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510(k) Data Aggregation
K Number
K180566Device Name
Unite Connect for Clinical Systems
Manufacturer
Date Cleared
2018-04-03
(29 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 intended use of the Ascom Unite Connect for Clinical Systems 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, Connect for Clinical Systems is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. Connect for Clinical Systems 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.
Connect for Clinical Systems is intended for use as a secondary alarm. It does not replace the primary alarm function on the monitor.
Device Description
Ascom Sweden AB (Ascom) Unite Connect for Clinical Systems (Unite Connect) is a software application installed on a Windows server environment capable of acquiring alarms, events, parameters and waveforms from clinical systems and intelligently forwarding that information as notifications to designated display devices provided by Ascom or third-party mobile device companies. The device operates within the Ascom Unite Messaging Suite for Healthcare application environment.
Unite Connect is designed to accept inputs from a variety of clinical systems utilizing standardized and proprietary protocols including the following:
● Spacelabs XprezzNet
● Dräger Infinity Gateway
Users receive interactive, time-critical information from clinical systems directly via their display devices as text, alarms, static waveform images or data. Received attributes related to the presentation of alerts include color and quantity of tones (beeps) in addition to and in coordination with event priorities. Unite Connect allows users to be aware of their patients' status and alarm conditions when they are away from the patient and patient monitoring system.
Unite Connect connects to the information sources through wired ethernet connections which are part of the customer's infrastructure, and acquires patient data from clinical systems. The user configures Unite Connect to determine which information, including alarm notifications, is delivered to which users. Unite Connect then formats the data for wireless delivery to the display devices through Unite Connectivity Manager (Unite CM) or the Unite Communication Server (Unite CS).
All messaging activities are recorded in Unite CM or Unite CS providing real-time activity logging for audit trail records and reporting. Unite Connect delivers near real-time text messaging alerts and information to text-capable display devices.
Ascom provides wireless communications system platform for delivery of notifications to display devices, the technologies include DECT (Digital Enhanced Cordless Telecommunications), WiFi, Paging and GSM/3G/4G.
Unite Connect, 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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