Device Dossier

Defibrillator monitor S8 - Physiologic-monitoring defibrillation system

Device Dossier for Defibrillator monitor S8 - Physiologic-monitoring defibrillation system (Physiologic-monitoring defibrillation system, Class III,…

Intended purpose

The monitor is used for manual defibrillation, AED defibrillation, pacing and 3-lead, 5-lead or 12 lead ECG monitoring, Arrhythmia Analysis, ST Segment Analysis, SpO2 monitoring, two channel TEMP measurement, NIBP measurement, IBP measurement and EtCO2 monitoring.

Functional description

The S8 defibrillator monitor uses a biphasic truncated exponential waveform defibrillation technique, utilizing pads or external paddles to deliver high-voltage energy stored in a large capacitor. Controlled by a discharge controller, the energy is released in milliseconds to the chest wall or directly to the heart via electrodes, depolarizing ventricular fibrillation. This allows the sinus node to regain control, restoring normal sinus rhythm from tachyarrhythmias.

TGA Public Summary