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510(k) Data Aggregation
K Number
K032004Device Name
AQUABOSS ECORO DIA 50
Manufacturer
LAUER LTD., HONG KONG
Date Cleared
2003-10-02
(94 days)
Product Code
FIP
Regulation Number
876.5665Why did this record match?
Applicant Name (Manufacturer) :
LAUER LTD., HONG KONG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Aquaboss® EcoRO Dia 50 Portable Water Treatment System for Hemodialysis is a device that is intended for use with a hemodialysis system. It is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. The device includes carbon filter and sediment filter. The device may include a water softener. Aquaboss® EcoRO Dia 50 Portable Water Treatment System for Hemodialysis is designed for the use in hospital or in home settings.
Device Description
The Aquaboss EcoRO Dia 50 Portable Water Treatment System is a complete water purification system and consists of a reverse osmosis (RO) and pre-treatment. It s designed to feed one Hemodialysis machine with water. In order to optimize the performance of the RO system, the following items for pre-treatment are utilized: 1) cartridge filters to remove suspended solids 2) activated carbon filtration to remove organics, namely chlorine and chloramines. To minimize bacterial growth in the permeate line, permeate is circulated dead space from the membrane to the point of use (dialysis machine). Excess permeate is circulated into the raw water tank and is reprocessed. Aquaboss® EcoRO Dia 50 works on the reverse osmosis principle. Reverse Osmosis describes a process involving a pressure operated cross filtration system. The water flows under high pressure tangentially to a semi permeable membrane. As it is the case with normal filtration the system is cleaned by allowing one component (water) of the mixture to be separated to pass through the membrane with almost no hindrance whereas the other components (dissolved and non-dissolved water contents) are held back to leave the filtration unit in the concentrate flow. This is a separation process in the molecular sector which does not change the components being separated either chemically, biologically or thermally. In order to ensure that the microbiological quality of the permeate will be maintained, this system has: A dead space free stainless steel pressure vessel for the RO membrane. A hygienic design with smooth surfaces. Automatic flushing program to remove impurities from the membrane surface (impulse backwashing). Automatic flushing during standby periods to exchange stagnant water. Dead space free connection between Reverse osmosis and Dialysis machine. When requested by the facility physician, optional devices can include the following components: 1) CART (four wheel transport unit for RO system and pretreatment) (Option) 2) water softener to remove scale-forming minerals (Option) 3) Wooden box to increase sound absorption (Option). After pretreatment ((i.e. filter, water softener; charcoal filter, etc) the incoming raw water (RW) flows through the solenoid valve (Y10) into the break tank (VL). From there it is delivered by means of a pump M1 to the membrane module MM1. by passing through the reverse osmosis membrane. The feed flow (raw water and circulation) is divided into the concentrate and permeate flow after the feed flow has passed through the membrane barrier. Concentrate leaves the membrane module and passes through a needle valve (NV), which restricts the water volume flowing out, thus ensuring the production pressure. The concentrate flow regulated in this way is either circulated internally through the solenoid valve Y2 back into the tank or is conducted to the drain outlet as waste water through solenoid valve Y9. The system between Y2 and Y9, and thus the regulation of the concentrate volume to be rejected is by means of time control. Before beginning dialysis and during the reflushing periods the needle valve can be bypassed by opening the solenoid valve Y6 so that the membrane can be cleaned with a higher volume for a defined period of time. The permeate is conducted through a hose to the dialysis machine. From here it is fed by means of a coupling into the dialysis machine. Should the end user not call for the full amount of permeate, the unused water be returned to the break tank via a pressure holding valve which, in turn ensures constant ringline pressure. The following is measured in accordance with the process diagram: conductivity raw water (CIS1), Conductivity Concentrate (CIS2), Conductivity Permeate (CIS3) System pressure (PIS1),, temperature concentrate (TIS) and Temperature Permeate (TS).
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