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The MAKY 21.1 is indicated for use in automating the in-vitro rinsing, cleaning, testing and disinfection of hollow fiber type hemodialyzers in accordance with the AAMI Recommended Practice for Reuse of Hemodialyzers when such automation is chosen for use by a prescribing physician. It is also indicated for record keeping of these functions.

The MAKY 21.1 Dialyzer Reprocessing System is designed and manufactured to reprocess standard, high efficiency, and high flux hollow-fiber dialyzers. Each type of dialyzer can be processed by one of two pre-programmed cycles, or by a custom cycle configured by HDC Maquinolas, LLC. Custom cycles meet the same minimum requirements as the pre-programmed cycles. The MAKY 21.1 may be configured to utilize one of two approved cleaning agents (peracetic acid, bleach), and one of three approved disinfection agents (peracetic acid, glutaraldehyde, formaldehyde). The MAKY 21.1 will automatically dilute the cleaning and disinfection agents, with the exception of glutaraldehyde, which must be diluted by the user.