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By Atlas High Purity Solutions team • February 11, 2016

510-K Dialysis Water System Upgrade in Massachusetts

Atlas High Purity Solutions summarizes the design and execution of a 510-K dialysis water system upgrade in Massachusetts

 Challenge: A New England-based dialysis clinic gradually procured AmeriWater equipment for several key components of their dialysis water system. The clinic wanted to upgrade the remaining components in order  to have a complete AmeriWater FDA 510-K dialysis system.

Solution: Facing increasingly stringent standards from the Association for the Advancement of Medical Instrumentation (AAMI), dialysis water system operators are often opting for upgraded equipment that is FDA 510-K certified. Few OEMs can deliver the quality of product required to obtain this certification. Atlas and Pure Flow are the New England dealers for AmeriWater, one of the leading OEMs producing FDA 510-K dialysis water systems. 

In this instance, Atlas and Pure Flow worked with the customer to swap in AmeriWater equipment for aged legacy equipment. Upgrades to the following components were addressed. 

  • AmeriWater MROX Reverse Osmosis system for legacy RO equipment
  • Existing water softener replaced with AmeriWater softener
  • New RO pre-filter header and system from AmeriWater
  • Replacement of existing control panel with new AmeriWater control panelMRO1

After each component had been replaced, the system was started up and commissioned. Water samples were drawn to test for bacteria and endotoxin in addition to total dissolved solids (TDS). Based on the successful start-up data and replacement of non-510K components, AmeriWater issued a FDA 510-K certificate for the system. 

 

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Atlas High Purity Solutions has been designing, installing, and servicing high purity water systems for more than thirty years, and is the leading provider of reverse osmosis and DI water solutions in the northeast United States.

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