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Patent Numbers: 5,262,035; 5,264,104; 5,264,105; 5,593,852; 5,899,855; 5,918,603; 5,965,380; 6,071,391; 6,103,033; 6,120,676; 6,121,009; 6,134,461; 6,143,164; 6,162,611; 6,175,752; 6,284,478; 6,299,757; 6,329,161; 6,338,790; 6,461,496; 6,484,046; 6,503,381; 6,514,718; 6,560,471; 6,565,509; 6,591,125; 6,592,745; 6,605,200; 6,605,201; 6,616,819; 6,618,934; 6,676,816; 6,749,740; 6,893,545; 6,932,894; 6,942,518; 6,973,706; 6,990,366; 7,003,340; 7,003,341; 7,074,308; 7,090,756; 7,299,082. Abbott Diabetes Care Inc., 1360 South Loop Road, Alameda, CA 94502 ©2008 Abbott CAUTION: Federal law restricts this device to sale by or on the order of a physician. ART16072 Rev. A 05/08 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 FreeStyle Navigator® Continuous Glucose Monitoring System are not intended to replace traditional blood glucose monitoring. Before adjusting therapy for diabetes management based on the 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). How to Use this Guide? This guide has many Sections arranged in a logical sequence that will be useful for the first time use and every use thereafter. Most Sections begin with a purpose for that Section, when to perform the steps in that Section, materials required to perform the steps in that Section and important cautions, warnings and helpful information. The first page of each Section will be very useful when you are getting familiar with the system. Once you are familiar with the system and the typical precautions, you may find yourself relying less on the first page of the individual Sections. The remainder of each Section describes the steps to perform the tasks. The steps are organized in a simple manner to allow you to see what to do based on what you experience and based on where you are in that particular Section. It is important that you go through the steps in the order that they have been presented. Every Section also indicates if you have reached the end of the Section. If you find it difficult to use the guide or if you seem lost or confused, use the table of contents, index, glossary and appendices to help you. The table of contents provides a list of Sections you will find in this guide and what each Section contains. The appendices have useful information that you may want to refer to. The glossary provides a list of terms and what they mean. The index is a tool you could use to quickly find terms and items that you are looking for. • FreeStyle Navigator® and FreeStyle® are registered trademarks of the Abbott Group of Companies in various jurisdictions. • OpSite® IV 3000 and Uni-Solve® are trademarks of Smith and Nephew Inc. • Bluetooth® wireless technology is a trademark of the Bluetooth SIG Inc. • YSI 2300 STAT Plus™ Glucose Analyzer is a trademark of Yellow Springs Instrument Inc. • Energizer® Max®, Energizer® e2® Titanium® and Energizer® Industrial Batteries are trademarks of the Eveready Battery Company Inc. Glossary of Symbols Do not re-use Temperature limitation Rx only. For use by Manufactured by prescription only Sterile Consult operating instructions Use by Batch code Serial number Catalog number Table of Contents n Section 1: Getting Acquainted. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 – 12 Parts of the System. Daily Activities and Traveling. Preparing the System for the First Time. Warnings, Cautions and Important Notes. Hypoglycemia Unawareness. Modes of Operation (Continuous Monitoring Mode (CM) and Blood Glucose Mode (BG)). n Section 2: Install or Replace Transmitter and Receiver Batteries . . . . . . . . . . . . . . . . . . . . . 15 – 18 Installing the Batteries in Your System. Battery Types for the Transmitter and the Receiver. When to Change the Batteries? n Section 3: Set the Time and Date . . . . . . . . . . . . . . . . . . ...