Roche cobas c 111 User manual

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cobas c 111

Roche Diagnostics

2 Operator’s Manual · Version 4.3

Document information

Revision history

Edition notice The cobas c 111 analyzer 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 up to 50 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 analyzer running software version 4.2.

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 analyzer will render the warranty or service

agreement null and void.

Software updates are done by service representatives.

Intended use The cobas c 111 analyzer 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.

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.

4.0 4.0 April 2012 Hardware improvements.

Adjustments to reflect latest

software version (time indication

for running tests and disk space

indication).

4.1 4.1 October 2013 The

TRL Check feature was

added.

Responsibility disclaimers were

added.

Minor textual adjustments.

4.2 4.2 March 2016 Product IT Security Risk update.

Upgraded analyzer display, and

updates to user interface design.

4.3 4.2 November 2016 Minor textual adjustments.

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Operator’s Manual · Version 4.3 3

cobas c 111

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.

Instrument approvals The cobas c 111 analyzer meets the protection requirements laid down in the

following directives:

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.

The following marks demonstrate compliance:

Contact address

Compliance with the applicable directive(s) is provided by means of

the Declaration of Conformity.

CUS

®

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

US.

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

cobas c 111

Roche Diagnostics

4 Operator’s Manual · Version 4.3

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Operator’s Manual · Version 4.3 5

cobas c 111

Table of contents

Document information 2

Contact address 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

1 Safety

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 analyzer

Overview A–17

User interface A–20

Wizards A–21

Daily operation A–22

Maintenance A–36

System status A–37

3 Hardware

Covers and panels A–41

LEDs and color indicators A–43

Main components A–45

Hardware overview A–46

Technical specifications A–69

4 Software

Introduction A–73

Screen layout A–74

Display items A–75

Workflows and wizards A–76

Working with the user interface A–77

Key screens A–90

Color interpretation of LEDs and Global action

buttons A–130

Buttons A–132

Operation Part B

5 Daily operation

Introduction B–5

Starting the shift B–11

Preparing the system B–13

Analyzing samples B–37

Validating sample results B–56

Performing calibrations B–64

Performing QC B–73

Finishing the shift B–83

Logging off B–95

Shutting down the system and switching off the

analyzer B–95

Using the barcode scanner B–96

6 Special operations

Deleting sample orders B–101

Deleting sample results B–102

Calibration B–103

Deleting QC results B–104

Lot handling B–106

Exporting data B–113

Importing data B–120

Preparing a new disk B–126

Assigning tests to test tabs B–129

Deleting bottle sets from the Inventory list B–130

Refilling printer paper B–132

Removing condensation water from the reagent

cooler B–134

Replacing the probe B–135

Connecting and disconnecting the external fluid

containers B–137

Adjusting the touchscreen B–141

Cleaning the touchscreen B–142

7 Configuration

Introduction B–145

Applications B–147

Configuration B–167

Maintenance Part C

8 General maintenance

Overview C–5

Maintenance actions C–8

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

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cobas c 111

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–33

Replacing electrodes E–36

Cleaning the ISE tower off the analyzer E–40

14 ISE maintenance

Introduction E–45

ISE maintenance actions E–46

15 ISE troubleshooting

Introduction E–73

Safety E–74

List of ISE flags E–75

Reacting to error messages E–84

Glossary and Index Part F

Glossary F–3

Index F–11

Revisions Part G

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Operator’s Manual · Version 4.3 7

cobas c 111

Preface

The cobas c 111 analyzer 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 up to 50 samples per day, utilizing photometric analysis and an optional

unit for ion selective electrodes (ISE).

This manual describes the cobas c 111 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 c 111 analyzer 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.

Version 4.3

Parts B through D describe the analyzer without using an ISE unit, ISE specific information

is given in part E.

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 4.3

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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Operator’s Manual · Version 4.3 9

cobas c 111

Abbreviations The following abbreviations are used:

Abbreviation Definition

Cfas Calibrator for automated systems

CISPR International Special Committee on Radio Interference

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 Electrotechnical 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

TRL Test range low (lower limit of measuring range)

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10 Operator’s Manual · Version 4.3

Units

Abbreviation Description

°C degree centigrade

μL microliter

μm micrometer

A ampère

cm centimeter

hhour

Hz hertz

in inch

kg kilogram

kVA kilo volt-ampere

Lliter

m meter

MB megabytes

min minute

mL milliliter

mm millimeter

nm nanometer

ssecond

Vvolt

VA volt-ampère

V AC volt alternating current

V DC volt direct current

Wwatt

System Description

A

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cobas c 111 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 c 111

analyzer.

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

Disposal recommendation ........................................................................................... A–12

Disposal label ........................................................................................................... A–12

Disposal of external components .......................................................................... A–12

In this chapter

Chapter

1

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1 Safety cobas c 111

Table of contents

Disposal of the analyzer ......................................................................................... A–12

Constraint ................................................................................................................ A–12

Safety labels .................................................................................................................... A–13

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cobas c 111 1 Safety

Safety classification

Before you attempt to use the cobas c 111 analyzer, you must be fully familiar with the

following symbols and their meanings:

Safety information

Before operating the cobas c 111 analyzer, 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 cobas c 111 analyzer must comply with safety stan-

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

laboratory use instruments.

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1 Safety cobas c 111

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

EN/IEC 60825-1 LED Safety: Class 1.

WARNING

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

mechanism

Do not touch moving parts during analyzer operation.

WARNING

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

mechanism

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

WARNING

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

mechanism

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

maintenance of the analyzer, proceed according to the instructions.

WARNING

Infection by biohazardous materials

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

rials 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 c 111 1 Safety

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-69.

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 method sheet, 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 method sheet.

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 analyzer indoor only.

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1 Safety cobas c 111

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 analyzer and incorrect results due to interfering electromagnetic

fields

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

use this device in close proximity to sources of strong electromagnetic radiation (for exam-

ple, mobile phone, transceiver, cordless phone) as these can interfere with the proper

operation.

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.

Class B International rules

Class B equipment is suitable for use in domestic establishments and in establishments

directly connected to a low voltage power supply network which supplies buildings used

for domestic purposes (CISPR 11, 4.2).

WARNING

Malfunction of analyzer and incorrect results due to nonapproved parts

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

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

tics.

WARNING

Malfunction of analyzer 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 c 111 1 Safety

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 analyzer, make sure

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

NOTICE

Malfunction due to spilled liquid

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

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

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1 Safety cobas c 111

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 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 equip-

ment.

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

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Roche cobas c 111 User manual

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