METROLOGICAL SUPPORT OF PULSE OXIMETERS

Abstract

The experience of the International Medical Device Regulators Forum in the use of products for oxygen therapy based on the study of guidelines, international and European regulations on medical devices is considered. Emphasis is placed on issues related to the metrological support of pulse oximeters. The global situation with the pandemic increases the relevance of selected topics. Continuous monitoring of blood oxygen saturation is one of the most important elements in the diagnosis and treatment of COVID-19. Despite the fact that the use of pulse oximeters does not require special medical knowledge, calibration and special maintenance, it is still necessary to control their reliability and accuracy of measurement. The study of pulse oximeter MD300M in accordance with the requirements of DSTU 8893:2019 "Metrology. Pulse oximeters. Calibration Method” 2020. Analysis of MD300M pulse oximeter calibration results revealed that this pulse oximeter was calibrated by the saturation and pulse measurement channel, as the maximum deviation of the measured saturation value from the pulse oximeter calibration measure does not exceed the pulse oximeter measurement documentation specified in the operating documentation. The discreteness of the MD300M pulse oximeter and the discreteness of the reference device MPPO-2, which are specified in the passports for the respective devices, have the greatest influence on the measurement uncertainty.