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[ { "Language": "en", "Value": "
Cedex Bio HT Analyzer  
1 cycle = 10.6 sec  
", "Country": "XG", "Code": "Typical run time", "Name": "Typical run time" }, { "Language": "en", "Value": "Test Ranges Cedex Bio HT Analyzer
For information about the ranges of the various tests, please refer to the relevant Instructions for Use for the test. In addition, the document \"Cedex Bio/Cedex Bio HT Analyzer tests\", located on the CustomBiotech Cedex Bio HT Analyzer product page under the download section Table: Cedex tests product details:  https://custombiotech.roche.com/global/en/products/instruments/cedex-bio-ht-ins-3590.html", "Country": "XG", "Code": "Detection range", "Name": "Detection range" }, { "Language": "en", "Value": "Number of measurement points taken by the instrument
The instrument works in cycles, with one cycle lasting 10.6 seconds. In each cycle, a pre-defined series of events takes place that includes exchanging cuvettes, pipetting, and absorbance measurements. For most applications that use absorbance photometer measurements, the maximum number of instrument cycles is 71. Therefore, 12.5 min is the maximum time-to-result for most absorbance photometer measurements (71 x 10.6 s = 752.6 s = 12.5 min). However, some applications that use absorbance photometer measurements require a long measurement mode that has a maximum number of instrument cycles of 140.

The time-to-result for each test depends on the last cycle, which is used for the result calculation (the \"calc. last\" value provided in the Instructions for Use of each test application). To calculate the results, the instrument uses absorbance measurements obtained at \"calc. first\" cycle, when the reaction starts, and \"calc. last\" cycle. Both \"calc. first\" and \"calc. last\" cycles are listed in the Instructions for Use of each test.


Length of time to generate a measurement result
The length of time required to generate a test result depends on the test.
  • ISE tests take approximately 2 - 3 minutes.
  • In the case of absorbance tests, the duration of a single measurement can be calculated by the last instrument cycle used for calculation (see the Instructions for Use of a specific test application for information about the respective \"calc. last\") multiplied by the time one cycle requires (10.6 seconds):
    • [\"calc last\" x 10.6 sec ] = time-to-result in seconds
The calculated time only applies for a single test. If a sample is tested for several parameters, or several samples are measured, the instrument must coordinate different measurements and pipetting steps. After the first result is generated, subsequent test results may be generated every cycle (10.6 secs) or after several cycles. Therefore, it is not possible to calculate exactly how long it will take to generate all results from multiple test requests.

Types of tubes or sample cups to use
The following tube and sample cup types are predefined for the instrument:
  • COBAS cup
  • Eppendorf cup
  • Sarstedt 5 mL
  • Sarstedt 5.5 mL
  • Sarstedt 7.5 mL
  • Vacutainer 7 mL
  • Vacutainer 10 mL
Each rack must be configured for a specific tube type or sample cup type. It is not possible to mix different tube or sample cup types on one rack.

Dead volume required for Eppendorf tubes and COBAS cups
For Eppendorf tubes and COBAS cups, a dead volume of 80 μL is recommended.

Preparing the Activator Bio, storage and stability on board
Before use, thaw one vial overnight at +2 to +8°C, or for one hour at +15 to +25°C. Mix the content of a vial of Activator Bio thoroughly (e.g., using a vortex mixer), avoiding generation of air bubbles. Remove the cap and place original vial containing the Activator solution in the Activator position of the ISE rack. Insert the rack into the analyzer, and start the maintenance procedure.
The vial can be used on the analyzer for 4 days, after which it will be marked as expired by the analyzer software.

Adding standby calibrations
It may be helpful to create a standby calibration for test cassettes with a set calibration type (i.e., single cassettes that must be calibrated before use), or for test cassettes from a new lot. A test cassette can be calibrated immediately after loading it on board, even if an already calibrated cassette for the same test is on board. The new calibration will be called a \"standby calibration\", and the new test cassette can be used by the instrument as soon as the previous cassette is empty. The standby calibration will be switched to the valid calibration for this test as soon as the previous cassette is empty. This way the instrument will switch automatically to the new set of cassettes without any delay or blocking of orders. To add a standby calibration for an additional test cassette, please refer to the Cedex Bio HT Analyzer User Training Guide.
It is possible create standby calibrations for additional cassettes placed on board for the same test. Follow the instructions in the Cedex Bio HT Analyzer User Training Guide to create a standby calibration for each additional cassette. Note that the standby calibration of one cassette must be completed before the next standby calibration can be ordered.
Each cassette has its own unique serial number in addition to the lot number; this allows the system to assign a specific calibration result to a specific cassette.

Performing a Lot calibration
A Lot calibration can only be created when the test application is predefined as Lot calibration type. In addition, some tests also require a calibration after a certain interval has elapsed. To see whether a test application has been defined as a Lot calibration, as well as whether a time interval has also been assigned for the test calibration, please refer to the relevant Instructions for Use. Once a valid Lot calibration has been created for a particular lot, the newly created calibration will apply to all reagent cassettes from the same lot as long as the reagent cassettes from that lot are used within the defined interval, if an interval also applies.

Ordering and starting a quality control (QC) measurement while the calibration is still in progress
It is possible to order and start a QC measurement for a test while the calibration for that test is being processed. The analyzer starts pipetting the QC measurement immediately after pipetting all reactions for the calibration. As soon as the calibration result is accepted, the QC result will be displayed. Roche recommends placing the calibrations and controls in the cooled sample slot on the instrument.

Assigning \"QC after Cal\" for controls
Roche recommends performing a quality control (QC) after each calibration to check the calibration curve created. When assigning a control to a test, ensure that the option \"QC after Cal\" has been chosen for the assigned controls.

Frequency of quality control (QC) checks
Roche recommends performing a quality control after each calibration to check the calibration curve created. All other control recommendations are indicated in the Instructions for Use for the relevant test. Further QC checks must be defined by each lab according to their own criteria, including the individual lab preferences and requirements.

Performing a test immediately after a valid calibration has been created
Tests can be performed immediately after a valid calibration for the relevant test has been created. If a control is not measured at all, the test will still be valid and samples can be run. If a control is measured and did not meet the acceptance criteria, all sample results will be flagged until the control is measured and meets the acceptance criteria.

Acceptable deviation for quality control checks
Roche recommends starting with a three-fold of the value of the standard deviation, 1s, defined in the relevant lot-specific Instructions for Use for the control. However, each lab must determine the appropriate values according to local preferences or requirements.
  • In the Accuracy control mode, any control measurement outside the permissible deviation will be flagged (>ACC RNG) and should be repeated.
  • The Precision and Limit control modes are not recommended.

Volume of calibrators and controls used during calibration and QC checks
In the case of a two-point calibration, the instrument must determine the absorbance of two different concentrations: the calibrator and water. Both measurements are performed in duplicate. Therefore, for a two-point calibration, the instrument requires two times the volume that is required for a sample measurement. For most tests that means <10 μL. The exact sample volume required for a specific test application is provided in the relevant Instructions for Use.

IgG Bio HT, Ig Fab Bio HT, Mouse IgG Bio HT, Sodium Bio HT and Acetate V2 Bio HT are is currently the Cedex Bio HT tests that do not use a two-point calibration.Instead, they use a calibration curve consisting of different calibrator concentrations. The calibrator dilutions required to generate the different concentrations for the calibration curve are produced by the instrument on board during the calibration. The required volume for the calibration of IgG Bio HT is, therefore, much higher compared to the two-point calibrations. In the case of the IgG Bio HT, the volume required also depends on the number of applications to be calibrated (e.g., all three IgG applications IGGLB, IGGHB, IGGHD). We recommend providing 500 μL of calibrator A in the case of the IgG Bio HT calibration.

Measurement of a control requires the same volume required for a sample measurement. See the respective Instructions for Use.

Maximum dilution factor possible for sample pre-dilution
The Cedex Bio HT Analyzer is capable of precisely pre- or post- diluting samples up to 1:100. However, please note that the test applications are only validated up to the dilution factor indicated in the Instructions for Use for the relevant test.

Order of sample processing
All samples are processed from position 1 to 15 of the rack in process. When all samples of one rack are processed, the next rack on the right-hand side of the rack that just finished will be processed next using the same pattern of processing samples from positions 1 to 15.

Changing the unit in which a result is displayed
It is possible to change the unit displayed for a test. This can be done via the Configuration menu for tests. Units and conversion factors are provided in the Instructions for Use for the respective tests. After changing the unit, sample results will be changed to reflect the selected unit. Results of calibrations and controls, as well as lot-specific data for calibrators and controls, will also be updated accordingly. See the Cedex Bio HT Test Application Software Installation Guide for more information. This guide is available on the CustomBiotech homepage.

Editing or deleting an order
Order information for already created orders can be edited, for example, in order to add or remove tests from the order.Go to ORDERS > WORKLIST, then right-click on the order to be edited and select > EDIT. The order will open and can be edited. Orders can be deleted using the same menu functions. See Chapter B, Editing or deleting test orders, in the Cedex Bio HT User Training Guide for more details.

Solution 1 factor in the 2-point calibration of the ISE module
The solution 1 factor is the slope of the calibration curve. If the Solution 1 factor is not within the permissible range, the flag \"Sol 1 F Dev\" will appear.See the Cedex Bio HT Operator's Manual for recommendations about this flag.

Calibrators required for the 2-point calibration of the ISE module
The ISE module requires two calibrators for the 2-point calibration of the ISE module:
  • ISE solution 1
  • ISE solution 2
2-point calibrations are required every 5 hours by the system.

1-point calibration
After each ISE measurement, the instrument automatically performs a 1-point calibration using the Calibrator-indirect, which is on board. The slope of the calibration curve is not changed; it is just shifted (\"change of offset\").

Volume used for ISE Direct and indirect measurement mode
Measurements are done using either the indirect or the direct mode. In the case of the indirect mode, the samples, controls, and standard solutions are diluted with system water 1:6.
The dilution and mixing are performed automatically in the ISE tower.
Roche recommends using the indirect mode for most sample measurements.However, the direct mode may be more appropriate in cases of very low concentrations.
Sample volumes:
  • 20 μL (indirect mode)
  • 97 μL (direct mode)

Purpose of the activator during initialization of ISE Unit
The Activator Bio is pumped into the ISE tower and then pumped into the two fluid detectors to check that tubing and pump are in order. The activator is only used as a colored fluid during this procedure.

Maintenance of installed ISE units that are not frequently used
The most important maintenance action required for installed ISE units is replacing the ISE Reference Electrolyte and ISE Calibrator Indirect before they run dry. Note that the calibration may not be as expected on the first run when the ISE unit is not used frequently. Therefore, we recommend doing daily maintenance actions. If the ISE module is not used for a longer time, we recommend
de-installing the module. Contact your local Roche Technical Support for more information about this procedure.

Frequency of control checks for Na+ and K+
Running a quality control (QC) after a calibration is generally recommended for test applications on the Cedex Bio HT Analyzer.For the ISE module, which is calibrated each day, a QC for Na+ and K+ would need to be run every day. It may be possible with ISE applications to rely on unflagged calibrations and not run daily QC checks. However, each lab must test and determine the preferred frequency of QC checks, based on local preferences or requirements.

Acceptance criteria for Na+ and K+ calibrations performed during BOD
1) The Calibration must be without flag.
2) The slope and Sol 1 Factor should be within the following ranges:
  • Slope ranges
    • Sodium Electrode (Na+): 54 and 63.
    • Potassium Electrode (K+): 54 and 62.
  • Solution 1 Factor ranges
    • The ISE Solution 1 Factor should be normally 1 and can vary from 0.96 to 1.04.
    • The absolute range values are min. 0.9 and max. 1.1

Entering concentration information for ISE solutions 1 and 2
The concentration values for ISE solutions 1 and 2 are fixed in the software, as each lot has the same concentrations. Only the lot and expiration dates need to be entered into the software.", "Country": "XG", "Code": "Protocols - Help Corner", "Name": "Protocols - Help Corner" }, { "Language": "en", "Value": "Calibration for test application
The calibration material required for test applications varies by application.Please refer to the Instructions for Use for the relevant test application for more information about calibration material.

Quality controls for test applications
Quality controls are available for the test applications. Please refer to the Instructions for Use for the relevant test application for more information about the recommended quality controls. For quality control checks of individual tests, Roche recommends using the Accuracy control mode and a three-fold of the value of the standard deviation, 1s (i.e., 3 x 1s). However, each lab must determine the appropriate values according to local preferences or requirements. Both the 1s and 3s values are provided for individual tests in the relevant lot-specific Instructions for Use for the control.
An overview of which controls work with each test is provided in the document \"Cedex Bio/Cedex Bio HT tests\", located on the CustomBiotech Cedex Bio HT Analyzer product page under download section Table: Cedex tests product details: https://custombiotech.roche.com/global/en/products/instruments/cedex-bio-ht-ins-3590.html


 ", "Country": "XG", "Code": "Quality Control", "Name": "Quality Control" }, { "Language": "en", "Value": "Additional Reagents and Consumables

Reagents and ConsumablesMaterial Number
Accelerator, 100 mL06609333001
NaCl Diluent 9%, 6 x 22 mL06609406001
Activator Bio07766700001
ISE Deproteinizer Bio HT06664288001
Microcuvettes Bio HT06609392001
Waste Container Bio HT07094302001
Cleaner Acidic06455590001
ISE Sodium Electrode Bio HT06664237001
ISE Potassium Electrode Bio HT06664253001
ISE Reference Electrode Bio HT06664245001
ELECTRODE ISE DUMMY ASSY28700667001
ISE Solution 106664229001
ISE Solution 206664202001
ISE Reference Electrolyte Bio HT06664199001
ISE Calibrator Direct Bio HT06664172001
ISE Calibrator Indirect Bio HT06660797001
ISE Etcher Bio HT06664261001
Adapter Cups06455638001
Kit 96-well plate Cedex*09181687001
Rack 96-well plate Cedex*09241400001

*SW version 6.0 only", "Country": "XG", "Code": "Additional Equipment and Reagent Required", "Name": "Additional Equipment and Reagent Required" }, { "Language": "en", "Value": "The calibration curve is a flat line and quality control results are out of range
Check the contents and position of the calibrators placed on the system. It is possible that either both positions have been filled with calibrator solution or both positions have been filled with water. The correct positioning of the calibrator and water for 2-point calibrations is:  
  • Std-1: Calibrator
  • Std-2: water
 
Lot-specific control values cannot be entered in the specified fields as expected
Ensure that the regional language settings is set to \"English (United States)\" in both the Windows Operating System of the Control Unit and in the Cedex Bio HT Software. If the regional language settings are set to any other option, it may not be possible to enter control values as expected. 

Results not transmitted after sample measurement via extended HIF
Results will not be transmitted via extended HIF if the automatic action for managing the raw data is set to Delete Raw Data after accepting results. If the automatic action is configured this way, the raw data will be immediately deleted after acceptance. Accepted results, including automatically accepted results, will not be transmitted back to the host.
Do not set the automatic action for managing the raw data to Delete Raw Data after accepting results.  Instead, choose the option Delete Raw Data after and enter at least 1 day as the value.

 
Loading the Extra Wash Cycle (EWC)
The EWC for the IgG test needs to be installed manually. To install the EWC, do the following:
  1. Log in as administrator, then go to: Configuration > System > Processing > EWC
  2. Add a EWC with the following parameters: BEFORE > IGGLB > SAMPLE > CLEAN > 100 μL. Note that the NaCl and Accelerator can be loaded from the latest TAS file.
 
ISE control was blocked
The 2-point calibration of the ISE (Na+ and K+) worked. But when loading the controls afterwards, the quality control measurement did not work. A message shows \"Control not on board\".
Solution: Load the controls on the instrument while the calibration is running, not afterwards.
 
Creating a Problem Report
Click on the Message button in the main Navigation menu on the right. Choose \"Options\" and click on \"Problem Report\". Click on \"Cancel\" in the dialog box that requests a diskette. The Problem Report is created into the folder C:\\Roche\\Instrument\\Report\\zip.  If a Problem Report is requested by Roche Technical Support, send the file \"PR.zip\", which is located in that folder.
 
Pretreatment of samples
We recommend centrifuging cell samples and analyzing the supernatant. If centrifugation is omitted, metabolites, such as LDH, from the intracellular compartment may be transferred to the reaction cuvette. In such a case, the result of the measurement would reflect not only the metabolite concentration in the supernatant but also the metabolite concentration in the cells.
However, it should generally be possible for the Cedex Bio HT Analyzer to pipette cellular material if cells cannot be separated from the supernatant before analysis. In that case, we recommend performing the service action \"Deproteinize probes\" manually two times per day, in addition to the Begin of Day, in order to avoid clotting of the probe.
 
Instrument calculated a result with a negative concentration and flagged it \"< test range\"
This can occur if no analyte is present in the sample. In such a case, no absorbance is detectable, and the concentration is zero and flagged with \" < test range\".  
A negative concentration may be shown in the following circumstances:
Water almost never has an absorbance of exactly 0.000 dA. If the absorbance values of the measurement of water (per definition set to 0.0 mmol/L) is slightly higher than the absorbance values in a sample that does not contain the analyte, the concentration of the analyte in the sample would be calculated with a negative concentration. This can also occur with water during calibration.
 
The Calibration button showed \"Next Lot, Status OK\" for a test (IGGLB), although the test was NOT calibrated
When a new reagent cassette is put on board for the first time, the cassette will be shown as green in the cassette overview tab even if it does not have a valid calibration. This can occur, for example, when a new lot of a reagent cassette is put on board. However, if the reagent cassette does not yet have a valid calibration associated with it, the cassette color will turn to yellow in the software when a test that requires the newly added cassette has been ordered. The test will be blocked until a calibration is performed.
 
Barcode not easily recognized
Barcodes may occasionally not be easily recognized by the instrument. One cause could be the glossiness of the barcode label, which can cause unwanted reflections of the laser scanner.
If this occurs, try the following actions:
  • Insert the cassette racks slowly, but keep in mind that being too slow will result in a time-out.
  • The reagent slots further away from the barcode scanner are less sensitive than those closer to the barcode scanner. For the affected cassettes try using mainly reagent slots A, B, or C.
  • When inserting a cassette rack, try to tilt the rack slightly clockwise (5-10°) so that the barcode scanner does NOT read the barcode exactly at a 90° angle. After inserting a tilted reagent rack, please check the software to ensure that the cassette rack information is displayed correctly.
", "Country": "XG", "Code": "Troubleshooting - Help Corner", "Name": "Troubleshooting - Help Corner" }, { "Language": "en", "Value": "Changing the reserved positions for the reagents on the ISE Rack
The reagents are pre-assigned to specific positions on the ISE Rack; Roche recommends not changing the predefined positions. Nevertheless, these positions can be changed via Configuration > System > Lab > Reserve Positions.However, in order to change the assigned positions of the reagents, the ISE Rack must first be removed from its dedicated slot on the Cedex Bio HT Analyzer.When the ISE Rack is on board, the software will show a locked symbol for the rack and it will not be possible to change the positions of the reagents.

Wavelengths A/B listed in the Instructions for Use
The signal from two wavelengths is determined for some tests in order to correct the change in absorbance during the enzymatic reaction for a matrix background. The signal of the first wavelength, A, is the specific signal, whereas the signal from the second wavelength, B, is used to eliminate or decrease nonspecific background signals. The A/B wavelengths should not be confused with emission/extinction wavelengths of fluorescent dyes.

Indication that a sample was measured with pre- or post-dilution or was a repeated measurement
Results from repeated measurements are flagged with \">\", whereas results from diluted samples are flagged with \"v\". All result flags are shown on the results report printout (File > Print Reports > Results). However, the flag will not be printed on the \"Automatic Printout\". Therefore, we recommend not using this function in cases where the flags should be shown.

Printing calibration and QC results
It is not possible to print calibration and QC results automatically, however it is possible to print out a QC Report as follows:
  • Results > QC Tab > File > QC Report
This printout will display QC Results. Information can be selected for sorting on the printout such as, test, time span, etc.

Changing regional settings in the Configuration menu
We recommend not changing the regional settings in the Configuration menu after the analyzer has been installed.Any changes may affect data entry (for example, entry of lot-specific information), as well as the format of exported data.Ensure that the number formats are always defined as follows:
  • Use a period (\".\") as the decimal symbol.
  • Ensure that the digit grouping symbol is not a period.

Transferring and storing data
Data from the Cedex Bio HT Analyzer can be transferred and stored in two ways:
  • Printing the data: It is possible to print out and preserve all results using a printer.
  • Electronically: Archived results (File > Archive > Results) are stored on the User disk (F:\\) as .txt files. They can be transferred to other computers via USB sticks and opened with Excel. Note that the data in the .txt file can be manually changed. Alternatively, it's possible to export raw data in Excel format (via Tools > Export Raw Data).

Tracking which user is logged in at a specific date/time and has performed a measurement
It is possible to see which user has performed a measurement in the Results menu.However, it is not possible to see this information on the results printout. The printout only displays the user who printed out the document and the time of the printout. It is not possible to track which user was logged in at a specific date or time.

Time remaining for a test to be completed
The Cedex Bio HT Analyzer does not display the time remaining until a test is completed.

Indication of insufficient cuvettes or reagents on board
The Cedex Bio HT Analyzer indicates that the cuvette reservoir is running low on cuvettes by displaying a yellow cuvette sign on the system button. The analyzer behaves similarly with regard to other resources.For example, if water is running low, the water symbol is displayed in yellow.

ISE electrode stability and test frequency
The stability and exchange frequency of the electrodes does not depend on the number of tests performed. The stability only depends on the shelf life and on board stability of the electrodes.
The shelf life (expiration date) is printed on the outer packaging label; the electrode must be put on board before this date.
  • Shelf life of Na+, K+, and Reference electrodes: 9 months
  • Shelf life of Dummy electrode: 36 months
The countdown for on-board stability starts as soon as the electrode is put on board.
  • Na+ and K+ electrodes: 180 days (6 months)
  • Reference electrode: 720 days (2 years)
  • Dummy electrode: unlimited
The instrument indicates when the on-board stability is exceeded.

Saving/printing information about the history of Cleaners, ISE Solutions, Cassettes
In the Configuration function it is possible to get information about the history of Cleaners, ISE Solutions, and Cassettes that are known to the system with regard to lot numbers used and when the reagents where opened. The information is not stored additionally on the C: drive. The only way to save this data is by actively printing/saving the information from the relevant dialog box in the Configuration on a regular basis using the Print button.

Typical sample throughput for a standard working day
During a typical working day of about 8 hours, up to approximately 120 samples can be measured with approximately 8 test applications per sample.

Precision and accuracy of application tests
The precision varies from test to test. An overview of the precision, test range, and traceability is provided in the Instructions for Use for each test. Information about the recovery for each test is provided in www.custombiotech.roche.com on the relevant test product page under \"Specification\".

Performing tests without a valid calibration
It is not possible to perform a test without a valid calibration for that test. If a test is requested, the test will be blocked until a valid calibration is performed. Note that the OD Bio HT test does not have a calibrator and does not require calibration.

Definition of calibration type and interval
Calibration intervals are defined within the system in terms of hours rather than days. For example, a calibration interval of 2 days would mean that the system would calculate that the next calibration is due 48 hours after the last calibration was performed.
The calibration type and interval for a specific application test are pre-defined and imported into the software during the importation of the Test Application (TAS) file. Roche strongly recommends not changing the default settings. Information about the calibration type and intervals required for calibrations can be found in the Instructions for Use for the respective tests.
For more information about importing tests into the software, please refer to the document \"Cedex Bio HT Test Application Software Installation Guide\", available from the CustomBiotech website:
http://www.custombiotech.roche.com/home/Product_Details/INS_3590.html

Checking that a reagent cassette has a valid calibration assigned to it
A test can only be performed if the reagent cassette required for the test has a valid calibration associated with it. When a new reagent cassette is put on board for the first time, the cassette will be shown as green in the cassette overview tab even if it does not have a valid calibration. This can occur, for example, when a new lot of a reagent cassette is put on board. However, if the reagent cassette does not yet have a valid calibration associated with it, the cassette color will turn to yellow in the software when a test that requires the newly added cassette has been ordered. The test will be blocked until a calibration is performed.
To check whether a reagent cassette has a valid calibration associated with it:
  1. Check the Lot ID of the reagent cassette on board: System > Cassettes tab > double-click on the relevant cassette to see the Lot ID and expiration information.
  2. Go to Results > Calibration tab.Select the relevant test calibration. The date and Lot IDs for the calibrated cassettes and calibrator used are displayed in the columns.

Entering calibrator lot values
For two point calibrations, the following values need to be entered:
  • Std-1 = Calibrator value, provided in the Instructions for Use
  • Std-2 = 0 (water)
In the case of multiple point calibrations, such as for the IgG test application, only the value for Std-1 needs to be filled in. There is no Std-2; water is not required for this type of calibration.


Differences between the Precision and Accuracy modes for quality control measurements
The acceptance range for quality control (QC) measurements can be set in three ways (referred to as modes). The three modes are:
  • Accuracy
  • Precision
  • Limit
Each mode is characterized by one or more rules; when the rule is broken, a flag is generated on the control (QC) result.
Precision
  • Checks whether control results have violated rules according to the Shewhart procedure, commonly known as the Westgard rules, or the Rili-BÄK precision rules. Depending on the rules violated, a systematic or random error may be occurring.
  • Rules and flags: Westgard rules: R(1)2s, R10x, R(1)3s, R(2)2s, R(4s), R4(1s). Rili-BÄK: R7x, R7↓, R7↑
Accuracy
  • Checks whether control results are within a range defined by the assigned value of an assayed control and a permissible deviation.
  • Rules and flags include \"> ACC RNG\" (accuracy range exceeded).
Limit
  • Checks whether control results have exceeded either upper or lower limits. This mode is particularly designed for DAT.
  • Rules and flags include \">Up Limit\", \"<Low Limit\" (upper or lower limit exceeded)
A single control can be viewed with any combination of the precision, accuracy and limit modes, provided the appropriate definitions are made in the definition of the control.
The Precision and Limit control modes are not recommended. Roche recommends starting with the Accuracy mode using a three-fold of the value of the standard deviation, 1s, defined in the relevant lot-specific Instructions for Use for the control. However, each lab must determine the appropriate values according to local preferences or requirements. See Chapter B, Defining new calibrator and control lots, in the Cedex Bio HT User Training Guide for more information about how to enter information about the acceptance range for QC measurement.

System status when performing maintenance actions
The system must be in the standby status when maintenance actions are performed. It is not possible to do maintenance actions in operating mode or sleep status.

Cleaning the probes manually
It is possible to clean the probes manually while they remain fixed in position. The probes do not need to be completely removed from their fixed positions.See Chapter 14, Service Actions, in the Cedex Bio HT Operator's Manual for more information.

Changing the absorbance photometer halogen lamp
It is possible to change the absorbance photometer halogen lamp without the assistance of an engineer. See Chapter 14, Service Actions, in the Cedex Bio HT Operator's Manual for more information about the procedure. We recommend having a Field Service Engineer demonstrate the procedure the first time it is done.
After performing the service action \"Replace Abs. halogen lamp\", the instrument automatically performs a water/air calibration. Reagent cassettes are not affected by this maintenance action and do not have to be calibrated again.
A spark may appear when a new ABS halogen lamp is plugged in. The energy of the spark is not enough to harm you or the instrument.

Creating a Test Profile
A test profile is a named group of tests and can be created via the menus Configuration > Profiles > New. Enter a Name and Profile ID/No., which can be any unique number from 1 - 999. Add tests that should be included in the profile. See Chapter B, Creating a test profile, in the Cedex Bio HT User Training Guide for more information.

Defining different user profiles
Go to Configuration > General > User access to add new user profiles. You will be asked to enter a user name, password, and User access level (from 1-5).The right of each user access level can be configured in the next tab \"User level\". Do not delete or change the user \"RDI\".

ISE Solution 1 and Solution 2 consumption per year based on number of measurements
ISE Solution 1 and ISE Solution 2 are stable for 2 weeks on board. This means that regardless of the number of ISE measurements run on the instrument, approximately 26 bottles of ISE Solution 1 and ISE Solution 2 are required per year for the ISE Unit on the Cedex Bio HT Analyzer.

Import Orders from File function Cedex Bio HT SW version 6.0
For more details see Operator’s Manual, Software version 6.0, chapter 8 “Importing orders using Excel”
Ensure that you are using the correct Excel template for software version 6.0.Templates designed for software version 5.1 are not compatible with software version 6.0.

Order Import function in Cedex Bio HT SW version 5.1:
A new function, “Import orders from file”, has been implemented in the Cedex Bio HT SW version 5.1. The function can be found under the “Tools” menu. This function allows for a more convenient import of sample data via an Excel file. A template Excel file, “OrderImport_ExampleTemp”, that can be used to fill in order information is provided with the software and is located at:
C:\\Roche\\Instrument\\OrderImport
Ensure that you are using the correct Excel template for software version 6.0.Templates designed for software version 5.1 are not compatible with software version 6.0.
Use only this Excel template as basis for importing orders.Excel is not mandatoryfor running the order import function. The Excel template can be placed on a separate computer with Excel installed, and then edited with the required information added. Afterwards, the edited Excel template can be placed on the Cedex Bio HT Control Unit and imported directly using the function in the SW.

To use the template, first carefully read the Guideline found in “OrderImport_ExampleTemp” on how to correctly fill in the information. Then adapt the template for the desired orders. Note the following:
  • The columns are fixed in this document. Please do not change the position of the columns.
  • The first row that you can use for import data is row number 10. Do not insert rows before row number 10.
  • Ensure that the tests ordered for the samples have been loaded in the Cedex Bio HT Software. If the test ID number entered in the template does not match a test ID available in the software, the order will be marked in red and will not imported.
  • The Sample ID entered in the template must not exist in the system and must be unique in the entire file. If the Sample ID already exists in the system, the order will be marked in red and will not imported.
  • Do not leave required fields empty.
  • Rows with an empty sample ID will not be imported. You can leave empty rows.
  • Order date will be set automatically to 'today'.
Check the guidelines marked in yellow for each column within the template. Note that some columns have required fields and some are optional. Ensure that all selected test/profile IDs refer to tests installed on the system.

To prepare and load the Order Import File in the Cedex Bio HT Software:
Upload the completed excel sheet to: C:\\Roche\\Instrument\\OrderImport
  1. Tools > Import Orders from File > choose your OrderImport Excel sheet. A dialog box opens listing all samples of the chosen OrderImport Excel sheet.
  2. Press <Start>.
  3. A message appears listing which rows were imported. Rows that could not be imported are listed and marked in red in the Import Orders from File list.
  4. Press <Ok> to confirm.
The software does not provide information about why ordered rows were not accepted. If a row is not accepted, check carefully that all instructions provided in the “OrderImport_ExampleTemp” have been followed. Also, make sure that the racks and rack positions chosen for the samples are empty and that the racks are not loaded and locked on the instrument.
", "Country": "XG", "Code": "Background Information - Help Corner", "Name": "Background Information - Help Corner" }, { "Language": "en", "Value": "Use the Cedex Bio HT Analyzer for fast and reliable analysis of your bioprocess.
The instrument delivers precise results for > 30 parameters of high importance for bio-process control in process development as well as in manufacturing.", "Country": "XG", "Code": "Applications", "Name": "Applications" }, { "Language": "en", "Value": "Automated analyzer for determination of a wide range of analytes in aqueous solutions like cell culture and fermentation media.
Recommended for use in high throughput environments.", "Country": "XG", "Code": "Product Description", "Name": "Product Description" }, { "Language": "en", "Value": "The technology of the Cedex Bio Analyzer is based on photometric analysis.
The Cedex metabolite analyzers provide consistant results using Cedex Bio and Cedex Bio HT analyzers.

Test Throughput (Theoretical Max):
  • 200-400 tests/hour
Sample Types:
  • Mammalian cell culture
  • Microbial fermentation
Sample Handling:
  • Up to 90 sample tubes (six 15-sample racks). If using 96-well plate + two 15-sample racks, up to 126 samples
  • Cooled rack position for controls and calibrators
  • Automated sample dilution
  • Barcode reading via laser scanner, with immediate STAT recognition
Sample Container Types:
  • Sampling tubes: 5-10 mL; 16 x 100; 16 x 75; 13 x 100; 13 x 75 mm
  • Standard cup: 1.5 mL Micro
  • Micro cup: 650 μL
  • Cup on tube definable
Sample Volume:
  • Minimal sample volume of 100 μL for several tests
  • 2-20 μL sample consumption per test
Sample Barcode Types:
  • Code 128, Codabar, Code 2 of 5 interleaved, code 39
Reagents Onboard Capacity:
  • Up to 32 Cedex Bio HT reagent cassettes in 8 racks on-board
  • 50-800 tests per cassette
  • Cooled reagent compartment (10-15°C), on-board stability up to 3 months
  • Calibration typically once per lot
Reaction Cells:
  • Holds 1,000 disposable cuvettes with 5 mm path length and 120-240 μL reaction volume
", "Country": "XG", "Code": "Properties", "Name": "Properties" }, { "Language": "en", "Value": "Dimensions
  • 135.0 cm x 66.0 cm x 75.0 cm (W x D x H)
Weight
  • 198 kg (436 lb)
Energy Requirement
  • 100-125/200-240 volts AC, 50 or 60 Hz, consumption 1200 VA
Control Unit  
  • HP workstation running Windows 10, Intel Core i5 with 8 GB RAM
  • Dual 500 GB hard drives, DVDRW drive, Ethernet
System Interfaces 
  • RS232 serial interface for HOST connection, Ethernet for remote access
Water Requirements
  • Up to 2 liters per hour in operation mode, Type 1 NCCLS
Operating Conditions
  •  Ambient temperature: +15 to +32°C
  •  Ambient humidity: 30 to 80% (RH, without condensation)
Certification
  • CE, UL, C-UL
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Cedex Bio HT Analyzer

Bioprocess analyzer

Cedex Bio HT Analyzer
Cedex Bio HT Analyzer
Powerful and comprehensive cell culture profiling

Cedex Bio HT Analyzer - the right instrument for improved workflow efficiency
 

  • High throughput: Numerous samples can be processed simultaneously with minimal manual intervention
  • Long-term operation: Long time on-board stability of reagents and assay cal
  • Flexible dilution: Automated sample dilution capabilities save time and accuracy
  • Full automation: Online integration with automated systems to optimize measurement points and timelines
  • Enhanced flexibility with the 96-well upgrade kit

 

Discover automated sampling integration with the Flownamics Seg-Flow S3

Discover the 96-well upgrade kit for Cedex Bio HT Analyzers

 
  • Use 96-well plates or conventional racks (total capacity: up to 96 + 30 samples)
  • Monitor one or more single-use microbioreactors with direct plate transfer
  • Reduce work with an intuitive Excel® template to import sample order

View 96-well plate flyer

pharma scientists

A smart path for novel biologics

Use case by Roche Pharma Research

Finding the optimal conditions to maximize yield can be a complex and time-consuming process. Traditional process development relies on costly and labor-intensive set-ups, significantly limiting throughput and the range of experimental conditions that can be assessed. 

Scientists in Roche Pharma Research and Early Development (pRED) have adopted an alternative approach, combining single-use microbioreactors with advanced automation and analytical platforms to streamline the workflow.

For use in quality control / manufacturing process only.

Overview

Ordering Information

Technical documents

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