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 a 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 steadystate 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
Medtronic Clinical Physiology Lab
Denver, Colorado, United States
Verification of Saturation Accuracy
Verification of Saturation Accuracy Saturation accuracy in a diverse subject population over a specified saturation range. The acceptance criteria for SpO2 during low saturation conditions across the saturation range of 60-80%: SpO2 Max-A ±3% (ARMS) Max-N ±3% (ARMS) OxySoft-N ±3% (ARMS) Max-Fast ±3%(ARMS)
Time frame: 2.5 hours
Acceptance criteria for SpO2 accuracy across the saturation range of 70-100%:
Verification of Saturation Accuracy Saturation accuracy in a diverse subject population over a specified saturation range. The acceptance criteria for SpO2 during saturation conditions across the saturation range of 70-100%: SpO2 Max-A ±2% (ARMS) Max-N ±2% (ARMS) OxySoft-N ±2% (ARMS) Max-Fast ±2%(ARMS)
Time frame: 2.5 hours
Acceptance criteria for pulse rate accuracy within 20-250 BPM
Pulse rate accuracy Max-A \<=3 BPM (ARMS) Max-N \<=3 BPM (ARMS) OxySoft-N \<=3 BPM (ARMS) Max-Fast \<=3 BPM(ARMS)
Time frame: 2.5 hours
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