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510(k) Data Aggregation
K Number
K180430Device Name
Digistat Smart Central
Manufacturer
Date Cleared
2018-11-23
(280 days)
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
ASCOM UMS srl unipersonale
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the Digistat Smart Central is to provide an interface with clinical systems to forward information associated to the particular event from patient monitors, ventilators, and infusion pumps to the designated display device(s). For medical, near real time alarms, the Digistat Smart Central is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. The Digistat Smart Central 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 Digistat Smart Central is intended for use as a secondary alarm. It does not replace the primary alarm function on the medical devices.
Device Description
Digistat Smart Central is an on-site integration solution which forwards medical device status and alarm information to the user via display devices provided by Ascom or third-party companies. Users receive, time-critical information from connected medical devices directly via their display devices as text, alarms or data. Digistat Smart Central allows users to be aware of their patients' status and alarm conditions when they are away from the patient and associated medical devices.
Digistat Smart Central connects to the information sources through wired ethernet connections which are part of the customer's infrastructure. Digistat Smart Central software acquires patient data and information through DIGISTAT Connect, a MDDS, from medical devices including patient monitors, ventilators, and infusion pumps. The user configures Digistat Smart Central to determine which information, including alarm notifications, is delivered to which users. Digistat Smart Central then formats the data for delivery to the display devices.
Digistat Smart Central is not in contact with the patient. It is intended to forward the information generated by the connected medical devices and systems and it does not generate patient related alarms. As such, the patient population and patient conditions are established by the medical devices and systems to which the product is connected.
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