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The CritiCool is a thermal regulating system, indicated for monitoring and controlling patient temperature.

The CritiCool system consists of the following elements: - Temperature controlled garment . - . Body sensors - Connecting flexible water pipes . - Heating/Cooling Unit . The system is operated by circulating water by a pump in a closed loop between the device and a disposable garment - CureWrap, worn by the patient. The water circulates through the thermoregulating unit. Temperature (body) sensors are placed on the patient's skin to measure surface temperature and in the rectum, nasopharynx or esophagus to measure core temperature. The operator selects the desired patient core temperature (between 30-40°C) and the unit automatically controls it via a feedback loop. The heating / cooling unit is based on a solid-state thermo-electric device, which operates as a heat pump

The Allon 2001 version 5 is intended to maintain pre- set body temperature as determined by the physician. It can also be utilized to maintain normal body temperature during surgical procedures. It is indicated for use in hospital invasive and coronary care units, in operating, recovery and emergency rooms, in burn units, and on medical / surgical floors. This system can be used with adult and pediatric patients.

The Allon 2001 vesion 5 system consists of the following elements: - Temperature controlled disposable garment - Body sensors - Connecting flexible water pipes - Heating/Cooling Unit The system is operated by circulating water by a pump in a closed loop between the device and a disposable garment worn by the patient. The water circulates through the heating/ cooling unit. Temperature (body) sensors are placed on the patient and in the rectum, nasopharynx or esophageal to measure core temperature. The operator selects the desired patient core temperature and the unit operates in an automatic mode. Patient temperature is controlled and maintained at any set point between 30-40°C using a feedback loop and sensors placed on the patient's body. The heating/cooling unit is based on a solid-state thermo-electric device, which operates as a heat pump. The system is intrinsically safe, due to the characteristics of the thermo-electric device, heating capacity drops off as the Thermo Electro Cooler (TEC) temperature rises. Hence, if for any reason, flow of coolant is interrupted, the TEC will overheat and the power output will fall, thus limiting water temperature rise. The disposable garment is provided in a variety of shapes and sizes, which are manufactured of the same materials and by the same process as those already cleared under K001546, K992386 and K003349.

The Allon 2000 System is intended to maintain pre-set body temperature as determined by the physician. It can also be utilized to maintain normal body temperature during surgical procedures. The Allon 2000 System is indicated primarily for use in hospital invasive and coronary care units, in operating, recovery and emergency rooms, in burn units, and on medical/surgical floors. This system can be used with adult and pediatric patients.

The Allon 2000 Hyper-Hypothermia system is used to either lower or raise a patient's temperature and/or maintain a desired patient temperature using a garment, which is wrapped around the body during and after surgery to achieve maximum coverage. This, for example, minimizes the tendency of the body to cool down as a result of anesthesia and exposure. The garment can be configured to cover any surface area of the patient's body and yet not to interfere with areas that must be exposed during surgery. As a flow of cooled or heated water is forced through the garment by the pump of the Allon 2000 System, the heat is exchanged with the body. The water temperature is controlled and maintained at any temperature between 59 and 104.3ºF (15 - 40.2ºC) using a feedback loop based on surface and core thermostat sensor readings.