Device Dossier

Physiologic monitoring system alarm

Device Dossier for Physiologic monitoring system alarm (Physiologic monitoring system alarm, Class IIb, sponsor GE Healthcare). ARTG record, intended…

Intended purpose

This device is intended for relaying primary alarm signal from the host device to a remote alarm system. It is intended for use in multiple areas within a professional healthcare facility. It is intended for use on distributed alarm system. This device is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. This device is not intended for confirmed delivery of alarm and is not intended for use within controlled MR environment.

TGA Public Summary