Abbott FreeStyle Libre 2 User manual

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ART41753-100_rev-A 5:36pm 18-JAN-2021

ART41753-100_rev-A 5:36pm 18-JAN-2021

User’s ManualUser’s Manual
App SymbolsApp Symbols
App icon
Alarms you have turned on
are unavailable
Direction your glucose is
going. See Understanding
Your Glucose Readings for
more information.
Scan button
Caution
Add/edit notes
Food note
Insulin (Rapid or Long-
acting) note
Exercise note
Time change
!
Multiple/Custom notes
⚌
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Share report
Additional information
Main menu
Calendar
Sensor too cold
Sensor too hot
Important Safety InformationImportant Safety Information
Indications for UseIndications for Use
The FreeStyle Libre 2 Flash Glucose Monitoring System (FreeStyle Libre 2 Reader
or FreeStyle Libre 2 app used with FreeStyle Libre 2 Sensor) is indicated for
measuring interstitial fluid glucose levels in people aged 4 years and older with
diabetes mellitus. The System is designed to replace blood glucose testing in the
self-management of diabetes, including dosing of insulin. Treatment decisions
should be based on real-time Sensor glucose readings and other information on
the results screen, including trend arrow and recent sequential readings on the
glucose graph. The System also detects trends and tracks patterns and aids in
the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating
both acute and long-term therapy adjustments.
ContraindicationContraindication
MRI/X-ray/CT:MRI/X-ray/CT: Remove the Sensor that you are wearing if you have a medical
appointment that includes strong magnetic or electromagnetic radiation, e.g. an
X-ray, MRI (Magnetic Resonance Imaging) or CT (Computed Tomography) scan.
mmol/L Apply a new Sensor after the appointment.
WarningsWarnings
• Do not ignore symptoms that may be due to low or high blood glucose. If you
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have symptoms that do not match the Sensor glucose reading or suspect that
your reading may be inaccurate, check the reading by conducting a fingerstick
test using a blood glucose meter. If you have symptoms that do not match
your glucose readings, consult your healthcare professional.
• 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:Choking hazard: The System contains small parts that may be dangerous if
swallowed.
Cautions and Important InformationCautions and Important Information
What to know about Glucose Alarms:What to know about Glucose Alarms:
• For you to receive alarms, they must be on, and your phone should be within
6 metres (20 ft) of you at all times. The transmission range is 6 metres (20 ft)
unobstructed. If you are out of range, you may not receive glucose alarms.
• Do not force close the App.
• Check to make sure that you have the correct settings and permissions
enabled on your phone to receive alarms.
• Enable Bluetooth and Notifications for the App. Be sure not to turn on any
features or modify phone settings that may interrupt the presentation of
notifications.
• Turn on Lock Screen notifications, Banner Notifications, Notification sounds
and general phone sounds or vibration.
• Turn off Do Not Disturb mode or select to turn on Override Do Not Disturb
in your alarm settings. Do this if you want the alarm to always play a sound
and appear on the lock screen even if your phone is muted or Do Not
Disturb is on.
Note:Note: You must accept the App’s permission request for Critical Alerts to use
this feature. You can also enable the Critical Alerts setting directly from the
App’s notification settings.
• Remember that alarm settings will follow your phone’s sound and vibration
settings, so these should be at a level that you can hear to prevent missed
alarms.
• You should disconnect headphones when you are not using them as you may
not receive audio with alarms.
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• If you are using peripheral devices connected to your phone, such as wireless
headphones or a smartwatch, you may receive alarms on only one device or
peripheral, not all.
• Keep your phone well charged and turned on.
Who should not use the System:Who should not use the System:
• The System has not been evaluated for use with other implanted medical
devices, such as pacemakers.
• The System has not been evaluated for use in pregnant women, persons on
dialysis or people less than 4 years of age.
• Do not use the System if you are critically ill. The System has not been
evaluated for use by critically ill patients and it is not known how different
conditions or medications common to this population may affect performance
of the System.
What to know about wearing the Sensor:What to know about wearing the Sensor:
• 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. Do not try to treat
any skin irritation with lotions/creams/ointments/sprays/barrier patches in
order to continue wearing the Sensor. Contact your healthcare professional
before continuing to use the System.
• Intense exercise may cause your Sensor to loosen due to sweat or movement
of the Sensor. If your Sensor comes loose, you may get no readings or
unreliable readings, which may not match how you feel. Follow the
instructions to select an appropriate application site.
• Glucose Going Low and Glucose Going High messages may mean that your
actual blood glucose is already <3.9 mmol/L or >13.3 mmol/L. Consider this
before making an activity or treatment decision.
• If you are going to participate in activities that could result in harm to yourself
or others in the event of a severe hypoglycaemic episode (e.g. driving a motor
vehicle without following the Canadian Diabetes Association
Recommendations for Private and Commercial Drivers), do not rely on
Glucose Messages (High Glucose, Low Glucose, Glucose Going High and
Glucose Going Low) alone. Talk to your healthcare professional about
checking your glucose before and while driving.
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• When using the System to replace blood glucose testing for making diabetes
treatment decisions, including insulin dosing, you should have a good
understanding of how to self-manage your diabetes, as determined by your
healthcare professional.
How to store the Sensor Kit:How to store the Sensor Kit:
• Store the Sensor Kit between 4°C and 25°C. While you don’t need to keep your
Sensor Kit in a refrigerator, you can as long as the refrigerator is between 4°C
and 25°C.
When not to use the System:When not to use the System:
• Do NOT use if the Sensor Pack or the Sensor Applicator seem to be damaged
or already opened.
• Do NOT use if past expiry date.
What to know before you apply the Sensor:What to know before you apply the Sensor:
• Clean the application site and ensure that it is dry prior to Sensor insertion.
This helps the Sensor stay attached to your body.
When is Sensor Glucose different from Blood Glucose:When is Sensor Glucose different from Blood Glucose:
• Glucose levels in the interstitial fluid can be different from blood glucose
levels and may mean that Sensor glucose readings are different from blood
glucose. You may notice this difference during times when your blood glucose
is changing quickly, for example after eating, taking insulin or exercising.
When to remove the Sensor: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.
• On rare occasions, you may get inaccurate Sensor glucose readings. If you
believe your glucose readings are not correct or do not match how you feel,
perform a blood glucose test on your finger to confirm your glucose. If the
problem continues, remove your Sensor and apply a new one.
What to know about FreeStyle Libre 2 app:What to know about FreeStyle Libre 2 app:
• FreeStyle Libre 2 app installed on a smartphone is intended for use by a single
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person. It must not be used by more than one person due to the risk of
misinterpreting glucose information.
Interfering SubstancesInterfering Substances
Taking more than 500 mg of ascorbic acid per day may affect the Sensor
readings which could cause you to miss a low glucose event. Ascorbic acid can
be found in supplements including multivitamins. Some supplements, including
cold remedies, may contain high doses of 1000 mg of ascorbic acid. Do not use
the Sensor while taking supplements that contain high doses of 1000 mg of
ascorbic acid.
Additional System InformationAdditional System Information
App:App:
• The FreeStyle Libre 2 Reader is a dedicated medical device. Even though you
can run FreeStyle Libre 2 app on your phone, it is not a dedicated medical
device and therefore the App may miss an alarm – for example, due to phone
settings, phone or App shutting off, low battery, etc.
• You are responsible for properly securing and managing your phone. If you
suspect an adverse cybersecurity event related to FreeStyle Libre 2 app,
contact Customer Service.
• FreeStyle Libre 2 app is not intended for use on a smartphone that has been
altered or customised to remove, replace or circumvent the manufacturer’s
approved configuration or use restriction, or that otherwise violates the
manufacturer’s warranty.
Sensor:Sensor:
• The Sensor Pack and Sensor Applicator are packaged as a set and have the
same Sensor code. Check that the Sensor codes match before using your
Sensor Pack and Sensor Applicator. Sensor Packs and Sensor Applicators with
the same Sensor code should be used together or your Sensor glucose
readings may be incorrect.
• Your Sensor has been tested to withstand immersion into 1 metre (3 ft) of
water for up to 30 minutes. It is also protected against insertion of objects
>12 mm in diameter. (IP27)
• Do not freeze the Sensor. Do not use if expiry date has passed.
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• The Sensor Pack is sterile unless opened or damaged.
• Do not reuse Sensors. The Sensor has been designed so that it cannot be re-
used. Not suitable for re-sterilisation.
FreeStyle Libre 2 App OverviewFreeStyle Libre 2 App Overview
IMPORTANT:IMPORTANT:
• Before you use FreeStyle Libre 2 app with a Sensor, review all the product
instructions. The Quick Reference Guide gives you quick access to important
aspects of the System. The User’s Manual includes all safety information and
instructions for use. Refer to your iPhone instructions for use for how to use
your iPhone.
• Go to www.FreeStyleLibre.com to view the ‘Tips for Kids’.
• Talk to your healthcare professional about how you should use your Sensor
glucose information to help manage your diabetes.
• FreeStyle Libre 2 app is available for download from the App Store. When
you’re ready to start using FreeStyle Libre 2 app, you’ll prepare and apply a
Sensor to the back of your upper arm. The App only works with FreeStyle Libre
2 Sensors and cannot be used with other Sensors. When they’re in range, the
Sensor and App automatically communicate to give you glucose alarms. These
alarms are on by default.
Note:Note:
• The Sensor comes in a FreeStyle Libre 2 Sensor kit. See Sensor Kit.
• The App is not compatible with all phones. Before upgrading your phone or
its operating system, check www.FreeStyleLibre.com.
Home ScreenHome Screen
The Home Screen gives you access to information about your glucose and the
App. To return to the Home Screen from another screen, go to the Main Menu
and tap HomeHome.
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Main MenuMain Menu – Tap to access the Home Screen, Alarms, Logbook, other history
options and Connected Apps. You can also access Settings, Help and other
information.
Glucose GraphGlucose Graph – Graph of your stored Sensor glucose readings.
Scan ButtonScan Button – Tap when you are ready to scan your Sensor. You can either tap
the blue box on the Home Screen or at the top right.
Glucose InformationGlucose Information – Your Time In Target, information about your last scan
and average glucose for the last 24 hours.
Target Glucose RangeTarget Glucose Range – The graph shows your target glucose range. This is
not related to glucose alarm levels.
High Glucose Alarm LevelHigh Glucose Alarm Level – Your High Glucose Alarm level displays only when
you have used the App to start a Sensor and have kept the alarm on.
Low Glucose Alarm LevelLow Glucose Alarm Level – Your Low Glucose Alarm level displays only when
you have used the App to start a Sensor and have kept the alarm on.
Sensor KitSensor Kit
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