Device Dossier
Single-patient physiologic monitoring system
Device Dossier for Single-patient physiologic monitoring system (Single-patient physiologic monitoring system, Class IIb, sponsor DocStock). ARTG record,…
- GMDN category: Single-patient physiologic monitoring system
Intended purpose
The patient monitors are intended for monitoring, displaying, reviewing, storing, notifying, and transferring of multiple physiological signs of a patient, such as ECG (3Lead, 5-Lead, 10-Lead selectable), arrhythmia detection, ST-segment analysis, Heart Rate (HR), Respiration rate (Resp), Temperature(Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), End-tidal Carbon Dioxide Concentration (EtCO2), Invasive Blood Pressure (IBP), Anesthetic Gas (AG), Non-Invasive Cardiac Output (ICG) , Depth of Anesthesia (qCON) , and Neuromuscular Transmission Monitoring (NMT).