Abbott FreeStyle Navigator User manual

Customer Care: +8000 - 2255 - 232 (+8000 - CALL - ADC)

User Guide

Continuous Glucose Monitoring System

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Indications for Use

• eFreeStyleNavigatorContinuousGlucoseMonitoringSystemisaglucosemonitoring

deviceindicatedforcontinuallymeasuringinterstitialuidglucoselevelsinpeople(ages6

andolder)withdiabetesmellitus.eindicationforchildren(ages6-17)islimitedtothose

whoaresupervisedbyacaregiverwhoisatleast18yearsofage.ecaregiverisresponsible

formanagingorassistingthechildtomanagetheFreeStyleNavigatorsystemandalsofor

interpretingorassistingthechildtointerpretFreeStyleNavigatoroutput.

eFreeStyleNavigatorContinuousGlucoseMonitoringSystemisintendedtobeused:

• Inthehomeandclinicalsettingstoaidinthemanagementofdiabetes.

• Toprovidereal-timeglucosereadingsdirectlytotheuser.

• Toprovideglucosetrendinformation.

• Toprovidealarmsforthedetectionandpredictionofepisodesoflowbloodglucose

(hypoglycaemia)andhighbloodglucose(hyperglycaemia).

• Bymorethanoneindividual,ifusedaccordingtoinstructions.

Warnings

• Duringtimesofrapidlychangingglucoselevels,continuouslyreportedinterstitialglucose

levelsasmeasuredbytheFreeStyleNavigatorSensormaynotaccuratelyreectbloodglucose

levels.Whenglucoselevelsarefallingrapidly,continuousglucoseresultsfromtheFreeStyle

NavigatorSensormaybehigherthanbloodglucoselevels.Converselywhenglucoselevels

arerisingrapidly,continuousglucoseresultsfromtheFreeStyleNavigatorSensormaybe

lowerthanbloodglucoselevels.Underthesecircumstancesusethebuilt-inFreeStyleBlood

Glucose(BG)Metertoconductnger-sticktestingtocheckthecontinuousglucoseresults

fromtheFreeStyleNavigatorSensor.

• InordertoconrmhypoglycaemiaorimpendinghypoglycaemiaasreportedbytheFreeStyle

NavigatorContinuousGlucoseSensor,usethebuilt-inFreeStyleBloodGlucoseMeterto

conductnger-sticktestingtochecktheFreeStyleNavigatorreading.

• Donotignoresymptomsthatmaybeduetolowbloodglucoseorhighbloodglucose.If

youhavesymptomsthatdonotmatchtheFreeStyleNavigatorreading,usethebuilt-in

FreeStyleBloodGlucoseMetertoconductnger-sticktestingtochecktheFreeStyleNavigator

ContinuousGlucosereading.

• Movementofthesensorsupportmountorexcessiveperspirationatthesensorinsertionsite

duetoactivitieslikevigorousexerciseorbumpingagainstobjectsmayleadtopooradhesion

ofthesupportmounttotheskinandcausethesensortodislodge.Ifthesensordislodgesdue

tothesensorsupportadhesivefailingtoadheretotheskin,youmaygetunreliableresults

ornoresultswithoutawarning.Choosethepropersensorinsertionsitewheninsertingthe

sensorandpreparethesitebyfollowingtheinstructionsforsitepreparation.

• Severedehydrationandexcessivewaterlossmaycausefalseresults.Ifyoubelieveyouare

sueringfromdehydration,consultyourphysicianimmediately.

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ART20775-001_Rev-A-Guide.indd 2 4/12/10 4:48 PM

DoNotRe-Use Manufacturer

Sterile ConsultOperatingInstructions

UseBy BatchCode

SerialNumber CatalogueNumber

Caution

AuthorisedRepresentativeinthe

EuropeanCommunity

TemperatureLimitation CEMark

Donotuseifpackageis

damaged

IPX7

Casecanwithstandimmersionintoone

metreofwaterforupto30minutes.

How to Use this Guide?

Note:YoursystemisdeliveredwithEnglishasthedefaultlanguage.erefore,

aerinstallingbatteriesforthersttimeandsettingthedateandtime

(Sections2and3),setthelanguageanddecimalformat(Section4)before

proceedingtousethesystem.

is guide has many Sections arranged in a logical sequence that will be useful

for rst-time use and every use thereaer. Most Sections begin with a purpose for

that Section, when to perform the steps in that Section, materials required to perform

the steps in that Section and important cautions, warnings and helpful information.

e rst page of each Section will be very useful when you are becoming familiar

with the system. Once you are familiar with the system and the general precautions,

you may nd yourself relying less on the rst pages of the individual Sections.

e remainder of each Section describes the steps for performing the tasks. e

steps are organised in a simple manner to allow you to see what to do based on

what you experience and based on where you are in that particular Section. It is

important that you go through the steps in the order that they have been presented.

Every Section also indicates if you have reached the end of the Section. If you nd

it dicult to use the guide or if you seem lost or confused, use the table of contents,

index, glossary and appendices to help you. e Table of Contents provides a list

of the Sections that you will nd in this guide and what each Section contains. e

Appendices contain useful information to which you may need to refer. e Glossary

provides a list of terms and their meanings. e Index is a tool you can use to quickly

nd terms and items that you seek.

•FreeStyleNavigatorandFreeStyleareregisteredtrademarksoftheAbbottGroupofCompaniesin

variousjurisdictions.

•OpSite®IV3000andUni-Solve®aretrademarksofSmithandNephewInc.

•Bluetooth®wirelesstechnologyisatrademarkoftheBluetoothSIGInc.

Glossary of Symbols

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Table of Contents

n Section 1: Getting Acquainted. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 – 12

 PartsoftheSystem.

 DailyActivitiesandTravelling.

 PreparingtheSystemfortheFirstTime.

 Warnings,CautionsandImportantNotes.

 HypoglycaemiaUnawareness.

 ModesofOperation(ContinuousMonitoringMode(CM)and

 BloodGlucoseMode(BG)).

n Section 2: Install or Replace Transmitter and Receiver Batteries . . . . . . . . . . . . . . . . . . . . . 13 – 16

InstallingtheBatteriesinYourSystem.

 BatteryTypesfortheTransmitterandtheReceiver.

 WhentoChangetheBatteries.

n Section 3: Set the Time and Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 – 19

SettheTimeandDate.

n Section 4: Change Country Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 – 24

ChangeLanguage,DateandTimeFormats,DecimalPointformat.

n Section 5: Perform a Control Solution Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 – 29

WhentoPerformaControlSolutionTest.

 HowtoPerformaControlSolutionTest.

n Section 6: Insert or Remove Your Sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 – 39

InsertYourSensor.

 RemoveYourSensor.

 SensorInsertionSites.

 PreparetheInsertionSite.

 HowLongCanYouWeartheSensor?

 ReconnecttheTransmitterandReceiver.

n Section 7: Attach your Transmitter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 – 44

 AttachtheTransmitter.

 SensorCode.

n Section 8: Calibrate your System/Test Blood Glucose Manually . . . . . . . . . . . . . . . . . . . . . . 45 – 55

SystemCalibration.

 TimetoPerformCalibrations.

 SampleCalibrationSchedules.

 PerformBloodGlucoseTests.

 InterpretYourBloodGlucoseTestResults.

n Section 9: Set, Review or Change the Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 – 68

AboutGlucoseAlarms.

ChooseAlarmsSettings:On/O,Type(beepvs.vibrate)andGlucoseAlarmreshold.

 SettheLowandHighGlucoseAlarms.

 SetProjected(Early-Warning)Alarms.

 WhatisAlarmSensitivity?

 SetDataLossAlarms,SystemAlarmsandProgressTones.

 MuteAlarms.

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n Section 10: Daily Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 – 73

MaintainConnectionBetweentheTransmitterandReceiver.

 InterprettheGlucoseResultsintheContinuousMonitoringMode.

 Symbols,ArrowsandIcons.



n Section 11: Respond to Alarms, Errors and Problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75 – 94

AlarmMessages:Whatarethey?Whatdotheymean?Whatyoushoulddo.

 ErrorCodes:Whatarethey?Whatdotheymean?Whatyoushoulddo.

 Problems:Howtotroubleshoottheproblemsyoumayencounter.

n Section 12: Add Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 – 98

EnterEvents:Insulin,Meals,ExerciseandStateofHealth.

 CustomiseGenericEvents.

n Section 13: Review Reports and Edit Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99 – 106

EnterGlucoseTargets.

 ViewLineGraph.

 ViewStatistics.

 ReviewtheHistoryofEvents.

 EditEvents.

n Section 14: Clean and Disinfect Your System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107 – 110

CleanYourTransmitter.

 CleanYourReceiver.

 CleanYourReceiverSkin.

 CleanandDisinfecttheSystemAeritwasUsedbyAnotherPerson.

n Section 15: Link and Unlink your Transmitter and Receiver . . . . . . . . . . . . . . . . . . . . . . . . 111 – 113

LinkandUnlinkyourSystem.

 WhatistheDierenceBetweenLinkingandReconnecting?

n Section 16: Reset User Settings and Erase History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115 – 117

ResetSettings.

 EraseHistory.

n Section 17: Appendix A: Site Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

HowtoMaintaintheSensorInsertionSite.

 HowtoImproveSensorAdhesion.

n Section 18: Appendix B: Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121 – 122

n Section 19: Appendix C: Electromagnetic Interference Information . . . . . . . . . . . . . . . . . 123 – 127

WirelessInterference.

n Section 20: Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129 – 134

DenitionsofTermsUsedinisGuide.

n Section 21: Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135 – 136

FindWhatYouAreLookingFor.

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Customer Care: +8000 - 2255 - 232 (+8000 - CALL - ADC)

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1

OVER

1 Getting Acquainted

Introduction

Important: Read all of the instructions in this User Guide and the FreeStyle Test Strip package insert

before using your FreeStyle Navigator Continuous Glucose Monitoring System. Adjustments to your

treatment should be done under the guidance of your healthcare team.

YourFreeStyleNavigatorsystemcontinuouslyreads,displaysandrecordstheglucoselevelsinthe

uidsfoundbetweenthecellsunderyourskin(interstitialuids).Itdoesthisbyusingasmall,thin,

plasticsensorinsertedjustundertheskin.

YourFreeStyleNavigatorsystemprovidesyouwithcontinuousglucosereadingsinreal-time.By

havingaccesstomorefrequentglucosemeasurements,youcanmonitoryourglucoselevelsandgain

anunderstandingofpatternsinyourglucoselevels.iswillhelpyouandyourhealthcareteamsee

howfactorssuchasyourdiet,insulin,exerciseanddiabetesmedicationaectyourglucoselevels,and

toadjustyourtreatmentplanaccordingly.

YourFreeStyleNavigatorsystemhasanumberofhelpfulfeatures.

•Wirelesscommunicationbetweenthetransmitterandreceiver.

•Disposablesensorthatcanbewornforupto5days.

•Alarmstoalertyoutoloworhighglucoselevels(hypoglycaemiaorhyperglycaemia)before

reachingthoselowandhighglucoselevelsandwhenreachingthoseglucoselevels.

•Graphsandstatisticsthatshowyourglucoseresultsineasy-to-understandformats.

•Directionalglucosetrendarrowsthatshowifyourglucosevaluesarerisingorfallingand

howfast.

•Memorytoholdupto60-daysworthofdata.

•Wirelesscommunicationcapabilitieswithapersonalcomputer.

•Built-inFreeStyleBloodGlucoseMeterforperformingbloodglucosemeasurements.

•Evententrycapabilities(meals,exercise,insulinandothers).

•Backlitdisplay.

Important: Keep this User Guide for future reference. It will come in handy when you have to do

procedures that you do not do oen enough to remember.

Section 1 1

Getting Acquainted

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How is the System Kit packaged?

The System Kit

• 1 FreeStyle Navigator Receiver in a receiver skin

• 2 AAA (LR03) Alkaline Batteries (for the receiver)

• 1 FreeStyle Navigator Transmitter

• 1 Silver Oxide 357 Coin Cell Battery (for the transmitter)

• 1 Belt Clip (for the receiver)

• 1 Lancing Device

• 1 Finger Cap (for the lancing device)

• 1 User Guide on CD-ROM

• 1 Getting Started Guide

• 1 Quick Reference Card

• 20 Sterile Lancets

•Dependinguponhowyouordertheproduct,youmayalsoreceiveFreeStyleTestStrips,FreeStyle

ControlSolution,adatamanagementsystemandaccessoriesforthedatamanagementsystem.e

FreeStyleNavigatorsystemcantransferdatatoacomputerwirelesslyusingBluetooth®technology.

Important Note:

•

eFreeStyleNavigatorContinuousGlucoseMonitoringSystemisdesignedasacompletesystem.

UseonlytheFreeStyleNavigatorSensor,theFreeStyleNavigatorTransmitter,theFreeStyleNavigator

ReceiverandFreeStyleTestStrips.

Customer Care: +8000 - 2255 - 232 (+8000 - CALL - ADC)

2 Section 1

Getting Acquainted

ART20775-001_Rev-A-Guide.indd 2 4/12/10 4:48 PM

OVER

What are the key parts of my system?

Your FreeStyle Navigator system includes the following major parts:

a.

AFreeStyleNavigatorSensorthatyouinsertabout5mmunderyourskin.Eachinsertedsensoris

intendedtoremaininplaceandprovidescontinuousglucosereadingsforupto5days.esensoris

containedintheSensorDeliveryUnit.

b.AwirelessFreeStyleNavigatorTransmitter(TX),asmallelectronicdevicethatconnectstothesensor

andsendsglucosevaluestothereceiveronceeveryminute.

c.AwirelessFreeStyleNavigatorReceiver(RX)thatcapturesanddisplaysglucosemeasurements.Withthe

pressofabutton,thereceiverdisplaystheglucosemeasurementtakenfromthesensor.

Note: ereceiveralsohasabuilt-inFreeStyleBloodGlucoseMeterthatcanbeusedforbloodglucose

testing.ereceivershouldalwaysbekeptwithyouonabelt,inapocketorinahandbag.

Sensor

Measures your glucose level.

Sensor Tip

Part of sensor inserted into your skin.

Locking Pin

Prevents accidental discharge;

must be removed before insertion.

Insertion Button

Pushes a tiny needle into the

skin to place the sensor tip just

under the surface of the skin.

Sensor Inserter

Inserts the sensor into

the skin. Must be disposed of

after inserting the sensor.

Release Tabs

Release the sensor inserter

from the sensor support mount.

Sensor Support Mount

Stays on your skin after sensor is inserted.

Holds the sensor in place. Attaches the

sensor to the transmitter.

Adhesive Protective Liner

Adhesive that is axed to your skin.

Tabs

Guides

Receiver in Receiver Skin

UP and DOWN Arrow Buttons

Used to move through lists to highlight

options and change numbers.

LEFT and RIGHT Option Buttons

Used to select options shown on the

screen. The RIGHT Option button also

turns the receiver on.

Display Screen

Displays glucose levels

and other information.

Test Strip Port

Where FreeStyle Test

Strips are inserted to

calibrate the receiver

or manually check

blood glucose levels.

Transmitter

Receiver

Sensor

Delivery

Unit

Section 1 3

Getting Acquainted

ART20775-001_Rev-A-Guide.indd 3 4/12/10 4:48 PM

Formoredetailsonthedierentsymbolsandiconsonthescreen,seeSection10on“DailyUse”.

Key features of the System

Statistics

Alarms

Event Log

Line Graph

4.7 mmol/L

16.6, 3.4, 8.9, 1.1 mmol/L

3.9, 7.8, 11.7, 15.6, 19.4 mmol/L

4 Section 1

Getting Acquainted

Stats 21 day 08:30

Highest CM: 298 mg/dL

Lowest CM: 61 mg/dL

Ave. CM: 160 mg/dL

Std. Dev: 20 mg/dL

Above Target: 19%

Next Back

Glucose CM 03:00

85

mg/dL

Acknowledge Main

Projected Low

Glucose

Select Event 08:30

Insulin

Meals

Exercise

State of Health

Generic

Main Select

8 12 16 20 0 4

350

280

210

140

70

ART20775-001_Rev-A-Guide.indd 4 4/12/10 4:48 PM

OVER

Using your system

For Daily Activities

Youwillbewearingasensorandatransmitteratalltimeswhileyouareusingthesystem.Keepthe

followinginmindasyougoaboutyournormalroutine;

•Onlywearthesensorandtransmitteronaatsurfaceofeitheryourabdomenorthebackofyour

upperarm.

•Sleeping –esensorandtransmittershouldnotinterferewithyournormalsleepingpatterns.Asyou

getreadytogotosleep,placethereceiverclosebytomaintainthetransmitter-to-receiverconnection.

•Bathing–Do NOTwearthereceiverwhilebathingorshowering.Do NOTallowthereceivertoget

wet.However,youcanwearthesensorandtransmitterwhilebathingorshowering.

•Swimming –Youmayswimwhilewearingthesensorandtransmitter.Do NOTgodeeperthan1metre.

Note:econnectionbetweenthetransmitterandreceiverisNOTmaintainedwhenthetransmitteris

underwater;thus,youwillNOTreceivecontinuousglucosereadings.However,whenyoutakethesensor

andtransmitteroutofthewater,thecontinuousglucosereadingswillresume.

When Travelling by Plane

Note:

DoNOTperformtheuploaddatafeaturewhenyouareonacommercialaircra.

Followtheguidelinesbelowwhentravelling.Alwayscheckwithlocalauthoritiespriortodepartureasrules

andregulationsmaychangewithoutnotice.

At the airport:

Notifythesecuritypersonnelofthepresenceofthedevicewhengoingthroughthesecuritysystems.

On the plane:

Checkwithyourairlinebeforedeparturewhetherthedevicewillbepermittedaboardtheaircra.e

airlinecompanieshavesetpoliciesregardingtheuseofmedicaldevicesonboardtheirights.

Ifyouwanttodisablethetransmitfunctionofthetransmitter,followthesesteps:

1.Ifyouarecurrentlywearingasensor,removethesensor.

2.Detachthetransmitterfromthesensorsupportmountandremovethebatteryfromthetransmitter.

3.Programmeintothereceiverthatyouhaveendedasensorsession.

4.Byremovingthebatteryfromthetransmitter,youhavebrokentheconnectionbetweenthe

transmitterandreceiver.iswillinitiateaReconnectalarm.YoucanusetheAlarmMutefunction,

programmablefrom1to12hours,topreventthedevicefromsoundingalarms.Onceyouputanew

batteryintothetransmitter,usetheReconnectfunctiontorestoretheconnectionandtheUn-Mute

functiontoturnalarmsbackon.

Note: Insertafreshbatteryintothetransmitteraertravelbeforeinsertinganewsensor.

YoucanalwaysuseyourreceivertocheckyourbloodglucosemanuallyintheBloodGlucosemode.

Section 1 5

Getting Acquainted

ART20775-001_Rev-A-Guide.indd 5 4/12/10 4:48 PM

How do I prepare my system for the ﬁrst time?

Whenyouaresettingupyourreceiverforthersttime,performalloftheprocedureslistedbelowin the

order that they are listed

.Tickoeachprocedurewhenyoucompleteit.

o

Installbatteriesinthetransmitterandreceiver(see Section 2).

o

Setthetimeanddate(see Section 3).

o

Setthelanguageanddecimalformat(see Section 4).

o

Performacontrolsolutiontest(see Section 5).

o

Insertyoursensor(see Section 6).

o

Attachyourtransmitter(see Section 7).

o

Calibrateyourreceiverwhenprompted(see Section 8).

o

Setthealarmsinthereceiver(see Section 9).

Note:

iscanbedonewhilewaitingtoperformtherstcalibration.

Result: Your system is operational.

Warnings, Cautions And Important Notes

Important Notes About System Performance

e following items describe situations that could lead to inaccurate or unreliable continuous glucose results.

Caution: Movement of the sensor support mount or excessive perspiration at the sensor insertion site due to

activities like vigorous exercise or bumping against objects may lead to poor adhesion of the support mount

to the skin and cause the sensor to dislodge. If the sensor dislodges due to the sensor support adhesive failing

to adhere to the skin, you may get unreliable results or no results. e system may not provide a warning in

such circumstances. Choose the proper sensor insertion site when inserting the sensor and prepare the site by

following the instructions for site preparation.

Caution: If your results from the Continuous Monitoring mode seem erroneous, check and make sure

that the sensor has not dislodged. If you notice the sensor is dislodged from the skin, or if you see that the

adhesive on your over-bandage or the sensor support mount is coming loose, discard the old sensor and

insert a new sensor.

Caution: During times of rapidly changing glucose levels, continuously reported interstitial glucose levels as

measured by the FreeStyle Navigator Sensor may not accurately reect blood glucose levels. When glucose

levels are falling rapidly, continuous glucose results from the FreeStyle Navigator Sensor may be higher than

blood glucose levels. Conversely when glucose levels are rising rapidly, continuous glucose results from the

FreeStyle Navigator Sensor may be lower than blood glucose levels. Under these circumstances use the built-

in FreeStyle Blood Glucose (BG) Meter to conduct nger-stick testing to check the continuous glucose results

from the FreeStyle Navigator Sensor.

6 Section 1

Getting Acquainted

ART20775-001_Rev-A-Guide.indd 6 4/12/10 4:48 PM

OVER

Warnings, Cautions And Important Notes (cont.)

•eFreeStyleNavigatorsystemincludesbuilt-inself-checkstodetectconditionsthatmaycause

thesensortonotfunctionproperly.Onrareoccasionsthesystemmaynotbeabletodetectallsuch

conditions(forexampleiftheadhesivepeelsawayfromyourskin),andyoumaygetinaccurateresults

intheContinuousMonitoringmode.Ifyoubelieveyourresultsarenotreliable,orareinconsistentwith

howyoufeel,performaBloodGlucosemodetesttomeasureyourglucose.Iftheproblemcontinues,

discardtheoldsensorandinsertanewsensor.

•OncethecodehasbeenenteredandyouhavehittheSetbutton,youwillnotbeabletochangethe

sensorcodenumber.Ifyouhaveenteredthecodeincorrectly,youwillhavetoreplacethesensorand

entertherightsensorcode.Ifyouchoosethewrongsensorcode,youmaygeterroneousresultsfrom

thesensor.ecodenumbersMUSTmatchtoensureaccuratetestresults.

•Do NOTremoveorreplacethetransmitterfromthesensorsupportmountwhilewearingasensor.If

younoticethatthetransmitterisnotproperlyattached,replacethesensorwithanewsensorandthen

re-attachthetransmitter.

•DonotreuseFreeStyleNavigatorSensorsduetoriskofinfection.Notsuitableforresterilisation.

•Youshouldneverresetyourusersettingswhenyouarewearingasensor.iswillresetparametersthat

mayaectyoursystemperformance.

•IfyouacceptanincorrecttransmitterIDwhenlinkingyourTransmitterandReceiver,yourglucose

readingswillbeincorrectornotavailable.

•Do NOTusethesensorinserterorsensorsupportmountiftheirsterilepackagesareopenordamaged.

Caution: Clean previously used transmitters and receivers according to the instructions in Section 14 prior

to using the FreeStyle Navigator system yourself.

Caution: If a FreeStyle Navigator system was previously used by another person, the system log should be

cleared using the “Erase History” command and the system settings should be returned to their defaults using

the “Reset User Settings” command. ese steps are important to ensure data integrity.

Caution: If the FreeStyle Navigator Receiver was previously used by another person, it may contain data

that is not your data. Make sure to only use data in the Statistics, Line Graph and Event History reports that

correspond to your actual sensor wear time.

Important Things to Remember About System Calibration

Caution: Always calibrate the system using a nger-stick blood sample. Do NOT use alternative site blood

glucose measurements to calibrate the system. e receiver contains a built-in FreeStyle Blood Glucose

Meter for performing calibration tests.

Important: Your blood glucose level must be between 60 and 400 mg/dL (3.3 and 22.2 mmol/L) to be able to

perform calibration tests. If your blood glucose level is changing rapidly, you may not be able to calibrate the

system. For example, during a meal or exercise, your glucose levels may vary rapidly. Try to time your sensor

insertion so that your calibration times do not coincide with your regular meal or exercise activities.

Section 1 7

Getting Acquainted

ART20775-001_Rev-A-Guide.indd 7 4/12/10 4:48 PM

Important Things to Remember About System Calibration (cont.)

Important: In clinical trials, we observed that the sensor signal sometimes temporarily decreases from

the true value. is typically happens at night during sleep, and recovers rapidly when the user moves

or is awakened. However, in order to avoid being aected by this phenomenon the system should not be

calibrated when the wearer is asleep.

•

Youmaynotbeabletocalibratethesystemifyourglucoselevelsarechangingrapidly.Undersuch

conditions,thesystemmaynotaskyoutocalibrate;instead,itwilldelayitsrequestuntilconditionsare

acceptable.

•

Youwillcalibrateatapproximately1,2,10,24and72hoursaersensorinsertion.Ifyoudonot

completecalibrationtestssuccessfullyintheallottedtimeperiods,yourglucosereadingswillNOT

bedisplayedandalarmswillbeinactive.esystemmayaskyoutoperformadditionalcalibrations

duringtherst24hoursdependingonthesensorsignal.Insuchcases,youwillbepromptedwitha

messagetodoadditionalBGtests.Somesensorsmaystopprovidingresultsforawhileifthesensor

signalisfoundtobeunstable.YouwillbepromptedwithamessagetodoadditionalBGteststorestore

operationwhenthesensorbecomesstable.

•ereceiverwillbeep(orvibrate)topromptyoutodoacalibration.ereceiverwilldisplayablood

dropicon andthemessage“DoBGTest.”esystemwillpromptyouwithalarmmessageswhen

yourcalibrationsareunsuccessful.

•Youwillnothavecontinuousmonitoringuntilyouhavesuccessfullycompletedtherstcalibration(at

leastforthersthouraersensorinsertion).

•Ifyougetarequestforacalibrationorexpectadditionalcalibrationrequestsduringatimewhenyou

donotwanttobedisturbed(e.g.sleeptime),youcanchoosetowaittoperformadditionalBGtests

atalaterpointintime.Ifyouchoosetowaitandtheallottedtimewindowforcalibrationhasexpired,

pleasenotethatyouwillnotgetglucoseresultsuntilyouhaveperformedasuccessfulcalibration.You

canusetheAlarmMutefunctiontopreventrequestsforcalibrationandotheralarmsfromoccurring.

isfunctionisprogrammablefrom1to12hours.

Before You Get Started

Caution:

In order to conrm hypoglycaemia or impending hypoglycaemia as reported by the FreeStyle

Navigator Sensor, use the built-in FreeStyle Blood Glucose Meter to conduct nger-stick testing to check the

FreeStyle Navigator reading.

•

PerformanceoftheFreeStyleNavigatorsystemhasnotbeenevaluatedinpregnantwomen.

Caution:

Performance of the system under conditions of uctuating hydration levels such as during renal

dialysis has not been evaluated.

•

InstallationandoperationoftheFreeStyleNavigatorContinuousGlucoseMonitoringSystem

requiresusingaspecialisedintroductoryneedletoinserttheglucosesensorintotheskin.Infection,

inammationorbleedingattheglucosesensorinsertionsitearepossiblerisksofinsertingasensorinto

yourskin.eglucosesensorshouldberemovedifredness,pain,tendernessorswellingdevelopsat

thesensorinsertionsite.

8 Section 1

Getting Acquainted

ART20775-001_Rev-A-Guide.indd 8 4/12/10 4:48 PM

OVER

Before You Get Started (cont.)

•Loworhighglucosemeasurementscanindicateapotentiallyseriousmedicalcondition.

•Ifyouhavehypoglycaemia,orhypoglycaemiaunawareness,thenONLYtestonyourngers.

•Donotignoresymptomsthatmaybeduetolowbloodglucoseorhighbloodglucose.Ifyouhave

symptomsthatdonotmatchtheFreeStyleNavigatorreading,usethebuilt-inFreeStyleBloodGlucose

Metertoconductnger-sticktestingtochecktheFreeStyleNavigatorreading.

•ehighandlowalarmsareintendedtoassistyouinmanagingyourdiabetesandshouldnotbe

exclusivelyusedtodetecthypoglycaemiaorhyperglycaemia.ealarmsshouldalwaysbeusedin

conjunctionwithotherindicationsofglycaemicstatesuchasyourglucoselevel,trend,linegraphetc.

•HighandlowglucosealarmsareDIFFERENTfromyourglucosetargets.Lowandhighglucosealarms

alertyouwhenyou’vecrossedacertainloworhighvalue.Glucosetargetsallowthereportsandline

graphstoshowhowyourglucoselevelshavebeenperformingcomparedtoyoursettargets.

•eLowGlucosealarmcannotbesetbelow60mg/dL(3.3mmol/L).erefore,itisnotintendedto

notifyyouofseverehypoglycaemia.

•eHighGlucosealarmcannotbesetabove300mg/dL(16.7mmol/L).erefore,itisnotintendedto

notifyyouofseverehyperglycaemia.

•Itisimportanttousethecorrecttypeofbatteriesinthereceiver,otherwisethebatterylifemaynotbe

accuratelymonitored.

•Becauseyoumustinsertanewsensoraereachbatteryreplacement,youshouldreplacethebatteries

justbeforeyouinsertanewsensor.Forexample,ifyoudropyourreceiverandthebatteriesfallout,you

willhavetoinsertanewsensor.

•DoNOTimmersethereceiverinwaterorinanyotherliquid.Avoidgettingwateroranyotherliquidin

theteststripport.

•Ifyouobserveasignicantchangeinyourcontinuousglucosereadingsthatyouthinkiserroneous,or

ifyoufeelthebloodglucosemeasurementintheBloodGlucosemodeiserroneousandyouarecloseto

anelectromagneticinterferencesource,moveawayfromthesourceofinterferenceandchecktoseeif

theconditionfadesaway.

•Ifyouhaveamedicalappointmentthatincludesstrongmagneticorelectromagneticelds,suchas

anX-ray,MRI(MagneticResonanceImaging),CT(ComputedTomography)scanoranothertype

ofexposuretoradiation,keepyoursystemandsensorawayfromthearea.Beforeexposuretosuch

radiation,discardanysensoryouarewearingandinsertanewsensoraertheradiationsession.e

eectofthesetypesofradiationontheperformanceofthesystemhasnotbeenevaluated.

• Warning:CHOKINGHAZARDduetosmallparts.Adultsupervisionisrecommended.

• Warning:eteststripvialandsensordeliveryunitpackagingmaycontainadryingagentthatcould

beharmfulifinhaledorswallowedandmaycauseskinandeyeirritation.

• Warning:NEVERpointapre-cockedsensorinsertertowardtheeyes,faceoranyotherbodypart

wheresensorinsertionisnotdesired.

•ChangesormodicationsnotexpresslyapprovedbyAbbottDiabetesCareInc.couldvoidtheuser’s

authoritytooperatetheequipment.

•esystemshouldnotbeusedinenvironmentsthatareoxygen-richorthatcontainacombustiblegas.

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Getting Acquainted

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Helpful health-related information:

efollowingpertaintoyourhealthandshouldalwaysbekeptinmind:

•esystemisintendedtoassistyouinbettermanagingyourdiabetesbyallowingyoutoknowyour

glucoselevelsthroughouttheday.

•Testresultsbelow60mg/dL(3.3mmol/L)meanyourglucoselevelsarelow.

•Testresultsabove240mg/dL(13.3mmol/L)meanyourglucoselevelsarehigh.

•Severedehydrationandexcessivewaterlossmaycausefalselowresults.Ifyoubelieveyouare

experiencingseveredehydration,consultyourhealthcareteamimmediately.

•Ifyougetresultsbelow60mg/dL(3.3mmol/L)orabove240mg/dL(13.3mmol/L)anddonothave

symptomsofhypoglycaemiaorhyperglycaemia,testyourglucoseusingtheBloodGlucosemode.

•Ifyouhavesymptomsofhypoglycaemiaorhyperglycaemiaorcontinuetogetresultsbelow

60mg/dL(3.3mmol/L)orabove240mg/dL(13.3mmol/L),consultyourhealthcareteam.

•Ifyouareexperiencingsymptomsthatarenotconsistentwithyourglucosetestresults,consultyour

healthcareteam.Physiologicaldierencesbetweentheinterstitialuidandcapillarybloodmayresult

indierencesinglucosemeasurements.Dierencesinglucosemeasurementbetweeninterstitialuid

andyourngermaybeobservedduringtimesofrapidchangeinbloodglucose,e.g.aereating,dosing

insulinorexercising.

– Interstitialuid(ISF)istheuidbetweencellsinthebody.Movementofnutrients,oxygenand

glucosefromthebloodintothecellshappensacrosstheISF.erefore,iftheglucoseinthe

bloodstreamrises(e.g.duringmeals),thatriseisnotseenintheISFuntillater.Similarly,ifglucose

levelsintheISFdrop(forexampleduringexercise,thecellsconsumeglucoserapidly)thatdropis

notseeninthebloodstreamuntillater.

•WhentestingyourglucoselevelsintheBloodGlucosemode,dierencesinthebloodcirculationin

yourngerandothertestsites(forearm,upperarm,hand,thighorcalf)mayresultindierentglucose

readings.Dierencesinbloodglucosereadingsbetweenyourngerandothertestsites(forearm,

upperarm,hand,thighorcalf)maybeobservedaereating,takinginsulin,diabetesmedicationor

exercising.

•Testyourngerifyouaretestingforhypoglycaemiaorifyouhavehypoglycaemiaunawareness(see

nextpagefordenitionofhypoglycaemiaunawareness).Changesinglucoselevelsmaybeobservedin

ngerbloodsamplessoonerthaninsamplesfromalternativesites(forearm,upperarm,hand,thighor

calf).Ifanalternativesitemustbeused,vigorousrubbingofthealternativesitebeforelancingcanhelp

minimisethisdierence.

10 Section 1

Getting Acquainted

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OVER

What is Hypoglycaemia Unawareness?

Hypoglycaemiaunawarenessisaconditionwhereyouhavehypoglycaemiabutyoudonothaveanyofthe

usualwarningsymptoms(suchasrapidheartbeat,sweating,shakiness,anxietyoratinglingsensationin

yourngersortoes).osewarningsymptomsareeitherabsentorgreatlyreduced.Instead,therstsign

maybeconfusionorimpairedthinking,whichmakesitevenmorediculttoknowifyouareexperiencing

lowbloodglucose.Youcouldndyourselfinthemidstofaseverehypoglycaemicepisodewithoutany

warningatall.

Symptoms of Hypoglycaemia Unawareness:

Becauseyouwouldhavemissedtheearlywarningsignsofhypoglycaemia,theonlysignsorsymptomsyou

mayhavewouldbeduetotheeectsoflowbloodglucoseonthebrain:

•Irritability

•Tiredness

•Confusion

•Forgetfulness

•Paleskin

•Slurredspeech

•Lossofconsciousness

isconditionispotentiallydangerousbecausehypoglycaemiaconfusioncanoccurwithoutwarning.

Ifyouweredrivingacaroroperatingheavymachinery,confusionordelayedreactioncouldcausean

accident.

Hypoglycaemia unawareness can develop for several reasons:

a.

Havingfrequenthypoglycaemicepisodes.

b.Havinglong-standingdiabetesandautonomicneuropathy(aformofdiabeticneuropathyinwhich

yourbodydoesnotreleaseitsusualhormonestowarnyouoflowbloodglucoseandtotellyourliverto

releaseglucoseasaprotectivemechanism).

Ifyouthinkyouhavehypoglycaemiaunawareness,talktoyourhealthcareteam.

Section 1 11

Getting Acquainted

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What are the Continuous Monitoring mode and Blood

Glucose mode?

Your FreeStyle Navigator system operates in two modes:

•ContinuousMonitoringmode(GlucoseCM).

•BloodGlucosemode(GlucoseBG).

Continuous Monitoring mode (Glucose CM)

eContinuousMonitoringmodeisthemodeyouwilluse

mostofthetime.Itcontinuouslydisplaystheglucoselevelin

theuidinthetinyspacesbetweenyourtissues(interstitial

uid).isglucosereadingcomesfromthesensoryouwill

placejustbeneathyourskinandisupdatedeveryminute.

• “GlucoseCM”atthetopleofthedisplay.

• eglucosereadingistypicallyaccompaniedbya

directionaltrendarrowthatindicateshowfastyourglucose

ischangingandinwhatdirection.

• Mostfrequentlyusedmode.

• Measuresglucosefrominterstitialuiddetectedbyasensor

inyourskin.

–Usesasensortomeasureglucoselevels.

–Atransmittersendstheglucosereadingstothereceiver.

–ShouldonlybeusedwithFreeStyleNavigatorsystem

TransmittersandFreeStyleNavigatorSensors.

Blood Glucose mode (Glucose BG)

Youwillperformtraditionalbloodglucosetesting

(BGtesting)intheBloodGlucosemodeusingaFreeStyle

TestStripandadropofblood.YoucanusetheBloodGlucose

modewheneveryouwishtoperformatraditionalblood

glucosetest.Itisalsousedforcalibratingthesystem.Blood

Glucosemodetestsusedforcalibratingthesystemcanalsobe

reliedoninthesamewayastraditionalbloodglucosetests.

• “GlucoseBG”atthetopleofthedisplay.

–Built-inFreeStyleBloodGlucoseMeter.

• Measuresglucosefromabloodsamplethatyousupply.

• UsesaFreeStyleTestStriptomeasurebloodglucoselevels.

Note: UseONLYFreeStyleTestStripsandControlSolution.

Otherbrandsofteststripsorcontrolsolutioncangiveyou

inaccurateresults.

esystemtypicallyworksintheContinuousMonitoringmode.ItswitchestotheBloodGlucosemode

whenyouinsertaFreeStyleTestStripintothereceiver’steststripport.InordertoturntheBloodGlucose

modeon,youhavetoinserttheteststripwhenthereceiveriseitherturnedoorwhenitdisplaysthe

glucosescreen.

END OF Section 1

4.7 mmol/L

5.9 mmol/L

12 Section 1

Getting Acquainted

Glucose BG

08:30

106

mg/dL

Home

ART20775-001_Rev-A-Guide.indd 12 4/12/10 4:48 PM

2

OVER

2 Install or Replace Transmitter and Receiver Batteries

Purpose ToensurethatyourFreeStyleNavigatorsystemhaspowertooperateproperly.

Start Dothisprocedure:

•ersttimeyouuseyourFreeStyleNavigatorsystem.

•WhenthereceiverdisplaystheLowBatterymessageandalarmandthebattery

icon appearsonthescreen.

•Whenthereceiversoundsanalarmanddisplaysthe“ReplaceTXBatterywith

NextSensor”message.

Materials Gatherthesematerialsbeforeyoubegin:

•2newAAAalkalinebatteries(LR03)forthereceiver.WerecommendEnergizer®

Max®andEnergizer®Industrialbatteries.Otherbatteriesmaynotprovide

expectedbatterylife.Formoreinformationonbatteries,contactCustomerCare.

•1SilverOxide357battery(coincell)forthetransmitter.Werecommend

RENATA357orVARTAV357HCbatteries.Otherbatteriesmaynotprovide

expectedbatterylife.

•Acoin.

•YourFreeStyleNavigatorReceiver.

•YourFreeStyleNavigatorTransmitter.

Helpful Information

Caution:

It is important to use the correct type of batteries in both the receiver and transmitter,

otherwise the battery life may not be accurately monitored.

Important:

• Analarmwillsoundandabatteryiconwillappearonthescreenwhenyourreceiverbatteriesare

running low. You must replace your receiver batteries the next time you replace your sensor. Make sure

to replace batteries before inserting your next sensor.

• Analarmwillsoundandamessagewillappearonthescreenwhenyourtransmitterbatteryisrunning

low. You have approximately 4 days of battery power remaining when this rst happens.

• Becauseyoumustinsertanewsensoraereachbatteryreplacement,youshouldreplacethebatteries

just before you insert a new sensor. For example, if you drop your receiver and the batteries fall out,

you will have to insert a new sensor.

• Aerinstallingthetransmitterorreceiverbatteries,allowacoupleofminutesforthesystemto

recognise the new batteries. You may then access the status of the battery life from the System menu

in your receiver (see Status Information in Section 11). If the batteries are new, the status screen will

show 75-100% as the remaining battery life.

•If your receiver batteries are low and you fail to replace them, they may run out without a

warning and the receiver will neither display your glucose levels nor sound alarms.

•etransmitter’sbatterylifeisestimatedtobeupto30days.

•ereceiver’sbatterylifeisestimatedtobe30days.However,batterylifemaybeshorterthan30days

ifyourreceiver’salarmsaresettovibrate,orifthetransmitter/receiverconnectionisbrokenoen.

•Ifyouwillnotbeusingyourreceiverforanextendedperiodoftime,removethebatteriesfromthe

receivertopreservebatterylife.

•Toavoiddrainingthereceiver’sbatteries,becarefulnottoaccidentallypressandholdthereceiver’s

buttonsforalongperiodoftime.

•Aerchangingthebatteries,makesurethatyoureconnectthetransmitterandreceivertoestablish

communicationbetweenthem.

Section 2 13

Install or Replace Transmitter and Receiver Batteries

ART20775-001_Rev-A-Guide.indd 13 4/12/10 4:48 PM

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