Device Dossier

Portable ventilator, electric

Device Dossier for Portable ventilator, electric (Portable ventilator, electric, Class IIb, sponsor Philips Electronics). ARTG record, intended purpose,…

Intended purpose

Provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Intended for pediatric through adult patients weighing at least 2.5 kg, and requiring tidal volume equal or greater than 15mL. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional, home, and nonemergency transport settings for example wheelchair, or personal vehicle. It may be used for both invasive and non-invasive ventilation.

TGA Public Summary