Innovatis Cedex hires Manuale utente

User Manual

Cedex HiRes 1.10 2005

User Manual Cedex HiRes Version 1.10 2005

Contents

CONTENTS ............................................................................................................3

1RIGHTS..........................................................................................................7

Copyright ...........................................................................................................................................7

Disclaimer..........................................................................................................................................7

FCC Notification................................................................................................................................7

Safety Instructions............................................................................................................................7

2INTRODUCTION............................................................................................9

3DESCRIPTION OF CEDEX HIRES..............................................................11

3.1 The Analyzer ..........................................................................................................................11

3.2 The Measurement Procedure...............................................................................................12

The Trypan Blue Exclusion Method ........................................................................................12

3.3 Data Analysis.........................................................................................................................12

4INSTALLATION AND OPERATION OF THE CEDEX HIRES.....................15

4.1 Installing Cedex HiRes..........................................................................................................15

Contents of Delivery................................................................................................................15

4.2 Choosing a Suitable Location..............................................................................................16

4.3 Preparing the Analyzer.........................................................................................................16

The Reagent Kit.......................................................................................................................16

Installing or Changing the Reagent Kit ..............................................................................16

Refilling the Containers by the User ..................................................................................18

4.4 Preparation and Configuration of the Analysis Software by the Cedex

Administrator.........................................................................................................................19

5WORKING WITH THE CEDEX HIRES ........................................................21

5.1 Cedex HiRes - General Instructions....................................................................................21

Switching on............................................................................................................................21

Logging in at the Computer Operating System Level .............................................................21

Starting the Cedex HiRes Software.........................................................................................21

Checking the Analyzer.............................................................................................................22

The Logout ..............................................................................................................................23

Automatic Logout.....................................................................................................................23

Shutting down the Workbench ................................................................................................23

5.2 Description of the Cedex HiRes Workbench......................................................................23

Menu Bar.................................................................................................................................24

File Menu............................................................................................................................24

Special Menu......................................................................................................................24

Setup Menu........................................................................................................................26

The Menu: Users................................................................................................................27

The Menu: Help..................................................................................................................27

User Identification area............................................................................................................27

Data Source Identification Area...............................................................................................27

Measure Button..................................................................................................................27

View Button........................................................................................................................27

Reprocess Button...............................................................................................................27

Sample Properties Area ..........................................................................................................28

Process Parameters Area .......................................................................................................28

Status Area..............................................................................................................................28

User Manual Cedex HiRes Version 1.10 2005 3

Reagent Area.......................................................................................................................... 28

Cell Image Area...................................................................................................................... 28

Result Data Area .................................................................................................................... 28

Liquid Management Button..................................................................................................... 28

Emergency Stop Button.......................................................................................................... 29

Assign and Start Buttons........................................................................................................ 29

5.3 Description of Access Rights.............................................................................................. 29

5.4 Carrying out a Measurement............................................................................................... 29

Performing a Prime................................................................................................................. 30

Choosing the Operating Mode and Specifying Sample Data................................................. 30

Entering a Comment............................................................................................................... 31

Defining the Measurement and Analysis (Process) Parameters............................................ 31

Preparing the Sample and Attaching it to the Sample Port.................................................... 32

Starting Measurement ............................................................................................................ 33

End of Measurement .............................................................................................................. 34

5.5 Interrupting a Measurement ................................................................................................ 35

5.6 Switching off the Cedex HiRes............................................................................................ 35

Carrying out an LM ShutDown ............................................................................................... 35

6WORKING WITH THE MULTI SAMPLER................................................... 37

6.1 Introduction........................................................................................................................... 37

6.2 Working with the Multi Sampler.......................................................................................... 38

The Multi Sampler SpecialCup............................................................................................... 38

Changing the default position of the SpecialCup.................................................................... 39

6.3 Preparing the Measurement................................................................................................ 39

Using the Multi Sample Tray................................................................................................... 39

Ejecting the Multi Sample Tray............................................................................................... 40

Calibrating the Measurement System with a Focus Adjustment............................................ 40

Performing a Prime................................................................................................................. 41

6.4 Carrying out a Measurement with the Multi Sampler........................................................ 41

The Multi Sampler Data Entry Window................................................................................... 41

Starting a Measurement ......................................................................................................... 42

Disruption of Measurements................................................................................................... 43

Modifying Data Entry, Changing Samples.............................................................................. 43

Non-Linear Measurements in a Sample Series...................................................................... 43

Interrupting or Stopping a Measurement................................................................................ 44

6.5 Results................................................................................................................................... 44

6.6 The Multi Sampler Result Table (Print Results)................................................................. 44

Printout of the Measurement Data.......................................................................................... 45

7ANALYSIS RESULTS ................................................................................. 47

7.1 Description of the Analysis Results................................................................................... 47

Viable Cell Density Value ....................................................................................................... 47

Total Cell Density Value ......................................................................................................... 47

Viability Parameter Value ....................................................................................................... 47

Total Cell Count Value............................................................................................................ 47

Average Compactness Value................................................................................................. 47

Average Diameter Value......................................................................................................... 48

Aggregate Rate Value ............................................................................................................ 48

Standard Deviation Value....................................................................................................... 48

7.2 Viewing Individual Analysis Results after Completion of the Measuring Process........ 48

7.3 Graphical Display of the Analysis Results......................................................................... 48

Enlarging the Diagrams.......................................................................................................... 48

Aggregate Histogram.............................................................................................................. 49

Measurement Statistics Histogram......................................................................................... 51

4 User Manual Cedex HiRes Version 1.10 2005

Contents

Compactness Histogram.........................................................................................................52

Diameter Histogram.................................................................................................................52

Cultivation Time Chart.............................................................................................................54

Areas in the Cultivation Time Chart Window .....................................................................55

The Cultivation Time Chart Diagram ...............................................................................55

The Data Selection Area..................................................................................................56

The View Area .................................................................................................................57

Saving a View..................................................................................................................57

Loading a View ................................................................................................................57

Deleting a View................................................................................................................58

General Area......................................................................................................................58

Printing User defined Results..........................................................................................58

Exporting the Results.......................................................................................................59

Entering a Comment........................................................................................................59

Hiding the Cultivation Time Chart Window......................................................................59

The Extras Area.................................................................................................................59

Data Series Area................................................................................................................61

List of Measurement Series in the Data Series Area.......................................................61

New Button ......................................................................................................................61

The Details Button ...........................................................................................................61

The Display of the Measurement Series in the Diagram.................................................61

Measurement Series Offset.............................................................................................62

Grouping Measurement Series ...............................................................................................62

Selection of Data Series Window.......................................................................................62

Select Source Area..........................................................................................................63

The Buttons in the Selection of Data Series Window......................................................63

The Selected Measurements Area..................................................................................64

7.4 Exporting the Data.................................................................................................................65

The Export Window............................................................................................................65

Output File Name Area....................................................................................................65

Output Format Area.........................................................................................................66

Data Series Mixing Area..................................................................................................66

Additional Information Area .............................................................................................66

CSV Options Area............................................................................................................67

Export Template Area......................................................................................................67

Buttons in the Export Template Area...............................................................................67

Available Export Templates for Excel..............................................................................68

Export Structure Area......................................................................................................68

Start Export Button...........................................................................................................69

Hide Button......................................................................................................................69

7.5 Viewing and Selecting Cell Images .....................................................................................69

Viewing Individual Cell Images................................................................................................69

Viewing a Cell Image Using the IP ResultViewer....................................................................70

Excluding Images from the Evaluation Process/Including Excluded Images..........................72

7.6 Printing the Analysis Results...............................................................................................72

7.7 Viewing and Evaluating the Data Audit Trail File...............................................................73

7.8 Editing Existing Analysis Results/Data Sets......................................................................73

Viewing Existing Analysis Results/Modifying Measurement Parameters ...............................74

Reprocessing Existing Data Sets............................................................................................75

8GENERAL FUNCTIONS OF THE SYSTEM ................................................77

8.1 Specifying Target Directories for the Analysis Data .........................................................77

8.2 Changing your own Password.............................................................................................77

8.3 Viewing your own Access Rights........................................................................................77

8.4 Data Entry Fields for the Data Source Indentification Area..............................................78

8.5 Specifying your own Default Measurement Parameters...................................................78

User Manual Cedex HiRes Version 1.10 2005 5

9ADMINISTRATOR FUNCTIONS................................................................. 79

9.1 Administration of User Profiles........................................................................................... 79

9.2 Adjustment of the Image Processing Operator’s Counting Routine using the Live-

Operator................................................................................................................................. 79

Description of the Individual Operator Parameters ................................................................ 80

9.3 Securing Data........................................................................................................................ 82

10 MAINTENANCE OF THE ANALYZER........................................................ 83

10.1 Cleaning and Maintenance Check List............................................................................... 83

10.2 Daily and, if necessary, manual Maintenance and Cleaning Routines........................... 84

Checking the Reagent Containers when manually refilling.................................................... 84

Cleaning Routines Carried out by the Liquid Management.................................................... 84

The Daily Events Area....................................................................................................... 85

The Cleaning Area............................................................................................................. 85

Automatic Request for Cleaning........................................................................................ 87

The Syringe Handling Area............................................................................................... 87

Carrying out a Cleaning Routine....................................................................................... 87

Interrupting/Terminating a Cleaning Routine .................................................................... 88

Verifying the cleaning with the help of the Chamber Viewer............................................. 88

10.3 Syringe Maintenance............................................................................................................ 89

Removing the Syringe ............................................................................................................ 89

Assembling and Installing the Syringe.................................................................................... 90

10.4 Maintenance of the Syringe Guide and Spindle................................................................ 91

10.5 Maintenance of the Flow chamber, Microscope Optic, 8-Way Valve and the

remaining Hardware Components...................................................................................... 92

APPENDIX........................................................................................................... 92

Contact Details ............................................................................................................................... 92

Technical Specifications................................................................................................................ 93

Suppliers ......................................................................................................................................... 94

Material Safety Data Sheets .......................................................................................................... 94

INDEX .................................................................................................................. 95

6 User Manual Cedex HiRes Version 1.10 2005

hts 1

1 Rights

instructions and manuals are protected by copyright. No part of this document may be

reproduced, edited or translated without prior written consent of innovatis AG except as

permitted under the terms of the copyright.

Disclaimer

The information in this document is subject to change without prior notice and should not be

construed as a commitment by innovatis AG.

Innovatis AG accepts no responsibility or liability for any errors or inaccuracies in this document

or for any damage occurring during delivery, performance or use of this product.

Windows XP and Windows 2000®are registered trademarks of the Microsoft Corporation. All

other trademarks are trademarks or registered trademarks of the respective companies.

Cedex ® is a registered trademark of innovatis AG.

FCC Notification

WARNING

Changes or modifications 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.

Safety Instructions

WARNING

It is important that the following safety instructions and guidelines be observed in order to

ensure safe and reliable operation of Cedex HiRes:

• 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 sufficient air circulation around the Cedex system during operation

(particularly around the computer and monitor).

• Operate within a constant temperature range of 50°F – 95°F (10°C – 35°C).

User Manual Cedex HiRes Version 1.10 2005 7

• For constant performance it is recommended to keep the analyzer permanently on and

only shut down the software application on a regular basis.

• Cedex HiRes should only be used with the supplied or specified 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

system.

• All services and repairs should be performed only by authorized service technicians.

• Always ensure that there are sufficient reagents in the reagent containers.

• Clean the containers before reusing them.

• Always observe the safety regulations when handling Trypan Blue, detergent, disinfectant

or acids and bases.

• Waste contaminated with tissue or cells, e.g. 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 sample cup attached to the single sample port.

• Only use Cedex Detergent or a detergent with identical specifications for the cleaning

process in the liquid management system (see “Suppliers”, page 94).

• Only use sample cups from suppliers specified on page 94 for the conveyance of cell

samples to the sample port.

Other sample cups with other catalog numbers can cause irreparable damage to

Cedex HiRes!

• Always wear protective clothing, particularly gloves, when handling samples.

• To prevent damage to the flow 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 unfunctional.

• Dirt or dust particles should not gain access into the device.

• Ensure that all equipment required for sample preparation, e.g. sample cups, pipette tips,

etc., are stored in a dust-free environment since coarse dust particles can impair the flow

chamber’s functionality.

• Check that the sample cup is free of contamination before use. Only clean sample cups

can guarantee optimal functioning of the Cedex.

• Ensure that the Trypan Blue solution is free of contamination, otherwise filter prior to use.

Innovatis recommends the use of the Cedex HiRes Reagent Kit (see “Suppliers”, page

94).

• Secure your measurement data, as well as the Cedex.ini and CedexSt.ini files (see

Cedex HiRes Administrator Manual).

NOTE

The software and hardware of your Cedex HiRes can differ from the information described here,

but this should not make a difference to the operational functions in general.

WARNING

8 User Manual Cedex HiRes Version 1.10 2005

hts 1

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.

User Manual Cedex HiRes Version 1.10 2005 9

2 Introduction

The Cedex HiRes determines the cell density and viability of cell suspensions automatically.

The analysis is based on the Trypan Blue exclusion method whereby cell suspensions are

stained and analyzed. The obtained data allows for the evaluation of the overall state of the cell

culture, including the specific 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 – right from the preparation 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 are done under standardized conditions and, therefore, provide

very precise and objective results.

Many parameters, including Viable Cell Density, Total Cell Density, Viability, Total Cell Count,

Average Compactness and Average Diameter are analyzed from a single image result data

(Image), as well as from all of the selected images of a sample (Overall). Standard Deviation is

also calculated, but only from all of the selected images of a sample (Overall). In addition, the

Aggregate Rate, which shows the percentage of the total cells that appear in aggregates

(clusters), is determined for both single images (Image) and all of the images (Overall).

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 or else a number

of images can be grouped together to give a better overview.

The Diameter Histogram shows the diameter distribution of the living cells (Cell Diameter

Histogram). In the current version, this function was extended with an additional diameter

histogram (Diameter Histogram for all Objects), which shows 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 gives a quick overview of the amount of aggregation found in the cell

culture.

The Cultivation Time Chart displays the growth curves and the 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 DIF (Data

Interchange Format, Excel- compatible) and CSV (Comma Separated Values, generally

applicable) is possible.The Cultivation Time Chart now includes calculations for the doubling

time Tau [T] and specific growth-rate [µ].

The Cedex 1.10. version (Cedex HiRes) can be operated on the Windows XP Professional and

Windows 2000 Professional operating systems. Secure data handling, as well as a carefully

designed user management system, guarantee the compatibility with CFR 21, Part 11.

Access security for Cedex HiRes has been stepped up. Access is allowed only for authorized

persons. The workstation can be automatically blocked after a certain number of consecutive

entries of a false password via the cedex.ini (see Administrator Handbook for more details).

Image recognition has been further improved. The use of a Live-Operator now makes it possible

to directly observe the effects on the analysis of a sample when the operator is adjusted.

10 User Manual Cedex HiRes Version 1.10 2005

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