Accuracy of the Evie Ring Pulse Oximeter in Profound Hypoxia
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.
Description
The study is an open enrollment, single-center, single blinded design using four test rings in motion compared to arterial blood gas measurements (SaO2) and to two commercially available hospital grade reference pulse oximeters (Masimo Radical-7 and Nellcor N-595) and at rest for two test rings and the test wrist device. To be included in the study, subjects had to meet all the inclusion criteria and not meet any of the exclusion criteria and to sign the written consent. Demographic data were obtained. The investigational (7/subject) and reference devices were placed. A radial arterial cannul…
Eligibility
- Age range
- 18–49 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: Subject is in good general health with no evidence of any medical problems. Subject is fluent in both written and spoken English. Subject provided written informed consent and is willing to comply with the study procedures. Subject is willing to have their skin color assessed. Exclusion Criteria: Subject is obese with a body mass index (BMI) over 30. Subject has a known history of heart disease, lung disease, kidney or liver disease. Subject has asthma, sleep apnea, or uses continuous positive airway pressure breathing support Subject has diabetes. Subject has a clotti…
Interventions
- DevicePulse 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.
Location
- Hypoxia Research LaboratorySan Francisco, California