This kit contains parts for replacing the fenwal ignition control on models btp540a or btp700a series 960 and earlier, 962 series and 964 series. This magnetic cell separator removes cell types from dense mixtures found in blood, bone marrow, and other tissue fluids drawn from patients. Principles of blood separation and apheresis instrumentation. Amicus mononuclear cell mnc procedures important product information regarding wb. Consult fenwals entire amicus separator catalogue on medicalexpo. Acd ratio for mnc procedures, the amicus separator allows for wb. Fss cfd control unit pn 3500338, acdc 910 figure 6. Accessgudid fenwal amicus single needle advanced kit 040860001070 for collection of platelets with optional plasma andor red blood cells. Fenwal troubleshooting guides customer service 800 536 1582. Designed for 12vdc applications such as recreation vehicles, flare stacks and construction equipment these small footprint controls offer the latest in features and functionality.
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. Fresenius kabi apheresis machine manual divine mettacine. In our blood center, 18,00020,000 random donor platelets are produced annually. The singleneedle or doubleneedle plateletpheresis procedures of the three instruments were compared in a retrospective, randomized study in 270 donors. Click here to fill out our guest registration form. Amicus separator is a highly efficient, easytouse system with options to collect.
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. We compared three apheresis instruments fenwal amicus, fresenius com. 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. Fresenius kabi is a global health care company that specializes in medicines and technologies for. Amicus separator platelets plasma by fenwal by fenwal inc. The baxter fenwal maxsep offers a powerful tool for magnetic cell separation in research settings. The fenwal amicus separator is an advanced medical device used to. 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.
Data submitted by fenwal in support of its original mnc clearance used a 12. Edwin burgstaler mayo foundation for medical education. Steininger pa, strasser ef, weiss d, achenbach s, zimmerman r, ekstein r. Wirelesswired data export drive data informed decision making with dxt relay. For more information, literature, technical details and working instructions as well as for. Wirelesswired data export drive data informed decision making with dxt relay 4r4580 amicus separator. Chief, division of immunotherapy, california pacific medical. Coronavirus covid19 due to the coronavirus covid19 outbreak worldwide, the global demand for some personal protective equipment ppe is exceeding current supply availability. Refer to the amicus separator operators manual and dxt relay instructions for use for a full list of warnings. The patient remains connected to the amicus device throughout the procedure.
We will deliver exceptional value by providing innovative solutions, anytimeanywhere responsiveness, special attention to detail, and an unwavering commitment to customers and associates. Food and drug administration has granted fenwal a new 510k clearance for its amicus blood cell separator. Are you interested in specifying kidde fire systems products. To compare the fenwal amicus and the fresenius com. Using anticoagulant citrate phosphate dextrose adenine solution. Fda grants fenwal new 510k clearance news provided by. Neither the manual nor any part thereof may be disclosed to others or used for purposes other than the maintenance of fenwal equipment. 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. Tec cell separators for autologous peripheral blood progenitor cell collection article in transfusion and apheresis science 362.
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. Tec cell separators article pdf available in transfusion medicine and hemotherapy 355. Peripheral blood progenitor cells pbpc are commonly used as a stem cell source for autologous transplantation. Amicus fenwal pdf catalogs technical documentation.
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. Score 2 indicates clear homogeneous swirling in all parts of the plateletproduct bag. Products in the prescription medications section 4r3622, 4r3626 fresenius kabi fenwal bloodpack units rx only. Bidirectional communication between the amicus separator and phelix device allow for easy control of the system. Amicus mononuclear cell mnc collection fenwal amicus. Fresenius kabi receives 510k clearance for the fenwal. The mean separation time was also significantly longer in. 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. The fenwal amicus gentle science design delivers precision youve come to expecteven for patients with lower blood volume. List of devices made by the manufacturer fenwal inc. Food and drug administration has granted fenwal 510k clearance for its amicus separator with new wireless dataexport capabilities. Four hundred and seventynine donors have met the appropriate criteria, and were directed to fenwal amicus for double dose platelet collection.
Fresenius kabi operators manual fenwal amicus mnc 6. With amyloidosis comparative evaluation of leukapheresis technology on unstimulated. Refer to the amicus separator operators manual for the full list of warnings and cautions associated with the use of the amicus device. Principles of blood separation and apheresis instrumentation dobri kiprov, m. This advanced system uses continuousflow centrifugation and optical detection technology, providing operators the ability to perform a wide variety of apheresis. These reports help identify opportunities for improvement and training. Prp recirculation hct countercurrent elutriation effect platelet separation interface position monitored by detector prp. Efficacy of fenwal amicus blood cell separator in double dose. 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.
Achieve more platelet doses per donor with the flexible component collection system. Amicus high collection efficiency yields multiple download fresenius apheresis machine manual. Food and drug administration for the fenwal amicus red blood cell exchange rbcx system. The amicus separator s singleuse disposable kit combined with the phelix photoactivation device create an online, closed system to perform photopheresis. Find leads, switches, cables and more available with great low prices. The parameters of the amicus device were as follows. The precision design and time tested technology of the amicus device is the foundation that support the therapeutic and collection protocols with. 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. 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. Swirling score results for the cell separator instruments amicus fenwal inc, lake zurich, il and com. Maximize platelet collections per donor userfriendly interface collect more plasma with intersol solution product. 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.
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. Mobilized patients using the amicus separator, december, 2000 and post hoc analysis for fcrp0297, march, 2014. Apr 28, 2010 the fenwal amicus separator is an advanced medical device used to collect platelets and other blood components from donors. One more dose collected may mean one more patient treated, one more person saved, or one more life renewed. Fresenius kabi recently announced it has received 510k clearance from the u. Fenwal amicus can tailor procedures around the individual donor anywhere from start to finish and inbetween. Fenwal europe sprl, rue edouard belin 24, 1435 montsaintguibert, belgium amicus. Fresenius kabi is dedicated to providing hospitals and blood centers with flexible therapeutic apheresis and cell collection platforms that help meet your organizations goals. Design, installation, operation, and maintenance manual. Platelets plasma concurrent red blood cells rbcs mononuclear cells mncs 6 fenwal, inc. Request membership to product performance online report site training resources printable quick guide. Therapeutic apheresis and cell amicus separator operators manual, fresenius kabi is a global health care company that specializes in. Fenwal dxt technology features opensource compatibility, enabling connection to virtually any bloodcenter information system. The fenwal amicus separator system is an automated blood cell separator indicated for the collection of blood components with options to collect.
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. Armstrong hwc premier 122 service reference manual pdf download. For current distributors, contact your company admin for access to portal. A call for heat closes the circuit between wires r 1. Principles of blood separation and apheresis instrumentation author. Hospitals and blood centers have trusted the reliabilityof the amicus separator with the care of their patients and donors. Accessgudid fenwal amicus apheresis kit double needle 040860001032 for extended platelet storage and plasma collection. Comparison of plateletpheresis on the fenwal amicus and fresenius com. Orr protection systems will be americas preeminent fire protection company for businesses with mission critical operations. The fenwal controls 3552 and 3553 have been reengineered to meet the new harmonized 6073025 standard. Fenwal receives fda clearance for therapeutic plasma. Fenwal amicus red blood cell exchange system medgadget. Fda grants fenwal new 510k clearance for amicusr blood.
The amicus separator efficiently collected single aps n 59 and double aps n 62 with mean platelet yields of 4. Fresenius kabi, a company based in bad homburg, germany, announced that its fenwal amicus red blood cell exchange rbcx system won clearance from the. Fast, accurate barcode scanning streamlines workflow and reduces risk of manual. Kidde fenwal assumes no responsibility for the application of any systems other than those addressed in this manual. Looking for fenwal ignition controls control board, 120v, fits brand fenwal ignition controls 40lx30. 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. Pdf comparison of the fenwal amicus and fresenius com. Collection of mncs and progenitor cells by two separators for pbpc transplantation. In 2004, 2451 units of 18,618 donations were apheresis procedures. Table top sealer with a hand unit, minimal user effort, adapts to different tube.
After photoactivation, amicus reinfuses the treated cells back to the. Platelets concurrent plasma concurrent red blood cells crbcs features. The control utilizes a microprocessor to continually and safely, analyze and control the proper operation of the gas burner. Comparative analysis of various aspects of plateletpheresis on the. Pdf comparison of plateletpheresis on the fenwal amicus. If multiple device types are used, increased variability may result and may be compounded by patient to patient variability. This manual is intended to describe the design, installation, operation and maintenance of kidde wet chemical fire suppression systems. The second cell separator used for plt collection was the blood cell separator com. Amicus separator is a highly efficient, easytouse system with options to collect platelets, concurrent plasma and concurrent red blood cells. This study was undertaken to evaluate blood cell separators with respect to separation results and content of the harvest. Amicus separator platelets plasma by fenwal grayline.
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. Evaluation of therapeutic plasma exchange tpe procedure. 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. The series 3560 is a 24 vac microprocessor based direct spark ignition control designed for use in all types of heating applications. 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. Efficacy of fenwal amicus blood cell separator in double.
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. 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. Accessgudid fenwal amicus double needle advanced kit 040860001087 for collection of platelets with optional plasma. Installation instructions fenwal control replacement kit 9004487. Comparison of plateletpheresis on the fenwal amicus and. Comparison of plateletpheresis on the fenwal amicus. The collection of platelets and plasma in japan, europe and the us bk960005, 1996. Control board, 120v, fits brand fenwal ignition controls. For platelet storage in plasma or platelet additive solution plus plasma. Tec cell separators for autologous peripheral blood progenitor cell collection. And its why the amicus separator is designed to help you increase your inventory of platelets, plasma, and red cells. The technical data contained herein is limited strictly for informational purposes only.
Amicus separators with dxt offer bloodcenter professionals easytoread, ondemand reports concerning donations at multiple locations. Fresenius apheresis machine manual muslim modest world. Fenwal receives fda clearance for amicusr separator with. 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. We are a fenwal wholesale distributor online and have most parts in immediate stock in our warehouses. Medical professionals, medical facility employees, individuals paying with medicaid or private insurance. Tec, and trima accel with regard to platelet plt yield, collection efficiency ce, and collection rate cr.
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