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 Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .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.
1
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 eect of MRI, CT scans, or
diathermy on the performance of the System has not been
evaluated. The exposure may damage the Sensor and may
impact proper function of the device which could cause
incorrect readings.
2
Cautions and Limitations
Below are important cautions and limitations to keep in mind so you can
use the System safely. They are grouped into categories for easy reference.
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
3
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 sucient 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.
4
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