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The intended use of the ThermoChem™ HT-2000 System is to raise the core temperature of the peritoneum to a desired target temperature by continuously lavaging the peritoneum with circulating and warmed Lactated Ringer's Solution, U.S.P., or another physiologically compatible sterile solution.

The ThermoChem HT-2000 System is a next-generation design of the currently marketed ThermoChem HT-1000 System and consists of the ThermoChem unit, a touchscreen monitor and an Intraperitoneal Hyperthermia (IPH) Procedure Kit, or "Disposable." The ThermoChem unit houses an internal heating unit that warms distilled or sterile water to a desired temperature. This water is circulated around a single-use heat exchanger (included in the IPH Procedure Kit) where it warms Lactated Ringer's (or another physiologically compatible sterile solution) for infusion into the patient's peritoneal cavity. The IPH Procedure Kit contains two temperature probes, two suction guards, and a pressure sensor as well as a Perfusion Kit consisting of a heat exchanger, a fluid reservoir, and tubing set. The warmed Lactated Ringer's (or other physiologically compatible sterile solution) is pumped through the tubing to the patient and then returns to the fluid reservoir. The IPH Procedure Kit is a convenience kit of previously 510(k)-cleared devices that are repackaged / relabeled by ThermaSolutions, Inc. The ThermoChem HT-2000 unit has been redesigned to physically reduce the size of the unit and to allow use of components that are more commercially available. The software and touchscreen monitor user interface have been redesigned to make the device easier to use. The redesigned ThermoChem unit will continue to use the currently-marketed IPH Procedure Kit for use with the ThermoChem HT-1000 System.

The Daytripper CAPD travel warmer carrying case's intended use is to warm a single bag of peritoneal dialysate (if below 37°C) up to body temperature and maintain it until required for an exchange procedure. The Daytripper also serves as a carrying case and insulator for the dialysate.

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The intended use of the ThermoChem-HT System is to raise the core temperature of the peritoneum to the desired targeted temperature by continuously lavaging the peritoneum with circulating warmed Lactated Ringer's Solution, U.S.P., or another physiologically compatible sterile solution.

The principal components, features and functions of the ThermoChem-HT System include an internal water heater/cooler, roller-type fluid pump, inputs for monitoring temperature, touch screen to direct the user through set-up and use, computer record storage, and disposable circuit that includes an integrated heat exchanger, fluid reservoir, and tubing connectors. The user provides and places commercially available introduction and drainage catheters into the patient's peritoneal cavity. One catheter acts as an Inlet and the other as an Outlet. The user also provides the Lactated Ringer's Solution. U.S.P., or another physiologically compatible sterile solution that is circulated into and out of the peritoneal cavity. The system heats Lactated Ringer's Solution, U.S.P., or another physiologically compatible sterile solution, and circulates it into and out of the peritoneal cavity. Flow from the patient Outlet Catheter gravity drains into a fluid reservoir, then through to a roller Pump and then to an inline, disposable Heat Exchanger. The Heat Exchanger is interfaced with heated water from a heater/cooler that provides regulated temperature control to the Heat Exchanger. The heated solution then passes to the peritoneal cavity through the Inlet Catheter. The inline reservoir also aids in priming the disposable circuit and maintaining adequate fluid volumes. The system monitors the temperature of the circulating Lactated Ringer's Solution, U.S.P., or another physiologically compatible sterile solution.

For kidney patients who are on continuous ambulatory peritoneal dialysis. To heat the cialysate to within one degree of 98.6.(body temperature) As a preferred alternative to heating the dialysate using a commercial heating pad on microwave oven. The solution is heated in it's original packaging, The solution (dialysate) can be heated when travelling the car cigarette lighter adapter.

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