Device Dossier

Single-patient physiologic monitoring system

Device Dossier for Single-patient physiologic monitoring system (Single-patient physiologic monitoring system, Class IIb, sponsor Draeger). ARTG record,…

Intended purpose

The Infinity M300/M300+ is intended for use with the Infinity CentralStation to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network. The Infinity M300/M300+ with TruST is intended for 12-Lead ECG monitoring with a reduced set of electrodes. Reconstructed leads are intended for real-time assessment of ST segment changes.

TGA Public Summary