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In contrast, the DRSB provide a traceable and highly exact check of one concentration, for adjustment of multiple systems. The exact concentration is not certified. The device-specific target value must be determined for each bottle and Cedex HiRes Analyzer before use.", "Country": "XG", "Code": "Background Information", "Name": "Background Information" }, { "Language": "en", "Value": "Composition of the Cedex Control BeadsCedex HiRes Control Beads are made of agarose.DiameterThe average diameter for the Cedex HiRes Control Beads is approximately 10 -14 μm, but the size can vary from 8 to over 40 μm.Obtaining Certificates of Analysis (CoA)CoAs can be downloaded at:technical-support.roche.comorinstructions.roche.com​​​​​​​To download the CoA, you will need the catalog number and lot number.Differences between Control Beads and Density Reference Standard BeadsDensity Reference Standard Beads (DRSBs) are used to verify instrument function within specification and to calibrate all Cedex Systems. DRSBs are measured the same way by all Cedex Systems, allowing for a calibration and for comparison of results between Cedex HiRes Systems. The average from replicate measurements (10, in the case of the Cedex HiRes System) should match the actual concentration for the DRSBs listed on the bottle label (expressed as particle number/ml) to within +/- 5%, when the instructions in the package insert have been used.DRSBs are used to determine whether the system is measuring accurately. Cedex HiRes Control Beads alone cannot be used for this purpose. Control Beads are different from DRSBs in one important way: Unlike DRSBs, due to slight variations in hardware from system to system, measurement results using a single bottle of Control Beads can differ slightly when measurements are carried out with different Cedex Analyzers. Therefore, bottles of Control Beads that have not been used before must be calibrated with respect to the certified nominal value.The 'device-specific target value' must be determined for each bottle of Control Beads and each analyzer. The device-specific target value is calculated by taking the mean of 10 measurements that have been carried out on the same Cedex Analyzer for which the Control Beads will be used. The device-specific target value is used as the benchmark (100%) for the evaluation of measurements carried out with that specific bottle of Control Beads. Before determining the device-specific target value for a new bottle of Control Beads, a system verification must first be performed using DRSBs.Using Control Beads instead of Density Reference Standard Beads to verify calibrationControl Beads cannot be used to ensure that systems are correctly calibrated. Density Reference Standard Beads (DRSBs) must be used to ensure that systems are properly calibrated and that the flow factor is correctly adjusted before the device-specific target value is determined for a bottle of Cedex HiRes Control Beads and unique Cedex HiRes System.", "Country": "XG", "Code": "Background Information - Help Corner", "Name": "Background Information - Help Corner" }, { "Language": "en", "Value": "Storage conditions

• Store at +2°C to +8°C. Stable until the expiration date printed on the label.
• Do not freeze!
• Keep bottle closed when not in use.

How to use this product

The Control Beads must be at +23 to +27°C before a sample can be used. Control Beads must always be stored in, and directly taken from, the original bottle. They cannot be put into another container. Before removing a sample, the Control Bead solution must be thoroughly mixed. Turn the bottle upside down and shake for two minutes. The bottle should then be rolled on a table for half a minute. A record of every sample drawn from the bottle should be kept by marking the container with the amount drawn. A bottle can be used until 5 ml of the solution remains in the bottle.

Recommended Cell Type Settings when performing blank checks and measuring Cedex HiRes Control Beads on the Cedex HiRes System

The following procedure is described in the Instructions for Use for the Cedex HiRes Control Beads. For best results, perform a blank check of the system with distilled, deionized, PCR grade water before measuring the Cedex HiRes Control Beads. For performing blank checks on the Cedex HiRes System, it is best to set the Cell Type to Min. Size. Doing this ensures that the blank check determines the level of cleanliness in the chamber by checking for small particles. It is important to ensure that all visible particles in the flow chamber are identified. Please note that the Cell Type Std. Size (and not Min. Size) should be used when performing measurements with the Cedex HiRes Control Beads. The size of the Control Beads ranges from 8μm up to 40 μm. The protocol for measuring the Control Beads is optimized using the parameter settings for the Cell Type Std. Size.
", "Country": "XG", "Code": "Protocols - Help Corner", "Name": "Protocols - Help Corner" }, { "Language": "en", "Value": "Unit of measure is \"piece\".", "Country": "XG", "Code": "CB - Order Information", "Name": "CB - Order Information" }, { "Language": "en", "Value": "Cedex HiRes Control Beads are used for carrying out System Suitability Tests (SST) on the Cedex HiRes Analyzer.", "Country": "XG", "Code": "Applications", "Name": "Applications" }, { "Language": "en", "Value": "

Vial / bottle	Label	Function / description	Content
1	Cedex HiRes Control Beads 5 × 105/mL	Beads in 20% ethanol (vol).	1 bottle, 30 mL

", "Country": "XG", "Code": "Content", "Name": "Content" }, { "Language": "en", "Value": "Regular use of Cedex Control Beads allows for monitoring trends in measurement results and permanent documentation of the system integrity. The entire linearity can be checked with Cedex Control Beads using three measurement points to confirm that a system is measuring consistently. Routine monitoring of the Cedex HiRes Analyzer allows for early initiation of counter-measures, such as thorough cleaning of the system as soon as minor deviations occur.", "Country": "XG", "Code": "Product Description", "Name": "Product Description" }, { "Language": "en", "Value": "Designed for use with Cedex HiRes Analyzer.
Low concentration", "Country": "XG", "Code": "Properties", "Name": "Properties" } ] } } ] }