User Guide

CardioChek®

Brand AnalyzersPortable Whole Blood Test

Systems

(CardioChek and CardioChek P•A)

For Professional and Self-Testing Use

TABLE OF CONTENTS

The CardioChek® Analyzer I.Introduction.................................................................4 II.HowtoUsetheUserGuide........................................5 III.IntroductiontotheCardioChek...................................6Analyzer-CardioChekTestSystem MEMoChipTM

TestStrip IV.SetUp........................................................................9 InstallingBatteries SettingLanguage SettingTime SettingDate SettingUnits SettingSound V.CheckingtheSystem.................................................16 CheckStrip QualityControl VI.ControlTesting............................................................18 RunningaControlTest VII.RunningaTest............................................................20 BloodTesting TestingSupplies QuickReference VIII.Memory.......................................................................24 RecallingResults ClearingMemory IX.CareandCleaning.....................................................25 StorageandHandling X.Troubleshooting..........................................................26 XI.CLIAInformation.........................................................29 XII.Specifications.............................................................30 XIII.ContactInformation....................................................31 Help CatalogNumbers XIV.Warranty.....................................................................32 XV.ExplanationofSymbols..............................................33 XVI.Index....................................................................34

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I. INTRODUCTION

ThankyouforselectingCardioChekAnalyzerfromPolymerTechnologySystems,Inc.(PTS).

Theanalyzerisavailableintwomodels:theCardioChekandtheCardioChekP•A.TheCardioChekP•AhasanoptionalprinteravailableandwillrunallPTSPANELSTestStrips,includingallmultipleTestStrips(e.g.LipidPanel,CHOL+GLU,etc.).

TheCardioChekisafast,portableandreliablewholebloodanalyzer.TheCardioChektestsystemincludesananalyzerandseparatelyavailablePTSPANELSTMTestStrips/MEMoChipTM.Thissystemisintendedforin vitro diagnosticusetotestwholeblood.Usingthissystem,youcanquicklymea-surevariousbloodcomponentsfromasmallsamplesize.TheCardioChektestsystemiscapableofscreeninglipids(includingCholesterol,HDLCholesterolandTriglycerides)andmonitoringfordiabetesandotherdiseasestates.

TheCardioChekusesreflectancephotometryfortesting.ItreadscolorchangesthatoccuronaTestStripafterbloodisplacedontheTestStrip.

Beforeyoubegintesting,pleasereadthisentireUserGuideandtheTestStrippackageinsertcompletely.Thisprovidesthenecessaryinformationfortheuseofthissystem. Pleaseremembertoreturntheenclosedwarrantycardtoensureyoureceiveproductupdates.

Polymer Technology Systems, Inc. 7736ZionsvilleRoad Indianapolis,IN46268USA (317)870-5610 www.cardiochek.com

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II. HOW TO USE THE USER GUIDE

ThisguideincludesalltheinformationyouneedtoproperlytestusingCardioChekAnalyzer.Foradditionalinformationandspecificinformationforeachindividualchemistrytest,pleasemakesureyoureadthepackageinsertincludedwiththeTestStrips.ThisUserGuideisarrangedintheorderanewuserwouldneedtheinformation.Eachsectioncanbeusedseparately,afteryouhavereadtheentireguide.

Ifyouhavequestionsaboutthissystem,pleasecontactPTSCustomerService.CustomerServiceassistanceisavailable8:00AM-5:00PMUSEasternStandardTime,MondaythroughFriday.Ifyouneedhelpinterpretingyourtestresults,pleasecontactyourhealthcareprovider.

ForquestionsorassistancewiththeCardioChek,call:PTS Customer ServiceHours: 8:00 AM - 5:00 PM US Eastern Standard TimeMonday - Friday1-877-870-5610 (Toll-free inside US)1-317-870-5610 Fax: 1-317-870-5608E-mail: inforequest@cardiochek.com

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III. INTRODUCTION TO THECARDIOCHEK ANALYZER

The CardioChek Test System:TheCardioChektestsystemconsistsofthreemainparts.Theseincludetheanalyzer,PTSPanelsTestStripsandaMEMoChip.WhenabloodsampleisappliedtotheTestStrip,achemicalreactionoccursproducingacolorchange.TheanalyzermeasuresthecolorreactionandcomparestheinformationtothecalibrationcurvestoredintheMEMoChip.Theanalyzerconvertsthiscolorreadingintoatestresult,thatisdisplayedonthescreen.

MEMo Chip Port (a)TheMEMoChipPortisonthetopoftheanalyzer.AlotspecificMEMoChipisinsertedintothisport.

Display (b)Displayshowstestresults,messages,time,date,andstoredresults.

ENTER Button (c)PressthisbuttontoturntheanalyzerONortoacceptthecurrentmenuchoice.

NEXT Button (d)PressthisbuttontoturntheanalyzerONortoadvancetothenextmenuoption.

Test Strip Insert Opening (e)TheTestStripInsertOpeningispositionedinthelowerfrontoftheanalyzer.Thestripisinsertedherewiththeraisedlinesfacingup.

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MEMo ChipThecolor-codedMEMoChipcontainsthesettingsforeachtest.ThetopoftheMEMoChiphasafingernotch.Thebottomhasalabelwiththetestnameandlotnumber.

The MEMo ChipEachpackageofPTSPanelsTestStripscontainsacolor-codedMEMoChip.

What does the MEMo Chip do?WheninsertedwiththefingernotchfacingupinyourCardioChek,theMEMoChipdoesthefollowing:•ReadstheTestStripexpirationdate.•Tellstheanalyzerwhichtest(s)torun.•Containsthecalibrationcurveandthelotnumberforthe specificTestStripLot.•Controlstestsequencesandtiming.•Establishesthemeasuringrangeforthetest.TheMEMoChipcontainspropersettingsfortheTestStriplotyouareusing.Guidelines for using the MEMo Chip:• TheMEMoChipmustbeinplacetorunatest.• UseonlytheMEMoChipthatisincludedwitheach

packageofstrips.ThelotnumbercodeontheTestStripvial,MEMoChip,andanalyzerdisplaymustmatch.

• IftheexpirationdateintheMEMoChiphasexpired,theanalyzerwilldisplayEXPIRED LOT.

• If your MEMo Chip is lost or missing, please call PTSCustomerServiceforareplacement.

III. INTRODUCTION TO THECARDIOCHEK ANALYZER, continued

MEMo Chip (Top and Bottom)

Top Bottom

8

III. INTRODUCTION TO THECARDIOCHEK ANALYZER, continued

Using the MEMo Chip (continued): TheMEMoChipPortisonthetopcenteroftheanalyzer.TheMEMoChipisinsertedintothisportwiththefingernotchfacingup.Pushfirmly,butgently,untiltheMEMoChipisfullyinserted.Important:Becarefulnottobendtheconnector.

Test StripTotestbloodontheCardioChek,useTestStripsspecificforeachtest.ATestStripisinsertedintotheanalyzer,thenbloodisappliedtothebloodapplicationwindow.Achemicalreactionoccursproducingacolorchange.TheanalyzermeasuresthecolorreactionandcomparestheinformationtothecalibrationcurvestoredintheMEMoChip.Theanalyzerconvertsthiscolorreadingintoatestresult,displayedonthescreen. EachPTSPanelsTestStripboxcontainsapackageinsertthatprovidesinstructionsforuseandinformationspecificforeachtest.Pleasereadtheinstructionscompletelybeforetesting.

PTSPanelsTestStrip

BloodApplicationWindow

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IV. SET UP

Battery Use and ReplacementTheCardioChekrequirestwo(2)AAA1.5volthighqualityalkalinebatteries.

When to Replace the Batteries:Theanalyzerwill giveyouan indicationon thedisplay thatthebatteriesneed tobechanged. When thedisplay readsCHANGEBATTERY,nomoretestscanberununtilthebatteriesarechanged.Alwaysreplacethebatterieswithhighqualityalkalinebatteries.Itisrecommendedtokeepasparesetofbatteriesonhand.Toextendbatterylife,removetheTestStripassoonasaresultisdisplayed.Thetime/dateandresultsstoredinmemorywillnotbeerasedwhenthebatteriesarechanged.

How to Install/Replace the Batteries:1. OpenthebatterydooronthebackoftheCardioChek

bypressingandslidingitinthedirectionofthearrow(towardtheMEMoChipport).

2. Removeoldbatteriesfromthecompartmentandsafelydiscard.

3. Insertthenewbatteriesintothebatterycompartmentwiththepositive(+)terminalfacingtotheleftonthetopbattery,andtotherightonthebottombatteryasmarkedontheinsidecompartment.

4. Replacethebatterydoor.Tomakesurethebatterieswereinstalledcorrectly,pusheitheroneofthetwobuttonsonthefrontoftheanalyzertoturntheCardioChekON.

WARNING! Disposeoftheoldbatteriesproperly.

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IV. SET UP, continued

ButtonsENTER Button:Pressthisbuttontoturntheana-lyzerONortoacceptthecurrentmenuchoice.NEXT Button: PressthisbuttontoturntheanalyzerONortoadvancetothenextmenuoption.

How to Turn the Analyzer OFF:Thebatterieswillhavealongerlifeduetotheanalyzer’sautomaticshutdownfeature.Afterthreeminutesofidletime(withoutaTestStriporCheckStripinserted)theanalyzerwillperforma10secondcountdownandturnOFF.Tostopshutdownpressdowneitherbutton.ToturnOFFpressbothbuttonsatthesametimeforthreesecondsatanyofthefol-lowingMainMenuheadings:RUNTEST,MEMORY,UTIL-ITY,orUSERSET.YoucanalsoremovethebatteriestoturntheanalyzerOFF.

Thefirsttimetheanalyzeristurnedonyouwillberequiredtosetthelanguage,date,andtime.

Setting LanguageThelanguagemenuconsistsofthefollowingchoices:English,(ENGLISH),German(DEUTSCH),Italian(ITALIANO),French(FRANCAIS),Spanish(ESPANOL),andPortuguese(PORTUGSE).

How to Set the Language:1. TurntheanalyzerONbypressingeitherbutton(Enteror

Next).2. ThedisplaywillreadLANGUAGE.PressEnter.3. ENGLISHwillbedisplayed.PressEnterifEnglishis

desired.4. ForotherlanguagespressNextuntilthedesiredlan-

guageisdisplayed,thenpressEnter.TosetthetimeproceedtoHow to Set the Time.

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IV. SET UP, continued

How to Reset the Language:1.AllowtheanalyzertoautomaticallyturnOFForremovethebatteriesandreplacethem.2. PressandholdEnterdownforapproximately5seconds,

duringtheanalyzerpower-upstageuntilLANGUAGEisdisplayed.

3. PressEnter.PressNexttoscrollthroughthelanguagechoices.

4. PressEntertoselectthelanguagethatisdisplayed.SETTIMEwillbedisplayed.

How to Set the Time:1. IftheanalyzerisOFF,presseitherbuttontoturnthe

analyzerON.WaitforthedisplaytoreadeitherINSTALLMEMOCHIP(ifacurrentMEMoChipisnotinstalled)orINSERTSTRIP(ifacurrentMEMoChipisinstalled).PressEnter.ThedisplaywillreadRUNTEST.

2. PressNextuntilUSERSETisdisplayed.3. PressEnter.PressNextuntilSETTIMEisdisplayed.4. PressEnterandtheclockformatisdisplayed:12/24HR.5. PressNexttoalternatelydisplaythe12houram/pm

clockorthe24-hourclock.PressEntertoacceptthedis-playedclockformat.ThedisplaywillreadHOURandthenumericalhour.

6. PressNexttoincrementthehour.Note:AM/PMintheupperrighthandcornerofthedisplay.

7. PressEntertoacceptthedisplayedhour.ThedisplaywillreadMINUTEandthenumericalminute.

8. PressNexttoincrementtheminutes.9. PressEntertoacceptthedisplayedminute.Thedisplay

willreadSETTIME.Tosetthedate,proceedto How to Set the Date -Step4.

10.Toexit,pressNextuntilEXITisdisplayed.PressEnter.11. PressNexttoreturnthedisplaytoRUNTEST.

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How to Set the Date:1. IfRUNTESTisdisplayed,gotoStep3.Iftheanalyzer

isOFF,presseitherbuttontoturntheanalyzerON.WaitforthedisplaytoreadINSTALLMEMOCHIPorINSERTSTRIP.

2. PressNext.ThedisplaywillreadRUNTEST.3. PressNextuntilUSERSETisdisplayed.PressEnter.4. PressNextuntilSETDATEisdisplayed.5. PressEnterandthenumericalmonthisdisplayed.6. PressNexttoincrementthemonth.7. PressEntertoacceptthedisplayedmonth.Thedisplay

willreadDAYandthenumericaldayofthemonth.8. PressNexttoincrementtheday.9. PressEntertoacceptthedisplayedday.Thedisplaywill

readYEARandthenumericalsetyear.10.PressNexttoincrementtheyear.11. PressEntertoacceptthedisplayedyear.Thedisplay

willreadSETDATE.Tosettheunits,proceedtoHow to Set the Units.12.PressNextuntilEXITisdisplayed.PressEnter.13. PressNexttoreturnthedisplaytoRUNTEST.

How to Set the Units:TheCardioChekhasbeenpresettoUSunits(e.g.mg/dL).TochangeyourunitstoINTL(InternationalStandardUnits)(i.e.mmol/L)followthestepslistedbelow:1. IfRUNTESTisdisplayed,gotoStep3.Iftheanalyzeris

OFF,presseitherbuttontoturntheanalyzerON.WaitforthedisplaytoreadINSTALLMEMOCHIPorINSERTSTRIP.

2. PressEnter.ThedisplaywillreadRUNTEST.3. PressNextuntilUSERSETisdisplayed.4. PressEnter.ThedisplaywillreadSOUND.5. PressNextuntilUNITSisdisplayed.

IV. SET UP, continued

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How to Set the Units, continued:6. PressEnter.ThedisplaywillreadUS.IfINTLunitsare

desiredpressNexttodisplayINTL.7. PressEntertoselecttheunits.DisplaywillreadUNITS.8. PressNextuntilEXITisdisplayed.9. PressEntertoreturndisplaytoUSERSET.10.PressNexttoreturntoRUNTEST.

How to Set the Sound:TheCardioCheksoundhasbeenpresettoBEEPON.Toturnthesoundonoroffpleasefollowthestepslistedbelow:1. IfRUNTESTisdisplayed,gotoStep3.Iftheanalyzer

isOFF,presseitherbuttontoturntheanalyzerON.WaitforthedisplaytoreadINSTALLMEMOCHIPorINSERTSTRIP.

2. PressNext.ThedisplaywillreadRUNTEST.3. PressNextuntilUSERSETisdisplayed.4. PressEnter.SOUNDwillbedisplayed.5. PressEnter.ThedisplaywillreadBEEPONorBEEP

OFF.6. PressNexttoselecteitherBEEPOFForBEEPON.7. PressEntertoacceptthesoundchoicedisplayed.8. PressNextuntilEXITisdisplayed.9. PressEntertoreturndisplaytoUSERSET.10.PressNexttoreturntoRUNTEST.

Introduction to the CardioChek P•A and Printer SystemTheCardioChekP•Aanalyzer(withsoftwareversion2.20andhigher)supportsprintingintwoformats,labelorpaper,ontheCardioChekP•AThermalPrinterorPortablePrinter.ToverifyCardioChekP•Asystemsoftware,turntheanalyzerONbypressingeitherbutton.Thesoftwareversionwillappearonthedisplay.

IV. SET UP, continued

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IV. SET UP, continued

How to Set Up the CardioChek P•A for Printing:Forcompletedetails,refertoeachprinter’sUserGuidesandSetUp/OperatingInstructionSheets.1. TurntheCardioChekP•AONbypressingeitherbutton.2. PressEnteruntilRUNTESTisdisplayed.3. PressNextuntilUSERSETisdisplayed.PressEnter.4. PRINTwillbedisplayed.PressEnter.MEDIAwillbe

displayed.5. PressEntertoselectthetypeofprintmaterial(MEDIA).

SelectLforLABELorPforPAPER.MEDIAwillbedisplayed.Note:Defaultissettolabels(L).6. PressNext.COPIESwillbedisplayed.Note:Defaultis

settoonecopy.7. PressEntertoselectCOPIES,pressNexttoscrolltothe

numberofcopiesofthetestresultstobeprinted.1,2,or3.

8. PressEntertoselectthenumberofcopiestobeprinted.COPIESwillbedisplayed.

9. PressNextuntilEXITisdisplayed.PressEnter.10.RepeatthisstepuntilyoureturntoRUNTEST.Make

suretheprinterpowerswitchisturnedOFF.11. ConnecttheinstrumenttotheCardioChekP•AThermal

PrinterviatheCommunicationCable.Insertthe9-pinendoftheCommunicationCableintotheprinter.InserttheotherendofthecableintotheanalyzerMEMoChipport.

12. InstalltheMEMoChipintothetopendoftheCommunicationCableconnectedtotheanalyzer.

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IV. SET UP, continued

How to Print Test Results:AtthecompletionoftestingontheCardioChekP•A,theselectednumberofcopiesofresultswillautomaticallybeprinted.

How to Print Results From Memory: (Upto30testresultsperchemistry;upto10Controlresults)1. TurntheCardioChekP•AONbypressingeitherbutton.2. FromtheRUNTESTmenupressNext.3. PressEnteruntilRUNTESTisdisplayed.4. MEMORYwillbedisplayed.PressEnter.5. PressEntertoselectCHEM.6. PressNexttoselectthetypeoftest,LIPIDSforexample.7. PressNexttoselectthedate/timeofthetestresultyou

wanttoprint.8. PressEntertoprinttheselectednumberofcopiesof

results.9. ControlresultscanbeprintedbyselectingCONTROL

insteadofCHEMandthenselectingthetypeofresultasabove.

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V. CHECKING THE SYSTEM

Instrument Check StripAgrayInstrumentCheckStrip(includedintheanalyzercarryingcase)canbeusedtoverifyproperfunctioningoftheCardioChek’selectronicandopticalsystems.TheInstrumentCheckStripprovidesacolorstandardreadbytheanalyzer.WhentheCheckStripisnotinuse,pleasestoreitintheanalyzercarryingcase.ItisrecommendedthatyoucheckyouranalyzerwiththeInstrumentCheckStripwhen:•Youfirstreceiveit.•Youdroptheanalyzer.•Yougetaresultthatisnotexpected.

How to Use the Instrument Check Strip:1. TurntheanalyzerONbypressingeitherbutton.2. WhenINSTALLMEMOCHIPorRUNTESTisdisplayed,

pressNextuntilUTILITYisdisplayed.PressEnter.3. PressEnterwhenCKSTRIPisdisplayed.4. InserttheCheckStrip,ribbedsideup,intotheTestStrip

InsertopeningwhenINSERTSTRIPisdisplayed.5. TheanalyzershoulddisplayPASSED.(Ifthedisplay

readsFAILED,seetheNOTEatendofthissection.)RemovetheCheckStripandstoreitintheanalyzer

carryingcase.7. PressNextuntilEXITisdisplayed.PressEnter.8. PressNextuntilRUNTESTisdisplayed.9. PressEnter.Theanalyzerisreadytoruntests.Note:IftheanalyzerdisplaysFAILED:1. CleantheCardioChekTestStripInsertOpening(where

thestripisinsertedintotheanalyzer)withasoft,lint-free,dampcloth.SeetheCareandCleaningsection.

2. InspecttheCheckStriptomakesureitisnotdirtyordamaged.UsethespareCheckStripandrepeat.

3. SeetheTroubleshootingsection.

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Quality ControlControls(alsoknownas“qualitycontrolmaterials”)aresolu-tionsforwhichanexpectedanalyteconcentrationrangehasbeenestablished.Controlsaretestedtochecktheperfor-manceofyourtestsystem:CardioChekanalyzer,MEMoChipandTestStrips.UsequalitycontrolmaterialsprovidedbyPTS.

PTSPANELSMulti-ChemistryControlsREF/Cat.No.721PTSPANELSHDLControlsREF/Cat.No.722Refertocontrolpackageinsertforcontrolspecifications.

Healthcareprofessionalstestingwiththissystemshouldfollowtheirfacility’sguidelinesandpoliciesregardingtheuseofqualitycontrolmaterials.

IMPORTANT:Donotusecontrolsolutionsthathaveexpired.Checktheexpirationdateprintedonthecontrolbottles.

Forperformingaqualitycontroltest,seeSectionVI.CONTROLTESTINGToperformacontroltestyouneed:

• CardioChekAnalyzer• PTSPANELSTestStrips• QualityControlMaterials• QualityControlInstructions• QualityControlRangeInsert

V. CHECKING THE SYSTEM

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VI. CONTROL TESTING

Control TestingControltesting,alsoknownasqualitycontroltesting,isusedtoensureallthepartsofthetestsystemareworkingproperlytogetherandthetestresultsareaccurateandreliablewithinthelimitsofthesystem.Aqualitycontrolmaterial,orcontrol,isaliquidcontainingananalyteknowntobewithinacertainrange.ThisrangeissuppliedwiththeQualityControlMaterialorisavailableonlineatwww.cardiochek.com.Healthcareprofessionalsshouldfollowtheirfacility’spoliciesonwhencontrolsshouldbetested(forexample:witheachnewTestStriplot;monthlyasacontinuedcheckonstorageconditions;wheneverissues(storage,operator,orother)areidentifiedortherearequestionsabouttheresults).

How To Run a Quality Control Test:1. InstallcorrectMEMoChipforthelotofstripsthatyouare

using.2. PresseitherbuttontoturntheanalyzerON.3. PressNextuntilthedisplayreadsUTILITY.PressEnter.4. PressNextuntilRUNCONTROLisdisplayed.Press

Enter.5. Inserttheteststripintotheanalyzer.TheCardioChek

willdisplayAPPLYSAMPLE.Thisindicatesthesystemisreadyforasample(control)tobeapplied.a. Immediatelyreplacethevialcap,makingsurethe

stripvialisclosedtightly.6. RemovecapfromtheControlMaterialandturnbottle

upsidedown.a. CONTROLMUSTBEAPPLIEDTOTESTSTRIP

WITHIN10SECONDSOFREMOVINGTHESTRIPFROMTHEVIAL.

7. HoldbottledirectlyoverandperpendiculartothebloodapplicationwindowontheTestStrip.

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VI. CONTROL TESTING, continued

How To Run a Quality Control Test (continued):8. Squeezebottle,soasmalldropofcontrolsolutionis

formed.9. AllowthedropofcontrolsolutiontofallontotheapplicationwidowoftheTestStrip.Donotallowthetipof

thebottletotouchtheTestStrip.10.ReplacecapontheControlMaterial.11. Resultswillbedisplayedwithinaboutonetotwo minutes.12.ComparecontrolresultstothevaluesontheQuality

ControlRangeInsertincludedwithcontrolmaterials.13.Thecontrolresult(s)willalsobestoredintheanalyzer’s

Memory.14.ToexitthecontroltestingmenupressEntertwice.RUN

CONTROLwillbedisplayed.15.PressNextuntilEXITisdisplayed.PressEnter.16.PressNextuntilRUNTESTisdisplayed.

If Quality Control Results are not in Range:1. EnsureTestStripinsertopeningareaisclean.2. MakesureneithertheTestStripsnorthecontrolsare

pasttheexpirationdateprintedonthelabel.3. MakesureMEMoChipmatchesstriplot.4. Repeatthetestagainusingfreshmaterials.5. CallCustomerServiceforassistance.

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VII. RUNNING A TEST

Blood TestingATestStrippackageinsertisincludedwitheachboxofTestStrips.PleasereadtheTestStrippackageinsertalongwiththissectionoftheUserGuidecompletelyandcarefullybeforetesting.

Testing SuppliesToperformabloodtestyouneed:

• CardioChekAnalyzer• PTSPANELSTestStrips• LotspecificMEMoChip• Sterilelancet• Capillarybloodcollectororpipet• Gauzeorcottonballs• Alcoholwipe(optional)

Thisanalyzerrequireswholebloodfortesting.Donotoperatetheanalyzerindirectlight.ReferencetheCareandCleaningsection.

Helpful Hints on Getting a Good Drop of Blood:1. Warmthefingerstoincreasebloodflow.2. Letthearmhangdownattheperson’ssidebrieflyto

allowbloodflowtothefingertips.3. Instructthepatienttowashhandsinwarm,soapywater.

Rinsewellanddrycompletely.Ifanalcoholwipeisused,letthefingerairdrybeforetesting.

How to Obtain a Blood Sample:Toperformafingerstick:1. Cleanthefinger.Besurethefingeriscompletelydry.2. Useanewsterile,disposablelancettopuncturethe

skin.

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VII. RUNNING A TEST, continued

How to Obtain a Blood Sample, continued:3. Stickthefingeronthesideofthefingertip,insteadofthe

center.Seepicturebelow.CORRECTWAYTOSTICKTHEFINGER

4. Togetadropofblood,gentlyapplypressuretothefingerstartingattheendofthefingerclosesttothehandandmovingtowardsthetip.Wipeawaythefirstdropofbloodwithgauzeandusethesecondblooddropfortesting.TheblooddropshouldbehangingdownfromthefingertomakeiteasiertocollectthesamplewithacapillarypipetortoapplydirectlytotheTestStrip.

5. FollowthespecificinstructionsfoundintheTestStrippackageinsertforeachtestforsampleapplicationandvolumeranges.Useofcapillarypipetensuresasuffi-cientvolumeofbloodhasbeenappliedtotheTestStrip.

6. MakesuretheTestStripisinsertedallthewayintotheTestStripInsertOpening.

7. UsetheTestStripandlancetonetimeonly.Disposeofproperly.

Healthcare Professionals:Iftheanalyzerisusedfortestingseveralpeople,besuretofollowtheproperinfectioncontrolproceduresforyourfacility.Discardtheusedlancetinaclosedpunctureresistantcontainer,suchasasharpscontainer.Useanewlanceteverytimeyoutest.DonotreuselancetsPrecaution: Handle and dispose of all materials coming in contact with blood according to universal precautions and guidelines.

22

How to Run a Test:1. InsertcorrectMEMoChipforthelotofstripsinuse.2. InsertMEMoChipwithfingernotch(top)sideup,lot

numbercodefacingdown.3. TurnCardioChekONbypressingeitherbutton.4. WhenINSERTSTRIPisdisplayed,insertthestripinto

theTestStripInsertOpeningasfarasitwillgo.*5. Obtainablooddropfollowingthecorrecttechnique.6. WhenAPPLYSAMPLEisdisplayed,applybloodtothe

TestStrip.Refertoeachspecificteststrippackageinsertforsamplevolumeandsampleapplicationinstructions.

7. Withinonetotwominutes,theresultswillbedisplayed.8. RemoveTestStripanddiscard.9. Theanalyzerautomaticallyshutsdownafterthreemin-

utesofidletimewithnoTestStripinserted.

Important: DonotleaveausedTestStriporCheckStripintheanalyzerTestStripOpening.Thispreventstheanalyzerfromautomaticallyshuttingdownand

shortensbatterylife.

VII. RUNNING A TEST, continued

*Asanalternative,theteststripmaybeinsertedintotheanalyzerwithin10secondsAFTERbloodisappliedtothestrip,whenbloodisappliedtothestripdirectlyfromafinger.Touchadropofbloodhangingfromthefingertothebloodapplicationwindowoftheteststrip.Theblooddropmustfilltheentirewindow.Insertthestripintotheanalyzer.Inaboutonetotwominutesreadresult.

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* Refer to each specific Test Strip package insert for sample volume and sample application instructions.

VII. RUNNING A TEST, continued

3. When APPLY SAMPLE is displayed, apply whole blood* sample with a capillary pipet to blood application window.

4. Within two minutes the result will appear on the display. Remove and discard strip. Do not add more blood to a Test Strip that has been used.

2. When INSERT STRIP is displayed, hold by the raised lines and insert strip into the analyzer as far as it will go.

1. Insert MEMo Chip with lot number that matches Test Strip vial lot number. Press either button to turn the CardioChek ON. Analyzer will display lot code.

Quick Reference Testing Guide

Ribsthatguidethestripintotheanalyzer

Bloodapplicationwindow

Holdstripbythisend

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Testresultsareautomaticallystoredintheanalyzer’smemory.CardioChekcanstoreupto30resultsofeachchemistryandatleast10resultsofeachcontroltest.Theanalyzerallowsreviewoftheresultsinorderfromthemostrecenttotheoldest.Eachresultisdisplayedwithtimeanddate.Resultsstoredinmemoryarenotdeletedwhenthebatteriesarechanged.How to Review Results Stored in Memory:1. PresseitherbuttontoturntheanalyzerON.Ifthedisplay

readsINSTALLMEMOCHIPgotoStep2.IfthedisplayreadsINSERTSTRIPpressEnter.

2. PressNextuntilMEMORYisdisplayed.3. PressEnter.CHEMisdisplayed.4. PressEnter,thenNexttoselectthedesiredchemistry.(Note:

Untilthechemistryhasbeenrunatleastonce,thetestnameisnotdisplayed.)

5. PressEntertoviewthetestresultincludingtimeanddate. a. TorecallControlresults,pressNextuntilEXITisdisplayed.

PressEnter.PressNextuntilCONTROLisdisplayed. b. PressEnterwhenthedesiredControltestisdisplayed. c. Forexample,toreviewLipidPanelresults,fromtheCHEM

display,pressNEXTuntilLIPIDSisdisplayed,thenENTER.Thetimeanddatewillbedisplayed.PressENTERwhenthedesiredtesttimeanddateisdisplaPressNEXTtoscrollthroughresults.6. Toexit,pressNextuntilthedisplayreadsEXIT,thenpress

Enter.RepeatthisstepuntilyoureturntoRUNTEST.How to Clear Results Stored in Memory:1. PresseitherbuttontoturntheanalyzerON.Waitforthedis-

playtoreadeitherINSTALLMEMOCHIPorINSERTSTRIP.2. PressEnter,thenpressNextuntilUTILITYisdisplayed.

PressEnter.3. PressNextuntilCLEARMEMORYisdisplayed.PressEnter.4. PressNextuntilthedisplayreadsCLRYES.PressEnter.

ThedisplaywillreadERASE,CLEAREDandthenCLEARMEMORY.

5. Toexit,pressEnteruntilthedisplayreadsEXIT,thenpressEnter.PressNextuntilyoureturntoRUNTEST.

VIII. MEMORY

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Storage and Handling

• TheCardioChekisasensitiveelectronicdevice;handlewithcare.Theanalyzershouldnotbedropped.

• Donotstoreoroperatetheanalyzerindirectlight,suchassunlight,spotlight,underalamporbyawindow.

Directlightmayadverselyeffecttestresults.• Donotexposetheanalyzeroranyofthesuppliesor

accessoriestohighhumidity,extremeheat,cold,dustordirt.Storetheanalyzeratroomtemperature(68-77o

F,20-25oC)and20-80%RelativeHumidity(RH).Do not freeze. Ifroomtemperaturefallsbelow18oC,allowanalyzertowarmupatleast30minutes-1hourbeforetesting.

• PleasereadtheTestStrippackageinsertforstorageandhandlinginformationthatappliestoeachTestStrip.

• Iftheexterioroftheanalyzerneedscleaning,dampenaclothwithwaterandwipethesurfacesandthedisplayareacarefully.BecarefulnottogettheTestStripInsertOpening(wheretheteststripisinserted)wet.Anumberofdisinfectantsareavailabletoclean/disinfectyourana-lyzer.Do not use bleach, window cleaner or

hydrogen peroxide.• CarefullywipetheTestStripInsertopeningwithaclean,

damp(notwet),lint-freetissueorcloth.Makesuretheglassisverycleanwithnodustorfingerprints.Theglassmustbecompletelydrybeforerunningatest.

• HandlethegrayCheckStripbythebaseoftheplasticstrip.Becarefulnottoscratchordamagethesurface.StoretheInstrumentCheckStripintheanalyzercarryingcasewhennotinuse.Donotstoreintheinstrument.

•Removing screws from the back of the analyzer voids all warranties. There are no user serviceable parts inside the case.

IX. CARE AND CLEANING

26

MESSAGE or ISSUE

PROBABLE CAUSE

WHAT TO DO

Desiredlanguageisnotdisplayed.

Languagehasbeensetincorrectly.

TurnanalyzerOFF.SeeSectionIV,SetUp-HowtoResettheLan-guage.

Thewrongdateand/ortimeisdisplayed.

Dateandtimehavenotbeensetcorrectly.

SeeSectionIV,SetUptosetthecorrectdateandtime.

FAILEDisdis-playedduringaCheckStriptest.

Analyzerneedstobecleaned.

CheckStripisdirtyordamaged.

WipetheTestStripInsertOpeningwithaclean,dampandlint-freecloth.

UsespareCheckStrip.IfCheckStripstillfails,callCustomerService.

TOO MUCH LIGHT Testisbeingperformedindirectlightoroutside.

Testinside,awayfromwindowsandawayfromdirectlamplight.

MEMO ERR MEMoChipisdefective. UseanotherMEMoChipfromthesamelot

TEST ERR InsufficientsamplehasbeenaddedtoTestStrip.

TestagainwithanewTestStripandmakesurethecorrectvolumeofsampleisused.

SET TIME AND DATE

Analyzerisneworlanguageoptionhasnotbeenset.

FollowUserGuideinstructionstosetlanguage.

TEST NOTALLOWED

TestselectedbyMEMoChipinstalledcannotberunonyouranalyzer.

CheckMEMoChipandmakesurethatthecorrectMEMoChipisinserted.CallCustomerService.

LOWTEMP Analyzerisbelowacceptableoperatingtemperature.

Movetowarmerenvironmentandtestafteranalyzerreachespropertemperature.

HITEMP Analyzerisaboveacceptableoperatingtemperature.

Movetoacceptableenvironmentandtestafteranalyzerreachespropertemperature.

X. TROUBLESHOOTING

27

X. TROUBLESHOOTING, continued

MESSAGE or ISSUE

PROBABLE CAUSE

WHAT TO DO

INSTALLMEMOCHIP

MEMoChipisnotproperlyinsertedorisdefective.

InsertsameornewMEMoChipproperly.

MEMOCHIPERROR

MEMoChipisdefective. UseanotherMEMoChipfromsamelotofproduct.

EXPIREDLOT TestStripsareexpired,wrongMEMoChipisin-sertedoranalyzerDateisnotsetproperly.

CheckTestStripexpirationdateandmakesurecorrectMEMoChipisinserted.CheckanalyzerDatesetting–followUserGuideinstruc-tions.

CHANGEBATTERY

Batteriesneedtobereplaced.

ReplacebothbatterieswithnewhighqualityAAAbatteries.(Theanalyzerwillnotruntestsuntilbat-teriesarereplaced.)

TESTABORTED

TestStripwasnotproperlyinsertedorwasremovedbeforetestwascomplete.

TestagainwithfreshTestStrip.

TRIGSTOOHIGHLDLN/A

LipidPaneltriglyceridestestresultwas400mg/dL(4.52mmol/L)orgreater.

Noactionneeded.LDLwillnotbecalculatedonsampleswithtriglyc-eridesof400mg/dL(4.52mmol/L)orgreater.

PRINTERROR Printfunctionhasbeeninterrupted.

PrintresultinMEMORYortestagain.

Resultswillnotprint.

CommunicationCablewasimproperlycon-nected.Printercoverisnotclosedproperly.(Printerindicatorlightisred.)

Labels/paperwerenotloadedintheprinter.

Checkallconnections.Reprinttestresultsstoredinmemory.

Closeprintercovercorrectly,ensur-ingthatthePrinterindicatorlightisgreen.Reprinttestresultsstoredinmemory.SeeSectionIV,SetUpforinstruc-tionsonhowtoloadlabels/paperintotheprinter.

28

Highorlowresultsthatareincorrectmayhaveseriousmedicalconse-quences.Iftheresultreads>(greaterthan)or<(lessthan)orresultsarenotasexpected,alwaysrepeatthetestcorrectlywithanewunusedTestStrip.Ifatestresultisdisplayedthatisnotexpected,consultthefollowingtable.

X. TROUBLESHOOTING, continued

PROBLEM PROBABLE CAUSE

SOLUTION

Resultsarenotasexpected.

Stripsimproperlystored.

Batteriesaredefective.

Theanalyzerwasimproperlystored.

TestStripInsertOpen-ingisdirty.

MEMoChipandTestStripsarenotthesamelotnumber.

Repeattest,usingadifferentvialofstrips.Runcontrols,confirmthatresultsareinrange.

Changebatteries.

Makesureanalyzerwasnotexposedtohighorlowtempera-turesorhumidityandrepeattest.

CleantheTestStripInsertOpen-ing.

UseMEMoChipandTestStripswiththesamelotnumber.

Adisplayedresultreads< (lessthan)avalue

Resultisbelowthemeasuringrangeofthetest.

Ifyouoryourpatienthavesymptomscallhealthcareprofessionalimmediately.Re-peatthetest.Runcontrolsandconfirmthatcontrolsareinrange.

Adisplayedresultreads > (greaterthan)avalue.

Resultisabovethemeasuringrangeofthetest.

Ifyouoryourpatienthavesymptomscallhealthcareprofes-sionalimmediately.Runtestagain.Runcontrolsandconfirmthatcontrolsareinrange.

Displayreads”____”orN/A

Resultisnotavailableduetoamissingvaluefromacalculation.Oravalueisoutsidethemeasuringrange.

Runtestagain.Runcontrolsandconfirmthatcontrolsareinrange.

29

XI. CLIA INFORMATION

General CLIA Information(ProfessionalsOnly-Pleasereadbeforetesting.)1. CLIAwaived(USonly).Eachlaboratoryortestingsite

usingthePTSPanelsTestStripsmusthaveaCLIACer-tificateofWaiverbeforetesting.ToobtainaCertificateofWaiver,callyourstatehealthdepartmentorPTSat877-870-5610(toll-free)or317-870-5610foranapplica-tion(formHCFA-116).

2. Beforeyoustarttesting,carefullyreadallinstructions.Failuretofollowallinstructions,includingqualitycontrolinstructions,willresultinahighcomplexityratingandsubjectthefacilitytoallapplicableCLIArequirementsforhighcomplexitytesting.ForcompleteinformationincludingSummaryofCLIAPerformance,pleaserefertothespecificTestStrippackageinsert.

3. CLIAwaivedforwholeblood(fingerstickandvenousEDTAorheparin)testingonly.

30

XII. SPECIFICATIONS

CardioChek & CardioChek P A:CalibrationCurve:InputfromMEMoChipperTestStriplotBattery:2AAA1.5voltalkaline,OperatingTemperatureRange:64.4-95°F(18-35°C)HumidityRange:Between20and80%RHDimensions:

Width: 3.0inches(7.62cm) Length: 5.5inches(13.97cm)

Height: 1.0inches(2.54cm)Weight: (withoutbatteries):4.3oz.(121.9g)

PTS PANELS Test Strips:Pleasereadtheinstructions(packageinsert)includedwiththeTestStripsforinformationspecifictoeachtest.

Optional CardioChek P A Thermal Printer / Power Sup-ply:

Width: 3.5in(8.89cm)Length: 7.0in(17.78cm)Height: 5.5in(13.97cm)Weight: 2.0lbs.(972g)Input: 100-240VAC,47-63Hz,1.5AOutput: +20VDC,2.5A

31

HelpForassistancewiththeCardioChektestsystem,pleaseContactPolymerTechnologySystems,Inc.Toll-Freeat1-877-870-5610(tollfreeinsidetheUSA)or1-317-870-5610.Fax:1-317-870-5608E-mail:inforequest@cardiochek.comWebsite:www.cardiochek.com

XIII. CONTACT INFORMATION

32

CardioChek Limited One Year Warranty:

PTSwarrantstotheoriginalpurchaseronly,thattheanalyzershallbefreeofanydefectsinmaterialsorworkmanshipforaperiodofoneyearfromthedateoforiginalpurchase.ActivationofthiswarrantyshallbeconditioneduponcompletionandreturnofthewarrantyregistrationcardtoPTS.Iftheequipmentbecomesinoperativeduringthistime,PTSwillreplacetheequipmentwithequivalentequipment,atitsoption,atnocosttothepurchaser.Thewarrantybecomesvoidiftheequipmentismodified,improperlyinstalledoroperationnotinaccordancewiththeUserGuide,damagedbyaccident,orneglect,orifanypartsareimproperlyinstalledorreplacedbytheuser.

Note:Removingorlooseningscrewsfromthebackoftheanalyzervoidsallwarranties.Therearenouserserviceablepartsinsidethecase.

XIV. WARRANTY

33

XV. EXPLANATION OF SYMBOLS

Symbols on the Analyzer and Analyzer Box:

ConsultInstructionsforUse

StorageTemperature

Forin vitrodiagnosticuse

SerialNumber

Manufacturedby

CatalogNumber

Self-Testing

34

AnalyzerIntroduction...............................................4BatteryInstallation...................................................9BloodTesting....................................................20-23CLIAInformation....................................................29CheckStrip............................................................16Cleaning................................................................25ContactInformation...............................................31Date(Setting)........................................................12Help.........................................................................5Language..........................................................10-11MEMoChip..............................................................6Memory..................................................................24QuickReference(ForRunningaTest)..................23QualityControl..................................................18-19ShutDown.............................................................10Sound....................................................................13Specifications........................................................30Symbols.................................................................33Testing(Blood)..................................................20-23Time(Setting)........................................................ 11TroubleshootingTable......................................26-28Units.................................................................12-13Warranty................................................................32

XVI. INDEX

TheCardioChek®systemiscoveredbyoneormorepatents:

USPatent5,597,532andEP0,750,739(DE,FR,GB,IT)

OtherPatentsPending.

Polymer Technology Systems, Inc.7736 Zionsville Rd.

Indianapolis, IN 46268 USA1-317- 870-5610 or 1-877- 870-5610

Fax: 317-870-5608E-mail: inforequest@cardiochek.com

www.cardiochek.com

AuthorizedRepresentativeMedicalDeviceSafetyService

Burckhardstr.D-30163Hannover

Germany

©Copyright2006PolymerTechnologySystems,Inc.

PS-002450ERev.0(06/06)

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