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The ClearFlux™ Dialyzer Reprocessing System is indicated for the reprocessing of polysulfone-based high-flux dialyzers for reuse, for preprocessing the dialyzers prior to their assignment to patients for first use, and for tracking the reprocessed dialyzer for use only by the patient to whom the dialyzer was initially assigned. The steps used in reprocessing hemodialyzers with the ClearFlux™ System include: (1) pre-cleaning, (2) cleaning, (3) rinsing, (4) volume and leak testing, and (5) disinfecting the dialyzers in accordance with the "AAMI Recommended Practice for Reuse of Hemodialyzers." The ClearFlux™ System performs the patented in-situ two-phase cleaning cycle during reprocessing, which recovers the total cell volume and the clearance of small and middle molecules of the dialyzers to levels that are approximately equivalent to those of new dialyzers. The ClearFlux™ Dialyzer Reprocessing System is also indicated for performing record keeping of the dialyzer processing operation. The ClearFlux™ Dialyzer Reprocessing System is indicated to be used only with the ClearFlux Formula™ cleaning solution.

The ClearFlux™ Dialyzer Reprocessing System includes hardware and software designed to preprocess dialyzers before their first use by patients, to assign preprocessed dialyzers to patients, and to reprocess the dialyzer for reuse by the same patient to whom the dialyzer was originally assigned. The ClearFlux™ System employs the Novaflux patented two-phase flow cleaning process which is to be used only with the ClearFlux Formula™ (Cleaning Solution) in reprocessing reusable polysulfone-based high-flux dialyzers, and recovers the total cell volume (TCV) and the clearance of small and middle molecules of the dialyzers to levels that are approximately equivalent to those of new dialyzers. The ClearFlux™ Dialyzer Reprocessing System consists of the following hardware and software components: the ClearFlux™ Machine(s), which performs the actual processing of the dialyzer; the ClearFlux™ Records Management System (CRMS), a patient-dialyzer tracking software loaded onto a System Computer to manage dialyzer reprocessing and reuse; a System Computer; a wireless hub for communication between the ClearFlux™ Machine(s) and the CRMS on the System Computer; a bar code reader to maintain identification of the dialyzers, the ClearFlux™ Machine(s), and the users of the System (e.g., technicians, administrators); a label printer to print the labels for the dialyzers, as well as to print the bar codes for the dialyzers. the users, and the ClearFlux™ Machine(s); a report printer; and an oil-less air compressor with a HEPA filter to provide the filtered airflow necessary for the operation of the ClearFlux™ Machine(s). The ClearFlux™ Dialyzer Reprocessing System (with one System Computer loaded with the CRMS software) can operate and track the dialyzer reprocessing operations of up to 12 ClearFlux™ Machines. The chemicals used by the ClearFlux™ System include: Peracetic Acid Disinfectant used in the preprocessing and reprocessing of the dialyzers and in the daily and weekly disinfection of the fluid pathways of the ClearFlux™ Machine(s); the ClearFlux Formula™, a proprietary cleaning solution used exclusively in the ClearFlux™ Dialyzer Reprocessing System and in the weekly cleaning of the fluid pathways of the ClearFlux™ Machine(s); and optionally, Formula 409 NF for the weekly cleaning of the fluid pathways of the ClearFlux™ Machine(s).