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Spectra Optia SPD procedure with a Column – Demonstration Videos

Operator’s Manual Information
Spectra Optia Apheresis System

Intended Use

The Spectra Optia Apheresis System, a blood component separator, may be used to perform the following therapeutic apheresis, cell collection, and cell processing procedures*:
  • Therapeutic plasma exchange
  • Therapeutic plasma exchange with a secondary plasma device
  • Red blood cell exchange, depletion, and depletion/exchange
  • Mononuclear cell collection from the peripheral blood
  • Granulocyte collection from the peripheral blood
  • White blood cell depletion
  • Platelet depletion
  • Processing of harvested bone marrow
*Procedure availability varies by country.

Contraindications for Use

  • Leukocytapheresis is contraindicated in AML FAB M3 (APL) because of the accompanying disseminated intravascular coagulation. (Vahdat L, et al., “Early mortality and the retinoic acid syndrome in acute promyelocytic leukemia: impact of leukocytosis, low-dose chemotherapy, PMN/RAR-alpha isoform and CD13 expression in patients treated with all-trans retinoic acid.” Blood 1994; 84: 3843-3849. Daver, et al., “Clinical characteristics and outcomes in patients with acute promyelocytic leukaemia and hyperleucocytosis.” British Journal of Haematology 2015, 168, 646-653.)
  • Other contraindications for the use of the Spectra Optia system are limited to those associated with the infusion of solutions and replacement fluids as required by the apheresis procedure, and those associated with all types of automated apheresis systems.

Possible adverse events of apheresis procedures include:

  • Anxiety, headache, light-headedness, digital and/or facial paresthesia, fever, chills, hematoma, hyperventilation, nausea and vomiting, syncope (fainting), urticaria, hypotension, allergic reactions, infection, hemolysis, thrombosis in patient and device, hypocalcemia, hypokalemia, thrombocytopenia, hypoalbuminemia, anemia, coagulopathy, fatigue, hypomagnesemia, hypogammaglobulinemia, adverse tissue reaction, device failure/disposable failure, air embolism, blood loss/anemia, electrical shock hazard, fluid imbalance, inadequate separation of blood components.

Reactions to Blood Products Transfused During Procedures

  • Reactions to transfused blood products can include fever, circulatory overload, shock, allergic reactions, alloimmunization, transfusion-related acute lung injury (TRALI), and graft-versus-host disease (GVHD), as well as transmission of infectious diseases and bacteria. (Sources: Circular of Information for the Use of Human Blood and Blood Components, AABB, et al, ed., April, 2006; Guide to the preparation, use and quality assurance of blood components, 10th Edition, Council of Europe Publishing; Blood. Toy P et al., “Transfusion-Related Acute Lung Injury: Incidence and Risk Factors.” Blood, 2012; 119: 1757-1767.)

Restricted to prescription use only:

  • Operators must be familiar with the system's operating instructions.
  • Procedures must be performed by qualified medical personnel.


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