2BGYO-00AAWireless ECG recording box

Device Name：Wireless ECG recording box Model: ZHYH002 APP Name：Monerr User Manual Ver：1. 00. 00 Intel love (Tianjin) Medical Device Co., Ltd. User Manual Ver：1. 00. 00 2 / 21 NOTICE: It is required that you read this instruction manual before trying to operate the Wireless ECG recording box and MONERR APP. It is not recommended that you start using the device before reading the whole manual. Failure to follow this instruction manual may result in measurement abnormalities and equipment damage. Intel love(Tianjin) Medical Device Co., Ltd. (the “Company”) assumes no responsibility for personal injury or device damage sustained by or through the use of this product. User Manual Ver：1. 00. 00 3 / 21 Table of content 1. Legal ............................................................................................................................................................. 4 1.1 Copyright & Disclaimer .......................................................................................................................... 4 2. Warnings and Cautions .................................................................................................................................... 5 2.1 Precautions ........................................................................................................................................... 5 2.2 Warnings .............................................................................................................................................. 5 2.3 Contraindications ................................................................................................................................... 6 2.4 Intended User ........................................................................................................................................ 6 3. Technical Specifications & Declarations ............................................................................................................ 6 3.1 Symbols Explantion ............................................................................................................................... 6 3.2 Technical ............................................................................................................................................. 7 3.3 Electromagnetic Compatibility ................................................................................................................. 8 3.4 Declaration of Conformance .................................................................................................................. 11 3.5 RF Conformance .................................................................................................................................. 11 3.6 Quality of Service and Security .............................................................................................................. 12 4. Overview ..................................................................................................................................................... 12 4.1 Indications for Use ............................................................................................................................... 12 4.2 Description of the Device ...................................................................................................................... 13 5. Getting Started ............................................................................................................................................. 13 5.1 Package Content .................................................................................................................................. 13 5.2 Device Setup Instructions ...................................................................................................................... 13 5.3 Software Installation ............................................................................................................................. 14 6. Operating Instructions ................................................................................................................................... 14 6.1 Create a User and Verify your Email Address .......................................................................................... 14 6.2 Recording Your ECG .......................................................................................................................... 15 6.3 Viewing Your ECG Waveform .............................................................................................................. 18 6.4 Medication information Recording ......................................................................................................... 18 6.4.1 Adding Medications ................................................................................................................... 18 6.4.2 Medication Reminders ................................................................................................................ 19 6.4.3 Viewing Records ........................................................................................................................ 20 7. Cleaning and Maintenance ............................................................................................................................. 20 7.1 Cleaning ............................................................................................................................................. 20 7.2 Maintenance ........................................................................................................................................ 20 7.3 Storage ............................................................................................................................................... 20 8. Troubleshooting ............................................................................................................................................ 21 9. Manufactured By .................…

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External Photos

Internal Photos

FCC ID: 2BGYO-00AA RF Exposure Evaluation REQUIREMENT KDB447498 D01 General RF Exposure Guidance v06, Clause 4.3.1(a) [(max. power of channel, including tune-up tolerance, mW) / (min. test separation distance, mm)] · [√f(GHz)] ≤ 3.0 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 test exclusions are applicable only when the minimum test separation distance is ≤ 50 mm, and for transmission frequencies between 100 MHz and 6 GHz. When the minimum test separation distance is < 5 mm, a distance of 5 mm according to 4.1 f) is applied to determine SAR test exclusion. TEST RESULT Passed Not Applicable Radio Type Frequency range (MHz) Conducted Power (dBm) Maximum Tune-up (dBm) Calculating data Limit Result Bluetooth 2402-2480 -1.44 -1.00 0.2467 3.00 Pass Note: 1) The maximum antenna gain is 3.00dBi 2) The exposure evaluation safety distance is 5mm.

Page: 1 of 39 TEST REPORT For Bluetooth-LE Report No. ...................................... : CHTW24070019 Report Verification: Project No.................................： SHT2405059502W FCC ID ............................................. : 2BGYO-00AA Applicant’s name ........................... : Intel love (Tianjin) Medical Device Co., Ltd Address ............................................. : No. 2, 1st Floor, No.8 Hongze Road, Dasi Town, Xiqing District, Tianjin,China Product Name ................................ : Wireless ECG recording box Trade Mark ....................................... : - Model No. ......................................... : ZHYH002 Listed Model(s) ................................. : - Standard ......................................... : FCC CFR Title 47 Part 15 Subpart C § 15.247 Date of receipt of test sample..........: May.29, 2024 Date of testing.............................: May.29, 2024 - Jul.03, 2024 Date of issue...............................: Jul.04, 2024 Result .................. ........................: PASS Compiled by ( Position+Printed name+Signature): File administrators Kiki Kong Supervised by (Position+Printed name+Signature): Project Engineer Kiki Kong Approved by (Position+Printed name+Signature): RF Manager Xu yang Testing Laboratory Name ............. : Shenzhen Huatongwei International Inspection Co., Ltd. Address ............................................. : Building 7, Baiwang Idea Factory, No.1051, Songbai Road, Yangguang Community, Xili Subdistrict, Nanshan District, Shenzhen, Guangdong, China Shenzhen Huatongwei International Inspection Co., Ltd. All rights reserved. This publication may be reproduced in whole or in part for non-commercial purposes as long as the Shenzhen Huatongwei International Inspection Co., Ltd. is acknowledged as copyright owner and source of the material. Shenzhen Huatongwei International Inspection 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. The test report merely correspond to the test sample. Report No.: CHTW24070019 Page: 2 of 39 Date of issue: 2024-07-04 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V06(2023-09) Contents 1. TEST S T A N D A R D S AND R E P O R T V E R S I O N 3 1.1. Test Standards 3 1.2. Report version 3 2. TEST DESCRIPTION 4 3. SUMMARY 5 3.1. Client Information 5 3.2. Product Description 5 3.3. Radio Specification Description 5 3.4. Testing Laboratory Information 6 4. TEST CONFIGURATION 7 4.1. Test frequency list 7 4.2. Descriptions of Test mode 7 4.3. Test sample information 7 4.4. Support unit used in test configuration and system 8 4.5. Testing environmental condition 8 4.6. Statement of the measurement uncertainty 8 4.7. Equipment Used during the Test 9 5. TEST CONDITIONS AND RESULTS 11 5.1. Antenna Requirement 11 5.2. AC Conducted Emission 12 5.3. Peak Output Power 15 5.4. Power Spectral Density 16 5.5. 6dB bandwidth 17 5.6. 99% Occupied Bandwidth 18 5.7. Duty Cycle 19 5.8. Conducted Band edge and Spurious Emission 20 5.9. Radiated Band edge Emission 21 5.10. Radiated Spurious Emission 23 6. TEST SETUP PHOTOS 30 7. EXTERNAL AND INTERNAL PHOTOS 33 7.1. External Photos 33 7.2. Internal Photos 36 8. APPENDIX REPORT 39 Report No.: CHTW24070019 Page: 3 of 39 Date of issue: 2024-07-04 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V06(2023-09) 1. TEST STANDARDS AND REPORT VERSION 1.1. Test Standards The tests were performed according to following standards: ‒ FCC CFR Title 47 Part 15 Subpart C § 15.247: Operation within the bands 902-928 MHz, 2400-2483.5 MHz, and 5725-5850 MHz ‒ ANSI C63.10:2020: American National Standard for Testing Unlicensed Wireless Devices ‒ KDB 558074 D01 15.247 Meas Guidance v05r02: Guidance for Compliance Measurements on Digital Transmission System, Frequency Hopping Spread Spectrum System, and Hybrid System Devices Operating under Section 15.247 of The FCC Rules 1.2. Report version Revision No. Date of issue Description N/A 2024-07-04 Original Report No.: CHTW24070019 Page: 4 of 39 Date of issue: 2024-07-04 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V06(2023-09) 2. TEST DESCRIPTION Report clause Test Items Standard Requirement Result Test Engineer 5.1 Antenna Requirement 15.203/15.247(c) PASS Chenxin Ling 5.2 AC Conducted Emission 15.207 PASS JUNMAN.WANG 5.3 Peak Output Power 15.247(b)(3) PASS Chenxin Ling 5.4 Power Spectral Density 15.247(e) PASS Chenxin Ling 5.5 6dB Bandwidth 15.247(a)(2) PASS Chenxin Ling 5.6 99% Occupied Bandwidth - PASS *1 Chenxin Ling 5.7 Duty cycle - PASS *1 Chenxin Ling 5.8 Conducted Band Edge and Spurious Emission 15.247(d)/15.205 PASS Chenxin Ling 5.9 Radiated Band Edge Emission 15.205/15.209 PASS Yifan Wang 5.10 Radiated Spurious Emission 15.247(d)/15.205/15.209 PASS Yifan Wang Note: ‒ The measurement uncertainty is not included in the test result. ‒ *1: No requirement on standard, only report these test data. Report No.: CHTW24070019 Page: 5 of 39 Date of issue: 2024-07-04 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V06(2023-09) 3. SUMMARY 3.1. Client Information Applicant: Intel love (Tianjin) Medical Device Co., Ltd Address: No. 2, 1st Floor, No.8 Hongze Road, Dasi Town, Xiqing District, Tianjin,China Manufacturer: Intel love (Tianjin) Medical Device Co., Ltd Address: No. 2, 1st Floor, No.8 Hongze Road, Dasi Town, Xiqing District, Tianjin,China 3.2. Product Description Main unit information: Product Name: Wireless ECG recording box Trade Mark: - Model No.: ZHYH002 Listed Model(s): - Power supply: DC 3.7V from Battery Hardware version: V2.0 Software version: 1140 Accessory unit information: Battery information: Model: ZWD932030K 570mAh 2.109Wh +4.2/3.7V 3.3. Radio Specification Description Bluetooth version: V5.0 Support function: BLE 1M, BLE 2M Modu…

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Antennaspecification Model: Y2-BT Brand: FutenTechnology(ShangHai)Co.,LTD.. Manufacturer: FutenTechnology(ShangHai)Co.,LTD.. 1.Antennadescribe: AntennaModel:Y2-BT Antennaplate:Built-inFPCantenna Frequency range:2402-2480 MHz Connector type: FPC+holder 2.Radiationpattern2450MHZ 3.Gain&Efficiency Gain&Efficiency 增益和效率 frequency 频率 (MHz) gain 增益 (dBi) mingain 最小增 益(dBi) efficiency 效率(%) 2400 2410 2420 2430 2440 2450 2460 2470 2480 2.34 2.58 2.68 3.00 2.66 2.61 2.63 2.65 2.92 38.21 39.26 38.10 37.39 36.29 35.52 34.92 44.67 -19.17 -19.57 -20.24 -20.55 -22.07 -24.41 -29.58 -21.84 -26.8754.63 4.Antennastructuredrawing

TEST SETUP PHOTOS Radiated Emission AC Conducted Emission