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510(k) Data Aggregation

    K Number
    K180375
    Device Name
    The IQoolTM Warm System
    Manufacturer
    Brain Cool AB
    Date Cleared
    2018-05-18

    (95 days)

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

    Brain Cool AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IQoolTM Warm System is a temperature regulating system indicated for monitoring and controlling patient temperature.
    Device Description
    The IQool™ Warm System is a non-invasive, thermal regulating system that monitors and controls patient temperature within a range of 32°C to 38.5°C (89.6°F to 101.3°F). The IQooL™ Warm System consists of: ECU 100 – refrigeration and control unit – an integrated control system operated via a touch screen monitor. BC COOL– a cooling liquid consisting of diluted monopropylene glycol (MPG5). The dilution is made by BrainCool AB to optimally serve the IQool TM Warm System. Five liters of BC COOL are delivered with the system. Cooling Pads – the single use pads are the only skin contacting component and can be fitted to the head/neck, torso, and thigh. Liquid coolant is circulated from the tank through the pads to control patient temperature. The pads are designed and molded to give a good fit during treatment and are intended for single patient use. Stabilization insulation – the patented stabilization insulation is made of insulating and moisture-absorbing neoprene which supports the cooling pads and insulates against the ambient environment condensation. The elasticity of the stabilization insulation keeps the cooling pads in place during treatment and ensures maximum contact between the skin and the surface of the cooling pad. The stabilizing insulation is intended for single use only. Accessories: BC Stick – a USB flash drive used to save system configurations, specifically prepared to communicate with the program of the IQoolTM Warm System. The BC stick does not store or capture any user identifying information. It can also be used to save a log file for system troubleshooting or to update the software. Filling pitcher – for refilling the tank with BC COOL (coolant). Fill the tank with coolant before or directly after start to avoid damage to the system.
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    K Number
    K162523
    Device Name
    The IQool System
    Manufacturer
    BRAIN COOL AB
    Date Cleared
    2017-05-03

    (236 days)

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

    BRAIN COOL AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Temperature reduction for adult patients where clinically indicated, e.g. in hyperthermic patients.
    Device Description
    The IQool™ System is a surface cooling device that sustains and monitors patient temperature within a range of 33°C to 37°C. The IQool™ System consists of: ECU 100 – refrigeration and control unit – The ECU 100 is a refrigerator unit with an integrated control system operated via a touch screen monitor. BC COOL- BC COOL is a cooling liquid consisting of diluted monopropylene glycol (MPG5). The dilution is made by BrainCool AB to optimally serve the IQool™ System. Five liters of BC COOL are delivered with the system. Cooling Pads – the single use cooling pads are the only skin contacting component and can be fitted to the head/neck, torso, and thigh. Liquid coolant is circulated from the tank through the pads to cool patients. The cooling pads are designed and molded to give a good fit during treatment and are intended for single patient use. Stabilization insulation – The patented stabilization insulation is made of insulating and moisture-absorbent neoprene. The stabilization insulation supports the cooling pads and insulates against the ambient environment condensation. The elasticity of the stabilization insulation keeps the Cooling Pads in place during treatment and ensures maximum cooling between the skin and the surface of the Cooling Pad. The stabilizing insulation is intended for single use only. Accessories: BC STICK — The BC STICK is a USB flash drive used to save system configurations, specifically prepared to communicate with the program of the IQool™ System. The BC stick does not store or capture any user identifying information. It can also be used to save a log file for system troubleshooting or to update the software. Filling pitcher – The filling pitcher is for refilling the tank with BC COOL (coolant). Fill the tank with coolant before or directly after start to avoid damage to the system. The ECU 100 pushes temperature-controlled BC COOL ranging between 4°C and 30°C through the Cooling Pads at approximately 1.2 liter per minute per pad. This results in heat exchange between the BC COOL and the patient. Patient temperature is monitored by one or two commercially available third-party temperature probes. The IQool™ System maintains a controlled patient temperature during the entire treatment period. Any deviations from the default temperature are automatically adjusted by the system. The default treatment settings for temperature and time can be changed through the touchscreen monitor. Alarms and notifications are activated if any errors are detected. Temperature graphs for each treatment are shown on the touchscreen display for visual monitoring.
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