User's Manual

Important Safety Information
Indications For Use
The FreeStyle Libre 2 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 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.
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 2 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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