Primary objective: To assess the accuracy of the EverOn™ piezoelectric sensor based contactless heart rate and respiration rate monitoring system.
Methods: Measurements of the EverOn™ and reference devices were performed in a sleep lab and an intensive care unit (ICU) setting. One minute measurements by both the reference device and the EverOn™ were averaged and compared. Accuracy was defined in accordance with industry criteria.
Results: Respiration rate (RR) accuracy in the 41 children and 16 adults evaluated in the sleep lab was 93.1% and 90.6% respectively, and heart rate (HR) accuracy was 94.4% and 91.5% respectively. For the 42 ICU patients RR accuracy was 82.0% and 75% (versus end-tidal CO(2) and manual respectively), while accuracy of HR was 94.0%. The EverOn™ was found to be superior to the impedance technique in measuring RR.
Conclusions: The system described was found to be accurate in accordance with regulatory and industry criteria.