BeneVision Central Monitoring System

The BeneVision Central Monitoring System is a networked patient monitoring platform installed in healthcare facilities to provide clinicians remote real-time viewing, storage, and historical review of patient clinical data and alarms from compatible physiological monitors and anesthesia devices. It supports multiple network connections (Ethernet, WiFi, WMTS), telemetry systems, and includes the AlarmGUARD mobile application for alarm notifications to clinicians' devices.

Key changes from predicate K220058 include: Windows 11 support for CMS Viewer and Multi Patient Viewer; increased CPU cores and memory requirements across multiple modules; increased maximum WorkStation/ViewStation connections from 32 to 128 per CentralStation; support for Mindray anesthesia systems (A8, A9) with non-real-time data display and waveform accuracy; new AlarmGUARD feature for mobile alarm notifications; and separation of Multi Patient Viewer as an independent multi-instance component previously integrated with CMS Viewer.

IEC 60601-2-27 (alarms in medical devices); IEC 60601-1-8 (alarms and alarm management); FDA guidance on Content of Premarket Submissions for Device Software Functions.

Although the subject device expands compatibility to anesthesia systems and adds the AlarmGUARD mobile notification feature, the fundamental intended use—networked remote patient monitoring in healthcare facilities—remains identical to the predicate. Software enhancements (increased system capacity, Windows 11 support, multi-instance viewing) and anesthesia integration (non-real-time display only, no bi-directional control) do not raise new questions of safety or effectiveness. Software verification and validation testing, plus bench testing for AlarmGUARD compliance with IEC 60601-2-27 and human factors, confirm these changes maintain the same safety profile as the predicate device.