Freestyle Libre 2 User manual

Quick Reference Guide
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Quick Reference Guide
IMPORTANT USER INFORMATION
Before you use your System, review all the product instructions and the
Interactive Tutorial. You can access the Interactive Tutorial at
www.FreeStyleLibre.com. 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.
Go to www.FreeStyleLibre.com to view the “Tips for Kids".
Talk to your health care professional about how you should use your Sensor
glucose information to help manage your diabetes.
During the first 12 hours of Sensor wear the symbol will display, and you
cannot use Sensor values to make treatment decisions during this time.
Confirm Sensor glucose readings with a blood glucose test before making
treatment decisions during the first 12 hours of Sensor wear when you see the
symbol.
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.
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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.
What you need to understand in the Indications For Use:
You can use the FreeStyle Libre 2 System if you’re 4 or older.
IMPORTANT:
After you scan the Sensor, consider all the information on your screen before
deciding what to do or what treatment decision to make.
Don’t take a correction dose within 2 hours of your meal dose. This may result
in “insulin stacking” and low glucose.
WARNING:
The System can replace blood glucose testing except in the below situations.
These are the times when you need to do a blood glucose test before deciding
what to do or what treatment decision to make as Sensor readings may not
accurately reflect blood glucose levels:
Do a blood glucose test if you think your glucose readings are not correct or do
not match how you feel. Do not ignore symptoms that may be due to low or high
glucose.
Do a blood glucose test when you see the symbol during the first 12 hours of
wearing a Sensor or the Sensor glucose reading does not include a Current
Glucose number.
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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 effect 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.
WARNING:
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 first 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.
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Choking hazard: The System contains small parts that may be dangerous if
swallowed.
Cautions and Limitations:
Below are important cautions and limitations to keep in mind so you can use the
System safely. They are grouped into categories for easy reference.
What to know about Alarms:
For you to receive alarms, they must be on and your device 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.
To prevent missed alarms, make sure your device has sufficient charge. If using
the Reader, make sure that sounds 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.
If your phone is not configured properly, you will not be able to use the App, so
you will not receive alarms or be able to check your glucose. Refer to the User
Manual to make sure you have the correct settings and permissions enabled
on your phone.
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 devices and Sensor kits are kept in a safe place, and
maintain your devices under your control during use. 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
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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 different
conditions or medications common to these populations may affect
performance of the System.
Performance of the System when used with other implanted medical devices,
such as pacemakers, has not been evaluated.
What should you know about wearing a Sensor:
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 off 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 App
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 off, telling you to replace your
Sensor. This may occur if the Sensor gets knocked off 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 significant skin irritation around or under
your Sensor, remove the Sensor and stop using the System. Contact your
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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 off 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. 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.
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What to know about the System:
The FreeStyle Libre 2 System is intended for use by a single person. It must not
be used by more than one person due to the risk of misinterpreting glucose
information.
FreeStyle Libre 2 app and FreeStyle Libre 2 Readers do not share data.
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 different 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 off early.
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 flat 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 different from Blood Glucose:
Physiological differences between the interstitial fluid and capillary blood may
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result in differences in glucose readings between the System and results from
a fingerstick test using a blood glucose meter. Differences in glucose readings
between interstitial fluid 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
effect 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 finger to confirm 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.
What to know about the Reader’s Built-in Meter:
The FreeStyle Libre 2 Reader has a built-in blood glucose meter that is
designed to be used only with FreeStyle Precision Neo blood glucose test strips
and MediSense Glucose and Ketone Control Solution. Using other test strips
with the Reader’s built-in meter will produce an error or cause the Reader’s
built-in meter to not turn on or start a test. The Reader’s built-in meter does
not have ketone testing functionality.
The Reader’s built-in meter is not for use on people who are dehydrated,
hypotensive, in shock, or for individuals in hyperglycemic-hyperosmolar state,
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with or without ketosis.
The Reader’s built-in meter is not for use on neonates, in critically-ill patients,
or for diagnosis or screening of diabetes.
See Using the Reader’s Built-in Meter section of User’s Manual for additional
important information on the use of the Reader’s built-in meter.
What to know about charging your Reader:
Be sure to select a location for charging that allows the power adapter to be
easily unplugged. Do NOT block access to the charger due to the potential risk
of electrical shock.
The maximum surface temperature of the Reader and/or the power adapter
could go as warm as 120 °F when it's charging or 117 °F during normal use.
Under these conditions, do not hold the Reader or the power adapter for five
minutes or more. People with disorders of peripheral circulation or sensation
should use caution at this temperature.
Interfering Substances:
Taking ascorbic acid (vitamin C) supplements while wearing the Sensor may
falsely raise Sensor glucose readings. Taking more than 500 mg of ascorbic acid
per day may affect the Sensor readings which could cause you to miss a severe
low glucose event. Ascorbic acid can be found in supplements including
multivitamins. Some supplements, including cold remedies such as Airborne®
and Emergen-C®, may contain high doses of 1000 mg of ascorbic acid and should
not be taken while using the Sensor. See your healthcare professional to
understand how long ascorbic acid is active in your body.
WARNING:
The System can replace blood glucose testing except in the below situations.
These are the times when you need to do a blood glucose test before deciding
what to do or what treatment decision to make as Sensor readings may not
accurately reflect blood glucose levels:
Do a blood glucose test if you think your glucose readings are not correct or do
not match how you feel. Do not ignore symptoms that may be due to low or high
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glucose.
Do a blood glucose test when you see the symbol during the first 12 hours of
wearing a Sensor or the Sensor glucose reading does not include a Current
Glucose number.
Using Sensor Glucose Readings for Treatment Decisions
After you scan your Sensor, use all of the information on the screen when
deciding what to do or what treatment decision to make.
Reader
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App
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Example Scenarios
Here are some example scenarios to help you understand how to use the
information on your screen. If you are not sure about what to do, consult your
health care professional.
What you see -
When you wake-up
Reader
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App
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What it means
When you wake-up on your first day of wearing a Sensor, your current glucose is
110 mg/dL. There is also the symbol on the screen.
During the first 12 hours of Sensor wear the symbol will display, and you
cannot use Sensor values to make treatment decisions during this time. Confirm
Sensor glucose readings with a blood glucose test before making treatment
decisions during the first 12 hours of Sensor wear when you see the symbol.
What you see -
Before breakfast
Reader
App
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What it means
Before breakfast, your current glucose is 115 mg/dL. The graph shows that your
glucose is going up and so does the trend arrow .
Consider what might be causing your glucose to go up and what you might do to
prevent a high glucose. For example:
How much insulin should you take before your meal?
Since you see , should you consider taking a little more insulin?
What you see -
Before lunch
Reader
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App
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What it means
When you checked your glucose before lunch, it was 90 mg/dL and rising. Before
eating lunch, you took enough insulin to cover the meal and a little more since
your trend arrow was .
What you see -
After lunch
Reader
App
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What it means
90 minutes later, your current glucose is 225 mg/dL. The graph shows that your
glucose is still going up, and so does the trend arrow .
Don’t take a correction dose within 2 hours of your meal dose. This may
result in “insulin stacking” and low glucose.
Consider what might be causing your glucose to go up and what you might do to
prevent a high glucose. For example:
Has the insulin you took for your meal reached its full effect?
Scan your Sensor again later.
What you see -
In the afternoon
Reader
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App
What it means
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