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. Many give themselves insulin through injection or an insulin pump.

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. Ability to manage glucose levels better than ever before.

The FreeStyle Navigator system features:

• Customizable early-warning alarms 10, 20, or 30 minutes in advance to significantly reduce hypoglycemic and hyperglycemic episodes
• Continuous glucose readings each minute, providing real-time access to information. Only the FreeStyle Navigator system provides readings every minute
• TRU™ Directional Arrow 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
   

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Why Continuous Glucose Monitoring?

Predict Glucose Highs and Lows

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Safety Information: Users should read all of the instructions in the User’s Guide before using FreeStyle Navigator® Continuous Glucose Monitoring System. Adjustments to treatment should be done under the guidance of the user’s healthcare 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 healthcare 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. A portion of the membrane polymer will remain in the skin each time the sensor is removed. Although no health effects were observed or reported in clinical studies, the long term effects of the sensor membrane fragments remaining in the skin have not been determined. Performance of the FreeStyle Navigator^® system has not been evaluated in pregnant women.

*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.