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
nSection 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.
nSection 3: SettheTimeandDate ................................................17–19
SettheTimeandDate.
nSection 4: Change Country Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 – 24
ChangeLanguage,DateandTimeFormats,DecimalPointformat.
nSection 5: Perform a Control Solution Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 – 29
WhentoPerformaControlSolutionTest.
 HowtoPerformaControlSolutionTest.
nSection 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.
nSection 7: Attach your Transmitter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 – 44
 AttachtheTransmitter.
 SensorCode.
nSection 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.
nSection 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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nSection 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.

nSection 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.
nSection 12: Add Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 – 98
EnterEvents:Insulin,Meals,ExerciseandStateofHealth.
 CustomiseGenericEvents.
nSection 13: Review Reports and Edit Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99 – 106
EnterGlucoseTargets.
 ViewLineGraph.
 ViewStatistics.
 ReviewtheHistoryofEvents.
 EditEvents.
nSection 14: CleanandDisinfectYourSystem.....................................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.
nSection 15: Link and Unlink your Transmitter and Receiver . . . . . . . . . . . . . . . . . . . . . . . . 111 – 113
LinkandUnlinkyourSystem.
 WhatistheDierenceBetweenLinkingandReconnecting?
nSection 16: Reset User Settings and Erase History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115 – 117
ResetSettings.
 EraseHistory.
nSection 17: AppendixA:SiteMaintenance............................................119
HowtoMaintaintheSensorInsertionSite.
 HowtoImproveSensorAdhesion.
nSection 18: AppendixB:Specications ..........................................121–122
nSection 19: Appendix C: Electromagnetic Interference Information . . . . . . . . . . . . . . . . . 123 – 127
WirelessInterference.
nSection 20: Glossary ..........................................................129–134
DenitionsofTermsUsedinisGuide.
nSection 21: Index.............................................................135–136
FindWhatYouAreLookingFor.
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Customer Care: +8000 - 2255 - 232 (+8000 - CALL - ADC)
ART20775-001_Rev-A-Guide.indd 6 4/12/10 4:48 PM

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
ART20775-001_Rev-A-Guide.indd 1 4/12/10 4:48 PM

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