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510(k) Data Aggregation
K Number
K993643Device Name
NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100
Manufacturer
Date Cleared
1999-12-28
(61 days)
Product Code
Regulation Number
870.2800Why did this record match?
Applicant Name (Manufacturer) :
NEXAN TELEMED LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Nexsystem ambulatory patient monitoring system is intended for use in the home or alternate care settings. It consists of a patient-worn sensor (Nexisensor), signal transfer unit (Nexender), communications module (Nextation), and a telemonitoring station computer based display and storage system (TMS) located at the health care professional's facility. The device stores and transmits ECG data, respiratory data, skin temperature, systolic and diastolic blood pressure (Non-invasive), and PEF and FEV1.
The Nexsystem is not for use as a critical care monitoring system. The Nexsystem is not an apnea monitor.
Device Description
The Nexystem is a non-invasive ambulatory patient monitoring system for recording multiple physiological parameters from patients who may be located at home or in an alternate care setting. The Nexystem continuously gathers physiological data from a sensor band attached to the patient and transmits the data wirelessly via a Signal Transfer Unit (Nexender) to a Base Station Unit (Nextation) where the data are recorded and stored. Additionally, the Base Station Unit has interfaces for auxiliary sensors - spirometer and blood pressure monitor - for recording point in time lung function and blood pressure measurements. A Call Discriminator Unit enables incoming telephone calls to be correctly routed to either the Nextation or a telephone handset.
The data are transmitted for display, monitoring and storage on a computer (Telemonitoring Station TMS running the Nexoft application software) at a distant location (Telemonitoring Centre). This data transfer is under the control of the Health Care Professional (HCP) at the TMS. Data may be transferred in real time to enable the HCP to check on the quality of the physiological data being recorded and/or the status of the patient. Normally data is transferred at a scheduled time after the end of a patient data recording session. Once transferred to the TMS the data can subsequently be displayed for analysis by the HCP. The Nexystem enables the HCP to print reports of raw or summary data.
The Nexystem comprises a number of system components identified below.
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