Itc VerifyNow System Platelet Reactivity Test User Manual

SystemUser Manual3985 Sorrento Valley Blvd.San Diego, California 92121 U.S.A.Telephone (for US): 1-800-643-1640Outside US: +1-858-643-1600Email addre

Page 97 14439.C 03/2013Index - 13VerifyNow System User Manual | USA13 IndexAabciximab 3, 5, 10, 11, 31, 32, 40, 79adenosine diphosphate 4, 83A

Page 99 14439.C 03/2013Index - 13VerifyNow System User Manual | USACustomer Support Accumetrics and its distribution partners are available to as

Accumetrics, Inc.3985 Sorrento Valley Blvd.San Diego, California 92121 U.S.A.Telephone (for US): 1-800-643-1640Outside US: +1-858-643-1600Email addres

Page 7 14439.C 03/2013Overview of System Components - 2VerifyNow System User Manual | USA2 Overview of System ComponentsThe VerifyNow System con

Overview of System Components - 2Page 8 14439.C 03/2013VerifyNow System User Manual | USA2.1.1 Test Device Port and CoverThe test device port hol

Page 9 14439.C 03/2013Overview of System Components - 2VerifyNow System User Manual | USA2.1.3 Icon KeysThe four icon keys directly to the right

Overview of System Components - 2Page 10 14439.C 03/2013VerifyNow System User Manual | USA2.1.8 Printer (Accessory)The printer is an optional acc

Page 11 14439.C 03/2013Overview of System Components - 2VerifyNow System User Manual | USA2.3 Sample Collection TubesTheVerifyNowSystemusesw

Overview of System Components - 2Page 12 14439.C 03/2013VerifyNow System User Manual | USA2.4.2 Wet Quality Controls (WQC)Wet Quality Controls co

Page 13 14439.C 03/2013Precautions - 3VerifyNow System User Manual | USA3 PrecautionsThissectionprovidesanoverviewofsafeoperatingprocedu

Page 15 14439.C 03/2013Reagent Storage and Handling - 4VerifyNow System User Manual | USA4 Reagent Storage and HandlingThis section describes sp

14439.C 03/2013VerifyNow System User Manual | USAAccumetrics Standard Terms and Conditions ... 1About thi

Page 17 14439.C 03/2013Quality Controls - 5VerifyNow System User Manual | USA5 Quality ControlsAccumetrics has designed the VerifyNow System wit

Quality Controls - 5Page 18 14439.C 03/2013VerifyNow System User Manual | USAUse the following procedure to perform an EQC:NOTE: Pressing the Back

Page 19 14439.C 03/2013Quality Controls - 5VerifyNow System User Manual | USA4. Remove the EQC device from the storage bay on the right side of

Quality Controls - 5Page 20 14439.C 03/2013VerifyNow System User Manual | USA7. Iftheinstrumentisoperatingwithinitsspecications,PASS wil

Page 21 14439.C 03/2013Quality Controls - 5VerifyNow System User Manual | USAProcedure1. Locate one test device and one WQC diluent tube. 2. P

Quality Controls - 5Page 22 14439.C 03/2013VerifyNow System User Manual | USA7. Openthecover.Usingthengergrip,insertthetestdeviceinto

Page 23 14439.C 03/2013Quality Controls - 5VerifyNow System User Manual | USA10. Wait for the image of the tube to display, then insert the WQC s

Quality Controls - 5Page 24 14439.C 03/2013VerifyNow System User Manual | USA13. When the results display, record the results or print the resul

Page 25 14439.C 03/2013Quality Controls - 5VerifyNow System User Manual | USAcontrol material does not produce a result within the expected range

14439.C 03/2013 VerifyNow System User Manual | USA7 Retrieving Test Results and Performance Data ... 437.1 Retrieving Patie

Quality Controls - 5Page 26 14439.C 03/2013VerifyNow System User Manual | USAQC26-Feb-201214:57:00 104AVerifyNowSystem®26-Feb-201214:57:00Figure 5

Page 27 14439.C 03/2013Quality Controls - 5VerifyNow System User Manual | USAFigure 5‑22 Scan Bar CodeBar CodeWQC P2Y12Use bar codescanner to rea

Quality Controls - 5Page 28 14439.C 03/2013VerifyNow System User Manual | USA12. Replace the cap on the diluent tube by pressing and turning simul

Page 29 14439.C 03/2013Quality Controls - 5VerifyNow System User Manual | USAFigure 5‑28 Test ProgressWQC P2Y1226-Feb-201214:57:00KEEP COVER CLOS

Quality Controls - 5Page 30 14439.C 03/2013VerifyNow System User Manual | USA18. At the conclusion of the test, the resulting value will be displa

Page 31 14439.C 03/2013Patient Testing - 6VerifyNow System User Manual | USA6 Patient TestingThe VerifyNow System has been developed to provide

Patient Testing - 6Page 32 14439.C 03/2013VerifyNow System User Manual | USA6.2 Sample CollectionSamples can be collected from an indwelling cath

Page 33 14439.C 03/2013Patient Testing - 6VerifyNow System User Manual | USA6. Gently invert the sample tube 5 times to ensure complete mixing o

Patient Testing - 6Page 34 14439.C 03/2013VerifyNow System User Manual | USA6.3 Sample HandlingFreshwholebloodsamplesintheappropriateparti

Page 35 14439.C 03/2013Patient Testing - 6VerifyNow System User Manual | USA3. From the main menu, enter Operator ID and Password, if requir

Patient Testing - 6Page 36 14439.C 03/2013VerifyNow System User Manual | USANOTE: If you make a mistake while entering a text character, press the

Page 37 14439.C 03/2013Patient Testing - 6VerifyNow System User Manual | USA9. If the test deviceistherstfromanewlot,theinstrumentwil

Patient Testing - 6Page 38 14439.C 03/2013VerifyNow System User Manual | USA12. Close the cover to the test port (Figure 6-11).Figure 6‑11 Close C

Page 39 14439.C 03/2013Patient Testing - 6VerifyNow System User Manual | USAFigure 6‑13 Remove Device Press the Next key to return to the main

Patient Testing - 6Page 40 14439.C 03/2013VerifyNow System User Manual | USA%26-Feb-201214:57:00VerifyNow® P2Y12PRU:164Figure 6‑15 P2Y12 ResultsTh

Page 41 14439.C 03/2013Patient Testing - 6VerifyNow System User Manual | USAUse the following procedure to calculate percent inhibition.NOTE: A s

Patient Testing - 6Page 42 14439.C 03/2013VerifyNow System User Manual | USA6.6 Shutting down the InstrumentPrior to shutting down the instrument

Page 43 14439.C 03/2013Retrieving Test Results - 7VerifyNow System User Manual | USA7 Retrieving Test Results and Performance DataThe instrument

Retrieving Test Results - 7Page 44 14439.C 03/2013VerifyNow System User Manual | USA3. Whenthefollowingscreendisplays(Figure7-1),enterthe

Page 45 14439.C 03/2013Retrieving Test Results - 7VerifyNow System User Manual | USA7.1.3 Test Results LogThe screen displays a scrollable log o

Page 1 14439.C 03/2013VerifyNow System User Manual | USAAccumetrics Standard Terms and ConditionsLimited Warranty and Disclaimer. Accumetrics war

Retrieving Test Results - 7Page 46 14439.C 03/2013VerifyNow System User Manual | USAIn addition to viewing earlier results, icons keys enable resu

Page 47 14439.C 03/2013Retrieving Test Results - 7VerifyNow System User Manual | USAFeature DescriptionEQC ResultDisplays the result as either a

Retrieving Test Results - 7Page 48 14439.C 03/2013VerifyNow System User Manual | USA7.2.2 Wet Quality Control Results LogThe cursor is positioned

Page 49 14439.C 03/2013Retrieving Test Results - 7VerifyNow System User Manual | USA3. Press the Next key four times. Refer to the Appendix fo

Retrieving Test Results - 7Page 50 14439.C 03/2013VerifyNow System User Manual | USA7.4 View Event LogThe instrument stores the last 50 error/att

Page 51 14439.C 03/2013Retrieving Test Results - 7VerifyNow System User Manual | USAIcon DescriptionPrint ResultScroll to the selected record, us

Page 53 14439.C 03/2013Instrument Settings - 8VerifyNow System User Manual | USA8 Instrument SettingsThissectiondescribestheinstrumentcong

Instrument Settings - 8Page 54 14439.C 03/2013VerifyNow System User Manual | USA5. Press the Lighten key or the Darken key to adjust the scre

Page 55 14439.C 03/2013Instrument Settings - 8VerifyNow System User Manual | USA8.3 Set the Date and TimeThedateandtimeisinitiallycongure

Page 2 14439.C 03/2013VerifyNow System User Manual | USAAbout this ManualThis user manual is the place to begin if you are not familiar with the V

Instrument Settings - 8Page 56 14439.C 03/2013VerifyNow System User Manual | USAuser login, if applicable. This time period can vary based on the

Page 57 14439.C 03/2013Instrument Settings - 8VerifyNow System User Manual | USA8.5 Enable Patient IDThe VerifyNow Instrument supports patient r

Instrument Settings - 8Page 58 14439.C 03/2013VerifyNow System User Manual | USA1. From the main menu, enter Operator ID and Password, if req

Page 59 14439.C 03/2013Instrument Settings - 8VerifyNow System User Manual | USA26-Feb-201214:57:00Use Password: YesOper Pswd Auth444 1323 M

Instrument Settings - 8Page 60 14439.C 03/2013VerifyNow System User Manual | USANOTE: When the established interval has elapsed, the user is locke

Page 61 14439.C 03/2013Instrument Settings - 8VerifyNow System User Manual | USA26-Feb-201214:57:00Version: X00191Use PtId> YesPtId Lth:3S/N:

Page 63 14439.C 03/2013Cleaning and Maintenance - 9VerifyNow System User Manual | USA9 Cleaning and MaintenanceThe VerifyNow Instrument does not

Cleaning and Maintenance - 9Page 64 14439.C 03/2013VerifyNow System User Manual | USA3. Open the cover and insert the cleaning device into the te

Page 65 14439.C 03/2013Cleaning and Maintenance - 9VerifyNow System User Manual | USAProcedureUse a recommended cleaning solution on the exterior

Page 3 14439.C 03/2013Introduction - 1VerifyNow System User Manual | USA1 IntroductionBefore you begin to use the VerifyNow System, it is approp

Cleaning and Maintenance - 9Page 66 14439.C 03/2013VerifyNow System User Manual | USANOTE: There are no screws to be removed.Figure 9‑4 Remove Fan

Page 67 14439.C 03/2013Troubleshooting - 10VerifyNow System User Manual | USA10 TroubleshootingOccasionally, an unanticipated event occurs which

Troubleshooting - 10Page 68 14439.C 03/2013VerifyNow System User Manual | USAElectronics Diagnostics- During an EQC, the system monitors the elect

Page 69 14439.C 03/2013Troubleshooting - 10VerifyNow System User Manual | USAIssue Description ResolutionMessage – Non-matching baseline values (

Troubleshooting - 10Page 70 14439.C 03/2013VerifyNow System User Manual | USANo. Issue Description Resolution4Error – Test device spot code The in

Page 71 14439.C 03/2013Troubleshooting - 10VerifyNow System User Manual | USANo. Issue Description Resolution12Attention - Tube or test device re

Troubleshooting - 10Page 72 14439.C 03/2013VerifyNow System User Manual | USANo. Issue Description Resolution21Error - Low proximal voltage Test o

Page 73 14439.C 03/2013Troubleshooting - 10VerifyNow System User Manual | USANo. Issue Description Resolution28Attention - Signal saturation High

Troubleshooting - 10Page 74 14439.C 03/2013VerifyNow System User Manual | USANo. Issue Description Resolution104Alarm 104Heater Timeout During Hea

Page 75 14439.C 03/2013Troubleshooting - 10VerifyNow System User Manual | USAParameter Issue Description ResolutionV2 Maximum leak rate This even

Introduction - 1Page 4 14439.C 03/2013VerifyNow System User Manual | USA1.1.1 Aspirin Test Acetylsalicylic acid (aspirin)hasasignicantantipl

Page 77 14439.C 03/2013Appendix - 11VerifyNow System User Manual | USA11 Appendix11.1 Technical SpecicationsFeature SpecicationDimensions (Wx

Appendix - 11Page 78 14439.C 03/2013VerifyNow System User Manual | USA11.3 System ComponentsManufacturer Catalog No.Description86000VerifyNow Sys

Page 79 14439.C 03/2013Appendix - 11VerifyNow System User Manual | USATerm DescriptionAdenosine diphosphateADP. When secreted by activated platel

Appendix - 11Page 80 14439.C 03/2013VerifyNow System User Manual | USATerm DescriptionDetection wellThe detection wells of an test device contain

Page 81 14439.C 03/2013Appendix - 11VerifyNow System User Manual | USATerm DescriptionInhibitor, glycoprotein (GP) IIb/IIIaGP IIb/IIIa inhibitors

Appendix - 11Page 82 14439.C 03/2013VerifyNow System User Manual | USATerm DescriptionPAR-4 receptorPAR-4 is one of four protease-activated recept

Page 83 14439.C 03/2013Appendix - 11VerifyNow System User Manual | USATerm DescriptionPouch The white test device package.Power indicatorWhen pow

Appendix - 11Page 84 14439.C 03/2013VerifyNow System User Manual | USAIcon Name DescriptionAdd/Update Record Select this icon to add an operator’s

Page 85 14439.C 03/2013Appendix - 11VerifyNow System User Manual | USAIcon Name DescriptionPrint All Select this icon to print the records starti

Page 5 14439.C 03/2013Introduction - 1VerifyNow System User Manual | USA1.1.3 IIb/IIIa Test Thenalcommonpathwaytoplateletaggregationinvo

Appendix - 11Page 86 14439.C 03/2013VerifyNow System User Manual | USA11.6 Instrument Software – Test and QCRetry scanMain menuStart screen Inse

Page 87 14439.C 03/2013Appendix - 11VerifyNow System User Manual | USARetry scanMain menuStart screen Insert as saydeviceScan barcode Insert tub

Appendix - 11Page 88 14439.C 03/2013VerifyNow System User Manual | USA11.7 Main screenMaintenanceMenu 1MaintenanceMenu 2MaintenanceMenu 3Maintenan

Page 89 14439.C 03/2013Appendix - 11VerifyNow System User Manual | USAMain screenMaintenanceMenu 1MaintenanceMenu 2MaintenanceMenu 3MaintenanceMe

Appendix - 11Page 90 14439.C 03/2013VerifyNow System User Manual | USA11.8 VerifyNow Instrument Cleaning and Maintenance Schedule Month_________

Page 91 14439.C 03/2013Appendix - 11VerifyNow System User Manual | USA11.9 Compliance with CLIA Control RequirementsThe CLIA Regulation, section

Appendix - 11Page 92 14439.C 03/2013VerifyNow System User Manual | USAprocedures or changing instrument parameters).• As an additional security f

Page 93 14439.C 03/2013Appendix - 11VerifyNow System User Manual | USAThe test device internal controls can detect failures of the reagent system

Appendix - 11Page 94 14439.C 03/2013VerifyNow System User Manual | USA• EachinstrumentistestedwithapreviouslyqualiedlotofVerifyNowtes

Page 95 14439.C 03/2013References - 12VerifyNow System User Manual | USA12 References1. Centers for Disease Control. Perspectives in Disease Pr