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Rapicide OPA-28 is a high level disinfectant solution for reprocessing of heat sensitive semicritical medical devices for which sterilization is not suitable. Rapicide OPA-28 may be used at or above its minimum recommended concentration (MRC) of 0.35% OPA as determined by Rapicide OPA-28 test strips in manual device reprocessing with an immersion time of at least 10 minutes at a minimum temperature of 20℃ for a reuse period not to exceed 28 days. Rapicide OPA-28 may also be used in compatible legally marketed automatic endoscope reprocessors at or above its MRC as determined by Rapicide OPA-28 test strips with an immersion time of at least 5 minutes at a minimum temperature of 25℃ for a reuse period not to exceed 28 days.

Rapicide OPA-28 is a reusable liquid ortho-Phthalaldehyde (OPA) based high level disinfectant solution intended for reprocessing of heat sensitive semi-critical medical devices for which sterilization is not suitable. Rapicide OPA-28 may be used in manual reprocessing or in compatible legally marketed automatic endoscope reprocessors at the appropriate labeled use conditions. Rapicide OPA-28 is a clear liquid chemical germicide solution with a pH between 7.5 and 8.0. The active microbicidal ingredient ortho-Phthalaldehyde is formulated at a nominal concentration of 0.575% together with a solvent, buffers, surfactants, an antifoaming agent and water to create Rapicide OPA-28 solution. Rapicide OPA-28 is labeled with an unopened bottle shelf-life of 24 months, an open bottle use-period of 75 days and a reuse period not to exceed 28 days. The germicide must be used at or above its MRC, as determined by Rapicide OPA-28 test strips, with the indicated immersion time, use temperature and reuse period. Rapicide OPA-28 is supplied in cases containing high density polyethylene plastic bottles. Individual bottles are labeled with all information necessary to use the device safely.

Medivators DSD Edge Endoscope Reprocessing System tests, washes, disinfects and rinses flexible endoscopes, such as fiberoptic and video endoscopes between patient uses. The DSD Edge system is indicated to provide high level disinfection, using Rapicide PA High Level Disinfectant, of heat sensitive semi-critical endoscopes. Manual cleaning of endoscopes is required prior to placement in the DSD Edge system. Rapicide PA contact conditions in the DSD Edge - 5 Minutes 30℃ 850 ppm peracetic acid .

The DSD Edge system is an electro-mechanical system intended to test, wash and high level disinfect flexible fiberoptic and video endoscopes between uses. The DSD Edge is capable of asynchronously reprocessing two scopes at a time. The DSD Edge system uses the peracetic acid based Rapicide PA High Level Disinfectant (K082988). The DSD Edge is a single use system in that it mixes Part A and Part B of Rapicide PA with water immediately prior to reprocessing and the disinfectant is not reused. Endoscopes must be pre-cleaned and manually cleaned to SGNA and facility guidelines prior to being placed in the system for reprocessing. After the endoscopes are connected to the DSD Edge the system tests the scopes for leaks in the outer skin. If the endoscopes pass the leak test the system will proceeds to a scope flush or an optional wash cycle followed by a flush. For the disinfection cycle, the incoming water is mixed with the two part germicide in the basin. The temperature of the incoming water is monitored to ensure that the water temperature is within the operating constraints (30℃) required for disinfection after the water and germicide are mixed together. A sample of the germicide is retained to test for MRC. Following disinfection, the endoscopes are rinsed and dried by the machine, either by filtered air or an optional alcohol rinse, and are then removed from the machine for the next use. The machine has built in safety features which stop the cycle and alarm when certain conditions exist which could indicate that disinfection might be compromised. These alarms and causes are defined in the directions for use for the product. The DSD Edge also prints records indicating the results of testing, disinfection, etc. which are required for permanent records.

The HF Junior Hemoconcentrator is intended for use in prevention or relief of fluid overload, electrolyte and acid imbalances in cases of acute renal failure with oliguria or anuria. Also, it is used to remove excess fluid in cases of congestive heart failure, pulmonary and cerebral edema, anasarca, ascites, septic shock, burns, etc. In hypervolemic patients requiring parenteral nutrition and/or large volume of medications, the hemofilter may be used to reduce fluid overload. In hypercatabolic patients requiring more intensive solute removal, a sterile dialysate fluid may be made to flow around the fibers via the dialysate ports in order to increase the clearance of small molecules. It is indicated for patients (including pediatric patients) according to physician assessment of the patient and the instructions for use.

The HF Junior Hemofilter consists of many individual polysulfone hollow fibers encapsulated into a polycarbonate case. The device has arterial and venous ports on opposite ends of the device. As the patient's blood enters the device through the arterial blood port, it passes through the fiber bundle and then exits the device through the venous blood port and is returned to the patient. As the blood passes through the fiber bundle, ultrafiltration occurs as a result of a hydrostatic pressure gradient that exists across the semipermeable membrane. The resulting hemofiltration removes large quantities of plasma water, and small and medium sized solutes (such as IL .- 6, C3a and C5a) are removed from the vascular space thereby concentrating the red cell mass and the plasma proteins.

The HPH™ Junior Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is employed. It is indicated for all patients (including all pediatric patients) according to physician assessment of the patient and the Instructions for Use. In pediatric patients this device must be used only as a part of a cardiopulmonary bypass or circulatory support circuit, with the circuit being connected to the patient.

The HPH Junior Hemoconcentrator consists of many individual polysulfone hollow fibers encapsulated into a polycarbonate case. The device has arterial and venous ports on opposite ends of the device. As the patient's blood enters the device through the arterial blood port, it passes through the fiber bundle and then exits the device through the venous blood port and is returned to the patient. As the blood passes through the fiber bundle, ultrafiltration occurs as a result of a hydrostatic pressure gradient that exists across the semipermeable membrane. The resulting hemoconcentration removes large quantities of plasma water, and small and medium sized solutes (such as IL-6, C3a and C5a) are removed from the vascular space thereby concentrating the red cell mass and the plasma proteins.

Minntech Corporation's RenaClean™ SH Dialyzer Cleaning System is used to facilitate the cleaning of blood and other debris from multiple-use hollow fiber dialyzers, prior to being reprocessed on a Renatron® Dialyzer Reprocessing System.

The Renaclean SH Dialyzer Cleaning System facilitates the cleaning and removal of blood and other debris from multiple-use hollow fiber dialyzers prior to reprocessing on a Renatron® Dialyzer Reprocessing System. The stand-alone countertop system utilizes ANSI/AAMI quality water and a pre-diluted sodium hypochlorite solution. The operator, through the use of a membrane switch front panel, controls the Renaclean SH Dialyzer Cleaning System. Operators have the following cycle choices: High Flux dialyzer clean, Low Flux dialyzer clean and System Sanitize.

The Minntech Corporation's EnGUARD™ CHC Dual Reservoir Cardioplegia Heater/Cooler is intended to be used as a self-contained temperature control device designed to deliver cooled or heated water to a cardioplegia heat exchanger in the cardiopulmonary bypass circuit.

The Minntech EnGUARD ™ CHC Dual Reservoir Cardioplegia Heater/Cooler is a portable heating and cooling circulation system with mechanical controls for delivery of warm or cool water to flow through type water pathway cardioplegia heat exchanger devices.

The Minntech Corporation's EnGuard™ Cardioplegia Heat Exchanger is used to cool or warm cardioplegia solution prior to delivery to the patient through connected tubing sets which provide various ratios of cardioplegia solution to blood, depending upon the tubing set chosen.

The administration of cardioplegia solution is commonly used to provide myocardial protection or controlled arrest of the heart during coronary bypass procedures. As the oxygenated blood enters the EnGuard™ device through the inlet blood port, it passes through the fiber bundle lumens where the temperature of the blood is cooled or warmed as desired by passing water of the desired temperature into the heater/cooler section of the device, which surrounds the fiber bundle. The water enters and leaves through standard Hansen connector ports molded into the polycarbonate case. The EnGuard™ heat exchanger must be used with separately purchased, sterile tubing sets attached as explained in the labeling. These tubing sets will determine the ratio of crystalloid to blood. The Minntech device will produce cardioplegia solution at ratios of 1:1, 2:1, 4:1 and 8:1 depending upon the chosen tubing set.

The Renaflo® II HF 2000 Hemofilter is intended for use in patients with fluid overload, uremia and/or electrolyte disturbances associated with oligoanuria acute renal failure. It may also be used when removal of excess fluid is indicated, such as patients in pulmonary edema or congestive heart failure refractory to diuretic therapy.

The Minntech Renaflo® II HF 2000 Hemofilter is made of glycerin-free, microporous, hollow fiber, polysulfone membrane encased in a polycarbonate housing having molded ultrafiltration ports and polycarbonate blood port header caps.

Minntech Corporation's RenaClear™ Dialyzer Cleaning System is used to facilitate the cleaning of blood and other debris from multiple-use hollow fiber dialyzers prior to being reprocessed in an approved dialyzer reprocessing program.

The RenaClear™ Dialyzer Cleaning System facilitates the cleaning and removal of blood and other debris from multiple-use hollow fiber dialyzers prior to an institutions approved dialyzer reprocessing program. The stand-alone countertop system is equipped with two header cleaners that attach to the blood ports of a dialyzer. The header cleaners have a retractable, rotating, directional needle jet that will inject a water/air mixture into the dialyzer header and blood pathway. Simultaneously the dialyzer dialysate compartment and the exterior of the dialyzer fibers will be pressurized water to achieve reverse ultrafiltration. The operator, through the use of a membrane switch front panel, controls the RenaClear™ Dialyzer Cleaning System. Operators have the following cycle choices: Dialyzer clean, system clean, system sanatize and system rinse.

The FiberFlo™ series of Hollow Fiber Capsule Water Filters is intended to filter bacteria, endotoxin and particulate matter from water used for hemodialysis applications.

The FiberFlo™ Hollow Fiber Capsule Water Filters consist of encapsulated microporous polysulfone membrane in a polycarbonate housing with multiple endcap connections to filter endotoxins, bacteria and particulates from water.