Abbott FreeStyle Libre 2 User manual

User’s Manual
©2020-2021 Abbott DOC40703 Rev. K 03/21
The circular shape of the sensor housing, FreeStyle, Libre, and related brand marks are
marks of Abbott. Other trademarks are the property of their respective owners.
Patent: https://www.abbott.com/patents
Distributed by:
Abbott Diabetes Care Inc.
1360 South Loop Road
Alameda, CA 94502 USA
Customer Service: 1-855-632-8658
7 Days aWeek from 8AM to 8PM Eastern Standard Time
www.FreeStyleLibre.com
FLASH GLUCOSE MONITORING SYSTEM
Manufacturer
CAUTION: Federal law restricts this device
to sale by or on the order of a physician.
.224”
.257”
4.6”4.6”
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Your Name _________________________________________________
.224”
.257”
4.6” 4.6”
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WARNING:
Before you use the FreeStyle Libre 2 System, review all the product
instructions and the Interactive Tutorial. The Quick Reference
Guide and Interactive Tutorial give you quick access to important
aspects and limitations of the System. The User’s Manual includes
all safety information and instructions for use. Talk to your health
care professional about how you should use your Sensor glucose
information to help manage your diabetes.
Failure to use the System according to the instructions for use
may result in you missing a severe low blood glucose or high
blood glucose event and/or making a treatment decision that
may result in injury. If your glucose alarms and readings from the
System do not match symptoms or expectations, use a ngerstick
blood glucose value from a blood glucose meter to make diabetes
treatment decisions. Seek medical attention when appropriate.
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Contents
Important Safety Information........................... 1
Indications For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Compatible Devices, Apps, and Software .................. 2
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Warnings................................................. 3
Cautions and Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Interfering Substances...................................12
Reader Symbols ........................................13
Getting to Know Your System . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Reader Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Sensor Kit ...............................................18
FreeStyle Libre Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Setting up Your Reader for the First Time . . . . . . . . . . . . . . 22
Using Your Sensor ......................................25
Applying Your Sensor....................................26
Starting Your Sensor .....................................30
Checking Your Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Making Treatment Decisions ...........................37
Making Treatment Decisions – Getting Started ...........38
Using Your Glucose Reading to Make a
Treatment Decision .....................................43
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Alarms..................................................56
Setting Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59
Setting Alarm Sounds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Using Alarms ............................................65
Adding Notes...........................................67
Reviewing Your History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Logbook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Daily Graph .............................................72
Other History Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Removing Your Sensor .................................75
Replacing Your Sensor .................................76
Using Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Using the Reader’s Built-in Meter . . . . . . . . . . . . . . . . . . . . . . 79
Intended Use............................................79
Blood Glucose Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Control Solution Testing .................................90
Charging the Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Changing the Reader Settings .........................96
Living With Your System................................99
Maintenance and Disposal ............................102
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .107
Reader Does Not Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . .107
Problems at the Sensor Application Site .................108
Problems Starting Your Sensor or Receiving
Sensor Readings........................................109
Problems Receiving Glucose Alarms.....................113
Blood Glucose Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Problems Checking Your Blood Glucose . . . . . . . . . . . . . . . . . 119
Perform a Reader Test...................................121
Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
System Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .122
Labeling Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .128
Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . .130
Electromagnetic Compatibility (EMC) .................160
Limited Warranty......................................172
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Important Safety Information
Indications For Use
The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous
glucose monitoring (CGM) device with real time alarms capability
indicated for the management of diabetes in persons age 4 and older.
It is intended to replace blood glucose testing for diabetes treatment
decisions, unless otherwise indicated.
The System also detects trends and tracks patterns and aids in the
detection of episodes of hyperglycemia and hypoglycemia, facilitating
both acute and long-term therapy adjustments. Interpretation of the
System readings should be based on the glucose trends and several
sequential readings over time.
The System is also intended to autonomously communicate with digitally
connected devices. The System can be used alone or in conjunction
with these digitally connected devices where the user manually controls
actions for therapy decisions.
Compatible Devices, Apps, and Software
For a list of compatible devices, apps, and software that can be used with
the FreeStyle Libre 2 Sensor please go to: https://freestylelibre.us/support/
overview.html
Use of the Sensor with devices, apps, and software that are not listed may
cause inaccurate glucose readings.
Contraindications
Automated Insulin Dosing: The System must not be used with
automated insulin dosing (AID) systems, including closed loop and insulin
suspend systems.
MRI/CT/Diathermy: The System must be removed
prior to Magnetic Resonance Imaging (MRI), Computed
Tomography (CT) scan, or high-frequency electrical heat
(diathermy) treatment. The eect of MRI, CT scans, or
diathermy on the performance of the System has not been
evaluated. The exposure may damage the Sensor and may
impact proper function of the device which could cause
incorrect readings.
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Cautions and Limitations
Below are important cautions and limitations to keep in mind so you can
use the System safely. They are grouped into categories for easy reference.
What to know about Glucose Alarms:
• For you to receive alarms, they must be on and your Reader should
be within 20 feet of you at all times. The transmission range is 20 feet
unobstructed. If you are out of range, you may not receive glucose
alarms.
WARNINGS:
• Do not ignore symptoms that may be due to low or high blood
glucose: If you are experiencing symptoms that are not consistent
with your glucose readings, consult your health care professional.
• Use your blood glucose meter to make diabetes treatment decisions
when you see the symbol during the rst 12 hours of wearing a
Sensor, if your Sensor glucose reading does not match how you feel,
or if the reading does not include a number.
• Choking hazard: The System contains small parts that may be
dangerous if swallowed.
• To prevent missed alarms, make sure the Reader has sucient charge
and that sound and/or vibration are turned on.
• Alarms you receive do not include your glucose reading so you must
scan your Sensor to check your glucose.
What to know before using the System:
• Review all product information before use.
• Take standard precautions for transmission of blood borne pathogens
to avoid contamination.
• Make sure that your Reader and Sensor kits are kept in a safe place,
under your control. This is important to help prevent anyone from
accessing or tampering with the System.
Who should not use the System:
• Do not use the System in people less than 4 years of age. The
System is not cleared for use in people under 4 years of age.
• Do not use the System if you are pregnant, on dialysis, or critically
ill. The System is not cleared for use in these groups and it is not
known how dierent conditions or medications common to these
populations may aect performance of the System.
• Performance of the System when used with other implanted medical
devices, such as pacemakers, has not been evaluated.
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What should you know about wearing a Sensor:
• Wash application site on the back of your upper arm using a plain
soap, dry, and then clean with an alcohol wipe. This will help remove
any oily residue that may prevent the Sensor from sticking properly.
Allow site to air dry before proceeding. Carefully preparing the site
according to these instructions will help the Sensor stay on your body
for the full 14 day wear period and help prevent it from falling o early.
• The Sensor can be worn for up to 14 days. Remember to always have
your next Sensor available before your current one ends so you can
keep getting your glucose readings.
• You must scan the Sensor to get your real-time current glucose level as
the Reader will not provide this information without a scan.
• In the event that your Sensor stops working and you do not have
another Sensor readily available, you must use an alternate method to
measure your glucose levels and inform your treatment decisions.
• The System is designed to detect certain conditions which may occur
where the Sensor is not working as intended and shut it o, telling
you to replace your Sensor. This may occur if the Sensor gets knocked
o from the skin or if the System detects that the Sensor may not be
performing as intended. Contact Customer Service if you receive a
Replace Sensor message before the end of the 14 day wear period.
Customer Service is available at 1-855-632-8658 7 Days a Week from
8AM to 8PM Eastern Standard Time.
• Some individuals may be sensitive to the adhesive that keeps the
Sensor attached to the skin. If you notice signicant skin irritation
around or under your Sensor, remove the Sensor and stop using the
System. Contact your health care professional before continuing to use
the System.
• Intense exercise may cause your Sensor to loosen due to sweat or
movement of the Sensor. If the Sensor is becoming loose or if the
Sensor tip is coming out of your skin, you may get no readings or
unreliable low readings. Remove and replace your Sensor if it starts to
loosen and follow the instructions to select an appropriate application
site. Do not attempt to reinsert the Sensor. Contact Customer Service
if your Sensor becomes loose or falls o before the end of the wear
period. Customer Service is available at 1-855-632-8658 7 Days a Week
from 8AM to 8PM Eastern Standard Time.
• Do not reuse Sensors. The Sensor and Sensor Applicator are designed
for single use. Reuse may result in no glucose readings and infection.
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Not suitable for re-sterilization. Further exposure to irradiation may
cause unreliable low results.
• If a Sensor breaks inside your body, call your health care professional.
How to Store the Sensor Kit:
• Store the Sensor Kit between 36°F and 82°F. Storage outside of this
range may cause inaccurate Sensor glucose readings.
• If you suspect that the temperature may exceed 82°F (for example, in
an un-airconditioned home in summer), you should refrigerate your
Sensor Kit. Do not freeze your Sensor Kit.
• Store your Sensor Kit in a cool, dry place. Do not store your Sensor Kit
in a parked car on a hot day.
• Store the Sensor Kit between 10-90% non-condensing humidity.
When not to use the System:
• Do NOT use if the Sensor Kit package, Sensor Pack, or Sensor
Applicator appear to be damaged or already opened due to risk of no
results and/or infection.
• Do NOT use if Sensor Kit contents are past expiration date.
• Do NOT use if the Reader appears to be damaged due to risk of
electric shock and/or no results.
What to know before you Apply the Sensor:
• The Sensor Pack and Sensor Applicator are
packaged as a set (separately from the Reader)
and have the same Sensor code. Check that the
Sensor codes match before using your Sensor
Pack and Sensor Applicator. Do not use Sensor
Packs and Sensor Applicators with dierent Sensor
codes together as this will result in incorrect
glucose readings.
• Wash application site on the back of your upper arm using a plain
soap, dry, and then clean with an alcohol wipe. This will help remove
any oily residue that may prevent the Sensor from sticking properly.
Allow site to air dry before proceeding. Carefully preparing the site
according to these instructions will help the Sensor stay on your body
for the full 14 day wear period and help prevent it from falling o
early.
CODE
FreeStyle Libr
Sensor Pack
XXXXXXXXX
XXX
YYYY-MM-DD
7 8
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• Clean hands prior to Sensor handling/insertion to help prevent
infection.
• Change the application site for the next Sensor application to prevent
discomfort or skin irritation.
• Only apply the Sensor to the back of the upper arm. If placed in other
areas, the Sensor may not function properly.
• Select an appropriate Sensor site to help the Sensor stay attached
to the body and prevent discomfort or skin irritation. Avoid areas
with scars, moles, stretch marks, or lumps. Select an area of skin
that generally stays at during normal daily activities (no bending
or folding). Choose a site that is at least 1 inch away from an insulin
injection site.
When is Sensor Glucose dierent from Blood Glucose:
• Physiological dierences between the interstitial uid and capillary
blood may result in dierences in glucose readings between the
System and results from a ngerstick test using a blood glucose meter.
Dierences in glucose readings between interstitial uid and capillary
blood may be observed during times of rapid change in blood
glucose, such as after eating, dosing insulin, or exercising.
What to know about X-Rays:
• The Sensor should be removed prior to exposing it to an X-ray
machine. The eect of X-rays on the performance of the System
has not been evaluated. The exposure may damage the Sensor and
may impact proper function of the device to detect trends and track
patterns in glucose values during the wear period.
When to remove the Sensor:
• If the Sensor is becoming loose or if the Sensor tip is coming out of
your skin, you may get no readings or unreliable readings, which may
not match how you feel. Check to make sure your Sensor has not come
loose. If it has come loose, remove it, apply a new one, and contact
Customer Service.
• If you believe your glucose readings are not correct or are inconsistent
with how you feel, perform a blood glucose test on your nger to
conrm your glucose. If the problem continues, remove the current
Sensor, apply a new one, and contact Customer Service. Customer
Service is available at 1-855-632-8658 7 Days a Week from 8AM to 8PM
Eastern Standard Time.
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What to know about the Reader’s Built-in Meter:
• The FreeStyle Libre 2 Reader has a built-in blood glucose meter
that is designed to be used only with FreeStyle Precision Neo blood
glucose test strips and MediSense Glucose and Ketone Control
Solution. Using other test strips with the Reader’s built-in meter will
produce an error or cause the Reader’s built-in meter to not turn
on or start a test. The Reader’s built-in meter does not have ketone
testing functionality.
• The Reader’s built-in meter is not for use on people who
are dehydrated, hypotensive, in shock, or for individuals in
hyperglycemic-hyperosmolar state, with or without ketosis.
• The Reader’s built-in meter is not for use on neonates, in critically-ill
patients, or for diagnosis or screening of diabetes.
• See Using the Reader’s Built-in meter section for additional important
information on the use of the Reader’s built-in meter.
Where to charge your Reader:
• Be sure to select a location for charging that allows the power
adapter to be easily unplugged. Do NOT block access to the charger
due to the potential risk of electrical shock.
Interfering Substances
Taking ascorbic acid (vitamin C) supplements while wearing the Sensor
may falsely raise Sensor glucose readings. Taking more than 500 mg of
ascorbic acid per day may aect the Sensor readings which could cause
you to miss a severe low glucose event. Ascorbic acid can be found in
supplements including multivitamins. Some supplements, including cold
remedies such as Airborne® and Emergen-C®, may contain high doses of
1000 mg of ascorbic acid and should not be taken while using the Sensor.
See your health care professional to understand how long ascorbic acid is
active in your body.
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Reader Symbols
Symbol What It Means
Active Sensor
Direction your glucose is going. See Checking Your
Glucose section for more information.
Caution
View previous/next screen
Sound and Vibration ON
Sound ON, Vibration OFF
Sound OFF, Vibration ON
Sound and Vibration OFF
Sensor communicating with Reader
Sensor not communicating with Reader
Symbol What It Means
When you see this symbol during the rst 12 hours
of wearing a Sensor, conrm Sensor glucose readings
with a blood glucose test before making treatment
decisions.
Notes
+
Add more information to notes
Food note
Rapid-acting insulin note
Time changed on Reader
Blood glucose test
Settings
Control solution test result
Low battery
Battery charging
Sensor too cold
Sensor too hot
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Getting to Know Your System
The FreeStyle Libre 2 System (“System”) has two main parts: a handheld
Reader and a disposable Sensor that you wear on your body. You use the
Reader to wirelessly scan the Sensor and display your glucose readings.
The Reader only works with FreeStyle Libre 2 Sensors and cannot be
used with other Sensors. When they’re in range, the Sensor and Reader
automatically communicate to give you glucose alarms. These alarms are
on by default. Remember that alarms you receive will not include your
glucose reading, so you need to scan your Sensor to check your glucose.
IMPORTANT:
• Before you use your System, review all the product instructions and
the Interactive Tutorial. The Quick Reference Guide and Interactive
Tutorial give you quick access to important aspects and limitations
of the System. The User’s Manual includes all safety information and
instructions for use.
• Go to www.FreeStyleLibre.com to view the “Tips for Kids".
• Talk to your health care professional about how you should use your
Sensor glucose information to help manage your diabetes.
• During the rst 12 hours of Sensor wear the symbol will display,
and you cannot use Sensor values to make treatment decisions
during this time. Conrm Sensor glucose readings with a blood
glucose test before making treatment decisions during the rst 12
hours of Sensor wear when you see the symbol.
Your System comes in a Reader Kit and a Sensor Kit. When opening your
kits, check that the contents are undamaged and that you have all parts
listed. If any parts are missing or damaged, contact Customer Service.
Customer Service is available at 1-855-632-8658 7 Days a Week from 8AM
to 8PM Eastern Standard Time.
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Reader Kit
The Reader Kit includes:
• FreeStyle Libre 2 Reader
• USB Cable
• Interactive Tutorial on USB
• Power Adapter
• User’s Manual
• Quick Start Guide
• Quick Reference Guide
The Reader gets glucose readings from a scan of your Sensor and can issue
glucose alarms. The Reader can store approximately 90-days of glucose
history and notes you enter about activities, such as taking insulin, eating
food, or exercising. This information can help you understand how these
activities aect your glucose. The Reader also includes a built-in meter
for blood glucose testing. To use the built-in meter, you need FreeStyle
Precision Neo blood glucose test strips, control solution, a lancing device,
and lancets. These items are not included in the Reader kit and must
be obtained separately from your FreeStyle Libre 2 System provider
(pharmacy or mail order supplier).
USB Port
Used to charge the
Reader and connect it
to a computer.
Test Strip Port
Insert a test strip here to
use the built-in meter.
Touchscreen
Home Button
Turns the Reader on/off
and takes you to the
Home screen from any
other screen.
Sensor Kit
The Sensor Kit includes:
• Sensor Pack
• Sensor Applicator
• Alcohol wipe
• Product insert
Sensor Pack
Used with the Sensor Applicator to
prepare the Sensor for use.
Sensor Applicator
Applies the Sensor to your body.
The Sensor measures and stores glucose readings when worn on your
body. It initially comes in two parts: one part is in the Sensor Pack and the
other part is in the Sensor Applicator. By following the instructions, you
prepare and apply the Sensor on the back of your
upper arm. The Sensor has a small, exible tip that is
inserted just under the skin. The Sensor can be worn
for up to 14 days.
Sensor
Measures your glucose while on your
body (only visible after applied).
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The Reader Home Screen provides access to information about your
glucose and the System. You can press the Home Button to get to the
Home Screen.
Home Screen
Note: Sound/Vibration setting and Signal Status symbols only display
when any alarm is on.
Ends in 14 days
10:23pm
Check
Glucose
Review
History
Current time set on
the Reader
Sensor Status
Information about your
current Sensor.
Battery charge remaining
Sound/Vibration setting
Signal Status
Shows if Sensor is
communicating with Reader.
Settings
Touch to access Alarms,
Reminders, and other
Reader settings.
Review History
Touch to review information
about your past glucose
readings.
Check Glucose
Touch to check your
Sensor glucose.
The Sensor Glucose Readings screen appears after you use the Reader to
scan your Sensor. Your Reading 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.
Sensor Glucose Readings
350
250
150
50
2pm 6pm 10pm
82
mg
dL
Glucose Going
Low
Rapid-Acting
Insulin Note
Message
Touch for more
information.
Current Glucose
Glucose from your
latest scan.
Add Notes
Touch to add notes to the
glucose reading.
Glucose Trend Arrow
Directionyour
glucose is going.
Glucose Graph
Graph of your current
and stored glucose
readings.
Food Note
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FreeStyle Libre Software
FreeStyle Libre software can be used to view reports and change Reader
settings. The software also allows you to change the name and/or ID that
will be printed on the reports. The name and ID will be saved to the Reader
but will not be visible on the Reader itself. The software is compatible with
most Windows and Mac operating systems. Go to www.FreeStyleLibre.com
and follow onscreen instructions to download and install the software.
You are responsible for keeping your computer secure and up to date,
for example by using anti-virus software and installing system updates.
INTENDED USE
FreeStyle Libre software is intended for use by individuals and
health care professionals to aid in the review, analysis, and
evaluation of information such as Sensor glucose readings,
blood glucose test results, and other data uploaded from the
FreeStyle Libre 2 Flash Glucose Monitoring System, in support of
an eective diabetes health management program.
FreeStyle Libre software is not intended for the diagnosis of
or screening for diabetes mellitus. Users should be aware that
FreeStyle Libre software is merely an information management
tool and it is therefore not intended to substitute for the
support of a health care professional. Individuals should always
consult their health care professional if they have any queries or
concerns about diabetes management.
Setting up Your Reader for the First Time
Before using the System for the rst time, the Reader must be set up.
Step Action
1Press the Home Button to turn on the Reader.
2If prompted, use the touchscreen to select your
preferred language for the Reader. Touch OK to
continue.
Note: Use the pad of your nger. Do NOT use
your ngernail or any other object on the screen.
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Step Action
3Set the Current Date using the arrows on the
touchscreen. Touch next to continue.
4Set the Current Time. Touch next to continue.
14
back next
Current Date
June
2020
12am 00
back next
Current Time
CAUTION: It is very important to set the time
and date correctly. These values aect the
Reader data and settings.
Step Action
5The Reader now displays important information about key
topics to help you use the System:
• How to understand the Glucose Trend Arrow included on
the Glucose Reading screen.
• When to do a blood glucose test.
• Where to apply the Sensor.
• Why not to take more than 500 mg of Vitamin C
supplements per day.
• How to return to the Home Screen from any other screen.
Touch next to move
to the next topic. At
the end of the Reader
setup, touch done
to go to the Home
Screen.
Note: Charge the Reader if the battery level is low. Only use the USB cable
and power adapter included with the System. A fully charged battery
should last up to 4 days but this may vary depending on your usage.
nextback
When you scan your
Sensor an arrow will
indicate your recent
glucose trend:
Rising quickly
Rising
Changing slowly
Falling
Falling quickly
If you see this symbol, do
a blood glucose test before
making treatment
decisions.
back next
If the Sensor glucose
reading does not match
how you feel, do a blood
glucose test.
back next
nextback
The Sensor can only be
applied to the back of
your upper arm.
nextback
Important
Do not take high doses
of vitamin C (more than
500 mg per day). This may
falsely raise your Sensor
readings. Supplements like
Airborne®or Emergen-C®
have high doses of vitamin
C. Read labeling for all
supplements to determine
vitamin C content.
doneback
While using the Reader, press
the Home Button to return to
the Home Screen.
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Using Your Sensor
CAUTIONS:
• The Sensor Pack and Sensor Applicator
are packaged as a set (separately from
the Reader) and have the same Sensor
code. Check that the Sensor codes match
before using your Sensor Pack and Sensor
Applicator. Do not use Sensor Packs and
Sensor Applicators with dierent Sensor codes
together as this will result in incorrect glucose readings.
• Intense exercise may cause your Sensor to loosen due
to sweat or movement of the Sensor. If the Sensor is
becoming loose or if the Sensor tip is coming out of your
skin, you may get no readings or unreliable low readings.
Remove and replace your Sensor if it starts to loosen and
follow the instructions to select an appropriate application
site. Do not attempt to reinsert the Sensor. Contact
Customer Service if your Sensor becomes loose or falls
o before the end of the wear period. Customer Service
is available at 1-855-632-8658 7 Days a Week from 8AM to
8PM Eastern Standard Time.
CODE
FreeStyle Libr
Sensor Pack
XXXXXXXXX
XXX
YYYY-MM-DD
Applying Your Sensor
Step Action
1Apply Sensors only on the back of your upper
arm. If placed in other areas, the Sensor may
not function properly and could give inaccurate
readings. Avoid areas with scars, moles, stretch
marks, or lumps.
Select an area of skin that generally stays at
during your normal daily activities (no bending
or folding). Choose a site that is at least 1 inch
(2.5 cm) away from an insulin injection site. To
prevent discomfort or skin irritation, you should
select a dierent site other than the one most
recently used.
2Wash application site using a plain soap, dry, and
then clean with an alcohol wipe. This will help
remove any oily residue that may prevent the
Sensor from sticking properly. Allow site to air
dry before proceeding.
Note:The area MUST be clean and dry following
these instructions, or the Sensor may not stay on
for the full 14 day wear period.
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Step Action
3Open the Sensor Pack by peeling the lid o
completely. Unscrew the cap from the Sensor
Applicator and set the cap aside.
4Line up the dark mark on the Sensor Applicator
with the dark mark on the Sensor Pack. On a
hard surface, press rmly down on the Sensor
Applicator until it comes to a stop.
5Lift the Sensor Applicator out of the Sensor Pack.
Lid
Cap
CAUTION: Do NOT use if the Sensor Pack or
the Sensor Applicator seem to be damaged
or already opened. Do NOT use if past
expiration date.
Step Action
6The Sensor Applicator is prepared and ready to
apply the Sensor.
7Place the Sensor Applicator over the prepared
site and push down rmly to apply the Sensor to
your body.
CAUTION: The Sensor Applicator now
contains a needle. Do NOT touch inside the
Sensor Applicator or put it back into the
Sensor Pack.
CAUTION: Do NOT push down on the Sensor
Applicator until placed over prepared site to
prevent unintended results or injury.
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Step Action
8Gently pull the Sensor Applicator away from your
body. The Sensor should now be attached to your
skin.
Note: Applying the Sensor may cause bruising
or bleeding. If there is bleeding that does not
stop, remove the Sensor and contact your
health care professional.
9Make sure the Sensor is secure after application.
Put the cap back on the Sensor Applicator.
Discard the used Sensor Pack and Sensor
Applicator according to local regulations.
Sensor
Starting Your Sensor
Step Action
1Press the Home Button to turn on the Reader.
2Touch Start New Sensor.
3Hold the Reader within 1.5 inches (4 cm) of the
Sensor to scan it. This starts your Sensor. If sounds
are turned on, the Reader beeps when the Sensor
has been successfully activated. The Sensor can
be used to check your glucose after 60 minutes.
Note: If the Sensor is not successfully scanned
within 15 seconds, the Reader displays a prompt
to scan the Sensor again. Touch OK to return to
the Home Screen and touch Start New Sensor
to scan your Sensor.
Start New
Sensor
Review
History
No Active Sensor
10:23pm
minutes
New Sensor
Starting Up
60
Sensor can be used in:
OK
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