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510(k) Data Aggregation
K Number
K111215Device Name
ASCOM MOBILE MONITORING GATEWAY (MMG)
Manufacturer
Date Cleared
2011-07-05
(64 days)
Product Code
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
ASCOM (SWEDEN) AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Ascom Mobile Monitoring Gateway (MMG) is intended to interface with the GE Healthcare patient monitoring network and the Ascom Messaging System, in order to provide a secondary means of automated visual and/or audible annunciating and displaying of patient alarm information to healthcare professionals, via display devices.
The MMG does not alter the behaviour of the monitoring system. Neither is it intended to replace or alter the primary alarm function on the patient monitor. The MMG is not intended to be used for diagnostic purposes.
The MMG is intended for use by professional clinical personnel and relies on proper use and operation of both the communication infrastructure in place at the healthcare facility and the display devices used.
The MMG software is installed on specified hardware located in a computer hall or similar, where the MMG can't come into physical contact with patients.
Device Description
The Ascom Mobile Monitoring Gateway (MMG) is an on-site messaging integration solution which forwards patient monitor status and alarm information to the user via display devices provided by Ascom or third-party mobile device companies. Users receive interactive, time-critical information from patient monitoring devices directly via their display devices as text, alarms or data. The Ascom MMG allows users to be aware of their patients' status and alarm conditions when they are away from the patient and patient monitoring svstem.
The Ascom MMG connects to the information sources through wired Ethernet connections which are part of the customer's infrastructure. The Ascom MMG software acquires patient data from patient monitoring devices. The user configures the Ascom MMG to determine which information, including alarm notifications, is delivered to which users. The Ascom MMG then formats the data for wireless delivery to the display devices.
All messaging activities are recorded in the Ascom Unite Connectivity Manager providing real-time activity logging for audit trail records and reporting. The Ascom MMG hardware consists of small, embedded network appliances, and application-specific software. The Ascom MMG delivers near real-time text messaging alerts and information to text-capable display devices.
The Ascom Mobile Monitoring Gateway operates on a wireless communications system platform. The communication platform uses DECT (Digital Enhanced Cordless Telecommunications), WiFi and Paging technology. The Ascom MMG combined with a wireless communication system, is part of an Ascom end-to-end solution designed to provide all the components necessary to optimize work flow, including display devices, gateways and device management.
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