ITC VerifyNow System Platelet Reactivity Test - Manual (Page 2)

14439.C 03/2013 VerifyNow System User Manual | USA
Accumetrics Standard Terms and Conditions ........................................... 1
About this Manual ....................................................................................... 2
Intended Use ................................................................................................ 2
Document Conventions ...........................................................................................2
1 Introduction ................................................................................. 3
1.1 Platelet Function Testing ......................................................................3
1.1.1 Aspirin Test ......................................................................................................................4
1.1.2 PRUTest ......................................................................................................................4
1.1.3 IIb/IIIa Test ......................................................................................................................5
1.2 Test Procedure .....................................................................................5
2 Overview of System Components .............................................. 7
2.1 Instrument ............................................................................................7
2.1.1 Test Device Port and Cover .....................................................................................8
2.1.2 Display Screen ........................................................................................................8
2.1.3 Icon Keys ................................................................................................................9
2.1.4 Keypad ...................................................................................................................9
2.1.5 Power Switch and Indicator .....................................................................................9
2.1.6 Bar Code Scanner...................................................................................................9
2.1.7 Fan .........................................................................................................................9
2.1.8 Printer (Accessory) ............................................................................................... 10
2.2 Test Device ........................................................................................10
2.2.1 Spot Code ............................................................................................................. 10
2.3 Sample Collection Tubes .................................................................... 11
2.4 Quality Control ................................................................................... 11
2.4.1 EQC Device and Storage Slot ............................................................................... 11
2.4.2 Wet Quality Controls (WQC) ................................................................................. 12
3 Precautions ............................................................................... 13
3.1 Safe Operating Procedures ................................................................13
3.1.1 Sample Collection and Handling ........................................................................... 13
3.1.2 Instrument Operation ............................................................................................ 13
4 Reagent Storage and Handling ................................................. 15
4.1 Storage and Stability ..........................................................................15
5 Quality Controls ........................................................................ 17
5.1 Electronic Quality Control ...................................................................17
5.2 Wet Quality Control ............................................................................19
5.2.1 Level 1 WQC......................................................................................................... 19
5.2.2 Level 2 WQC......................................................................................................... 25
6 Patient Testing........................................................................... 31
6.1 Patient Preparation.............................................................................31
6.2 Sample Collection ..............................................................................31
6.2.1 Peripheral Samples ............................................................................................... 31
6.2.2 Indwelling Catheter ............................................................................................... 32
6.3 Sample Handling ................................................................................33
6.4 Performing a Test ...............................................................................34
6.5 Interpreting Test Results .....................................................................39
6.5.1 Aspirin Test Results .............................................................................................. 39
6.5.2 PRUTest Test Results ........................................................................................... 39
6.5.3 IIb/IIIa Test Results ............................................................................................... 40
6.6 Shutting down the Instrument .............................................................41
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