Cautions And Limitations - Freestyle Libre User Manual

WARNINGS (cont.)
•
Hypoglycemic unawareness: The FreeStyle Libre 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 FreeStyle Libre 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 FreeStyle Libre 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 .
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•
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:
•
After the 12 hour start-up period, the Sensor can be worn for up to 10
days .
•
Some individuals may be sensitive to the adhesive that keeps the
Sensor attached to the skin . If you notice significant skin irritation
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