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.

Introduction

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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.

Introduction

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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

24

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

25

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

Introduction

26

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

27

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 .


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


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


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


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.


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


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


39

Foremergencies,ShortTurn-AroundTimetests(STAT)testscanbeconfiguredinthemeter.Thisoptionallowsthemetertoperformalimitednumberofpatientglucosetests,ifcircumstancesrequire,despitethemeterbeinginQCLockoutorDownloadLockout(seepage63).

InMeasurementmodeonly:Ifyouareperformingatest(patient,control,proficiencyorlinearity),themeterwillpoweroffafter10minutesofinactivity(noscreentouches),independentlyofconfiguredautomaticpowerofftime.Ifaresultisalreadypresent,themeterwillemitthreewarningbeepseveryminuteafter5minutesofinactivityandwillsavetheresultbeforepoweringoffafter10minutesofactivity.

n Observetheapplicableregulationsanddirectivesforhygieneandsafetywhencollectingbloodsamples.

n Observetheapplicableregulationsanddirectivesfordisposingofpotentiallyinfectioussamplesandmaterials.


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.


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.


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


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


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.


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


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.


12:48 pm

09/18/13


47

Applying a blood sampleOncethemeterhascheckedtheteststrip,thehourglassicondisappearsandyouarepromptedtoapplyabloodsample.


12:48 pm

09/18/13

1 Waituntiltheflashingdropappearsinthedisplaybeforeapplyingtheblood.Themeterbeeps.

2 Applythedropofbloodtothefrontedge(yellowdosingarea)oftheteststrip.Bloodispulledintotheteststripbycapillaryaction.Donotapplythebloodtothetopofthestrip.Bloodontopoftheteststripisnotavailablefortestingbecauseitwillnotbepulledintothestrip.Onceasufficientbloodsamplehasbeendetected,themeterbeepsandthemeasurementbegins.


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


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.


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


34

Patient 123456789Date 09/18/13 12:48 pm

mg/dL

12:48 pm

09/18/13

Patient Test


305

Patient 123456789Date 09/18/13 12:48 pm

mg/dL

09/18/13


Out of Reportable Range

RR HI

Patient 123456789Date 09/18/13 12:48 pm

12:48 pm

09/18/13


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.


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.


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


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.


GlucoseControlTesting

53

4 GlucoseControlTesting

Informationregardingglucosecontroltests

Observetheapplicableregulationsanddirectivesoftheresponsibleregulatoryagencieswhenperformingglucosecontroltests.

Accuratelytestingknownlevelsofglucoseensuresthatthesystemandyourtechniqueusedintestinggiveaccurateresultsonpatienttests.Glucosecontrolsolutionshavedefined(known)values.Theresultsforthesesolutionsmustfirstfallwithinacertainacceptablerangeinordertoallowvalidpatienttesting.

Thesystemmaybeconfiguredtorequirein-rangeglucosecontroltestingbeforepatienttestingisallowed.ThisiscalledQC Lockout,andthesystemactuallypreventspatientandproficiencytestingwhenthecontrolresultsarenotwithintheacceptedrange.


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


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 Theproperteststripsmustbeavailable.

n AnoperatorIDmustbeentered(withpassword,ifapplicable),ifthemeterisconfiguredforlogin.


56

Performingglucosecontroltests

Overview of test procedureAglucosecontroltestusingcontrolsolutioncomprisesthefollowingsteps:

n Selectthedesiredlevelofcontrolsolutionforthetest.

n Checkthelotnumberofthecontrolsolution.

n Checkthelotnumberoftheteststrips.

n Performthetestwiththecontrolsolution.

Asmentionedpreviously,thefollowingstepsmustbecompletedalready:

1 Themeterisswitchedon.



Theresultmustfallwithinthespecifiedrange(asshownonthelabeloftheteststripvialordefinedperconfiguration)forthecontroltesttobecompletedsuccessfully.Patienttestscannowbeperformed(again).


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.


58

Confirming or selecting the lot number for control solutions

Onceyouhaveselectedthelevel,youareaskedtoconfirmorenterthelotnumberofthecontrolsolution.Comparethenumberdisplayedbythemetertothenumberonthelabelofthecontrolsolutionbottle.


n Toreadthelotnumberfromthecontrolsolutionbottleviabarcodescanner,pressandrelease .FollowtheinstructionsforscanningIDs(seepage35).*

n Tousethepreselectednumberdisplayedbythemeter,touch toconfirm.

n Touseadifferentnumberthanthelotnumberdisplayed,touch toopenthekeypadandenterthenumbermanually.

2 Touch toconfirmtheselectedcontrollotnumber.


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


59


Onceyouhaveenteredandconfirmedthelotnumberofthecontrolsolution,youareaskedtochoosetheteststriplotnumber.Comparethenumberdisplayedbythemetertothenumberonthelabeloftheteststripvial.


n Toreadtheteststriplotnumberfromtheteststripvialviabarcodescanner,pressandrelease .FollowtheinstructionsforscanningIDs.*

n Tousethepreselectedteststriplotnumberdisplayedbythemeter,touch toconfirm.

n Touseadifferentlotnumberotherthantheonedisplayed,touch toopenthekeypadandenterthenumbermanually,ortodisplayalistofstoredlotnumbersandthenselectthedesiredlotnumberfromthelist..

2 Touch toconfirmtheselectedteststriplotnumber.


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


60

Inserting test stripsAfterconfirmingtheteststriplot,aflashinggreenarrowappearsonthescreenandpromptsyoutoinserttheteststrip.

Control TestControl L2 (Hi) 123456Strip Lot 545794

12:48 pm

09/18/13



3 Slidetheteststripintotheteststripportasfarasitgoesinthedirectionindicatedbythearrowsontheteststrip.Themeterbeeps.Thehourglassiconappearsandindicatesthatthemeterischeckingtheteststrip.Donotapplycontrolsolutionwhileitisdisplayed.


12:48 pm

09/18/13


61

Applying the control solutionOncethemeterhasdetectedtheteststrip,thehourglassicondisappearsandyouarepromptedtoapplycontrolsolution.


12:48 pm

09/18/13

1 Waituntiltheflashingdropappearsinthedisplaybeforeapplyingthecontrolsolution.Themeterbeeps.

2 Applyadropofglucosecontrolsolutiontothefrontedgeoftheteststrip.Donotapplythecontrolsolutiontothetopofthestrip.Thecontrolsolutionispulledintotheteststripbycapillaryaction.

Oncesufficientcontrolsolutionhasbeendetected,themeterbeepsandthemeasurementbegins.


62


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.


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


64


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


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


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


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.


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.


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


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'


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


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.


73

Onceyouhavefinishedupdatingtheteststripinformation,youcanusethenextscreentoselectthelotnumberyouarecurrentlyeditingasthecurrentlotnumber.


5 Touch toconfirmthatyouwantthislotnumbertobethelotnumbercurrentlyinuse,or

6 Touch tostoretheentrieswithoutmakingthelotnumberthecurrentlotnumber.

7 Continueenteringadditionallotnumbers,or


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


74

Storingcontrolsolutioninformation

Glucosecontrolsolutionlotinformationcanbeenteredbeforetesting,ifloteditinghasbeenallowedatthemeterlevelinthesetup,andappearsinalistforoperatorstoreferto.UsethefollowingproceduretoaddglucosecontrollotnumberstotheControlLotlist.

Entering the lot number of the control solution


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


2 TouchControl Lotstoopentherelatedmenu.

3 TouchAddtoenteranewlotnumber.


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.


76

Onceyouhavefinishedupdatingthecontrolsolutioninformation,youcanusethenextscreentoselectthelotnumberyouarecurrentlyeditingasthecurrentlotnumber.


9 Touch toconfirmthatyouwantthiscontrollotnumbertobethelotnumbercurrentlyinuse,or

10 Touch tostoretheentrieswithoutmakingthelotnumberthecurrentlotnumber.

11 Continueenteringadditionalcontrollotnumbers,or


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'


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


09/18/13

1 Touch inthemainmenutoopentheMain Menu 2screen.

2 TouchControl Lotstoopentherelatedmenu.Thecurrentlotnumberisindicatedbyanasterisk(*).


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


09/18/13

3 Touchthelotnumberyouwishtoselectasthecurrentlotnumber.Thisopenstherelateddetailview.

4 TouchMake Currenttomakethelotnumberthecurrentlotnumber.TheinformationCurrentisthenalsodisplayedinthedetailview.

5 Touch toreturntothelistoflotnumbers,or



79

Storinglinearitytestinformation

Observetheapplicableregulationsanddirectivesoftheresponsibleregulatoryagencieswhenperforminglinearitytests.

Entering the lot number of the linearity test


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.


09/18/13


2 TouchLinearity Lotstoopentherelatedmenu.

3 TouchAddtoenteranewlotnumber.


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.


7 Touch toconfirmthatyouwantthislotnumbertobethelotnumbercurrentlyinuse,or

8 Touch tostoretheentrieswithoutmakingthelotnumberthecurrentlinearitylotnumber.

9 Continueenteringadditionallotnumbers,or


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


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.


09/18/13

1 Touch inthemainmenutoopentheMain Menu 2screen.

2 TouchLinearity Lots toopentherelatedmenu.Thecurrentlinearitylotnumberisindicatedbyanasterisk(*).


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.


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


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 Timeanddateoftest


Linearity test kitThelinearitytestkitcontainsglucosesolutionsinsixlevels(6vials,2.5mLeach).Foradditionalinformationaboutthecontentsandhandlingofthekit,refertothepackageinsert.

Preparing to run a linearity testAsidefromspecialpreparations(seethefollowingsection),alinearitytestisrunthesameasapatienttest.Pleasecheckthefollowing:




LinearityTesting

85

Performingalinearitytest

Overview of test procedureAlinearitytestcomprisesthefollowingsteps:

n Checkthelotnumberofthelinearitysolutions.


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).


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

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1 Removetheteststripfromtheteststripvialandclosethevialagainwiththecap.


3 Slidetheteststripintotheteststripportasfarasitwillgointhedirectionindicatedbythearrowsontheteststrip.Themeterbeeps.Thehourglassiconappearsandindicatesthatthemeterischeckingtheteststrip.Donotapplylinearitysolutionwhileitisdisplayed.

Linearity Test

L1

L5

L3

L6

L4

L2

Linearity 12345678Strip Lot 545794

12:48 pm

09/18/13


12:48 pm

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LinearityTesting

88

Applying a linearity test sampleOncethemeterhascheckedtheteststrip,thehourglassicondisappearsandyouarepromptedtoapplylinearitysolution.


12:48 pm

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1 Waituntiltheflashingdropappearsinthedisplaybeforeapplyingthesolution.Themeterbeeps.

2 Applyadropofthelinearitysolutiontothefrontedgeoftheteststrip.Donotapplythesolutiontothetopofthestrip.Thelinearitysolutionispulledintotheteststripareabycapillaryaction.

Oncesufficientlinearitysolutionhasbeendetected,themeterbeepsandthemeasurementbegins.

LinearityTesting

89


Linearity Test

45

Linearity 12345678 L1Date 09/18/13 12:48 pm

mg/dL

12:48 pm

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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.


LinearityTesting

90


ProficiencyTesting

91

8 ProficiencyTesting

Informationregardingproficiencytests

Observetheapplicableregulationsanddirectivesoftheresponsibleregulatoryagencieswhenperformingproficiencytests.

Bloodglucoseproficiencytestsarerunonsampleswhosevaluesareunknowntotheoperatorperformingthetest.Thesesamplesareprovidedbyanoutsidesource,andtheresultsshouldbeforwardedtotheappropriatesourceaftercompletingthetest.Thesuppliedsamplesaretreatedinthesamemannerasregularpatientsamples.

Bloodglucoseproficiencytestingprovidesanothermeanstoverifythatyourtechnique,reagents,system,andtestingperformanceareastheyshouldbe.Someregulatoryagenciesrequirethattheseproficiencysamplesbetestedaspartofaninstitution’squalityassuranceprogrambeforecertificationoftheinstitutionisallowed.

Note:Whenusingadatamanagementsystemforconfiguration,itispossibletopartiallyorfullydisablethefunctionsdescribedinthischapter.Inthiscase,therespectivebuttonsinMain Menu 2donotappear.(SeealsoAppendixA).

ProficiencyTesting

92

Information stored during proficiency testing

Thefollowinginformationisstoredforeveryproficiencytest:

n Testresult

n SampleID


n Timeanddateoftest



Forbloodglucoseproficiencytests,thesampleID(insteadofpatientID)mustbestoredasidentification.SampleIDswithupto20characterscanbeentered.

Preparing a proficiency testToperformaproficiencytestyouneedthefollowing:




ProficiencyTesting

93

Performingaproficiencytest

Overview of test procedureAproficiencytestcomprisesthefollowingsteps:

n EnterasampleIDfortheproficiencysample.


n Performtheactualtestwiththeproficiencysample.

Starting a proficiency testThefollowingdescriptionassumesthatthemeterispoweredonandthemainmenuisdisplayed.

Main Menu

Review Results

Control Test

Patient Test

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Main Menu 2

Maintenance

Strip Lots

Profi ciency

Control Lots

Beeper

Linearity

Diagnostics

Linearity Lots

Admin.

12:48 pm

09/18/13


2 TouchProficiencytostarttheproficiencytest.

ProficiencyTesting

94

Entering the proficiency sample ID

YouwillnowbeaskedtoenterthesampleID.

1 UsethekeypadtomanuallyenterthesampleID,orpressandrelease toreadthesampleIDfromthesamplevialviabarcodescanner.Makesureinthiscasethattheproficiencysamplehasacompatiblebarcode(seeAppendixA).

2 Touch toconfirmtheselectedorscannedsampleID.


OnceyouhaveenteredandconfirmedthesampleID,youwillbeaskedtochoosetheteststriplotnumber.Comparethenumberdisplayedbythemetertothenumberonthelabeloftheteststripvial.

3 Ifyouwanttousethepreselectednumberdisplayedbythemeter,touch toconfirm.Touseadifferentnumberthanthelotnumberdisplayed,touch toselectthenumberfromalist,enterthenumbermanuallyviakeypad,orusethebarcodescannertoenterthelotnumber.

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Profi ciency TestSample 123456789

Use Strip Lot

12:48 pm

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123456?

ProficiencyTesting

95

Inserting test stripsAfterconfirmingtheteststriplot,aflashinggreenarrowappearsonscreenandpromptsyoutoinserttheteststrip.

Proficiency TestSample 123456789Strip Lot 545794

12:48 pm

09/18/13



3 Slidetheteststripintotheteststripportasfarasitwillgointhedirectionindicatedbythearrowsontheteststrip.Themeterbeeps.Thehourglassiconappearsandindicatesthatthemeterischeckingtheteststrip.Donotapplytheproficiencysamplewhileitisdisplayed.

Profi ciency TestSample 123456789Strip Lot 545794

12:48 pm

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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


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.



ProficiencyTesting

98


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.

InitialStartup

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.

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Date

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09/30/13

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1 2 3

4 5 6

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AM/PM0

Time 12:48 pm

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12:15 pm

InitialStartup

104

Dockingthemeter

Dockingthemeterinthebaseunitallowsyoutochargethebattery.Whendocked,themetershowsdifferentmessagesaccordingtothecurrentmeterstatus.

ThefollowingdisplaysappearonthemeterwhenitisdockedinanACCU-CHEKInformIIBaseUnitoranACCU-CHEKInformIIBaseUnitLightandcommunicating.Thesamedisplaysappearwhetherthemeteristransferringdataviabaseunitorviawirelessconnection.

Docked

Connecting...

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Docked

Synchronizing Database...

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Docked

Transferring...50 Results to Transmit

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InitialStartup

105

ThisdisplayisvisiblewhencommunicationisstillactivebutthemeterisbusyprocessingthedatareceivedorwaitingforthenextdatamessagefromtheDataManagementSystem(DMS).

Thisdisplayisvisiblewhensoftwareupdatesaretransferredtothemeter.

Thisdisplayisvisiblewhensoftwareupdatesaretransferredtothemeter.

Note:

n Ifthemetertransfersdatawirelesslyimmediatelyafteratest,thiscommunicationisnotvisibleonthedisplay.Thedisplayremainsunchanged(usuallyintheMain Menuviewafteratest).

n Ifameterisinstandby(butnotdocked)andcommunicatingwirelessly,thiscommunicationisnotvisibleonthedisplay.

Docked

Busy...

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Docked

Idle

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Docked

Updating Software...

12:48 pm

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InitialStartup

106

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

InitialStartup

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

InitialStartup

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.

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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


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

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InitialStartup

112

Displayoptionsandoptionaltests

Usethismenutoselecttheunitofmeasurefortestresultsandenableordisableoptionaltests.


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:


ThedisplayreturnsinbothcasestotheSetup Menu(afterenteringthenumberofSTATtestsallowed).

Test Disp. Options

mg/dLmmol/L

Enable Tests:StatLinearityProfi ciencyMaintenance

Display Strip LimitationsWarning

Result Units

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0

STAT Test Allowed

8

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InitialStartup

113

Optionsforteststrips

Thismenuallowsyoutoselectoptionsforhandlinglotnumbersandspecifywhethertheoperatorisallowedtoaddordeletereagentlots,edittheexpirationdateandlimitvaluesonthemeter(optionallywithpasswordrequired).


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


Whenusingadatamanagementsystemforconfiguration,itispossibletofullydisabletheReagent Editingoption.

Reagent Options

AllowedPassword Needed

Display onlyConfi rmationList selectionScan only

Reagent Editing

Strip Lot Verifi cationNot Allowed

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InitialStartup

114

Onthesecondsettingsscreen,youcanselectoptionsforhandlinglotnumberswithglucosecontrolandlinearitytests.


n ControlLotVerification



– Lot entry:Theoperatormustenterthelotnumber.

– Scan only:Lotnumberscanbeverifiedviabarcodescanneronly.

n LinearityLotVerification



– 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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InitialStartup

115

Optionsforglucosecontroltests

Thismenucontainsoptionsthatallowyoutospecifywhetherandatwhatintervalsglucosecontroltestsareperformed.Ifyourequirecontroltests,checkyoursettingsforSTATtests(seepage112).


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:



QC Frequency

Control Frequency

Last QC OKAlways OK

Strip CountHours

Rotating QC

ShiftTime Of Day

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QC Hours

50

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QC Strips

50

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InitialStartup

116

Valueranges(normal,critical,reportable)

ThismenuallowsyoutosetlimitvaluesforresultsasNormal,Critical,orReportable.Resultsoutsidetheselimitswillbeflaggedtoalertyouofthisevent.TheReportable Rangeallowsthesystemadministratortosetaninstitutiondefinedrangeforreportingpatientresults.

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Report. Range Lo

11 mg/dL

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Normal Range Lo

70 mg/dL

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Critical Range Lo

40 mg/dL

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Report. Range Hi

600 mg/dL

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Normal Range Hi

200 mg/dL

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Critical Range Hi

301 mg/dL

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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.


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:



Operator ID Entry

PromptNone

Length

Scan only

None

Operator Entry

Operator ValidationPrompt (numeric only)

ListList with password

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Op. ID Min Length

8

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Op. ID Max Length

12

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InitialStartup

118

PatientIDoptions

ThismenuallowsyoutospecifythecriteriaforenteringapatientID.


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:


ThedisplayalwaysreturnstotheSetup Menu(afterenteringthedesirednumbers).

Patient ID Options

Scan onlyPrompt (numeric only)

Patient EntryPrompt

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Prompt or List

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Pat. ID Min Length

8

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Pat. ID Max Length

12

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Patient ID Options

LengthNone

Patient Validation

Length if numeric

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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.

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120

Settingthedateandtime

Thissettingcanbehiddenorrequireentryofthesetuppassword,basedonconfiguration.

Main Menu

Review Results

Control Test

Patient Test

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Main Menu 2

Maintenance

Strip Lots

Profi ciency

Control Lots

Beeper

Linearity

Diagnostics

Linearity Lots

Admin.

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Admin Menu

Date / Time

Language Selection

Setup Menu

12:48 pm

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3 TouchDate/Timetobeginenteringthedate.

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Date

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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


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.

MaintenanceandCare

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.

MaintenanceandCare

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.


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


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


2 TouchDiagnosticstocallupthemainscreenforthismenu.

MaintenanceandCare

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.


MaintenanceandCare

133

UnlockingaDownloadLockout

Whenusingadatamanagementsystemforconfigura-tion,aDownload Lockoutcanbeconfigured.Thislockoutpreventsameterfrombeingusedfortesting,ifthemeterdatahavenotbeendownloadedforadefinedperiodoftime.Ifadownloadlockoutoccurs,theoperatormayuseaSTATtesttotemporarilyoverridethelockout.IfnoSTATtestisconfiguredorleft,themetercannotbeuseduntilthestoreddataisdownloadedvianetwork(eitherwirelessorbydockingthemeter).

Incasesofe.g.,networkfailures(whichmakeadownloadimpossible),orotheremergencies,itmaybenecessarytounlockameterwithoutaccesstothedatamanagementsystem.SinceunlockingisafunctionoftheSetup Menu,itisrestrictedtopersonswhoknowthesetuppassword.


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


Unlock Delete Pat.

12:48 pm

09/18/13

Tounlockameter:



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


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


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.


Chapter3).– Runaglucosecontroltestwithanewteststrip(see

Chapter4).– Repeatthetestorproceedaccordingtotherequirements

ofyourfacility.– Iftheerrorpersists,contactACCU-CHEKCustomerCare.

MeterdisplaysanerrorTypeBadDose

Insufficientamountofbloodontheteststrip.– Refertothepackageinsertfortheteststrips.– Reviewpropertestingprocedure.– Repeatthetestusinganewteststrip,ensuringproper

sampleapplication.– Iftheerrorpersists,contactACCU-CHEKCustomerCare.

Meterdisplays(QC)FAILorOutofRange


Chapter4).– Repeattheglucosecontroltestwithanewteststrip.– Iftheerrorpersists,contactACCU-CHEKCustomerCare.

Troubleshooting

137


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


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...



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)



Airpressure 0.7to1.06bar70to106kPa

0.7to1.06bar70to106kPa

N/A

*ACCU-CHEKInformIIBaseUnitLight:onlyred,green


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


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


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.


147

Contact RocheForallquestionsabouttheACCU-CHEKInformIIsystemthatarenotansweredinthismanual,contactyourRocherepresentative.Ifyoudonotalreadyhavecontactdetails,visitourwebsiteonwww.roche.com.Select“Rocheinyourcountry”atthetopofthepageandthenselectyourcountrytofindtheappropriatelocalofficecontactinformation.

TheACCU-CHEKInformIIsystemismanufacturedforanddistributedby:

IntheUnitedStates:

RocheDiagnostics9115HagueRoadIndianapolis,IN46256


148



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


150


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


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


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


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


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


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)


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


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.)



ObservedTestSequence(OTS)

OTSfunctionality* 0:disabled1:enabled

0 N Y


Appendix

157

OtherTestEntry(OTE)

OTEfunctionality* 0:disabled1:enabled

0 N Y


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)


2-WPA_PSK 2-TKIP(WPA)


-

2-WPA_PSK 3-AES/TKIP(WPA2/WPA)


2-WPA_PSK 3-AES/TKIP(WPA2/WPA)


-

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.

Appendix

162

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.

Appendix

163

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.

Appendix

164

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.

Appendix

165

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.

Appendix

166


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.


168

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)


169

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.


170

RecordingOtherTestEntries

Thefollowingstepsmustbecompletedalready:

1 Themeterispoweredon.


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.


171

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.


172

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.


173

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.


174

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.


175

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


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.





176

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)


177

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.


178




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.


179

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.


180

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.





182

Warning screensThemetermaydisplayself-explanatorywarningorerrorscreensatvarioustimeswhenenteringOther Patient TestsandOther Control Tests.Thesewarningscreensdisplaywhenthevalidityoftherecordedresultisinquestion.Thesescreensareimportantflagsastheycautionthattestinformationmaynotbevalidoraccurate.(SeePop-Up Messagessectionofthismanual)

Whenenteringotherpatientandothercontroltestresults,theusermaybepromptedtoenteracontroltest(controlbar)resultaseitheracceptableornotacceptable.Iftheresultisenteredasnotacceptable,subsequentpatientresultsmaynotbevalidduetotheinvalidcontrolbarresult.


183

ReviewingOtherTestResults

TheOther Test Resultscreendisplaysallstoredresults.Resultscanbeviewedinthreeways:All,Patient,orQC.





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.


184

Other Test Results

Patient QC

All -- 09/18/13 Type ID

12:15 pm12:25 pm

StrepVUA


VUAF Occ


54344478

8:31 am Preg 150 88 256

Time

150 88 256

150 88 256

09/18/13


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


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.


185

Other Test Results

Patient QC

All -- 09/18/13 Type ID

12:15 pm12:25 pm

StrepVUA


VUAF Occ


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



186

OtherTestEntryConfigurationOptions

Other Test EntryoptionscanonlybeconfiguredusingaDMS.Theavailabilityofelectronicconfigurationoptionswillthusvaryaccordingtothedatamanagementsoftwareutilizedbyyourinstitution.Consultyoursystemadministrator.

SupplementforObservedTestSequence

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.


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


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.


190


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.

193

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

195

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

196


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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