC Routine component

• Impact of QC bracketing on the result release timing

for cobas e flow tests.

• Table of QC bracketing actions updated

• Structuring data on an external storage device when

using the TraceDocViewer,

• The SUI button does not change its color and stays

yellow if a mandatory release was acknowledged.

• Target values for non-Roche QC material can be

negative.

• Make sure that all tests in the Formula input are

used in the formula.

• New default profile function added for routine and

STAT samples without test orders.

• About resending a cobas e flow test result to the host

when the cobas e flow test was deactivated.

• Modifying the result type value might be necessary

after test installation to change the default result type

(qualitative/quantitative) to another value.

• Show intermediate results check box on the Test

details panel.

• Where to display the currently installed versions of the

cobas

®

8000 data manager software.

u About the Day list component (103)

u About masking and unmasking tests (154)

u About the QC Routine component (177)

u About QC bracketing (182)

u About the TraceDocViewer (224)

u About the software update installer (SUI) (248)

Screenshots The following screenshots have been updated:

u Test result report with sample lifetime

information (150)

u cobas 8000 data manager Service > Service-related

configuration > TSN agent tab (216)

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cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14

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What is new in manual version 12?

An overview of the changes compared to the previous

version of the manual is provided below.

Archiving to network storage The system supports data archiving to a network storage.

u Archiving data (199)

What is new in manual version 10?

An overview of the changes compared to the previous

version of the manual is provided below.

QC standby bottles The QC standby bottles component has been removed

from the cobas 8000 data manager QC Routine

workplace. Its functionality has been integrated in the QC

Routine component.

u Data manager workplaces overview (51)

u QC tasks (166)

u Monitoring QC standby bottles (193)

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14

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What is new in the manual version 9?

An overview of the changes compared to the previous

version of the manual is provided below.

Additional cobas e flow test information Detailed information provided for a better understanding

of the cobas e flow test and its behavior.

u See:

About cobas e flow tests (78)

Quality control for cobas e flow tests (166)

Uploading single QC results for calculated QC Use the Send single QC results for calculated QC

check-box to send single QC results that are used for

calculated QC results to the host.

Send additional linkage information If the Send additional link information for calculated

QC check-box is selected, the following additional

information is uploaded to the host for a cobas e flow

test.

Replacement of deprecated terms Following terms are replaced in the document:

• SOP popup -> SOP callout

• Variables and formulas for cobas e flow tests ->

cobas e flow test generated subresults

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14

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What is new in the manual version 8?

An overview of the changes compared to the previous

version of the manual is provided below.

Calculated QC result validation You can filter for calculated QC results and display result

details. You can validate calculated QC results.

Test configuration dialog box The test configuration dialog box only displays test type

related elements.

Host code assignment for cobas e flow test You can activate host codes and assign them to

cobas e flow test results, formulas, and variables.

Test result suppression You can activate or deactivate the display suppression on

reports or TraceDoc for test results that are measured

outside the technical limits.

Data cleanup options You can include incomplete sample orders in the data

cleanup process. You can activate/deactivate cleanup

options according to your laboratory needs via check

boxes.

u See:

About data cleanup and archiving (197)

Defining automatic data cleanup (203)

Sample lifetime option You can assign different time ranges for the sample

lifetime option according to your laboratory workflow.

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14

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What is new in the manual version 7?

An overview of the changes compared to the previous

version of the manual is provided below.

Copy QC Identical applications can share QC data. On the

instrument, it is only necessary to measure the master

application. It is not required to measure the QC material

for additional applications. The master QC result is

assigned automatically to these applications.

u About copy QC (180)

QC chart The 3 types of QC chart can be supported in a single view

or summarized.

• QC range with target value

• Asymmetric QC range with target value

• Asymmetric QC range without target value

New sample types The 3 new sample types are added to the sample type list.

• Hemolysate

• Amniotic fluid

• Processed stool

cobas e flow test • The cobas e 801 module with the option to run

cobas e flow test is implemented. The cobas e flow

test combines single assay measurements into a

sequence of automatically processed steps.

Test definition If you install a test and the host code is already used by

another test, the host code field stays empty. You must

enter the host code manually before starting any

measurements for the test.

Higher uncertainty The test result can only be validated against the higher

uncertainty limit. You can only assign quantitative or

quantitative/qualitative test results to the validation

against the Roche value.

The following limits are no longer available:

• Limit of blank

• Limit of detection

• Limit of quantitation

New layout and structure In response to customer feedback, we have updated the

layout and the structure of this publication to help you

find information more easily and perform tasks more

quickly.

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14

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Roche cobas 8000 Data Manager User manual

Roche cobas 8000 Data Manager User manual

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