Device Dossier
Radius VSM Patient-Worn Vital Signs Monitor - Wearable multiple vital physiological parameter monitoring system
Device Dossier for Radius VSM Patient-Worn Vital Signs Monitor - Wearable multiple vital physiological parameter monitoring system (Wearable multiple…
Intended purpose
The Radius VSM and accessories are intended to be used as both a wearable multi-parameter patient monitor and an accessory to a multi-parameter patient monitor that is intended for continuous non-invasive multi-parameter physiological patient monitoring in hospital and healthcare facilities. The Radius VSM and accessories are indicated for the monitoring of hemodynamic (including ECG, arrhythmia detection, non-invasive blood pressure, SpO2, Pulse Rate, PVi, heart rate, and temperature), and respiratory (e.g., impedance, acoustic, and pleth-based respiration rate) physiological parameters along with the orientation and activity of adults including those susceptible to pressure ulcers.