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The HDF Assist Module is indicated for use, with the Fresenius 2008K2, and 2008T dialysis machines, for treatment of adult patients with acute or chronic renal failure or whenever hemodiafiltration is physician. The HDF Assist Module works in conjunction with a qualified host high permeability (UF controlled) hemodialysis machine and its accessories (i.e., bloodlines, dialysate, concentrates, etc.), the HDF Assist Module accessories (HDF Infusion Set and Substitution Filter), appropriately purified water and ultrapure dialysate for hemodialysis, and a high permeability hemodialyzer / hemodiafilter (i.e., the OLPür™ MD 220 Hemodiafilter).

The HDF Assist Module is a software controlled; electro-mechanical medical device designed to work in combination with a sterile single use HDF Infusion Set (an accessory included in this submission) and a qualified host high permeability (UF controlled) hemodialysis machine, which produces ultrapure dialysis fluid. Upon installation the HDF Assist Module is connected to the host dialysis machine's IV Pole and plugged into a Standard 120VAC electrical mains power source. To perform a hemodiafiltration treatment with the HDF Assist Module, the device is used in unison with the accessory sterile, single-use HDF Infusion Set to generate and control the online substitution fluid for hemodiafiltration from the ultrapure dialysis fluid of the host dialysis machine. The sterile HDF Infusion Set consists of an 0.25 m² ultrafilter, tubing including a peristatic pump segment, pressure sensor pods, and check valves. The HDF Infusion Set is primed prior to treatment to remove air from the Set. The HDF Infusion Set is placed on the unit in preparation for each HDF treatment. A peristatic pump in the HDF Assist Module pumps a preset amount of ultrapure dialysis fluid produced by the host dialysis machine via the peristatic pump segment in the HDF Infusion Set. The dialysis fluid is drawn from an input dialysate Hansen T-connector and pumped through a sterile single use 0.25 m² ultrafilter in the HDF Infusion Set. The rest of the dialysis fluid flows outside of the fiber in the OLPūr™ MD 220 Hemodiafilter as in conventional hemodialysis. During priming and treatment, the ultrafilter in the HDF Infusion Set removes bacteria and endotoxins from the ultrapure dialysis fluid, thereby generating an injectable quality substitution (replacement) fluid of correct electrolyte composition. The ultrafiltered substitution fluid flows through tubing connected to the extracorporeal circuit where it is infused as part of the hemodiafiltration treatment at the MD220 Mid-Dilution port. The ultrafilter is 100% tested in a production integrity check during manufacture.

The EndoPur Endotoxin 10" Filter Flat is intended to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.).

The EndoPur Endotoxin 10" Filter Flat is a hollow fiber ultrafilter that retains bacteria, viruses, endotoxin and particulate from water used in hemodialysis.

The HydraGuard 10" UltraFilter is intended to be used to filter EPA quality drinking water. The filter retains bacteria, viruses and endotoxin. By providing ultrapure water for patient washing and drinking, the filter aids in infection control. The filter produces water that is suitable for patient wound cleaning of equipment used in medical procedures and washing of surgeon's hands. Medical: The filter is not intended to provide water that can be used as a substitute for USP sterile water.

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The S100 Point of Use Filter is intended to be used to filter EPA quality drinking water. The filter retains bacteria. By retaining bacteria in water for washing and drinking, the filter may aid in infection control. The filter produces water that is suitable for cleaning of equipment used in medical procedures and washing of surgeon's hands. The filter is not intended to provide water that can be used as a substitute for USP sterile water.

The S100 Point of Use Filter is a hollow fiber microfilter that retains bacteria from water used for washing and drinking.

The DSU-H and SSU-H Ultrafilters are intended to be used to filter EPA quality drinking water. The filters retain bacteria, viruses and endotoxin. By providing ultrapure water for patient washing and drinking, the filters aid in infection control. The filters produce water that is suitable for wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon's hands. The filters are not intended to provide water that can be used as a substitute for USP sterile water.

The DSU-H and SSU-H Ultrafilters are hollow fiber ultrafilters that retain bacteria, viruses, endotoxin and particulate from water used for washing and drinking.

The OLPur H2H Hemodiafiltration (HDF) Module is indicated for use, with a UF controlled hemodialysis machine that provides ultrapure dialysate in accordance with current ANSI/AAMI/ISO standards, for treatment of patients with chronic renal failure as prescribed by a physician. The OLPur MD 220 Hemodiafilter is indicated for use for hemodiafiltration of patients with chronic renal failure. The OLPur MD 220 Hemodiafilter is only to be used with the OLpur H2H Hemodiafiltration Module. Selection of patients, as well as treatment operating parameters, are a medical decision and the responsibility of the prescribing physician.

The H₂H™ Hemodiafiltration Module is a programmable electro-mechanical medical device designed to work in conjunction with and in close proximity to a hemodialysis machine during patient treatments. Upon installation, the H₂H Module is placed next to the hemodialysis machine (which can be on either side depending upon type and model of the hemodialysis machine) and is connected to the clinic's water supply, drain, and electricity. The H₂H Hemodiafiltration Module serves two basic functions. The Module's primary function is to generate on-line substitution fluid for hemodiafiltration. The H₂H Module does this by ultrafiltering dialysate, provided by the hemodialysis machine, through a reusable substitution filter. The secondary function of the H₂H Hemodiafiltration Module is to serve as a substitution filter reprocessing machine. These steps are performed when the H₂H Hemodiafiltration Module is not connected to the hemodialysis machine. More detailed descriptions of the device, its accessories and how the system functions can be found in Section 11 (Device Description) of this submission.

The DSU, MSU, SSU Filters are intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. The DSU, MSU, SSU Filters assist in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore, it must be used in conjunction with other water treatment equipment (i.e., RO, DI, etc.).

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The DSU Dual Stage Ultrafilter is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. The DSU Ultrafilter assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore, it must be used in conjunction with other water treatment equipment (i.e., RO, DI, etc.).

The DSU Dual Stage Ultrafilter is a hollow fiber filter that removes bacteria, viruses, endotoxin and particulate from water and bicarbonate concentrate used in hemodialysis.

The OLpūr™ HD 190 Dialyzer is indicated for hemodialysis and hemodiafiltration of patients with acute or chronic renal failure.

The OLpur"M HD 190 Dialyzer is a sterile, non-pyrogenic, single use, high permeability hemodialyzer intended to be used in providing hemodiafiltration to patients with acute or chronic renal failure. This dialyzer is designed for use only with UF controlled dialysis equipment and is compatible with all models of this generic type of equipment currently in use in the US. The individual dialyzers are packaged in a pouch constructed of Polyamide/Polyethylene film and a Tyvek® backing. The individually packaged dialyzers are packaged twelve to a carton and thirty-six to a shipping container. The dialyzer membranes used in this device consist of polyethersulfone (PES). The hollow fiber membranes are potted in a polyurethane compound at each end within a polycarbonate dialyzer casing to form a tubesheet. A polycarbonate blood inlet header attached to the end of the casing directs the incoming blood into the hollow fibers. The blood then flows through the inside of the hollow fibers and exits out through the polycarbonate blood outlet header attached to the other end of the casing. Inlet and outlet dialysate (Hansen) ports on the dialyzer casing allow for the flow of dialysate around the outside of the hollow fibers counter-current to the blood flow. Uremic toxins and excess plasma water are removed from the blood across the semi-permeable hollow fibers. A combination of diffusion, due to the concentration differences between the blood and dialysate, and convection, due to the transmembrane pressure differential across the hollow fibers, leads to the toxin removal. The spent dialysate exits the device via the dialysate outlet port. As received by the customer, the dialyzer's blood and dialysate ports are covered with polyethylene sterility caps. Silicone o-rings are included in the connections between the headers and the dialyzer tubesheet at each end of the dialyzer to provide a fluid-tight seal between the headers and the tubesheet.