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The intended use of the TTS100 Portable Hyperthermic Perfusion Device is to raise the temperature of the thoracic or peritoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating, warmed, physiologically compatible sterile solution, according to a protocol to be selected by the physician.

The TTS100 Portable Hyperthermic Perfusion Device is a prescription device comprised of two components - one durable and one disposable. The TTS L00 Console is the durable component - a portable, unit containing heater, pump, user touchscreen, microprocessor, and interface electronics. The primary user interface of the TTS100 is a large, color touchscreen display that receives operational commands from the clinical user, and presents normal operating conditions, flow rate, output fluid temperature, patient temperature, target temperature, line pressure, alarm and status messages, various timers and auxiliary temperatures. The TTS100 software monitors various sensors in the fluid path to ensure safe operation, automatically reacts to unsafe conditions, and alerts the clinical user to those conditions for resolution. Independent protection circuits prevent unsafe operation in the event of system software fault. The disposable, single-use component is the Hyperthermic Lavage Tubing Set, which has two subcomponents - a Circulation Loop and an Accessory Kit. The Circulation Loop contains the filtered soft-shell fluid reservoir, inlet ports, vent lines, integrated distributed sensors, patient inlet circulation loop tubing, patient outlet circulation loop tubing, and drain line. The Accessory Kit - an integral component of the Hyperthermic Lavage Tubing Set - contains patient inlet and patient outlet tubing, tubing connectors, and auxiliary temperature sensors. Portions of the Accessory Kit can be implanted into the patient for use during the lavage procedure. The Circulation Loop does not have direct patient contact - only the circulating fluid within the loop contacts the patient. The Hyperthermic Lavage Tubing set is designed such that fluid travels through the Disposable Set without wetting the heater, pump or other TTS system components (e.g., only the internal surfaces of the Disposable Set are wetted), enabling rapid and straightforward post-processing of the TTS100 Console between patients. The Hyperthermic Lavage Tubing Set is supplied sterile, packaged in a proprietary-design container, and is only intended to be used in conjunction with the TTS100 Portable Hyperthermic Perfusion Device.