Device Dossier

Analyser, blood gas, extracorporeal

Device Dossier for Analyser, blood gas, extracorporeal (Analyser, blood gas, extracorporeal, Class IIb, sponsor Spectrum Medical). ARTG record, intended…

Intended purpose

THE MONITORING SYSTEM IS INTENDED FOR THE CONTINUOUS AND REAL TIME MEASUREMENT OF OXYGEN SATURATION, HEMATOCRIT AND HAEMOGLOBIN CONCENTRATION, BLOOD FLOW, GASEOUS EMBOLI, PRESSURE AND RESERVOIR LEVEL IN AN EXTRACORPOREAL CIRCUIT. THE DEVICE PROVIDES MONITORING INFORMATION TO TRAINED CLINICIANS AND CAN BE CONFIGURED BY THEM TO SET PARAMETER SPECIFIC ALARMS AND RECORD DATA

TGA Public Summary