Roche Cobas C111 User manual

cobas c111 system

Operator’s Manual Version 3.0

Document information

cobas c111

Revision history

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

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.

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.

Tr ad e m ar k 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.

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cobas c111

CUS

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 o EN/IEC 61010-2-101 1

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

Regulatory compliance is demonstrated by the following marks:

Edition

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

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

Contact addresses

Manufacturer

Distributor

Roche Diagnostics Ltd. Forrenstrasse CH-6343 Rotkreuz Switzerland

Roche Diagnostics GmbH Sandhofer Strasse 116 D-68305 Mannheim Germany

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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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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

Glossary and Index Part F

Glossary F–3 Index F–11

Revisions Part G

18 Revisions

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

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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.

Online Help system

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.

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 c 111 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

h Call-up (software navigation path)

Color of display item on the screen

Cross-reference

Tip

Safety alert

cobas c111

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 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.

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Abbrev iations The following abbreviations are used:

Abbreviation Definition C

Cfas Calibrator for automated systems

DIL Diluent

DM Data management

DRAM Dynamic random access memory

e.g. Exempli gratia – for example

EMC Electromagnetic compatibility

EN European standard

i.e. Id est – that is to say

IEC International Electrical Commission

ISE Ion selective electrode

LED Light-emitting diode

LIS Laboratory information system

LLD Liquid level detection

n/a Not applicable

QC Quality control

REF Reference solution for ISE unit

ROM Read only memory

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

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System Description

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

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

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

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

cobas c111 1Safety

Table of co ntents

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

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

Chapter

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Tab l e o f c o nt en ts

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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WARNING

CAUTION

NOTICE

WARNING

Safety classification

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

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, may result in minor or moderate injury.

Notice

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

Safety information

Transport

Electrical safety

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.

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.

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 peripheral 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 610101 for laboratory use instruments.

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WARNING

Safety information

Optical safety

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.

Mechanical safety

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

Do not touch moving parts during instrument operation.

Instrument covers

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

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

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

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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WARNING

Safety information

Waste

Infection by waste solution

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 dis-

infectant. Consult a physician.

Reagents and other working solutions

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.

Installation

Incorrect results or damage to the analyzer due to wrong installation

Follow the specified installation instructions carefully.

Environmental conditions

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

Use the instrument indoor only.

For details on the required environmental conditions, see Environmental conditions on page A-66.

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1Safety cobas c111

NOTICE

WARNING

NOTICE

WARNING

Safety information

Power interruption

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

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

Approved parts

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.

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 Diagnostics.

Third-party software

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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WARNING

CAUTION

WARNING

NOTICE

Safety information

Operator qualification

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.

Operation over an extended period of time

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.

Cross contamination of sample

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.

Insoluble contaminants in sample

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.

Spillage

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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CAUTION

Data security

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.

For further information, contact your Roche service representative.

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cobas c111 1Safety

WARNING

License notices

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

The cobas c111 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 c111 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 c111 instrument in conjunction with the cobas c 111 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 c 111 Development Channel Operator’s Manual.

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1Safety cobas c111

WARNING

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

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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cobas c111 1Safety

Safety labels

Read all safety labels on the instrument and equipment.

The following illustration shows where on the instrument labels are displayed.

A This label on the electrode block of the ISE unit indicates that

there is a danger of hazardous situations arising within the vicinity of this label, which may result in death or serious injury. The relevant laboratory procedures on safe use must be observed. (You will find this label only if an ISE unit is installed.)

Figure A-1 Safety labels on the cobasc111 instrument

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

These safety notes give more detailed information about potentially hazardous situations that may arise during daily operation or when carrying out maintenance procedures.

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

B This label on the main cover indicates that there are potential bio-

hazards within the vicinity of this label, which may result in death or serious injury. The relevant laboratory procedures on safe use must be observed.

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Safety labels

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cobas c111 2 Introduction to the instrument

Table of co ntents

Introduction to the instrument

What you need to know before you start

In this chapter, you will find basic information on the features that are relevant for working with the cobas c111 instrument.

In this chapter

Overview .................................................................................................................... A-17

Principles of operation ........................................................................................A-19

User interface .............................................................................................................A-20

Wizards ......................................................................................................................A-21

Daily operation ..........................................................................................................A-22

Overview .............................................................................................................. A-22

Reagent and diluent handling ............................................................................. A-25

Calibration ...........................................................................................................A-26

Calibration type ............................................................................................. A-27

Calibration sequence ..................................................................................... A-28

Calibration status of a set ..............................................................................A-28

Calibration result storage ..............................................................................A-28

Validating calibration results ........................................................................A-29

Calibration procedures .................................................................................. A-29

Quality control (QC) ..........................................................................................A-30

Sample handling ..................................................................................................A-31

Order handling .................................................................................................... A-32

Results ..................................................................................................................A-34

Maintenance ..............................................................................................................A-34

System status ..............................................................................................................A-35

Chapter

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Tab l e o f c o nt en ts

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cobas c111 2 Introduction to the instrument

WARNING

Overview

Only trained personnel working in a professional laboratory environment may operate the cobas c111 instrument.

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.

Features As part of the cobas family of instruments, the cobas c 111 instrument offers small

laboratories the following advantages: o High analytical performance

The same bulk reagents, 12-wavelength photometer and disposable cuvettes generate results that are highly correlated to other cobas instruments.

o Efficient operation

Cooled, exchangeable reagent disks ensure economical reagent use; disposable cuvette segments allow for easy cuvette loading and removal.

o High reliability, low maintenance

Innovative "low impact" instrument design and software-driven preventive maintenance improves up-time and reduces maintenance costs.

o Adaptable user interface

The built-in color touchscreen, process-driven software, and reagent and sample barcode entry adapts to users of different skills and access levels.

o High safety standards

Built-in safety devices, such as level detection, tube bottom detection, cuvette quality control, and ISE clot detection anticipate potential hazards during operation.

o Flexible sampling

Eight on-board sample positions accommodate virtually any type of sample carrier, and enable continuous sample placing and removal during operation.

o Data management

Bidirectional RS-232 and USB ports, on-board thermal printer, and drivers offer the latest in data management capabilities.

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2 Introduction to the instrument cobas c111

L NM

B D

Overview

Measuring principles Measurements are performed by means of an absorbance photometer and optionally

an ISE (ion selective electrode) module that uses ion selective potentiometry.

A first look at the instrument

A Left service flap (covers wash station, ISE

tower, tubing)

B Main cover (covers rotor, reagents, cuvettes,

photometer unit)

C Main switch D Transfer head (holds probe) E Rear service flap (covers computer boards,

power supply, degasser)

F Sample area LED G Sample area (space for 8 sample tubes)

Figure A-2 The cobas c 111 instrument

H Touchscreen I Fluid connectors J Right service flap (covers photometer unit,

sample area)

K Printer panel L Main cover LED M Paper slot N Release button for printer panel O USB connector (not shown)

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Overview

Principles of operation

The cobas c111 main instrument uses absorption photometry for determining the amount of absorbance in a fluid. The absorbance is used to calculate the concentration in the solution.

Loading the sample The operator identifies the sample, places it on the instrument, and defines the order.

(If you work with a host system, the order is defined automatically.)

Measuring process The measuring process for each test consists of forty regular cycles, each lasting 18

seconds. In each of these cycles, a measurement is taken, irrespective of what other actions take place during this cycle. The application definitions determine what is done in which cycle, and they also define which results are taken into account for the result calculation.

With each cycle, a new test can be started.

The basic process works as follows:

1. Checking the cuvette.

A measurement is taken to check the quality of the cuvette.

2. Pipetting reagent (R1) to the cuvette.

After each pipetting action, the system performs a wash cycle to minimize carryover. During this cycle, the probe and tubing are flushed with water and cleaner.

3. Wait.

The fluid needs to reach the prescribed temperature. Such a phase can last several cycles.

During the wait cycles, activities for other tests are performed.

4. Pipetting the next fluid.

Typically, this would be the sample. The details are defined in the application definitions.

5. Wait.

6. Pipetting the next fluid.

7. Wait.

8. And so on.

Calculating the results The test result is calculated on the basis of the photometric measurement results.

During this process, various checks are performed to ensure that the whole measuring process was technically correct. If values are above or below predefined limits, the test result is flagged.

The results are stored on the system. This includes both the forty measurement results (raw data) and the calculated test result.

Sequence of processing For a given sample, the tests are processed in the order defined by the time required

for their processing (number of cycles), starting with the one that takes the longest. This order can be altered manually by defining a specific process sequence list.

Status of the measuring process At any stage of the measuring process, the user can check its status on the screen.

Result data management The system provides storage space for the results of one working day. For backup

purposes, the results must be exported to an external storage device once a day.

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2 Introduction to the instrument cobas c111

User interface

The cobas c111 instrument is equipped with a touchscreen, an on-screen keyboard and four global action buttons. LEDs and acoustic signals let you know when it is safe to add or remove samples, reagents and other fluids.

With buttons and other display items, “traffic light” color coding is used: Green means OK, yellow: watch out, you need to do something, and red means that your intervention is required for processing to continue.

The screens have a clear and consistent layout and are easy to use. The topics are divided in the proven work areas: Overview for order and fluid handling, Wo rk p la ce for result handling and details on orders, and Utilities for administration tasks.

For details on the user interface, see Chapter 5 Software.

The following is an example of a screen. It contains the full range of display items.

A The status line displays the system status. B Tab s represent the major work areas. C The headline characterizes the content or

function of the screen. If the screen is part of a sequence of screens (wizard), the headline tells you where you are within this sequence.

D The working area displays the main content

of the screen.

E The buttons vary depending on the content

of the working area and the screen position within a series of steps (wizard).

Figure A-3 Example of a screen

F The Help button leads to concise information

that is relevant to the current screen and situation.

G The global action buttons represent the

functions that are permanently available: Start, Stop, Alarm, Line Feed. The LEDs next to them point to their status.

Roche Diagnostics A-20 Operator’s Manual · Version 3.0

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