Roche Cedex HiRes Operator's 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 a 0 812
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
683 05 Mannheim
Germany
© 2012 Roche Diagnostics.
All rights reserved.
www.roche-applied-science.com
066385 97001 0112
For life science research only.
Not for use in diagnostic procedures.
CE DEX 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 Notifi cation ..............................................................................................................................................................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 Specifi cations 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 ...................................................................................3 9
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
4
Cedex 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. Refi lling 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 Defi ning 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 Defi ning 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 fi le ......................................................................................................................................................................... 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
6
Cedex 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 Confi guration ................................................................................................................................. 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 Refi lling .........................................................................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 Verifi cation ..................................................................................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
8
Cedex 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 specifi ed in the sales contract. Contact your Roche Diagnostics representative for
further information.
Any unauthorized modifi cation 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 confi guration.
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 affi liates, distributors and/or third parties.
For further information, please contact your local Roche Applied Science support organization. You will fi nd
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 fi tness 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 specifi cally 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 specifi cations 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
15
Prologue
Symbols
In this Operator’s 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.
Procedure continued on next page.
■
End of procedure.
The following symbols appear on the analyzer
Symbol Heading Description
CE MARK The CE mark on the analyzer type plate indicates conformity with
requirements of the directives relevant for this analyzer.
XII. FCC Notifi cation
Changes or modifi cations to this unit not expressly approved by the party responsible for compliance may
void the user‘s authority to operate the equipment.
Note: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant
to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful
interference when the equipment is operated in a commercial environment. This equipment generates, uses
and can radiate frequency energy and, if not installed and used in accordance with the instruction manual, may
cause harmful interference to radio communications. Operating this equipment in a residential area is likely to
cause harmful interference, in which case the user will be required to correct the interference at his own expense.
FCC Notifi cation
16
Cedex HiRes Analyzer Operator’s Guide
XIII. 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 Cedex HiRes Analyzer:
Place the device on a dry and sturdy surface, free of vibrations.
Avoid transporting the device as much as possible once it has been assembled.
Prevent the device from getting wet.
Protect the device from dust and smoke.
Do not expose the device to direct sunlight.
Ensure there is suffi cient air circulation around the Cedex HiRes Analyzer during operation (particularly
around the computer and monitor).
Operate within a constant temperature range of 50°F – 100°F (10°C – 40°C).
For best performance it is recommended to keep the analyzer permanently on and only shut down the
software application on a regular basis.
The Cedex HiRes Analyzer should only be used with the supplied or specifi ed devices (Cedex HiRes
Analyzer, Cedex HiRes Software, monitor, computer, Multi Sampler, Reagent Tray).
Do not install any additional software on the corresponding computer.
Only trained personnel in a controlled laboratory environment should operate the Cedex HiRes Analyzer.
All services and repairs should be performed only by authorized service technicians.
Always ensure that there are suffi cient reagents in the reagent containers.
Clean the containers before reusing them.
Always observe the safety regulations when handling Trypan Blue, Detergent, Cleaning Solution or acids
and bases.
Waste contaminated with tissue or cells, e.g. Cedex Sample Cups, pipette tips, etc., must be disposed of
according to the recommended rules for handling biohazard materials.
Any leaks in the Liquid Management system must be repaired immediately. Contact your distributor or
authorized service technician.
Always ensure that there is a Cedex Sample Cup attached to the single sample port or placed in the Default-
Cup position on the Multi Sample tray.
Only use Cedex Detergent for the cleaning process in the Liquid Management system.
Only use Cedex Sample Cups from Roche Diagnostics GmbH for the conveyance of cell samples to the
sample port.
Other sample cups can cause irreparable damage to the Cedex HiRes Analyzer!
Always wear protective clothing, particularly gloves, when handling samples.
To prevent damage to the fl ow chamber, no particles larger than 80 µm should enter the measurement
system.
Particles ( especially microcarriers) larger than 90 µm should not gain access into the analyzer because they
cause irreparable damage and render the device non-functional.
Dirt or dust particles should not gain access into the device.
Ensure that all equipment required for sample preparation, e.g. Cedex Sample Cups, pipette tips, etc., are
stored in a dust-free environment since coarse dust particles can impair the fl ow chamber’s functionality.
Check that the Cedex Sample Cup is free of contamination before use. Only clean Cedex Sample Cups can
guarantee optimal functioning of the Cedex HiRes Analyzer.
Warnings and Precautions
17
Prologue
Ensure that the Trypan Blue solution is free of contamination, otherwise fi lter prior to use. Roche Diagnostics
GmbH recommends the use of the Cedex HiRes Reagent Kit.
Secure your measurement data.
If the system has been upgraded from some previous version to Software version 2.2, it is possible that some
default settings in the System Options may have slightly different values than those described in this manual.
The settings described in this manual apply to systems on which Software version 2.2 has been installed as
the original software.
The software and hardware of your Cedex HiRes System can differ from the information described here, but
this should not make a difference to the operational functions in general.
The manufacturer is not responsible or liable for any damages resulting from improper use or failure to
comply with the regulations in the Operating Instructions.
Electrical Safety
The Cedex HiRes Analyzer is designed in accordance with Protection Class I
(IEC). The chassis/
housing of the instrument is grounded to protection earth
(PE) by means of a cord. For protection
against electrical shock hazards, the instrument must be directly connected to an approved
power source
such as a three-wire grounded receptacle for the 110 V or 230 V line. Do not use
an ungrounded receptacle; have a qualifi ed electrician replace the ungrounded receptacle with
a properly (PE) grounded receptacle in accordance with the local electrical code. Do not use an
extension. Any break in the electrical ground path, whether inside or outside the instrument,
could be hazardous.
Under no circumstances should the user attempt to modify or deliberately
defeat the safety
features of this instrument. If the power cord becomes
cracked, frayed, broken, or otherwise
damaged, replace it immediately with the equivalent part from Roche Diagnostics.
XIV. Disposal of the Analyzer
Disposal Recommendations
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.
The analyzer must be treated as biologically contaminated hazardous
waste.
Decontamination (i.e.,
a combination of processes, including cleaning, disinfection
and/or sterilization) is required before
reuse, recycling or disposal.
Dispose of the analyzeraccording to local and/or laboratory regulations.
For more information contact your local Roche Support personnel.
Components of your control unit such as the computer, monitor, keyboard, etc. which are marked
with the crossed-out wheeled bin symbol are covered by the European Directive 2002/96/EC on
waste electrical and electronic equipment (WEEE) of the European Parliament and the Council of
January 27, 2003.
These items must be disposed of via designated collection facilities appointed by government or
local authorities.
For more information about disposal of your old product, please contact your city offi ce, waste
disposal service or local Roche Support personnel.
Disposal Recommendations
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 analyzer.
Disposal of the Analyzer
18
Cedex HiRes Analyzer Operator’s Guide
19
Overview
A
A
A Overview
The Cedex HiRes Analyzer automatically determines the cell concentration and viability of cell suspensions.
The analysis is based on the Trypan Blue Exclusion Method whereby cell suspensions are stained and analyzed.
The data obtained allows for the evaluation of the overall state of the cell culture, including the specifi c growth
rate and doubling time of a cell population, as well as the documentation of the cultivation process.
The evaluation of the samples is based on automatically obtained digital images that are analyzed using analysis
software on a separate computer (Cedex HiRes Control Unit). All the necessary steps – from the staining of
the samples to the recording and evaluation of the image data – are automatically performed by the analyzer.
Recognition and differentiation of cells as either viable or dead is done under standardized conditions, which
provides very precise and objective results.
A variety of parameters, including Viable Concentration, Total Concentration, Viability, Total Object Count,
Average Compactness and Average Diameter are analyzed using result data from single images, as well as from
all of the selected images of a sample. Standard deviation (Std. Dev.) of the number of cells from image to image is also calculated. In addition, the Aggregate Rate, which shows the percentage of the total number of cells
that appear in aggregates (clusters), is determined for both single images and all of the images. The use of a Live
Operator makes it possible to directly observe the effects on the analysis of a sample when the image analysis
software ( Operator) is adjusted.
Graphical representations of the measurement results can be viewed in the Measurement Statistics Histogram,
Diameter Histogram, Compactness Histogram, Aggregate Histogram and Cultivation Time Chart. In the
Measurement Statistics histogram, individual images can be compared to give a better overview of the distribution of the cells in the images. The Cell Diameter Histogram shows the diameter distribution of living cells.
The Object Diameter Histogram shows the diameter distribution of all objects detected such as cells, debris,
air bubbles and viable and dead cell aggregates. The deviation of the shape of living cells from that of an ideal
sphere is represented in the Compactness Histogram. The Aggregate Histogram provides an overview of the
amount and size of aggregation found in the cell culture.
The Cultivation Time Chart displays growth curves and cultivation parameters in a time- dependent manner.
The results of the Cultivation Time Chart can be separately printed out. For further processing of the results in
other programs, data export in formats such as Excel-compatible formats and CSV (Comma Separated Values,
generally applicable) is possible. The Cultivation Time Chart includes calculations for the doubling time [T]
and specifi c growth-rate [µ].
The Cedex HiRes Software 2.2 can be operated on Windows® XP Professional. Secure data handling, as well as a
carefully designed user management system, guarantee compatibility with 21 CFR, Part 11. Access security for
the Cedex HiRes System has been stepped up. Access is only allowed for authorized persons. The workstation
can be automatically blocked after a certain number of consecutive entries of a false password via the Systems
Options. A warning message will appear before the last allowed attempt.
20
Cedex HiRes Analyzer Operator’s Guide
A
A
1 Description of the Cedex HiRes System
The Cedex HiRes System consists of two functional units, the Analyzer (see Figure 1) and the Control Unit
(computer equipped with Cedex HiRes Software 2.2).
Preparation and processing of the samples takes place in the analyzer. The analysis software is installed on a
computer and controls the analyzer, as well as the analysis and evaluation of the images obtained.
Multi Sampler tray with
Cedex Sample Cups
Syringe module with 8-way valve
Tray with the Cedex Reagent Kit
ON/OFF Switch
Figure 1: The Cedex HiRes Analyzer
The analyzer consists of two main components, the hardware for image capturing (scanner) and the Liquid
Management system.
The fl ow chamber is specially developed to allow for the analysis of a defi ned volume of cell suspension. The
Liquid Management system is responsible for staining the sample as well as for fi lling and cleaning the fl ow
chamber and liquid feed system.
The volumes of sample and dye, as well as specifi c cleaning solutions required for each cleaning routine, are
precisely controlled via the syringe module with the 8-way distribution valve. The individual components of the
Liquid Management system are easily accessible to allow for trouble-free maintenance and control.
Description of the Cedex HiRes System
21
Overview
A
A
2 The Measurement Procedure
The determination of the number of viable cells (cells/ml) and viability of cell suspensions (the percentage
of viable cells from the total cell sample) is a fully automated, standardized procedure based on the manual
Trypan Blue Exclusion Method. A defi ned volume of Trypan Blue is added by the syringe to the Cedex Sample
Cup containing the cell suspension. The cell suspension and dye are optimally mixed between the syringe and
Cedex Sample Cup by controlled pump actions and then incubated for exactly the same amount of time for
each measurement. This minimizes effects on the viability measurements that might be caused by the toxicity
of the Trypan Blue.
After the incubation period, the stained cell suspension in the syringe is then transported in one portion via
the capillary tubes and the 8-way valve into the precision fl ow chamber, an image of which is scanned with the
scanner. The scanned image of the fl ow chamber is then cut up into smaller images for evaluation.
Once the measurement procedure is completed, a cleaning routine is automatically per formed by the Liquid
Management system. It is only possible to begin a new measurement after the cleaning routine has fi nished.
The Trypan Blue Exclusion Method
The Trypan Blue Exclusion Method is based on the principle that viable cells will not take up the dye, while
dead or dying cells have a compromised membrane that allows for the up take of the dye. Thus, dead cells will
appear darkly stained.
Trypan Blue has a greater affi nity for serum proteins than cellular proteins. If the image has a dark
background due to high quantities of stained serum proteins, centrifuge the cell sample and resuspended it in
a protein-free medium or physiological saline solution prior to counting.
The Measurement Procedure
22
Cedex HiRes Analyzer Operator’s Guide
A
A
3 Data Analysis
The analysis software and its graphical user interface ( GUI), known as the Cedex Control Center, enables
the user to work with Cedex HiRes Analyzer. The image analysis software (Operator) recognizes structures
and identifi es particles, thus differentiating cells from cell debris and dirt particles. Live and dead cells are
differentiated according to their degree of Trypan Blue staining.
The image processing is integrated in the Cedex Control Center in such a way that the user or Administrator
can check on its function in the system. The analysis process cannot be altered during data recording in order
to allow for consistent and objective measurement results.
Data Analysis
23
Overview
A
A
4 Technical Specifi cations of the Analyzer
Cedex HiRes Analyzer
Method of measurement
Digital image and pattern recognition
Viable/dead cell differentiation
Trypan Blue Exclusion Method
Detectable cell concentration range
5 × 10
4
– 1 × 107 cells per ml
Detectable cell diameter range
2 µm – 40 µm
Detectable object diameter range
1 µm – 90 µm
Required sample volume
300 µl
Average measurement period
< 4.0 min
Geometric resolution
0.8 µm/Pixel
Chamber height
100 µm
Material and diameter of the capillaries
Te fl on, 765 µm
Operating temperature
(Optimal image quality is achieved
between 20°C and 30°C)
+10 to +40°C
Maximum temperature change
5°C per hour
Maximum humidity deviation
5% per hour
Operating Humidity
20% – 80% relative humidity (non-condensing)
Dimensions
Height: 470 mm
Width: 405 mm
Depth: 505 mm
Weight with Multi Sampler: 28.9 kg
Weight without Multi Sampler: 26.9 kg
Energy requirements
100 – 250 VAC, 50 – 60 Hz
Energy consumption
24 VDC 2.0 A
Pollution Degree
2 (according to IEC 61010-1)
Installation Category
II (according to IEC 61010-1)
Technical Specifi cations of the Analyzer
24
Cedex HiRes Analyzer Operator’s Guide
A
A
Hardware Requirements for the Cedex HiRes Control Unit
Computer x86-Architecture, Intel Pentium IV
minimum 2 GHz required, 3 GHz recommended
Operating system Windows® XP Professional
RAM Minimum 1 GB RAM
Hard-disk storage 100 MB free hard-disk storage for installation of application.
Minimum 20 GB free hard-disk storage for data storage of
approx. 1000 measurements
Recommended 80 GB
USB 2 free ports
Firewire 1 free port
(400 Mbps, with 4 or 6 contacts)
CD/DVD burner Minimum CD burner required, DVD burner recommended if
computer will not be connected to a server
Graphic card Resolution: 1024 × 768 Pixel, 24-bit color
Monitor (color monitor or -TFT) 1024 × 768 Pixel, 24-bit color
Multi Sampler
Number of samples 1 – 20
Average measurement period for
20 samples < 90 min
Dimensions Height: 170 mm
Width: 190 mm
Depth: 260 mm
completely integrated into the Cedex HiRes Analyzer
Energy requirements 24 VDC, 2,0 A
derived from internal supply
Energy consumption max. 10 W
Technical Specifi cations of the Analyzer
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