Roche cobas 8000 Data Manager User manual

cobas

®

8000 data manager

Operator’s Manual

Version 11

Software version 1.06.07

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06.07 · Operator's Manual · Version 11

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

y Revision history

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06.07 · Operator's Manual · Version 11

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Edition notice

This Operator's Manual describes the cobas

®

8000 data

manager software, which is part of the cobas

®

8000

modular analyzer series. The cobas

®

8000 data manager

is the software which coordinates data in real time

between the cobas

®

8000 instrument and the host

(usually the laboratory information system (LIS)).

Every effort has been made to ensure that all the

information is correct at the time of publishing. However,

Roche Diagnostics International Ltd. reserves the right to

make changes necessary without notice as part of

ongoing product development.

Any customer modification to the cobas

®

8000 data

manager renders the warranty or service agreement null

and void.

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 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

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? (9)

Version 11 1.06.07 Nov-2018 No changes

Manual version Software version Revision date Main changes

y Revision history

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06.07 · Operator's Manual · Version 11

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Intended use

The cobas

®

8000 data manager provides data and

workflow management for the in vitro diagnostic medical

device cobas

®

8000 modular analyzer series.

reserved.

License information

The cobas

®

8000 data manager is protected by contract

law, copyright laws, and international treaties. The

cobas

®

8000 data manager is licensed for use between

F. Hoffmann-La Roche Ltd and a licensee, and only

operators authorized there under are permitted to access

and use the software. Unauthorized use and distribution

may result in civil and criminal penalties.

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 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

®

8000 data manager see the CD/ DVD

provided with the product.

The product and the cobas

®

8000 data manager as a

whole may form a regulated device in accordance with

the applicable laws - refer to the installation DVD of the

cobas

®

8000 data manager software for details. The

respective authorization in accordance with the

applicable laws lapses if any unauthorized changes are

made to the cobas

®

8000 data manager.

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06.07 · Operator's Manual · Version 11

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Trademarks

cobas

®

8000 data manager is a trademark and the

cobas

®

8000 data manager logo is a trade-mark of

Roche. Other product names and trademarks are the

property of their respective owners.

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.

Approvals

The cobas

®

8000 modular analyzer series meets the

protection requirements specified in IVD Directive

98/79/EC. Furthermore, the cobas

®

8000 data manager

is manufactured and tested according to the following

international safety standards:

The following labels demonstrate compliance:

Complies with the IVD directive 98/79/EC.

Contact addresses

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06.07 · Operator's Manual · Version 11

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Table of contents 7

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06.07 · Operator's Manual · Version 11

Table of contents

Document information 2

Contact addresses 5

Table of contents 7

Preface 9

What is new in manual version 10? 9

What is new in the manual version 9? 10

What is new in the manual version 8? 11

What is new in the manual version 7? 12

How to use this manual 14

Online Help 14

Symbols and abbreviations 15

Safety classification 18

Safety precautions 18

Operator qualification 19

Safe and proper use of the data manager 19

Miscellaneous safety precautions 19

Safety summary 20

Warning messages 20

Electrical safety 20

Caution messages 20

Fatigue due to long hours of operation 21

Malfunction due to interfering electromagnetic

fields 21

Data security 22

Notices 23

Disposal of the equipment 23

Operation

1 Introduction

Introduction to the cobas

®

8000 data

manager 29

The cobas

®

8000 data manager and

associated workflows 30

Starting the data manager 36

Working with the interface 37

Features accessed via Sidebar 43

Working with tables 51

About searching for data 56

Searching for Value Sheets 59

Using the Online Help 61

2 Routine tasks

Quick reference: Main workflow 67

About cobas e flow tests 70

Working with samples 77

Working with tests 109

Validating test results 130

Reporting test results 148

Masking and unmasking tests 152

Reviewing system status 162

Viewing system alarm details 163

QC tasks 164

3 Data cleanup and archiving

Data cleanup 195

About the Interface options tab 208

About uploading data to Roche or to the

host 211

Data archiving 212

About deleting data 218

Browsing data using the TraceDocViewer 219

List of TraceDocViewer interface elements 226

4 Software update installer (SUI)

Software update 243

Update procedures 253

Troubleshooting 264

Glossary

5 Glossary

Index 273

8 Table of contents

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06.07 · Operator's Manual · Version 11

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06.07 · Operator's Manual · Version 11

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Preface

The cobas

®

8000 data manager implements data and

workflow management functions and provides an

interface between the cobas

®

8000 modular analyzer

series, the host, and the Roche remote service platform

(TSN). Through TSN, it enables remote access to and

from Roche and allows information exchange. It provides

enhanced sample tracking, test management, result

traceability, storage and reporting, together with QC and

calibration management. Additionally, it has host back up

functionality and serves as a robust storage location for

the instrument.

This manual provides detailed descriptions of the data

manager features and operational concepts, specific

functions, and administration procedures.

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 (42)

u QC tasks (164)

u Monitoring QC standby bottles (192)

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cobas® 8000 data manager · Software version 1.06.07 · Operator's Manual · Version 11

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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 (70)

Quality control for cobas e flow tests (164)

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

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cobas® 8000 data manager · Software version 1.06.07 · Operator's Manual · Version 11

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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.

u See:

About the QC Routine component (175)

Validating calculated QC results (172)

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 (195)

Defining automatic data cleanup (198)

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

lifetime option according to your laboratory workflow.

u See:

About reusing sample IDs (200)

Defining the sample ID lifetime option (205)

Closing all sample orders (207)

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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 (178)

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.

u See:

About cobas e flow tests (70)

Deleting a cobas e flow test order during

processing (105)

Viewing cobas e flow test result details after

measurement (131)

Repeating a cobas e flow test (138)

Validating a failed cobas e flow test (134)

Masking and unmasking a cobas e flow test (159)

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

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cobas® 8000 data manager · Software version 1.06.07 · Operator's Manual · Version 11

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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.

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cobas® 8000 data manager · Software version 1.06.07 · Operator's Manual · Version 11

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How to use this manual

q Always keep this Operator’s Manual in a safe, easily

accessible place.

To help you find information quickly, there is a table of

contents at the beginning of the manual and each

chapter. In addition, a complete index can be found at the

end.

Online Help

The cobas

®

8000 data manager has a context-sensitive

Online Help feature to support you in its operation.

Context sensitive means that the help system always

displays information related to the current work area or

software element.

The instrument software offers 2 help features:

• Accessed via menu bar: opens on title page.

• Accessed via F1 key: opens help page related to

current work area.

F1 Help - This help feature displays information related to

the current work area. Use the F1 Help feature if you

require detailed information about this work area.

Hypertext links guide you to additional information and

procedures related to this work area.

q The Operator's Manual is included in the F1 Help

system. This option allows you to search for information

throughout the software reference and the manual. All

cross-references are implemented as hyperlinks.

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cobas® 8000 data manager · Software version 1.06.07 · Operator's Manual · Version 11

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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 The following symbols are used:

Abbreviations The following abbreviations are used:

Symbol Explanation

o List item

u Related topics containing further information

q Tip. Extra information on correct use or useful

hints.

r Start of a task

I Extra information within a task

f Result of a user action within a task

c Frequency of a task

n Duration of a task

d Materials that are required for a task

j Prerequisites of a task

u Topic. Used in cross-references to topics.

p Task. Used in cross-references to tasks.

w Figure. Used in figure titles and cross-

references to figures.

y Table. Used in table titles and cross-references

to tables.

y Symbols used for easy recognition of information

Abbreviation Definition

A

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

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

y Abbreviations

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cobas® 8000 data manager · Software version 1.06.07 · Operator's Manual · Version 11

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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

D

DM Data manager

E

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

H

HIS Hospital information system

I

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

IVDD In Vitro Diagnostic Directive

L

LIS Laboratory information system

N

n/a Not applicable

P

PC/CC ProCell/CleanCell, system reagents

used on the e 602 and e 801 module

PCCC1 PreciControl ClinChem Multi 1, a

Roche QC material

PCCC2 PreciControl ClinChem Multi 2, a

Roche QC material

Q

QC Quality control

S

SB Standby

SD Standard deviation

SPR Special Reagent

Abbreviation Definition

y Abbreviations

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06.07 · Operator's Manual · Version 11

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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)

W

WEEE European Waste Electrical and

Electronic Equipment Directive

Abbreviation Definition

y Abbreviations

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06.07 · Operator's Manual · Version 11

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Safety classification

This section explains how precautionary information is

presented in this manual.

The safety precautions and important user notes are

classified according to the ANSI Z535.6 Standard.

Familiarize yourself with the following meanings and

icons:

Generic hazard statements

The safety alert symbol by itself without a signal word is

used to promote awareness to hazards which are generic

or to direct the reader to safety information provided

elsewhere in the document.

WARNING

!

Warning

r If not avoided, a hazardous situation can be indicated,

which could result in death or serious injury.

CAUTION

!

Caution

r If not avoided, a hazardous situation can be indicated,

which could result in minor or moderate injury.

NOTICE

Notice

r If not avoided, a hazardous situation can be indicated,

which could result in damage to equipment.

q Tip

Indicates additional information on correct use or useful

tips.

Safety precautions

Generic hazard statements

Particular attention must be paid to the following safety

precautions. If these safety precautions are ignored, the

operator may suffer serious or fatal injury. Each

precaution is important.

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06.07 · Operator's Manual · Version 11

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Operator qualification

Operators are required to have a sound knowledge of

relevant guidelines and standards as well as the

information and procedures contained in the Operator’s

Manual.

• Do not carry out operation and maintenance unless

Roche Diagnostics has trained you.

• Carefully follow the procedures specified in the

Operator’s Manual for the operation and maintenance

of the data manager.

• Leave maintenance, installation, or service that is not

described in the Operator’s Manual to Roche Service.

Safe and proper use of the data manager

Keep the Operator’s Manual in a safe place to ensure that

it is not damaged and remains available for use. It must

be easily accessible always.

Installation • Only the Roche Service representative performs

installations.

• Leave installation tasks that are not described in the

Operator’s Manual to Roche Service.

Approved parts Use of non-approved parts or devices may result in

malfunction and may render the warranty null and void.

Only use parts and devices approved by Roche

Diagnostics.

Third-party software If you install third-party software not approved by Roche

Diagnostics, the data manager may behave incorrectly.

Do not install any non-approved software.

Miscellaneous safety precautions

Power interruption A power failure or momentary drop in voltage may

damage the data manager or lead to data loss. Perform

regular backups of measurement results. Operate only

with an uninterruptible power supply. Do not switch off

power while the PC accesses the hard disk or other

storage device.

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06.07 · Operator's Manual · Version 11

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Safety summary

This safety summary contains the most important and

general warning, caution, and notice messages.

Warning messages

WARNING

!

List of warning messages

r Before operating the data manager, read the warning

messages contained in this summary carefully. Failure

to observe them may result in death or serious injury.

Electrical safety

WARNING

!

Electrical shock by electronic equipment

Removing the covers of electronic equipment can cause

electric shock, as there are high-voltage parts inside. In

addition, opening the top cover during operation can also

cause electric shock.

r Do not attempt to work in any electronic

compartment.

r Only authorized and qualified Roche personnel install,

service, and repair the system.

Caution messages

CAUTION

!

List of caution messages

r Before operating, read the caution messages

contained in this summary carefully. Failure to observe

them may result in minor or moderate injury.

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Roche cobas 8000 Data Manager User manual

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