Roche cobas 8000 / ISE Module User manual

cobas

®

8000 modular analyzer

series

Operator’s Manual – Version 5.1

Software Version 06-03

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-03 · Operator’s Manual · 5.1

2

Publication information

Edition notice This publication is intended for operators of the

cobas

®

8000 modular analyzer series.

The cobas

®

8000 modular analyzer series is composed of

2 main components:

• The instrument includes the analytical modules, the

control unit, and other core components.

• The cobas

®

8000 data manager consists of a PC

which coordinates data in real time between the

instrument and the host.

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.

Publication

version

Software version Revision date Change description

1.0 01–01 2009-06 First version

2.0 02–01 2010-01 e 602 module added

3.0 03–01 2010-10 c 702 module added

4.0 04–01 2013-04 General update including, by way of example:

o New software features such as review of calibrator status,

PT link, rack unloading, change rack priority, reagent

cassette masking

o Revised software features such as download of

applications, calibrators, and QC material

o Hitergent was replaced by EcoTergent

4.0.1 04–01 2013-05 Manual cleaning revised

4.0.2 04–01 2013-06 Cleaning of pipetter probes revised

4.1 04–02 2013-11 o Changed ISE measuring ranges

o Use of different sample tubes on a rack

o Other changes and corrections

4.2 05–01 2014-10 New software features added

u What is new in publication version 4.2? (17)

5.0 06–02 2016-05 Publication redesigned according to the new Roche

documentation concept.

e 801 module added.

u What is new in publication version 5.0? (16)

5.1 06–03 2016-10 o Inclusion of information on the ISE support box

o New section about fluorinated greenhouse gas

o Updated cobas link information

o Minor changes throughout the document

u What is new in publication version 5.1? (16)

y Revision history

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-03 · Operator’s Manual · 5.1

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Where to find information The Online Help 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

instrument.

The Quick Reference Guide provides you with an

overview of pre-routine and routine tasks on the data

manager and instrument.

The Operator’s Manual focuses on routine operation

and maintenance. The chapters are organized according

to the normal operation workflow.

A separate Operator’s Manual is available for the

cobas

®

8000 data manager.

The PC manufacturer’s manual contains all information

about the control unit hardware.

!

General attention

To avoid serious or fatal injury, ensure that you are

familiar with the system and safety information before you

use the system.

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 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.

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.

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-03 · Operator’s Manual · 5.1

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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.

License information

cobas

®

8000 modular analyzer series software is

protected by contract law, copyright law, and

international treaties. cobas

®

8000 modular analyzer

series 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.

License agreement for UltraVNC software and

Linux Kernel

UltraVNC and Linux Kernel are pieces of free software for

all commercial uses, which are installed on the control

unit PC.

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. 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.

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-03 · Operator’s Manual · 5.1

5

Open Source and Commercial Software

cobas

®

8000 modular analyzer series 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 modular analyzer series, refer to the

electronic distribution included with this product.

This open source and commercial software and

cobas

®

8000 modular analyzer series as a whole can

constitute a device regulated in accordance with

applicable law. For more detailed information, refer to the

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 modular

analyzer series.

Trademarks The following trademarks are acknowledged:

COBAS, COBAS C, COBAS E, COBAS INTEGRA, 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 purpose. 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 cobas

®

8000 modular analyzer series 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.

Directive 2014/53/EU of the European Parliament and of

the Council of 16 April 2014 on the harmonization of the

laws of the Member States relating to the making

available on the market of radio equipment and repealing

Directive 1999/5/EC.

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 is provided by means of the Declaration of

Conformity.

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-03 · Operator’s Manual · 5.1

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The following marks demonstrate compliance:

Instrument approvals Furthermore, the instrument is manufactured and tested

according to the following international safety standards:

• IEC 61010-1

• IEC 61010-2-081 and A1

• IEC 61010-2-101

• UL 61010-1

• CAN/CSA C22.2 No. 61010-1

• CAN/CSA C22.2 No. 61010-2-101

• CAN/CSA C22.2 No. 61010-2-081

The instrument complies with the emission and immunity

requirements described in standard IEC 61326-2-

6/EN 61326-2-6.

Fluorinated greenhouse gas The product contains a fluorinated greenhouse gas in the

hermetically sealed refrigeration.

c 502 module:

c 701 and c 702 module:

e 801 module:

For in vitro diagnostic use.

Complies with the IVD directive 98/79/EC on in vitro

diagnostic medical devices

Issued by Intertek for Canada and the US.

Type

Charge weight

(kg)

Tonne of CO

2

equivalent

GWP (Global

warming

potential)

R-134a 0.102 0.14 1430

y Fluorinated greenhouse gas detail (c 502 module).

Type

Charge weight

(kg)

Tonne of CO

2

equivalent

GWP (Global

warming

potential)

R-134a 0.160 0.23 1430

y Fluorinated greenhouse gas detail (c 701 and c 702

module).

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-03 · Operator’s Manual · 5.1

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Type

Charge weight

(kg)

Tonne of CO

2

equivalent

GWP (Global

warming

potential)

R-134a 0.170 0.24 1430

y Fluorinated greenhouse gas detail (e 801 module).

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-03 · Operator’s Manual · 5.1

8

Contact addresses

Inside the European Union and

EFTA member states

Outside the European Union and

EFTA member states

Manufacturer of the

instrument

Hitachi High-Technologies

Corporation

1-24-14 Nishi-Shimbashi

Minato-ku Tokyo 105-8717

Japan

Manufacturer of

cobas

®

8000 data

manager

Roche Diagnostics GmbH

Sandhofer Strasse 116

D-68305 Mannheim

Germany

Authorized

representative

Roche Diagnostics GmbH

Sandhofer Strasse 116

D-68305 Mannheim

Germany

Manufactured by: Hitachi High-Technologies

Corporation

Manufactured for: Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Table of contents 9

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-03 · Operator’s Manual · 5.1

Table of contents

Publication information 2

Contact addresses 8

Table of contents 9

Intended use 13

Symbols and abbreviations 13

What is new in publication version 5.1? 16

What is new in publication version 5.0? 16

What is new in publication version 4.2? 17

Operation

1 Overview of the system

About the system 23

About the data manager 26

About the control unit 27

About the core components 29

About the cobas

®

ISE module 40

About the cobas c 701 module 53

About the cobas c 702 module 68

About the cobas c 502 module 87

About the cobas e 801 module 103

About the cobas e 602 module 123

2 Overview of operation

Overview of the user interface 143

Using the help system 156

Overview of cobas

®

link 163

3 Before operation

Quick reference: Main workflow 175

Starting the instrument 179

Troubleshooting system alarms 199

Preparing the instrument for operation 200

Measuring samples 215

4 Reagents

About reagent statuses 223

Working with reagent masking 226

Reagents of the ISE module 230

Reagents of the c 701 module 240

Reagents of the c 702 module 254

Reagents of the c 502 module 278

Reagents and consumables of the e 801

module 293

Reagents and consumables on the e 602

module 344

5 Calibration

Calibration 367

Calibrating tests on the ISE and cobas c

modules 386

Calibrating tests on the cobas e modules 390

6 Quality control

About quality control (QC) 401

About QC types 403

Performing routine QC 405

Performing QC for standby reagents 407

Performing timeout QC 409

Performing QC after calibration 411

Performing manual QC 413

Checking QC results 415

Deactivating tests for QC material 417

Assigning non-barcoded QC material to

rack positions 418

Unloading auto QC racks from the auto QC

compartment 420

7 Orders and results

About sample processing 425

About data distribution 426

About barcode and non-barcode mode 428

Switching between barcode and

non-barcode mode 430

About the Rack Reception mode 432

Ordering tests 433

Working with barcodes 442

Loading samples 445

Processing samples 456

Working with sample results 464

Processing rerun tests 478

Unloading samples manually 483

About the Calibration Review submenu 484

8 After operation

Performing manual finalization on cobas e

modules 489

Performing data backup and archiving 492

Preparing the instrument for powering off 504

Powering off the instrument 505

9 Special operation

Overview of masking functions 527

Operating with a pre-analytical system 529

Operating the instrument in backup

operating mode 532

10 Table of contents

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-03 · Operator’s Manual · 5.1

Maintenance

10 Overview of maintenance

Maintenance definitions 543

About performing maintenance 545

About modes for maintenance 546

About maintenance pipes and

maintenance pipe functions 558

Checking maintenance due time 567

Checking maintenance status 568

Requesting the maintenance report 569

List of maintenance actions 572

List of maintenance checks 577

List of maintenance schedules for all

modules 580

List of cleaning solutions 583

List of spare parts and replacement

intervals 584

List of maintenance videos 586

11 Maintenance of the core unit and the MSBs

List of maintenance actions on the core unit

and the MSBs 589

Daily maintenance of the core unit and the

MSBs 590

Monthly maintenance of the core unit and

the MSBs 592

Maintenance as required on the core unit

and the MSBs 597

12 Maintenance of the ISE module

List of maintenance actions on the ISE

module 609

Daily maintenance of the ISE module 611

Weekly maintenance of the ISE module 621

Monthly maintenance of the ISE module 624

Every 2 months maintenance of the ISE

module 631

Quarterly maintenance of the ISE module 637

Every 6 months maintenance of the ISE

module 643

Maintenance as required on the ISE

module 647

13 Maintenance of the c 701 and c 702 modules

List of maintenance actions on the c 701

and c 702 modules 667

Daily maintenance of the c 701 and c 702

modules 669

Weekly maintenance of the c 701 and c 702

modules 678

Monthly maintenance of the c 701 and

c 702 modules 690

Quarterly maintenance of the c 701 and

c 702 modules 707

Every 6 months maintenance of the c 701

and c 702 modules 712

Maintenance as required on the c 701 and

c 702 modules 718

14 Maintenance of the c 502 module

List of maintenance actions on the c 502

module 755

Daily maintenance of the c 502 module 757

Weekly maintenance of the c 502 module 765

Monthly maintenance of the c 502 module 772

Quarterly maintenance of the c 502

module 790

Every 6 months maintenance of the c 502

module 793

Maintenance as required on the c 502

module 798

15 Maintenance of the e 801 module

List of maintenance actions on the e 801

module 813

Daily maintenance of the e 801 module 815

Every 2 weeks maintenance of the e 801

module 820

Maintenance as required on the e 801

module 844

16 Maintenance of the e 602 module

List of maintenance actions on the e 602

module 869

Daily maintenance of the e 602 module 870

Weekly maintenance of the e 602 module 874

Every 2 weeks maintenance of the e 602

module 891

Quarterly maintenance of the e 602

module 895

Maintenance as required on the e 602

module 901

Table of contents 11

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-03 · Operator’s Manual · 5.1

Appendix

17 Specifications

General specifications 919

Specifications of the control unit 924

Specifications of the core components 925

Specifications of the ISE module 927

Specifications of the cobas c modules 929

Specifications of the cobas e modules 932

List of available accessories and

consumables 935

Specifications of barcodes 946

18 Glossary

Index 955

12 Table of contents

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-03 · Operator’s Manual · 5.1

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-03 · Operator’s Manual · 5.1

13

Intended use

The cobas

®

8000 modular analyzer series system is a

fully automated random-access software-controlled

system for immunoassays and photometric analysis

intended for qualitative and quantitative in vitro

determinations using a wide variety of tests.

The cobas

®

8000 modular analyzer series is an in vitro

diagnostic (IVD) medical equipment.

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

®

8000 modular analyzer

series

System

cobas

®

8000 data manager

Data manager

cobas

®

ISE module

cobas c 702 module c 702 module

cobas c 701 module c 701 module

cobas c 502 module c 502 module

cobas e 801 module e 801 module

cobas e 602 module e 602 module

cobas c pack reagent cassette

cobas e pack reagent cassette

cobas e pack green reagent cassette

cobas e flow cobas e flow test

Self-Contained ISE Support Box ISE support box

Sample Cup standard cup

Micro-Sample Cup micro cup

Sarstedt micro tube cryo cup

AssayTip/AssayCup tray magazine

WasteLiner solid waste box

y Product names

Symbol Explanation

o List item

u Related topics containing further information

q

Tip. Extra information on correct use or useful

hints

r Start of a task

I Extra information within a task

y Symbols used in the publication

Roche Diagnostics

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Symbols used on products

Abbreviations The following abbreviations are used:

f Result of an action within a task

c Frequency of a task

n Duration of a task

d Materials that are required for a task

j Prerequisites of a task

u Topic. Used in cross-references to topics

p Task. Used in cross-references to tasks

w

Figure. Used in figure titles and cross-

references to figures

y

Table. Used in table titles and cross-references

to tables

z

Equation. Used in cross-references to

equations

Symbol Explanation

y Symbols used in the publication

Symbol Explanation

Global Trade Item Number

Quantity contained in the package

Orientation of the package during

transportation

Complies with the directive 2011/65/EU on

RoHS

y Symbols used on products

Abbreviation Definition

ACN Application Code Number

ANSI American National Standards Institute

CellCln1 Basic reaction cell wash solution

(NaOH-D)

y Abbreviations

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-03 · Operator’s Manual · 5.1

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CellCln2 Acid reaction cell wash solution

CFAS Calibrator for automated systems

(C.f.a.s.)

CSV Comma-separated values

CV Coefficient of variation

DIL ISE Diluent

EC European Community

ECL Electrochemiluminescence

ECO-D EcoTergent, additive to the incubation

bath to reduce surface tension

EFTA European Free Trade Association

EN European standard

ICVC Initial cassette volume check

IEC International Electrical Commission

IS ISE Internal Standard

ISE Ion-selective electrode

ISE COMP ISE Standard High, used as calibrator 3

ISE HIGH ISE Standard High, used as calibrator 2

ISE LOW ISE Standard Low, used as calibrator 1

IVD In vitro diagnostic

LED Light-emitting diode

LIS Laboratory information system

LLD Liquid level detection

MSB Module sample buffer

n/a Not applicable

NACL NaCl solution, used as diluent

NaOHD Wash solution for reagent probes and

reaction cells (D1)

QC Quality control

RCM Reaction calculation mode

REF ISE Reference Electrolyte solution

RFID Radio-frequency identification

SCCS Additive to prevent reaction cell

carryover in long HbA1c batches (D3)

SD Standard deviation

SmpCln1 Basic sample probe wash solution

SmpCln2 Acid sample probe wash solution

SMS Wash solution for reagent probes and

reaction cells (D2)

STAT Short turn-around time

SysClean ISE Cleaning Solution/Elecsys SysClean

WEEE Waste Electrical and Electronic

Equipment

Abbreviation Definition

y Abbreviations

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-03 · Operator’s Manual · 5.1

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What is new in publication version 5.1?

This section provides an overview of all major changes in

this publication and the software.

ISE support box The ISE support box is used in conjunction with the

ISE module and is available for the cobas

®

8000 modular

analyzer series without a c 702 module or c 701 module

in the configuration.

u The Self-Contained ISE Support Box (52)

Fluorinated greenhouse gas The product contains a fluorinated greenhouse gas in the

hermetically sealed refrigeration.

u Fluorinated greenhouse gas (6)

Update of cobas

®

link information

Update of the cobas

®

link chapter.

u Overview of cobas® link (163)

What is new in publication version 5.0?

This section provides an overview of all major changes in

this publication and the software.

New layout and structure Resulting from customer feedback, we have updated the

layout and the structure of this publication to help you

find information easier and perform tasks quicker.

cobas e flow (e 801 module) cobas e flow is a feature of the data manager and the

e 801 module. cobas e flow tests are a pre-defined

combination of conventional immunology tests.

cobas e flow tests can be ordered from the data

manager and the host. They are managed via the data

manager. The involved immunology tests are performed

automatically on the e 801 module.

u About cobas e flow tests on the e 801 module (294)

Multiple application tests (e 801 module) Multiple application tests use the same reagent cassette,

but with different measurement protocols from different

applications.

Up to 4 applications can be part of 1 multiple application

test. The different applications have individual application

code numbers. Multiple application tests are pre-defined

in the application file.

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-03 · Operator’s Manual · 5.1

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Unlike cobas e flow tests, multiple application tests can

be ordered manually on the control unit or automatically

by the host.

u About multiple application tests on the e 801

module (302)

Quick Start Mode (e 801 module) When you enable the quick start mode, the instrument

can start a run in approximately 6:30 minutes instead of

about 12 minutes. Some steps, such as the reagent prime,

are only performed once when the instrument is powered

on, not during preparation for a run. You need

administrator access rights to enable the quick start

mode.

What is new in publication version 4.2?

This section provides an overview of all major changes in

this publication and software version 05-01.

This version requires Windows 7 on the control unit,

Windows XP is not supported.

Mixing sample types and container types on a

rack

You can consolidate different sample types and container

types on a single rack. Sample consolidation can be

useful, for example, if the instrument is connected with a

CLAS. The CLAS can use the same rack range for pre-

processing of different samples types.

On the Standard tab of the Rack Assignment dialog

box, you must define a rack range for the sample type

None to consolidate samples. The information about the

sample type and in some cases also the information

about the container type is sent via HL7 protocol to the

control unit.

u About mixing different sample types on a rack (450)

Reagent registration by maintenance pipe You can include registration of reagents in a

maintenance pipe. Then new reagents are registered on

c 701/c 702 modules and the maintenance action

inventory update is performed on e 602 modules.

If you execute a maintenance pipe with this option, you

do not need to register new reagents manually. After

returning from manual cleaning mode, the required

reagent registration can be executed by a maintenance

pipe. If the reagent registration was already performed

before, it is skipped in the maintenance pipe.

u Creating a maintenance pipe (559)

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-03 · Operator’s Manual · 5.1

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Overwriting editable parameters when

updating an application

When you download an updated application from the

data manager, you can now choose between the

Overwrite option and the Partial Overwrite option:

• To download the application with all new settings,

choose the Overwrite option.

• To keep the settings of all editable application

settings, choose Partial Overwrite option.

In previous software versions, editable application

settings were not updated when you downloaded an

updated application from the data manager.

New ISE calibration scheme ISE Standard High is also used as compensator (S3).

u About calibration methods for ISE tests (370)

Further changes and improvements • By limiting the number of racks on the instrument via

the new Rack Delivery dialog box, the turnaround

time of racks is improved.

• Integration of ISE data alarms: If an ISE.N or ISE.E data

alarm occurs, it is attached to all ISE test results for

this sample.

• For ISE calibrations, the software now uses separate

compensated limit checks for slope and calibrator S3

concentration.

• The user rights for downloading application settings,

calibrator data, QC material data, and special wash

data are reorganized.

u For links to the associated topics, refer to the Online

Help.

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-03 · Operator’s Manual · 5.1

Operation

1 Overview of the system........................................................................................ 21

2 Overview of operation.........................................................................................141

3 Before operation ...................................................................................................173

4 Reagents..................................................................................................................219

5 Calibration...............................................................................................................365

6 Quality control .......................................................................................................399

7 Orders and results................................................................................................423

8 After operation ......................................................................................................487

9 Special operation..................................................................................................525

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