Device Dossier

Spirometer, diagnostic

Device Dossier for Spirometer, diagnostic (Spirometer, diagnostic, Class IIa, sponsor Elevate Medtech). ARTG record, intended purpose, GMDN category —…

Intended purpose

The ambulatory lung diagnosis system (ALDS) is used to determine forced spirometry parameters and oscillatory airway resistances. It uses this information together with data from patient anamnesis to make physiological interpretations in spontaneously breathing patients. The ALDS diagnostic system (DS) is based on published concepts for physiological interpretation of obstructive and restrictive limitations. The ALDS shall be easy to use, so that it is possible to screen and diagnose multiple patients per day efficiently. The typical duration of use with the patient is one minute per measurement.

TGA Public Summary