UbiqVue™ 2A Multi-parameter System (UX2550)
LifeSignals, Inc.The UbiqVue 2A Multi-parameter System is a wireless wearable biosensor system for continuous monitoring of vital signs such as ECG, heart rate, respiration, temperature, SpO2, and blood pressure (optional). It transmits data wirelessly to a central server for storage, display, and analysis, enabling healthcare professionals to remotely monitor multiple patients at home and in clinical settings with alert notifications and visual alarms for abnormal physiologic parameters.
Intended Use
The UbiqVue 2A 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 including ECG, heart rate, SpO2%, respiration rate, pulse rate, skin & body temperature, posture, motion, R-R interval, HRV and optional blood pressure. It notifies professionals through alerts for out-of-range parameters and displays data for remote monitoring and active clinical monitoring with visual alarms.
Technology
The system consists of a wearable biosensor that acquires multi-parameter physiological signals including 2-channel ECG, respiration signals, skin temperature, photoplethysmography signals for SpO2 and pulse rate, accelerometer data for motion and posture, and optional integration with third-party blood pressure devices. It connects via WLAN and BLE to relay devices, which transmit encrypted data to a central Linux server for storage, analysis, and display via a web-based active monitoring portal with alert notifications and visual alarms.
Performance
The device underwent comprehensive testing including biocompatibility, electrical safety, electromagnetic compatibility, clinical and bench validation for SpO2, pulse rate, body and skin temperature accuracy, ECG and heart rate performance, wear-life study for 120 hours, respiration algorithm validation, alert and alarm system compliance, usability and software validation per IEC standards, wireless coexistence, packaging, shelf-life, and reliability testing.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/10/2024
4 months - 2
FDA Approval
11/12/2024
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