OVERVIEW OF SYSTEM COMPONENTS - 2VerifyNow System User Manual Page 18 14340.JAssay devices are calibrated at the factory. No additional calibration is required bythe user. Information about calibration and the device expiration date is contained inthe bar code on the pouch of each assay device. The bar code must be scannedwhenever a new lot of assay devices is to be used.NOTE: Handle assay devices as biohazardous material. Dispose of them in anappropriate manner.2.3 Sample Collection TubesThe VerifyNow System uses whole blood collected in a partial-fill vacuum tube.During the test, the tube is inserted onto the needle in the sample well of the assaydevice - requiring no cap removal, specimen preparation, or pipetting step. There areseveral types of sample collection tubes recommended for use with the system(Table 2-1).Table 2-1 Sample Collection TubesCollection Tube Description AssayGreiner Bio-One Vacuette tube(Greiner #454321)Partial fill, 2 mL,3.2% sodiumcitrate. Blue topAspirin, P2Y12,IIb/IIIa (only for use with ReoPro –abciximab)Greiner Bio-One Vacuette tube(Greiner #454082)Partial fill, 3 mLlithium heparin.Green topIIb/IIIa - for use with Integrilin(eptifibatide) or ReoPro (abciximab)Greiner Bio-One Vacuette tube(Greiner #454237)Partial fill, 2 mLlithium heparin.Green topIIb/IIIa - for use with Integrilin(eptifibatide) or ReoPro (abciximab)NOTE: The use of sample collection tubes other than those listed may adverselyaffect assay results.2.4 Quality ControlAccumetrics rigorously tests each VerifyNow System to ensure it meets performancestandards. In addition, the system supports several types of quality controls to verifycontinued performance during use.2.4.1 EQC Device and Storage SlotThe Electronic Quality Control (EQC) is the primary quality control mechanism for theVerifyNow instrument. It consists of a re-usable device that is inserted by theoperator into the assay port and is used to perform a comprehensive testing routinethat confirms instrument performance.