SMTLWVGSM/WCDMA Mobile Phone

Dear LifeWatch V owner: Thank you for selecting the LifeWatch V mobile medical phone. This user manual includes information and instructions for using your new LifeWatch V device and should be read carefully before starting to use the device. If you have any questions about your LifeWatch V, please contact your representative: Illustrations included in this manual are general representations only and are not meant to comply with specific regulatory requirements. By default, your device is provided with pre-set applications. Installation of new applications may affect the performance of your device and is the sole responsibility of the user. Before using the LifeWatch V, medical functions please read the Warnings and Precautions, Appendix A, thoroughly. This User Guide is for the enhanced LifeWatch V mobile medical device, also known as the LifeWatch V+ device. For the sake of brevity, we will refer to the device as the LifeWatch V device due to the five main medical functions included in the device: ♦ ECG ♦ Heart Rate ♦ Temperature ♦ Pulse oximeter (SpO 2 ) ♦ Blood glucose 1 Copyright Declaration Copyright © 2013 LifeWatch Technologies Ltd.® All rights reserved. LifeWatch Technologies Ltd., LifeWatch Inc., LifeWatch Inc. logo, and LifeWatch V are trademarks or registered trademarks of LifeWatch AG®. All other brand names and product names used in this document are trade names, service marks, trademarks, or registered trademarks of their respective owners. The information and screens provided in this manual are subject to change without notice. Android™ is a trademark of Google Inc. LIFEWATCH TECHNOLOGIES LTD. SHALL NOT BE LIABLE FOR TECHNICAL OR EDITORIAL ERRORS OR OMISSIONS CONTAINED HEREIN; NOR FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM THE FURNISHING, PERFORMANCE, OR USE OF THIS MATERIAL. Authorized representatives: Europe Obelis s.a Boulevard Général Wahis 53 1030 Brussels, BELGIUM Tel: + (32) 2. 732.59.54 Fax: + (32) 2.732.60.03 E-mail: [email protected] USA Lifewatch, Inc. O’Hare International Center 10255 West Higgins Road Suite 120 Rosemont, IL 60018 Tel: 847-720-2295 Fax: 847-720-1995 Toll Free: 800-633-3361 Fax: 800-954-2375 Email: [email protected] Israel LifeWatch Technologies Ltd. ® 2 Pekeris St. Rehovot 7670202 Israel Tel: 972 8 9484000 Fax: 972 8 9484044 Email: [email protected] 2 LifeWatch V Packaging Contents ♦ LifeWatch V ♦ Charger ♦ Earphones ♦ User manual ♦ Quick user guide ♦ USB cable Optional – LifeWatch V Gluco Accessories Kit Contents ♦ Lancing device ♦ 10 lancets ♦ Gluco strip vial ♦ Control solution ♦ 10 Alcohol pads ♦ Gluco strip Quick user guide ♦ Lancer Quick user guide Indications for Use The LifeWatch V is a mobile health and wellness device designed for self-testing in order to measure and display blood saturation, blood glucose, ECG (1 lead), heart rate and body temperature. The LifeWatch V is able to transmit the test results by wireless communication to a remote server for storage. The LifeWatch V blood glucose monitoring system is intended to be used by a single person and should not be shared. The blood glucose monitoring system is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, and the upper- arm. The blood glucose monitoring system is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. 3 Contraindications for Use: • The LifeWatch V is not intended for use by persons with external defibrillators. • The LifeWatch V is not intended for the treatment or alleviation of disease. • The LifeWatch V is not to be used in a magnetic resonance imaging (MRI) environment. • The blood glucose monitoring system is not intended for the diagnosis of, or screening for, diabetes mellitus. • Do not place the thermometer probe on scarred tissue or tissue compromised by skin disorders; patients in trauma; patients treated with certain drug therapies. • Do not place the thermometer probe on skin exposed to direct sunlight, fireplace heat, cold compress therapies, air conditioner flow, and other similar scenarios that may interfere with IR skin Body temperature determinations. Warnings: • Do not expose the unit to rain or immerse in water. • Servicing of the device shall be done by qualified personnel only. • The user of the LifeWatch V should not take any actions of a medical or clinical nature based on his/her understanding or interpretation of test results without consulting a healthcare professional. • Classifications of test results obtained for medical applications into categories such as “Low”, “Normal”, “Average”, etc. are based on well-established and widely accepted clinical references; as other classifications may exist, the test results should not constitute the sole basis for diagnosis or for deciding on the appropriate course of medical treatment or therapy. • The Blood Glucose monitoring system is not for use on patients who are dehydrated, hypotensive, in 4 shock, or for individuals in hyperglycemic-hyperosmolar state, with or without ketosis. • Not for use by critically ill patients. • Users whose vision is impaired to the extent that their sight does not enable them to operate the device should not use the Blood Glucose monitoring system. • The blood glucose monitoring system and lancing device are for single patient use. Do not share them with anyone including other family members! Do not use on multiple patients! • All parts of the glucose kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection. Important Symbols A number of symbols are used throughout this manual in order to draw attention to safety items and other important information. Symbols on Equipment and Labeling The following section contains a description of symbols that may be located either on the Lif…

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LifeWatch Technologies Ltd. Add: 2 Pekeris Street, Rehovot, 7670202, Israel Tel:+97289484000 Fax: +97289484044 FCC Authorization Date: 2013-11-8 FEDERAL COMMUNICATIONS COMMISSIONS Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 Subject: Agent Authorization To whom it may concern: We, LifeWatch Technologies Ltd., the undersigned, Hereby authorizes Bay Area Compliance Laboratories Corporation to act on its behalf in all matters relating to application for Equipment authorization, including the signing of all documents relating to these matters. All acts carried out by Bay Area Compliance Laboratories Corp. on our behalf shall have the same effect as our own action. We, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). This authorization is valid until further written notice from the applicant. Sincerely Yours, Signature: Asher Kassel / Manager Asher Kassel / Manager

Life Watch Technologies Ltd. Add: 2 Pekeris Street, Rehovot, 7670202, Israel Tel:+97289484000 Fax: +97289484044 FCC Confidential Auth orization Date: 2 013-11-8 FEDERAL COMMUNICATIONS COMMISSIONS Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 Confidentiality Request regarding application for certification of FCC ID: SMTLWV Pursuant to Sections 0.457 and 0.459 of the Commission’s Rules, we hereby request confidential treatment of information accompanying this application as outlined below: Detailed Circuit Schematics of EUT--- (Long term) Tune up Procedure---(Long Term) Block Diagram--- (Long term) Circuit Description--- (Long term) The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these materials may be harmful to the applicant and provide unjustified benefits to its competitors. The applicant understands that pursuant to Section 0.457 of the Rules, disclosure of this application and all accompanying documentation will not be made before the date of the Grant for this application. Sincerely Yours, Asher Kassel /Director of RA & QA

EXHIBIT B - EUT EXTERNAL PHOTOGRAPHS EUT – All View EUT – Top View EUT – Bottom View EUT –Right Side View EUT –Left Side View EUT –Adapter View EUT –Adapter Label View

EXHIBIT A - FCC ID LABELING AND LOCATION FCC ID Label FCC ID Label Location The label shown shall be permanently affixed at a conspicuous location on the device and be readily visible to the user at the time purchase (Labeling requirements per 2.925) Label Here

EXHIBIT B - EUT EXTERNAL PHOTOGRAPHS EUT – Back Cover Off View EUT –Uncover View EUT –GSM Antenna View EUT –GPS Antenna View EUT –Main Board Off View EUT –Main Board Top View EUT –Main Board Bottom View EUT – BT & Wifi Antenna View EUT – Main Board Top Shielding Off View EUT –Main Board Bottom Shielding Off View EUT –RF Chip View EUT –Sub-Board Top View EUT –Sub-Board Top Shielding Off View EUT –Sub-Board Bottom View EUT –LED Cover Off View EUT –LED Top View EUT –LED Bottom View

Note: This test report is prepared for the customer shown above and for the equipment described herein. It may not be duplicated or used in part without prior written consent from Bay Area Compliance Laboratories Corp. SAR EVALUATION REPORT For LifeWatch Technologies Ltd. 2 Pekeris Street, Rehovot, 7670202, Israel FCC ID: SMTLWV Report Type: Original Report Product Type: GSM/WCDMA Mobile Phone Test Engineer: Sandy Wang Report Number: R1DG130916005-20 Report Date: 2013-11-19 Reviewed By: Alvin Huang RF Leader Prepared By: Bay Area Compliance Laboratories Corp. (Shenzhen) 6/F, the 3rd Phase of WanLi Industrial Building, ShiHua Road, FuTian Free Trade Zone Shenzhen, Guangdong, China Tel: +86-755-33320018 Fax: +86-755-33320008 www.baclcorp.com.cn Bay Area Compliance Laboratories Corp. (Shenzhen) Report No: R1DG130916005-20 SAR Evaluation Report 2 of 146 Attestation of Test Results EUT Information Company Name LifeWatch Technologies Ltd. EUT Description GSM/WCDMA mobile phone FCC ID SMTLWV Model Number LifeWatch V Test Date 2013-11-14 to 2013-11-16 Frequency Max. SAR Level(s) Reported Limit (W/Kg) GSM 850 0.469 W/kg 1g Head SAR 0.901 W/kg 1g Body SAR 1. 6 PCS 1900 0.282 W/kg 1g Head SAR 0.914 W/kg 1g Body SAR WCDMA850 0.391 W/kg 1g Head SAR 0.484 W/kg 1g Body SAR WCDMA1900 0.289 W/kg 1g Head SAR 0.584 W/kg 1g Body SAR Simultaneous 0.886 W/kg 1g Head SAR 1.123 W/kg 1g Body SAR Applicable Standards ANSI / IEEE C95.1 : 2005 IEEE Standard for Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fileds,3 kHz to 300 GHz. ANSI / IEEE C95.3 : 2002 IEEE Recommended Practice for Measurements and Computations of Radio Frequency Electromagnetic Fields With Respect to Human Exposure to SuchFields,100 kHz—300 GHz. IEEE1528:2003 IEEE Recommended Practice for Determining the Peak Spatial-Average Specific Absorption Rate (SAR) in the Human Head from Wireless Communications Devices: Measurement Techniques KDB procedures KDB 447498 D01 Mobile and Portable Devices RF Exposure Procedures and Equipment Authorization Policies. KDB 648474 D04 SAR Evaluation Considerations for Wireless Handsets KDB 865664 D01 SAR Measurement Requirements for 100 MHz to 6 GHz KDB 941225 D01 SAR Measurement Procedures for 3G Devices-CDMA 2000/EV-Do WCDMA/HSDPA/HSUPA KDB 941225 D06 SAR Evaluation Procedures for Portable Devices with Wireless Router Capabilities. Note: This wireless device has been shown to be capable of compliance for localized specific absorption rate (SAR) for General Population/Uncontrolled Exposure limits specified in ANSI/IEEE Standards and has been tested in accordance with the measurement procedures specified in IEEE 1528-2003 and RF exposure KDB procedures. The results and statements contained in this report pertain only to the device(s) evaluated. Bay Area Compliance Laboratories Corp. (Shenzhen) Report No: R1DG130916005-20 SAR Evaluation Report 3 of 146 TABLE OF CONTENTS DOCUMENT REVISION HISTORY ............................................................................................................................ 5 EUT DESCRIPTION ........................................................................................................................................................ 6 TECHNICAL SPECIFICATION............................................................................................................................................. 6 REFERENCE, STANDARDS AND GUILDELINES .................................................................................................. 7 SAR LIMITS ..................................................................................................................................................................... 8 FACILITIES ...................................................................................................................................................................... 9 DESCRIPTION OF TEST SYSTEM ........................................................................................................................... 10 EQUIPMENT LIST AND CALIBRATION ................................................................................................................ 17 EQUIPMENTS LIST & CALIBRATION INFORMATION ...................................................................................................... 17 SAR MEASUREMENT SYSTEM VERIFICATION ................................................................................................ 18 LIQUID VERIFICATION ................................................................................................................................................... 18 SYSTEM ACCURACY VERIFICATION .............................................................................................................................. 21 SAR SYSTEM VALIDATION DATA ........................................................................................................................ 22 EUT TEST STRATEGY AND METHODOLOGY .................................................................................................... 30 TEST POSITIONS FOR DEVICE OPERATING NEXT TO A PERSON’S EAR ......................................................................... 30 CHEEK/TOUCH POSITION .............................................................................................................................................. 31 EAR/TILT POSITION ....................................................................................................................................................... 31 TEST POSITIONS FOR BODY-WORN AND OTHER CONFIGURATIONS ................................................................................ 32 SAR EVALUATION PROCEDURE .................................................................................................................................... 33 CONDUCTED OUTPUT POWER MEASUREMENT ......................................................................…

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Note: This test report is prepared for the customer shown above and for the device described herein. It may not be duplicated or used in part without prior written consent from Bay Area Compliance Laboratories Corp. This report must not be used by the customer to claim product certification, approval, or endorsement by NVLAP*, or any agency of the Federal Government. * This report may contain data that are not covered by the NVLAP accreditation and shall be marked with an asterisk “★” (Rev.2). This report is valid only with a valid digital signature. The digital signature may be available only under the Adobe software above version 7.0. FCC PART 22H, PART 24E MEASUREMENT AND TEST REPORT For LifeWatch Technologies Ltd. 2 Pekeris Street, Rehovot,7670202, Israel Report Type: Original Report Product Type: GSM /WCDMA mobile phone Test Engineer: Ares Liu Report Number: R2DG130916005-00C Report Date: 2013-11-23 Reviewed By: Ivan Cao RF Leader Test Laboratory: Bay Area Compliance Laboratories Corp. (Dongguan) No.69 Pulongcun, Puxinhu Industrial Zone, Tangxia, Dongguan, Guangdong, China Tel: +86-769-86858888 Fax: +86-769-86858891 www.baclcorp.com.cn FCC ID: SMTLWV Bay Area Compliance Laboratories Corp. (Dongguan) Report No.: R2DG130916005-00C FCC Part 22H/24E Page 2 of 57 TABLE OF CONTENTS GENERAL INFORMATION.......................................................................................................................................4 PRODUCT DESCRIPTION FOR EQUIPMENT UNDER TEST (EUT) .....................................................................................4 OBJECTIVE...................................................................................................................................................................4 RELATED SUBMITTAL(S)/GRANT(S).............................................................................................................................4 TEST METHODOLOGY..................................................................................................................................................4 TEST FACILITY.............................................................................................................................................................5 SYSTEM TEST CONFIGURATION ..........................................................................................................................6 JUSTIFICATION.............................................................................................................................................................6 EQUIPMENT MODIFICATIONS.......................................................................................................................................6 SUPPORT EQUIPMENT LIST AND DETAILS....................................................................................................................6 CONFIGURATION OF TEST SETUP.................................................................................................................................6 BLOCK DIAGRAM OF TEST SETUP................................................................................................................................7 SUMMARY OF TEST RESULTS...............................................................................................................................8 FCC §1.1310 & §2.1093- RF EXPOSURE ....................................................................................................................9 APPLICABLE STANDARD..............................................................................................................................................9 TEST RESULT...............................................................................................................................................................9 FCC §2.1047 - MODULATION CHARACTERISTIC ............................................................................................10 FCC § 2.1046, § 22.913 (A) & § 24.232 (C) - RF OUTPUT POWER......................................................................11 APPLICABLE STANDARD............................................................................................................................................11 TEST PROCEDURE......................................................................................................................................................11 TEST EQUIPMENT LIST AND DETAILS.........................................................................................................................14 TEST DATA................................................................................................................................................................14 FCC §2.1049, §22.917, §22.905 & §24.238 - OCCUPIED BANDWIDTH ..............................................................18 APPLICABLE STANDARD............................................................................................................................................18 TEST PROCEDURE......................................................................................................................................................18 TEST EQUIPMENT LIST AND DETAILS.........................................................................................................................18 TEST DATA................................................................................................................................................................18 FCC §2.1051, §22.917(A) & §24.238(A) - SPURIOUS EMISSIONS AT ANTENNA TERMINALS ..................25 APPLICABLE STANDARD............................................................................................................................................25 TEST PROCEDURE......................................................................................................................................................25 TEST EQUIPMENT …

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EXHIBIT D - TEST SETUP PHOTOGRAPHS Radiated Emission View---Below 1G Radiated Emission View---Above 1G