Device Dossier

Patient positioning sensor

Device Dossier for Patient positioning sensor (Patient positioning sensor, Class IIa, sponsor Bird Healthcare). ARTG record, intended purpose, GMDN…

Intended purpose

Somnibel is a body-worn, active device able to detect the position of the patient during sleep and to generate a gentle vibration, depending on the detected position, that induces the patient to change body position. The Somnibel Pro is a body-worn, active device intended to be used by medical staff for the treatment of positional Sleep Apnea Hypopnea Syndrome (SAHS) or positional snoring by applying gentle vibration to induce a change in the body position, to reduce the incidence of sleep respiratory events and to record the body position, actigraphy and stimulus power signals for subsequent analysis.

TGA Public Summary