QXS-LIB01Freestyle Libre Glucose Monitoring System

DO NOT PRINT FROM THIS FILE - FOR REFERENCE ONLY Reader Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Important Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Getting to Know Your System . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Reader Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Sensor Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 FreeStyle Libre Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Setting up Your Reader for the First Time . . . . . . . . . . . . . . 14 Using Your Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Applying Your Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Starting Your Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Checking Your Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Adding Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Contents Reviewing Your History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Logbook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Daily Graph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Other History Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Removing Your Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Replacing Your Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Using Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Using the Built-in Meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Blood Glucose Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Blood Ketone Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 Control Solution Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 Using the Rapid-Acting Insulin Calculator . . . . . . . . . . . . . . . . 56 Charging the Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 Changing the Reader Settings . . . . . . . . . . . . . . . . . . . . . . . . . 64 Living With Your FreeStyle Libre System . . . . . . . . . . . . . . . 67 Maintenance and Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70 Reader Does Not Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70 Problems at the Sensor Application Site . . . . . . . . . . . . . . . . . . 71 Problems Starting Your Sensor or Receiving Sensor Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72 Blood Glucose or Ketone Error Messages . . . . . . . . . . . . . . . . . 75 Problems Checking Your Blood Glucose or Ketone . . . . . . . . 79 Perform a Reader Tes t . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81 Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81 Professional Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82 Changing Dose Increments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83 Setting up the Insulin Calculator . . . . . . . . . . . . . . . . . . . . . . . . . 84 Easy Setup of the Insulin Calculator . . . . . . . . . . . . . . . . . . . . . . 86 Advanced Setup of the Insulin Calculator . . . . . . . . . . . . . . . . . 90 Changing the Insulin Calculator Settings . . . . . . . . . . . . . . . . 101 System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102 Rapid-Acting Insulin Calculator Specifications . . . . . . . . 106 Labeling Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108 Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . 109 DOC28687_rev-E_manual.indd 2-3 3/30/14 2:52 PM Symbol What It Means Blood glucose or ketone test Settings Control solution test result Rapid-acting insulin calculator Details of your suggested insulin dose Estimated rapid-acting insulin remaining in body Low battery Battery charging Sensor too cold Sensor too hot Reader Symbols Symbol What It Means Acti ve sensor Direction your glucose is going . See Checking Your Glucose section for more information Caution View previous/next screen Notes + Add more information to notes Food note Rapid-acting insulin note Time changed on Reader Reminders 1 2 DOC28687_rev-E_manual.indd 1-2 3/30/14 2:52 PM Important Safety In formation Indications for Use The FreeStyle Libre Flash Glucose Monitoring System is indicated for measuring interstitial fluid glucose levels in adults aged 18 years and older . It is designed to replace blood glucose testing in the self-management of diabetes with the exceptions listed below . Under the foll owing circumstances, use a blood glucose meter to check the current glucose readings from the FreeStyle Libre Flash Glucose Monitoring System Sensor: • During times of rapidly changing glucose levels, interstitial glucose le vels as measured by the Sensor and reported as current may not accurately reflect blood glucose levels . When glucose levels are falling rapidly, glucose readings from the Sensor may be higher than blood glucose levels . Conversely when glucose levels are rising rapidly, glucose readings from the Sensor may be lower than blood gluc…

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TUV Rheinland Product Under Test Photo 1279 Quarry Lane, Ste. A, Pleasanton, CA 95466 Tel: (925) 249-9123, Fax: (925) 249-9124 Report Number: 31362360.001 Page 1 of 6 EUT: Glucose Monitoring System Model: Apollo 1.1 Product Under Test Photo FCC ID: QXS-LIB01 Figure 1: External Photo of EUT (Front) TUV Rheinland Product Under Test Photo 1279 Quarry Lane, Ste. A, Pleasanton, CA 95466 Tel: (925) 249-9123, Fax: (925) 249-9124 Report Number: 31362360.001 Page 2 of 6 EUT: Glucose Monitoring System Model: Apollo Figure 2: External Photo of EUT (Bottom) TUV Rheinland Product Under Test Photo 1279 Quarry Lane, Ste. A, Pleasanton, CA 95466 Tel: (925) 249-9123, Fax: (925) 249-9124 Report Number: 31362360.001 Page 3 of 6 EUT: Glucose Monitoring System Model: Apollo Figure 3: External Photo of EUT (Side) TUV Rheinland Product Under Test Photo 1279 Quarry Lane, Ste. A, Pleasanton, CA 95466 Tel: (925) 249-9123, Fax: (925) 249-9124 Report Number: 31362360.001 Page 4 of 6 EUT: Glucose Monitoring System Model: Apollo Figure 4: External Photo of RFID Tag (Top) TUV Rheinland Product Under Test Photo 1279 Quarry Lane, Ste. A, Pleasanton, CA 95466 Tel: (925) 249-9123, Fax: (925) 249-9124 Report Number: 31362360.001 Page 5 of 6 EUT: Glucose Monitoring System Model: Apollo Figure 5: External Photo of RFID Tag (Bottom) TUV Rheinland Product Under Test Photo 1279 Quarry Lane, Ste. A, Pleasanton, CA 95466 Tel: (925) 249-9123, Fax: (925) 249-9124 Report Number: 31362360.001 Page 6 of 6 EUT: Glucose Monitoring System Model: Apollo Figure 6 – View of Power Supply Adapter with USB cord

DRAWING NO.: ART26462 PAGE: 1 of 1 SCALE: 1/1 REV.: A BLACK 90%BLACK 30% Dieline is shown for reference only. Do not print dieline. Human readable serial number and 2-D barcode printed online. ABCYXXX-XXXXX Abbott Diabetes Care Inc. 1360 South Loop Road Alameda, CA 94502 USA Customer Service: 800-527-3339 FCC ID: QXS-LIB01 Product of China ART26462 Rev. A 06/14 23.40 mm 47.40 mm FLASH GLUCOSE MONITORING SYSTEM ART26462_rev-A.pdf 1 6/6/14 3:54 PM

Photo 3 – Internal View of the Reader Photo 4 – Internal View of the Reader Photo 5 – Overall Top View of the Sensor Photo 6 – Overall Bottom View of the Sensor Photo 7 – Internal View of the Sensor Photo 8 – View of Power Supply Adapter with USB cord

Report Number: 31362360.001 Appendix: A EUT: Glucose Monitoring System Model: Apollo EMC / Rev 11/11/2013 FCCID: QXS-LIB01 Page 1 of2 RF Exposure Exhibit EUT N ame: Glucose Monitoring System Model N os.: Apollo CFR Part 1. 1310, RSS 102 and KDB 447498 D01 Prepared for: Abbott Diabetics Care, I nc. 1360 S Loop Road Alameda, CA 94502 USA Tel: 510 864 4405 Prepared by: TUV Rhe inl and of N or th America, Inc. 1279 Quarry Lane Pleasanton, CA 94566 Tel: (925) 249-9123 Fax: ( 925) 249-9124 http://www.tuv .com/ Report/Issue Date: September 18, 2014 Report Number: 31362360.001 Appendix A Report Number: 31362360.001 Appendix: A EUT: Glucose Monitoring System Model: Apollo EMC / Rev 11/11/2013 FCCID: QXS-LIB01 Page 2 of2 TUV Rheinland 1279 Quarry Lane, Ste. A, Pl easanton, CA 95466 Tel: (925) 249-9123, Fax: (925) 249-9124 Test Results 1 RF Exposure 1.1 Test Methodology In thi s document, we try to prov e the safety of radiation harmful ne ss to the human body for ou r pr od uct and the EUT is excluded from SAR test. 1.2 RF Exposure limit General SAR test reduction and exclusion guidance of KDB 447498 D01 General RF Exposure Guidance v05r02 was used for determination of SAR test exclusion. As per above KDB, At frequencies below 100 MHz, the following may be considered for SAR test exclusion, and as illustrated in Appendix C a) The power threshold at the corresponding test separation distance at 100 MHz in step 2) is multiplied by [1 + log(100/f(MHz))] for test separation distances > 50 mm and < 200 mm b) The power threshold determined by the equation in a) for 50 mm and 100 MHz is multiplied by ½ for test separation distances ≤ 50 mm c) SAR measurement procedures are not established below 100MHz. When SAR test exclusion cannot be applied, a KDB inquiry is required to determine SAR evaluation requirements for any test results to be acceptable. As per table in Appendix C power limit at 100MHz and distance <50mm is 237mWatts Device operates at 13.56 MHz Further application for correction of operating frequency 237 x [1 + log (100/f (MHz)] 237 x [1+log (100/13.56)] 237 x 1.8677 = 442.644mWatts The limit is 442 mWatts Manufacturer also declared that max input power to the antenna is 23dBm = 199mWatts EUT Power input to antenna is 199mWatts < the limit, hence qualifies for SAR test exclusion. As s tated, the E UT was f ou nd to be compliant t o the r equirements of t he test s tandard(s).

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Report Number: 31362360.001 Page 1 of 55 EUT: Glucose Monitoring System Model: Apollo Report Date: September 30, 2013 FCC ID: QXS-LIB01 Emissions Test Report EUT Name: Glucose Monitoring System Model No.: Apollo CFR 47 Part 15.225:2013 and RSS-210:2010 Prepared for: William Matievich Abbott Diabetes Care 1360 S. Loop Road Alameda CA, 94502 U.S.A. Tel: (510) 864-4405 Fax: (510) 239-2683 Prepared by: TUV Rheinland of North America, Inc. 1279 Quarry Lane, Ste. A Pleasanton, CA 94566 U.S.A. Tel: (925) 249-9123 Fax: (925) 249-9124 http://www.tuv.com/ Report/Issue Date: September 30, 2013 Report Reissue Date: June 26, 2014 Report Number: 31362360.001 Job Number: 0000112429 Revision Number: 1 Report Number: 31362360.001 Page 2 of 55 EUT: Glucose Monitoring System Model: Apollo Report Date: September 30, 2013 FCC ID: QXS-LIB01 Revisions Revision No. Dat e MM/DD/YYYY Reason for C hange Author 0 09/30/2013 Original Document N/A 1 06/26/2014 Corrected Report Date in footer. Jeremy Luong Not e: L atest r evision report w ill r eplace all previou s reports. Statement of Compliance Report Number: 31362360.001 Page 3 of 55 EUT: Glucose Monitoring System Model: Apollo Report Date: September 30, 2013 FCC ID: QXS-LIB01 Manufacturer: Abbott Diabetes Care 1360 S. Loop Road Alameda CA, 94502 U.S.A. (510) 864-4405 Requester / Applicant: William Matievich Name of Equipment: Glucose Monitoring System Model No. Apollo Type of Equipment: Industrial, Scientific, or Medical (ISM) Application of Regulations: CFR 47 Part 15.225:2013 and RSS-210:2010 Test Dates: September 10, 2013 to September 13, 2013 Guidance Documents: Emissions: ANSI C63.10: 2009 Test Methods: Emissions: ANSI C63.10: 2009 The electromagnetic compatibility test and documented data described in this report has been performed and recorded by TUV Rheinland, in accordance with the standards and procedures listed herein. As the responsible authorized agent of the EMC laboratory, I hereby declare that the equipment described above has been shown to be compliant with the EMC requirements of the stated regulations and standards based on these results. If any special accessories and/or modifications were required for compliance, they are listed in the Executive Summary of this report. This report must not be used to claim product endorsement by A2LA or any agency of the U.S. Government. This report contains data that are not covered by A2LA accreditation. This report shall not be reproduced except in full, without the written authorization of TUV Rheinland of North America. Jeremy Luong September 27, 2013 Conan Boyle June 26, 2014 (Reissue Date) Test Engineer Date Laboratory Signature Date Industry Canada Testing Cert #3331.02 US5254 2932M-1 Table of Contents Report Number: 31362360.001 Page 4 of 55 EUT: Glucose Monitoring System Model: Apollo Report Date: September 30, 2013 FCC ID: QXS-LIB01 1 Executive Summary _______________________________________________________ 7 1.1 Scope______________________________________________________________________ 7 1.2 Purpose____________________________________________________________________ 7 1.3 Summary of Test Results _____________________________________________________ 7 1.4 Special Accessories __________________________________________________________ 7 1.5 Equipment Modifications _____________________________________________________ 7 2 Laboratory Information ____________________________________________________ 8 2.1 Accreditations & Endorsements _______________________________________________ 8 2.1.1 US Federal Communications Commission _______________________________________________ 8 2.1.2 NIST / A2LA _____________________________________________________________________ 8 2.1.3 Canada – Industry Canada ___________________________________________________________ 8 2.1.4 Japan – VCCI _____________________________________________________________________ 8 2.2 Test Facilities _______________________________________________________________ 9 2.2.1 Emission Test Facility ______________________________________________________________ 9 2.2.2 Immunity Test Facility ______________________________________________________________ 9 2.3 Measurement Uncertainty ____________________________________________________ 9 2.3.1 Sample Calculation – radiated & conducted emissions ____________________________________ 10 2.3.2 Measurement Uncertainties _________________________________________________________ 10 2.4 Calibration Traceability _____________________________________________________ 11 3 Product Information ______________________________________________________ 12 3.1 Product Description ________________________________________________________ 12 3.2 Equipment Configuration ___________________________________________________ 12 3.3 Operating Mode ___________________________________________________________ 12 3.4 Unique Antenna Connector __________________________________________________ 13 3.4.1 Results _________________________________________________________________________ 13 4 Emissions ______________________________________________________________ 14 4.1 Carrier Field Strength Requirements __________________________________________ 14 4.1.1 Test Method _____________________________________________________________________ 14 4.1.2 Results _________________________________________________________________________ 15 4.2 Occupied Bandwidth _______________________________________________________ 16 4.2.1 Test Method _____________________________________________________________________ 16 4.2.2 Results _________________________________________________________________________ 17 4.3 Out-of-Band Emissions ______________________________________________________ 25 4.3.1 Test Method _____________________________________________________________________ 25 4.3.2 Test Result ______________________________________________________________________ 26 4.4 Transmitter Spurious Emissions ______________________________________________ 30 …

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TUV Rheinland Test Setup Photo 1279 Quarry Lane, Ste. A, Pleasanton, CA 95466 Tel: (925) 249-9123, Fax: (925) 249-9124 Report Number: 31362360.001 Page 1 of 8 EUT: Glucose Monitoring System Model: Apollo 1 Photo 1.1 Test Setup Photo Figure 1: Test Setup for 9 kHz to 30MHz (Front View) – Loop Facing Away TUV Rheinland Test Setup Photo 1279 Quarry Lane, Ste. A, Pleasanton, CA 95466 Tel: (925) 249-9123, Fax: (925) 249-9124 Report Number: 31362360.001 Page 2 of 8 EUT: Glucose Monitoring System Model: Apollo Figure 2: Test Setup for 9 kHz to 30MHz (Rear View) – Loop Facing EUT TUV Rheinland Test Setup Photo 1279 Quarry Lane, Ste. A, Pleasanton, CA 95466 Tel: (925) 249-9123, Fax: (925) 249-9124 Report Number: 31362360.001 Page 3 of 8 EUT: Glucose Monitoring System Model: Apollo Figure 3: Test Setup for 30 MHz to 1000 MHz (Front View) TUV Rheinland Test Setup Photo 1279 Quarry Lane, Ste. A, Pleasanton, CA 95466 Tel: (925) 249-9123, Fax: (925) 249-9124 Report Number: 31362360.001 Page 4 of 8 EUT: Glucose Monitoring System Model: Apollo Figure 4: Test Setup for 30 MHz to 1000 GHz (Rear View) TUV Rheinland Test Setup Photo 1279 Quarry Lane, Ste. A, Pleasanton, CA 95466 Tel: (925) 249-9123, Fax: (925) 249-9124 Report Number: 31362360.001 Page 5 of 8 EUT: Glucose Monitoring System Model: Apollo Figure 5: Test Setup for AC Conducted Emission (Front View) TUV Rheinland Test Setup Photo 1279 Quarry Lane, Ste. A, Pleasanton, CA 95466 Tel: (925) 249-9123, Fax: (925) 249-9124 Report Number: 31362360.001 Page 6 of 8 EUT: Glucose Monitoring System Model: Apollo Figure 6: Test Setup for AC Conducted Emission (Side View) TUV Rheinland Test Setup Photo 1279 Quarry Lane, Ste. A, Pleasanton, CA 95466 Tel: (925) 249-9123, Fax: (925) 249-9124 Report Number: 31362360.001 Page 7 of 8 EUT: Glucose Monitoring System Model: Apollo Figure 7: Frequency Stability Test Setup (Outside Thermal) TUV Rheinland Test Setup Photo 1279 Quarry Lane, Ste. A, Pleasanton, CA 95466 Tel: (925) 249-9123, Fax: (925) 249-9124 Report Number: 31362360.001 Page 8 of 8 EUT: Glucose Monitoring System Model: Apollo Figure 8: Frequency Stability Test Setup (Inside Thermal Chamber) RX Antenna Thermal Couple