The iBSM is a wireless patient monitoring system designed for hospital use on non-critical patients aged 18 and older. It continuously displays vital signs such as ECG waveforms, heart rate, respiratory rate, oxygen saturation, and blood pressure using biocompatible sensors. It aids clinicians by providing real-time physiological data, visual and audio alarms, and patient orientation notifications to help prevent complications like pressure ulcers.
Intended Use
iBSM is a wireless monitoring system intended for display of ECG waveform, heart rate, respiratory rate, SpO2, activity, body position, fall detection, skin temperature, and Blood Pressure parameter measurements by healthcare professionals in healthcare settings for general care patients 18 years and older.
Technology
The system consists of wireless skin-mounted sensors (chest and limb) that measure ECG, PPG, accelerometry, and temperature. Data are transmitted wirelessly via Bluetooth LE to an iBSM hub tablet running secure kiosk mode software for real-time display and storage. Compatible with FDA-cleared third-party blood pressure devices. Provides visual and audio alarms for physiological parameter thresholds.
Performance
Performance testing included electrical safety, biocompatibility, wireless coexistence, software verification, human factors and usability testing, mechanical and electrical tests, and compliance with IEC and ISO standards relevant to physiological monitoring devices. The device meets accuracy requirements for heart rate, respiratory rate, SpO2, temperature, and blood pressure measurements.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/13/2024
5 months - 2
FDA Approval
5/16/2025
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.