Abbott FreeStyle Libre 2 Manuale utente

User’s Manual

The circular shape of the sensor housing, FreeStyle, Libre, and related brand marks are

marks of Abbott. Other trademarks are the property of their respective owners.

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

Distributed by:

Abbott Diabetes Care Inc.

1360 South Loop Road

Alameda, CA 94502 USA

Customer Service: 1-855-632-8658

7 Days aWeek from 8AM to 8PM Eastern Standard Time

www.FreeStyleLibre.com

FLASH GLUCOSE MONITORING SYSTEM

Manufacturer

CAUTION: Federal law restricts this device

to sale by or on the order of a physician.

.224”

.257”

4.6”4.6”

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Your Name _________________________________________________

.224”

.257”

4.6” 4.6”

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WARNING:

Before you use the FreeStyle Libre 2 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. Talk to your health

care professional about how you should use your Sensor glucose

information to help manage your diabetes.

Failure to use the System according to the instructions for use

may result in you missing a severe low blood glucose or high

blood glucose event and/or making a treatment decision that

may result in injury. If your glucose alarms and readings from the

System do not match symptoms or expectations, use a ngerstick

blood glucose value from a blood glucose meter to make diabetes

treatment decisions. Seek medical attention when appropriate.

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Contents

Important Safety Information........................... 1

Indications For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Compatible Devices, Apps, and Software .................. 2

Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Warnings................................................. 3

Cautions and Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Interfering Substances...................................12

Reader Symbols ........................................13

Getting to Know Your System . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Reader Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Sensor Kit ...............................................18

FreeStyle Libre Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Setting up Your Reader for the First Time . . . . . . . . . . . . . . 22

Using Your Sensor ......................................25

Applying Your Sensor....................................26

Starting Your Sensor .....................................30

Checking Your Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Making Treatment Decisions ...........................37

Making Treatment Decisions – Getting Started ...........38

Using Your Glucose Reading to Make a

Treatment Decision .....................................43

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Alarms..................................................56

Setting Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59

Setting Alarm Sounds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Using Alarms ............................................65

Adding Notes...........................................67

Reviewing Your History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Logbook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

Daily Graph .............................................72

Other History Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

Removing Your Sensor .................................75

Replacing Your Sensor .................................76

Using Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Using the Reader’s Built-in Meter . . . . . . . . . . . . . . . . . . . . . . 79

Intended Use............................................79

Blood Glucose Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

Control Solution Testing .................................90

Charging the Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

Changing the Reader Settings .........................96

Living With Your System................................99

Maintenance and Disposal ............................102

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .107

Reader Does Not Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . .107

Problems at the Sensor Application Site .................108

Problems Starting Your Sensor or Receiving

Sensor Readings........................................109

Problems Receiving Glucose Alarms.....................113

Blood Glucose Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . 115

Problems Checking Your Blood Glucose . . . . . . . . . . . . . . . . . 119

Perform a Reader Test...................................121

Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

System Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .122

Labeling Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .128

Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . .130

Electromagnetic Compatibility (EMC) .................160

Limited Warranty......................................172

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Important Safety Information

Indications For Use

The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous

glucose monitoring (CGM) device with real time alarms capability

indicated for the management of diabetes in persons age 4 and older.

It is intended to replace blood glucose testing for diabetes treatment

decisions, unless otherwise indicated.

The System also detects trends and tracks patterns and aids 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 also intended to autonomously communicate with digitally

connected devices. The System can be used alone or in conjunction

with these digitally connected devices where the user manually controls

actions for therapy decisions.

Compatible Devices, Apps, and Software

For a list of compatible devices, apps, and software that can be used with

the FreeStyle Libre 2 Sensor please go to: https://freestylelibre.us/support/

overview.html

Use of the Sensor with devices, apps, and software that are not listed may

cause inaccurate glucose readings.

Contraindications

Automated Insulin Dosing: The System must not be used with

automated insulin dosing (AID) systems, including closed loop and insulin

suspend systems.

MRI/CT/Diathermy: The 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 2

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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 Glucose Alarms:

• For you to receive alarms, they must be on and your Reader should

be within 20 feet of you at all times. The transmission range is 20 feet

unobstructed. If you are out of range, you may not receive glucose

alarms.

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.

• Use your blood glucose meter to make diabetes treatment decisions

when you see the symbol during the rst 12 hours of wearing a

Sensor, if your Sensor glucose reading does not match how you feel,

or if the reading does not include a number.

• Choking hazard: The System contains small parts that may be

dangerous if swallowed.

• To prevent missed alarms, make sure the Reader has sucient charge

and that sound and/or vibration are turned on.

• Alarms you receive do not include your glucose reading so you must

scan your Sensor to check your glucose.

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.

• Make sure that your Reader and Sensor kits are kept in a safe place,

under your control. This is important to help prevent anyone from

accessing or tampering with the System.

Who should not use the System:

• Do not use the System in people less than 4 years of age. The

System is not cleared for use in people under 4 years of age.

• Do not use the System if you are pregnant, on dialysis, or critically

ill. The System is not cleared for use in these groups and it is not

known how dierent conditions or medications common to these

populations may aect performance of the System.

• Performance of the System when used with other implanted medical

devices, such as pacemakers, has not been evaluated.

3 4

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What should you know about wearing a Sensor:

• Wash application site on the back of your upper arm using a plain

soap, dry, and then clean with an alcohol wipe. This will help remove

any oily residue that may prevent the Sensor from sticking properly.

Allow site to air dry before proceeding. Carefully preparing the site

according to these instructions will help the Sensor stay on your body

for the full 14 day wear period and help prevent it from falling o early.

• The Sensor can be worn for up to 14 days. Remember to always have

your next Sensor available before your current one ends so you can

keep getting your glucose readings.

• You must scan the Sensor to get your real-time current glucose level as

the Reader will not provide this information without a scan.

• In the event that your Sensor stops working and you do not have

another Sensor readily available, you must use an alternate method to

measure your glucose levels and inform your treatment decisions.

• The System is designed to detect certain conditions which may occur

where the Sensor is not working as intended and shut it o, telling

you to replace your Sensor. This may occur if the Sensor gets knocked

o from the skin or if the System detects that the Sensor may not be

performing as intended. Contact Customer Service if you receive a

Replace Sensor message before the end of the 14 day wear period.

Customer Service is available at 1-855-632-8658 7 Days a Week from

8AM to 8PM Eastern Standard Time.

• 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.

• Intense exercise may cause your Sensor to loosen due to sweat or

movement of 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 low readings. Remove and replace your Sensor if it starts to

loosen and follow the instructions to select an appropriate application

site. Do not attempt to reinsert the Sensor. Contact Customer Service

if your Sensor becomes loose or falls o before the end of the wear

period. Customer Service is available at 1-855-632-8658 7 Days a Week

from 8AM to 8PM Eastern Standard Time.

• Do not reuse Sensors. The Sensor and Sensor Applicator are designed

for single use. Reuse may result in no glucose readings and infection.

5 6

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Not suitable for re-sterilization. Further exposure to irradiation may

cause unreliable low results.

• If a Sensor breaks inside your body, call your health care professional.

How to Store the Sensor Kit:

• Store the Sensor Kit between 36°F and 82°F. Storage outside of this

range may cause inaccurate Sensor glucose readings.

• If you suspect that the temperature may exceed 82°F (for example, in

an un-airconditioned home in summer), you should refrigerate your

Sensor Kit. Do not freeze your Sensor Kit.

• Store your Sensor Kit in a cool, dry place. Do not store your Sensor Kit

in a parked car on a hot day.

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

When not to use the System:

• Do NOT use if the Sensor Kit package, Sensor Pack, or Sensor

Applicator appear to be damaged or already opened due to risk of no

results and/or infection.

• Do NOT use if Sensor Kit contents are past expiration date.

• Do NOT use if the Reader appears to be damaged due to risk of

electric shock and/or no results.

What to know before you Apply the Sensor:

• The Sensor Pack and Sensor Applicator are

packaged as a set (separately from the Reader)

and have the same Sensor code. Check that the

Sensor codes match before using your Sensor

Pack and Sensor Applicator. Do not use Sensor

Packs and Sensor Applicators with dierent Sensor

codes together as this will result in incorrect

glucose readings.

• Wash application site on the back of your upper arm using a plain

soap, dry, and then clean with an alcohol wipe. This will help remove

any oily residue that may prevent the Sensor from sticking properly.

Allow site to air dry before proceeding. Carefully preparing the site

according to these instructions will help the Sensor stay on your body

for the full 14 day wear period and help prevent it from falling o

early.

CODE

FreeStyle Libr

Sensor Pack

XXXXXXXXX

XXX

YYYY-MM-DD

7 8

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• 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.

• Only apply the Sensor to the back of the upper 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

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 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, apply a new one, and contact

Customer Service.

• 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, apply a new one, and contact Customer Service. Customer

Service is available at 1-855-632-8658 7 Days a Week from 8AM to 8PM

Eastern Standard Time.

9 10

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