Abbott FreeStyle Libre 2 User manual

User’s Manual
FLASH GLUCOSE MONITORING SYSTEM
.224”
.257”
4.6”4.6”

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

Contents
Reader Symbols ......................................... 1
Important Safety Information........................... 3
Indications for Use........................................ 3
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Interfering Substances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Getting to Know Your System . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Reader Kit ...............................................11
Sensor Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
FreeStyle Libre Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Setting up Your Reader for the First Time . . . . . . . . . . . . . . 16
Using Your Sensor ......................................19
Applying Your Sensor ....................................20
Starting Your Sensor .....................................24
Checking Your Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Alarms..................................................31
Setting Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Setting Alarm Sounds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Using Alarms ............................................39
Adding Notes...........................................41

Reviewing Your History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Logbook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Daily Graph .............................................46
Other History Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Removing Your Sensor .................................49
Replacing Your Sensor .................................50
Using Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Using the Built-in Meter................................53
Blood Glucose Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Blood Ketone Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Control Solution Testing .................................64
Using the Rapid-Acting Insulin Calculator . . . . . . . . . . . . . . . . 68
Charging the Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Changing the Reader Settings .........................76
Living With Your System................................79
Activities ................................................79
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Disposal.................................................82

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Reader Does Not Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Problems at the Sensor Application Site ..................84
Problems Starting Your Sensor or Receiving
Sensor Readings.........................................85
Problems Receiving Glucose Alarms......................88
Blood Glucose or Ketone Error Messages .................90
Problems Checking Your Blood Glucose or Ketone ........94
Perform a Reader Test....................................96
Customer Service........................................96
Professional Options ...................................97
Changing Dose Increments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
Setting up the Insulin Calculator .........................99
Easy Setup of the Insulin Calculator . . . . . . . . . . . . . . . . . . . . .101
Advanced Setup of the Insulin Calculator................105
Changing the Insulin Calculator Settings ................116
System Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .117
Rapid-Acting Insulin Calculator Specications........121
Labelling Symbols.....................................122
Electromagnetic Compatibility........................123

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
Notes
+
Add more information to notes
Food note
Rapid-acting insulin note
Time changed on Reader
Sound and Vibration ON
Sound ON, Vibration OFF
Sound OFF, Vibration ON
Sound and Vibration OFF
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Symbol What It Means
Sensor communicating with Reader
Sensor not communicating with Reader
Blood glucose or ketone test
Settings
Control solution test result
Rapid-acting insulin calculator
Details of your suggested insulin dose
Estimated rapid-acting insulin remaining in body
Low battery
Battery charging
Sensor too cold
Sensor too hot
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Important Safety Information
Indications for Use
The FreeStyle Libre 2 Flash Glucose Monitoring System Reader (“Reader”),
when used with a FreeStyle Libre 2 Flash Glucose Monitoring System
Sensor (“Sensor”), is indicated for measuring interstitial uid glucose levels
in people (aged 4 and older) with diabetes mellitus, including pregnant
women. The Reader and Sensor are designed to replace blood glucose
testing in the self-management of diabetes, including dosing of insulin.
The indication for children (aged 4-12) 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 Reader and
Sensor and also for interpreting or assisting the child to interpret Sensor
glucose readings.
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Contraindications
The Sensor must be removed prior to Magnetic Resonance Imaging (MRI).
WARNING:
• 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 that your reading may be inaccurate, check the
reading by conducting a ngerstick test using a blood glucose meter.
If you are experiencing symptoms that are not consistent with your
glucose readings, consult your health care professional.
• The FreeStyle Libre 2 Flash Glucose Monitoring System (“System”)
contains small parts that may be dangerous if swallowed.
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Cautions and Important System Information:
What the System has not been evaluated for:
• The System has not been evaluated for use with other implanted
medical devices such as pacemakers.
• The System has not been evaluated for use in persons on dialysis, or
people less than 4 years of age.
How to store the Sensor:
• 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.
When is Sensor Glucose dierent to Blood Glucose:
• Glucose levels in the interstitial uid can be dierent to blood glucose
levels and may mean that Sensor glucose readings are dierent to blood
glucose. You may notice this dierence during times when your blood
glucose is changing quickly; for example, after eating, taking insulin,
or exercising.
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