Vital Signs
Oxehealth LimitedOxehealth Vital Signs is a software device that uses optical cameras to noninvasively measure pulse rate and estimated breathing rate from video footage of patients. It facilitates vital sign monitoring in single-occupancy hospital rooms and care environments without physical contact, helping clinicians monitor patients effectively, especially those who do not require critical or continuous monitoring.
Intended Use
Noninvasive spot measurement of pulse rate and estimated breathing rate via optical camera video footage in hospital and care settings; intended for adults not requiring critical or continuous monitoring.
Technology
Software analyzes video footage from fixed-installation optical cameras capturing subtle pulse and breathing-related movements. Uses C++ and Node.js with third-party libraries, interfacing via a web-based user interface on touchscreen monitors.
Performance
Performance testing demonstrates pulse rate measurement accuracy between 50 to 130 ±3 beats per minute in 9 second windows and estimated breathing rate of 8 to 31 ±2 breaths per minute in 30 second windows, using RMSE accuracy criterion. Accuracy may reduce in subjects with pulse rates above 110 bpm.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/21/2021
29 days - 2
FDA Approval
7/20/2021
Other devices from Oxehealth Limited
- Oxehealth Vital Signs2022 • 510K
- Oxehealth Vital Signs2021 • DE NOVO
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