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The AquaA water purification system is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system, and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.

The Visual LED Indicator is used to remotely monitor the operating status of a connected device (e.g., the reverse osmosis water treatment system).

The AquaDETECTOR leakage monitoring system provides full leakage monitoring of a dialysis center, typically during non-treatment hours. The central control unit can be programed to switch off dialysis water supply systems, dialysis concentrate preparation systems, dialysis concentrate supply systems, booster pump assemblies, and pre-filtration devices when a leak is detected.

The AquaA system is a software controlled electromechanical device. It is a reverse osmosis (RO) water purification system that uses pretreated soft water to produce dialysis water for hemodialysis (HD) devices and for the preparation of dialysis concentrates.

The AquaA system is a modular system consisting of a base module that can be used on its own or in conjunction with other modules. AquaA is the base module. AquaA2 is a second RO unit that can be added to increase the quality of dialysis water. AquaHT is a flow heater unit that can be added to provide heat disinfection for the RO system including membranes and ring main. The AquaHT module can also supply hot product water to connected HD devices. AquaUF is an ultrafiltration module for the AquaA system intended to improve dialysis water quality by retaining constituents such as endotoxins and bacteria.

The AquaA system is configured by combining the different modules with the AquaA base module. The system configurations are:

• AquaA (Single stage RO system)
• AquaA + AquaUF (Single stage RO system with ultrafiltration)
• AquaA + AquaHT (Single stage RO system with heat disinfection)
• AquaA + AquaHT + AquaUF (Single stage RO system with heat disinfection and ultrafiltration)
• AquaA + AquaA2 (Double stage RO system)
• AquaA + AquaA2 +AquaUF (Double stage RO system with ultrafiltration)
• AquaA + AquaA2 + AquaHT (Double stage RO system with heat disinfection)
• AquaA + AquaA2 + AquaHT + AquaUF (Double stage RO system with heat disinfection and ultrafiltration)

The Visual LED Indicator, Aqua DETECTOR, and Connecting Tube PVDF are accessories to the AquaA system.

The Visual LED Indicator is a required accessory installed in the dialysis clinic. It reproduces the AquaA's visual indicator color signals in the clinic and communicates the AquaA system's operating status (including visual and audible alarm states) to the user.

The AquaDETECTOR system monitors leakage throughout a dialysis center. The AquaDETECTOR system consists of a monitoring control center and up to 40 leakage sensors connected to 1–3 BUS lines.

The Connecting Tube PVDF is used to connect the fluid path of the installed modules while maintaining placeholders for future modular expansion.

The AquaA water purification system uses pretreated soft water to produce dialysis water for HD devices and for the preparation of dialysis concentrates. The system features the following main operating modes:

• STANDBY – The system is on and dialysis water is not being produced
• SUPPLY – The system produces dialysis water, controls the programmed yield, and monitors all relevant parameters
• RINSE – The system is cleaned with water by rinsing all tubing sections and by replacing the specified dialysis water volume
• CLEANING – The cleaning mode is used to decalcify or alkaline clean the RO system including membranes. (NOTE: The water distribution system is not included.) An acidic or alkaline solution is circulated in the system for a programmed time period. A Disinfection phase is initiated and followed by a Rinse phase.
• DISINFECTION – The system, including the ring main, is chemically disinfected. The disinfectant is circulated throughout the system for a programmed time period and then a Rinse phase is initiated.
• HEAT DISINFECTION – The AquaA system with the AquaHT module allows for heat disinfection of the AquaA system including RO membranes, ring main, and HD device interfaces
• EMERGENCY OPERATION – In the event of a system malfunction if emergency mode is initiated, AquaA or AquaA2, depending on which RO module failed, begins emergency operation as a single stage RO system. Dialysis water is still produced to complete any HD therapy that is in progress. Dialysis water conductivity (AquaA and AquaA2) and temperature (AquaA) are monitored.

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