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510(k) Data Aggregation

    K Number
    K140078
    Device Name
    TECOTHERM NEO (T NEO)
    Date Cleared
    2014-11-14

    (305 days)

    Product Code
    Regulation Number
    870.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSPIRATION HEALTHCARE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TECOTHERM NEO is a temperature management system for pediatric patients, indicated for controlling and monitoring patient's temperature through conductive heat transfer.
    Device Description
    The TECOTHERM NEO is designed for controlled cold & heat treatment procedures and application of specific cold and heat doses to neonate and babies. The system applies cold and heat to total body, body parts and areas depending on therapy target by means of mattresses and/wrap. The main application is Total Body Treatment of Children up to body mass of 50 kg. TECOTHERM NEO consists of a unique cold & heat generating device, applied parts like mattresses/wrap, interconnecting hoses (tubing set), accessories. Applied parts are connected to the device via hoses by self- sealing quickdisconnect couplings. The patient is provided with cold or heat according to the therapy target in a fully controlled way by a circulating fluid. This physiologic safe water- based fluid is cooled or warmed in the device and flows through the mattress or wrap continuously supplying the patient with therapeutically prescribed doses. Patient temperatures are measured with approved calibrated probes connected to the TECOTHERM NEO device. Temperature data is permanently communicated to the device Operational System. Circulation of thermalizing fluid to provide cold and heat, accurately reaching set points and operating at set point temperatures accurately with max. deviation of +/-0.3 °C, monitoring the treatment, and alarming when exceeding or falling below temperature limits are performances of TECOTHERM NEO. TECOTHERM NEO is a system with built-in physiologic closed loop circuit PCLC. TECOTHERM NEO is electronically divided into an Operational System and a Controlling System. Both sub systems are micro computer (uC) based. Both uC communicate permanently to ensure safe and proper operation according to therapy needs. A comfortable user MENU will guide the operator to the treatment modes, advise how to proceed the treatment and how to manage treatment details.
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