Roche Cedex HiRes Manual

Cedex HiRes Analyzer
Addendum 2 to
Operator’s Guide, Version 1.0
Software Version 2.2.1 August 2012
For life science research only.
Not for use in diagnostic procedures.

Information regarding
the Cedex HiRes Analyzer
Dear Valued User of the Cedex HiRes Analyzer,
Roche Diagnostics Ltd. has merged into Roche Diagnostics International Ltd and therefore
the company name has changed to
Roche Diagnostics International Ltd
In order to harmonize and improve our support, the legal manufacturer changes as follows:
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
If you have any further questions regarding this matter, please do not hesitate to contact your
Roche Diagnostics representative. To call, write, fax, or email us, visit the Roche Applied Science
home page, http://www.roche-applied-science.com and select your home country.
Country-specific contact information will be displayed.
The address of the legal manufacturer in section
“Prologue/Contact Addresses” changes as follows:
Old adress New adress
Roche Diagnostics Ltd.
Forrenstrasse
CH-6343 Rotkreuz
Switzerland
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
CEDEX and INNOVATIS are trademarks of Roche.
06845932001 a0812
For life science research only. ©2012 Roche Diagnostics.
Not for use in diagnostic procedures. All rights reserved.

Cedex HiRes Analyzer
Addendum 1 to Operator’s Guide, Version 1.0
Software Version 2.2.1 January 2012
For life science research only.
Not for use in diagnostic procedures.

Information Regarding the
Cedex HiRes Analyzer Operator’s Guide
Please read the following information, which updates information given
in the Cedex HiRes Analyzer Operator’s Guide
Dear valued user of the Cedex HiRes Analyzer
This addendum includes:
c Updated information about the procedure for removal, reinstallation or replacement of the syringe.
If you have any further questions regarding this matter, please do not hesitate to contact
our Technical Services Department at your best convenience. To call, write, fax, or email
us, visit the Roche Applied Science home page, http://www.roche-applied-science.com
and select your home country. Country-specific contact information will be displayed.

3
Maintenance and Care
E
E
Syringe Maintenance
Section E: Maintenance and Care
Chapter 5: Syringe Maintenance
Follow the syringe maintenance procedure described on pages 130 – 131 to remove, reinstall or replace the
syringe of the Cedex HiRes System. After removal, reinstallation or replacement of the syringe, a calibration
check of the Cedex HiRes System must also be performed. Use Cedex Density Reference Standard Beads to
check the calibration and confirm that the FlowFactor is correct. If necessary, adjust the FlowFactor.
To perform the Cedex HiRes System calibration check and FlowFactor adjustment, follow the instructions
described in the online Instructions for Use for the Density Reference Standard Beads, available for download
at:
https://www.roche-applied-science.com/PROD_INF/index.jsp?&id=iforu
Ordering Information
Product Pack Size Cat. No.
Density Reference Standard Beads 1× 10 ml Batch A 06 422 659 001
Density Reference Standard Beads 1× 10 ml Batch B 06 422 667 001

Published by
Roche Diagnostics GmbH
Sandhofer Straße 116
68305 Mannheim
Germany
© 2012 Roche Diagnostics.
All rights reserved.
www.roche-applied-science.com
06638597001  0112
For life science research only.
Not for use in diagnostic procedures.
CEDEX and INNOVATIS are trademarks of Roche.

Cedex HiRes Analyzer Operator’s Guide
Software Version 2.2.1 May 2011
For life science research only.
Not for use in diagnostic procedures.

3
Table of Contents
Prologue 9
I. Revision History ................................................................................................................................................................ 9
II. Contact Addresses .......................................................................................................................................................... 9
III. Declaration of Conformity .........................................................................................................................................10
IV. Warranty ..............................................................................................................................................................................10
V. Trademarks ........................................................................................................................................................................10
VI. Copyrights ..........................................................................................................................................................................10
VII. Intended Use.....................................................................................................................................................................10
VIII. Software License Agreement ..................................................................................................................................11
IX. Preamble .............................................................................................................................................................................14
X. Contents of this Operator’s Guide ........................................................................................................................14
XI. Conventions used in this Guide .............................................................................................................................14
XII. FCC Notification..............................................................................................................................................................15
XIII. Warnings and Precautions........................................................................................................................................16
XIV. Disposal of the Analyzer ............................................................................................................................................ 17
A Overview 19
1 Description of the Cedex HiRes System ...........................................................................................................20
2 The Measurement Procedure..................................................................................................................................21
3 Data Analysis ..................................................................................................................................................................22
4 Technical Specifications of the Analyzer..........................................................................................................23
B System Description 25
1 Installing the Cedex HiRes System......................................................................................................................25
2 Choosing a Suitable Location.................................................................................................................................26
2.1 Connecting or disconnecting the device..................................................................................................................26
3 Connecting Hardware Components ....................................................................................................................27
3.1 Completing the Windows Mini-setup ........................................................................................................................27
4 Installing Cedex HiRes Software 2.2 or Updating to Cedex HiRes Software 2.2.......................28
4.1 Installing the Cedex HiRes Software 2.2 ..................................................................................................................28
4.1.1. Setting the Cedex Server to Autostart .......................................................................................................................32
4.2 Starting up the Software .................................................................................................................................................33
4.3 Updating Older Cedex HiRes Software version 2.x to Cedex HiRes Software 2.2.....................................34
4.3.1. Overview................................................................................................................................................................................34
4.3.2. Updating to Cedex HiRes Software 2.2 .....................................................................................................................34
4.3.3. Restoring a Cedex HiRes Software 2 Backup.........................................................................................................37
5 Starting the Cedex HiRes System after Installation ...................................................................................39
6 Securing Access Rights..............................................................................................................................................40
6.1 Access Control at the Windows Operating System Level...................................................................................40
6.2 Access Control at the Cedex HiRes System Software Level..............................................................................40

4Cedex HiRes Analyzer Operator’s Guide
Table of Contents
C Operation 41
1 Overview of the Cedex Control Center...............................................................................................................41
1.1 Menu Bar ..............................................................................................................................................................................41
1.2 System Menu.......................................................................................................................................................................41
1.3 Measurement Menu .........................................................................................................................................................42
1.4 Functions Menu..................................................................................................................................................................42
1.5 Reports Menu ....................................................................................................................................................................43
1.6 Master Data Menu............................................................................................................................................................43
1.7 Setup Menu .........................................................................................................................................................................43
1.8 Help Menu............................................................................................................................................................................44
1.9 Shortcut Area ......................................................................................................................................................................44
1.10 Tracking of Status of Events Carried out by the Analyzer ..................................................................................44
2 Preparing the Analyzer for Measurements......................................................................................................45
2.1 Switching on ........................................................................................................................................................................45
2.2 Logging in at the Computer Operating System Level ..........................................................................................45
2.3 Starting the Cedex HiRes Software 2.2 ....................................................................................................................45
2.4 Performing a HW Startup and Prime..........................................................................................................................46
2.5 Preparing the Reagent Kit ..............................................................................................................................................47
2.5.1. Installing or Changing the Reagent Kit .................................................................................................................... 47
2.5.2. Refilling Containers Individually ..................................................................................................................................48
2.6 Checking the Analyzer.....................................................................................................................................................49
3 Carrying out a Single Measurement ...................................................................................................................50
3.1 Opening the Measurement window and specifying the Operating Mode and Sample Data ..............51
3.2 Defining the Measurement and Analysis (Process) Parameters .....................................................................52
3.3 Preparing the Sample and Attaching it to the Multi Sample Tray or Sample Port....................................53
3.3.1. Starting the Measurement .............................................................................................................................................53
3.3.2. End of Measurement........................................................................................................................................................54
3.4 Interrupting a Measurement..........................................................................................................................................55
4 Working with the Multi Sampler............................................................................................................................56
4.1 The Multi Sampler DefaultCup .....................................................................................................................................57
4.2 Preparing the Measurement..........................................................................................................................................58
4.2.1. Using the Multi Sample Tray..........................................................................................................................................58
4.2.2. Ejecting the Multi Sample Tray .....................................................................................................................................58
4.2.3. Performing a Prime............................................................................................................................................................59
4.3 Carrying out Measurements with the Multi Sampler...........................................................................................59
4.3.1. The Multi Run Data Entry Window..............................................................................................................................59
4.3.2. Preparing for Multiple Measurements in the Multi Run Window ...................................................................59
4.3.3. Activating Sample Rows and Starting the Measurement .................................................................................60
4.3.4. Adding Measurements to the List while Measurements are Running .........................................................62
4.3.5. Modifying Data Entry, Changing Samples ..............................................................................................................63
4.3.6. Non-Linear Measurements in a Sample Series ....................................................................................................63
4.4 Interrupting a Multi Run..................................................................................................................................................63
4.5 Disruption of Measurements.........................................................................................................................................63
4.6 Results ...................................................................................................................................................................................64
4.6.1. The Multi Run Result List................................................................................................................................................64
5 Switching off the Cedex HiRes Analyzer...........................................................................................................65
5.1 Carrying out an LM Shutdown and HW Shutdown ..............................................................................................65
5.2 Logging out..........................................................................................................................................................................66
5.3 Shutting down the Control Center ..............................................................................................................................66

5
Table of Contents
D Software 67
1 Using the Measurement Results Window........................................................................................................67
1.1 Result Data area.................................................................................................................................................................68
1.2 Sample Parameters and Processing Parameters areas.......................................................................................69
1.3 Image Area...........................................................................................................................................................................70
1.3.1. Viewing Individual Cell Images.....................................................................................................................................70
1.3.2. Viewing a Cell Image Using the Image View Window ........................................................................................71
1.3.3. Excluding Images from the Evaluation Process/Including Excluded Images .............................................72
1.3.4. Viewing the Prescan Image ...........................................................................................................................................73
2 Using the Measurement List.................................................................................................................................... 74
2.1 Viewing Analysis Results ................................................................................................................................................75
2.2 Searching for Measurements........................................................................................................................................75
3 Editing Existing Analysis Results/Data Sets...................................................................................................76
3.1 The Reprocess Button......................................................................................................................................................76
3.2 Effective Data Sets ............................................................................................................................................................77
4 Graphical Display of the Analysis Results........................................................................................................78
4.1 Enlarging the Histograms ...............................................................................................................................................78
4.2 Aggregate Histogram....................................................................................................................................................... 79
4.3 Cell Diameter Histogram.................................................................................................................................................81
4.4 Object Diameter Histogram ...........................................................................................................................................82
4.5 Defining Diameter Intervals in the Diameter Histograms...................................................................................82
4.6 Compactness Histogram.................................................................................................................................................83
4.7 Measurement Statistics Histogram.............................................................................................................................84
5 Cultivation Time Chart.................................................................................................................................................85
5.1 Creating a CTC View.........................................................................................................................................................85
5.1.1. The View Area .....................................................................................................................................................................86
5.1.2. The Series of Measurements Belonging to Selected View Area .....................................................................86
5.1.3. Adding Measurements to a View ................................................................................................................................ 87
5.1.4. Editing Measurements in a View .................................................................................................................................88
5.1.5. Viewing List of Measurements in a Series...............................................................................................................88
5.1.6. Deleting Views and Series..............................................................................................................................................89
5.1.7. Exporting a View ................................................................................................................................................................89
5.2 Creating a Cultivation Time Chart ...............................................................................................................................89
5.2.1. The Data Selection Area .................................................................................................................................................90
5.2.2. Fitting to the Lowest Common Value .........................................................................................................................91
5.2.3. Measurement Series Offset ...........................................................................................................................................91
5.2.4. Variable Axis Calibration .................................................................................................................................................91
5.2.5. The Exponential Regression Button............................................................................................................................92
5.2.6. Printing out a Cultivation Time Chart .........................................................................................................................92
6 General Functions of the System ..........................................................................................................................93
6.1 Data Management ............................................................................................................................................................93
6.1.1. Printing Reports..................................................................................................................................................................93
6.1.2. Export to file.........................................................................................................................................................................94
6.2 Data Exchange....................................................................................................................................................................95
6.2.1. Export ....................................................................................................................................................................................95
6.2.2. Import.....................................................................................................................................................................................96
6.3 Viewing and Evaluating the Audit Trail File..............................................................................................................96
6.4 User Preferences................................................................................................................................................................ 97
6.4.1.
Adjusting Result Display in the Measurement List and Multi Run windows.............................................. 97
6.4.2. Specifying Default Measurement Parameters ........................................................................................................98
6.4.3. Specifying Other Default Parameters.........................................................................................................................98
6.4.4. Specifying the Workarea for the Analysis Data......................................................................................................99
6.5 Changing own Password ................................................................................................................................................99

6Cedex HiRes Analyzer Operator’s Guide
Table of Contents
D Software Continued
7 Administrator Functions...........................................................................................................................................100
7.1 Administration of User Accounts...............................................................................................................................100
7.1.1. Creating User Accounts ...............................................................................................................................................100
7.1.2. Assigning Access Rights ............................................................................................................................................ 101
7.1.3. Creating user groups......................................................................................................................................................102
7.1.4. Editing and Deleting User Accounts ........................................................................................................................102
7.1.5. Creating and Editing User roles .................................................................................................................................103
7.2 Password Management................................................................................................................................................ 104
7.2.1. Specifying Password Characteristics....................................................................................................................... 104
7.2.2. Assigning New Passwords...........................................................................................................................................105
7.3 Assigning Work Areas....................................................................................................................................................105
7.4 The System Options ....................................................................................................................................................... 106
7.4.1. Automatically Start the Hardware Management................................................................................................ 106
7.4.2. Modifying the Standard Setting for the Multi Sampler DefaultCup.............................................................107
7.4.3. Turning off Automatic Incrementation of Sample Cup Position.....................................................................107
7.4.4. Turning off the Flow Chamber Prescan .................................................................................................................. 108
7.4.5. Error Level Displayed to Users................................................................................................................................... 109
7.4.6. Liquid Container Configuration................................................................................................................................. 109
7.4.7. Disabling the Reagent Control .................................................................................................................................. 109
7.4.8. Default Settings............................................................................................................................................................... 109
7.5 Adjustment of the Image Analysis using the Live Operator ..................................................................................110
7.5.1. Description of the Cell Type List and Live Operator ...........................................................................................111
7.5.2. The Cell Type List Window............................................................................................................................................111
7.5.3. Creating a New Cell Type..............................................................................................................................................112
7.5.4. Editing an Existing Cell Type........................................................................................................................................113
7.5.5. Viewing an Existing Cell Type......................................................................................................................................113
7.5.6. Deleting an existing Cell Type.....................................................................................................................................114
7.5.7. Working with the Live Operator..................................................................................................................................115
7.5.8. Description of the Individual Operator Parameters ............................................................................................117
7.6 Archiving Data .................................................................................................................................................................119
7.6.1. Archive.................................................................................................................................................................................119
7.6.2. Restore.................................................................................................................................................................................120
7.6.3. Deleting Archived Data .................................................................................................................................................120

7
E Maintenance and Care 121
1 Cleaning and Maintenance Check List............................................................................................................121
2 Scheduling Automatic Cleaning Routines .....................................................................................................122
3
Daily and Manual Maintenance and Cleaning Routines .......................................................................... 123
3.1 Checking the Reagent Containers when Manually Refilling .........................................................................123
3.2 Cleaning Routines Carried out by the Liquid Management............................................................................124
3.2.1. Cleaning Options .............................................................................................................................................................124
3.2.2. The Hardware Management Window ......................................................................................................................126
3.2.3. Carrying out a Cleaning Routine................................................................................................................................126
3.2.4. Interrupting/Terminating a Cleaning Routine........................................................................................................126
3.3 Scanning the Chamber to Verify the Effectiveness of Cleaning Routines ................................................126
4 Automatic Adjustment and Alignment Verification ..................................................................................128
5 Syringe Maintenance................................................................................................................................................ 130
5.1 Removing the Syringe ................................................................................................................................................... 130
5.2 Assembling and Installing the Syringe................................................................................................................... 131
5.3 Maintenance of the Syringe Guide and Spindle ..................................................................................................132
6 Maintenance of the Flow chamber, 8-Way Valve and the remaining Hardware
Components.................................................................................................................................................................133
7 Operational Data ..........................................................................................................................................................133
8 The System Suitability Test (SST) ..................................................................................................................... 134
8.1 Creating SST Checkpoints........................................................................................................................................... 134
8.1.1. Creating SST Checkpoints With and Without Measurements....................................................................... 134
8.1.2. Running a Water Blank ............................................................................................................................................... 136
8.1.3. Setting up the SSTFailureReaction in the System Options Menu ................................................................ 136
8.2 Performing an SST...........................................................................................................................................................137
8.2.1. Performing an SST with Measurements .................................................................................................................137
8.2.2. Performing an SST without Measurements.......................................................................................................... 138
8.3 Tracking Trends in SST Results over Time............................................................................................................. 139
8.3.1. Tracking Trends in SST Checkpoints with Measurements.............................................................................. 139
8.3.2. Tracking SST Checkpoints without Measurements .......................................................................................... 141
8.4 Locking – Unlocking the System................................................................................................................................142
F Troubleshooting 143
1 Diagnosis of the Cedex HiRes Analyzer..........................................................................................................143
2 Trace and Logging....................................................................................................................................................... 144
3 The System Audit Trail File..................................................................................................................................... 144
G Appendix 145
1 System Options und User Preferences ............................................................................................................145
Table of Contents

8Cedex HiRes Analyzer Operator’s Guide

9
Prologue
Prologue
I. Revision History
Version Revision Date
1.0 May 2011
© Copyright 2011, 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 Operator’s Guide can be directed to your local Roche
Diagnostics representative.
Every effort has been made to ensure that all the information contained in the Cedex HiRes System Operator’s
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.
II. Contact Addresses
Manufacturer Roche Diagnostics Ltd.
Forrenstrasse
CH-6343 Rotkreuz
Switzerland
Distribution Roche Diagnostics GmbH
Sandhofer Straße 116
D-68305 Mannheim
Germany
Distribution in USA Roche Diagnostics
9115 Hague Road
PO Box 50457
Indianapolis, IN 46250
USA
Revision History

10 Cedex HiRes Analyzer Operator’s Guide
III. Declaration of Conformity
The instrument meets the requirements laid down in Council Directive 2004/108/ EC relating
to “Electromagnetic Compatibility” and Council Directive 2006/95/EC relating to “Low Voltage
Equipment”. The following standards were applied: IEC/EN 61326-1 (EMC) and IEC/EN 61010-1
(Safety).
UL 61010-1 Electrical Equipment for Measurement, Control and Laboratory Use; Part 1:
General Requirements CAN/CSA-C22.2 No. 61010-1 (Second Edition) — Safety Requirements
for Electrical Equipment
IV. Warranty
The warranty conditions are specified in the sales contract. Contact your Roche Diagnostics representative for
further information.
Any unauthorized modification of the Cedex HiRes Analyzer and/or the Cedex HiRes Software will result in
invalidity of the guarantee and service contract.
V. Trademarks
CEDEX and INNOVATIS are trademarks of Roche.
Other brands or product names are trademarks of their respective holders.
VI. Copyrights
Cedex HiRes Analyzer Operator’s Guide. Copyright© 2011 Roche Diagnostics GmbH, all rights reserved.
Operating instructions and manuals are protected by copyright. No part of this document may be reproduced,
edited or translated without prior written consent of Roche Diagnostics GmbH except as permitted under the
terms of the copyright.
VII. Intended Use
The Cedex HiRes Analyzer automatically determines the cell concentration and viability of cell suspensions for
the purpose of life science research only.
The Cedex HiRes Analyzer is for life science research only. Not for use in diagnostic procedures.
It was neither developed nor validated by the manufacturer for any kind of in vitro diagnostic application.
Declaration of Conformity

11
Prologue
VIII. Software License Agreement
Read the following terms and conditions of this Software License Agreement (“Agreement”) carefully before
installing the Cedex 2 Software, hereinafter referred to as (“Software”). Proceeding with the installation of the
Software will constitute acceptance of the terms and conditions of this Agreement. By accepting the terms and
conditions of this Agreement, the end user (“Licensee”) assumes all responsibility and liability for the selection
of this Software to achieve the intended results, and for its installation and subsequent use. If Licensee is not
willing to be bound by the terms and conditions of this Agreement, the Software package must be promptly
returned to Roche (“Supplier”) with a copy of the receipt against refunding of the purchase price for this
Software.
1. Programm License Agreement
Licensee assumes all responsibility and liability for the selection of this Software to achieve the intended results,
and for its installation and subsequent use. The Software is protected by copyright.
2. Grant of Software License
Supplier is entitled to grant to Licensee subject to continuous compliance with all the provisions hereinafter, a
non exclusive, single use license to use the Software upon the terms and conditions contained in this Agreement.
Licensee may:
a. Use the Software on workstations which have to be owned, leased or otherwise controlled by Licensee,
whether in a network or other configuration.
b. Transfer the Software by assigning the rights under this Agreement to another party, provided that the other
party agrees in writing to accept the terms and conditions of this Agreement. In addition, Licensee must
ensure that the copyright notice is maintained on the Software transferred.
Licensee may not:
a. Use the Software, in whole or in part, except as expressly provided in this Agreement.
b. Use the Software on more than one workstation at a time.
c. Copy, sell, or otherwise transfer the Software or assign its rights under this Agreement, in whole or in part,
to another party, except as expressly provided in this Agreement.
d. Rent, distribute, license or sublicense the Software.
e. Create derivative works based on Software.
f. Modify, adapt, translate, reverse engineer, decompile or disassemble the Software.
Supplier reserves all rights not expressly granted herein, including, but not limited to, the rights to market the
Software either directly or through affiliates, distributors and/or third parties.
For further information, please contact your local Roche Applied Science support organization. You will find
the contact information on the following webpage:
www.roche applied science.com.
3. Limited Warranty
The Software is provided “as is” without warranty of any kind, either expressed or implied, including, but not
limited to the implied warranties of merchantability and fitness for a particular purpose. The entire risk as to
the quality and performance of the Software is with Licensee, should the Software prove to be defective. Licensee
assumes the entire costs of all necessary servicing, repair, or correction. However, Supplier warrants that the
program media on which the Software is furnished is free from defects in materials and workmanship under
normal use for a period of ninety (90) days from the date of delivery as evidenced by a copy of your receipt.
SUPPLIER MAKES NO FURTHER WARRANTIES OR GUARANTEES NOR EXPLICIT NOR IMPLIED
Software License Agreement

12 Cedex HiRes Analyzer Operator’s Guide
4. Disclaimer of Warranties
AS FAR AS PERMITTED UNDER THE GOVERNING LAW AS SET FORTH UNDER SECTION 11 OF THIS
AGREEMENT THE WARRANTY SET FORTH IN THE PREVIOUS PARAGRAPH, IS IN LIEU OF ALL
OTHER WARRANTIES, EXPRESS OR IMPLIED, ARISING BY LAW, FROM A COURSE OF PERFORMANCE,
A COURSE OF DEALING, TRADE USAGE, OR OTHERWISE. AS FAR AS PERMITTED UNDER THE
GOVERNING LAW AS SET FORTH UNDER SECTION 11 OF THIS AGREEMENT SUPPLIER AND ANY
ENTITY CONTROLLING, CONTROLLED BY OR UNDER COMMON CONTROL WITH SUPPLIER
(“SUPPLIER’S AFFILIATE”) SPECIFICALLY DISCLAIM, WITHOUT LIMITATION, ALL WARRANTIES
OF ANY KIND, WHETHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, THE
IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND
NON INFRINGEMENT. SUPPLIER AND SUPPLIER’S AFFILIATES MAKE NO REPRESENTATION OR
WARRANTY AS TO THE SOFTWARE OR AS TO THE RESULTS TO BE ATTAINED BY LICENSEE OR ANY
THIRD PARTY FROM THE SOFTWARE. LICENSEE ACKNOWLEDGES THAT IT HAS NOT RELIED UPON
ANY REPRESENTATIONS OR WARRANTIES MADE BY SUPPLIER OR A SUPPLIER’S AFFILIATE EXCEPT
FOR THOSE EXPRESSLY AND SPECIFICALLY SET FORTH IN THIS AGREEMENT.
5. Limitations of Remedies
Supplier’s sole liability and Licensee’s sole remedy shall be:
a. The replacement of the program media not meeting Supplier’s limited warranty and which is returned to
Supplier with a copy of Licensee’s receipt;
b. If Supplier is unable to deliver replacement of program media which is free of defects in material and
workmanship, Licensee may terminate this Agreement by returning the Software and a copy of Licensee’s
receipt to Supplier, and Licensee’s money will be refunded.
IN NO EVENT WILL SUPPLIER OR ANY OF SUPPLIER’S AFFILIATES (OR THEIR RESPECTIVE OFFICERS,
EMPLOYEES, CONSULTANTS, ATTORNEYS OR AGENTS), BE LIABLE FOR ANY SPECIAL, INDIRECT,
INCIDENTAL, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, LOST PROFITS,
LOST DATA OR INFORMATION, LOSS OF USE OF THE SOFTWARE, BUSINESS INTERRUPTION, LOSS
OF BUSINESS REPUTATION OR GOODWILL, OR DOWNTIME COSTS) WHICH THE LICENSEE OR
THIRD PARTIES MAY INCUR OR EXPERIENCE, DIRECTLY OR INDIRECTLY ARISING OUT OF OR
RELATING TO THE SOFTWARE, THIS AGREEMENT, OR THE TERMINATION OF THIS AGREEMENT,
EVEN IF SUPPLIER OR A SUPPLIER’S AFFILIATE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH
DAMAGES AND NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE. THE AGGREGATE
LIABILITY, ON A COMBINED BASIS, OF SUPPLIER AND SUPPLIER’S AFFILIATES (AND THEIR
RESPECTIVE OFFICERS, EMPLOYEES CONSULTANTS, ATTORNEYS, AND AGENTS) FOR DAMAGES
FOR ANY CAUSE WHATSOEVER DIRECTLY OR INDIRECTLY RELATING TO OR ARISING OUT OF
THIS AGREEMENT OR THE SOFTWARE, AND REGARDLESS OF THE FORM OF ACTION, SHALL BE
LIMITED TO, AT SUPPLIER’S OPTION, REPLACEMENT OF THE SOFTWARE OR REFUND OF THE
FEES RECEIVED BY SUPPLIER OR A SUPPLIER’S AFFILIATE FROM LICENSEE WITH RESPECT TO THE
SOFTWARE.
6. General Information
Licensee may not sublicense, assign or transfer the license or the Software, in whole or in part, except as expressly
provided in this Agreement. Any attempt otherwise to sublicense, assign or transfer any of the rights, duties or
obligations hereunder is void.
Software License Agreement

13
Prologue
7. Intellectual Property Rights
Licensee shall only hold those rights to the Software that are expressly described in Section 2 of this Agreement.
Any other rights with regard to the Software, including without limitation, ownership rights and patent,
copyright, trademark, trade secret and other intellectual property rights, shall remain the sole property
of Supplier. Licensee will not remove from the Software any references to copyrights, trademarks or other
ownership rights, or cover up or alter any such references. Licensee will take all reasonable steps to prevent any
unauthorized use, reproduction, sale, or publication of the Software or the unauthorized provision of access
thereto. Licensee will indemnify and hold harmless Supplier from any losses, damages, claims and expenses
(including, without limitation, reasonable legal expenses) relating to any infringement of the rights of Supplier
caused by Licensee, Licensee’s breach of this Agreement or Licensee’s use of the Software in a manner not
authorized under this Agreement.
8. Duration and Termination
The Agreement is effective until terminated.Licensee may terminate this Agreement at any time by destroying the
Software and documentation relating to the Software in any form. The Agreement will terminate automatically
and without notice from Supplier, if Licensee fails to comply with any term or condition of this Agreement.
Licensee agrees to destroy the Software upon termination of this Agreement by Supplier. On any termination of
this Agreement, all rights of use of the Software held by Licensee shall expire.
9. Import, Export and Use of the Software
Licensee shall be exclusively responsible for ensuring compliance with the relevant legislation relating to its
rights to import, export or use the Software.
10. Miscellaneous
Should any part of this Agreement be declared void or unenforceable by a court of competent jurisdiction, the
remaining terms shall remain in full force and effect.
Failure of Supplier to enforce any of its rights in this Agreement shall not be considered a waiver of its rights,
including but not limited to its rights to respond to subsequent breaches.
By opening and using this Software Licensee acknowledges that he has read this Agreement, understands it,
and agrees to be bound by its terms and conditions. Licensee further agrees that this Agreement is the complete
and exclusive statement of the Agreement between Licensee and Supplier and supersedes any proposal or prior
agreement, oral or written, any other communications between Licensee and Supplier relating to the subject
matter of this Agreement.
The headings of the several Sections of this Agreement are intended for convenience of reference only and are
not intended to be a part of or to affect the meaning or interpretation of this Agreement.
11. Governing Law and Place of Jurisdiction
This Agreement shall be governed by and construed in accordance with the laws of Germany, without giving
effect to any choice of law principles thereof. The parties agree that the United Nations Convention on Contracts
for the International Sale of Goods (1980) is specifically excluded from application to this Agreement.
The parties agree that courts of Mannheim, Germany, shall have exclusive jurisdiction over any dispute arising
out of or in connection with this Agreement.
Software License Agreement

14 Cedex HiRes Analyzer Operator’s Guide
IX. Preamble
Before setting up operation of the Cedex HiRes Analyzer, it is important to read this Operator’s Guide thoroughly
and completely. Non-observance of the instructions contained herein or performing an operation not stated in
this Operator’s Guide could involve safety hazards.
X. Contents of this Operator’s Guide
This Operator’s Guide describes the operation of the Cedex HiRes Analyzer. It contains the following chapters:
Chapter A Overview presents the specifications of the Cedex HiRes Analyzer.
Chapter B System Description contains the installation requirements of the Cedex HiRes Analyzer and a
description of the system’s components. This chapter also gives a short overview of the basic functions and
operation of the system.
Chapter C Operation describes the operating procedures for the Cedex HiRes Analyzer, including the correct
placement of the reagents and disposables and instructions for carrying out single and multiple measurements
of cell samples.
Chapter D Software provides a detailed description of the Cedex HiRes Analyzer software functions and
features.
Chapter E Maintenance and Care describes the maintenance and care procedures that are required for the
Cedex HiRes Analyzer.
Chapter F Troubleshooting contains troubleshooting information for the Cedex HiRes Analyzer.
Chapter G Appendix contains a detailed list of System Options and User Preferences, and an index.
XI. Conventions used in this Guide
Text Conventions
To present information consistently and memorably the following text conventions are used in this Operator’s
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 Operator’s Guide, which should be consulted.
Preamble