Oxehealth Vital Signs
Oxehealth LimitedOxehealth Vital Signs is a software device that analyzes video images captured by standard cameras to noninvasively measure a patient's pulse rate and estimated breathing rate. It uses proprietary algorithms to monitor skin pixel intensity changes and chest wall movements, allowing healthcare staff to perform vital sign spot checks without disturbing the patient. This is especially useful in hospital or secured environments where minimizing patient contact is advantageous.
Intended Use
The Oxehealth Vital Signs device is intended for noninvasive spot measurement of pulse rate and estimated breathing rate (chest wall movements) when the subject is still, for use in hospitals, general care, and secured environments by trained healthcare staff.
Technology
The device employs software algorithms to analyze video data collected from near-infrared spectrum cameras capturing pixel intensity changes in exposed skin to determine pulse rate, and motion tracking of the chest wall movements to estimate breathing rate.
Performance
Clinical studies on 60 adult patients demonstrated pulse rate and breathing rate measurements with root mean square differences (RMSD) significantly below predefined accuracy objectives. The pulse rate RMSD was 1.81 bpm and breathing rate RMSD was 1.17 breaths per minute. Human factors and software validation testing ensured appropriate accuracy and usability.
Device Timeline
- 1
Submission
3/27/2020
0 years, 12 months - 2
FDA Approval
3/26/2021
Other devices from Oxehealth Limited
- Oxehealth Vital Signs2022 • 510K
- Vital Signs2021 • 510K
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