Search Results

The AmeriWater MediQA Reverse Osmosis System is one component of a water treatment system designed to pre-treat and purify potable water using reverse osmosis for making dialysate for hemodialysis applications. The device is intended to be a component in a complete water purification system, and is not a complete water treatment system. It must be preceded by pretreatment devices, and may need to be followed by post-treatment devices as well to meet current AAMI and Federal (U.S.) standards. The AmeriWater MediQA is intended for use in water rooms in a hospital, clinic, or dialysis center. The device includes an integrated heat sanitization process.

This Special 510(K) submission is for the addition of a new model to the AmeriWater MediQA Reverse Osmosis System product line originally cleared for market under 510(k) number K131904. The new model. MSP3HF is complementary to the rest of the product line and is not intended to replace or enhance features of any existing model. The MSP3HF is a single pass reverse osmosis (RO) that uses pretreated soft water to produce water for hemodialysis applications. The system is capable of producing dialysis quality water at a flow rate up to 16.0 gallons per minute (gpm). The new model, like the predicate device, includes heat sanitization capabilities for the reverse osmosis system. Model MSP3HF, is identical in design to the existing model MSP3 (K131904) with the exception of the RO pump. While model MSP3 includes a pump with a 20-stage impeller, the new model MSP3HF includes a pump with a 24-stage impeller (currently used on model MDP4). The increase in impeller stages results in the pump forcing more water through the existing membrane elements per unit time. Both the 20-stage pump and the 24-stage pump include the same pump motor. The increase in flow rate does not exceed the operating parameters of the membrane elements per the membrane manufacturer's specifications, and operating pressures remain the same as the predicate device. The increased flow rate does not change the product water quality (level of impurities), and the product water continues to meet all current AAMI/ISO and Federal requirements as confirmed by verification and validation testing. There are no changes to the software used in the device or to the water contacting materials. All software and materials used in the new model are identical to the predicate device. The new model does not result in any changes to the heat sanitization process. The temperatures, contact times, and operating pressures remain the same as the predicate device. During the heat sanitization process, the heated water is recirculated through the MediQA system for the duration of the contact time. The flow path, operating pressure, water temperature, and contact time are identical between the predicate device and the new device during heat sanitization. There are no new issues regarding safety or effectiveness of the heat sanitization process. The scientific concept for the operation of the AmeriWater MEDIQA Reverse Osmosis System is the principle of reverse osmosis. The MEDIQA system uses a pump (RO pump) to apply the pressure required for reverse osmosis. Pretreated soft water enters the MEDIQA through an inlet solenoid valve, filling the feed water tank. The RO pump forces water from the feed tank through the RO membrane elements. The water entering the RO membrane element exits the membrane element in two flow streams. The water forced through the RO membrane element is known as permeate water. It is purified water that meets all current AAMI/ISO and Federal requirements for water used in hemodialysis applications. The water rejected by the membrane contains an increased level of dissolved contaminants. It passes out of the RO module as the second flow stream called concentrate, and is sent to drain. The built in heat sanitization feature provides heat sanitization of the reverse osmosis membranes and the MEDIQA system's pipe work. Heat sanitization can be activated manually using the HEATSAN buttons on the touch screen display or automatically if timer clock settings are implemented. The frequency of heat sanitization will depend upon usage and application demands. Monitoring of the system for bacterial content is required at regular intervals to determine the optimum frequency for heat sanitization.

The AmeriWater Ozone Disinfection System is an optional accessory for the AmeriWater Bicarb Solution Mix and Distribution System (SDS) cleared for market under K051031 and the AmeriWater Water Purification System (WPS) for Hemodialysis cleared for market under K991519. It is intended for use in hospitals and dialysis clinics for the disinfection of the AmeriWater SDS and WPS system. The disinfection process is completed during off-hours when the SDS or WPS are not being used for patient treatment. The AmeriWater Ozone Disinfection System provides dissolved aqueous ozone concentrations of at least 0.5 ppm with a contact time of at least 30 minutes for disinfection of the WPS and SDS systems (the entire disinfection process takes approximately 2 hours to complete and longer contact times may be necessary based on microbial loads). The Ozone Disinfection System is designed to produce water with a microbial count of 50 CFU/ml or less.

The AmeriWater Ozone Disinfection System is a compact portable device that connects to the AmeriWater Bicarb Solution Mix and Distribution System (SDS) and the AmeriWater Water Purification System (WPS) for Hemodialysis for disinfection of the systems. Microbial reduction is achieved by a combination of disinfection by ozone and by physical removal by draining, flushing, and refilling the system being disinfected with fresh water. The Heatsan system has been designed to be in compliance with the requirements of ANSI/AAMI/ISO 13959:2009 Water for hemodialysis and related therapies and ANSI/AAMI/ISO 26722:2009 Water treatment equipment for hemodialysis applications and related therapies. The AmeriWater Ozone Disinfection System uses a high technology corona discharge process for producing ozone. Ozone is manufactured by drawing oxygen (O2) into the ozone generator and exposing it to multiple high voltage electrical discharges. This causes a percentage of the oxygen molecules to dissociate and reassemble as ozone (03). The ozone is drawn into the water by a venturi injector / mixer allowing the ozone to be injected into the water under a vacuum condition. The AmeriWater Ozone Disinfection System is a complete unit with ozone generator, venturi injector mixer, gas off chamber with excess ozone gas destruct, feed water flow meter, oxygen flow meter, and vacuum gauge. The driving force of the AmeriWater Ozone Disinfection System is the distribution pump on the WPS water loop and the mix and distribution pumps on the SDS. A valve arrangement installed on the outlet of the WPS distribution pump and the SDS pumps allow for the diversion of purified water flow into the AmeriWater Ozone Disinfection System and back into the SDS or WPS storage tanks. The pumps force the purified water from the WPS storage tank into the Ozone Disinfection System, which enriches it with ozone and returns it to the WPS storage tank. Likewise, the purified water from the SDS mix and distribution tanks is pumped into the Ozone Disinfection System where it is enriched with ozone and returned to the tanks. When the water flow has been adjusted properly, a vacuum will draw oxygen (from a medical grade oxygen source) into the ozone generator and ozone will be created. The ozone generator has a vacuum switch and will not operate without an adequate vacuum from the venturi injector as indicated on the Ozone Disinfection System vacuum gauge. The purified water from the WPS or SDS flows into the Ozone system through the feed flow meter and into a venturi injector creating a vacuum that draws the oxygen through the generator creating ozone in concentrations greater than 0.5 ppm. The ozone is then mixed in the ozone rich water enters the gas off tank to remove any excess, un-dissolved ozone gas. The water-ozone mixture enters and exits at the bottom of the gas off tank. The excess (un-dissolved) ozone will slowly displace the water in the tank and is vented at the top of the tank. The excess ozone gas then enters the ozone destruct chamber where it is destroyed while the ozone-rich water is directed back to the system being disinfected. Ozone concentrations are monitored using RPC Ozone Test strips, cleared for market under K132344. The intended disinfection endpoint for the AmeriWater Ozone Disinfection System with the AmeriWater Water Disinfection System (WPS) and the AmeriWater Solution System (SDS) following disinfection and rinse is a total bacterial count less than or equal to 50 CFU/mL; when the system being disinfected is properly maintained (with bacterial counts < 100 CFU/mL; and endotoxin < 0.25 EU/mL). In the event that the system being disinfected has not been properly maintained, additional contact time or additional disinfection cycles may be required to achieve the desired end point. ANSI/AAMI/ISO 13959:2009 requires that monitoring of the water storage tanks for bacteria and endotoxin levels is accomplished indirectly by monitoring the water at the distribution loop. Water distribution systems are monitored by taking samples of the water at the first and last outlets of the water distribution loop. ANSI/AAMI/ISO 26722:2009 specifies that an ozone level of 0.5 ppm, sustained for at least 10 minutes, is considered necessary to kill bacterial organisms. AmeriWater recommends an ozone level of 0.5 ppm or greater for disinfection with a contact time of at least 30 minutes. The AmeriWater disinfection process takes approximately 2 hours to complete using the Ozone Disinfection System. This includes the time to build the ozone concentration in the storage tank and loop, as well as contact times.

The AmeriWater Heatsan is an optional accessory for water treatment systems intended for use in hemodialysis applications. The Heatsan is designed to heat water received from the water purification system, and circulate the heated water around the distribution loop at a controlled sanitizing temperature (minimum temperature of 185°F) for a programmed length of time (minimum hold time of 2 hours) to provide heat disinfection of the water distribution loop. The AmeriWater Heatsan is intended for use in hospitals, clinics, or dialysis centers to provide heat disinfection resulting in total viable microbial counts below 50 CFU/ml.

The AmeriWater Heatsan is intended for use in hospitals, clinics, or dialysis centers to provide heat disinfection resulting in total viable microbial counts below 50 CFU/ml. It is an integrated hot water disinfection unit that incorporates equipment to heat water received from a direct feed Water Purification System , and circulate around a distribution loop at a controlled sanitizing temperature of 185°F) for a specified length of time (minimum hold time of 2 hours). The Heatsan system has been designed to be in compliance with the requirements of ANSI/AAMI/ISO 13959:2009 Water for hemodialysis and related therapies and ANSI/AAMI//SO 26722:2009 Water treatment equipment for hemodialysis applications and related therapies. The operation of the Heatsan unit is controlled entirely through the touch screen panel located on the front of the main control box. The touch screen displays systems performance data and the status of the device. The Heatsan unit incorporates monitoring devices and will report alarms and warnings messages via the user display. The Heatsan is used only during non-treatment hours when there are no patients being dialyzed. There is no patient contact with the device. The unit can be configured to disinfect up to two distribution loops, either individually or together. The user can set for each day of the week which loop is to be disinfected and in what configuration. The Heatsan has been designed to provide up to 100 gallons of hot water for the purpose of sanitizing connected dialysis equipment. The number of machines that can be disinfected at any one time will be dependent on the requirement of those machines regarding the amount of water each machine needs for disinfection, the time taken to perform heat disinfection and the flow at which they require the hot water. When in "Dual" mode, sanitizing two distribution loops, the unit can potentially supply up to 200 gallons of water so that 100 gallons of water will be available for each distribution loop. Following disinfection of the first loop the unit will refill and reheat to disinfection temperature then proceed automatically to disinfect the second distribution loop. The system allows the user to input the specific requirements of the dialysis machines to be disinfected, the days requiring heat disinfection and the times which heat disinfection can occur. If the system detects that any of the entered user values cannot be achieved by the Heatsan unit will raise an "Incorrect number" alarm warning the user that the parameters loaded cannot be achieved. The Heatsan operation stages include Pre-heat. Heating, Hold, Water draw off, and Cool down. The typical stage duration times for disinfection are as follows: Pre-heat 120 minutes, Hold* 120 minutes, Water draw off 60 minutes, Cool down 60 minutes.

The AmeriWater Centurion 1500+ Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in making dialysate for hemodialysis and to meet current AAM and Federal (U.S.) standards. The device is intended to be a component in a complete water purification system, and is not a complete water treatment system. It must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well to meet current AAM and Federal (U.S.) standards. The Centurion 1500+ Reverse Osmosis System is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The device includes an integrated heat sanitization process.

The AmeriWater Centurion 1500+ Reverse Osmosis System is a water treatment system intended for use in hemodialysis applications. The system is designed to remove organic and inorganic substances and contaminants from potable water. The purified (or treated) water will then be used to prepare and dilute dialysate concentrate to form dialysate. The AmeriWater Centurion 1500+ Reverse Osmosis System is intended to be used in hospitals, clinics, dialysis centers, and for home care use. There is no direct contact between the patient and any part of the device invasive. Materials that contact that contact the product water include: Nylon, Polypropylene, Stainless Steel, EPDM, and Thin Film Composite Membrane (Polyamide). The Centurion 1500+ Reverse Osmosis System purifies water by applying pressure (greater than the osmotic pressure difference) to the feed water to reverse the water flow through a semi-permeable membrane so that the water moves from a more concentrated solution to a less concentrated solution resulting in purified permeate flow. The feed water enters the Centurion through an inlet solenoid valve filling the feed water tank. A high pressure pump forces water from the feed tank through the RO membrane where it is split into permeate which has passed through the membrane and the concentrate which passes over the membrane and carries the contaminants to drain. The AmeriWater Centurion 1500+ Reverse Osmosis System produces water that meets current AAMI and Federal (U.S.) standards for water used in hemodialysis applications. The AmeriWater Centurion 1500+ Reverse Osmosis System also includes a built in heat sanitization feature. Heat sanitization can be activated manually using the HEAT SANITIZATION function from the controller's main menu. The frequency of thermal sanitization will depend upon usage and application demands. Monitoring of the system for bacterial content should be conducted at regular intervals to determine the optimum frequency for thermal sanitization.

The AmeriWater MediQA Reverse Osmosis System is one component of a water treatment system designed to pre-treat and purify potable water using reverse osmosis for making dialysate for hemodialysis applications. The device is intended to be a component in a complete water purification system, and is not a complete water treatment system. It must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well to meet current AAMI and Federal (U.S.) standards. The AmeriWater MediQA is intended for use in water rooms in a hospital, clinic, or dialysis center. The device includes an integrated heat sanitization process.

Reverse osmosis, the scientific concept used in the AmeriWater MEDIQA Reverse Osmosis System, is the opposite of osmosis. The MEDIQA system uses a pump to apply the pressure required for reverse osmosis. Potable tap water enters the MEDIQA through an inlet solenoid valve filling the feed water tank. A high pressure pump forces water from the feed tank through the RQ modules, each module containing a high performance membrane. The water entering the RO module is split into two flows. The water which passes through the membrane is known as permeate and is purified water. The water rejected by the membrane contains an increased level of dissolved contaminants. It passes out of the RO module as the second flow stream called concentrate, and is sent to drain. The MEDIQA is available as a single pass or a double pass reverse osmosis (RO) unit. In a double pass (two RO stages) system, permeate from the first stage is pressurized by a second high pressure oump and fed to the second stage RO module set. Permeate from the second stage RO module set is fed via a manifold to the distribution loop. Unused permeate returning from the distribution loop is fed back into the feed tank. The concentrate from the first stage is sent to drain while the concentrate from the second stage is returned to the feed water tank for reprocessing. The feed and permeate water flows are monitored at various points in the process to verify temperature, conductivity, and flow. This data is displayed on a touch screen panel to give instant feedback of water quality and process activity. The MEDIQA system is controlled and operated by a touch screen mounted on the machine. The AmeriWater MEDIQA Reverse Osmosis System also includes a built in heat sanitization feature to enable a heat sanitization of the reverse osmosis membranes and its pipe work. Heat sanitization can be activated manually using the HEATSAN buttons on the touch screen display or automatically if timer clock settings are implemented. The frequency of heat sanitization will depend upon usage and application demands. Monitoring of the system for bacterial content should be conducted at regular intervals to determine the optimum frequency for heat sanitization.

The Amerilyater MROZ Reverse Osmosis System is a water treatment device intended for use in hemodialysis applications. It is intended to be used as a component in the AmeriWater Water Purification System (K991519), and is intended to purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The AmeriWater MROZ is intended for use in water rooms in a hospital, clinic, or dialysis center. The device is intended to be a component in a complete water purfication system, and is not a complete water treatment system. It must be preceeded by pro-treatment devices, and may need to be followed by post-treatment devices as well to meet current AAM and Federal (U.S.) standards. Model MRO3Z is a 3 membrane system designed to supply 6,600 gallons per day (gpd) of product water. Model MRO4Z is a 4 membrane system designed to supply 8,800 gpd of product water. Model MRO5Z Is a 5 membrane system designed to supply 11,000 gpd of product water. Model MRO6Z is a 6 membrane systems designed to supply 13,200 gpd of product water. Model MRO7Z is a 7 membrane system designed to supply 15,400 gpd of product water. Model MRO8Z is an 8 membrane system designed to supply 17,600 gpd of product water. Each model is available in a 208V, 230V, or 460V variant and includes a divert- to-drain feature to prevent patient exposure to unsafe product water. Each model includes temperature compensated online monitors that display conductivity and percent rejection. The conductivity monitor activates an audible and visual alarm when the product water conductivity exceeds a preset alarm limit.

The AmeriWater MROZ Reverse Osmosis System is a water treatment system intended for use in hemodialysis applications. The system is designed to remove organic and inorganic substances and contaminants from potable water. The purified (or treated) water will then be used to prepare and dilute dialysate concentrate to form dialysate. The AmeriWater MROZ Reverse Osmosis System is intended to be used in water rooms located in hospitals, clinics, and dialysis centers. There is no direct contact between the patient and any part of the device invasive. Materials that contact that contact the product water include: ABS, Acrylic, Nylon, PVC, Polyethylene, Polypropylene, Stainless Steel, Tygon, and Thin Film Composite Membrane (polyimide). The MROZ Reverse Osmosis System purifies water by applying pressure (greater than the osmotic pressure difference) to the feed water to reverse the water flow through a semi-permeable membrane so that the water moves from a more concentrated solution to a less concentrated solution resulting in purified permeate flow. Basically, the feed water is supplied to the membrane where it is split into permeate which has passed through the membrane and the concentrate which passes over the membrane and carries the contaminants to drain. The AmeriWater MROZ Reverse Osmosis System produces water that meets current AAMI and Federal (U.S.) standards for water used in hemodialysis applications.

The AmeriWater Alarm Panel is intended for use in hospitals and dialysis clinics as an optional component in the AmeriWater Water Purification System (WPS) for hemodialysis applications. The AmeriWater Alarm Panel is intended to notify the operator of conditions that exist with the Water Purification System requiring the operator's attention. The AmeriWater WPS is intended to remove organic and inorganic substances and microbial contaminants from water. The Purified (or treated) water will then be used to prepare and dilute dialysate concentrate to form dialysate and/or rinse dialyzers for multiple use and/or to prepare dilute solutions for reprocessing procedures in multiple-use dialyzers. The Alarm Panels are designed to meet current AAMI and Federal (U.S.) standards.

The AmeriWater Alarm Panel is designed to let technicians and nurses know when something is not functioning properly with the water equipment. The Alarm Panels warn the user by illuminating an alarm light and sounding an audible alarm, indicating that some limit has been exceeded. This submission is for a design change to the existing AmeriWater Alarm Panel cleared for market use in the AmeriWater Water Purification System (WPS) for hemodialysis applications (K991519). The AmeriWater Alarm Panel design has been upgraded from a panel with switches operating relays, to a digital panel operated by a microprocessor. All of the Alarm Panels are provided with an LCD display that will indicate the status of the water system. The nurse's station remote will correspond to what is indicated on the alarm panel. The selection of possible water properties to be monitored has been chosen during the original purchase of this equipment. The properties that this system can monitor include Low Resistivity, High Conductivity, R/O Alarm, Low Storage Tank, and Low Bicarb. There are also 5 additional dry contact inputs provided.

The AmeriWater MRO Portable Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The AmeriWater Portable MROS model is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The AmeriWater Portable MRO1 model is for treatment of up to two patients in a hospital, clinic, or dialysis centers.

Osmosis is a natural process where two liquids of different concentration are separated by a semi-permeable membrane and the liquid moves from the lower concentration to the higher concentration in order to achieve chemical equilibrium. Reverse osmosis, the scientific concept used in the AmeriWater MRO Portable Reverse Osmosis System, is the opposite of osmosis. Liquid is forced from a region of higher solute concentration through a semi-permeable membrane to a region of lower solute concentration. This is achieved by applying a pressure in excess of the osmotic pressure. Osmotic pressure is the pressure which needs to be applied to a solution to prevent the inward flow of water across a semi-permeable membrane. The MRO system uses a submersible pump to apply the pressure required for reverse osmosis. The semi-permeable membrane used in the MRO system is a thin film composite (TFC) membrane. A TFC membrane is essentially a molecular sieve constructed in the form two or more layered materials. The membranes are made out of polyamide, chosen for its permeability to water and relative impermeability to various dissolved impurities and unfilterable molecules. The MRO Portable Reverse Osmosis System purifies tap water by applying pressure (greater than the osmotic pressure difference) to the feed water supply in order to reverse the water flow through the semi-permeable reverse osmosis membrane so that the water moves from a more concentrated solution to a less concentrated solution resulting in purified permeate flow. Basically, the tap water is supplied to the MRO pump where ist is pressurized and sent to the membrane splits the tap water into permeate, which has passed through the membrane, and the concentrate, which passes over the membrane and carries the contaminants to drain. The AmeriWater MRO Reverse Osmosis System produces water that meets ANSI/AAMI RD62 requirements for water used in hemodialysis applications. It provides quiet operation for bedside use and may be used for acute care cases, small dialysis wings in a hospital, or for home care. Materials that contact the product water include: ABS, Acrylic, Carbon, Nylon, PVC, Polyester, Polyethylene, Polypropylene, Stainless Steel, Tygon, EPDM, Viton, and Buna N. Tap water enters the AmeriWater MRO Portable Reverse Osmosis System and passes through dual carbon block filters to remove chlorine, chloramines, and sediment which may damage the RO membranes. The dual chloramine removal carbon cartidges are a special blended carbon that salisfies AAMI and CMS requirements. Rated at 1 micron, the filters have a capacity of 8000 gallons with 3 PPM of chloramine at 9.5 pH. The submersible RO pump then pressurizes the feed water to pressures greater than the osmotic pressure. The pressurized feed water is sent through the RO membranes where contaminants are removed, and the feed water is split into permeate, or product water, and concentrate, or reject water. The purified permeate water passes through a Nephros Dsu filter capsule (K110285) to remove microbiological contaminants (down to 0.005 microns) and then is directed to the point of use. A portion of the reject water is returned to the RO pump to reduce waste, and the remainder is sent to drain. Optional antiscalant (K991519) may be included for use on un-softened water supplies to remove hardness minerals that may scale the membrane. The AmeriWater MRO Portable Reverse Osmosis System includes safety features for the user and to protect patient safety. The safety features meet current and include product water conductivity monitor with audible alarm, a low -pressure cut-off switch to prevent damage to the RO pump in low pressure situations, and a divert to drain feature that prevents product water with conductivity above the alarm set point limit from being used for patient treatment. The MRO also includes a simple disinfection procedure using hydrogen peroxide/peroxyacetic acid (PAA).

The AmeriWater Solution Mix and Distribution System for Hemodialysis is intended to be used in a hemodialysis facility to mix and deliver, to the point(s) of use, bicarbonate and acid solutions necessary for hemodialysis. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications. AmeriWater Bicarb Mix and Distribution System, Models 00BC55-55, 00BC100-100, and 00BC100-200 (Dual Tanks): The AmeriWater Bicarb Mix and Distribution System for Hemodialysis is intended to be used in a hemodialysis facility to mix and deliver, to the point(s) of use, bicarbonate solutions necessary for hemodialysis. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications. AmeriWater Solution Mixing System, Model 00BC100 (Single Tank): The AmeriWater Solution Mixing System is intended to be used in a hemodialysis facility to mix and deliver, to the point(s) of use, bicarbonate solutions necessary for hemodialysis. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications. AmeriWater Acid Concentrate Distribution System, Models 00AS130, 00AS300, and 00AS500: The AmeriWater Acid Concentrate Distribution System is intended to be used in a hemodialysis facility to store and deliver, to the point(s) of use, acid concentrate solutions necessary for hemodialysis. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications. AmeriWater Wallboxes for Dialysis: The AmeriWater Wallbox for Dialysis is intended to be used in a hemodialysis facility as the point of connection for purified water, bicarbonate, and acid solution, for use in hemodialysis applications. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications.

The AmeriWater Bicarb Mix and Distribution System utilizes purified water from the dialysis facility's water purification system to mix bicarbonate solution and to distribute the solution to the point(s) of use. The system features automatic fill and mix, high vortex pumped mixing action, lightly pressurized distribution, and efficient disinfection. A single tank version, the AmeriWater Solution Mixing System, is also available to mix solutions from concentrate. The AmeriWater Acid Concentrate Distribution System is used to store and distribute the acid concentrate(s) required for hemodialysis to the point(s) of use. Solution stored in and distributed by the Acid Concentrate Distribution System is mixed prior to being transferred to the system. Lightly pressurized distribution and recirculation provides steady, consistent delivery. AmeriWater Wall Boxes are recessed boxes located at the point(s) of use that are intended to provide acid, bicarb, and/or water connections for the dialysis machine fittings used in the hemodialysis facility. Wall boxes are available in several configurations. Wall dialysis machine fittings are professionally installed by AmeriWater.

The AmeriWater Purification System for Hemodialysis is used to remove organic and inorganic substances and microbial contaminants from water. Purified (or treated) water will then be used to prepare and dilute dialysate concentrate to form dialysate and/or rinse dialyzers for multiple-use dialyzers. AmeriWater does not recommend nor endorse any other use for water treated with AmeriWater systems. AmeriWater further does not endorse any specific hemodialysis or reprocessing procedures or equipment.

The AmeriWater Purification System for Hemodialysis may include pretreatment components, reverse osmosis and/or deionization, post-treatment components, and a distribution system. All or some of the following components may be included in an AmeriWater Purification System for Hemodialysis based on the customer's needs: Tempering Valve, Float and Pressure Control, Temperature Gauge, Return Flow Diffuser, Backflow Preventor, Booster Pump(s), Multimedia Filter, Water Softener, Carbon Filtration, Micron Prefilter, Chemical Feed System, Reverse Osmosis, Pressure Gauges, Storage Vessel, Deionization, Submicron Filter, Distribution System, Distribution Pump(s), PVC Pipe and Fittings, PVC Ball Valves, PVC Labcock Valves, Automatic Lockout, and System Alarms. System design is determined by the customer's needs and the water conditions at their facility. Components for the water system are selected based on a survey of the customer's requirements and a complete chemical analysis of the water to be treated. The system is complete with monitors and audible/visible alarms with remote activation in the area of patient care to notify staff of problems if they occur. The AmeriWater Chemical Feed System is a pretreatment device that is designed to deliver chemicals to the city tap water in order to adjust various chemistries in the water. The chemical feed system is located at the front-end of a water treatment system and may be used for pH adjustment, or to mitigate certain water contaminants to help improve the performance of the complete water system.