Device Dossier
Pulmonary function analysis system, adult
Device Dossier for Pulmonary function analysis system, adult (Pulmonary function analysis system, adult, Class IIa, sponsor MGC Diagnostics). ARTG…
- GMDN category: Pulmonary function analysis system, adult
Intended purpose
'Intended for measuring pulmonary function in spontaneously breathing patients. The Exhalyzer D system is suited for testing neonates, infants, paediatric and adult patients. The Exhalyzer D includes the following pulmonary function tests: exhaled nitric oxide (all ages), breath by breath monitoring of exhaled Carbon dioxide and oxygen (all ages) and the Multiple-Breath Washout test for lung volumes and ventilation distribution (using sulphur hexafluoride for neonates and infants and 100% oxygen in paediatric and adult ages). The interpretation of the results are the responsibility of the specialist clinician.'