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
The RootiCare Sleep Monitoring is a software that provides analysis results and allows a general-purpose medical platform to generate reports which are intended to assist medical professionals to drive clinical management for the sleep apnea. The target patient population of the software are adult (>16 years of age) without persistent atrial fibrillation and implanted pacemaker. The software is intended to be installed in a general-purpose medical platform by experienced technical professionals. It does not monitor or diagnose the patient and does not issue any alarms. The intended operating environment for the software is any dry space suitable for the operation of a conventional computer.