Device Dossier

CDI OneView Monitoring System - Analyser, blood gas, extracorporeal

Device Dossier for CDI OneView Monitoring System - Analyser, blood gas, extracorporeal (Analyser, blood gas, extracorporeal, Class IIb, sponsor Terumo).…

Intended purpose

A patient parameter monitoring system to be used on a single patient during cardiopulmonary bypass procedures. By measurement or acquisition from other devices, it displays and outputs information to provide continuous, in-line monitoring of various patient parameters contained within the extracorporeal perfusion circuit and patient. The following parameters are available, based on configuration: Potential of Hydrogen pH, Partial Pressure of Carbon Dioxide (pCO2), Partial Pressure of Oxygen (pO2), Potassium Ion (K+), Oxygen Saturation (SO2), Haematocrit (HCT), Haemoglobin (Hgb), Blood Flowrate (Q), Cardiac Index (CI), Base Excess (BE), ꞏ Bicarbonate (HCO−3), Oxygen Consumption (VO2), Indexed Oxygen Consumption (VO2i), Oxygen Delivery (DO2), Indexed Oxygen Delivery (DO2i), Cerebral regional oxygen saturation (rSO2), Oxygen Extraction Ratio (O2ER), Body Surface Area (BSA), Shunt Sensor Temperature.

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