Elitech FreezePoint 6000 Series User Manual page 133

Installation, Operation, and Performance Qualification
Setting the Instrument
1. Setting the Instrument Zero using water
Purpose: Linearization and fixing of instrument's ZERO-point
Method:
A. Choose calibration from the measurement menu.
B. Perform the measuring as described as described on the touchscreen and/or the User's Manual.
C. Depending on the selection in Quality Assurance Preset the user has to run one, two or three
D. Continues with First Standard Calibration after all required measurements were successful.
2. Setting the Instrument CAL1 using a calibration solution
Purpose: Linearization and fixing of instrument's CAL1-point
Method:
A. Choose the osmolality of the standard by pressing the << or >> button until the osmolality of the
B. Perform the measuring as described as described on the touchscreen and/or the User's Manual.
C. Depending on the selection in Quality Assurance Preset the user has to run one, two or three
D. Continues with Second Standard Calibration after all required measurements were successful.
3. Setting the Instrument CAL2 using a calibration solution (depending on the selection in Quality
Assurance Preset optional or obligatory)
Purpose: Linearization and fixing of instrument's CAL2-point
Method:
A. Choose the osmolality of the standard by pressing the << or >> button until the osmolality of the
B. Perform the measuring as described as described on the touchscreen and/or the User's Manual.
C. Depending on the selection in Quality Assurance Preset the user has to run one, two or three
4. Apply calibration values.
Purpose: Finalize calibration
Method:
A. If necessary deselect individual results to prevent that outliers distort calibration.
B. Apply to calibration or retry.
5. Verification Procedure - Check of Precision*
Purpose: Verification of precision at calibrated points.
Method: In case of verification fails at one step, re-calibration should be performed first!
A. Choose measurement from measurement menu.
B. Verification of Instruments Zero-Point:
C. Verification of Instruments CAL1:
passes to confirm the result.
standard is displayed.
passes to confirm the result.
standard is displayed.
passes to confirm the result.
Perform 5 measurements with distilled water.
Compute mean value and standard deviation.
Compare the standard deviation (SD) with the specified repeatability of the device at this point.
If the mean value exceeds the repeatability specification at zero (0), the calibration needs to be
repeated.("Precision (within run repeatability)" on page 126).
Perform 10 measurements with the previously used calibration solution for CAL1.
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