Roche Cedex HiRes Reference guide

Type
Reference guide

Roche Cedex HiRes is a high-resolution analyzer designed for rapid and precise cell counting and viability assessment in biopharmaceutical manufacturing processes. With its advanced imaging technology, Cedex HiRes provides accurate and reliable cell concentration, viability, and size distribution data. The system's user-friendly software allows for easy setup, operation, and data analysis, making it suitable for both research and quality control applications.

Roche Cedex HiRes is a high-resolution analyzer designed for rapid and precise cell counting and viability assessment in biopharmaceutical manufacturing processes. With its advanced imaging technology, Cedex HiRes provides accurate and reliable cell concentration, viability, and size distribution data. The system's user-friendly software allows for easy setup, operation, and data analysis, making it suitable for both research and quality control applications.

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For use in quality control/manufacturing process only.
Performing a Measurement — (October 2017)
Moving parts of the Multi Sampler may cause hand injuries. The Multi Sampler needle
may cause injuries during operation. Never use the Cedex HiRes Analyzer without the
protective cover in place for the Multi Sampler.
Start the Cedex HiRes Analyzer and Software
1
Turn on the Cedex HiRes Analyzer.
2
Turn on the monitor and PC.
3
Log in to Windows Operating System.
4
Start the Cedex Software by double-clicking on the Cedex Client icon located on the
desktop (the Cedex Server should already be automatically started. It must be first started
before the Cedex Software can be started). The Log In dialog box of the Cedex HiRes
Software will open.
5
Enter the username in the User Name field and password in the Password field and press
<Return>. The Cedex Control Center appears after a successful login.
Perform a Hardware Startup and Prime
1
Click on the HWM button in the Cedex Control Center to open the Hardware Management
dialog box.
If the Hardware Management has not been started, the current status field will
have the message “Not started”.
2
Click on HW Startup if the Hardware Management has not been started. The Hardware
Management will start and the current status field will have the message “HW started and
LM not primed”.
3
Ensure that a clean, empty Cedex Sample Cup is correctly positioned on the Multi Sample
Tray in the DefaultCup position (usually sample cup position 1), or on the single sample port,
and click on Prime in the Hardware Management dialog box. The status field will have the
message “HW started and LM primed”.
Perform a single measurement
1
Click on MEASURE in the Cedex Control Center to open the Measurement dialog box.
2
In the Measurement dialog box, enter a clearly defined Reactor ID to describe the sample
(e.g., the name of the cell culture or bioreactor name) in the Reactor ID area. You may either
choose a Reactor ID from the drop-down list or enter a new Reactor ID.
3
Enter a clearly defined Sample ID in the Sample ID area. Multiple Sample IDs can be listed
under one Reactor ID. The Sample ID can be freely defined.
4
Choose the appropriate dilution factor from the Dilution drop-down list. For undiluted
samples, enter a dilution factor of 1:1. When a dilution of 1:2 is prepared, then
1 part cell
suspension has been added to 1 part dilution medium. A dilution of 1:3 means that 1 part
cell suspension has been added to 2 parts dilution medium. The dilution factor will be
automatically taken into account in the results.
5
Select the sample volume of 300 µL in the Volume drop-down menu.
6
Enter comments (if desired) in the Comment box.
7
Enter the cup position for the sample in the Cup Position dialog box.
8
Select the cell type that optimally recognizes your cells from the Cell Type drop-down list:
c Min. Size: small cells with a diameter of about 6 µm.
c Std. Size: normal sized cells with a diameter of about 12 µm.
c Max. Size: large cells of more than 16 µm.
If a new cell type has been created, it can also be selected from the same Cell Type
drop-down list.
Do not select the Cell Type option HR-Illumination. This Cell Type is designed for
service purposes only and is not intended for analysis of cells.
ccc
Cedex HiRes Software 2.4 Quick Guide
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08385548001
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102017
For use in quality control/manufacturing process only.
CEDEX is a trademark of Roche.
All other product names and trademarks are the property of their respective owners.
Performing a Measurement — (October 2017)
9
Select the desired precision level in the Precision drop-down list:
c Minimum: 3 images are used for the analysis.
c Normal: 6 images are used for the analysis.
c Superior: 8 images are used for the analysis.
c Maximum: 11 images are used for the analysis.
10
Prepare the sample. The Cedex HiRes Analyzer requires a volume of 300 µL +/- 10%.
Any greater variation in sample volume will lead to inaccurate results.
11
Attach the Cedex Sample Cup containing the sample to the single sample port, or place it
in the appropriate
sample cup position on the Multi Sample Tray. For a single sample port,
the sample cup is correctly attached
when it is in an upright position directly beneath the
sample port, and the capillary tube almost reaches the base of the sample cup.
12
Click on the START MEASUREMENT button to start the measurement.
13
When the measurement is finished, the top section of the Result Data area in the
Measurement dialog box displays the overall results from the measurement.
The bottom section displays, in succession, the results from each image taken.
Logging out and/or shutting down
1
Open the Hardware Management dialog box (HWM button on the Cedex Control Center).
2
Click on LM Shutdown to shut down the Liquid Management system.
3
Click on the LOGOUT button on the Cedex Control Center to log out of the Cedex Control
Center. The Cedex Control Center software program will be ended, and the Login dialog
box will
reappear.
4
Alternatively, shut down the software by selecting Exit under the System menu or by clicking
on
to close the Cedex Control Center dialog box.
5
The security query, “Do you really want to exit the Cedex Control Center?“, will appear.
Click on Yes to shut down the program.
6
For a Multi Sampler, a sample cup should always be left in the DefaultCup position on the
Multi Sample Tray (see Quick Guide “Working with the Multi Sampler”). For a single sample
port, the sample cup from the last measurement should remain attached to the sample port
during the entire shutdown procedure and should only be removed when a new sample cup
has been attached for the next measurement.
Cedex HiRes Software 2.4 Quick Guide
Roche Diagnostics GmbH
Sandhofer Straße 116
68305 Mannheim
Germany
© 2017 Roche Diagnostics.
All rights reserved.
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Roche Cedex HiRes Reference guide

Type
Reference guide

Roche Cedex HiRes is a high-resolution analyzer designed for rapid and precise cell counting and viability assessment in biopharmaceutical manufacturing processes. With its advanced imaging technology, Cedex HiRes provides accurate and reliable cell concentration, viability, and size distribution data. The system's user-friendly software allows for easy setup, operation, and data analysis, making it suitable for both research and quality control applications.

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