Hypoxia Clinical Trial
Official title:
Accuracy Validation of Belun SpO2 Pulse Oximeter FDA Submission Study
The purpose of this study is to evaluate the oxygen saturation accuracy performance of Belun Ring Oximeter placed on the index fingers during non-motion conditions
The purpose of this study is to evaluate the SpO2 accuracy performance of Belun Ring Oximeter
placed on the index fingers during non-motion conditions over the range of 70-100% SaO2,
arterial blood samples, assessed by CO-Oximetry. It is expected that the Accuracy Root Mean
Square (ARMS) performance of the oximetry system will meet the required specification of ARMS
of 3.5% or less allowed for reflectance technology in non-motion conditions for the range of
70 - 100% SaO2.
The Clinimark proprietary Desaturation Fixture with Automated Data Collection is a single
limb blow by system used to deliver medical grade oxygen and nitrogen gas mixtures to induce
various hypoxic levels in subjects at a slow steady rate allowing an automatic marking and
collection of the Control or secondary Transfer reference Pulse Oximeter and other pulse
oximetry systems at 1 second intervals.
The Control Pulse Oximeter, an FDA cleared device, is used to monitor the oxygen saturation
levels real time throughout the study for subject safety and to target stable plateaus. This
device is used to assess the stability of the data.
Multi-parameter monitor used during the study to observe a subject's vital signs including
ECG tracing, heart rate, respiratory rate, end-tidal CO2 with capnograph, secondary monitor
for the oxygen concentration being delivered to the subject.
A whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining
the functional SaO2 value from arterial blood samples obtained during the study.
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