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H2Only Water Purification System for Hemodialysis is intended for use in hemodialysis treatment. It is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. When used as a medical device, Federal law restricts this device to sale by or on the order of a physician.

The H2Only Water Purification System for Hemodialysis is a complete water purification system and consists of either one (1) or two (2) reverse osmosis units (RO). Our recommendation to use an RO individually is based upon feed water quality and the demand of water to be used. Pretreatment includes activated carbon filtration media to remove organics, namely chlorine and chloramines. In order to optimize the performance of the RO system, the following items, are utilized: 1) a water break tank or back flow preventer as required; - booster pumps as required to increase the feed pressure to the treatment equipment; 2) - a water softener to remove scale-forming minerals; 3) - cartridge filters to remove suspended solids; 4) - a temperature blending valve to produce the desired water temperature. 5) In order to compensate for fluctuations in demand, an air-tight storage tank with a 0.2 micron vent filter, level control and internal spray array is utilized to store RO product water until needed. The first RO system feeds the storage tank, the second RO system is fed from the storage tank and its product water is directly fed to the distribution plumbing. What ever water is not used in the distribution loop is returned to the storage tank, thus a constant recirculation flow is maintained in the distribution plumbing loop. - when only one RO system is utilized, Ultraviolet disinfection, Deionization Exchange 6) Tanks and Ultrafilters are also incorporated into the system design. By utilizing this twin RO system concept a few components can be eliminated from the system design. These components are: Deionization backup tanks, ultraviolet sanitizer, ultrafilters and repressurization pumps. The elimination of these additional components improves system reliability and reduces overall system operational costs . Also by using the twin RO design the system may be safely operated on either RO system feeding the distribution loop, this feature provides system backup and eliminates down time. When feed water quality demands or when requested by the facility physician, optional devices can include the following components: - cartridge filtration for the removal of silt or feed water sediment; 1) - 2) automatic backwashing multimedia fitter for the removal of suspended solids; - 3) ultraviolet disinfection to reduce bacteria either in the influent water supply or on the product supply; - 4) a booster pump to increase influent water pressure sufficient to provide adequate flow and pressure to the water treatment system. Water treatment components are recommended based on the demand of water required, a feed water analysis, and the ability to produce water which meets AAMI standards. H2Only Water Systems will always recommend a water purfication system which will exceed Hemodialysis Water Quality Standards as set forth by AAMI.