Innovatis Cedex HiRes User manual

User Manual

Cedex HiRes 1.10 2005

User Manual Cedex HiRes Version 1.10 2005

2

Contents

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

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

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

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

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

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

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

3 DESCRIPTION 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

4 INSTALLATION 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

5 WORKING 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

6 WORKING 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

7 ANALYSIS 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

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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

8 GENERAL 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

9 ADMINISTRATOR 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

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1 Rights

Copyright

Cedex

®

Operating Instructions. Copyright

©

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

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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

Introduction

2

User Manual Cedex HiRes Version 1.10 2005 11

3 Description of Cedex HiRes

The Cedex HiRes consists of two functional units, the Analyzer (see Figure 1, page 11 ) and the

Control Unit (computer or laptop equipped with HiRes software).

The preparation and processing of the samples takes place in the Analyzer.

The analysis software is installed on a computer and controls the Analyzer; it also controls the

analysis and evaluation of the images obtained.

Single sample port with sample cup

Syringe module with 8-way valve

Tray with the Cedex Reagent Kit

(containers with Trypan Blue,

detergent, disinfectant, distilled

or de-ionized water, waste)

ON/OFF Switch

Figure 1

Cedex Analyzer

3.1 The Analyzer

The Analyzer consists of two main components, the hardware for image capturing (scanner)

and the liquid management system.

The flow chamber is specially developed to analyze a defined volume of cell suspension. The

Liquid Management system is responsible for the staining of the sample as well as for the filling

and cleaning of the flow chamber and the liquid feed system.

The volumes of sample and dye, as well as specific 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.

12 User Manual Cedex HiRes Version 1.10 2005

Description of the Cedex HiRes

3

3.2 The Measurement Procedure

The determination of the number of viable cells (cells/mL) and cell viability of cell suspensions

(the percentage of viable cells of the total cell sample) is a fully automated and highly

standardized procedure based on the manual Trypan Blue Exclusion Method. A defined volume

of Trypan Blue is added by the syringe to the sample cup containing the cell suspension. The

cell suspension and dye are optimally mixed by controlled pump actions between the syringe

and sample cup and then incubated for the exact same 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 flow chamber, whose

image is recorded with the scanner. The scanned image of the flow chamber is then broken up

into smaller images for evaluation. By default, 150 images are analyzed. 20 images of previous

Cedex versions correspond to 155 Cedex HiRes images.

Once the measurement procedure is completed, a cleaning routine is automatically performed

by the Liquid Management. It is only possible to begin a new measurement after the cleaning

routine has finished.

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 uptake of the

dye. Thus, dead cells will appear darkly stained in a microscope.

NOTE

Trypan Blue has a greater affinity to serum proteins than to cellular proteins. If the microscopic

image has a dark background due to high quantities of stained serum proteins, then centrifuge

the cell sample and re-suspended it in a protein free medium or physiological saline solution

prior to counting.

3.3 Data Analysis

The analysis software and its graphical user interface (GUI), known as the Workbench,

enables the user to work with Cedex HiRes.

The Cedex HiRes software is installed on a computer provided by the customer. If a computer is

part of delivery, the software is by default pre-installed. The software analyzes the digital image

information extracted by the scanner.

The analysis software recognizes structures and identifies particles, thus differentiating cells

from cell debris and dirt particles. Viable and dead cells are differentiated according to their

degree of Trypan Blue staining.

The image processing is integrated in the Cedex HiRes Workbench in such a way that it allows

the user or Administrator to check on its function in the system constantly. The analysis process

cannot be altered during data recording in order to allow for consistent and objective

measurement results.

User Manual Cedex HiRes Version 1.10 2005 13

The Cedex HiRes can register several thousand cells per minute depending on cell density. The

rapid processing of image data allows for a significant increase in random checks, which greatly

improves the reliability and statistical accuracy compared to manual counting.

This analysis method provides information on, e.g., cell viability and morphology (diameter,

compactness).

14 User Manual Cedex HiRes Version 1.10 2005

Description of the Cedex HiRes

3

User Manual Cedex HiRes Version 1.10 2005 15

4 Installation and Operation of the Cedex HiRes

4.1 Installing Cedex HiRes

The installation of Cedex HiRes is done in the following steps:

• Cedex HiRes is delivered and assembled by a service technician or a sales partner

authorized by innovatis AG.

• The computer provided by the user must be equipped with the operating system Windows

XP Professional or Windows 2000 Professional. For further information, please refer to

the Cedex HiRes Administrator Manual.

• The Cedex software and Cedex Security Pack should be installed by your system

administrator before the service technician or sales partner can install the Analyzer. The

relevant instructions will be delivered once the contract is confirmed.

• Your system administrator should, if desired, have set up net access and/or printer

installation before the service technician or sales partner assembles Cedex HiRes.

• The system technician or sales partner installs the Analyzer and checks the security

settings in the software.

• The system technician or sales partner will check the Cedex entries, perform the focus

adjustment and ensure that Cedex HiRes is ready to use. Finally, he/she will create a

current status report of the device.

• The system administrator is responsible for setting up the user account for the operating

system, for example CedexSA.

• If required, the system administrator activates the Security Pack in order to control access

to the applications and desktop.

• The Administrator for the Cedex then sets up Cedex user accounts and assigns them the

required rights (see Cedex HiRes Administrator Manual).

Contents of Delivery

• 1 x Cedex HiRes Analyzer

• 1 x USB hardware key (Dongle)

• Power Supply adaptor 100-240V AC, 100W

• Power supply cable (country specific)

• Cords:

2 x Firewire cables, one with a 4 point and one with a 6 point connection, for connecting

the Analyzer to the Control Unit (PC)

• 1 x USB cable

• Cedex HiRes Install CD

• 1 x User Manual incl. License agreement, 1 x Administrator Manual

• Reagent Kit (Cat.No. 7 61 50 00 00 see Suppliers, page 94)

• Set of empty Reagent Kit bottles

• Sample cups (4 mL) (Cat.No. 6 00 05 00 00, see Suppliers, page 94)

• Cedex Calibration Beads (Cat.No. 7 60 00 00 16 see Suppliers, page 94)

• 2 x ferrite cores for use with Fire Wire cable

16 User Manual Cedex HiRes Version 1.10 2005

Installation and Operation of Cedex HiRes

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If the PC is

not provided by the customer but delivered by innovatis AG instead:

• 1 x PC or 1 x laptop (customer choice) including manual and DVD-burner with Windows

XP

®

or Windows 2000

®

and Cedex Analysis software

• 1 x keyboard

• 1 x mouse (only with PC)

• 1 x monitor incl. the manual

• 1 x recovery image cd

NOTE

The software and hardware of your Cedex HiRes may differ from the information described

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

NOTE

A printer is not included with the Cedex HiRes shipment. Follow the instructions for installing a

printer in the Cedex HiRes Administrator Manual.

4.2 Choosing a Suitable Location

The Cedex HiRes is highly sensitive and consists of top-quality electronic and optical

components. To guarantee optimal and reliable performance of the Cedex HiRes, select the

appropriate location according to the safety regulations described in the first section.

Avoid further transportation of Cedex HiRes after the professional installation.

WARNING

The transportation locks for the scanner must be attached to the inside of the casing before

Cedex HiRes is transported once again. Please contact an innovatis authorized service

technician in such a case. Vibrations or shaking must also be avoided when transporting the

Analyzer over short distances. Focus adjustment must be done after transportation (see Cedex

HiRes Administrator Handbook).

4.3 Preparing the Analyzer

The Reagent Kit

To ensure optimal performance of the Analyzer, the reagents must be free of impurities such as

dust, crystals, biological material or fluff. Innovatis AG’s Cedex Reagent Kit is manufactured

under GMP (Good Manufacturing Practice) conditions and guarantees optimal handling with the

best possible safety. One Reagent Kit pack is sufficient for 100 measurements, including the

standard cleaning routines.

Installing or Changing the Reagent Kit

Proceed as follows to install or change the Reagent Kit:

1. Perform an LM Shutdown if Liquid Management system has been primed (see “Carrying

out an LM ShutDown”, page 35).

User Manual Cedex HiRes Version 1.10 2005 17

2. Open the Reagent Kit chamber in Cedex HiRes by pushing the front upwards until it

clicks into place (see , page 17).

3. Remove the old Reagent Kit with the tray and dispose of the old reagent bottles if

necessary.

4. Open the new Reagent Kit and remove the covers from the individual containers.

5. Place the new Reagent Kit containers in the appropriate positions in the Reagent Tray

(see , page 17).

6. Close the front cover by pulling it all the way down. When the front cover is closed, the

capillaries are automatically correctly positioned in the individual containers.

7. Start the Cedex software to confirm that the Reagent Kit has been changed (see “”, page

22).

8. Confirm the changing of the Reagent Kit in the Setup menu of the Cedex HiRes

Workbench (see , page 17). The Reagent Control display on the Cedex HiRes

Workbench will turn from red to green.

9. Perform a Prime (see “Performing a Prime”, page 30).

10. Do not forget to attach a clean sample cup to the sample port.

Container for Detergent

Container for Trypan Blue

Container for disinfectant

Waste container

Container for distilled or de-ionized water

Figure 3

Position of the Reagent Tray with the individual containers

Figure 5

Confirming change of the Reagent Kit

18 User Manual Cedex HiRes Version 1.10 2005

Installation and Operation of Cedex HiRes

4

NOTE

For reliable functioning of the reagent control (correct number of possible measurements,

reporting an impending overflow of the waste container), it is critical that all of the reagent

containers are correctly filled to the line with the appropriate liquid (or, in the case of the waste

container, emptied) all at the same time (see “Refilling the Containers by the User”, page 18).

The changing of the Reagent Kit must then be confirmed in the software as soon as the

Reagent Tray has been put back into the chamber. Also, it is important that the sample cup is

filled with only the prescribed sample volume (+/-10 %) and that there is an empty cup in the

sample port when cleaning functions are being carried out. Failure to do all of the above will

result in a mis-match between the calculated reagents available as shown in the Reagent

Control and the actual reagent amounts in the containers or space available in the waste

container.

Refilling the Containers by the User

In order to ensure the optimal functioning of the Analyzer, the Reagent Kit containers must be

thoroughly cleaned before refilling (liquid change by the user is recommended once a week).

Impurities such as dust and fluff or contamination with micro-organisms may thus be avoided.

WARNING

If you are using your own reagents, it may be necessary to filter them before use.

Innovatis AG recommends using the Cedex HiRes Reagent Kit (see “Suppliers”, pg. 94).

For refilling the containers with reagents, follow the instructions below:

1. Rinse all reagent containers well before refilling! Make sure that there are no impurities

such as dust or fluff in the containers.

2. Fill the detergent container to the required level with Cedex Detergent (see label).

WARNING

Only Cedex Detergent or a detergent with identical specifications should be used for the cleaning

procedures in order to prevent damage to the sensitive surface of the Liquid Management

components (see “Suppliers”, page 94).

1. Fill disinfectant or 70% Isopropyl in the disinfectant container to the required level (see

label).

2. Fill distilled or de-ionized water in the water container to the required level (see label).

3. Fill 0.2% Trypan Blue solution in the Trypan Blue container to the required level (see label).

Innovatis AG recommends using 0.2%Trypan Blue solution. If necessary, dilute a more

concentrated Trypan Blue solution with buffer (Phosphate Buffered Saline (PBS), pH 7.4).

4. Put all of the reagent containers, as well as the emptied waste container, in the appropriate

positions in the Reagent Tray (see , page 17).

5. There should always be a sample cup attached to the single sample port (see , page 33).

The sample cup (4 mL) is correctly attached when it is in an upright position beneath the

sample port and the capillary tube almost reaches the bottom of the sample cup.

NOTE

If the Trypan Blue is completely used up during measurements and then refilled, a Prime must

be performed again before running the next sample (see “Performing a Prime”, page 30). If a

Prime is not performed, the first measurement after refilling of Trypan Blue will be labeled

User Manual Cedex HiRes Version 1.10 2005 19

Invalid (“Invalid Measurement” in red will appear in the Result Data window, see , page 25 ).

Subsequent measurements will be valid.

4.4 Preparation and Configuration of the Analysis Software by

the Cedex Administrator

The operating system of the PC will automatically start after the individual components of the

Cdex HiRes have been switched on in the correct order (first the Analyzer and then the

computer, see “Switching on”, page 21). The Cedex HiRes administrator has to execute the

following operations before the Cedex HiRes software can be used routinely:

• secure access rights and define the Administrator password.

• create user profiles and delegate access rights.

• define target directories for the analysis data.

• perform the focus adjustment.

Detailed information can be found in the Cedex HiRes Administrator Manual.

NOTE

For security reasons, the Cedex HiRes Administrator is only accorded administrative rights.

He/she cannot carry out, reprocess or view measurements.

After the successful configuration of a user profile, the access rights of the user can be defined.

Access to the following areas can then be determined:

• Available work areas

• Default work area

• Cell Types / Operators (software routines for image recognition)

• User Management

• System

Detailed information can be found in the Cedex HiRes Administrator Manual.

20 User Manual Cedex HiRes Version 1.10 2005

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