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Temperature reduction for adult patients where clinically indicated, e.g., in hyperthermic patients.

Global Healthcare SG has developed the CarbonCool® products as a portable, non-invasive body cooling solution designed to enhance temperature reduction for adult patients. The CarbonCool® also enables more widespread applications by reducing treatment cost and increasing treatment flexibility and accessibility. The CarbonCool® System is a single use passive body cooling solution designed for medical and comfort cooling purposes. The CarbonCool® System utilizes the MPad™ which consist of multiple cooling-cells made of thermoplastic polyurethane, filled with high thermal conductivity material.

Thermogard HO™ Temperature Management System Temperature reduction in adult patients where clinically indicated, e.g., in hyperthermic patients. Thermogard XP® Temperature Management System Temperature reduction in adult patients where clinically indicated, e.g., in hyperthermic patients.

The subject of this 510(k) is the new surface feature which makes minor modifications to the existing IVTM Start-Up Kits (SUKs) to enable connection of a Thermogard console to the STx™ Vest provides for circulation of thermally conditioned fluid supplied by the Thermogard console (either Thermogard HQ™ or Thermogard XP®). Transfer of heat between the patient and the circulating fluid results in modification of patient core temperature for the purpose of therapeutic patient temperature modulation. The existing, commercialized Thermogard Systems (Thermogard HQTM and Thermogard XP®) are used in conjunction with catheters placed in the vasculature to support intravascular cooling. The TGHQ-SURF accessory is a modification of the model TGHQ-500D accessory which was verified, validated, and commercialized. The CG-SURF accessory is a modification of the model CG-500D accessory which was verified, validated, and commercialized. These Surface SUK models are identical to their predecessors with the exception of longer inflow and outflow tubing lengths and replacing the Luers for catheters with 0.25inch hose barb valved connectors for the STx™ Vest. The Surface SUK also has a label on the fluid spike to indicate the size of bag of fluid (3000ml) to use and to mark it as non-sterile. The Surface SUKs are otherwise identical to their predecessors in terms of materials that contact the heat exchange fluid (i.e., saline), manufacturing process, and packaging materials. There are no changes to the commercially available Thermogard XP® (K213031) and Thermogard HO™ (K220008) consoles. There are no changes to the commercially available STxTM Vest.

Temperature reduction for adult patients where clinically indicated, e.g. in hyperthermic patients.

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.

Temperature reduction in adult patients where clinically indicated, e.g. in hyperthermic patients.

The EMCOOLSpad is a single use surface (skin) cooling device, which is adherent to the patien's skin and so highly adjustable during the cooling procedure. An EMCOOLSpad consists of multiple cooling-cells made of thermoplastic polyurethane, filled with high thermal conductivity material, stored frozen at 0 to -10°C.

The ThermoSuit System™ is a thermal requlating system. Indications for Use are a. Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients; b. Monitoring of patient temperature.

The ThermoSuit System (TSS) is a device that allows rapid patient cooling by the circulation of cold water in direct contact with the skin of the patient. Patient temperature measurements control the extent and duration of cooling, by controlling pump output and drainage of cooling fluid. Temperature measurements and associated alarm signals are designed to prevent overcooling. The ThermoSuit System™ consists of the following main components: - . ThermoSuit Body Enclosure - Multi-lumen Umbilicus Hose . - . Reservoir/Pump Assembly - . Pump Controller Console - . Other Components