Device Dossier

Breas Ventilators - Ventilator, adult

Device Dossier for Breas Ventilators - Ventilator, adult (Ventilator, adult, Class IIb, sponsor Taleb Medical and Vetequip). ARTG record, intended…

Intended purpose

The device intended to provide continuous long-term support or intermittent ventilatory support for the care of individuals who require mechanical ventilation for respiratory insufficiency or respiratory failure, with or without obstructive sleep Apnea. Depending on the model chosen, the device is applicable for pediatric through to adult patients weighing more than 5 - 10 kg. Optional accessories like SpO2 & CO2 sensors can be used for added physiological monitoring. The devices operate from both AC mains and an internal/external battery backup power supply. The Models are intended to be used in home, institution, hospitals, ground ambulances and civil aircraft, excluding helicopters and portable applications such as wheelchairs and gurneys. It may be used for both invasive and noninvasive ventilation. The monitored data can be stored internally on the device to transfer to a PC or could be transmitted to external cloud storage using specific accessories which can be viewed remotely via web browsers.

TGA Public Summary