CELL-DYN
®
3200 System Operator’s Manual
6-5
9140181H—October 2001
Section 6 Calibration Procedures
Calibration Materials
WARNING: Potential Biohazard. Consider all specimens and reagents,
controls, calibrators, etc., that contain human blood or serum as potentially
infectious. Wear gloves, lab coats, and safety glasses, and follow other
biosafety practices as specified in the OSHA Bloodborne Pathogen Rule
(29 CFR Part 1910.1030) or other equivalent biosafety procedures.
Three types of calibration materials can be used to calibrate the CELL-DYN 3200:
• CELL-DYN 22 Calibrator (List Number: 99120-01) or
CELL-DYN HemCal
™
Calibrator (List Number: 01H61-01)
CELL-DYN Calibrator may be used to calibrate the Open and Closed
Modes. The same Calibrator used to calibrate should also be used to confirm
calibration.
• Fresh Whole Blood
Fresh whole blood may be used to calibrate the Open and Closed Modes.
The Auto-Cal method uses one sample to calibrate compared to the Enter
Factor method which uses five samples. Reference values are obtained by
running the sample(s) on a reference instrument, using acceptable reference
methodology, and calculating the mean reference value for each parameter.
The same sample(s) used to calibrate should also be used to confirm
calibration.
•Latex
Latex is used to calibrate the Optical Bench. This calibration is verified by
an Abbott representative during installation of the instrument.
Instrument Logbook
Create a logbook for the instrument. This logbook should contain all necessary
calibration documentation and other information that is pertinent to your
instrument. Suggested sections that you may wish to include in the logbook are:
• Installation documentation
• Laboratory’s operating procedure
• Quality control
• Calibration
• Maintenance
• Reagent lot number changes
• Troubleshooting
• Problem resolution
• Service calls
• Software upgrades
This logbook should be stored near the instrument and be accessible to all operators
and Abbott Service Personnel.
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