Device Dossier
Sleep disorder interpretive software, professional-use
Device Dossier for Sleep disorder interpretive software, professional-use (Sleep disorder interpretive software, professional-use, Class IIa, sponsor…
- GMDN category: Sleep disorder interpretive software, professional-use
Intended purpose
Intended to analyze subject activity, movement and physiological sign data associated with movement during sleep and to extract information about certain sleep parameters from these movements and physiological sign data. The device provides a timeline of periods when a bed space is occupied, and periods when a subject is asleep when the bed space is occupied. The device assesses video footage from a fixed-installation device for use within single occupancy bed spaces within hospitals, general care and secured environments. It is indicated for use on subjects 18 years of age or older.