Abbott FreeStyle Libre User manual

User’s Manual
FLASH GLUCOSE MONITORING SYSTEM

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
FreeStyle Libre 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
Using the Rapid-Acting Insulin Calculator . . . . . . . . . . . . . . . . 56
Charging the Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Changing the Reader Settings .........................64
Living With Your FreeStyle Libre System . . . . . . . . . . . . . . . 67
Maintenance and Disposal .............................69

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Reader Does Not Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Problems at the Sensor Application Site ..................71
Problems Starting Your Sensor or Receiving Sensor
Readings ................................................72
Blood Glucose or Ketone Error Messages .................75
Problems Checking Your Blood Glucose or Ketone ........79
Perform a Reader Test....................................81
Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Professional Options ...................................82
Changing Dose Increments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Setting up the Insulin Calculator .........................84
Easy Setup of the Insulin Calculator . . . . . . . . . . . . . . . . . . . . . . 86
Advanced Setup of the Insulin Calculator.................90
Changing the Insulin Calculator Settings ................101
System Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .102
Rapid-Acting Insulin Calculator Specications........106
Labelling Symbols.....................................108
Electromagnetic Compatibility........................109

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
Reminders
1

Symbol What It Means
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 Flash Glucose Monitoring System is indicated
for measuring interstitial uid glucose levels in adults aged 18 years
and older. It is designed to replace blood glucose testing in the
self-management of diabetes with the exceptions listed below.
Under the following circumstances, use a blood glucose meter
to check the current glucose readings from the FreeStyle Libre Flash
Glucose Monitoring System Sensor:
• During times of rapidly changing glucose levels, interstitial glucose
levels as measured by the Sensor and reported as current may not
accurately reect blood glucose levels. When glucose levels are falling
rapidly, glucose readings from the Sensor may be higher than blood
glucose levels. Conversely when glucose levels are rising rapidly,
glucose readings from the Sensor may be lower than blood glucose
levels.
• In order to conrm hypoglycaemia or impending hypoglycaemia as
reported by the Sensor.
• If symptoms do not match the FreeStyle Libre Flash Glucose
Monitoring System reading. Do not ignore symptoms that may be
due to low blood glucose or high blood glucose.
3

Contraindications
The FreeStyle Libre Flash Glucose Monitoring System must be removed
prior to Magnetic Resonance Imaging (MRI).
WARNING:
• The FreeStyle Libre Flash Glucose Monitoring System contains
small parts that may be dangerous if swallowed.
• During times of rapidly changing glucose (more than 0.1 mmol/L
per minute), interstitial uid glucose levels as measured by the
FreeStyle Libre Flash Glucose Monitoring System Sensor may not
accurately reect blood glucose levels. Under these circumstances,
check the Sensor glucose readings by conducting a ngerstick test
using a blood glucose meter.
• In order to conrm hypoglycaemia or impending hypoglycaemia
as reported by the FreeStyle Libre Flash Glucose Monitoring
System Sensor, conduct a ngerstick test using a blood glucose
meter.
• Do not ignore symptoms that may be due to low or high blood
glucose. If you have symptoms that do not match the FreeStyle
Libre Flash Glucose Monitoring System 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.
4

CAUTION:
• On rare occasions, you may get inaccurate Sensor glucose
readings. 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 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.
5

System-Related Information
• The FreeStyle Libre Flash Glucose Monitoring System 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.
• Physiologic 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.
• Severe dehydration and excessive water loss may cause inaccurate
results. If you believe you are suering from dehydration, consult your
health care professional immediately.
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 you are wearing and apply a new one after the appointment.
The eect of these types of procedures on the performance of the
system has not been evaluated.
• The FreeStyle Libre Flash Glucose Monitoring System has not been
evaluated for use in pregnant women, persons on dialysis, or people
less than 18 years of age.
7

Getting to Know Your System
The FreeStyle Libre Flash Glucose Monitoring System has two main parts:
a handheld Reader and a disposable Sensor, which 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:
• 1FreeStyle Libre Reader
• 1 USB Cable
• 1 Power Adapter
• User’s Manual
• Quick Start Guide
The Reader is used to get glucose readings from your Sensor. 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/o
and takes you to the
Home screen from any
other screen.
9

Sensor Kit
The Sensor Kit includes:
• 1 Sensor Pack
• 1 Sensor Applicator
• 1 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).
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

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 install 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 Flash Glucose
Monitoring System, in support of an eective diabetes health
management program.
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 substitute for 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.
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
back next
Current Date
June
2014
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
back next
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

Step Action
6The Reader now displays important information about two key
topics to help you use the system:
•How to understand the Glucose Trend Arrow included on
the Glucose Reading screen.
•How to return to the Home Screen from any other screen.
Touch next to move to the
next topic. At the end of the
Reader setup, touch done to
go to the Home Screen.
Note: Charge the Reader if the battery level is low. Only use the USB cable
and power adapter included with the System.
nextback
When you scan your Sensor
an arrow will indicate your
recent glucose trend:
Rising quickly
Rising
Changing slowly
Falling
Falling quickly
doneback
While using the Reader, press
the home button to return to
the Home screen.
16