Edan Instruments RespArray™ Patient Monitor

The RespArray™ patient monitor is intended to be used for monitoring, storing, reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates for use by trained healthcare professionals in hospital environments for prescription use only. The monitored physiological parameters include ECG, RESP,TEMP, SpO2, PR, NIBP, and CO2. The arrhythmia detection and ST Segment analysis are intended for adult patients. The SpO2 Nellcor module is intended to be used for spot-check or continuous non-invasive monitoring of functional SpO2 and PR, in motion and no motion conditions, and in patients who are well or poorly perfused. The Microstream capnography module is intended for continuous non- invasive monitoring of etCO2 and RR monitor also provides the clinician with IPI, A/hr and ODI values. IPI is not intended for patients up to the age of one year. A/hr and ODI are intended for ages 22 and up. The monitors are not intended for MRI environments.