Knowledge Nuggets Miniseries 1 · Episode 4
Calibration
Why calibration is necessary for medical devices and which guidelines, measures, and procedures should be observed.
3 min
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Transcript
Transcript of the original English audio.
Welcome to another Knowledge Nugget. Today's focus will be on calibration requirements when handling a CORTEX device. The content of today's clip includes the purpose of calibrating a system, classifying calibration into different types, and lastly the processing steps for successful calibration.
Calibration in metrology is a standard measuring process that determines and documents the deviation of gas readings in a measuring device. Thus, calibration is a process of regulating those values periodically. We have to perform calibration so we can expose the sensors to a gas of known concentration in order to adjust and correct any drifts of the values, ensuring precise measurements this way.
Calibration in CORTEX devices is classified into a one-point and a two-point calibration. Both calibrations look at the linear relationship between a defined gas concentration and the measured gas signal that is collected from the sensor. The one-point calibration lasts less than one minute, and the two-point calibration only two minutes.
The one-point calibration is called sensor adjustment in our software and uses fresh ambient air to ensure its validity. As described earlier, this step is repeated before each test. The two-point calibration consists of two steps: sampling of the ambient air and sampling of the medical gas. By reading these two values, we check for any potential drifts of the sensor. Two-point calibration is performed once a month.
Moreover, the calibration of the reusable turbine is mandatory to ensure accurate flow and volume data. It is performed before every test with the help of a 3-liter calibration pump; five successful strokes need to be completed. This is not necessary when using a disposable turbine, since these are pre-calibrated during manufacturing.
To sum it up, calibration is necessary for medical devices, where reliability and validity are vital across different occupations in medicine, exercise and sports. Standardized guidelines and actions must be followed when conducting calibration in order to achieve high measurement accuracy through reliable gas and volume sensors. Thank you for joining.
Additions in [square brackets] are editorial. CPET and spirometry support clinical judgment; they do not replace it.
