Roche Cedex Bio User manual

Cedex Bio System
Operator’s Manual
Software Version 2.1

Cedex Bio System
Roche Diagnostics
2 Operator’s Manual · Version 3.1
Document information
Revision history
Edition notice The Cedex Bio instrument is a continuous random-access analyzer intended for the
determination of chemical and biochemical parameters in aqueous solutions. It is
optimized for small throughput workloads of approximately 20 samples per day,
utilizing photometric analysis and a unit for ion selective electrodes (ISE).
This manual is for users of the Cedex Bio instrument with software version 2.1.
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 Cedex Bio instrument is a continuous random-access analyzer intended for the
determination of chemical and biochemical parameters in aqueous solutions
For use in quality control/manufacturing process only.
It is important that the operators read this manual thoroughly before using the
system.
Copyrights © 2011-2013, Roche Diagnostics GmbH. All rights reserved.
Trademarks The following trademarks are acknowledged:
CEDEX, COBAS, and ISE are trademarks of Roche.
All other trademarks are the property of their respective owners.
Contact address
Manual version Software version Revision date Changes
1.0 1.0 June 2011 First publication.
2.0 1.0 September 2011 Editorial corrections
3.0 2.0 July 2012 Hardware improvements.
Adjustments to reflect latest
software version (time indication
for running tests and disk space
indication).
3.1 2.1 November 2013 The TRL Check feature was
introduced. Minor textual
adjustments were made.
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland

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Cedex Bio System
Table of contents
Document information 2
Contact address 2
Table of contents 3
Preface 5
How to use this manual 5
Online Help system 5
Conventions used in this manual 6
System Description Part A
1Safety
Safety classification A–5
Safety information A–5
Data security A–10
Disposal recommendation A–11
Legal liability 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–33
System status A–34
3 Hardware
Covers and panels A–39
LEDs A–41
Main components A–43
Hardware overview A–44
Technical specifications A–65
4 Software
Introduction A–69
Screen layout A–70
Display items A–71
Workflows and wizards A–72
Working with the user interface A–73
Key screens A–82
Color interpretation for LEDs A–117
Buttons A–119
Operation Part B
5 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
Shutting down the system and switching off
the instrument 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–131
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
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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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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Preface
The Cedex Bio Instrument is a continuous random-access analyzer intended for the
determination of chemical and biochemical parameters in aqueous solutions. It is
optimized for small throughput workloads of approximately 20 samples per day,
utilizing photometric analysis and a unit for ion selective electrodes (ISE).
This manual describes the Cedex Bio system 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 Cedex Bio instrument has a context-sensitive online Help feature to aid in its
operating. “Context-sensitive” means that wherever you are located within the
Cedex Bio 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.
Parts B through D describe the instrument without using an ISE unit, ISE specific informa-
tion is given in part E.
oKeep this Operator’s Manual in a safe place to ensure that it is not damaged and
remains available for use.
oThis Operator’s Manual should be easily accessible at all times.

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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:
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
aStart of procedure
oList item
e
Cross-reference
hCall-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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Cedex Bio System
Abbreviations The following abbreviations are used:
Abbreviation Definition
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
TRL Test range low (lower limit of measuring range)

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Units Abbreviation Description
°C degree centigrade
μLmicroliter
μm micrometer
A ampère
cm centimeter
hhour
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
ssecond
Vvolt
VA volt-ampère
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
4 Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-67
System Description A

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Table of contents
Safety
Protecting yourself and the environment
In this chapter, you will find information on the safe operation of the Cedex Bio
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
Disposal recommendation ........................................................................................... A–11
Disposal label ........................................................................................................... A–11
Disposal of external components ......................................................................... A–11
Disposal of the instrument .................................................................................... A–11
Constraint ................................................................................................................ A–12
In this chapter Chapter 1

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Table of contents
Legal liability .................................................................................................................. A–12
Safety labels .................................................................................................................... A–13

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Safety classification
Safety classification
Before you attempt to use the Cedex Bio instrument, you must be fully familiar with
the following symbols and their meanings:
Safety information
Before operating the Cedex Bio 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 Cedex Bio 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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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 mate-
rials and mechanical components associated with samples of human origin are potentially
biohazardous.
oBe 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.
oIf any biohazardous material is spilled, wipe it up immediately and apply disinfectant.
oIf waste solution contacts your skin, wash it off immediately with water and apply a dis-
infectant. Consult a physician.

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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-65.
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.
oBe 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.
oIf any biohazardous material is spilled, wipe it up immediately and apply disinfectant.
oIf 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:
oMobile phone
oTransceiver
oCordless phone
oOther electrical devices that generate electromagnetic waves
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 Diagnos-
tics.
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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Cedex Bio System 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.
oDo not carry out operation and maintenance unless you have been trained by Roche
Diagnostics.
oCarefully follow the procedures specified in the Operator’s Manual for the operation
and maintenance of the system.
oLeave maintenance that is not described in the Operator’s Manual to trained service
representatives.
oFollow 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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Data security
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 Cedex Bio instrument 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 Cedex Bio instrument unusable.
Roche recommends the following precautions:
oAllow connection to authorized external devices only.
oEnsure that all external devices are protected by appropriate security software.
oEnsure that access to all external devices is protected by appropriate security equip-
ment.
oDo not copy or install any software on the Cedex Bio instrument unless it is part of the
system software or you are instructed to do so by a Roche service representative.
oIf additional software is required, contact your Roche service representative to ensure
validation of the software in question.
oDo 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.
oExercise 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
Cedex Bio instrument.
oKeep all external storage devices in a secure place and ensure that they can be
accessed by authorized persons only.

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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
Disposal of external components
Disposal of the instrument
WARNING
Malfunction of instrument and incorrect results due to software modifications by
the customer
The Cedex Bio instrument uses open source software. For details see document CedexBio
System License Notes.
The Cedex Bio instrument has been designed to be operated with the unmodified soft-
ware 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. For details see document CedexBio Sys-
tem License Notes.
The portions of used open source software are part of MIKRAPs CPU-X168LCD/NET board
support package and may be obtained from Mikrap AG ([email protected]).
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.
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 govern-
ment or local authorities.
For more information about disposal of your old products, contact your city office, waste
disposal service or your local service representative.
WARNING
The instrument must be treated as biologically contaminated hazardous waste. Final dis-
posal 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.

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Legal liability
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.
Legal liability
It is the users’ sole responsibility to determine whether they activate the TRL Check
feature, and if they do so to define the lower measuring range in accordance with the
country specific requirements. If the users activate the TRL Check feature, they are
also responsible for validation of the ranges they define.