cobas c 111 Operators Manual Version 3.0

cobas c 111

Document information Revision history

Manual version

Software version

1.0 2.0

2.0

Revision date

Changes

July 2006

First publication.

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.

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 c111 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.

Copyrights

© 2009, Roche Diagnostics GmbH. All rights reserved.

Trademarks

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.

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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 2nd Edition

o

EN/IEC 61010-2-101 1st Edition

The Operator’s manual meets the European Standard EN 591. Regulatory compliance is demonstrated by the following marks: Complies with European Union (EU) Directive 98/79/EC.

C

®

US

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

Contact addresses Manufacturer

Roche Diagnostics Ltd. Forrenstrasse CH-6343 Rotkreuz Switzerland

Distributor

Roche Diagnostics GmbH Sandhofer Strasse 116 D-68305 Mannheim Germany

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Table of contents Document information Contact addresses Table of contents Preface How to use this manual Online Help system Conventions used in this manual

System Description 1

Part A

A–5 A–5 A–10 A–11 A–11 A–12 A–13

6

A–39 A–41 A–43 A–44 A–66

B–5 B–10 B–12 B–34 B–51 B–59 B–68 B–77 B–88 B–88 B–89

Special operations

Deleting sample orders Deleting sample results Calibration Deleting QC results Lot handling Exporting data Importing data Preparing a new disk Assigning tests to test tabs Deleting bottle sets from the Inventory list Refilling printer paper Removing condensation water from the reagent cooler Replacing the probe Connecting and disconnecting the external fluid containers Adjusting the touchscreen Cleaning the touchscreen

A–17 A–20 A–21 A–22 A–34 A–35

Part B

Daily operation

Introduction Starting the shift Preparing the system Analyzing samples Validating sample results Performing calibrations Performing QC Finishing the shift Logging off Switching off the system Using the barcode scanner

Hardware

Covers and panels LEDs Main components Hardware overview Technical specifications 5

6

Introduction to the instrument

Overview User interface Wizards Daily operation Maintenance System status 3

Operation

Safety

Safety classification Safety information Data security License notices Legal liability Disposal recommendation Safety labels 2

2 3 5 7 7 7 8

B–93 B–94 B–95 B–96 B–98 B–104 B–111 B–116 B–119 B–120 B–122 B–124 B–125 B–127 B–130 B–131

Software

Introduction Screen layout Display items Workflows and wizards Working with the user interface Key screens Color interpretation for LEDs Buttons

A–71 A–72 A–73 A–74 A–75 A–84 A–122 A–124

7

Configuration

Introduction Applications Configuration

B–135 B–137 B–157

Maintenance

Part C

8

General maintenance

Overview Maintenance actions

C–5 C–8

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Troubleshooting 9

Part D

Messages and alarms

About messages Message screen Acoustic signals Alarm monitor List of alarm messages

D–5 D–5 D–6 D–6 D–10

Glossary and Index

Part F

Glossary Index

F–3 F–11

Revisions

Part G

18 Revisions 10 Result flags

About flags Safety List of flags

D–25 D–27 D–28

11 Troubleshooting

Introduction Dealing with exceptional situations Reacting to messages Detailed procedures

ISE

D–41 D–42 D–44 D–46

Part E

12 ISE description

Overview Hardware Basic operation Technical specifications

E–5 E–9 E–12 E–13

13 ISE operation

Daily operation Replacing ISE fluid bottles Replacing electrodes Cleaning the ISE tower off the instrument

E–17 E–30 E–32 E–36

14 ISE maintenance

Introduction ISE maintenance actions

E–41 E–42

15 ISE troubleshooting

Introduction Safety List of ISE flags Reacting to error messages

E–69 E–70 E–71 E–80

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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 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.

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.

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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: 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.

Buttons

Screenshots

When used for identification purposes, a generic form of the buttons is used, without color or navigation indicators. The screen representations shown in this publication are for illustrative purposes only. The screens do not necessarily show valid data.

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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

A

ampère

cm

centimeter

h

hour

Hz

hertz

LB

pound (weight)

in

inch

kg

kilogram

kVA

kilo volt-ampere

L

liter

m

meter

MB

megabytes

min

minute

mL

milliliter

mm

millimeter

nm

nanometer

s

second

V

volt

VA

volt-ampère

V AC

volt alternating current

V DC

volt direct current

W

watt

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A

1

Safety... A-3

2

Introduction to the instrument... A-15

3

Hardware... A-37

5

Software... A-69

cobas c111

1 Safety Table of contents

Safety Protecting yourself and the environment

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

In this chapter

Chapter

1

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

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Table of contents

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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1 Safety Safety classification

Safety classification Before you attempt to use the cobas c111 instrument, you must be fully familiar with the following symbols and their meanings: 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.

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 Injury from heavy loads WARNING

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

Electrical safety Electrical shock by electronic equipment WARNING

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 peripheral devices that are connected to the cobas c 111 instrument must comply with safety standard IEC 60950 for information technology equipment, or with IEC 61010-1, UL 610101 for laboratory use instruments.

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Safety information

Optical safety Loss of sight The intense light of the LEDs may severely damage you eyes. Do not stare into the LEDs. WARNING

Scanning equipment using LED technology is covered by the international standard IEC 60825-1 LED Safety: Class 1.

Mechanical safety Personal injury or damage to the analyzer due to contact with instrument mechanism WARNING

Do not touch moving parts during instrument operation.

Instrument covers Personal injury or damage to the analyzer due to contact with instrument mechanism WARNING

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

Operation and maintenance Personal injury or damage to the analyzer due to contact with instrument mechanism WARNING

Do not touch any parts of the instrument other than those specified. During operation and maintenance of the instrument, proceed according to the instructions.

Biohazardous materials Infection by biohazardous materials WARNING

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 disinfectant. Consult a physician.

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1 Safety Safety information

Waste Infection by waste solution WARNING

Contact with waste solution may result in infection. All materials and mechanical components 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 disinfectant. Consult a physician.

Reagents and other working solutions Injury through reagents and other working solutions WARNING

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.

Installation Incorrect results or damage to the analyzer due to wrong installation Follow the specified installation instructions carefully. WARNING

Environmental conditions Incorrect results or damage to the analyzer due to heat and humidity Use the instrument indoor only. WARNING

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

page A-66.

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Safety information

Power interruption 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.

Electromagnetic devices Malfunction of instrument and incorrect results due to interfering electromagnetic fields WARNING

NOTICE

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

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 reasonable protection against harmful interferences when the equipment is operated in a residential area. However, this equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the present manual, may cause harmful interference to radio communications. The electromagnetic environment should be evaluated prior to operation of the device.

Approved parts Malfunction of instrument and incorrect results due to nonapproved parts WARNING

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 Diagnostics.

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

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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Operator qualification Incorrect results or damage to the analyzer due to wrong operation WARNING

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.

Operation over an extended period of time Fatigue due to long hours of operation CAUTION

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.

Cross contamination of sample Incorrect results due to carryover WARNING

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.

Insoluble contaminants in sample Incorrect results and interruption of analysis due to contaminated samples WARNING

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

Spillage

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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Data security

Data security Unauthorized access and data loss due to malicious software and hacker attacks CAUTION

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 c 111 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 c 111 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 equipment.

o

Do not copy or install any software on the cobas c111 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 cobas c 111.

o

Keep all external storage devices in a secure place and ensure that they can be accessed by authorized persons only.

e For further information, contact your Roche service representative.

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License notices Malfunction of instrument and incorrect results due to software modifications by the customer WARNING

The cobas c 111 instrument uses open source software. Among other things, the holders of the proprietary rights grant licenses under the terms of the GNU General Public Licence (GPL edition 2 or above) as well as under the GNU Lesser General Public License (LGPL). The cobas c 111 instrument has been designed to be operated with the unmodified software as shipped. The user assumes full responsibility for changing any part of the open source software, which excludes any liability of Roche Diagnostics Ltd. This program is distributed without any warranty; without even the implied warranty of merchantability or fitness for a particular purpose. See the GNU General Public License for more details (www.gnu.org/copyleft/gpl.html). The source code of the used open source software is part of MIKRAPs CPUX255LCDNET board support package and may be obtained from SYSGO (http://www.sysgo.com/products/board-support-packages/).

Legal liability Roche Diagnostics Ltd. assumes only limited liability when using the cobas c 111 instrument in conjunction with the cobas c111 Development Channel Programming Software. For detailed information on this matter refer to the latest version of the Development Channel Registration Form cobas c111 and the cobas c111 Development Channel Operator’s Manual.

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Disposal recommendation

Disposal recommendation All electrical and electronic products should be disposed of separately from the municipal waste system. Proper disposal of your old appliance prevents potential negative consequences for the environment and human health.

Disposal label Electrical and electronic equipment marked with this symbol are covered by the European directive on waste electrical and electronic equipment (WEEE) 2002/96/EC. The symbol denotes that the equipment must not be disposed of in the municipal waste system.

Disposal of external components External components such as the scanner and the ISE power supply, which are marked with the crossed-out wheeled bin symbol, are covered by the European Directive 2002/96/EC (WEEE). These items must be disposed of via designated collection facilities appointed by government or local authorities. For more information about disposal of your old products, contact your city office, waste disposal service or your local service representative.

Disposal of the instrument

WARNING

The instrument must be treated as biologically contaminated hazardous waste. Final disposal must be organized in a way that does not endanger waste handlers. As a rule, such equipment must be sterile before it is passed on for final disposal. For more information contact your local 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.

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