Indications and Important Safety Information for the FreeStyle Navigator System

Safety Information:

Users should read all of the instructions in the Users Guide before using the FreeStyle Navigator Continuous Glucose Monitoring System. Adjustments to treatment should be done under the guidance of the users 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. Performance of the FreeStyle Navigator system has not been evaluated in pregnant women.
2009 Abbott. ART18030 Rev. A 05/09

A Revolutionary Advance in Continuous Glucose Monitoring
Continuous glucose monitoring with the FreeStyle Navigator Continuous Glucose Monitoring System allows you to see a more complete picture of your glucose fluctuations. With continuous glucose readings each minute, you dont miss the significant highs and lows that can occur between traditional blood glucose tests. The FreeStyle Navigator system shows you where your glucose levels are now, and more importantly, where your glucose levels are headed so you can act instead of react.
Worn for up to 5 days on the back of the upper arm or abdomen.

SENSOR

RECEIVER
Receives glucose information from the transmitter and displays it on the screen. Continuous Glucose Readings every minute, in real time, provide access to information anywhere, night and day. TRU Directional Arrow Indicator accurately projects glucose rate and direction of change (illustration shows glucose declining between 1 and 2 mg/dL per minute). Customizable Early Warning Alarms* -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)

WIRELESS TRANSMITTER

Sends glucose readings to the receiver anywhere within a 10-foot range. With wireless technology, enjoy the freedom from cables, wires and tubes.
Built-in FreeStyle Blood Glucose Meter provides a convenient way to calibrate and to perform confirmatory blood glucose tests.
*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.
Reach a whole new level of glucose control with continuous readings and PREDICT ABILITY
Indications and Important Safety Information for the FreeStyle Navigator System Safety Information: Users should read all of the instructions in the Users Guide before using the FreeStyle Navigator Continuous Glucose Monitoring System. Adjustments to treatment should be done under the guidance of the users 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. (Indications and Important Safety Information continued on reverse)
Enjoy the benefits of the FreeStyle Navigator Continuous Glucose Monitoring System1
Feature Wireless Range Projected Alarms Directional Arrows Built-in Blood Glucose Meter Transmitter Water Resistance Minimum Number of Calibrations (averaged over total wear period) Frequency of Glucose Readings FreeStyle Navigator Continuous Glucose Monitoring System 10 ft Yes Yes Yes (FreeStyle blood glucose meter) Yes (up to 3 feet for 30 min) Less than once a day per sensor Every minute DexCom SEVEN PLUS Continuous Glucose Monitoring System 5 ft No Yes No Yes Twice a day per sensor Every 5 minutes Guardian REAL-Time Continuous Glucose Monitoring System 6 ft Yes Yes No Yes Twice a day per sensor Every 5 minutes

Talk to your doctor or healthcare professional and find out if the FreeStyle Navigator system is right for you.
You will need a prescription from your doctor before you can purchase this system. In order to assist you in the process of obtaining a FreeStyle Navigator system, Abbott Diabetes Care (ADC) has developed a Resource Center to help you determine whether or not your health insurance plan covers this product and to provide information on the distribution process.
In order to find out more about how to obtain your system, download all forms from the website www.FreeStyleNavigator.com. Please complete the forms and have them ready before contacting the ADC Resource Center.
1 Complete and sign the Authorization to Release Patient Information. 2 Complete and sign the Patient Information Questionnaire. All information is confidential. 3 Obtain a completed Statement of Medical Necessity from your physician. 4 Submit this information to ADC Resource Center by Fax: Attention: ADC Resource Center, 1-888-423-2435 or by Mail: ADC Resource Center, P. O. Box 1087, San Bruno, CA 94066 After we receive your information, an ADC Resource Counselor will contact you to discuss how you wish to proceed. Insurance coverage for the FreeStyle Navigator system varies by plan on an individual case-by-case basis. Please contact the ADC Resource Center by phone at 1-877-423-2463 (Mon-Fri, 8am - 8pm EST) for assistance with insurance coverage.
For information about the FreeStyle Navigator Continuous Glucose Monitoring System, please visit www.FreeStyleNavigator.com or call ADC Customer Care 24 hours/day, 7 days/week at 1-866-597-5520
1. This comparison of design features is based on each products published product information and is not intended to imply comparable safety or effectiveness. The product features and description for other products are listed here for information purposes. They are subject to change at the discretion of their respective manufacturers. This comparison is based on information available as of May 2009. FreeStyle and FreeStyle Navigator are registered trademarks of Abbott Diabetes Care Inc. All other trademarks are the property of their respective owners.
Indications and Important Safety Information for the FreeStyle Navigator System - continued 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. Performance of the FreeStyle Navigator system has not been evaluated in pregnant women.