Roche cobas c 111 User manual

cobas c111 system

Operator’s Manual

Version 3.0

cobas c111

Roche Diagnostics

2 Operator’s Manual · Version 3.0

Document information

Revision history

Edition notice The cobas c111 instrument is a continuous random-access analyzer intended for the

in vitro determination of clinical chemistry and electrolyte parameters in serum,

plasma, urine or whole blood (HbA1c). It is optimized for small throughput

workloads of approximately samples per day, utilizing photometric analysis and an

optional unit for ion selective electrodes (ISE).

This manual is for users of the cobas c 111 instrument.

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

manual is correct at the time of printing. However, Roche Diagnostics GmbH reserves

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

development.

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

agreement null and void.

Software updates are done by service representatives.

Intended use The cobas c111 instrument is a continuous random-access analyzer intended for the

in vitro determination of clinical chemistry and electrolyte parameters in serum,

plasma, urine or whole blood (HbA1c).

It is important that the operators read this manual thoroughly before using the

system.

Tradem ark s The following trademarks are acknowledged:

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

All other trademarks are the property of their respective owners.

Manual version Software version Revision date Changes

1.0 July 2006 First publication.

2.0 2.0 December 2007 Full mode added.

Improved calibration concept.

Additional maintenance and

troubleshooting information.

Additions, improvements, and

corrections.

3.0 3.0 June 2009 Inventory, processing sequence,

and ratio functions added.

Improvements and corrections.

Layout upgraded.

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Operator’s Manual · Version 3.0 3

cobas c111

Instrument approvals The cobas c111 instrument meets the protection requirements laid down in IVD

Directive 98/79/EC and the European Standard EN 591. Furthermore, our

instruments are manufactured and tested according to the following international

standards:

o EN/IEC 61010-1 2

nd

Edition

o EN/IEC 61010-2-101 1

st

Edition

The Operator’s manual meets the European Standard EN 591.

Regulatory compliance is demonstrated by the following marks:

Contact addresses

Manufacturer

Distributor

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

CUS

®

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

US.

Roche Diagnostics Ltd.

Forrenstrasse

CH-6343 Rotkreuz

Switzerland

Roche Diagnostics GmbH

Sandhofer Strasse 116

D-68305 Mannheim

Germany

cobas c111

Roche Diagnostics

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cobas c111

Table of contents

Document information 2

Contact addresses 3

Table of contents 5

Preface 7

How to use this manual 7

Online Help system 7

Conventions used in this manual 8

System Description Part A

1Safety

Safety classification A–5

Safety information A–5

Data security A–10

License notices A–11

Legal liability A–11

Disposal recommendation A–12

Safety labels A–13

2 Introduction to the instrument

Overview A–17

User interface A–20

Wizards A–21

Daily operation A–22

Maintenance A–34

System status A–35

3 Hardware

Covers and panels A–39

LEDs A–41

Main components A–43

Hardware overview A–44

Technical specifications A–66

5Software

Introduction A–71

Screen layout A–72

Display items A–73

Workflows and wizards A–74

Working with the user interface A–75

Key screens A–84

Color interpretation for LEDs A–122

Buttons A–124

Operation Part B

6 Daily operation

Introduction B–5

Starting the shift B–10

Preparing the system B–12

Analyzing samples B–34

Validating sample results B–51

Performing calibrations B–59

Performing QC B–68

Finishing the shift B–77

Logging off B–88

Switching off the system B–88

Using the barcode scanner B–89

6 Special operations

Deleting sample orders B–93

Deleting sample results B–94

Calibration B–95

Deleting QC results B–96

Lot handling B–98

Exporting data B–104

Importing data B–111

Preparing a new disk B–116

Assigning tests to test tabs B–119

Deleting bottle sets from the Inventory list B–120

Refilling printer paper B–122

Removing condensation water

from the reagent cooler B–124

Replacing the probe B–125

Connecting and disconnecting the

external fluid containers B–127

Adjusting the touchscreen B–130

Cleaning the touchscreen B–131

7 Configuration

Introduction B–135

Applications B–137

Configuration B–157

Maintenance Part C

8 General maintenance

Overview C–5

Maintenance actions C–8

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cobas c111

Troubleshooting Part D

9 Messages and alarms

About messages D–5

Message screen D–5

Acoustic signals D–6

Alarm monitor D–6

List of alarm messages D–10

10 Result flags

About flags D–25

Safety D–27

List of flags D–28

11 Troubleshooting

Introduction D–41

Dealing with exceptional situations D–42

Reacting to messages D–44

Detailed procedures D–46

ISE Part E

12 ISE description

Overview E–5

Hardware E–9

Basic operation E–12

Technical specifications E–13

13 ISE operation

Daily operation E–17

Replacing ISE fluid bottles E–30

Replacing electrodes E–32

Cleaning the ISE tower off the instrument E–36

14 ISE maintenance

Introduction E–41

ISE maintenance actions E–42

15 ISE troubleshooting

Introduction E–69

Safety E–70

List of ISE flags E–71

Reacting to error messages E–80

Glossary and Index Part F

Glossary F–3

Index F–11

Revisions Part G

18 Revisions

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cobas c111

Preface

The cobas c111 instrument is a continuous random-access analyzer intended for the

in vitro determination of clinical chemistry and electrolyte parameters in serum,

plasma, urine or whole blood (HbA1c). It is optimized for small throughput

workloads of approximately samples per day, utilizing photometric analysis and an

optional unit for ion selective electrodes (ISE).

This manual describes the cobas c111 features and general operational concepts, and

it provides operating, maintenance, and emergency procedures.

How to use this manual

To help you find information quickly, there is a table of contents at the beginning of

the manual and each chapter. In addition, a complete index can be found at the end.

Online Help system

The cobas c111 instrument has a context-sensitive online Help feature to aid in its

operating. “Context-sensitive” means that wherever you are located within the

cobas c111 software, choosing Help ( ) displays Help text relating to that area of

the software. The online Help offers a quick and convenient way of finding

information, such as explanations of screens and dialog boxes and on how to perform

particular tasks.

o Keep this Operator’s 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.

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8 Operator’s Manual · Version 3.0

Conventions used in this manual

Visual cues are used to help locate and interpret information in this manual quickly.

This section explains the formatting conventions used in this manual.

Symbols The following symbols are used:

Buttons When used for identification purposes, a generic form of the buttons is used, without

color or navigation indicators.

Screenshots The screen representations shown in this publication are for illustrative purposes

only. The screens do not necessarily show valid data.

Symbol Used for

a Start of procedure

o List item

e

Cross-reference

h Call-up (software navigation path)

Color of display item on the screen

Tip

Safety alert

Electrical and electronic equipment marked with this symbol are

covered by the European directive WEEE.

The symbol denotes that the equipment must not be disposed of in

the municipal waste system.

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cobas c111

Abbreviations The following abbreviations are used:

Abbreviation Definition

C

Cfas Calibrator for automated systems

D

DIL Diluent

DM Data management

DRAM Dynamic random access memory

E

e.g. Exempli gratia – for example

EMC Electromagnetic compatibility

EN European standard

I

i.e. Id est – that is to say

IEC International Electrical Commission

ISE Ion selective electrode

L

LED Light-emitting diode

LIS Laboratory information system

LLD Liquid level detection

N

n/a Not applicable

Q

QC Quality control

R

REF Reference solution for ISE unit

ROM Read only memory

S

SD Standard deviation

SRAM Static random access memory

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Units

Abbreviation Description

°C degree centigrade

µL microliter

µm micrometer

Aampère

cm centimeter

hhour

Hz hertz

LB pound (weight)

in inch

kg kilogram

kVA kilo volt-ampere

Lliter

mmeter

MB megabytes

min minute

mL milliliter

mm millimeter

nm nanometer

ssecond

Vvolt

VA v o l t - a m p è r e

V AC volt alternating current

V DC volt direct current

Wwatt

1 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

2 Introduction to the instrument . . . . . . . . . . . . . . . . . . . . . . . . . A-15

3 Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-37

5 Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-69

System Description

A

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cobas c111 1Safety

Table of c ontents

Safety

Protecting yourself and the environment

In this chapter, you will find information on the safe operation of the cobas c111

instrument.

Safety classification ......................................................................................................A-5

Safety information ......................................................................................................A-5

Transport ...............................................................................................................A-5

Electrical safety ......................................................................................................A-5

Optical safety .........................................................................................................A-6

Mechanical safety ..................................................................................................A-6

Instrument covers ..................................................................................................A-6

Operation and maintenance .................................................................................A-6

Biohazardous materials .........................................................................................A-6

Waste ......................................................................................................................A-7

Reagents and other working solutions .................................................................A-7

Installation .............................................................................................................A-7

Environmental conditions ....................................................................................A-7

Power interruption ................................................................................................A-8

Electromagnetic devices ........................................................................................A-8

Approved parts ......................................................................................................A-8

Third-party software .............................................................................................A-8

Operator qualification ...........................................................................................A-9

Operation over an extended period of time ......................................................... A-9

Cross contamination of sample ............................................................................A-9

Insoluble contaminants in sample ........................................................................A-9

Spillage ...................................................................................................................A-9

Data security ..............................................................................................................A-10

License notices ...........................................................................................................A-11

Legal liability ..............................................................................................................A-11

In this chapter

Chapter

1

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Tab le o f cont e n t s

Disposal recommendation ........................................................................................A-12

Disposal label .......................................................................................................A-12

Disposal of external components .......................................................................A-12

Disposal of the instrument .................................................................................A-12

Constraint ............................................................................................................A-12

Safety labels ................................................................................................................A-13

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cobas c111 1Safety

Safety classification

Before you attempt to use the cobas c111 instrument, you must be fully familiar with

the following symbols and their meanings:

Safety information

Before operating the cobas c111 instrument, it is essential that you both read and

understand the safety information listed below.

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

Transport

Electrical safety

WARNING

Warning

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

injury.

CAUTION

Caution

Indicates a hazardous situation which, if not avoided, may result in minor or moderate

injury.

NOTICE

Notice

Indicates a hazardous situation which, if not avoided, may result in property damage.

WARNING

Injury from heavy loads

You may injure your hands, fingers, or back when putting the analyzer in place. Carry the

analyzer according to the transport instructions.

WARNING

Electrical shock by electronic equipment

Do not attempt to work in any electronic compartment. Installation, service, and repair

must only be performed by authorized and qualified personnel.

Electrical safety

Connect the analyzer to grounded power outlets only (IEC protection class 1). All periph-

eral devices that are connected to the cobasc111 instrument must comply with safety

standard IEC 60950 for information technology equipment, or with IEC 61010-1, UL 61010-

1 for laboratory use instruments.

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1Safety cobas c111

Safety information

Optical safety

Mechanical safety

Instrument covers

Operation and maintenance

Biohazardous materials

WARNING

Loss of sight

The intense light of the LEDs may severely damage you eyes. Do not stare into the LEDs.

Scanning equipment using LED technology is covered by the international standard IEC

60825-1 LED Safety: Class 1.

WARNING

Personal injury or damage to the analyzer due to contact with instrument

mechanism

Do not touch moving parts during instrument operation.

WARNING

Personal injury or damage to the analyzer due to contact with instrument

mechanism

Keep all covers closed, operate them as instructed on the screen.

WARNING

Personal injury or damage to the analyzer due to contact with instrument

mechanism

Do not touch any parts of the instrument other than those specified. During operation and

maintenance of the instrument, proceed according to the instructions.

WARNING

Infection by biohazardous materials

Contact with samples containing material of human origin may result in infection. All

materials and mechanical components associated with samples of human origin are

potentially biohazardous.

o Be sure to wear protective equipment. Take extra care when working with protective

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

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

o If waste solution contacts your skin, wash it off immediately with water and apply a dis-

infectant. Consult a physician.

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cobas c111 1Safety

Safety information

Waste

Reagents and other working solutions

Installation

Environmental conditions

e

For details on the required environmental conditions, see Environmental conditions on

page A-66.

WARNING

Infection by waste solution

Contact with waste solution may result in infection. All materials and mechanical compo-

nents associated with the waste systems are potentially biohazardous.

o Be sure to wear protective equipment. Take extra care when working with protective

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

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

o If waste solution contacts your skin, wash it off immediately with water and apply a dis-

infectant. Consult a physician.

WARNING

Injury through reagents and other working solutions

Direct contact with reagents, cleaning solutions, or other working solutions may cause

personal injury.

When handling reagents, exercise the precautions required for handling laboratory

reagents, observe the cautions given in the package insert, and observe the information

given in the Safety Data Sheets available for Roche Diagnostics reagents and cleaning

solutions.

Skin inflammation caused by reagents

Direct contact with reagents may cause skin irritation, inflammation, or burns.

When handling reagents, be sure to wear protective equipment and observe the cautions

given in the package insert.

WARNING

Incorrect results or damage to the analyzer due to wrong installation

Follow the specified installation instructions carefully.

WARNING

Incorrect results or damage to the analyzer due to heat and humidity

Use the instrument indoor only.

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Safety information

Power interruption

Electromagnetic devices

Approved parts

Third-party software

NOTICE

Data loss or damage to the system due to voltage drop

By a power failure or momentary voltage drop the operation unit or software of this system

may get damaged or data loss may occur. Use only uninterruptible power supply.

WARNING

Malfunction of instrument and incorrect results due to interfering electromagnetic

fields

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

operate the following devices in the same room where the system is installed:

o Mobile phone

o Transceiver

o Cordless phone

o Other electrical devices that generate electromagnetic waves

NOTICE

Instructions for in vitro diagnostic (IVD) equipment for professional use

The IVD equipment complies with the emission and immunity requirements described in

the particular requirements for IVD medical equipment of the EN/IEC 61326-2-6 standard.

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

Class B FCC rule compliance

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

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

able protection against harmful interferences when the equipment is operated in a resi-

dential area. However, this equipment generates, uses, and can radiate radio frequency

energy and, if not installed and used in accordance with the present manual, may cause

harmful interference to radio communications.

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

WARNING

Malfunction of instrument and incorrect results due to nonapproved parts

Use of nonapproved parts or devices may result in malfunction of the instrument and may

render the warranty null and void. Only use parts and devices approved by Roche Diag-

nostics.

WARNING

Malfunction of instrument and incorrect results due to third-party software

Installation of any third-party software that is not approved by Roche Diagnostics may

result in incorrect behavior of the system. Do not install any nonapproved software.

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cobas c111 1Safety

Safety information

Operator qualification

Operation over an extended period of time

Cross contamination of sample

Insoluble contaminants in sample

Spillage

WARNING

Incorrect results or damage to the analyzer due to wrong operation

Operators are required to have a profound knowledge of relevant guidelines and norms as

well as 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.

o Carefully follow the procedures specified in the Operator’s Manual for the operation

and maintenance of the system.

o Leave maintenance that is not described in the Operator’s Manual to trained service

representatives.

o Follow standard laboratory practices, especially when working with biohazard material.

CAUTION

Fatigue due to long hours of operation

Looking at the monitor screen over an extended period of time may lead to fatigue of your

eyes or body. Take a rest for 10 to 15 minutes every hour to relax. Avoid spending more

than 6 hours per day looking at the monitor screen.

WARNING

Incorrect results due to carryover

Traces of analytes or reagents may be carried over one test to the next. Take adequate

measures (e.g. sample aliquoting) to safeguard additional testing and to avoid potentially

false results.

WARNING

Incorrect results and interruption of analysis due to contaminated samples

Insoluble contaminants in samples may cause clogging or pipetting volume shortage and

deterioration in measurement accuracy. When loading samples on the instrument, make

sure that samples contain no insoluble contaminants such as fibrin or dust.

NOTICE

Malfunction due to spilled liquid

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

does spill on the instrument, wipe it up immediately and apply disinfectant.

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1Safety cobas c111

Data security

e

For further information, contact your Roche service representative.

CAUTION

Unauthorized access and data loss due to malicious software and hacker attacks

Portable storage media can be infected with and transmit computer malware, which may

be used to gain unauthorized access to data or cause unwanted changes to software.

The cobas c111 is not protected against malicious software and hacker attacks.

The customers are responsible for IT security of their IT infrastructure and for protecting it

against malicious software and hacker attacks. Failure to do so may result in data loss or

render the cobas c111 unusable.

Roche recommends the following precautions:

o Allow connection to authorized external devices only.

o Ensure that all external devices are protected by appropriate security software.

o Ensure that access to all external devices is protected by appropriate security equip-

ment.

o Do not copy or install any software on the cobasc111 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 while connecting to the

cobasc111.

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

accessed by authorized persons only.

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Roche cobas c 111 User manual

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