The objective of the study was to conduct a respiratory rate (RR) accuracy evaluation comparing the Health Tag to an FDA-cleared end-tidal carbon dioxide monitor (etCO2) reference device in a mixed population of 20 adults, ranging from healthy to those with varying cardiopulmonary diseases.
The reference etCO2 device used in this study was the GE Healthcare S5Multi-parameter Monitor™, M-COVX module.
The range evaluated during the study was 8-35 breaths per minute (bpm).
The accuracy of the Device Under Test (DUT), Health Tag, passed with an average root mean square (ARMS) value of 0.8 bpm.
To access the full validation study, please contact us at RPM@spirehealth.com
Note: Spire Health Tags are general wellness devices that are intended to promote a healthy lifestyle and reduce the impact of chronic diseases such as COPD. Spire Health is currently pursuing FDA clearance for a future version of Health Tags for expanded remote patient monitoring applications.