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The HydroPure "Acute" Portable Exchange Deionization (PEDI) System consists of two each small carbon and mixed bed DI tanks with pre & post-filtration. It is intended to be placed on the back of a dialysis machine or on a handcart for single patient dialysis. The HydroPure "Central" PEDI System consists of two or more carbon and mixed bed DI tanks with pre & post-filtration. It is intended to be installed in a central location for multiple patient dialysis. The HydroPure "Back-up" PEDI System consists of two or more mixed bed DI tanks as a component in a "back-up" condition when a RO system or major component on a water purification system for hemodialysis is in need of repair. It may also be used in DI polishing mode to remove ions that an RO could not lower to safe levels. All three PEDI systems with appropriate pre & post-filtration and components is intended for use with a hemodialysis system to remove organic and inorganic substances from water that is used to dilute dialysis concentrates to form dialysate and to produce purified water for other purposes such as dialyzer reprocessing and equipment rinse and disinfection.

The HydroPure systems purify potable feed water through deionization. Deionization is used to remove 99.99+% of ions from water. Deionization alone does not remove particulates, organics, bacteria, viruses or endotoxins. The systems require adequate pretreatment and post-treatment. Deionizers are designed for the hemodialysis application to treat RO or carbon filtered potable water. Inappropriate use can result in the formation of Nitrosamines in the effluent of the deionizer. The purpose of the pretreatment section of the system is to condition the feed water supplying the deionizers. Conditioning the feed water will include: pressure reducing valves to regulate system pressure, check valves to prevent back-flow of the treated water into the potable water source, cartridge filters to reduce particulates and sediment, carbon filtration tanks to remove chloramines and sample ports after each carbon tank to check feed water conductivity and for any chlorine/chloramine residual. The purpose of the post-treatment section of the system is to remove bacteria and endotoxins or lower them to acceptable levels as required by the AAMI standards. The post-treatment section of the system will include: submicron/ultrafilters after the deionizers. sample ports to check for microbial contamination and to test for comprehensive AAMI analysis, a 200K ohm quality control light at mid tank and a temperature compensated audible visual resistivity alarm set at one megohm or greater for final water quality. A remote alarm will be installed if the deionization system is not located in the patient treatment area. A distribution section of a system is necessary to deliver product water that meets ANSI/AAMI standards to the points of use. During use, continual monitoring of the effluent through the use of the temperature compensated audible and visual resistivity alarm is required. Routine monitoring of the mid tank quality indicator is also required on intervals during the day, at least before and after each patient treatment. Should final water quality fall at or below 1 megohm, the alarm will sound and light up red and all patient treatments must be discontinued. The deionization tanks must be replaced as per Appendix C of the operating manual prior to resuming any patient treatment. Depending upon the PEDI system size and feed water quality of 10grains TDS, HydroPure systems produce typically 250 gallons per deionization tank exchange at a flow-rate of up to 0.75gpm, to 3,600 gallons per deionization tank exchange at a flowrate of up to 15gpm. HydroPure's water purification systems will produce product water that meets the requirements of the standard issued by the American National Standard Institute and the Association for the Advancement of Medical Instrumentation: ANSI/AAMI RD62:2001, Water Treatment Equipment For Hemodialysis Applications.