Accuracy of Continuous SpO2 Measurement in Adults

SpO2 Accuracy Validation of Sotera Wireless Pulse Oximetry Systems During Non-Motion and Motion Conditions of Induced Hypoxia as Compared to Arterial Blood CO-Oximetry

The purpose of this study is to compare the accuracy of the Sotera ViSi, an investigational device, to standard devices in estimating the level of blood oxygen (SpO2) in adult human subjects.

This study is a single-center blinded study that will enroll up to 15 adult subjects, male or female, of any ethnic background.

SpO2 and pulse rate measurements reported by ViSi will be compared with simultaneous measurements of blood SaO2 and pulse rate made by an FDA-cleared CO-oximeter and pulse oximeter, respectively. The paired measurements will be made in a well-controlled environment under optimal laboratory conditions.

Inclusion Criteria:

• Subject is at least 18 years of age.
• Subject is a healthy volunteer capable of undergoing controlled hypoxemia to the level of 70% SaO2 (±3%) with no or minimal medical risk.
• Subject is willing and able to participate in the measurement period for up to two hours.

Exclusion Criteria:

• Subject has a carboxyhemoglobin level (COHb) ≥3%.
• Subject has a MetHb level ≥2%.
• Subject has a ctHb value ≤10g/dl.
• Subject is in another clinical study that may interfere with the results of this study.
• Subject is unable or unwilling to have a blood gas and oxygen saturation measurements taken from either wrist/hand.
• Subject is deemed by the Investigator to be medically unsuitable for participation in this study.