Roche cobas 8000 Data Manager User manual

cobas

®

8000 data manager

Operator’s Manual

Version 7

Software version 1.06

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7

3

Document information

Revision history

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)).

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.

y Revision history

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7

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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.

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.

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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7

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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 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 lapse in case of any unauthorized

changes to the cobas

®

8000 data manager.

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.

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7

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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

Table of contents 7

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7

Table of contents

Document information 3

Contact addresses 6

Table of contents 7

Preface 9

What is new in the manual version 7? 9

How to use this manual 10

Online Help 11

Symbols and abbreviations 11

Safety classification 13

Safety precautions 14

Operator qualification 15

Safe and proper use of the data manager 15

Miscellaneous safety precautions 15

Safety summary 16

Warning messages 16

Electrical safety 16

Caution messages 16

Fatigue due to long hours of operation 17

Malfunction due to interfering

electromagnetic fields 17

Data security 18

Notices 19

Disposal of the equipment 19

Operation

1 Introduction

Introduction to the cobas

®

8000 data

manager 25

The cobas

®

8000 data manager and

associated workflows 26

Starting the data manager 30

Working with the interface 31

Features accessed via Sidebar 36

Working with tables 44

About searching for data 48

Searching for Value Sheets 51

Using the Online help 53

2 Routine tasks

Quick reference: Main workflow 57

Working with samples 60

Working with tests 84

Validating test results 106

Reporting test results 116

Masking and unmasking tests 119

Reviewing system status 127

Viewing system alarm details 128

QC tasks 129

3 Data cleanup and archiving

Data cleanup 147

About uploading data to Roche or to the

host 155

Data archiving 157

About deleting data 162

Browsing data using the TraceDocViewer 163

List of TraceDocViewer interface elements 169

4 Software update installer (SUI)

Software update 183

Update procedures 193

Troubleshooting 203

Glossary

5 Glossary

Index 209

8 Table of contents

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7

9

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 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 (132)

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

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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7

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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 the cobas e flow test (84)

Deleting a cobas e flow test order during

processing (81)

Viewing cobas e flow test result details after

measurement (93)

Repeating a cobas e flow test (104)

Validating a failed cobas e flow test (113)

Masking and unmasking a cobas e flow test (124)

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 easier and perform tasks quicker.

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.

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7

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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:

• Help, accessed via menu bar: opens on title page.

• Help, 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.

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:

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.

y Symbols used for easy recognition of information

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Abbreviations The following abbreviations are used:

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.

Symbol Explanation

y Symbols used for easy recognition of information

Abbreviation Definition

A

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

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

y Abbreviations

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7

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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:

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

PNU Precinorm Universal, a Roche QC

material

PPU Precipath Universal, a Roche QC

material

Q

QC Quality Control

S

SB Standby

SD Standard deviation

SPR Special Reagent

STAT Short Turn-Around 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 · Operator's Manual · Version 7

14

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 · Operator's Manual · Version 7

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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 Not Roche Diagnostics approved installation of any third-

party software may result in incorrect behavior of the data

manager. 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.

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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7

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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 The system is installed, serviced, and repaired by

authorized and qualified Roche personnel only.

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.

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7

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Fatigue due to long hours of operation

CAUTION

!

Fatigue due to long hours of operation

Looking at the monitor screen over an extended period

may lead to eye strain or body fatigue.

r Take a break for 10–15 minutes every hour to relax.

r Avoid spending more than 6 hours per day looking at

the monitor screen.

Malfunction due to interfering electromagnetic fields

CAUTION

!

Malfunction of the data manager and incorrect

results due to interfering electromagnetic fields

This data manager has been designed and tested to

CISPR 11 Class A. In a domestic environment, it may

cause radio interference, in which case, you may need to

take measures to mitigate the interference.

r The electromagnetic environment should be evaluated

prior to operation of the device.

r Do not operate the data manager close to sources of

strong electromagnetic fields (for example unshielded

intentional RF sources), as these may interfere with

the proper operation.

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7

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Data security

CAUTION

!

Unauthorized access and data loss due to malicious

software and hacker attacks

Portable storage media can be infected with and transmit

computer malware, which may be used to gain

unauthorized access to data or cause unwanted changes

to software.

The cobas

®

8000 data manager is not protected against

malicious software and hacker attacks.

The customers are responsible for IT security of their IT

infrastructure and for protecting it against malicious

software and hacker attacks. Failure to do so may result

in data loss or render the cobas

®

8000 data manager

unusable.

r Roche recommends the following precautions:

o Allow connection to authorized external devices

only.

o Ensure that all external devices are protected by

appropriate security software.

o Ensure that access to all external devices is

protected by appropriate security equipment.

Roche strongly recommends the use of a cobas IT

Firewall or Fortigate 400.

o Do not copy or install any software on the

cobas

®

8000 data manager unless it is part of the

system software or you are instructed to do so by

Roche Service.

o If extra software is required, contact Roche Service

to ensure validation of the software in question.

o Do not use the USB ports to connect other storage

devices unless you are instructed to do so by

official user documentation or by Roche Service.

o Exercise utmost care when using external storage

devices such as CDs or DVDs. Do not use them on

public or home computers while connecting to the

cobas

®

8000 data manager.

o Keep all external storage devices in a secure place

and ensure that the authorized persons can access

only.

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7

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Notices

NOTICE

List of notices

r Before operating, read the notices contained in this

summary carefully. Failure to observe them may result

in damage to equipment.

Disposal of the equipment

Disposal of the data manager components.

Components of your data manager (such as the

computer, monitor, keyboard) which are marked with this

symbol are covered by the European Directive on Waste

Electrical and Electronic Equipment (WEEE, 2002/96/EC).

Prior to disposal, all patient data and information must be

erased according to local regulations.

These items must be disposed of via designated

collection facilities appointed by government or local

authorities.

For more information about disposal of your old product,

contact your city office, waste disposal service, or Roche

Service.

Constraint:

It is left to the responsible laboratory organization to

determine whether control unit components are

contaminated or not. If contaminated, treat them in the

same way as the analytical modules of the cobas

®

8000

modular analyzer series.

Roche Diagnostics

cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7

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Roche cobas 8000 Data Manager User manual

Roche cobas 8000 Data Manager User manual

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