Freestyle Libre 14 day User manual

User’s Manual
FLASH GLUCOSE MONITORING SYSTEM
CAUTION: Federal law restricts this device
to sale by or on the order of a physician.
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4.6”4.6”

Your Name _________________________________________________
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4.6” 4.6”

Contents
Important Safety Information........................... 1
Indications For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Contraindications ........................................1
Warnings................................................. 2
Cautions and Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Reader Symbols ........................................10
Getting to Know Your System . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Reader Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Sensor Kit ...............................................14
FreeStyle Libre Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Setting up Your Reader for the First Time . . . . . . . . . . . . . . 18
Using Your Sensor ......................................21
Applying Your Sensor....................................22
Starting Your Sensor .....................................26
Checking Your Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Making Treatment Decisions ...........................33
Making Treatment Decisions – Getting Started ...........34
Making Treatment Decisions – Advanced ................39

Adding Notes...........................................50
Reviewing Your History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Logbook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Daily Graph .............................................55
Other History Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Removing Your Sensor .................................58
Replacing Your Sensor .................................59
Using Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Using the Reader’s Built-in Meter . . . . . . . . . . . . . . . . . . . . . . 62
Intended Use............................................62
Blood Glucose Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Control Solution Testing .................................71
Charging the Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Changing the Reader Settings .........................77
Living With Your System................................80

Maintenance and Disposal .............................83
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Reader Does Not Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Problems at the Sensor Application Site ..................89
Problems Starting Your Sensor or Receiving
Sensor Readings.........................................90
Blood Glucose Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Problems Checking Your Blood Glucose . . . . . . . . . . . . . . . . . . 97
Perform a Reader Test....................................99
Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
System Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .100
Labeling Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .105
Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . .107
Electromagnetic Compatibility (EMC) .................123
Limited Warranty......................................134

Important Safety Information
Indications For Use
The FreeStyle Libre 14 day Flash Glucose Monitoring System is a
continuous glucose monitoring (CGM) device indicated for the
management of diabetes in persons age 18 and older. It is designed to
replace blood glucose testing for diabetes treatment decisions.
The System detects trends and tracks patterns aiding 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 intended for single patient use and requires a
prescription.
Contraindications
MRI/CT/Diathermy: The FreeStyle Libre 14 day Flash Glucose
Monitoring 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.
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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.
• Check Sensor glucose readings by conducting a ngerstick test
with a blood glucose meter under the following conditions,
when Sensor glucose readings may not be accurate and should
not be used to make a diabetes treatment decision:
• If you suspect that your reading may be inaccurate for any reason
• When you are experiencing symptoms that may be due to low or
high blood glucose
• When you are experiencing symptoms that do not match the
Sensor glucose readings
• During the rst 12 hours of wearing a FreeStyle Libre 14 day Sensor
• During times of rapidly changing glucose (more than 2 mg/dL per
minute)
• When the Sensor glucose reading does not include a Current
Glucose number or Glucose Trend Arrow
• In order to conrm hypoglycemia or impending hypoglycemia as
reported by the Sensor
• When you see the symbol, you must check your
blood glucose with a blood glucose meter before
making any treatment decisions. Sensor readings may
not accurately reect blood glucose levels. 350
250
150
50
82
mg
dL
2pm 6pm 10pm
Glucose Going
Low
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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/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.
WARNINGS (cont.)
• Hypoglycemic unawareness: The System has not been evaluated
for use in patients with hypoglycemic unawareness and will not
automatically alert you of a hypoglycemic event without you
scanning your Sensor.
• No alarms without a Sensor scan: The System does not have
alarms that will automatically notify you when you are having a
severe low (hypoglycemic) or high (hyperglycemic) glucose event
unless you scan your Sensor. For example, the System does not have
an alarm that can alert or wake you when you are sleeping in the
case of low or high glucose.
• Choking hazard: The System contains small parts that may be
dangerous if swallowed.
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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 dierent
conditions or medications common to the critically ill population may
aect 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 14 days.
• Some individuals may be sensitive to the adhesive that keeps the
Sensor attached to the skin. If you notice signicant 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.
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• 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.
• The System uses all available glucose data 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.
• 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.
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.
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