Device Dossier

Telemetry system, physiological signal

Device Dossier for Telemetry system, physiological signal (Medical networking interface unit, Class IIb, sponsor Mindray Medical). ARTG record, intended…

Intended purpose

An assembly of devices that together function as a complete system for the transmission, reception, recording and viewing of wireless physiological signals (commonly known as vital signs) via radio; frequency within a defined coverage area in health care facility setting. These are sent from a transmitter connected to an ambulatory patient; and/or from other devices used by the patient so that the patient can be monitored when remote to static patient monitoring systems. These physiological signals can include Electrocardiogram (ECG), NIBP (non-invasive blood pressure), Heart Rate (HR), PR (Pulse Rate), Saturation of Pulse Oxygen (SpO2), Respiration Rate (Resp) and Temperature (Temp) for adult and pediatric patients. The main unit is also intended for home use.

TGA Public Summary