Diagnostics Accu-Chek Inform II Blood Glucose Monitoring System. Nurse Educator: Lois Sandford, RN.
ACCU-CHEK Inform II - San Francisco General Hospital … · The ACCU-CHEK® Inform II test strips...
Transcript of ACCU-CHEK Inform II - San Francisco General Hospital … · The ACCU-CHEK® Inform II test strips...
ACCU-CHEK ® Inform II BLOOD GLUCOSE MONITORING SYSTEM
Operator’s Manual
1©2015 Roche Diagnostics. All rights reserved. 05234646004 2015-03 USA
ACCU-CHEK® Inform II System
OPERATOR’S MANUAL
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Manual version Revision date ChangesVersion 1.0 2012-10 New documentVersion 2.0 2013-02 Upgrade to FW 03.04; Revise
critically ill statementVersion 3.0 2013-03 Update cleaning and disinfecting
chapterVersion 4.0 2014-02 Transition to new meter hardware;
2D barcode scanner, modifications to wireless LAN option (separate insertable RF card replaced by integrated WLAN component); new battery pack. Update to SW 04.00; misc. editorial revisions.
Version 5.0 2015-03 Correct two typographical errors in chapter 1, Introduction, Overview of the ACCU-CHEK Inform II Base Unit Hub section.
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©2015, Roche Diagnostics. All rights reserved.
The contents of this document, including all graphics, are the property of Roche Diagnostics. Information in this document is subject to change without notice. Roche Diagnostics shall not be liable for technical or edi torial errors or omissions contained herein. No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, for any purpose, without the express written permission of Roche Diagnostics.
Please send questions or comments about this manual to your local Roche representative.
ACCU-CHEK, ACCU-CHEK INFORM and COBAS are trademarks of Roche. All other trademarks are the property of their respective owners.
The Wi-Fi CERTIFIED Logo is a certification mark of the Wi-Fi Alliance.
On the packaging, on the identification plate of the meter, the battery pack, the base unit, or the code key reader you may encounter the following symbols, shown here with their meaning:
Caution, consult accompanying documents. Refer to safety-related notes in the instruction for use accompanying this instrument.
Temperature limitation (Store at)
Manufacturer
Catalog number
IVD In vitro diagnostic medical device
The system fulfills the Canadian and U.S. safety requirements (UL LISTED, in accordance with UL 61010A-1:02 and CAN/CSA-C22.2 No. 61010-1-04).
7.5V 1.7A Power supply connection
On meters with WLAN capability:
This device complies with Part 15 of the FCC Rules and with RSS-210 of Industry Canada.
For other WLAN certifications, see label on bottom of battery compartment and list included in meter kit.
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1 Introduction 11Beforeyoustart..........................................................................................................................................11
Intendeduse........................................................................................................................................11Importantinformationregardinguse.........................................................................................12Ifyouneedhelp..................................................................................................................................13Noteontheuseof“baseunit”inthismanual.........................................................................13Noteonillustrationsinthismanual.............................................................................................13Whatcanthesystemdoforyou?.................................................................................................14
Importantsafetyinstructionsandadditionalinformation...........................................................15Importantinformationregardingsafety.....................................................................................16Disposalofthesystem.....................................................................................................................17Productsafety.....................................................................................................................................17Generalcare........................................................................................................................................17Accessorybox.....................................................................................................................................17Meter......................................................................................................................................................17BatteryPack.........................................................................................................................................18Touchscreen........................................................................................................................................19Electrostaticdischarge(ESD)........................................................................................................19LocalAreaNetwork:protectionfromunauthorizedaccess...............................................20Wirednetworkconnection.............................................................................................................20Wirelessnetworkconnection........................................................................................................20Radiofrequencyradiationexposureinformation....................................................................21
Systemcomponents.................................................................................................................................24Overviewofthemeter..............................................................................................................................25Overviewofthecodekeyreader..........................................................................................................26Overviewofthebaseunit.......................................................................................................................27OverviewoftheACCU-CHEKInformIIBaseUnitHUB................................................................28Overviewoftheaccessorybox..............................................................................................................29Reagentsandconsumables...................................................................................................................29Instructionsforinitialsetup....................................................................................................................29
2 PoweringUpandEnteringanOperatorID 31Poweringupthemeter............................................................................................................................31
Adjustingthedisplay........................................................................................................................32Enabling/disablingwirelessconnectivity..................................................................................33Closingstartup...................................................................................................................................34
EnteringtheoperatorID..........................................................................................................................34EnteringanoperatorIDwithbarcodescanner.......................................................................35EnteringtheoperatorIDmanually...............................................................................................36Enteringapassword.........................................................................................................................36
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3 PatientGlucoseTesting 37Informationregardingbloodglucosetesting..................................................................................37
Preparingtotest.................................................................................................................................38Performingapatientglucosetest........................................................................................................40
Overviewoftestprocedure............................................................................................................40EnteringorselectingthepatientID.............................................................................................40EnteringthepatientIDmanually..................................................................................................42SelectingthepatientIDfromalist...............................................................................................43EnteringapatientIDwithbarcodescanner.............................................................................44Confirmingorselectingtheteststriplot...................................................................................45Insertingteststrips............................................................................................................................46Applyingabloodsample.................................................................................................................47Resultsscreen.....................................................................................................................................48Addingcomments.............................................................................................................................52
4 GlucoseControlTesting 53Informationregardingglucosecontroltests....................................................................................53
Glucosecontroltestingintervals..................................................................................................54Informationstoredduringglucosecontroltesting................................................................55Controlsolutions................................................................................................................................55Preparingtorunaglucosecontroltest......................................................................................55
Performingglucosecontroltests.........................................................................................................56Overviewoftestprocedure............................................................................................................56Startingaglucosecontroltest......................................................................................................57Confirmingorselectingthelotnumberforcontrolsolutions............................................58Confirmingorselectingtheteststriplot...................................................................................59Insertingteststrips............................................................................................................................60Applyingthecontrolsolution........................................................................................................61Resultsscreen.....................................................................................................................................62PerformingaSTATtest....................................................................................................................63
5 ReviewResults 65Displayingtestresultsfromthememory...........................................................................................65
Informationstoredindatarecordsfortestresults.................................................................65Listofresultsstoredinthememory............................................................................................65
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6 StoringTestStrip,ControlSolution,andLinearitySolutionInformationintheMeter 67Storinginformationaboutteststrips..................................................................................................67
Transferringcodekeyinformationtothemeter.....................................................................68Editingteststripdata........................................................................................................................71
Storingcontrolsolutioninformation...................................................................................................74Enteringthelotnumberofthecontrolsolution......................................................................74Selectingastoredlotnumberasthecurrentlotnumber....................................................77
Storinglinearitytestinformation..........................................................................................................79Enteringthelotnumberofthelinearitytest.............................................................................79Selectingastoredlotnumberasthecurrentlotnumber....................................................81
7 LinearityTesting 83Informationregardinglinearitytests...................................................................................................83
Linearitytestingintervals................................................................................................................83Informationstoredduringlinearitytesting...............................................................................84Linearitytestkit..................................................................................................................................84Preparingtorunalinearitytest.....................................................................................................84
Performingalinearitytest.......................................................................................................................85Overviewoftestprocedure............................................................................................................85Startingalinearitytest.....................................................................................................................85Confirmingorselectingthelotnumberforlinearitytestkits.............................................86Confirmingorselectingtheteststriplot...................................................................................86Insertingteststrips............................................................................................................................87Applyingalinearitytestsample....................................................................................................88Resultsscreen.....................................................................................................................................89
8 ProficiencyTesting 91Informationregardingproficiencytests............................................................................................91
Informationstoredduringproficiencytesting.........................................................................92Preparingaproficiencytest...........................................................................................................92
Performingaproficiencytest................................................................................................................93Overviewoftestprocedure............................................................................................................93Startingaproficiencytest...............................................................................................................93EnteringtheproficiencysampleID.............................................................................................94Confirmingorselectingtheteststriplot...................................................................................94Insertingteststrips............................................................................................................................95Applyingaproficiencysample......................................................................................................96Resultsscreen.....................................................................................................................................97
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9 InitialStartup 99Connectingthebaseunit........................................................................................................................99Installingorreplacingthebatterypack...........................................................................................100
Removingthebatterypack..........................................................................................................101Installingthebatterypack............................................................................................................102
Dockingthemeter...................................................................................................................................104Initialsetuponthemeter......................................................................................................................106
Menuoverview.................................................................................................................................107OpeningtheSetupMenu.....................................................................................................................110Dateandtimeformat..............................................................................................................................111Displayoptionsandoptionaltests.....................................................................................................112Optionsforteststrips.............................................................................................................................113Optionsforglucosecontroltests.......................................................................................................115Valueranges(normal,critical,reportable).....................................................................................116OptionsforOperatorIDEntry..............................................................................................................117PatientIDoptions....................................................................................................................................118Creatingasetuppassword...................................................................................................................119Settingthedateandtime......................................................................................................................120Beeperoptions.........................................................................................................................................121
10 MaintenanceandCare 122Conditionsforstorageandshipping................................................................................................122
Generaloperatingconditions......................................................................................................122Storage................................................................................................................................................123
CleaninganddisinfectingtheACCU-CHEKInformIIsystem..................................................123GuidetocleaninganddisinfectingtheACCU-CHEKInformIIsystem.................................124
Cleaninganddisinfectingthemeter.........................................................................................124Acceptablecleaning/disinfectingagents.............................................................................125Whattoclean/disinfect................................................................................................................126TechnicalAssistance......................................................................................................................126
HowtocleananddisinfecttheACCU-CHEKInformIIsystem................................................127Cleaningthemeter..........................................................................................................................128Disinfectingthemeter...................................................................................................................129
Loggingmaintenanceactivities..........................................................................................................130Diagnosticsview......................................................................................................................................131UnlockingaDownloadLockout.........................................................................................................133Deletingpatientdata..............................................................................................................................134
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11 Troubleshooting 135Errorsandunusualbehaviorwithouterrormessages........................................................135Pop-upmessages............................................................................................................................139Meterreset.........................................................................................................................................141
12 GeneralProductInformation 143Technicaldata...........................................................................................................................................143FurtherInformation.................................................................................................................................145
Ordering..............................................................................................................................................145Accu-ChekInformIIOperator’sManualandQuickReferenceGuide.........................146ReagentsandSolutions.................................................................................................................146Informationaboutsoftwarelicenses.........................................................................................146ContactRoche..................................................................................................................................147
A Appendix 149Tableofconfigurationoptions............................................................................................................149Exampleofbarcodesymbologies......................................................................................................159
B Appendix 161Option:Wirelessnetwork(WLAN)....................................................................................................161
Preliminarynote...............................................................................................................................161Background.......................................................................................................................................161Technicalimplementation............................................................................................................162RFspecificfunctionalitiesandeffectiveperformancespecifications...........................164
C SupplementforOtherTestEntry 167Beforeyoustart........................................................................................................................................167
Description.........................................................................................................................................167OverviewofOtherTestEntry...............................................................................................................168
Introduction.......................................................................................................................................168RecordingOtherTestEntries..............................................................................................................170RecordingOtherControlTestEntries...............................................................................................176
Introduction.......................................................................................................................................176OtherControlTestingIntervals...................................................................................................176StoredControlInformation...........................................................................................................176Warningscreens..............................................................................................................................182
ReviewingResultsforOtherTestEntry............................................................................................183OtherTestEntryConfigurationOptions...........................................................................................186
D SupplementforObservedTestSequence 187ObservedTestSequence(OTS)..................................................................................................187UsingtheOTSfunction..................................................................................................................188
E LimitedWarranty 191ACCU-CHEKInformIILimitedWarranty.................................................................................191
Index 193
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Thispageintentionallyleftblank.
Introduction
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1 Introduction
Beforeyoustart
Intended useTheACCU-CHEK®InformIIteststripsareforusewiththeACCU-CHEKInformIImetertoquantitativelymeasureglucose(sugar)invenouswholeblood,arterialwholeblood,heelstickneonatal,orfreshcapillarywholebloodsamplesdrawnfromthefingertipsasanaidinmonitoringtheeffectivenessofglucosecontrol.Thesystemisnotforuseindiagnosisorscreeningofdiabetesmellitus,norfortestingneonatecordbloodsamples.
TheACCU-CHEKInformIIBloodGlucoseMonitoringSystemisintendedfortestingoutsidethebody(in vitrodiagnosticuse)andisintendedformultiplepatientuseinprofessionalhealthcaresettings.Thissystemshouldonlybeusedwithsingle-use,auto-disablinglancingdevices.
Themultiple-patientuseACCU-CHEKInformIIBloodGlucoseMonitoringSystemwillconsistof:
•Meter:ACCU-CHEKInformIIMeter
•TestStrip:ACCU-CHEKInformIITestStrip
•Controls:ACCU-CHEKInformIIControlSolutions
•Linearity:ACCU-CHEKLinearityKit
Introduction
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Important information regarding use
Readthisoperator’smanual,aswellasthepackageinsertsforallrelevantconsumables,beforeusingthesystemforthefirsttest.
YoumustconfiguretheACCU-CHEKInformIIsystemaccordingtoyourneedsbeforeinitialuse.Youcanconfigurethesystemeitherdirectlyonthemeterorbyusingasuitabledatamanagementsystem.RefertoChapter9“Initialsetuponthemeter”foron-meterconfiguration.RefertoAppendixAforconfigurationviaadatamanagementsystem.
Besuretoreadthe“Importantsafetyinstructionsandadditionalinformation”sectioninthischapterbeforeoperatingthesystem.
TheFDA,CDC,andCMSrecommendthatPointofCarebloodtestingdevicessuchastheACCU-CHEKInformIImetershouldbeusedonlyononepatientandnotshared.Ifdedicatingbloodglucosemeterstoasinglepatientisnotpossible,themetersmustbeproperlycleanedanddisinfectedaftereveryusefollowingtheguidelinesprovidedinthismanual(seesection“MaintenanceandCare”).3
Introduction
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If you need helpInformationaboutusingthesystem,thescreenmenusandperformingatestcanbefoundinthisoperator’smanual.
Errormessagesthatappearon-screenincludeinformationorinstructionsonhowtocorrecttheerror.
ForallquestionsabouttheACCU-CHEKInformIIsystemthatarenotansweredinthismanual,contacttheACCU-CHEKCustomerCareServiceCenterat1-800-440-363824hoursaday,365daysayear.Inordertoexpeditetroubleshooting,pleasehavereadyyourACCU-CHEKInformIImeter,itsserialnumber,thismanual,andallrelatedconsumableswhenyoucall.Ifyoususpectacommunicationerrorbeyondthemeter,alsohaveyourACCU-CHEKInformIIBaseUnitserialnumberreadytohelpassistourcustomercaregroupintroubleshooting.
Note on the use of “base unit” in this manual
Unlessotherwisespecified,theterm“baseunit”referstoboththeACCU-CHEKInformIIBaseUnitandtheACCU-CHEKInformIIBaseUnitLight.
Note on illustrations in this manual
Illustrationsinthismanualshowtwodifferentkindsofhands:
Handwithoutglove Handwithglove
Adashedarrowbetweenscreenillustrationsindicatesthatsomescreenshavebeenskippedintheseillustrations.
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What can the system do for you?TheACCU-CHEKInformIIsystemhasthefollowingfeaturesandproperties:
n Performpatientbloodglucosetestsandglucosecontroltestswithcontrolsolution.
n Automaticallyrecordallrelevantdatafortheapplication,whichincludes:
– Timeanddateoftest
– IDsforoperator,patient,andsamples
– Informationaboutcontrolsolutions,teststrips,andlinearity
– Testresultsandcomments
n Recordpatienttestresults,qualitycontroltestresultsandreagentinformationforcertainoff-metermanualtests.
n Forpurposesofqualityassurance,informationonthefollowingareascanbecollected,stored,andtransferred:
– Meters
– Teststrips
– Glucosecontrolsolutions
– Linearitysolutions
– Testresults
Introduction
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Importantsafetyinstructionsandadditionalinformation
Thissectionexplainshowsafety-relatedmessagesandinformationrelatedtotheproperhandlingofthesystemarepresentedinthisACCU-CHEKInformIImanual.Pleasereadthesepassagescarefully.
Thesafetyalertsymbolalone(withoutasignalword)promotesawarenesstohazardswhicharegenericordirectsthereadertorelatedsafetyinformation
WARNING
WARNINGIndicatesahazardoussituationwhich,ifnotavoided,couldresultindeathorseriousinjury.
CAUTION
CAUTIONIndicatesahazardoussituationwhich,ifnotavoided,couldresultinminorormoderateinjury.
NOTICE NOTICEIndicatesahazardoussituationwhich,ifnotavoided,mayresultindamagetothesystem.
Importantinformationthatisnotsafetyrelevantispresentedagainstacoloredbackground(withoutasymbol).Hereyouwillfindadditionalinformationoncorrectuseofthemeterorusefultips.
Introduction
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Important information regarding safety
OperatorqualificationOnlytrainedhealthcareprofessionalsmayoperatetheACCU-CHEKInformIIsystem.Operatorsmustalsohavereceivedcomprehensiveinstructionintheoperation,qualitycontrol,andcareoftheACCU-CHEKInformIIsystem.
WARNING
Protectionagainstinfectionandblood-bornepathogensHealthcareprofessionalsusingtheACCU-CHEKInformIIsystemtoperformtestsonmorethanonepatientmustbeawarethatanyobjectcomingintocontactwithhumanbloodisapotentialsourceofinfection.OperatorsneedtoadheretoStandardPrecautionswhenhandlingorusingtheACCU-CHEKInformIIsystem.Allpartsofthissystemshouldbeconsideredpotentiallyinfectiousandarecapableoftransmittingblood-bornepathogensbetweenpatientsandhealthcareprofessionals.
nUsegloves.Wearanewpairofcleanglovesfortestingeachpatient.
nWashhandsthoroughlywithsoapandwaterbeforeputtingonanewpairofglovesandperformingthenextpatienttest.
nUseanauto-disablingsingle-uselancingdeviceforeachpatient.
nDisposeofusedlancetsinasturdysharpscontainerwithlid.
nDisposeofusedteststripsfrompatientandproficiencytestsaccordingtoyourinstitution’sinfectioncontrolpolicy.
nFollowallhealthandsafetyregulationsinforcelocally.nFormoreinformation,refertothefollowingpractice
guidelines:– “GuidelineforIsolationPrecautions:PreventingTransmissionofInfectiousAgentsinHealthcareSettings2007”,http://www.cdc.gov/hicpac/2007ip/2007isolationprecautions.html.
– “BiosafetyinMicrobiologicalandBiomedicalLaboratories(BMBL)”foundathttp://www.cdc.gov/biosafety/publications/bmbl5/
– “ProtectionofLaboratoryWorkersFromOccupationallyAcquiredInfections;ApprovedGuideline-ThirdEdition”ClinicalandLaboratoryStandardsInstitute(CLSI)M29-A3.
Introduction
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Disposal of the system
WARNING
InfectionbyapotentiallybiohazardousinstrumentTheACCU-CHEKInformIIsystemoritscomponentsmustbetreatedaspotentiallybiohazardouswaste.Decontamination(i.e.,acombinationofprocessesincludingcleaning,disinfectionand/orsterilization)isrequiredbeforereuse,recycling,ordisposal.
DisposeofthesystemoritscomponentsaccordingtotheappropriatelocalregulationsoryoumayreturnittoRoche.Formoreinformation,callyourlocalRocherepresentativeorcontactACCU-CHEKCustomerCare.
Product safetyObservethefollowinginformationtoensureproductsafety:
n Thesystemissuitableforcontinuousoperation.
NOTICE Thesystemisnotprotectedagainsttheharmfulingressoffluids(IPX0ratingaccordingtoIEC60529).
General careNOTICE Toavoiddamagingthesystem,useonlysolutions
recommendedtocleananddisinfectthesystem.Usingothersolutionsmayresultinincorrectoperationandpossiblefailureofthesystem.
Accessory boxNOTICE Carrytheaccessoryboxcarefullybythehandleforeasy
transport.Droppingorhittingtheboxmaydamageit.
Metern Disposeofthemeterinaccordancewithapplicable
lawsandregulations.
n Unlessotherwiseconfigured,thesystemautomaticallypowersdownafter5minutesofinactivity(i.e.,noscreentouches).
n InMeasurementmodeonly:Ifyouareperformingatest(patient,control,proficiencyorlinearity),themeterwillpoweroffafter10minutesofinactivity(noscreentouches),independentlyofconfiguredautomaticpowerofftime.Ifaresultisalreadypresent,themeterwillemitthreewarningbeepseveryminuteafter5minutesofinactivityandwillsavetheresultbeforepoweringoffafter10minutesofactivity.
Automatic Power Off
Introduction
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Battery PackThemetercontainsarechargeablebatterypackthatbeginschargingassoonasitisplacedinanactivebaseunit(i.e.,oneconnectedtoapowersupply).
NOTICE UseonlythespeciallydesignedbatterypackprovidedbyRocheDiagnostics.Usinganyothertypeofbatterymaydamagethesystem.
Observethefollowinggeneralsafetyinstructionsforhandlingbatterypack:
Donotdisposeofthebatterypackwithnormaldomesticwaste.AsacomponentoftheACCU-CHEKInformIIsystem,itmustbedeemedaspotentiallybiohazardous.Treatitaccordingly.See“Disposalofthesystem”onpage17.
n Whenstoringordisposingofthebatterypack,usethemanufacturer’soriginalpackaging.
Saveordownloaddatafromthemeterpriortoreplacingthebatterypacktopreventlossofdata(seeChapter9).
n Alwayspoweroffthemeterbeforeremovingthebatterypack.
n WhentheBattery Low warningisdisplayed,themetermustbereturnedassoonaspossibletothebaseunitforrecharging.
n TheBattery Critically Lowwarningindicatesthatthemetermustbereturnedimmediatelytothebaseunitforrecharging.Nomoretestscanbeperformed.
Introduction
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TouchscreenNOTICE nUseonlyyourfingertotouchthescreenelements.
Usingasharp-edgedobject(e.g.,tipofapen)candamagethetouchscreen.
nDonotusethesystemindirectsunlight.Directsunlightmayreducethelifeexpectancyandfunctionalityofthedisplay,aswellastheintegrityofteststrips.
Electrostatic discharge (ESD)TheACCU-CHEKInformIIsystemcomplieswithboththeelectromagneticimmunityrequirementsandradiointerferenceimmunityrequirementsatthefrequencyandtestlevelsaccordingtoENISO15197AnnexA.Thesystemalsocomplieswiththeelectrostaticdischarge(ESD)immunityrequirementsasspecifiedinIEC61000-4-2andcomplieswithapplicableelectromagneticemissions(EMC)requirementsaccordingtoEN61236-1andEN61326-2-6.Thesystem’semissionsoftheenergyusedarelowandnotlikelytocauseinterferenceinnearbyelectronicallydrivenequipment.
Electrostaticdischarge(ESD)isanelectricalchargeatrest,mostcommonlyknownasstaticelectricity.IftheACCU-CHEKInformIImeterexperiencesaformofESDbeforeorafterrunningabloodglucosetest,thetestresultwillbestoredinthemetermemoryandtransmittedwhenthemeterisdockedinaconnectedbaseunitorwhenawirelessconnectionisestablished.IfthemeterexperiencesESDduringabloodglucosetest,anerrormessageisdisplayedandnobloodglucoseresultisdisplayedbythemeterorstoredinthemeter’smemory.Thebloodglucosetestwillneedtoberepeated.
ToavoidESD,donotusethemeterinaverydryenvironment,particularlyoneinwhichsyntheticmaterials(e.g.,carpets)arepresentthatmightcausedamagingstaticdischarges,ornearelectronicequipmentthatisasourceofelectromagneticradiation.
Introduction
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Local Area Network: protection from unauthorized access
Ifthisproductisconnectedtoalocalareanetwork,thisnetworkmustbeprotectedagainstunauthorizedaccess.Inparticular,itmustnotbelinkeddirectlytoanyothernetworkortheInternet.Customersareresponsibleforthesecurityoftheirlocalareanetwork,especiallyinprotectingitagainstmalicioussoftwareandattacks.Thisprotectionmightincludemeausres,suchasafirewall,toseparatethedevicefromuncontrollednetworksaswellasmeasuresthatensurethattheconnectednetworkisfreeofmaliciouscode.
Wired network connectionIfconnectedtoalocalareanetwork,theACCU-CHEKInformIIBaseUnitorACCU-CHEKInformIIBaseUnitHUBmustbeprotectedagainstunauthorizedaccess.ForadditionalinformationabouttheACCU-CHEKInformIIBaseUnitorACCU-CHEKInformIIBaseUnitHUB,refertotheACCU-CHEK Inform II Base Unit HUB Operator’s Manual.
Wireless connectivityIfthemeterisequippedwithWLANfunctionality:Wirelessconnectivityallowsthemetertosenddata(testresults,patientIDs,operatorIDs,etc.)tothedatamanagementsystemwithouttheneedtoreturnthemetertothebaseunit.Thisfeaturemustbeconfiguredbythesystemadministrator.Observetheguidelinesofyourfacilityforusingwirelesslocalareanetworkconnections.Forinformationabouthowtotemporarilyenableordisablethisfunction,seepage33.ForadescriptionoftheACCU-CHEKInformIImeter’sabilitytoconnecttoWirelessLocalAreaNetworks(WLAN,Wi-Fi),seeappendixB.
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Radiofrequency radiation exposure information
Glossary:
n“FCC”standsfor“FederalCommunicationsCommission”(USA).
n“RF”standsfor“radiofrequency”n“RSS”standsfor“RadioStandardsSpecification”
(Canada)n“WLAN”standsfor“WirelessLocalAreaNetwork”
TheIndustrial,ScientificandMedical(ISM)radiofrequenciesmaycontainemissionsfrommicrowaveovens,heaters,andothernon-communicationdevices.Whilethesetypesofdevicesusuallyposenothreatofinterferenceastheyarelow-powereddevices,thepossibilityexiststhatsomeindustrialhighpowersystemsmaywipeoutanyattemptedcommunicationuseofaWLAN.Therefore,performasitesurveyandinterferenceanalysiswithaspectrumanalyzertoviewtheentirespectrum,lookingforsignalsthatmightnotonlybewithinthefrequencyrangeoftheintendedWLANbutalsocouldbenearoratthesamefrequencyandcauseinterference.
Introduction
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RochesupportsindustrywirelessstandardsandrecommendsusingproductsthathaveWi-Ficertification.Thiscertificationtestsproductstothe802.11industrystandardsforbasicconnectivity,security,authentication,QualityofService(QoS),interoperabilityandreliability.TheWi-FiCERTIFIEDTMlogoisanassurancethattheWi-FiAlliance®hastestedaproductinnumerousconfigurationsandwithadiversesamplingofotherdevicestoensurecompatibilitywithotherWi-FiCERTIFIEDequipmentthatoperatesinthesamefrequencyband.TheWi-FiAlliancenetworkofindependenttestlabsconductsinteroperabilitytestingprogramstoensurethatwirelessdevicesworktogetherandsupportsecureconnections.
TheACCU-CHEKInformIIsystemcomplieswithFCCradiationexposurelimitssetforthforanuncontrolledenvironment.Thisequipmentshouldbeinstalledandoperatedwithminimumdistanceof8inches(20cm)betweentheradiatorandyourbody.
Thistransmittermustnotbeco-locatedoroperatedinconjunctionwithanyotherantennaortransmitter.
ChangesormodificationsmadetothisequipmentnotexpresslyapprovedbyRocheDiagnosticsmayvoidtheFCCauthorizationtooperatethisequipment.
ThisdevicecomplieswithPart15oftheFCCRulesandwithRSS-210ofIndustryCanada.Operationissubjecttothefollowingtwoconditions:
(1)thisdevicemaynotcauseharmfulinterference,
and
(2)thisdevicemustacceptanyinterferencereceived,includinginterferencethatmaycauseundesiredoperation.
TheACCU-CHEKInformIIsystemcomplieswiththeemissionandimmunityrequirementsdescribedinIEC61326-2-6:2006.IthasbeendesignedandtestedtoCISPR11ClassB.
Inadomesticenvironmentitmaycauseradiointerference,inwhichcase,youmayneedtotakemeasurestomitigatetheinterference.
TheelectromagneticenvironmentinwhichtheACCU-CHEKInformIIdevicewillbeoperatedshouldbethoroughlyevaluatedpriortooperationofthedevice.
Introduction
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ThisequipmenthasbeentestedandfoundtocomplywiththelimitsforaClassBdigitaldevice,pursuanttoPart15oftheFCCRules.Theselimitsaredesignedtoprovidereasonableprotectionagainstharmfulinterferenceinaresidentialinstallation.Thisequipmentgenerates,usesandcanradiateradiofrequencyenergyand,ifnotinstalledandusedinaccordancewiththeinstructions,maycauseharmfulinterferencetoradiocommunications.However,thereisnoguaranteethatinterferencewillnotoccurinaparticularinstallation.Ifthisequipmentdoescauseharmfulinterferencetoradioortelevisionreception,whichcanbedeterminedbyturningtheequipmentoffandon,theuserisencouragedtotrytocorrecttheinterferencebyoneormoreofthefollowingmeasures:
n Reorientorrelocatethereceivingantenna.
n Increasetheseparationbetweentheequipmentandreceiver.
n Connecttheequipmentintoanoutletonacircuitdifferentfromthattowhichthereceiverisconnected.
n Consultthedealeroranexperiencedradio/TVtechnicianforhelp.
ThisClassBdigitalapparatuscomplieswithCanadianICES-003.
Introduction
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Systemcomponents
TheACCU-CHEKInformIIsystemincludesthefollowingcomponentsandaccessories:
A Meter
B Codekeyreader
C Baseunitwithpowersupply
D BaseunitHUB
E Accessorybox(notincluded)
Themetercanbeconfiguredbytwodifferentmethods:
1 ConfigurationviatheSetupfunctiononthemeter(seeChapter9)
2 Configurationviadatamanagementsystem
Note:NotalloptionscanbeconfiguredusingtheSetupfunctiononthemeter.
Themeterperformsthefollowingtaskswithinthesystem:
n Servesastheprimaryoperatorinterfacethroughthetouchscreenandon/offbutton
n Performsglucosetests
n Scansbarcodes(teststriplots,controls,patientandoperatorIDs)inavarietyofsupportedformats
n Displaystestresultsfrompatienttestsandcontroltests
n Transfersstoreddatatothedatamanagementsystemviawirelesscommunication(WLAN,optional)ortheACCU-CHEKInformIIBaseUnit(LAN)
D
A
B
C
E
Introduction
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Overviewofthemeter
Themeterhasthefollowingelements:
1 TeststripportInserttheteststriphere.
2 Touchscreen(touch-sensitivedisplay)Thisscreenallowsyoutoperformpatienttests,performcontroltests,andreviewresults.Toselectanyofthesefunctions,simplytouchthebuttononthescreen.
3 On/OffbuttonPressthisbuttontopoweroffthemeteronoroff.
4 BarcodescannerTheintegratedbarcodescannercanbeusedtoreadoperatorandpatientIDs,andpatientinformation.
5 BatterycompartmentcoverRemovetoinsertthebatterypack.
6 ChargingcontactsThesecontactsareusedtochargethebatterypackwhenthemeterisinthebaseunit.
7 InfraredwindowFacilitatesdatacommunicationwithcodekeyreaderandbaseunit.
1
2
3
4
7
5
6
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Overviewofthecodekeyreader
Teststripvialsincludeacodekey.1Thiscodekeyisreadbythecodekeyreaderandthedataissenttothemeter.Foradditionalinformationaboutthecodekeyreader,seeChapter6.
Thecodekeyreaderhasthefollowingelements:
8 Codekeyslot
9 LED(green)fordisplayingstatus
10 Infraredwindowfortransmittingthecodefiletothemeter
DonotexchangecodekeyswhiletheCodeKeyReaderLEDstatuslightisstillflashinggreen.IftheCodeKeyReaderisstillflashinggreen,itwillcontinuetotransmitthepreviouslyloadedcodefileandignorethecodefileonthenewlyinsertedcodekey.Youmaygetanerrormessageonthemeter.
1 Thecode keyisalsofrequentlyreferredtoasacode chip.Thetermsaresynonymous.
10
9
8
Introduction
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Overviewofthebaseunit
Toprovideflexibilityinlinewithcustomerrequirements,twoversionsofthebaseunitareavailable.
n TheACCU-CHEKInformIIBaseUnit
n TheACCU-CHEKInformIIBaseUnitLight
Bothversionsofthebaseunitcan:
n chargethemeterbatterypack.
TheACCU-CHEKInformIIBaseUnitsupports:
n communicationwithadatamanagementsystem.*
n communicationwithacomputer.
Bothversionsofthebaseunithavethefollowingelements:
11 Chargingcontacts
12 Infraredwindowforcommunicationwiththemeter
13 StatusLED(lightsupwhenpowerisconnected):
– Lightsupred:Powersupplyisconnected,applicationisstartingup(ACCU-CHEKInformIIBaseUnitonly)
– Lightsupgreen:Ready
– Flashesred:Error
– Lightsupblue:Configurationmode(ACCU-CHEKInformIIBaseUnitonly)
14 Jackforthepowersupplyunitprovided
15 Removablemountforwallinstallation
TheACCU-CHEKInformIIBaseUnithasthefollowingadditionalelements:
16 Networkconnection—LAN,Ethernet(RJ45)
17 USBconnection*Note: The ACCU-CHEK Inform II Base Unit Light can support communication with a data management system only when used together with the ACCU-CHEK Inform II Base Unit Hub.
12
11
13
15
16 17 14
Introduction
28
Electricalconnectionsarelocatedonthebackofthebaseunit(forabetterviewtheremovablewallmountisshownastransparent).
Forinstructionsonconnectingthebaseunit,seeChapter9.
OverviewoftheACCU-CHEKInformIIBaseUnitHUB
TheACCU-CHEKInformIIBaseUnitHUBisabletoconnectupto4ACCU-CHEKInformIIBaseUnitsLight(RJ25)andsupportscommunicationtoadatamanagementsystemviaEthernet(RJ45).
TheHUBalsoprovidespowerfortheACCU-CHEKInformIIBaseUnitLight.WhenconnectedtoaHUB,anACCU-CHEKInformIIBaseUnitLightdoesnotrequireaseparatepowersupply.TheLEDcolorsoftheHUBarethesameasfortheACCU-CHEKInformIIBaseUnitLight.
18 StatusLED(lightsupwhenpowerisconnected)
19 Jackforthepowersupplyunitprovided
20 Networkconnection-LAN,Ethernet(RJ45)
21 USBconnection
22 Connectionsforupto4ACCU-CHEKInformIIBaseUnitsLight(RJ25,datatransfer,andpower)FormoreinformationabouttheACCU-CHEKInformIIBaseUnitHUB,refertotheACCU-CHEK Inform II HUB Operator’s Manual.
18
1921 2022
Introduction
29
Overviewoftheaccessorybox
Theaccessoryboxprovidesanareaforstoringandtransportingconsumablesneededforperformingpoint-of-carebloodglucosetests.
Reagentsandconsumables
Youneedthefollowingreagentstoperformpatienttestsandglucosecontroltests:
n ACCU-CHEKInformIITestStrips
n ACCU-CHEKInformIIControlSolutions:Availableforpurchaseseparately,consistsoftwo2.5mLbottles.OnebottlecontainstheLevel1(Lo)control,whiletheotherbottlecontainstheLevel2(Hi)control.
n ACCU-CHEKLinearityKit(ifrequiredbyyourfacilityguidelines):Availableforpurchaseseparately,containssix2.5mLbottles.Thesebottlesspantheglucoserangeinsixlevels(L1toL6)
Yourfacilityprovidesadditionalconsumablessuchasbloodcollectionsupplies.Observethecurrentrulesandsafetyguidelinesforcollectingandhandlingbloodsamples.
Instructionsforinitialsetup
Themetermustbeconfiguredpriortoinitialuse.Duringthissetup,thefollowingparametersareconfigured:
n Dateandtimeformat
n InputmodeforPatientID
Introduction
30
n InputmodeforOperatorID
n Glucosecontrols:Typeandschedule
n Resultsscreenforglucosecontrol
n Commentsforentryafteratest
n Settingsfordatatransfer
YoucanperformthesesettingsonalimitedbasisdirectlyintheSetup Menuofthemeter.FormoreinformationaboutconfigurationusingtheSetup Menu,seeChapter9,aswellasAppendixA.Inadditiontothisoption,themetercanbeconfiguredusingadatamanagementsystem.Suitabledatamanagementsystemsprovidearangeoffunctionsforconfiguringthemeterthatgobeyondwhatispossiblewiththemeter-basedconfigurationfeature.
Forquestionsaboutusingdatamanagementsystems,contactyourRocherepresentative(seeChapter12).
Toensurestandardizedconfigurationwithinafacility,themeter-basedSetup Menumaybedisabled.
PoweringUpandEnteringanOperatorID
31
2 PoweringUpandEnteringanOperatorID
Poweringupthemeter
1 PressandreleasetheOn/Offbutton .Themeterisnowon.
2 ThePower Upscreenappears.
3 CheckinthePower Upscreenwhetherthedate(lowerleft)andtime(upperright)aredisplayedcorrectly.Ifnecessary,refertotheinstructionsforupdatingthesesettingsinChapter9.
Contrast
Power Up 12:48 pm
09/18/13
Performing self-checks...
n Ifduringself-checkanerrorisdetected,theappropriateerrormessageappearson-screen.
n IftheQC Lockoutfeatureisenabledandglucosecontrolisrequired,acorrespondingmessageisdisplayed.
n Thebatteryiconshowsthecurrentbatterylevel.Acompletelyfilledicon indicatesafullychargedbattery,andapartialchargeisdisplayedasapartiallyfilledbatteryicon .Ifthebatteryisnearlyempty,thebatteryiconturnsred .
PoweringUpandEnteringanOperatorID
32
Adjusting the displayUsingtheDisplayoptions,youcanadjustdisplaycontrasttotheambientlightconditions.
1 InthePower Upscreen,touchContrast.TheDisplayscreenappears.
2 Touch or tomakethedisplaylighterordarker.
3 Touch toconfirmthesetting.
After30secondswithoutanyactivity(e.g.,withoutascreentouch)themeterautomaticallydimsthedisplaybacklighttoconserveenergy(“LowPowerMode”)..
Display
Lighter Darker
12:48 pm
09/18/13
PoweringUpandEnteringanOperatorID
33
Enabling/disabling wireless connectivity
Ifthemetersupportswirelessconnectivity,youcantemporarilyenableordisablethisfunctionalityasrequired.
Wirelessconnectivityisautomaticallyreactivatedthenexttimeyoupoweronthemeter.Youcanthendisableitagaintemporarily,ifrequired.
WARNING
IfyoususpectthattheRFemisionsofwirelsscommunicationsareharmingthepatientoraffectingotherdevices,youshouldcarefullyreassesstheappropriatenessofcontinueduseoftheWLANfunctionalityoftheACCU-CHEKInformIIsystemusingtheguidelinesofyourfacility.
Ifwirelessconnectivityisactivated,the (RF OFF)iconisdisplayedasabuttoninthePower Upscreen.
n Totemporarilydisablethewirelessnetworkconnection,touch (RF OFF)inthePower Upscreen.Theiconthenchangesto (RF ON).
n Totemporarilyenablethewirelessnetworkconnection,touch (RF ON)inthePower Upscreen.Theiconthenchangesto (RF OFF).
TheRF ON/RF OFFbuttonalwaysdisplaystheoptionyoucurrentlyhave.Thecurrentcommunicationstatusisdisplayedinthestatusbar(bottomline)ofthedisplayinallmenusandscreens.
n The iconisdisplayed,ifwirelessconnectivityisenabled.
n The iconisdisplayedifthelastattempttocommunicatewiththedatamanagementsystemwassuccessfulandwasterminatedaccordingtothecommunicationprotocol.
n The iconisdisplayedifthelastattempttocommunicatewiththedatamanagementsystemwasnotsuccessfulorwasunintentionallyterminated.Ifthisiconpersists,contactyoursystemadministrator.IgnoringthisinformationmayleadtoaDownload Lockout(ifconfigured,seepage38).
Contrast
Power Up 12:48 pm
09/18/13
Contrast
Power Up 12:48 pm
09/18/13
PoweringUpandEnteringanOperatorID
34
Closing startupOnceyouhavecompletedallthenecessarychanges,
n touch toproceedtothescreenusedtoentertheoperatorID,or
n wait5secondsandthemeterautomaticallyproceedstothescreenusedtoentertheoperatorID.
EnteringtheoperatorID
HowandwhenanoperatorIDisenteredandifapasswordisrequired,dependsontheconfigurationofthesystem.Itisalso,forexample,possibletorequiretheoperatorIDonlywhenstartingcontroltests.Ingeneral,thesystemcanmanageandcheckoperatorIDsaswellasmakeadditionalfunctionsID-dependent.
IfanoperatornamematchingtheenteredoperatorIDisavailableonthemeter,thisnamewillbedisplayedintheMain Menu(shownhereas“MariaS.”).
ThereareanumberofoptionsforenteringoperatorIDsandthesedependontheconfigurationofthesystem:
n Viabarcodescanneronly(alistofsupportedbarcodesymbologiescanbefoundinAppendixA2.)
n Manuallyoroptionallyviabarcodescanner
OperatorIDscanconsistofupto20alphanumericcharacters.
AlphanumericcharactersareanycombinationofA-Zand0-9,additionally“.”(period),or“-”(hyphen)maybeused.Seealsopage36.
BarcodemaskingcanbeusedtoeliminateanycharactersnotbelongingtotheOperatorID.Seeinformationon“OperatorandpatientIDbarcodemasks”onpage158.
Main Menu
Review Results
Control Test
Patient Test
Maria S.
12:48 pm
09/18/13
PoweringUpandEnteringanOperatorID
35
Entering an operator ID with barcode scanner
WhenthescreenforenteringtheoperatorIDisdisplayed:
1 2 3
4 5 6
7 8 9
A-O0
Operator ID 12:48 pm
09/18/13
1 Pressandrelease .Thebuttonnowappearswithablackbackground(duringthescan).
2 Holdthemetersothatthewindowofthebarcodescannerisapproximately4-8inchesabovethebarcodeyouwishtoread.
Themeterbeepsoncethebarcodehasbeenreadsuccessfully.ThebarcodeinformationappearsintheoperatorIDfield.Thebarcodescannerturnsoffafter10seconds,ifabarcodeisnotscanned.
PoweringUpandEnteringanOperatorID
36
Entering the operator ID manually
WhenthescreenforenteringtheoperatorIDisdisplayed:
1 2 3
4 5 6
7 8 9
A-O0
Operator ID 12:48 pm
09/18/13
A B C D E
F G H I J
K L M N O
P-Z123
Operator ID
MARIA
12:48 pm
09/18/13
P Q R S T
U V W X Y
Z .
123 A-O
Operator ID
MARIA S.
12:48 pm
09/18/13
-
1 TouchthelettersornumberstoentertheID.
2 Usethefollowingbuttonstotogglebetweenrangesofcharacters:
– A-O forlettersA-O
– P-Z forlettersP-Z
– 123 fornumbers0-9
3 Touch tobackspaceanddeleteacharacterenteredincorrectly.Touch todeletethewholeentry.Touch toenteraspace.
4 Touch toconfirm.
IftheoperatorIDyouhaveenteredisnotvalid(ortheoperatorisnotstoredinthemeter),anerrormessageisdisplayed.ConfirmingthemessageallowsyoutoentertheIDagain.
Entering a passwordOncetheoperatorIDhasbeenenteredcorrectly,ascreenforenteringapasswordmayappear(ifconfigured).EnterthepasswordinthesamemannerasdescribedabovefortheoperatorID.
Onceallentriesarecomplete,Main Menuappears.
PatientGlucoseTesting
37
3 PatientGlucoseTesting
Informationregardingbloodglucosetesting
Beforeperformingabloodglucosetest,observethefollowingsafetyprecautions:
nObservetheapplicableregulationsanddirectivesforhygieneandsafetywhencollectingbloodsamples.
nObservetheapplicableregulationsanddirectivesfordisposingofpotentiallyinfectioussamplesandmaterials.
nRefertothesection“Importantinformationregardingsafety”startingonpage16ofthismanual,inparticular:“Protectionagainstinfectionandblood-bornepathogens.”
nUsegloves.Wearanewpairofcleanglovesfortestingeachpatient.
nWashhandsthoroughlywithsoapandwaterbeforeputtingonanewpairofglovesandperformingthenextpatienttest.
nUseanauto-disablingsingle-uselancingdeviceforeachpatient
PatientGlucoseTesting
38
Preparing to test
FormoredetailedinformationregardingtheACCU-CHEKInformIIteststrip,refertothepackageinsertforinstructionsforuse,performancecharacteristics,andlimitationsofthesystem.
Thefollowingrequirementsmustbemetbeforeyoucanperformatest:
n TheACCU-CHEKInformIIteststripsareavailable.
n Atleastonecodefileforteststripsmustbestoredinthemeterandmatchthelotnumberoftheteststripsused(seeChapter6).
n AnoperatorIDmustbeentered(withpassword,ifrequired),ifthemeterisconfiguredforlogin.
n Glucosecontroltestsspecifiedinthesystemconfigurationmustberunandcompletedsuccessfullybeforerunningpatienttests.InformationwhetherglucosecontroltestsarenecessaryisdisplayedinthePower Upscreen.
n Ifconfigured,themetermayrequiredownloadingstoreddatatothedatamanagementsystemwithindefinedtimeintervals.Ifsuchadownload(eitherviaWLANorbydockingthemeterinabaseunit)doesnothappenwithinthespecifiedtime,themeterislocked(Download Lockout)andcannotbeusedfortesting.
Ifaglucosecontroltestisshownasrequired,patientglucosetestingcannotbeperformeduntilthecontrolsarerunsuccessfully.
Dependingonhowyourmeterisconfigured,QCLockoutoccurswhen
n patienttestingisattemptedandcontrolshavenotbeenruninthetimeintervalorfrequencyestablishedbyyourfacility.
n controlshavebeenrunbutthecontrolvalueswerenotinrange.
n ateststriplototherthanthe“current’lotisselected.
n newsoftwarehasbeeninstalled.
Docked
Synchronizing Database...
12:48 pm
09/18/13
PatientGlucoseTesting
39
Foremergencies,ShortTurn-AroundTimetests(STAT)testscanbeconfiguredinthemeter.Thisoptionallowsthemetertoperformalimitednumberofpatientglucosetests,ifcircumstancesrequire,despitethemeterbeinginQCLockoutorDownloadLockout(seepage63).
InMeasurementmodeonly:Ifyouareperformingatest(patient,control,proficiencyorlinearity),themeterwillpoweroffafter10minutesofinactivity(noscreentouches),independentlyofconfiguredautomaticpowerofftime.Ifaresultisalreadypresent,themeterwillemitthreewarningbeepseveryminuteafter5minutesofinactivityandwillsavetheresultbeforepoweringoffafter10minutesofactivity.
n Observetheapplicableregulationsanddirectivesforhygieneandsafetywhencollectingbloodsamples.
n Observetheapplicableregulationsanddirectivesfordisposingofpotentiallyinfectioussamplesandmaterials.
PatientGlucoseTesting
40
Performingapatientglucosetest
Overview of test procedure
Apatientglucosetestcomprisesthefollowingsteps:
n EnterthepatientID.Thiscanbedoneeithermanuallyorbyusingthebarcodescanner.
n Confirmthattheteststriplotmatchestheteststripsinuse(ifconfigured).
n Performthetest.
n OptionallyatestmaybecategorizedasanObserved Test Sequence(seepage187).
Asmentionedpreviously,thefollowingstepsmustbecompletedalready:
1 Themeterisswitchedon.
2 YouhaveenteredyouroperatorID.
3 Youhavecompletedloginbyselecting andtheMain Menuscreenisdisplayed.
Entering or selecting the patient ID
Afterpreparingthemeterasdescribed,youcanproceedtothestepsdirectlyrelatedtotesting:
A B C D E
F G H I J
K L M N O
P-Z 123
Patient ID
123456789
12:48 pm
09/18/13
D-503: Patient ID: 123456789 Name: Mary-Jane MillerDOB: 12/03/56
Is this correct?
Patient Confi rmation
Main Menu
Review Results
Control Test
Patient Test
12:48 pm
09/18/13
1 2 3
4 5 6
7 8 9
A-O0
Patient ID 12:48 pm
09/18/13
1 FromtheMain MenuscreentouchPatient Test.
2 EnterorselectthePatient IDasdescribedonthefollowingpages.
3 IfthefunctionPatient Confirmationisenabled,verifyandconfirmthedisplayedpatientinformation,afteryouenteredorselectedtheID.
PatientGlucoseTesting
41
Younowhavethreedifferentoptions,dependingonsetup,forassigningthesubsequenttesttoapatient.
ThepatientIDfunctioncanbeconfiguredbyyoursystemadministratorto:
nEnteranycombinationofupto20alphanumericcharacters,withspecifiedminimumandmaximumlengths.
AlphanumericcharactersareanycombinationofA-Zand0-9,additionally“.”(period),or“-”(hyphen)maybeused.
nEnterpatientIDviabarcodescanner.nSelectapatientfromalist.*
ThefollowingoptionsareavailableforvalidatingpatientIDs:
nManualentriescanbevalidatedbasedonandownloadedlist.
nConfirmationofpatientname,dateofbirth,andIDcanberequired.**
nBarcodemaskingcanbeusedtoeliminateanycharactersnotbelongingtothePatientID.Seeinformationon“OperatorandpatientIDbarcodemasks”onpage158.
*AlistofsupportedbarcodesymbologiescanbefoundinAppendixA2.
**DependingontheDMSyouareusing,thisfeaturemaybedisabled.
PatientGlucoseTesting
42
Entering the patient ID manuallyUsethedisplayedkeypadtoenterthepatientID.YoucanselectcharactersinthesamemanneraswhenenteringanoperatorID.
1 TouchthelettersornumberstoentertheID.
2 Usethefollowingbuttonstotogglebetweenrangesofcharacters:
– A-O forlettersA-O
– P-Z forlettersP-Z
– 123 fornumbers0-9
3 Touch tobackspaceanddeleteacharacterenteredincorrectly.Touch todeletethewholeentry.Touch toenteraspace.
4 Touch toconfirm,ortouch tocancelthisprocedureandreturntotheMain Menu.
IfthepatientIDyouhaveenteredisnotvalid(orthepatientisnotfoundinthedownloadedlist),anerrormessageisdisplayed.ConfirmingthemessageallowsyoutoentertheIDagain.
A B C D E
F G H I J
K L M N O
P-Z123
Patient ID 12:48 pm
09/18/13
PatientGlucoseTesting
43
Selecting the patient ID from a list
ChoosethepatientIDfromalist*,ifalisthasbeendownloadedtothemeter(fromthedatamanagementsystem).
1 Touch or toscrollupordowninthelist.
Ifoneofthebuttonsishidden,youhavereachedthetoporbottomofthelist.
2 Touchthedesiredentrytoselectapatient,or
3 Touch tocancelthisprocedureandreturntotheMain Menu.
*DependingontheDMSyouareusing,thisfeaturemaybedisabled.
Patient ID
Keyboard
ID: 2222222222Name: Jane DoeID: 3333333333
Name: John DoeID: 4444444444Name: Jenny Doe
ID: 5555555555
Name: James Doe
12:48 pm
09/18/13
PatientGlucoseTesting
44
Entering a patient ID with barcode scanner
WhenthescreenforenteringthepatientIDisdisplayed:
A B C D E
F G H I J
K L M N O
P-Z123
Patient ID 12:48 pm
09/18/13
Patient ID
Keyboard
ID: 2222222222Name: Jane DoeID: 3333333333
Name: John DoeID: 4444444444Name: Jenny Doe
ID: 5555555555
Name: James Doe
12:48 pm
09/18/13
1 Pressandrelease .Thebuttonnowappearswithablackbackground(duringthebarcodescan).
2 Holdthemetersothatthewindowofthebarcodescannerisapproximately4-8inchesabovethebarcodeyouwishtoread.
Themeterbeepsoncethebarcodehasbeenreadsuccessfully.ThebarcodeinformationappearsinthepatientIDfield.Thebarcodescannerturnsoffafter10seconds,ifabarcodeisnotscanned.
PatientGlucoseTesting
45
Confirming or selecting the test strip lot
OnceyouhaveenteredandconfirmedthepatientID,youareaskedtochoosethelotnumberfortheteststrips.Comparethenumberdisplayedbythemetertothenumberonthelabeloftheteststripvial.
1 Selectthelotnumberasfollows:
n Toreadthelotnumberfromtheteststripvialviabarcodescanner,pressandrelease .FollowtheinstructionsforscanningIDs(seenotebelow).
n Tousethepreselectedlotnumberdisplayedbythemeter,touch toconfirm.
n Touseadifferentlotnumberthantheonedisplayed,touch todisplayalistofstoredlotnumbers.Selectthedesiredlotnumberfromthelist.
2 Touch toconfirmtheselectedteststriplotnumber.
Themetercanbeconfiguredsothatmanualconfirmationisnotnecessary.Inthissetup,onlythelotnumberisdisplayed.Additionaloptionsarenotavailable.
Themetercanbeconfiguredsothatlotnumbersareenteredviabarcodescanneronly(seenotebelow).
Foradditionalinformationaboutstoringlotnumbersforteststrips,seepage67.
Note:Barcodesoncontrolsolutionsmaynotbeavailableinallcountries.Inthiscaseeither
nmanuallyenterthelotnumbereachtime(recommended),
npickapreviouslyenteredlotnumberfromthelist,or
nconfigurethemetertoonlydisplaythelotnumber(withoutconfirmationbytheoperator).
Patient TestPatient 123456789
Use Strip Lot
12:48 pm
09/18/13
123456?
Strip Lots
344789
545794
545777
344654
12:48 pm
09/18/13
PatientGlucoseTesting
46
Inserting test stripsAfterconfirmingtheteststriplot,aflashinggreenarrowappearsonscreenandpromptsyoutoinserttheteststrip.
Patient TestPatient 123456789Strip Lot 545794
12:48 pm
09/18/13
1 Removetheteststripfromtheteststripvialandclosethevialwiththecap.
2 Holdtheteststripsothelettering“ACCU-CHEK”isfacingupward.
3 Slidetheteststripintotheteststripportasfarasitgoesinthedirectionindicatedbythearrowsontheteststrip.Themeterbeeps.Themeterbeeps.Thehourglassiconappearsandindicatesthatthemeterischeckingtheteststrip.Donotapplybloodwhileitisdisplayed.
Patient TestPatient 123456789Strip Lot 545794
12:48 pm
09/18/13
PatientGlucoseTesting
47
Applying a blood sampleOncethemeterhascheckedtheteststrip,thehourglassicondisappearsandyouarepromptedtoapplyabloodsample.
Patient TestPatient 123456789Strip Lot 545794
12:48 pm
09/18/13
1 Waituntiltheflashingdropappearsinthedisplaybeforeapplyingtheblood.Themeterbeeps.
2 Applythedropofbloodtothefrontedge(yellowdosingarea)oftheteststrip.Bloodispulledintotheteststripbycapillaryaction.Donotapplythebloodtothetopofthestrip.Bloodontopoftheteststripisnotavailablefortestingbecauseitwillnotbepulledintothestrip.Onceasufficientbloodsamplehasbeendetected,themeterbeepsandthemeasurementbegins.
PatientGlucoseTesting
48
Results screenThehourglassiconindicatesthetestisrunning.Whenthetestiscompletedandtheresultisready,themeterbeepsagain.
Patient TestPatient 123456789Date 09/18/13 12:48 pm
150
L22
12:48 pm
09/18/13
RangeI-502: Normal Range:
Critical Range:
Reportable Range:
70-200 mg/dL
40-301 mg/dL
11-600 mg/dL
Patient TestPatient 123456789Strip Lot 545794
12:48 pm
09/18/13
Patient Test
Range
150
Patient 123456789Date 09/18/13 12:48 pm
mg/dL
09/18/13
12:48 pm
Whentheresultisdisplayed,amessageorwarningmayalsoappear(dependingonsystemconfiguration)notifyingyouiftheresultexceedsthespecifiedlimitvalues.Additionally,aredflashingarrow(seePatient Testscreenbelow)nexttothetestresultindicatesthataresultisoutofrange.
:thevalueisabovethenormal/criticalupperrange.
:thevalueisbelowthenormal/criticallowerrange.
Theselimitvaluesdefinerangesthatcaneitherbeconfiguredindividuallybythesystemadministratorinlinewithfacilityguidelines,orarethe(technical)limitsofthesystem.Thecharacteristicsoftheserangesareexplainedonthefollowingpage.
Theresultsscreencontainsabuttonthatchangesitsnamebasedontheresult(RangeorOut of ... Range).Touchthisbuttontodisplaytheconfiguredlimitvalues.
PatientGlucoseTesting
49
Patient Test
Out of Critical Range
CR LO
Patient 123456789Date 09/18/13 12:48 pm
09/18/13
12:48 pmPatient Test
Out of Normal Range
220
Patient 123456789Date 09/18/13 12:48 pm
mg/dL
09/18/13
12:48 pm Patient Test
Out of Critical Range
34
Patient 123456789Date 09/18/13 12:48 pm
mg/dL
12:48 pm
09/18/13
Patient Test
Out of Critical Range
305
Patient 123456789Date 09/18/13 12:48 pm
mg/dL
09/18/13
12:48 pm Patient Test
Out of Reportable Range
RR HI
Patient 123456789Date 09/18/13 12:48 pm
12:48 pm
09/18/13
PatientGlucoseTesting
50
n TheSystemMeasurementRangereferstothemeasurementrangeofthesystemitself(teststripsandmeter)andistheonlyrangewhichcannotbeconfigured.WithACCU-CHEKInformIIteststripsthisfixedrangeis10to600mg/dL.Ifaresultfallsoutsidethisrange,themessageHIorLOappears,i.e.,theresultcannotbequantifiedproperly.
n GlucoseresultsaboveorbelowtheReportableRange,asdefinedbytheinstitutionorlocalregulatorybody,areabovethehighestorbelowthelowestnumericalresultstobereported.Resultsoutsidethisrangemustnotbeusedforinterventiondecisions.
n GlucoseresultsaboveorbelowtheCriticalRange,asdefinedbytheinstitution,requireimmediateactionasdefinedbyhospitalpolicy.
n GlucoseresultswithintheNormalRange,asdefinedbytheinstitution,areconsiderednormalandrequirenotherapeuticaction.
PatientGlucoseTesting
51
Thefollowingmessages1mayappearinadditiontothestandardtestresult:
n CRLO(belowtheCriticalRangethreshold,butwithintheReportableRange)
n CRHI(abovetheCriticalRangethreshold,butwithintheReportableRange)
n RRLO(belowtheReportableRangethreshold,butwithintheSystemMeasurementRange)
n RRHI(abovetheReportableRangethreshold,butwithintheSystemMeasurementRange)
n LO(belowtheSystemMeasurementRange)
n HI(abovetheSystemMeasurementRange)
Fortestresultsthatlieoutsidethecriticalorreportablerange,amessage(upto100charactersinlength)canbeconfiguredduringsetup.Thismessageisthendisplayedwiththecorrespondingtestresults.
Instructionsonhowtoaddcommentsareprovidedinthefollowingsection.
Ifcommentsarenotsetasrequiredandyoudonotwishtoaddacommenttothetestresult,touch toreturntotheMain Menu.
Testresultsarealsosavedwhenthemeterispoweredoffintheresultsscreenorwhenitpowersoffautomatically.
Removetheteststripanddisposeofitinaccordancewithapplicableregulationsanddirectivesfordisposalofpotentiallyinfectioussamplesandmaterials.
1ResultsthatarebeloworabovetheCriticalRangethreshold,butwithintheReportableRangecanbeconfiguredtodisplayaseithernumericresultsorasCRLOorCRHI.AllotherresultsexceedingspecifiedlimitvalueswillalwaysbedisplayedasRRLO,RRHI,LO,orHI.
PatientGlucoseTesting
52
Adding commentsYoucanadduptoatotalofthreecommentstoatestresult.Commentscanprovide,forexample,additionalinformationaboutthetestconditionsorthepatient.
Ofthesethreecommentsonlyonecanbeacustomcomment;theotherscanbeselectedfromthepredefinedcommentslist.
Themetercanbeconfiguredsothatcommentsarealwaysrequired,requireddependingontheresultrange,optional,ordisabled.Youcancallupthefunctionforaddingcommentsdirectlyintheresultsscreen.Ifcommentsaresetasrequired,themeterwillnotacceptanemptycommentfield.
Add Comments
09/18/13
New Strip Lot
Will Repeat Test
RN Notifi ed
Doctor Notifi ed
12:48 pm Patient Test
Out of Normal Range
220
Patient 123456789Date 09/18/13 12:48 pm
mg/dL
New Strip LotDoctor Notifi edWill Repeat Test
09/18/13
12:48 pmPatient Test
Out of Normal Range
220
Patient 123456789Date 09/18/13 12:48 pm
mg/dL
09/18/13
12:48 pm
Toaddcomments:
1 InthePatient Testscreen,touch .
2 Selectuptothreedesiredpredefinedcomment(s)fromthedisplaylist(ifconfigured)or
3 Touch toenteruptoonecustomcomment(ifcustomcommentingisenabled).Usethekeypad(aswithlogin)toenteryourcomment.
4 Onceyouhaveselectedthedesiredcomment(s),touch toreturntotheresultsscreen.
5 Touch toreturntotheMain Menu.
Testresultsarealsosavedwhenthemeterispoweredoffintheresultsscreenorautomaticallypowersoff.
Removetheteststripanddisposeofitinaccordancewithapplicableregulationsanddirectivesfordisposalofpotentiallyinfectioussamplesandmaterials.
GlucoseControlTesting
53
4 GlucoseControlTesting
Informationregardingglucosecontroltests
Observetheapplicableregulationsanddirectivesoftheresponsibleregulatoryagencieswhenperformingglucosecontroltests.
Accuratelytestingknownlevelsofglucoseensuresthatthesystemandyourtechniqueusedintestinggiveaccurateresultsonpatienttests.Glucosecontrolsolutionshavedefined(known)values.Theresultsforthesesolutionsmustfirstfallwithinacertainacceptablerangeinordertoallowvalidpatienttesting.
Thesystemmaybeconfiguredtorequirein-rangeglucosecontroltestingbeforepatienttestingisallowed.ThisiscalledQC Lockout,andthesystemactuallypreventspatientandproficiencytestingwhenthecontrolresultsarenotwithintheacceptedrange.
GlucoseControlTesting
54
Glucose control testing intervalsIntervalsbetweenrunningglucosecontroltestsaredeterminedbyyourfacility.Theseintervalsareenteredwhenthesystemisconfigured.Attheendofthespecifiedinterval(orafteraspecificeventsuchasstartingtotestwithanewteststriplot),awarningisdisplayedwhenthemeterisswitchedonandwhentheGlucose Testfunctionisselected.
Glucosecontroltestsshouldberuninthefollowingcircumstances:
n Beforeusingthemeterforpatienttestingthefirsttime
n Attheglucosecontrolintervalsestablishedbyyourfacility,ifestablished
n Whenusinganewteststripvialforthefirsttime
n Whenusinganewteststriplotforthefirsttime(andasaresultanewteststripcode)
n Ifateststripvialwasleftopen
n Ifquestionabletestresultsaredisplayedrepeatedly
n Ifyouwishtotesttheperformanceofthesystem
Inaddition,thefollowingeventscanbespecifiedduringsetupasareasonforaglucosecontroltest:
n Ifapreviouscontroltestisoutofrange
n Ifglucosecontroltestswerenotrunattheproperintervals
Ifaglucosecontroltestisrequired(asshownintheillustrationontheleft),youwillnotbeabletotestbloodglucoseuntilthecontrolshavebeenrunsuccessfully.Foremergencies,STATtestscanbeconfiguredinthemeter.Thisoptionallowsthemetertoperformalimitednumberofbloodglucosetests,ifcircumstancesrequire,despitethemeterbeinginQCLockout(seepage63).
Contrast
Power Up
QC Due: Immediately
12:48 pm
09/18/13
GlucoseControlTesting
55
Information stored during glucose control testing
Thefollowinginformationisstoredforeveryglucosecontroltestusingcontrolsolution:
n Glucosecontroltestresult
n Lotnumberofthecontrolsolution
n OperatorID(ifconfigured)
n Levelofcontrolsolution(L1orL2)
n Lotnumberoftheteststrips
n Timeanddateoftest
n Comments(ifapplicable)
n Outofrangemeasurements
Control solutionsForbloodglucoseteststrips,controlsolutionshavetwolevels:
n Level1(L1):Lo(lowvaluesintestresults)
n Level2(L2):Hi(highvaluesintestresults)
Preparing to run a glucose control test
Asidefromspecialpreparations(seethefollowingsection),aglucosecontroltestisruninthesamemannerasapatienttest:
n Atleastonecodefileforteststripsmustbestoredinthemeterandmatchthelotnumberoftheteststripsused(seeChapter6).
n Theproperteststripsmustbeavailable.
n AnoperatorIDmustbeentered(withpassword,ifapplicable),ifthemeterisconfiguredforlogin.
GlucoseControlTesting
56
Performingglucosecontroltests
Overview of test procedureAglucosecontroltestusingcontrolsolutioncomprisesthefollowingsteps:
n Selectthedesiredlevelofcontrolsolutionforthetest.
n Checkthelotnumberofthecontrolsolution.
n Checkthelotnumberoftheteststrips.
n Performthetestwiththecontrolsolution.
Asmentionedpreviously,thefollowingstepsmustbecompletedalready:
1 Themeterisswitchedon.
2 YouhaveenteredyouroperatorID.
3 Youhavecompletedloginbyselecting andtheMain Menuscreenisdisplayed.
Theresultmustfallwithinthespecifiedrange(asshownonthelabeloftheteststripvialordefinedperconfiguration)forthecontroltesttobecompletedsuccessfully.Patienttestscannowbeperformed(again).
GlucoseControlTesting
57
Starting a glucose control testAfterpreparingthemeterasdescribed,youcanproceedtothestepsdirectlyrelatedtocontroltesting:
Control Test
Level 2 (Hi)
Level 1 (Lo)
Required
12:48 pm
09/18/13
Main Menu
Review Results
Control Test
Patient Test
12:48 pm
09/18/13
1 FromtheMain MenuscreentouchControl Test.
IntheControl Testscreen,thelevelsavailableforthecontrolsolutionaredisplayed.Totherightofthebuttons,thewordRequiredidentifiesthelevelatwhichaglucosecontroltestmustberuntoremoveQCLockout.
2 TouchLevel 1 (Lo)orLevel 2 (Hi)toselectthelevelforthefollowingtest.Intheexampleabove,Level 2 (Hi)ismarked.
GlucoseControlTesting
58
Confirming or selecting the lot number for control solutions
Onceyouhaveselectedthelevel,youareaskedtoconfirmorenterthelotnumberofthecontrolsolution.Comparethenumberdisplayedbythemetertothenumberonthelabelofthecontrolsolutionbottle.
1 Selectthelotnumberasfollows:
n Toreadthelotnumberfromthecontrolsolutionbottleviabarcodescanner,pressandrelease .FollowtheinstructionsforscanningIDs(seepage35).*
n Tousethepreselectednumberdisplayedbythemeter,touch toconfirm.
n Touseadifferentnumberthanthelotnumberdisplayed,touch toopenthekeypadandenterthenumbermanually.
2 Touch toconfirmtheselectedcontrollotnumber.
Themetercanbeconfiguredsothatmanualconfirmationisnotnecessary.Inthissetup,onlythelotnumberisdisplayed.Additionaloptionsarenotavailable.
Themetercanbeconfiguredsothatlotnumbersareenteredviabarcodescanneronly.
Foradditionalinformationaboutstoringlotnumbersforcontrolsolutions,seepage74.
Control TestControl L2 (Hi)
123456?Use Control Lot
12:48 pm
09/18/13
1 2 3
4 5 6
7 8 9
0
Control Lot 12:48 pm
09/18/13
GlucoseControlTesting
59
Confirming or selecting the test strip lot
Onceyouhaveenteredandconfirmedthelotnumberofthecontrolsolution,youareaskedtochoosetheteststriplotnumber.Comparethenumberdisplayedbythemetertothenumberonthelabeloftheteststripvial.
1 Selectthelotnumberasfollows:
n Toreadtheteststriplotnumberfromtheteststripvialviabarcodescanner,pressandrelease .FollowtheinstructionsforscanningIDs.*
n Tousethepreselectedteststriplotnumberdisplayedbythemeter,touch toconfirm.
n Touseadifferentlotnumberotherthantheonedisplayed,touch toopenthekeypadandenterthenumbermanually,ortodisplayalistofstoredlotnumbersandthenselectthedesiredlotnumberfromthelist..
2 Touch toconfirmtheselectedteststriplotnumber.
Themetercanbeconfiguredsothatmanualconfirmationisnotnecessary.Inthissetup,onlythelotnumberisdisplayed.Additionaloptionsarenotavailable.
Themetercanbeconfiguredsothatlotnumbersareenteredviabarcodescanneronly.
Themetercanbeconfiguredsothatlotnumberscanonlybeselectedfromalist.
Foradditionalinformationaboutstoringlotnumbersforteststrips,seepage67.
Control TestControl L2 (Hi) 123456
Use Strip Lot
12:48 pm
09/18/13
123456?
Strip Lots
344789
545794
545777
344654
12:48 pm
09/18/13
GlucoseControlTesting
60
Inserting test stripsAfterconfirmingtheteststriplot,aflashinggreenarrowappearsonthescreenandpromptsyoutoinserttheteststrip.
Control TestControl L2 (Hi) 123456Strip Lot 545794
12:48 pm
09/18/13
1 Removetheteststripfromtheteststripvialandclosethevialwiththecap.
2 Holdtheteststripsothelettering“ACCU-CHEK”isfacingupward.
3 Slidetheteststripintotheteststripportasfarasitgoesinthedirectionindicatedbythearrowsontheteststrip.Themeterbeeps.Thehourglassiconappearsandindicatesthatthemeterischeckingtheteststrip.Donotapplycontrolsolutionwhileitisdisplayed.
Control TestControl L2 (Hi) 123456Strip Lot 545794
12:48 pm
09/18/13
GlucoseControlTesting
61
Applying the control solutionOncethemeterhasdetectedtheteststrip,thehourglassicondisappearsandyouarepromptedtoapplycontrolsolution.
Control TestControl L2 (Hi) 123456Strip Lot 545794
12:48 pm
09/18/13
1 Waituntiltheflashingdropappearsinthedisplaybeforeapplyingthecontrolsolution.Themeterbeeps.
2 Applyadropofglucosecontrolsolutiontothefrontedgeoftheteststrip.Donotapplythecontrolsolutiontothetopofthestrip.Thecontrolsolutionispulledintotheteststripbycapillaryaction.
Oncesufficientcontrolsolutionhasbeendetected,themeterbeepsandthemeasurementbegins.
GlucoseControlTesting
62
Results screenThehourglassiconindicatesthetestisrunning.Whenthetestiscompletedandtheresultisready,themeterbeepsagain.
Control Test
PASS
Control L2 (Hi) 123456Date 09/18/13 12:48 pm
12:48 pm
09/18/13
Control Test
Range
Control L2 (Hi) 123456Date 09/18/13 12:48 pm
308mg/dL
09/18/13
12:48 pm Control TestControl L2 (Hi) 123456Date 09/18/13 12:48 pm
FAIL
12:48 pm
09/18/13
Dependingonconfiguration,theresultisdisplayedeitherasavalueoronlyasaqualitativeresultPassorFail.Yoursystemmaybeconfiguredtodisallowfurthertestinguntilalltherequiredglucosecontrollevelsaresuccessfullyrun(QCLockout).
Whentheresultsaredisplayedasavalue,theresultsscreencontainsabuttonthatchangesitsnamebasedontheresult(RangeorOut of … Range).Touchthisbuttontodisplaytheminimumandmaximumtargetvaluesforthecontrollevels.
Youcanaddcommentstoatestresult(aswithbloodglucosetests)(seepage52).
Ifyoudonotwishtoaddacommenttothetestresult,touch tocontinuetothenextlevelofthecontroltest,ifnecessary,ortoreturntotheMain Menu.
Testresultsarealsosavedwhenthemeterispoweredoffintheresultsscreenorwhenitautomaticallypowersoff.
Removetheteststripanddisposeofitinaccordancewithapplicableregulationsanddirectives.
GlucoseControlTesting
63
Performing a STAT testThemetercanbeconfiguredtoallowaSTATpatientglucosetesttoberunevenifthemeterisinQCLockoutorDownloadLockout.Thisoptionistobeusedinsituationswithcriticalpatients.Thesystemadministratorcanallowcontrolteststobedelayedonetoninetimes.
Run STATappearsintheQC Lockoutwarningboxunderthefollowingconditions:
n YouaresuccessfullyloggedinandhaveselectedPatient Testfromthemainmenu.
n Aglucosecontroltestisrequired(duetospecifiedcontrolintervalsorotherconditions).
n TheadministratorhasenabledtheSTATtestoptionduringsetup.
n ThenumberofSTATtestsavailablehasnotbeenexceeded.
Iftheseconditionsarefulfilled,twobuttonsappearinthewarningmessagethatallowyoutochoosethenextstep:
n TouchRun QCtoruntherequiredcontroltestinsteadofapatienttest.
n TouchRun STATtoperformapatienttestevenifaglucosecontroltestisrequired.ThestatusasSTATtestisstoredwiththedatarecordforthetest.
IfthemeterisinaDownload Lockoutstatus,andnoSTATtestisavailable,themetercanbeunlockedbyasystemadministrator(seepage133).
Glucose Test
Patient Test Menu
Run QC Run STAT
QC LockoutD-513: Warning! Glucose control is due. Required Controls must be run in order to proceed. 9 STAT test(s) available.
12:48 pm
09/18/13
GlucoseControlTesting
64
Thispageintentionallyleftblank.
ReviewResults
65
5 ReviewResults
Displayingtestresultsfromthememory
Information stored in data records for test results
Whenyouretrievethedatarecordforstoredtestresults,thefollowinginformationisdisplayed.
n PatientID,glucosecontrol,orsampleID
n Thetestresult
n Thelotnumbersofthereagentsusedforglucosecontrolandlinearitytests
n Dateandtimeofthetest
n Commentsenteredatthetimethetestwasperformed
Maintenanceresults(fordocumentationofmaintenanceactivities)arestoredanddisplayedwithdateandtimeonlyifcommentswereadded.
List of results stored in the memory
Todisplaytheresultsfromthememoryasalist:
Glucose Results
Patient QC
All -- 04/19/13 -- mg/dLTime Rslt
7:15 pm 74 123456789ABC5:32 pm 229 123456789ABC2:25 pm FAIL QC L2
12:15 pm 79 56789ABC123411:46 am PASS QC L110:01 am 74 Linearity L3
ID
09/18/13
12:48 pmMain Menu
Review Results
Control Test
Patient Test
12:48 pm
09/18/13
1 FromthemainmenuscreentouchReview Results.
Allstoredtestresultsaredisplayedinasequentiallist.
2 Touch or toscrollupordowninthelist.Theresultsaregroupedbydate.
Glucose Results
Patient QC
All -- 04/19/13 -- mg/dLTime Rslt
7:15 pm 74 123456789ABC5:32 pm 229 123456789ABC2:25 pm 290 QC L2
12:15 pm 79 56789ABC123411:46 am 65 QC L110:01 am 74 Linearity L3
ID
09/18/13
12:48 pm
ReviewResults
66
Glucose Results
Patient QC
All -- 04/19/13 -- mg/dLTime Rslt
7:15 pm 74 123456789ABC5:32 pm 229 123456789ABC2:25 pm 290 QC L2
12:15 pm 79 56789ABC123411:46 am 65 QC L110:01 am 74 Linearity L3
ID
09/18/13
12:48 pm Patient Result
Patient QC
ID: 123456789ABCDEFGName: Joe M. DoeStrip Lot: 400433229 mg/dL04/19/13 05:32 pmComment 1
Comment 2Comment 3
12:48 pm
09/18/13
Glucose Results
All QC
ID: 123456789ABCDEFGPatient -- 04/18/13 -- mg/dL
Time Rslt7:15 pm 1535:12 pm 1121:01 pm 99
11:20 am 2319:25 am 142
12:48 pm
09/18/13
3 Touchanentryinthelisttodisplaytherelateddetails.
4 TouchPatient,ifyouwishtodisplayresultsforaspecificpatientonly.
– IfyoutouchPatientfromthefulllistview,youwillbeaskedtoenterthepatientIDmanuallyorviabarcodescanner.Thelistnowcontainsonlytheresultsfortheselectedpatient.
– IfyoutouchPatientinthePatient Resultview(middlescreenabove),thelistoftestresultsforthispatientwillbedisplayed.
5 TouchQC,ifyouwishtodisplayalistofglucosecontroltests.
6 TouchAllintheGlucose ResultsscreentoremovethePatientorQCselectionanddisplayallresults.
7 Touch toreturntothepreviousmenuscreen,ortouch toreturntotheMain Menu.
IfthemeterisconfiguredtoshowPASS/FAILinsteadofanumericalQCresult,youcanusethelisttocheckwhetherameterlockoutisduetoafailedoroverduecontroltest.
Glucose Results
Patient QC
All -- 04/19/13 -- mg/dLTime Rslt
7:15 pm 74 123456789ABC5:32 pm 229 123456789ABC2:25 pm FAIL QC L2
12:15 pm 79 56789ABC123411:46 am PASS QC L110:01 am 74 Linearity L3
ID
09/18/13
12:48 pm
StoringTestStrip,ControlSolution,andLinearitySolutionInformationintheMeter
67
6 StoringTestStrip,ControlSolution,andLinearitySolutionInformationintheMeter
Storinginformationaboutteststrips
Eachboxofteststripscontainsacodekey.1Eachcodekeybelongstoasinglelotnumberandprovidesimportantinformationaboutthelot-specificpropertiesoftheteststrip.Thepropertiesoftheteststripsaredownloaded(asacodefile)fromthecodekeyusingthecodekeyreaderandsenttothemeter.Thecodefileisstoredinthemeter.
Thisprocedurealsoallowsthecodekeyinformationtobestoredcentrallyinthedatamanagementsystem,fromwhereitcanbesenttoallthemetersusedinyourfacility.
Makesurewitheachtestthatthecodestored(andselectedbyyou)matchesthelotnumberoftheteststripsinuse.
Asidefromtheunchangeabledatadirectlylinkedtothelot-specificproperties,someoftheinformationfromthecodekeycanbemodified(dependingonyourmetersetup).Thisinformationincludes:
n Expirationdate(canbesettoadatebeforethedatestoredinthekey)
n Parametersforcontrolsolutions(minimumandmaximumvaluesforlevelsL1/LoandL2/Hi)
Note:Whenusingadatamanagementsystemforconfiguration,itispossibletopartiallyorfulldisablethefunctionsdescribedinthischapter.Inthiscase,therespectivebuttonsinMain Menu 2donotappear.(SeealsoAppendixA).
1 Thecode keyisalsofrequentlyreferredtoasacode chip.Thetermsaresynonymous.
StoringTestStrip,ControlSolution,andLinearitySolutionInformationintheMeter
68
Transferring code key information to the meter
Thefollowingdescriptionassumesthatthemeterispoweredonandthemainmenuisdisplayed.
Main Menu
Review Results
Control Test
Patient Test
12:48 pm
09/18/13
Main Menu 2
Maintenance
Strip Lots
Profi ciency
Control Lots
Beeper
Linearity
Diagnostics
Linearity Lots
Admin.
12:48 pm
09/18/13
Strip Lots
Add
Strip12/31/14 855732
* 11/21/14 845678
Strip 11/21/14 845723
Type Exp. Date Lot Num.
Strip
12:48 pm
09/18/13
1 Touch toopentheMain Menu 2screen.
2 TouchStrip Lotstoopentherelatedmenu.
3 TouchAddifyouwanttoaddtheinformationforanewteststriplotfromanewcodekey.TheAdd Strip Lotscreenopens.
4 Insertthenewcodekeyintheopeningofthecodekeyreader.TheLEDlightstartsflashinggreenandsignalsthatthereaderisreadytotransferdata.
Thecodekeyreaderremainsreadytosendforafewsecondsafterithastransmitteddata.Asaresult,youcanperformthefollowingprocedureonmultiplemeterswithouthavingtoreinsertthecodekey.
StoringTestStrip,ControlSolution,andLinearitySolutionInformationintheMeter
69
5 Placethecodekeyreaderonalevelsurfacesuchasabench.Holdthemeter4-6inchesabovethecodekeyreadersothataconnectioncanbemadebetweenthetwoinfraredwindows.
6 Touch tobegindownloadingdata.
nThecodefileisreadyfortransmissionaslongastheLEDonthecodekeyreaderisflashinggreen,evenifthecodekeyisremoved.– AftertheLEDstopsflashing,removethecodekeyandinsertanewcodekeyfordownload,ifrequired.
– Ifyougetanerrormessagethatthedownloadwasnotsuccessful,re-insertthesamecodekeyandtryagain.
nDonotexchangecodekeyswhilethecodekeyreaderisstillflashing.Ifthecodekeyreaderisstillflashing,itwillcontinuetotransmitthepreviouslyloadedcodefileandignorethecodefileonthenewlyinsertedcodekey.Youmaygetanerrormessageonthemeter.
Oncetheconnectionismade,themeterprovidesyouwithstatusinformationonthedownload.
Add Strip Lot
Please Wait
I-302: Connecting to code key reader...
12:48 pm
09/18/13
Place Meter above the Code Key Reader and then press the Right Arrow button to start.
Add Strip Lot 12:48 pm
09/18/13
Add Strip Lot
Please Wait
I-303: Receiving code key contents...
12:48 pm
09/18/13
StoringTestStrip,ControlSolution,andLinearitySolutionInformationintheMeter
70
Informationabouttheexpirationdateandparametersforcontrolsolutionsissubsequentlydisplayed.
1 Touch tostorethedataforthisteststriplotnumberinthemeterwithoutchanges,or
2 Touch tomodifythedataforthisteststriplotnumberbeforestoringitinthemeter.
Ifyouacceptthesuggestedvalues,thefollowingscreenappears.Youcanusethisscreentoselectthelotnumberyouhavejusttransmittedasthecurrentlotnumber.
Thecurrentlotnumberisprovidedautomaticallyforusewithsubsequenttests.
3 Touch toconfirmthatyouwantthislotnumbertobethelotnumbercurrentlyinuse,ortouch tostoretheentrieswithoutmakingthelotnumberthecurrentlotnumber.
4 Continueenteringadditionallotnumbers,ortouchtoreturntotheMain Menu.
Add Strip Lot
Strip Lot Confi rmation
D-530: Do you want touse the suggestedvalues for strip 545603?Use by: 02/10/14L1(Lo): 43-74 mg/dLL2(Hi): 288-389 mg/dL
12:48 pm
09/18/13
Add Strip Lot 12:48 pm
09/18/13
Place Meter above the Code Key Reader and then press the Right Arrow button to start.
D-314: Do you want to make Strip lot: 545603 the 'current' lot?
Make 'Current'
StoringTestStrip,ControlSolution,andLinearitySolutionInformationintheMeter
71
Editing test strip dataAsmentionedatthebeginningofthischapter,youcaneditseveralparametersforteststrips,theexpirationdateandthevaluerangesforcontrolsolutions.
1 Usethekeypadtoenterthedesiredexpirationdate(usetwodigitsandleadingzero,ifnecessary).Itisnotpossibletoenteradatebeyondtheexpirationdatestoredinthekey.
2 Touch toacceptthemodifieddateandcontinuetothevalueranges.
Add Strip Lot
Strip Lot Confi rmation
D-530: Do you want touse the suggestedvalues for strip 545603?Use by: 02/10/14L1(Lo): 43-74 mg/dLL2(Hi): 288-389 mg/dL
12:48 pm
09/18/13
1 2 3
4 5 6
7 8 9
0
Strip Expiration
11/30/13
12:48 pm
09/18/13
StoringTestStrip,ControlSolution,andLinearitySolutionInformationintheMeter
72
Theparametersforcontrolsolutionsconsistoffourseparatevalues.
1 2 3
4 5 6
7 8 9
0
Control L2 Max
353 mg/dL
12:48 pm
09/18/13
.
1 2 3
4 5 6
7 8 9
0
Control L1 Min
31 mg/dL
12:48 pm
09/18/13
.
1 2 3
4 5 6
7 8 9
0
Strip Expiration
11/30/13
12:48 pm
09/18/13
3 Usethekeypadtoenterthedesiredvaluesoneafteranother:
– MinimumlimitvalueforLevel1
– MaximumlimitvalueforLevel1
– MinimumlimitvalueforLevel2
– MaximumlimitvalueforLevel2
4 Touch toconfirmeachseparateentryandcontinuetothenextentry.
StoringTestStrip,ControlSolution,andLinearitySolutionInformationintheMeter
73
Onceyouhavefinishedupdatingtheteststripinformation,youcanusethenextscreentoselectthelotnumberyouarecurrentlyeditingasthecurrentlotnumber.
Thecurrentlotnumberisprovidedautomaticallyforusewithsubsequenttests.
5 Touch toconfirmthatyouwantthislotnumbertobethelotnumbercurrentlyinuse,or
6 Touch tostoretheentrieswithoutmakingthelotnumberthecurrentlotnumber.
7 Continueenteringadditionallotnumbers,or
8 Touch toreturntotheMain Menu.
1 2 3
Control L2 Max
353 mg/dL
D-314: Do you want to make Strip lot: 545603 the 'current' lot?
Make 'Current'
12:48 pm
09/18/13
StoringTestStrip,ControlSolution,andLinearitySolutionInformationintheMeter
74
Storingcontrolsolutioninformation
Glucosecontrolsolutionlotinformationcanbeenteredbeforetesting,ifloteditinghasbeenallowedatthemeterlevelinthesetup,andappearsinalistforoperatorstoreferto.UsethefollowingproceduretoaddglucosecontrollotnumberstotheControlLotlist.
Entering the lot number of the control solution
Thefollowingdescriptionassumesthatthemeterispoweredonandthemainmenuisdisplayed.
Main Menu
Review Results
Control Test
Patient Test
12:48 pm
09/18/13
Main Menu 2
Maintenance
Strip Lots
Profi ciency
Control Lots
Beeper
Linearity
Diagnostics
Linearity Lots
Admin.
12:48 pm
09/18/13
Control Lots
Add
* QC L2 11/21/13 77767812/31/13 77773211/21/13 777723
QC L1QC L2
Type Exp. Date Lot Num.12:48 pm
09/18/13
1 Touch toopentheMain Menu 2screen.
2 TouchControl Lotstoopentherelatedmenu.
3 TouchAddtoenteranewlotnumber.
StoringTestStrip,ControlSolution,andLinearitySolutionInformationintheMeter
75
1 2 3
4 5 6
7 8 9
0
Control Lot 12:48 pm
09/18/13
Add Control Lot 12:48 pm
09/18/13
Level 1 (Lo)
Level 2 (Hi)
1 2 3
4 5 6
7 8 9
0
Control Expiration
11/30/13
12:48 pm
09/18/13
4 Selectthelevel(L1/LoorL2/Hi).
5 Usethekeypadtoenterthelotnumber.Touchtoconfirmtheenteredlotnumber,or
6 Pressandrelease toreadthelotnumberfromthecontrolsolutionbottleviabarcodescanner.FollowtheinstructionsforbarcodescanningIDs(seepage35).
7 Usethekeypadtoentertheexpirationdateasstatedonthecontrolsolutionbottle.
8 Touch toconfirmtheenteredexpirationdate.
StoringTestStrip,ControlSolution,andLinearitySolutionInformationintheMeter
76
Onceyouhavefinishedupdatingthecontrolsolutioninformation,youcanusethenextscreentoselectthelotnumberyouarecurrentlyeditingasthecurrentlotnumber.
Thecurrentlotnumberisprovidedautomaticallyforusewithsubsequenttests.
9 Touch toconfirmthatyouwantthiscontrollotnumbertobethelotnumbercurrentlyinuse,or
10 Touch tostoretheentrieswithoutmakingthelotnumberthecurrentlotnumber.
11 Continueenteringadditionalcontrollotnumbers,or
12 Touch toreturntotheMain Menu.
1 2 3
Control Expiration
11/30/13
12:48 pm
09/18/13
4 5 6
D-312: Do you want to make Control lot 134526 the 'current' lot for Level 1 (Lo)?
Make 'Current'
StoringTestStrip,ControlSolution,andLinearitySolutionInformationintheMeter
77
Selecting a stored lot number as the current lot number
Youcanselectanystoredlotnumberasthecurrentlotnumber.
Main Menu
Review Results
Control Test
Patient Test
12:48 pm
09/18/13
Main Menu 2
Maintenance
Strip Lots
Profi ciency
Control Lots
Beeper
Linearity
Diagnostics
Linearity Lots
Admin.
12:48 pm
09/18/13
Control Lots
Add
* QC L2 11/21/13 77767812/31/13 77773211/21/13 777723
QC L1QC L2
Type Exp. Date Lot Num.12:48 pm
09/18/13
1 Touch inthemainmenutoopentheMain Menu 2screen.
2 TouchControl Lotstoopentherelatedmenu.Thecurrentlotnumberisindicatedbyanasterisk(*).
StoringTestStrip,ControlSolution,andLinearitySolutionInformationintheMeter
78
Control Lot Details
Edit Delete
Control Lot: 777732Control Level: 1Use by 12/31/13Current
12:48 pm
09/18/13
Control Lot Details
Edit Delete
Control Lot: 777732Control Level: 1Use by 12/31/13
Make Current
12:48 pm
09/18/13
Control Lots
Add
* QC L2 11/21/13 77767812/31/13 77773211/21/13 777723
QC L1QC L2
Type Exp. Date Lot Num.12:48 pm
09/18/13
3 Touchthelotnumberyouwishtoselectasthecurrentlotnumber.Thisopenstherelateddetailview.
4 TouchMake Currenttomakethelotnumberthecurrentlotnumber.TheinformationCurrentisthenalsodisplayedinthedetailview.
5 Touch toreturntothelistoflotnumbers,or
6 Touch toreturntotheMain Menu.
StoringTestStrip,ControlSolution,andLinearitySolutionInformationintheMeter
79
Storinglinearitytestinformation
Observetheapplicableregulationsanddirectivesoftheresponsibleregulatoryagencieswhenperforminglinearitytests.
Entering the lot number of the linearity test
Thefollowingdescriptionassumesthatthemeterispoweredonandthemainmenuisdisplayed.
Main Menu
Review Results
Control Test
Patient Test
12:48 pm
09/18/13
Main Menu 2
Maintenance
Strip Lots
Profi ciency
Control Lots
Beeper
Linearity
Diagnostics
Linearity Lots
Admin.
12:48 pm
09/18/13
Linearity Lots
Add
* Lin. 12/31/13 77773203/15/14 777723Lin.
Type Exp. Date Lot Num.12:48 pm
09/18/13
1 Touch toopentheMain Menu 2screen.
2 TouchLinearity Lotstoopentherelatedmenu.
3 TouchAddtoenteranewlotnumber.
StoringTestStrip,ControlSolution,andLinearitySolutionInformationintheMeter
80
1 2 3
4 5 6
7 8 9
A-O0
Linearity Lot 12:48 pm
09/18/13
1 2 3
4 5 6
7 8 9
0
Linearity Expiration
09/30/13
12:48 pm
09/18/13
4 Usethekeypadtoenterthelinearitylotnumber.
5 Touch toconfirmtheenteredlinearitylotnumber.
6 Entertheexpirationdate(usetwodigitsandleadingzero,ifnecessary)andtouch toconfirmtheexpirationdateyouhaveentered.
Onceyouhavefinishedupdatingthelinearitytestinformation,youcanusethenextscreentoselectthelotnumberyouarecurrentlyeditingasthecurrentlotnumber.
Thecurrentlotnumberisprovidedautomaticallyforusewithsubsequenttests.
7 Touch toconfirmthatyouwantthislotnumbertobethelotnumbercurrentlyinuse,or
8 Touch tostoretheentrieswithoutmakingthelotnumberthecurrentlinearitylotnumber.
9 Continueenteringadditionallotnumbers,or
10 Touch toreturntotheMain Menu.
Linearity Lots
D-311: Do you want tomake Linearity lot 777678 the 'current' lot?
Make 'Current'
* 12/31/13 777732Lin.03/15/14 777723Lin.
Exp. Date Lot Num.Type12:48 pm
09/18/13
StoringTestStrip,ControlSolution,andLinearitySolutionInformationintheMeter
81
Selecting a stored lot number as the current lot number
Youcanselectanystoredlotnumberasthecurrentlotnumber.
Main Menu
Review Results
Control Test
Patient Test
12:48 pm
09/18/13
Main Menu 2
Maintenance
Strip Lots
Profi ciency
Control Lots
Beeper
Linearity
Diagnostics
Linearity Lots
Admin.
12:48 pm
09/18/13
Linearity Lots
Add
* Lin. 11/21/13 77767812/31/13 77773211/21/13 777723
Lin.Lin.
Type Exp. Date Lot Num.12:48 pm
09/18/13
1 Touch inthemainmenutoopentheMain Menu 2screen.
2 TouchLinearity Lots toopentherelatedmenu.Thecurrentlinearitylotnumberisindicatedbyanasterisk(*).
StoringTestStrip,ControlSolution,andLinearitySolutionInformationintheMeter
82
Linear. Lot Details
Edit Delete
Linearity Lot: 777732Use by 12/31/13Current
12:48 pm
09/18/13
Linearity Lots
Add
* Lin. 11/21/13 77767812/31/13 77773211/21/13 777723
Lin.Lin.
Type Exp. Date Lot Num.12:48 pm
09/18/13
Linear. Lot Details
Edit Delete
Linearity Lot: 777732Use by 12/31/13
Make Current
12:48 pm
09/18/13
3 Touchthelinearitylotnumberyouwishtoselectasthecurrentlotnumber.Thisopenstherelateddetailview.
4 TouchMake Currenttomakethislotnumberthecurrentlotnumber.TheCurrentinformationisthenalsodisplayedinthedetailview.
5 Touch toreturntothelistoflotnumbers,or
6 Touch toreturntotheMain Menu.
LinearityTesting
83
7 LinearityTesting
Informationregardinglinearitytests
Observetheapplicableregulationsanddirectivesoftheresponsibleregulatoryagencieswhenperforminglinearitytests.Forinformationaboutsourcesforproductsrequiredduringlinearitytesting,callyourlocalRocherepresentativeorfortechnicalassistancecontactACCU-CHEKCustomerCare.
Linearitytestscanhelpyoutocheckthefunctionandaccuracyoftheentiresystemoverthefullrangeofspecifiedvalues.Linearitysamplesshouldbetreatedinexactlythesamemanneraspreviouslydescribedforcontrolsolutionsusedinglucosecontroltesting.
Theterm“Linearity”describestheabilityofthesystemtomaintainaconstantaccuracyoverthefullrangeofspecifiedvalues.Iftestresultswereplottedagainstreferencevaluesasacurveoverthefullrangeofthesevalues,theideal(highlinearity)wouldbeastraightline.Linearityistherangeofvaluesfromthelowesttothehighestforwhichaninstrumentisprovencapableofgivingaccurateresults.
Linearity testing intervalsThelinearityofthesystemshouldbecheckedbeforeitisusedthefirsttimeforpatienttesting.Theintervalsforsubsequentlinearitytestsaredeterminedbythefacilitythatoperatesthesystem.Linearitytestingcanalsoberunwhenyouwanttochecktheoverallperformanceofthesystem.
Note:Whenusingadatamanagementsystemforconfiguration,itispossibletopartiallyorfullydisablethefunctionsdescribedinthischapter.Inthiscase,therespectivebuttonsinMain Menu 2donotappear.(SeealsoAppendixA).
LinearityTesting
84
Information stored during linearity testing
Thefollowinginformationisstoredforeverylinearitytest:
n Testresult
n Lotnumberofthelinearitysolution
n Leveloflinearitysolution(L1toL6)
n OperatorID(ifconfigured)
n Lotnumberoftheteststrips
n Timeanddateoftest
n Comments(ifapplicable)
Linearity test kitThelinearitytestkitcontainsglucosesolutionsinsixlevels(6vials,2.5mLeach).Foradditionalinformationaboutthecontentsandhandlingofthekit,refertothepackageinsert.
Preparing to run a linearity testAsidefromspecialpreparations(seethefollowingsection),alinearitytestisrunthesameasapatienttest.Pleasecheckthefollowing:
n Atleastonecodefileforteststripsmustbestoredinthemeterandmatchthelotnumberoftheteststripsused(seeChapter6).
n Theproperteststripsmustbeavailable.
n AnoperatorIDmustbeentered(withpassword,ifapplicable),ifthemeterisconfiguredforlogin.
LinearityTesting
85
Performingalinearitytest
Overview of test procedureAlinearitytestcomprisesthefollowingsteps:
n Checkthelotnumberofthelinearitysolutions.
n Checkthelotnumberoftheteststrips.
n Performthetestwithaminimumofthreelinearitysolutions.
Starting a linearity testThefollowingdescriptionassumesthatthemeterispoweredonandthemainmenuisdisplayed.
Linearity Test
12345678?Use Linearity Lot
12:48 pm
09/18/13
Main Menu
Review Results
Control Test
Patient Test
12:48 pm
09/18/13
Main Menu 2
Maintenance
Strip Lots
Profi ciency
Control Lots
Beeper
Linearity
Diagnostics
Linearity Lots
Admin.
12:48 pm
09/18/13
1 Touch intheMain MenutoopentheMain Menu 2screen.
2 TouchLinearitytostartthelinearitytest.TheLinearity Testscreenopens.
LinearityTesting
86
Confirming or selecting the lot number for linearity test kits
Youarenowpromptedtoconfirmorenterthelotnumberofthelinearitytestkit.Comparethenumberdisplayedbythemetertothenumberonthelabelofthelinearitytestkit.
3 Ifyouwanttousethepreselectedlinearitylotnumberdisplayedbythemeter,touch toconfirm.Touseadifferentnumberthanthelotnumberdisplayed,touch toopenthekeypadandenterthenumbermanually(seepage79).
Confirming or selecting the test strip lot
Onceyouhaveenteredandconfirmedthelotnumberofthelinearitytestkit,youareaskedtochoosetheteststriplotnumber.Comparethenumberdisplayedbythemetertothenumberonthelabeloftheteststripvial.
4 Selecttheteststriplotnumberasfollows:Toreadtheteststriplotnumberfromtheteststripvialviabarcodescanner,pressandrelease .FollowtheinstructionsforscanningIDs.Tousethepreselectedteststriplotnumberdisplayedbythemeter,touch toconfirm.Touseadifferentnumberotherthanthelotnumberdisplayed,touch toopenthekeypadandenterthenumbermanually,ortodisplayalistofstoredlotnumbersandthenselectthedesiredlotnumberfromthelist.Touch toconfirmtheselectedteststriplotnumber
Linearity Test
12345678?Use Linearity Lot
12:48 pm
09/18/13
Linearity TestLinearity 12345678
Use Strip Lot
12:48 pm
09/18/13
123456?
LinearityTesting
87
IntheLinearity Testmenu,thelevelsavailableforthelinearitytestaredisplayed.
5 TouchL1tostartthesubsequenttestwiththis(first)level.
Inserting test stripsAfterselectingthelevel,aflashinggreenarrowappearsonscreenandpromptsyoutoinserttheteststrip.
Linearity TestLinearity 12345678 L1Strip Lot 545794
12:48 pm
09/18/13
1 Removetheteststripfromtheteststripvialandclosethevialagainwiththecap.
2 Holdtheteststripsothelettering“ACCU-CHEK”isfacingupward.
3 Slidetheteststripintotheteststripportasfarasitwillgointhedirectionindicatedbythearrowsontheteststrip.Themeterbeeps.Thehourglassiconappearsandindicatesthatthemeterischeckingtheteststrip.Donotapplylinearitysolutionwhileitisdisplayed.
Linearity Test
L1
L5
L3
L6
L4
L2
Linearity 12345678Strip Lot 545794
12:48 pm
09/18/13
Linearity TestLinearity 12345678 L1Strip Lot 545794
12:48 pm
09/18/13
LinearityTesting
88
Applying a linearity test sampleOncethemeterhascheckedtheteststrip,thehourglassicondisappearsandyouarepromptedtoapplylinearitysolution.
Linearity TestLinearity 12345678 L1Strip Lot 545794
12:48 pm
09/18/13
1 Waituntiltheflashingdropappearsinthedisplaybeforeapplyingthesolution.Themeterbeeps.
2 Applyadropofthelinearitysolutiontothefrontedgeoftheteststrip.Donotapplythesolutiontothetopofthestrip.Thelinearitysolutionispulledintotheteststripareabycapillaryaction.
Oncesufficientlinearitysolutionhasbeendetected,themeterbeepsandthemeasurementbegins.
LinearityTesting
89
Results screenThehourglassiconindicatesthetestisrunning.Whenthetestiscompletedandtheresultisready,themeterbeepsagain.
Linearity Test
45
Linearity 12345678 L1Date 09/18/13 12:48 pm
mg/dL
12:48 pm
09/18/13
Linearity TestLinearity 12345678 L1Strip Lot 545794
12:48 pm
09/18/13
Linearity Test
L1
L5
L3
L6
L4
L2
Linearity 12345678Strip Lot 545794
12:48 pm
09/18/13
Youcanaddcommentstoatestresult(aswithbloodglucosetests,seepage52).
Ifyoudonotwishtoaddacommenttothetestresult,touch tocontinuetothenextlevelofthelinearitytest.
Removetheteststripanddisposeofitinaccordancewithapplicableregulationsanddirectives.Repeattheabovestepsforalllevelsofthelinearitytest.
Testresultsarealsosavedwhenthemeterispoweredoffintheresultsscreenorwhenitautomaticallypowersoff.
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ProficiencyTesting
91
8 ProficiencyTesting
Informationregardingproficiencytests
Observetheapplicableregulationsanddirectivesoftheresponsibleregulatoryagencieswhenperformingproficiencytests.
Bloodglucoseproficiencytestsarerunonsampleswhosevaluesareunknowntotheoperatorperformingthetest.Thesesamplesareprovidedbyanoutsidesource,andtheresultsshouldbeforwardedtotheappropriatesourceaftercompletingthetest.Thesuppliedsamplesaretreatedinthesamemannerasregularpatientsamples.
Bloodglucoseproficiencytestingprovidesanothermeanstoverifythatyourtechnique,reagents,system,andtestingperformanceareastheyshouldbe.Someregulatoryagenciesrequirethattheseproficiencysamplesbetestedaspartofaninstitution’squalityassuranceprogrambeforecertificationoftheinstitutionisallowed.
Note:Whenusingadatamanagementsystemforconfiguration,itispossibletopartiallyorfullydisablethefunctionsdescribedinthischapter.Inthiscase,therespectivebuttonsinMain Menu 2donotappear.(SeealsoAppendixA).
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92
Information stored during proficiency testing
Thefollowinginformationisstoredforeveryproficiencytest:
n Testresult
n SampleID
n Lotnumberoftheteststrips
n Timeanddateoftest
n Comments(ifapplicable)
n OperatorID(ifconfigured)
Forbloodglucoseproficiencytests,thesampleID(insteadofpatientID)mustbestoredasidentification.SampleIDswithupto20characterscanbeentered.
Preparing a proficiency testToperformaproficiencytestyouneedthefollowing:
n Atleastonecodefileforteststripsmustbestoredinthemeterandmatchthelotnumberoftheteststripsused(seeChapter6).
n Theproperteststripsmustbeavailable.
n AnoperatorIDmustbeentered(withpassword,ifapplicable),ifthemeterisconfiguredforlogin.
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93
Performingaproficiencytest
Overview of test procedureAproficiencytestcomprisesthefollowingsteps:
n EnterasampleIDfortheproficiencysample.
n Checkthelotnumberoftheteststrips.
n Performtheactualtestwiththeproficiencysample.
Starting a proficiency testThefollowingdescriptionassumesthatthemeterispoweredonandthemainmenuisdisplayed.
Main Menu
Review Results
Control Test
Patient Test
12:48 pm
09/18/13
Main Menu 2
Maintenance
Strip Lots
Profi ciency
Control Lots
Beeper
Linearity
Diagnostics
Linearity Lots
Admin.
12:48 pm
09/18/13
1 Touch intheMain MenutoopentheMain Menu 2screen.
2 TouchProficiencytostarttheproficiencytest.
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94
Entering the proficiency sample ID
YouwillnowbeaskedtoenterthesampleID.
1 UsethekeypadtomanuallyenterthesampleID,orpressandrelease toreadthesampleIDfromthesamplevialviabarcodescanner.Makesureinthiscasethattheproficiencysamplehasacompatiblebarcode(seeAppendixA).
2 Touch toconfirmtheselectedorscannedsampleID.
Confirming or selecting the test strip lot
OnceyouhaveenteredandconfirmedthesampleID,youwillbeaskedtochoosetheteststriplotnumber.Comparethenumberdisplayedbythemetertothenumberonthelabeloftheteststripvial.
3 Ifyouwanttousethepreselectednumberdisplayedbythemeter,touch toconfirm.Touseadifferentnumberthanthelotnumberdisplayed,touch toselectthenumberfromalist,enterthenumbermanuallyviakeypad,orusethebarcodescannertoenterthelotnumber.
1 2 3
4 5 6
7 8 9
A-O0
Sample ID 12:48 pm
09/18/13
Profi ciency TestSample 123456789
Use Strip Lot
12:48 pm
09/18/13
123456?
ProficiencyTesting
95
Inserting test stripsAfterconfirmingtheteststriplot,aflashinggreenarrowappearsonscreenandpromptsyoutoinserttheteststrip.
Proficiency TestSample 123456789Strip Lot 545794
12:48 pm
09/18/13
1 Removetheteststripfromtheteststripvialandclosethevialwiththecap.
2 Holdtheteststripsothelettering“ACCU-CHEK”isfacingupward.
3 Slidetheteststripintotheteststripportasfarasitwillgointhedirectionindicatedbythearrowsontheteststrip.Themeterbeeps.Thehourglassiconappearsandindicatesthatthemeterischeckingtheteststrip.Donotapplytheproficiencysamplewhileitisdisplayed.
Profi ciency TestSample 123456789Strip Lot 545794
12:48 pm
09/18/13
ProficiencyTesting
96
Applying a proficiency sampleOncethemeterhascheckedtheteststrip,thehourglassicondisappearsandyouarepromptedtoapplytheproficiencysample.
Proficiency Test Sample 123456789Strip Lot 545794
12:48 pm
09/18/13
1 Waituntiltheflashingdropappearsinthedisplaybeforeapplyingthesample.Themeterbeeps.
2 Applyadropofsampletothefrontedgeoftheteststrip.Donotapplythesampletothetopoftheteststrip.Thesampleispulledintotheteststripareabycapillaryaction.
Oncesufficientsamplehasbeendetected,themeterbeepsandthemeasurementbegins.
ProficiencyTesting
97
Results screenThehourglassiconindicatesthetestisrunning.Whenthetestiscompletedandtheresultisready,themeterbeepsagain.
Profi ciency Test
HI
Sample 123456789Date 09/18/13 12:48 pm
09/18/13
12:48 pmProfi ciency Test
150
Sample 123456789Date 09/18/13 12:48 pm
mg/dL
09/18/13
12:48 pm Profi ciency Test
LO
Sample 123456789Date 09/18/13 12:48 pm
09/18/13
12:48 pm
Theresultisdisplayedasanumericalvalue,unlessitfallsoutsidethesystemmeasurementrange.Inthiscase,themessageHIorLOisdisplayed.
Youcanaddcommentstoatestresult(aswithbloodglucosetests)(seepage52).
Ifyoudonotwishtoaddacommenttothetestresults,touch tocompletethetestandstoretheresult.
Testresultsarealsosavedwhenthemeterispoweredoffintheresultsscreenorwhenitautomaticallypowersoff.
Removetheteststripanddisposeofitinaccordancewithapplicableregulationsanddirectivesfordisposalofpotentiallyinfectioussamplesandmaterials.
ProficiencyTesting
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InitialStartup
99
9 InitialStartup
Connectingthebaseunit
NOTICE Toensurecontinuoussafeandreliableoperation,useonlythepowersupplyunitprovidedfortheACCU-CHEKInformIIsystem(fororderinginformationseepage145).
1 Slidethebaseunitupwardandremoveitfromthewallmount(ifinuse).
2 Connectthepowercordtotheproperoutlet.
3 IfyouwanttoconnecttheACCU-CHEKInformIIBaseUnitinawiredenvironment:ConnecttheEthernet(RJ45)cableortheUSBcabletotherespectiveoutlet.UseonlytheUSBcableprovidedwiththeACCU-CHEKInformIIsystem.
4 Slidethebaseunitbackontothewallmount(ifinuse).
FordetailsonconfiguringtheACCU-CHEKInformIIBaseUnit,consultyourRocherepresentativeorfortechnicalassistancecontactACCU-CHEKCustomerCare.
InitialStartup
100
Installingorreplacingthebatterypack
Whenshipped,thebatterypackisnotinstalledintheACCU-CHEKInformIImeter.
Afterinstallinganewbatterypack,themetershouldbechargedfortwohoursinthebaseunitbeforetesting.
Wheneverthemeterisinthebaseunit,the iconisdisplayed.Thisiconshowsthatpowerisavailableandthemetercancharge,ifnecessary.
Makesurethattheallowabletemperaturerangeforchargingthebatterypack(37-104°For3-40°C)ismaintainedduringinstallationandinitialsetup.
Replacethebatterypackwithinapproximately10minutestoretainthedateandtimesettings.Beyondthisperiodoftime,youmayhavetore-enterthedateandtime,oryoumayreturnthemetertothebaseunittoobtainthecorrectdateandtime.
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101
Removing the battery pack1 Ifabatterypackisalreadyinstalled,makesurethat
themeterispoweredoff.
2 Placethemeterfacedownonalevelsurface.
3 UsingaTorxscrewdriversizeT5,removethethreescrewsholdingthebatterycompartmentcoverinplace.
4 Removethebatterycompartmentcoverfromthemeter.Thebatterypacknowvisibleisconnectedtothemeterbyaplug.
5 Carefullyliftthebatterypackandremovetheplugconnector.
DisposalofusedbatteriesDonotdisposeofthebatterieswithnormaldomesticwaste.Disposeofusedbatteriesinaccordancewithapplicablelocalregulationsanddirectivesandyourfacility’sguidelinesonthedisposalofelectronicwasteequipment.
InitialStartup
102
Installing the battery pack1 Loosenthescrewsonthebatterycompartment
coveruntiltheyareprotrudingabout2/10inch.
2 Holdthebatterypackinyourhand,withthewiresandtheplugpinchedbetweenyourthumbandindexfinger.
3 Plugtheconnectorplugintothesocket.
4 Placethebatterypackinsidethebatterycompartmentasshownabove.
Topositionthebatterypackcorrectly,alwaysaligntheridgesonthesideofthebatterypackwiththeridgesontheinsideofthebatterycompartment.
InitialStartup
103
5 Closethebatterycompartmentwiththecover.
6 Tightenallthreescrewsuntilsnug(donotovertighten).
Afterinsertinganewbatterypack,themeterpowersonautomatically.
n TheRochelogoisdisplayed.Ifthemeterdoesnotpoweronautomatically,thebatterypackmaybenearlyempty.Placethemeterinabaseunitforaminimumof15minutes,thenremovethemeterandtrytopoweriton.Ifitpowerson,thebatterypackischargingproperly.
n Withinashortperiodoftime,thestartscreenshouldappear.
n Ifthemeterhasbeenwithoutpowerfortoolong,amessagemayappearinformingyouthatthedateandtimesettingshavebeenlostduetopowerloss.
n Thescreensforenteringthedateandthetimeappear.
7 Enterthedateandtime.Afteryouhaveenteredthecorrectinformation,confirmeachscreenwith
n UnlessyourQCconfigurationisAlwaysOK,themeterwillnowbeinQCLockoutduetothemanuallyentereddate/time.
8 Synchronizethemeter’sdate/timewiththedate/timeofyourfacilityviabaseunitor,ifworkingwirelessly,waitatleast10minutesforthenextWLANsynchronizationbeforeperforminganyfurthertests.
Afterinstallinganewbatterypack,themetershouldbechargedforthreehoursinthebaseunitbeforetesting.
1 2 3
4 5 6
7 8 9
0
Date
09/18/13
09/30/13
12:48 pm
1 2 3
4 5 6
7 8 9
AM/PM0
Time 12:48 pm
09/18/13
12:15 pm
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104
Dockingthemeter
Dockingthemeterinthebaseunitallowsyoutochargethebattery.Whendocked,themetershowsdifferentmessagesaccordingtothecurrentmeterstatus.
ThefollowingdisplaysappearonthemeterwhenitisdockedinanACCU-CHEKInformIIBaseUnitoranACCU-CHEKInformIIBaseUnitLightandcommunicating.Thesamedisplaysappearwhetherthemeteristransferringdataviabaseunitorviawirelessconnection.
Docked
Connecting...
12:48 pm
09/18/13
Docked
Synchronizing Database...
12:48 pm
09/18/13
Docked
Transferring...50 Results to Transmit
12:48 pm
09/18/13
InitialStartup
105
ThisdisplayisvisiblewhencommunicationisstillactivebutthemeterisbusyprocessingthedatareceivedorwaitingforthenextdatamessagefromtheDataManagementSystem(DMS).
Thisdisplayisvisiblewhensoftwareupdatesaretransferredtothemeter.
Thisdisplayisvisiblewhensoftwareupdatesaretransferredtothemeter.
Note:
n Ifthemetertransfersdatawirelesslyimmediatelyafteratest,thiscommunicationisnotvisibleonthedisplay.Thedisplayremainsunchanged(usuallyintheMain Menuviewafteratest).
n Ifameterisinstandby(butnotdocked)andcommunicatingwirelessly,thiscommunicationisnotvisibleonthedisplay.
Docked
Busy...
12:48 pm
09/18/13
Docked
Idle
12:48 pm
09/18/13
Docked
Updating Software...
12:48 pm
09/18/13
InitialStartup
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Initialsetuponthemeter
Therearetwowaystocustomizethesetupofthemeter:directlyonthemeter(seethefollowingmenuoverview)orviathedatamanagementsystem(seeAppendixA).Thetwomethodsdifferaccordingtotherangeofoptionsavailable.
Ifthemeterisconfiguredbyasystemadministratorusingadatamanagementsystem,theconfigurationoptionsonthemetermaybedisabledtoavoidconflictsinthesettings.Theseoptionsthenappeargrayedoutonthedisplay.
Themeterisdeliveredwithpreconfigureddefaultsettings.Thefollowingsettingscanbeconfiguredonthemeter:
n Dateandtimeformat
n Dateandtimeeditingenabled
n Units
n Testtypes
n Lotinformationeditingenabled
n Methodsforverifyinglotinformation
n Enablebarcodescanner
n Normal,critical,andreportableranges
n OperatorIDoptions
n PatientIDoptions
n SettingsforglucosecontrolsandQCLockout
n Beeper
InitialStartup
107
Menu overviewThefollowingtablescontainabriefoverviewofthemenustructure.Themenuscanbeusedtooperatethemeterfullyandenterthemostimportantbasicsettings.
MainMenu
ObserverLogin – EnterObserverID– EnterObserverPassword
PatientTest – EnterPatientID– VerifyTestStripLot– InsertTestStrip– ApplyBloodSample– ViewTestResults– AddComments
ControlTest – SelectLevel– VerifyControlLot– VerifyTestStripLot– InsertTestStrip– ApplyControlSolution– ViewTestResults– AddComments
ReviewResults – ViewAllTestResults
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108
MainMenu2
Maintenance – AddComment– MaintenanceResult
Proficiency – EnterSampleID– VerifyTestStripLot– InsertTestStrip– ApplySample– ViewTestResults– AddComments
StripLots – ViewLotList– AddLot– EnterExpirationDate– SetControlRanges– ViewLotDetails– MakeLotCurrent– Edit/DeleteLot
ControlLots – ViewLotList– SelectControlLevel– AddLot– EnterExpirationDate– MakeLotCurrent– Edit/DeleteLot
LinearityLots – ViewLotList– AddLot– EnterExpirationDate– MakeLotCurrent– Edit/DeleteLot
Linearity – VerifyLinearityLot– VerifyTestStripLot– SelectLinearityLevel– InsertTestStrip– ApplyLinearitySolution– ViewTestResults– AddComments
Beeper – SetBeeperVolume
Diagnostics – ListSoftwareVersions– TestBarcodeScanner– MeterEventsLog– Statistics– Configuration– Ranges– WirelessSetup– WirelessStatus– WirelessTest
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109
AdminMenu
Admin – Language– Date/Time– Setup
Language – German– French– Spanish– Italian– Dutch– Swedish– English– Danish– Portuguese
Date/Time – EnterCurrentDate– EnterCurrentTime
SetupMenu
Date/TimeOptions – Date/TimeEditing– TimeFormat– DateFormat
TestDisplayOptions – ResultUnit– EnableTests– NumberofSTATTests(if
enabled)
ReagentOptions – ReagentEditing– LotVerificationMode
QCFrequency – ControlFrequency
TestRanges – Normal– Critical– Reportable
OperatorIDEntry – OperatorEntry– OperatorValidation– Barcode
PatientID – PatientEntry– PatientValidation– Barcode
SetupPassword – ChangeSetupPassword
DeletePatient – Deleteallpatient-relateddata(patientlist&results)
Touch toconfirmandsaveanychangestothesettings.
InitialStartup
110
OpeningtheSetupMenu
Thefollowingdescriptionassumesthatthemeterispoweredonandthemainmenuisdisplayed.AllsettingsdescribedhereareconfiguredviatheSetup Menu.ToopentheSetup Menu,proceedasfollows:
Main Menu 2
Maintenance
Strip Lots
Profi ciency
Control Lots
Beeper
Linearity
Diagnostics
Linearity Lots
Admin.
12:48 pm
09/18/13
Admin Menu
Date / Time
Language Selection
Setup Menu
12:48 pm
09/18/13
Setup Menu
Date / Time
QC
Test Display
Password
Test Ranges
Reagents
Operator ID Patient ID
Unlock Delete Pat.
12:48 pm
09/18/13
1 Touch intheMain MenutoopentheMain Menu 2screen.
2 TouchAdmin.toopentheAdmin Menu.
3 TouchSetup MenutoopentheSetup Menu.
4 EntertheSetuppasswordifrequested.
InitialStartup
111
Dateandtimeformat
Usethismenutoselectthedateandtimeformatforthedisplay.Youcanalsochoosewhethertheoperatorisallowedtoeditdateandtime(optionallywithpasswordrequired).
1 Touchthedesiredoptiontoenableit:
n Date/TimeEditing
– Allowed:Enablestheoperatortoeditthedateandtime
– Password Needed:Enablestheoperatortoeditthedateandtimeonlyafterenteringapassword
n TimeFormat
– 12 hour (AM/PM)
– 24 hour
n DateFormat
– mm/dd/yy:Thedateisdisplayedintwo-digitmonth/day/yearformat
– dd.mm.yy:Thedateisdisplayedintwo-digitday/month/yearformat
2 Touch tosavethesettings,or
3 Touch toexitthismenuwithoutsavinganychanges.
ThedisplayreturnsinbothcasestotheSetup Menu.
Whenusingadatamanagementsystemforconfiguration,itispossibletofullydisabletheDate/Time Editingoption.
Date/Time Options
Date/Time EditingAllowedPassword Needed
Time Format12 hour (AM / PM)24 hour
Date Formatmm/dd/yydd.mm.yy
Not Allowed
12:48 pm
09/18/13
InitialStartup
112
Displayoptionsandoptionaltests
Usethismenutoselecttheunitofmeasurefortestresultsandenableordisableoptionaltests.
1 Touchthedesiredoptiontoenableit:
n ResultUnits
– mg/dL
– mmol/L
n EnableTests
– STAT:STATtestsmaybeperformed.Whenthisoptionisenabled,youmustenterthenumberofSTATtestsallowed(afterconfirmingthesettings).
– Linearity isdisplayedintheMain Menu 2screen
– Proficiency isdisplayedintheMain Menu 2screen
– Maintenance isdisplayedintheMain Menu 2screen
2 Touch tosavethesettings.IftheSTAToptionisenabled,enterthenumberofSTATtestsallowed,or:
3 Touch toexitthismenuwithoutsavinganychanges.
ThedisplayreturnsinbothcasestotheSetup Menu(afterenteringthenumberofSTATtestsallowed).
Test Disp. Options
mg/dLmmol/L
Enable Tests:StatLinearityProfi ciencyMaintenance
Display Strip LimitationsWarning
Result Units
12:48 pm
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1 2 3
4 5 6
7 8 9
0
STAT Test Allowed
8
12:48 pm
09/18/13
InitialStartup
113
Optionsforteststrips
Thismenuallowsyoutoselectoptionsforhandlinglotnumbersandspecifywhethertheoperatorisallowedtoaddordeletereagentlots,edittheexpirationdateandlimitvaluesonthemeter(optionallywithpasswordrequired).
1 Touchthedesiredoptiontoenableit:
n ReagentEditing
– Allowed:Enablestheoperatortoeditthereagentinformationwithoutneedingapassword
– Password Needed:Enablestheoperatortoeditthereagentinformationonlyafterenteringapassword
n StripLotVerification
– Display only:Thelotnumberisshownon-screenbuttheoperatorcannotconfirmitorselectadifferentlotnumber.
– Confirmation:Theoperatormustconfirmthelotnumberdisplayedandcanenteralternativelotnumbersmanuallyorviabarcodescanner.
– List selection:Theoperatorcanalsoselectfromalistofstoredlotnumbers.
– Scan only:Lotnumberscanbeverifiedviabarcodescanneronly.
2 Touch tochangetothesecondscreenofoptions,or
3 Touch toexitthismenuwithoutsavinganychanges.
Whenusingadatamanagementsystemforconfiguration,itispossibletofullydisabletheReagent Editingoption.
Reagent Options
AllowedPassword Needed
Display onlyConfi rmationList selectionScan only
Reagent Editing
Strip Lot Verifi cationNot Allowed
12:48 pm
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InitialStartup
114
Onthesecondsettingsscreen,youcanselectoptionsforhandlinglotnumberswithglucosecontrolandlinearitytests.
1 Touchthedesiredoptiontoenableit:
n ControlLotVerification
– Display only:Thelotnumberisshownon-screenbuttheoperatorcannotconfirmitorselectadifferentlotnumber.
– Confirmation:Theoperatormustconfirmthelotnumberdisplayedandcanenteralternativelotnumbersmanuallyorviabarcodescanner.
– Lot entry:Theoperatormustenterthelotnumber.
– Scan only:Lotnumberscanbeverifiedviabarcodescanneronly.
n LinearityLotVerification
– Display only:Thelotnumberisshownon-screenbuttheoperatorcannotconfirmitorselectadifferentlotnumber.
– Confirmation:Theoperatormustconfirmthelotnumberdisplayedandcanenteralternativelotnumbersmanuallyorviabarcodescanner.
– Lot entry:Theoperatormustenterthelotnumber.
2 Touch tosavethesettings(forbothsettingsscreens),or
3 Touch toreturntothefirstsettingsscreen.
Reagent Options
Control Lot Verifi cation
Confi rmationDisplay only
Scan onlyLinearity Lot Verifi cation
Display onlyConfi rmation
Lot entry
Lot entry
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115
Optionsforglucosecontroltests
Thismenucontainsoptionsthatallowyoutospecifywhetherandatwhatintervalsglucosecontroltestsareperformed.Ifyourequirecontroltests,checkyoursettingsforSTATtests(seepage112).
1 Touchthedesiredoptiontoenableit:
n ControlFrequency
– Always OK:QCLockoutisdisabled,patienttestscanbeperformedatanytime.Thisappliesregardlessoftheresultofrunningglucosecontroltests.
– Last QC OK:QCLockoutisactivatedonlywhenthelastglucosecontroltestisoutofrangeoracontroltestisnotavailable(e.g.,whenchangingtheteststriplot).
– Hours:QCLockoutisactivatedafterthespecifiedtime.Whenaglucosecontroltestisrunsuccessfully,thecounterisresetto“0”.
– Strip Count:QCLockoutisactivatedafterreachingthespecifiednumberoftests.Whenaglucosecontroltestisrunsuccessfully,theteststripcounterisresetto“0”.
– Shift:QCLockoutisactivatedpershift.
– Time Of Day:QCLockoutisactivatedatthespecifiedtimeofday.(Uptosixtimesperdaycanbeconfigured.)
– Rotating QC:QCtestsrequirealternatinguseofL1andL2controls,insteadofrequiringbothcontrolswhenperformingaQCtest.
2 Touch tosavethesettings.IftheHoursorStrip Countoptionisenabled,enterthedesirednumber,or:
3 Touch toexitthismenuwithoutsavinganychanges.
ThedisplayreturnsinbothcasestotheSetup Menu.
QC Frequency
Control Frequency
Last QC OKAlways OK
Strip CountHours
Rotating QC
ShiftTime Of Day
12:48 pm
09/18/13
1 2 3
4 5 6
7 8 9
0
QC Hours
50
12:48 pm
09/18/13
1 2 3
4 5 6
7 8 9
0
QC Strips
50
12:48 pm
09/18/13
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116
Valueranges(normal,critical,reportable)
ThismenuallowsyoutosetlimitvaluesforresultsasNormal,Critical,orReportable.Resultsoutsidetheselimitswillbeflaggedtoalertyouofthisevent.TheReportable Rangeallowsthesystemadministratortosetaninstitutiondefinedrangeforreportingpatientresults.
1 2 3
4 5 6
7 8 9
0
Report. Range Lo
11 mg/dL
12:48 pm
09/18/13
1 2 3
4 5 6
7 8 9
0
Normal Range Lo
70 mg/dL
12:48 pm
09/18/13
1 2 3
4 5 6
7 8 9
0
Critical Range Lo
40 mg/dL
12:48 pm
09/18/13
1 2 3
4 5 6
7 8 9
0
Report. Range Hi
600 mg/dL
12:48 pm
09/18/13
1 2 3
4 5 6
7 8 9
0
Normal Range Hi
200 mg/dL
12:48 pm
09/18/13
1 2 3
4 5 6
7 8 9
0
Critical Range Hi
301 mg/dL
12:48 pm
09/18/13
Valuesforrangelimitsareenteredonedirectlyaftertheotherinthefollowingorder:
n Normal(low/highlimitvalue)
n Critical(low/highlimitvalue)
n Reportable(low/highlimitvalue)
1 Usethekeypadtoenterthefirstvalue.
2 Touch toenterthefollowingvalue,or
3 Touch toreturntothepreviousview.
4 Afterenteringthelastvalue,touch tosavealltheprevioussettings.
InitialStartup
117
OptionsforOperatorIDEntry
Thismenuallowsyoutospecifyifandhowoperatorloginisperformed.
1 Touchthedesiredoptiontoenableit:
n OperatorEntry
– None:Themetercanbeusedwithoutoperatorlogin.
– Prompt or Prompt (numeric only):Operatorloginisrequired.TheOperatorIDcanbeenteredmanuallyviakeypadorviabarcodescanner.
– Scan only:Operatorloginisrequired.EntryofIDviabarcodescanneronly.
n OperatorValidation
– None:TheoperatorIDcanhaveanylength.
– Length:TheoperatorIDmustbeaspecifiedlength(upto20characters).Entertheminimumandmaximumlengthsafterselectingthisoption.
– List:TheoperatorIDmustbeonalistreceivedfromtheDMS.
– List with password:TheoperatorIDmustbeonalistreceivedfromthedatamanagementsystem(DMS).Additionally,apasswordmustbeentered.
2 Touch tosavethesettings.IftheLengthoptionisenabled,enterthedesirednumbers,or:
3 Touch toexitthismenuwithoutsavinganychanges.
ThedisplayreturnsinbothcasestotheSetup Menu.
Operator ID Entry
PromptNone
Length
Scan only
None
Operator Entry
Operator ValidationPrompt (numeric only)
ListList with password
12:48 pm
09/18/13
1 2 3
4 5 6
7 8 9
0
Op. ID Min Length
8
12:48 pm
09/18/13
1 2 3
4 5 6
7 8 9
0
Op. ID Max Length
12
12:48 pm
09/18/13
InitialStartup
118
PatientIDoptions
ThismenuallowsyoutospecifythecriteriaforenteringapatientID.
1 Touchthedesiredoptiontoenableit:
n PatientEntry
– Prompt or Prompt (numeric only):ThePatientIDcanbeenteredmanuallyviakeypadorviabarcodescanner.
– Scan only:EnterofIDviabarcodescanneronly.
– Prompt or List:ThePatientIDcanbeenteredmanuallyviakeypadorviabarcodescanner,orcanbepickedfromalistreceivedfromtheDMS.
n PatientValidation
– None:ThepatientIDcanhaveanylength.
– Length:ThepatientIDmustbeaspecifiedlength(upto20characters).Entertheminimumandmaximumlengthsafterselectingthisoption.
– Length if numeric:OnlynumericpatientIDsarevalidatedfortheirlength.AlphabeticpatientIDsarenotvalidated.
– List - must be on list:ThepatientIDmustbeonalistreceivedfromtheDMS.
– List - allowed to add new:ThepatientIDwillbecheckedagainstalistreceivedfromtheDMS.However,itisallowedtocreateanewpatientIDusingthemeter.
2 Touch tosavethesettings.IftheLengthoptionisenabled,enterthedesirednumbers,or:
3 Touch toexitthismenuwithoutsavinganychanges.
ThedisplayalwaysreturnstotheSetup Menu(afterenteringthedesirednumbers).
Patient ID Options
Scan onlyPrompt (numeric only)
Patient EntryPrompt
12:48 pm
09/18/13
Prompt or List
1 2 3
4 5 6
7 8 9
0
Pat. ID Min Length
8
12:48 pm
09/18/13
1 2 3
4 5 6
7 8 9
0
Pat. ID Max Length
12
12:48 pm
09/18/13
Patient ID Options
LengthNone
Patient Validation
Length if numeric
12:48 pm
09/18/13
List - allowed to add newList - must be on list
InitialStartup
119
Creatingasetuppassword
Thisscreenallowsyoutocreateapasswordforallthesettingsdescribedinthischapter,aswellasforeditingdate/timeandlotinformation(ifpasswordprotected).Thesetuppasswordensuresthatonlyauthorizedpersonscanmakechangestothesetup.
Pleasenotethatpasswordprotectioncanonlyberesetormodifiedafterenteringthecurrentpassword.ProperauthenticationisrequiredtoaccesstheSetup Menu.Storeyourpasswordinasafeplace.
1 Usethekeypadtoenterthepassword.
2 Touch tosavethepasswordandenablepasswordprotection.(Passwordprotectionwilltakeeffectonlyafterthenextpoweron.)ThedisplayreturnstotheSetup Menu,or:
3 Touch toexitthisscreenwithoutsavinganychanges.ThedisplayreturnstotheMain Menu.
Todisablepasswordprotection:
1 OpentheSetup Menu(youmustenterthecurrentpassword).
2 TouchPassword.
3 Deletethecurrentpasswordbytouching .
4 Touch todisablepasswordprotection.
1 2 3
4 5 6
7 8 9
A-O0
Setup Password 12:48 pm
09/18/13
InitialStartup
120
Settingthedateandtime
Thissettingcanbehiddenorrequireentryofthesetuppassword,basedonconfiguration.
Main Menu
Review Results
Control Test
Patient Test
12:48 pm
09/18/13
Main Menu 2
Maintenance
Strip Lots
Profi ciency
Control Lots
Beeper
Linearity
Diagnostics
Linearity Lots
Admin.
12:48 pm
09/18/13
Admin Menu
Date / Time
Language Selection
Setup Menu
12:48 pm
09/18/13
1 Touch intheMain MenutoopentheMain Menu 2screen.
2 TouchAdmin.toopentheAdmin Menu.
3 TouchDate/Timetobeginenteringthedate.
1 2 3
4 5 6
7 8 9
0
Date
09/18/13
09/30/13
12:48 pm
1 2 3
4 5 6
7 8 9
AM/PM0
Time 12:48 pm
09/18/13
12:15 pm
Admin Menu
Date / Time
Language Selection
Setup Menu
12:15 pm
09/18/13
4 Enterthedatefirst,thentime(allvaluesaretwo-digitwithaleadingzero,ifnecessary)bytouching .
Ifthetimeformatis“12h”,toucham/pmtoselectthecorrecttime.
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121
Beeperoptions
Thissettingcanbeusedtosetthevolumeofthebeeper.
Main Menu
Review Results
Control Test
Patient Test
12:48 pm
09/18/13
Main Menu 2
Maintenance
Strip Lots
Profi ciency
Control Lots
Beeper
Linearity
Diagnostics
Linearity Lots
Admin.
12:48 pm
09/18/13
Beeper Setup
Medium
Low
High
Beeper Volume:12:48 pm
09/18/13
1 Touch intheMain MenutoopentheMain Menu 2screen.
2 TouchBeepertosetthevolume.
3 Touchthebuttonwiththedesiredvolume.Whenyoutouchabutton,themeterwillbeepatthecorrespondingvolume.
4 Touch tosavethesettingandreturntotheMain Menu 2screen.
MaintenanceandCare
122
10 MaintenanceandCare
Conditionsforstorageandshipping
Allinformationgivenonmaintenanceandcareofthe“baseunit”inthischapterappliestoboththeACCU-CHEKInformIIBaseUnitandtheACCU-CHEKInformIIBaseUnitLight.
General operating conditionsPleaseobservethefollowingpointstoensurethereliableoperationofyoursystemoverthelongterm:
n Handlethemeteranditssystemcomponentscarefully.Avoiddroppingitorbangingit.
n Protectthebaseunitfromdrippingliquid.
n Donotimmersethemeterorbaseunitinanyliquid.
n Followtheinstructionsforcleaninganddisinfecting,beginningonpage123.
Observethefollowingsafetyinformationtoensurethesystemfunctionsproperly.Improperhandlingcanleadtoerroneoustestresults.
n Donotexposethemetertoexcessivesourcesofheatforprolongedperiodsoftimewhenperformingatest.Potentialsourcesofheatcanbe,butarenotlimitedto:
– Leavingthemeterunderabilirubinlightorphototherapylight
– Leavingthemeteronabedwarmer
– Leavingthemeterinanisolette
SeeChapter12foroperatingandstoragetemperatureranges.
MaintenanceandCare
123
Storagen Storethesystemandteststripsinthesame
environmentinwhichtheyareused.
n Donotstorethemeterindirectsunlightorunderextremetemperatureconditions.
n Observethelimitsfortemperatureandhumiditywhenstoringandusingthemeter(seeChapter12).
CleaninganddisinfectingtheACCU-CHEKInformIIsystem
Cleaninganddisinfectingtheexteriorsurfaceofthemeteris,atminimum,recommendeddailyfordedicatedpatientdevices.Metersusedwithmultiplepatientsmayrequiremorefrequentcleaninganddisinfecting.FollowrecommendationsfromtheFDA,CDC,andCMCandyourfacility’spoliciesandproceduresforinfectioncontrol.1,2
TheFDArecommendsthatPointofCaretestingdevices,suchasbloodglucosemeters,shouldbeusedonlyononepatientandnotshared.Ifdedicatingbloodglucosemeterstoasinglepatientisnotpossible,themetersmustbeproperlycleanedanddisinfectedaftereveryusefollowingtheguidelinesgiveninthissection.3
Fortechnicalassistanceorquestionsoncleaninganddisinfecting,pleasecontactACCU-CHEKCustomerCareat1-800-440-3638.
1 FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication,(2010).http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm
2 CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens,(2010).http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html
3 Healthcare Infection Control Practices Advisory Committee (HICPAC), William A. Rutala, Ph.D., M.P.H., and David J. Weber, M.D., M.P.H. Centers for Disease Control and Prevention, 2008. Guideline for Disinfection and Sterilization in Healthcare Facilities. Atlanta, GA.
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124
GuidetocleaninganddisinfectingtheACCU-CHEKInformIIsystem
Priortocleaninganddisinfectingabloodglucosetestingequipment:
1. Followtheinfectioncontrolproceduresofyourinstitutionwhenhandlingbloodglucosetestingequipment
2. Weargloves3. Thegloveswornduringcleaninganddisinfectingshouldbe
removedandhandswashedthoroughlywithsoapandwaterbeforeperformingthenextpatienttest
Cleaninganddisinfectingthemeter
nCleanthemetertoremovevisiblesoilandorganicmaterialpriortodisinfecting.3
nDisinfectthemetertodestroypathogenicandothertypesofmicroorganisms.Disinfectiondestroysmostrecognizedpathogenicmicroorganismsbutnotnecessarilyallmicrobialforms(e.g.,bacterialspores).3
NOTE:Themetershouldbecleanedanddisinfectedbetweeneachpatientuse.
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125
AcceptableCleaning/DisinfectingAgents
nTopurchaseapproveddisinfectingproducts,pleaserefertoyourfacility’sguidelines,whichmayincludeinstructionsondirectpurchasefromthemanufacturerorthroughanapproveddistributor.Foradditionalinformationonproductavailabilityforpurchase,refertomanufacturer’swebsite:http://www.cloroxprofessional.comforClorox®GermicidalWipesorhttp://www.pdipdi.com/forSuperSani-Cloth®GermicidalDisposableWipes.
nDisposeofacceptablecleaninganddisinfectionsolutionsperfacilityguidelines.
Acceptableactiveingredientsandproductsforcleaninganddisinfectingare:
– Clorox®GermicidalWipes(EPA*reg.no.67619-12)Pre-moisteneddisinfectingcloths(activeingredient1%(orless)solutionofsodiumhypochloriteinwater)
– SuperSani-Cloth®GermicidalDisposableWipes(EPA*reg.no.9480-4)Pre-moisteneddisinfectingcloths(activeingredient0.5%quaternaryammoniumchloridesandupto60%isopropanol)
nCleanersanddisinfectantswerevalidatedseparatelyandonlyonecleaning/disinfectingsolutionshouldbeusedonthedeviceastheeffectofusingmorethanonecleaner/disinfectantinterchangeablyhasnotbeenevaluated.
NOTE:AlwaysuseCloroxGermicidalWipes(EPA*reg.no.67619-12)orSuperSani-ClothGermicidalDisposableWipes(EPA*reg.no.9480-4)tocleananddisinfectthemeter.Donotuseanyothercleaningordisinfectingsolution.UsingsolutionsotherthanCloroxGermicidalWipes(EPA*reg.no.67619-12)orSuperSani-ClothGermicidalDisposableWipes(EPA*reg.no.9480-4)couldresultindamagetothesystemcomponents.
NOTE:Rochehastestedtheapprovedcleaninganddisinfectingproductforatotalof12,045cycles,whichisequaltocleaninganddisinfectingaftereachpatientuseupto11testsperdayoverthe3yearuselifeofthedevice.
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126
WhattoClean/Disinfect
Thefollowingpartsofthemeterandsystemcomponentsmaybecleanedanddisinfected:
– Theareaaroundtheteststripport– Themeterdisplay(touchscreen)– Themeterhousing(entiremetersurface)
TechnicalAssistance
Ifyounoticeanyofthefollowingsignsofdeteriorationaftercleaningordisinfectingofyourmetersystem,stopusingthesystemcomponentandcontactACCU-CHEKCustomerCareat1-800-440-3638forassistance:cloudingofthetouchscreendisplay,on/offbuttonbuttonmalfunction,cloudingoftheinfrareddataportand/orbarcodescanner,orqualitycontrolresultsoutsideofthespecifiedrange.
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127
HowtocleananddisinfecttheACCU-CHEKInformIIsystem
WARNING
Avoidgettingliquidintotheteststripport!Failuretofollowtheseinstructionsmaydamagethemeterandstopitfromworkingproperly.
nDoNotcleanordisinfectthemeterwhileperformingabloodglucoseorcontroltest.
nDoNotgetanymoistureintheteststripport.nDoNotsprayanythingontothemeter.nDoNotimmersethemeterinliquid.
Ifyoususpectthatmoisturemayhaveenteredtheteststripport,performaglucosecontroltest.
NOTICE Donotallowliquidtoentertheteststripportorallowpoolingofliquidonthetouchscreen.Ifliquiddoesgetintotheteststripport,immediatelydrythecomponentswithadryclothorgauze.Ifsolutionisallowedtocollectinanymeteropening,severedamagetothesystemcanoccur.
MaintenanceandCare
128
Cleaning the meter1 Placethemeteronalevelsurfacepriortocleaning.
2 Poweroffthemeter.
Becertainthatsolutionscontainacceptableactiveingredientsforcleaningthesystem.Whenusingcommerciallyavailablepre-moistenedcleaningcloths,squeezeoffexcesscleaningsolutionorblotonadrypapertoweltoremoveanyexcesscleaningsolutionbeforecleaningthesurfaceofthemeter.
3 UseaCloroxGermicidalWipeorSuperSani-ClothGermicidalDisposableWipetocleanbygentlywipingtheoutsideofthemeterandcarefullywipearoundtheteststripportarea,makingsurethatnoliquidenterstheteststripportandthenwipedrywithatissue.
4 Drythemeterthoroughlywithadryclothorgauze.Visuallyverifythatnosolutionisseenanywhereonthemeteratthecompletionofcleaninganddisinfecting.Ensurethatthemeteristhoroughlydriedaftercleaning(seesafetymessage“Avoidgettingliquidintotheteststripport!”andNOTICEinthissection).
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129
Disinfecting the meterNOTE:Themetershouldbecleanedpriortoeachdisinfectionstep.
Remembertokeepthemeteronalevelsurfacepriortodisinfectingandpoweredoff.
Becertainthatsolutionscontainacceptableactiveingredientsfordisinfectingthesystem.Whenusingcommerciallyavailablepre-moisteneddisinfectingcloths,squeezeoffexcessdisinfectingsolutionorblotonadrypapertoweltoremoveanyexcessdisinfectingsolutionbeforedisinfectingthesurfaceofthemeter.
1 UseafreshCloroxGermicidalWipeorSuperSani-ClothGermicidalDisposableWipetodisinfectbygentlywipingtheoutsideofthemeterthreetimeshorizontallyandthreetimesverticallyandcarefullywipearoundtheteststripportarea,makingsurethatnoliquidenterstheteststripport.
2 Allowthesurfaceofthemetertoremaindampwiththerecommendeddisinfectingsolution.Therecommendedcontacttimesareasfollows:CloroxGermicidalWipes,a1-minutecontacttime,andSuperSani-ClothGermicidalDisposableWipe,a2-minutecontacttime.NOTE:Metersurfaceshouldstaymoistfortheentirecontacttime.
3 Drythemeterthoroughlywithadryclothorgauze.Visuallyverifythatnosolutionisseenanywhereonthemeteratthecompletionofcleaninganddisinfecting.Ensurethatthemeteristhoroughlydriedaftercleaninganddisinfecting(seesafetymessage“Avoidgettingliquidintotheteststripport!”andNOTICEinthissection).
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130
Loggingmaintenanceactivities
Cleaning,disinfecting,andothermaintenanceactivitiescanbeloggedinthemeter.Makesurethatallcleaninganddisinfectingactivitiesarecompleteandthesystemisthoroughlydrybeforeswitchingonthemeter.
Thefollowingdescriptionassumesthatthemeterispoweredonandthemainmenuisdisplayed.
Tostorecleaninganddisinfectinginformationinthemeter,proceedasfollows:
Main Menu
Review Results
Control Test
Patient Test
12:48 pm
09/18/13
Main Menu 2
Maintenance
Strip Lots
Profi ciency
Control Lots
Beeper
Linearity
Diagnostics
Linearity Lots
Admin.
12:48 pm
09/18/13
Add Comments
09/18/13
Cleaned Meter
12:48 pm
1 Touch intheMain MenutoopentheMain Menu 2screen.
2 TouchMaintenancetoopenthescreenforaddingcomments.
3 Selectthedesiredcomment(s)fromthelistortouch toenteryourowncommentviakeypad.
4 Onceyouhaveenteredyourcomments,touch tosavethemaintenancecomments.TheMaintenance Resultscreenopensup.
5 Touch toreturntoMain Menu 2.
Youcanadduptothreecomments.Formoreinformation,seethesectionAdding Commentsinthismanual.
Maintenance Test
NEW BATTERY PACK
Cleaned Meter12:48 pm
09/18/13
MaintenanceandCare
131
Diagnosticsview
UnderDiagnosticsyoucanfindinformationaboutthesystem,suchassoftwareversion,numberofdatarecordsstored,andconfigurationdetails.Usethismenutodisplaystorederrormessagesandtestthebarcodescannerandthewirelessstatus(ifyourmeterieequippedwiththeWLANoption).TheDiagnosticsscreensshownhereareforillustrationpurposesonly.Informationshownonyourmetermaydiffer.
Main Menu
Review Results
Control Test
Patient Test
12:48 pm
09/18/13
Main Menu 2
Maintenance
Strip Lots
Profi ciency
Control Lots
Beeper
Linearity
Diagnostics
Linearity Lots
Admin.
12:48 pm
09/18/13
Diagnostics
S/W Version: 04.00.00BSP Version: 05.00.00Last Download: 09/16/13Battery Voltage: 3,976 VBattery Percent: 83Scan:
Log
Serial No: 10000740
12:48 pm
09/18/13
1 Touch intheMain MenutoopentheMain Menu 2screen.
2 TouchDiagnosticstocallupthemainscreenforthismenu.
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132
Diagnostics
S/W Version: 04.00.00BSP Version: 05.00.00Last Download: 09/16/13Battery Voltage: 3,976 VBattery Percent: 83Scan:
Log
Serial No: 10000740
12:48 pm
09/18/13
Diagnostics
List - allowed to add newReagent Editing:Date/Time Editing:STATs:
Patient Validation:
9
NoneOperator Validation:
0
Confi guration: Page 3
Hours: 24QC Freq:Strip Limitations Warning:
Used:
Disabled
Enabled
Allowed:Allowed
12:48 pm
09/18/13
Diagnostics
TestAuthenticated:
RF activated:Associated:
Confi gured IP:IP:Subnet:Gateway:DNS:Contacted DMS:Connected to DMS:Completed:
Wireless Status:12:48 pm
09/18/13
3 Touch or toscrollbetweenscreens.
4 TouchLogtodisplaystorederrormessages.
5 Pressandrelease totestthebarcodescanner.
6 Touch toreturntotheMain Menu.
MaintenanceandCare
133
UnlockingaDownloadLockout
Whenusingadatamanagementsystemforconfigura-tion,aDownload Lockoutcanbeconfigured.Thislockoutpreventsameterfrombeingusedfortesting,ifthemeterdatahavenotbeendownloadedforadefinedperiodoftime.Ifadownloadlockoutoccurs,theoperatormayuseaSTATtesttotemporarilyoverridethelockout.IfnoSTATtestisconfiguredorleft,themetercannotbeuseduntilthestoreddataisdownloadedvianetwork(eitherwirelessorbydockingthemeter).
Incasesofe.g.,networkfailures(whichmakeadownloadimpossible),orotheremergencies,itmaybenecessarytounlockameterwithoutaccesstothedatamanagementsystem.SinceunlockingisafunctionoftheSetup Menu,itisrestrictedtopersonswhoknowthesetuppassword.
Thefollowingdescriptionassumesthatthemeterispoweredonandthemainmenuisdisplayed.
Main Menu 2
Maintenance
Strip Lots
Profi ciency
Control Lots
Beeper
Linearity
Diagnostics
Linearity Lots
Admin.
12:48 pm
09/18/13
Admin Menu
Date / Time
Language Selection
Setup Menu
12:48 pm
09/18/13
Setup Menu
Date / Time
QC
Test Display
Password
Test Ranges
Reagents
Operator ID Patient ID
Unlock Delete Pat.
12:48 pm
09/18/13
Tounlockameter:
1 Touch intheMain MenutoopentheMain Menu 2screen.
2 TouchAdmin.toopentheAdmin Menu.
3 TouchSetup MenutoopentheSetup Menu.
4 EntertheSetuppasswordifrequested.
5 TouchUnlocktoresetthelockouttimer.
Themeterswitchesoff,andisreadyfortestingafterpoweringupagain.
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134
Deletingpatientdata
Thisfeatureallowsyoutodeleteallpatient-relateddata(patientlistsandresults).Thismaybecomenecessarytocomplywithdataprotectionandprivacypolicieswhensendingameterbacktothemanufacturerorpassingitontoanotherfacility.
Setup Menu
Date / Time
QC
Test Display
Password
Test Ranges
Reagents
Operator ID Patient ID
Unlock Delete Pat.
12:48 pm
09/18/13
Test Display Test Ranges
Setup Menu
Date / Time Reagents
F G H I J
K L M N O
P-Z 123
D-201: Delete Data:
Are you sure you want to delete all patients and all results from this meter? This operation cannot be undone.
Patient Confi rmation
12:48 pm
09/18/13
ToensuredeleteddataisnottransferredbackthroughanunwantedautomaticsynchronizationwiththeDMS,removethebatterypackimmediatelyafterdeletingpatientdata.
BeawarethatthefunctionDelete Patientirrevocablydeletesalldataonceyoutouch toconfirm.Thesystemwilldeleteanypatientresultsregardlessofwhethertheyhavebeensynchronizedwithadatamanagementsystemornot.Therefore,alwaysensurethatyouhavedownloadedallrelevantpatientresultsbeforeyouusethisfunction.
Troubleshooting
135
11 Troubleshooting
TheACCU-CHEKInformIImetercontinuallychecksitssystemsforunexpectedandunwantedconditions.
Atroubleshootingtablefollowsthatwillhelpyouwhenthesystemisnotperformingasexpected.Mostconcernscanberesolvedquicklybyreferringtothistableforhelp.Takethefollowingstepswhenanunexpectedconditionarises:
n FindthedisplayedmessageorconditionintheTroubleshootingTable.
n TaketheactionsuggestedunderthecolumnheaderPossible Solution.
Iffurtherassistanceisrequired,contactACCU-CHEKCustomerCare.
Errors and unusual behavior without error messages
Someconditionsmayarisethathavenoassociatederrormessage.Refertothefollowingtable,ifsuchaconditionarisesontheACCU-CHEKInformIIsystem.
Display/symptom Possiblesolution
Nomessageorunusualbehavior
Meterdisplaydoesnotpoweron – Wait10secondsandtryturningontheunitagain.– Placethemeterinthebaseunitandconfirmthatitis
charging.– Checkthatthebatterypackiscorrectlyinstalledand
connected.
FollowtheinstructionsinChapter9toavoiddatalosswhenreplacingthebatterypack.
Meterdisplaysanunexpectedresult Refertothepackageinsertfortheteststrips.
Troubleshooting
136
Display/symptom Possiblesolution
TestresultLO/HI Theglucoseresultmaybebelow(LO)orabove(HI)themeasurementrangeofthesystem.
– Refertothepackageinsertfortheteststrips.– Checkthatyouareperformingthetestcorrectly(see
Chapter3).– Runaglucosecontroltestwithanewteststrip(see
Chapter4).– Repeatthetestorproceedaccordingtotherequirements
ofyourfacility.
TestresultRRLO/RRHI Theglucoseresultmaybebelow/abovethereportablerangesetbysystemadministrator.
– Runaglucosecontroltestwithanewteststrip(seeChapter4).
– Repeatthetestorproceedaccordingtotherequirementsofyourfacility.
TestresultCRLO/CRHI Theglucoseresultmaybebelow/abovethecriticalrangesetbysystemadministrator.
– Runaglucosecontroltestwithanewteststrip(seeChapter4).
– Repeatthetestorproceedaccordingtotherequirementsofyourfacility.
MeterdisplaysStripdefectError Theteststripisdefectiveorthebloodglucoseresultisextremelylowandbelowthemeter’smeasurementrange.
– Refertothepackageinsertfortheteststrips.– Checkthatyouareperformingthetestcorrectly(see
Chapter3).– Runaglucosecontroltestwithanewteststrip(see
Chapter4).– Repeatthetestorproceedaccordingtotherequirements
ofyourfacility.– Iftheerrorpersists,contactACCU-CHEKCustomerCare.
MeterdisplaysanerrorTypeBadDose
Insufficientamountofbloodontheteststrip.– Refertothepackageinsertfortheteststrips.– Reviewpropertestingprocedure.– Repeatthetestusinganewteststrip,ensuringproper
sampleapplication.– Iftheerrorpersists,contactACCU-CHEKCustomerCare.
Meterdisplays(QC)FAILorOutofRange
– Refertothepackageinsertfortheteststrips.– Checkthatyouareperformingthetestcorrectly(see
Chapter4).– Repeattheglucosecontroltestwithanewteststrip.– Iftheerrorpersists,contactACCU-CHEKCustomerCare.
Troubleshooting
137
Display/symptom Possiblesolution
MeterdisplaysGlucoseError Detectionofanunexpectedhardwareerror– Repeatthetestorproceedaccordingtotherequirements
ofyourfacility.– Runaglucosecontroltestwithanewteststrip(see
Chapter4).– Powerthemeteroffandon.– ResetthemeterbypressingtheOn/Offbuttonfor12
seconds.– Iftheerrorpersists,contactACCU-CHEKCustomerCare.
MeterdisplaysUnexpectedSWError Detectionofanunexpectedsoftwareerror– Repeatthetestorproceedaccordingtotherequirements
ofyourfacility.– Placemeterintoaconnectedbaseunittosynchronize
configurationswiththedatamanagementsystem– Resetthemeterbypressingtheresetbutton(see
page141)– Iftheerrorpersists,contactACCU-CHEKCustomerCare.
CommunicationProblemswiththeDataManagementSystemviaRF
TheACCU-CHEKInformIIMeterisunabletocommunicatewiththeDataManagementSystem
– CheckwhetherWLANisactivatedonthemeter(seeChapter2)
– Checkwhetherthedatatransfericonshowsthatthelastattemptatdatatransferwassuccessful(seeChapter2)
– DocktheRFenabledmeterintoahard-wiredbaseunittotransferthedata(seeChapter9)
– CheckthemeterWLANperformanceinDiagnosticScreen#7onthemeter.
– ResetthemeterbypressingtheOn/Offbuttonfor12seconds.
– Iftheerrorpersists,contactACCU-CHEKCustomerCare.Baseunit
LEDisnotilluminated Notconnectedtopowersupplyunitorpowersupplyunitisdefective,baseunitisdefective,orpoweroutletnotactive.
– Disconnectandconnectthepowersupplyagain.– Iftheerrorpersists,contactACCU-CHEKCustomerCare.
LEDflashesred Communicationorconfigurationerror.– Checktheconfigurationand/ortheconnectiontotheData
ManagementSystem(DMS).ContacttheDMSorITadministratorofyourinstitution.
– Iftheerrorpersists,contactACCU-CHEKCustomerCare.
Automaticshutdown(poweroff)
Themeterpowersoffafteraconfigurabletimewithoutactivity(e.g.,touchingakey,touchingthescreen)toconserveenergy.Inaddition,themetermaypoweroffautomaticallyforthereasonslistedbelow.Reactivatethemeter/screenasdescribedinthefollowing:
Troubleshooting
138
Display/symptom Possiblesolution
Poweroffaftertimespecifiedbysystemadministrator(defaultis5minutes,configurablebysystemadministrator)
– PresstheOn/Offbuttononthemeter.
BatteryLow – Chargethebatterybyplacingthemeterinthebaseunit.
BatteryCriticallyLow – Chargethebatterybyplacingthemeterinthebaseunit.– Checkthatthebatterypackiscorrectlyinstalledand
connected.– Replacethedefectivebatterypack.
FollowtheinstructionsinChapter9toavoiddatalosswhenreplacingthebatterypack.
Troubleshooting
139
Pop-up messagesAllmessages,includingpurelyinformativemessages,areprecededbyaletter,identifyingthemessagetype,andanumber.
Allerrormessagesdisplayedbythesystemareaccompaniedbyadescriptionoftheerrorandapossiblesolution.Taketheactionsuggestedonscreentoresolvetheproblem.
Thedifferentmessagetypesareillustratedinthefollowingtable.
Samplemessagetype Description
Linearity Lots
D-311: Do you want tomake Linearity lot 777678 the 'current' lot?
Make 'Current'
* 12/31/13 777732Lin.03/15/14 777723Lin.
Exp. Date Lot Num.Type12:48 pm
09/18/13
– D:Decision;Toconfirm,touch .Toreject,touch .
Patient TestPatient 123456789Date 09/18/13 12:48 pm
150
L22
12:48 pm
09/18/13
RangeI-502: Normal Range:
Critical Range:
Reportable Range:
70-200 mg/dL
40-301 mg/dL
11-600 mg/dL
– I:Information;touch toconfirm.
Troubleshooting
140
Samplemessagetype Description
Operator ID
E-314: Invalid Scan. Thescan returned an entry > 20 characters. Please seeyour SystemAdministrator.
Invalid Scan
12:48 pm
09/18/13
1 2 3
– E:Error;touch toconfirm.Toresolvetheproblem,taketheactionssuggested.
Patient Test
09/18/13
Out of Crit. Range
12:48 pmPatient 123456789Date 09/18/13 12:48 pm
310 mg/dL
W-511: Out of Critical Range.
Out of Critical Range – W:Warning;touch toconfirm.
Troubleshooting
141
Meter resetAmeterresetshouldonlybeperformedifallotherremedieshavefailed.
1 Placethemeteronalevelsurface.
2 PresstheOn/Offbuttonforatleast12secondsandreleasethebutton.
n Themeterpowersoffandonagain.
n Rochelogoisdisplayed.IftheRochelogodoesnotappearwithin60seconds,placethemeteronabaseunitforaminimumof15minutestorechargethebattery.
n Themeterperformsasystemcheck.Duringthesystemcheck,theVersionsscreenappearsforafewseconds,thendisappears.TheVersionsscreenshowstheversionnumbersofthemetercomponents.(TheVersionsscreenshownhereisforillustrationpurposesonly.Versionnumbersonyourmetermaydiffer).
n Amessageappearsinformingyouthatthedateandtimesettingshavebeenlostduetothemeterreset.
3 ConfirmthemessageLoss of Date/Time.
Checking system...
Performing self-checks...
Performing self-checks...
W-1302: D/T settings lost due to meter reset or loss of power. Enter D/T manually, then synchronize meter or see System Administrator before performing further tests.
Loss of Date/Time
Troubleshooting
142
n Thescreensforenteringthedateandthetimeappear.
4 Enterthedateandtime.Afteryouhaveenteredthecorrectinformation,confirmeachscreenwith .
n UnlessyourQCconfigurationisAlways OK,themeterwillnowbeinQCLockoutduetothemanuallyentereddate/time.
5 Metermayhavetobedockedinthebaseunitforsynchronizationofthemeter’sdate/timewiththedate/timeofyourfacility.
1 2 3
4 5 6
7 8 9
0
Date
09/18/13
09/30/13
12:48 pm
1 2 3
4 5 6
7 8 9
AM/PM0
Time 12:48 pm
09/18/13
12:15 pm
GeneralProductInformation
143
12 GeneralProductInformation
Technicaldata
Specification Meter Baseunit Powersupplyunit
Height 1.73in/44mm(max.) 4.33in/110mm(max.) 1.34in/35mm+ACplug(1.1-1.6in/28-40mm)(max.)
Width 3.74in/95mm(max.) 4.65in/118mm(max.) 2.05in/51mm(max.)
Length 7.60in/193mm(max.) 4.06in/103mm(max.) 3.46in/87mm(max.)
Weight approx.347g(withrechargeablebattery)
ACCU-CHEKInformIIBaseUnitapprox.615gwithwallmount
ACCU-CHEKInformIIBaseUnitLightapprox.573gwithwallmount
N/A
Userinterface Touchscreenandbarcodescanner
LED(tricolor:red,green,blue)*
LED:green
Displayresolution(touchscreen)
320x240pixel N/A N/A
Memory 1,000Results5,000OperatorIDs4,000PatientIDs300Predefinedcomments20CodeFiles(=teststriplots)100ReagentLots(=control,linearity)
N/A N/A
Measurementtemperature
61to95°F16to35°C
N/A N/A
Storagetemperature(long-termstorage)
41to104°F5to40°Cat10-85%RH(non-condensing)
41to104°F5to40°Cat10-85%RH(non-condensing)
41to104°F5to40°Cat10-85%RH(non-condensing)
Airpressure 0.7to1.06bar70to106kPa
0.7to1.06bar70to106kPa
N/A
*ACCU-CHEKInformIIBaseUnitLight:onlyred,green
GeneralProductInformation
144
Specification Meter Baseunit Powersupplyunit
Batteryvoltage/type 3.7voltrechargeable(lithiumtechnology)
N/A N/A
Inputvoltage +7.5VDC +7.5VDC 100to240VAC
Inputfrequency DC DC 50to60Hz
Inputcurrent 1.7A(max) 1.7A(max) 350to150mA
Batterycapacity 50(subsequent)measurementspossibleafter120minofcharging
N/A N/A
Interfaces ChargecontactsIRportBarcodescannerWLAN(Channel1-11only)
ChargecontactsIRportRJ45Ethernet*USBtypeB*
DCconnectorReplaceableACinputcontacts
Datatransferrate WLAN:upto54Mbps IR:9.6K-115Kbps*Ethernet:10Mbps*USB:12Mbps*
N/A
Supportedbarcodes Code128,Code39,Code93,EAN13**,Interleaved2of5+,Codabar.,GS1DataBarLimited,QRCode,DataMatrix,PDF417
N/A N/A
*NotapplicabletoACCU-CHEKInformIIBaseUnitLight**EAN13barcodesarenotrecommendedforidentificationofoperatorsandpatients.+Interleaved2of5codescanonlybedecodediftheycontainacheckdigit.
Specification Accessorybox Codekeyreader BaseunitHUB
Height 3.35in/85mm 0.72in/18.4mm 1.38in/35mm
Width 11.02in/280mm 1.37in/34.8mm 6.65in/169mm
Length 10.71in/272mm 2.78in/70.7mm 5in/127mm
Weight 1100g 28g 470g
Storagetemperature -13to158°F-25to70°C
36to77°F2to25°C
-13to158°F-25to70°C
Relativehumidity(storage)
<93% <93% <93%
Batteryvoltage/type N/A Notreplaceable N/A
Interfaces N/A IRport;Codekeysocket LED(red,green,blue)
Inputvoltage N/A N/A +12VDC
Inputcurrent N/A N/A 2.0A
GeneralProductInformation
145
Specification ACCU-CHEKInformIITestStrip
Systemmeasurementrange: 10-600mg/dL
Hematocrit 10-65%
Altitude upto10,000feet
Measurementtemperature 61to95°F(16to35°C)
Operatinghumidity: 10-80%
Acceptablesamples: WholeBlood:capillary,venous,arterial,andneonateheelstick
Samplesize 0.6mL
Theperformanceofthissystemhasnotbeenevaluatedinthecriticallyill.FormoreinformationabouttheACCU-CHEKInformIIteststrip,refertothepackageinsertforinstructionsforuse,performancecharacteristics,andlimitationsofthesystem.
FurtherInformationOrdering
Item Description REF/CatalogNumber
ACCU-CHEKInformIIMeter Meteronly 05060311001
ACCU-CHEKInformIIMeter Meter,equippedwithWLANfunctionality 05060303001
ACCU-CHEKInformIIBaseUnit Equippedwithchargingandconnectivityfunctionality
05060290001
ACCU-CHEKInformIIBaseUnitLight Equippedwithchargingfunctionality 05920353001
ACCU-CHEKInformIIBaseUnitWallMount
WallMountforBaseUnit/BaseUnitLight 05404878001
ACCU-CHEKInformIIBaseUnitHUB HUBonly 05888760001
ACCU-CHEKInformIIBaseUnitHUBPowerSupply
PowersupplyforbaseunitHUB(NorthAmerica)
03868133001
ACCU-CHEKInformIIBatteryPack Rechargeablebatterypack 06869904001
ACCU-CHEKInformIIBatteryCompartmentCover
Replacementcoverformeterbatterycompartment
06869823001
ACCU-CHEKInformIICodeKeyReader
04884671001
PowerSupply Powersupplyforbaseunit(NorthAmerica) 05388805001
ACCU-CHEKInformIIAccessoryBox 05060281001
GeneralProductInformation
146
ACCU-CHEK Inform II Operator’s Manual and Quick Reference Guide
ForadditionalcopiesoftheACCU-CHEKInformIIOperator’sManualandQuickReferenceGuideorcopiesinotherlanguages,pleasecontactyourlocalRocherepresentativeorACCU-CHEKCustomerCare.
Reagents and Solutions
SuppliesareavailablethroughRocheDiagnostics.ContactyourlocalRocherepresentative.
Information about software licenses
Thisproductincorporatessoftwaremodulesdevelopedunderopensourcelicenses.Thesourcecodeofthissoftwarecanberequestedonastandarddataexchangemediumfromthemanufactureratthefollowingaddress
RocheDiagnosticsGmbHSandhoferStr.11668305MannheimGermany
Thecompletelicenseagreementsarestoredasatextfile(filename“license.PDF”)ontheACCU-CHEKInformIIBaseUnitoftheACCU-CHEKInformIIsystem.Thefile“License.PDF”islocatedinthesamefolderasthefile“ROCHEHBU-BUTechnicalNote.pdf”.
YoucanaccessthesefilesbyconnectingtheACCU-CHEKInformIIBaseUnittoaPCwiththeUSBcable.Fordetailedinstructionsonhowtodothis,seetheinstructionsheet“SettingUptheBaseUnit”includedintheACCU-CHEKInformIIBaseUnitKit.
Everyoneispermittedtocopyanddistributeverbatimcopiesofthislicensedocument,butchangingitisnotallowed.
GeneralProductInformation
147
Contact RocheForallquestionsabouttheACCU-CHEKInformIIsystemthatarenotansweredinthismanual,contactyourRocherepresentative.Ifyoudonotalreadyhavecontactdetails,visitourwebsiteonwww.roche.com.Select“Rocheinyourcountry”atthetopofthepageandthenselectyourcountrytofindtheappropriatelocalofficecontactinformation.
TheACCU-CHEKInformIIsystemismanufacturedforanddistributedby:
IntheUnitedStates:
RocheDiagnostics9115HagueRoadIndianapolis,IN46256
GeneralProductInformation
148
Thispageintentionallyleftblank.
GeneralProductInformation
149
A Appendix
Tableofconfigurationoptions
Thissectionprovidesanoverviewofallthesettingsavailable.
Thetworightmostcolumnsdescribetheaccessibilityofaconfigurationparameteronthedevice(Setup Menu)andviathedatamanagementsystem(DMS).“Y”(Yes)means,thatthisparameterisavailable,“N”(No)means,thatthisparameterisnotavailableusingtherespectiveconfigurationmethod.
DEVICE:Ifthemeterisconfiguredbyasystemadministratorusingadatamanagementsystem,theconfigurationoptionsonthemetermaybedisabledtoavoidconflictsinthesettings.Thisoptionisindicatedbytheuseofparenthesese.g.,(Y).
DMS:ConfigurationoptionsmayvarydependingonavailableDMSsettings.
Configurationoptions
Subject/Attribute Range Default Device DMS
Timer
Shutdowntimeout(meterpowersoffifnoactivity)
30-3,600s 300 N Y
Beeper
Beepervolume 0:low1:medium2:high
2 Y Y
MeasurementFlow
Commentsrequired 0:optional1:outofrange2:required3:disabled
0 N Y
Commentsrequirementlevel:ifoutof...(onlyvalidifComments required=1)
0:normalrange1:criticalrange2:reportablerange3:measurementrange
0 N Y
GeneralProductInformation
150
Subject/Attribute Range Default Device DMS
Customcomments 0:enabled1:disabled
0 N Y
Controllotverification 0:displayonly1:yes/noconfirmation2:promptforentry3:scanonly
1 Y Y
Controlresultdisplay 0:value(numeric)1:PASS/FAIL
0 N Y
Criticalrangedisplay 0:value(numeric)1:HI/LO
0 N Y
CriticalrangeHIlimit 10–600mg/dL0.6–33.3mmol/L
600mg/dL33.3mmol/L
Y Y
CriticalrangeLOlimit 10–600mg/dL0.6–33.3mmol/L
10mg/dL0.6mmol/L
Y Y
Criticalrangemessageenabled Whethertodisplaytheout-of-criticalrangewarningmessage(1)ornot(0)
1 N Y
Criticalrangetext 0–100characters “” N Y
Appendix
151
Subject/Attribute Range Default Device DMS
NormalrangeHIlimit 10–600mg/dL0.6–33.3mmol/L
600mg/dL33.3mmol/L
Y Y
NormalrangeLOlimit 10–600mg/dL0.6–33.3mmol/L
10mg/dL0.6mmol/L
Y Y
STATtestsallowed 0:no1:yes
1 Y Y
NumberofSTATtestsallowed 0–9 9 Y Y
ReportablerangeHIlimit 10–600mg/dL0.6–33.3mmol/L
600mg/dL33.3mmol/L
Y Y
ReportablerangeLOlimit 10–600mg/dL0.6–33.3mmol/L
10mg/dL0.6mmol/L
Y Y
Reportablerangemessage Whethertodisplayareportablerangemessage(1)ornot(0)
1 N Y
Reportablerangemessagetext 0–100characters “” N Y
Striplimitationswarning Configuration,whethertodisplaythestriplimitationswarning(1)ornot(0).
0 Y Y
Striplotverification 0:displayonly1:yes/noconfirmation2:listselection3:scanonly
1 Y Y
Linearitylotverification 0:displayonly1:yes/noconfirmation2:promptforlotentry
1 Y Y
Display
Contrast 1-15 7 Y Y
FormatsandLanguage
Dateformat 1:MM/DD/YY2:DD.MM.YY
1 Y Y
Timeformat 1:24hours2:12hours
2 Y Y
Languagesetting* 1:German3:French4:Spanish5:Italian6:Dutch7:Swedish8:English(USA)9:Danish11:Portuguese
8 Y Y
Appendix
152
Subject/Attribute Range Default Device DMS
Glucoseresultunits 0:mg/dL1:mmol/L
0 Y Y
*Otherlanguages:Fortheavailabilityoflanguagesnotlistedabove,contactRoche.
PowerUp
Location(astringtoshowwhereacertainmeteroughttobelocated);tobeshownonthePowerUpscreen.
0–20characters “” N Y
MeterFunctionality
Dateandtimeeditingallowed 0:electronicallyonly(onlytheDMScansetdateandtime)1:anyone(anyonecansetdateandtime)2:passwordrequired(thesetuppasswordisrequiredtosetdateandtime)
1 N Y
Mainmenu2“Linearity”(ifenabled,linearitytestsareallowed)
0:disabled1:enable
1 Y Y
Mainmenu2“Maintenance”(ifenabled,maintenancecommentsareallowed)
0:disabled1:enable
1 Y Y
Mainmenu2“Proficiency”allowed(ifenabled,proficiencytestsareallowed)
0:disabled1:enable
0 Y Y
Adminmenu“Setup”(ifenabled,accesstosetupscreensispossible)
0:disabled1:enable
1 Y Y
Setuppassword 0–20characters “” Y Y
Reagenteditingallowed 1:Allowed2:Passwordneeded0:Notallowed
1 (Y) Y
OperatorID
OperatorIDentrycontrol 0:None1:Prompt2:Scanonly3:Prompt(numericonly)
1 Y Y
OperatorIDentrycontrolonGlucosecontrolonly
0:no(always)1:yes(oncontrolsonly)
0 Y Y
OperatorIDvalidation(Allowedcharacters:a-z,0-9,“.”[period],“-”[hyphen])
0:none1:length2:list3:list&password
0 Y Y
OperatorIDmaxlength(usedtovalidateanoperatorIDifoperatorIDvalidationmodeissetto“Length”)
0–20 20 Y Y
**EAN13barcodesarenotrecommendedforidentificationofoperatorsandpatients.
Appendix
153
Subject/Attribute Range Default Device DMS
OperatorIDminlength 0–20 0 Y Y
OperatorIDtimeout(determinesthetimeinsecthatanoperatorremainsloggedinafterpowerdown).0secdisablesthisfeature.
0–3,600sec 0 N Y
Operatorpasswordlength 4-20characters(onlya-z,0-9allowed)
N/A N N
Operatorcertificationexpirywarning 0-90days 0(=off) N Y
OperatorNamelength 0-25characters N/A N N
OperatorIDandpatientIDbarcodemasks
OperatorIDbarcodemask(seeseparatetableattheendofthischapter)
0–300characters* “” N Y
PatientIDbarcodemask(seeseparatetableattheendofthischapter)
0–300characters* “” N Y
*Thenumberofcharactersintheunmaskedbarcodemaynotexceed20.
PatientID
PatientIDconfirmation 0:disabled1:name2:dateofbirth(DOB)*3:name/DOB*
0 N Y
*DependsonavailableDMSsettings.
PatientIDentrymode 0:Keyboard/Scan1:List/Keyboard/Scan2:Scanonly3:Prompt(numeric)
0 Y Y
PatientIDvalidationmode(Allowedcharacters:a-z,0-9,“.”[period],“-”[hyphen])
0:none1:length2:list3:listallowingentryifnotonlist4:lengthifnumeric
0 Y Y
PatientIDmaximumlength(usedtovalidateapatientIDifpatientIDvalidationmodeissetto“Length”
0-20 20 Y Y
PatientIDminimumlength(usedtovalidateapatientIDifpatientIDvalidationmodeissetto“Length”
0-20 0 Y Y
Patientnamelength 0-25characters N/A N N
Appendix
154
Subject/Attribute Range Default Device DMS
QCalgorithm
QCalgorithm 0:None(alwaysOK)1:LastresultOK2:Timeofday(DMSonly)3:Shift(DMSonly)4:Hours5:Stripcount6:Timeofdayrotate(DMSonly)7:Shiftrotate(DMSonly)8:Hoursrotate(DMSonly)9:Stripcountrotate(DMSonly)
0 (Y) Y
QChours(NumberofhoursbetweenrequiredcontrolmeasurementsifQCalgorithmissetto“Hours”or“hoursrotate”)
0–9,999hours 24 Y Y
QCshiftlength(aPASScontrolremainsvalidfortwicethisamountintimeaftershiftstartiftheQCalgorithmissetto“Shift”or“Shiftrotate”)
1,2,3,4,6,8,12,24hours 8 N Y
QCshiftstart(timeoftheshiftstartiftheQCalgorithmissetto“Shift”or“Shiftrotate”)
0–23hours 6 N Y
QCstripcount(numberoftestsaPASScontrolremainsvalid)
1–999 50 Y Y
QCtimeofday 6POCT1-Adatafields00:00–23:59
06:0009:0012:0015:0018:0022:00
N Y
QCtimeofdayset 6POCT1-Adatafields0or1
100000 N Y
Resultdeletion
Resultdeletionalgorithm.AutomaticorFirstinFirstout.
0:automatic1:FIFO
1 N Y
Resultretentiontime(numberofdayssincearesultwasmeasuredbeforeitcanbedeletedautomaticallyifresultdeletionalgorithmissetto“automatic”andnomorememoryisavailable)
1–1,000d 30 N Y
Resultdownloadrequired 0:disabled1:enabled
0 N Y
Appendix
155
Subject/Attribute Range Default Device DMS
Electroniccommunication
Downloadwarning 0–999h 0:disabled N Y
DownloadLockout 0–999h 0:disabled N Y
MaximumnumberoflistitemstransferredinonePOCT1-Amessage
1–500 75 N Y
Applicationtimeout(withinthistimetheapplicationexpectsaresponsebytheDMStoanyPOCT1-Acommand)
5–6,000s 60 N Y
WLANsettings(general)
WLANenabled 0:disabled1:enabled
1 N Y
UseDHCP 0:disabled1:enabled
0 N Y
IP(themeter’sstaticIP-addressifnoDHCPisused)
0.0.0.0–255.255.255.255 0.0.0.0 N Y
SubnetMask(subnetmasktobeusedbythemeterifstaticIPisused.Note:ifDHCPisused;theDHCP-subnetmaskwillbeused.)
0.0.0.0–255.255.255.255 0.0.0.0 N Y
UseDNS 0:disabled1:enabled
0 N Y
DMShost(thehost’sDNSnameifDNSisused)
0–20characters “” N Y
DMSIPaddress(thehost’sIPaddressifnoDNSisused)
0.0.0.0–255.255.255.255 0.0.0.0 N Y
DMSport(theportnumbertorequestopensocketfromtheDMS.Rocherecommendsuseofportnumbers≥1024.)
0–65,535 0 N Y
DNSIP(IPaddressoftheDNS-serverifDHCPisnotusedandDNSisconfigured)
0.0.0.0–255.255.255.255 0.0.0.0 N Y
GateIP(staticgatewayIPaddress) 0.0.0.0–255.255.255.255 0.0.0.0 N Y
WLANsettings(security)
CipherType(encyrptionmethod) 0:None(nociphertype)1:AES(symmetrickeycryptography)2:TKIP(usingdynamickeys)3:AES|TKIP(AESandTKIPtogether)4:WEP40(WEPwith64bitkeylength)5:WEP104(WEPwith128bitkeylength)
0:disabled N Y
Appendix
156
Subject/Attribute Range Default Device DMS
SecurityType* 0:open(nosecurity/encryption)1:WEP2:WPA_PSK(WPAwithpresharedkey)3:-4:EAP**
0 N Y
*Note:Onlythosecombinationsofciphertypeandsecuritytypeareallowedthatarelistedbelow,seetable“Allowedcombinationsofcipherandsecuritytype”.
**Whenusingoption4ensurethatanappropriateWLANEAPpackagehasalreadybeendownloadedfromtheDMStothemeter.WithinthisEAPcontainer,theappropriateEAPtype(TLS,PEAPorTTLS)andthediverseEAPconfigurationsettingshavetobeconfigured).
SSID 0–32characters “” N Y
WEP-key(40or104bits) NUL-terminatedstringof10or26chs(HEX)
„0000000000“
N Y
WEP-authentication 0:opensystemauthentication1:sharedkeyauthentication
0 N Y
WPAKeyType 0:Passphrase1:Key
0 N Y
WPAKey stringof64characters(HEX)
“000000000000000000000000000000000000000000000000000000000000”
N Y
WPApassphrase(Un-encryptedtextusedtogeneratethe256-bitpresharedkey.)
8–63characters “” N Y
Subject/Attribute Range Default Device DMS
ObservedTestSequence(OTS)
OTSfunctionality* 0:disabled1:enabled
0 N Y
*DependsonavailableDMSsettings.
Appendix
157
OtherTestEntry(OTE)
OTEfunctionality* 0:disabled1:enabled
0 N Y
*DependsonavailableDMSsettings.
Allowedcombinationsofcipherandsecuritytype
security_type cipher_type wep_auth_type wep_key wpa_key_type wpa_key wpa_passphrase
0-open 0-none - - - - -
1-WEP 4-WEP40 0-open/1-shared
10charactersHEX
- - -
1-WEP 5-WEP104 0-open/1-shared
26charactersHEX
- - -
2-WPA_PSK 1-AES(WPA2)
- - 0-passphrase - 8-63characters
2-WPA_PSK 1-AES(WPA2)
- - 1-key 64charactersHEX
-
2-WPA_PSK 2-TKIP(WPA)
- - 0-passphrase - 8-63characters
2-WPA_PSK 2-TKIP(WPA)
- - 1-key 64charactersHEX
-
2-WPA_PSK 3-AES/TKIP(WPA2/WPA)
- - 0-passphrase - 8-63characters
2-WPA_PSK 3-AES/TKIP(WPA2/WPA)
- - 1-key 64charactersHEX
-
3-WEP2 - - - - - -
4-EAP - - - - - -
Appendix
158
OperatorandpatientIDbarcodemasks
Barcodemaskcharacter Definition
A-Z,0-9 IfnotprecededbytheCaret(“^”),thescandatacharactermustbethesameasthemaskcharacter.ThischaracterisnotsavedaspartoftheID.Ifthecharactersarenotthesame,thescandataisnotavalidID.
Dollar(“$”) ThescandatacharacterinthispositioniskeptaspartoftheID.
Asterisk(“*“) ThescandatacharacterinthispositionisnotkeptaspartoftheID.
Tilde(“~”) Thescandatacharacterinthispositionmustbeanumber,0-9,anditisnotkeptaspartoftheID.Ifthescandatacharacterisnotanumber,thescandataisnotavalidID.
Plus(“+”) Thescandatacharacterinthispositionmustbeanalphacharacter,A–Z,anditisnotkeptaspartoftheID.Ifthescandatacharacterisnotanalphacharacter,thescandataisnotavalidID.
Caret(“^”) Thismaskcharacterdenotesthatthescandatacharactermustbeequaltothenextcharacterinthebarcodemaskafterthe“^”,andthatthescandatacharacteriskeptaspartoftheID.Ifthescandatacharacterisnotequaltothemaskcharacterfollowingthe“^”,thebarcodereadingisinvalidasanID.
Appendix
159
Exampleofbarcodesymbologies
Whencreatingpatientoroperatorbarcodes,alwaysadheretotheapplicableinternationalIEC/ISOstandardsfortherespectivebarcodesymbology.Inparticular,ensurethatbarcodesizeandprintquality(asdefinedinISO/IEC15421)areadequate.Inadequateprintsizeand/orqualitymayleadtoerroneousdecoding.
EAN13barcodes,althoughwidelyusedinretail,arelessrecommendableforpatient/operatorbarcodes.Ifused,theydemandtheveryhighestqualitystandardsofbarcodecreationandreproduction.
Thebarcodesamplesshownhereareforillustrationpurposesonly.Ifprintedout,theycanbeusedtocheckthebarcodescanner.However,theyarenotmeanttobeusedasareferenceforsizeorresolutionofrealpatientoroperatorIDbarcodes.AlwaysrefertotherelevantstandardISO/IEC15421forsizeandresolutionrequirementswhencreatingpatientoroperatorbarcodes.
Appendix
160
– Codabar
– Code39
– Code93
– Code128
– EAN13**
– Interleaved2of5(canonlybedecodediftheycontainacheckdigit)
– GS1DataBarLimited
– PDF417
– DataMatrix
– QRCode
Appendix
161
B Appendix
Option:Wirelessnetwork(WLAN)
Preliminary noteAppendixBhasbeendevelopedtoexplainthewirelesscommunicationprinciplesoftheACCU-CHEKInformIIsystem1andtohelpyourfacility’sinformationtechnology/managementteam(s)ineffectivelydeployingtheACCU-CHEKInformIIsystemonyourwirelessnetwork.
Whetheryourmeterhaswirelesscapabilityornotdependsonthesystemconfigurationthatyoupurchased.
Background
TheACCU-CHEKInformIImetercanonlybeconfiguredthroughadatamanagementsystemtocommunicatewirelessly.Thedatamanagementsystemisalsousedtoset-upandconfigurethemetertoconnecttoonehospitalspecificWirelessLocalAreaNetwork(WLAN2).WLANsuseelectromagneticwavesinthe2.4and/or5.0GHzfrequencyrangetowirelesslytransmitdata3.TheACCU-CHEKInformIIsystemadherestoIEEEStandard802.11b(2.4GHzrange)4.Thesystemisbackwardscompatibleto802.11b.DuringwirelesscommunicationtoanAccessPoint(AP),theACCU-CHEKInformIImeterrecognizestheexistentAPWLANprotocolconfiguration(802.11bor802.11g)andautomaticallytransmitsdatausingtheappropriatecommunicationprotocol5.
1 TheACCU-CHEKInformIIsystemiscertifiedbytheWi-FiAlliance.
2 WLANisalsocommonlyreferredtoaswirelessLANorWi-Fi.
3 Forthewirelessfunctionalitytoworkproperly,thewirelessmodulemustfirstbeconfiguredbyyoursystemadministrator.
4 WhiletheACCU-CHEKInformIIsystemadherestothe802.11gstandard,itusesonlychannels1-11.Channels12-14arenotusedbythesystem.
5 WLANsareorganizedincells.AtypicalWLANcellconsistsofAccessPoint(s)thatareconnectedtothe(wired)LocalAreaNetworkandoneormoreclients,e.g.,ACCU-CHEKInformIImetersalongwithotherclientssuchasportablecomputers.
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Thelossofsignaloraccesstobandwidthofoneparticularclientmayvarydependingononeormoreofthefollowingsituations:thetypeandnumberofotherclients,theperformanceoftheAccessPoint,thepresenceofelectromagneticdisturbances,andotherpotentialinterferingfactors,e.g.,concretewalls.
TheACCU-CHEKInformIImeterusesaburst-likecommunicationprotocolthatwillonlyconsumebandwidthifthereisactuallydatatobetransferred.Comparedtootherapplications,suchasVoiceoverInternetProtocol(VoIP)ormulti-mediaapplications,themeter’sbandwidthconsumptionisminimal.IftheWLANthattheACCU-CHEKInformIImeterseekstoconnecttoisdegraded,themeterdesignminimizestheimpactonfunctionality.
Technical implementationPriortoconnectinganywirelessdevicetoawirelessnetwork,itisrecommendedthataWLANsitesurveybeperformed.ThegoalofaWLANsitesurveyistoensurethatAccessPointswillprovideenoughcoverageandperformancetosupportanynewradiofrequency(RF)applicationordevice.ThesurveywillalsodetailRFsignals,includingallexistingWLANsalongwithanycompetingRFsignalsandinterferences(buildingstructurerelatedandotherwirelessequipment/devices).
AspartofanRFimplementationoftheACCU-CHEKInformIIsystem,itisrecommendedthatatminimumonebaseunitbehardwiredperfloor.Anetworkedbaseunitprovidesredundancyifawirelessnetworkmalfunctionsorlosesservice.IftheACCU-CHEKInformIImeterwithRFisusedinanareawithlowsignalorinterferences,itisrecommendedtoinstallaconnectedbaseunitforredundancy.Theredundancyoftheconnectedbaseunitallowsimmediatetransmissionofpatientresultswhenthemeterisdocked.
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ThecurrentRFsystemconsistsofanantennaandaWLANsystem-on-chip(SoC)alongwithothercomponents.TheWLANsystem-on-chipisthecoreoftheWLANsystem.TheRFsystemusedintheACCU-CHEKInformIIspecificallyadherestothefollowingspecifications:
n ItsWLANsystem-on-chipsupportsIEEE802.11band802.11g.ItworksseamlesslytogetherwithotherWLANcertifiedtransceivers.ItalsoimplementstheWi-FiProtectedAccess(WPATM-EnterpriseandWPATM-Personal),Wi-FiProtectedAccess2(WPA2TM-EnterpriseandWPA2TM-Personal),andWiredEquivalentPrivacy(WEP)securitymechanismswithTemporalKeyIntegrityProtocol(TKIP)andAdvancedEncryptionStandard(AES).Inaddition,thesystemsupportstheextensibleauthenticationprotocol(EAP)withEAP-TLS,EAP-TTLS/MSCHAPv2andPEAPv0/EAP-MSCHAPv2.TheACCU-CHEKInformIImeterinteroperabilityWi-Ficertificatecanbeaccessedathttp://certifications.wi-fi.org/search_products.php.Furtherinformationincludingaglossaryofterms,frequentlyaskedquestions,andothertopicsrelatedtoWi-FitechnologycanbefoundontheWi-FiAlliancesite(http://www.wi-fi.org/).
n Usedchannelsinthe2.4GHZ-bandarechannels1-11,whicharetheallowedchannelsintheUSA.(Channels12-13arenotusedbytheACCU-CHEKInformIImeter.)
n RFoutputpowerisapproximately13dBmatadatarateof54MBPS.
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RF specific functionalities and effective performance claims
TheACCU-CHEKInformIIsystemofferstheoptionofwirelessnetworkconnectivity(WLAN/Wi-Fi).Ifyoupurchaseasystemwiththisoption,theWLANfunctionisenabledduringproduction.
Thismodulecanonlybeconfiguredbyadatamanagementsystem(DMS),whichactivatesthemeter’swirelesscommunicationanddatatransfercapabilities.WirelessconnectivitycanhelptoensurethatupdatestoinformationintheDMSaresentimmediatelytoallnetworkedmeters.
Meterswithanintegratedandactivatedwirelessoptionusethebaseunitforrechargingand/orasaredundantcommunicationoptiontoexchangedatawiththeDMS.
Themeteralsohastobedockedifthehospitalchangessecurityprotocols.Whenthischangeoccurs,itmaylockoutallmetersuntildockedandreconfiguredwiththenewprotocol.
Asdescribedabove,theACCU-CHEKInformIImetersupportsthe802.11gstandard.ThistranslatesintothefollowingRFspecificperformanceclaims:
n TheACCU-CHEKInformIImeteriscapableoftransferringtoasuitableDMS,viaWLAN,adatasetofupto1000resultrecords,100reagentrecords,and500operatorIDrecordsinlessthan15minutes,whenoperatedinatypicalWLANenvironment(correctWLANadministration,typicalpopulationofotherclientspresent,anyofthesupportedsecuritymodelsenabled).
n Immediatelyaftertheoperatorhasinitiatedthesendingofabloodglucoseresult,theACCU-CHEKInformIImeterwillattempttoconnecttotheDMS.InlinewiththeindustrycommunicationstandardPOCT1-A,theDMSmustacknowledgethemeter’srequestforconnectionandactivelyqueryfortheresult.OnlyuponreceiptofthisDMSquery,themeterwillsendtheresult.Hencetheeffectivetimefortransmittingresultsdependsoninfrastructure,DMSworkload,etc.OncetheDMSsendsaquery,however,themeterwillrespondwithinafewseconds.
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n AnACCU-CHEKInformIImeterwithwirelessconnectivityenabledwillcommunicateresultsaftereverytestor,whenthemeterisidle;itwillautomaticallyattempttocommunicatewiththeDMSevery10minutes.
AtypicalrangefordirectconnectionbetweentheACCU-CHEKInformIImeterandtheaccesspoint(air,directview,lowdisturbances)isupto49to66feet(15to20meters).Theactualrangedependsonthepositioningoftheaccesspoint’santennasandothertopologicalpropertiesofthespacebetweenWLANdeviceandAP.Additionally,dynamiccontrolofthetransmittingpoweroftheaccesspointmayreducethemaximumdistancebetweenWLANdeviceandAPwithinwhichcommunicationcanbeguaranteed.
TheACCU-CHEKInformIIsystemisdesignedsuchthatitcoexistswithotherwirelesslycommunicatingdevices.TheACCU-CHEKInformIIsystemdoesNOTincludeanyreal-timeoreventimecriticalwirelessfunctionality.Itcommunicatesexclusivelysingle,digitaldatafields.ItdoesNOTcommunicatecontinuouswaveformdata.
Note:TheACCU-CHEKInformIImetermonitorstheQualityofService(QoS)oftheWLANcommunicationconnection.Shouldthelastattempttocommunicatehavefailed,aniconappearsonthescreen(seepage33).AdegradedQoSwillnotimpactthefunctionalityofthemeterbutmaydelaythecommunicationofresultstotheDMS.Usersshouldbeawarethatreal-timecommunicationofbloodglucosereadingscannotbeguaranteedbytheACCU-CHEKInformIImeter.
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Thispageintentionallyleftblank.
SupplementforOtherTestEntry
167
C SupplementforOtherTestEntry
Beforeyoustart
DescriptionTheOther Test Entry(OTE)featureisdesignedtoallowtheprofessionalusertodocumentpatienttestresultsfromcertainoff-metertests.
LiquidorexternalcontrolsareenteredintheControl Testsection.Themeterfacilitatesthetransferofthisinformationtoadatamanagementsystem(DMS).TheavailabilityofOTEtestsmayvarybyDMSfunctionality.
TheactivationofthisfeatureisonlypossibleviaasuitableDMS.
ActivatingthisfeaturepermanentlyaddsanadditionalsteptothePatient TestoraControl Testsequence.Oncethisfeatureisactivated,youwillhavetoselectthetypeoftest(Glucose Test/Other TestorGlucose Control Test/Other Control Test)eachtime.
Theexamplesinthismanualareforillustrationpurposesonly.ConsulttheinstructionswiththeDMSfordetailandconfigurationoptions.
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OverviewofOtherTestEntry
IntroductionTheOther Test Entryfeatureallowsyoutoenterpatientresultsforthefollowingtests:
n Pregnancy
n VisualUrinalysis(UA)
n RapidStreptococcus
n RapidDrugsofAbuseTests(DAT)
n FecalOccult
n GastricOccult
TheOther Test Entryfeaturealsoallowsyoutoaddinformationaboutprescribedinsulintypeandnumberofunits:
n Rapid-ActingInsulin
n RegularInsulin
n Intermediate-ActingInsulin
n LongActingInsulin
n InsulinMixtures
IntheReview Resultlisting,thetestnamesfortheabovetestswillbeabbreviatedasfollows:
n Pregnancy(Preg)
n VisualUA(VUA)
n RapidStrep(Strep)
n RapidDAT(DAT)
n FecalOccult(FOcc)
n GastricOccult(GOcc)
n Ketones(Ket)
n Rapid-Acting(Rap-I)
n Regular(Reg-I)
n Intermediate-Acting(Int-I)
n Long-Acting(Long-I)
n InsulinMixtures(Mix-I)
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EnteringpatienttestresultsusingtheOther Test Entrymenucomprisesofthefollowingsteps:
n EnterthepatientID.
Thiscanbedoneeithermanuallyorbyusingthebarcodescanner.
n Enterthedateandtimethetestwasperformed.
n Enterorconfirmtheteststrip,kitand/orotherreagentlotnumbers.
Thiscanbedoneeithermanuallyorbyusingthebarcodescanner(ifabarcodeisavailable).
n Entertheteststrip,kitand/orotherreagentexpirationdatethefirsttimealotnumberisentered.
n Entertheonboardcontrolresult(s)ifavailable.
n Enterthetestresult(s).
n Selectappropriatecomments.
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RecordingOtherTestEntries
Thefollowingstepsmustbecompletedalready:
1 Themeterispoweredon.
2 YouhaveenteredyouroperatorID.
3 Youhavecompletedloginbytouching andtheMain Menuscreenisdisplayed.
Main Menu
Review Results
Control Test
Patient Test
12:48 pm
09/18/13
Other Patient Tests
Pregnancy
Visual UA (MS)
Visual UA (CS)
Rapid Strep
Rapid DAT
09/18/13
12:48 pmPatient Test Menu
Glucose Test
Other Test
09/18/13
12:48 pm
1 FromtheMain MenuscreentouchPatient Test.
2 FromthePatient Test MenutouchOther Test.
3 Touch or toscrollupordowninthelist.
4 Selectthedesiredtestfromthedisplaylist.
Ifyouneedtochangeanentry,touch toreturntothepreviousscreen.
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1 2 3
4 5 6
7 8 9
A-O0
Patient ID 12:48 pm
09/18/13
Other Patient Tests
Fecal Occult
Ketones
Gastric Occult
Rapid-Acting Insulin
Regular Insulin
09/18/13
12:48 pm
5 EnterorselectthePatient ID(seeChapter3formoreinformation).Touch toproceedtothenextscreen.
1 2 3
4 5 6
7 8 9
0
Date Tested
09/18/13
09/18/13
12:48 pm
1 2 3
4 5 6
7 8 9
0
Time Tested
AM/PM
12:48 pm
09/18/13
12:48 pm
6 Usethekeypadtoenterthedatethetestwasperformed.Forsingledigitnumbers,addaleadingzero.Touch toproceedtothenextscreen.
7 Usethekeypadtoenterthetimethetestwasperformed.Forsingledigitnumbers,addaleadingzero.Touch toproceedtothenextscreen.
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1 2 3
4 5 6
7 8 9
0
Expiration Date
12/30/13
09/18/13
12:48 pm
1 2 3
4 5 6
7 8 9
A-O0
Fecal Card Lot
11/13/63
09/18/13
12:48 pm
Fecal Card Lot
Use card 131163?
ID: 150 88 25611/19/13 9:12 am
09/18/13
12:48 pm
8 UsethekeypadorbarcodescannertoentertheFecal Card Lotnumber,andtouch toproceedtothenextscreen.OR,ifconfigured:
n Touch toconfirmthatyouwanttousethepreselectedlotnumberdisplayedbythemeter.
n Touch toenteranewlotnumber,ifyouwanttouseadifferentlotnumberthantheonedisplayed.
Ifyoutouch toconfirmthedisplayedlotnumber,themeterwillnotpromptforexpirationdate.
9 UsethekeypadtoentertheFecal Card Lotexpirationdate.Touch toproceedtothenextscreen.
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1 2 3
4 5 6
7 8 9
0
Expiration Date
12/30/13
09/18/13
12:48 pm
1 2 3
4 5 6
7 8 9
A-O0
Fecal Developer Lot
09/18/13
12:48 pm
Fecal Developer Lot
Use developer 131163?
ID: 150 88 25609/18/13 9:12 am
09/18/13
12:48 pm
10 Usethekeypadorthebarcodescanner(ifabarcodeisavailable)toentertheFecal Developer Lotnumber,andtouch toproceedtothenextscreen.Or,ifconfigured:
n Touch toconfirmthatyouwanttousethepreselectedlotnumberdisplayedbythemeter.
n Touch toenteranewlotnumber,ifyouwanttouseadifferentlotnumberthantheonedisplayed.
Ifyoutouch toconfirmthedisplayedlotnumber,themeterwillnotpromptforexpirationdate.
11 UsethekeypadtoentertheFecal Developer Lotexpirationdate.Touch toproceedtothenextscreen.
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Fecal Occult Pat.ID: 150 88 256
Positive CtrlSelect a positive control result.
acceptablenot
acceptable
09/18/13
12:48 pm Fecal Occult Pat.ID: 150 88 256
Negative CtrlSelect a negative control result.
acceptablenot
acceptable
09/18/13
12:48 pm Fecal Occult Pat.ID: 150 88 256
ResultSelect a Fecal Occult result.
positive negative
09/18/13
12:48 pm
12 SelecttheresultofthePositive Controlasacceptableornot acceptablebytouchingtheappropriatebutton.
13 SelecttheresultoftheNegative Controlasacceptableornot acceptablebytouchingtheappropriatebutton.
14 Selectthepatienttestresultaspositiveornegativebytouchingtheappropriatebutton.
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Fecal Occult Pat.
Card Lot #
D/T Tested
Dev Lot #
ID: 150 88 256
Positive Ctrl
Negative Ctrl acceptable
acceptable
11/19/139:12 am
4523307/30/14
128312/30/13
09/18/13
12:48 pm Fecal Occult Pat.
Result
ID: 150 88 256
negative
09/18/13
12:48 pm Fecal Occult Pat.
Doctor Notifi ed
Result
ID: 150 88 256
negative
09/18/13
12:48 pm
Oncetheresult(s)areentered,theFecal Occult Pat.resultscreenisdisplayed.
15 Tochangeanentryoraresult,touchtheappropriatebutton.
Toaddcomments,(refertoAdding Commentsinthismanualformoreinformation):
16 Intheresultscreen,touch .
17 Selectthedesiredpredefinedcommentfromthedisplaylist(ifconfigured)or
18 Touch toenteryourowncustomcomment.Usethekeypad(aswithlogin)toenteryourcomment.
19 Onceyouhaveselectedthedesiredcomment(s),touch toreturntotheresultsscreen.
20 Touch toreturntotheMain Menu.
Testresultsarealsosavedwhenthemeterispoweredoffintheresultsscreenorautomaticallypowersoff.
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RecordingOtherControlTestEntries
IntroductionTheOther Control Test Entryfeatureallowsyoutoenterliquidcontrolresultsforthefollowingtests:
n Pregnancy(Preg)
n VisualUA(VUA)
n RapidStrep(Strep)
n RapidDAT(DAT)
RunningcontrolsensuresthatyourtechniqueusedintestingwillgiveaccurateresultsonOther Patient Tests.Controlsolutionshavedefined(known)values.Commerciallypreparedcontrolsolutionsshouldbeusedonaregularbasis,asestablishedbyyourinstitution’squalitycontrolprotocols.TheresultsforthesesolutionsshouldbewithinacertainacceptablerangeinordertoensurevalidOTEtesting.
Other Control Testing IntervalsIntervalsbetweenrunningcontroltestsaredeterminedbyyourinstitution.QualitycontrollockoutisnotavailableforOther Test Entry.
Stored Control InformationThemetercanrecordthefollowinginformationaboutOther Control Tests:
n OperatorID
n Typeofcontrol
n Datetested
n Timetested
n Kitlotnumber
n Controllotnumber
n Controltestresult(s)
n Comment(ifapplicable)
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EnteringcontroltestresultsusingtheOther Control Test Entrymenucomprisesofthefollowingsteps:
n Selectthetypeofcontroltoberecorded.
n Enterthedatetested(ifrequired).
n Enterthetimetested(ifrequired).
n Enterorconfirmthekitorteststriplotnumber.
Thiscanbedoneeithermanuallyorbyusingthebarcodescanner(ifabarcodeisavailable).
n Enterthekitorteststripexpirationdate.
n Enterorconfirmthecontrollotnumber.
n Enterthecontrollotexpirationdate.
n Selectthecontrolresult(s).
Thecontrolsolutionresultsmustfallintotheacceptablerangeindicatedonthetestkitorreagentpackaging,orasdefinedbyyourinstitution,beforebeingconsideredsuccessful.
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Thefollowingstepsmustbecompletedalready:
1 Themeterispoweredon.
2 YouhaveenteredyouroperatorID.
3 Youhavecompletedloginbytouching andtheMain Menuscreenisdisplayed.
Main Menu
Review Results
Control Test
Patient Test
12:48 pm
09/18/13
Other Control Tests
Pregnancy
Visual UA (MS)
Visual UA (CS)
Rapid Strep
Rapid DAT
09/18/13
12:48 pmControl Test Menu
Glucose Control Test
Other Control Tests
09/18/13
12:48 pm
1 FromtheMain MenuscreentouchControl Test.
2 FromtheControl Test MenutouchOther Control Tests.
Other Control Tests
Pregnancy
Visual UA (MS)
Visual UA (CS)
Rapid Strep
Rapid DAT
09/18/13
12:48 pm Pregnancy Control
Positive Liquid Control
Negative Liquid Control
09/18/13
12:48 pm
3 Selectthedesiredtestfromthedisplaylist.(Pregnancycontrolwillbeusedastheexample.)
4 Selectthetype(level)ofcontrolbeingused.
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1 2 3
4 5 6
7 8 9
A-O0
Pregnancy Ctrl Lot
09/18/13
12:48 pm
1 2 3
4 5 6
7 8 9
0
Expiration Date
12/30/13
09/18/13
12:48 pm
5 Usethekeypadorthebarcodescanner(ifabarcodeisavailable)toenterthePregnancy Ctrl Lotnumber.Touch toproceedtothenextscreen.
6 UsethekeypadtoenterthePregnancy Ctrl Lotexpirationdate.Touch toproceedtothenextscreen.
1 2 3
4 5 6
7 8 9
0
Date Tested
09/18/13
09/18/13
12:48 pm
1 2 3
4 5 6
7 8 9
0
Time Tested
AM/PM
12:48 pm
09/18/13
12:48 pm
7 Usethekeypadtoenterthedatethetestwasperformed.Forsingledigitnumbers,addaleadingzero.Touch toproceedtothenextscreen.
8 Usethekeypadtoenterthetimethetestwasperformed.Forsingledigitnumbers,addaleadingzero.Touch toproceedtothenextscreen.
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9 Usethekeypadorthebarcodescanner(ifabarcodeisavailable)toenterthePregnancy Kit Lotnumber.Touch toproceedtothenextscreen.
10 UsethekeypadtoenterthePregnancy Kit Lotexpirationdate.Touch toproceedtothenextscreen.
1 2 3
4 5 6
7 8 9
A-O0
Pregnancy Kit Lot
09/18/13
12:48 pm
1 2 3
4 5 6
7 8 9
0
Expiration Date
07/30/14
.
09/18/13
12:48 pm
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Pregnancy ControlPositive Liquid Control
Control Bar
Select a Pregnancy control bar result.
acceptablenot
acceptable
09/18/13
12:48 pm Pregnancy ControlPositive Liquid Control
Ctrl Result
Select a Pregnancy liquid control result.
acceptablenot
acceptable
09/18/13
12:48 pm Pregnancy Control
Control Lot #
D/T Tested
Kit Lot #
Positive Liquid Control
Control Bar
Ctrl Result acceptable
acceptable
09/18/138:30 am
4523311/30/13
128312/30/13
09/18/13
12:48 pm
11 SelecttheresultoftheControl bar testasacceptableornot acceptablebytouchingtheappropriatebutton.
12 Selecttheresultoftheliquidcontroltest(Ctrl Result)asacceptableornot acceptablebytouchingtheappropriatebutton.
Oncetheresultsareentered,thePregnancy Control resultscreenisdisplayed.
13 Tochangeanentryoraresult,touchtheappropriatebutton.
Toaddcomments(refertoAdding Commentsinthismanualformoreinformation):
14 Intheresultscreen,touch .
15 Selectthedesiredpredefinedcomment(s)fromthedisplaylist(ifconfigured)or
16 Touch toenteryourowncustomcomment(s).Usethekeypad(aswithlogin)toenteryourcomment.
17 Onceyouhaveselectedthedesiredcomment(s),touch toreturntotheresultsscreen.
18 Touch toreturntotheMain Menu.
Testresultsarealsosavedwhenthemeterispoweredoffintheresultsscreenorautomaticallypowersoff.
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Warning screensThemetermaydisplayself-explanatorywarningorerrorscreensatvarioustimeswhenenteringOther Patient TestsandOther Control Tests.Thesewarningscreensdisplaywhenthevalidityoftherecordedresultisinquestion.Thesescreensareimportantflagsastheycautionthattestinformationmaynotbevalidoraccurate.(SeePop-Up Messagessectionofthismanual)
Whenenteringotherpatientandothercontroltestresults,theusermaybepromptedtoenteracontroltest(controlbar)resultaseitheracceptableornotacceptable.Iftheresultisenteredasnotacceptable,subsequentpatientresultsmaynotbevalidduetotheinvalidcontrolbarresult.
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ReviewingOtherTestResults
TheOther Test Resultscreendisplaysallstoredresults.Resultscanbeviewedinthreeways:All,Patient,orQC.
Thefollowingstepsmustbecompletedalready:
1 Themeterispoweredon.
2 YouhaveenteredyouroperatorID.
3 Youhavecompletedloginbyselecting andtheMain Menuscreenisdisplayed.
PerformthefollowingstepstoReview Other Testresult(s):
Main Menu
Review Results
Control Test
Patient Test
12:48 pm
09/18/13
Other Test Results
Patient QC
All -- 09/18/13 Type ID
12:15 pm12:25 pm
StrepVUA
Positive Ctrl10:32 am9:12 am
VUAF Occ
Negative Ctrl8:20 am DAT
54344478
8:31 am Preg 150 88 256
Time
150 88 256
150 88 256
09/18/13
12:48 pmTest Result Menu
Review Glucose Test
Review Other Test
09/18/13
12:48 pm
1 FromtheMain MenuscreentouchReview Results.
2 FromtheTest Result MenutouchReview Other Test.
Allstoredtestresultsaredisplayedinasequentiallist.
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184
Other Test Results
Patient QC
All -- 09/18/13 Type ID
12:15 pm12:25 pm
StrepVUA
Positive Ctrl10:32 am9:12 am
VUAF Occ
Negative Ctrl8:20 am DAT
54344478
8:31 am Preg 150 88 256
Time
150 88 256
150 88 256
09/18/13
12:48 pm Fecal Occult Pat.
QCPatient
ID: 150 88 256
Dev Lot #
Card Lot #
Name: Helen Schneider
4523311/30/13
128312/30/13
09/18/13 9:12 am
Page 1/2
09/18/13
12:48 pm Fecal Occult Pat.
QCPatient
ID: 150 88 256
Doctor Notifi ed
Negative Ctrl
Positive Ctrl
Page 2/2
acceptable
negativeResult
acceptable
09/18/13
12:48 pm
3 Touch or toscrollupordowninthelist.Theresultsaregroupedbydate.
4 Touchanentryinthelisttodisplaytherelateddetails.
5 Touch or todisplayallavailablepagesofatestresult.
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Other Test Results
Patient QC
All -- 09/18/13 Type ID
12:15 pm12:25 pm
StrepVUA
Positive Ctrl10:32 am9:12 am
VUAF Occ
Negative Ctrl8:20 am DAT
54344478
8:31 am Preg 150 88 256
Time
150 88 256
150 88 256
09/18/13
12:48 pm Other Test Results
QCAll
ID: 150 88 256
Type12:25 pm VUA9:12 am F Occ
TimePatient -- 09/18/13
8:31 am Preg8:02 am DAT7:25 am Strep
09/18/13
12:48 pm Other Test Results
Patient All
QC -- 09/18/13 Type ID
12:15 pm Strep Positive Ctrl8:20 am DAT Negative Ctrl
Time
09/18/13
12:48 pm
6 TouchPatient,ifyouwishtodisplayresultsforaspecificpatientonly.
– IfyoutouchPatientfromthefulllistview,youwillbeaskedtoenterthepatientIDmanuallyorviabarcodescanner.Thelistnowcontainsonlytheresultsfortheselectedpatient.
7 TouchQC,ifyouwishtodisplayalistofothercontroltests.
8 TouchAllintheOther Test ResultsscreentoremovethePatientorQCselectionanddisplayallresults.
9 Touch toreturntothepreviousmenuscreen,or
10 Touch toreturntotheMain Menu.
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OtherTestEntryConfigurationOptions
Other Test EntryoptionscanonlybeconfiguredusingaDMS.Theavailabilityofelectronicconfigurationoptionswillthusvaryaccordingtothedatamanagementsoftwareutilizedbyyourinstitution.Consultyoursystemadministrator.
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187
D SupplementforObservedTestSequence
Observed Test Sequence (OTS)TheObserved Test Sequence(OTS)functionallowsanobserver(supervisor)toassessandrecordanoperator’sperformance(e.g.,forrecertificationpurposes).Theobservermonitorsanoperatorduringatesttocheckthatthetestisbeingperformedaccordingtotherecommendedprocedures.He/shethenevaluatestheperformanceandpassesorfailstheoperator.Thisassessmentissavedtogetherwiththeglucosetestresultandanydesiredcomments.
ThisfunctionneedstobeconfiguredbythesystemadministratoranddependsonavailableDMSsettings.Electronicconfigurationoptionswillthusvaryaccordingtothedatamanagementsoftwareutilizedbyyourinstitution..
Ifsoconfigured,theoperatormayreceiveamessagefromtheDMSwhenheorshetriestologintothemeter.Thismessageinformstheoperatorthattheyhavetorenewtheircertification.ThecontentsofthemessageiscreatedontheDMSandmayvary.Thescreenmessageshownhereisforillustrationpurposesonly.
Login Message
I-300: Hello Dan Brown. You have to perform an OTS training before you can use the meter.
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188
Using the OTS functionArequestforanObservedTestSequencecomesfromtheDMS.
Patient Test Menu
Observer Login
Glucose Test
Other Test
12:48 pm
09/18/13
1 2 3
4 5 6
7 8 9
A-O0
Observer ID 12:48 pm
09/18/13
Main Menu
Review Results
Control Test
Patient Test
12:48 pm
09/18/13
Observer:1 TouchPatient Test.
InthePatient Test Menu,theGlucose Testbuttonisgrayedout(disabled)untiltheobserverhasloggedin.
2 TouchObserver Login.
3 WaituntiltheObserver IDscreenisdisplayed.
4 EnteryouroperatorIDorscanyouroperatorIDbarcode.Enterthe(optional)passwordintheObserverPasswordscreen,andtouch tologin.
ThePatient Test Menuisdisplayedagain.TheGlucose Test buttonisnowavailable.
5 Handthemetertotheoperatorwhocannowperformthepatienttestundersupervision.
Other Test
Patient Test Menu
Observer Login
Glucose Test
12:48 pm
09/18/13
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189
Operator:6 TouchGlucose Test.
Performthepatienttestasusual.Oncethetestiscompleted,theobserverhastocompletethenextsteps.
7 Handthemeterbacktotheobserver.
Observer Login
I-301: Observer Alan Smithee, please log in to proceed. Otherwise the OTS test will not be complete.
OTS
Valid Glucose Result
NoYes
OTSPassFail
12:48 pm
09/18/13
Patient Test - OTS
Range
150
Patient 123456789Date 09/18/13 12:48 pm
mg/dL
09/18/13
12:48 pm
Observer:8 Touch tologinagain.
9 Afteryouenteryourpassword,touch toproceedwiththeassessment.
10 AssessthetestresultvaliditybytouchingYesorNo.
11 Assesstheoperator’sperformancebytouchingPassorFail.
12 Touch ,ifyouwanttoaddacomment.
13 Touch toreturntotheMain Menuscreen.
TheOTSinformationissavedtogetherwiththetestresult.
SupplementforObservedTestSequence
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LimitedWarranty
191
E LimitedWarranty
ACCU-CHEK®InformIImeterLIMITEDWARRANTY
RocheDiagnosticswarrantstotheoriginalpurchaserthattheACCU-CHEK®InformIImeterwillbefreefromdefectsinmaterialsandworkmanshipfor1yearfromthedateofpurchaseorforthetermofanACCU-CHEK®InformIIteststripcontract,whicheverislonger.
If,duringthewarrantyperiod,themeterdoesnotworkproperlybecauseofadefectinmaterialsorworkmanship,RocheDiagnosticswillrepairitorreplaceitwithaneworrefurbishedACCU-CHEK®InformIImeterorequivalentproductfreeofcharge.Thewarrantyoftherepairedorreplacementmeterwillexpireonthedateoftheoriginalwarrantyexpirationor90daysaftershipmentofareplacementmeter,whicheverperiodislonger.Thepurchaser’ssoleandexclusiveremedywithrespecttotheACCU-CHEK®InformIImetershallberepairorreplacement,inRocheDiagnosticssolediscretion.
AnoptionalwirelesscardismadeavailableforuseintheACCU-CHEKInformIIsystem.ThesewirelesscardshavebeenvalidatedforusewiththeACCU-CHEKInformIImeter.UseofamatchedorunmatchedwirelesscardsuppliedbyanothermanufacturermaypreventorimpairtheproperfunctionoftheACCU-CHEKInformIIsystem.
ThiswarrantydoesnotapplytotheperformanceofanACCU-CHEK®InformIImeterthathasbeendamagedbyaccidentorhasbeenaltered,misused,tamperedwithorabusedinanyway.
THEABOVEWARRANTYISEXCLUSIVEOFALLOTHERWARRANTIES,ANDROCHEDIAGNOSTICSMAKESNOOTHERWARRANTIES,EXPRESSORIMPLIED,INCLUDINGWITHOUTLIMITATIONTHEIMPLIEDWARRANTYOFMERCHANTABILITYORFITNESSFORAPARTICULARPURPOSE.
LimitedWarranty
192
INNOEVENTSHALLROCHEDIAGNOSTICSBELIABLETOTHEPURCHASERORANYOTHERPERSONFORANYINCIDENTAL,CONSEQUENTIAL,INDIRECT,SPECIALORPUNITIVEDAMAGESARISINGFROMORINANYWAYCONNECTEDWITHTHEPURCHASEORUSEOFTHEACCU-CHEK®INFORMIIMETER.NOWARRANTYOFMERCHANTABILITYORFITNESSFORAPARTICULARPURPOSE,IFANYISIMPLIEDFROMTHESALEOFTHEMETER,SHALLEXTENDFORALONGERDURATIONTHAN1YEARFROMTHEDATEOFPURCHASE.
Somestatesdonotallowlimitationsonhowlonganimpliedwarrantywilllastortheexclusionofincidentalorconsequentialdamages,sotheabovelimitationandexclusionmaynotapplytoyou.Thiswarrantygivesyouspecificlegalrights,whichvaryfromstatetostate.
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Index
AAccessorybox
Overview..............................................................29Addresses(Roche)................................................ 142
BBarcode
Masks................................................................ 151Symbologies.................................................... 152
BaseUnit,BaseUnitLightConnecting.........................................................97Overview..............................................................28
BatterypackInstallingorreplacing........................... 98–102
Beeper....................................................................... 120
CCipher........................................................................ 149Cleaning...........................................................124–129Cleaningagents..................................................... 126Codechip. SieheCode keyCodekey...............................................................27, 65Codekeyreader
Downloadingcodekeyinformation...........66Overview..............................................................27
CommentsAdding..................................................................50Maintenancelog............................................ 130
Components...............................................................25Configuration..............................105–120, 143–152
Menuoverview......................................106–108Contrast........................................................................32Controlfrequency.................................................. 114
ControllotsEditingcontrollotdata.............................70–75Selecting..............................................................56Storinginformation...................................65–80
ControlsolutionLotnumber..........................................................56
Criticalrange.................................................... 49, 115CRLO/HI......................................................................49
DDateandtime.......................................................... 119Dateandtimeformat........................................... 110Diagnostics.............................................................. 120Disinfecting.....................................................124–129Disinfectingagents............................................... 126Displayoptions....................................................... 111Disposal.......................................................................19Dockingthemeter................................................. 103Downloadlockout.............................................39, 61
Unlocking......................................................... 122
EErrormessages.............................................. 135-136Errors(withouterrormessage)................131–134
GGlucosecontrol
Controlsolutions...............................................53Intervals................................................................52Performingatest........................................54–60Preparing.............................................................53STATtest..............................................................61
Glucosecontroloptions...................................... 114Glucosecontroltesting....................................51–62
Results..................................................................60
HHI....................................................................................49
194
IIcons
Identificationplate............................................. 4Packaging.............................................................. 4
Informationservice............................................... 142Initialstartup.................................................... 97–122
LLicense(GPL).......................................................... 142Linearitylots
Editinglinearitylotdata...........................76–79Storinginformation...................................65–79
Linearitytesting..................................................81–88Intervals................................................................81Performingatest........................................83–87Preparing.............................................................82Results..................................................................87
LO...................................................................................49Lots.........................................................................65–79
MMaintenance..................................................123–130
Log...................................................................... 130Meter
Cleaning............................................................ 129Diagnostics...................................................... 121Disinfecting...................................................... 129Overview..............................................................26Poweringup........................................................31Reset.................................................................. 137Setup.........................................................143–152
Metersetup....................................................105–120Menuoverview......................................106–108
NNormalrange................................................... 49, 115
OObservedtestsequence.............................179–180Operatingconditions(general)........................ 123OperatorID..........................................................34–36
BarcodeScanner..............................................35Enteringmanually.............................................36Options.............................................................. 116Password.............................................................36
Ordering.................................................................... 141
PPassword.................................................................. 118Patientglucosetesting....................................37–50
Performingatest........................................39–49Preparing.............................................................38Results..................................................................47
PatientID..............................................................39–43Barcodescanner...............................................43Enteringmanually.............................................41Options.............................................................. 117
Poweringup...............................................................31Productinformation.....................................143–146Proficiencytesting.............................................89–96
Performingatest........................................91–96Preparing.............................................................90Results..................................................................95
QQClockout..................................................................51
RRanges(results)........................................................48Reagentoptions..................................................... 113Reagents......................................................................29REF(catalognumbers)........................................ 141Reportablerange............................................ 49, 115Reset.......................................................................... 137Resultmemory....................................................63–64Resultsscreen..................................... 47, 60, 87, 95RRLO/HI......................................................................49
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SSafety
Protectionagainstinfection..........................17Userqualification..............................................17
Safetyinformation.............................................17–23Sample
Applying......................................... 46, 59, 86, 94Screen
Contrast................................................................32Setup..............................................105–120, 142–152
Beeper............................................................... 120Dateandtime.................................................. 119Dateandtimeformat................................... 110Displayoptions............................................... 110Glucosecontroloptions.............................. 114Menuoverview......................................106–108OperatorIDentry........................................... 116Password.......................................................... 118PatientIDentry............................................... 117Reagentoptions............................................. 113Setupmenu............................................109, 122Teststripoptions............................................ 112Valueranges.................................................... 115
Specifications.......................................................... 140STATtest......................................................................61Storage...................................................................... 124Striplot
Selecting.......................................................44, 57System
Cleaning...................................................124–129Components.......................................................25Disinfecting.............................................124–129Generalinformation.............................143–152Initialstartup............................................. 97–122Maintenance..........................................124–129Overview(accessorybox)..............................29Overview(baseunit)........................................28Overview(codekeyreader)..........................27Overview(meter)..............................................26Technicaldata................................................ 139Troubleshooting....................................130–136
TTechnicaldata........................................................ 139Teststriplots
Storinginformation...................................65–79Teststripoptions.................................................... 112Teststrips
Applyingbloodsample...................................46Applyingcontrolsolution...............................59Applyinglinearitysample..............................86Applyingproficiencysample........................94Editingdata..................................................68–71Inserting......................................... 45, 58, 85, 93Setupoptions.................................................. 112
Troubleshooting............................................130–136
UUnit(results)............................................................ 111
WWarranty................................................................... 183WLAN........................................................................ 153WLANsecurity........................................................ 149
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ACCU-CHEK, ACCU-CHEK INFORM and COBAS are trademarks of Roche.
Manufactured for and distributed in the U.S.A. by:Roche Diagnostics9115 Hague RoadIndianapolis, IN 46256
Roche Diagnostics GmbHSandhofer Strasse 11668305 MannheimGermany
www.accu-chekinformii.comwww.roche.comwww.accu-chek.com 05
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