The verification of an investigational pulse oximetry board to verify pulse rate and saturation accuracy over a specified saturation range in diverse populations.
To verify the SpO2 and pulse rate accuracy in comparison to reference-standard blood measurements. To achieve paired observations of SpO2 and SaO2 values over the specified SpO2 accuracy range of the prototype pulse oximeter on a group of healthy adult volunteers. The fraction of inspired oxygen (FiO2) delivered to test subjects is varied to achieve a series of targeted steady-state saturation periods. In this study, the investigational pulse oximetry PCBA system saturation measurements will be compared to saturation measurements made by a multi-wavelength CO-oximeter, taken from arterial blood samples from a diverse pool of healthy human subjects.
Study Type
OBSERVATIONAL
Enrollment
28
Element
Louisville, Colorado, United States
Verification of Saturation Accuracy
Saturation accuracy in a diverse subject population over a specified saturation range. The acceptance criteria for the investigational Pulse Oximetry PCBA system, SpO2 across the saturation range of 70-100%: SpO2 Max-A ±2% (ARMS) OxySoft-N ±2% (ARMS) Max-Fast ±2% (ARMS) FlexMax ±2.5%(ARMS) DS-100A ±3% (ARMS) D-YS ±3% (ARMS)
Time frame: 2.5 hours
Verification of Pulse Rate
Pulse rate in a diverse subject population over a specified saturation range. The acceptance criteria for pulse rate from 20-250 BPM over a specified saturation range of 70-100%: Pulse Rate Max-A ≤3% BPM (ARMS) OxySoft-N ≤3% BPM (ARMS) Max-Fast ≤3% BPM (ARMS) FlexMax ≤3% BPM (ARMS) DS-100A ≤3% BPM (ARMS) D-YS ≤3% BPM (ARMS)
Time frame: 2.5 hours
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