Freestyle LIBRE PRO Operator's Manual

Operator’s Manual

FLASH GLUCOSE MONITORING SYSTEM

CAUTION: Federal law restricts this device
to sale by or on the order of a physician.

Spine depth for perfect binding will be determined by supplier.

Contents

Reader Symbols .........................................1

Important Safety Information........................... 2

Indications for Use........................................ 2

Contraindications ........................................3

Getting to Know the System.............................7

Reader Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Sensor Kit ................................................ 9

FreeStyle Libre Pro Software .............................11

Setting up the Reader for the First Time................12

Using the Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Applying the Sensor .....................................15

Starting the Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Patient Wear.............................................21

Getting Sensor Data .....................................22

Removing the Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Charging the Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Reader Symbols

Symbol What It Means

View previous/next screen

Options

Low battery

Battery charging

Conrm Sensor reminder

Communication strength

Data to report

Reader Options.........................................27

Maintenance and Disposal .............................30

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Reader Does Not Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Problems at the Sensor Application Site ..................32

Problems Starting the Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Problems Getting Sensor Data . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Reader Error Messages...................................36

Perform a Reader Test....................................37

Customer Service........................................37

System Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Labeling Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Electromagnetic Compatibility.........................64

Limited Warranty.......................................74

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Important Safety Information

Indications for Use

The FreeStyle Libre Pro Flash Glucose Monitoring System is a professional
continuous glucose monitoring (CGM) device indicated for detecting trends
and tracking patterns in persons (age 18 and older) with diabetes. The System
is intended for use by health care professionals and requires a prescription.
Readings from the FreeStyle Libre Pro Sensor are only made available to
patients through consultation with a health care professional. The System
does not require user calibration with blood glucose values.

The FreeStyle Libre Pro System aids in the detection of glucose level
excursions above or below the desired range, facilitating therapy adjustments.
Interpretation of the FreeStyle Libre Pro Flash Glucose Monitoring System
readings should be based on the trends and patterns analyzed through time
using the reports available.

IMPORTANT: The device may inaccurately indicate hypoglycemia.
The results of the clinical study conducted for this device
showed that 40% of the time when the device indicated that
user sensor glucose values were at or below 60 mg/dL, user
glucose values were actually in the range of 81-160 mg/dL.
Therefore, interpretation of the FreeStyle Libre Pro Flash Glucose
Monitoring System readings should only be based on the trends
and patterns analyzed through time using the reports available
per the intended use.

Contraindications

The FreeStyle Libre Pro 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 to detect
trends and track patterns in the user’s glucose values during
the wear period.

WARNING: The FreeStyle Libre Pro Flash Glucose Monitoring
System contains small parts that may be dangerous if
swallowed.

CAUTIO N:

• Performance of the System when used with other implanted

medical devices, such as pacemakers, has not been evaluated.

• Some individuals may be sensitive to the adhesive that

keeps the Sensor attached to the skin. If your patient notices
signicant skin irritation around or under their Sensor, they
should remove the Sensor and stop using the FreeStyle Libre
Pro System. Follow your facility’s procedures for handling
skin reactions.

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Warnings/Limitations

• Review all product information before use.

• 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.

• 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.

• Interfering Substances: 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. Taking medications with acetaminophen (such as Tylenol and
some cold medicines) while wearing the Sensor may falsely raise

Sensor glucose readings. The level of inaccuracy depends on the
amount of acetaminophen active in the body and may be dierent for
each person.

• Take standard precautions for transmission of blood borne pathogens

to avoid contamination.

• The Reader should be cleaned between patients.

• If a Sensor breaks inside a patient, remove with tweezers, treat any

medical complications and call Customer Service.

• Use of the System is not recommended in the critically ill population

since performance is unknown due to dierent conditions and
medications.

• 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.

• If the Sensor Kit package or contents or the Reader appear to be

damaged, do not use as there may be a risk of electric shock, no results,
and/or infection.

• Store the Sensor Kit between 39°F-77°F. While you don’t need to keep

the Sensor Kit in a refrigerator, you can as long as the refrigerator is
between 39°F-77°F.

• Store the Sensor Kit between 10-90% non-condensing humidity.

• The System does not provide real-time results. Patients need to rely on

blood glucose readings for monitoring glucose during System use.

• Clean hands prior to Sensor handling/insertion to help prevent

infection.

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• Clean the application site and ensure that it is dry prior to Sensor

insertion. This helps the Sensor stay attached to the body.

• Change the application site for the next Sensor application to prevent

discomfort or skin irritation.

• 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 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.

• The Sensor should not be worn more than 14 days. Readings are not

obtained after 14 days.

• 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 the
user’s glucose values during the wear period.

• The FreeStyle Libre Pro Flash Glucose Monitoring System has not been

evaluated for use in pregnant women, persons on dialysis, or people less
than 18 years of age.

Getting to Know the System

The FreeStyle Libre Pro Flash Glucose Monitoring System has three main
parts: a handheld Reader, a disposable Sensor, and FreeStyle Libre Pro
software. A single FreeStyle Libre Pro Reader can be used to gather data
from FreeStyle Libre Pro Sensors on multiple patients.

When opening the Reader Kit and Sensor Kit, 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 Operator’s Manual. Read all of
the information in the Operator’s Manual before
using the System.

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Reader Kit

The Reader Kit includes:

• FreeStyle Libre

Pro Reader

• USB Cable

• Power Adapter

• Operator’s Manual

• Quick Start Guide

The Reader is used to start the Sensor on a patient and gather their
glucose readings. Multiple patients can have their Sensor started by the
same Reader.

USB Port

Used to charge the
Reader and connect
it to a computer.

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 the patient’s body.

The Sensor measures and stores glucose readings when worn on the
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, prepare and apply the Sensor on the back
of the patient’s 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 glucose while on body

(only visible after applied).

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FreeStyle Libre Pro Software

FreeStyle Libre Pro software can be used to create reports based on
glucose readings from the most recently downloaded Sensor. The
software is compatible with most Windows and Mac operating systems.
Go to www.FreeStyleLibrePro.com and follow onscreen instructions to
download and install the software.

INTENDED USE

The FreeStyle Libre Pro software is intended for use by health
care professionals to aid in the review, analysis and evaluation of
a patient’s glucose readings uploaded from the FreeStyle Libre
Pro Flash Glucose Monitoring System in support of an eective
diabetes health management program.

The Reader Home Screen provides access to starting a new Sensor, getting
Sensor data, and information about the System.

Home Screen

10:23pm

Start New

Sensor

Get Sensor

Data

Time

Current time set on
the Reader.

Battery Level

Battery charge remaining.

Options

Touch to view or change

the Reader’s options.

Get Sensor Data

Touch to download all

glucose readings from the

Sensor into the Reader.

Start New Sensor

Touch to start a new
Sensor.

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Step Action

4

Set the Current Time. Touch next to continue.

5

mg
dL

80

to

140

back next

Target Glucose
Range

?

Set the Target Glucose Range. Touch next to
continue.

Note: The Target Glucose Range is displayed on
the Daily Graph on the Reader once Sensor data
has been downloaded. While the glucose data
are gathered in the System range of 40-500 mg/dL,
the Daily Graph display range is 0-350 mg/dL for
ease of review on screen.

6

doneback

While using the Reader, press
the Home button to return to
the Home screen.

The Reader now indicates how to return to the
Home Screen from any other screen. 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 include d with the System.

12 am 00

back next

Current Time

CAUTIO N: It is very important to set the time
and date correctly for correct interpretation
of Sensor data.

Setting up the 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.

11

back next

Current Date

June
2017

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Applying the Sensor

Step

Action

1

Apply Sensors only on the back of your patient’s
upper arm. Avoid areas with scars, moles, stretch
marks, or lumps.

Select an area of skin that generally stays at
during 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 dierent 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 the body.

Note: The area MUST be clean and dry, or the
Sensor may not stick to the site.

Using the Sensor

After you assemble and apply the Sensor to your patient’s body, start
the Sensor with the Reader and conrm it is working. The Sensor stores
glucose readings every 15 minutes for up to 14 days. The rst reading is
stored 1 hour after the Sensor is successfully started.

CAUTIO N:
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
the Sensor Pack and Sensor Applicator. Sensor
Packs and Sensor Applicators with the same
Sensor code should be used together or
Sensor glucose readings may be incorrect.

CODE

FreeStyle Libre

Sensor Pack

XXXXXXXXX

XXX

YYYY-MM-DD

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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
the 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.

Step

Action

3

Open the Sensor Pack by peeling the lid o
completely. Unscrew 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. 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.

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Starting the 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 start it. If sounds are turned on, the
Reader beeps when the Sensor has been started.
You can check the Sensor has successfully started
in 2 minutes.

Note: If communication is not established within
15 seconds, the Reader displays a prompt to try
again. Touch OK to return to the Home Screen
and touch Start New Sensor to start the Sensor.

10:23pm

Start New

Sensor

Get Sensor

Data

Check Sensor status
when prompted in:

minutes

OK

Sensor Starting

2

Step

Action

8

Gently pull the Sensor Applicator away from the
body. The Sensor should now be attached to the
skin.

Note: Applying the Sensor may cause bruising
or bleeding. If there is bleeding that does not
stop, remove the Sensor, and apply a new one at
a dierent site.

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 your facility’s procedures.

Sensor

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Step Action

4

When prompted, touch yes to check the Sensor
status. Hold the Reader within 1.5 inches (4 cm)
of the Sensor to verify Sensor is working.

5

Touch OK to go to the Home Screen.

Reminder

yesno

Check Sensor Status?

Sensor can be used for
up to 14 more days.

OK

Sensor Working

Patient Wear

The Sensor stores your patient ’s glucose readings every 15 minutes for up
to 14 days. The rst reading is stored 1 hour after the Se nsor is successfully
started.

IMPORTANT:

• The Sensor should not be worn for more than 14 days.

• Data can be downloaded at anytime from Sensors that are on or o

the body.

• Before your patient goes home, revi ew and give them the “Living

with Your FreeStyle Libre Pro Sensor” section of th e insert in the
Sensor Kit.

CAUTIO N: Intense exercise may cause the Sensor to loosen
due to sweat or movement of the Sensor. If the Sensor
becomes loose, the Sensor readings may be unavailable or
unreliable. Your patient should return to your facility for
application of a new Sensor.

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Step Action

4

The Reader will indicate how many days of
Sensor wear are left, if any. Touch view to
view the daily graph. Touch next. For more
information about the daily graph, se e Daily
Graph section.

5

To create reports, connect the Reader to a
computer. See Creating Reports section in th e
FreeStyle Libre Pro software Use r’s Manual. The
User’s Manual can be found in the Help Menu of
the software. Touch done to return to the Home
Screen.

Note: The Home Screen will show this
symbol

near the top of the screen when
there is new Sensor data in the Reader that has
not been transferred to a computer. A report
should be generated from this data before the
next Sensor is downloaded.

Sensor can be used for
up to 7 more days.

Sensor Data Received

view next

Days Recorded

7

doneback

To create reports,
connect Reader to a
computer.

Getting Sensor Data

Data can be downloaded at anytim e from Sensors that are on or o
the body.

Step Action

1

Press the Home Button to turn on the Reader.

2

Touch Get Sensor Data.

3

Hold the Reader within 1.5 inches (4 cm) of the
Sensor. If sounds are turned on, the Reader will
beep when all the data has been successfully
downloaded from the Sensor. This may take up
to 5 seconds.

Note: If communication is not established within
15 seconds, the Reader displays a prompt to try
again. Touch OK to return to the Home Screen
and touch Get Sensor Data again.

10:23pm

Start New

Sensor

Get Sensor

Data

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Removing the Sensor

The Sensor automatically stops working and should be removed 14 days
after being started. You should also replace the Sensor if there is any
irritation or discomfort at the application site or if the Reader reports a
problem with the Sensor currently in use.

Step Action

1

Pull up the edge of the adhesive that keeps the
Sensor attached to the skin. Slowly peel away
from the skin in one motion.

Note: Any remaining adhesive residue on the
skin can be removed with warm soapy water or
isopropyl alcohol.

2

Discard the used Sensor according to your facility’s procedures.
See Maintenance and Disposal section.

Daily Graph

The Daily Graph shows the Sensor glucose rea dings
by day and the Target Glucose Range that is set on
the Reader. You can change the target glucose range
by touching the Options symbol

on the Home

Screen and selecting Target Range.

Notes:

• If you want the graph to show the current

patient’s target range, set their target range before
downloading their data.

• The graph displays glucose readings up to

350 mg/dL. 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.

12am6am12pm6pm12

am

350

250

150

50

OK

Daily Graph
(mg/dL)

22 Feb

Wednesday

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Reader Options

You can go to the Options menu to check Sensor or System Status or
change settings on the Reader, like Time & Date or Sounds.

Step

Action

1

To get to the Options menu, touch the Options
symbol

on the Home Screen.

10:23pm

Start New

Sensor

Get Sensor

Data

Check Sensor Status

Target Range

Sounds

1 / 2

Options

Charging the Reader

A fully charged Reader battery should last up to 2 weeks. The battery life
may vary depending on your usage.

Plug the included USB cable into an electrical
outlet using the included power adapter. Then,
plug the other end of the USB cable into the USB
port on the Reader.

OK

Please charge the Reader to
continue using it.

Low Battery

Charging

CAUTIO N: Be sure to select a location for
charging that allows the power adapter to be
easily unplugged.

Notes:

• You must charge the Reader when the battery is low to

keep using the Reader.

• To fully charge the battery, charge the Reader for at least

3 hours.

• Only use the USB cable and power adapter included with

the system.

• Fully charge the Reader before storing it for more than

3 months.

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Step

Action

2

(cont.)

•Perform a Reader Test: The Reader Test will perform internal

diagnostics and allow you to check that the display is
showing all pixels, sounds (including both tones and
vibrations) are working, and the touchscreen is responding
when touched

•View Event Logs: A list of events recorded by the Reader,

which may be used by Customer Service to help troubleshoot
the System

Touch OK when you are done.

Step

Action

2

Touch the option you want to view or change:

Check Sensor Status – Check if a Sensor is working or has
ended

Target Range – Set range displayed on Reader Daily Glucose
graph

Sounds – Set tones and vibrations
Time & Date – Change the Time or Date
Language – Change the language on the Reader (option only

available on Readers with multiple languages)
System Status – Check Reader information and performance

•View System Information: The Reader will display information

about the system including:

- Reader serial and version numbers

- Sensor serial number for most recently downloaded Sensor

- Sensor version for most recently downloaded Sensor

- Sensor start date and time for most recently downloaded
Sensor

- Sensor download date and time for most recently
downloaded Sensor

- Amount of data downloaded from Sensor

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Troubleshooting

This section lists problems or observations that may occur, the possible
cause(s), and recommended actions. If the Reader experiences an error, a
message will appear on the screen with directions to resolve the error.

Reader Does Not Power On

Problem What It May Mean What To Do

Reader does not
power on after
you press the
Home Button.

Reader battery is
too low.

Charge the Reader.

Reader is outside
of its operating
temperature range.

Move the Reader to a
temperature between 50 °F
and 113 °F and then try to
power it on.

If the Reader still does not power on after trying these steps, contact
Customer Service.

Maintenance and Disposal

Cleaning

You may clean the Reader using a damp cloth. Gently wipe the exterior of
the Reader and allow to air dry.

Maintenance

The FreeStyle Libre Pro Flash Glucose Monitoring System has no
serviceable parts.

Disposal

This product should be disposed of in accordance with all applicable local
regulations related to the disposal of electronic equipment, batteries,
sharps, and materials potentially exposed to body uids.

Contact Customer Service for further information on the appropriate
disposal of system components.

CAUTIO N: Do NOT place the Reader in water or other liquids.
Avoid getting dust, dirt, water, or any other substance in the
USB port.

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Problems Starting the Sensor

Display What It May Mean What To Do

Sensor Ended You may be trying

to start a used
Sensor.

If you need to start a Sensor,
then apply and start a new
one. Otherwise, return to the
Home Screen to get Sensor
data.

Communication
Error

The Reader
was unable to
communicate with
the Sensor.

Hold the Reader within

1.5 inches (4 cm) of the Sensor.

Note: You may need to
move away from potential
sources of electromagnetic
interference.

Replace Sensor The System

has detected a
problem with the
Sensor.

Apply and start a new Sensor.

Problems at the Sensor Application Site

Problem What It May Mean What To Do

The Sensor is not
sticking to the
patient’s skin.

The site is not free
of dirt, oil, hair, or
sweat.

1. Remove the Sensor.

2. Consider shaving and/or
cleaning the site with soap
and water.

3. Follow the instructions in

Applying and Starting the
Sensor sections.

Skin irritation
at the Sensor
application site.

Seams or other
constrictive
clothing or
accessories causing
friction at the site.

Ensure that nothing rubs on
the site.

The patient may
be sensitive to the
adhesive material.

Follow your facility’s
procedures for handling
skin reactions.

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Problems Getting Sensor Data

Display What It May Mean What To Do

Data Transfer
Error

The Reader is not
held close enough
or long enough to
the Sensor.

Hold the Reader within

1.5 inches (4 cm) of the

Sensor for up to 5 seconds.

New Sensor
Found

The Sensor was
never star ted.

If you would like to begin
using this Sensor, touch Yes .

Communication
Error

The Reader
was unable to
communicate with
the Sensor.

Hold the Reader within

1.5 inches (4 cm) of the

Sensor.

Note: You may need to
move away from potential
sources of electromagnetic
interference.

Display What It May Mean What To Do

Sensor Starting The Sensor has

not completed
starting.

Wait for the reminder to
check Sensor status. This
will take approximately 2
minutes.

No Data
Available

There is no data
available to
download.

Sensor data is usually
available for download
80 minutes after a Sensor
was started. Try again after
this time.

Sensor Error Th ere is no data

available from
this Sensor. The
Sensor may not
be working.

If the Sensor was recently
applied, wait 1 hour and try
again. If this doesn’t work,
contact Customer Service.

34 35

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Display What It May Mean What To Do

Data to Report You have not yet

generated reports
from the data
already on the
Reader.

To create reports from the
data already on the Reader,
connect the Reader to a
computer. Or, to overwrite
with data from the current
Sensor, touch yes.

Reader Error Messages

Display What It May Mean What To Do

E-2

Reader error. Turn off the Reader and try

again. If the error reappears,
contact Customer Service.

E-9

Reader error. Turn off the Reader and try

again. If the error reappears,
contact Customer Service.

Perform a Reader Test

If you think the Reader is not working prop erly, you
can check the Reader by per forming a Reader Test.
Touch the Options symbol

from the Ho me

Screen, select System Status and then selec t

Reader Test.
Note: The Reader Test will perform internal

diagnostics and will allow you to check that the
display, sounds, and touchscreen are working
properly.

Customer Service

Customer Service is available to answer any questions you may have
about the FreeStyle Libre Pro Flash Glucose Monitoring System. Please go
to the back cover of this manual for your Customer Service phone number.

System Info

Reader Test

Event Log

System Status

OK

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System Specications

Sensor Specications

Sensor glucose assay
method

Amperometric electrochemical sensor

Sensor glucose reading
range

40 to 500 mg/dL

Sensor size 5 mm height and 35 mm diameter

Sensor weight 5 grams

Sensor power source One silver oxide battery

Sensor wear period Up to 14 days

Sensor memory

Up to 14 days (glucose readings stored
every 15 minutes)

Operating temperature 50 °F to 113 °F

Sensor Applicator and
Sensor Pack storage
temperature

39 °F to 77 °F

Operating and storage
relative humidity

10-90%, non-condensing

Sensor water resistance

IP27: Can withstand immersion into
3 ft (one meter) of water for up to
30 minutes

Operating and storage
altitude

-1,250 ft (-381 meters) to 10,000 ft
(3,048 meters)

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Reader Specications

Reader size 95 mm x 60 mm x 16 mm

Reader weight 65 grams

Reader power source One lithium-ion rechargeable battery

Reader battery life 2 weeks of typical use

Reader Sensor memory 1 Sensor

Reader operating
temperature

50 °F to 113 °F

Reader storage
temperature

-4 °F to 140 °F

Operating and storage
relative humidity

10-90%, non-condensing

Reader moisture
protection

Keep dry

Operating and storage
altitude

-1,250 ft (-381 meters) to 10,000 ft
(3,048 meters)

Reader display timeout 60 seconds

Radio Frequency

Near Field Communication*
(13.56 MHz RFID); ASK Modulation;
124 dBuV/m;

1.5 inch communication range

Data port Micro USB

Minimum Computer
Requirements

System must only be used with
EN60950-1 rated computers

Mean service life 3 years of typical use

Power Adapter

Abbott Diabetes Care PRT25611
Operating temperature: 50 °F to 104 °F

USB Cable

Abbott Diabetes Care PRT21373
Length: 37 inches (94 cm)

* Security measures: The communication between Reader and Sensor is a short range near

eld communication method making it dicult to interfere with or intercept data that is
being transferred. The Sensor and Reader are protected by proprietary data format, memory
mapping, and cyclic redundancy check (CRC) generation and verication of data.

Quality of Ser vice (QoS): QoS for the FreeStyle Libre Pro Reader and Sensor wireless

communications using the near eld communications is assured within the eective range
of 4 cm between the Sensor and Reader that is specied to occur within 15 seconds.

40 41

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Labeling Symbols

Consult instructions for
use

Use-by date

Temperature limit Catalog number

Manufacturer Serial number

Batch code

Do not use if package is
damaged

Type BF applied part Keep dr y

CODE

Sensor code Non-ionizing radiation

Do not re-use Caution

MR unsafe Humidity limitation

FCC Declaration of
Conformity mark

Sterilized using
irradiation

Not made with natural rubber latex

CAUTION: Federal law restricts this device to sale by or on the
order of a physician.

This product contains electronic equipment, batteries, sharps
and materials that may contact bodily uids during use.
Dispose of product in accordance with all applicable local
regulations.

42 43

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Performance Characteristics

Clinical Study Overview

Performance of the FreeStyle Libre Pro Flash Glucose Monitoring System (the System) was
evaluated in a clinical study. The study was conducted in 4 centers; a total of 72 subjects with
diabetes (81.9% Type 1, 18.1% Type 2) aged eighteen and older were included in the study; all
subjects required insulin administration either by an insulin pump or via multiple daily injections
to manage their diabetes. Each subject wore two sensors for up to 14 days, one on the back of
each upper arm. During the study, subjects tested their blood glucose using ngerstick capillary
samples using a FreeStyle Precision blood glucose meter. Additionally, subjects had their venous
blood glucose analyzed approximately 96 times over three separate visits to the clinical center
using the Yellow Spring Instrument Life Sciences 2300 STAT Plus™ Glucose & Lactate Analyzer
(YSI). YSI is a laboratory-grade glucose and lactate analyzer of whole blood and plasma and is a
widely recognized standard in laboratory analysis of blood glucose. Glucose readings obtained
from the System were compared to glucose readings obtained from the YSI to evaluate the
performance of the System. Three lots of sensors were evaluated in the study.

Agreement with YSI Levels

Agreement between GM and venous blood was characterized by using paired GM and plasma
equivalent Yellow Springs Instrument measurements (YSI).
The accuracy of GM versus YSI reference was assessed by calculating the percentage of System
readings that were within 15%, 20%, 30% and 40% for reference values 80 mg/dL and above,
and 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL when glucose levels
are assigned using the YSI values. The results are presented in Table 1. Overall 83.8% of results
were within ±20 mg/dL / 20% of YSI reference.

Table 1: Number and Percent of Results within YSI Reference

YSI
Glucose
Level
(mg/dL)

Number
of GM­Reference
Pairs

Within
±15% /
±15 mg/dL

Within
±20% /
±20 mg/dL

Within
±30% /
±30 mg/dL

Within
±40% /
±40 mg/dL

Outside
±40% /
±40 mg/dL

Overall 12323 71.8 83.8 95.2 98.5 1.5

40-50 30 53.3 83.3 93.3 100.0 0.0

51-80 505 58.4 73.3 89.1 96.0 4.0

81-180 7373 68.3 80.2 93.7 98.0 2.0

181-300 4115 79.0 90.4 98.3 99.5 0.5

301-400 286 84.6 96.5 99.7 100.0 0.0

401-500 14 85.7 100.0 100.0 100.0 0.0

44 45

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Agreement with GM Glucose Levels

The accuracy of GM versus YSI reference was also assessed by calculating the percentage of System
readings that were within 15%, 20%, 30% and 40% for reference values 80 mg/dL and above, and
15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL when glucose levels are
assigned using the GM readings. The results are presented in Table 2. Overall 83.6% of results were
within ±20 mg/dL / 20% of the YSI reference.

Table 2: Number and Percent of Results within YSI Reference

GM
Glucose
Level
(mg/dL)

Number
of GM­Reference
Pairs

Within
±15% /
±15 mg/dL

Within
±20% /
±20 mg/dL

Within
±30% /
±30 mg/dL

Within
±40% /
±40 mg/dL

Outside
±40% /
±40 mg/dL

Overall 12323 71.7 83.6 94.9 98.2 1.8

40-50 28 17.9 28.6 50.0 71.4 28.6

51-80 586 54.1 70.6 88.2 94.2 5.8

81-180 6685 72.2 83.0 94.2 97.9 2.1

181-300 4449 73.9 86.2 96.9 99.2 0.8

301-400 541 70.1 86.7 97.2 98.9 1.1

401-500 34 55.9 88.2 97.1 100.0 0.0

Agreement on Day 1 against YSI Reference

The accuracy of GM versus YSI reference on the rst day of sensor wear was assessed by calculating
the percentage of System readings that were within 15%, 20%, 30% and 40% for reference values
80 mg/dL and above, and 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL
by hourly intervals. The results are presented in Table 3.

Table 3: Number and Percent of Results within YSI Reference

Time
Interval
(hour)

Number
of GM­Reference
Pairs

Within
±15% /
±15 mg/dL

Within
±20% /
±20 mg/dL

Within
±30% /
±30 mg/dL

Within
±40% /
±40 mg/dL

Outside
±40% /
±40 mg/dL

(0-2) 235 60.9 73.2 92.8 98.3 1.7

(2-4) 552 67.4 77.7 90.4 96.4 3.6

(4-6] 557 61.4 74.3 89.2 95.9 4.1

(6-8] 534 65.5 80.5 94.0 98.3 1.7

(8-12] 239 66.1 83.3 97.9 99.2 0.8

(12-24] 436 59.9 77.1 93.6 97.7 2.3

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Overall Accuracy against YSI Reference

Accuracy was measured by comparing the absolute relative dierence between the System and
reference YSI glucose values. The absolute relative dierence measures the level of disagreement
between the System and the reference value, but does not tell you whether the System glucose
value was, on average, higher or lower than the reference glucose value. The Mean Absolute
Relative Dierence gives an indication of the average percent disagreement between the GM and
the reference. Table 4 shows the absolute dierence measures by glucose level. Overall the Mean
Absolute Relative Dierence was 12.3% for the comparison with YSI reference. The Median Absolute
Relative Dierence shows that half of the time the System was within 10.1% of the YSI reference.

Table 4: Dierence Measures by YSI Reference Glucose Levels

YSI Reference

Reference Glucose
Level (mg/dL)

Number of GM­Reference Pairs

Median Absolute
Relative Dierence (%)

Mean Absolute Relative
Dierence (%)

Overall 12323 10.1 12.3

40-50* 30 14.2 15.8

51-80* 505 12.5 15.5

81-180 7373 10.7 12.9

181-300 4115 8.7 10.1

301-400 286 7.8 8.8

401-500 14 4.2 7.2

* For reference values ≤ 80 mg/dL, the mean and median absolute dierences (mg/dL) are presented instead of

mean and median absolute relative dierences (%).

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Agreement with BG Levels

Agreement between the System and capillary FreeStyle Precision blood glucose values (BG) was
characterized by using paired System Glucose Measurements (GM) and BG reference.
The accuracy of GM versus BG reference was assessed by calculating the percentage of System
readings that were within 15%, 20%, 30% and 40% for reference values 80 mg/dL and above, and
15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL. The results are presented
in Table 5. Overall 79.4% of results were within ±20 mg/dL / 20% of BG reference. Please note
that dierent blood glucose meters have dierent levels of performance compared to the meter
used in this study. The performance presented here is not representative of a comparison to all
blood glucose meters.

Table 5: Number and Percent of Results within BG Reference*

BG
Glucose
Level
(mg/dL)

Number
of GM­Reference
Pairs

Within
±15% /
±15 mg/dL

Within
±20% /
±20 mg/dL

Within
±30% /
±30 mg/dL

Within
±40% /
±40 mg/dL

Outside
±40% /
±40 mg/dL

Overall 11918 66.5 79.4 93.4 97.9 2.1

40-50 152 57.2 66.4 86.8 92.8 7.2

51-80 841 68.4 80.6 93.6 98.1 1.9

81-180 6397 65.7 78.5 92.6 97.4 2.6

181-300 3719 66.5 80.2 94.1 98.7 1.3

301-400 695 71.7 83.5 97.3 99.3 0.7

401-500 114 81.6 90.4 97.4 99.1 0.9

* Comparison to BG was performed using the FreeStyle Precision blood glucose meter. Dierent performance

may be expected when compared to other models of blood glucose meters.

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Table 6: Dierence Measures by BG Reference Levels*

BG Reference

Reference Glucose
Level (mg/dL)

Number of GM­Reference Pairs

Median Absolute
Relative Dierence (%)

Mean Absolute Relative
Dierence (%)

Overall 11918 11.1 13.9

40-50** 152 13.5 19.1

51-80** 841 10.0 12.6

81-180 6397 10.9 13.5

181-300 3719 10.9 12.9

301-400 695 9.1 11.3

401-500 114 7.1 9.2

* Comparison to BG was performed using the FreeStyle Precision blood glucose meter. Dierent performance may be expected when compared to

other models of blood glucose meters.

** For reference values ≤ 80 mg/dL, the mean and median absolute dierences (mg/dL) are presented instead of mean and median absolute relative

dierences (%).

Overall Accuracy against BG Reference

Accuracy was measured by comparing the absolute relative dierence between the System and
reference BG values. The absolute relative dierence measures the level of disagreement between
the System and the reference value, but does not tell you whether the System glucose value was, on
average, higher or lower than the reference glucose value. The Mean Absolute Relative Dierence
gives an indication of the average percent disagreement between the GM and the reference.
Table 6 shows the absolute dierence measures by glucose level. Overall the Mean Absolute
Relative Dierence was 13.9% for the comparison with BG reference. The Median Absolute Relative
Dierence shows that half of the time the System was within 11.1% of the BG reference.

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Concurrence of System and Reference (YSI vs. GM)
The percentage of concurring glucose values (YSI vs. GM) in each glucose reference range is
presented for each YSI range in Table 7. For example, when the YSI glucose results are within the
81 to 120 mg/dL range, you can expect the GM values were less than 40 mg/dL 0.2% of the time,
between 40 and 60 mg/dL 1.8% of the time, between 61 and 80 mg/dL 9.0% of the time, between
81 and 120 mg/dL 61.4% of the time, between 121 and 160 mg/dL 26.7% of the time, between 161
and 200 mg/dL 0.8% of the time, and above 201 mg/dL 0.0% of the time.

Table 7: Concurrence Analysis by Glucose Level

YSI

(mg/dL)

GM Glucose Level (mg/dL)

N

<40* 40-60 61-80

81­120

121­160

161­200

201­250

251­300

301­350

351­400

401­500

>500*

<40 20.0 80.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 5

40-60 0.0 26.4 60.0 11.8 1.8 0.0 0.0 0.0 0.0 0.0 0.0 0.0 110

61-80 0.2 11.1 42.9 43.6 1.7 0.2 0.2 0.0 0.0 0.0 0.0 0.0 422

81-120 0.2 1.8 9.0 61.4 26.7 0.8 0.0 0.0 0.0 0.0 0.0 0.0 2472

121-160 0.0 0.1 0.4 12.4 60.8 25.0 1.2 0.0 0.0 0.0 0.0 0.0 3338

161-200 0.0 0.0 0.1 1.1 16.8 49.8 31.5 0.6 0.1 0.0 0.0 0.0 2853

201-250 0.0 0.0 0.0 0.1 0.8 9.6 62.0 26.6 0.8 0.0 0.0 0.0 1937

251-300 0.0 0.0 0.0 0.0 0.0 0.1 11.3 56.6 29.8 2.1 0.0 0.0 892

301-350 0.0 0.0 0.0 0.0 0.0 0.0 0.0 12.4 53.1 33.2

1.3

0.0 226

351-400 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 35.0 35.0

30.0

0.0 60

401-500 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 6.3 81.3

12.5

16

>500 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0

* Levels outside of system dynamic range.

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Agreement with ‘LO’ or ‘HI’ GM Reading against YSI Reference

The system reports glucose concentrations between 40 and 500 mg/dL. When the system determines
that glucose level is below 40 mg/dL, it will report as ‘LO’. When the system determines that glucose
level is above 500 mg/dL, it will report as ‘HI’. Table 8 displays the concurrence between the GM and
YSI reference glucose when GM reads ‘LO’. For example, when GM reads ‘LO’ you can expect that YSI
glucose values were less than 40 mg/dL 16.7% of the time, between 40 and 50 mg/dL 0.0% of the
time, between 51 and 60 mg/dL 0.0% of the time, between 61 and 70 mg/dL 16.7% of the time,
between 71 and 80 mg/dL 0.0% of the time, and above 80 mg/dL 66.7% of the time.

Table 8: Concurrence Analysis with LO GM Reading

GM Glucose Level

(mg/dL)

YSI (mg/dL)

N

<40 40-50 51-60 61-70 71-80 >80

<40 (LO) 16.7 0.0 0.0 16.7 0.0 66.7 6

Table 9 displays the concurrence between the GM and YSI reference glucose when GM reads ‘HI’. For

example, when GM reads ‘HI’ you can expect that YSI glucose values were less than 200 mg/dL 0.0%
of the time, between 200 and 300 mg/dL 0.0% of the time, between 301 and 400 mg/dL 0.0% of the
time, between 401 and 500 mg/dL 100% of the time, and above 500 mg/dL 0.0% of the time.

Table 9: Concurrence Analysis with HI GM Reading

GM Glucose Level

(mg/dL)

YSI (mg/dL)

N

<200 200-300 301-400 401-500 >500

>500 (HI) 0.0 0.0 0.0 100.0 0.0 2

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Accuracy by Day of Wear

The sensor can be worn for up to 14 days. To show sensor performance over time, the absolute
relative dierence between the System and reference YSI glucose and capillary blood glucose
values (BG) over the 14 day wear is presented in Table 10 and Table 11. The accuracy of GM
versus YSI reference and BG reference was assessed by calculating the percentage of System
readings that were within 15%, 20%, 30% and 40% for reference values 80 mg/dL and above,
and 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL. The results are
presented in Table 12 for GM vs. YSI reference and in Table 13 for GM vs. BG reference.

Table 10: Dierence Measures by Day (YSI Reference)

YSI Reference

Day

Number of GM­Reference Pairs

Median Absolute

Relative Dierence (%)

Mean Absolute

Relative Dierence (%)

1 2117 11.4 13.8

2-5 4036 11.0 13.3

6-9 2919 10.2 12.3

10-13 2214 8.4 10.4

14 1037 7.3 9.6

Table 11: Dierence Measures by Day (BG Reference*)

BG Reference

Day

Number of GM-

Reference Pairs

Median Absolute

Relative Dierence (%)

Mean Absolute

Relative Dierence (%)

1 1087 11.9 15.0

2-5 4005 11.9 14.6

6-9 3432 11.7 14.5

10-13 2841 9.8 12.5

14 553 8.3 10.6

* Comparison to BG was performed using the FreeStyle Precision blood glucose meter. Dierent performance

may be expected when compared to other models of blood glucose meters.

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Table 12: Number and Percent of Results within YSI Reference

Day Number

of GM­Reference
Pairs

Within
±15% /
±15 mg/dL

Within
±20% /
±20 mg/dL

Within
±30% /
±30 mg/dL

Within
±40% /
±40 mg/dL

Outside
±40% /
±40 mg/dL

1 2117 64.5 77.7 92.1 97.3 2.7

2-5 4036 68.0 80.9 94.2 98.2 1.8

6-9 2919 71.5 84.3 95.7 99.0 1.0

10-13 2214 80.4 90.4 97.9 99.1 0.9

14 1037 84.7 91.3 98.0 99.3 0.7

Table 13: Number and Percent of Results within BG Reference*

Day Number

of GM­Reference
Pairs

Within
±15% /
±15 mg/dL

Within
±20% /
±20 mg/dL

Within
±30% /
±30 mg/dL

Within
±40% /
±40 mg/dL

Outside
±40% /
±40 mg/dL

1 1087 61.8 74.1 91.5 96.9 3.1

2-5 4005 64.4 77.6 92.2 97.7 2.3

6-9 3432 64.4 78.2 92.9 97.4 2.6

10-13 2841 71.0 83.4 95.7 98.8 1.2

14 553 80.7 90.2 96.9 99.6 0.4

* Comparison to BG was performed using the FreeStyle Precision blood glucose meter. Dierent performance

may be expected when compared to other models of blood glucose meters.

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System Glucose Availability

The System is designed to generate a GM value every 15 minutes throughout the sensor wear time. Overall, 202
sensors were inserted. 167 sensors produced glucose readings and are included in the analysis. There were
35 sensors that failed at insertion (i.e. no glucose reading generated) and are not included in the analysis. There
were 62.5% of primary sensors that worked for 14 days. The mean sensor duration for all primary sensors was
determined to be 258 hours, and the median duration of was 327 hours.
Table 14 shows the number of available glucose readings reported by all sensors (by sensor operational hour)
that produced at least one GM reading during the clinical study over the 14-day wear period. The percentage of
available GM readings is presented in comparison to the number of expected GM readings based on the number of
hours of sensor wear. Overall, 96.9% (153,169 GM readings out of expected 158,052) of GM readings were available.

Table 14: GM Availability

Operational Hour No. Historic GM Expected No. %

0 - 24 81 83 97.6
24 - 48 795 813 97.8
48 - 72 1170 1201 97.4
72 - 96 1053 1080 97.5
96 - 120 1187 1230 96.5

120 - 144 2630 2725 96.5
144 - 168

3262

3356 97.2

168 - 192

4478

4617 97.0

192 - 216

5101

5223 97.7

216 - 240

3413

3531 96.7

240 - 264

5611

5759 97.4

264 - 288

7021

7184 97.7

288 - 312

6300

6400 98.4

312 - 336

111067

114850 96.7

Overall

153169

158052 96.9

Precision

Precision of the System was evaluated by comparing the results from two separate sensors worn on
the same subject at the same time. Data from two sensors worn at the same time for 72 subjects
provided 49,806 pairs of GM measurements. The mean PARD during the study was 8.6% with a
coecient of variation of 6.1%.

Sensor Wear Duration

Sensors may be worn for up to 14 days (≥324 hours). To estimate how long a sensor will work over
14 days, 34 sensors were evaluated to determine how many days of readings each sensor provided.
Results show that 85.3% of sensors lasted for the intended 14-day wear duration.

Adverse Events

No device-related serious adverse events occurred during the study. Mild skin irritation, such as
erythema, edema, rash, bleeding, itching, bruising, scaling skin, and induration were reported
around the insertion site and adhesive area by a moderate frequency of subjects (26 out of 72 or
36%). Pain was mostly reported as none with only one reported instance of mild pain.

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Electromagnetic Compatibility

• The System needs special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided in this manual.

• Portable and mobile RF communications equipment can aect the System.

• The use of accessories, transducers and cables other than those specied by Abbott Diabetes Care

may result in increased EMISSIONS or decreased IMMUNITY of the System.

• The System should not be used adjacent to or stacked with other equipment and that if adjacent
or stacked use is necessary, the System should be observed to verify normal operation in the
conguration in which it will be used.

• This device complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) This device may not cause harmful interference, and (2) this device must accept any
interference received, including interference that may cause undesired operation.

• Changes or modications not approved by Abbott could void the user’s authority to operate the
equipment.

Guidance and manufacturer’s declaration –
electromagnetic emissions

The System is intended for use in the electromagnetic environment specied below. The customer or
the user of the System should assure that it is used in such an environment.

Emissions test Compliance

RF emissions CISPR 11 Group 1

RF emissions CISPR 11 Class B

Harmonic emissions IEC 61000-3-2 Not applicable

Voltage fluctuations / flicker emissions Not applicable

The System uses RF energy only for its internal function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby electronic equipment.

The System is suitable for use in all establishments, other than domestic and those directly connected
to the public low-voltage power supply network that supplies buildings used for domestic purposes.

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Guidance and manufacturer’s declaration –
electromagnetic immunity

The System is intended for use in the electromagnetic environment specied below. The customer or
the user of the System should assure that it is used in such an environment.

IMMUNITY

test

IEC 60601
test level

Compliance

Level

Electromagnetic

environment – guidance

Electrostatic
discharge (ESD)

IEC 61000-4-2

Reader:
± 6 kV contact
± 8 kV air

Sensor:
± 8 kV contact
± 15 kV air

Reader:
± 6 kV contact
± 8 kV air

Sensor:
± 8 kV contact
± 15 kV air

Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30 %.

Electrical fast
transient/burst

IEC 61000-4-4

± 2 kV for
power supply
lines

± 1 kV for input/
output lines

± 2 kV for
power supply
lines

± 1 kV for input/
output lines

Mains power quality should be that
of a typical commercial or hospital
environment.

IMMUNITY

test

IEC 60601
test level

Compliance

Level

Electromagnetic

environment – guidance

Surge
IEC 61000-4-5

±1 kV
differential
mode

±2 kV common
mode

±1 kV
differential
mode

±2 kV common
mode

Mains power quality should be that
of a typical commercial or hospital
environment.

Voltage
dips, short
interruptions and
voltage variations
on power supply
input lines

IEC 61000-4-11

<5 % U

T

(>95 % dip in

U

T

) for 0.5 cycle

40 % U

T

(60 % dip in U

T

)

for 5 cycles
70 % U

T

(30 % dip in U

T

)

for 25 cycles
<5 % U

T

(>95 % dip
in U

T

) for 5

seconds

<5 % U

T

(>95 % dip in

U

T

) for 0.5 cycle

40 % U

T

(60 % dip in U

T

)

for 5 cycles
70 % U

T

(30 % dip in U

T

)

for 25 cycles
<5 % U

T

(>95 % dip
in U

T

) for 5

seconds

Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the System requires continued
operation during power mains
interruptions, it is recommended
that the System be powered from
an uninterruptible power supply or
a battery.

66 67

ART26944_rev-C_manual.indd 67 9/23/16 9:19 AM

IMMUNITY

test

IEC 60601
test level

Compliance

Level

Electromagnetic

environment – guidance

Power frequency
(50/60 Hz)
magnetic field

IEC 61000-4-8

Reader: 3 A/m
Sensor: 30 A/m

Reader: 3 A/m
Sensor: 30 A/m

Power frequency magnetic
fields should be at levels
characteristic of a typical location
in a typical commercial or hospital
environment.

NOTE U

T

is the a.c. mains voltage prior to application of the test level.

IMMUNITY

test

IEC 60601
test level

Compliance

Level

Electromagnetic

environment – guidance

Conducted RF
IEC 61000-4-6

3 Vrms
150 kHz to

80 MHz

3 Vrms Portable and mobile RF

communications equipment should
be used no closer to any part of the
System, including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.

Recommended separation
distance

=

1.2

d

68 69

ART26944_rev-C_manual.indd 69 9/23/16 9:19 AM

IMMUNITY

test

IEC 60601
test level

Compliance

Level

Electromagnetic

environment – guidance

Radiated RF
IEC 61000-4-3

3 V/m
80 MHz to

2.5 GHz

3 V/m Recommended separation

distance

80 MHz to 800 MHz

800 MHz to 2.5 GHz

P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,

a

should

be less than the compliance level in each frequency range.

b

Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

=

1.2

d

=

2.3

d

a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)

telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the System is used exceeds the applicable RF compliance
level above, the System should be observed to verify normal operation. If abnormal performance
is observed, additional measures may be necessary, such as re-orienting or relocating the System.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

70 71

ART26944_rev-C_manual.indd 71 9/23/16 9:19 AM

Recommended separation distances between portable
and mobile RF communications equipment and the
System

The System is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the System can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the System as recommended below, according to the maximum output power of
the communications equipment.

Rated maximum
output power of
transmitter

W

Separation distance according to frequency of transmitter

m

150 kHz to

80 MHz

80 MHz to

800 MHz

800 MHz to

2.5 GHz

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

=

1.2

d

=

1.2

d

=

2.3

d

For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects and people.

Font License

©2013 Abbott

Licensed under the Apache License, Version 2.0 (the “License”); you may
not use this le except in compliance with the License. You may obtain
a copy of the License at: http://www.apache.org/licenses/LICENSE-2.0

Unless required by applicable law or agreed to in writing, software
distributed under the License is distributed on an “AS IS” BASIS,
WITHOUT WARRANTIES OR CONDITIONS OF ANY KIND, either express
or implied. See the License for the specic language governing
permissions and limitations under the License.

72 73

ART26944_rev-C_manual.indd 73 9/23/16 9:19 AM

Limited Warranty

We hope that you are happy with your FreeStyle Libre Pro system. Please refer to the Operator’s
Manual before using your Reader for the rst time.

Abbott Diabetes Care (“Abbott”) warrants that the FreeStyle Libre Pro reader (“Reader”) shall be free
from defects in material and workmanship and shall be of satisfactory quality for a period of one
(1) year from the original date of purchase provided it is not modied, altered, damaged, misused
or used other than in accordance with the applicable labeling, inserts and/or manuals. This Limited
Warranty is valid if the Reader is defective in material or workmanship, and it has been used only
in accordance with the Operator’s Manual. Abbott’s sole obligation is to replace the Reader, free of
charge, with the same or an alternative reader as determined by Abbott in its sole discretion. Your
replacement may be a dierent model or type. This Limited Warranty covers only the Reader, does
not cover disposable accessories, extends only to the original purchaser, and is not assignable or
transferable. This warranty does not aect or preclude any other rights which you may have by law.

TO THE EXTENT POSSIBLE UNDER LAW, THE FOREGOING ARE ABBOTT’S ONLY WARRANTIES FOR THE
READER AND STATE YOUR EXCLUSIVE REMEDIES. ABBOTT MAKES NO OTHER WARRANTIES, EXPRESS
OR IMPLIED, AND ABBOTT EXCLUDES AND DISCLAIMS ANY OTHER WARRANTIES INCLUDING, BUT
NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR
PURPOSE. ABBOTT DOES NOT WARRANT THAT OPERATION OF THE READER WILL BE UNINTERRUPTED
OR ERROR FREE AND ABBOTT WILL NOT BE LIABLE FOR ANY LOST PROFITS, LOST SAVINGS OR OTHER
SPECIAL, PUNITIVE, INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING DIREC TLY OR INDIRECTLY
FROM PURCHASE, OPERATION OR USE OF THE READER OR FAILURE OF THE READER TO PERFORM
IN ACCORDANCE WITH SPECIFICATIONS. NO WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE, IF ANY IS IMPLIED FROM THE SALE OF THE READER DESPITE ABBOTT’S SPECIFIC
DISCLAIMER OF SUCH WARRANTIES, SHALL EXTEND FOR A LONGER DURATION THAN ONE YEAR FROM
THE DATE OF PURCHASE OF THE READER.

This Limited Warranty and any dispute or claim arising out of or in connection with it shall be
governed by and construed in accordance with the laws of the United States.

Some states do not allow the exclusion or limitation of other express or implied warranties or
incidental or consequential damages, so the above limitations or exclusions may not apply to you.
Your Rights Under State Law: This Limited Warranty gives you specic legal rights, and you may also
have other rights that vary from state to state.

FreeStyle and related brand marks are trademarks of Abbott Diabetes Care Inc.

LIMITED WARRANTY SERVICES
If you do not agree to the terms and conditions of this Limited Warranty, you may return the FreeStyle
Libre Pro reader for a full refund within 30 days of purchase. You must have proof of purchase, i.e.,
a copy of the dated itemized purchase receipt and the original packaging to obtain this refund. For
questions or warranty service, contact Customer Service at 1-855-632-5297.

ABBOTT MAY MODIFY OR DISCONTINUE THIS PROGRAM AT ANY TIME WITHOUT NOTICE.

74 75

ART26944_rev-C_manual.indd 75 9/23/16 9:19 AM

©2016 Abbott ART26944 Rev. C 09/16

Manufacturer:

FreeStyle 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: 1-855-632-5297
Monday through Friday,
8AM to 8PM Eastern Standard Time

www.FreeStyleLibrePro.com

Assembly | Application instructions:
STEP 1: Select site.

STEP 2:

Clean site with alcohol wipe and allow site to

dry.

STEP 3:

Peel lid completely o Sensor Pack. Unscrew

cap from Sensor Applicator.

CAUTION: Sensor codes must match on
Sensor Pack and Sensor Applicator. Do
NOT use if damaged or already opened.

STEP 4:

Line up dark marks on Sensor Applicator and

Sensor Pack. Press down rmly on Sensor
Applicator until it comes to a stop.

STEP 5:

Lift Sensor Applicator out of Sensor Pack.

STEP 6:

Sensor Applicator is ready to apply Sensor.

CAUTION: Sensor Applicator now

contains a needle. Do not touch inside
Sensor Applicator or put it back into
Sensor Pack.

STEP 7:

Place Sensor Applicator over site. Push down

rmly to apply Sensor.

CAUTION: Do NOT push down on Sensor
Applicator until placed over prepared site
to prevent unintended results or injury.

STEP 8:

Gently pull Sensor Applicator away.

STEP 9:

Make sure Sensor is secure. Discard used

Sensor Applicator and Sensor Pack according
to your facility’s procedures.

Refer to your Operator’s Manual for full system instructions
and information.

Distributed by:
Abbott Diabetes Care Inc.
1360 South Loop Road
Alameda, CA 94502 USA
Customer Service: 1-855-632-5297
Monday through Friday,
8AM to 8PM Eastern Standard Time

For Health Care Professionals

READ THE READER KIT OPERATOR’S
MANUAL BEFORE HANDLING THE
SENSOR KIT PARTS.

CAUTION: Federal law restricts this device to sale by
or on the order of a physician.

Indications for Use

The FreeStyle Libre Pro Flash Glucose Monitoring System is a
professional continuous glucose monitoring (CGM) device indicated
for detecting trends and tracking patterns in persons (age 18 and
older) with diabetes. The system is intended for use by health care
professionals and requires a prescription.
Readings from the FreeStyle Libre Pro Sensor are only made available
to patients through consultation with a health care professional. The
System does not require user calibration with blood glucose values.
The FreeStyle Libre Pro System aids in the detection of glucose level
excursions above or below the desired range, facilitating therapy
adjustments. Interpretation of the FreeStyle Libre Pro Flash Glucose
Monitoring System readings should be based on the trends and
patterns analyzed through time using the reports available.

CONTRAINDICATION: The FreeStyle Libre Pro 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 to detect trends and track
patterns in the user’s glucose values during the wear period.

WARNING:

The FreeStyle Libre Pro Flash Glucose Monitoring System contains
small parts that may be dangerous if swallowed.

CAUTION:

• Intense exercise may cause the Sensor to loosen due to sweat or
movement of the Sensor. If the Sensor becomes loose, the Sensor
readings may be unavailable or unreliable. Your patient should
return to your facility for application of a new Sensor.

• Severe dehydration and excessive water loss may cause inaccurate
results.

• 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.

• The Sensor Pack and Sensor Applicator are packaged as a set and
have the same Sensor code. Check that the Sensor codes match
before using the Sensor Pack and Sensor Applicator. Sensor Packs
and Sensor Applicators with the same Sensor code should be used
together or Sensor glucose readings may be incorrect.

• Some individuals may be sensitive to the adhesive that keeps the
Sensor attached to the skin. If your patient notices signicant skin
irritation around or under their Sensor, they should remove the
Sensor and stop using the FreeStyle Libre Pro System. Follow your
facility’s procedures for handling skin reactions.

User Safety, Storage, and Handling

• The Sensor Pack is sterile and non-pyrogenic unless opened or damaged.
Using a non-sterile or pyrogenic Sensor might cause infection.

• Store the Sensor Kit between 39 °F and 77 °F. 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.

• The Sensor has been tested to withstand immersion into 3 feet
(1 meter) of water for up to 30 minutes.

• Do not freeze. Do not use if expiration date has passed.

• Interfering Substances: 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. Taking medications
with acetaminophen (such as Tylenol and some cold medicines) while
wearing the Sensor may falsely raise Sensor glucose readings. The level of
inaccuracy depends on the amount of acetaminophen active in the body
and may be dierent for each person.

• The alcohol wipe is labeled as follows: Saturated with 70% Isopropyl
alcohol; For External Use only; Single use; Do not use if package is
opened or damaged; Sterilized using irradiation; Not made with natural
rubber latex. Covidien llc, 15 Hampshire St., Manseld, MA 02048
www.covidien.com

Living With Your FreeStyle

Libre Pro Sensor

The FreeStyle Libre Pro Sensor measures and
stores your glucose data while worn on your body
for up to 14 days. Your health care professional
can download your data at anytime from a Sensor
that’s on or o your body.

IMPORTANT:

• You should not wear a Sensor for more than 14 days.

• Contact your health care professional if:
– Your Sensor becomes loose or is removed.
– You have irritation or discomfort at the Sensor site.
– You have any questions about your Sensor.

Your Sensor is water-resistant and can be worn while bathing, showering,
or swimming.
Note: Do NOT take your Sensor deeper than 3 feet (1 meter) or immerse it
longer than 30 minutes in water.

Removing Your Sensor

Follow these instructions if you need to remove your Sensor.

Pull up the edge of the adhesive that keeps your
Sensor attached to your skin. Slowly peel away
from your skin in one motion.
Note: Any remaining adhesive residue on the
skin can be removed with warm soapy water or
isopropyl alcohol.

CONTRAINDICATION: The FreeStyle Libre Pro Sensor
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 to detect
trends and track patterns in the user’s glucose values during
the wear period.

WARNING: The FreeStyle Libre Pro Sensor contains small parts that may
be dangerous if swallowed.

CAUTION: 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
FreeStyle Libre Pro Sensor. Contact your health care professional for
handling skin reactions.

INTERFERING SUBSTANCES: Taking ascorbic acid (vitamin C)
while wearing the Sensor may falsely raise your Sensor glucose
readings. Taking salicylic acid (used in some pain relievers such as
aspirin and some skin care products) may slightly lower your 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. Taking medications with
acetaminophen (such as Tylenol and some cold medicines) while
wearing the Sensor may falsely raise your Sensor glucose readings.
The level of inaccuracy depends on the amount of acetaminophen
active in your body and may be dierent for each person.

✂

8

1
2
3
4
5
6
7

9

2.25”

2.2”

2.25”

2.25”

2.2”

2.25”

Front

3rd fold2nd fold

1st fold (to half)

Final Facing Fold

ART26946-001_rev-B.indd 1 9/23/16 9:16 AM

Labeling Symbols

CODE

Sensor code

Do not re-use

Sterilized using irradiation

Use-by date

Serial number

Caution

Temperature limit

Do not use if package is
damaged

Type BF applied part

Manufacturer

Consult instructions for use

Batch code

Catalog number

CAUTION: Federal law
restricts this device to sale by
or on the order of a physician.

Humidity limitation

MR unsafe

Not made with natural rubber
latex

This product contains
electronic equipment,
batteries, sharps and materials
that may contact bodily
uids during use. Dispose of
product in accordance with all
applicable local regulations.

FreeStyle and related brand marks are trademarks of Abbott
Diabetes Care Inc. in various jurisdictions. Other trademarks are the
property of their respective owners.
©2016 Abbott ART26946-001 Rev. B 09/16

FreeStyle and related brand marks are trademarks of Abbott Diabetes
Care Inc. in various jurisdictions.
©2016 Abbott ART26946-001 Rev. B 09/16

Manufacturer | Fabricante: Manufacturer:

Cómo vivir con su sensor

FreeStyle Libre Pro

El sensor FreeStyle Libre Pro mide y guarda sus
datos de glucosa hasta por 14 días mientras
lo lleva en el cuerpo. Su profesional de la
salud puede descargar sus datos del sensor en
cualquier momento sin importar si lo lleva en
el cuerpo o no.

IMPORTANTE:

• No debe llevar puesto el sensor durante más de 14 días.

• Comuníquese con su profesional de la salud si:
– Su sensor se aoja o se le cae.
– Tiene irritación o molestias en el lugar donde lleva puesto el

sensor.

– Tiene alguna pregunta acerca de su sensor.

Su sensor es resistente al agua y puede utilizarlo mientras se baña en la
bañera, se ducha o cuando nada.
Nota: NO sumerja el sensor a más de 3 pies (1 metro) de profundidad ni
lo mantenga sumergido durante más de 30minutos en el agua.

Cómo quitarse el sensor

Siga estas instrucciones si necesita quitarse el sensor.

Desprenda el borde del adhesivo que
mantiene el sensor adherido a la piel.
Despréndalo lentamente de la piel con un solo
movimiento.
Nota: Puede retirar cualquier residuo de
adhesivo que quede en la piel con agua tibia
con jabón o alcohol isopropílico.

CONTRAINDICACIÓN: El sensor FreeStyle Libre Pro debe
retirarse antes de realizar una imagen resonancia magnética
(RM), una tomografía axial computarizada (TAC) o un
tratamiento termoeléctrico (diatermia) de alta frecuencia. No
se ha evaluado el efecto que la RM, la TAC o la diatermia
tiene en el sistema. La exposición puede dañar el sensor y
puede alterar el funcionamiento correcto del dispositivo para
detectar tendencias y seguir patrones en los valores de
glucosa mientras el usuario lo lleva puesto.

ADVERTENCIA: El sensor FreeStyle Libre Pro contiene piezas
pequeñas que pueden ser peligrosas si se ingieren.

PRECAUCIÓN: Algunas personas podrían ser sensibles al adhesivo
que mantiene el sensor sujeto a la piel. Si observa una irritación
signicativa en la piel alrededor o debajo del sensor, quite el sensor
FreeStyle Libre Pro y deje de utilizarlo. Póngase en contacto con su
profesional de la salud para tratar las reacciones cutáneas.

SUSTANCIAS INTERFERENTES: La lectura de glucosa del sensor
podría aumentar falsamente si se encuentra tomando ácido ascórbico
(vitamina C). La lectura de glucosa del sensor podría disminuir
ligeramente si se encuentra tomando ácido salicílico (utilizado en algunos
analgésicos, como aspirina, y en algunos productos para el cuidado de
la piel). El nivel de inexactitud depende de la cantidad de sustancia que
interere y que está activa en el cuerpo. Los resultados de la prueba no
indicaron interferencia en el caso de la metildopa (utilizada en algunos
fármacos para tratar la presión arterial alta) ni de la tolbutamida (utilizada
rara vez en algunos fármacos para tratar la diabetes en los Estados
Unidos) a niveles circulantes máximos. Sin embargo, no se conocen
las concentraciones de sustancias que posiblemente pueden interferir
en el líquido intersticial en comparación con la sangre circulante.
Tomar los medicamentos con acetaminofeno (como Tylenol y algunos
medicamentos para el resfriado) mientras lleva puesto el sensor podría
elevar falsamente las lecturas de glucosa de su sensor. El nivel de error
depende de la cantidad de acetaminofeno activo que tenga en su cuerpo
y podría ser diferente para cada persona.

✂

2.25”

2.2”

2.25”

2.25”

2.2”

2.25”

Back

ART26946-001_rev-B.indd 2 9/23/16 9:16 AM

ART33738-006 Rev. A 01/16

For use with | À utiliser avec |

使用対象| Para uso con:

Flash Glucose Monitoring Systems
Systèmes Flash de surveillance du glucose

フラッシュグルコースモニタリングシステム

Sistemas Flash de monitoreo de glucosa

1

Imported contents. See articles for country of origin. |
Contenu importé. Voir les articles pour connaître leur pays d’origine.

71613-01

Abbott Diabetes Care, Canada
Mississauga, Ontario L5N 3R3

Abbott Diabetes Care Inc.
1360 South Loop Road
Alameda, CA 94502 USA

アボットジャパン株式会社
千葉県松戸市松飛台278

USB Cable and Power Adapter |
Câble USB et adaptateur de courant |

USBケーブルと電源アダプタ |
Cable USB y adaptador de alimentación eléctrica

ART33738-006_rev-A.pdf 1 1/20/16 11:20 AM

P150021 Amendment

ADC Confidential

Attachment L9, Page 2 of 2

71687-01

For use with FreeStyle Libre Pro Sensor

Reader, USB Cable, and Power Adapter products of China.

Patent: https://www.abbott.com/patents

FreeStyle and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions.

ART27034 Rev. B 03/16 ©2016 Abbott

NDC 57599-0716-87

Do not use if seal is broken or missing.

Distributed by:

FreeStyleLibrePro.com

Abbott Diabetes Care Inc.

1360 South Loop Road

Alameda, CA 94502

1-855-632-5297

Accurate, Convenient and Insightful

READER

Start Sensor

See Glycemic Prole

Wear Up to 14 days

Review

CONTENTS:
1 FreeStyle Libre Pro Reader
1 USB Cable
1 Power Adapter
1 Operator’s Manual
1 Quick Start Guide

Type BF applied part

Consult instructions for use

Catalog number

Humidity limitation

Temperature limit

This product contains electronic

equipment, batteries, sharps and

materials that may contact bodily

uids during use. Dispose of

product in accordance with all

applicable local regulations.

Manufacturer

FLASH GLUCOSE MONITORING SYSTEM

ART27034_rev-B.pdf 1 3/22/16 5:34 PM

P150021 Amendment

ADC Confidential

Attachment L7B, Page 2 of 2

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ART26950_rev-A.pdf 1 11/30/15 6:33 PM

P150021 Amendment

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ART26951_rev-A.pdf 1 12/1/15 12:12 PM

P150021 Amendment

ADC Confidential

Attachment L4, Page 2 of 2

CONTENTS:
1 Sensor Applicator
1 Sensor Pack
1 Alcohol Wipe
Product Insert

Open Here

FreeStyleLibrePro.com

SENSOR

Accurate, Convenient and Insightful

The Sensor Pack and Sensor Applicator are packaged as a set and are intended to be used together.

For use with FreeStyle Libre Pro Reader

Sensor Applicator and Sensor Pack products of Ireland. Alcohol Wipe
product of USA.
FreeStyle and related brand marks are trademarks of Abbott Diabetes
Care Inc. in various jurisdictions. Other trademarks are the property of
their respective owners. ©2016 Abbott
Patent: https://www.abbott.com/patents

Distributed by:
Abbott Diabetes Care Inc.
1360 South Loop Road
Alameda, CA 94502
1-855-632-5297

Manufacturer

ART26942 Rev. B 03/16

NDC 57599-0715-62

Type BF applied part

Consult instructions for use

Do not re-use

Catalog number

Do not use if package

is damaged

Humidity limitation

Temperature limit

This product contains electronic

equipment, batteries, sharps

and materials that may contact
bodily uids during use. Dispose
of product in accordance with all

applicable local regulations.

FLASH GLUCOSE MONITORING SYSTEM

NO COAT

AREA

NO COAT

AREA

CAD Reference

AD4

ABBOTT DIABETES CARE

Customer

Size (mm)

18/12/13

Date

118.1 x 57.3 x 86

Copyright

Material

440mic Performa White

32 mm

22 mm

19.05 mm

NO COAT

AREA

CLEAR

ZONE

1.975” x 0.875”

71562-01

ART26942_rev-B.pdf 1 3/18/16 2:40 PM

P150021 Amendment

ADC Confidential

Attachment L3B, Page 2 of 2