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Cedex HiRes Analyzer Addendum 2 to Operator’s Guide, Version 1.0 Software Version 2.2.1 August 2012 For life science research only. Not for use in diagnostic procedures.
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Germany If you have any further questions regarding this matter, please do not hesitate to contact your Roche Diagnostics representative. To call, write, fax, or email us, visit the Roche Applied Science home page, http://www.roche-applied-science.com and select your home country.
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Cedex HiRes Analyzer Addendum 1 to Operator’s Guide, Version 1.0 Software Version 2.2.1 January 2012 For life science research only. Not for use in diagnostic procedures.
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Cedex HiRes Analyzer Operator’s Guide Please read the following information, which updates information given in the Cedex HiRes Analyzer Operator’s Guide Dear valued user of the Cedex HiRes Analyzer This addendum includes: c Updated information about the procedure for removal, reinstallation or replacement of the syringe. If you have any further questions regarding this matter, please do not hesitate to contact our Technical Services Department at your best convenience.
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Cedex HiRes System. After removal, reinstallation or replacement of the syringe, a calibration check of the Cedex HiRes System must also be performed. Use Cedex Density Reference Standard Beads to check the calibration and confirm that the FlowFactor is correct. If necessary, adjust the FlowFactor.
Connecting or disconnecting the device ........................26 Connecting Hardware Components ........................27 Completing the Windows Mini-setup ........................27 Installing Cedex HiRes Software 2.2 or Updating to Cedex HiRes Software 2.2 .......28 Installing the Cedex HiRes Software 2.2 ........................28 4.1.1. Setting the Cedex Server to Autostart ........................32 Starting up the Software ..............................33...
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Tracking of Status of Events Carried out by the Analyzer ..................44 Preparing the Analyzer for Measurements ......................45 Switching on ..................................45 Logging in at the Computer Operating System Level ..................45 Starting the Cedex HiRes Software 2.2 ........................45 Performing a HW Startup and Prime ..........................46 Preparing the Reagent Kit .............................. 47 2.5.1.
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Table of Contents Software Using the Measurement Results Window ......................67 Result Data area .................................68 Sample Parameters and Processing Parameters areas ..................69 Image Area ................................... 70 1.3.1. Viewing Individual Cell Images ............................. 70 1.3.2. Viewing a Cell Image Using the Image View Window ..................71 1.3.3.
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7.5.6. Deleting an existing Cell Type .............................114 7.5.7. Working with the Live Operator..........................115 7.5.8. Description of the Individual Operator Parameters ....................117 Archiving Data .................................119 7.6.1. Archive ....................................119 7.6.2. Restore ....................................120 7.6.3. Deleting Archived Data ..............................120 Cedex HiRes Analyzer Operator’s Guide...
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8.3.2. Tracking SST Checkpoints without Measurements ..................141 Locking – Unlocking the System ..........................142 Troubleshooting Diagnosis of the Cedex HiRes Analyzer ......................143 Trace and Logging ............................... 144 The System Audit Trail File ............................. 144 Appendix System Options und User Preferences ......................145...
Questions or comments regarding the contents of this Operator’s Guide can be directed to your local Roche Diagnostics representative. Every effort has been made to ensure that all the information contained in the Cedex HiRes System Operator’s Guide is correct at the time of printing.
The warranty conditions are specifi ed in the sales contract. Contact your Roche Diagnostics representative for further information. Any unauthorized modifi cation of the Cedex HiRes Analyzer and/or the Cedex HiRes Software will result in invalidity of the guarantee and service contract.
Software to achieve the intended results, and for its installation and subsequent use. If Licensee is not willing to be bound by the terms and conditions of this Agreement, the Software package must be promptly returned to Roche (“Supplier”) with a copy of the receipt against refunding of the purchase price for this Software.
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Licensee may not sublicense, assign or transfer the license or the Software, in whole or in part, except as expressly provided in this Agreement. Any attempt otherwise to sublicense, assign or transfer any of the rights, duties or obligations hereunder is void. Cedex HiRes Analyzer Operator’s Guide...
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Software License Agreement 7. Intellectual Property Rights Licensee shall only hold those rights to the Software that are expressly described in Section 2 of this Agreement. Any other rights with regard to the Software, including without limitation, ownership rights and patent, copyright, trademark, trade secret and other intellectual property rights, shall remain the sole property of Supplier.
Preamble Preamble Before setting up operation of the Cedex HiRes Analyzer, it is important to read this Operator’s Guide thoroughly and completely. Non-observance of the instructions contained herein or performing an operation not stated in this Operator’s Guide could involve safety hazards.
FCC Notifi cation Symbols In this Operator’s Guide the following symbols are used as visual signals: Symbol Heading Description WARNING This symbol is used to indicate that non-compliance with instructions or procedures could lead to physical injury or even death or could cause damage to the system.
For best performance it is recommended to keep the analyzer permanently on and only shut down the software application on a regular basis. The Cedex HiRes Analyzer should only be used with the supplied or specifi ed devices (Cedex HiRes Analyzer, Cedex HiRes Software, monitor, computer, Multi Sampler, Reagent Tray).
Disposal of the Analyzer Ensure that the Trypan Blue solution is free of contamination, otherwise fi lter prior to use. Roche Diagnostics GmbH recommends the use of the Cedex HiRes Reagent Kit. Secure your measurement data. If the system has been upgraded from some previous version to Software version 2.2, it is possible that some default settings in the System Options may have slightly different values than those described in this manual.
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 – from the staining of the samples to the recording and evaluation of the image data – are automatically performed by the analyzer.
Description of the Cedex HiRes System Description of the Cedex HiRes System The Cedex HiRes System consists of two functional units, the Analyzer (see Figure 1) and the Control Unit (computer equipped with Cedex HiRes Software 2.2). Preparation and processing of the samples takes place in the analyzer. The analysis software is installed on a computer and controls the analyzer, as well as the analysis and evaluation of the images obtained.
The Measurement Procedure The Measurement Procedure The determination of the number of viable cells (cells/ml) and viability of cell suspensions (the percentage of viable cells from the total cell sample) is a fully automated, standardized procedure based on the manual Trypan Blue Exclusion Method.
The analysis software and its graphical user interface ( GUI), known as the Cedex Control Center, enables the user to work with Cedex HiRes Analyzer. The image analysis software (Operator) recognizes structures and identifi es particles, thus differentiating cells from cell debris and dirt particles. Live and dead cells are differentiated according to their degree of Trypan Blue staining.
Technical Specifi cations of the Analyzer Technical Specifi cations of the Analyzer Cedex HiRes Analyzer Method of measurement Digital image and pattern recognition Trypan Blue Exclusion Method Viable/dead cell differentiation Detectable cell concentration range 5 × 10 – 1 × 10 cells per ml 2 µm –...
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Technical Specifi cations of the Analyzer Hardware Requirements for the Cedex HiRes Control Unit Computer x86-Architecture, Intel Pentium IV minimum 2 GHz required, 3 GHz recommended ® Operating system Windows XP Professional Minimum 1 GB RAM Hard-disk storage 100 MB free hard-disk storage for installation of application.
The service technician will check the software information, perform a focus adjustment and ensure that the Cedex HiRes System 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 accounts for the operating system. The system administrator is also responsible for ensuring data safety and security of the system.
Injury from heavy loads The Cedex HiRes Analyzer weight is 29 kg. (63.8 lbs). No attempt should be made by the user to remove or set up the instrument alone. You may injury your hands, fi ngers, or back when putting the analyzer in place.
Completing the Windows Mini-setup When starting the Cedex HiRes Control Unit for the very fi rst time, a Windows mini-setup may run. The setup allows the user tweak the fi nal settings of the new system (e.g., selection of time zone, keyboard etc.). The mini-setup dialogs should be self-explanatory.
Installing Cedex HiRes Software 2.2 or Updating to Cedex HiRes Software 2.2 The Cedex HiRes Software 2.2 is pre-installed on the computer delivered with the Cedex HiRes System. This chapter provides instructions for installing the Cedex HiRes Software 2.2, should it be required. In addition, instructions are provided for updating older Cedex HiRes Software 2 versions to Cedex HiRes Software 2.2.
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Installing Cedex HiRes Software 2.2 or Updating to Cedex HiRes Software 2.2 Installing the Cedex HiRes Software 2.2 If an older Cedex HiRes Software version 2.x is installed on the computer, the confi rmation dialog shown in Figure 4 will not appear. Instead, the following window will appear:...
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Installing Cedex HiRes Software 2.2 or Updating to Cedex HiRes Software 2.2 Installing the Cedex HiRes Software 2.2 The Installations Settings window will appear. Select Cedex Server and Cedex Client, then click on Next. Figure 10 In the Installation Folder window (shown below), choose the folder recommended by the program. Ensure that the option Install Cedex 2.2 for Everyone is selected, then click on Next.
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To continue with the installation, certain actions must be carried out in this window: 1) a password for the Database User must be entered, 2) the serial number of the Cedex HiRes Analyzer must be entered, and 3) the system settings must be verifi ed.
Installing Cedex HiRes Software 2.2 or Updating to Cedex HiRes Software 2.2 Installing the Cedex HiRes Software 2.2 After installation of the software, the Installation Complete window will appear. Click on Close to confi rm. Figure 16 The Setup Succeeded window will appear if the installation was completed successful. Confi rm with OK.
Open the Diagnosis window via the Setup menu of the Cedex Control Center and verify the confi guration of the system. For a Cedex HiRes Analyzer with Multi Sampler there must be a module ASXPort (or AS20Port if the Multi Sampler was confi gured for AS20 mode).
Updating to Cedex HiRes Software 2.2 Make sure that you have created a backup of the Cedex HiRes Database and that you have fully read and understood the following instructions before proceeding with the update of the Cedex HiRes Software! If an error occurs or if you do something wrong, this could result in data loss and/or could prevent the Cedex HiRes Software 2.2 from operating!
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After the update of the Firebird database software has fi nished, the following main dialog will appear: Figure 21 If an older Cedex HiRes Software version 2.x is not installed on the computer, the confi rmation dialog shown in Figure 21 will not appear. Instead the following dialog will appear:...
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Installing Cedex HiRes Software 2.2 or Updating to Cedex HiRes Software 2.2 Updating Older Cedex HiRes Software version 2.x to Cedex HiRes Software 2.2 In the next window, check that the source directory/database fi le and destination (backup) directory settings are correct.
The Cedex HiRes Software version 2 installation is now updated to version 2.2. 4.3.3. Restoring a Cedex HiRes Software 2 Backup This procedure should only be carried out in case a failure occurs during installation of the Cedex HiRes Software 2.2 update as described in “Updating to Cedex HiRes Software 2.2”.
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Installing Cedex HiRes Software 2.2 or Updating to Cedex HiRes Software 2.2 Updating Older Cedex HiRes Software version 2.x to Cedex HiRes Software 2.2 Carry out the following steps to restore the Cedex HiRes Software 2 backup that was created in step step 7 in the chapter “Updating to Cedex HiRes Software...
■ Starting the Cedex HiRes System after Installation The hardware components of the Cedex HiRes System must be switched on before the analysis software can be started, otherwise the software will not be properly initialized. After the initial installation, switch on the individual devices in the order given below: Switch on the Cedex HiRes Analyzer.
Cedex Server icon on the desktop. Start the Cedex HiRes Software 2.2 by double clicking the Cedex Client icon on the desk top (the Cedex Server must be successfully launched before the Cedex Client can be started). The Log In window of the Cedex HiRes System will open.
Overview of the Cedex Control Center Menu Bar Operation Overview of the Cedex Control Center The Cedex Control Center is divided into three elements: Menu bar Shortcuts area Event window detailing status of events carried out by the analyzer A description of the individual areas is given below (see Figure 37): Figure 37: The Cedex Control Center Menu Bar The menu bar at the top of the Control Center has 7 menu items:...
Data Exchange: Data can be imported or exported from the database of one system to the database of another system using these windows. Archiving: Data from the database can be archived or restored in these windows. Cedex HiRes Analyzer Operator’s Guide...
User and Rights Management: The Administrator can create new users and administer their rights in this window. Diagnosis: At the request of local Roche technical services, a diagnosis of the entire system can be run with the options listed in this window.
If, for example, a cleaning routine is run, the completion of the routine will be noted in this window. Previous events can be looked at by using the scroll bar on the right. The window is cleared each time the software is shut down. Cedex HiRes Analyzer Operator’s Guide...
■ The user may be prompted to create a new password the fi rst time the Cedex HiRes Software 2.2 is started. This serves the purpose of replacing the temporary password given to the user by the Administrator when the user account was created.
Both the HW Startup and the Prime functions are located in the same window. Follow the instructions below to perform a HW Startup and Prime: Click on the HWM button in the Cedex HiRes Control Center or else select Hardware Management under the Functions menu. The Hardware Management window will open.
Shutdown and HW Shutdown”). Open the Reagent Kit chamber in Cedex HiRes Analyzer by pushing the front upwards until it clicks into place (see Figure 38, below). Remove the old Reagent Kit with the tray and dispose of the old reagent bottles if necessary.
Set Full button or Empty button, in the case of waste, in the Reagent Kit Status window (see Figure 39). If you are using your own reagents, it may be necessary to fi lter them before use. Roche Diagnostics GmbH recommends using the Cedex HiRes Reagent Kit.
Fill distilled or de-ionized water in the water container to the required level (see label). Fill 0.2% Trypan Blue solution in the Trypan Blue container to the required level (see label). Roche Diagnostics GmbH 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).
The measurement procedure can only begin when the steps above have been completed. Perform a HW Startup and Prime prior to the fi rst measurement if the Liquid and Hardware Management system were previously shut down (see “Performing a HW Startup and Prime”). Cedex HiRes Analyzer Operator’s Guide...
Dilutions that are an automatic part of the measurement process in the analyzer are already taken into account by the Cedex HiRes Software. The calculations are carried out automatically and have nothing to do with the entered dilutions.
“Working with the Multi Sampler”). In the case of single measurements run via the Measurement window on a Cedex HiRes System with a Multi Sampler attached, the software will auto matically incrementally increase the sample cup position number with each new measurement. The cup position can also be fi xed (see “Turning off automatic...
Transfer the selected volume of a well-mixed cell suspension to a clean Cedex Sample Cup. The Cedex HiRes Analyzer tolerates volume variations of +/- 10%. Any greater variation in sample volume will lead to inaccurate results, and the Reagent Control monitor will no longer function correctly.
Image area (see “Image Area”). Figure 41: Cedex HiRes Analyzer Measurement window with the fi nal results The measurement results can be directly printed out via the Print button in the middle of the measurement window.
Cedex Sample Cup has been attached for the next measurement. If the Cedex HiRes Analyzer is to be shut down after a set of measurements, or at the end of the day, the complete Liquid Management system should be cleaned with an LM Shutdown procedure to maximize the life- span of the Cedex HiRes Analyzer and guarantee optimal performance.
Multi Sampler. The Multi Sampler is part of the Cedex HiRes Analyzer (see Figure 42 and Figure 43). The Multi Sampler can convey up to 20 cell suspension samples in sequence to the Cedex HiRes System for analysis. Once the samples have been loaded in the Multi Sample Tray and the analysis parameters for each sample have been set, the samples are automatically delivered to the Cedex HiRes System and analyzed.
The Multi Sampler DefaultCup Sampling probe Multi Sample Tray Figure 43: Cedex HiRes Analyzer including Multi Sampler The Multi Sampler DefaultCup The position of the Cedex Sample Cup used for the Prime, LM Shutdown, calibration and cleaning routines is called the DefaultCup. This sample cup does not differ from the usual Cedex Sample Cups. The standard (de- fault) position for the DefaultCup is position 1 of the Multi Sample Tray.
Hardware Management to render the tray ejectable again (see “Carrying out an LM Shutdown and HW Shutdown”). In some cases it may be necessary to restart the Cedex HiRes Software 2.2 and Analyzer. Cedex HiRes Analyzer Operator’s Guide...
Working with the Multi Sampler Carrying out Measurements with the Multi Sampler 4.2.3. Performing a Prime The Prime and HW Startup are performed as usual in the Liquid Management window as described in “Performing a HW Startup and Prime”. An empty Cedex Sample Cup must be placed in the DefaultCup position (default position 1) of the Multi Sample Tray when running a Prime.
Images taken of the sample are displayed in the upper right-hand corner of the Multi Run window during the measurement. In addition, results for Total Cell Concentration, Viable Cell Concentration and Viability are displayed in the upper left-hand corner of the Multi Run window during and after a measurement has fi nished. Cedex HiRes Analyzer Operator’s Guide...
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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.
In addition, sample rows containing fi nished measurements (status: done) can be cleared and prepared for a new measurement by double-clicking in the Status fi eld of the row with the fi nished measurement. Sample data for a measurement cannot be modifi ed after that measurement has begun. Cedex HiRes Analyzer Operator’s Guide...
Working with the Multi Sampler Disruption of Measurements 4.3.5. Modifying Data Entry, Changing Samples Information about the operation and process parameters for samples that have not yet been analyzed can be modifi ed during the run. To modify information of measurements that are in active or schedule mode but have not yet been started, do the following: Double-click on the Status fi...
Working with the Multi Sampler Results Results After a Multi Run has fi nished, the results for all measurements obtained by the Cedex HiRes System are stored and displayed as described in “Using the Measurement List”. In addition, some results for the measurements carried out are displayed in the Analyzed Measurements fi...
Carrying out an LM Shutdown and HW Shutdown Switching off the Cedex HiRes Analyzer Switching off the Cedex HiRes Analyzer should always be carried out in the following order: Carry out an LM Shutdown. Shut down the analysis software (optional, see note below regarding the use of the scheduler).
Switching off the Cedex HiRes Analyzer Shutting down the Control Center Logging out To log out of the Cedex Control Center, select Logout under the System menu or click on the Logout button in the Cedex Control Center. If an LM Shutdown has not yet been carried out, the message, “Do you really want to log out without performing an LM Shutdown?”, will appear.
Using the Measurement Results Window Software Using the Measurement Results Window Measurement results are displayed in the Measurement window (see Figure 49). 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.
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. Cedex HiRes Analyzer Operator’s Guide...
Using the Measurement Results Window Sample Parameters and Processing Parameters areas In addition, the Result Data area for the individual images has an Excluded column next to the image number. Images that could lead to incorrect measurement results during analysis, e.g. due to impurities or large bubbles, are automatically recognized as invalid and excluded from evaluation by the analysis software.
Viewing Individual Cell Images The Cedex HiRes Software 2.2 enables a close view of a single image or an enlarged display for evaluation. 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 user can thus get a sense of how cell shapes and clusters have been evaluated by the software. The Cedex HiRes Software 2.2 offers various options for optimizing measurement results by adjusting the Operator used for the image analysis. Thus, the image analysis Operator can be adjusted for abnormal cell culture images or for specifi...
Should stripy shadows or lines appear on the images, a new focus adjustment needs to be run as poor image quality can affect the results of the measurement (see “Automatic Adjustment and Alignment Verifi cation”). Cedex HiRes Analyzer Operator’s Guide...
Using the Measurement Results Window Image Area 1.3.4. Viewing the Prescan Image During a measurement, a so-called Prescan is carried out before the cells are scanned. The entire fl ow chamber is scanned in order to identify impurities and bubbles that may infl uence the measurement. 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.
Other results, such as Average Diameter or Compactness, can be added for display in the result list of the Measurement List window via the User Preferences (see “Adjusting Result Display in the Measurement List and Multi Run windows”). Figure 54: Measurement List window with the option Show measurement results selected Cedex HiRes Analyzer Operator’s Guide...
Using the Measurement List Searching for measurements A number of actions can be carried out in the Measurements List window including searching for measurements using a variety of fi lters, viewing measurement sample and process parameters, viewing measurement results, printing reports, exporting measurements to a fi le and reprocessing measurements (see “The Reprocess Button”).
Editing Existing Analysis Results/ Data Sets The Cedex HiRes Software 2.2 allows for existing measurement results or data sets to be modifi ed and reprocessed. These changes are done on existing software data (image and analysis results) and, therefore, do not require any adjustments to the analyzer.
Editing Existing Analysis Results/Data Sets Effective Data Sets Effective Data Sets When measurements are reprocessed, it is possible to label one of the resultant data sets as Effective. 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.
Graphical Display of the Analysis Results In addition to displaying the overall analysis values, the Cedex HiRes Software 2.2 can also display graphic diagrams of the results. These diagrams can be viewed after the analysis is fi nished by clicking on the Diagrams button in the Result Data area of the Measurement window.
Aggregate Histogram Aggregate Histogram The Cedex HiRes Analyzer offers an evaluation of aggregates in cell cultures. Clusters of up to 15 cells are displayed. Click on the Aggregate Histogram button in the Histograms window to open the corresponding histogram window.
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Figure 57 shows, for example, that 188 cells of the measurement are found in aggregates of two cells. Figure 57: The Aggregate Histogram, total view (sum of living and dead cells), here: number of cells Cedex HiRes Analyzer Operator’s Guide...
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 58. Figure 58: The Aggregate Histogram, total view (sum of living and dead cells), Here: percentage Cell Diameter Histogram Clicking on the Cell Diameter Histogram button will bring up the Cell Diameter Histogram.
Cell Diameter or Object Diameter histograms can be saved for future reference. In addition, default intervals can be automatically set for all measurements via the User Preferences (see “Specifying Default Measurement Parameters”). Cedex HiRes Analyzer Operator’s Guide...
Graphical Display of the Analysis Results Compactness Histogram Compactness Histogram The ratio between the cell circumference and the cell area is based on an ideal sphere (4 ), which is equivalent to the value >1< on the abscissa of the Cell Compactness Histogram. The extent of variation between the cell shapes and an ideal sphere is refl...
Area”). 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. Cedex HiRes Analyzer Operator’s Guide...
Cultivation Time Chart Creating a CTC View Cultivation Time Chart In the Cultivation Time Chart ( cultivation progress/ result diagram), the growth patterns of cell cultures can be graphically evaluated. It is also possible to export and print out the data. The CTC Views window required for creating a Cultivation Time Chart can be opened by clicking on the CTC button in the Shortcuts area of the Cedex Control Center or by selecting the Cultivation Time Chart option in the Measurements menu.
This area is used for creating, editing, viewing and deleting measurement series for a particular View. In order add to or modify specifi c measurement series for a particular View, that View must be highlighted in the View area. Cedex HiRes Analyzer Operator’s Guide...
Cultivation Time Chart Creating a CTC View 5.1.3. Adding Measurements to a View Do the following to fi nd and select measurements for a new View or for a View that has already been created: Highlight the View to be modifi ed in the View area of the CTC Views window and click on the New button on the right-hand side of the Series belonging to the selected view area.
Measurements area in the lower left-hand corner. 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. Figure 65: Series List window Cedex HiRes Analyzer Operator’s Guide...
Cultivation Time Chart Creating a Cultivation Time Chart 5.1.6. Deleting Views and Series Entire Views can be deleted by highlighting the View and clicking on the Delete button in the View area of the CTC Views 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.
Also, the graphic representation can be enlarged or scaled down again with the use of the mouse (see “Enlarging the Diagrams”). Cedex HiRes Analyzer Operator’s Guide...
Cultivation Time Chart Creating a Cultivation Time Chart 5.2.2. 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...
Exponential Regression window. 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. Cedex HiRes Analyzer Operator’s Guide...
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. These functions allow for easy and user-friendly operations with the Control Center, although some functions may only be available to the Administrator (see “Administrator...
Click on the Export Selected Data button. A message window will appear to confi rm successful export of information. Click on OK. ■ The measurement data can then be viewed in the fi le created. Figure 69: The Export window Cedex HiRes Analyzer Operator’s Guide...
General Functions of the System Data Exchange Data Exchange The Data Exchange function allows for the exchange of measurement data between different Cedex Software 2.2 Databases (DBs). The user can export selected data from one Cedex Software 2.2 DB and import it into another. 6.2.1.
The Audit Trail fi le data can never be overwritten. This ensures that all recorded, analyzed and modifi ed measurement data is documented (see “The System Audit Trail File”). Cedex HiRes Analyzer Operator’s Guide...
General Functions of the System User Preferences User Preferences The User Preferences window is located under the Master Data drop-down fi le menu in the Cedex Control Center (see Figure 71, below). A logged-in user with specifi c access rights to the User Preferences option can set preferences for a number of elements including the result parameters to be displayed in the Multi Run result list and Measurement List window and default measurement parameters for carrying out measurements.
CTC Views Default Filter: Create or alter default parameters for the fi lter settings in the CTC Views window. Audit Trail Default Filter: Create or alter default parameters for the fi lter settings in the Audit Trail window. Cedex HiRes Analyzer Operator’s Guide...
General Functions of the System Changing own Password 6.4.4. 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. If analysis results from a specifi c workarea are to be viewed, the appropriate workarea needs to be chosen from the drop-down list in the Measurement List window.
“must change on fi rst login” is selected, the user will be forced to change the password the fi rst time he or she logs into the Control Center. Restart the Cedex Software 2.2 application. ■ A user is only authorized to carry out measurements after he has been assigned at least one work area. Cedex HiRes Analyzer Operator’s Guide...
Administrator Functions Administration of User Accounts 7.1.2. Assigning Access Rights The user is normally denied access rights to certain areas, e.g., administration of user accounts and sensitive system functions (focus adjustment etc.). The user, therefore, cannot access all of the menus on the Control Center after login.
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. Cedex HiRes Analyzer Operator’s Guide...
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. Access to the System Options should be restricted to the Administrator, Superuser and Support. All options necessary for a user to modify his workplace according to his needs can be found under User Preferences.
Administrator Functions Password Management Password Management The Cedex HiRes Software 2.2 has been equipped with a detailed password management that is compliant with CFR 21 Part 11 guidelines. 7.2.1. Specifying Password Characteristics Password settings can be specifi ed and changed in the User Rights Management window. The following password settings can be confi...
Administrator Functions Assigning Work Areas 7.2.2. Assigning New Passwords Follow the instructions below: Click on User and Rights management, and the User Rights Management window will appear. 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.
Preferences” in the Appendix for a detailed description of all of the System Options. The Cedex HiRes Software 2.2 may need to be restarted in order for changes in the System Options to take effect. All elements in the System Options that have not been explicitly described in this Operator’s Guide must not be changed without prior arrangement with Roche Diagnostics GmbH.
Administrator Functions The System Options 7.4.2. Modifying the Standard Setting for the Multi Sampler DefaultCup The default setting for the Multi Sampler DefaultCup (Cedex Sample Cup used for Prime, LM ShutDown, focus calibration and all cleaning routines) is position 1 on the Multi Sample tray. The default position can be changed to any other position.
If the Prescan should be enabled again, re-enter 1 in the Value column of the parameter MeasurementPrescan- Required. The Cedex HiRes Software 2.2 requires one Prescan image to optimize the image brightness. 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.
Administrator Functions The System Options 7.4.5. 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.
The Cell Type (operator) selected for a measurement takes care of the image evaluation. For various application scenarios, Roche Diagnostics GmbH has put in three pre-settings that are adapted to a wide cell size spectrum: Min. Size for small cells with a diameter of about 6 µm, e.g. lymphocytes, default sedimentation time is 90 seconds.
Administrator Functions Adjustment of the Image Analysis using the Live Operator 7.5.1. Description of the Cell Type List and Live Operator The Live Operator window, in which Cell Types can be created and modifi ed, is accessed in two ways: Via the Measurement window in the View mode Via the Cell Type List option in the Master Data menu on the Control Center.
The default value for the Sedimentation Duration is 90 or 45 seconds, depending on the Cell Type. This can be shortened depending on the Cell Type. Please consult with local Roche technical services before choosing other sedimentation times. Roche support will provide instructions for optimizing sedimentation times for specifi...
Administrator Functions Adjustment of the Image Analysis using the Live Operator 7.5.4. Editing an Existing Cell Type An existing Cell Type can be modifi ed. 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.
All parameters of the measurements are logged. Deleted Cell Types have no infl uence on future measurements, but the parameters of deleted Cell Types used for past measurements will still be appear in the printed reports of those measurements. Figure 74: Cell Type window Cedex HiRes Analyzer Operator’s Guide...
Administrator Functions Adjustment of the Image Analysis using the Live Operator 7.5.7. Working with the Live Operator The Live Operator window can be opened via the Cell Type List window, the Cell Type window and the Measurement window. If the Live Operator button in a Measurement window containing specifi c results is clicked on, the Live Operator will open with the images of that measurement already loaded.
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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).
Administrator Functions Adjustment of the Image Analysis using the Live Operator 7.5.8. Description of the Individual Operator Parameters Classifi cationBias Range: [-20, 20], Default: 0, Unit: [absolute value]. This parameter infl uences the classifi cation behavior of viable and dead cells. Since dying cells of different cell lines absorb Trypan Blue differently, dead cells can be variably stained.
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This parameter determines when an image will not be analyzed, i.e. the size (diameter in micrometer) that an object (e.g. dirt or bubbles) must have for an image to no longer be analyzed is given here. The use of the sliders, especially in combination, can lead to unexpected results. Cedex HiRes Analyzer Operator’s Guide...
Measurement data must be secured at regular intervals and thereafter deleted from the Measurement List in order to ensure enough storage capacity on the Cedex HiRes Control Unit. All data from a single or a set of measurements, or optionally only the images, can be deleted from the database once the measurement or measurements have been archived.
7.6.3. Deleting Archived Data Only data that has been archived can be deleted from the Cedex HiRes System Database. Archived data still located in the database can be searched for and displayed in the upper right-hand corner of the Measurement List window.
Run a focus adjustment of the analyzer every month or after any change of position or vibration of the measurement system. In order to ensure that the Cedex HiRes Analyzer is fully operational, an Intensive Clean must be carried out once per week even if the system is not in use for measurements.
Prime or LM Shutdown is run (e.g. the hardware is shut down in the evening before a scheduled Prime is to be performed in the morning). Prime and LM Shutdown can only be executed if the Hardware Management is active. Cedex HiRes Analyzer Operator’s Guide...
Daily and Manual Maintenance and Cleaning Routines Checking the Reagent Containers when Manually Refi lling Daily and Manual Maintenance and Cleaning Routines The following cleaning and maintenance routines should be carried out on a regular basis or whenever necessary. Checking the Reagent Containers when Manually Refi lling Empty reagent containers lead to wrong measurement results and can cause a dry run, thereby damaging the syringe and the 8-way valve.
Cleaning Routines Carried out by the Liquid Management The Liquid Management plays a key role in the Cedex HiRes Analyzer. It is necessary to Prime the system at the beginning of the day, and to carry out an LM Shutdown prior to shut down of the system in the evening (see “Carrying out an LM Shutdown and HW...
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Daily and Manual Maintenance and Cleaning Routines Cleaning Routines Carried out by the Liquid Management Standard Clean (with cleaning solution, detergent, and distilled water for approx. 90 seconds) The entire Liquid Management system is rinsed with distilled water, cleaning solution, detergent and fi nally with distilled water again.
Prime and LM Shutdown can be executed in this window. Prime and LM Shutdown can be executed in this window. An LM Shutdown must be carried out after the last measurement has been run and before shutting down the Cedex HiRes Software 2.2. The Liquid Management system is then prepared for an extended pause, i.e. overnight or weekend.
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Daily and Manual Maintenance and Cleaning Routines Scanning the Chamber to Verify the Effectiveness of Cleaning Routines The Current area displays the scanned image. Since the fl ow chamber is represented as a whole, it is necessary to enlarge single regions (especially the inlet and outlet) with the help of the zoom function in order to be able to effectively check the chamber.
The service technician will carry out a focus adjustment before the initial operation of the Cedex HiRes Analyzer. The focus adjustment is always necessary after the Analyzer has been moved. Additionally, we recommend running a focus adjustment once per month for control purposes.
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The focus position automatically set for the four corner areas (optimal position) must lie between 850 and 1250. Otherwise, an authorized service technician must re-adjust the Cedex HiRes Analyzer. Another important value is the allowed maximum difference between the optimal focus values of the four corner areas. The focus difference must be between 0 and 20.
Remove the bottom screw that connects the plunger to the syringe module with the other hand. Remove the syringe from the syringe module. ■ Figure 82: Syringe Maintenance window Cedex HiRes Analyzer Operator’s Guide...
Put the protective cover back on with the use of a philips head screwdriver. Turn the screws 90 degrees clockwise to lock the screw. ■ Never use the Cedex HiRes Analyzer without the protective cover on the Multi Sampler and Syringe Module. Maintenance and Care...
The syringe guide and spindle are mounted on either side of the syringe module inside the casing (see Figure 84). They should be lubricated half-yearly (or, when necessary, more often, e.g. if conspicuous noise comes from the syringe guide) with the lubricant supplied by your local Roche representative to guarantee optimal performance of the syringe.
An arrangement for a maintenance contract with your local Roche representative is recommended. During maintenance, worn-out and defective components are replaced and the functioning of Cedex HiRes Analyzer checked. Only an authorized service technician is permitted to carry out maintenance when the Cedex HiRes Analyzer needs to be opened! Operational Data The Cedex HiRes System keeps track of some operational data including operating hours, number of measurements and liquid consumption.
The System Suitability Test ( SST) To ensure proper operation of the Cedex HiRes Analyzer and valid analysis results, it is essential that the system is in good condition. The majority of the critical parameters are regulated by design or preventive maintenance activities carried out by local Roche technical services.
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In general, the Target Value is determined before the SST checkpoint is activated. For further information on the procedure for the determination of a target value, Roche technical services provides appropriate recommendations. It is necessary to re-determine the target value if a new container of Control Beads is used.
Click on Save to store the change. ■ Measurements that are run despite the fact that not all SST procedures are up to date or valid will have no check-mark in the SST Valid box in the Measurement window. Cedex HiRes Analyzer Operator’s Guide...
The System Suitability Test (SST) Performing an SST Performing an SST All procedures related to the System Suitability Test can be controlled via the System Suitability Test List. To access the list, open the Functions menu in the Control Center and click on SST or directly click on the SST button in the Control Center.
Figure 85: System Suitability Test List window On some systems, an inactive list of proposed SST checkpoints may automatically be provided in the System Suitability Test List window. Check with the Administrator to see if these SST checkpoints should be activated. Cedex HiRes Analyzer Operator’s Guide...
The System Suitability Test (SST) Tracking Trends in SST Results over Time Tracking Trends in SST Results over Time The results of SST checkpoints can be tracked over time using the SST Trending button. Trends for both checkpoints with and without measurements can be tracked. 8.3.1.
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Clicking on the normalized view checkbox will normalize the results to the target value and display the differences in percent. Both the mean curve and the moving average curve can be shown or hidden by selecting or de-selecting the appropriate checkboxes. Cedex HiRes Analyzer Operator’s Guide...
The System Suitability Test (SST) Tracking Trends in SST Results over Time 8.3.2. Tracking SST Checkpoints without Measurements To see results from SST checkpoints without measurements over time, do the following: Select the SST checkpoint to be monitored by clicking on the fi...
System is fully usable until system re- SSTLock, checks validity of SST checkpoints (which SSTManualUnlock or is done at an interval of 300 sec.) MeasurementLock Table 3: Manually settable system status Figure 89: System Status window Cedex HiRes Analyzer Operator’s Guide...
Di agnosis of the Cedex HiRes Analyzer For technical support purposes, the user is able to run a diagnosis of the Cedex HiRes Analyzer at the request of an authorized service technician. The diagnosis of the System provides a fi le containing information about the System software and hardware.
The System Audit Trail File All user-initiated activities, as well as important actions carried out by the Cedex HiRes Software 2.2, are recorded in the Audit Trail fi le. The system also logs all errors in the audit trail, including information from the error message.
Sys tem Options und User Preferences The following list provides a description of all of the Systems Options that can be found in the Cedex HiRes Software 2.2 via the Systems Options window found under the Setup menu of the Cedex Control Center.
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Flow Factor, adjustable with the use of the Density Standard Reference Beads. HistogramBarWidth The width of the histogram bars InnovatisCertifi cate Innovatis AG Specifi cation of the certifi cate to be used for inspection Test of the license. Cedex HiRes Analyzer Operator’s Guide...
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Maximum acceptable delay (in seconds) between the Delay end of the sedimentation phase and the beginning of the main scan in the case of the Cedex HiRes Analyzer. The user is warned if the time interval is exceeded. Measurement Maximum acceptable time delay during a critical CriticalTime measurement phase (i.e.
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Measurement Use of the Prescan in the case of the Cedex HiRes PrescanRequired System (0: don’t run, 1: run). ObjectDiameter (0) (0) (0) divider settings for use in the object diameter histogram ×...
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ChamberHeight Height of the measurement chamber. Do not change this parameter without consulting with Roche technical services! ErrorLevelFor Error level at which a Multi Run will be automatically BatchStopping interrupted. (1: only fatal, 2: also critical, 3: also error, 4:...
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Settings in the section “Tracing“: Option Value Description Save last value DeleteTraces Number of days after which the tracefi les are deleted OlderThan TraceOutputPath C:\Cedex2\Logs\ Default fi le name for the trace fi le. CedexTrace.txt Cedex HiRes Analyzer Operator’s Guide...
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System Options und User Preferences Settings in the section “Logging“: Option Value Description Save last value DeleteLogs Number of days after which the logfi les are deleted OlderThan LogOutputPath C:\Cedex2\Logs\ Default fi le name for the log fi le. CedexLog.log Settings in the section “Series Default Filter“: Option Value...
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FocusFinderMinZ (not adjustable) Minimum focus position increments for the focus adjustment. SaveAutomatic Determines whether the images should be stored with AlignmentImages the automatic adjustment in the database (0: don’t save, 1: save). Cedex HiRes Analyzer Operator’s Guide...
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System Options und User Preferences Settings in the section “Report Settings“: Option Value Description Save last value Audit Trail Report standard The name of the report template for report type Template "Audit Trail" Automatic Align- standard The name of the report template for report type ment Adjustment "Automatic Alignment Adjustment"...
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External XML fi le name FileName Example.xml ExternalXML C:\Import External XML input directory ImportPath ExternalXML English External XML report's language ID ReportLanguage Name ExternalXML list External XML report's template name Report TemplateName Magic Magic The application connection authentication string Cedex HiRes Analyzer Operator’s Guide...
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Ordering Information Index Compact Histogram ..........83 Container volume ............123 8-way-valve ...............133 Control Beads ............134 Control Center .............41, 93 Control Unit ..............25 Access control ............40 Copyright ..............10 Access Rights ..........40, 101, 103 Count For Passing ......... 135, 137 Adiministrator password ........
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Live Operator parameters ......115, 117 LM Shutdown ............65, 121 Location of the Analyzer ......... 26 Locking the System ..........142 Lock Level ..............109 Log .................. 91 Logging ...............144 Log In ................45 Log Out................66 LogOutputPath ............144 Cedex HiRes Analyzer Operator’s Guide...
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Index Index Reactor ID ..............51 Target Value ............. 135, 137 Reagent containers .........48, 123 Total Conc..............68 Reagent Kit ..............49 Total Object Count ............ 68 Reagent Kit Status ............ 42 Trace ................144 Reagents ............... 49 TraceOutputPath ............144 Refi...
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Index Cedex HiRes Analyzer Operator’s Guide...
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