Abbott FreeStyle Libre User manual

User’s Manual
FLASH GLUCOSE MONITORING SYSTEM

Your Name _________________________________________________

Contents
Reader Symbols ......................................... 1
Important Safety Information........................... 3
Indications for Use........................................ 3
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Getting to Know Your System . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Reader Kit ................................................ 9
Sensor Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Data Management Software .............................13
Setting up Your Reader for the First Time . . . . . . . . . . . . . . 14
Using Your Sensor ......................................17
Applying Your Sensor ....................................18
Starting Your Sensor .....................................22
Checking Your Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Adding Notes...........................................29
Reviewing Your History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Logbook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Daily Graph .............................................34
Other History Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Removing Your Sensor .................................37
Replacing Your Sensor .................................38
Using Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Using the Built-in Meter................................41
Blood Glucose Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Blood Ketone Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Control Solution Testing .................................52
Charging the Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Changing the Reader Settings .........................58
Living with Your System ................................61
Activities ................................................61
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Disposal.................................................64

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Reader Does Not Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Problems at the Sensor Application Site ..................66
Problems Starting Your Sensor or Receiving
Sensor Readings.........................................67
Blood Glucose or Ketone Error Messages .................70
Problems Checking Your Blood Glucose or Ketone ........74
Perform a Reader Test....................................76
Customer Service........................................76
System Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Labelling Symbols......................................81
Electromagnetic Compatibility.........................82
Warranty Statement....................................91

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
1

Symbol What it Means
Time changed on Reader
Reminders
Blood glucose or ketone test
Settings
Control solution test result
Low battery
Battery charging
Sensor too cold
Sensor too hot
2

Important Safety Information
Indications for Use
The FreeStyle Libre Flash Glucose Monitoring System Reader (“Reader”)
when used with a FreeStyle Libre System Sensor (“Sensor”) is indicated for
measuring interstitial uid glucose levels in people (age 4 and older) with
diabetes mellitus. 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 (age 4 - 17) 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 Flash Glucose Monitoring System (‘System’)
contains small parts that may be dangerous if swallowed.
4

CAUTION:
• On rare occasions, you may get inaccurate Sensor glucose readings.
If you believe that 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 and apply a new one.
• Performance of the System when used with other implanted
medical devices, such as pacemakers, has not been evaluated.
• 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 performing the cleaning procedure.
• 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
Sensor. Contact your health care professional before continuing to
use the Sensor.
• The System uses all available glucose data to give you readings so
you should scan your Sensor at least once every eight hours for the
most accurate performance. Scanning less frequently may result in
decreased performance.
5

System-Related Information
• The Reader is designed to be used only with FreeStyle Optium blood
glucose and blood ketone test strips and MediSense control solution.
• Avoid getting dust, dirt, blood, control solution, water or other
substances in the Reader’s USB and test strip ports.
• Physiological dierences between the interstitial uid and capillary
blood may result in dierences in glucose readings. 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.
• Do not reuse Sensors. The Sensor and Sensor Applicator are designed
for single use. Reuse may result in infection and no glucose readings.
Not suitable for re-sterilisation. Further exposure to irradiation may
cause inaccurate results.
• 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.
6

• 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 that 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.
• The System has not been evaluated for use in pregnant women, persons
on dialysis or people less than 4 years of age.
7

Getting to Know Your System
The FreeStyle Libre 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 get your
glucose readings. The Reader also has a built-in blood glucose and ketone
meter, which works with FreeStyle Optium blood glucose and blood
ketone test strips.
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.
8

Reader Kit
The Reader Kit includes:
• FreeStyle Libre
Reader
• USB Cable
• Power Adaptor
• User’s Manual
• Quick Start Guide
• Performance Data
Insert
The Reader is used to get glucose readings from your Sensor. It can store
approximately 90 days of glucose history and notes that 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/o
and takes you to the
Home screen from any
other screen.
9

Sensor Kit
The Sensor Kit includes:
• Sensor Pack
• Sensor Applicator
• 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).
10

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
Ends in 14 days
22:23
Check
Glucose
Review
History
Time
Current time set on
the Reader.
Sensor Status
Information about your
current Sensor.
Battery Level
Battery charge remaining.
Settings
Touch to change the
Reader’s settings.
Review History
Touch to review information
about your past glucose
readings.
Check Glucose
Touch to check your
Sensor glucose.
Reminder
Touch to set or change
reminders.
11

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.
12

Data Management Software
To upload data from the Reader, please visit www.FreeStyleLibre.com and
nd out more about the data management software that you can use.
13

Setting up Your Reader for the First Time
Before using the System for the rst time, the Reader must be set up.
Step Action
1Press the Home Button to turn on the Reader.
2If prompted, use the touchscreen to select your
preferred language for the Reader. Touch OK to
continue.
Note: Use the pad of your nger. Do NOT use
your ngernail or any other object on the screen.
3Set the Current Date using the arrows on the
touchscreen. Touch next to continue.
14
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Current Date
June
2020
14

Step Action
4Set the Current Time. Touch next to continue.
5Set your Target Glucose Range. Work with your
health care professional to determine your Target
Glucose Range. Touch next to continue.
Note: Your Target Glucose Range is displayed
on glucose graphs on the Reader and used to
calculate your Time In Target.
12 00
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Current Time
CAUTION: It is very important to set the time
and date correctly. These values aect the
Reader data and settings.
mmol
L
4.4 to 7.8
back next
Target Glucose
Range
?
15