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POLYFLUX R is indicated for use in hemodialysis for the treatment of chronic or acute renal failure. The choice of the filter is the responsibility of the physician. Special attention must be paid in connection with pediatric use. CAUTION! If POLYFLUX R is reused, the procedure and disinfection specified in the RENATRON INSTRUCTION MANUAL must be followed. The POLYFLUX R may be reprocessed for reuse on the same patient.

The Gambro Polyflux 17R and 21R, Capillary Dialyzers/Filters labeled for multiple use (reuse) are identical in construction in function to Gambro Polyflux 17S and 21S Hemodialyzers / Hemofilters labeled for single use which are currently marketed in the United States and have been previously cleared by the FDA under 510(k) Notification K981414. Only the product designation "R" has been changed from "S" to designate that they are labeled for multiple use (reuse). These devices are intended for use in hemodialysis for the treatment of acute and chronic renal failure and for certain types of intoxications for both single when reprocessed for reuse for a maximum of 15 reprocessing reuse cycles on the same patient. If reprocessing and reuse is practiced, it is recommended that the reuse be done under the conditions as existed in the in vitro and confirmatory clinical studies undertaken by Gambro and presented in the labeling for this device. It may also be used in cases of acute fluid overload for the removal of plasma water. The membrane used in these devices is polyethersulfone (PES) which is identical to the membrane utilized in the Gambro Polyflux 17S and 21S Hemodialyzers / Hemofitters for labeled for single use which have been previously approved for marketing in the United States under a 510K Notification (K982414). Blood enters a blood inlet port where it is distributed to polyethersulfone hollow fibers. Each hollow fiber has an inner diameter of approximately 215 microns (wet hollow fiber internal diameter) and a wall thickness of 50 microns. The number of polyethersulfone hollow fibers in each hemodialyzer / hemofilter is 10,000 for the Polyflux 17R and 12,500 for the 21R. These dialyzers have an effective membrane length of 250 mm. The effective membrane surface area is 1.7 square meters for the 17R and 2.1 square meters for the 21R. The housing and end caps of these hemodialyzers / hemofiters are made of polycarbonate. The fibers used in the Gambro Polyflux 17R and 21R are identical in design and materials to the previously approved Gambro Polyflux 17S and 21S Hemodialyzers / Hemofilters for labeled for single use (K982414). The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port. By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the polyethersulfone membrane, plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate or filtrate compartment of the device. Removal of uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through polyethersulfone membrane and into the counter current flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.

The Gambro Dialysis Quality Monitor DQM 200 is to act as a clinical tool aiding the physician to establish a dialysis dose of treatment of the patient. The DQM 200 performs a continuous measurement of the spent dialysate flow from a dialysis machine. From this measured data together with patient and treatment data provided by the operator, the DQM 200 derives clinical parameters helpful to the physician in evaluating the dialysis dose.

The Gambro DOM 200 measures the urea concentration in the dialysis solution leaving the waste outlet of a dialysis machine. Measurements obtained by this device are used in the treatment of certain renal diseases for patients on hemodialysis. The purpose of the Gambro DQM 200is to act as a clinical tool aiding the physician to evaluate the dialysis dose of a treatment. The DQM 200 performs a continuous urea measurement of the spent dialysate flow from a Cobe C3 machine, A Gambro AK 10 Machine, a Gambro AK 100/200 or a Gambro AK 100/200 ULTRA machine. From this measured data together with patient and treatment data provided by the operator of the DOM 200 derives clinical parameters to help define the dialysis dose. The urea measurement is achieved by catalyzing urea with the urease enzyme, with carbon dioxide gas present into ammonium ions and bicarbonate ions. The produced ions cause an increase in the electrical conductivity in proportion to the urea concentration.

The. Cobe Arylane Hemodialyzers/Filters H1, H4, H9 are intended for use in hemodialysis and hemofiltration and associated modalities for the treatment of chronic renal failure. The size, weight, state of uremia, cardiac status and general physical condition of the patient must be evaluated by the prescribing physician before each treatment. The choice of the appropriate heomdialyzer/filter and associated equipment as well as the treatment operating parameters are the sole responsibility of the physician.

The Hospal Cobe Arylane H1, H4, H6 & H9 Hemodialyzers/filters are identical in construction in function to other hemodialyzers currently marketed in the United States. These devices are intended for use in hemodialysis and hemofiltration for the treatment of acute and chronic renal failure and for certain types of intoxications. They may also be used in cases of acute fluid overload for the removal of plasma water. The membrane used in this device is polyarylethersulfone (polyethersulfone) (PES) which is identical to the membrane utilized in the Cobe Centrysystem 14 PES hemodialyzer which has been previously approved for marketing in the United States under a 510K Notification (K95-5592). Blood enters a blood inlet port where it is distributed to polyarylethersulfone hollow fibers. Each hollow fiber has an inner diameter of approximately 215 microns (wet hollow fiber internal diameter) and a wall thickness of 50 microns. The number of polyarvlethersulfone hollow fibers in each hemodialyzer are 6400 for the H1, 8300 for the H4, 8300 for the H6, and 10600 for the H9. These dialyzers have effective membrane lengths of either 240mm (H1 & H4) or 280 mm (H6 & H9). In the Cobe Arylane H1 hemodialyzers/filter solid polyester filaments are interspersed in between the polyarylethersulfone hollow fibers and act as spacers to accommodate fewer numbers of fibers in the same housing used for the Cobe Arylane H4 hemodialyzer/filter. These same polyester spacing filaments have been used previously in other Cobe hemodialyzers for the same purpose. The effective membrane surface areas are 1.04 m2 for the H1, 1.35 m2 for the H4, 1.57 m2 for the H6, and 2.01 m2 for the H9. At either end of the device, the hollow fibers (and polyester filaments in the Cobe Arylane HI only) are potted in polyurethane to isolate the blood compartment from the filtrate compartment. The housing of this hemodialyzer is also made of polycarbonate. The fibers used in this device are identical in design and materials to the previously approved Cobe Centrysystem 14 PES (K95 5592) The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port. By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the polyarylethersulfone membrane, plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate or filtrate compartment of the device. Removal of uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through polyarylethersulfone membrane and into the counter current flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.

The Gambro Polyflux 11S, 14S, 17S, and 21S hemodialyzers / filters can be used whenever hemodialysis or hemofiltration is indicated. These can be used for acute or chronic hemodialysis or hemofiltration. In these therapies, monitoring of patient vital signs, the therapy delivery system, heparin administration and clotting times should be performed under the supervision / direction of a physician.

The Gambro Polyflux 11S, 14S, & 21S Hemodialyzers/Hemofiters are identical in construction in function to other hemodialyzers/filters currently marketed in the United States. These devices are intended for use in hemodialysis and hemofiltration for the treatment of acute and chronic renal failure and for certain types of intoxications. They may also be used in cases of acute fluid overload for the removal of plasma water. The membrane used in this device is polyarylether sulfone (polyethersulfone) (PES) which is identical to the membrane utilized in the Cobe Centrysystem 14 PES hemodialyzer which has been previously approved for marketing in the United States under a 510K Notification (K95-5592). Blood enters a blood inlet port where it is distributed to polyarylethersulfone hollow fibers. Each hollow fiber has an inner diameter of approximately 215 microns (wet hollow fiber internal diameter) and a wall thickness of 50 microns. The number of polyarylethersulfone hollow fibers in each hemodialyzer / hemofilter are 8000 for the 11S. 10000 for the 14S, 10000 for the 17S, and 12500 for the 21S. These dialyzers have effective membrane lengths of either 210mm (11S & 14S) or 250 mm (17S & 21S). The effective membrane surface areas are 1.1 m2 for the 11S, 1.4 m2 for the 14S, 1.7 m2 for the 17S, and 2.1 m2 for the 21S. The housing of this hemodialyzer is also made of polycarbonate. The fibers used in this device are identical in design and materials to the previously approved Cobe Centrysystem 14 PES (K95 5592). The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port. By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the polyarylethersulfone membrane, plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate or filtrate compartment of the device. Removal of uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through polyarylethersulfone membrane and into the counter current flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.

The Hospal Multiflow 100 and Multiflow 100 Kits A0 (A0/B A0 and A0/0 ) and Multiflow 100 Kits B22 (B22, B22B, & B22/0) can be used whenever continuous arterio-venous or veno-venous hemofiltration, ultrafiltration or hemodialysis is indicated. This can be used for acute hemodialysis, hemofiltration or continuous ultrafiltration. In these therapies, monitoring of patient vital signs, the therapy delivery system, heparin administration, and clotting times should be performed under the direction of a physician

The Hospal Multiflow 100, Multiflow 100 Kit A0, Multiflow 100 Kit B22 are identical in construction in function to other hemofilters currently marketed in the United States. These devices are intended for use in continuous pump assisted veno-venous The membrane used in this device is Acrylonitrile and sodium hemofiltration and. methallyl sulfonate copolymer (AN69) which is identical to the membrane utilized in the Kit Multiflow 60P which have been previously approved for marketing in the United States under a 510K Notification (K884365). Blood enters a blood inlet port where it is distributed to Acrylonitrile and sodium methallyl sulfonate copolymer (AN69) hollow fibers. Each hollow fiber has an inner diameter of approximately 240 microns (wet hollow fiber internal diameter) and a wall thickness of 50 microns. There are 6,000 Acrylonitrile and sodium methallyl sulfonate copolymer (AN69) hollow fibers having an effective length of 27 cm. The effective membrane surface area of the Multiflow 100 hemofilter is 0.90 m2. At either end of the device the hollow fibers are potted in polyurethane to isolate the blood compartment from the filtrate compartment. Each end of the hemofilter is sealed using a silicone O-ring and polycarbonate end cap. The housing of this hemofilter is also made of polycarbonate. The fibers used in this device are identical in design and materials to the previously approved Hospal Kit Multiflow 60P. The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port. By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the Acrylonitrile and sodium methallyl sulfonate copolymer (AN69) membrane, plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate or filtrate compartment of the device. Removal of uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through the Acrylonitrile and sodium methallyl sulfonate copolymer (AN69) membrane and into the counter current flowing dialysis solution during CVVHD. During CVVH, no dialysis solution is perfused through the filtrate compartment in which case removal of plasma water and uremic toxins is accomplished by means of convection alone. The dialysate exits the devices via a dialysate outlet port. Schematic drawings of the Hospal Multiflow 100, Multiflow 100 Kit A0, and Multiflow 100 Kit B22 are included in this Section. - The Multiflow 100 Kit A0 (A0, A0/B and A0/0) and Multiflow 100 Kit B22 (B22, ● B22/B, & B22/0) are an extracorporeal blood circuit with the Multiflow 100 , Hemofilter and are intended to be used with a variety of equipment for pump assisted The Multiflow 100 Kit B22 consists of the Multiflow 100 CVVH, and CVVHD. Hemofilter pre-attached to blood tubing. The Multiflow 100 Kits A0 (A0, A0/B and A0/0) and Multiflow 100 Kits B22 (B22/B22/B/B22/0) can be used for continuous veno-venous hemodialysis (CVVHD), continuous veno-venous hemofiltration (CVVH). These kits are designed to operate with pump-assisted blood circulation. An ultrafiltrate / dialysate collection and measurement set is also included with these kits. - The component parts of the Multiflow Kits 100 B22/B22/0 are: . - A Multiflow 100 Hemofilter 1. - A arterial blood line 2. - 3. A venous blood line - 4. An ultrafiltrate line - 5. A ultrafiltrate/dialysate measuring container (not in the B22/0 Kit) - A 5 liter ultrafiltrate/dialysate collection container (included in only the B22Kit) 6. - 7. A priming adaptor - A reinfusion line 8. - The component parts of the Multiflow Kits 100 A0. A0/B and A0/0 are: - A Multiflow 100 Hemofilter 1. - 2. An ultrafiltrate line - A ultrafiltrate/dialysate measuring container (included in only the A0 Kit) 3. - A 5 liter ultrafiltrate/dialysate collection container (included in only the A0/B Kit) ব: - 5. A priming adaptor

The COBE C Hemodialysis Delivery System is indicated for patients in acute or chronic renal failure and when the physician prescribes hemodialysis or ultrafiltration. The COBE® Cx System may be used with both high permeability and low permeability (conventional) dialyzers. The COBE® Cartridge Set is intended for use with the COBE Centrysystem 3 Hemodialysis Delivery System, or the COBE C* Hemodialysis Delivery System only.

COBE® Model Cx™ Hemodialysis Delivery System and COBE® Cartridge Blood Tubing Set

TIPSTOP is intended to be used as a sterile compression dressing for puncture of the vascular access site.

The Hospal TIPSTOP is a compressive dressing made of polyamide compressive element covered with alginate, which is placed on an adhesive film. TIPSTOP has been specially designed to stop bleeding after venipuncture in a manner similar to other compression dressings. The action mechanism consists of prolonging the manual compression with a mechanical compression carried out by the compressive element. TIPSTOP is sterilized by gamma irradiation.

The Gambro Central Water Treatment System CWP 100 – WRO H is designed to produce water of adquate quality for hemodialysis, both chemically and microbiologically with an adequate flow, provided that the feed water complies with the existing standards for drinking water and has been properly pre-treated.

The Gambro Central Water Treatment System CWP 100 - WRO H is designed to produce water of adquate quality for hemodialysis, both chemically and microbiologically with an adequate flow, provided that the feed water complies with the existing standards for drinking water and has been properly pre-treated. The WRO or the base unit of the CWP system, operates under the principle of reverse osmosis (RO) which is the preferred method for the purificationof water for hemodialysis. This system removes at least 95% of the total dissolved salts (based on conductivity measurements) and more than 99% of the bacteria and endotoxins from the inlet water. The WRO H also include a heat disinfection unit for disinfection of the distribution system which utilizes hot water to minimize any form of microbial growth and biofilf formation. With this system, dialysis machines can be included in this heat disinfection cycle, provided that they have heat disinfection capability. This procedure is called integrated heat disinfection. In order to ensure that the microbiological quality will be maintained, this system has: - an automated disinfection procedure to keep the membrane surfaces clean and to . minimize bacterial growth; - a hygenic design with smooth surfaces and a minimum of stagnant zones; . - automatic flushing programs at preset intervals when the system is not in use ● In addition, the WRO H has been designed to reduce water consumption by automatically regulating the pump speed to the actual demand of pure water. After pretreatment (i.e. sediment filter, water softener, charcoal filter, etc.) the water enters an inlet tank (please refer to position 4 on the following diagram) via a solenoid valve (1). The inlet water tank (4) has a float valve (5) and an air gap to help isolate the flowpath from the municipal water system. The main pump (33) then creates a pressure of up to 20 bar that is required for the reverse osmosis process. Pure water from the WRO unit is distributed directly to the distribution system in the hemodialysis unit via solenoid valves (48), (103), and (105). Excess pure water that has not been used in the hemodialysis unit is recirculated back to the inlet water tank (4) via solenoid valve (106). In order to reduce water consumption, the speed of the pump is automatically adjusted so that the return flow of water is kept constant. Part of the reject water is recirculated back to the sucking side of the main pump via valve (71) to help minimize water consumption and to maintain a high flow velocity over the membrane surface. The rest of the reject water is, however, continuously sent to the drain via a needle valve (41). The WRO unit utilizes a proportioning pump (45) and solution container (46) to proportion disinfectant during the disinfection cycle. The proportioning pump is disconnected from the flow path during normal operation. The pure water line has a solenoid valve (36) for automatic flushing to drain at the start up, in conductivity alarm situations, every two hours, when the unit is in stand-by mode and at rinse during disinfection. The pure water line also has a solenoid valve arrangement to isolate the system from the distribution system during disinfection. The WRO unit has an overflow valve (64) on the pure water side to control pressure and to relieve pressure peaks.

The PRISMA™ System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. All treatments administered via the PRISMA System must be prescribed by a physician.

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The Gambro® Water Treatment System is intended to be used by hemodialysis clinics for the purification of water to be used for the dilution of dialysate concentrate and in the reprocessing of dialyzers for reuse.

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