FreeStyle Navigator(R) Blood Glucose Monitoring System
Introducing the new FreeStyle Navigator® Continuous
Glucose Monitoring System, a revolutionary advance in managing
diabetes.
People manage diabetes in a variety of ways. Some manage with careful diet
and exercise; others test their blood glucose frequently.
The problem is that no matter what your usual experience may be, it can all
change without warning, at any time: while working, while driving, while
sleeping. And that’s the kind of uncertainty nobody needs.
Finally, the technology has arrived to allow you to reach a whole new level
of glucose control with continuous readings and predict ability.
Predict glucose highs and lows.
The FreeStyle Navigator system features:
- Customizable
early-warning alarms* in advance of ~10 to 30 minutes
- Continuous
glucose readings each minute, providing real-time readings, graphs and
trends. Only the FreeStyle Navigator system provides readings every minute
- TRU Directional Arrow™ Indicator technology to
accurately project glucose direction and rate of change
- Suitable for
everyday activities—including exercise**, bathing, and swimming
- Contains a
built-in FreeStyle® meter for convenient calibration (minimum of 4
calibrations averaged over the total 5 day period) and confirmatory blood
glucose tests
- Sensor
continuously worn on body for up to 5 days
- Wireless
transmitter sends glucose readings to the receiver anywhere within a 10-foot
range
- Graphs and
reports show glucose patterns
*
Projected Alarm High Setting = maximum
detection; more alarms; earliest warning (~30 minutes).
Projected Alarm Low Setting = minimum detection;
fewer alarms with less advanced notice (~10 minutes)
The FreeStyle Navigator® system has a projected
alarm that can be set at a low, medium or high sensitivity to alert the user
~10 to 30 minutes before glucose levels reach the high or low glucose threshold
settings, assuming glucose keeps changing at the same rate. The performance of
the projected alarms has not been established.
Projected alarms increase the overall ability to
detect high and low glucose conditions. Using the projected alarms AND
threshold alarms provides maximum notification of high or low glucose
conditions. Always perform a traditional blood glucose test before adjusting
therapy based on system results and alarms.
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Call us 24
hours a day, 7 days a week: 1-866-597-5520
**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 support mount to the skin and cause the sensor to
dislodge. If the sensor dislodges due to the sensor support adhesive failing to
adhere to the skin, you may get unreliable results or no results. The system
may not provide a warning in such circumstances. Choose the proper sensor
insertion site when inserting the sensor and prepare the site by following the
instructions for site preparation.
Indications and Important Safety Information for the FreeStyle
Navigator® System
Safety Information: Users should read all of the
instructions in the User's Guide before using the FreeStyle
Navigator® Continuous Glucose Monitoring System. Adjustments to
treatment should be done under the guidance of the user's health care team.
Indications for Use: The FreeStyle Navigator Continuous
Glucose Monitoring System is indicated for continually recording interstitial
fluid glucose levels in people (ages 18 and older) with diabetes mellitus for
the purpose of improving diabetes management. Readings and alarms about glucose
levels from the FreeStyle Navigator Continuous Glucose Monitoring System are
not intended to replace traditional blood glucose monitoring. Before adjusting
therapy for diabetes management based on results and alarms from the FreeStyle
Navigator Continuous Glucose Monitoring System, traditional blood glucose tests
must be performed. The FreeStyle Navigator Continuous Glucose Monitoring System
provides a built-in blood glucose meter to confirm the continuous glucose
result.
The FreeStyle Navigator Continuous Glucose Monitoring System provides
real-time readings, graphs, trends, and glucose alarms directly to the user.
The FreeStyle Navigator Continuous Glucose Monitoring System is intended to be
used in home settings to aid people with diabetes in predicting and detecting
episodes of hypoglycemia and hyperglycemia and in clinical settings to aid
health care professionals in evaluating glucose control. The FreeStyle
Navigator Continuous Glucose Monitoring System is available only by
prescription.
Contraindications: The FreeStyle Navigator Continuous
Glucose Monitoring System must be removed prior to Magnetic Resonance Imaging
(MRI).
Prescription Device: Federal law restricts the sale of this
device by or on order of a physician.
Warnings/Precautions: Infection, inflammation, or bleeding
at the glucose sensor insertion site are possible risks of inserting a sensor
into your skin. If you believe your results are not reliable, or are
inconsistent with how you feel, perform a blood glucose mode test to measure
your glucose. If the problem continues, discard the old sensor and insert a new
sensor. Performance of the system under conditions of fluctuating hydration
levels such as during renal dialysis has not been evaluated. Unintended
dislodging of the sensor due to excessive perspiration, exercise, or bumping,
may cause unreliable or no results without warning. Performance of the
FreeStyle Navigator system has not been evaluated in pregnant women.
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DOC19079_Rev-A
06/09
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