The spectra optia system is a therapeutic apheresis, cell processing and cell collection platform that allows operators to spend more time focusing on patient. The system draws whole blood from a donor or patient, adds anticoagulant, separates the blood components, collects or removes specific components and returns uncollected components back to the donor or patient. The cobe spectra page 3 of 37 nice medical technology consultation document. Spectra optia apheresis system operators manual part no. It will be used internally and externally with us customers.
Installing and transporting the spectra optia system. Therapeutic white blood cell and platelet depletions using. The spectra optia automated apheresis system, indicated for red blood cell exchange in people with sickle cell disease, underwent evaluation by the national institute for health and care excellence, which uses its medical technologies advisory committee to make recommendations. Autologous, collection, efficiency, stem cell, apheresis received. The mnc protocol is not available for sale in the u. Spectra optia apheresis system operators manual english, en.
The cobe spectra apheresis system uses unique centrifugal technology to separate whole blood into its major components. Oct 16, 2018 the spectra optia apheresis system has only recently been approved by the food and drug administration fda for therapeutic white blood cell wbc depletions and is not yet approved for platelet depletions. The apheresis system operator uses the spectra optia systems touch screen to communicate with the system. Our data suggest that cryovials can serve as a representative surrogate for the primary product cryobag. Prior to 2018, cobe spectra was the machine of choice for apheresis treatments. Best practices for red blood cell exchange procedures on the.
It is operationally more efficient than manual red blood cell exchange, resulting in improved clinical and patient outcomes and improved regulation of iron levels. There have been few attempts to validate the advantages of the spo. In 2017, learned that cobe spectra being sundowned by company in 2018 needed to get fda approval for wbc depletion on spectra optia. The optia is used for the primary separation of blood components through continu. Caridianbct stands behind the spectra optia system with experienced therapeutic apheresis and cell therapy clinical and technical support. Spectra optia apheresis system terumo medical pdf catalogs.
Please contact your caridianbct representative for additional information. The spectra optia system can help you achieve consistent, predictable results. Optia system caridianbct, lakewood, dnv, co, usa introduced as the replacement for the cobe spectra system tpe, rce available all over the world mnz, granulo, leukodepletion are available in europe bm processing is pending universal apheresis system for therapies and collection of blood and tissue products. Date hs code description origin country port of discharge unit quantity value inr per unit inr nov 17 2016. Principles of blood separation and apheresis instrumentation. Spectra optia apheresis system advancing therapeutic apheresis and cell collections to the next level of patient care intuitive graphical user interface gui. This advanced system uses continuousflow centrifugation and optical detection technology, providing operators the ability to perform a wide variety of apheresis. We have 1 caridianbct spectra optia manual available for free pdf download. Return pump motor successfully completed the pump functional test and pump autotest 100x.
It is operationally more efficient than manual red blood cell exchange, resulting in improved clinical and patient outcomes and. The spectra optia apheresis system is an automated centrifugal system that separates whole blood into its cellular and plasma components. Spectra optia apheresis system operators manual fda. Data collection of routine clinical use with the spectra. Jul 15, 2015 the spectra optia spo is a novel continuousflow centrifugal apheresis system based on the cobe spectra csp platform. Cannulation of deep peripheral veins or central veins in the neck region or groin may require ultrasound guidance. Read online now optia spectra manual ebook pdf at our library. Venous access for spectra optia may be through peripheral or central veins. The spectra optia apheresis system is a transportable, automatic blood component separator that uses centrifugation and optical detection automated interface. Pdf anne klink, silke rummler department of therapeutic apheresis, institute of transfusion medicine, university hospital jena, jena. Spectra optiaapheresis system service manual part no. Sales inquiries for more information on the secondary plasma device protocol or about the spectra optia system, simply contact your caridianbct representative. Return pump functional test and pump autotest performed. The spectra optia system also allows the operator to run the procedure with a positive 100% or negative spectra apheresis system has been the main apheresis device for several decades.
The apheresis system operator uses the spectra optia system s touch screen to communicate with the system. Successful development of a hospitalbased outpatient. Mononuclear cell mnc collection with the spectra optia apheresis system the spectra optia collection set maxim urn ecv with reservoir filled to high level. Venous access apheresis require large bore venous catheters to sustain the flow rates required 50100 mlmin type of catheters. Apr 16, 2018 terumobct has issued a voluntary medical device safety alert for two purposes. Spectra, optia, overview, brochure, system created date. The spectra optia device is an automated apheresis system that is indicated for the elective treatment of sickle cell disease as well as for other indications such as plasma exchange and stem cell harvesting. Comparison of two apheresis systems of cobe and optia for. Therapeutic plasma exchange using the spectra optia cell.
Spectra optia apheresis system, alan medical equipment. The spectra optia apheresis system has only recently been approved by the food and drug administration fda for therapeutic white blood cell wbc and is. Spectra optia for automated red blood cell exchange in. Optia system caridianbct, lakewood, dnv, co, usa introduced as the replacement for the cobe spectra system tpe, rce available all over the world mnz, granulo, leukodepletion are available in europe bm processing is pending universal apheresis. Caridianbct supports the spectra optia system with experienced therapeutic apheresis and cell therapy clinical and technical support. The spectra optia apheresis system, based on the cobe spectra system, is the industrys nextgeneration therapeutic apheresis and cell therapy platform that allows operators to spend more time focusing on patient care. Contact your terumo bct sales representative or visit terumobct. In a first phase a, 16 apheresis procedures with cobe spectra using an inlet. Terumobct has issued a voluntary medical device safety alert for two purposes. This brochure gives a high level overview of the spectra optia system for tpe only. The operator follows the instructions on the screens to enter patient and procedure data, load and prime the disposable tubing set, and perform and troubleshoot procedures.
Spectra optia launched in the us in 2007 will ultimately replace the cobe spectra for all therapeutic procedures. The spectra optia apheresis system is an automatic blood component separator used to perform various therapeutic apheresis procedures, cell collection and. Evidencebased recommendations on spectra optia for automated red blood cell exchange in patients with sickle cell disease implementation. Data collection of routine clinical use with the spectra optia apheresis system for white blood cell depletion wbcd the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Streamlined to provide quality apheresis procedures. Spectra optia manuals and user guides for caridianbct spectra optia. Nice has developed tools, in association with relevant stakeholders, to help organisations put this guidance into practice. Spectra optia apheresis system service manual part no. 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. Software used to convert postscript files to portable document format pdf files.
Many products that you buy can be obtained using instruction manuals. Overview spectra optia for automatic red blood cell. The spectra optia apheresis system has only recently been approved by the food and drug administration fda for therapeutic white blood cell wbc depletions and is not yet approved for platelet depletions. Optia efficiency considerations with mnc collection. The spectra optia system also allows the operator to run the procedure with a positive 100% or negative 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. This study of a small cohort demonstrates that the spectra optia v. To remind spectra optia system users of this potential safety hazard. An evaluation of the spectra optia cmnc collection procedure.
The spectra optia spo is a novel continuousflow centrifugal apheresis system based on the cobe spectra csp platform. Performing clinical procedures and optimal management of spectra optia in. Spectra optia for automatic red blood cell exchange in. Spectra optia service manual english, en franks hospital. Mononuclear cell mnc collection with the spectra optia apheresis system the spectra optia collection set maxim urn ecv with reservoir filled to highlevel. However, the transition to the next generation system, spectra optia, is currently underway in many apheresis centers due to many advanced features. We performed a retrospective study comparing the two cell separators for therapeutic plasma exchange tpe procedures in kidney transplant kt patients and. Caridianbct spectra optia service manual pdf download. This product information is for europeanasia pacific distribution.
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