Abbott FreeStyle Libre 2 User manual

User’s Manual
FLASH GLUCOSE MONITORING SYSTEM
CAUTION: Federal law restricts this device to
sale by or on the order of a physician.
FreeStyle Libre 2 app
A FreeStyle Libre product
.224”
.257”
4.6”4.6”

Your Name _________________________________________________
.224”
.257”
4.6” 4.6”

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.

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...................................15
Reader Symbols ........................................16
App Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Getting to Know Your System . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Sensor Kit ...............................................22
Reader Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
FreeStyle Libre 2 app ....................................24
Reader Home Screen ....................................25
App Home Screen .......................................26
Reporting Software......................................27
Setting up Your System for the First Time . . . . . . . . . . . . . . 28
Reader Setup............................................28
App Setup...............................................31
Applying Your Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Starting Your Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Starting Your Sensor with the Reader.....................39
Starting Your Sensor with the App . . . . . . . . . . . . . . . . . . . . . . . 41
Checking Your Glucose .................................44
Checking Your Glucose with the Reader ..................44

Checking Your Glucose with the App .....................47
Understanding Your Glucose Readings . . . . . . . . . . . . . . . . . . . 51
Making Treatment Decisions ...........................55
Making Treatment Decisions – Getting Started ...........56
Using Your Glucose Reading to Make a
Treatment Decision .....................................61
Reader Alarms..........................................77
Setting Reader Alarms ...................................80
Setting Reader Alarm Sounds ............................85
Using Reader Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
App Alarms.............................................88
Setting App Alarms......................................94
Using App Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
Adding Notes to Glucose Readings....................103
Adding Notes in the Reader ........................... 103
Adding Notes in the App................................105
Reviewing Your History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .107
Reviewing Your History in the Reader . . . . . . . . . . . . . . . . . . .107
Reviewing Your History in the App . . . . . . . . . . . . . . . . . . . . . . 113
Removing Your Sensor ................................117
Replacing Your Sensor ................................118
Using Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .119
Using Reminders in the Reader . . . . . . . . . . . . . . . . . . . . . . . . . 119
Using Reminders in the App ............................121

Using the Reader’s Built-in Meter . . . . . . . . . . . . . . . . . . . . .123
Intended Use...........................................123
Blood Glucose Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
Control Solution Testing ................................134
Living With Your System...............................139
Activities ...............................................139
Charging the Reader....................................142
Reader Settings and Information ........................145
App Settings and Other Menu Options . . . . . . . . . . . . . . . . .148
Maintenance and Disposal ............................150
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .155
Reader Does Not Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . .156
Problems at the Sensor Application Site .................157
Problems Starting Your Sensor or Receiving
Sensor Readings........................................158
Problems Receiving Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . .164
Blood Glucose Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . .169
Problems Checking Your Blood Glucose . . . . . . . . . . . . . . . . . 173
Perform a Reader Test...................................175
Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175
System Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .176
Labeling Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .183
Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . .185
Electromagnetic Compatibility (EMC) .................215
Limited Warranty......................................227

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.
1

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:
www.FreeStyleLibre.us/support/overview.html
Use of the Sensor with devices, apps, and software that are not listed may
cause inaccurate glucose readings.
FreeStyle Libre 2 app is only compatible with certain mobile devices
and operating systems. Please check www.FreeStyleLibre.com for more
information about device compatibility before upgrading your phone or its
operating system.
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.
2

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.
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.
• If you are using FreeStyle Libre 2 app, you must have access to a
blood glucose monitoring system as the App does not provide one.
• Choking hazard: The System contains small parts that may be
dangerous if swallowed.
Warnings
3

What to know about Reader 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.
• 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 about App Alarms:
• For you to receive alarms, your phone 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 alarms. If you want to receive the App's
optional alarms, make sure these are turned on.
• Do not force close the App. The App must be running in the background
to receive alarms. If you force close the App you will not receive alarms.
Re-open the App to ensure you will receive alarms.
4

• If you restart your phone, open your App to make sure it’s working
properly.
• Glucose alarms you receive do not include your glucose reading so you
must scan your Sensor to check your glucose.
• The App will ask for phone permissions which are needed to receive
alarms. Allow these permissions when requested.
• Check to make sure that you have the correct phone settings and
permissions enabled. If your phone is not congured properly, you will
not be able to use the App, so you will not receive alarms or be able to
check your glucose.
oIn the phone settings, keep Bluetooth ON
oIn the phone settings for the App, allow the App to access Bluetooth
oIn the phone settings for the App under Notications, keep Allow
Critical Alerts ON
• If your phone is not congured correctly, the App will be in "Alarms
Unavailable" state and you will not be able to check your glucose or
receive any alarms, including the Urgent Low Glucose Alarm.
• To turn on Critical Alerts and Bluetooth, follow the instructions in the
App.
5

• If you adjust the phone ringer volume to silent or use the phone Do Not
Disturb setting, keep‘Override Do Not Disturb’setting in the App ON
for Low Glucose, High Glucose, and Signal Loss alarms to ensure you
receive audible alarms.
• You should disconnect headphones or speakers from your phone when
you are not using them as you may not hear audio for alarms. If using
headphones, keep them in your ears.
• If you are using peripheral devices connected to your phone, such as
wireless headphones or a smartwatch, you may receive alarms on only
one device or peripheral, not all.
• Keep your phone well charged and turned on.
• Disable your phone’s automatic operating system updates. After
an operating system update, open your App and check your device
settings to make sure it’s working properly.
• Some operating system features may impact your ability to receive
alarms. For example, if you use the iOS Screen Time feature, add
FreeStyle Libre 2 to the list of Always Allowed apps to ensure that you
receive alarms.
6

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 devices and Sensor kits are kept in a safe place, and
maintain your devices under your control during use. 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.
7

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
both the Reader and App 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.
8

• 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.
9

• Do not reuse Sensors. The Sensor and Sensor Applicator are designed
for single use. Reuse may result in no glucose readings and infection.
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.
10

• 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 about the System:
• The FreeStyle Libre 2 System 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.
• FreeStyle Libre 2 app and FreeStyle Libre 2 Readers do not share data.
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.
CODE
FreeStyle Libre
Sensor Pack
A
b
b
o
t
t
D
i
a
b
e
t
e
s
C
a
r
e
L
t
d
.
R
a
n
g
e
R
o
a
d
,
W
i
t
n
e
y
,
O
x
o
n
,
O
X
2
9
0
Y
L
,
U
K
D
O
C
3
0
3
9
1
R
e
v
.
B
0
9
/
1
3
XXXXXXXXX
XXX
YYYY-MM-DD
11

• 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.
• 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.
12

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.
13

• 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.
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.
14