QXSTX111004Diabetes Monitor Transmitter

Continuous Glucose Monitoring System User’s Guide Clinical Trial Support Line: 1-888-971-4766 - 2 - ART05005 REV 4 The FreeStyle Navigator™ Continuous Glucose Monitoring System (the “System”) continually reads, displays, and records interstitial fluid glucose levels in people with diabetes as an alternative to traditional blood glucose monitoring. It provides readings directly to the user in real time. It also provides alarms for the detection and assessment of episodes of hypoglycemia or hyperglycemia. It is intended for everyday use in the home to aid people with diabetes, and for use in clinical settings to aid healthcare professionals in evaluating glucose control. It is intended for prescription use only. CAUTION: Read all the instructions provided in this User’s Guide before using the System. Glucose management (therapy adjustment) should be done only under the guidance of your healthcare team. Clinical Trial Support Line: 1-888-971-4766 - 3 - ART05005-REV-4 IMPORTANT INFORMATION System-Related Information • The FreeStyle Navigator Continuous Glucose Monitoring System is designed as a complete System. Use only the FreeStyle Navigator Sensor, FreeStyle Navigator Transmitter, and FreeStyle Navigator Receiver. • The System is intended for your own personal use; do NOT share your System. • If you are unsure about the meaning of any Receiver messages or results, consult your healthcare team or call the Clinical Trial Support Line at 1-888-971- 4766. System-Related Warnings and Cautions • WARNING: Keep the System and its components away from young children, as there are small parts that may be dangerous if swallowed. The caps are choking hazards. The Test Strip cap or vial may contain a drying agent that could be harmful if inhaled or swallowed and may cause skin and eye irritation. • WARNING: Never point the pre-cocked Sensor Inserter toward the eyes, face, or any other body part where Sensor insertion is not desired. • Changes or modifications not expressly approved by Abbott Diabetes Care could void the user's authority to operate the equipment. • The System should not be used in an oxygen-rich environment or one related to anesthetic gas. • To reduce the chance of infection, do NOT leave a Sensor inserted for more than 3 days. • Once the Locking Pin has been removed from the Sensor Delivery Unit, the Sensor will be released if the button is pressed (see page 48). Do NOT press the button until you are ready to insert the Sensor. Clinical Trial Support Line: 1-888-971-4766 - 4 - ART05005 REV 4 • The Sensor should be removed if redness, pain, tenderness, or swelling develops at the insertion site. • The Sensor Support Mount and Transmitter are water resistant and may be worn while bathing, showering, or swimming. While swimming, make sure you do not go deeper than 1 meter (roughly 3 feet) or the Sensor gasket might leak, causing the Transmitter to stop working properly. When the Transmitter is underwater, the Transmitter/Receiver connection will be broken and you will not receive continuous glucose readings. • Do NOT immerse the Receiver in water or any other liquid. Avoid getting water or any other liquid in the Receiver’s Test Strip Port. • The Transmitter should be removed from the Sensor Support Mount and cleaned (see page 141) each time you remove a used Sensor (every 3 days). • If the Sensor Support Mount fails to adhere to the skin, the Sensor will not work and you will need to insert a new Sensor. • Do NOT drop the Receiver. • When using the System in the Blood Glucose Mode, use only FreeStyle Test Strips and FreeStyle Control Solution. Other brands of test strips or control solution can give you inaccurate results. • Do NOT use FreeStyle Control Solution for calibration. • If you get a Control Solution test result that falls outside the range printed on the Test Strip vial, repeat the test with a new Test Strip. If the test result is still outside the range on the vial, the System may not be working properly. Do NOT use the System to test your glucose levels unless you get a Control Solution test result within the range printed on the Test Strip vial. Health-Related Information • The System is intended to assist you in better managing your diabetes by allowing you to know your glucose levels throughout the day. Clinical Trial Support Line: 1-888-971-4766 - 5 - ART05005-REV-4 • The System is not intended to be used for diagnosing diabetes, testing newborns, or testing arterial blood. • Test results below 60 mg/dL (3.3 mmol/L) mean your glucose levels are too low. • Test results above 300 mg/dL (16.7 mmol/L) mean your glucose levels are too high. • Severe dehydration and excessive water loss may cause false low results. If you believe you are suffering from severe dehydration, consult your healthcare team immediately. • If your results do not reflect how you feel, wait at least 1 minute and review the new data from the Continuous Monitoring Mode or test your glucose using the Blood Glucose Mode. • If you get results below 60 mg/dL (3.3 mmol/L) or above 300 mg/dL (16.7 mmol/L) and do not have symptoms of hypoglycemia or hyperglycemia, wait at least 1 minute and review the new data from the Continuous Monitoring Mode or test your glucose using the Blood Glucose Mode. • If you have symptoms of hypoglycemia or hyperglycemia, or continue to get results below 60 mg/dL (3.3 mmol/L) or above 300 mg/dL (16.7 mmol/L), consult your healthcare team. • If you are experiencing symptoms that are not consistent with your glucose test results, consult your healthcare team. • When testing your glucose levels in the Blood Glucose Mode, differences in the blood circulation in your finger or palm at the base of your thumb* and other test sites (forearm, upper arm, hand, thigh, calf) may result in different glucose readings. Differences in blood glucose readings between your finger or palm and other test sites may be observed after eating, taking insulin medication, or exercising. * Palm testing a…

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October 21, 2004 American TCB 6731 Whittier Avenue, Suite C110 McLean, VA. 22101 Gentlemen: The enclosed documents constitute a formal submittal and application for a Grant of Equipment Authorization pursuant to Subpart C of Part 15 of FCC Rules (CFR 47) regarding intentional radiators. Data within this report demonstrates that the equipment tested complies with the FCC limits for intentional radiators. Elliott Laboratories, as duly authorized agent prepared this submittal. A copy of the letter of our appointment as agent is enclosed. If there are any questions or if further information is needed, please contact Elliott Laboratories for assistance. Sincerely, Mark Briggs Vice President of Engineering MB/jls Enclosures: Agent Authorization Letter Emissions Test Report with Exhibits

XXXXXXX-XXXXX ART04993 Rev. B FCC ID: QXSTX111004 IPX7 NOT FOR SALE P/N PRT03831-001 TheraSense, Inc. Alameda, CA U.S.A. 1.888.971.4766 WARNING: Investigational Use ONLY Per Federal Law = DIELINE COLOR, does not print. = FPO COLOR, does not print. THERASENSE COMPONENT SPECIFICATION Part #: PRT04993 rev B Effective Date: 07/15/04 Page 1 of 2 Material: Label, Housing, Bottom, Navigator Transmitter TheraSense Confidential Form # DOC02302-003 Rev A Date Printed: 1/5/2005 11:52 AM PACKAGING REQUIREMENTS Individual Rolls Labeled with the Following Information: TheraSense Part Number and Revision Level – Human Readable and Bar Coded (39 or 128) Manufacturers Lot/Job Number – Human Readable and Bar Coded (39 or 128) Individual Part Quantity – Human Readable and Bar Coded (39 or 128) Cases/Shippers Labeled with the Following Information: TheraSense Part Number and Revision Level – Human Readable and Bar Coded (39 or 128) Manufacturers Lot/Job Number – Human Readable and Bar Coded (39 or 128) Individual Part Quantity – Human Readable and Bar Coded (39 or 128) TheraSense P.O. Number – Human Readable and Bar Coded (39 or 128) Manufacturer TheraSense Part Number, Revision Level, Quantity and P.O. Number on Packing Slip A Certificate of Compliance/Conformance is required with every shipment Rolls must be packaged in cases Each case weight must not exceed 45 lbs Cases to fit onto 40” x 48” standard pallets Height of pallet and boxes not to exceed 48” PRINTING REQUIREMENTS Label Stock: THERMfilm Select 3002 Thermal Transfer Face Stock 50# Face Stock: Face stock must be thermal transfer printable Adhesive: L-23 permanent solvent-based acrylic adhesive Liner: Notch as required to provide index for printing location Core Size: 3” Max Roll Diameter: n/a Min Roll Diameter: n/a Labels per Roll: n/a Label Size: 21.7 ± .25 x 18.2 ± .25 mm; Note: uses same die as PRT04769 Label Corner Radius: 1.8 ± .25 mm Label Spacing: 3.2 ± .3 mm Liner Size: 25.4 ± .2 mm Label Centered Label Copy Position: Copy Position – Labels on outside of roll; top side of copy dispenses first; short axis of label oriented in web direction Artwork: ART04993 rev B Ink: UV cured – no overcoat Print to Label Registration:± 2 mm in both axis Splices: No more than 2 splices per roll In Roll Rejects: No missing, rejected, smeared or incompletely printed labels THERASENSE COMPONENT SPECIFICATION Part #: PRT04993 rev B Effective Date: 07/15/04 Page 2 of 2 Material: Label, Housing, Bottom, Navigator Transmitter TheraSense Confidential Form # DOC02302-003 Rev A Date Printed: 1/5/2005 11:52 AM STORAGE, HANDLING AND INSPECTION REQUIREMENTS Special Handling Instruction: None Storage Condition: N/A Expiration/Shelf Life: 3 years from manufacture date Sample Size: ANSI/ASQC AQL Level 4.0, Inspection Level S-4 Retain Sample: 3 Samples for each new revision QC Inspection (Non-Certified Supplier): 1.) Verify Part and Artwork Numbers and Revision Levels 2.) Verify that labeling matches the requirements listed above 3.) Verify that correct Certificate is present 4.) Verify received quantity matches documentation 5.) Measure Liner Width and Liner Registration – As per drawing 6.) Check Print Registration 7.) Confirm Payoff Direction 8.) Inspect Roll Condition – No telescoping or uneven wraps 9.) Check Cosmetics – Assure printing is complete, clear and legible and there is no ink smearing/bleeding or tattered edges QC Inspection (Certified Supplier): 1.) For the first lot of each new artwork revision, perform first article inspection on items 1, 5, 6 and 9 as defined above. 2.) No inspection required for any subsequent lots, unless noted. 21.7 18.2 R 1.8 6 places 4.10 25.40 TOP OF LABEL R 2.9 10.85 Dimensions in mm

File: R57616 Page 1 of 15 Electromagnetic Emissions Test Report In Accordance With FCC Part 15 Section 15.231 on the Therasense (Abbott Diabetes Care) Transmitter Model: Navigator Continuous Glucose Monitor FCC ID: QXSTX111004 GRANTEE: Therasense (Abbott Diabetes Care) 1360 South Loop Road Alameda, CA 94502 TEST SITE: Elliott Laboratories, Inc. 684 W. Maude Ave Sunnyvale, CA 94086 REPORT DATE: October 21, 2004 FINAL TEST DATE: October 8, 2004 AUTHORIZED SIGNATORY: ______________________________ Mark Briggs Vice President of Engineering Elliott Laboratories, Inc. is accredited by the A2LA, certificate number 2016-01, to perform the test(s) listed in this report. This report shall not be reproduced, except in its entirety, without the written approval of Elliott Laboratories, Inc. Elliott Laboratories, Inc. -- EMC Department Test Report Report Date: October 21, 2004 File: R57616 Page 2 of 15 Pages TABLE OF CONTENTS COVER PAGE...................................................................................................................................................................................1 TABLE OF CONTENTS..............................................................................................................................................................2 SCOPE............................................................................................................................................................................................3 OBJECTIVE...................................................................................................................................................................................3 STATEMENT OF COMPLIANCE..............................................................................................................................................4 TEST RESULTS SUMMARY......................................................................................................................................................4 15.231 / RSS 210 SECTION 6.1.................................................................................................................................................4 MEASUREMENT UNCERTAINTIES.........................................................................................................................................5 EQUIPMENT UNDER TEST (EUT) DETAILS..........................................................................................................................6 GENERAL...................................................................................................................................................................................6 ENCLOSURE..............................................................................................................................................................................6 MODIFICATIONS.....................................................................................................................................................................6 SUPPORT EQUIPMENT...........................................................................................................................................................6 EUT INTERFACE PORTS........................................................................................................................................................6 EUT OPERATION.....................................................................................................................................................................7 ANTENNA SYSTEM................................................................................................................................................................7 TEST SITE......................................................................................................................................................................................8 GENERAL INFORMATION.....................................................................................................................................................8 CONDUCTED EMISSIONS CONSIDERATIONS.................................................................................................................8 RADIATED EMISSIONS CONSIDERATIONS....................................................................................................................8 MEASUREMENT INSTRUMENTATION..................................................................................................................................9 RECEIVER SYSTEM..................................................................................................................................................................9 INSTRUMENT CONTROL COMPUTER...............................................................................................................................9 LINE IMPEDANCE STABILIZATION NETWORK (LISN)................................................................................................9 FILTERS/ATTENUATORS....................................................................................................................................................10 ANTENNAS.............................................................................................................................................................................10 ANTENNA MAST AND EQUIPMENT TURNTABLE.....................................................................................................10 INSTRUMENT CALIBRATION............................................................................................................................................10 TEST PROCEDURES.................................................................................................................................................................11 EUT AND CABLE PLACEMENT.....................................................................…

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Tx: AAAF293-80229 1 Min per Division. Tested by: Thomas Pongo Date: 1/17/05 Note: The pulse protocol calls for a pulse every one minute, plus or minus ten seconds, to prevent a nearby constant one minute pulse from continuously blocking signal transmission. plots showing pulse duration (20ms) for a single transmission

Test Configuration Photographs