What to know about Alarms/Alerts:
- There are NO alarms or alerts unless you scan the Sensor.
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.
Who should not use the System:
- Do not use the System in people less than 18 years of age. The System is not
approved for use in people under 18 years of age and Sensor readings in this population
may be inaccurate. In general, continuous glucose monitoring systems are recognized to
be less accurate in children than in adults.
- Do not use the System in critically ill patients. The System is not approved
for use in these patients. It is not known how different conditions or medications
common to the critically ill population may affect performance of the System. Sensor
glucose readings may be inaccurate in critically ill patients.
- Do not use the System in pregnant women or persons on dialysis. The System is
not approved for use in pregnant women or persons on dialysis and has not been evaluated
in these populations.
- 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:
- The Sensor can be worn for up to the wear duration specified in your Sensor Kit's
product insert.
- 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 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. Remove and replace your Sensor if it starts to loosen and follow the
instructions to select an appropriate application site.
- If you are wearing a FreeStyle Libre 14 day Sensor, all available glucose data is used
to give you readings so you should scan your Sensor at least once every 8 hours for the
most accurate performance. Scanning less frequently may result in decreased performance.
If you are using both the App and Reader with the same FreeStyle Libre 14 day Sensor, be
sure to scan frequently with both devices.
- 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.
- If a Sensor breaks inside your body, call your health care professional.
How to Store the Sensor Kit:
- Store the Sensor Kit between 39°F and 77°F. Storage outside of this range may cause
inaccurate Sensor glucose readings. 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. Do not
freeze.
- Store the Sensor Kit between 10-90% non-condensing humidity.
How to Store the Reader:
- Store the Reader between -4°F and 140°F. Storage in temperatures outside of this
range, such as in a parked car on a hot day, may cause the Reader to not function
properly.
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 different Sensor codes together as this will result in incorrect glucose
readings.
- Clean the application site and ensure that it is dry prior to Sensor insertion. This
helps the Sensor stay attached to your body.
- 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.
- 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.
- 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
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 interfering substances such as Vitamin C and Aspirin:
- 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 fluid are unknown compared to circulating blood.
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 and apply a
new one.
- 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 and apply a new one.
What to do if you are dehydrated:
- Severe dehydration and excessive water loss may cause inaccurate Sensor glucose
readings. If you believe you are suffering from dehydration, consult your health care
professional immediately.
What to know about the Reader:
- Do NOT place the Reader in water or other liquids as this may cause it to not function
properly and may lead to risk of fire or burns.
- FreeStyle Libre and FreeStyle Libre 14 day Readers have 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, 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 the Reader Kit User’s Manual
for additional important information on the use of the Reader’s built-in meter.
What to know about charging your Reader:
- Always use the Abbott provided power adapter and yellow USB cable that came with your
Reader to minimize the risk of fire or burns. Take care when plugging and
unplugging your USB cable. Do not force or bend the end of the USB cable into the
Reader’s USB port.
- Choose a location for charging where you can easily access the power adapter and
quickly disconnect to prevent 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 118°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.
- Do NOT expose the USB cable or power adapter to water or other liquids as this may
cause them to not function properly and may lead to risk of fire or burns
What to know about FreeStyle LibreLink:
- FreeStyle LibreLink installed on a smartphone 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 LibreLink and FreeStyle Libre or FreeStyle Libre 14 day Readers do not share
data. For complete information on a device, be sure to scan your Sensor every 8 hours
with that device; otherwise, your reports will not include all your data.
- Disable your phone’s automatic operating system (OS) updates. Prior to updating your
phone’s OS or updating the App, you should check the Mobile Device and OS Compatibility
Guide to determine if the FreeStyle LibreLink App is compatible with your OS and your
phone. The OS Compatibility Guide is available in the Help Section of the App or on
www.FreeStyleLibre.com. You should check the OS Compatibility Guide
periodically to make sure that your OS and your phone continue to be compatible with the
App.
- In the event that an App or OS update causes your previously compatible phone to
become incompatible, you may be notified ahead of time via e-mail or through the App.
Make sure that your LibreView account has your current e-mail address to receive
important information.
- After an OS update, open your App and check your device settings to make sure it's
working properly.