Freestyle Libre 14 day User manual

User’s Manual
FLASH GLUCOSE MONITORING SYSTEM
CAUTION: Federal law restricts this device
to sale by or on the order of a physician.
.224”
.257”
4.6”4.6”

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

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

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 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 Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .100
Labeling Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .105
Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . .107
Electromagnetic Compatibility (EMC) .................123
Limited Warranty......................................134

Important Safety Information
Indications For Use
The FreeStyle Libre 14 day 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 14 day 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 eect 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.
1

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.
• Check Sensor glucose readings by conducting a ngerstick test
with a blood glucose meter under the following conditions,
when Sensor glucose readings may not be accurate and should
not be used 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 the
Sensor glucose readings
• During the rst 12 hours of wearing a FreeStyle Libre 14 day Sensor
• During times of rapidly changing glucose (more than 2 mg/dL per
minute)
• When the Sensor glucose reading does not include a Current
Glucose number or Glucose Trend Arrow
• In order to conrm 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 reect blood glucose levels. 350
250
150
50
82
mg
dL
2pm 6pm 10pm
Glucose Going
Low
2

Cautions and Limitations
Below are important cautions and limitations to keep in mind so you can
use the System safely. They are grouped into categories for easy 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.
• Take standard precautions for transmission of blood borne pathogens
to avoid contamination.
WARNINGS (cont.)
• Hypoglycemic unawareness: The 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 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 System contains small parts that may be
dangerous if swallowed.
3

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 dierent
conditions or medications common to the critically ill population may
aect 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:
• The Sensor can be worn for up to 14 days.
• 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.
4

• 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.
• The System uses all available glucose data to give you readings so
you should scan your Sensor at least once every 8 hours for the
most accurate performance. Scanning less frequently may result in
decreased performance.
• 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.
5

• 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 dierent 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
A
b
b
o
t
t
D
i
a
b
e
t
e
s
C
a
r
e
L
t
d
.
R
a
n
g
e
R
o
a
d
,
W
i
t
n
e
y
,
O
x
o
n
,
O
X
2
9
0
Y
L
,
U
K
D
O
C
3
0
3
9
1
R
e
v
.
B
0
9
/
1
3
XXXXXXXXX
XXX
YYYY-MM-DD
6

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 dierent from Blood Glucose:
• Physiological dierences between the interstitial uid and capillary
blood may result in dierences in glucose readings between the
System and results from a ngerstick test using a blood glucose meter.
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.
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 salicylic 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.
7

What to know about X-Rays:
• The Sensor should be removed prior to exposing it to an X-ray
machine. The eect 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
conrm 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 suering from
dehydration, consult your health care professional immediately.
8

What to know about the Reader’s Built-in Meter:
• The FreeStyle Libre 14 day Reader 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 hyperglycemic-
hyperosmolar 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.
9

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
10

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
11

Getting to Know Your System
The FreeStyle Libre 14 day 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 your System, review all the product instructions and
the Interactive Tutorial. The Quick Reference Guide and Interactive
Tutorial give you quick access to important aspects and limitations
of the System. The User’s Manual includes all safety information and
instructions for use.
• During the rst 12 hours after insertion of a Sensor, Sensor readings
will be accompanied by the symbol. Whenever is displayed, a
blood glucose test should be performed to conrm the Sensor
reading prior to treatment.
• Talk to your health care professional about how you should use your
Sensor glucose information to help manage your diabetes.
12

Reader Kit
The Reader Kit includes:
• FreeStyle Libre 14 day
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 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.
13

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).
14

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
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.
15