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Instructions for use

No part of these instructions for use or the products it describes may be reproduced by any means or in any form without prior consent in writing from iLine Microsystems.

The information contained in these instructions for use was correct at the time of printing. However, iLine Microsystems reserves the right to introduce changes to the specifications, equipment and maintenance procedures of the system at any time, without prior notification. Any substantial changes will be added to the next revision of these instructions for use. In case of conflict between the information of the instructions for use of the microINR Meter and the microINR Chip, the information contained in the instructions for use of the microINR Chip will have priority.

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For monitoring of oral anticoagulation treatment based on Vitamin K

antagonist drugs.CONTENTS

Eng

lish

microINR Meter

INTRODUCTION INTENDED USE BEFORE STARTING TO USE THE microINR® SYSTEM Safetyinformation ORAL ANTICOAGULANT THERAPY INRandProthrombinTime MEASURING PRINCIPLE microINR® SYSTEM DESCRIPTION OF THE microINR® KIT PARTS OF THE microINR® METER CHARGING THE microINR® METER SETTING THE TIME AND DATE PATIENT IDENTIFICATION (OPTIONAL) QUALITY CONTROL CONDUCTING THE TEST PREPARING THE NECESSARY MATERIALS MEASUREMENT PROCEDURE TurningtheMeterOn InsertingtheChip

1.1.11.2

1.3

1.42.2.12.22.32.42.52.63.3.13.2

ModesofUse ConductingtheTest TestResultandAssayEnd TurningtheMeterOff OBTAINING AND APPLYING THE CAPILLARY BLOOD SAMPLE INTERPRETING THE RESULTS LIMITATIONS OF USE MEMORY AND DATA EXTRACTION TO A COMPUTER CLEANING AND DISINFECTING THE microINR® METER ERROR GUIDE ADDITIONAL INFORMATION SPECIFICATIONS CE DECLARATION OF CONFORMITY WARRANTY TECHNICAL SERVICE SYMBOLS GLOSSARY

99

1010

111213

13

141516161616161718

3.3

3.43.54.

5.

6.7.7.17.27.37.47.57.6

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22334556667788888

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1.1 INTENDED USEThemicroINRsystemisintendedtomonitororalanticoagulationtherapy(OAT)withvitaminKantagonistdrugs.ThemicroINRsystemdeterminesquantitativeprothrombintime(PT)inINR(InternationalNormalizedRatio)unitswithfreshcapillarybloodperformedbyfingersticking.ThemicroINRsystemisamedicaldeviceforin-vitrodiagnosticsintendedforprofessionalandself-testinguse.

1.2 BEFORE STARTING TO USE THE microINR® SYSTEM ThemicroINRMeterisintendedtobeusedexclusivelywiththemicroINRChipsmanufacturedbyiLineMicrosystems.BeforestartingtousethemicroINRsystem,readtheseinstructionsforusecompletely,aswellastheinstructionsforuseofthemicroINRChip.Also,donotforgettoreadtheinstructionsforuseofthelancingdeviceandlancetsusedtoobtainthecapillarybloodsample.

KeeptheseinstructionsforusenearthemicroINRsystemandrefertothemifyouhaveanyquestionsaboutproperoperationofthesystem.

Users of the microINR system (patients and healthcare professionals) must receive proper training before starting to use the system.

BeforestartingtousethemicroINRsystem,verifythecompatibilitybetweenthesoftwareversionofyourMeterandthereferenceoftheChipsyouaregoingtouse.

REF SOFTWAREVERSION*CHA0025AA AllsoftwareversionsCHB0025AA >07:03

*Thesoftwareversionappearsatthetopofthedisplay,immediatelyafterturningtheMeteron.Ifyoucannotreadtheversion,repeattheattemptbyturningtheMeteroffandonagain.

Safety InformationGeneral Safety WarningsThroughouttheseinstructionsforuseyouwillfindsafetywarningsandinformationonthecorrectuseofthemicroINRsystem:

This warning symbol indicates a possibility of danger which could result in death, injury or harm to the patient or user if the procedures and instructions for use are not strictly followed.

This precaution symbol indicates the possibility of deteriorating or damaging the equipment and losing data, if the procedures and instructions for use are not strictly followed.

1. INTRODUCTION

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Important information regarding the correct use of the system that does not affect the safety of the patient or the integrity of the device is displayed over a blue background.

Infection Risk Control on Multi-Patient Test System• Healthcareprofessionalsmustwearglovesduringtheentireprocessofthetest.

• Aseparatelancetorlancingdeviceshouldbeusedforeachindividual.

• UsedChips,lancetsandglovesmightbesourceofinfection.Disposeoftheminaccordancewithlocalregulationstopreventinfections.

• Also,complywithyourcentre’sinternalhygieneandsafetyregulations.

There is a potential risk of infection. Healthcare professionals using the microINR system on multiple patients must take into account that all objects that come into contact with human blood are a possible source of infection. (See: Clinical and Laboratory Standards Institute: Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline, Fourth Edition CLSI document M29-A4, 2014).

Electromagnetic Compatibility and Electrical SafetyThemicroINRsystemcomplieswithelectromagneticcompatibilityrequirementsaccordingtoIEC61326-1and61326-2-6standards.

Do not use the microINR system near sources of intense electromagnetic radiation, as this could interfere with its correct operation.

ThemicroINRsystemcomplieswithelectricalsafetyrequirementsaccordingtostandardsIEC61010-1andIEC61010-2-101.

Do not connect the Meter to computers that do not comply with standard IEC 60950.

TheMetermustbedisposedofasindicatedintheWEEEDirective(WasteElectricalandElectronicEquipment2012/19/UE).

1.3 ORAL ANTICOAGULANT THERAPY Oralanticoagulanttherapyisgiventopatientstopreventthromboemboliceventssuchasvenousthrombosisandpulmonaryembolismorthoselinkedtoatrialfibrillationorartificialheartvalves.

Thetreatmententailstheneedtomonitorandadjustthedosesperiodicallyforeachpatientbasedonabloodtest.

Dependingonthereasonfororalanticoagulanttherapyatherapeuticrangeisdefinedforeachpatientmeaningthevalueofthetestshouldliewithinthatrange.

INR and Prothrombin TimeTheactivityoforalanticoagulantsismonitoredbymeasuringtheprothrombintime(PT)inseconds,whichisthetimeit

1.4 MEASURING PRINCIPLEThetechnologyusedbythemicroINRsystemisbasedonthemicrofluidicsofthemicroINRChip,whichallowsstoring,dosing,movingand/ormixingsmallvolumesofliquidstoperformachemicalreaction.

ThemicroINRChipscontaintwochannels,oneformeasurementandtheotherforcontrol.AnimageoftheChipisshownbelow:

Eachchannelconsistsofamicro-reactorthatcontainsthereagentandamicrocapillarywheretheINRisdetermined.Thereagentusedinthemeasuringchannelcontainshumanrecombinantthromboplastinandthereagentinthecontrolchannelcontainsrecombinantthromboplastinandhumancoagulationfactorstonormalizethepatient’sblood.

ThebloodisappliedtotheChipthroughtheentrychannel,separatedintotwochannelsandmixedwiththereagentscontainedineachmicro-reactor.Thecoagulationcascadeistriggeredinstantly.Whenbloodcoagulates,itsviscosity

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takesforafibrinclottoform.Thromboplastinisusedasareagenttocalculatetheprothrombintime(PT).DependingonthenatureofthisreagentandtheequipmentusedvariationsofthePTresultsaretobeexpected.

Therefore,theWorldHealthOrganization(WHO)recommendedasystemstandardisationmethodin1977.ProthrombintimevaluesareconvertedintoINRvalues,InternationalNormalizedRatio,usingthefollowingequation:

WherePTistheprothrombintimeobtainedinthetest,MNPTisthemeannormalprothrombintimeandISItheinternationalsensitivityindexcorrespondingtothethromboplastin.ThevaluesoftheMNPTandISIparameterscomefromclinicalcalibrationstudies.

The pharmacological activity of vitamin K-antagonist oral anticoagulants can be modified by other drugs; therefore, you should only take the medicines prescribed by your physician.

Certain liver diseases, thyroid disorders and other diseases or conditions, as well as nutritional supplements, medicinal herbs or changes in diets can affect the therapeutic activity of oral anticoagulants and INR results.

INR = PT ISI

MNPT( )

ENTRYCHANNELMICROREACTORS

DATAMATRIXMICROCAPILLARYCHANNELS

CONTROLCHANNEL MEASURINgCHANNEL

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increases,whichresultsintoachangeinbloodflowbehaviour.TheMetercapturesthepositionofthesamplebymeansofaMachinevisionsystemandthepositionistransformedmathematicallyintospeedandaccelerationcurves,fromwhichanINRvalueisobtained.

Calibration

EachbatchofmicroINRChipshasbeencalibratedagainstareferencebatchofhumanrecombinantthromboplastintracedtoInternationalReferenceThromboplastinoftheWorldHealthOrganization1.

Thesecalibrationvalues(ISIandMNPT)areencodedintheprintedDatamatrixofeachmicroINRChip.Therefore,everytestisautomaticallyandindividuallycalibratedeliminatinganyriskofhumanerror.

(1).ExpertcommitteeoftheWHOonbiologicalnormalization.Reportforty-eight.geneva,WorldHealthOrganization,1999(WHOtechnicalreportseriesNo.889)

2.1 DESCRIPTION OF THE microINR® KITThemicroINRkitincludes:

-Case-microINRMeter-Charger-Poweradapter-MiniUSBcable-microINRDataExtractionSoftwareCD-InstructionsforuseofthemicroINRMeter-Quickguide-Errorguide-Lancingdevice(exclusiveforReferenceKitKTA0001XX)-Lancets(exclusiveforReferenceKitKTA0001XX)

microINRChipsaresoldseparately.

Always carry the Meter inside its case.

2. microINR® SYSTEM

2.2 PARTS OF THE microINR® METER

2.3 CHARGING THE microINR® METERTheMeterusesalithiumbatterythatcanberechargedthroughtheminiUSBconnectiononthetopoftheMeter.Donotplacethedeviceinawaythathandlingthedisconnectionelementismadedifficult.

Therecommendedchargingtimeisapproximately3hours.

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Charge the battery completely before using the Meter for the first time.

Do not open or manipulate the Meter.Do not pierce or burn the battery.Do not change the battery. The manufacturer will not warranty Meters that have been opened.For battery replacement or meter repairs, the equipment must be sent to the manufacturer.

Use only the supplied USB cable and wall power adapter provided by the manufacturer or you may damage the Meter.

2.4 SETTING THE TIME AND DATE• Dateformat:DD/MM/YY;Timeformat:24hours.

• Pressandholdtheleftandrightbuttons(EandM)atthesametimefor10secondsuntilthetimefieldflashes.

• Presstheleftbutton(E)tosetthehour.

• Afterselectingthecorrecthour,presstherightbutton(M)andsettheminutes.

• Afterselectingtheminutes,presstherightbutton(M)againandthedatefieldswillstartflashing.

• Usetheleftbutton(E)toselectthecorrectday.

• Whenyoureachthecorrectday,presstherightbutton(M)tosetthemonth.Usetheleftbutton(E)toselectthecorrectmonth.

• Whenyoureachthecorrectmonth,presstherightbutton(M)to

MINIUSBCONNECTION

EXIT(E)BUTTON

MEMORY(M)BUTTON

CHIPINSERTION

AREA

DISPLAY

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settheyear.Usetheleftbutton(E)toselectthecorrectyear.

• Aftersettingthemonth,timeanddate,presstherightbutton(M)againtosaveyoursettings.

Conducting a test without setting the date correctly might cause a non-detection of expired Chips (E02).

2.5 PATIENT IDENTIFICATION (OPTIONAL)Toidentifythepatient(PID),takethefollowingstepsbeforeconductingatest:

• HoldtherightbuttonwhileinsertingaChipandreleaseitafterwards.Uponreleasingthebutton,“PID”anda24alphanumericfieldwillbedisplayed,tofillin.

• ToenterthecharacterscorrespondingtothePID:

-Thefirstfieldwillflashwhenselected.

-Toenterthefirstcharacter,presstheleftbuttonuntilyou reachthedesiredcharacter.

-Validatethecharacterwiththerightbuttonandgotothe nextfield.

-Repeatthepreviousstepsuntilyoureachthelastfield. -Afteracceptingthelastfield,thefirstfieldisautomatically selectedincaseyouwanttocorrectanycharacters.

-ToconfirmtheIDenteredandgoback,holdtheright buttonfor3seconds.

While you are entering the PID, if one minute elapses without pressing any buttons, an E01 message will be displayed.

WhenconsultingtheresultsontheMeter,theresultofatest(INRorerrormessage)isdisplayedalongwithitscorrespondingPID,dateandtime.WhenexportingthemicroINRresultstoaPC,thePIDwillbeexportedasonemorepieceoftestinformation.

2.6 QUALITY CONTROLInternal quality control Meterperformanceisautomaticallycheckedwhenthesystemisturnedon.

Integrated and independent on-board quality controls

Level 1 – Pre-test• Chipintegritycheck

• Correctinsertioncheck

• AutomaticsystemcalibrationandrejectionofexpiredChips

Level 2 - Measuring channel• Analyticverificationperformedonthemeasuringchannelthatidentifiesfailureswhenprocessingthesampleduringthetest,aswellasproperpre-analyticaltreatmentofthesample.

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Level 3 - Control channel• Controlchannelprovideshighlycontrolledclottingtimes.Systemreliabilityisassuredwhencontrolclottingtimelieswithinapre-definedrange.

PROFESSIONAL USE:Liquid control: The microINR system has a number of on-board quality control functions integrated into the Meter and the Chip and therefore there is no need to run quality control tests with liquid quality controls. However, iLine Microsystems has available an optional liquid control (plasma) for the microINR system. This control is provided to help meet the regulatory requirements applicable to your facility. To purchase, contact your local distributor.

3.1 PREPARING THE NECESSARY MATERIALS• microINRMeter

• microINRChips(notsupplied)

• Fingerstickingmaterial

-Professionaluse:disposablelancets(notsupplied)

-Self-testing:lancingdeviceandlancets(exclusive ReferenceKitKTA0001XX)

• Skincleaningmaterial(notsupplied)

3. CONDUCTING THE TEST

Always use CE marked lancing devices and lancets.

3.2 MEASUREMENT PROCEDURE

Turning the Meter OnTheMetercanbeturnedon:

-ByinsertingtheChip:-Bypressinganybutton:

Inserting the ChipVerify the expiry date and the storage conditions of the Chip before conducting the test..

• Openthepouch.HoldtheChipbytheyellowpartsothatthe“microINR”inscriptioncanbereadcorrectly.InserttheChipintotheslotandpushituntilitstops.MakesuretheChiphasreachedtheend.

Conducting the Test• OncetheChipisinserted,theMeterwillperformthequalitycontrolsmentionedinsection2.6oftheseinstructionsforuse.Afterconductingtheaforementionedqualitycontrolspriortothetest,the“control”symbolwilllightup.Ifthefirstlevelofqualitycontrolisnotpassed,anerrormessagewillbedisplayedonthescreenoftheMeter.

• TheChipbeginstoflashandheats upuntilitreachestheproper temperature.Oncethistemperatureisreached:

-Thedeviceemitsanaudible signal(beep). -Thedropsymbolbeginsto flashonthedisplay. -Acountdownappears(80s). -TheChipemitsasteadylight. • Performthefingerstick(seesection3.3oftheseinstructionsforuse).

• Makesuretoobtainasphericalandproperlysizeddrop,equivalenttoateardrop.

• ApplythedropofbloodontheChipimmediately,bycontactwiththeentrychannel,withoutrestingthefingerontheChip.

• TheMeterwillemitabeepwhenitdetectsthesampleforthetestandthedropsymbolwillstopflashing.

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If the pouch of the Chip is open, damaged or the film of the Chip is removed, please, dispose of the Chip and use a new one.

Modes of UseThemicroINRsystemprovidestwoapplicationmodesofthesample:

iLine Microsystems only recommends the option of approaching the Meter to the sample for users who are experienced in conducting INR assays with the microINR system.

COUNTDOWN

-Approachingthe sampletotheMeter.

-ApproachingtheMeterto thesample.

• Afterthebeep,gentlymovethefingerawayandwaituntiltheINRresultsaredisplayedonthescreen.

Ifyouapplythesampleandnosoundisemitted,thismeansthatthereisnotenoughsamplevolume.RemovetheChipandrepeatthetestwithanewChip.Ensurethatthesizeofthedropisenoughandtheentrychannelisnotblockedwhenplacingit.

Do not reapply sample or try to add more blood to the channel. Never perform the fingerstick before the start of the countdown.Do not touch the Chip’s entry channel with the finger while inserting the sample.

Keep the Meter away from direct sunlight during the test.Do not shake or drop the Meter. If the Meter is dropped or gets wet and the frequency of errors messages increases, contact your distributor.

Test Result and Assay End

• ThemeasurementisperformedandtheMeterdisplaystheresultinINRunitsoranerrormessage.

Errormessagesaredisplayedasaletter“E”followedbyanumber.Ifanerrormessageisshown,followthestepsinthe“Errorguide”section”.

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If the message E08 appears, do not attempt a new test and proceed to charge the Meter.

• RemovetheChip,holdingitfrombothsides.

The used Chips, lancets and gloves might be source of infection. For healthcare professionals: dispose the materials according to your institution´s infection control policy and the appropriate local regulations. For self-testing patients: you can dispose all the materials in your garbage bin. Discard the used lancets with care to prevent injuries.

Turning the Meter OffTherearetwowaystoturntheMeteroff:

• TheMeterturnsoffautomaticallyafter5minutesofinactivity.

• Presstheleftbutton(EXIT)toturntheMeteroff,holdingitfor3or4seconds.

If you don´t remove the Chip before turning the Meter off, the results will not be stored.

TheMetercannotbeturnedoffwhileconnectedtothepowersupplyortoacomputerwiththeUSBcable.

• Youcanuseanyfingerforthefingerstick.Therecommendedsiteistheoneshownonthefollowingimage.

• Placethelancingdevicefirmlyagainstthefingerandpressthebutton.Pressthebaseofthefingergentlyuntiladropofbloodforms.Donotpressthefingersticksiteexcessivelyorletthedropofbloodsmearonthefinger.BeforeplacingthedropofbloodontheChip,makesureithasasphericalshapeandislargeenoughtoleaveasmallamountofblood(remnant)attheentrychannel.

Pressing the fingerstick site may accelerate the process of coagulation or release of interstitial fluid into the sample which may cause incorrect results.

• ApplythedroptotheChipimmediately,incontactwiththeentrychannel.

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3.3 OBTAINING AND APPLYING THE CAPILLARY BLOOD SAMPLEThestepstoobtain and apply a capillary blood sample correctly aredetailedbelow:

• Readtheinstructionsofthe fingerstickdevices.

• Handsshouldbewarmedbeforeconductingthefingerstick.Youcanachievethisbydifferentmeans:keepinghandsbelowyourwaist,massagingyourfingersoftly,washingyourhandswithhotwater,etc.

• Thefingersticksitemustbeclean,completelydryandfreeofcontaminants.Washingyourhandswithwarmwaterandsoapisrecommended.Ifdisinfectingwithalcoholorsomeotherdisinfectingsolution,youmustthoroughlydrytheareatoremoveanytracesofsubstancesthatmightinterferewiththeresult.Drywithacleananddrygauzeandneverusethesameoneyouusedtoapplythedisinfectant.

Any alcohol contamination (disinfectants, shaving creams, etc.), lotions or sweat on the fingerstick area or the blood sample may cause incorrect results.

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Using a correct technique to obtain and apply the sample is essential. Make sure to follow the instructions. Otherwise, the results might be incorrect.

3.4 INTERPRETING THE RESULTSTheresultsareshownasInternationalNormalizedRatio(INR)units.ThemicroINRsystem’sresultsrangebetween0.8and8.0.Ifyouobtainaresultoutofthemeasuringrange,thedisplaywillshowanarrow.

Ifanerrormessageisdisplayed,seethe“Errorguide”sectionandfollowtheinstructions.

If an unexpected result is obtained, repeat the test making sure that the indications described in these instructions for use are strictly followed. If an unexpected result is obtained again, contact your doctor and/or distributor.

Resultsareunexpectedwhentheylieoutsidethetherapeuticrangeordonotmatchthepatient ssymptoms:haemorrhages,bruises,etc.

The sample must be applied immediately after obtaining it, otherwise coagulation would start naturally and an error message or an incorrect result might appear.

Avoid contact between the Chip and the finger in order not to obstruct the entry channel and thus allow for uninterrupted blood absorption. Only the drop of blood must make contact with the Chip.

Apply the sample on a single attempt. Never add more blood to the Chip.

• Afterthebeep,gentlyremove thefinger,leavingasmall amountofblood(remnant)at theentrychannelasshownin thepicture.

• Ifthetestmustberepeated, performthefingerstickina differentsite.

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3.5 LIMITATIONS OF USE• OncetheChipistakenoutofitsoriginalpouch,itshouldbeusedwithinthefollowing6hours.

• Donotusetomeasureormonitortheanticoagulationstatusofpatientsundertreatmentwithdirectoralanticoagulationtreatments(nonvitamin-kantagonistdrugs).

• TheperformanceofthemicroINRsystemhasnotbeendemonstratedonbloodsampleswithhematocritvaluesoutsidetherangeof25%to55%.Hematocritoutofthisrangemayaffecttestresults.

• ThedeviceishighlysensitivetovitaminKdependentcoagulationfactordeficiencies.

FormoreinformationoninterferencesofthemicroINRsystemwithotherdrugsanddiseases,refertotheinstructionsforuseofthemicroINRChip.

ThemicroINRMetercanstoreupto199resultsofpatientsandliquidqualitycontrols.Eachresultisstoredwiththedateandtimeofthetest.Whenconductingatest,ifthereisnofreestoragespace,theoldestresultwillbeautomaticallydeletedtostorethenewone.

Tochecktheresults:

• Presstherightbutton(M).TheresultofthelasttestconductedwillbedisplayedwithitsdateandtimeandtheIDofthecorrespondingpatient(ifitwasentered).

• Pressagaintodisplaythenextresult,correspondingtothesecond-to-lasttestandsoon.

• Presstheleftbutton(E)toreturntotheinitialscreen.IfyouenteraChipwhileyouarecheckingthememory,anewtestwillbeginnormally.

Topreventlosingstoreddata,downloadthedatatoyourcomputerwiththeDataExtractionSoftwareontheCDthatyouwillfindinsidetheMeter’scasealongwithitsinstructions.

Thedownloadedinformationwillbedisplayedinthefollowingorder:

1. MeterID(MID) 2. Numberoftest 3. Date 4. Time 5. PatientID(PID) 6. INR 7. INRofthecontrolchannel 8. Datamatrixcode 9. Acceptancerangeofthecontrolchannel 10. Typeofsample(bloodorplasma)

4. MEMORY AND DATA EXTRACTION TO A COMPUTER

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CleaninganddisinfectionofthemicroINRMeterisessentialtoensurepropermicroINRsystemoperationandtopreventblood-bornetransmissionofpathogensinmulti-patienttests.

CleantheMeterwhenitisvisiblydirtyandbeforedisinfecting.

UseanewpairofgloveseverytimeyoucleananddisinfecttheMeter.

BeforecleaningordisinfectingtheMeter,turnitoffandmakesurethecablesareunplugged.

To clean the Meter:• CleantheMeterwithacleangauzeorwipemoistenedwithisopropylalcohol70%untilthereisnovisibledirt.

• EnsuretherearenoremainingfibresorlintonanypartoftheMeter,especiallyontheChipinsertionareaandtheUSBport.

To disinfect the Meter:• DisinfectallthepartsoftheMeterwithacleangauzeorwipemoistenedwithisopropylalcohol70%.

• Waitoneminuteforthealcoholtoact.

• ThoroughlydrytheMeterwithadryandcleanlint-freeclothorgauze.

• Afterwards,wait15minutesfortheMetertodryandensureitiscompletelydrybeforeconductinganewtest.

• Ensuretherearenoremainingfibresorlintonanypartof

theMeter,especiallyontheChipinsertionareaandtheUSBport.

• Discardtheusedwipesandgloves.

DonotcleanordisinfecttheMeterwhileconductingatest.

Donotuseaerosolsoranycleaningordisinfectingagentsotherthanacleangauzeorwipemoistenedwithisopropylalcohol70%.

Verifythatthegauzeorwipeisjustmoist,notsoaked.DonotsprayfluidsontheMeterorsubmergetheMeter.

MakesurethatnofluidsentertheMeterortheChipinsertionarea.

TheChipinsertionareamustalwaysbecleananddrybeforeconductingatest.WheninsertingaChip,remainsofbloodoralcoholcancontaminatethesample.

DonothandletheChipswithalcohol-contaminatedgloves.

Comply with all recommendations regarding cleaning and disinfection of the Meter.Not doing so could cause incorrect results.

5. CLEANING AND DISINFECTING THE microINR® METER

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Messages when preparing to testError Probable Cause Possible Solution

The Datamatrix could not be read. Expired Chip.

The 80 second interval for applying the sample has been exceeded.Chip inserted backwards.Faulty or incorrectly inserted Chip.

E01

E02

E03

E04E11

Insert the same Chip again, ensuring correct insertion. If the problem persists, repeat the test with a new Chip.Verify the date of the Meter. If the date is not correct, enter the current date and insert the same Chip again. If the date is correct, repeat the test with a new batch of Chips after verifying their expiry date. If the sample has not yet been applied, repeat the test with the same Chip.

Rotate the Chip and repeat the test.Insert the same Chip again, ensuring complete insertion. If the problem persists, repeat the test with a new Chip.

Messages related to the testInadequate coagulation of the sample during the test.

The INR value of the control channel is outside the defined range.Error while processing the sample during the test.

Inadequate coagulation of the sample during the test. ATTENTION: Possible sample with abnormally high clotting times.Inadequate sample handling or hematocrit outside the defined range.

E05/E09

E10

E14/E15/E17E16

E18

Repeat the test with a new Chip. Strictly follow instructions on obtaining and applying the sample. If the problem persists, repeat the test with a new box or batch of Chips.Repeat the test with a new Chip. If the problem persists, repeat the test with a new box or batch of Chips.Repeat the test with a new Chip. Strictly follow instructions for conducting the test. If the problem persists, repeat the test with a new box or batch of Chips.Repeat the test with a new Chip. If error E16 is displayed again, use a different measurement method. This error occurs mainly in patients with high clotting times.Repeat the test with a new Chip. Strictly follow instructions on obtaining and applying the sample. If error E18 is displayed again, use a different measurement method. This error occurs mainly in patients with a hematocrit outside the defined range for the microINR system (25%-55%).

Other messagesFailure while checking the electronic components of the Meter.Temperature below the defined range.Low battery.Temperature above the defined range.

E06

E07E08E12

If the problem persists, contact your local distributor.

Repeat the test in a warmer location.Charge the device with the charger supplied by the manufacturer.Repeat the test in a cooler location.

6. ERROR GUIDE

7.1 SPECIFICATIONS • DimensionsoftheMeter:119x65x35mm.

• Weight:213±3gr.(Batteryincluded).

• Screen:LCD45x45mm.

• Memory:199results/errormessageswiththeirdateandtime.

• Powersupply:

-Battery:Lithium2400mAh/2800mAh;3.7V.Consumption:1A. -Powersupply:Onlyplugthechargertopowersupplieswith thefollowingcharacteristics(Input):100-240V,50-60Hz, Consumption:0.2A. -Powersupply(Output):5Vdc,1000mAviaaminiUSB connection.

• Batterylife:*approximately70tests.

• Operationconditions:

-Temperature:15ºC-35ºC. -Maximumrelativehumidity:80%.

• Meterstoragetemperature:-20ºCto50ºC.

• Measurementrange:0.8–8.0INR.

• Samplevolume:atleast3µL.

• DatatransferviaaminiUSBconnection.

*Testconductedat22ºCwitha10minuteperiodbetweentests.

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7. ADDITIONAL INFORMATION 7.2 CE DECLARATION OF CONFORMITYThismedicaldevicecomplieswiththestandardsandlegalrequirementsofDirective98/79/ECoftheEuropeanCommunityforInvitrodiagnosticmedicaldevices,of27October1998,andwithDirective2011/65/EUoftheEuropeanParliamentandCouncil(RoHS)of8June2011onrestrictionsofuseofcertainhazardoussubstancesonelectricalandelectronicequipment.

7.3 WARRANTYiLineMicrosystemswarrantiestotheoriginalbuyerthatthemicroINRsystemisfreeofmaterialandmanufacturedefectsfortwoyearsafterthepurchasedate.

Thiswarrantydoesnotcoveranycomponentdamagedduetoinadequatestorageinenvironmentalconditionsoutsidethedefinedrange,accidentsormodifications,incorrectuseorhandlingandmisuse.Thebuyermustdeliverawrittenwarrantycomplainttothemanufacturerwithinthecorrespondingwarrantyperiod.

7.4 TECHNICAL SERVICEIfaproblempersistsafterperformingtheactionsstatedinthetableoferrorsorifyouwantadditionalinformation,youcancontactyourlocaldistributor.

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TESTRESULTSININRUNITSORERRORCODE.

TIME(HOURS:MINUTES).

THERESULTISABOVEORBELOWTHEMEASURINgRANgEOFTHESYSTEM(↓0.8-↑8.0).

DATE(DAY:MONTH:YEAR).

BLINKINgINDICATES“APPLY

SAMPLE”.

THEDEVICEISCONNECTEDVIA

THEMINIUSBCONNECTION.

DEBUgMODE,USEDFOR

METERUPDATE.

THERESULTSOFTHEBLOODTEST

AREDISPLAYEDININRFORMAT.

INSTRUCTSTHEUSERTOWAITUNTILTHE

METERCOMPLETESACERTAINACTION.

THECODEDISPLAYEDISAN

ERRORCODE.

THEPRE-ANALYTICALCONTROLSHAVEBEENCOMPLETEDSUCCESSFULLY.

AMOUNTOFREMAININgBATTERYPOWER.

THEFLUIDBEINgTESTEDISPLASMA(LIQUIDCONTROL).

THESTOREDRESULTSAREBEINgDISPLAYED.

BLINKINgINDICATES

“INSERTCHIP”.

7.5 SYMBOLS

“Manufacturer”

“Temperature limit”

“Consult the instructions for use”

”Catalogue number”

“in vitro diagnostic medical device”

“Serial number”

”Direct current”

“Electronic waste selective collection”

CE “CE Marking”0120 Notified Body Identification Number(only applies for the Selftesting Use certification)

“Batch code / Lot Number”

“Biological hazard”

“Precaution”

“Warning”

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7.6 GLOSSARYCapillary blood:bloodfromthesmallestbloodvesselsinthebody,usuallyobtainedbypuncturingafingertip.

Capillary fingerstick:smallpunctureonafingertoobtaincapillaryblood.

Chip:disposableelementinsertedintotheMeter.ServestoenterthesamplefortheINRtest.

Control channel:channelusedtomeasurethenormalisedcoagulationtimeinordertodetectdegradationofthereagents.

Entry channel:slotonthebottomoftheChipthatreceivestheblood.

International Normalized Ratio [INR]: standardisedprothrombintimemeasurementsystemthataccountsforthedifferentsensitivityofthethromboplastinsusedindifferentmethods.TheINRresultsfromdifferentprothrombintimemeasurementsystemscanbecomparedtoeachother.

Lancet:piercingtoolusedtomakeasmallcutorpuncturetocollectasmalldropofblood,whichwillbeusedfortheINRtest.

Microcapillary:siteonwhichtheINRtesttakesplace.

Microfluidics:technologyforstoring,dosing,transferringand/ormixingsmallvolumesoffluidtocauseachemicalreaction.

MicroINR Meter:electronicdevicethatservestoconductINRtests.

Microreactor:areaoftheChipmeanttostorethereagents.

Mini-USB connector:connectoronthetopfrontofthe

microINRMeter.

Oral anticoagulant therapy:orallyadministeredtreatmentthatinhibitsorinterfereswiththecoagulationoftheblood.

Plasma:liquidpartoftheblood.

Prothrombin time (PT):coagulationanalysisperformedtoanalysetheextrinsiccoagulationpathway.

Quality control: teststoprovethatasystemperformscorrectlyprovidingreliableresults.

Reagent:substanceusedtocauseachemicalreactioninordertomeasureasubstanceorprocess(suchastheINRtest).

Remnant: smallamountofexcessbloodthatremainsontheentrychanneloftheChip.

Therapeutic range:saferangeofINRvalues.Thephysiciandeterminesaspecifictherapeuticrangeforeachpatient.

Thromboplastin:Asubstanceusedbybloodplateletsandcombinedwithcalciumthatconvertsprothrombin(protein)intothrombin(enzyme)aspartoftheclottingcascade.

© 2017 iLine Microsystems. All rights reserved. Made in Spain. This product is covered by patent technology EP2201365(B1). iLine Microsystems and microINR are registered trademarks of iLine Microsystems S.L. INA0

001A

A -

Rev

2017

-02

Charge completely the battery of the Meter before its first use.

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