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.
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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.
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• 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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