Abbott FreeStyle Libre 2 Manual de usuario

User’s Manual

FLASH GLUCOSE MONITORING SYSTEM

CAUTION: Federal law restricts this device to

sale by or on the order of a physician.

FreeStyle Libre 2 app

A FreeStyle Libre product

.224”

.257”

4.6”4.6”

Your Name _________________________________________________

.224”

.257”

4.6” 4.6”

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.

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...................................15

Reader Symbols ........................................16

App Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Getting to Know Your System . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Sensor Kit ...............................................22

Reader Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

FreeStyle Libre 2 app ....................................24

Reader Home Screen ....................................25

App Home Screen .......................................26

Reporting Software......................................27

Setting up Your System for the First Time . . . . . . . . . . . . . . 28

Reader Setup............................................28

App Setup...............................................31

Applying Your Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Starting Your Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Starting Your Sensor with the Reader.....................39

Starting Your Sensor with the App . . . . . . . . . . . . . . . . . . . . . . . 41

Checking Your Glucose .................................44

Checking Your Glucose with the Reader ..................44

Checking Your Glucose with the App .....................47

Understanding Your Glucose Readings . . . . . . . . . . . . . . . . . . . 51

Making Treatment Decisions ...........................55

Making Treatment Decisions – Getting Started ...........56

Using Your Glucose Reading to Make a

Treatment Decision .....................................61

Reader Alarms..........................................77

Setting Reader Alarms ...................................80

Setting Reader Alarm Sounds ............................85

Using Reader Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

App Alarms.............................................88

Setting App Alarms......................................94

Using App Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

Adding Notes to Glucose Readings....................103

Adding Notes in the Reader ........................... 103

Adding Notes in the App................................105

Reviewing Your History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .107

Reviewing Your History in the Reader . . . . . . . . . . . . . . . . . . .107

Reviewing Your History in the App . . . . . . . . . . . . . . . . . . . . . . 113

Removing Your Sensor ................................117

Replacing Your Sensor ................................118

Using Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .119

Using Reminders in the Reader . . . . . . . . . . . . . . . . . . . . . . . . . 119

Using Reminders in the App ............................121

Using the Reader’s Built-in Meter . . . . . . . . . . . . . . . . . . . . .123

Intended Use...........................................123

Blood Glucose Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

Control Solution Testing ................................134

Living With Your System...............................139

Activities ...............................................139

Charging the Reader....................................142

Reader Settings and Information ........................145

App Settings and Other Menu Options . . . . . . . . . . . . . . . . .148

Maintenance and Disposal ............................150

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .155

Reader Does Not Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . .156

Problems at the Sensor Application Site .................157

Problems Starting Your Sensor or Receiving

Sensor Readings........................................158

Problems Receiving Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . .164

Blood Glucose Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . .169

Problems Checking Your Blood Glucose . . . . . . . . . . . . . . . . . 173

Perform a Reader Test...................................175

Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175

System Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .176

Labeling Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .183

Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . .185

Electromagnetic Compatibility (EMC) .................215

Limited Warranty......................................227

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:

www.FreeStyleLibre.us/support/overview.html

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

cause inaccurate glucose readings.

FreeStyle Libre 2 app is only compatible with certain mobile devices

and operating systems. Please check www.FreeStyleLibre.com for more

information about device compatibility before upgrading your phone or its

operating system.

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.

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.

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.

• If you are using FreeStyle Libre 2 app, you must have access to a

blood glucose monitoring system as the App does not provide one.

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

dangerous if swallowed.

Warnings

What to know about Reader 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.

• 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 about App Alarms:

• For you to receive alarms, your phone 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 alarms. If you want to receive the App's

optional alarms, make sure these are turned on.

• Do not force close the App. The App must be running in the background

to receive alarms. If you force close the App you will not receive alarms.

Re-open the App to ensure you will receive alarms.

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