OPTIMedical OPTI CCA-TS, Руководство оператора, Страница: 72 / 271

Operator’s Manual – OPTI CCA-TS 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’s bar code is 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 using a precision gas mixture and the cassette’s internal
storage buffer, in a manner similar to other combined blood gas / ion analyzers.
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 HbCal options, see Section 6.3 “Quarterly Maintenance” in this manual.
4.2 QC Overview
The intent of a Quality Control program is to assure reliable patient values over the clinically
significant ranges for all the measured parameters. The program should involve the total process
of specimen collection, preparation and results analysis, reporting and interpretation, and the
training of personnel involved in all of these processes.
A Quality Control program for blood gas analysis includes the analysis of materials with known
values or ranges of expected values and the comparisons of the results from the analyzer with
these values. This program allows the analytic performance of a laboratory to be evaluated and
documented.
An effective Quality Control program should include:
• evaluation of precision over the entire analytical range
• an assessment of failure modes and their effects and means of management, throughout the
process