Operator’s Manual – OPTI CCA-TS2
4-1
4 CALIBRATION AND QUALITY CONTROL
4 CALIBRATION AND QUALITY CONTROL
4.1 Calibration
Each lot of OPTI cassettes is calibrated during the manufacturing process.
The calibration is
performed using high precision standard solutions and gravimetrically-prepared gas mixtures
to determine the cassette’s measurement characteristics at multiple points within the analyte’s
measurable range. Every cassette package is then labeled with a bar code containing this
calibration information, as well as its lot number and expiration date.
Prior to running a sample, the cassette bar code is either entered manually or scanned into the
analyzer by holding the cassette package in front of a conveniently located bar code scanner.
The cassette is then installed and a calibration verification is performed according to the method
described in Section 9.3 for each cassette style. In addition, an optical zero-point calibration of all
optical channels is performed.
During the calibration and measurement processes, diagnostic tests are automatically performed
to assure correct operation of the instrument and measurement of the cassette. These tests
include automatic checks of the cassette for packaging integrity, temperature control, fluidic
control during calibration, proper equilibrium behavior of the sensors during calibration and
measurement, automatic detection of bubbles and short sample during aspiration, and automatic
detection of low gas, low battery, dirty optics, or worn pump conditions.
Calibration of the tHb channel is required every 3 months. This calibration is performed using
the tHb Calibration Cassette in a manner similar to other instruments that measure tHb and/
or hemoglobin derivatives optically. The tHb calibration verifies the measurement optics and
electronics and corrects any potential drift.
For more information, including detailed instructions, on the tHb calibration, see Section 7.3
“Quarterly Maintenance” in this manual.