2AA923614-04In Touch Blood Glucose Monitoring System

1 IN TOUCH™ BLOOD GLUCOSE MONITORING SYSTEM OWNER’S MANUAL V1.6 2 CONTENTS Chapter 1 – Your In Touch™ .................................................. 5 Your In Touch™ 5 Register Your In Touch™ 6 Contact Us 7 Important – Staying Safe 7 Using This User Guide 9 Chapter 2 – Overview ........................................................ 10 Indications for Use 11 Your Doctor 13 Chapter 3 – Components ..................................................... 14 In Touch™ 14 Glucose Test Strips 14 Important In Touch™ Glucose Test Strip Information 15 Lancing Device 16 Control Solution 18 Chapter 4 – Getting Started ................................................ 19 Turning On and Setting up your In Touch™ 19 Your In Touch™ Monitor 22 The Display Screen 24 Chapter 5 – Checking Your Blood Glucose .......................... 25 Before Testing 25 Safety Tips 25 How To Test 26 Mealtime Tags 31 Feeling 32 Changing Your Selections 34 If Data Transmission Is Unsuccessful 36 Chapter 6 ‐ What Do Your Results Mean? ........................... 38 Blood Sugar 38 High Or Low Readings 38 References 39 Chapter 7 – Forearm or Palm Testing.................................. 40 3 How to Test 40 Limitations & Considerations 41 Chapter 8 – Viewing Results and Trends ............................. 43 Logbook 44 Mealtime Values 44 Patterns & Stats 46 Steps and Calories 48 Snapshot Summary 50 Chapter 9 – Your Messages ................................................. 51 Messages 51 Team 52 MyCoach 53 MyMD 53 MyFamily 55 MyMobile 56 Chapter 10 – Your Personal Web Portal .............................. 57 Logging In 57 Dashboard 58 More Detail 58 Chapter 11 – Checking your In Touch™ ............................... 60 The Control Solution Test 60 Using Control Solution 61 Control Solution Troubleshooting 65 Important Tips 66 Chapter 12 – Maintenance .................................................. 68 Cleaning 68 Battery 69 Storing Your In Touch™ & Test Strips 71 Chapter 13 – Settings Options ............................................. 73 Help 73 Airplane Mode 73 Activity Monitor Settings 75 Reminders 76 Calibrate Control 76 About 78 Chapter 14 ‐ Troubleshooting ............................................. 79 Issues With Tests 79 Basic Troubleshooting 79 Error Messages 80 Communication Errors 81 4 Getting Support 82 Chapter 15 – Specifications and Limitations ....................... 83 Specifications 83 Operating Ranges 83 Glucose Test Imprecision 83 Environmental 84 Limitations 84 Chapter 16 – Warranty and Compliance ............................. 86 Limitations On Warranty 86 For Warranty Service 87 FCC Interference Statement 87 FCC Caution 88 FCC Radiation Exposure Statement 88 Privacy Policy 88 US Patent No. 7,935,307, 8,066,640, 6,837,976, 6,942,770, and other US and foreign patents pending. In Touch™ is a trademark of EosHealth, Inc. Copyright 2013 EosHealth, Inc. 09/10/2013 v1.1 5 Chapter 1 – Your In Touch™ Thank you for choosing In Touch TM your gateway to better management of your diabetes. Your new In Touch TM system will monitor your glucose and your daily physical activity to help you lead a healthier life. This user guide has important information on your new system and how it works. Please read it carefully before using In Touch™, it will help you make the most of your new In Touch™, Your In Touch™ Your In Touch™ is easy to use. It has a color touch screen display which will show your blood glucose, view trends, share with your healthcare team, and view and retrieve personalized messages. 6 It gives accurate glucose test results in just 5 seconds using a very small blood sample. This small sample allows you to use a thinner lancet because not as much blood is needed to do a glucose test. It’s a lot less painful. In Touch™ has a memory that stores your glucose and activity results. It also automatically sends all your data directly and securely to your personalized health account wirelessly. You can also choose to send your results to your healthcare team and receive personalized advice to help you, your coach, and your healthcare professional to manage your diabetes. It even lets you know when you are running out of test strips and need to reorder. But remember, In Touch™ is not intended to provide automated treatment guidance or decisions, nor is it a substitute for your professional healthcare provider. It’s a guide and a helper. Register Your In Touch™ Before you get started, please fill out the Warranty Registration card included in your kit and mail the card back to the address printed on the card, or complete the Warranty Registration online at: www.InTouch.eoshealth.com We use the information collected to improve our service. 7 Contact Us In Touch™ is made by EosHealth, Inc. 2800 Post Oak Boulevard, 4100 Houston, Texas 77056 Inside the USA, please call Customer Service toll‐ free at 1‐800‐945‐4355 or visit our website at: www.InTouch.eoshealth.com Outside the USA, please contact your supplier for support. Important – Staying Safe Please take a moment to read through this important safety information. Remember, this is a medical device and it needs to be treated with respect.  The In Touch™ Blood Glucose Monitoring System and lancing device must only be used by one person. For safety reasons, do not share it with anyone, including your family members.  Many parts of your device come into contact with your blood. Kit parts can potentially transmit infectious diseases, even after being cleaned and disinfected. 8  Always wash your hands thoroughly with soap and water and dry well after handling the meter, test strips, or your lancing device.  Always consult your diabetes healthcare professional and follow his or her guidance about your blood glucose monitoring routine.  The recommendations in this manual apply to all blood glucose monitors and are supported by the American Association of Diabetes Educators (AADE), the American Diabetes Association (ADA), the US Food and Drug Administration (FDA), a…

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TÜV SÜD AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121‐2912 Phone: 858 678 1400 FAX: 858 546 0364 TÜV SÜD America Inc. (San Diego) December 13, 2013 BABT FCB Forsyth House Churchfield Road, Walton‐on‐Thames, Surrey, KT12 2TD In Touch Blood Glucose Monitoring System Model:BG200 FCC ID: 2AA923614‐04 EosHealth, Inc. 2800 Post Oak Boulevard, 41st Floor, Houston, Texas 77057 USA RE: Test Report from RFI Global Services LTD (Test of: GE865‐QUAD To FCC Part 22:2009 Subpart H, FCC part 24:2009 Subpart E with Seial No: RFI/RPT/RP76937JD03A V3.0) corresponding to Telit Model: GE865‐QUAD FCC ID: R17GE865C meets the current published version of the FCC Rules and will be used as a proof of compliance for the In Touch Blood Glucose Monitoring System Model:BG200 FCC ID: 2AA923614‐04 ( Please see Telit Letter Of Permission FCC GE865 Eoshealth Attached in the Submittal Package). Sincerely, Juan Manuel Gonzalez EMC/Wireless Engineer

Dear Sir or Madam: Telit Communications S.p.A. has applied for, and has been granted Federal Communications Commission (FCC) registration number RI7GE865 for its radio module which carries the Telit Communications S.p.A. model number GE865-QUAD. This letter will grant permission on a one-time basis to EosHealth a company in United States of America, to apply for a “new FCC ID approval” for the above mentioned radio module, with FCC. Telit Communications S.p.A. understands that EosHealth must make this change in order to comply with Federal Communication Commission (FCC) regulations that apply to the EosHelth product called In Touch TM FCC identifier 2AA923614-04 and Telit authorize FCC to use information on file to grant such new FCC ID approval for this device. Telit Communications S.p.A. is supplying the GE865-QUAD to EosHealth unmodified and equivalent to the originally certified unit. The device is being supplied to the applicant unmodified and equivalent to the original approved unit. The original test results continue to be representative of and applicable to the equipment bearing the new FCC ID approval. Yours sincerely ____________________________________ Brian Tucker Global Vice President of Quality Telit Wireless Solutions, Inc. December 12, 2013 EosHealth, Inc. 2800 Post Oak Boulevard 41st Floor Houston, Texas 77057 Brian Tucker Tel +1-919-415-1505 Fax +1-919-840-0337 Mobile +1-919-449-8607 E-Mail [email protected] www.telit.com

2800 Post Oak Boulevard, 41 st Floor Houston, Texas 77057 USA November 22, 2013 TUV SUD BABT TCB Octagon House, Segensworth Road, Fareham, Hampshire, PO15 5RL Dear Sir or Madam, We, EosHealth, Inc. hereby authorize TUV to act as our agent in all matters relating to applications for equipment authorization, including the signing of all documents relating to these matters. This authorization expires March 30, 2014 Sincerely, Company Officer: Kimon Angelides Telephone Number: 866-435-5643 Email: [email protected]

November 22, 2013 TUV SUD BABT TCB Octagon House, Segensworth Road, Fareham, Hampshire, PO15 5RL Confidentiality Request FCC ID: 2AA923614-04 Pursuant to Sections 0.457(d)(1)(ii) and 0.459 of the Commission’s Rules, EosHealth, Inc. hereby requests permanent confidential treatment of information accompanying this application as outlined below: Design Drawings Schematics Bill of Materials/Parts List Block Diagrams Theory of Operation EosHealth, Inc. also hereby requests short-term confidential treatment of information accompanying this application as outlined below for a period of (up to 180) days: Internal Photos External Photos User Manual Test Set-up Photographs The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to the Applicant and provide unjustified benefits to its competitors. The Applicant understands that pursuant to Rule 0.457(d)(1)(ii), disclosure of this Application and all accompanying materials will not be made before the date of the Grant for this Application. Yours sincerely, Company Officer: Kimon Angelides Chief Executive Officer Telephone Number: 866-435-5643 Email: [email protected]

External Photographs of In Touch TM FCC ID: 2AA923614‐04 FRONT BACK SIDE‐USB Charging port SIDE‐On/Off Button FRONT‐Screen On

Exhibit 1. Markings on Device Exhibit 1‐B. ID Labeling and Location

Exhibit 9. Internal Photos

TEST REPORT FROM RFI GLOBAL SERVICES LTD Test of: GE865-QUAD To: FCC Part 22: 2009 Subpart H, FCC Part 24: 2009 Subpart E, RSS 132 Issue 2 September 2005 and RSS-133 Issue 5 February 2009 Test Report Serial No: RFI/RPT/RP76937JD03A V3.0 Version 3.0 Supersedes All Previous Versions This Test Report Is Issued Under The Authority Of Brian Watson, COO Payments and Consultancy: Checked By: A. Henriques Signature: Date of Issue: 09 July 2010 This report is issued in Adobe Acrobat portable document format (PDF). It is only a valid copy of the report if it is being viewed in PDF format with the following security options not allowed: Changing the document, Selecting text and graphics, Adding or changing notes and form fields. This report may not be reproduced other than in full, except with the prior written approval of RFI Global Services Ltd. The results in this report apply only to the sample(s) tested. TEST REPORT SERIAL NO: RFI/RPT/RP76937JD03A ISSUE DATE: 09 JULY 2010 Page 2 of 54 RFI Global Services Ltd This page has been left intentionally blank. TEST REPORT SERIAL NO: RFI/RPT/RP76937JD03A ISSUE DATE: 09 JULY 2010 RFI Global Services Ltd Page 3 of 54 Table of Contents 1. Customer Information .................................................................................................................. 4 2. Summary of Testing ..................................................................................................................... 5 3. Equipment Under Test (EUT) ....................................................................................................... 8 4. Operation and Monitoring of the EUT during Testing ............................................................. 11 5. Measurements, Examinations and Derived Results ................................................................ 12 6. Measurement Uncertainty .......................................................................................................... 53 Appendix 1. Test Equipment Used ................................................................................................54 TEST REPORT SERIAL NO: RFI/RPT/RP76937JD03A ISSUE DATE: 09 JULY 2010 Page 4 of 54 RFI Global Services Ltd 1. Customer Information Company Name: Telit Communications S.p.A. Address: Via Stazione di Prosecco, 5/B Sgonico TS 34010 Italy TEST REPORT SERIAL NO: RFI/RPT/RP76937JD03A ISSUE DATE: 09 JULY 2010 RFI Global Services Ltd Page 5 of 54 2. Summary of Testing 2.1. General Information Specification Reference: 47CFR22 Specification Title: Code of Federal Regulations Volume 47 (Telecommunications) 2009: Part 22 Subpart H (Public Mobile Services) Specification Reference: RSS-GEN Issue 2 June 2007 Specification Title: General Requirements and Information for the Certification of Radiocommunication Equipment Specification Reference: RSS-132 Issue 2 Sep 2005 Specification Title: Cellular Telephones Employing New Technologies Operating in the Bands 824-849 MHz and 869-894 MHz Specification Reference: SRSP-503 Issue 7 Sep 2008 Specification Title: Technical Requirements for Cellular Radiotelephone Systems Operating in the Bands 824 – 849 MHz and 869 – 894 MHz Specification Reference: 47CFR24 Specification Title: Code of Federal Regulations Volume 47 (Telecommunications) 2009: Part 24 Subpart E (Personal Communication Services) Specification Reference: RSS-133 Issue 5 Feb 2009 Specification Title: 2 GHz Personal Communications Services Specification Reference: SRSP-510 Issue 5 Feb 2009 Specification Title: Technical Requirements for Personal Communications Services (PCS) in the Bands 1850-1915 MHz and 1930-1995 MHz Site Registration: FCC: 209735, Industry Canada: 3245B-2 Location of Testing: RFI Global Services Ltd, Wade Road, Basingstoke, Hampshire, RG24 8AH. Test Dates: 29 April 2010 to 27 May 2010 TEST REPORT SERIAL NO: RFI/RPT/RP76937JD03A ISSUE DATE: 09 JULY 2010 Page 6 of 54 RFI Global Services Ltd 2.2. Summary of Test Results FCC Reference (47CFR ) IC Reference Measurement Result GSM850 Part 15.109 RSS-Gen 4.10/6 RSS-132 4.6 Receiver/Idle Mode Radiated Spurious Emissions Part 22.913/ 2.1046(a) RSS-132 4.4 SRSP-503 5.1.3 Transmitter Carrier Output Power (Conducted) Part 22.355 RSS-132 4.3 RSS Gen 4.7 Transmitter Frequency Stability (Temperature & Voltage Variation) Part 2.1049 RSS-Gen 4.6.1 Transmitter Occupied Bandwidth Part 2.1051/22.917 RSS-132 4.5 Transmitter Out of Band Conducted Emissions Part 2.1051/22.917 RSS-132 4.5 Transmitter Band Edge Conducted Emissions Part 2.1053/22.917 RSS-132 4.5 Transmitter Out of Band Radiated Emissions Part 2.1053/22.917 RSS-132 4.5 Transmitter Band Edge Radiated Emissions PCS1900 Part 15.109 RSS-Gen 4.10/6 RSS-133 6.6 Idle Mode Radiated Spurious Emissions Part 24.232/ 2.1046(a) RSS-133 6.4 SRSP-510 5.1.2 Transmitter Carrier Output Power (Conducted) Part 24.235 RSS-133 6.3 RSS Gen 4.7 Transmitter Frequency Stability (Temperature & Voltage Variation) Part 2.1049/24.238 RSS-Gen 4.6.1 Transmitter Occupied Bandwidth Part 2.1051/24.238 RSS-133 6.5 Transmitter Out of Band Conducted Emissions Part 2.1051/24.238 RSS-133 6.5 Transmitter Band Edge Conducted Emissions Part 2.1053/24.238 RSS-133 6.5 Transmitter Out of Band Radiated Emissions Part 2.1053/24.238 RSS-133 6.5 Transmitter Band Edge Radiated Emissions Key to Results = Complied = Did not comply TEST REPORT SERIAL NO: RFI/RPT/RP76937JD03A ISSUE DATE: 09 JULY 2010 RFI Global Services Ltd Page 7 of 54 2.3. Methods and Procedures Reference: ANSI/TIA-603-C-2004 Title: Land Mobile Communications Equipment, Measurements and performance Standards Reference: ANSI C63.4 (2009) Title: American National Standard for Methods of Measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 kHz 2.4. Deviations from the Test Specification For the measurements contained within this test report, there were no deviations from, additions to, or exclusions from the test specification identified above. T…

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GE865 QUAD Test set up Photographs