2ADEEWG103Wegene ECG Patch

Copyright © 2015 by Wegene Technology Inc... All Rights Reserved. 1 “Wegene” Wireless ECG Patch (WG-103) Operation Manual Ver. 2.0 Wegene Technology Inc. Copyright © 2015 by Wegene Technology Inc... All Rights Reserved. 2 Table of Contents Page 1. Safety Information.................................................................................. 3 2. Introduction ............................................................................................ 4 3. Specifications ......................................................................................... 6 4. Installation .............................................................................................. 9 5. Contact Information ............................................................................. 18 6. Warranty ............................................................................................... 18 Copyright © 2015 by Wegene Technology Inc... All Rights Reserved. 3 1. Safety Information Please read the following items before using the ECG Patch. Warnings z Do NOT use ECG Patch in an environment with flammable materials. z Do NOT use ECG Patch with MRI (magnetic resonance imaging) environment. z Do NOT use ECG Patch with a defibrillator, an electro-cautery, cardiac pacemakers or other stimulators together. z To prevent possible explosion hazard. Do NOT use ECG Patch in the presence of flammable anesthetics. Caution z It’s necessary to read this user’s manual carefully before using this product. z Make sure that ECG Patch is on the right position of chest and confirm the correctly signal source. z Follow local governing ordinances and recycling instructions regarding disposal or recycling of the device and components. z Please handle ECG Patch with care. Hitting or dropping the device may stop it from working. If there is any damage resulting from abnormal use, please contact service personnel. z It is not recommended to use ECG Patch to diagnose children under 12 or expectant mothers. z The electrodes are for single use only. z Portable and mobile wireless communications device (RF, radio frequency) maybe affect the ECG Patch. z Please do not disassemble the ECG Patch and direct contact with the dealers and Leadtek if have any questions about maintenance and repair. z The electrodes of ECG Patchapproved ISO10993 test. Copyright © 2015 by Wegene Technology Inc... All Rights Reserved. 4 2. Introduction ECG Patch has some features, that including: small size, light weight, power-saving, no signal cable, battery-powered, wireless transmission, real-time ECG and immediate heart rate. It can also have long-term monitoring in those applications: academic research, sports training, home care, and clinical research. ECG Patch can measure single lead ECG and use advanced physiological analysis technology to evaluate the function of the autonomic nervous system from heart rhythms. The collected ECG signals are analyzed by frequency spectrum to discover minor fluctuations in the heart rate variability data. The fluctuations can be categorized into 3 distinct patterns, namely High Frequency, Low Frequency and Very Low Frequency, as follows: 1. The High Frequency (HF) component is synchronized with respiration, also called the respiration component, which represents the function of the parasympathetic nerves. 2. The Low Frequency (LF) component is related to vasomotion or the baroreflex. The ratio of the LF component to the HF component can reflect the activity of the sympathetic nerves. 3. The meaning of the Very Low Frequency (VLF) component is not yet clearly understood. It has been confirmed that the function of the autonomic nervous system can be determined by using HRV analysis. Its sensitivity greatly exceeds that of the conventional detection approach for the autonomic nerves. For results measured by an ordinary nerve conduction Copyright © 2015 by Wegene Technology Inc... All Rights Reserved. 5 instrument (NCI), only the value of the R-R interval is given, but no standard value is provided for reference. Contrary to ordinary NCI, this device can not only obtain the average heart rate (including the average R-R interval) and the Standard Deviation of NN interval (SDNN), but also the integral function of autonomic nerve, functions of sympathetic nerve and parasympathetic nerve. Meanwhile, the obtained values can be used to compare with the standard values in the database composed of different age and gender groups at a later stage. Hence, ECG Patch will become a new tool for measuring the function of IHR, HRV index. Copyright © 2015 by Wegene Technology Inc... All Rights Reserved. 6 3. Specifications 3.1 Electrocardiogram: z Lead I ECG z Immediate heart rate (IHR) z Heart rate variability (HRV) parameters: SDNN, LF, HF, LF% z Frequency: 250 Hz z Resolution: 8 bits 3.2 Wireless: z Channel: 2.401 GHz- 2.480 GHz z Transmission distance: < 10M 3.3 Appearance: z Dimensions: 80 x 40 x 8 mm z Weight: 19g (include battery) z Power consumption: Operating at full capacity: 1mA-3mA Standby: 10 μA z Battery: CR2032 3.4 I/O Port Descriptions: Electrode set Battery holder ON/OFF Copyright © 2015 by Wegene Technology Inc... All Rights Reserved. 7 ECG Patch 3.5 Package contents: The product is shipped with the following parts: main device*1, ECG electrode*10, USB RF Dongle*1 and CD*1, 4 parts in total. No. Item Picture 1 main device 2 ECG electrode 3 USB RF Dongle Copyright © 2015 by Wegene Technology Inc... All Rights Reserved. 8 4 CD 3.6 Disc content: z ECG Patch Operation Manual .pdf z How to Use ECG Patch .pdf z Dongle Driver \USB Driver\CDM 2.04.16.exe z Patch test ECG_Patch_Monitor.exe z Patch test (2) \Multiple Patch Monitor Demo Program \ HRVIC_test.exe 3.7 System requirement of PC for data transmission: Hardware requirement: CD ROM, USB Port, CPU: 1.50GHz or upper Software requirement: windows 2000 (SP4), WIN XP, windows vista Copyright © 2015 by Wegene Technology Inc... All Rights Reserved. 9 4. Installation 4.1 …

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We Gene Technologies Date (02/07/2015) BABT TCB Forsyth House, Churchfield Road, Walton-on-Thames, Surrey, KT12 2TD Dear Sir or Madam, We, We Gene Technologies, hereby authorize Compliance Certification Services Inc. / Miller Lee to act as our agent in all matters relating to applications for equipment authorization. This authorization expires on 31/12/2015. Sincerely, Company Officer: Louis Hsiao Telephone Number: +886-2-8226-5800 Email: [email protected]

We Gene Technologies Date (02/07/2015) BABT TCB Forsyth House, Churchfield Road, Walton-on-Thames, Surrey, KT12 2TD Confidentiality Request FCC ID: 2ADEEWG103 Pursuant to Sections 0.457(d)(1)(ii) and 0.459 of the Commission’s Rules, We Gene Technologies hereby requests permanent confidential treatment of information accompanying this application as outlined below: [Common exhibits for which confidentiality is requested are: Schematics Bill of Materials/Parts List Block Diagrams Theory of Operation] We Gene Technologies also hereby requests short-term confidential treatment of information accompanying this application as outlined below for a period of (31/12/2015): [Common exhibits for which short-term confidentiality is requested are: 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: Louis Hsiao signed Telephone Number: +886-2-8226-5800 Email: [email protected]

We Gene Technologies address: 18F, No.166, Jien-Yi Rd., Chung-Ho Dist., New Taipei City 23511, Taiwan, R.O.C Tel: +886-2-8226-5800 Date: July 02, 2015 Federal Communications Commission Authorization and Evaluation Division 1435 Oakland Mills Road Columbia, MD 21046 SUBJECT: FCC Application for FCC ID: 2ADEEWG103 To Whom It May Concern: We, We Gene Technologies, hereby attest to the fact that we will apply the Declaration of Conformity procedure to the class B computer peripheral portion of this composite filing. Sincerely yours, Contact Person: Louis Hsiao Company: We Gene Technologies E-mail: [email protected]

Compliance Certification Services Inc. Report No.: T141002J01-RP A1 - 1 / 18 Rev. 00 APPENDIX 1 - PHOTOGRAPHS OF EUT EXTERNAL PHOTOGRAPHS OF EUT Compliance Certification Services Inc. Report No.: T141002J01-RP A1 - 2 / 18 Rev. 00 Model no.: WG-103 (TX) Compliance Certification Services Inc. Report No.: T141002J01-RP A1 - 3 / 18 Rev. 00 Model no.: WG-103-A (TX) Compliance Certification Services Inc. Report No.: T141002J01-RP A1 - 4 / 18 Rev. 00 Compliance Certification Services Inc. Report No.: T141002J01-RP A1 - 5 / 18 Rev. 00 RX: Compliance Certification Services Inc. Report No.: T141002J01-RP A1 - 6 / 18 Rev. 00 Compliance Certification Services Inc. Report No.: T141002J01-RP A1 - 7 / 18 Rev. 00 Compliance Certification Services Inc. Report No.: T141002J01-RP A1 - 8 / 18 Rev. 00 Compliance Certification Services Inc. Report No.: T141002J01-RP A1 - 9 / 18 Rev. 00 Antenna (RX)

WG-103 Label design and label location WG-103-A Label design and label location

Compliance Certification Services Inc. Report No.: T141002J01-RP A1 - 10 / 18 Rev. 00 INTERNAL PHOTOGRAPHS OF EUT Model no.: WG-103 (TX) Compliance Certification Services Inc. Report No.: T141002J01-RP A1 - 11 / 18 Rev. 00 Compliance Certification Services Inc. Report No.: T141002J01-RP A1 - 12 / 18 Rev. 00 Compliance Certification Services Inc. Report No.: T141002J01-RP A1 - 13 / 18 Rev. 00 Module PCB Antenna Compliance Certification Services Inc. Report No.: T141002J01-RP A1 - 14 / 18 Rev. 00 Model no.: WG-103-A (TX) Compliance Certification Services Inc. Report No.: T141002J01-RP A1 - 15 / 18 Rev. 00 Compliance Certification Services Inc. Report No.: T141002J01-RP A1 - 16 / 18 Rev. 00 Module PCB Antenna Compliance Certification Services Inc. Report No.: T141002J01-RP A1 - 17 / 18 Rev. 00 RX: Compliance Certification Services Inc. Report No.: T141002J01-RP A1 - 18 / 18 Rev. 00 Module

Compliance Certification Services Inc. FCC ID: 2ADEEWG103 Report No.: T141002J01-RP Note: This report shall not be reproduced except in full, without the written approval of Compliance Certification Services Inc. This document may be altered or revised by Compliance Certification Services Inc. personnel only, and shall be noted in the revision section of the document. Page 1 / 32 Rev.00 FCC 47 CFR PART 15 SUBPART C TEST REPORT For “Wegene” ECG Patch Model Number: WG-103, WG-103-A Trade Name: Wegene Issued to We Gene Technologies 18F, No.166, Jien-Yi Rd., Chung-Ho Dist., New Taipei City 23511, Taiwan, R.O.C Issued by Compliance Certification Services Inc. No.11, Wugong 6th Rd., Wugu Dist., New Taipei City 24891, Taiwan. (R.O.C.) http://www.ccsrf.com [email protected] Issued Date: April 24, 2015 Compliance Certification Services Inc. FCC ID: 2ADEEWG103 Report No.: T141002J01-RP Page 2 Rev.00 Revision History Rev. Issue Date Revisions Effect Page Revised By 00 April 24, 2015 Initial Issue ALL Becca Chen Compliance Certification Services Inc. FCC ID: 2ADEEWG103 Report No.: T141002J01-RP Page 3 Rev.00 TABLE OF CONTENTS 1. TEST RESULT CERTIFICATION ....................................................................................4 2. EUT DESCRIPTION ........................................................................................................5 3. TEST METHODOLOGY ..................................................................................................6 3.1 EUT CONFIGURATION .............................................................................................6 3.2 EUT EXERCISE .........................................................................................................6 3.3 GENERAL TEST PROCEDURES ..............................................................................6 3.4 FCC PART 15.205 RESTRICTED BANDS OF OPERATIONS ...................................7 3.5 DESCRIPTION OF TEST MODES .............................................................................7 4. INSTRUMENT CALIBRATION ........................................................................................8 4.1 MEASURING INSTRUMENT CALIBRATION .............................................................8 4.2 MEASUREMENT EQUIPMENT USED .......................................................................8 4.3 MEASUREMENT UNCERTAINTY .............................................................................9 5. FACILITIES AND ACCREDITATIONS .......................................................................... 10 5.1 FACILITIES .............................................................................................................. 10 5.2 EQUIPMENT ............................................................................................................ 10 5.3 TABLE OF ACCREDITATIONS AND LISTINGS ...................................................... 11 6. SETUP OF EQUIPMENT UNDER TEST ....................................................................... 12 6.1 SETUP CONFIGURATION OF EUT ......................................................................... 12 6.2 SUPPORT EQUIPMENT .......................................................................................... 12 7. FCC PART 15.249 REQUIREMENTS ........................................................................... 13 7.1 20 DB BANDWIDTH ................................................................................................. 13 7.2 BAND EDGES MEASUREMENT ............................................................................. 16 7.3 SPURIOUS EMISSION ............................................................................................ 22 7.4 POWERLINE CONDUCTED EMISSIONS ................................................................ 30 APPENDIX I PHOTOGRAPHS OF TEST SETUP ............................................................... 31 APPENDIX 1 - PHOTOGRAPHS OF EUT Compliance Certification Services Inc. FCC ID: 2ADEEWG103 Report No.: T141002J01-RP Page 4 Rev.00 1. TEST RESULT CERTIFICATION Applicant: We Gene Technologies 18F, No.166, Jien-Yi Rd., Chung-Ho Dist., New Taipei City 23511, Taiwan, R.O.C Equipment Under Test: “Wegene” ECG Patch Trade Name: Wegene Model Number: WG-103, WG-103-A Date of Test: April 15, 2015 APPLICABLE STANDARDS STANDARD TEST RESULT FCC 47 CFR Part 15 Subpart C(10–1–12 Edition) No non-compliance noted We hereby certify that: The above equipment was tested by Compliance Certification Services Inc. The test data, data evaluation, test procedures, and equipment configurations shown in this report were made in accordance with the procedures given in ANSI C63.4: 2009 and the energy emitted by the sample EUT tested as described in this report is in compliance with the requirements emission limits of FCC Rules Part 15.207, 15.209 and 15.249. The test results of this report relate only to the tested sample identified in this report. Approved by: Reviewed by: Miller Lee Angel Cheng Manager Section Manager Compliance Certification Services Inc. Compliance Certification Services Inc. Compliance Certification Services Inc. FCC ID: 2ADEEWG103 Report No.: T141002J01-RP Page 5 Rev.00 2. EUT DESCRIPTION Product “Wegene” ECG Patch Trade Name Wegene Model Number WG-103, WG-103-A Model Discrepancy All the specification and layout are identical except they come with differences for different shell shapes. Received Date October 2, 2014 Power Supply Powered from host device (DC 3V) Frequency Range 2401 ~ 2480 MHz Modulation Technique GFSK Antenna Gain Gain: 0dBi Antenna Designation PCB Antenna WEGENE / WG-103 Remark: 1. The sample selected for test was production product and was provided by manufacturer. 2. This submittal(s) (test report) is intended for FCC ID: 2ADEEWG103 filing to comply with Section 15.107, 15.109, 15.207, 15.209, 15.249 (FCC Part 15, Subpart C Rules.) Compliance Certification Services Inc. FCC ID: 2ADEEWG103 Report No.: T141002J01-RP Page 6 Rev…

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Compliance Certification Services Inc. FCC ID: 2ADEEWG103 Report No.: T141002J01-RP Page 31 Rev.00 APPENDIX I PHOTOGRAPHS OF TEST SETUP Conducted Emissions Setup Photos Compliance Certification Services Inc. FCC ID: 2ADEEWG103 Report No.: T141002J01-RP Page 32 Rev.00 RADIATED EMISSION SET UP PHOTOS