Device Dossier

Defibrillator Monitor S80 - Physiologic-monitoring defibrillation system

Device Dossier for Defibrillator Monitor S80 - Physiologic-monitoring defibrillation system (Physiologic-monitoring defibrillation system, Class III,…

Intended purpose

The defibrillator monitor is intended for manual defibrillation, semi-automatic external defibrillation, noninvasive cardiac pacing and monitoring of ECG (3-lead, 5-lead, 6-lead or 12-lead selectable), impedance respiration (RESP), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), temperature (TEMP) and End-tidal CO2 (EtCO2). The monitoring function is intended for use on adult, pediatric and neonatal patients.

Functional description

The defibrillator monitors support four operating modes, including manual defibrillation mode, monitor mode, pacer mode and AED mode. When the device is being used, only one mode can be selected.

TGA Public Summary