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 during motion and non-motion conditions. 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
30
Element
Louisville, Colorado, United States
Verification of saturation accuracy during motion and non-motion conditions
Saturation accuracy in a diverse subject population over a specified saturation range during motion and non-motion conditions. The acceptance criteria for the Nellcor™ Pro 7 Pulse Oximetry PCBA are as follows: The acceptance criteria for SpO2 during motion and non-motion conditions across the saturation range of 70-100%: Motion: SpO2 Max-A ±3% (ARMS) Max-N ±3% (ARMS) OxySoft-N ±3% (ARMS) Non-Motion: SpO2 SC-A ±2 % (ARMS)
Time frame: 2.5 hours
Verification of Pulse Rate during motion and non-motion conditions
The acceptance criteria for pulse rate during motion and non-motion conditions from 20-250 BPM over a specified saturation range of 70-100%: Motion: Pulse Rate Max-A ≤5% BPM (ARMS) Max-N ≤5% BPM (ARMS) OxySoft-N ≤5% BPM (ARMS) Non-Motion: Pulse Rate SC-A ≤3% BPM (ARMS)
Time frame: 2.5 hours
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