Roche Cedex Bio System Operator's Manual
Cedex Bio System
Operator’s Manual
Software Version 2.1
Document information
Cedex Bio System
Revision history
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.
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.
Intended use The Cedex Bio instrument is a continuous random-access analyzer intended for the
Copyrights © 2011-2013, Roche Diagnostics GmbH. All rights reserved.
Trademarks The following trademarks are acknowledged:
Contact address
Software updates are done by service representatives.
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.
CEDEX, COBAS, and ISE are trademarks of Roche.
All other trademarks are the property of their respective owners.
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland
Roche Diagnostics
2 Operator’s Manual · Version 3.1
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
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
4 Software
Maintenance Part C
Introduction A–69
Screen layout A–70
Display items A–71
Workflows and wizards A–72
8 General maintenance
Overview C–5
Maintenance actions C–8
Working with the user interface A–73
Key screens A–82
Color interpretation for LEDs A–117
Troubleshooting Part D
Buttons A–119
9 Messages and alarms
Operation Part B
About messages D–5
Message screen D–5
Acoustic signals D–6
5 Daily operation
Introduction B–5
Alarm monitor D–6
List of alarm messages D–10
Starting the shift B–10
Preparing the system B–12
Analyzing samples B–34
Validating sample results B–51
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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
Cedex Bio System
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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Cedex Bio System
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.
Parts B through D describe the instrument without using an ISE unit, ISE specific information is given in part E.
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 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.
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Operator’s Manual · Version 3.1 5
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
h Call-up (software navigation path)
Color of display item on the screen
Cross-reference
Tip
Safety alert
Cedex Bio System
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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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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Cedex Bio System
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
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System Description
1 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
2 Introduction to the instrument . . . . . . . . . . . . . . . . . . . . . . . . . A-15
3 Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-37
4 Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-67
A
Cedex Bio System 1Safety
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.
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
Disposal recommendation ........................................................................................... A–11
Disposal label ........................................................................................................... A–11
Disposal of external components ......................................................................... A–11
Disposal of the instrument .................................................................................... A–11
Constraint ................................................................................................................ A–12
Chapter
1
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1Safety Cedex Bio System
Table of contents
Legal liability .................................................................................................................. A–12
Safety labels .................................................................................................................... A–13
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Cedex Bio System 1Safety
WARNING
CAUTION
NOTICE
WARNING
WARNING
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:
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 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.
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 Cedex Bio 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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1Safety Cedex Bio System
WARNING
WARNING
WARNING
WARNING
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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Cedex Bio System 1Safety
WARNING
WARNING
WARNING
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.
e
For details on the required environmental conditions, see Environmental conditions on
page A-65.
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1Safety Cedex Bio System
NOTICE
WARNING
WARNING
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
Third-party software
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.
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
WARNING
CAUTION
WARNING
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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1Safety Cedex Bio System
CAUTION
Data security
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 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:
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 Cedex Bio instrument 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
Cedex Bio instrument.
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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Cedex Bio System 1Safety
WARNING
WARNING
Disposal recommendation
Disposal recommendation
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 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. For details see document CedexBio System 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 (info@mikrap.ch).
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.
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1Safety Cedex Bio System
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.
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Cedex Bio System 1Safety
A
B
Safety labels
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 rele-
vant laboratory procedures on safe use must be observed.
Figure A-1 Safety labels on the Cedex Bio 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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1Safety Cedex Bio System
Safety labels
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A-14 Operator’s Manual · Version 3.1
Cedex Bio System 2 Introduction to the instrument
Table of contents
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 Cedex Bio 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–24
Calibration ............................................................................................................... A–26
Calibration type ................................................................................................ A–26
Calibration sequence ........................................................................................ A–27
Calibration status of a set ................................................................................. A–28
Calibration result storage ................................................................................ A–28
Validating calibration results .......................................................................... A–28
Calibration procedures .................................................................................... A–28
Quality control (QC) .............................................................................................. A–29
Sample handling ...................................................................................................... A–30
Order handling ........................................................................................................ A–31
Results ....................................................................................................................... A–33
Maintenance .................................................................................................................. A–33
System status ..................................................................................................................A–34
Chapter
2
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2 Introduction to the instrument Cedex Bio System
Table of contents
Roche Diagnostics
A-16 Operator’s Manual · Version 3.1
Cedex Bio System 2 Introduction to the instrument
WARNING
Overview
Overview
The Cedex Bio instrument is a continuous random-access analyzer intended for
metabolite analysis in mammalian cell cultures and microbial fermentation. The
Cedex Bio instrument is a low throughput, bench top instrument used in
manufacturing and quality control of pharma biotech environments. Core test
parameters cover sodium, potassium, glucose, lactate, lactate dehydrogenase,
ammonia, glutamine, and glutamate.
Only trained personnel working in a professional laboratory environment may
operate the Cedex Bio 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 The Cedex Bio 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 Cedex Bio System
A
L NM
B D
I
F
E
G
H
O
J
K
C
Overview
Measuring principles Measurements are performed by means of an absorbance photometer and 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 Cedex Bio 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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Cedex Bio System 2 Introduction to the instrument
Overview
Principles of operation
The Cedex Bio 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 Cedex Bio System
E
G
F
D
C
B
A
User interface
User interface
The Cedex Bio 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, Workplace
for result handling and details on orders, and Utilities for administration tasks.
e
For details on the user interface, see Chapter 4 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 Tabs 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.
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Cedex Bio System 2 Introduction to the instrument
Wizards
Wizards
Screens help you perform your tasks. If not all steps of a task can be performed from
one screen, the workflow is realized as a sequence of screens, a so-called wizard.
Cedex Bio wizards do not usually force you to perform a task at a certain stage, they
just make your work easier.
e
For details on workflows, see Workflows and wizards on page A-72.
When intervention is required On the screen, there are several methods of telling when your intervention is
required:
o Buttons and texts are color coded.
Everything is fine.
To ensure smooth operation, you need to perform some task.
The current process or action has not started yet or stopped. You need to
do something for it to start or continue.
o Screens can contain instructions. For example the text may ask you to place the
sample on the sample area or to remove a reagent bottle from the reagent disk.
o Messages inform you about the status of current actions.
o A permanent alarm monitor alerts you to events you should know about.
Wizards There are three major wizards: Prepare wizard, Orders wizard, and End Shift wizard.
With most tasks that involve more than one step, such as exchanging reagent or other
fluid bottles, you are supported by wizards.
Prepare wizard The Prepare wizard guides you through the tasks that need to be performed at the
beginning of a shift. When this wizard is done, the system is ready for processing
orders.
Orders wizard The Orders wizard guides you through the process of creating and changing orders.
End Shift wizard The End Shift wizard guides you through the tasks that need to be performed at the
end of the day or to prepare the instrument for handing over to another operator.
Individual tasks can be performed outside the wizards
Most tasks that make up a workflow can be performed without using a wizard.
If you perform a task independently, you first need to navigate to the appropriate screen
and then start the task from there; whereas if you use a wizard, the appropriate screen is
displayed automatically.
Using the wizards also ensures that all necessary steps are performed and in the right
order.
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2 Introduction to the instrument Cedex Bio System
Daily operation
Daily operation
Overview
Daily operation includes the routine tasks that are required to prepare and monitor
the system, and to analyze samples.
When you switch on the system, it performs several checks to make sure that all
preconditions are met, for example that all covers are closed or that there are cuvettes
available. It then performs self-tests to ensure that all modules function properly.
At the end of the startup phase, the screen is updated to display the current status of
the system.
The following table gives an overview of the tasks you might need to perform during
daily operation.
Task Steps Navigation
Starting the system 1. Switch on the system.
1
Logging on the system Overview > Logon
2
Preparing the system Start the Prepare wizard. Overview > Prepare
3
Defining orders Start the Orders wizard. Overview > Order (or Overview > STAT)
4
Monitoring the progress n/a Overview
5
With wizard As individual steps
1. Check the external fluid containers. Overview > >
2. Perform the maintenance actions
that are due.
3. Load the reagent disk. Overview >
4. Check the reagents. Overview >
5. Check the cuvettes. Overview >
6. Perform mixing Overview > > test >
7. Perform calibrations that are due. Workplace > Calibrations > >
1. Identify the sample. n/a
2. Select the tests. n/a
3. Place the sample. n/a
4. Start the run.
Utilities > Maintenance
Validating results 1. View results. n/a Workplace > Result Review
6
2. Handle flagged results. n/a Workplace > Result Review >
... > Repeat
... > Rerun
3. Accept results. n/a Workplace > Result Review > >
Accept
Table A-1 Overview of the daily operation tasks
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