Protocol for Controlled Desaturation Tests for Non-Invasive Pulse Oximeter Performance Testing

Abstract

To prove that the investigational pulse oximeter device is accurate also on low oxygen saturation levels, the testing must be done on human beings since there are no reference materials to ensure correct operation. The ISO standard 80601-2-61:2019 Particular requirements for basic safety and essential performance of pulse oximeter equipment offers the option to measure the accuracy of the investigational pulse oximeter by comparing the readings to a secondary standard pulse oximeter equipment. This non-invasive protocol erases the need for arterial cannulation, which is unpleasant for the subject, needs specific medical and laboratory competence and itself involves risks for adverse events. This study protocol enabled a fluent, non-invasive execution of desaturation measurements for pulse oximeter performance testing.