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.
.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...................................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

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) .................159
Limited Warranty......................................171

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:
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.
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.
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.
3

• 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.
4

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
5

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.
6

• 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.
7

• 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.
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8

• 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.
9

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.
10

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.
11

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.
12

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
13

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
14