This is a single arm study where healthy volunteers were subjected to a controlled desaturation protocol to ascertain if the investigational device could correctly track changes in oxygen saturation.

A subject rests comfortably on a hospital bed, so that they do not have to move during the desaturation process.

The subject wears the altitude simulator head bivy and breathes freely without any oxygen regulation. During the measurement, the time in low O2 saturation plateaus is limited to ten minutes in each desaturation plateau.

They are monitored with ECG, clinical pulse oximeter, EtCO2 from non-invasive capnography with nasal cannulas and periodically non-invasive blood pressure. The monitoring is supervised by two medical doctors, present during the entire duration of the study.

Accuracy as measured by Root Mean Square Error should be less than or equal to 4% for SpO2 as per ISO 80601-2-61:2019. It is calculated from the difference of the SpO2 measured from the investigational device and that of the reference device.

Accuracy as measured by Mean Absolute Error should be less than or equal to 4% for SpO2 as per ISO 80601-2-61:2019. It is calculated from the difference of the SpO2 measured from the investigational device and that of the reference device.

To validate the accuracy of Vitacam interbeat intervals, both the intervals and heart rate variability metrics derived from these intervals, will be compared to the RR intervals and heart rate variability metrics derived from a 5-lead ECG