Device Dossier

UbiqVue 2A/2AY/1AX Multiparameter System - Wearable multiple vital physiological parameter monitoring system

Device Dossier for UbiqVue 2A/2AY/1AX Multiparameter System - Wearable multiple vital physiological parameter monitoring system (Wearable multiple vital…

Intended purpose

The UbiqVue Multiparameter System is a wireless remote patient monitoring system intended for use by healthcare professionals for continuous collection of physiological data at home and in healthcare settings. This can include electrocardiography (2-Channel ECG), heart rate, SpO2%, respiration rate, pulse rate, photoplethysmography waveform, skin temperature, body temperature, body posture, body motion, R-R interval, heart rate variability (HRV) and blood pressure at home and in healthcare settings. Data is transmitted wirelessly near real-time from the UbiqVue Wearable Biosensor and 3rd party device to remote central server for display, storage, and analysis. The UbiqVue Multiparameter System is intended for non-critical and adult population. The UbiqVue Multiparameter System shall include the ability to notify healthcare professionals through alerts when physiological parameters fall outside the set limits, manual trigger by the patient and to display multiple patient’s physiological data with visual alarm for remote monitoring at home and active monitoring in hospitals and out-of-hospital patient care settings (such as clinics, outpatient surgery facilities, long-term care facilities and physician offices) in which care is administered by healthcare professionals.

TGA Public Summary