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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: [email protected]
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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
9
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.
10
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
13
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
14
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.
15
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.
17
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
18
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.
19
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.
20
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.
21
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.
23
* 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
24
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
25
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.
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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.
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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:[email protected]: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: [email protected]
www.cardiochek.com
AuthorizedRepresentativeMedicalDeviceSafetyService
Burckhardstr.D-30163Hannover
Germany
©Copyright2006PolymerTechnologySystems,Inc.
PS-002450ERev.0(06/06)
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