Device Dossier

Sleep assessment device

Device Dossier for Sleep assessment device (Sleep assessment device, Class IIa, sponsor Bird Healthcare). ARTG record, intended purpose, GMDN category —…

Intended purpose

This device is an actigraph used to analyze activity and monitor circadian rhythms. Furthermore it can be used to detect body position or movement (e.g. in the case of PLM) and to analyze movement (e.g. in the case of tremor). Additional sensors can be connected to the device via an external channel such as EEG, ECG, EMG and skin resistance (electro-dermal activity). In addition, the respiratory flow or snoring can be measured by means of a pressure sensor (alternatively therapy control for CPAP).