Device Dossier

Home CPAP unit

Device Dossier for Home CPAP unit (Home CPAP unit, Class IIa, sponsor Wiselink Group). ARTG record, intended purpose, GMDN category — compiled by…

Intended purpose

The device is indicated to provide non-invasive ventilator support to treat patients weighing over 30kg with Obstructive Sleep Apnea (OSA). ASV and Auto ASV modes can also be used for the treatment of central and/or mixed apneas, or periodic breathing. This device is intended for hospital and home use. It cannot be intended for those patients who are dependent on mechanical ventilation.

TGA Public Summary