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The AMICUS Separator System is an automated blood cell separator intended for use in therapeutic apheresis applications and may be used to perform Therapeutic Plasma Exchange (TPE). The AMICUS Separator System is an automated blood cell separator intended for use in the collection of blood components and mononuclear cells. The AMICUS Separator System is an automated blood cell separator indicated to perform Therapeutic Plasma Exchange (TPE). The AMICUS Separator System is an automated blood cell separator indicated for the collection of blood components and mononuclear cells. The device is designed to collect products while maintaining an extracorporeal volume at or below 10.5 ml/kg and a donor post platelet count greater than or equal to 100,000 platelets/microliter. Depending on the AMICUS Separator System apheresis kit used in the collection of products, the AMICUS Separator System has been cleared to collect: - Platelets Pheresis, Leukocytes Reduced (single, double, or triple units) . - Platelets Pheresis, Leukocytes Reduced, Platelet Additive Solution (InterSol) (single, double . or triple units) - Red Blood Cells, Leukocytes Reduced (by apheresis) . - . Mononuclear Cells - Plasma . - o Fresh Frozen Plasma - . Must be prepared and placed in a freezer at -18° C or colder within 8 hours after phlebotomy. - o Plasma Frozen Within 24 Hours After Phlebotomy (PF24) - Must be stored at 1-6°C within 8 hours after phlebotomy and placed . in a freezer at -18° C or colder within 24 hours after phlebotomy. - Indicated for replacement of non-labile clotting factors. This product . is not equivalent to Fresh Frozen Plasma. - o Plasma Frozen Within 24 Hours After Phlebotomy (PF24) Held at Room Temperature Up to 24 Hours After Phlebotomy (PF24RT24) - . Can be stored at room temperature for up to 24 hours after phlebotomy. Product must be placed in a freezer at -18° C or colder within 24 hours after phlebotomy. - Indicated for replacement of non-labile clotting factors. This product . is not equivalent to Fresh Frozen Plasma. - o Source Plasma Platelet Pheresis (single, double, or triple units) may be manufactured from products that do not meet leukocyte reduction product standards. This does not apply to Platelet Pheresis, Platelet Additive Solution (InterSol) (single, double, or triple units).

The AMICUS Separator System is comprised of the AMICUS separator instrument and a disposable apheresis kit specific to the procedure being performed. The instrument is a continuous-flow, centrifugal device that draws whole blood from a donor/patient, separates the blood into its components, collects one or more of the blood components, and returns the remainder of the blood components to the donor/patient. The instrument operates using pumps, clamps and valves that move donor/patient blood through a single-use, sterile fluid path disposable kit. The cells are centrifugally separated within the kit by density differences. The operator is responsible for preparing and monitoring the donor/patient and operating and monitoring the AMICUS separator during the automatic blood collection cycle. The operator controls the separator through a touch screen. When necessary, the operator is warned of problems with messages on the screen and corresponding audible alarms. Once the cell separation is complete, the operator removes the needle(s) from the donor/patient, dismantles the kit, and disposes of the kit in a safe manner. The kit is packaged in a recyclable plastic tray.

The AMICUS Separator System is an automated blood cell separator indicated for the collection of blood components and mononuclear cells. The AMICUS Separator System is an automated blood cell separator indicated to perform Therapeutic Plasma Exchange (TPE). The Blood Component Filter Set with Vented Spike and Luer Adapter is indicated for the administration of blood and blood components during a therapeutic plasma exchange procedure. For use with the AMICUS Separator System.

The AMICUS separator is a continuous-flow, centrifugal device that separates whole blood into its components. Blood components are collected using sterile fluid path, single-use, apheresis kits. The cells are centrifugally separated within the kit by density differences. The Therapeutic Plasma Exchange (TPE) procedure is an apheresis collection procedure coupled with an infusion procedure. The collected plasma, which contains most of the anticoagulant, is pumped to a waste container(s). The patient's WBCs, the majority of platelets and a small amount of plasma and anticoagulant are mixed with a physician-prescribed replacement fluid, such as FFP, human albumin and/or crystalloid solutions, and returned to the patient. This process continues until the target plasma volume has been removed and replaced per physician order. The operator is responsible for preparing and monitoring the patient as well as operating and monitoring the AMICUS separator during the TPE procedure. The operator controls the separator through a touch screen. When necessary, the operator is alerted to problems, or given notes via messages displayed on the screen with corresponding audible alarms. Once complete, the operator disconnects the donor/patient, removes the kit, and disposes of the kit per institutional SOPs. The kit is packaged in a recyclable plastic tray. The Blood Component Filter Set with Vented Spike and Luer Adapter is an optional accessory intended to be used in conjunction with the AMICUS Separator System in Therapeutic Plasma Exchange (TPE) procedures to administer physician prescribed replacement fluids during the TPE procedure, when blood component filtration is needed (e.g. when using fresh frozen plasma). The filter set has a common blood transfusion set design and is comprised of a blood component filter, tubing, vented spike and a luer lock/cap. The filter set is a single use, sterile fluid path intravascular administration set. The filter set is connected to the TPE kit via the male luer connector and the vented spike is used to access the prescribed replacement fluid container. The flow rate through the filter set is controlled by the AMCUS Separator System.

Administration of blood and blood by-products.

Fenwal markets a broad range of intravascular administration sets for administration of I.V. solutions or blood involving hundreds of different sets marketed. While the design of these sets differs for each particular application, they are all based on a common basic design involving polyvinyl chloride extruded tubings, with attendant extruded or injection molded connecting parts of other thermoplastics (such as acrylic, ABS, nylon, and similar polymers) plus latex and synthetic rubber injection sites.