Device Dossier
Polysomnograph System - Sleep assessment device
Device Dossier for Polysomnograph System - Sleep assessment device (Sleep assessment device, Class IIa, sponsor Emergo). ARTG record, intended purpose,…
- GMDN category: Sleep assessment device
Intended purpose
The device is intended to record patient data such as patient respiratory airflow, snoring, blood oxygen saturation, pulse, respiratory effort, body position, EEG, EOG, ECG, EMG and wrist movement during sleep. It can also be connected to a CPAP/Auto CPAP/BPAP system through the pressure monitoring port of the mask to record and display continuous positive airway pressure. The device uses these recordings to produce report that may aid in the screening or diagnosis of sleep disordered breathing for further clinical investigation. The device is intended for the hospital / institutional environment (supervised) and the home environment (unsupervised) use for adults.