Device Dossier

Breas Sleep Theraphy - Home CPAP unit

Device Dossier for Breas Sleep Theraphy - Home CPAP unit (Home CPAP unit, Class IIa, sponsor Taleb Medical and Vetequip). ARTG record, intended purpose,…

Intended purpose

A portable, mains electricity (AC-powered) device, which may include rechargeable batteries, intended to assist noninvasive ventilation (i.e., without use of an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous respiration, primarily to treat adult patients affected by obstructive sleep apnoea (OSA); it may also be intended to treat snoring. It is a small desktop unit with controls, and may include a built-in humidifier; the airway pressure may be automatically adjusted to help provide optimal CPAP through use of a sensor (auto CPAP). The device is intended for use in the home but may also be used in healthcare facilities

TGA Public Summary