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The Esophageal Cooling Device is a thermal regulating device, intended to: - connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management System to control patient temperature, and - provide gastric decompression and suctioning.

The Esophageal Cooling Device is a multi-lumen silicone tube that is placed in the esophagus in a similar manner to a standard orogastric tube to modulate a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage and maintain the functionality of the standard orogastric tube. Modulation and control of patient temperature is achieved by connecting the Esophageal Cooling Device to an external heat exchanger. Two lumens connect to the exchanger. A third central lumen connects to wall suction and is used for standard gastric decompression. The Esophageal Cooling Device is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with an intended duration of use of 36 hours or less.

Model #: ECD01-A: The Esophageal Cooling Device is a thermal regulating device, intended to: - connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System to control patient temperature, and - provide gastric decompression and suctioning. Model #: ECD02-A: The Esophageal Cooling Device is a thermal regulating device, intended to: - connect to a Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia System to control patient temperature, and - provide gastric decompression and suctioning.

The Esophageal Cooling Device (ECD) is a multi-lumen silicone tube that is placed in the esophagus in a similar manner to a standard orogastric tube to modulate a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage and maintain the functionality of the standard orogastric tube. Modulation and control of patient temperature is achieved by connecting the ECD to an external heat exchanger. Two lumens connect to the external heat exchanger. A third central lumen connects to wall suction and is used for standard gastric decompression. The ECD is made of standard medical-grade silicone. It is a single-use, disposable, nonimplantable device.

The Esophageal Cooling Device is a thermal regulating device, intended to: - · connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System to control patient temperature, and - · provide gastric decompression and suctioning.

The Esophageal Cooling Device (ECD) is a silicone tube with three lumens that is placed in the esophagus (Figure 1). The intended function of the device is to control a patient's temperature. while simultaneously maintaining access to the stomach to allow gastric decompression and drainage. Modulation and control of patient temperature is intended to be achieved by connecting the ECD to an external heat exchanger and circulating temperaturecontrolled fluid (distilled water). Two lumens (the cooling lumens) connect to the external heat exchanger and are in contact with the esophageal tissues. A third central lumen connects to wall suction and is used for standard gastric decompression. A web supports the inner gastric lumen and separates the cooling lumens. The ECD is made of standard medical-grade silicone. It is a single-use, disposable, nonimplantable device with a stated intended duration of use of 36 hours or less. The ECD is intended to be used in conjunction with the Gaymar Medi-Therm III Conductive Hyper/Hypothermia System (cleared under K100585) with the following operating specifications: - · Dead Head Pressure: Maximum 9 psi (62 kPa) - Flow: Minimum 16 gallons/h (60.6 L/hr) - · Water Temperature Control Range: 4°C 42°C The Gaymar System supplies temperature-controlled water through a connector hose to the ECD. An accessory probe interfaces between the Gaymar System and the patient to sense patient temperature, which is displayed on the Gavmar System's control panel. The Gaymar device 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.