Innovatis Cedex hires Manual

Cedex HiRes Analyzer Operator’s Guide

Software version 2.1

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. Preamble .............................................................................................................................................................................11

IX. Contents of this Operator’s Guide ........................................................................................................................11

X. Conventions used in this Guide .............................................................................................................................11

XI. FCC Notiﬁcation..............................................................................................................................................................12

XII. Warnings and Precautions........................................................................................................................................13

XIII. Disposal of the Analyzer ............................................................................................................................................14

A Overview 15

1 Description of the Cedex HiRes System ...........................................................................................................16

2 The Measurement Procedure.................................................................................................................................. 17

3 Data Analysis ..................................................................................................................................................................18

4 Technical Speciﬁcations of the Analyzer..........................................................................................................19

B System Description 21

1 Installing the Cedex HiRes System......................................................................................................................21

1.1 Completing the Windows Mini-setup ........................................................................................................................21

1.2 Conﬁguring Access to the Cedex HiRes Software for Windows User Accounts ......................................22

2 Choosing a Suitable Location.................................................................................................................................27

3 Starting the Cedex HiRes System after Installation ...................................................................................27

4 Securing Access Rights ............................................................................................................................................28

4.1 Access Control at the Windows Operating System Level...................................................................................28

4.2 Access Control at the Cedex HiRes System Software Level..............................................................................28

4Cedex HiRes Analyzer Operator’s Guide

Table of Contents

C Operation 29

1 Overview of the Cedex Control Center...............................................................................................................29

1.1 Menu Bar ..............................................................................................................................................................................29

1.2 System Menu.......................................................................................................................................................................29

1.3 Measurement Menu .........................................................................................................................................................30

1.4 Functions Menu..................................................................................................................................................................30

1.5 Reports Menu ....................................................................................................................................................................31

1.6 Master Data Menu ............................................................................................................................................................31

1.7 Setup Menu .........................................................................................................................................................................31

1.8 Help Menu............................................................................................................................................................................32

1.9 Shortcut Area ......................................................................................................................................................................32

1.10 Tracking of Status of Events Carried out by the Analyzer ..................................................................................32

2 Preparing the Analyzer for Measurements......................................................................................................33

2.1 Switching on ........................................................................................................................................................................33

2.2 Logging in at the Computer Operating System Level ..........................................................................................33

2.3 Starting the Cedex HiRes Software 2.1 ....................................................................................................................33

2.4 Performing a HW Startup and Prime..........................................................................................................................34

2.5 Preparing the Reagent Kit ..............................................................................................................................................35

2.5.1. Installing or Changing the Reagent Kit ....................................................................................................................35

2.5.2. Reﬁlling Containers Individually ..................................................................................................................................36

2.6 Checking the Analyzer..................................................................................................................................................... 37

3 Carrying out a Single Measurement ...................................................................................................................38

3.1 Opening the Measurement window and specifying the Operating Mode and Sample Data ..............39

3.2 Deﬁning the Measurement and Analysis (Process) Parameters .....................................................................40

3.3 Preparing the Sample and Attaching it to the Multi Sample Tray or Sample Port....................................41

3.3.1. Starting the Measurement .............................................................................................................................................41

3.3.2. End of Measurement........................................................................................................................................................42

3.4 Interrupting a Measurement..........................................................................................................................................43

4 Working with the Multi Sampler............................................................................................................................44

4.1 The Multi Sampler DefaultCup.....................................................................................................................................45

4.2 Preparing the Measurement..........................................................................................................................................46

4.2.1. Using the Multi Sample Tray..........................................................................................................................................46

4.2.2. Ejecting the Multi Sample Tray .....................................................................................................................................46

4.2.3. Performing a Prime............................................................................................................................................................46

4.3 Carrying out Measurements with the Multi Sampler........................................................................................... 47

4.3.1. The Multi Run Data Entry Window..............................................................................................................................47

4.3.2. Starting a Measurement .................................................................................................................................................47

4.3.3. Adding Measurements to the List while Measurements are Running .........................................................48

4.3.4. Disruption of Measurements.........................................................................................................................................49

4.3.5. Modifying Data Entry........................................................................................................................................................49

4.3.6. Non-Linear Measurements in a Sample Series .....................................................................................................49

4.3.7. Interrupting or Stopping a Measurement.................................................................................................................49

4.4 Results ...................................................................................................................................................................................50

4.4.1. The Multi Sampler Result Table (Print Report) .......................................................................................................50

5 Switching off the Cedex HiRes Analyzer...........................................................................................................51

5.1 Carrying out an LM Shutdown and HW Shutdown..............................................................................................51

5.2 Logging out ..........................................................................................................................................................................52

5.3 Shutting down the Control Center ..............................................................................................................................52

Table of Contents

D Software 53

1 Using the Measurement Results Window........................................................................................................53

1.1 Result Data area.................................................................................................................................................................54

1.2 Sample Parameters and Processing Parameters areas.......................................................................................55

1.3 Image Area...........................................................................................................................................................................56

1.3.1. Viewing Individual Cell Images.....................................................................................................................................56

1.3.2. Viewing a Cell Image Using the Image View Window ........................................................................................57

1.3.3. Excluding Images from the Evaluation Process/Including Excluded Images .............................................58

1.3.4. Viewing the Prescan Image ...........................................................................................................................................59

2 Using the Measurement List....................................................................................................................................60

2.1 Viewing Analysis Results ................................................................................................................................................60

2.2 Searching for Measurements........................................................................................................................................61

3 Editing Existing Analysis Results/Data Sets...................................................................................................62

3.1 The Reprocess Button......................................................................................................................................................62

3.2 Effective Data Sets ............................................................................................................................................................63

4 Graphical Display of the Analysis Results........................................................................................................64

4.1 Enlarging the Histograms ...............................................................................................................................................64

4.2 Aggregate Histogram.......................................................................................................................................................65

4.3 Cell Diameter Histogram................................................................................................................................................. 67

4.4 Object Diameter Histogram ...........................................................................................................................................68

4.5 Deﬁning Diameter Intervals in the Diameter Histograms...................................................................................68

4.6 Compactness Histogram.................................................................................................................................................69

4.7 Measurement Statistics Histogram............................................................................................................................. 70

5 Cultivation Time Chart.................................................................................................................................................71

5.1 Creating a CTC View.........................................................................................................................................................71

5.1.1. The View Area .....................................................................................................................................................................72

5.1.2. The Series of Measurements Belonging to Selected View Area .....................................................................72

5.1.3. Adding Measurements to a View ................................................................................................................................73

5.1.4. Editing Measurements in a View ................................................................................................................................. 74

5.1.5. Viewing List of Measurements in a Series............................................................................................................... 74

5.1.6. Deleting Views and Series..............................................................................................................................................75

5.1.7. Exporting a View ................................................................................................................................................................75

5.2 Creating a Cultivation Time Chart ...............................................................................................................................75

5.2.1. The Data Selection Area .................................................................................................................................................76

5.2.2. Fitting to the Lowest Common Value ......................................................................................................................... 77

5.2.3. Measurement Series Offset ...........................................................................................................................................77

5.2.4. Variable Axis Calibration .................................................................................................................................................77

5.2.5. The Exponential Regression Button............................................................................................................................78

5.2.6. Printing out a Cultivation Time Chart ......................................................................................................................... 78

6 General Functions of the System ..........................................................................................................................79

6.1 Data Management ............................................................................................................................................................ 79

6.1.1. Printing Reports..................................................................................................................................................................79

6.1.2. Export to ﬁle.........................................................................................................................................................................80

6.2 Data Exchange....................................................................................................................................................................81

6.2.1. Export ....................................................................................................................................................................................81

6.2.2. Import.....................................................................................................................................................................................82

6.3 Viewing and Evaluating the Audit Trail File..............................................................................................................82

6.4 User Preferences................................................................................................................................................................83

6.4.1. Specifying Default Measurement Parameters ........................................................................................................83

6.4.2. Specifying Other Default Parameters.........................................................................................................................84

6.4.3. Specifying the Workarea for the Analysis Data......................................................................................................84

6.5 Changing own Password ................................................................................................................................................84

6Cedex HiRes Analyzer Operator’s Guide

Table of Contents

D Software continued

7 Administrator Functions.............................................................................................................................................85

7.1 Administration of User Accounts.................................................................................................................................85

7.1.1. Creating User Accounts .................................................................................................................................................85

7.1.2. Assigning Access Rights ...............................................................................................................................................86

7.1.3. Creating user groups........................................................................................................................................................ 87

7.1.4. Editing and Deleting User Accounts .......................................................................................................................... 87

7.1.5. Creating and Editing User roles ...................................................................................................................................88

7.2 Password Management...................................................................................................................................................89

7.2.1. Specifying Password Characteristics..........................................................................................................................89

7.2.2. Assigning New Passwords.............................................................................................................................................89

7.3 Assigning Work Areas......................................................................................................................................................90

7.4 The System Options ..........................................................................................................................................................91

7.4.1. Automatically Start the Hardware Management ...................................................................................................91

7.4.2. Modifying the Standard Setting for the Multi Sampler DefaultCup...............................................................92

7.4.3. Turning off Automatic Incrementation of Sample Cup Position.......................................................................92

7.4.4. Turning off the Flow Chamber Prescan.....................................................................................................................93

7.4.5. Error Level Displayed to Users......................................................................................................................................94

7.4.6. Liquid Container Conﬁguration....................................................................................................................................94

7.4.7. Default Settings..................................................................................................................................................................94

7.5 Adjustment of the Image Analysis using the Live Operator .....................................................................................95

7.5.1. Description of the Cell Type List and Live Operator .............................................................................................96

7.5.2. The Cell Type List Window..............................................................................................................................................96

7.5.3. Creating a New Cell Type................................................................................................................................................97

7.5.4. Editing an Existing Cell Type..........................................................................................................................................98

7.5.5. Viewing an Existing Cell Type........................................................................................................................................98

7.5.6. Deleting an existing Cell Type.......................................................................................................................................99

7.5.7. Working with the Live Operator....................................................................................................................................99

7.5.8. Description of the Individual Operator Parameters ........................................................................................... 101

7.6 Archiving Data .................................................................................................................................................................103

7.6.1. Archive.................................................................................................................................................................................103

7.6.2. Restore................................................................................................................................................................................ 104

7.6.3. Deleting Archived Data ................................................................................................................................................ 104

E Maintenance and Care 105

1 Cleaning and Maintenance Check List............................................................................................................105

2 Scheduling Automatic Cleaning Routines .................................................................................................... 106

Daily and Manual Maintenance and Cleaning Routines .......................................................................... 107

3.1 Checking the Reagent Containers when Manually Reﬁlling .........................................................................107

3.2 Cleaning Routines Carried out by the Liquid Management........................................................................... 108

3.2.1. Cleaning Options ............................................................................................................................................................ 108

3.2.2. The Hardware Management Window ......................................................................................................................110

3.2.3. Carrying out a Cleaning Routine................................................................................................................................110

3.2.4. Interrupting/Terminating a Cleaning Routine........................................................................................................110

3.3 Scanning the Chamber to Verify the Effectiveness of Cleaning Routines ................................................110

4 Automatic Adjustment and Alignment Veriﬁcation ..................................................................................112

5 Syringe Maintenance.................................................................................................................................................114

5.1 Removing the Syringe ....................................................................................................................................................114

5.2 Assembling and Installing the Syringe ....................................................................................................................115

5.3 Maintenance of the Syringe Guide and Spindle..................................................................................................116

6 Maintenance of the Flow chamber, 8-Way Valve and the remaining Hardware

Components....................................................................................................................................................................117

7 Operational Data ..........................................................................................................................................................117

8 The System Suitability Test (SST) ......................................................................................................................118

8.1 Creating SST Checkpoints............................................................................................................................................118

8.1.1. Creating SST Checkpoints With and Without Measurements........................................................................118

8.1.2. Running a Water Blank ................................................................................................................................................120

8.1.3. Setting up the SSTFailureReaction in the System Options Menu .................................................................120

8.2 Performing an SST...........................................................................................................................................................121

8.2.1. Performing an SST with Measurements .................................................................................................................121

8.2.2. Performing an SST without Measurements...........................................................................................................122

8.3 Tracking Trends in SST Results over Time..............................................................................................................123

8.3.1. Tracking Trends in SST Checkpoints with Measurements...............................................................................123

8.3.2. Tracking SST Checkpoints without Measurements ...........................................................................................125

8.4 Locking – Unlocking the System................................................................................................................................126

F Troubleshooting 127

1 Diagnosis of the Cedex HiRes Analyzer..........................................................................................................127

2 Trace and Logging........................................................................................................................................................128

3 The System Audit Trail File......................................................................................................................................128

G Appendix 129

1 System Options und User Preferences ............................................................................................................129

2 Index................................................................................................................................................................................... 140

Table of Contents

8Cedex HiRes Analyzer Operator’s Guide

Prologue

I. Revision History

Version Revision Date

1.0 October 2010

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 the address below or

to your Roche Diagnostics representative.

Roche Diagnostics GmbH

Roche Applied Science

Customer Support

Nonnenwald 2

82377 Penzberg, Germany

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

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

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