FreeStyle Navigator(R) Blood Glucose Monitoring System

FreeStyle Navigator(R)

The FreeStyle Navigator® system…let’s talk a little bit about science…

With current glucose monitoring, even frequent testers may miss significant highs and lows. Continuous monitoring reveals readings traditional monitoring may miss.

You can reach a whole new level of glucose control with predict ability. Predicting glucose highs and lows allows for the ability to manage glucose better than ever before.

The FreeStyle Navigator system is technology that performs. Unique to the FreeStyle Navigator system is advanced Wired Enzyme™ technology.

With a stable signal, minimal oxygen dependence, and insensitivity to interferents—Wired Enzyme technology is designed for reliable and accurate sensor readings.

Illustration of the Advanced Wired Enzyme™ Technology

Using amperometry, the sensor utilizes a working electrode coated with a sensing element (Wired Enzyme) that converts glucose concentration to electrical current.

Sound technical? It is and our years of research and clinical application have made the technology as reliable as it is today. Now, you can put your diabetes under new management with the FreeStyle Navigator Continuous Glucose Monitoring System.

 
 
 

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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.

 
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