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510(k) Data Aggregation

    K Number
    K103796
    Device Name
    TELEMEDCARE HEALTH MONITOR
    Manufacturer
    TELEMEDCARE PTY LTD
    Date Cleared
    2011-08-03

    (219 days)

    Product Code
    DRG
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    TELEMEDCARE PTY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TMC Health Monitor is intended to facilitate monitoring and transmission to a remote server of certain physiological parameters relevant to the remote management of health status and chronic disease conditions. The TMC Health Monitor is a system that provides: - Monitoring and display of vital signs/health parameters. - Management and scheduling of clinical measurements and questionnaires. - A web connection to patient health information. - Reporting to clinicians and allied health workers. The device has been designed to provide the user with information to assist with an appropriate treatment program or further investigation.
    Device Description
    The TeleMedCare Health Monitor is designed to be used in the home or community setting to enable remote care management of patients with chronic illness. The TeleMedCare Health Monitor is an ergonomic design table top device with a touch screen and associated measurement components that may be integral or connected to it wirelessly or by cable. After measurements are recorded, the data is viewed and stored on the device then automatically transmitted via telephone modem or local area network (LAN) to a secure remote server. This data is then able to be viewed remotely over the web by the user's health care professional to assist them with chronic care management. Access to information stored and processed by the device is by means of password protection, encryption and use of collocated secure servers. The device also provides a means of messaging and video teleconferencing between the patient and carer to discuss their health and treatment. Questionnaires may also be configured by the carer to gauge other aspects of a patients well being. TeleMedCare software, captures, stores and transmits health data and access controlled carer's may set upper and lower limits to allow notification to them when these limits are exceeded to review health care management. The device however does not offer critical care or emergency support and requires professional medical interpretation for treatment of prescribed users. The System has functionality and devices to record, store and transmit data for body blood pressure, glucose and oximetry, heart rate (ECG), lung function (Spirometry), body temperature and weight. Power to the device is supplied by a medical grade power supply delivering 12 volts D.C to the system via a cable plugged into the back of the unit along with connection to tethered external measurement modules and the internet. The TeleMedCare Health Monitor has been tested and complies with international standards for electrical and electrocardiograph safety, electromagnetic compatibility and telecommunication standards.
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