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

The device provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Intended for paediatric through adult patients weighing at least 5kg. The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.

TGA Public Summary