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Support Mount to the skin and cause the Sensor to dislodge . If the
Sensor dislodges due to the Sensor Support Mount adhesive failing to
adhere to the skin, you may get unreliable results or no results without
a warning . Choose the correct Sensor insertion site when inserting
the Sensor and prepare the site by following the instructions for site
preparation .
• Severe dehydration and excessive water loss may cause false results . If
you believe you are suffering from dehydration, consult your physician
immediately .
Cautions
• To ensure accuracy and correct performance, the FreeStyle Navigator II
System includes built-in self-checks to detect some conditions that
may cause the Sensor to not function correctly . On rare occasions,
the system may not be able to detect all conditions that affect Sensor
function and you may get inaccurate continuous monitoring results .
If the problem continues, discard the current Sensor and insert a new
one .
• If you have hypoglycaemia or hypoglycaemia unawareness, then
perform blood glucose checks ONLY on your fingers . Changes in
glucose levels may be observed in finger blood samples sooner than
in samples from approved alternate sites . If an alternate site must be
used, vigorous rubbing of the alternate site before lancing can help
minimise this difference .
• Performance of the FreeStyle Navigator II System has not been
evaluated in pregnant women .
• The system should not be used in environments that are oxygen-rich
or that contain a combustible gas .
• Performance of the system under conditions of fluctuating hydration
levels, such as during renal dialysis, has not been evaluated .
• The Receiver and Transmitter of your FreeStyle Navigator II System
operate on a frequency that may be used by other communications
devices, including amateur “HAM” radio transmitters (which
may be fixed, mobile or handheld “walkie-talkie” type units) . The
communication between your Transmitter and Receiver may
occasionally be lost when you are near HAM radio equipment . If your
FreeStyle Navigator II System loses wireless communication, move
away from the HAM radio to re-establish wireless communication .
• If you have a medical appointment that includes strong magnetic or
electromagnetic fields, such as an X-ray, MRI (Magnetic Resonance
Imaging), CT (Computed Tomography) scan or another type of
exposure to radiation, keep your Receiver and Transmitter/Sensor Unit
away from the area . Before exposure to such radiation, discard any
Sensor you are wearing and insert a new Sensor after the radiation
session . The effect of these types of radiation on the performance of
the system has not been evaluated .
• Changes or modification to the device not expressly approved by
Abbott Diabetes Care Inc . could void the user’s authority to operate
this equipment .
Indications for Use
The FreeStyle Navigator II Continuous Glucose Monitoring System
is a glucose monitoring device indicated for continually measuring
interstitial fluid glucose levels in people (age 6 and older) with diabetes
mellitus . The indication for children (age 6 - 17) is limited to those
who are supervised by a caregiver who is at least 18 years of age . The
caregiver is responsible for managing or assisting the child to manage
the FreeStyle Navigator II System and also for interpreting or assisting
the child to interpret FreeStyle Navigator II readings .
The FreeStyle Navigator II Continuous Glucose Monitoring System is
designed to replace blood glucose testing in the self-management
of diabetes with the exceptions listed below . Under the following
circumstances, use a blood glucose meter to check the current glucose
readings from the FreeStyle Navigator II Continuous Glucose Monitoring
System Sensor:
• During times of rapidly changing glucose levels, interstitial glucose
levels as measured by the Sensor and reported as current may not
accurately reflect blood glucose levels . When glucose levels are
falling rapidly, glucose readings from the Sensor may be higher
than blood glucose levels . Conversely when glucose levels are rising
rapidly, glucose readings from the Sensor may be lower than blood
glucose levels .
• In order to confirm hypoglycaemia or impending hypoglycaemia as
reported by the Sensor .
• If symptoms do not match the FreeStyle Navigator II Continuous
Glucose Monitoring System reading . Do not ignore symptoms that
may be due to low blood glucose or high blood glucose .
For more detailed information on the FreeStyle Navigator II system, see
the Expert Guide. The Expert Guide can be found on a CD-ROM inside
your system kit. For a printed copy of the Expert Guide, please contact
Customer Care.
Warnings
• During times of rapidly changing glucose (more than 120 mg/dL
per hour or 6 .7 mmol/L per hour), continuously reported interstitial
glucose levels as measured by the FreeStyle Navigator II Sensor may
not accurately reflect blood glucose levels . Under these circumstances,
use the built-in FreeStyle Lite Blood Glucose (BG) Meter to conduct
finger-stick testing to check the continuous glucose results from the
FreeStyle Navigator II Sensor .
• In order to confirm hypoglycaemia or impending hypoglycaemia as
reported by the FreeStyle Navigator II Continuous Glucose Sensor, use
the built-in FreeStyle Lite Blood Glucose Meter to conduct finger-stick
testing to check the FreeStyle Navigator II reading .
• Do not ignore symptoms that may be due to low blood glucose or
high blood glucose . If you have symptoms that do not match the
FreeStyle Navigator II reading, use the built-in FreeStyle Lite Blood
Glucose Meter to conduct finger-stick testing to check the FreeStyle
Navigator II Continuous Glucose reading . If you are experiencing
symptoms that are not consistent with your glucose readings, consult
your healthcare team .
• Movement of the Sensor Support Mount or excessive perspiration
at the Sensor insertion site due to activities like vigorous exercise or
bumping against objects may lead to poor adhesion of the Sensor
Customer Care: + 8000 - 2255 - 232 (+ 8000 - CALL - ADC)
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