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The IQool System is a thermal regulating system indicated for monitoring and controlling patient temperature.

The IQool™ System is a non-invasive, thermal regulating system that monitors and controls patient temperature within a range of 33°C to 38.5°C (91.4°F to101.3°F). The IOooL™ 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™ System. Five liters of BC COOL are delivered with the system. - Cooling Pads The Cooling Pads are made of non-sterile, biocompatible material and do ● not contain latex. The Cooling Pads are intended for single use only. - . Stabilization Insulation - The patented stabilization is made of insulating and moisture-absorbent neoprene. It insulates against the ambient environment while counteracting condensation. The elasticity of the stabilization keeps the Cooling Pad 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 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 should be used to fill or refill the coolant tank. Fill the tank with coolant before or directly after starting to enable start of the system. The IQool™ System is a thermoregulatory device that monitors and controls patient temperature within a range of 33°C to 38.5°C. The IQool System refrigeration and control unit (ECU 100) pushes a temperature-controlled cooling agent (BC COOL), ranging between 4°C and 40°C, through the Cooling Pads applied to the patient. This results in heat exchange between the BC COOL and the patient. Patient core temperature is monitored and controlled based on the temperature probe (PT1) attached to the system. The IQool™ System maintains a controlled patient temperature during the entire treatment period. The default treatment settings for temperature and time can be changed via 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. After a treatment, a detailed log file can be collected with the memory stick (BC STICK).

The Cooral Device is intended to cool the oral mucosa during chemotherapy treatments to reduce the likelihood and severity of chemotherapy induced Oral Mucositis in adult patients.

The Cooral System is an intraoral mouthpiece that cools the oral mucosa using a water coolant which circulates internally through the mouthpiece for patients undergoing chemotherapy treatment to reduce the likelihood and severity of oral mucositis. Oral mucositis is one of the most common, debilitating complications of cancer treatment. The device consists of an energy control unit with a computerized control system to which an intraoral mouthpiece is connected via plastic tubing. Liquid coolant (sterile water) is circulated from the tank through the plastic tubes of the intraoral mouthpiece and is designed to specifically cool the areas where the major arteries enter the oral cavity. The cooling is initiated 30 minutes prior to start of chemotherapy infusion and continues 30 minutes after termination of the infusion time can vary between 15 min to 3 hours based on the half-life of the chemotherapeutics. The Cooral System pushes temperature-controlled coolant which results in heat exchange between the Cooral System, and the patient's oral mucosa. The coolant temperature is controlled by a thermostat and its temperature probe. The Cooral System maintains a controlled coolant temperature at 8°C during the entire treatment period. The device is intended to use is intended to reduce the severity and likelihood of oral mucositis in patients undergoing chemotherapy treatment. The device is a system made out of different components. The device consists of three components: - 1) Computerized Control System (ECU 200 refrigeration and control unit) - 2) Plastic tubing connecting the ECU to the mouthpiece - 3) Intraoral Mouthpiece