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Accuracy of the EvieMED Ring Pulse Oximeter in Profound Hypoxia
Sponsor: Movano Health
Summary
The goal of this study was to evaluate the accuracy of pulse oximeters over the range of 70-100% per the International Organization for Standardization (ISO) 80601-2-61:2019. Four test devices were placed on each subject on the left or right hand with two at the finger base and two at the fingertip. Motion equipment was used to control motion of the test devices. In addition, two test devices were placed on the contralateral hand on the base of a finger and also on the fingertip. Finally, a test wrist device was placed on either the left or right wrist. SpO2 measurements from these devices were compared to sampling of arterial blood during brief stable oxygen desaturation in healthy volunteers to evaluate the claimed range.
Official title: Accuracy of the Evie Ring Pulse Oximeter in Profound Hypoxia
Key Details
Gender
All
Age Range
18 Years - 49 Years
Study Type
OBSERVATIONAL
Enrollment
12
Start Date
2024-06-11
Completion Date
2024-06-13
Last Updated
2024-06-14
Healthy Volunteers
Yes
Conditions
Interventions
Pulse oximeter
Devices (4) were placed on the finger base and the fingertip of two right or left fingers and placed in motion for the duration of the study. Devices (3) were placed on the contralateral side and maintained motionless for the duration of the of study. Blood samples were taken at each stable level of oxygenation.
Locations (1)
Hypoxia Research Laboratory
San Francisco, California, United States