Device Dossier

Physiologic-monitoring defibrillation system

Device Dossier for Physiologic-monitoring defibrillation system (Physiologic-monitoring defibrillation system, Class IIb, sponsor Philips Electronics).…

Intended purpose

The Tempus LS is a defibrillator that can deliver a shock in automatic, manual or Pacemaker mode with the following feature: CPR Feedback sensor. In addition, the ECG signal of the 3/4-wire ECG patient cable can be display (used normally for the Demand Pacemaker) and can be used for a continuously attended patient ECG signal display (without alarm handling). The device is for use by professional persons who are trained in basic life support (BLS) and defibrillation or advanced cardiac life support (ACLS). The device is intended for single patient use only.

TGA Public Summary