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