Device Dossier

Patient monitor, multiparameter

Device Dossier for Patient monitor, multiparameter (Single-patient physiologic monitoring system, Class IIb, sponsor Mindray Medical). ARTG record,…

Intended purpose

A unit that, utilizing built-in functions, modules or other equipment, for monitoring, displaying, reviewing, storing and transferring of multiple physiological parameters and displays these by the bed/patient. A bedside unit can be coupled up to a central unit, but can operate independently. The monitoring parameters can be, e.g. ECG, heart rate (HR), respiration (Resp), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), oxygen (O2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS), respiration mechanics (RM), continuous cardiac output(PiCCO), central venous oxygen saturation(ScvO2), electroencephalograh (EEG), neuromuscular transmission (NMT), regional oxygen saturation (rSO2), continuous cardiac output (CCO: FloTrac), electroencephalograph status index(ESI), pain (ANI), CPR Quality Index(CQI), and interpretation of resting 12-lead ECG.

TGA Public Summary