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This device is intended to remove organic and inorganic substances and microbial contaminants from water that is used to dilute dialysis concentrate to form dialysate, and to produce purified water for dialyzer reprocessing and equipment rinse and disinfection.

The PURE WATER Solutions' Water Purification System for Hemodialysis is designed to provide water of the required quality to meet AAMI standards for riohodialysto is actigate will remove organic, inorganic and microbial contaminants from the influent water supplied to Hemodialysis clinics. This system comes in various sizes to provide the proper volume of water for each individual clinic. It is easily used and maintained by clinic technicians. The water treatment phase or pretreatment includes multi-media filtration to reduce suspended solids, water softening to reduce hardness and granular activated carbon filters to remove chlorine and chloramines. If finer filtration is required, cartridges with appropriate housings may be used. The purifier phase includes reverse osmosis (RO) and or portable-exchange deionization (DI). The primary method will be reverse osmosis using an existing FDA cleared device. DI may be selected for use either independently or in conjunction with RO depending upon the influent water analysis, the available space and the demand required. If DI is selected, then 0.1 micron, absolute, final filters will be installed downstream of the DI and a temperaturecompensated, conductivity instrument will be used to monitor the quality. The circulation phase or post treatment may consist of an RO storage tank with an appropriate 0.2 micron, absolute, vent filter, a stainless steel repressurization pump, ultraviolet sterilization, and 0.05 micron, absolute, final filter. Auxiliary devices such as booster pumps, temperature blending valves, pressure gauges, sample ports, fittings, piping, level control switches and remote alarms are used as needed throughout the system. A clean-in-place system consisting of an inert plastic or stainless steel pump and a solution tank is used to clean RO membranes. A paracetic acid disinfection product may be used to chemically disinfect the RO while ozone is used to disinfect the circulation phase.