Continuous Monitoring System
A revolutionary advance in managing diabetes!
The FreeStyle Navigator® Continuous Glucose Monitoring System offers the potential to significantly increase the amount of clinically relevant information available to individuals with diabetes. Such information could be used to help improve clinical decisions made by the user and their healthcare provider. To learn about the FreeStyle Navigator System, please visit www.FreeStyleNavigator.com.
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.
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.
