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510(k) Data Aggregation
(269 days)
The AquaC UNO H Portable Water Purification System is a 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.
The AquaC UNO H can be connected to hemodialysis equipment used in hospitals, clinics and in home environments. 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 and FDA recognized U.S. standards.
The AquaC UNO H water purification system is a microcontroller-controlled, fully automatic reverse osmosis (RO) system with heat disinfection function, which uses pretreated soft water (hereinafter referred to as "feed water") to produce highly deionized water (hereinafter referred to as "dialysis water") for use by a hemodialysis (HD) device and preparation of dialysis concentrates.
Feed water is defined as the water supplied to a water treatment system or an individual component of a water treatment system per ISO 23500-1:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements. The feed water must be of drinking water standard, filtered, free of iron and chlorine, and softened. Potentially critical limits must be monitored by regular checks. Bacterial growth in the system must be prevented by continuous operation of the system with a minimum of idle times and by preventive measures such as chemical or heat disinfection.
The dialysis water flows through the heater, across the dialysis water conductivity/temperature sensor and the dialysis water stop valve or outlet into the ring main. The ring main can be connected to a HD device or to a device used for the preparation of dialysis concentrates. Excess dialysis water flows through the check valve and back into the break tank. The concentrate flows through the concentrate drain restrictor and is either returned into the break tank or drained via the drain valve.
The system features the following operating modes:
- Standby
- Supply
- Rinse
- Module Heat Disinfection
- Ring Disinfection
- Chemical Disinfection
- Decalcification
- Isolated Standby
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