2AGPVWOOTOP-P001Mobile & Wireless ECG Systems

Mobile & Wireless ECG Systems Model: WOOTOP-P001 Instructions for Use Edition of the Instructions: Manufacturer/After-sales Service: Shenzhen Qianhai MDE Medical Technology Co., Ltd. Address: Room 201, Building A, Qianwan Yi Road No.1, Qianhai Shenzhen-Hong Kong Cooperation Zone, Shenzhen， Guangdong， P.R. China Address of Manufacturing Site: Floor 6, Block B, Building 6, Baoneng Science & Technology Park, Qinghu Industrial Zone, Qingxiang Road, Longhua Office, Longhuan New Zone, Shenzhen Tel: 0755-23972355 Fax: 0755-23972355 Website: http: //www.wootop.cn Registration Certificate for Medical Apparatus and Technical Specification of Product: License for Manufacture of Medical Apparatus and Instruments: Contents I. General ............................................................................................................................................................... 1 III. Description of Product ..................................................................................................................................... 2 1. Basic Information ...................................................................................................................................... 2 2. Performance of the Product ....................................................................................................................... 2 3. Working Principle ..................................................................................................................................... 3 4. Primary Structure ....................................................................................................................................... 3 5. Intended Use and Features ......................................................................................................................... 3 IV. Instructions for Use and Operation ................................................................................................................. 4 1. Charging .................................................................................................................................................... 4 2. Turning on/off ........................................................................................................................................... 4 3. Software Installation and Hooking-up ....................................................................................................... 5 4. Placement of Electrode .............................................................................................................................. 5 5. Placement Modes ....................................................................................................................................... 6 6. Single-Pass Electrocardiogram Monitoring ............................................................................................... 6 7. Continuous Electrocardiogram Monitoring ............................................................................................... 7 8. Data Retrieval ............................................................................................................................................ 7 9. Indicator Light Status ................................................................................................................................ 7 V. Cleaning, Maintenance and Service ................................................................................................................. 8 1. Cleaning ..................................................................................................................................................... 8 2. Maintenance and Service ........................................................................................................................... 8 VI. Fault Analysis and Trouble-shooting .............................................................................................................. 8 1. Common Faults ......................................................................................................................................... 8 2. Guarantee/Warranty Card .......................................................................................................................... 8 VII. Accessories and Packing List ......................................................................................................................... 8 VIII. Signs and Symbols ........................................................................................................................................ 9 IX. Storage and Transport ..................................................................................................................................... 9 1. Storage ....................................................................................................................................................... 9 2. Transport.................................................................................................................................................... 9 X. Production Information and After-sales Service .............................................................................................. 9 Annex: Description of Electromagnetic Compatibility ....................................................................................... 11 1 I. General WOOTOP-P001 is a Mobile & Wireless ECG Systems (hereinafter referred to as "ECG Systems") independently developed by Shenzhen Qianhai MDE Medical Technology Co., Ltd. (hereinafter referred to as MEDICAL). All parts of this ECG Systems, including any software and hardware, belong to and are exclusive properties of MEDICAL and shall not be reproduced, copied and plagiarized by any individual or group unless otherwise authorized by MEDICAL. This product is manufactured as per Medical Device Registration Standards and fully complies with the precise requirements of national and …

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Shenzhen Qianhai MDE Medical Technology Co., Ltd. Room 201, Building A, Qianwan Yi Road No.1, Qianhai Shenzhen-Hong Kong Cooperation Zone, Shenzhen， Guangdong， P.R. China TEL: +86-755-23972355 FAX: +86-755-23972355 DATE 11-30-2015 Equipment Autorisation Division Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 FCC ID: 2AGPVWOOTOP-P001 Product Name: Mobile & Wireless ECG Systems Request for Confidentiality Pursuant to Sections 0.457 and 0.459 of the commissions rules, we hereby request that the following documents be held confidential: (List here the documents for which you are seeking confidentiality – for example ...) • Schematics • Block diagram • Operation description These materials contain trade secrets and proprietary information and are not customarily released to the public. The public disclosure of this information might be harmful to the company and provide unjustified benefits to our competitors. Dated this 11-30-2015 By: Jiawen Liu Signature Printed Title: Manager On behalf of : Shenzhen Qianhai MDE Medical Technology Co., Ltd. Telephone: +86-755-23972355

Shenzhen Qianhai MDE Medical Technology Co., Ltd. Room 201, Building A, Qianwan Yi Road No.1, Qianhai Shenzhen-Hong Kong Cooperation Zone, Shenzhen， Guangdong， P.R. China TEL: +86-755-23972355 FAX: +86-755-23972355 USB Port Statement FCC ID: 2AGPVWOOTOP-P001 Date: Nov. 30, 2015 To whom it may concern: We, the undersigned, state that the device's (Model: WOOTOP-P001) USB port only used for charge, no any data transfer to PC. Sincerely, Jiawen Liu/Manager

Or 3. FCC ID Label: FCC ID: 2AGPVWOOTOP-P001 FCCID Label Location

RF Exposure evaluation According to 447498 D01 General RF Exposure Guidance v05 The 1-g and 10-g SAR test exclusion thresholds for 100 MHz to 6 GHz at test separation distances ≤ 50 mm are determined by: [(max. power of channel, including tune-up tolerance, mW)/(min. test separation distance, mm)] ·[√f(GHz)] ≤ 3.0 for 1-g SAR and ≤ 7.5 for 10-g extremity SAR, where  f(GHz) is the RF channel transmit frequency in GHz  Power and distance are rounded to the nearest mW and mm before calculation  The result is rounded to one decimal place for comparison eirp = pt x gt = (EXd) 2 /30 where: pt = transmitter output power in watts, gt = numeric gain of the transmitting antenna (unitless), E = electric field strength in V/m, --- 10 ((dBuV/m)/20) /10 6 d = measurement distance in meters (m)---3m So pt = (EXd) 2 /30 x gt Field strength = 91.18dBuV/m @3m Ant gain 0dBi; so Ant numeric gain=1 So pt={[10 (91.18/20) /10 6 x3] 2 /(30x1 )}x1000mW = 0.4 mW So ( 0.4 mW/5mm)x √2.440 GHz = 0.13 <3 Then SAR evaluation is not required

- Shenzhen CTL Testing Technology Co., Ltd. Tel: +86-755-89486194 Fax: +86-755-26636041 FCC PART 15 SUBPART C TEST REPORT Report Reference No.: CTL1511123283-WF Compiled by: ( position+printed name+signature) Happy Guo (File administrators) Tested by: ( position+printed name+signature) Nice Nong (Test Engineer) Approved by: ( position+printed name+signature) Tracy Qi (Manager) Product Name...............................: Mobile & Wireless ECG Systems Model/Type reference..................: WOOTOP-P001 Trade Mark....................................: WOOTOP FCC ID...........................................: 2AGPVWOOTOP-P001 Applicant’s name.........................: Shenzhen Qianhai MDE Medical Technology Co., Ltd. Address of applicant...................: Room 201, Building A, Qianwan Yi Road No.1, Qianhai Shenzhen-Hong Kong Cooperation Zone, Shenzhen, Guangdong, P.R. China Test Firm.......................................: Shenzhen CTL Testing Technology Co., Ltd. Address of Test Firm...................: Floor 1- A, Baisha Technology Park, No.3011, Shahexi Road, Nanshan District, Shenzhen, China 518055 Test specification.........................: Standard........................................: FCC Part 15.249: Operation within the bands 920-928 MHz, 2400- 2483.5 MHz, 5725-5850 MHz and 24.0 - 24.25 GHz. TRF Originator..........................: Shenzhen CTL Testing Technology Co., Ltd. Master TRF..............................: Dated 2011-01 Date of Receipt.............................: Nov. 12, 2015 Date of Test Date..........................: Nov. 12, 2015 - Nov. 30, 2015 Data of Issue.................................: Nov. 30, 2015 Result............................................: Positive Shenzhen CTL Testing Technology Co., Ltd. All rights reserved. This publication may be reproduced in whole or in part for non-commercial purposes as long as the Shenzhen CTL Testing Technology Co., Ltd. is acknowledged as copyright owner and source of the material. Shenzhen CTL Testing Technology Co., Ltd. takes no responsibility for and will not assume liability for damages resulting from the reader's interpretation of the reproduced material due to its placement and context. V1.0 Page 2 of 28 Report No.: CTL1511123283-WF T E S T R E P O R T Test Report No. :CTL1511123283-WF Nov. 30, 2015 ______________________________________________________________________________________________ Date of issue Equipment under Test : Mobile & Wireless ECG Systems Model /Type : WOOTOP-P001 Applicant : Shenzhen Qianhai MDE Medical Technology Co., Ltd. Address : Room 201, Building A, Qianwan Yi Road No.1, Qianhai Shenzhen-Hong Kong Cooperation Zone, Shenzhen, Guangdong, P.R. China Manufacturer : Shenzhen Qianhai MDE Medical Technology Co., Ltd. Address : Room 201, Building A, Qianwan Yi Road No.1, Qianhai Shenzhen-Hong Kong Cooperation Zone, Shenzhen, Guangdong, P.R. China Test Result according to the standards on page 4: Positive The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test result without the written permission of the test laboratory. V1.0 Page 3 of 28 Report No.: CTL1511123283-WF Contents 1.TEST STANDARDS .................................................................. 4 2.SUMMARY............................................................................. 5 2.1.Equipment Under Test 5 2.2.Description of the Equipment under Test (EUT) 5 2.3.EUT operation mode 6 2.4.EUT configuration 6 2.5.Related Submittal(s) / Grant (s) 6 2.6.Modifications 6 3. TEST ENVIRONMENT............................................................... 7 3.1.Address of the test laboratory 7 3.2.Test Facility 7 3.3.Environmental conditions 7 3.4.Configuration of Tested System 7 3.5.Statement of the measurement uncertainty 8 3.6.Equipments Used during the Test 9 4. TEST CONDITIONS AND RESULTS ............................................ 10 4.1.Conducted Emissions Test 10 4.2. Transmitter Radiated Unwanted Emissions and Bandedge 13 4.3.Occupied Bandwidth Measurement 19 5. ANTENNA REQUIREMENT ....................................................... 21 6.TEST SETUP PHOTOS OF THE EUT .......................................... 22 7.EXTERNAL AND INTERNAL PHOTOS OF THE EUT ....................... 24 V1.0 Page 4 of 28 Report No.: CTL1511123283-WF 1. TEST STANDARDS The tests were performed according to following standards: FCC Rules Part 15.249: Operation within the bands 902 - 928 MHz, 2400 - 2483.5 MHz, 5725 - 5875 MHz, and 24.0 - 24.25 GHz. ANSI C63.10-2013 ANSI C63.4-2014 V1.0 Page 5 of 28 Report No.: CTL1511123283-WF 2. SUMMARY 2.1. Equipment Under Test Power supply system utilised Power supply voltage : o 120V / 60 Hz o 115V / 60Hz o 12 V DC o 24 V DC ƽ Other (specified in blank below) DC 3.7V from battery 2.2. Description of the Equipment under Test (EUT) TheEUT (Mobile & Wireless ECG Systems) support Bluetooth 4.0LE function. Name of EUT Mobile & Wireless ECG Systems Model Number WOOTOP-P001 Antenna Type Internal BT CE Operation frequency 2402MHz-2480MHz BT Modulation Type GFSK (BT V4.0LE) Bluetooth BT V4.0LE Channel List: Channel Frequency (MHz) Channel Frequency (MHz) 00 2402 21 2444 01 2404 22 2446 02 2406 23 2448 03 2408 24 2450 04 2410 25 2452 05 2412 26 2454 06 2414 27 2456 07 2416 28 2458 08 2418 29 2460 09 2420 30 2462 10 2422 31 2464 11 2424 32 2466 12 2426 33 2468 13 2428 34 2470 14 2430 35 2472 15 2432 36 2474 16 2434 37 2476 17 2436 38 2478 18 2438 39 2480 19 2440 20 2442 For more details, refer to the user’s manual of the EUT. Serial number: Prototype V1.0 Page 6 of 28 Report No.: CTL1511123283-WF 2.3. EUT operation mode Test Mode(TM) Description Remark TM1 Bottom Channel Transmitting / TM2 Middle Channel Transmitting / TM3 Top Channel Transmitting / TM4 Charging and keeping TX power by adapter The field strength of radiation emission was measured in the following position: EUT stand-up position (Y axis), lie-down position (X, Z axis). The following data show only with the …

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