Device Dossier

Analyser, gas, carbon dioxide

Device Dossier for Analyser, gas, carbon dioxide (Analyser, gas, carbon dioxide, Class IIb, sponsor Medtronic). ARTG record, intended purpose, GMDN…

Intended purpose

The portable device is intended to provide continuous, non-invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath. The device also monitors respiration rate, functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The device is indicated for monitoring by qualified healthcare providers in any environment where continuous, noninvasive monitoring of these parameters is desired. The monitor is indicated for use on adult, pediatric, and infant/neonatal patients. The device provides integrated pulmonary index (IPI) for paediatric and adult patients, and apnoea per hour and oxygen desaturation index for age 22 and up. The device has the capability to wirelessly transmit data to remote patient monitoring systems.

TGA Public Summary