SECTION 1 – INTRODUCTION

SECTION 1 INTRODUCTION1-1 SECTION 1 INTRODUCTIONINTRODUCTIONTheCOBE Spectra Apheresis System Operator s Manualis intended for the person who will be operatingthe COBE SpectraTMApheresis System. The recommended procedures in thisManualhave beendeveloped and tested to provide safe, reliable, and efficient operation of the Spectra system. It is importantthat you, the operator, read and thoroughly understand the information in thisManualbefore attempting touse the Spectra DESCRIPTIONThe Spectra Apheresis System is intended to separate and collect blood components from both donorsand patients. From donors, blood products are collected for transfusion to patients. If desired, plasma canbe collected concurrently with platelets. The plasma thus collected is available for use as plasma or freshfrozen plasma . Alternatively, it may be used as source plasma for further processing into Factor VIII andFactor IX Spectra system with Version LRS (LeukoReduction System) software can be used to collectleukocyte-reduced, extended life platelets for transfusion to appropriate thrombocytopenic of the Spectra system s ability to estimate platelet yields before a platelet collection procedurestarts, donor pools can be optimized by collecting double-platelet products from donors with sufficientlyhigh platelet counts and sufficient total blood volumes.

1-2 SECTION 1 – INTRODUCTION Spectra platelet collection and plasma exchange procedures can be performed in either the Dual-Needle mode (one access needle and one return needle) or Single-Needle mode (one access/return needle).

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