User’s Manual
©2018 Abbott ART38553-101 Rev. A 01/18
FreeStyle, Libre, and related brand marks are trademarks of Abbott Diabetes Care Inc.
in various jurisdictions. Other trademarks are the property of their respective owners.
Patent: https://www.abbott.com/patents
Distributed by:
Abbott Diabetes Care Inc.
1360 South Loop Road
Alameda, CA 94502 USA
Customer Service: 1-855-632-8658
Monday through Friday,
8AM to 8PM Eastern Standard Time
www.FreeStyleLibre.com
FLASH GLUCOSE MONITORING SYSTEM
Manufacturer:
CAUTION: Federal law restricts this device
to sale by or on the order of a physician.
.224”
.257”
4.6”4.6”
ART38553-101_rev-A_cover.indd 1-2 2/1/18 2:18 PM
Your Name _________________________________________________
.224”
.257”
4.6” 4.6”
ART38553-101_rev-A_cover.indd 3-4 2/1/18 2:18 PM
Contents
Important Safety Information........................... 1
Indications For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Contraindications ........................................1
Warnings................................................. 2
Cautions and Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Reader Symbols ........................................10
Getting to Know Your System . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Reader Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Sensor Kit ...............................................14
FreeStyle Libre Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Setting up Your Reader for the First Time . . . . . . . . . . . . . . 18
Using Your Sensor ......................................21
Applying Your Sensor....................................22
Starting Your Sensor .....................................26
Checking Your Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Making Treatment Decisions ...........................33
Making Treatment Decisions – Getting Started ...........34
Making Treatment Decisions – Advanced ................39
ART38553-101_rev-A_manual.indd 1 2/1/18 2:13 PM
Adding Notes...........................................50
Reviewing Your History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Logbook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Daily Graph .............................................55
Other History Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Removing Your Sensor .................................58
Replacing Your Sensor .................................59
Using Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Using the Reader’s Built-in Meter . . . . . . . . . . . . . . . . . . . . . . 62
Intended Use............................................62
Blood Glucose Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Control Solution Testing .................................71
Charging the Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Changing the Reader Settings .........................77
Living With Your FreeStyle Libre System . . . . . . . . . . . . . . . 80
Maintenance and Disposal .............................83
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Reader Does Not Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Problems at the Sensor Application Site ..................89
Problems Starting Your Sensor or Receiving
Sensor Readings.........................................90
Blood Glucose Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Problems Checking Your Blood Glucose . . . . . . . . . . . . . . . . . . 97
Perform a Reader Test....................................99
Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
System Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .100
Labeling Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . .107
Electromagnetic Compatibility (EMC) .................123
Limited Warranty......................................134
ART38553-101_rev-A_manual.indd 2-3 2/1/18 2:13 PM
Important Safety Information
Indications For Use
The FreeStyle Libre Flash Glucose Monitoring System is a continuous
glucose monitoring (CGM) device indicated for the management of
diabetes in persons age 18 and older. It is designed to replace blood
glucose testing for diabetes treatment decisions.
The System detects trends and tracks patterns aiding 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 intended for single patient use and requires a
prescription.
Contraindications
MRI/CT/Diathermy: The FreeStyle Libre Flash Glucose Monitoring
System must be removed prior to Magnetic Resonance Imaging
(MRI), Computed Tomography (CT ) scan, or high-frequency
electrical heat (diathermy) treatment. The eect 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.
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.
• Checking Sensor glucose readings with a blood glucose meter:
Under the following conditions, Sensor glucose readings may not
be accurate and you should conduct a ngerstick test using a blood
glucose meter. You should not use Sensor glucose readings to make
a diabetes treatment decision:
• If you suspect that your reading may be inaccurate for any reason
• When you are experiencing symptoms that may be due to low or
high blood glucose
• When you are experiencing symptoms that do not match FreeStyle
Libre System readings
• During times of rapidly changing glucose (more than 2 mg/dL per
minute), when interstitial uid glucose levels as measured by the
Sensor may not accurately reect blood glucose levels
• When the Sensor glucose reading does not include a Current
Glucose number or Glucose Trend Arrow
• In order to conrm hypoglycemia or impending
hypoglycemia as reported by the Sensor
• When you see the symbol, you must check your
blood glucose with a blood glucose meter before
making any treatment decisions. Sensor readings may
not accurately reect blood glucose levels.
350
250
150
50
82
mg
dL
2pm 6pm 10pm
Glucose Going
Low
1 2
ART38553-101_rev-A_manual.indd 1-2 2/1/18 2:13 PM
Cautions and Limitations
Below are important cautions an d limitations to keep in mind so you can
use the System safely. They are grouped into categories for e asy reference.
What to know about Alarms/Alerts:
• There are NO alarms or alerts unless you scan the Sensor.
What to know before using the System:
• Review all product information before use.
WARNINGS (cont.)
• Hypoglycemic unawareness: The FreeStyle Libre System has not
been evaluated for use in patients with hypoglycemic unawareness
and will not automatically alert you of a hypoglycemic event without
you scanning your Sensor.
• No alarms without a Sensor scan: The FreeStyle Libre System does
not have alarms that will automatically notify you when you are
having a severe low (hypoglycemic) or high (hyperglycemic) glucose
event unless you scan your Sensor. For example, the System does
not have an alarm that can alert or wake you when you are sleeping
in the case of low or high glucose.
• Choking hazard: The FreeStyle Libre System contains small parts
that may be dangerous if swallowed.
• Take standard precautions for transmission of blood borne pathogens
to avoid contamination.
Who should not use the System:
• Do not use the System in people less than 18 years of age. The
System is not approved for use in people under 18 years of age and
Sensor readings in this population may be inaccurate. In general,
continuous glucose monitoring systems are recognized to be less
accurate in children than in adults.
• Do not use the System in critically ill patients. The System is not
approved for use in these patients. It is not known how dierent
conditions or medications common to the critically ill population may
aect performance of the System. Sensor glucose readings may be
inaccurate in critically ill patients.
• Do not use the System in pregnant women or persons on dialysis.
The System is not approved for use in pregnant women or persons on
dialysis and has not been evaluated in these populations.
• Performance of the System when used with other implanted medical
devices, such as pacemakers, has not been evaluated.
What should you know about wearing a Sensor:
• After the 12 hour start-up period, the Sensor can be worn for up to 10
days.
• Some individuals may be sensitive to the adhesive that keeps the
Sensor attached to the skin. If you notice signicant skin irritation
3 4
ART38553-101_rev-A_manual.indd 3-4 2/1/18 2:13 PM
around or under your Sensor, remove the Sensor and stop using the
FreeStyle Libre System. Contact your health care professional before
continuing to use the FreeStyle Libre System.
• Intense exercise may cause your Sensor to loosen due to sweat or
movement of the Sensor. Remove and replace your Sensor if it starts to
loosen and follow the instructions to select an appropriate application
site.
• 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-sterilization. Further exposure to irradiation may
cause inaccurate results.
• If a Sensor breaks inside your body, call your health care professional.
How to Store the Sensor Kit:
• Store the Sensor Kit between 39°F and 77°F. Storage outside of this
range may cause inaccurate Sensor glucose readings. While you don’t
need to keep your Sensor Kit in a refrigerator, you can as long as the
refrigerator is between 39°F and 77°F. Do not freeze.
• Store the Sensor Kit between 10-90% non-condensing humidity.
When not to use the System:
• Do NOT use if the Sensor Kit package, Sensor Pack, or Sensor
Applicator appear to be damaged or already opened due to risk of no
results and/or infection.
• Do NOT use if Sensor Kit contents are past expiration date.
• Do NOT use if the Reader appears to be damaged due to risk of electric
shock and/or no results.
What to know before you Apply the Sensor:
• The Sensor Pack and Sensor Applicator are
packaged as a set (separately from the Reader)
and have the same Sensor code. Check that the
Sensor codes match before using your Sensor
Pack and Sensor Applicator. Do not use Sensor
Packs and Sensor Applicators with dierent Sensor
codes together as this will result in incorrect
glucose readings.
• Clean the application site and ensure that it is dry prior to Sensor
insertion. This helps the Sensor stay attached to your body.
• Clean hands prior to Sensor handling/insertion to help prevent
infection.
• Change the application site for the next Sensor application to prevent
discomfort or skin irritation.
• Sensor placement is not approved for sites other than the back of the
arm. If placed in other areas, the Sensor may not function properly.
• Select an appropriate Sensor site to help the Sensor stay attached
to the body and prevent discomfort or skin irritation. Avoid areas
with scars, moles, stretch marks, or lumps. Select an area of skin
CODE
FreeStyle Libre
Sensor Pack
XXXXXXXXX
XXX
YYYY-MM-DD
5 6
ART38553-101_rev-A_manual.indd 5-6 2/1/18 2:13 PM
that generally stays at during normal daily activities (no bending
or folding). Choose a site that is at least 1 inch away from an insulin
injection site.
When is Sensor Glucose dierent from Blood Glucose:
• Physiological dierences between the interstitial uid and capillary
blood may result in dierences in glucose readings between the
System and results from a ngerstick test using a blood glucose meter.
Dierences 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.
What to know about interfering substances such as Vitamin C
and Aspirin:
• Taking ascorbic acid (vitamin C) while wearing the Sensor may falsely
raise Sensor glucose readings. Taking salic ylic acid (used in some pain
relievers such as aspirin and some skin care products) may slightly
lower Sensor glucose readings. The level of inaccuracy depends on the
amount of the interfering substance active in the body.
• Test results did not indicate interference for methyldopa (used in some
drugs to treat high blood pressure) or tolbutamide (infrequently used
in some drugs to treat diabetes in the US) at maximum circulating
levels. However, concentrations of potential interferents in interstitial
uid are unknown compared to circulating blood.
What to know about X-Rays:
• The Sensor should be removed prior to exposing it to an X-ray
machine. The eect of X-rays on the performance of the System
has not been evaluated. The exposure may damage the Sensor and
may impact proper function of the device to detect trends and track
patterns in glucose values during the wear period.
When to remove the Sensor:
• If the Sensor is becoming loose or if the Sensor tip is coming out of
your skin, you may get no readings or unreliable readings, which may
not match how you feel. Check to make sure your Sensor has not come
loose. If it has come loose, remove it and apply a new one.
• 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
conrm your glucose. If the problem continues, remove the current
Sensor and apply a new one.
What to do if you are dehydrated:
• Severe dehydration and excessive water loss may cause inaccurate
Sensor glucose readings. If you believe you are suering from
dehydration, consult your health care professional immediately.
7 8
ART38553-101_rev-A_manual.indd 7-8 2/1/18 2:13 PM
What to know about the Reader’s Built-in Meter:
• The FreeStyle Libre Flash Glucose Monitoring System has a built-in
blood glucose meter that is designed to be used only with FreeStyle
Precision Neo blood glucose test strips and MediSense Glucose and
Ketone Control Solution. Using other test strips with the Reader’s
built-in meter will produce an error or cause the Reader’s built-in
meter to not turn on or start a test. The Reader’s built-in meter does
not have ketone testing functionality.
• The Reader’s built-in meter is not for use on people who are
dehydrated, hypotensive, in shock, or for individuals in hyperglycemichyperosmolar state, with or without ketosis.
• The Reader’s built-in meter is not for use on neonates, in critically-ill
patients, or for diagnosis or screening of diabetes.
• See Using the Reader’s Built-in meter section for additional important
information on the use of the Reader’s built-in meter.
Where to charge your Reader:
• Be sure to select a location for charging that allows the power adapter
to be easily unplugged. Do NOT block access to the charger due to the
potential risk of electrical shock.
Reader Symbols
Symbol What It Means
Sensor may be inaccurate. Check blood glucose with
a test strip before making any treatment decisions
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
9 10
ART38553-101_rev-A_manual.indd 9-10 2/1/18 2:13 PM
Symbol What It Means
Time changed on Reader
Reminders
Blood glucose test
Settings
Control solution test result
Low battery
Battery charging
Sensor too cold
Sensor too hot
Getting to Know Your System
The FreeStyle Libre Flash Glucose Monitoring System has two main
parts: a handheld Reader and a disposable Sensor that you wear on your
body. The Sensor does not need to be calibrated with blood glucose
values. You use the Reader to wirelessly scan the Sensor and get your
glucose readings. The Reader also has a built-in blood glucose meter,
which works with FreeStyle Precision Neo blood glucose 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:
• Before you use you r System , review all the
product instructions an d the Interactive
Tutorial. The Quick Reference Guide and
Interactive Tutorial give you quick access
to important aspect s and limitations of the
System. The User’s Manual includes all safet y
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.
11 12
ART38553-101_rev-A_manual.indd 11-12 2/1/18 2:13 PM
Reader Kit
The Reader Kit includes:
• FreeStyle Libre Reader
• USB Cable
• Interactive Tutorial on USB
• Power Adapter
• User’s Manual
• Quick Start Guide
• Quick Reference 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 aect 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.
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. After the 12 hour
start-up period, the Sensor can be worn for up to
10 days.
Sensor
Measures your glucose while on your
body (only visible after applied).
13 14
ART38553-101_rev-A_manual.indd 13-14 2/1/18 2:13 PM
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 10 days
10:23pm
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.
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
350
250
150
50
2pm 6pm 10pm
82
mg
dL
Glucose Going
Low
Rapid-Acting
Insulin Note
Message
Touch for more
information.
Current Glucose
Glucose from your
latest scan.
Add Notes
Touch to add notes to the
glucose reading.
Glucose Trend Arrow
Direction your
glucose is going.
Glucose Graph
Graph of your current
and stored glucose
readings
.
Food Note
Check Blood
Glucose symbol
Touch for more
information.
15 16
ART38553-101_rev-A_manual.indd 15-16 2/1/18 2:13 PM
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, and other data uploaded from the
FreeStyle Libre Flash Glucose Monitoring System, in support of
an eective 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.
Setting up Your Reader for the First Time
Before using the System for the rst time, the Reader must be set up.
Step Action
1
Press the Home Button to turn on the Reader.
2
If 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.
3
Set the Current Date using the arrows on the
touchscreen. Touch next to continue.
14
back next
Current Date
June
2018
17 18
ART38553-101_rev-A_manual.indd 17-18 2/1/18 2:13 PM
Step Action
4
Set the Current Time. Touch next to continue.
5
Set 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 am 00
back next
Current Time
CAUTIO N: It is very important to set the time
and date correctly. These values aect the
Reader data and settings.
mg
dL
80
to
140
back next
Target Glucose
Range
?
Step Action
6
The Reader now displays important information about key
topics to help you use the System:
• How to understand the Glucose Trend Arrow included on
the Glucose Reading screen.
• When to do a blood glucose test.
• Where to apply the Sensor.
• 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 bat tery 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
If you see this symbol, do
a blood glucose test before
making treatment
decisions.
back next
If the Sensor glucose
reading does not match
how you feel, do a blood
glucose test.
back next
nextback
The Sensor can only be
applied to the back of
your upper arm.
doneback
While using the Reader, press
the Home Button to return to
the Home Screen.
19 20
ART38553-101_rev-A_manual.indd 19-20 2/1/18 2:13 PM
Using Your Sensor
CAUTIO NS:
• The Sensor Pack and Sensor Applicator are packaged as a
set (separately from the Reader) and have the same Sensor
code. Check that the Sensor codes match
before using your Sensor Pack and Sensor
Applicator. Do not use Sensor Packs and
Sensor Applicators with dierent Sensor
codes together as this will result in
incorrect glucose readings.
• Intense exercise may cause your Sensor to loosen due to
sweat or movement of the Sensor. Remove and replace
your Sensor if it starts to loosen and follow the instructions
to select an appropriate application site.
CODE
FreeStyle Libre
Sensor Pack
XXXXXXXXX
XXX
YYYY-MM-DD
Applying Your Sensor
Step
Action
1
Apply Sensors only on the back of your upper
arm. If placed in other areas, the Sensor may
not function properly and could give inaccurate
readings. The application of the Sensor is not
approved for other sites. Avoid areas with scars,
moles, stretch marks, or lumps.
Select an area of skin that generally stays at
during your normal daily activities (no bending
or folding). Choose a site that is at least 1 inch
(2.5 cm) away from an insulin injection site. To
prevent discomfort or skin irritation, you should
select a dierent site other than the one most
recently used.
2
Clean application site with an alcohol wipe and
allow site to dry before proceeding. This helps
the Sensor stay attached to your body.
Note: The area MUST be clean and dry, or the
Sensor may not stick to the site.
21 22
ART38553-101_rev-A_manual.indd 21-22 2/1/18 2:13 PM
Step
Action
3
Open the Sensor Pack by peeling the lid o
completely. Unscrew the cap from the Sensor
Applicator and set the cap aside.
4
Line up the dark mark on the Sensor Applicator
with the dark mark on the Sensor Pack. On a
hard surface, press rmly down on the Sensor
Applicator until it comes to a stop.
5
Lift the Sensor Applicator out of the Sensor Pack.
Lid
Cap
CAUTIO N: Do NOT use if the Sensor Pack or
the Sensor Applicator seem to be damaged
or already opened. Do NOT use if past
expiration date.
Step
Action
6
The Sensor Applicator is prepared and ready to
apply the Sensor.
7
Place the Sensor Applicator over the prepared
site and push down rmly to apply the Sensor to
your body.
CAUTIO N: The Sensor Applicator now
contains a needle. Do NOT touch inside the
Sensor Applicator or put it back into the
Sensor Pack.
CAUTIO N: Do NOT push down on the Sensor
Applicator until placed over prepared site to
prevent unintended results or injury.
23 24
ART38553-101_rev-A_manual.indd 23-24 2/1/18 2:13 PM
Step
Action
8
Gently pull the Sensor Applicator away from your
body. The Sensor should now be attached to your
skin.
Note: Applying the Sensor may cause bruising
or bleeding. If there is bleeding that does not
stop, remove the Sensor and contact your
health care professional.
9
Make sure the Sensor is secure after application.
Put the cap back on the Sensor Applicator.
Discard the used Sensor Pack and Sensor
Applicator according to local regulations.
Sensor
Starting Your Sensor
Step
Action
1
Press the Home Button to turn on the Reader.
2
Touch Start New Sensor.
3
Hold the Reader within 1.5 inches (4 cm) of the
Sensor to scan it. This starts your Sensor. If sounds
are turned on, the Reader beeps when the Sensor
has been successfully activated. The Sensor can
be used to check your glucose after 12 hours.
During the 12 hour period, you can scan the
Sensor to check its status.
Note: If the Sensor is not successfully scanned
within 15 seconds, the Reader displays a prompt
to scan the Sensor again. Touch OK to return to
the Home Screen and touch Start New Sensor
to scan your Sensor.
No Active Sensor
10:23pm
Start New
Sensor
Review
History
hours
OK
New Sensor
Starting Up
12
Sensor can be used in:
25 26
ART38553-101_rev-A_manual.indd 25-26 2/1/18 2:13 PM
Checking Your G lucose
Step Action
1
Turn the Reader on by pressing
the Home Button or touch
Check Glucose from the Home
Screen.
2
Hold the Reader within 1.5 inches (4 cm) of your
Sensor to scan it. Your Sensor wirelessly sends
glucose readings to the Reader. If sounds are
turned on, the Reader beeps when the Sensor
has been successfully scanned.
Note: If the Sensor is not successfully scanned wi thin 15
seconds, the Reader displays a prompt to scan the Sensor
again. Touch OK to return to the Home Screen and touch
Check Glucose to scan your Sensor.
10:23pm
Check
Glucose
Review
History
Ends in 10 days
OR
Step Action
3
The Reader displays your current glucose reading
along with your glucose graph and an arrow
indicating the direction your glucose is goin g.
350
250
150
50
236
mg
dL
6am 10am 2pm
Glucose Going
High
27 28
ART38553-101_rev-A_manual.indd 27-28 2/1/18 2:13 PM
Sensor Glucose Readings
Notes:
• While Sensor glucose readings are gathered in the System range of
40-500 mg/dL, the graph display rang e is 0-350 mg/dL for eas e of
review on screen. Glucose readings above 350 mg/dL are displayed
at 350 mg/dL. For sequential readings above 350 mg/dL, a line is
displayed at 350 mg/dL.
• The symb ol may appear, indicating the Reader time was changed.
Gaps in the graph may result or glucose readings may be hidden .
350
250
150
50
2pm 6pm 10pm
82
mg
dL
Glucose Going
Low
Glucose Trend Arrow
Current Glucose
Target Glucose Range
Check Blood Glucose
When you see this symbol,
do a blood glucose test
before making treatment
decisions.
The Glucose Trend Arrow gives you an indication of the direction your
glucose is going.
Glucose is rising quickly
(more than 2 mg/dL per minute)
Glucose is rising
(between 1 and 2 mg/dL per minute)
Glucose is changing s lowly
(less than 1 mg/dL per minute)
Glucose is falling
(between 1 and 2 mg/dL per minute)
Glucose is falling quickly
(more than 2 mg/dL per minute)
Note: The Glucose Trend Arrow may not always appear with your readin g.
29 30
ART38553-101_rev-A_manual.indd 29-30 2/1/18 2:13 PM
The following table shows messages you may see with your glucose
readings.
Display What To Do
350
250
150
50
2pm 6pm 10pm
mg
dL
Low Glucose
LO
350
250
150
50
2pm 6pm 10pm
mg
dL
High Glucose
HI
If LO appears on the Reader, your reading is lower
than 40 mg/dL. If HI appears on the Reader, your
reading is higher than 500 mg/dL. You can touch
the message button for more information. Check
your blood glucose on your nger with a test strip.
If you get a second LO or HI result, contact your
health care professional immediately.
350
250
150
50
2pm 6pm 10pm
mg
dL
63
Low Glucose
350
250
150
50
2pm 6pm 10pm
289
mg
dL
High Glucose
If your glucose is higher than 240 mg/dL or lower
than 70 mg/dL, you will see a message on the
screen. You can touch the message button for
more information and set a reminder to check
your glucose.
Display What To Do
350
250
150
50
2pm 6pm 10pm
mg
dL
72
Glucose Going
Low
350
250
150
50
2pm 6pm 10pm
237
mg
dL
Glucose Going
High
If your glucose is projected to be higher than
240 mg/dL or lower than 70 mg/dL within 15
minutes, you will see a message on the screen.
You can touch the message button for more
information and set a reminder to check your
glucose.
If your glucose reading is less than 70 mg/dL,
projected to be less than 70 mg/dL, rapidly
changing, or there is no number or trend arrow,
you will see this symbol
. You can touch the
symbol for more information. Check your blood
glucose on your nger with a test strip before
making treatment decisions.
Note: If you are not sure about a message o r reading, contact your
health care professional before you do anything.
350
250
150
50
2pm 6pm 10pm
mg
dL
63
Low Glucose
31 32
ART38553-101_rev-A_manual.indd 31-32 2/1/18 2:13 PM
Making Treatment Decisions
Work with your health care professional to put together a plan for
managing your diabetes that includes when to use the FreeStyle Libre
System information for making treatment decisions.
WARNING: The FreeStyle Libre System can replace blood glucose testing
except in a few situations. These are the times when you need to do a
blood glucose test before deciding what to do or what treatment decision
to make as Sensor readings may not accurately reect blood glucose levels:
Do a blood glucose test if you see the Check
Blood Glucose
symbol. The symbol
means your Sensor glucose reading may not be
accurate. For example, there may be times when
you get a low glucose reading but you do not
actually have low glucose.
Do a blood glucose test if you think your
glucose readings are not correct or do not
match how you feel. Do not ignore symptoms
that may be due to low or high glucose.
Note: The
symbol will NOT appear in this
situation.
Making Treatment Decisions – Getting Started
Before you start using the FreeStyle Libre System for treatment decisions,
make sure you have a good understanding of how the System works for
your body. Continue to use your blood glucose meter for treatment
decisions until you are comfortable with the information you receive
from your FreeStyle Libre System. This includes understanding that:
Sensor performance can vary in between Sensors, within a Sensor wear,
and in dierent situations.
Getting familiar with the System could take days, weeks, or even months.
The more you check readings from the FreeStyle Libre System with a
blood glucose meter, the better you will understand how the System
works for you.
Work with your health care professional to put together a plan for
managing your diabetes that includes when to use the FreeStyle Libre
System information for making treatment decisions.
Helpful Tips
• Conrm your Sensor glucose readings with a blood glucose meter until
you understand:
• Sensor accuracy may vary between Sensors.
• Sensor accuracy may vary during a Sensor wear session.
• Sensor accuracy may vary in dierent situations (meals, exercise, rst
day of use, etc.).
33 34
ART38553-101_rev-A_manual.indd 33-34 2/1/18 2:13 PM
• Scan your Sensor often to see how carbs, medication, exercise, illness, or
stress levels impact your Sensor glucose readings. The information you
get can help you gure out why your glucose sometimes goes too high
or too low, and how to prevent it from doing so in the future.
• Talk to your health care professional about how your insulin works. The
more you understand about your insulin, including how long it takes to
start working and how long it lasts in your body, the more likely you will
be to make better treatment decisions.
• Making a treatment decision doesn’t just mean taking insulin. Treatment
decisions can also include things like taking fast-acting carbs, eating, or
even doing nothing and scanning again later.
• Your health care professional can also help you to understand when
doing nothing and scanning again later is the right treatment decision.
For example, if your glucose is high and going up, your rst instinct may
be to take more insulin to lower your glucose, however depending on
when you last took insulin or your recent activity, the right treatment
decision may be to do nothing and scan again later. Avoid “insulin
stacking”.
When not to use Sensor Glucose readings for treatment decisions
Glucose is Falling Quickly or Rising Quickly
Sensor glucose values, which are based on interstitial uid glucose levels,
can be dierent from blood glucose levels (ngersticks), particularly
during times when your blood glucose is changing quickly. For example
after eating, taking insulin, or exercising. When glucose levels are falling
quickly, glucose readings from the Sensor may be higher than blood
glucose levels. On the other hand, when glucose levels are rising quickly,
glucose readings from the Sensor may be lower than blood glucose levels.
If glucose is rising quickly or falling quickly, you will see the
symbol.
Whenever you see the
symbol, do a blood glucose test and treat
based on that result.
Glucose
Rising
Quickly
Blood Glucose
100 mg/dL
Sensor Glucose
95 mg/dL
Glucose
Falling
Quickly
Sensor Glucose
80 mg/dL
Blood Glucose
70 mg/dL
Low Glucose or Glucose Going Low message
The System lets you know about hypoglycemia or impending
hypoglycemia with a Low Glucose or Glucose Going Low message. These
messages may not accurately reect blood glucose. When there is a Low
35 36
ART38553-101_rev-A_manual.indd 35-36 2/1/18 2:13 PM
Loading...