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510(k) Data Aggregation
K Number
K103634Device Name
ASCOM CLINICALCONNEX CARDIOMAX
Manufacturer
ASCOM (US), INC.
Date Cleared
2011-02-23
(72 days)
Product Code
MSX
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
ASCOM (US), INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Ascom ClinicalConneX Cardiomax (Cardiomax) is to provide an interface with clinical systems to forward information associated to the particular event to the designated display device(s). For medical, near real time alarms, the Ascom Cardiomax is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. Ascom Cardiomax does not alter the behavior of the primary medical devices and associated alarm annunciations. The display device provides a visual, and/or audio and/or vibrating mechanism upon receipt of the alert. The Ascom Cardiomax is intended for use as a secondary alarm. It does not replace the primary alarm function on the monitor.
Device Description
The Ascom (US), Inc. (Ascom) ClinicalConneX | Cardiomax (Cardiomax) 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 voice, text, alarms or data. The Ascom Cardiomax allows users to be aware of their patients' status and alarm conditions when they are away from the patient and patient monitoring system. The Ascom Cardiomax connects to the information sources through wired ethernet connections which are part of the customer's infrastructure. The Ascom Cardiomax software acquires patient data from patient monitoring devices. The user configures the Ascom Cardiomax to determine which information, including alarm notifications, is delivered to which users. The Ascom Cardiomax then formats the data for wireless delivery to the display devices. All messaging activities are recorded in the Ascom Communications Server providing real-time activity logging for audit trail records and reporting. The Ascom Cardiomax hardware consists of small, embedded network appliances, and application-specific software. The Ascom Cardiomax delivers near real-time text messaging alerts and information to text-capable display devices. Ascom provides a wireless communications system platform on which the Ascom Cardiomax may operate: DECT (Digital Enhanced Cordless Telecommunications) technology. The Ascom Cardiomax, combined with an Ascom 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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