Device Dossier

Single-patient physiologic monitoring system

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

Intended purpose

This monitor is intended to be used for monitoring, trends, storing, reviewing, recording, and generating alarms for multiple physiological parameters which may include ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), Cardiac Output (C.O.) and Anesthetic gas (AG) of adults, pediatrics and neonates in hospital environments. This monitor is configurable to be suitable for use in hospital environments which may include intra-hospital transport and hospital environments including clinic, emergency department, wards, PACU and NICU.OR, ICU, NICU, PACU and wards.

TGA Public Summary