Device Dossier

Single-patient physiologic monitoring system

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

Intended purpose

An assembly of devices designed for continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient. It can include a central station monitor, and a bedside patient monitor; it often includes telemetry systems to allow monitoring of an ambulatory patient. The system is used to evaluate and observe trends in a compromised or unstable patient in intensive or general healthcare settings.

TGA Public Summary