The i3 TWO direct and i3 TWO connect Point-of-Care disposable shower water filters with dual membrane layers are validated for the retention of bacteria in accordance with ASTM F838 for sterilizing grade membrane filters. The membranes retain bacteria, protozoa, fungi and particles larger than 0.2 µm. They are used in medical settings, e.g., NICUs, or on oncological, transplant, burns and intensive care units to reduce the incidence of infection caused by waterborne pathogens. These pathogens may include Legionella pneumophila, Pseudomonas aeruginosa and other gram-negative species.
i3 TWO direct and i3 TWO connect, class II medical devices, have an engineered design with a prefilter layer over a 0.6 µm layer which collectively protect the vital sterilizing grade 0.2 µm membrane to give a prolonged onstream life.
Intended use and areas of application
The intended use of the i3 TWO direct and i3 TWO connect water filters is to filter EPA quality drinking water. They retain bacteria in water which may aid in infection control. The filters produce water that is appropriate for washing and drinking, superficial wound cleansing (minor cuts, scrapes and abrasions), cleaning of equipment used in medical procedures and washing of hands. The water filters are not intended to provide water that can be used as a substitute for USP grade sterile water.