COBAS 6000 new 2.pptx

clinical chemistry cobas machine details

1. COBAS 6000

2. COBAS 6000 - OVERVIEW sampler e601 c501

3. Manual start-up To manually start up the analyzer Switch on the operation power switch, located on the left side of the rack sampler unit.

4. Cont. Switch on each power switch of the computer, printer, and monitor. The analyzer starts the initialization routine (time for c 501 , e 601 , and control unit approximately 12 min). While the analyzer is performing initialization the Log-on screen is displayed. Enter your Operator ID logon and Password to log on. Choose OK to gain access to the software and begin operation. When initialization is completed, the analyzer goes into standby.

5. Calibration What is calibration? Calibration is the process that establishes a relation between measurement values (such as absorbance values or ECL signals) and the corresponding results (concentration of an analyte). Automatic calibration T he relation between measurement values and results is subject to various environment and reagent conditions and may drift in the course of time. Therefore it is necessary to repeat calibrations regularly. To keep the resulting calibration management simple and efficient, the system automatically recommends calibrations.

6. Cont. Validation of calibration After a calibration is performed, it needs to be validated. The system performs this task through automatic calibration checks. Whenever it detects an irregular condition or result, the calibration is classified as failed, a calibration alarm is issued, and the system recommends that calibration be repeated.

7. Cont. Calibration masking If a calibration fails one or more quality criteria applied in the validation process, tests should no longer be performed with the affected reagent. This is achieved automatically by means of the auto masking function.

8. Causes For Automatic Calibration Automatic calibration at start-up of the analyzer. Manual calibration of a group of applications by selection of the Start Up button. Automatic calibration recommendation at change of reagents (Changeover calibration) Automatic calibration recommendation without reagent change: Calibration at regular intervals (Timeout) Calibration in combination with Preventive action Calibration due to QC out of range (QC-triggered calibration) Automatic recommendation for recalibration when a calibration failed (Failed)

9. Cont. Start-up calibration: With this function you can select a predefined set of tests that are calibrated when you order a start-up calibration manually. Changeover calibration: Calibrations also have to be performed when the following events occur: A change in reagent lot (of COBAS c packs or COBAS e packs) takes place. At installation of a new test on the system

10. Cont. Time-out: Calibrations are performed at regular intervals to compensate for changes over time in reagents and in the measurement systems. Timeout calibrations can be performed for lot or cassette calibration. QC-triggered calibration (QC Violation): Calibration recommendation will be initiated if the QC results are outside the confidence limit.

11. Requesting calibration and QC The Calibration and QC Select button on the System Overview screen turns yellow when a calibration or quality control is recommended by the system. Choose the Calibration and QC Select button to display the Calibration and QC Select window. Use the Calibration and QC Select window to perform following actions: Accept the recommended calibrations or quality controls.

12. To request a routine sample Choose Workplace > Test Selection . Select the sample type . Only the available tests for the corresponding sample type are displayed in the test matrix. Select the Routine option from the Sample area on the top left of the Test Selection screen. Type in the sequence number for the sample in the Sequence No. text box and press <Enter>. The cursor moves to the Sample ID box. Type in the sample ID of the sample in the Sample ID box and press <Enter>.

13. Cont. Select this check box if the sample has already been diluted and press <Enter>. The cursor moves to the Sample Cup box on its own. Select the sample container type and press <Enter>. The cursor moves to the Sample Volume / Dilution box. Select the necessary dilution , if any, for the sample and press <Enter>. The cursor moves to the test key matrix . Select the test, combination of tests or test profiles for the sample. Selected tests and profile keys appear white. Choose Save to save the test selection.

14. Quality Control Regularly perform QC measurements to continually monitor the instrument performance. The following QC methods are available on a Cobas 6000 system: Individual (intra-day) QC cumulative (long-term) QC real-time QC.

15. System implementations for QC measurements In addition to the QC methods explained above, there are six types of implementations which are available to manage the measurement of QC samples: Routine QC Stand by reagent QC Timeout QC Automatic QC QC after calibration Manual QC

16. Cont. Routine QC Each test has one or more controls assigned to it. Routine QC contains all activated tests of all installed controls. You can request a QC measurement for all of these tests—for example, at the beginning of a work shift—with one single command ( System Overview > Calibration and QC Select > Routine QC ) Stand by reagent QC QC measurements can be requested individually for stand by reagents. Stand by reagents are Cobas c packs and Cobas e packs already on board but not in use at present.

17. Cont. Timeout QC QC measurements can be performed at predefined (test-specific) time intervals. When the time interval has elapsed, the system issues a recommendation for a QC measurement. Automatic QC It is possible to keep frequently used controls in the rack rotor—ready to be used any time before or during routine operation. Thus, in combination with Timeout QC, the system is able to perform QC measurements without any intervention by the operator.

18. Cont. Manual QC This function allows to measure QCs of any activated test for the corresponding control whenever needed.