Roche COBAS INTEGRA 400 plus User manual

User Manual

Software Version 3.5

User Manual Version 2.8, 2.9, and 2.9.1

Review the section "Revisions" at the end of this

document for new information and changes to

previous editions.

ii User Manual · Version 2.7

Revision history

Publication notice

This publication is for users of the COBAS INTEGRA

®

400 plus analyzer.

Every effort has been made to ensure that all the information contained in this

publication is correct at the time of publishing. However, Roche Diagnostics GmbH

reserves the right to make any changes necessary without notice as part of ongoing

product developments and improvements.

Any customer modification to the instrument will render the warranty or service

agreement null and void.

Intended use The COBAS INTEGRA 400 plus analyzer is a fully automated, computerized chemistry

analyzer. It is intended for in vitro quantitative or qualitative determination of a wide

range of analytes in various body fluids.

Trademarks The following trademarks are acknowledged:

Acrobat, Windows, Windows XP.

COBAS and COBAS INTEGRA are registered trademarks of a member of the Roche

group.

Manual

version

Software

version

Revision date Changes

1.0 November 1998

1.1 April 1999

2.0 December 2000

2.1 June 2001

2.2 October 2002

2.3 August 2004

2.4 3.4 (Windows XP) July 2006 Slight content changes due to new

software version

2.5 3.5 June 2009 Minor content changes due to new

software version

2.5 3.5 September 2012 Updated laser information

2.6 3.5 April 2013 Diluents handling, purge, internet

connection disclaimer

2.7 3.5 September 2013 Hardware specifications, data handling via

USB

User Manual · Version 2.7 iii

Instrument approvals The instrument meets the protection 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. Compliance is provided by means of the Declaration of Conformity.

Regulatory compliance is demonstrated by the following marks:

Contact address

Complies with European Union (EU) Directive 98/79/EC.

Issued by Underwriters Laboratories, Inc. (UL) for Canada and the

US.

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

iv User Manual · Version 2.7

User Manual · Version 2.7 v

Table of contents

Table of contents v

Preface ix

Software virus warning xviii

Safety labels on the system xx

Safety information for laser transmitters xxi

Overview Part A

1 System overview

Introduction A-4

A first look at a COBAS INTEGRA 400 plus

analyzer A-5

Overview of user tasks A-8

Basic principles A-10

2 System description

Panels and logos A-16

Modules and main components A-18

Functional systems A-19

System states A-42

3 User interface

A first look at the user interface A-46

Work areas A-47

Working with the user interface A-49

Tips and techniques A-51

4 Online Help

Introduction A-54

Starting and closing online Help A-55

Help window A-56

Finding information A-60

Context Help A-63

General Help A-65

Message Help A-66

Related topics A-68

Glossary A-69

Accessing additional information in Acrobat A-70

Operation Part B

5 Daily workflow

Introduction B-5

Daily start-up B-8

Daily routine (without sample barcode and without

host) B-13

Daily routine (with sample barcode and without

host) B-19

Daily routine (with sample barcode and with host)

B-25

End of day B-30

6 Routine tasks

Starting up and logging on to the system B-35

Logging off and shutting down the system B-39

(Re)Starting and stopping a run B-41

Handling test materials B-42

Managing resources B-48

Checking due service actions B-56

Checking the Memo Pad B-57

Printing reports B-58

Purging and deleting information and items B-67

Archiving system information B-70

7 Status

About Status B-72

Status work area overview B-73

Missing & Blocked tab B-74

Samples tab B-76

Cassettes tab B-78

Test Status tab B-80

Analyzer tab B-82

ISE tab B-84

Displaying item details B-86

Selected tasks B-88

8 Orders

About orders B-90

Orders at a glance B-91

Orders work area B-93

Worklist tab B-95

Sample tab B-97

Calibration tab B-99

Quality Control tab B-100

Creating an order B-101

Working with Orders B-110

9 Results

About results B-120

Results work area overview B-123

Validate tab B-124

Sample tab B-127

Calibration tab B-129

Quality Control tab B-130

Selecting specific patients and orders B-132

Displaying detailed information B-134

Working with results B-137

vi User Manual · Version 2.7

10 Calibration

About calibration B-146

Calibrations at a glance B-149

Reviewing the status of calibrators on board B-151

Loading calibrators on board B-154

Requesting calibrations B-156

Postponing a calibration B-158

Validating calibration results B-160

Setting up calibrators B-165

11 Quality controls

About controls B-172

Controls at a glance B-174

Reviewing the status of controls on board B-176

Loading controls on board B-179

Requesting controls B-180

Reviewing and validating control results B-182

Setting up controls B-192

Flags Part C

12 Result flags

About result flags C-5

Flags and recommended actions C-6

Service Part D

13 Service action software

About service actions D-4

Service work area overview D-5

Due tab D-6

All tab D-7

Begin of Day tab D-8

Performing a service action D-10

Service notes D-12

Counters and timers D-14

14 Service actions

Deproteinize probes D-21

Clean probes and splash guard D-22

Clean internal water reservoir D-25

Clean wash station D-28

Clean external water reservoir and fluid waste

reservoir D-31

Clean instrument D-34

Clean the waste box fitting D-40

Clean and lubricate the rotor D-41

Prime the fluid system D-44

Roche service D-45

Backup database D-46

Replace ventilation filter D-47

Replace Abs. halogen lamp D-49

Replace probe B (or C) D-52

Replace plunger tip dosage pipette B (or C) D-55

Replace dosage pipette B (or C) D-59

Replace external water reservoir filter D-62

Managing data D-63

Troubleshooting Part E

15 Messages

About messages E-4

New Messages tab E-6

Message Log tab E-7

Options tab E-8

Working with messages E-9

Putting the system into Standby E-11

Stopping and restarting the system E-12

16 Troubleshooting

Introduction E-17

Start-up problems E-18

Blocked orders, tests, calibrations, or controls E-19

Results E-26

Hardware E-29

Software error messages E-34

Data station accessories E-35

External connectors E-37

Checking and replacing fuses E-40

Contacting Roche Service E-44

ISE measurements Part F

17 ISE module

Overview F-4

How the ISE module works F-8

Making ISE measurements F-11

ISE solutions summary F-12

Technical specifications F-12

18 ISE service actions

About ISE service actions F-14

Initialize ISE module F-15

Electrode service F-16

Activate electrodes F-17

Prime ISE calibrators F-18

Clean ISE tower automatically F-19

Clean ISE tower manually F-20

Replace ISE module tubing F-23

Replace electrode F-25

Condition ISE tubing F-29

Replace ISE solutions on the ISE rack F-30

Replace bottles on ISE module F-32

Replace ISE tower F-34

ISE Performance Check F-35

19 ISE flags and troubleshooting

About ISE flags F-38

Flags and user actions F-39

Flag descriptions F-41

General ISE troubleshooting F-47

User Manual · Version 2.7 vii

Configuration Part G

20 Configuration

Configuration overview G-4

About the Definitions group G-6

Loading test application software G-18

Archiving and reloading definitions G-20

System group G-21

Windows group G-23

Appendix Part H

21 Appendix

Technical specifications H-4

Fluid system schematic H-12

Keyboard shortcuts H-13

Menu structure H-14

Glossary and Index Part I

Glossary I-3

Index I-9

Revisions Part J

viii User Manual · Version 2.7

User Manual · Version 2.7 ix

Preface

This manual refers specifically to the COBAS INTEGRA 400 plus analyzer and

software version 3.5 (Windows XP). It is intended for users of the instrument and

software.

About the COBAS INTEGRA 400 plus analyzer

The COBAS INTEGRA 400 plus analyzer is an advanced integrated system for

diagnostic clinical chemistry testing.

Classical chemistry, electrolytes, specific proteins, therapeutic drug monitoring, drugs

of abuse, and thyroid hormone testing are consolidated into one system with one

reagent cassette design.

Random sample access, innovative robotics, and an advanced user interface, using

Windows XP, optimize time management and streamline workflow.

The Ion Selective Electrode (ISE) module allows the determination of sodium,

potassium, chloride, and lithium ions in parallel with absorbance- and FP

photometric measurements.

Reagent cassettes, samples, calibrators, and controls are identified by a barcode

scanner.

The high performance, flexibility, and versatility of the COBAS INTEGRA 400 plus

analyzer make this system suitable as a routine and a STAT analyzer as well as a

dedicated instrument for specific tasks.

A Data station

B Instrument

A B

R

o

c

h

e

x User Manual · Version 2.7

How to use this manual

This manual is designed to help you perform all of the tasks that are required as part of

your work with the INTEGRA 400 plus analyzer.

If you are a new user, the manual will also help you to understand general hardware

principles, the user interface, the status of the instrument and its modules. You should

familiarize yourself with these areas before attempting to perform daily tasks.

You can also find information about how to use the COBAS INTEGRA 400 plus

analyzer in the COBAS INTEGRA 400 plus Short Guide and in the Online Help.

Content The manual is divided into the following parts:

o Part A - Overview: Contains general information about the COBAS INTEGRA 400

plus analyzer, about the basic concepts of using the instrument, the hardware, the

software, and the online Help.

o Part B - Operation: Starts with a workflow description for some typical laboratory

setups, using step-by-step instructions. It then describes how to perform all the

day-to-day tasks necessary to create orders, monitor the status of the instrument,

view results, and deal with some simple problems that do not require detailed

analysis.

o Part C - Flags: Describes the flags that are generated for unaccepted results and

gives recommended actions.

o Part D - Service: Describes how to start and perform service actions that are

essential to maintain maximum productivity from this instrument.

o Part E - Troubleshooting: Describes how to pinpoint potential problems and how

to solve them.

o Part F - ISE measurements: Describes the principles of operation of the ISE

module and contains specialized sections on ISE flags and troubleshooting, and

ISE service actions.

o Part G - Configuration: Describes some of the most common configuration tasks

for a fully operational system. Full details on all configuration procedures are

given in the online Help.

o Appendix: Contains additional information including a technical specification of

the instrument.

o Glossary and index: Provides reference and look-up material.

Other COBAS INTEGRA 400 plus publications

Additional publications relating to the COBAS INTEGRA 400 plus analyzer are also

available:

Data Analysis This publication describes the calculation, calibration, and control modes for

absorbance, FP, and ISE measurements, as well as the quality control methods and

checks.

Method Sheet A detailed guide to the COBAS INTEGRA reagents, including test definitions and

performance data.

Short Guide A short-form manual containing step-by-step information on the most commonly

used tasks.

User Manual · Version 2.7 xi

Conventions used in the COBAS INTEGRA 400 plus documentation

This section describes the conventions used in this manual, including symbols, user-

interface conventions, and units.

Symbols The following symbols are used:

User interface

conventions

The following conventions are used throughout the user documentation:

Symbol Used for

a Step-by-step procedure

Cross reference

m Checklist

i Notes

User action Meaning

Configuration / Tests / ID

1 Click Configuration in the navigation bar.

2 Double-click Tests in the Definitions

group.

3 Click the ID tab.

Choose File > Print Report > BOD Report

1 Click File in the menu bar.

2 Select Print Report from the menu.

3 Select BOD Report from the next menu.

Shift + F3 Press the Shift key and hold it down; press

and release the F3 function key; then release

the Shift key.

Click Press the left button on the mouse or the

equivalent button on the system keyboard.

Click OK Move the cursor to the OK button, and then

press the left mouse button.

Click Status Click the Status button on the navigation bar.

Click Print Click the Print button in the current window

or dialog box.

Right-click Click the right mouse button (or equivalent

on the keyboard).

Press Press a key on the keyboard.

Double-click Click the left mouse button (or equivalent on

the keyboard) twice in rapid succession.

Open Open the window or dialog box.

Close Close the window or dialog box.

xii User Manual · Version 2.7

Units SI units (Système International d’Unités) are used throughout the manual, where

appropriate. The following units are either non-SI or may be unfamiliar to some users:

Abbreviations and acronyms

The following abbreviations and acronyms are used throughout the documentation.

Abbreviation Unit

BTU British thermal unit

cm Centimeters

in Inches

lb. Pounds (weight)

M Megaohm

psi Pounds per square inch

VA Volt-Amperes

VAC Volts (alternating current)

S Microsiemens

Abbreviation Meaning Usage

abs. absorbance abs. measurement

BOD Begin of Day BOD service action

CAL calibrator (legend on graphic)

DIL diluent (legend on graphic)

FP Fluorescence Polarization FP photometer

ID Identification (number) User ID, patient ID

in. internal in. water reservoir

ISE Ion Selective Electrode ISE module

LCD Liquid crystal device LCD monitor

LED Light-emitting diode LED status indicator

No. number Lot No.

STAT immediate order Priority samples, tests and results

TAS Test Application Software Roche default test, calibration,

control, and diluent definitions

User Manual · Version 2.7 xiii

Safety classifications

The safety precautions and important user notes are classified according to the

following description. Before you attempt to use the COBAS INTEGRA 400 plus

analyzer, you must be fully familiar with the following symbols and their meanings:

Safety information

Before operating the COBAS INTEGRA 400 plus analyzer, it is essential that you both

read and understand the safety information listed below.

Read all Roche safety notices carefully and make sure you understand them.

Indicates a direct danger that, if not avoided, may result in death or serious injury.

Indicates a possibly hazardous situation that, if not avoided, may result in death or serious injury.

Indicates a possibly hazardous situation that, if not avoided, may result in slight or minor injury

or may result in damage to equipment.

Electrical safety



Danger of electric shock when touching power supply components. Never attempt to access

any parts of the instrument other than those specifically described in the user documentation. In

particular, never open or manipulate any components on the rear of the instrument.

Electrical safety



Before removing main cover disconnect mains plug from socket. Hazardous voltage is present

on ISE power supply even if main switch is off. Danger of electric shock when touching power

supply components.

Biological safety 

Samples analyzed with this instrument may contain potentially infectious material. Samples

derived from humans, animals, tissue culture, or in vitro cultures should be handled and

processed with appropriate safety precautions. Such samples may contain bacterial, fungal or

viral agents. Spills should be immediately disinfected with an approved disinfectant solution to

avoid contamination of laboratory personnel and equipment.

xiv User Manual · Version 2.7

Loss of sight due to staring into laser beam

Barcode scanner contains a class 2 laser diode.



Do not stare into the laser transmitter beam as your eyesight may be severely damaged.



For position of the laser transmitters, see "Safety information for laser transmitters" on page xxi.

Danger of explosion 

Danger of explosion through sparks. Keep all potentially inflammable or explosive material (for

example anesthetic gas) away from the instrument.

Fire risk 

Spraying liquid on the power supply parts can cause a short circuit and result in a fire. Keep the

cover closed while the instrument is connected to the main power supply and do not use sprays

in the vicinity of the COBAS INTEGRA 400 plus analyzer.



During fire-fighting operations disconnect the COBAS INTEGRA 400 plus analyzer from the

main power supply.

Instrument in use

Danger of injury to hands by moving parts. Keep the instrument cover closed while initialization

or measuring is in progress.

Malfunction of instrument and incorrect results due to interfering

electromagnetic fields



Devices that emit electromagnetic waves may cause the instrument to malfunction. Do not use

this device in close proximity to sources of strong electromagnetic radiation (e.g. unshielded

intentional RF sources), as these can interfere with the proper operation.

Sample 

Danger of infectious sample material which can cause severe illness. Avoid direct contact with

sample material. Clean contaminated surfaces immediately and dispose of waste according to

regulations.

Sample 

Samples containing solids (e.g. separation gel residuals, or fibrin strands) can produce incorrect

results or block probes. For good sample quality, follow the instructions given by the primary

tube manufacturers.

Light source 

Danger of eye damage from the bright light of the absorbance photometer lamp. Always wear

dark safety glasses when looking at the light.

Waste

Danger of infectious waste material. This can cause severe illness. Avoid direct contact with

waste.

User Manual · Version 2.7 xv

Carry-over

Traces of analytes may be carried over from one sample to the next. Take adequate measures to

safeguard correct testing of high-sensitive methods (e.g. heterogeneous immuno-assays).

Cassette interchange



Do not interchange cassettes among different COBAS INTEGRA systems and instruments. Each

cassette rack with its cassettes may be used on one individual COBAS INTEGRA instrument

only. Each cassette has its own individual cassette number, which the instrument uses to

identify it. Using a cassette already used on a different COBAS INTEGRA instrument may lead to

incorrect results.



If more than one COBAS INTEGRA instrument is used in the same lab, be sure to dedicate each

cassette rack with its cassettes to one single, individual instrument (e.g. by color coding).

Sample

Samples containing solids can produce false results and block probes. Ensure that samples are

free from insoluble particles.

Reagents

Danger of cauterization and skin poisoning through contact with reagents. Pay attention to the

notes in the corresponding Method Sheet and the warnings on the cassettes.

Quality control

Danger of false results. Patients can be put at risk if false results lead to incorrect diagnosis and

therapy. Carry out the quality control according to regulations.

Waste material

Disposal of all waste material should be in accordance with local guidelines.

Correct use

Use the COBAS INTEGRA 400 plus system only to measure liquid samples with the provided

reagents.

User qualification

Danger due to incorrect operation.



The COBAS INTEGRA 400 plus analyzer should be used by qualified users only.

xvi User Manual · Version 2.7

Cleaning and maintenance

Incorrect cleaning and maintenance can cause damage to personnel and equipment. Perform

cleaning and maintenance according to the procedures described in this publication.

Environmental conditions

Incorrect location can cause incorrect results and damage equipment components. Follow the

installation instructions carefully. Relocating the COBAS INTEGRA 400 plus analyzer should be

carried out by Roche Service only.

Cleaner 

Incorrect cleaning materials can damage the COBAS INTEGRA 400 plus analyzer. Organic

solutions damage cuvettes, tubing, and other plastic materials. Use only 70% ethanol solution to

clean the equipment.

Disposal recommendations

All electrical and electronic products should be disposed of separately from the municipal waste

system. Proper disposal of your old appliance prevents potential negative consequences for the

environment and human health.

Disposal of Control Unit Components

Components of your Control Unit such as the computer, monitor, keyboard, etc. which are

marked with the crossed-out wheeled bin symbol are covered by the European Directive on

Waste Electrical and Electronic Equipment (WEEE).



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, please contact your city office, waste

disposal service or your local Roche Support personnel.

Disposal of the Instrument

The instrument must be treated as biologically contaminated-hazardous waste.

Decontamination (i.e., a combination of processes, including cleaning, disinfection and/or

sterilization) is required before reuse, recycling or disposal.



Dispose of the instrument according to local and/or labor regulations. For more information

contact your local Roche Support personnel.

User Manual · Version 2.7 xvii

This equipment has been tested and found to comply with the limits for Class B digital

device, pursuant to part 15 of the FCC Rules. These limits are designed to provide

reasonable protection against harmful interferences when the equipment is operated

in a residential area. However, this equipment generates, uses, and can radiate radio

frequency energy and, if not installed and used in accordance with the present user

manual, may cause harmful interference to radio communications.

Uninterruptible power supply (UPS)

Depending upon the quality of electrical grounding of the local electrical power

supply, an uninterruptible power supply (UPS) may be required. A UPS is not

provided with the COBAS INTEGRA 400 plus analyzer. The UPS should provide at

least the maximum power listed in the Technical specifications provided in this

manual.

The electromagnetic environment should be evaluated prior to operation of the device.

xviii User Manual · Version 2.7

Software virus warning

Recommendations 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.

o Do not copy or install any software on the COBAS INTEGRA 400 plus unless it is

part of the system software or you are instructed to do so by Roche Service.

o Do not move or delete any software on control units unless you are instructed to

do so by Roche Service.

o If additional 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 instructed to do

so by the official user documentation or Roche Service.

o Exercise utmost care when using external storage devices such as USB flash drives,

CDs, or DVDs. Do not use them on public or home computers while connecting

to the COBAS INTEGRA 400 plus.

o Keep all external storage devices in a secure place and ensure that they can be

accessed by authorized persons only.

o Use the remote service only for contacting Roche Service or other authorized

usage.

Failure to observe these recommendations may result in data loss or the non-

availability of the system, which may put patients at risk.

Portable storage media can be infected with and transmit computer malware (for example virus,

Trojan horse).



The COBAS INTEGRA 400 plus is not protected against malware.



The customers are responsible for IT security of their IT infrastructure and for preventing the

spread of malware from system to system.

User Manual · Version 2.7 xix

If this product is connected to a local area network, this network must be protected against

unauthorized access. In particular, it must not be linked directly to any other network or the

Internet. Customers are responsible for the security of their local area network, especially in

protecting it against malicious software and attacks. This protection might include measures,

such as a firewall, to separate the device from uncontrolled networks as well as measures that

ensure that the connected network is free of malicious code.

For further information, contact Roche Service.

The 2nd LAN connector must only be used for Roche remote service connectivity. If a remote

service connection is established over an insecure network via an AXEDA client, the device

must be installed behind either a Roche “connect 2” device or a cobas link gateway. The use of

an AXEDA client is the only approved and supported remote service solution. Other non-

intended usage of the LAN connectors could lead to unauthorized database access resulting in

possible disclosure or modification of sensitive data.

xx User Manual · Version 2.7

Safety labels on the system

Warning labels have been placed on the analyzer to draw your attention to areas of

potential hazard. The labels for the laser transmitter are listed below according to their

location on the analyzer.

The safety labels on the instrument comply with the following standards: ANSI Z535,

IEC 61010-1, IEC 60417-DB-3M, or ISO 7000.

If the labels are damaged, they must be replaced by Roche Service personnel. For replacement

labels contact your local Roche representative.

Safety label on analyzer Location and meaning

Laser transmitter warning

Situated inside of the rack access panel

to designate the presence of a laser

transmitter. Do not stare into the laser

transmitter.

Laser transmitter warning

Situated outside of the rack access panel

to designate the presence of a laser

transmitter. Do not stare into the laser

transmitter.

For details, see "Safety information for laser transmitters" on page xxi.

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Roche COBAS INTEGRA 400 plus User manual

Roche COBAS INTEGRA 400 plus User manual

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