FreeStyle Navigator(R) - Daily Use

Know Yourself

If you tested yourself 1440 times a day (in other words, every minute), your fingers would be very unhappy. And you’d have time to do little else. But the FreeStyle Navigator^® system shows you a new reading every 60 seconds, no matter what you’re doing: eating, exercising*, swimming, driving, sleeping—living.

Not only that, the FreeStyle Navigator system stores the data and keeps track of your glucose trends up to 60 days. So instead of being left wondering what’s going on, you’ll be able to make whatever adjustments you need to keep within your target range.

Best of all, the FreeStyle Navigator system brings a new tool to diabetes management—an experience we hope you will find remarkable.

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*	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.