Vista CMS

Vista CMS is a software-only central monitoring system for hospitals and clinical settings that integrates and displays patient clinical data from networked Dräger physiological monitors. It enables healthcare professionals to view real-time patient data and alarms, store and review historical data, print reports, configure monitor settings remotely, and access patient information across departments. The system is intended for use by well-trained healthcare professionals monitoring adult, pediatric, and neonatal patients.

Vista CMS is a software-only networked system with Monitoring Station and Viewer Station clients running on standard Windows operating systems and Intel-based computers. It supports wired and wireless Ethernet connectivity with TLS encryption, accommodates up to 128 Dräger patient monitors, and provides monitoring of ECG, RESP, NIBP, SpO2, PR, TEMP, IBP, CO2, C.O., AG, and BIS parameters. The system stores up to 720 hours of trend data and waveforms, provides drug and hemodynamic calculations, and supports multiple concurrent user stations.

IEC 60601-1-8:2006 + Am1:2012 (Medical electrical equipment - alarm systems in medical electrical equipment and medical electrical systems). Software verification and validation testing were conducted per FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Functional and system-level bench testing validated device performance.

Vista CMS is substantially equivalent to the predicate device (MFM-CMS, K232694) because both are Class II arrhythmia detectors classified under 21 CFR 870.1025, share identical intended use for centralized patient monitoring in hospital/clinical environments by trained healthcare professionals across adult/pediatric/neonatal populations, and provide equivalent core functionalities including real-time data viewing, alarm management with audible and visual indicators, data storage and review, printing, and remote configuration. Minor differences in compatible monitor types and some parameter support do not affect substantial equivalence.