Roche cobas 6000 Operator’s Manual

Download

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

cobas®6000 analyzer series 1 General safety information

Safety precautions

Standard cups Although non-Roche Diagnostics sample cups look similar, they may have a different

inner geometry and may have been produced using non-specified materials. The liquid level detection and the level tracking are influenced by the inner geometry of the cup. Thus, air may be pipetted when non-Roche Diagnostics cups are used. This might not be detected under certain circumstances.

Sample cups from other vendors may cause inaccurate sample pipetting, which may lead to incorrect results.

o Use only cups certified by Roche Diagnostics.

Only the following original standard cups are certified by Roche Diagnostics:

o Hitachi standard cup o cobas sample cup (catalog no. 10394246001)

Barcodes Undetected barcode read errors may lead to sample mismatch and, therefore, to

incorrect results.

o Use only barcodes with check digits.

Sample loss

In case of sample loss, there may not be enough sample left for measuring and, therefore, it is impossible to report results for diagnosis. This may lead to false diagnosis.

Stop (global button) Choosing Stop (global button) stops all sampling and sample processing, and results

in process are lost.

o Before choosing Stop (global button), be sure sample processing has finished.

Interlock system The interlock system of c 501 senses top cover opening and immediately stops the

operation by cutting off the power. All pipetted samples are lost and must be reloaded.

o Before starting operation or maintenance, be sure to close and lock the top cover. o Do not open the top cover during operation.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-17

1 General safety information cobas®6000 analyzer series

Safety precautions

Software and data security

The control unit comprises a personal computer which controls the instrument, monitors the instrument functions, and provides and stores data (for example, test results, patient data, calibration, and control results, and so on). Therefore, there is a risk of unauthorized access and data loss due to malicious software and hacker attacks.

Unauthorized access

Portable storage media can be infected with and transmit computer malware, which may be used to gain unauthorized access to data or cause unwanted changes to software.

The instrument is not protected against malicious software and hacker attacks.

The users are responsible for IT security of their IT infrastructure and for protecting it against malicious software and hacker attacks. Failure to do so may result in data loss or render the instrument unusable.

Roche Diagnostics recommends the following precautions:

o Access to your data and the configuration should only be granted to authorized

experts. All user interventions are logged in the system.

o Allow connection to authorized external devices only. o Ensure that all external devices are protected by appropriate security software. o Ensure that access to all external devices is protected by appropriate security

equipment. Roche Diagnostics strongly recommends the use of a cobas IT firewall.

o Do not copy or install any software on the instrument unless it is part of the

system software or you are instructed to do so by a Roche service representative.

o If additional software is required, contact your Roche service representative to

ensure validation of the software in question.

o Do not use the USB ports to connect other storage devices unless you are

instructed to do so by official user documentation or a Roche service representative.

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.

o Before using a removable storage medium, it should be scanned by an antivirus

program.

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

accessed by authorized persons only.

Roche Diagnostics

A-18 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 1 General safety information

Safety precautions

Incorrect or corrupt data

The aim of passwords is to ensure that only authorized personnel have access to a system or information source. The combination of your unique user ID and password tells the system who you are and whether you are permitted access or not.

SECURE HANDLING OF YOUR PASSWORD IS CRUCIAL

o Always enter your password unobserved. o Do not write down your password. o Never note down the password in a contact form, in the address book, or in a file

on the computer.

o Do not disclose your password to anyone. o Roche Diagnostics will never ask you for your password. o If you ever disclose your password to anyone, change it immediately afterwards. o If you think your account has been compromised, then contact your Roche

service representative.

USB storage devices

USB storage devices can be used for several kinds of data backups and restores. Wrong handling of a USB storage device may result in data loss or malfunction of the instrument.

Computer viruses

Third-party software

o Insert or remove a USB storage device only when the instrument is in standby

mode.

o At any one time only one USB storage device can be in use. Before inserting a USB

storage device, check that no other USB storage device is inserted.

o Only remove USB storage devices after choosing USB (global button). o Use only USB storage devices that are tested and installed by your local Roche

service representative.

If you detect an unexpected operation or program/data damage, the PC may be infected with a computer virus.

o Never use a program or storage medium that is suspected of containing a virus. o If you think your PC is infected with a computer virus, call your local Roche

service representative. Your local Roche service representative will disinfect your PC and will check the restoration.

Installation of any third-party software that is not approved by Roche Diagnostics may result in incorrect behavior of the instrument.

o Do not install any non-approved third-party software. o Do not install a commercially available program on the control unit computer or

change any PC settings.

o If additional software is required, contact your Roche service representative to

ensure validation of the software in question.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-19

1 General safety information cobas®6000 analyzer series

Safety precautions

Backup

Data may get lost due to aging of the hard disk or due to a hard disk failure because of electric power failure.

o Back up your data (measurement results and system parameters) at regular

intervals.

o Use the backup function in a daily maintenance pipe to store relevant data on the

hard disk.

o Make a backup copy if you have changed any system parameters.

Instrument damage

During operation, always check for any abnormal sound, water leakages, or other abnormal conditions. If a problem occurs, take suitable safety measures according to the condition and contact your Roche service representative.

Should one of the instrument circuit breakers or fuses blow, do not attempt to operate the instrument before contacting your Roche service representative.

Moving parts

Spillage

Contact with moving parts may bend the probes or damage some other component. If the system detects a collision, an alarm will sound, stopping the operation immediately.

o Keep all covers closed and in place during operation. o Do not touch any parts of the instrument other than those specified. Keep away

from moving parts during operation.

o Only load or unload racks when the green status LEDs at the rack loading area are

on.

Maintenance If the instrument power is turned ON when performing manual maintenance, parts

or tools may contact the instrument mechanisms and damage the instrument.

o Do not power on the instrument while performing manual maintenance.

Any liquid spilled on the instrument may result in malfunction or damage of the instrument.

o Do not place samples, reagents, or any other liquid on the surface of the

instrument.

o When removing and replacing the reaction cells, be careful not to spill water from

the incubator bath.

o If liquid does spill on the instrument, wipe it up immediately and apply

disinfectant. Wear protective equipment.

See Personal protective equipment on page A-9.

Roche Diagnostics

A-20 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 1 General safety information

Safety precautions

Cleaning agents

Some cleaning agents may damage the instrument. Observe the following instructions to avoid instrument damage during cleaning.

Alcohol or bleach Alcohol or bleach may damage the surfaces of the instrument.

o Do not use alcohol or bleach to clean the instrument surfaces.

Acid or alkaline solutions The pre-wash mixer, the incubator, and the AssayCup vortex mixer are made of

aluminum. Acid solution or an alkaline solution degrades the metal.

o Do not use an acid solution or an alkaline solution to clean these parts of the

instrument.

o Use deionized water to clean these parts of the instrument.

Excessive weight

Excessive weight on the instrument may damage the instrument.

c 501 module Excessive weight on the cassette table of the c 501 module may lead to damage.

o Do not place anything other than cobas c packs on the table. o Maximum load of the table is 2 kg.

e 601 module Excessive weight on the magazine drawer of the e 601 module may lead to damage.

o Do not open the front door of the magazine drawer and do not pull out the

magazine drawer when the indicator lamp is off or blinking.

o Pull out the magazine drawer gently and do not lean on the magazine drawer.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-21

1 General safety information cobas®6000 analyzer series

Safety labels of the system

Warning labels have been placed on the analyzer to draw your attention to areas of potential hazards. The labels and their definitions are listed below according to their location on the instrument.

The safety labels on the system comply with the following standards: ANSI Z535, IEC 61010, IEC 60417, or ISO 7000.

If the labels are damaged, they must be replaced by your local Roche service representative. For replacement labels, contact your local Roche service representative.

Spillage warning

This label indicates the instrument may be damaged if a spillage occurs within the vicinity of this label. Do not place liquids in this area.

Protective equipment warning

This label indicates protective goggles and gloves should be worn when working within the vicinity of this label as there is a danger of coming into contact with corrosive material.

Warning

This label indicates there is a danger of hazardous situations within the vicinity of this label, which may result in death or serious injury. Refer to the Operator’s Manual for safety operation.

Biohazard warning

This label indicates there are potential biohazards within the vicinity of this label. Follow standard laboratory practices for working with biohazardous materials.

Electrical warning

This label indicates there is a danger of coming into contact with electrical components when gaining access to parts of the system marked with this label.

Mechanical parts warning

This label indicates there is a danger of coming into contact with moving mechanical parts within the vicinity of this label.

Sharp object warning

This label indicates there is a danger of coming into contact with sharp objects which may result in injuries.

Hot surface warning

This label indicates the area within the vicinity of this label may be hot. Do not touch this area as you may be burned.

Roche Diagnostics

A-22 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 1 General safety information

Safety labels of the system

Maximum weight

This label indicates the maximum weight. Do not place anything heavier than the specified weight on the label.

2 kg Max.

Green button light states

This label indicates the meaning of the status of the green button lights. DO NOT perform an action unless the correct state is indicated.

The following sections describe the meaning of the safety labels on the instrument in a short form.

For more information about the safety labels on the instrument, see:

Front view on page A-24 Side view on page A-26 Top view on page A-27 Rear view on page A-29 Safety information for barcode readers on page A-30

In addition to safety labels on the instrument there are safety notes in the corresponding parts of the Operator’s Manual and Online Help.

For more information, see: Part Operation on page B-1 Part Maintenance on page C-1

These safety notes give more detailed information about potentially hazardous situations in the context of all kinds of working procedures.

When working with the analyzer be sure to observe both safety labels on the instrument and safety notes in the Operator’s Manual and Online Help.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-23

1 General safety information cobas®6000 analyzer series

F-1 F-2 F-3 F-9

F-10 F-12

F-11 F-13

F-4

F-5

F-6

F-7 F-17F-15

F-8 F-14 F-16 F-19F-18

Safety labels of the system

Front view

Figure A-1 Front view of the analyzer

F-1 Attention to interlock!

F-2 Caution against contact with pierce pin!

F-3 Caution against contact with mechanism!

F-4 Caution against pinch by syringe!

F-5 Caution against false result due to loose tube

F-6 Caution against infection due to contact with sipper

F-7 Caution against infection due to contact with waste

connector!

syringe!

from the vacuum tank!

F-8 Caution against irritation by detergent and/or

reagent!

F-9 Caution against pinch by syringe

Roche Diagnostics

A-24 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 1 General safety information

Safety labels of the system

F-10 Caution against injury and infection due to contact

with mechanical parts!

F-11 Attention to handling the magazine drawer!

F-12 Attention to auxiliary reagent setting!

F-13 Attention to auxiliary reagent misplacement!

F-14 Caution against irritation by detergent and/or

reagent!

F-15 Caution against irritation by detergent and/or

reagent!

F-16 Caution against irritation by detergent and/or

reagent!

F-17 Caution against injury by contact with needle!

F-18 Attention to the status of the green lights!

F-19 Caution against infection due to contact with tips

and AssayCups!

Roche Diagnostics

Operator´s Manual · Version 8.2 A-25

1 General safety information cobas®6000 analyzer series

Safety labels of the system

Side view

Figure A-2 Right side of the analyzer

S-1 Caution against infection due to contact with waste

solution in waste solution tank!

Roche Diagnostics

A-26 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 1 General safety information

Safety labels of the system

Top view

Figure A-3 Top view of the analyzer

T-1 Attention to rack direction when loading racks at

T-2 Attention to sampler cover!

T-3 Caution against pinch by rotor mechanism!

T-4 Attention to rack direction when loading racks at

T-5 Caution against burn at photometer lamp

T-6 Caution against entanglement by reagent disk!

T-7 Attention during incubator maintenance!

the STAT port!

the backup operation port!

replacement!

T-8 Instrument damage by water!

T-9 Instrument damage by water!

Roche Diagnostics

Operator´s Manual · Version 8.2 A-27

1 General safety information cobas®6000 analyzer series

2 kg Max.

Safety labels of the system

T-10 Reminder to use cover for KCL bottle replacement

T-11 Attention when opening or closing ISE cover!

T-12 Attention to cassette direction when loading

cassettes!

T-13 Caution against infection due to contact with parts

of the ISE compartment!

T-14 Attention to cassette table maximum weight!

T-15 Instrument damage by water!

T-16 Attention to cassette table maximum weight!

T-17 Instrument damage by water!

T-18 Attention when opening or closing reagent disk

cover!

T-19 Caution against infection due to contact with

mechanism!

T-20 Instrument damage by water!

Roche Diagnostics

A-28 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 1 General safety information

Safety labels of the system

Rear view

Figure A-4 Rear view of the analyzer

R-1 Caution against contact with mechanism!

R-2 Attention to cover with a key!

R-3 Caution against entanglement by rack rotor!

R-4 Attention during water filter maintenance!

R-5 Attention to electric shock at the back side of the

R-6 Caution against infection due to contact with ISE

R-7 Attention to electric shock at the lower part of the

instrument!

waste solution!

rack sampler unit!

Roche Diagnostics

Operator´s Manual · Version 8.2 A-29

1 General safety information cobas®6000 analyzer series

WARNING

Safety information for barcode readers

The cobas 6000 instrument uses barcode readers to scan the barcodes on samples and racks.

o Most of the barcode readers use LED technology with very low output power. o One optional laser barcode reader is used in the core unit. The laser beam is fully

covered during normal operation.

The cobas 6000 instrument complies with the lowest laser class (Class 1) as long as the laser barcode reader is covered. However, the following safety message must be observed.

Loss of sight caused by intense light of barcode readers

The intense light of a laser or LED barcode reader may severely damage your eyes or result in hazardous radiation exposure.

o Do not stare into the beam of a LED barcode reader.

o Do not remove covers from barcode readers.

o Do not perform any maintenance actions on barcode readers. If problems concerning

the barcode readers occur, contact your local Roche service representative.

The cobas 6000 core unit with optional laser barcode reader is a class 1 laser product (which is the lowest class).

The mentioned classes refer to the standard IEC 60825-1:2014

o Class 1: Eye-safe under normal operating conditions. o Class 2: Visible lasers. Eye-safe for accidental viewing. However, it may not be

safe for a person who deliberately stares into the laser beam for longer than 0.25 s, by overcoming their natural aversion response to the very bright light.

The following figure shows the position of the barcode readers and the directions of the LED apertures used by the cobas 6000 analyzer series:

Figure A-5 Top view of the analyzer - localization of barcode readers

Roche Diagnostics

A-30 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 1 General safety information

Safety information for barcode readers

The following table gives technical information about the intensity of the barcode readers:

Barcode no. Module Barcode reader used for Maximum radiation output

power

LED class / Laser class

Classified standard

BC-1 cu 150 Rack ID and sample ID 10.0 μW Class 1 LED product

IEC 60825-1, +A2:2001BC-2 c 501 Rack ID and sample ID 10.0 μW

BC-3 Reagent 10.0 μW

BC-4 e 601 Reagent 166.9 μW

BC-5 Rack ID 10.0 μW

BC-1 (laser option)

Table A-1 Barcode readers of the cobas 6000 analyzer series

cu 150 Rack ID and sample ID 304.8 μW Class 1 Laser product

IEC 60825-1:2014

Roche Diagnostics

Operator´s Manual · Version 8.2 A-31

1 General safety information cobas®6000 analyzer series

Interlock function

The top cover of the c 501 module is equipped with an interlock function to protect the operator from being injured by moving parts. If the top cover of the c 501 module is opened, the interlock function cuts the power to and stops all moving parts. An alarm is triggered.

If you want to continue operation or perform a maintenance item, you have to put the instrument back to standby.

To put the instrument back to standby, see Interlock function: Reset after stop on page B-239.

A Top cover

Figure A-6 c 501 module

Roche Diagnostics

A-32 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 1 General safety information

Disposal of the instrument

The instrument must be treated as potentially biohazardous waste. Decontamination (that is, a combination of processes, including cleaning, disinfection and/or sterilization) is required before reuse, recycling, or disposal of the instrument.

Dispose of the instrument according to the appropriate local regulations. Before disposing of the instrument, contact your Roche service representative.

Disposal of control unit components

Components of your control unit (such as the computer, monitor, keyboard) that are marked with this symbol are covered by the European Directive on Waste Electrical and Electronic Equipment (WEEE, 2002/96/EC).

These items must be disposed of through 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 Roche service representative.

Constraint:

It is left to the responsible laboratory organization to determine whether control unit components are contaminated or not. If contaminated, treat in the same way as the instrument.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-33

1 General safety information cobas®6000 analyzer series

Disposal of the instrument

Roche Diagnostics

A-34 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 2 Overview modules

Table of contents

Overview modules

This chapter provides an overview of all modules of the cobas 6000 analyzer series. A description of possible configuration is provided, as well as system specifications and environmental conditions.

In this chapter

Overview ......................................................................................................................... A-37

Modules of the cobas 6000 analyzer series ................................................................ A-38

Control unit and cobas link ................................................................................... A-39

Core unit .................................................................................................................. A-40

c 501 module ............................................................................................................ A-41

Photometric unit ............................................................................................... A-41

ISE unit ............................................................................................................... A-42

e 601 module ............................................................................................................ A-42

Second rotor module .............................................................................................. A-43

Chapter

Roche Diagnostics

Operator´s Manual · Version 8.2 A-35

2 Overview modules cobas®6000 analyzer series

Table of contents

Roche Diagnostics

A-36 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 2 Overview modules

Overview

The cobas 6000 analyzer series is a fully automated, software-controlled system for clinical chemistry and immunoassay analysis. It is designed for both quantitative and qualitative in vitro determinations using a large variety of tests for analysis. It is ready to use 24 hours per day. The cobas 6000 analyzer series:

o is fully automated o is modular o is computerized o uses serum/plasma, urine, CSF, supernatant and whole blood sample types o performs in vitro quantitative and qualitative tests on a wide range of analytes o performs photometric assays and ion-selective electrode measurements on

c 501 modules as well as electrochemiluminescence assays on e 601 modules

Roche Diagnostics

Operator´s Manual · Version 8.2 A-37

2 Overview modules cobas®6000 analyzer series

Modules of the cobas 6000 analyzer series

The cobas 6000 analyzer series comprises of a control unit, core unit cu 150 and the following hardware units, which can be combined in various combinations:

o c 501 module o e 601 module

Figure A-7 The cobas 6000 analyzer series

The modularity of the system allows for up to seven combinations of the above hardware units and thus provides tailored solutions for all medium workload requirements:

Clinical chemistry

ECL technology

Hybrid combinations

< c > < c c > Up to 2000 tests/h (photometric and ISE)

for a <cc> system Up to 1000 test/h for a single <c> system Up to 60 cobas c packs per c 501 module

< e > < e e > Up to 340 tests/h for a <ee> system

Up to 170 test/h for a single <e> system Up to 25 cobas e packs per e 601 module

< c e > < c c e > < c e e > Up to 2170 tests/h

Up to 145 reagent packs

Roche Diagnostics

A-38 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 2 Overview modules

cobas link Control unit

Modules of the cobas 6000 analyzer series

Control unit and cobas link

The control unit uses a graphical user interface to control all instrument functions. The cobas link PC is used as the gateway for retrieving and distributing information—such as important notes and test- and lot-specific analyzer settings—from Roche TeleService-Net to cobas analyzers.

The following figure shows the control unit together with the cobas link PC:

Acobaslink PC B Control unit computer

Figure A-8 Control unit and cobas link PC

Any component of the control unit is subject to change without prior notice.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-39

2 Overview modules cobas®6000 analyzer series

Modules of the cobas 6000 analyzer series

Core unit

The core unit comprises several components that manage the transport of samples to each assigned analytical module.

A Rack sampler unit

B STAT port

C Barcode reader

D Rack rotor

Figure A-9 Core unit cu 150

E Conveyor line (depending on system

configuration)

F Rack loader

G Rack unloader

Other core module components (installed into the rack sampler unit) are:

o Water supply o System interface port o Power switches

Roche Diagnostics

A-40 Operator´s Manual · Version 8.2

o Main circuit breaker

cobas®6000 analyzer series 2 Overview modules

Modules of the cobas 6000 analyzer series

c 501 module

The c 501 module comprises a photometric unit and an ISE unit (for ion-selective electrode [ISE] determinations).

Photometric unit

Sampling system The sampling system is composed of a sample pipetter (consisting of a pipetter arm

Reagent system The reagent system is composed of a refrigerated reagent compartment consisting of

Reaction disk system The reaction disk system is composed of a reaction disk, immersed in an incubator

Figure A-10 c 501 module

The photometric unit provides the analyzer with a flexible photometric method of assaying up to 600 in vitro tests per hour on a wide range of analytes. The following are the main components of the c 501 module:

o Sampling system o Reagent system o Reaction disk system

and the sample probe), a sample syringe, and a rinse station for internal and external rinsing of the sample probe.

two storage rings for reagent cassettes, and a reagent pipetting system with two rinse stations for internal and external rinsing of the reagent probes.

Another integral part of the reagent system is the cassette management system, which provides a fully automated management of reagent cassettes—from the point of loading of new cassettes all the way to the disposal of empty cassettes.

bath, three ultrasonic mixing units, a photometric measuring system, and a cell rinse unit for cleaning the reaction cells once test measurement is complete.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-41

2 Overview modules cobas®6000 analyzer series

Modules of the cobas 6000 analyzer series

ISE unit

Moreover, the c 501 module has an integrated ISE unit, which provides the analyzer with a potentiometric method for assaying sodium, potassium and chloride samples. The ISE unit can process up to 200 samples per hour. The following are the main components of the ISE unit:

o ISE measuring compartment with measuring cartridges for Cl

, K+, Na+ and

Reference cartridge

o ISE pipetter o ISE sipper o IS bath o ISE reagent compartment

e 601 module

The e 601 module is an immunoassay analyzer with a throughput of up to 170 tests per hour. The cobas 6000 analyzer series can be configured with up to two e 601 modules.

Figure A-11 e 601 module

The following are the main components of the e 601 module:

o Reagent area o Measuring area o Consumables area o Pre-wash area

Reagent area The reagent area comprises the left side of the analyzer and consists of a reagent disk,

a barcode reader, a cap open/close mechanism, a microbead mixer, a reagent probe and two rinse stations.

Roche Diagnostics

A-42 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 2 Overview modules

Modules of the cobas 6000 analyzer series

Measuring area The measuring area is in the middle of the analyzer and consists of an incubator, a

sample probe, two sipper probes, two sipper rinse stations, and the two measuring cells.

Pre-wash area The Pre-wash station, located in the middle at the back of the analytical module,

carries out a pre-wash step to remove special contents of serum from the reaction solution before measuring if required by the assay protocol. The Pre-wash station consists of a Pre-wash gripper, Pre-wash sipper, Pre-wash dispenser, rinse station, separation stations, and the vortex mixing station.

Consumables area The consumables area is on the right side of the e 601 and consists of the gripper, the

mixing station, the AssayTip station, the magazine lifter trays, two solid waste containers, the magazine waste compartment, and the auxiliary reagents and cleaning solutions.

Second rotor module

Only cobas 6000 analyzer series with a specific configuration have a second rotor module.

Figure A-12 Second rotor module

The second rotor module routes racks from the core unit to the second and third analyzer modules and back to the first rack rotor. The second rack rotor also acts as rack buffer for the automatic rerun function.

Systems with the following configurations have a second rotor module:

o <c 501> <c 501> o <c 501> <c 501> <e 601> o <c 501> <e 601> <e 601>

The second rotor module is always placed between the first and the second analyzer module.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-43

2 Overview modules cobas®6000 analyzer series

Modules of the cobas 6000 analyzer series

Roche Diagnostics

A-44 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 3 Control unit, cobas link and core unit

Table of contents

Control unit, cobas link and core unit

This chapter provides a detailed description of the control unit, the cobas link platform, and the core unit. The description of the core unit includes the rack sampler unit, the rotor, and the conveyor line, as well as line movements within these components. The sample containers, sample racks, and the rack identification are also described in this chapter.

In this chapter

Control unit ................................................................................................................... A-47

Control unit computer ........................................................................................... A-47

Touchscreen Monitor ............................................................................................. A-48

Keyboard .................................................................................................................. A-48

Mouse ....................................................................................................................... A-48

Printer ....................................................................................................................... A-48

cobas link ........................................................................................................................ A-49

Overview .................................................................................................................. A-49

Main functions ........................................................................................................ A-51

Working with cobas link functions ...................................................................... A-52

Using e-barcodes via download ...................................................................... A-52

Using the backup function .............................................................................. A-53

Using e-package inserts ................................................................................... A-53

Core unit cu 150 ............................................................................................................ A-54

Rack sampler unit ................................................................................................... A-55

Rack loader/unloader ....................................................................................... A-56

STAT port .......................................................................................................... A-57

Barcode reader / cup sensor ............................................................................ A-57

Power switches .................................................................................................. A-58

System interface port ........................................................................................ A-58

Water supply ..................................................................................................... A-59

Rack rotor ................................................................................................................ A-60

Chapter

Roche Diagnostics

Operator´s Manual · Version 8.2 A-45

3 Control unit, cobas link and core unit cobas®6000 analyzer series

Table of contents

Trays, racks, tubes, and cups ....................................................................................... A-61

Rack trays ................................................................................................................. A-61

Racks ......................................................................................................................... A-62

Rack types .......................................................................................................... A-62

Rack number ranges ......................................................................................... A-63

Rack ID ............................................................................................................... A-63

Rack classes and colors of standard racks ..................................................... A-64

Rack classes and colors of MPA racks ........................................................... A-65

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

Sample containers ................................................................................................... A-68

Sample tubes and cups ..................................................................................... A-68

Sample identification ....................................................................................... A-69

Maximum fill height ......................................................................................... A-69

Roche Diagnostics

A-46 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 3 Control unit, cobas link and core unit

Control unit

The control unit uses a graphical user interface to control all instrument functions. The following figure shows the control unit together with the cobas link PC:

A Monitor cobas link

B Keyboard/Mouse cobas link

Ccobaslink PC

Figure A-13 Control unit and cobas link PC

Do not place the computer, touchscreen or any data storage media in the vicinity of electric or magnetic fields, since this may led to damage and/or data loss.

D Touchscreen Monitor

E Keyboard/Mouse

F Control unit computer

G Ergonomic PC stand

Control unit computer

The control unit computer monitors the system functions, and operation modes for all modules.

o A hard disk drive is used to store the operating system, the analyzer software, the

Online Help system and data, for example patient data, calibration data, QC data and system parameters.

o A 31/2 inch floppy disk drive is available for reading and writing parameters and

other information for backup purposes.

o A CD or a DVD drive is available for loading software updates.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-47

3 Control unit, cobas link and core unit cobas®6000 analyzer series

Control unit

Touchscreen Monitor

The system uses a 17" SVGA with color monitor touchscreen adapter to:

o Display information o Navigate through the software o Initiate instrument functions

To use a touchscreen, touch what you want to request or change directly on the screen. Most of the items within the software can be accessed using the touchscreen. Touch the item desired (for example, menu bar, list box, text box, button, etc.) to complete your task. For example, to display the Data Review screen in the Workplace menu, touch Workplace, then the Data Review tab.

When touching the screen, be sure to “tap” not “press”. The tap must be of short duration. When touching the screen, you can use your finger or a pointing device.

Selecting Items To select a consecutive range of items in a list, press <Shift> and touch the first item

in the range. While continuing to press <Shift>, touch the last item in the range. All items, including the first and last items touched in the range, are highlighted. You may also touch the first item in the list and drag your finger to the last item in the list.

Keyboard

Mouse

Printer

To select multiple, nonconsecutive items, press <Ctrl>, then touch the desired items.

A 101-key enhanced keyboard is used to navigate through the software and to enter information.

Most items that can be accessed via the touchscreen can also be accessed via the keyboard.

For more information, see Shortcut Keys on page B-13.

A mouse is available to navigate through the software.

The mouse can be used to select items on the screen and to place the cursor at an insertion point in a text box. To select an item using the mouse, move the mouse over the item and then click.

The system uses a graphics-capable printer. Patient results can be printed in report format (long) or in monitor format (short). The printer can be ordered as an optional accessory.

See Report Format on page B-310.

Roche Diagnostics

A-48 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 3 Control unit, cobas link and core unit

cobas link

This section explains the principles of the cobas link platform and gives an introduction to working with cobas link.

Overview

cobas link platform The cobas link platform is the gateway for retrieving and distributing information

from the Roche remote service infrastructure to cobas analyzers in the laboratory (Figure A-14). Information such as instructions for use, value sheets, important notes, as well as test-specific and lot-specific analyzer settings are made available through cobas link

cobas link is an integral and mandatory part of the cobas modular platform analyzers.

A Remote service infrastructure

Bcobas analyzers

Figure A-14 cobas link platform

Ccobaslink PC

A number of applications and other information, for example about controls and calibrators, are available on the cobas link, which automates manual tasks, improving efficiency and reducing errors.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-49

No patient names or patient IDs are transferred to or stored within the remote service infrastructure.

3 Control unit, cobas link and core unit cobas®6000 analyzer series

cobas link

Remote service infrastructure Remote service infrastructure is the technical infrastructure which provides the cobas

analyzers and operators with important product information from Roche Diagnostics. Remote service infrastructure offers several applications to manage and display data and information gathered from remotely connected instruments which are uploaded by cobas link located in the laboratory systems.

cobas link PC A dedicated desktop computer consisting of monitor, keyboard, mouse, and printer

located in the customer laboratory, which has been configured to act as a gateway between Roche Diagnostics systems and the internet. As well as providing a communication link, the cobas link PC also stores data and documentation for assay processing.

cobas e-library cobas e-library runs on the cobas link platform. cobas e-library receives data, from

the remote service infrastructure, about assay parameters as well as labeling information for the applications, controls, and calibrators used on cobas analyzers. This data is then made available to the connected analyzers, ensuring that they always have the current data when it is required. Laboratory staff can also view and print this data, when needed, through cobas e-library.

cobas e-library is updated daily by an automatic download if it is connected to a network. New catalogue numbers, calibrator lots, and control lots are displayed by default.

Regular updates

It is important to update cobas e-library regularly to ensure you receive all important information as it becomes available.

There is a separate Operator’s Manual for the cobas e-library available.

For information on working with the cobas e-library, refer to the cobas e-library Operator’s Manual.

If your laboratory does not have an online connection to remote service infrastructure, the cobas e-library data is provided on a CD, distributed by your local Roche service representative.

For information on working with CDs, refer to the cobas e-library Operator’s Manual.

Roche Diagnostics

A-50 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 3 Control unit, cobas link and core unit

Analyzer control unit

Download

e-barcodes

Upload backups

Provide e-package inserts

cobas link PC

cobas link

Main functions

From the operator’s point of view the main functions of cobas link are:

Figure A-15 cobas link - main functions

e-package inserts (e-PI) The cobas e-library stores many documents (e-package inserts) which can be viewed,

printed, and saved:

o Instructions for use for the applications o Value sheets of controls and calibrators o Important notes (for example, reassigned control values) o Announcements from Roche service representatives (for example, customer

letter)

See Using e-package inserts on page A-53.

e-barcodes (e-BC) Providing e-barcodes like application parameters to be downloaded from cobas link

to the analyzer by the operator. e-BCs are readable by the instrument only.

See Using e-barcodes via download on page A-52.

e-reference documents e-reference documents provide current product information.

Screen sharing Screen sharing is a function to support the instrument and the user.

Backup function Providing the possibility of data backup for the cobas 6000 analyzer series.

See Using the backup function on page A-53.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-51

3 Control unit, cobas link and core unit cobas®6000 analyzer series

cobas link

Working with cobas link functions

This section explains the working principles of the main cobas link functions.

Using e-barcodes via download

The operator downloads the required e-barcodes from the cobas link PC to the analyzer.

The following types of e-barcodes are available:

o Application data o Calibrator data o Control data

The following figure gives an overview of the installation process.

Figure A-16 Installation process of a new cobas application

If the data of a particular application (application parameters, calibrator data, and control data) is not available on the analyzer, it has to be downloaded from cobas link.

For more information, see Installing an application on page B-256.

A detailed description for installing new applications, calibrators, and controls is given in the corresponding chapters.

For a more detailed description see:

To download application parameters from cobas link on page B-259 To download calibrator data from cobas link on page B-190 To download control data from cobas link on page B-226

Roche Diagnostics

A-52 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 3 Control unit, cobas link and core unit

cobas link

Using the backup function

Instrument and process related data can be stored on the hard disk of the cobas link PC for recovery. In order to initiate this backup function it is necessary to include the cobas link upload function (Smart. Com Essential information upload) in a maintenance pipe that is carried out daily (for example, as part of the Power ON pipe).

This item can only be performed in a maintenance pipe.

For more information, see:

Defining and editing maintenance pipes on page C-11 Recommended maintenance pipes on page C-33 Smart. Com Essential information upload on page C-42

Perform daily backups to preserve the operational availability of the analyzer!

Include the cobas link upload function (Smart. Com Essential information upload) into a maintenance pipe that is executed daily. If a hard disk error on the control unit occurs, the last backup can be restored from the cobas link PC by a Roche service representative.

Using e-package inserts

You can view, print, and save e-package inserts from the cobas e-library.

The e-package inserts (e-PI) consists of the following electronic documents:

Instructions for use

Value sheets of calibrators and controls

Important notes (for example, reassigned control values)

Announcements from Roche service representatives (for example, customer letter)

Check your cobas e-library daily to obtain important information

It is important to check your cobas e-library daily (New Entries) because important information that is necessary for analysis—like reassigned control values—is announced through the cobas e-library.

For information on working with the cobas e-library, refer to the cobas e-library Operator’s Manual.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-53

3 Control unit, cobas link and core unit cobas®6000 analyzer series

Core unit cu 150

The core unit comprises several components that manage the conveyance of samples to each assigned analytical module. Therefore, the actual composition depends on the current module configuration of the analyzer. The core unit comprises at least the rack sampler unit and one rack rotor as main components. Conveyor line(s) and second rack rotor are possible extensions.

Roche Diagnostics

A-54 Operator´s Manual · Version 8.2

A Rack sampler unit

B STAT port

C Barcode reader

D Rack rotor

Figure A-17 Core unit cu 150

E Conveyor line (depending on system

configuration)

F Rack loader

G Rack unloader

cobas®6000 analyzer series 3 Control unit, cobas link and core unit

Core unit cu 150

The following are main components of the core unit:

o Rack sampler unit o Rack rotor(s) o (Conveyor line[s])

Other core unit components (installed into the rack sampler unit) are:

o Rack loader/unloader o STAT port o Barcode reader (for racks and samples) o Water supply o System interface port o Power switches o Main circuit breaker

Rack sampler unit

A Rack loader/unloader

B STAT port

Figure A-18 Rack sampler unit

C Operation power switch

D Main circuit breaker

All central control and supply functions of the core unit are installed into the rack sampler unit.

The following subsections describe the rack loader/unloader, STAT port, barcode reader, and power switches. Then, we turn to the rear of the rack sampler unit and discuss the system interface and the water supply.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-55

3 Control unit, cobas link and core unit cobas®6000 analyzer series

Core unit cu 150

Rack loader/unloader

A Rack loader

B Rack unloader

Figure A-19 Rack loader/unloader

C Rack tray (with racks)

D Green LED

Viewed from above, the rack sampler unit features two lanes where sample racks (or rack trays with sample racks) are to be inserted; the left lane is the rack loader, the right lane is the rack unloader. Both the loader and the unloader have a capacity of 150 samples, corresponding to 30 racks each. The racks are supplied on rack trays.

Make sure the rack barcode label is on the right side when placing a rack on a tray. The barcode label can be read only when racks are supplied in correct orientation.

The rack loader is designed for continuous loading. That is, the operator can load new samples while others are still being processed. When the analyzer is in operation, the green LEDs indicate when a rack tray can be exchanged. That is, when new sample racks can be inserted or when a rack tray can be removed from the unloader.

When the analyzer is in operation, rack loading proceeds automatically. When the analyzer is in standby, rack loading initiates after the operator starts the run.

Rack loading The rack loader automatically pushes the sample racks forward. One after another,

the racks are pushed onto a feeder, which transports each rack into the rack rotor. When transporting the racks into the rack rotor, a barcode reader scans the barcode and a sensor checks the height of each sample container. From the rack rotor, the racks move to the analytical module where their samples are analyzed.

After analysis, the racks move from the analytical module via the rack rotor to the unloader. The unloader collects the processed sample racks up to a maximum of 30 racks.

Roche Diagnostics

A-56 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 3 Control unit, cobas link and core unit

Core unit cu 150

STAT port

Barcode reader / cup sensor

Figure A-20 STAT port

Use the STAT port to send any racks directly onto the rack rotor, bypassing all racks on the trays of the rack loader. A rack loaded through the STAT port will be processed with higher priority than other racks in rack rotor.

To locate the STAT port on the rack sampler unit, see Figure A-18 on page A-55.

Make sure the rack barcode label is on the right side when inserting a rack into the STAT port. The barcode label can be read only when racks are supplied in correct orientation.

Any rack can be put into the processing track at any time by using the STAT port. However, when operating in non-barcode mode, routine (gray) racks must not be put into the processing track by using the STAT position! Doing so would disrupt the predefined sample sequence and lead to sample mismatch for all subsequent samples.

For information on the different types of racks, see Racks on page A-62.

When racks are loaded onto the analyzer, either via rack loader or via STAT port, they pass by a barcode reader and a height sensor before they enter the rack rotor. This barcode reader performs the following tasks:

o Scans rack barcode of each rack o Detects if there is a sample in each of the five rack positions o Detects the type of sample tube or cup present o Scans barcodes on each sample within a rack

The height sensor cannot distinguish between sample cups and microcups.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-57

3 Control unit, cobas link and core unit cobas®6000 analyzer series

Core unit cu 150

Power switches

There are two types of power switches: Superordinate power switches and power switches for each module.

Superordinate power switches (on the left of the rack sampler unit):

o Operation power switch o Main circuit breaker

To locate the superordinate power switches, see Figure A-18 on page A-55.

Power switches for each module (at the rear of each module):

o Module power switch for the rack sampler unit o Module power switch for the c 501 module and the e 601 module

Power switch Dependent components

Operation power switch Whole analyzer except for cooling unit

Main circuit breaker Whole analyzer including the cooling unit

Module power switch for the rack sampler unit

Module power switch for the c 501 module and the e 601 module

Table A-2 Power switches and dependent components

Rack sampler unit (including rack rotor)

c 501 module, e 601 module

System interface port

The following components take part in the data communication within the analyzer and its network environment:

o Rack sampler unit o Connected analytical modules o cobas link o Host computer

There are two devices to accomplish the data communication: A serial port for bidirectional communication with the Host computer and a hub for network connections. The hub is located on the PC stand.

For technical information about the serial interface, see System interface on page A-119.

Roche Diagnostics

A-58 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 3 Control unit, cobas link and core unit

Core unit cu 150

Water supply

A Fitting with inlet filter

B System interface port

C Water tank

Figure A-21 Water supply

D Tap for water tank

E High concentration waste container

The deionized water supply system consists of the water tank, located behind the rack sampler unit, connecting tubing, and a series of electronic valves. Water is automatically added to the water tank when necessary. Water from this source is supplied directly to the cell rinse unit, to the rinse stations, and to the incubator bath.

For more information about water consumption and specifications, see Water requirements on page A-118.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-59

3 Control unit, cobas link and core unit cobas®6000 analyzer series

Core unit cu 150

Rack rotor

Figure A-22 Rack rotor

The rack rotor is located at the rear between the rack sampler unit and the analytical module (c 501 or e 601, depending on system configuration). The rotor has 20 positions for sample racks. It receives sample racks from the rack loader, passes them on to the c 501 module or the conveyor line, receives sample racks from the c 501 module after pipetting or from the conveyor line, and passes them on to the unloader.

In addition, the rack rotor can hold special racks (auto QC) readily available and reserve special positions for STAT racks. Any of the 20 positions is freely definable for STAT or auto QC.

If your cobas 6000 analyzer is equipped with two c 501 modules or with one c 501 and two e 601 modules, then a module with a second rack rotor is placed between the first and the second analyzer module.

Roche Diagnostics

A-60 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 3 Control unit, cobas link and core unit

Trays, racks, tubes, and cups

This section describes the different containers and components used to transport samples.

Rack trays

A Rack Trays B Sample racks with different tubes, cups and

cup on tube

C Standard cup, micro cup

Figure A-23 Trays, racks, tubes, and cups

Samples are supplied to the analyzer in sample tubes or cups. These sample containers are inserted in sample racks, which are placed on rack trays.

Rack trays are used to transport sample racks to and from the rack loader/unloader. Each tray has a capacity of 15 racks. This corresponds to a number of 75 samples that can be loaded onto the analyzer with one tray.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-61

3 Control unit, cobas link and core unit cobas®6000 analyzer series

Trays, racks, tubes, and cups

Racks

For the cobas 6000, different rack types and classes are available. This chapter explains all rack details.

Rack types

For the cobas 6000, two rack types are available: Standard racks and MPA racks.

o Standard racks are used as transport carriers for all types of sample containers

throughout the cobas 6000. You can mix 13 and 16 mm sample tubes on one standard rack.

o MPA racks are used as transport carriers either for 13 mm or 16 mm sample

tubes.

A Standard rack

B Spring clips, allow the use of different tube

diameters

C Rubber bottom, ensures the proper

orientation for reading of sample barcode

Figure A-24 Comparison of racks

Characteristics Standard rack MPA rack

Tube diameter Flexible, ∅ 13 mm – 16 mm

D MPA rack (without spring clips and rubber

bottom)

Fixed, ∅ 13 mm or 16 mm

Cup adapters available for tubes with ∅ 13 mm or less

Cup on rack

Can be used Not supported

(standard or micro cup)

Sample classes All For routine, STAT, and rerun

samples only

Color of routine rack Gray Different colors and rack

ranges available for different

Table A-3 Rack types and characteristics

For more information, see:

sample types

Rack classes and colors of standard racks on page A-64 Rack classes and colors of MPA racks on page A-65

Roche Diagnostics

A-62 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 3 Control unit, cobas link and core unit

Trays, racks, tubes, and cups

Rack number ranges

Different sample types, such as Ser/Pl or urine, can be processed on the analyzer. To process these different sample types on the different rack types (routine, rerun, STAT), rack number ranges must be defined for each sample type and rack type.

As an example, some number ranges are presented below:

o Serum: Rack number range 001–100 o Urine: Rack number range 401–500

Rack ID

Each rack is equipped with an identification number. This unique number is called rack ID.

Every rack is identified and registered when its barcode ID is scanned by the barcode reader of the core unit.

A Rack ID – operator readable B Barcoded rack ID – system readable

(displayed in user interface)

Figure A-25 Rack ID positions

The rack labels displayed in the software differ from those printed on the racks.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-63

3 Control unit, cobas link and core unit cobas®6000 analyzer series

Trays, racks, tubes, and cups

Rack classes and colors of standard racks

Racks are available in different colors which are allocated to individual sample classes. This simplifies the handling of sample classes.

The table below provides an overview of rack classes.

Rack class Rack color Display in software Rack ID on label

Routine

Gray N00001-N03999 0001-3999

STAT

Rerun

Calibrator

Wash rack

Red E00001-E00999 S001–S999

Pink R00001-R00999 R001–R999

Note: Pink racks are only used for manual reruns in non-barcode mode!

Black S00001-S00999 C001–C999

White C00001-C00999 Q001–Q999

Green W00999 W999

Table A-4 Rack classes and colors of standard racks

Roche Diagnostics

A-64 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 3 Control unit, cobas link and core unit

Trays, racks, tubes, and cups

Rack classes and colors of MPA racks

MPA racks for routine samples are available in different colors. This allows the use of racks in different colors for each sample type, such as Ser/Pl or urine, according to the rack ranges defined under Utility > System > Rack Assignment.

Overlapping of the rack ranges

The MPA racks share part of the same rack range with the standard racks. Therefore, only one type can be used within the same rack range, either MPA or standard racks.

If you load a rack into the instrument and another rack with the same rack ID is already being processed, the samples on the second rack will not be processed.

The table below provides an overview of MPA racks:

Rack class Rack color Display in software Rack ID on label

Routine

13 mm

Navy blue

Light green

Yellow

Brown

60001–90000

(a)

1001–4000

(a)

STAT

13 mm

Routine

16 mm

Navy blue S4501–S4600 S501–S600

Light blue

60001–90000

(a)

1001–4000

Light green

(a)

Yellow

STAT

16 mm

Table A-5 MPA racks for 13 mm and 16 mm sample tubes

(a) Each color has its specific ID range.

Navy blue S4801–S4900 S801–S900

The racks for 13 and 16 mm tubes use different colors and rack ranges, so that you can also distinguish between them.

Please contact your local Roche Diagnostics sales representative for a detailed ordering list for MPA racks.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-65

3 Control unit, cobas link and core unit cobas®6000 analyzer series

WARNING

Trays, racks, tubes, and cups

Correct alignment of sample tubes on a rack

Take special care to place sample tubes correctly on the rack. This is especially important for 13 mm tubes which are narrower and more likely to tilt if placed incorrectly. If the tubes are not correctly seated in an upright position on the rack, the sample probe may attempt to sample outside the tube. Or the sample probe may hit the side of the tube, causing errors and incorrect results.

Incorrect results when sample tubes are not aligned vertically

Incorrect placement of sample tubes in racks may cause incorrect sample pipetting, which may lead to false low results, especially when testing immunoassays.

o Ensure that sample tubes are always placed vertically in the racks.

o For sample tubes with an outer diameter of 13 mm or less, use the Roche Diagnostics

cup adapter or use 13 mm MPA racks alternatively.

See Sample tube alignment on page A-66.

o Only use sample tubes specified for use with the cobas 6000 analyzer series.

See Sample cups and tubes on page A-122.

Sample tube alignment The following figure illustrates correct and incorrect alignment of a sample tube on

the rack.

The tube position must be straight vertically for correct sampling. The vertical position also reduces possible barcode reading errors and incorrect pipettings.

Roche Diagnostics

A-66 Operator´s Manual · Version 8.2

A Incorrect - position misaligned B Correct - position perfectly aligned

Figure A-26 Sample tube alignment

cobas®6000 analyzer series 3 Control unit, cobas link and core unit

CA B

Trays, racks, tubes, and cups

Cup adapters for tubes ≤13 mm To improve the alignment of tubes with an outer diameter ≤ 13 mm, Roche

Diagnostics strongly recommends that Roche Diagnostics cup adapters are used.

Cup adapters are inserted into standard racks as shown in the following figure.

Conditions for 13 mm tubes

without cup adapters

A Roche Diagnostics cup adapter

B Insert adapter into rack

Figure A-27 Placing a cup adapter into a rack

C 13 mm tube placed in a rack position with

cup adapter

If immunoassays are requested, cup adapters must be used for sample tubes with an outer diameter ≤ 13 mm.

Do not use cup adapters for tubes with an outer diameter > 13 mm, because the barcode label might be damaged.

For MPA racks, the cup adapters cannot be used.

You can omit the cup adapters for 13 mm sample tubes if the following preconditions are fulfilled:

o The cobas 6000 is connected with a cobas



8100 automated workflow series. In this clinical laboratory automation system, a gripper arm places the sample tubes into the racks.

o The sample probes are precisely adjusted in horizontal and vertical direction on

all modules. The adjustment of the sample probes must be performed by your Roche Service representative.

o All spring clips are symmetrically bent in the used racks so that the sample tubes

are held vertically.

A Incorrect - spring clips are not symmetric B Correct - spring clips are symmetric

Table A-6 Spring clips in racks

Roche Diagnostics

Operator´s Manual · Version 8.2 A-67

3 Control unit, cobas link and core unit cobas®6000 analyzer series

Trays, racks, tubes, and cups

Sample containers

There are three general kinds of sample containers: Sample tubes, sample cups, and calibrator or control vials.

Sample tubes and cups

Sample tubes are 13 mm or 16 mm in diameter and 75 mm or 100 mm in length. Sample cups (both standard and micro cups) can be inserted into 16-millimeter sample tubes (cup on tube) or they can be used without tubes.

For sample container specifications, see Sample cups and tubes on page A-122.

A Sample cup on rack

B 16 mm x 75 mm tube

C Sample cup on 16 mm x 75 mm tube

Figure A-28 Sample container heights

D 16 mm x 100 mm tube

E Sample cup on 16 mm x 100 mm tube

F Micro cup

Restrictions for the use of micro cups

When the end of sample probe touches the inner wall of a micro cup this may result in improper sample aspiration.

Roche Diagnostics

A-68 Operator´s Manual · Version 8.2

o Do not use micro cups on e 601 modules.

o Do not use micro cups for calibrators and controls.

cobas®6000 analyzer series 3 Control unit, cobas link and core unit

WARNING

-10 mm

Trays, racks, tubes, and cups

Non-standard tubes

Sample tubes with the following dimensions can also be used:

o Length between 73 mm and 102 mm

o Outer diameter between 12 mm and 16 mm

Non-standard tubes and false bottom tubes can be used for patient samples and controls.

Please contact your Roche service representative for more information about the use of non-standard tubes and other sample containers.

Sample identification

When operating in barcode mode, each sample’s barcode label is scanned by the barcode reader of the rack sampler unit. The sample barcode label provides the sample ID, which is used for sample identification and test selection purposes.

For label dimensions and placement specifications, see Barcode types on page A-120.

The combination of the sample ID and the rack identification number provides tracking for the system. To track samples by means of the software, select Sample Tracking from the System Overview screen.

When operating in non-barcode mode, samples are identified by a sequence number, the rack number, and their position in the sample rack. This assignment has to be done on the Workplace > Test Selection screen.

Maximum fill height

To prevent any splashing during processing of sample containers, the maximum fill height should not exceed 10 mm below the top edge of each container.

Figure A-29 Maximum fill height for containers

Infection and danger by spilled sample during operation

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.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-69

3 Control unit, cobas link and core unit cobas®6000 analyzer series

Trays, racks, tubes, and cups

Roche Diagnostics

A-70 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 4 c 501 module

Table of contents

c 501 module

This chapter provides a detailed description of the c 501 module, its hardware components and technical specifications.

In this chapter

Overview ......................................................................................................................... A-73

System characteristics ............................................................................................. A-73

Components of the c 501 module ......................................................................... A-74

Sampling area components .......................................................................................... A-76

Sample pipetter ........................................................................................................ A-76

Sample probe rinse station .................................................................................... A-77

Sample syringe ......................................................................................................... A-77

Reagent area components ............................................................................................ A-78

Reagent storage compartment .............................................................................. A-78

Reagent pipetting system ....................................................................................... A-79

Reagent pipetters .............................................................................................. A-79

Reagent syringes ............................................................................................... A-80

Reagent probe rinse stations ........................................................................... A-80

Cassette management system ................................................................................ A-81

Cassette loading port ........................................................................................ A-81

Cassette preparation station ............................................................................ A-82

Piercer and Gripper .......................................................................................... A-82

Cassette disposal ............................................................................................... A-82

Reaction disk area components .................................................................................. A-83

Reaction disk ........................................................................................................... A-84

Ultrasonic mixers .................................................................................................... A-84

Incubator bath ......................................................................................................... A-84

Photometer .............................................................................................................. A-85

Cell rinse unit .......................................................................................................... A-86

Flow of photometric analysis ................................................................................ A-88

Main functions on the reaction disk area ...................................................... A-88

Main steps of photometric analysis ................................................................ A-89

Reaction monitoring .............................................................................................. A-91

Chapter

Roche Diagnostics

Operator´s Manual · Version 8.2 A-71

4 c 501 module cobas®6000 analyzer series

Table of contents

Behind the front doors ................................................................................................. A-92

Auxiliary reagents and cleaning solutions ........................................................... A-93

Vacuum system ....................................................................................................... A-93

Rear view ........................................................................................................................ A-94

ISE area components .................................................................................................... A-95

ISE pipetting system ............................................................................................... A-96

Internal standard bath ............................................................................................ A-96

ISE sipper mechanism ............................................................................................ A-96

ISE measuring system ............................................................................................. A-97

ISE rinse station ...................................................................................................... A-97

ISE reagent compartment ...................................................................................... A-97

Flow of an ISE analysis ........................................................................................... A-98

Roche Diagnostics

A-72 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 4 c 501 module

Overview

The c 501 module is a fully automated, discreet, computerized analyzer for in vitro tests on a wide range of analytes. It is designed to use serum/plasma, urine, CSF, supernatant and whole blood sample types. The c 501 module performs photometric assays as well as ion-selective electrode (ISE) determinations. The throughput is up to 1000 tests per hour for a combination of photometric and ISE tests.

System characteristics

Figure A-30 c 501 module

This chapter describes the c 501 module. The rack rotor and rack sampler unit belong to the core unit.

For a detailed description of the core unit, see Chapter 3 Control unit, cobas link and core unit.

o 131 on board pre-programmable applications o STAT sample processing within less than 2 min. o Automatic reagent cassette loading and unloading o Automated maintenance functions o Automatic rerun capability o Automatic calibration notification o Automatic sample dilution capabilities o Non-contact ultrasonic mixing o Reduced water consumption o HbA1c whole blood support o Backup solution for core unit

Roche Diagnostics

Operator´s Manual · Version 8.2 A-73

4 c 501 module cobas®6000 analyzer series

Overview

Components of the c 501 module

The c 501 module contains an ISE unit and a photometric unit. Figure A-31 sketches the different areas from a top-view perspective:

A Rack sampling position

B Sampling area

C Reaction disk area

D ISE area

Figure A-31 Areas of the c 501 module

E Reagent cassette loading port

F Reagent pipetters (pipetting area)

G Reagent area

Roche Diagnostics

A-74 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 4 c 501 module

Overview

The c 501 module can be subdivided into the following areas:

o Sampling area

See Sampling area components on page A-76.

o Reagent area

See Reagent area components on page A-78.

o Reaction disk area

See Reaction disk area components on page A-83.

o Behind the front doors

See Behind the front doors on page A-92.

o Rear side

See Rear view on page A-94.

o ISE area

See ISE area components on page A-95.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-75

4 c 501 module cobas®6000 analyzer series

Sampling area components

The sampling area of the c 501 module consists of the following components:

o A rack sampling position. o A sample pipetter (consisting of pipetter arm and probe) for pipetting samples

from the sample tubes to the reaction cells on the reaction disk.

o A rinse station for internal and external rinsing of the sample probe.

A Pipetter arm

B Sample probe

C Shield pipe (against electrostatic noise)

Figure A-32 Sample pipetting system

D Drying cylinder (whole blood applications)

E Sample probe rinse station

Sample pipetter

The sample pipetter consists of the pipetter arm and the sample probe. When a rack is in the sampling position, the pipetter transports sample liquid from the sample tube to a reaction cell. When aspirating, liquid level detection is accomplished by a highly sensitive capacitance measurement, as well as clot detection by means of pressure measurements.

To protect the probe against electrostatic noise, which would interfere with the capacitance measurement, a metal shield pipe is mounted over the sampling position.

The sample probe is equipped with an extra sensitive level detection and clot detection. That is, it is not identical in construction and therefore not exchangeable with the ISE pipetter probe.

After sample has been aspirated, the probe is raised from the sample and is moved to the reaction disk. The sample probe arm lowers the probe into the reaction cell at the sample dispense position. Sample is dispensed while the beveled sample probe tip is in contact with the bottom of the reaction cell. This ensures that a precise volume of sample is deposited into the bottom of the cell even when using a low dispense volume. The sample probe is spring-mounted on the arm to avoid damage to the probe or reaction cell.

Roche Diagnostics

A-76 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 4 c 501 module

Sampling area components

Sample probe rinse station

The sample probe rinse station is located between the sample aspiration position at the sample tubes in the sample racks and the sample dispense position at the reaction disk. To prevent carryover, the sample probe is rinsed here with deionized water both externally and internally before aspirating from a new sample.

The sample probe stops at the drying cylinder only when whole blood is pipetted for HbA1c tests.

The rinse station is the home position for the sample probe when the pipetter is in standby.

Sample syringe

The sample pipetter is connected by tubing to the sample syringe, which controls the pipetting action.

A Sample syringe B Reagent syringes

Figure A-33 Sample syringe

The sampling syringe, which is located behind the left front door of the module, is filled with degassed and deionized water. The syringe uses positive displacement to aspirate and dispense samples via the sample probes.

The syringe motor retracts the plunger within the chamber of the syringe, and sample is aspirated into the tip of the sample probe. The pipetter arm moves the sample probe to the reaction disk. The sample probe lowers into the reaction cell and the syringe motor reverses to dispense the sample. The pipetter arm lifts the sample probe from the reaction cell and moves it to the sample probe rinse station.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-77

4 c 501 module cobas®6000 analyzer series

Reagent area components

The reagent area of the c 501 module consists of the following components:

o A refrigerated reagent compartment for storing up to 60 reagent cassettes. o Two reagent pipetters for aspirating and dispensing reagents from the reagent

compartment to the reaction cells on the reaction disk.

o Two rinse stations for internal and external rinsing of the reagent probes. o A fully automated cassette management system

Reagent storage compartment

A Reagent pipetters

B Shutter

C Cutouts for R1 reagent pipetter probe

D Cutouts for R2 reagent pipetter probe

Figure A-34 Reagent storage compartment

E Reagent compartment (cover closed)

F Reagent compartment (cover opened)

Reagent cassettes are stored in a closed, temperature-controlled (5-12°C) compartment containing two concentric rings with a total of 60 positions for reagent cassettes. There are 24 positions on the inner and 36 positions on the outer ring.

To prevent reagents from evaporating, the reagent compartment is equipped with a cover. By design, this cover is not meant to be opened or removed. Cassettes are placed into and removed from the compartment by way of the shutter and cutouts in the cover allow reagent probes to access the reagents.

Roche Diagnostics

A-78 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 4 c 501 module

Reagent area components

Reagent pipetting system

The reagent pipetting system is composed of two reagent pipetters—R1 and R2—and two reagent syringes. The pipetters are mounted on two independent x-y-motion mechanisms.

Reagent pipetters

A R2 pipetter B R1 pipetter

C Rinse stations

Figure A-35 Reagent pipetters

Two reagent pipetters, which are mounted above the reagent disk, transport the reagents from the reagent compartment to the reaction disk.

Before each pipetting, the reagent probes are externally and internally rinsed with deionized water and dried. After reagent has been aspirated, the probe moves from the reagent compartment to the reaction disk. There, the reagent volume is dispensed into a reaction cell containing the sample. Unlike the sample probe, the reagent probes are not lowered into the reaction cell. Reagent is dispensed from the top of the reaction cell.

The mechanical cycle of the c 501 module allows for three different reagent timings: R1, R2, and R3. The R1 pipetter pipettes reagents at R1 timing. The R2 pipetter pipettes reagents at R2 and R3 timing.

In contrast to R2, the R1 reagent probe is equipped with a pressure sensor to detect the reagent fill level of manually filled cobas c packs at the preparation station. Ready to use prefilled cobas c packs are not checked. The gripper and the piercer are mounted on the same x-y-motion mechanism as the R1 reagent probe.

See Cassette preparation station on page A-82.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-79

4 c 501 module cobas®6000 analyzer series

Reagent area components

Reagent syringes

A R1 syringe B R2 syringe

Reagent probe rinse stations

Figure A-36 Reagent syringes

The reagent syringes are located behind the left front door of the module. They are filled with degassed and deionized water, using positive displacement to aspirate and dispense reagents.

The reagent probe rinse stations are located between the reagent compartment and the reaction disk. After each reagent dispense, water is flushed through the probes and onto their outside surfaces. The probes are then dried at a drying cylinder.

The rinse stations are the home position for the reagent probes when the module is in standby.

Roche Diagnostics

A-80 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 4 c 501 module

Reagent area components

Cassette management system

Reagents for all Roche Diagnostics applications are provided in reagent cassettes. These cassettes contain one to three specially designed reagent bottles and carry barcode labels with detailed reagent and test related information.

From the time of check-in until an empty cassette is discharged the c 501 manages the registration, internal transportation, and placement fully automatically. This rules out any possibility of misplacement or usage of inappropriate reagents. The cassette management system consists of the following components:

o Cassette loading port o Cassette preparation station o Piercer and Gripper o Cassette disposal

A Cassette preparation station

B Cassette loading port

Figure A-37 Components of the cassette management system

C Cassette table

D Cassette disposal

Cassette loading port

The cassette loading port is located behind the reagent cassette table at the front of the c 501 module. It is used for loading reagent cassettes onto the module.

When loading a reagent cassette, it is important that its barcode label is facing to the right.

After loading, the system handles the cassette without any further intervention of the operator: The cassette is pulled in to the preparation station where a barcode reader scans the cassette’s barcode label and checks its integrity.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-81

A cassette is rejected and not loaded but pushed out of the loading port again in the following cases:

o The cassette’s barcode is unreadable

o The cassette has been on the analyzer before and it was previously dumped

(discarded) by the system

4 c 501 module cobas®6000 analyzer series

Reagent area components

Cassette preparation station

The cassette preparation station is located directly behind the cassette loading port. When a new cassette is pulled in to the preparation station, a barcode reader scans the following data from the cassette’s barcode label:

o System-ID (for example, 07-3755-0) o Lot number o Production date o Cassette number (serial number, for example, 01983) o Expiration date o Bottle configuration information

In case, the current cassette has been registered before, the shutter of the reagent compartment opens and the gripper loads the cassette.

If the current cassette is new, the system proceeds with the following actions while the cassette is at the preparation station:

o By reading the cassette barcode, the system checks the availability of the

corresponding test application.

o The piercer pierces the reagent bottle caps.

Piercer and Gripper

Cassette disposal

Now, the cassette is ready to be transported to the reagent compartment by the gripper.

The piercer and gripper are mounted—together with the R1 pipetter—on an x-y-z motion mechanism. When a cassette is ready to be transported to the reagent compartment, the gripper lowers down on the cassette, grips it, lifts it, and moves it to the shutter. The shutter automatically opens and the cassette is placed in a registered position in the reagent compartment.

Empty reagent cassettes are automatically transported to the cassette disposal. With the aid of gravity, the cassettes drop down the cassette disposal shaft at the end of which they can be removed by the operator. The cassette disposal has a capacity of 10 cassettes.

To locate the cassette disposal, see Figure A-37 on page A-81.

Roche Diagnostics

A-82 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 4 c 501 module

Reaction disk area components

The reaction disk area of the c 501 module consists of the following components:

o A reaction disk with the reaction cells, which are immersed in the incubator bath. o Three ultrasonic mixing units for non-contact mixing of reaction mixtures

(15 levels).

o A photometric measuring system which continually measures the absorbance of

the reaction mixture in each of the reaction cells.

o A cell rinse unit for cleaning the reaction cells once test measurement is complete. o The auxiliary reagents Sample Cleaner 2 (acid wash), Sample Cleaner 1 (basic

wash), and EcoTergent.

A Reaction disk

B Water level sensor

C Ultrasonic mixing units

Figure A-38 Reaction disk area

Roche Diagnostics

Operator´s Manual · Version 8.2 A-83

D Photometric unit

E Incubator bath

F Reaction cell segment

G (1) Sample Cleaner 1 (basic wash)

(2) Sample Cleaner 2 (acid wash)

H Reaction cell rinse unit

I EcoTergent

4 c 501 module cobas®6000 analyzer series

Reaction disk area components

Reaction disk

The reaction disk of the c 501 module carries 160 reusable plastic reaction cells (cuvettes). These reaction cells are grouped together in eight segments with 20 cells each. All reaction cells are placed in a temperature-controlled bath. This incubator bath maintains the cells at the required temperature of 37°C.

The reaction cells should be replaced once a month since they gradually deteriorate over time. Carry out cell blank measurement once a week after rinsing the reaction system to check the integrity of all cells.

For more information, see:

To perform a cell blank measurement on page C-80 Replacing reaction cells on page C-88

Ultrasonic mixers

The ultrasonic mixing units mix the reagents within each of the reaction cells to ensure a homogeneous distribution of reactants. Corresponding to the three reagent timings R1, R2, and R3, there are three independent mixing units.

Incubator bath

To avoid spillage, the water level of the incubator bath is checked before mixing by calculating the volume. If the liquid level is too low or too high, an alarm (Mix.E) is issued and mixing is not performed.

Contamination on the surface of the ultrasonic mixing units causes inadequate mixing. It should be cleaned at least once every three months. The ultrasonic output intensity is continually monitored. If the intensity falls below a certain limit, an alarm (<Mix) is issued, and replacement of the ultrasonic mixing unit is required. Contact your Roche service representative for the replacement.

See Cleaning the ultrasonic mixers on page C-100.

The circular incubator bath, positioned beneath the reaction disk, maintains the reaction mixtures in the reaction cells at a temperature of 37°C. Water in the incubator bath is circulated by a pump through a refrigeration unit where it is cooled and then onto the heater where it is heated, as necessary, to maintain the temperature (±0.1 °C).

Two glass windows (inner and outer) are positioned in opposite walls of the incubator bath. These windows permit light from the photometer lamp to pass through the incubator bath water and through the reaction cells in the bath. The light beam emerges from the outer window of the incubator bath and enters the instrument photometer.

A liquid level sensor detects the water level of the bath. Deionized water is automatically added to the incubator bath, as determined by the liquid level sensor, to compensate for evaporation. This occurs even in standby.

Roche Diagnostics

A-84 Operator´s Manual · Version 8.2

cobas®6000 analyzer series 4 c 501 module

Reaction disk area components

Bath detergent EcoTergent is a non-ionic, bacteriostatic detergent automatically added to the

incubator bath by the ISE pipetter whenever the water is exchanged. It acts as a surfactant to minimize the formation of bubbles that could potentially interfere with the photometer readings. EcoTergent is located between the ISE reagent compartment and the reaction disk. EcoTergent is the substitute product to the previously used Hitergent.

To locate the reagent bottle for EcoTergent, see Figure A-38 on page A-83.

Photometer

The c 501 module is equipped with a photometer to measure the absorbencies of the reaction mixtures in the reaction cells.

The photometer lamp is located against the inner ring of the incubator bath beneath the reaction disk. The detector is outside the incubator bath ring, behind the ISE reagent compartment.

To locate the photometer unit, see Figure A-38 on page A-83.

Measurements are taken of all the 160 reaction cells, as the reaction disk is turning.

C EADFGHIJBK

A Photometer lamp

B Water jacket

C Infrared cut filter

D Mask

E Condenser lens

Figure A-39 Illustration of light path through photometer components

F Slit (in)

G Incubator bath

H Reaction cell and contents

I Slit (out)

J Imaging lens

K Slit

L Photometer

M Grating

N Detector

Photometer lamp The photometer lamp beneath the reaction disk, is encased in a constant-temperature

water jacket, which helps to maintain a constant energy output from the lamp, and also extends the lamp life.

For more information about replacing the photometer lamp, see Replacing the photometer lamp on page C-110.

Roche Diagnostics

Operator´s Manual · Version 8.2 A-85

4 c 501 module cobas®6000 analyzer series

Reaction disk area components

Light path The light from the photometer lamp passes through the following main components:

o Inner incubator bath window o Incubator bath water o Reaction cell and its contents o Incubator bath water o Outer incubator bath window o ...and into the photometer

When the light beam enters the photometer, it strikes a diffraction grating. This separates the light into its constituent wavelengths and reflects them onto a fixed array of 12 photodiodes. Each photodiode is permanently positioned to detect light at a different wavelength.

The instrument computer uses the available assay parameter information to select the wavelengths and the times at which a reaction mixture’s absorbance is read and results are calculated.

The instrument computer keeps tracks of which test is being performed in each reaction cell. The instrument computer also knows when each reaction cell passes through the photometer light path. The instrument computer uses this tracking ability and the programmed read instructions to obtain test results.

Cell rinse unit

A Cell rinse unit B Cell rinse nozzles

C Reaction disk

Figure A-40 Reaction cell rinsing system

The cell rinse unit is located to the left of the reaction disk. It cleans, rinses, and dries the reaction cells once the chemical reaction of the reaction measurement is completed. To ensure cell integrity (optical characteristics), a photometric reading of the cell containing water is performed during the cleaning process (cell blank) and compared with the stored value from the weekly cell blank measurement.

Roche Diagnostics

A-86 Operator´s Manual · Version 8.2

Roche cobas 6000 Operator’s Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Publication information

Contact addresses

Table of contents

Intended use

Symbols and abbreviations

What is new in publication Version 8.2?

Maintenance

System description

General safety information

Safety classifications

Safety precautions

Operator qualification

Commissioning and decommissioning

Relocation and transportation

Disposal

Operating conditions

Power interruption

Electromagnetic compatibility

Safe and proper use of the instrument

Personal protection measures

Biohazardous materials

Electrical safety

Mechanical safety

Reagents and working solutions

Skin contact

Fire and burns

Incorrect results

Samples

Reagents

Instrument covers

Others

Sample loss

Software and data security

Unauthorized access

Incorrect or corrupt data

USB storage devices

Computer viruses

Third-party software

Backup

Instrument damage

Moving parts

Spillage

Cleaning agents

Excessive weight

Safety labels of the system

Front view

Side view

Top view

Rear view

Safety information for barcode readers

Interlock function

Disposal of the instrument

Overview modules

Overview

Modules of the cobas 6000 analyzer series

Control unit and cobas link

Core unit

c 501 module

Photometric unit

ISE unit

e 601 module

Second rotor module

Control unit, cobas link and core unit

Control unit

Control unit computer

Touchscreen Monitor

Keyboard

Mouse

Printer

cobas link

Overview

Main functions

Working with cobas link functions

Using e-barcodes via download

Using the backup function

Using e-package inserts