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
2

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.
3

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.
4

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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When to remove the Sensor:
• On rare occasions, you may get inaccurate Sensor glucose readings.
If you believe your glucose readings are not correct or do not match how
you feel, perform a blood glucose test on your nger to conrm your
glucose. If the problem continues, remove your Sensor and apply a
new one.
• 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.
• If you have a medical appointment that includes strong magnetic
or electromagnetic radiation, for example an X-ray, MRI (Magnetic
Resonance Imaging) or CT (Computed Tomography) scan, remove the
Sensor you are wearing and apply a new one after the appointment. The
eect of this type of procedure on the performance of the System has
not been evaluated.
6

What to know about wearing the Sensor:
• 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-sterilisation. Further exposure to irradiation may cause
inaccurate results.
What to know about Glucose Alarms:
• For you to receive alarms, they must be turned ON and you should
ensure that your Reader is within 6 metres (20 ft) of you at all times.
Thetransmission range is 6 metres (20 ft) 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.
7

What to know about the Reader’s Built-in Meter:
• The Reader is designed to be used only with FreeStyle Optium blood
glucose and blood ketone test strips and MediSense control solution.
• The Reader is for use by a single person. It must not be used on
more than one person including other family members due to the
risk of spreading infection. All parts of the Reader are considered
biohazardous and can potentially transmit infectious diseases, even
after cleaning the Reader.
• Avoid getting dust, dirt, blood, control solution, water or other
substances in the Reader’s USB and test strip ports.
8

Interfering Substances
You can take standard doses of ascorbic acid (vitamin C) and still make
treatment decisions with the Sensor. Taking higher than the maximum
recommended daily allowance (RDA) of ascorbic acid may aect the
Sensor readings and make them look higher than they really are.
9

Getting to Know Your System
The FreeStyle Libre 2 Flash Glucose Monitoring 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. The FreeStyle Libre 2
Sensor automatically communicates with the Reader and can give you
glucose alarms if you choose to turn those on. The Reader also has a
built-in meter for blood glucose and ketone testing.
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.
IMPORTANT: Safety information about the
System is in this User’s Manual. Read all of
the information in the User’s Manual and the
FreeStyle Optium blood glucose and ketone
test strip instructions for use before using
your System.
10

Reader Kit
The Reader Kit includes:
• FreeStyle Libre 2 Reader
• USB Cable
• Power Adaptor
• User’s Manual
• Quick Start Guide
• Performance Data Insert
The Reader gets glucose readings from your Sensor and can also issue
glucose alarms if they are turned on. It 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.
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.
11

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).
12

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 if
any of the alarms are turned on.
Ends in 14 days
22:23
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.
13

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
21
15
9
3
14:00 18:00 22:00
4.0
mmol
L
Glucose Going
Low
Rapid-Acting
Insulin Note
Message
Touch for more
information.
Add Notes
Touch to add notes to the
glucose reading.
Food Note
Current Glucose
Glucose from your
latest scan.
Glucose Trend Arrow
Directionyour
glucose is going.
Glucose Graph
Graph of your current
and stored glucose
readings.
14

FreeStyle Libre Software
FreeStyle Libre software can be used to view reports and change Reader
settings. The software is compatible with most Windows and Mac
operating systems. Go to www.FreeStyleLibre.com and follow onscreen
instructions to download and instal the software.
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, blood ketone test results and
other data uploaded from the FreeStyle Libre 2 Flash Glucose
Monitoring System, in support of an eective diabetes health
management programme.
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 replace 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.
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