English
ART39408_rev_A 02-Mar-18 5:45
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App!Symbols
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Direction!your!glucose!is
going.!See!Understanding
Your!Glucose!Readings
for!more!information.
Scan!button
Caution
Add/edit!notes
Food!note
Insulin!(Rapid!or!Long-
acting)!note
Exercise!note
Time!change
Sensor!too!cold
Sensor!too!hot
App!icon
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Multiple/Custom!notes
User's!Manual
App!Symbols
Important!Information
Indications!for!Use
FreeStyle!LibreLink!Overview
Home!Screen
FreeStyle!Libre!Sensor!Kit
App!Setup
Applying!Your!Sensor
Starting!Your!Sensor
Checking!Your!Glucose
Understanding!Your!Glucose!Readings
Adding!Notes
Reviewing!Your!History
Logbook
Other!History!Options
Removing!Your!Sensor
Replacing!Your!Sensor
Setting!Reminders
Settings!and!Other!Options!
in!the!Main!Menu
Activities
Maintenance!and!Disposal
Troubleshooting
Problems!at!the!Sensor!Application!Site
Problems!Starting!Your!Sensor
or!Receiving!Sensor!Readings
Customer!Service
Labelling!Symbols!and!Definitions
Electromagnetic!Compatibility
Performance!Characteristics
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ART39408_rev_A 02-Mar-18 5:45
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App!Symbols
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!
Direction!your!glucose!is
going.!See!Understanding
Your!Glucose!Readings
for!more!information.
Scan!button
Caution
Add/edit!notes
Food!note
Insulin!(Rapid!or!Long-
acting)!note
Exercise!note
Time!change
Sensor!too!cold
Sensor!too!hot
App!icon
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Multiple/Custom!notes
User's!Manual
ART39408_rev_A 02-Mar-18 5:45
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Important!Information
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Indications!for!Use
The!FreeStyle!LibreLink!app!("App")!is!indicated!for!measuring!interstitial!fluid
glucose!levels!in!people!(age!4!and!older)!with!diabetes!mellitus!when!used!with
the!FreeStyle!Libre!Flash!Glucose!Monitoring!System!Sensor!("Sensor").!The
indication!for!children!(age!4!-!17)!is!limited!to!those!who!are!supervised!by!a
caregiver!who!is!at!least!18!years!of!age.!The!caregiver!is!responsible!for
managing!or!assisting!the!child!to!manage!the!Sensor!and!the!FreeStyle!LibreLink
App!and!also!for!interpreting!or!assisting!the!child!to!interpret!readings.!It!is
designed!to!replace!blood!glucose!testing!in!the!self-management!of!diabetes
with!the!exceptions!listed!below.!Under!the!following!circumstances,!use!a!blood
glucose!meter!to!check!the!current!glucose!readings:
WARNING:!If!you!are!using!FreeStyle!LibreLink,!you!must!also!have!access!to!a
blood!glucose!monitoring!system!as!the!App!does!not!provide!one.
During!times!of!rapidly!changing!glucose!levels,!interstitial!glucose!levels!as
measured!by!the!Sensor!and!reported!as!current!may!not!accurately!reflect
blood!glucose!levels.!When!glucose!levels!are!falling!rapidly,!glucose!readings
from!the!Sensor!may!be!higher!than!blood!glucose!levels.!Conversely!when
glucose!levels!are!rising!rapidly,!glucose!readings!from!the!Sensor!may!be!lower
than!blood!glucose!levels.
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In!order!to!confirm!hypoglycaemia!or!impending!hypoglycaemia!as!reported!by
the!Sensor.
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If!symptoms!do!not!match!the!reading.!Do!not!ignore!symptoms!that!may!be
due!to!low!blood!glucose!or!high!blood!glucose.
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Share!report
Additional!information
Main!menu
Calendar
ART39408_rev_A 02-Mar-18 5:45
CAUTION:!FreeStyle!LibreLink!installed!on!a!smartphone!is!intended!for!use!by!a
single!person.!It!must!not!be!used!by!more!than!one!person!due!to!the!risk!of
misinterpreting!glucose!information.
Additional!Safety!Information
FreeStyle!LibreLink!and!FreeStyle!Libre!Flash!Glucose!Monitoring!System!Readers
("Readers")!do!not!share!data.!For!complete!information!on!a!device,!be!sure!to
scan!your!Sensor!every!8!hours!with!that!device;!otherwise,!your!reports!will!not
include!all!your!data.
Security!Information
The!following!Contraindication,!Warnings,!and!other!safety!information!apply
to!the!Sensor,!when!used!with!FreeStyle!LibreLink.
CONTRAINDICATION:!The!Sensor!must!be!removed!prior!to!Magnetic!Resonance
Imaging!(MRI).
WARNING:
You!are!responsible!for!properly!securing!and!managing!your!smartphone.!If
you!suspect!an!adverse!cybersecurity!event!related!to!FreeStyle!LibreLink,
contact!Customer!Service.
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FreeStyle!LibreLink!is!not!intended!for!use!on!a!smartphone!that!has!been
altered!or!customised!to!remove,!replace!or!circumvent!the!manufacturer’s
approved!configuration!or!use!restriction,!or!that!otherwise!violates!the
manufacturer’s!warranty.
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The!Sensor!is!only!intended!to!be!used!by!patients!(aged!4!years!and!older)!with
insulin!dependent!diabetes!mellitus.
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Health!care!professionals!and!consumers!should!be!aware!about!the!limitations
of!available!scientific!evidence!for!use!of!this!device!in!any!other!groups!of
patients!who!require!diabetes!management.
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The!Sensor!contains!small!parts!that!may!be!dangerous!if!swallowed.•
During!times!of!rapidly!changing!glucose!(more!than!0.1!mmol/L!per!minute),
interstitial!fluid!glucose!levels!as!measured!by!the!Sensor!may!not!accurately
reflect!blood!glucose!levels.!Under!these!circumstances,!check!the!Sensor
glucose!readings!by!conducting!a!fingerstick!test!using!a!blood!glucose!meter.
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In!order!to!confirm!hypoglycaemia!or!impending!hypoglycaemia!as!reported!by
the!Sensor,!conduct!a!fingerstick!test!using!a!blood!glucose!meter.
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ART39408_rev_A 02-Mar-18 5:45
CAUTION:
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Additional!Safety!Information
Do!not!ignore!symptoms!that!may!be!due!to!low!or!high!blood!glucose.!If!you
have!symptoms!that!do!not!match!the!Sensor!glucose!reading,!or!suspect!your
reading!may!be!inaccurate,!check!the!reading!by!conducting!a!fingerstick!test
using!a!blood!glucose!meter.!If!you!are!experiencing!symptoms!that!are!not
consistent!with!your!glucose!readings,!consult!your!health!care!professional.
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On!rare!occasions,!you!may!get!inaccurate!Sensor!glucose!readings.!If!you
believe!your!readings!are!not!correct!or!are!inconsistent!with!how!you!feel,
perform!a!blood!glucose!test!on!your!finger!to!confirm!your!glucose!and!check
to!make!sure!your!Sensor!has!not!come!loose.!If!the!problem!continues!or!if
your!Sensor!is!coming!loose,!remove!the!current!Sensor!and!apply!a!new!one.
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Intense!exercise!may!cause!your!Sensor!to!loosen!due!to!sweat!or!movement!of
the!Sensor.!If!your!Sensor!comes!loose,!you!may!get!no!readings!or!unreliable
readings,!which!may!not!match!how!you!feel.!Follow!the!instructions!to!select!an
appropriate!application!site.
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Some!individuals!may!be!sensitive!to!the!adhesive!that!keeps!the!Sensor
attached!to!the!skin.!If!you!notice!significant!skin!irritation!around!or!under!your
Sensor,!remove!the!Sensor!and!stop!using!the!Sensor.!Contact!your!health!care
professional!before!continuing!to!use!the!Sensor.
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Performance!of!the!Sensor!when!used!with!other!implanted!medical!devices,
such!as!pacemakers,!has!not!been!evaluated.
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Do!not!reuse!Sensors.!The!Sensor!has!been!designed!so!that!it!cannot!be!reused.
Not!suitable!for!re-sterilisation.
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Severe!dehydration!and!excessive!water!loss!may!cause!inaccurate!Sensor
results.!If!you!believe!you!are!suffering!from!dehydration,!consult!your
healthcare!professional!immediately.
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The!Sensor!Pack!and!Sensor!Applicator!are!packaged!as!a!set!and!have!the!same
Sensor!code.!Check!that!the!Sensor!codes!match!before!using!your!Sensor!Pack
and!Sensor!Applicator.!Sensor!Packs!and!Sensor!Applicators!with!the!same
Sensor!code!should!be!used!together!or!your!Sensor!glucose!readings!may!be
incorrect.
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Physiological!differences!between!the!interstitial!fluid!and!capillary!blood!may•
ART39408_rev_A 02-Mar-18 5:45
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FreeStyle!LibreLink!Overview
IMPORTANT:
result!in!differences!in!glucose!readings.!Differences!in!Sensor!glucose!readings
between!interstitial!fluid!and!capillary!blood!may!be!observed!during!times!of
rapid!change!in!blood!glucose,!such!as!after!eating,!dosing!insulin,!or!exercising.
Interfering!Substances:!Taking!ascorbic!acid!while!wearing!the!Sensor!may
falsely!raise!your!Sensor!glucose!readings.!Taking!salicylic!acid!may!slightly!lower
your!Sensor!glucose!readings.!The!level!of!inaccuracy!depends!on!the!amount!of
the!interfering!substance!active!in!your!body.
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Store!the!Sensor!Kit!between!4°C!and!25°C.!While!you!don’t!need!to!keep!your
Sensor!Kit!in!a!refrigerator,!you!can!as!long!as!the!refrigerator!is!between!4°C
and!25°C.
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If!you!have!a!medical!appointment!that!includes!strong!magnetic!or
electromagnetic!radiation,!for!example!an!X-ray,!MRI!(Magnetic!Resonance
Imaging),!or!CT!(Computed!Tomography)!scan,!remove!the!Sensor!you!are
wearing!and!apply!a!new!one!after!the!appointment.!The!effect!of!these!types!of
procedures!on!the!performance!of!the!Sensor!has!not!been!evaluated.
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The!Sensor!has!not!been!evaluated!for!use!in!pregnant!women,!persons!on
dialysis!or!people!less!than!4!years!of!age.
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The!Sensor!Pack!is!sterile!unless!opened!or!damaged.•
Your!Sensor!has!been!tested!to!withstand!immersion!into!one!metre!(3!ft)!of
water!for!up!to!30!minutes.
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Do!not!freeze!the!Sensor.!Do!not!use!if!expiry!date!has!passed.•
Read!all!of!the!information!in!this!User’s!Manual!before!using!FreeStyle!LibreLink
with!a!Sensor.!Refer!to!your!iPhone!instructions!for!use!for!how!to!use!your
iPhone.!If!you!are!using!a!Reader,!refer!to!the!User's!Manual!in!the!Reader!Kit.
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You!are!responsible!for!properly!securing!and!managing!your!smartphone.!If
you!suspect!an!adverse!cybersecurity!event!related!to!FreeStyle!LibreLink,
contact!Customer!Service.
•
FreeStyle!LibreLink!installed!on!a!smartphone!is!intended!for!use!by!a!single
person.!It!must!not!be!used!by!more!than!one!person!due!to!the!risk!of
misinterpreting!glucose!information.
•
ART39408_rev_A 02-Mar-18 5:45
FreeStyle!LibreLink!is!available!for!download!from!the!App!Store.!When!you're
ready!to!start!using!FreeStyle!LibreLink,!you'll!prepare!and!apply!a!Sensor!to!the
back!of!your!upper!arm.!You!can!then!use!the!App!to!get!glucose!readings!from
the!Sensor!and!store!your!glucose!history!and!notes.!The!Sensor!can!be!worn!on
your!body!for!up!to!14!days.
Note:
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Home!Screen
The!Home!Screen!gives!you!access!to!information!about!your!glucose!and!the!App.
To!return!to!the!Home!Screen!from!another!screen,!go!to!the!Main!Menu!and!tap
Home.
FreeStyle!LibreLink!and!FreeStyle!Libre!Flash!Glucose!Monitoring!System!Readers
("Readers")!do!not!share!data.!For!complete!information!on!a!device,!be!sure!to
scan!your!Sensor!every!8!hours!with!that!device;!otherwise,!your!reports!will!not
include!all!your!data.
•
FreeStyle!LibreLink!is!not!intended!for!use!on!a!smartphone!that!has!been
altered!or!customised!to!remove,!replace!or!circumvent!the!manufacturer’s
approved!configuration!or!use!restriction,!or!that!otherwise!violates!the
manufacturer’s!warranty.
•
The!Sensor!comes!in!the!FreeStyle!Libre!Sensor!kit.!See!FreeStyle!Libre!Sensor
Kit.
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Go!to!www.FreeStyleLibre.com
!for!smartphone!requirements!and!compatibility.
Please!keep!in!mind!that!the!ease!of!scanning!a!Sensor!may!vary!between
devices.
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ART39408_rev_A 02-Mar-18 5:45
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Main!Menu!-!Tap!to!access!the!Home!Screen,!Logbook,!other!history!options,!and
the!Share!option.!You!can!also!access!Settings,!Help,!and!other!information.
Glucose!Graph!-!Graph!of!your!stored!Sensor!glucose!readings.
Scan!Button!-!Tap!when!you!are!ready!to!scan!your!Sensor.!You!can!either!tap!the
blue!box!on!the!Home!Screen!or!
!at!the!top!right.
Glucose!Information!-!Your!Time!In!Target,!information!about!your!last!scan,!and
average!glucose!for!the!last!24!hours.
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FreeStyle!Libre!Sensor!Kit
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The!FreeStyle!Libre!Sensor!Kit!includes:
ART39408_rev_A 02-Mar-18 5:45
When!opening!your!kit,!check!that!the!contents!are!undamaged!and!that!you!have
all!parts!listed.!If!any!parts!are!missing!or!damaged,!contact!Customer!Service.!The
Sensor!(only!visible!after!applied)!is!initially!in!two!parts:!one!part!is!in!the!Sensor
Pack!and!the!other!part!is!in!the!Sensor!Applicator.!Once!prepared!and!applied!to
your!body,!the!Sensor!measures!your!glucose!using!a!small,!flexible!tip!that!inserts
just!under!the!skin.
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Sensor!Pack.!Used!with!the!Sensor!Applicator!to!prepare!the!Sensor!for!use.
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Sensor!Applicator.!Applies!the!Sensor!to!your!body.
Sensor!Pack•
Sensor!Applicator•
Alcohol!wipe•
Product!insert•
ART39408_rev_A 02-Mar-18 5:45
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App!Setup
Before!using!the!App!for!the!first!time,!you!must!complete!the!setup.
Check!that!your!iPhone!is!connected!to!a!network!(WiFi!or!cellular).!You!can
then!install!FreeStyle!LibreLink!from!the!App!Store.!Tap!the!App!icon!to!open
the!App.
1.
Note:!You!only!need!to!be!connected!to!a!network!for!setup,!using!LibreView,
and!sharing!with!other!apps.!You!do!not!need!to!be!connected!to!scan!a!Sensor,
add!notes,!or!review!your!history!in!the!App.
Swipe!left!to!view!some!helpful!tips!or!tap!GET!STARTED!NOW!at!any!point.2.
Confirm!your!country!and!tap!NEXT.3.
You!need!a!LibreView!account!to!use!the!App.!Follow!onscreen!instructions!to
review!legal!information!and!create!a!new!account!or!login!to!your!existing
account.
4.
LibreView!Data!Management!Software!is!developed!and!distributed!by!Newyu,!Inc.!Use!of!FreeStyle
LibreLink!requires!registration!with!LibreView,!a!service!provided!by!Abbott!and!Newyu,!Inc.
Confirm!your!glucose!unit!of!measure!and!tap!NEXT.5.
Set!your!Target!Glucose!Range!and!tap!NEXT.!Work!with!your!health!care
professional!to!determine!your!Target!Glucose!Range.!Your!Target!Glucose
Range!is!displayed!on!glucose!graphs!in!the!App!and!is!used!to!calculate!your
Time!In!Target.
6.
Select!how!you!count!carbohydrates!(in!grams!or!portions)!and!tap!NEXT.!The7.
ART39408_rev_A 02-Mar-18 5:45
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Applying!Your!Sensor
CAUTION:
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carbohydrate!unit!will!be!used!in!any!food!notes!you!enter!in!the!App.
The!App!now!displays!useful!information!about!the!My!Glucose!screen.!Tap
NEXT!to!view!information!about!the!Glucose!Trend!Arrow.!Tap!NEXT!again.
8.
Apply!a!new!Sensor!and!then!tap!NEXT.!Go!to!Starting!Your!Sensor
.9.
Note:!If!you!need!help!applying!your!Sensor,!tap!HOW!TO!APPLY!A!SENSOR!or
go!to!Applying!Your!Sensor
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The!Sensor!Pack!and!Sensor!Applicator!are!packaged!together!as!a!set!and
have!the!same!Sensor!code.!Check!that!the!Sensor!codes!match!before!using
your!Sensor!Pack!and!Sensor!Applicator.!Sensor!Packs!and!Sensor!Applicators
with!the!same!Sensor!code!should!be!used!together!or!your!Sensor!glucose
readings!may!be!incorrect.
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Intense!exercise!may!cause!your!Sensor!to!loosen!due!to!sweat!or!movement
of!the!Sensor.!If!your!Sensor!comes!loose,!you!may!get!no!readings!or
unreliable!readings,!which!may!not!match!how!you!feel.!Follow!the
instructions!to!select!an!appropriate!application!site.
•
Apply!Sensors!only!on!the!back!of!your!upper!arm.!Avoid!areas!with!scars,
moles,!stretch!marks!or!lumps.!Select!an!area!of!skin!that!generally!stays!flat
during!your!normal!daily!activities!(no!bending!or!folding).!Choose!a!site!that
is!at!least!2.5!cm!(1!inch)!away!from!an!insulin!injection!site.!To!prevent
discomfort!or!skin!irritation,!you!should!select!a!different!site!other!than!the
one!most!recently!used.
1.
ART39408_rev_A 02-Mar-18 5:45
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Clean!application!site!with!an!alcohol!wipe!and!allow!site!to!dry!before
proceeding.!This!helps!the!Sensor!stay!attached!to!your!body.
2.
Note:!The!area!MUST!be!clean!and!dry,!or!the!Sensor!may!not!stick!to!the!site.
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Open!the!Sensor!Pack!by!peeling!the!lid!off!completely.!Unscrew!the!cap!from
the!Sensor!Applicator!and!set!the!cap!aside.
3.
CAUTION:!Do!NOT!use!if!the!Sensor!Pack!or!Sensor!Applicator!seem!to!be
damaged!or!already!opened.!Do!NOT!use!if!past!expiry!date.
ART39408_rev_A 02-Mar-18 5:45
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Line!up!the!dark!mark!on!the!Sensor!Applicator!with!the!dark!mark!on!the
Sensor!Pack.!On!a!hard!surface,!press!down!firmly!on!the!Sensor!Applicator
until!it!comes!to!a!stop.
4.
ART39408_rev_A 02-Mar-18 5:45
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Lift!the!Sensor!Applicator!out!of!the!Sensor!Pack.5.
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The!Sensor!Applicator!is!prepared!and!ready!to!apply!the!Sensor.6.
CAUTION:!The!Sensor!Applicator!now!contains!a!needle.!Do!NOT!touch!inside
the!Sensor!Applicator!or!put!it!back!into!the!Sensor!Pack.
ART39408_rev_A 02-Mar-18 5:45
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Place!the!Sensor!Applicator!over!the!prepared!site!and!push!down!firmly!to
apply!the!Sensor!to!your!body.
7.
CAUTION:!Do!NOT!push!down!on!Sensor!Applicator!until!placed!over
prepared!site!to!prevent!unintended!results!or!injury.
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Gently!pull!the!Sensor!Applicator!away!from!your!body.!The!Sensor!should
now!be!attached!to!your!skin.
8.
Note:!Applying!the!Sensor!may!cause!bruising!or!bleeding.!If!there!is!bleeding
that!does!not!stop,!remove!the!Sensor,!and!apply!a!new!one!at!a!different!site.
ART39408_rev_A 02-Mar-18 5:45
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Starting!Your!Sensor
IMPORTANT:
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Make!sure!Sensor!is!secure!after!application.!Put!the!cap!back!on!the!Sensor
Applicator.!Discard!the!used!Sensor!Applicator!and!Sensor!Pack!according!to
local!regulations.
9.
Note:!Tap!Help!in!the!Main!Menu!to!access!an!in-app!tutorial!on!applying!a
Sensor.
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The!App!requires!that!your!iPhone!has!date!and!time!enabled!to!set
automatically.!You!can!check!this!in!your!iPhone!settings.
•
When!using!the!App,!you!should!keep!your!iPhone!well!charged!and!be!sure!you
have!access!to!a!blood!glucose!meter.
•
ART39408_rev_A 02-Mar-18 5:45
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When!you!scan!your!Sensor,!you!will!receive!a!tone!and!vibration.!If!your
iPhone's!volume!is!turned!off,!you!will!not!hear!the!tone.
•
The!NFC!(Near!Field!Communication)!antenna!is!on!the!top!edge!of!iPhone.!Hold
this!area!near!your!Sensor!when!you!are!scanning.!You!may!need!to!adjust!your
scan!distance!based!on!what!clothing!you!are!wearing.!In!addition!to!proximity
and!orientation,!other!factors!can!affect!NFC!performance.!For!example,!a!bulky
or!metallic!case!can!interfere!with!the!NFC!signal.!Keep!in!mind!that!the!ease!of
scanning!a!Sensor!may!vary!between!devices.
•
Tap!the!scan!button!
.
1.
Note:
•!!You!can!either!tap!the!blue!box!on!the!Home!Screen!or!
!at!the!top!right.
•!!If!the!Ready!to!Scan!dialog!disappears,!push!the!scan!button!again.
NFC!is!now!activated!and!your!iPhone!is!ready!to!scan!the!Sensor.
Hold!the!top!of!your!iPhone!near!the!Sensor!(this!can!be!done!over!clothing).
Do!not!move!your!iPhone!until!you!hear!a!tone!and/or!feel!a!vibration.!This
completes!the!scan.
2.
Note:
•!!If!you!need!help,!tap!HOW!TO!SCAN!A!SENSOR!to!view!an!in-app!tutorial.
You!can!also!access!this!later!by!going!to!the!Main!Menu!and!then!tapping
Help.
•!!If!your!Sensor!is!not!successfully!scanned,!you!may!receive!this!Scan!Error:
"Your!scan!was!unsuccessful.!Tap!the!scan!button!and!scan!again."
See!Troubleshooting
!for!additional!error!messages.
The!Sensor!can!be!used!to!check!your!glucose!after!60!minutes.!While!the
Sensor!is!starting!up!you!can!navigate!away!from!the!App.!If!notifications!are
enabled,!will!see!a!notification!when!the!Sensor!is!ready.
3.
Note:
The!App!is!able!to!scan!a!Sensor!that!has!been!started!by!another!device.
However,!you!must!use!the!App!to!perform!the!first!scan!of!the!Sensor!within
its!60!minute!start-up!period!to!do!this.!!After!this!time!period,!you!will!not!be
able!to!scan!a!Sensor!that!was!started!by!another!device.
•
ART39408_rev_A 02-Mar-18 5:45
!
Checking!Your!Glucose
Scan!Button!-!Tap!when!you!are!ready!to!scan!your!Sensor.
Message!-!Tap!for!more!information.
Back!-!Tap!to!return!to!Home!screen.
Current!Glucose!-!Glucose!value!from!your!latest!scan.
Add!Note!-!Tap!to!add!notes!to!the!glucose!reading.
Glucose!Trend!Arrow!-!Direction!your!glucose!is!going.
Note!Symbol!-!Tap!to!review!notes!you've!entered.
Remember!that!FreeStyle!LibreLink!and!Readers!do!not!share!data.!For
complete!information!on!a!device,!be!sure!to!scan!your!Sensor!every!8!hours
with!that!device;!otherwise,!your!reports!will!not!include!all!your!data.
•
Open!the!App!and!tap!the!scan!button!
.
1.
Note:!If!the!Ready!to!Scan!dialogue!disappears,!push!the!scan!button!
!again.
Hold!the!top!of!your!iPhone!near!the!Sensor!until!you!hear!a!tone!and/or!feel!a
vibration.
2.
The!My!Glucose!screen!now!displays!your!glucose!reading.!It!includes!your
Current!Glucose,!a!Glucose!Trend!Arrow!indicating!which!way!your!glucose!is
going,!and!a!graph!of!your!current!and!stored!glucose!readings.
3.
!
ART39408_rev_A 02-Mar-18 5:45
Glucose!Graph!-!Graph!of!your!current!and!stored!glucose!readings.
Target!Glucose!Range!-!The!graph!shows!your!target!glucose!range.
Note:
!
Orange
!-!High!glucose!(above!13.3!mmol/L)
!
Yellow
!-!Between!the!Target!Glucose!Range!and!high!or!low!glucose!level
!
Green
!-!Within!the!Target!Glucose!Range
!
Red
!-!Low!glucose!(below!3.9!mmol/L)
!
Understanding!Your!Glucose!Readings
!
Glucose!Trend!Arrow
The!Glucose!Trend!Arrow!gives!you!an!indication!of!the!direction!your!glucose!is
going.
!
!
A!Sensor!can!store!up!to!8!hours!of!glucose!data,!so!scan!it!at!least!once!every
8!hours!to!capture!all!of!your!available!glucose!data.
•
The!graph!will!scale!to!27.8!mmol/L!to!accommodate!glucose!readings!above
21!mmol/L.
•
The!
!symbol!may!appear,!indicating!the!smartphone's!time!was!changed.
Gaps!in!the!graph!may!result!or!glucose!readings!may!be!hidden.
•
Your!current!glucose!value!determines!the!background!colour!on!the!My
Glucose!screen:
•
Glucose!is!rising!quickly
(more!than!0.1!mmol/L!
per!minute)
Glucose!is!rising
(between!0.06!and
0.1!mmol/L!per!minute)
ART39408_rev_A 02-Mar-18 5:45
!
!
!
Note:!The!Glucose!Trend!Arrow!may!not!always!appear!with!your!reading.
!
Messages
Below!are!messages!you!may!see!with!your!glucose!readings.
LO!|!HI:!If!LO!appears,!your!reading!is!lower!than!2.2!mmol/L.!If!HI!appears,!your
reading!is!higher!than!27.8!mmol/L.!You!can!touch!
!for!more!information.!Check
your!blood!glucose!on!your!finger!with!a!test!strip.!If!you!get!a!second!LO!or!HI
result,!contact!your!health!care!professional!immediately.
!
!
Low!Glucose!|!High!Glucose:!If!your!glucose!is!higher!than!13.3!mmol/L!or!lower
than!3.9!mmol/L,!you!will!see!a!message!on!the!screen.!You!can!touch!
!for!more
information!and!set!a!reminder!to!check!your!glucose.
Glucose!is!changing
slowly!(less!than
0.06!mmol/L!per!minute)
Glucose!is!falling
(between!0.06!and
0.1!mmol/L!per!minute)
Glucose!is!falling!quickly
(more!than!0.1!mmol/L!
per!minute)
ART39408_rev_A 02-Mar-18 5:45
!
!
Glucose!Going!Low!|!Glucose!Going!High:!If!your!glucose!is!projected!to!be
higher!than!13.3!mmol/L!or!lower!than!3.9!mmol/L!within!15!minutes,!you!will!see
a!message!on!the!screen.!The!background!colour!corresponds!to!your!current
glucose!value.!You!can!touch!
!for!more!information!and!set!a!reminder!to!check
your!glucose.
!
Note:!If!you!are!not!sure!about!a!message!or!reading,!contact!your!health!care
professional!for!information.
!
!
ART39408_rev_A 02-Mar-18 5:45
Adding!Notes
Notes!can!be!saved!with!your!glucose!readings!to!help!you!track!food,!insulin,!and
exercise.!You!can!also!add!your!own!comment.
Notes!you!add!are!shown!on!your!glucose!graph!and!in!your!Logbook!as!symbols.
You!can!review!a!note!by!tapping!its!symbol!on!your!glucose!graph!or!by!going!to
the!Logbook.!See!Reviewing!Your!History
!for!more!information!about!the!Logbook.
To!edit!a!note!from!the!glucose!graph,!tap!the!symbol!and!then!tap!on!the
information!you!would!like!to!change.!Tap!DONE!when!you!are!finished.
!
!
!
!
!
Tap! !on!the!My!Glucose!screen.
1.
Select!the!checkbox!next!to!the!notes!you!would!like!to!add.!After!you!check
the!box,!you!can!add!more!specific!information!to!your!note.
2.
•!!Food!notes:!Enter!meal!type!and!grams!or!portion!information
•!!Insulin!notes:!Enter!the!number!of!units!taken
•!!Exercise!notes:!Enter!intensity!and!duration
Tap!DONE!to!save!your!note.3.
Food
Insulin!(Rapid!or!Long-
acting)
Exercise
Food!+!insulin
5
Multiple/Custom!notes!!–
indicates!different!types
of!notes!entered!together
or!notes!entered!within!a
short!period!of!time.!A
numbered!badge!next!to
the!symbol!indicates!the
number!of!notes.
ART39408_rev_A 02-Mar-18 5:45
!
Reviewing!Your!History
Reviewing!and!understanding!your!glucose!history!can!be!an!important!tool!for
improving!your!glucose!control.!The!App!stores!about!90!days!of!information!and
has!several!ways!to!review!your!past!glucose!readings!and!notes.!From!the!Main
Menu,!tap!Logbook!to!view!the!Logbook!or!tap!on!one!of!the!other!history!options
under!Reports.
IMPORTANT:
!
!
Logbook
The!Logbook!contains!entries!for!each!time!you!scanned!your!Sensor!as!well!as
notes!you!added.!If!you!would!like!to!view!a!different!day,!tap!the!
!symbol!or
use!the!arrows.!To!add!a!note!to!a!Logbook!entry,!tap!on!the!entry!and!then!tap!
.!Select!your!note!information!and!tap!DONE.
To!add!a!note!that!is!independent!of!a!Logbook!entry,!tap!
!on!the!main!Logbook
screen.!Tap!
!if!you!want!to!add!a!note!on!a!different!date.
!
!
Other!History!Options
Daily!Patterns:!!A!graph!showing!the!pattern!and!variability!of!your!Sensor
glucose!readings!over!a!typical!day.!The!thick!black!line!shows!the!median
(midpoint)!of!your!glucose!readings.!The!light!blue!shading!represents!the!10th!-
90th!percentile!range!of!your!glucose!readings.!Dark!blue!shading!represents!the
25th!-!75th!percentile!range.
Note:!Daily!Patterns!needs!at!least!5!days!of!glucose!data.
Work!with!your!health!care!professional!to!understand!your!glucose!history.•
Remember!that!FreeStyle!LibreLink!and!Readers!do!not!share!data.!For!complete
information!on!a!device,!be!sure!to!scan!your!Sensor!every!8!hours!with!that
device;!otherwise,!your!reports!will!not!include!all!your!data.
•
ART39408_rev_A 02-Mar-18 5:45
!
!
Time!In!Target:!A!graph!showing!the!percentage!of!time!your!Sensor!glucose
readings!were!above,!below,!or!within!your!Target!Glucose!Range.
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!
!
Low!Glucose!Events:!Information!about!the!number!of!low!glucose!events
measured!by!your!Sensor.!A!low!glucose!event!is!recorded!when!your!Sensor
glucose!reading!is!lower!than!3.9!mmol/L!for!longer!than!15!minutes.!The!total
number!of!events!is!displayed!below!the!graph.!The!bar!graph!displays!the!low
glucose!events!in!different!periods!of!the!day.
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!
!
Average!Glucose:!!Information!about!the!average!of!your!Sensor!glucose
readings.!The!overall!average!for!the!selected!time!period!is!displayed!below!the
graph.!The!average!is!also!shown!for!different!periods!of!the!day.!Readings!above
or!below!your!Target!Glucose!Range!are!yellow,!orange,!or!red.!Readings!in!range
are!green.
ART39408_rev_A 02-Mar-18 5:45
!
!
Daily!Graph:!A!graph!of!your!Sensor!glucose!readings!by!day.!The!graph!shows
your!Target!Glucose!Range!and!symbols!for!notes!you!have!entered.
The!graph!will!scale!to!27.8!mmol/L!to!accommodate!glucose!readings!above
21!mmol/L.
•
You!might!see!gaps!in!the!graph!during!times!when!you!have!not!scanned!at
least!once!in!8!hours.
•
The!
!!symbol!may!appear!indicating!a!time!change.!Gaps!in!the!graph!may
result!or!glucose!readings!may!be!hidden.
•
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!
!
Estimated!A1c:!Your!estimated!A1c!level!(also!called!HbA1c)!is!based!on!available
Sensor!glucose!data!from!the!last!90!days.!The!more!data!available,!the!better
your!estimation!will!be.!However,!the!estimated!level!may!not!match!your!A1c
measured!in!a!laboratory
*
.!A1c!can!be!used!as!an!indicator!of!how!well!your
glucose!levels!have!been!controlled!and!may!be!used!to!monitor!your!diabetes
treatment!regimen.
*
!
The!formula!is!based!on!the!published!reference,!which!compared!average!Sensor!glucose!and
laboratory-measured!A1c:
A1c
%
!=!(Avg!SG
mg/dL
!+!46.7)/28.7
A1c
%
!=!(Avg!SG
mmol/L
!+!2.59)/1.59
Reference:!!Nathan!DM,!Kuenen!J,!Borg!R,!Zheng!H,!Schoenfeld!D,!Heine!RJ!for!the!A1c-Derived!Average!Glucose!(ADAG).!Study!Group:!Translating
the!hemoglobin!A1c!assay!into!estimated!average!glucose!values.!Diabetes!Care!2008,!31:1473-8.
ART39408_rev_A 02-Mar-18 5:45
!
!
Sensor!Usage:!Information!about!how!often!you!scan!your!Sensor.!This!includes
the!total!number!of!scans,!an!average!of!how!many!times!you!scanned!your
Sensor!each!day,!and!the!percentage!of!possible!Sensor!data!recorded!from!your
scans.
ART39408_rev_A 02-Mar-18 5:45
!
Note:
!
Removing!Your!Sensor
Tap!the! !symbol!on!any!report!to!share!a!screenshot!of!the!report.
•
Tap!the!
!symbol!to!view!a!description!of!the!report.
•
To!view!a!different!report,!tap!the!drop!down!menu!above!the!report,!or!go!to
the!Main!Menu.
•
On!all!reports!except!the!Daily!Graph!and!Estimated!A1c,!you!can!select!to!show
information!about!your!last!7,!14,!30,!or!90!days.
•
Pull!up!the!edge!of!the!adhesive!that!keeps!your!Sensor!attached!to!your!skin.
Slowly!peel!away!from!your!skin!in!one!motion.
1.
Note:!Any!remaining!adhesive!residue!on!the!skin!can!be!removed!with!warm
soapy!water!or!isopropyl!alcohol.
ART39408_rev_A 02-Mar-18 5:45
!
Replacing!Your!Sensor
Your!Sensor!automatically!stops!working!after!14!days!of!wear!and!must!be
replaced.!You!should!also!replace!your!Sensor!if!you!notice!any!irritation!or
discomfort!at!the!application!site!or!if!the!App!reports!a!problem!with!the!Sensor
currently!in!use.!Taking!action!early!can!keep!small!problems!from!turning!into
larger!ones.
CAUTION:!If!the!glucose!readings!from!the!Sensor!do!NOT!seem!to!match!with
how!you!feel,!check!to!make!sure!that!your!Sensor!has!not!come!loose.!If!the
Sensor!tip!has!come!out!of!your!skin,!or!your!Sensor!is!coming!loose,!remove!the
Sensor!and!apply!a!new!one.
!
Setting!Reminders
You!can!create!single!or!repeating!reminders!to!help!you!remember!things!like
checking!your!glucose!or!taking!insulin.!There!is!one!default!reminder!to!help!you
remember!to!scan!your!Sensor.!This!Scan!Sensor!reminder!can!be!changed!or
disabled!but!cannot!be!deleted.
Note:!To!receive!reminders,!make!sure!notifications!for!the!App!are!enabled.!If
you!want!to!receive!a!sound/vibration!with!your!reminder,!ensure!that
!
Discard!the!used!Sensor!according!to!local!regulations.!See!Maintenance!and
Disposal.!When!you!are!ready!to!apply!a!new!Sensor,!follow!the!instructions!in
Applying!Your!Sensor
!and!Starting!Your!Sensor.!If!you!removed!your!last!Sensor
before!14!days!of!use,!you!will!be!prompted!to!confirm!that!you!would!like!to
start!a!new!Sensor!when!you!first!scan!it.
2.
ART39408_rev_A 02-Mar-18 5:45
sound/vibration!on!your!smartphone!is!turned!on,!sound!is!set!at!a!level!you!can
hear,!and!your!smartphone's!Do!Not!Disturb!feature!(if!available)!is!turned!off.!If
Do!Not!Disturb!is!on,!you!will!only!see!your!reminder!on!the!screen.
Note:
To!add!a!new!reminder,!go!to!the!Main!Menu!and!tap!Reminders.!Tap!ADD
REMINDER.
1.
Name!your!reminder.2.
Tap!the!time!fields!to!set!the!time!for!the!reminder.3.
!
Note:!If!you!would!like!the!reminder!to!repeat,!tap!the!slider!to!the!right.!You
can!also!select!which!days!you!would!like!to!receive!the!reminder.
Tap!DONE.!You!will!now!see!your!reminder!on!the!list!along!with!the!time!you
will!receive!it.
4.
To!turn!off!a!reminder,!tap!the!slider!to!the!left.•
To!delete!a!reminder,!swipe!the!reminder!to!the!left!and!tap!the!
!symbol.
The!Scan!Sensor!reminder!cannot!be!deleted.
•
ART39408_rev_A 02-Mar-18 5:45
!
Settings!and!Other!Options!in!the!Main!Menu
You!can!go!to!the!Main!Menu!to!change!settings!like!your!Target!Glucose!Range!or
LibreView!password.!You!can!also!access!the!Share!option,!Help,!and!information
about!the!App.
Settings
App!Settings:
Unit!of!Measurement!-!View!the!glucose!unit!of!measure!used!in!the!App.
Target!Glucose!Range!-!Set!the!target!range!you!want!to!be!displayed!on!the!App
glucose!graph.!It!is!also!used!to!calculate!your!Time!In!Target.!Tap!SAVE!when!you
are!done.
Carbohydrate!Units!-!Choose!grams!or!portions!for!food!notes!that!you!enter.
Tap!SAVE!when!you!are!done.
Text!to!Speech!-!Turn!on!Text!to!Speech!to!have!the!glucose!reading!read!aloud
when!you!scan!the!Sensor.!You!will!hear!only
!your!current!glucose!value!and!trend
arrow!direction.!Additional!information,!such!as!the!glucose!graph!and!any
message,!are!available!on!your!My!Glucose!screen.!Always!review!your!My!Glucose
screen!to!get!complete!information.!Remember!that!Text!to!Speech!inherits!the
volume!settings!on!your!smartphone.!If!your!smartphone!volume!is!turned!off,
you!will!not!hear!the!glucose!reading!read!aloud.!Tap!SAVE!when!you!are!done.
Account!Settings:
Account!Settings!-!View/change!your!LibreView!account!information.
Account!Password!-!Change!your!LibreView!account!password.
Share
The!Share!option!in!the!Main!menu!opens!a!web!browser!within!the!App.!It!lists
different!apps!you!can!connect!with!to!share!your!data.!The!available!apps!may
vary!based!on!your!country.!To!connect!your!data!with!apps!listed!in!the!Share
option,!select!them!from!the!list!of!apps,!and!follow!the!onscreen!instructions.
Help
View!in-app!tutorials,!access!this!User's!Manual,!and!review!the!App’s!legal
information.!You!can!also!view!the!Event!Log,!which!is!a!list!of!events!recorded!by
the!App.!This!may!be!used!by!Customer!Service!to!help!troubleshoot.
Your!reminders!will!be!received!as!notifications!that!you!can!swipe!or!tap!to
dismiss.
•
ART39408_rev_A 02-Mar-18 5:45
About
View!App!software!version!and!other!information.
!
Activities
Bathing,!Showering,!and!Swimming:!!Your!Sensor!is!water-resistant!and!can!be
worn!while!bathing,!showering,!or!swimming.!Do!NOT!take!your!Sensor!deeper
than!1!metre!(3!feet)!or!immerse!it!longer!than!30!minutes!in!water.
Sleeping:!Your!Sensor!should!not!interfere!with!your!sleep.!It!is!recommended
that!you!scan!your!Sensor!before!going!to!sleep!and!when!you!wake!up!because
your!Sensor!holds!8!hours!of!data!at!a!time.!If!you!have!reminders!set!to!go!off
while!you!are!sleeping,!place!your!smartphone!nearby.
Travelling!by!Air:!Check!with!the!airline!prior!to!departure!as!rules!and
regulations!may!change!without!notice.!Notify!security!personnel!of!the!presence
of!your!device!when!going!through!security!systems.!After!you!have!put!your
smartphone!in!airplane!mode,!you!can!continue!to!get!Sensor!glucose!readings.
Do!not!scan!your!Sensor!if!restricted!by!flight!regulations.
Note:!Changing!the!time!affects!the!graphs,!statistics,!and!settings!programmed
by!time!of!day!since!these!are!dependent!on!the!time!setting!being!accurate.!The!
!symbol!may!appear!on!your!glucose!graph!indicating!a!time!change.!Gaps!in
the!graph!may!result!or!glucose!readings!may!be!hidden.
!
Maintenance!and!Disposal
Maintenance:!The!Sensor!has!no!serviceable!parts.
Disposal:!The!product!contains!electronic!equipment,!batteries,!sharps!and
materials!that!may!contact!bodily!fluids!during!use.!Dispose!of!product!in
accordance!with!all!applicable!local!regulations.!Contact!Customer!Service!for
further!information!on!the!appropriate!disposal!of!components.
!
Troubleshooting
This!section!lists!problems!that!you!may!experience,!the!possible!cause(s),!and
recommended!actions.!If!there!is!an!error,!a!message!will!appear!on!the!screen
with!directions!to!resolve!the!error.
IMPORTANT:!If!you!are!having!issues!with!the!App,!please!keep!in!mind!that
ART39408_rev_A 02-Mar-18 5:45
uninstalling!the!App!will!cause!you!to!lose!all!historical!data!and!end!the!Sensor
currently!in!use.!Please!call!Customer!Service!if!you!have!any!questions.
!
!
Problems!at!the!Sensor!Application!Site
!
Problem:!The!Sensor!is!not!sticking!to!your!skin.
What!it!may!mean:!The!site!is!not!free!of!dirt,!oil,!hair,!or!sweat.
What!to!do:!1.!Remove!the!Sensor.!!2.!Consider!shaving!and/or!cleaning!the!site
with!soap!and!water.!3.!Follow!the!instructions!in!Applying!Your!Sensor
!and
Starting!Your!Sensor
.
!
Problem:!Skin!irritation!at!the!Sensor!application!site.
What!it!may!mean:!Seams!or!other!constrictive!clothing!or!accessories!causing
friction!at!the!site!OR!you!may!be!sensitive!to!the!adhesive!material.
What!to!do:!Ensure!that!nothing!rubs!on!the!site.!If!the!irritation!is!where!the
adhesive!touches!skin,!contact!your!health!care!professional!to!identify!the!best
solution.
!
!
Problems!Starting!Your!Sensor!or!Receiving!Sensor!Readings
!
Display:!Sensor!Starting!Up
What!it!may!mean:!Sensor!is!not!ready!to!read!glucose.
What!to!do:!Wait!until!the!60!minute!Sensor!start-up!period!has!completed.
!
Display:!Sensor!Ended
What!it!may!mean:!The!Sensor!life!has!ended.
What!to!do:!Apply!and!start!a!new!Sensor.
!
Display:!New!Sensor!Found
ART39408_rev_A 02-Mar-18 5:45
What!it!may!mean:!You!scanned!a!new!Sensor!before!your!previous!Sensor!ended.
What!to!do:!Your!smartphone!can!only!be!used!with!one!Sensor!at!a!time.!If!you
start!a!new!Sensor,!you!will!no!longer!be!able!to!scan!your!old!Sensor.!If!you!would
like!to!begin!using!the!new!Sensor,!select!“Yes”.
!
Display:!Sensor!Error
What!it!may!mean:!The!Sensor!is!unable!to!provide!a!glucose!reading.
What!to!do:!Scan!again!in!10!minutes.
!
Display:!Glucose!Reading!Is!Unavailable
What!it!may!mean:!The!Sensor!is!unable!to!provide!a!glucose!reading.
What!to!do:!Scan!again!in!10!minutes.
!
Display:!Sensor!Too!Hot
What!it!may!mean:!Your!Sensor!is!too!hot!to!provide!a!glucose!reading.
What!to!do:!Move!to!a!location!where!the!temperature!is!appropriate!and!scan
again!in!a!few!minutes.
!
Display:!Sensor!Too!Cold
What!it!may!mean:Your!Sensor!is!too!cold!to!provide!a!glucose!reading.
What!to!do:!Move!to!a!location!where!the!temperature!is!appropriate!and!scan
again!in!a!few!minutes.
!
Display:!Sensor!Already!in!Use
What!it!may!mean:!The!Sensor!was!started!by!another!device.
What!to!do:!This!Sensor!was!started!by!another!device.!In!order!for!a!Sensor!to
work!with!this!smartphone,!you!must!use!this!smartphone!to!start!the!Sensor!or!
scan!the!Sensor!within!its!first!hour.
ART39408_rev_A 02-Mar-18 5:45
!
Display:!Check!Sensor
What!it!may!mean:!The!Sensor!tip!may!not!be!under!your!skin.
What!to!do:!Try!to!start!your!Sensor!again.!If!you!see!“Check!Sensor”!again!on!the
screen,!your!Sensor!was!not!applied!properly.!Apply!and!start!a!new!Sensor.
!
Display:!Replace!Sensor
What!it!may!mean:!The!App!has!detected!a!problem!with!your!Sensor.
What!to!do:!Apply!and!start!a!new!Sensor.
!
Display:!Unexpected!Application!Error
What!it!may!mean:!The!App!has!detected!an!unexpected!error.
What!to!do:!Shut!down!the!App!completely!and!restart.
!
Display:!Incompatible!Sensor
What!it!may!mean:!The!Sensor!cannot!be!used!with!the!App.
What!to!do:!Call!Customer!Service.
!
Display:!Scan!Error
What!it!may!mean:!iPhone!was!unable!to!scan!the!Sensor.
What!to!do:!Your!scan!was!unsuccessful.!Tap!the!scan!button!and!scan!again.
!
Customer!Service
Customer!Service!is!available!to!answer!any!questions!you!may!have!about
FreeStyle!LibreLink.!Please!go!to!www.FreeStyleLibre.com
!or!refer!to!the!product
insert!in!your!Sensor!Kit!for!your!Customer!Service!phone!number.!A!printed!copy
of!this!User's!Manual!is!available!upon!request.
!
ART39408_rev_A 02-Mar-18 5:45
Sensor!Specifications
Sensor!glucose!assay!method:!!Amperometric!electrochemical!sensor
Sensor!glucose!reading!range:!2.2!to!27.8!mmol/L
Sensor!size:!5mm!height!and!35mm!diameter
Sensor!weight:!5!grams
Sensor!power!source:!!One!silver!oxide!battery
Sensor!life:!Up!to!14!days
Sensor!memory:!8!hours!(glucose!readings!stored!every!15!minutes)
Operating!temperature:!10°C!to!45°C
Sensor!Applicator!and!Sensor!Pack!storage!temperature:!4°C!to!25°C
Operating!and!storage!relative!humidity:!10-90%,!non-condensing
Sensor!water!resistance:!IP27:!Can!withstand!immersion!into!one!metre!(3!ft)!of
water!for!up!to!30!minutes
Operating!and!storage!altitude:!-381!metres!(-1,250!ft)!to!3,048!metres!(10,000!ft)
!
Labelling!Symbols!and!Definitions
!
!
!
!
!
!
Consult!instructions!for
use
Temperature!limit
Manufacturer
CE!Mark
Batch!code
Type!BF!applied!part
ART39408_rev_A 02-Mar-18 5:45
!
!
!
!
!
!
!
!
!
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!
Electromagnetic!Compatibility
The!Sensor!needs!special!precautions!regarding!EMC!and!needs!to!be!installed!and!put!into!service
according!to!the!EMC!information!provided!in!this!manual.
•
Portable!and!mobile!RF!communications!equipment!can!affect!the!Sensor.•
The!use!of!accessories,!transducers!and!cables!other!than!those!specified!by!Abbott!Diabetes!Care!may
result!in!increased!EMISSIONS!or!decreased!IMMUNITY!of!the!Sensor.
•
The!Sensor!should!not!be!used!adjacent!to!or!stacked!with!other!equipment!and!that!if!adjacent!or
stacked!use!is!necessary,!the!Sensor!should!be!observed!to!verify!normal!operation!in!the!configuration
•
Sensor!code
Do!not!re-use
Use-by!date
Catalogue!number
Serial!number
Caution
Sterilised!by!irradiation
Humidity!limitation
Do!not!use!if!package!is
damaged
This!product!must!not!be
disposed!of!via!municipal
waste!collection.!Contact
the!manufacturer!for
details.
ART39408_rev_A 02-Mar-18 5:45
Guidance!and!manufacturer’s!declaration!–!electromagnetic!emissions
The!Sensor!is!intended!for!use!in!the!electromagnetic!environment!specified!below.!The!customer!or!the
user!of!the!Sensor!should!assure!that!it!is!used!in!such!an!environment.
Emissions!test:!RF!emissions;!CISPR!11
Compliance:!Group!1
Electromagnetic!environment!–!guidance:!The!Sensor!uses!RF!energy!only!for!its!internal!function.
Therefore,!its!RF!emissions!are!very!low!and!are!not!likely!to!cause!any!interference!in!nearby!electronic
equipment.
!
Emissions!test:!RF!emissions;!CISPR!11
Compliance:!Class!B
Electromagnetic!environment!–!guidance:!The!Sensor!is!suitable!for!use!in!all!establishments,!including
domestic!establishments!and!those!directly!connected!to!the!public!low!voltage!power!supply!network
that!supplies!buildings!used!for!domestic!purposes.
Guidance!and!manufacturer’s!declaration!–!electromagnetic!immunity
The!Sensor!is!intended!for!use!in!the!electromagnetic!environment!specified!below.!The!customer!or!the
user!of!the!Sensor!should!assure!that!it!is!used!in!such!an!environment.
Immunity!test:!Electrostatic!discharge!(ESD);!IEC!61000-4-2
IEC!60601!test!level:!±!6!kV!contact;!±!8!kV!air
Compliance!level:!±!6!kV!contact;!±!8!kV!air
Electromagnetic!environment!–!guidance:!Floors!should!be!wood,!concrete!or!ceramic!tile.!If!floors!are
covered!with!synthetic!material,!the!relative!humidity!should!be!at!least!30%.
!
Immunity!test:!Power!frequency!(50/60!Hz);!magnetic!field
IEC!60601!test!level:!3!A/m
Compliance!level:!3!A/m
Electromagnetic!environment!–!guidance:!Power!frequency!magnetic!fields!should!be!at!levels
characteristic!of!a!typical!location!in!a!typical!domestic,!commercial,!or!hospital!environment.
!
Immunity!test:!Radiated!RF;!IEC!61000-4-3
IEC!60601!test!level:!3!V/m;!80!MHz!to!2.5!GHz
Compliance!level:!3!V/m
Electromagnetic!environment!–!guidance:
Recommended!separation!distance
d!=!1.2!√P
80!MHz!to!800!MHz
d!=!2.3!√P
800!MHz!to!2.5!GHz
P!is!the!maximum!output!power!rating!of!the!transmitter!in!watts!(W)!according!to!the!transmitter
in!which!it!will!be!used.
ART39408_rev_A 02-Mar-18 5:45
manufacturer!and!d!is!the!recommended!separation!distance!in!metres!(m).
Field!strengths!from!fixed!RF!transmitters,!as!determined!by!an!electromagnetic!site!survey,
a
!should!be
less!than!the!compliance!level!in!each!frequency!range.
b
Interference!may!occur!in!the!vicinity!of!equipment!marked!with!the!following!symbol:
!
NOTE!1!At!80!MHz!and!800!MHz,!the!higher!frequency!range!applies.
NOTE!2!These!guidelines!may!not!apply!in!all!situations.!Electromagnetic!propagation!is!affected!by
absorption!and!reflection!from!structures,!objects!and!people.
a
!Field!strengths!from!fixed!transmitters,!such!as!base!stations!for!radio!(cellular/cordless)!telephones!and
land!mobile!radios,!amateur!radio,!AM!and!FM!radio!broadcast!and!TV!broadcast!cannot!be!predicted
theoretically!with!accuracy.!To!assess!the!electromagnetic!environment!due!to!fixed!RF!transmitters,!an
electromagnetic!site!survey!should!be!considered.!If!the!measured!field!strength!in!the!location!in!which
the!Sensor!is!used!exceeds!the!applicable!RF!compliance!level!above,!the!Sensor!should!be!observed!to
verify!normal!operation.!If!abnormal!performance!is!observed,!additional!measures!may!be!necessary,
such!as!re-orienting!or!relocating!the!Sensor.
b
!Over!the!frequency!range!150!kHz!to!80!MHz,!field!strengths!should!be!less!than!3!V/m.
Recommended!separation!distances!between!portable!and!mobile!RF
communications!equipment!and!the!Sensor
The!Sensor!is!intended!for!use!in!an!electromagnetic!environment!in!which!radiated!RF!disturbances!are
controlled.!The!customer!or!the!user!of!the!Sensor!can!help!prevent!electromagnetic!interference!by
maintaining!a!minimum!distance!between!portable!and!mobile!RF!communications!equipment
(transmitters)!and!the!Sensor!as!recommended!below,!according!to!the!maximum!output!power!of!the
communications!equipment.
!
For!transmitters!rated!at!a!maximum!output!power!not!listed!above,!the!recommended!separation
distance!d!in!metres!(m)!can!be!estimated!using!the!equation!applicable!to!the!frequency!of!the
transmitter,!where!P!is!the!maximum!output!power!rating!of!the!transmitter!in!watts!(W)!according!to!the
transmitter!manufacturer.
NOTE!1!At!80!MHz!and!800!MHz,!the!separation!distance!for!the!higher!frequency!range!applies.
NOTE!2!These!guidelines!may!not!apply!in!all!situations.!Electromagnetic!propagation!is!affected!by
absorption!and!reflection!from!structures,!objects!and!people.
!
ART39408_rev_A 02-Mar-18 5:45
Performance!Characteristics
Note:!Please!consult!your!health!care!team!on!how!to!use!the!information!in!this!section.
Interfering!Substances
Taking!ascorbic!acid!while!wearing!the!Sensor!may!falsely!raise!your!Sensor!glucose!readings.!Taking
salicylic!acid!may!slightly!lower!your!Sensor!glucose!readings.!The!level!of!inaccuracy!depends!on!the
amount!of!the!interfering!substance!active!in!your!body.
Performance!Characteristics
Performance!of!the!Sensor!was!evaluated!in!a!controlled!clinical!study.!The!study!was!conducted!in!4
centres!and!a!total!of!72!subjects!with!diabetes!were!included!in!the!effectiveness!analysis.!Each!subject
wore!two!Sensors!for!14!days,!on!the!back!of!the!upper!arm.!During!the!study,!subjects!tested!their!blood
glucose!using!fingerstick!capillary!samples!eight!times!a!day.!Three!lots!of!Sensors!were!evaluated!in!the
study.
Fig!1.!Comparison!of!the!Sensors!vs.!fingerstick!reference.
!
Table!1.!!Regression!analysis!of!the!Sensors!vs.!fingerstick!reference
!
Table!2.!Sensor!accuracy!for!all!results!vs.!fingerstick!reference
ART39408_rev_A 02-Mar-18 5:45
!
Table!3.!Sensor!performance!relative!to!fingerstick!reference!at!different!glucose!levels
!
*!For!glucose!≤80!mg/dL!(4.4!mmol/L),!the!differences!in!mg/dL!(mmol/L)!are!presented!instead!of!relative!differences!(%).
Table!4.!Sensor!accuracy!over!time!vs.!fingerstick!reference
!
Skin!Interaction
Based!on!the!examination!of!72!study!participants,!the!following!incidence!of!skin!issues!were!observed!in
202!site!exams.
Moderate!to!severe!itching!–!0.5%!of!the!time
Moderate!erythema!–!4.0%!of!the!time
Moderate!pain!–!0.0%!of!the!time
Rate!of!mild!incidences!for!any!individual!category!of!skin!issues!above!including!oedema,!rash,
ART39408_rev_A 02-Mar-18 5:45
induration,!bruising,!bleeding!and!others!was!less!than!9%.
!
Customer!Service:!www.FreeStyleLibre.com
Patent:!https://www.abbott.com/patents
FreeStyle,!Libre,!and!related!brand!marks!are!trademarks!of!Abbott!Diabetes!Care
Inc.!in!various!jurisdictions.!Other!trademarks!are!the!property!of!their!respective
owners.
!
Apple!and!the!Apple!logo!are!trademarks!of!Apple!Inc.,!registered!in!the!U.S.!and
other!countries.
App!Store!is!a!service!mark!of!Apple!Inc.,!registered!in!the!U.S.!and!other
countries.
!
!
ART39408!Rev.!A!03/18
!
ART39408_rev_A 02-Mar-18 5:45
