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The Arctx Cool Catheter Set is a thermal regulating device, intended to: connect to a Blanketrol III Hyper-Hypothermia System to control patient temperature, allow enteral administration of fluids, and provide gastric decompression and suctioning.

The ACC Set is comprised of the Arctx Catheter and the Arctx Extension Line.

The ACC Set is intended to cool or warm a patient's temperature for up to 72 hours when connected to a commercial external thermal regulating system, provide gastric decompression and suctioning, and allow enteral administration of fluids. The Arctx Catheter is inserted through the nasopharynx, past the oropharynx and into the esophagus and stomach/duodenum where two lumens deliver cooled or heated water in a closed circuit, from a commercial thermal regulating system to control patient temperature. The circulating water does not contact the patient.

A third catheter lumen enables gastric suction and decompression as well as enteral administration of fluids.

The Arctx Catheter is made of standard medical-grade thermoplastic elastomers. It is a single-use, disposable, non-implantable device. The ACC Set has a quick-connect system that allows the Arctx Catheter to be easily disconnected from the Arctx Extension Line while the catheter remains in place. The quick-connect system allows the patient to move around freely for bathroom breaks, and other medical procedures outside the hospital room. The Arctx Catheter connects to the external thermal regulating system via the Arctx Extension Line.

The ACC Set is intended to be used with the Gentherm Medical Blanketrol III System, model #233. The Blanketrol III System supplies temperature-controlled water through a connector conduit to the ACC Set. An accessory temperature probe interfaces with the Blanketrol and the patient to measure patient temperature, which is displayed on the Blanketrol III System control panel. The Blanketrol III System controls water temperature by mixing hot and cold water using hot and cold solenoid valves under microprocessor control, and includes a circulating pump, heater, and refrigeration system.

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