Roche cobas 6000 Operator’s Manual

cobas

6000 analyzer series

Operator´s Manual – Version 8.2 Software Version 06-03

Publication information

cobas®6000 analyzer series

Revision history

Publication

version

1.0 01-01 June 2006 First version

1.1 02-01 September 2007 General update

2.0 02-01 – 02-07 March 2008 General update

3.0 03-01 June 2008 General update

4.0 04-01 February 2009 General update

5.0 05-01 March 2010 General update

5.1 05-01 April 2011 Two safety alerts added

6.0 05-02 July 2013 General update

6.0.1 05-02 March 2014 Minor changes concerning

7.0 06-01

7.1 06-01

8.0 06-01

8.1 06-02

8.2 06-03

(a) Also valid for software version 05-02 (b) Also valid for software version 06-01 (c) Also valid for software version 06-02

Software version Revision date Change description

expired reagents and controls

(a)

(a) (b)

(a) (b) (c)

December 2014 General update

January 2015 Minor changes

September 2016 General update

October 2017 Online Help also applies to

software version 06-02.

December 2018 General update including the

addendum 1.0, 2.0, and 3.0.

Edition notice This publication is intended for operators of the cobas 6000 analyzer series.

Every effort has been made to ensure that all the information contained in this publication is correct at the time of publishing. However, the manufacturer of this product may need to update the publication information as output of product surveillance activities, leading to a new version of this publication.

Where to find information The Online Help contains all information about the product, including the

following:

o Routine operation o Maintenance o Safety o Troubleshooting information o A software reference o Configuration information o Background information

See The help system of the instrument on page B-15

The Operator´s Manual contains information about safety, hardware modules and operating the system as well as maintenance and troubleshooting.

The manual Interlock function cobas c 501 with ISE describes maintenance actions of the cobas 6000 analyzer series that can only be performed by special trained person.

Roche Diagnostics

2 Operator´s Manual · Version 8.2

cobas®6000 analyzer series

Training Do not carry out operation tasks or maintenance actions unless you have received

Images The screenshots and hardware images in this publication have been added exclusively

Warranty Any customer modification to the system renders the warranty or service agreement

General attention

To avoid serious or fatal injury, ensure that you are familiar with the system and safety information before you use the system.

o Pay particular attention to all safety precautions.

o Always follow the instructions in this publication.

o Do not use the instrument in a way that is not described in this publication.

o Store all publications in a safe and easily retrievable place.

training from Roche Diagnostics. Leave tasks that are not described in the user documentation to trained Roche Service representatives.

for illustration purposes. Configurable and variable data in screenshots, such as tests, results, or path names visible therein must not be used for laboratory purposes.

null and void. For conditions of warranty, contact your local sales representative or refer to your warranty contract partner. Always leave software updates to a Roche Service representative, or perform such updates with their assistance.

License information cobas 6000 analyzer series software is protected by contract law, copyright law, and

License agreement for

UltraVNC software

Open Source and Commercial

Software

international treaties. cobas 6000 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.

UltraVNC is a piece of free software for all commercial uses. It is installed on the control unit PC of the cobas 6000 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. 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.

cobas 6000 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 6000 analyzer series, refer to the electronic distribution included with this product.

This open source and commercial software and cobas 6000 analyzer series as a whole can constitute a device regulated in accordance with applicable law. For more detailed information, refer to the user manual and labeling.

Please note that the respective authorization is no longer valid according to the corresponding legislation should any unauthorized changes be made to cobas 6000 analyzer series.

Roche Diagnostics

Operator´s Manual · Version 8.2 3

cobas®6000 analyzer series

Trademarks The following trademarks are acknowledged:

COBAS, COBAS C, COBAS INTEGRA, ELECSYS and LIFE NEEDS ANSWERS are trademarks of Roche.

All other trademarks are the property of their respective owners.

Feedback Every effort has been made to ensure that this publication fulfills the intended use. All

feedback on any aspect of this publication is welcome and is considered during updates. Contact your Roche representative, should you have any such feedback.

Approvals The cobas 6000 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 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 with the applicable directives is provided by means of the Declaration of Conformity.

The following marks demonstrate compliance:

For in vitro diagnostic use.

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

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

Instrument approvals Furthermore, the instrument is manufactured and tested according to the following

international safety standards:

o IEC 61010-1 o IEC 61010-2-101

The instrument complies with the emission and immunity requirements described in standard IEC 61326-2-6/EN 61326-2-6.

The Operator’s manual meets the European Standard DIN EN ISO 18113-3.

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

refrigeration.

Type Charge weight (kg) CO2 equivalent

(tonne)

R-134a 0.102 0.14 1430

Roche Diagnostics

4 Operator´s Manual · Version 8.2

Global warming

potential

cobas®6000 analyzer series

Contact addresses

Inside the European Union and

EFTA member states

Outside the European Union

and EFTA member states

Manufacturer of the cobas 6000 analyzer series instrument

Authorized representative

Manufactured by: Hitachi High-Technologies Corporation

Manufactured for: Roche Diagnostics GmbH

Hitachi High-Technologies Corporation

1-24-14 Nishi-Shimbashi

Minato-ku, Tokyo 105-8717

Japan

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Sandhofer Strasse 116

68305 Mannheim

Germany

Roche Diagnostics

Operator´s Manual · Version 8.2 5

cobas®6000 analyzer series

Roche Diagnostics

6 Operator´s Manual · Version 8.2

cobas®6000 analyzer series

Publication information 2 Contact addresses 5 Table of contents 7 Intended use 9 Symbols and abbreviations 9 What is new in publication Version 8.2? 13

System description Part A

1 General safety information

Safety classifications A–5 Safety precautions A–6 Safety labels of the system A–22 Safety information for barcode readers A–30 Interlock function A–32 Disposal of the instrument A–33

2 Overview modules

Overview A–37 Modules of the cobas 6000 analyzer series A–38

3 Control unit, cobas link and core unit

Control unit A–47 cobas link A–49 Core unit cu 150 A–54 Trays, racks, tubes, and cups A–61

4 c 501 module

Overview A–73 Sampling area components A–76 Reagent area components A–78 Reaction disk area components A–83 Behind the front doors A–92 Rear view A–94 ISE area components A–95

5 e 601 module

Overview A–101 Reagent area components A–103 Reaction area components A–105 Pre-wash area components A–107 Consumables area components A–109 Auxiliary reagents and cleaning solutions A–112

6 Specifications

General system specifications A–117 Control unit A–124 Core unit cu 150 A–124

c 501 module A–125 e 601 module A–128

Operation Part B

7 Software basics

General description of the user interface B–5 The help system of the instrument B–15 Main menus B–24

8 Daily operation

Overview B–33 Starting the analyzer B–34 Preroutine operation B–47 Routine operation B–65 Shutting down the analyzer B–78

9 Orders and results

Overview B–83 Barcode and non-barcode mode B–84 Test Selection screen B–85 Data Review screen B–93 Calib. Review screen B–101 Tracking samples on the analyzer B–103

10 Reagents

Reagent concept – c 501 B–109 Reagent concept – e 601 B–119 Operator-related reagent management B–129 Reagent Setting screen B–130 Reagent Status screen B–135 Reagent Overview button B–146

11 Calibration

Calibration concept B–159 Calibration concept – c 501 B–162 Calibration concept – e 601 B–166 Calibration concept – masking B–169 Overview B–170 Calibration Status screen B–170 Calibration Calibrator screen B–182 Calibration Install screen B–185 System Overview screen B–198

12 QC

QC concept B–201 Overview B–206 QC Status screen B–206 QC Run Status screen B–211 QC Individual screen B–213 QC Cumulative screen B–221 QC Control screen B–222 QC Install screen B–224 Automatic QC measurement B–232

Roche Diagnostics

Operator´s Manual · Version 8.2 7

cobas®6000 analyzer series

13 Extended operation

Instrument status B–237 Interlock function: Reset after stop B–239 Masking functions B–240 Backup operation B–244 Data storage B–248

14 Configuration

Application B–255 Description of application parameters B–264 System configuration B–281 Module Set B–291 Calculated Tests (c 501) B–295 Special Wash B–301 Report Format B–310 Saving system parameters B–314 Restoring system parameters B–316

Maintenance Part C

15 General maintenance

Overview C–5 Maintenance pipes C–10 Maintenance types C–18 Maintenance report C–22 Maintenance schedules C–23 Automating instrument care with maintenance pipes C–32 Background and parallel maintenance C–35 List of maintenance items C–39 List of maintenance checks C–43

18 Maintenance e 601

Maintenance schedule C–119 Daily maintenance C–120 Weekly maintenance C–123 Every two weeks maintenance C–139 Every three months maintenance C–142 As needed C–145

Troubleshooting Part D

19 Data alarms

Introduction D–7 Data alarm list D–10 Data alarms c 501 (ISE) D–12 Data alarms c 501 (P) D–19 Data alarms e 601 module D–30 Data alarms for calibrations D–40 Data alarms for controls D–52 Data problems without alarm D–57 Rerun list D–60

20 Troubleshooting

General troubleshooting D–65 Instrument troubleshooting D–68

c 501 (ISE) troubleshooting D–72 c 501 (P) troubleshooting D–77 e 601 troubleshooting D–84

Glossary Part E

16 Maintenance cu 150

Maintenance schedule C–47 Daily maintenance C–48 Monthly maintenance C–51 Every six months maintenance C–56 As needed C–59

17 Maintenance c 501 with ISE

Maintenance schedule C–67 Periodic replacement of parts C–69 Daily maintenance C–70 Weekly maintenance C–79 Monthly maintenance C–86 Every three months maintenance C–100 Every six months maintenance C–103 As needed maintenance C–108

Index Part F

Notes Part G

Roche Diagnostics

8 Operator´s Manual · Version 8.2

cobas®6000 analyzer series

Intended use

The cobas 6000 analyzer series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 analyzer series is a powerful tool for complete diagnostic laboratory automation. It is optimized for high throughput workloads using a combination of an ion selective electrode (ISE) and photometric analysis (c 501 module), and an immunoassay analysis module (e 601 module).

This publication has detailed descriptions of features of the cobas 6000 analyzer series and general operational concepts, specification functions and use of controls, operating techniques, emergency procedures, product labeling and maintenance procedures.

Observe the instructions of the Operator’s Manual for safe operation of the system

o If the system is used in a manner not specified in this Operator’s Manual, the

protection provided by the system may be impaired.

o Keep this manual in a safe place to ensure that it is not damaged and remains available

for use.

o This Operator´s Manual should be easily accessible at all times.

Symbols and abbreviations

Product names Except where the context clearly indicated otherwise, the following product names

and descriptors are used.

Product name Descriptor

cobas 6000 analyzer series System

cobas c 501 module c 501 module

cobas e 601 module e 601 module

cobas cu 150 module cu 150 module

cobas c pack reagent cassette

cobas e pack reagent cassette

cobas e-library Software

cobas link Software

Sample Cup standard cup

Micro-Sample Cup micro cup

AssayTip/AssayCup tray magazine

WasteLiner solid waste box

Roche Diagnostics

Operator´s Manual · Version 8.2 9

cobas®6000 analyzer series

Symbols used in the publication

Symbols used on products

Symbol Explanation

a Start of procedure

 End of procedure

o List item

e Cross-reference

Tip

Safety alert

Symbol Explanation

Global Trade Item Number.

Quantity contained in the package.

Complies with the directive 2011/65/EU on RoHS.

Disposal of electronic equipment.

Roche Diagnostics

10 Operator´s Manual · Version 8.2

cobas®6000 analyzer series

Abbreviations The following abbreviations are used:

Abbreviation Definition

Abs Absorbance

ACN Application code number

ANSI American national standards institute

A.U. Analytical unit (module short name and measuring cell, if applicable)

c 501 (ISE) ISE unit of the c 501 module

c 501 (P) Photometric unit of the c 501 module

CLAS 2 Clinical laboratory automation system 2

CSA Canadian standards association

CSF Cerebrospinal fluid

DIL Diluent

e 601 cobas e 601 module for immunoassay analysis

EC European community

ECL Electrochemiluminescence

EN European standard

FBT False bottom tube

HbA1c Hemoglobin A1c, glycosylated hemoglobin

HPE High priority elecsys

IEC International electrical commission

IS Internal standard (ISE module)

ISE Ion selective electrode

IVD In vitro diagnostic

KCL Potassium chloride, reference solution for the ISE unit of the c 501

module

kVA Kilovolt-ampere. unit for expressing rating of AC electrical

machinery.

LDL Lower detection limit see analytical sensitivity

LIS Laboratory information system

LLD Liquid level detection

Roche Diagnostics

Operator´s Manual · Version 8.2 11

cobas®6000 analyzer series

Abbreviation Definition

MPA MODULAR PRE-ANALYTICS

n/a Not applicable

NaCl Sodium chloride

NG Not good (calibration)

PC/CC ProCell M (ProCell) /CleanCell M (CleanCell)

PRE Pretreatment reagent for immunoassays

PSM Process system manager (software)

QC Quality control

RCM Reaction calculation mode

REF Reference solution for ISE module

RF Radio frequency

R.M. Result message

RoHS Restriction of Hazardous Substances Directive

R.P. or R. pack cobas e pack (reagent pack)

RRM Rack reception mode

SCCS Special cell cleaner solution

SD Standard deviation

SMS Selective mode solution (Detergent for special washes of reagent

probes)

STAT Short turn-around time

Std Standard, commonly used for calibrator

SVGA Super video graphics adapter

TPA Tripropylamine

UL Underwriters laboratories Inc.

UPS Uninterruptible power supply

WEEE Waste Electrical and Electronic Equipment

Roche Diagnostics

12 Operator´s Manual · Version 8.2

cobas®6000 analyzer series

What is new in publication Version 8.2?

This section provides an overview of all major changes in this publication.

Software version This documentation is valid for the software version 05–02, 06-01, 06–02, and 06–03.

Instrument approvals The international standard IEC 61010-2-081 and IEC 61010-2-010 have been deleted

in section Instrument approvals.

CAN/CSA 61010-1 has been deleted.

UL 61010-1 has been deleted.

See Instrument approvals on page 4.

Safety information for barcode

readers

Correct alignment of sample

tubes on a rack

ISE calibrations For ISE calibrations, the software now uses separate compensated limit checks for

Maintenance

General maintenance In section Recommended maintenance pipes the descriptions for the following pipes

The section has been revised.

A new optional laser barcode reader has been added to the description.

The maximum LED radiation output power of the e 601 reagent barcode reader has increased to 166.9 μW.

See Safety information for barcode readers on page A-30.

The specification of the safety precaution about the tube alignment has been changed to WARNING.

See Correct alignment of sample tubes on a rack on page A-66.

slope and calibrator S3 concentration.

have been revised:

o Extended power ON (2-17 days – only e 601) o Extended power OFF (2-17 days – only e 601)

For associated topics see:

Extended power ON 2 (2 to17 days – only e 601) on page C-34 Extended power OFF (2 to17 days – only e 601) on page C-34

Maintenance cu 150 As needed maintenance Cleaning rack tray surfaces:

Safety message has been revised.

See Cleaning rack tray surfaces on page C-62.

Roche Diagnostics

Operator´s Manual · Version 8.2 13

cobas®6000 analyzer series

Maintenance c 501 with ISE During product surveillance, a risk of personal injury at the edges of the cell cover

above the ultrasonic mixers was found.

A safety message was added to all maintenance actions that involve handling of the cell cover above the ultrasonic mixers.

For associated topics see:

Cleaning the cell covers on page C-81 Cleaning the incubator bath on page C-90 Cleaning the ultrasonic mixers on page C-100 Replacing the photometer lamp on page C-103

Cleaning instrument surfaces Materials required were revised concerning the use of alcohol or bleach.

For associated topics see:

Cleaning instrument surfaces on page C-59 Cleaning instrument surfaces on page C-112 Cleaning instrument surfaces on page C-152

Maintenance e 601 The procedures for extended power on and power off have been reworked.

See Extended Power OFF procedures on page C-154.

Roche Diagnostics

14 Operator´s Manual · Version 8.2

System description

1 General safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

2 Overview modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-35

3 Control unit, cobas link and core unit . . . . . . . . . . . . . . . . . . . A-45

4 c 501 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-71

5 e 601 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-99

6 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-115

cobas®6000 analyzer series 1 General safety information

Table of contents

General safety information

Before operating with the cobas 6000 analyzer series it is essential that the warnings, cautions, and safety requirements contained in this manual, as well as the explanation of safety labels on the system are read and understood by the user.

In this chapter

Safety classifications ........................................................................................................ A-5

Safety precautions ........................................................................................................... A-6

Operator qualification .............................................................................................. A-6

Commissioning and decommissioning ................................................................. A-6

Relocation and transportation .......................................................................... A-7

Disposal ................................................................................................................ A-7

Operating conditions ................................................................................................ A-7

Power interruption ............................................................................................. A-7

Electromagnetic compatibility .......................................................................... A-8

Safe and proper use of the instrument ................................................................... A-8

Personal protection measures ........................................................................... A-9

Biohazardous materials ...................................................................................... A-9

Electrical safety .................................................................................................. A-11

Mechanical safety .............................................................................................. A-12

Reagents and working solutions ........................................................................... A-13

Skin contact ....................................................................................................... A-13

Fire and burns ................................................................................................... A-13

Incorrect results ...................................................................................................... A-13

Samples ............................................................................................................... A-14

Reagents ............................................................................................................. A-15

Instrument covers ............................................................................................. A-16

Others ................................................................................................................. A-16

Sample loss ............................................................................................................... A-17

Software and data security ..................................................................................... A-18

Unauthorized access ......................................................................................... A-18

Incorrect or corrupt data ................................................................................. A-19

USB storage devices .......................................................................................... A-19

Computer viruses .............................................................................................. A-19

Third-party software ........................................................................................ A-19

Backup ................................................................................................................ A-20

Roche Diagnostics

Operator´s Manual · Version 8.2 A-3

Chapter

1 General safety information cobas®6000 analyzer series

Table of contents

Instrument damage ................................................................................................. A-20

Moving parts ..................................................................................................... A-20

Spillage ............................................................................................................... A-20

Cleaning agents ................................................................................................. A-21

Excessive weight ................................................................................................ A-21

Safety labels of the system ............................................................................................ A-22

Front view ................................................................................................................ A-24

Side view ................................................................................................................... A-26

Top view ................................................................................................................... A-27

Rear view .................................................................................................................. A-29

Safety information for barcode readers ..................................................................... A-30

Interlock function ......................................................................................................... A-32

Disposal of the instrument ........................................................................................... A-33

Roche Diagnostics

A-4 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 1 General safety information

WARNING

CAUTION

NOTICE

Safety classifications

This section explains how precautionary information is presented in the manual.

The safety precautions and important user notes are classified according to ANSI Z535.6 Standards. Familiarize yourself with the following meanings and icons:

Safety alert

The safety alert symbol is used to alert you to potential physical injury hazards. Obey all safety messages that follow this symbol to avoid possible damage to the system, injury, or death.

These symbols and signal words are used for specific hazards:

Warning

Indicates a hazardous situation which, if not avoided, could result in death or serious injury.

Caution

Indicates a hazardous situation which, if not avoided, could result in minor or moderate injury.

Notice

Indicates a hazardous situation which, if not avoided, may result in damage to the instrument.

Important information which is not safety relevant, is indicated with the following icon:

Tip

Indicates additional information on correct use or useful tips.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-5

1 General safety information cobas®6000 analyzer series

Safety precautions

Pay attention to the following safety precautions!

If you ignore them you may be killed or suffer serious injuries.

Each precaution is important.

Keep in mind that the hazard warnings in this manual and on the instrument cannot cover every possible case, as it is impossible to predict and evaluate all circumstances beforehand.

Just following the given directions may, therefore, be inadequate for operation. Always be alert and use your common sense.

Operator qualification

As a user, you are required to be a licensed person according to your country’s specific laws. You must have sound knowledge of relevant safety precaution guidelines and standards and of the information and procedures contained in the Operator´s Manual.

o Do not carry out operation and maintenance unless you have been trained by

Roche Diagnostics to do so.

o Leave maintenance, installation, or service that is not described in the Operator´s

Manual to the Roche service representative.

o Carefully follow the procedures specified in the Operator´s Manual for the

operation and maintenance.

o Follow standard laboratory practices, especially when working with biohazardous

material.

Commissioning and decommissioning

Only the Roche service representatives can perform commissioning.

For installation described in the Operator´s Manual (such as Installing an application), follow the installation instructions carefully.

Correct grounding of the power supply cord is essential for the correct function of the analyzer. The system can only be connected to a power supply source with the specified power supply cord and only by authorized personnel.

o Contact your Roche service representative for any changes to the power supply

cord.

Roche Diagnostics

A-6 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 1 General safety information

Safety precautions

Relocation and transportation

Do not attempt to relocate or transport the instrument.

o Leave relocation and transportation to trained and authorized Roche Diagnostics

personnel.

Disposal

For information about disposal of the instrument, see Disposal of the instrument on page A-33.

Operating conditions

Operation outside the specified ranges may lead to incorrect results or malfunction of the instrument.

o Never modify the instrument. o Ensure that the instrument is operated in compliance with the system

specifications.

o Use the instrument indoors only and avoid heat and humidity. o Make sure that the instrument's ventilation openings remain unobstructed at all

times.

o Perform maintenance according to the specified intervals to maintain the

operating conditions of the instrument.

o Keep the Operator’s Manual in a safe place to ensure that it is not damaged and

remains available for use. This Operator’s Manual must be easily accessible at all times.

Power interruption

A power failure or momentary drop in voltage may damage the instrument or lead to data loss.

o Operate only with an uninterruptible power supply (UPS). o Ensure regular maintenance of the UPS. o Perform regular backups of measurement results. o Do not switch off the power while the PC accesses the hard disk or another

storage medium.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-7

1 General safety information cobas®6000 analyzer series

Safety precautions

Electromagnetic compatibility

This instrument complies with the standard IEC 61326-2-6/EN 61326-2-6. It 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.

o The electromagnetic environment should be evaluated prior to operation of the

instrument.

o Do not operate this instrument in close proximity to sources of strong

electromagnetic fields (for example, unshielded intentional radio frequency sources), as they may interfere with proper operations.

o Do not operate the following devices in close proximity to the instrument:

O Mobile phone O Transceiver O Cordless phone O Other electrical devices that generate strong electromagnetic fields

Safe and proper use of the instrument

Fatigue due to long hours of

operation

Instrument unused for an

extended period of time

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

For safe and proper use of the instrument, observe the following information.

Looking at the monitor screen over an extended period of time may lead to eye strain or body fatigue.

o Take a break for 10 to 15 minutes every hour to relax. o Avoid spending more than 6 hours per day looking at the monitor screen.

If the instrument is not used for an extended period of time, the main circuit breaker must be switched to OFF.

o Remove, cap, and refrigerate any remaining reagents. o For information on power off for a period up to 7 days and power on after this

time, see the corresponding maintenance chapter.

See Extended Power OFF procedures on page C-154.

o For information on power off for a period more than 7 days and power on after

this time, call the Roche service representative.

The necessary procedure is performed by your Roche service representative.

and incorrect results. It also may render the warranty null and void.

o Only use parts and devices approved by Roche Diagnostics.

Roche Diagnostics

A-8 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 1 General safety information

Safety precautions

Personal protection measures

This section describes how you can minimize your own risk during operation or maintenance.

Personal protective equipment Wear appropriate protective equipment, including, but not limited to: safety glasses

with side shields, fluid-resistant lab coat, and approved disposable gloves.

Wear a face shield if there is a chance of splash or splatter.

Handling of reagents and other

working solutions

Biohazardous materials

Reagents, calibrators, and controls must be handled, stored, and disposed of according to the instructions for use.

You are responsible for handling, storing, and disposing of samples and chemicals in accordance with the appropriate standards.

Contact with samples containing material of human origin (for example, sample, waste) may result in infection. All materials and mechanical components (for example, reaction system, waste systems) associated with samples of human origin are potentially biohazardous.

o Follow standard laboratory practices, especially when working with biohazardous

material.

o Keep the top and the front cover closed while the system is operating. o Always switch the system to maintenance or shutdown mode before working with

an opened cover (for example, cleaning or maintenance).

o Wear appropriate protective equipment.

See Personal protective equipment on page A-9.

o If any biohazardous material is spilled, wipe it up immediately and apply

disinfectant.

o If sample or liquid waste comes into contact with your skin, wash it off

immediately with soap and water and apply a disinfectant. Consult a physician.

Spilled sample The sample containers may vibrate during rack transport. Sample may be spilled on

the transport mechanisms.

o Avoid overfilling sample tubes and cups. o Only use specified sample tubes and cups. o Leave approximately 10 mm clearance between the liquid and the top of the

sample tube or cup.

o If sample is spilled on the instrument, wipe it up immediately and apply

disinfectant. Be sure to wear protective equipment.

Sharp objects Contact with probes may result in infection.

o When wiping probes, use several layers of gauze and wipe from the top down. o Be careful to not puncture yourself. o Wear appropriate protective equipment. Take extra care when working with

protective gloves; these can easily be pierced or cut, which can lead to infection.

See Personal protective equipment on page A-9.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-9

1 General safety information cobas®6000 analyzer series

Safety precautions

Instrument mechanism Aerosols could be formed inside the instrument, which are potentially hazardous.

Contact with the sampling mechanism or other mechanisms may result in biohazardous contamination, causing personal injury and/or infection.

o Whenever possible, keep all of the instrument’s covers closed and in place.

O Do not open any cover while the instrument is operating or is performing

maintenance. O Before starting any operation or maintenance, be sure to close and lock the top

cover. O When working with an open top cover while the instrument is powered on

(for example, for cleaning probes), always switch the system to Maintenance

or Shut Down mode first. Observe all instructions given in the Operator´s

Manual very carefully.

O Allow only trained personnel access to the keys of the instrument covers. O Do not use the key for any purpose other than locking and unlocking the

cover.

o During cleaning and maintenance, wear appropriate protective equipment. Take

extra care when working with protective gloves; these can easily be pierced or cut, which can lead to infection.

See Personal protective equipment on page A-9.

o Do not touch any parts of the instrument other than those specified. Keep away

from moving parts during system operation.

o During operation and maintenance of the instrument, proceed according to the

instructions.

Roche Diagnostics

A-10 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 1 General safety information

Safety precautions

Waste Contact with liquid waste may result in infection. All materials and mechanical

components associated with the waste systems are potentially biohazardous.

o Wear appropriate protective equipment.

See Personal protective equipment on page A-9.

o If any biohazardous material is spilled, wipe it up immediately and apply

disinfectant.

o If liquid waste comes into contact with your skin, wash it off immediately with

water and apply a disinfectant. Consult a physician.

Waste must be treated in accordance with the relevant laws and regulations. Any substances contained in reagents, calibrators, and quality controls, which are legally regulated for environmental protection, must be disposed of according to the relevant water discharge facility regulations. For the legal regulations on water discharge, please contact the reagent supplier.

Two kinds of liquid waste are discharged by the instrument:

o Concentrated liquid waste that contains highly concentrated reaction solution.

Treat this waste as infectious waste. Dispose of this waste according to the appropriate local regulations.

o Dilute waste: A non-concentrated liquid waste diluted with rinsing water from

cell wash or water from the incubator bath. When using NaOH-D for washing the reaction cells, alkaline concentration is 0.1 to 1.0 mmol/L in terms of sodium hydroxide equivalence. Dilute waste is discarded through tubes at the rear of the instrument.

Electrical safety

When disposing of any waste generated by the instrument, do so according to the relevant laws and local regulations.

Liquid waste and replacement parts such as reaction cells and ISE electrodes have to be treated as infectious medical waste.

For information on disposal of the instrument, see Disposal of the instrument on page A-33.

Removing the covers of electronic equipment can cause electric shock, as there are high voltage parts inside. In addition, opening the top cover of a photometric module (c 501) during operation can also cause electric shock.

o Do not attempt to work in any electronic compartment. o Do not remove any covers from the instrument other than those specified in the

Operator's Manual.

o Only authorized and qualified Roche Diagnostics personnel are authorized to

perform an installation, service, and repair of the system.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-11

1 General safety information cobas®6000 analyzer series

Safety precautions

Mechanical safety

Contact with the instrument mechanism could result in personal injury.

o Keep all covers closed and in place while the system is operating. o Always switch the system to Maintenance or Shut Down mode first, before

working with an open cover (for example, cleaning or maintenance).

o Only trained and authorized Roche Diagnostics personnel should have access to

the keys for the protective covers of the system.

o Do not touch any parts of the system other than those specified. Keep away from

moving parts during operation.

o Do not put your hands into the pathway of any moving parts during instrument

operation.

o During operation and maintenance, proceed according to the instructions.

Fan Contact with the cooling fan during operation of the instrument may result in

personal injury. There is a grille to protect the user from coming into contact with the moving fan.

o Do not insert your fingers into the opening of the ventilation grille. o Shut down the instrument before cleaning. If you clean the fan while the

instrument is not in shutdown mode, you risk personal injury.

Pierce pin A pierce pin for cobas c packs is located adjacent to the reagent probe rinse station.

Contact with the pierce pin may result in personal injury.

o Do not touch the pierce pin and gripper during operation, cleaning, or

maintenance.

Rack transfer mechanism The rack transfer mechanism can cause personal injury.

o Only load or unload racks when the green light on the rack loader is on. o Do not insert your fingers or any objects into the rack loading/unloading area

while the instrument is operating.

o Keep all covers closed and in place while the instrument is operating.

Cover Be careful when opening or closing a top cover. If you let go of the handle, the top

cover may drop onto your fingers.

o Always keep a firm grip on the handle and do not let go when opening or closing

a top cover.

o If a top cover does not stay open properly, please contact your local Roche service

representative.

Open cover Injury to your head or body may be caused by an open cover.

o Be careful not to hit yourself when working with open covers (for example,

during maintenance).

Roche Diagnostics

A-12 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 1 General safety information

Safety precautions

Reagents and working solutions

The cobas 6000 analyzer series uses reagent and working solutions, such as cleaners or diluents. Observe the following information on reagents and working solutions.

Skin contact

Direct contact with reagents, detergents, cleaning solutions, or other working solutions may cause skin irritation, inflammation, or burns.

o When handling reagents, exercise the precautions required for handling

laboratory reagents.

o Wear appropriate protective equipment.

See Personal protective equipment on page A-9.

o Observe the cautions given in the instructions for use. o Observe the information given in the Material Safety Data Sheets (available for

Roche Diagnostics reagents and cleaning solutions).

o Be careful when removing open reagent packs from the instrument. They may

contain residues of reagents.

o If a reagent, detergent, or other working solution comes into contact with your

skin, wash it off immediately with water and apply disinfectant. Consult a physician.

Fire and burns

Incorrect results

Alcohol is a flammable substance.

o Keep all sources of ignition (for example, sparks, flames, or heat) away from the

system when conducting maintenance or checks using alcohol.

o When using alcohol on or around the system, use no more than 20 mL at a time.

An incorrect result may lead to an error in diagnosis, therefore posing danger to the patient.

o For proper use of the instrument, run QC tests and monitor the instrument

during operation.

o Do not use reagents or consumables that have exceeded their expiration date,

otherwise inaccurate data may be obtained.

o For diagnostic purposes: always assess the results in conjunction with the patient's

medical history, clinical examination, and other findings.

Varying factors can influence the accuracy or precision of measured results. Pay particular attention to the following information on risks for incorrect results.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-13

1 General safety information cobas®6000 analyzer series

Safety precautions

Samples

Any problem regarding the samples can cause incorrect results. Observe the following information on sample handling.

Sample mismatch Be aware that in non-barcode mode there is a risk of sample mismatch. If samples are

not placed in the proper positions, incorrect measurement results may occur.

o When operating in non-barcode mode, make sure to load the samples according

to the Requisition List as provided by the instrument.

o Do not exchange or remove samples. o Avoid empty positions within the racks. Do not place non-registered samples in

any empty rack position.

o Do not insert any gray rack into the STAT port when operating in non-barcode

mode because the predefined sequence of samples will be disrupted by the routine rack inserted through the STAT port.

o Do not reload an unloaded rack when working in non-barcode mode. In

non-barcode mode, pink racks have to be used to reload samples.

Contamination Insoluble contaminants in samples, bubbles, or film inside a sample container may

cause blockage or pipetting volume shortage leading to compromised measurement accuracy.

o Make sure that samples contain no insoluble contaminants such as fibrin, dust, or

bubbles.

o Make sure to prepare enough sample volume for measurement.

If foreign material falls inside the rack loading area, samples may get contaminated.

o Keep the cover of the rack loading area closed while the instrument is operating. o Do not place anything on the cover of the rack loading area.

Evaporation of samples Evaporation of samples may lead to incorrect results. For critical analytes in terms of

on-board time, you must ensure a short turn-around time.

o After pipetting, do not leave sample, calibrators, or QC materials in a sample

container for any length of time.

Foam or films Foam, fibrin clots, or bubbles in sample types may cause pipetting volume shortage

and lead to incorrect results.

o When loading samples, calibrators, and controls, make sure that they do not

contain any foam, fibrin clots, or bubbles.

o Avoid the formation of foam in all sample types (specimens, calibrators,

controls).

Carryover Traces of analytes or reagents may be carried over from one test to the next.

o Take adequate measures to safeguard additional testing and to avoid potentially

false results.

Sample volume When using standard cups or micro cups, the correct sample cup type must be

selected. Otherwise, the sample pipetting may be inaccurate and thus lead to inaccurate measurement results.

o Be sure to specify the sample cup type for standard cups and micro cups.

Roche Diagnostics

A-14 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 1 General safety information

Safety precautions

Reagents

Wrong reagent handling could cause incorrect results. Observe the following information on reagent handling.

Reagent volume In case of an undetected loss of reagent, the instrument pipettes no reagent or the

wrong volume of reagent. The system will calculate incorrect results.

o Do not reuse a reagent pack from which reagent was spilled. o Reload a reagent pack only if you are sure the reagent volumes remained

unchanged while it was not on the instrument.

o Do not use a single reagent pack for different instruments.

Reagents, auxiliary reagents, calibrators, and controls are sensitive regarding temperature and/or light, especially if the container is already open.

o Store reagents, calibrators, and controls always according to specified storage

conditions.

When using cobas c pack MULTI, it must be filled with the exact filling volume specified in the instructions for use. Failure to do so may lead to incorrect results.

Additionally, an alarm (reagent short) may occur if the instrument detects low reagent volume.

Expired reagents or mixing

reagents

Foam or films Foam on top or bubbles in reagents can cause pipetting volume shortage and lead to

o Ensure that the cobas c pack MULTI contains the correct filling volume. Refer to

the instructions for use.

Results obtained using expired reagents are not reliable. Mixing new reagent and residues of old reagent may cause concentration changes or carryover, leading to incorrect results.

o Do not use expired reagents. o Always store reagents according to the specified storage conditions. o Do not top off old reagents with new reagents. When a bottle is empty, replace it

with a new one.

o Do not leave reagents on the instrument for any length of time.

incorrect results.

o Avoid the formation of foam in all reagent types. o Do not shake reagents.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-15

1 General safety information cobas®6000 analyzer series

Safety precautions

Instrument covers

The instrument comprises various covers. Some covers are important for correct results. Observe the following information for instrument covers.

ISE measuring system If the cover of the ISE measuring system is not reinstalled after maintenance, the

temperature level or the noise level may be affected, leading to incorrect results.

o Only perform measurements if the cover of the ISE measuring system is closed. o Before opening or closing the cover of the ISE measuring system, make sure the

c 501 module is in standby or powered off.

e 601 module If the covers of the reagent compartment or the incubator are not reinstalled after

maintenance, the temperature may become inaccurate, leading to incorrect results.

o Only perform measurements, when the covers are closed.

Others

Other causes can lead to incorrect results. Observe the following information on other causes.

Foam on ProCell/CleanCell Foam on the surface of the e 601 ProCell/CleanCell reservoirs may also lead to

incorrect results.

o Before start of analysis, check that no foam has accumulated on the surface of the

e 601 ProCell/CleanCell reservoirs.

o Clean the ProCell/CleanCell reservoirs if foam has accumulated.

Incubator temperature Measuring before the incubator has reached the correct temperature may lead to

incorrect results and to incorrect results for the photometer check (maintenance (3) Photometer Check).

Measuring with open top cover or reagent disk cover may lead to abnormal temperature control, which may also cause incorrect results. Depending on the ambient temperature, it can take up to 30 minutes to reach the correct temperature after switching on the analyzer or after exchange of incubation water (maintenance item (5) Incubation Water Exchange).

o Before starting any measurement, check that the temperature of the incubator is

within 37 ±0.1 °C (98.6 ±0.2 °F). Select each module on the System Overview screen to display the temperature of the incubator bath of the selected module.

o Be sure to close the covers before starting analysis.

Roche Diagnostics

A-16 Operator´s Manual · Version 8.2

+ 726 hidden pages