Device Dossier
Patient monitor, multiparameter
Device Dossier for Patient monitor, multiparameter (Single-patient physiologic monitoring system, Class IIa, sponsor Rose Health Services). ARTG record,…
- GMDN category: Single-patient physiologic monitoring system
Intended purpose
Non-invasive, multi-modality physiological monitoring devices. Insight Discovery performs 5 different scans: Surface electrode paraspinal electromyography, thermography,inclinometry, heart rate variablility and Algometry. The inclinometer is used to perform accurate spinal range-of-motion (ROM) measurements. The Insight? algometer enables the doctor to obtain accurate information concerning the sensory portion of the nervous system by mapping pressure/pain sensitivity along the spine. The Pulse waver profiler measures variability in heart rate which reflects the vagal and sympathetic function of the autonomic nervous system, and has been used as a monitoring tool in clinical conditions characterized by altered autonomic nervous system function. Spectral analysis of beat-to-beat variability is a simple, non-invasive technique to evaluate autonomic dysfunction.