Cedex HiRes User manual

Cedex HiRes Analyzer Operator’s Manual
Software Version 2.4
October 2017

How to Use the Cedex HiRes Analyzer Guides
Before reading, please review all Addenda for important information.
Addenda
Provide updates to the Cedex HiRes Analyzer Guides, including new supplementary information and
corrections to previous editions.
User Training Guide
Provides detailed step-by-step instructions for routine operation using the main applications of
the Cedex HiRes Analyzer, including instrument startup and shutdown.
Quick Guide
Provides a short set of instructions for use in the laboratory, describing the basic handling steps.
This shorter form of information is for routine use after you are familiar with the details of the Cedex
HiRes Analyzer described in the User Training Guide.
Operator´s Guide
Provides a detailed description of the Cedex HiRes Analyzer, system components and all relevant
software information not covered by the User Training Guide. For safety and installation
requirements, always refer to the Operator´s Guide.

Cedex HiRes Analyzer User Training Guide
Software Version 2.4
October 2017

3
Table of Contents
Prologue 5
I Document Information .................................................................................................................................................. 5
1 Revision History.................................................................................................................................................................... 5
2 Edition Notice........................................................................................................................................................................ 5
3 Copyright................................................................................................................................................................................. 5
4 Trademarks............................................................................................................................................................................. 5
II Contact Addresses .......................................................................................................................................................... 6
III. Declaration of Conformity ........................................................................................................................................... 6
IV Intended Use....................................................................................................................................................................... 6
V Preamble ............................................................................................................................................................................... 6
VI Conventions Used in this Guide............................................................................................................................... 7
VII Warnings and Precautions.......................................................................................................................................... 8
A Startup 10
1 Turning on the Cedex HiRes Analyzer, Control Unit, and Software ..................................................11
2 Preparing the Cedex HiRes Analyzer for Measurements.............................................................................. 12
2.1 Working with the Multi Sampler ..................................................................................................................................12
2.2 Installing a Reagent Kit ...................................................................................................................................................13
2.3 Perform a Prime..................................................................................................................................................................14
B Main Application: Counting Cells and Determining Viability 15
1 Check the Analyzer Before Starting Measurements..................................................................................15
2 Prepare the Samples ....................................................................................................................................................15
3 Setting Up a Single Measurement in the Measurement Dialog Box................................................16
3.1 Open the Measurement Dialog Box and Define the Sample Parameters....................................................16
3.2 Define the Measurement and Analysis Parameters ............................................................................................. 17
4 Starting the Measurement........................................................................................................................................18
5 End of Measurement....................................................................................................................................................19
6 Viewing the Results in the Measurement Dialog Box...............................................................................20
6.1 Viewing the Results in the Measurement Dialog Box .........................................................................................20
6.2 Viewing the Results in the Histograms......................................................................................................................22
6.3 Viewing the Images...........................................................................................................................................................22
7 Setting up Multiple Measurements Using the Multi Run Dialog Box ..............................................23
7.1 Open the Multi Run Dialog Box and Prepare Samples for Analysis ..............................................................23
7.2 Define the Sample Parameters and the Measurement and Analysis Parameters
in the Multi Run Dialog Box...........................................................................................................................................24
7.3 Schedule Samples and Start the Measurement ....................................................................................................25
7.4 Interrupting a Multi Run..................................................................................................................................................26
7.5 Results ...................................................................................................................................................................................26
7.6 The Multi Run Result List................................................................................................................................................27
8 Measurement List..........................................................................................................................................................28

4Cedex HiRes Analyzer Software Version 2.4 - Training Guide
Table of Contents
C Additional Applications 29
1 Monitoring Growth of Cells Over Time...............................................................................................................29
1.1 Performing Measurements for Growth Curve Analysis.......................................................................................29
1.2 Result Analysis....................................................................................................................................................................29
1.2.1 Create a CTC View.............................................................................................................................................................30
1.2.2 Add One or More Series of Measurements to the CTC View ...........................................................................31
1.2.3 Create a CTC Chart Associated with the View to Analyze Pattern of Growth Over Time.......................34
1.2.4 Exponential Regression Function to Determine the Specific Growth Rate
and Doubling Time of the Cell Culture......................................................................................................................36
1.2.5 Checking Regression Curve Fitting.............................................................................................................................39
1.2.6 Editing Measurements in a View .................................................................................................................................40
2 Analyzing Unusual Cells.............................................................................................................................................41
2.1 Overview................................................................................................................................................................................41
2.2 Example of Cells Not Recognized by the Cell Type Std. Size ............................................................................42
2.2.1 Create a New Cell Type ...................................................................................................................................................43
2.2.2 Modify the Parameters for the New Cell Type via the Live Operator Dialog Box......................................45
2.2.3 Reprocess the Measurement Using the New Cell Type......................................................................................48
D Shutting Down the Cedex HiRes Analyzer 50
1 Perform an LM Shutdown..........................................................................................................................................50
2 Log Out.................................................................................................................................................................................50
3 Shut Down the Cedex Control Center ................................................................................................................51
E Index 52

5
Prologue
Prologue
I Document Information
1 Revision History
Version Software Version Revision Date Changes
1.0 V2.3 August 2013 First version
2.0 V2.3.2 April 2014 Updated Intended Use statement
Updated for SW version 2.3.2
3.0 V2.4 October 2017 Completely revised version due to
Software update, SW version 2.4
2 Edition Notice
The Cedex HiRes Analyzer User Training Guide, Software version 2.4, is for users of the Cedex HiRes Analyzer
together with the Cedex HiRes Analyzer Operator’s Guide for Software Version 2.4.
Every effort has been made to ensure that all the information contained in the Cedex HiRes Analyzer User
Training Guide 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.
3 Copyright
© Copyright 2017, Roche Diagnostics GmbH, all rights reserved.
Information in this document is subject to change without notice. No part of this document may be reproduced
or transmitted in any form or by any means, electronic or mechanical, for any purpose, without the express
written permission of Roche Diagnostics GmbH.
Questions or comments regarding the contents of this User Training Guide can be directed to your local Roche
Diagnostics representative.
4 Trademarks
CEDEX is a trademark of Roche.
All other product names and trademarks are the property of their respective owners.
Document Information

6Cedex HiRes Analyzer Software Version 2.4 - Training Guide
II Contact Addresses
Manufacturer Roche Diagnostics GmbH
Sandhofer Straße 116
68305 Mannheim
Germany
Distribution Roche Diagnostics GmbH
Sandhofer Straße 116
68305 Mannheim
Germany
Distribution in USA Roche Diagnostics
9115 Hague Road
Indianapolis, Indiana
III. Declaration of Conformity
Instrument
approvals
The Cedex HiRes Analyzer meets the protection requirements laid down in:
c Directive 2014/30/EU of the European Parliament and Council of 26. February 2014 relating to
electromagnetic compatibility (EMC).
c 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.
c 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.
Regulatory compliance is demonstrated by the following marks:
cComplies with the provisions of the applicable EU directives.
cRoHS (Restriction of Hazardous Substances) compliant from Serial No. G037E0001.
Issued by Underwriters Laboratories, Inc. (UL) for Canada and the US. ‘Laboratory Equipment’ is
the product identifier as shown on the type plate.
IV Intended Use
The Cedex HiRes Analyzer automatically determines the cell concentration and viability of cell suspensions. It
must be used exclusively by laboratory professionals who are trained in laboratory techniques and have studied
the Instructions for Use of this system.
The Cedex HiRes Analyzer is for use in quality control/manufacturing process only.
It was neither developed nor validated by the manufacturer for any kind of in vitro diagnostic application.
V Preamble
Before setting up operation of the Cedex HiRes Analyzer, it is important to read this User Training Guide and
the Cedex HiRes Analyzer Operator’s Guide thoroughly and completely. Non-observance of the instructions
contained herein or performing an operation not stated in this Training Guide could cause safety hazards.
Contact Addresses

7
Prologue
Conventions Used in this Guide
VI Conventions Used in this Guide
Text Conventions
To present information consistently and memorably, the following text conventions are used in this Training Guide:
Numbered list Steps in a procedure that must be performed in the order listed.
Italic type Used for operating instructions for the Cedex HiRes Software. In addition, important notes
and information notes are shown in italic type.
Blue italic type Refers to a different section in this Training Guide or the Cedex HiRes Analyzer Operator’s
Guide, which should be consulted.
Symbols
In this Training Guide, the following symbols are used as visual signals:
Symbol Heading Description
WARNING This symbol is used to indicate that non-compliance with instructions or
procedures could lead to physical injury or even death or could cause
damage to the system.
IMPORTANT NOTE Information critical to the success of the procedure or use of the product.
INFORMATION NOTE Additional information about the current topic or procedure.
ccc Procedure continued on next page.
nEnd of procedure.
The following symbols appear on the analyzer:
Symbol Heading Description
CE MARK The CE mark on the instrument type plate indicates conformity with
requirements of the directives relevant for this instrument.
cUL MARK On the instrument type plate.
CAUTION On the instrument type plate. Consult the accompanying documents for
important safety-related information such as warnings and precautions.

8Cedex HiRes Analyzer Software Version 2.4 - Training Guide
VII Warnings and Precautions
Moving parts may cause hand injuries. Never use the Cedex HiRes Analyzer without the protective cover
on the Multi Sampler and Syringe Module.
It is important that the following safety instructions and guidelines be observed in order to ensure safe and
reliable operation of the Cedex HiRes Analyzer.
In an emergency, immediately turn the power switch off and unplug the instrument.
cPlace the device on a dry and sturdy surface, free of vibrations.
cAvoid transporting the device once it has been assembled.
cPrevent the device from getting wet.
cProtect the device from dust and smoke.
cDo not expose the device to direct sunlight.
cEnsure there is sufficient air circulation around the Cedex HiRes Analyzer during operation (particularly
around the Control Unit and monitor).
cOperate within a constant temperature range of 10°C to 40°C (50°F to 100°F).
cFor best performance, it is recommended to keep the Cedex HiRes Analyzer permanently on and only shut
down the Software application on a regular basis. The Analyzer needs at least 2 hours to warm up before
it can be used for measurements.
cThe Cedex HiRes Analyzer should only be used with the supplied or specified devices (Cedex HiRes
Analyzer, Cedex HiRes Software, monitor, Control Unit, Multi Sampler, Reagent Tray).
cDo not install any additional software, or change any general operating system configurations, on the
Control Unit.
cOnly trained personnel in a controlled laboratory environment should operate the Cedex HiRes Analyzer.
cAll services and repairs should be performed only by an authorized Roche Service representative.
cAlways ensure that there are sufficient reagents in the reagent containers.
cClean the containers before reusing them.
cAlways observe the safety regulations when handling Trypan Blue, Detergent, Cleaning Solution, or acids
and bases.
cWaste contaminated with tissue or cells, for example, Cedex Sample Cups, pipette tips, etc., must be
disposed of according to the recommended rules for handling biohazard materials.
cAny leaks in the Liquid Management system must be repaired immediately. Contact your distributor or
authorized Roche Service representative.
cAlways ensure that there is a Cedex Sample Cup attached to the single sample port or placed in the
DefaultCup position on the Multi Sample Tray.
cOnly use Cedex Detergent for the cleaning process in the Liquid Management system.
cOnly use Cedex Sample Cups from Roche Diagnostics for the conveyance of cell samples to the single
sample port.
Other sample cups can cause irreparable damage to the Cedex HiRes Analyzer.
Warnings and Precautions