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Cedex Bio Analyzer
User Guide version 3.5
Software version 3.0
Roche Diagnostics
Cedex Bio Analyzer · Software version 3.0 · User Guide · Version 3.5
2
Publication information
Edition notice This publication is intended for operators of the
Cedex Bio Analyzer with the installed software
version 3.0.
Every effort has been made to ensure that all the
information contained in this publication is correct at the
time of publishing. However, the manufacturer of this
product may need to update the publication information
as output of product surveillance activities, leading to a
new version of this publication.
Where to find information The User Assistance contains all information about the
product, including the following:
• Routine operation
• Maintenance
• Safety
• Troubleshooting information
• A software reference
• Configuration information
• Background information
The Safety Guide contains important safety information.
You must read the Safety Guide before operating the
instrument.
The User Guide focuses on routine operation and
maintenance. The chapters are organized according to
the normal operation workflow.
Publication
version
Software version Revision date Change description
1.0 1.0 June 2011 First version
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.
3.2 2.2 April 2016 Product IT Security Risk update.
Upgraded analyzer display, and updates to user interface
design.
3.3 2.2.1.0 December 2017 New feature implemented to recover a damaged database.
3.4 2.3 June 2018 New software update.
3.5 3.0 July 2021 Migration to task-oriented structure and FutureDoc layout.
Implementation of the User Assistance. Updated to include
new functions and features included in SW 3.0. Updated safety
and data security information.
uWhat is new in publication version 3.5 (11)
yRevision history
Roche Diagnostics
Cedex Bio Analyzer · Software version 3.0 · User Guide · Version 3.5
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!
General attention
To avoid serious or fatal injury, ensure that you are
familiar with the analyzer and safety information before
you use the analyzer.
rPay particular attention to all safety precautions.
rAlways follow the instructions in this publication.
rDo not use the instrument in a way that is not
described in this publication.
rStore all publications in a safe and easily retrievable
place.
The Online Help is a context-sensitive feature. For help
information in the Cedex Bio software, choose
the to display Help text that relates to the work area
of the software. The Online Help offers a quick and
convenient way of finding information, such as
explanations of screens, dialog boxes, and on how to
perform particular tasks.
To help you find information quickly, there is a table of
contents at the beginning of the User Assistance and
each chapter. In addition, a complete index can be found
at the end.
Training Do not carry out operation tasks or maintenance actions
unless you have received training from Roche
Diagnostics. Leave tasks that are not described in the
user documentation to trained Roche Service
representatives.
Images The screenshots and hardware images in this publication
have been added exclusively for illustration purposes.
Configurable and variable data in screenshots, such as
tests, results, or path names visible therein must not be
used for laboratory purposes.
Warranty Any customer modification to the analyzer renders the
warranty or service agreement null and void.
For conditions of warranty, contact your local sales
representative or refer to your warranty contract partner.
Always leave software updates to a Roche Service
representative, or perform such updates with their
assistance.
Copyright © 2021, F. Hoffmann-La Roche Ltd. All rights reserved.
Roche Diagnostics
Cedex Bio Analyzer · Software version 3.0 · User Guide · Version 3.5
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License information Cedex Bio Analyzer software is protected by contract law,
copyright law, and international treaties.
Cedex Bio Analyzer contains a user license between F.
Hoffmann-La Roche Ltd. and a license holder, and only
authorized users may access the software and use it.
Unauthorized use and distribution may result in civil and
criminal penalties.
Open-source and commercial software Cedex Bio Analyzer may include components or modules
of commercial or open-source software. For further
information on the intellectual property and other
warnings, as well as licenses pertaining to the software
programs included in Cedex Bio Analyzer, refer to the
electronic distribution included with this product.
This open-source and commercial software and
Cedex Bio Analyzer as a whole can constitute a device
regulated in accordance with applicable law. For more
detailed information, refer to the User Assistance and
labeling.
Note that the respective authorization is no longer valid
according to the corresponding legislation should any
unauthorized changes be made to Cedex Bio Analyzer.
Trademarks The following trademarks are acknowledged:
CEDEX and ISE are trademarks of Roche.
All other trademarks are the property of their respective
owners.
Feedback Every effort has been made to ensure that this publication
fulfills the intended use. All feedback on any aspect of
this publication is welcome and is considered during
updates. Contact your Roche representative, should you
have any such feedback.
Approvals The Cedex Bio Analyzer meets the requirements laid
down in the following directives:
Directive 2014/30/EU of the European Parliament and
Council of 26. February 2014 relating to electromagnetic
compatibility (EMC).
Directive 2014/35/EU of the European Parliament and
Council of 26. February 2014 relating to electrical
equipment designed for use within certain voltage limits.
Roche Diagnostics
Cedex Bio Analyzer · Software version 3.0 · User Guide · Version 3.5
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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.
Compliance with the applicable directive(s) is provided by
means of the Declaration of Conformity.
The following marks demonstrate compliance:
Contact address
Complies with the provisions of the applicable EU
directives.
Issued by Underwriters Laboratories, Inc. (UL) for
Canada and the US.
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland
Roche Diagnostics
Cedex Bio Analyzer · Software version 3.0 · User Guide · Version 3.5
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Table of contents 7
Roche Diagnostics
Cedex Bio Analyzer · Software version 3.0 · User Guide · Version 3.5
Table of contents
Publication information 2
Contact address 5
Table of contents 7
Intended use 9
Symbols and abbreviations 9
What is new in publication version 3.5 11
System description
1 System overview
System description 17
Hardware description 28
Supported material 69
2 Software overview
Overview of the software 77
Key panels 98
Operation
3 Before operation
Quick Guide: Daily operations 171
Quick Guide: Prepare wizard 176
About preparing the analyzer 179
Checklist: Before operation 181
Starting up and shutting down the analyzer 185
Checking supplies, water, and waste 197
Instrument alarms 218
4 Reagents and consumables
Overview of the reagents and consumables 247
Reagent handling 249
Monitoring reagent status 278
Managing supplies and waste 286
ISE unit 316
5 Calibration
Quick Guide: Performing calibrations 329
Calibration overview 330
Performing calibration and handling calibration
results 333
Calibrator lot change 349
General calibration information 365
6QC
Quick Guide: Performing QCs 377
QC overview 378
Performing a QC order and handling QC
results 379
QC lot change 405
General QC information 415
7 Orders and results
Quick Guide: Ordering and analyzing
samples 421
About the sample tube handling 423
Defining a sample order 426
Adding tests to an order 449
Monitoring the analysis progress 454
Test result validation 457
Printing sample results 490
Retransmitting test results to the host 492
Deleting sample orders 495
Deleting test results 497
8 After operation
Quick Guide: End Shift wizard 501
Checking for unfinished orders 504
Checking for not accepted test results 507
Starting the End Shift wizard 510
Performing the daily backup 513
Exporting the log files 516
Exporting full results data 518
Cleaning up the database 521
9 Maintenance
List of maintenance intervals 525
About the periodic maintenance actions 527
About the maintenance action status 529
Performing maintenance actions 531
Maintenance actions 534
Troubleshooting
10 Troubleshooting
Messages 645
Flags 648
Troubleshooting 674
Glossary
11 Glossary
Index 703
8Table of contents
Roche Diagnostics
Cedex Bio Analyzer · Software version 3.0 · User Guide · Version 3.5
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Cedex Bio Analyzer · Software version 3.0 · User Guide · Version 3.5
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Intended use
The Cedex Bio Analyzer is a continuous random-access
analyzer intended for process control in industrial
biotechnological production processes in pharmaceutical,
biochemical, and food manufacturing companies.
It is intended for determination of a wide range of
analytes in various aqueous solutions such as cell culture
and fermentation media.
For use in quality control/manufacturing process only.
Not for use in human clinical or diagnostic procedures.
Symbols and abbreviations
Product names Except where the context clearly indicated otherwise, the
following product names and descriptors are used.
Symbols used in the publication
Product name Descriptor
Cedex Bio Analyzer analyzer
Cuvette Segment Cuvette segment
Ion selective electrode ISE
Activator Bio Activator
ISE Reference Solution REF
yProduct names
Symbol Explanation
oList item
uRelated topics containing further information
qTip. Extra information on correct use or useful
hints.
rStart of a task
IExtra information within a task
fResult of an action within a task.
cFrequency of a task.
nDuration of a task.
dMaterials that are required for a task.
jPrerequisites of a task.
uTopic. Used in cross-references to topics.
pTask. Used in cross-references to tasks.
wFigure. Used in figure titles and cross-
references to figures.
ySymbols used in the publication
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Symbols used on product
Abbreviations The following abbreviations are used.
yTable. Used in table titles and cross-references
to tables.
zEquation. Used in cross-references to
equations.
kCode example. Used in code titles and cross-
references to codes.
Symbol Explanation
ySymbols used in the publication
Symbol Explanation
Global Trade Item Number.
ySymbols used on product
Abbreviation Definition
ANSI American National Standards
Institute
CAL Calibration
CISPR International Special Committee on
Radio Interference
CL-I Chloride indirect
DRAM Dynamic random access memory
e.g. Exempli gratia – for example
EMC Electromagnetic compatibility
EN European standard
F Solution 1 factor
GUI Graphical user interface
i.e. Id est – that is to say
IEC International Electrical Commission
ISE Ion-Selective Electrode
K-I Potassium indirect
LED Light-emitting diode
LLD Liquid level detection
n/a Not applicable
NA-I Sodium indirect
p.a. Pro analysi
ROM Read only memory
S Slope in mV/dec
SRAM Static random access memory
Std 1/1 First measurement of ISE Solution 1
Std 1/2 Second measurement of ISE
Solution 1
yAbbreviations
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Abbreviations for units The following abbreviations for units are used.
What is new in publication version 3.5
New layout and structure Resulting from customer feedback, we have updated the
layout and the structure of this publication to help you
find information easier and perform tasks quicker.
Std 2 Measurement of ISE Solution 2
TRL Test range low (lower limit of
measuring range)
UL Underwriters Laboratories Inc.
Abbreviation Definition
yAbbreviations
Abbreviation Definition
°C Degree centigrade
A Ampère
cm Centimeter
h Hour
Hz Hertz
in Inch
kg Kilogram
kVA Kilo volt-ampere
L Liter
m Meter
MB Megabytes
min Minutes
mL Milliliter
mm Millimeter
mV Measured voltage in millivolt
nm Nanometer
s Second
V Volt
V AC Volt alternating current
V DC Volt direct current
VA Volt-ampère
WWatt
î‚—L Microliter
î‚—m Micrometer
yAbbreviations for units
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New functions and features of Cedex Bio
Software 3.0
New user roles and rights functions. Audit Trail function
introduced. Extended Host Interface provides new
features for the host connection. The Graphical User
Interface has been adapted as needed for the new
features. The Cedex Bio Software is now 21 part 11
compliant.
Roche Diagnostics
Cedex Bio Analyzer · Software version 3.0 · User Guide · Version 3.5
System description
1 System overview
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Table of contents
System overview 1
In this chapter 1
System description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
About the Cedex Bio Analyzer . . . . . . . . . . . . . . . . 17
About the covers, panels, and service flaps . . . . . 20
About the LEDs and their color indicators . . . . . . 23
About the analyzer main power switch . . . . . . . . . 25
About the open/close cover buttons . . . . . . . . . . . 26
About the user interface . . . . . . . . . . . . . . . . . . . . . 27
Hardware description. . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Analyzer overview. . . . . . . . . . . . . . . . . . . . . . . . . . . 29
About the sample area. . . . . . . . . . . . . . . . . . . . . . . 31
Fluid system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
About the fluid system components . . . . . . . . 32
About the probe . . . . . . . . . . . . . . . . . . . . . . . . . 34
About the rinse station. . . . . . . . . . . . . . . . . . . . 35
About the syringe assembly . . . . . . . . . . . . . . . 36
About internal waste tank . . . . . . . . . . . . . . . . . 37
About the external fluid container connectors 38
About the water container. . . . . . . . . . . . . . . . . 39
About the waste container . . . . . . . . . . . . . . . . 40
About the Cleaner bottle . . . . . . . . . . . . . . . . . . 41
Rotor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
About the rotor . . . . . . . . . . . . . . . . . . . . . . . . . . 42
About the reagent disk . . . . . . . . . . . . . . . . . . . 44
About the reagent disk container. . . . . . . . . . . 46
About the reagent cooler. . . . . . . . . . . . . . . . . . 46
About the cuvette ring . . . . . . . . . . . . . . . . . . . . 47
Transfer unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
About the transfer unit. . . . . . . . . . . . . . . . . . . . 48
About the transfer head. . . . . . . . . . . . . . . . . . . 49
About the hand-held barcode reader . . . . . . . . . . 51
About the printer . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
About the absorbance photometer . . . . . . . . . . . . 54
About the absorbance measuring mode. . . . . . . . 55
About the connectors . . . . . . . . . . . . . . . . . . . . . . . 57
About the fuses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
ISE unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
About the ISE cover and panel . . . . . . . . . . . . . 59
About the ISE main components . . . . . . . . . . . 61
About the ISE measuring mode . . . . . . . . . . . . 63
Technical specifications overview. . . . . . . . . . . . . . 66
Supported material. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
1 System overview
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Table of contents
Tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
About the tubes . . . . . . . . . . . . . . . . . . . . . . . . . 69
List of supported tube types . . . . . . . . . . . . . . . 71
Roche Adapter Cup . . . . . . . . . . . . . . . . . . . . . . 72
List of allowed cleaning solutions . . . . . . . . . . . . . 73
List of available accessories and consumables . . 74
1 System overview
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System overview 17
System description
In this section
About the Cedex Bio Analyzer (17)
About the covers, panels, and service flaps (20)
About the LEDs and their color indicators (23)
About the analyzer main power switch (25)
About the open/close cover buttons (26)
About the user interface (27)
About the Cedex Bio Analyzer
The Cedex Bio Analyzer is a continuous random-access
analyzer intended for metabolite analysis in mammalian
cell cultures and microbial fermentation. The
Cedex Bio Analyzer is a low throughput, bench top
analyzer used in manufacturing and quality control of
pharma biotech environments. Core test parameters
cover sodium, potassium, glucose, lactate, lactate
dehydrogenase, ammonia, glutamine, and glutamate.
It is optimized for a small workload of up to 50 samples
per day, utilizing photometric analysis and an optional
unit for ion selective electrodes (ISE).
The Cedex Bio Analyzer is compliant with 21 CFR Part 11
regulation by default after initial installation of the system
by a Roche Service representative.
WARNING
!
Insufficient knowledge and skills
As an operator, ensure that you know the relevant safety
precaution guidelines and standards and the information
and procedures contained in these instructions.
rDo not carry out operation and maintenance unless
Roche Diagnostics has trained you to do so.
rLeave maintenance, installation, or service that is not
described to trained Roche Service representatives.
rCarefully follow the procedures specified in the
instructions for operation and maintenance.
rFollow laboratory best practices, especially when you
work with biohazardous material.
Features The Cedex Bio Analyzer offers laboratories the following
advantages:
High analytical performance
1 System overview
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Efficient operation
• Cooled, exchangeable reagent disks ensure
economical reagent use; disposable cuvette segments
allow for easy cuvette loading and removal.
High reliability, low maintenance
• Innovative "low impact" analyzer design and software-
driven preventive maintenance improves up-time and
reduces maintenance costs.
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.
High safety standards
• Built-in safety devices, such as liquid level detection,
tube bottom detection, and cuvette QC anticipate
potential hazards during operation.
Flexible sampling
• 8 on-board sample positions accommodate virtually
any type of sample carrier, and enable continuous
sample placing and removal during operation.
Data management
• Bidirectional RS-232 and USB ports, on-board thermal
printer, and drivers offer the latest in data
management capabilities.
Measuring principles Measurements are performed with an absorbance
photometer and optionally an ISE (ion selective electrode)
module that uses ion selective potentiometer.
The analyzer consists of the following components:
• Analyzer unit
• Control unit
• Fluid system
• Transfer unit
• Sample area
• Reagent storage
• ISE unit
1 System overview
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System overview 19
Cedex Bio Analyzer
The Cedex Bio Analyzer allows you to measure Na+, K+,
and Cl- in addition to the regular photometric tests.
The main features are:
• Cooled, exchangeable reagent disks
• Easy disposable cuvette segment handling
• Continuous sample placing and removal during
operation
Component Function
Analyzer unit Contains the incubators and photometers, used for making measurements; also contains the
analyzer rotor, which moves the cuvettes for pipetting, mixing, and measuring.
Control unit Controls the analyzer functions.
Fluid system Moves all the fluids used by the analyzer, including water, samples, reagents, liquid waste, and
Cleaner.
Transfer unit Pipettes samples, reagents, and other fluids from their containers into cuvettes for mixing so that
measurements can be performed.
Sample area Includes the area for placing different types of tubes.
Reagent storage Refrigerates and stores the reagent sets for testing.
ISE unit Contains the electrodes and solutions that are used for making measurements. The ISE unit also
contains the ISE tower, which mixes samples and QC materials before measuring.
yComponents of the analyzer
1 System overview
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About the covers, panels, and service flaps
All covers, panels, and service flaps must correctly be
mounted and closed during operation.
The following figure shows the removable panels, covers,
and the flaps that can be opened.
wThe Cedex Bio Analyzer
Transfer head cover Provides access to:
• Transfer mechanism
• Probe
q Shut down the operating software and switch off the
analyzer before you open this cover.
Left service flap Provides access to:
• Rinse station
• Tubing
• Internal waste tank
• Initialization plate
ATransfer head cover ERear service flap
BLeft side panel FRight side panel
CLeft service flap GRight service flap
DMain cover HPrinter panel
A
B
C
D
H
G
F
E
/
