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 reflect blood glucose levels.
If you are using the FreeStyle LibreLink app, you must also have access to a blood glucose monitoring system as the App does
not provide one.
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.
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.
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:
Summary of Contents for FreeStyle Libre
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