Single-patient physiologic monitoring system

Intended purpose

Intended for use by professional healthcare providers for complete physiologic/hemodynamic monitoring. The system may be used to display and analyse surface ECG (electrocardiogram), respiration, invasive pressure, pulse oximetry (SpO2), end tidal CO2 (EtCO2), fractional flow reserve (FFR), non‐invasive blood pressure (NIBP), surface body temperature and thermal cardiac output. The system also provides for clinical data acquisition, medical image/data processing, and analytical assessment. The system is indicated for use in the following areas: cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology and other areas where cardiac monitoring may be required. The system is not intended to be used in the proximity of magnetic resonance imaging. The data may also be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices.