Device Dossier

Physiologic-monitoring defibrillation system

Device Dossier for Physiologic-monitoring defibrillation system (Physiologic-monitoring defibrillation system, Class IIb, sponsor Mindray Medical). ARTG…

Intended purpose

An assembly of electrically-powered devices designed to defibrillate the heart that may incorporates additional therapeutic and/or monitoring features intended to resuscitate and/or monitor a cardiac patient. The defibrillator is intended for automatic defibrillation (AED) and/or manual defibrillation treatments. It guides operators through Cardiopulmonary resuscitation (CPR). The monitoring functions are for use in pre-hospital settings by qualified medical personnel trained in the operation of the equipment and qualified by training in basic life support, advanced cardiac life support or defibrillation, and may include one or more of the following: electrocardiogram (ECG) monitoring (electrocardiograph), noninvasive cardiac pacing (temporary pacemaker), cardioversion (CV), pulse oximetry (oximeter), invasive and/or noninvasive blood pressure monitoring, and end-tidal carbon dioxide (EtCO2) monitoring (i.e., a CO2 monitor). It may have data recording/printing capabilities.

TGA Public Summary