Oximeter, cerebral

Intended purpose

The Nonin Medical CO-Pilot™ Wireless Handheld Multi-Parameter System (Model H500), is intended for noninvasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2 ), pulse rate, carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), and cerebral or somatic hemoglobin oxygen saturation (%rSO2 ). This device is not meant for the sole use of clinical decision making; it must be used in conjunction with additional methods of assessing clinical signs and symptoms. • For %SpO2 and pulse rate, the CO-Pilot System is intended for spotchecking and/or measuring during clinician assessment of adult, pediatric, infant, and neonate patients who are well or poorly perfused, during both motion and non-motion conditions in professional healthcare facilities, mobile, and EMS settings. • For %rSO2 , the CO-Pilot System is intended for spot-checking and/or measuring during clinician assessment of adult, pediatric, infant, and neonate patients in professional healthcare facilities, mobile, and EMS settings. • For %COHb and %MetHb, the CO-Pilot System is intended for spotchecking, multiple spot-checks to observe change, and/or measuring during clinician assessment of adult and pediatric patients in professional healthcare facilities, mobile, and EMS settings. Refer to the applicable sensor Instructions for Use (IFU) for sensor indications for use and accuracy claims.