Tec, and trima accel with regard to platelet plt yield, collection efficiency ce, and collection rate cr. Orr protection systems will be americas preeminent fire protection company for businesses with mission critical operations. Amicus separator is a highly efficient, easytouse system with options to collect. Platelets plasma concurrent red blood cells rbcs mononuclear cells mncs 6 fenwal, inc. Armstrong hwc premier 122 service reference manual pdf download. Fast, accurate barcode scanning streamlines workflow and reduces risk of manual. Peripheral blood progenitor cells pbpc are commonly used as a stem cell source for autologous transplantation. Fresenius kabi is dedicated to providing hospitals and blood centers with flexible therapeutic apheresis and cell collection platforms that help meet your organizations goals. Fenwal receives fda clearance for therapeutic plasma. Designed for 12vdc applications such as recreation vehicles, flare stacks and construction equipment these small footprint controls offer the latest in features and functionality. Principles of blood separation and apheresis instrumentation author. Service reference manual sequence of operations 217 simplified sequence hwc122,182, 242, 302 w fenwal triton 2461d dsi ignition control refer to figure 23 call for heat call for cooling 1. Double needle kit with platelet additive solution connectorintegral saline and acda inlet line sampling pouch with attached sample barrel platelet additive solution connector with inline 0. Kidde fenwal assumes no responsibility for the application of any systems other than those addressed in this manual.
Efficacy of fenwal amicus blood cell separator in double dose. If multiple device types are used, increased variability may result and may be compounded by patient to patient variability. Fenwal amicus plateletpheresis amicus fda approved in 1996 top panel 6 pumps, 3 cassettes, 10 valves, 4 sensors, electric scales for solutions, 4 clamps, optical sensor single needle double needle continuous flow features. Fenwal s amicus separator platform is a centrifugebased apheresis system which collects the blood components of interest and returns the remaining blood components along with saline back to a donorpatient. Mobilized patients using the amicus separator, december, 2000 and post hoc analysis for fcrp0297, march, 2014. For current distributors, contact your company admin for access to portal. The series 3560 is a 24 vac microprocessor based direct spark ignition control designed for use in all types of heating applications. The amicus separator from fenwal is now one of the most advanced cell separation systems available for therapeutic plasma exchange and mononuclear cell collection, which are used to treat a wide. Request membership to product performance online report site training resources printable quick guide. Table top sealer with a hand unit, minimal user effort, adapts to different tube. Amicus is indicated to perform red blood cell exchange rbcx, including exchange and depletionexchange procedures, for the transfusion management of sickle cell disease in adults and children. Comparison of plateletpheresis on the fenwal amicus and.
With demands on hospital and blood center resources being a challenge, the amicus separator supports the need for a versatile, multiprocedural instrument with the convenience of a single device. Hospitals and blood centers have trusted the reliabilityof the amicus separator with the care of their patients and donors. The baxter fenwal maxsep offers a powerful tool for magnetic cell separation in research settings. List of devices made by the manufacturer fenwal inc. Coronavirus covid19 due to the coronavirus covid19 outbreak worldwide, the global demand for some personal protective equipment ppe is exceeding current supply availability. The fenwal amicus separator is also cleared in europe and the united states for therapeutic plasma exchange tpe, mononuclear cell mnc collection and platelet collection.
Fresenius kabi, a company based in bad homburg, germany, announced that its fenwal amicus red blood cell exchange rbcx system won clearance from the. Design, installation, operation, and maintenance manual. In 2004, 2451 units of 18,618 donations were apheresis procedures. The fenwal controls 3552 and 3553 have been reengineered to meet the new harmonized 6073025 standard. Apheresis collection fenwal amicus separator meeting more of your missioncritical goals open the catalog to page 1 the fresenius kabi fenwal amicus separator helps blood centers increase their inventory of lifesaving platelet and plasma products, enhance the efficiency of their apheresis professionals, and expand the impact of their donors. Amicus separators with dxt offer bloodcenter professionals easytoread, ondemand reports concerning donations at multiple locations. Fenwal amicus manual color monitoring to optimize hpc collections, jca 2011 hpc collections, effects of increasing cycle volume on ce, transfusion and apheresis science 20 comparison hpc collections spectra vs. Evaluation of therapeutic plasma exchange tpe procedure.
Comparison of plateletpheresis on the fenwal amicus and fresenius com. The spectra optia system is an industryleading therapeutic apheresis, cell processing and cell collection platform that allows operators to spend more time focusing on patient care. Food and drug administration has granted fenwal 510k clearance for its amicus separator with new wireless dataexport capabilities. The patient remains connected to the amicus device throughout the procedure. Maximize platelet collections per donor user friendly interface collect more plasma with intersol solution product options calculator enhance donor comfort data management dxt relay the performance standard in platelet dose maximization is complemented with a user friendly interface and a product options calculator. Pdf comparison of plateletpheresis on the fenwal amicus. In our blood center, 18,00020,000 random donor platelets are produced annually. The apheresis product may be collected by one of several devices, such as the fenwal amicus separator fresenius kabi, or the spectra optia apheresis system terumobct. We are a fenwal wholesale distributor online and have most parts in immediate stock in our warehouses. The precision design and time tested technology of the amicus device is the foundation that support the therapeutic and collection protocols with. The amicus separator s singleuse disposable kit combined with the phelix photoactivation device create an online, closed system to perform photopheresis. Food and drug administration for the fenwal amicus red blood cell exchange rbcx system.
Platelets concurrent plasma concurrent red blood cells crbcs features. The parameters of the amicus device were as follows. Swirling score results for the cell separator instruments amicus fenwal inc, lake zurich, il and com. The collection of platelets and plasma in japan, europe and the us bk960005, 1996. Accessgudid fenwal amicus single needle advanced kit 040860001070 for collection of platelets with optional plasma andor red blood cells. Comparative analysis of various aspects of plateletpheresis on the. Find leads, switches, cables and more available with great low prices. Fenwal dxt technology features opensource compatibility, enabling connection to virtually any bloodcenter information system. Accessgudid fenwal amicus double needle advanced kit 040860001087 for collection of platelets with optional plasma. Neither the manual nor any part thereof may be disclosed to others or used for purposes other than the maintenance of fenwal equipment. Using anticoagulant citrate phosphate dextrose adenine solution. Refer to the amicus separator operators manual for the full list of warnings and cautions associated with the use of the amicus device. Achieve more platelet doses per donor with the flexible component collection system. The amicus separator efficiently collected single aps n 59 and double aps n 62 with mean platelet yields of 4.
Sep 16, 2008 the parameters of the amicus device were as follows. Event type malfunction event description a report received from the user facility indicated that a male donor who donated frequently was undergoing a double needle amicus apheresis procedure. Acd ratio for mnc procedures, the amicus separator allows for wb. Accessgudid fenwal amicus apheresis kit double needle 040860001032 for extended platelet storage and plasma collection. Amicus high collection efficiency yields multiple download fresenius apheresis machine manual. Steininger pa, strasser ef, weiss d, achenbach s, zimmerman r, ekstein r. A call for heat closes the circuit between wires r 1. The second cell separator used for plt collection was the blood cell separator com. Fenwal receives fda clearance for amicusr separator with.
Fenwal amicus red blood cell exchange system medgadget. The fenwal amicus gentle science design delivers precision youve come to expecteven for patients with lower blood volume. And its why the amicus separator is designed to help you increase your inventory of platelets, plasma, and red cells. This study was undertaken to evaluate blood cell separators with respect to separation results and content of the harvest. With amyloidosis comparative evaluation of leukapheresis technology on unstimulated. Looking for fenwal ignition controls control board, 120v, fits brand fenwal ignition controls 40lx30. Amicus mononuclear cell mnc collection fenwal amicus.
The technical data contained herein is limited strictly for informational purposes only. These reports help identify opportunities for improvement and training. Amicus separator platelets plasma by fenwal grayline. The mean separation time was also significantly longer in. Therapeutic apheresis and cell amicus separator operators manual, fresenius kabi is a global health care company that specializes in. Fresenius kabi recently announced it has received 510k clearance from the u. Bidirectional communication between the amicus separator and phelix device allow for easy control of the system. Control board, 120v, fits brand fenwal ignition controls. Installation instructions fenwal control replacement kit 9004487. Fss cfd control unit pn 3500338, acdc 910 figure 6. To compare the fenwal amicus and the fresenius com. The fenwal amicus separator system is an automated blood cell separator indicated for the collection of blood components with options to collect.
Collection of mncs and progenitor cells by two separators for pbpc transplantation. Tec cell separators for autologous peripheral blood progenitor cell collection article in transfusion and apheresis science 362. Intersol solution is to be used with the amicus separator system or the trima accel system. The fenwal amicus separator is an advanced medical device used to. Tec cell separators article pdf available in transfusion medicine and hemotherapy 355. This advanced system uses continuousflow centrifugation and optical detection technology, providing operators the ability to perform a wide variety of apheresis.
Fresenius apheresis machine manual muslim modest world. Refer to the amicus separator operators manual and dxt relay instructions for use for a full list of warnings. The control utilizes a microprocessor to continually and safely, analyze and control the proper operation of the gas burner. Chief, division of immunotherapy, california pacific medical. Fda grants fenwal new 510k clearance for amicusr blood. Amicus fenwal pdf catalogs technical documentation. Click here to fill out our guest registration form. About fenwal protection systems orr protection systems. Are you interested in specifying kidde fire systems products. Fenwal europe sprl, rue edouard belin 24, 1435 montsaintguibert, belgium amicus. Fresenius kabi operators manual fenwal amicus mnc 6. One more dose collected may mean one more patient treated, one more person saved, or one more life renewed.
Baxter fenwel maxsep magnetic cell separator biosurplus. Fresenius kabi receives 510k clearance for the fenwal. Apr 28, 2010 the fenwal amicus separator is an advanced medical device used to collect platelets and other blood components from donors. Prp recirculation hct countercurrent elutriation effect platelet separation interface position monitored by detector prp. Food and drug administration has granted fenwal a new 510k clearance for its amicus blood cell separator. Amicus separator platelets plasma by fenwal by fenwal inc.
Medical professionals, medical facility employees, individuals paying with medicaid or private insurance. Wirelesswired data export drive data informed decision making with dxt relay 4r4580 amicus separator. Principles of blood separation and apheresis instrumentation. Tec cell separators for autologous peripheral blood progenitor cell collection. Edwin burgstaler mayo foundation for medical education. Fresenius kabi is a global health care company that specializes in medicines and technologies for. The singleneedle or doubleneedle plateletpheresis procedures of the three instruments were compared in a retrospective, randomized study in 270 donors. For platelet storage in plasma or platelet additive solution plus plasma. For more information, literature, technical details and working instructions as well as for. This manual is intended to describe the design, installation, operation and maintenance of kidde wet chemical fire suppression systems. We will deliver exceptional value by providing innovative solutions, anytimeanywhere responsiveness, special attention to detail, and an unwavering commitment to customers and associates.
Comparison of plateletpheresis on the fenwal amicus. Fda grants fenwal new 510k clearance news provided by. Principles of blood separation and apheresis instrumentation dobri kiprov, m. Pdf comparison of the fenwal amicus and fresenius com. Refer to the amicus separator operators manual and dxt relay instructions for use for a full. Amicus mononuclear cell mnc procedures important product information regarding wb. Use of various offset settings in the fenwal amicus during hematopoietic progenitor cell collection to increase lymphocyte yield and reduce crosscellular contamination article jan 2010. Efficacy of fenwal amicus blood cell separator in double. As part of our automated component collection portfolio, the amicus separator helps you meet the demand for blood components by maximizing inventory of singledonor platelets and providing the flexibility to collect concurrent plasma and concurrent red cellsat the donors side.
Fresenius kabi apheresis machine manual divine mettacine. Fresenius kabi, a company based in bad homburg, germany, announced that its fenwal amicus red blood cell exchange rbcx system won clearance from the fda. Wirelesswired data export drive data informed decision making with dxt relay. Four hundred and seventynine donors have met the appropriate criteria, and were directed to fenwal amicus for double dose platelet collection. This magnetic cell separator removes cell types from dense mixtures found in blood, bone marrow, and other tissue fluids drawn from patients. Instruction manual continuous fire and overheat detection systems for industry cfd installation, operation and maintenance the contents of this manual are proprietary to fenwal and are submitted in confidence. This kit contains parts for replacing the fenwal ignition control on models btp540a or btp700a series 960 and earlier, 962 series and 964 series. Amicus separator is a highly efficient, easytouse system with options to collect platelets, concurrent plasma and concurrent red blood cells.
Fenwal amicus can tailor procedures around the individual donor anywhere from start to finish and inbetween. Products in the prescription medications section 4r3622, 4r3626 fresenius kabi fenwal bloodpack units rx only. Data submitted by fenwal in support of its original mnc clearance used a 12. Maximize platelet collections per donor userfriendly interface collect more plasma with intersol solution product. We compared three apheresis instruments fenwal amicus, fresenius com. In vitro biochemical and functional evaluations intersol platelet concentrates n70 prepared using the amicus separator and stored for 5 days showed a median and mean ph value on day 5 of 7. After photoactivation, amicus reinfuses the treated cells back to the. Fenwal troubleshooting guides customer service 800 536 1582. Fenwal instruction manual fenwal continuous fire and overheat detection system for industry fss publication 602 page iii 21 november 1996 list of illustrations and tables contd page figure 4. Score 2 indicates clear homogeneous swirling in all parts of the plateletproduct bag. The addition of wireless data management allows blood centers to easily access procedure information to monitor machine and operator performance without the added cost or capital investment of rewiring facilities. Consult fenwals entire amicus separator catalogue on medicalexpo.
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