Know The FreeStyle Navigator System

The sensor is placed on the back of your upper arm or your abdomen, and is held there with a special adhesive. A tiny filament 5mm long—as thin as several strands of hair—goes just under the skin. It measures the glucose level in the interstitial fluid, which flows between the cells, and it’s similar to measuring the blood glucose level.*

The transmitter is attached to the sensor and sends glucose readings to the wireless receiver up to 10 feet away. You can wear the sensor/transmitter for up to five days straight, and do just about anything with it on: work, exercise, bathe, sleep.**

The receiver is like a little computer. It stores all your glucose readings, for up to 60 days, and it gives you an accurate picture of what your glucose is doing. You can program it to predict out-of-range highs and lows based upon thresholds you set, and it lets you know with alarms1 if any are heading towards high and lows so you can take action to avoid them. The receiver is also the only CGM device on the market to have a built-in blood glucose meter for convenient calibration—no need for a separate device.

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*	Interstitial fluid and capillary blood can vary during times of rapid change.
**	Note: 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.
1	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. Projected Alarm High Setting = maximum detection; more alarms; earliest warning (~30 minutes). Projected Alarm Low Setting = minimum detection; fewer alarms with less advanced notice (~10 minutes) 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.