TABLE OF CONTENTS
VerifyNow System User Manual Page 3 14340.J
Table of Contents
About this Manual......................................................................................................6
Intended Use ..............................................................................................................6
Document Conventions....................................................................................6
1
Introduction ...................................................................................................9
1.1
Platelet Function Testing .....................................................................9
1.1.1
Aspirin Assay ...................................................................... 10
1.1.2
P2Y12 Assay....................................................................... 10
1.1.3
IIb/IIIa Assay ....................................................................... 11
1.2
Test Procedure .................................................................................. 12
2
Overview of System Components............................................................... 13
2.1
Instrument ......................................................................................... 13
2.1.1
Assay Device Port and Cover .............................................. 14
2.1.2
Display Screen .................................................................... 14
2.1.3
Icon Keys ............................................................................ 15
2.1.4
Keypad................................................................................ 15
2.1.5
Power Switch and Indicator ................................................. 15
2.1.6
Bar Code Scanner............................................................... 16
2.1.7
Fan ..................................................................................... 16
2.1.8
Printer (Accessory).............................................................. 16
2.2
Assay Device..................................................................................... 16
2.2.1
Humidity Indicator ............................................................... 17
2.2.2
Spot Code ........................................................................... 17
2.3
Sample Collection Tubes ................................................................... 18
2.4
Quality Control................................................................................... 18
2.4.1
EQC Device and Storage Slot ............................................. 18
2.4.2
Assay Wet Quality Controls (WQC) ..................................... 19
3
Precautions .................................................................................................. 21
3.1
Safe Operating Procedures................................................................ 21
3.1.1
Sample Collection and Handling .......................................... 21
3.1.2
Instrument Operation........................................................... 21
4
Reagent Storage and Handling ................................................................... 23
4.1
Storage and Stability.......................................................................... 23
5
Quality Controls........................................................................................... 25
5.1
Electronic Quality Control .................................................................. 26
5.2
Wet Quality Control............................................................................ 29