FreeStyle Navigator(R) - Predictive Technology

See The Future
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The FreeStyle Navigator® system provides many benefits to the user. You can see past, present and future glucose data, revealing which way and how quickly your glucose is heading. Utilizing our unique TRU™ Directional Arrow technology provides you a quick snapshot of your glucose trends right next to your glucose reading.on the screen. Just as important, there are alarms that can warn you before you go high or low. You can preset the alarm to give you a warning 10, 20 or 30 minutes before. The system can be set to different volumes or to vibrate. (for privacy)
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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.
DOC13835_Rev-A 01/08








