Cedex hires manual




















As it is desirable to have a back-up, validated instrument for QC operation, the instrument-to-instrument variation was also evaluated in this validation study. Inactivity refers to the hardware of the Cedex HiRes Analyzer. Performing cleaning routines, measurements and scans of the flow cell is considered activity. The Seg-Flow met the criteria needed for the autosampler such as: automation, dual sample streams cell-containing and cell-free , the ability to integrate multiple analyzers, configuration options for sample dilution, and the ability to sample for multiple analytes from a single analyzer.

Once components were selected, the initial phase of the project involved the integration of the cell-containing stream from the Seg-Flow to the Cedex HiRes analyzer. Merck found that sample dilutions easily met their criteria for success. Initially, some samples at a dilution did not meet their acceptance criteria. Troubleshooting studies showed that this deviance was caused by incorrect mixing flow and not by errors in dilution, thus the issue was quickly resolved by adjustment of the mixing flow rate.

The ability to configure mixing flow rate in the Seg-Flow was cited as one of the strengths of the system. The second phase of the project involved the integration of the Cedex Bio HT analyzer with the cell-free stream. One assay of particular interest was the lactate dehydrogenase LDH assay, a measurement of cellular damage. The LDH assay was successfully integrated into the system, as was configuration to enable automatic dilution for an analyte measured with the Cedex Bio HT, the ability to determine glucose concentrations using both the low and high measuring ranges of the Cedex Bio HT.

Merck found that the function of the system was acceptable, as expected, and comparable to manual sampling. This sample cup does not differ from the usual Cedex Sample Cups. In some cases it may be necessary to restart the Cedex HiRes Software 2. Page 67 Working with the Multi Sampler Carrying out Measurements with the Multi Sampler The Status column can display the following information see Figure 45, above and Figure 46 : Edit: Indicates that sample data is actively open for editing and is in the process of being edited.

Sample data in edit mode has not yet been added to the process queue, and samples placed in positions in edit mode will not be analyzed when the Multi Run is started.

Shut down the analysis software optional, see note below regarding the use of the scheduler. If a single measurement has been run using the Measurement window, the analysis results obtained from that measurement are automatically displayed in the same window after the analysis process has been completed. Page Result Data Area This value indicates the number of viable cells counted.

Dead Cell Count Value: This value indicates the number of dead cells counted. Total Object Count Value: This value indicates the number of all detected objects counted.

Images that could lead to incorrect measurement results during analysis, e. Individual images can be viewed in the Image area of the Measurement window. The results from the individual images are listed at the bottom of the Measurement window in the Result Data area. The Cedex HiRes Software 2. Viewing the Prescan Image During a measurement, a so-called Prescan is carried out before the cells are scanned. The Prescan image is stored together with the measurement and can be viewed when the Measurement window with results has been opened for that measurement.

These changes are done on existing software data image and analysis results and, therefore, do not require any adjustments to the analyzer. The Effective data set is the version of the measurement original or reprocessed that has the correct parameters. Once a data set has been selected as Effective it will be labeled as such in the Measurement List window. Clusters of up to 15 cells are displayed. Click on the Aggregate Histogram button in the Histograms window to open the corresponding histogram window.

Page 86 Figure 57 shows, for example, that cells of the measurement are found in aggregates of two cells. Page Cell Diameter Histogram Graphical Display of the Analysis Results Cell Diameter Histogram The percentage of cells found in aggregates, in relation to the total cell count, can be displayed using the percent button as is shown in Figure The results of each individual image can be seen again by clicking on the Single button.

If an image has been automatically excluded by the software or manually excluded by the user, the corresponding position in the diagram will be empty. It is also possible to export and print out the data. Page The View Area This area is used for creating, editing, viewing and deleting measurement series for a particular View. Only series that contain measurements with the correct parameters will be displayed in the Series area in the upper left-hand corner of the Series List window.

If one series of a particular View should be deleted, highlight the relevant View in the View area, then highlight the series to be deleted in the Series belonging to the selected view area.

Fitting to the Lowest Common Value The Fit lowest common value button enables automatic shifting of the zero-point of single measurement series to each other. The following can be selected: Viable Cell Density Dead Cell Density Total Cell Density By means of this function, the zero-point of each series will automatically be shifted on the x-axis, in order to be To print out a chart, click on the Print button.

A window will open in which the printer settings can be selected or the chart can be directly printed. Clicking on the Print button will open a window with a preview of the page to be printed.

Page General Functions Of The System General Functions of the System Data Management General Functions of the System The Cedex Control Center offers users with the appropriate rights access to a set of functions in addition to the basic functions of analyzing, modifying and reprocessing samples and measurement results. Click on OK. The user can export selected data from one Cedex Software 2. Specifying the Workarea for the Analysis Data The analysis results are stored in the workarea that is selected in the Measurement window before a measurement is run.

Restart the Cedex Software 2. Assigning Access Rights The user is normally denied access rights to certain areas, e. The user, therefore, cannot access all of the menus on the Control Center after login. Page Creating User Groups In order to avoid confusion, the software will not allow for the creation of a new user with the same user name as a user name that has been deleted. Measurements that have been run under a user name that has been deleted are still available for viewing.

Page Creating And Editing User Roles Superuser: The Superuser is allowed to use all operational functions of the system mainly for maintenance purposes. Support: Support of the Cedex HiRes System by Roche technical services requires access to all operational functions similar to the Superuser role.

All options necessary for a user to modify his workplace according to his needs can be found under User Preferences. Open the All Users main menu and right click on the user account menu that is to be edited.

Click on Edit the user and the User Account window will appear. The default position can be changed to any other position. It is necessary to ensure that at least one Trypan blue stained sample has been run on the system before switching off the Prescan feature. Error Level Displayed to Users Errors in the software and hardware will be displayed to the user in the form of an error message.

The level of error that will result in the display of an error message depends on the setting of the parameter ErrorLevelDisplayToUser in the General tab of the System Options window. For various application scenarios, Roche Diagnostics GmbH has put in three pre-settings that are adapted to a wide cell size spectrum: Min. This can be shortened depending on the Cell Type. Please consult with local Roche technical services before choosing other sedimentation times. However, it is NOT advisable for data safety reasons to modify an existing Cell Type that has been used for measurements.

A new Cell Type based on an existing Cell Type should be created instead. Page After loading a measurement Reactor ID and Sample ID and selecting an image, the selected image is displayed in the upper right-hand corner of the Live Operator window. Each single cell detected by Cedex HiRes Analyzer is marked as dead red circle or living green circle.

Since dying cells of different cell lines absorb Trypan Blue differently, dead cells can be variably stained. Page This parameter determines when an image will not be analyzed, i. The use of the sliders, especially in combination, can lead to unexpected results.



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