BeneVision Central Monitoring System
Shenzhen Mindray Bio-medical Electronics Co., LTD.The BeneVision Central Monitoring System is a networked patient monitoring solution designed for use in professional healthcare settings. It enables clinicians to remotely view, store, and manage physiological data and alarms from various compatible monitors and anesthesia devices, including ECG and cardiac data. This system improves patient care by providing real-time and historical patient data access and supports alarm notifications to caregivers, enhancing clinical decision-making and patient safety.
Intended Use
The BeneVision Central Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in professional healthcare facilities to provide clinicians remote patient monitoring. It supports real-time viewing, storage, printing, and transfer of patient clinical data and alarms from compatible physiological monitors and anesthesia devices.
Technology
The system operates on Windows platforms and runs as an application or service on a host computer, supporting data collection from multiple compatible wireless and wired physiological and telemetry devices. It includes modules for alarm management, remote viewing, and supports multi-patient and multi-instance viewers. The device supports integration with anesthesia systems and transmits alarm notifications to caregivers' mobile devices via AlarmGUARD.
Performance
Verification and validation testing were conducted per FDA guidance to ensure software functionality and performance. Bench testing covered waveform display accuracy and alarm compliance with IEC standards. No clinical or animal testing was required to establish substantial equivalence. The system met requirements for electrical safety and electromagnetic compatibility through predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/10/2024
10 months - 2
FDA Approval
7/31/2025
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