US Indication for Use: The CoSense® ETCO Monitor is intended for non-invasive measurement of end tidal carbon monoxide (ETCO) concentration in the breath of spontaneously breathing patients (neonates through adults). ETCO levels indicate blood levels of carbon monoxide, which can be elevated in disorders such as hemolysis, CO poisoning, and in smokers. It is for use by health professionals.

Intended Use Statement for CE Mark Certification: The CoSense End-Tidal CO Monitor is intended for non‐invasive measurement of end tidal carbon monoxide (ETCO) concentration in the breath of spontaneously breathing patients (neonates through adults). ETCO levels indicate blood levels of carbon monoxide, which can be elevated in disorders such as hemolysis, CO poisoning, and in smokers. It is for use by health professionals.

The CoSense End-Tidal Carbon Monoxide Monitor is not intended to screen or diagnose a specific disease or condition. Rather, it is a tool intended for the monitoring of carbon monoxide in medical conditions in which the rate of hemolysis may be relevant.