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2AK5KU16H25008Wrist Electronic Blood Pressure Monitor

Shenzhen Urion Technology Co.,Ltd.
Wrist Electronic Blood Pressure Monitor - FCC ID 2AK5KU16H25008 - Shenzhen Urion Technology Co.,Ltd.
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Application Details

Equipment Class
DTS - Digital Transmission System
Date of Grant
Apr 23, 2025
Application Purpose
Original Equipment
Equipment Note
Wrist Electronic Blood Pressure Monitor
Frequency Range
2402.00000000 - 2480.00000000
Company
Shenzhen Urion Technology Co.,Ltd.
Country
China

Documents & Files

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Users Manual

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Attestation Statements

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Cover Letter(s)

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External Photos

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ID Label/Location Info

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Internal Photos

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RF Exposure Info

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Test Report

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Test Setup Photos

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Document Text

Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.

Users Manual

Wrist Electronic Blood Pressure Monitor Instruction Manual Regulation information FCC Caution: Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: —Reorient or relocate the receiving antenna. —Increase the separation between the equipment and receiver. —Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. —Consult the dealer or an experienced radio/TV technician for help. FCC RF Exposure Statement: 1. This Transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. 2. This equipment complies with RF radiation exposure limits set forth for an uncontrolled environment. The device has been evaluated to meet general RF exposure requirement. The device can be used in portable exposure condition without restriction. CE Caution: Risk of explosion if battery is replaced by an incorrect type. Dispose of used batteries according to the instructions. Radio-frequency exposure: The device has been evaluated to meet general RF exposure requirement. The device can be used in portable exposure condition without restriction. Hereby, Shenzhen Urion Technology Co.,Ltd. declares that this product is in compliance with essential requirements and other relevant provisions of Directive 2014/53/EU. This product is allowed to be used in all EU member states. Frequency bands Maximum output power BLE -8.29 dBm (EIRP) Copyright This manual is copyrighted with all rights reserved. No portion of this manual may be copied or reproduced by any means. While every precaution has been taken in the preparation of this manual, no responsibility for errors or omissions is assumed. Neither is any liability assumed for damages resulting from the use of the information contained herein. Trademarks All brand names, logos and registered trademarks mentioned are property of their respective owners. Preface Thank you for purchasing the wrist-type electronic blood pressure monitor. In order to use this product safely and to avoid harm or loss due to improper use, please be sure to read this manual carefully and use it correctly before using the product. After reading, please keep it in a safe place for future reference. A warranty card is included; please do not lose it. *The illustrations in this manual are for reference only. 0.Safe to use 1.Failure to fully comply with the operations outlined in this manual may result in inaccurate measurement results. 2.Our company will not notify users of any changes to this manual. 3.The warning symbols and illustrations in this manual are intended to help you use this product safely and correctly, and to prevent injury to yourself and others. 4.Under no circumstances shall our company be held responsible for any issues, damages, or losses arising from calibration or maintenance of this system performed by individuals not authorized by our company. 5.This instruction contains warnings about potential foreseeable dangers, and a high level of vigilance should be maintained at all times for those dangers that are not stated. Instructions for use and outer packaging symbols Symbol Explanation Symbol Explanation Caution Type BF applied part Follow instructions for use Non-ionizing electromagnetic radiation Batch code Serial number Model number Manufacturer Authorized Representative in the European Union Country of manufacture MR unsafe Direct current Unique device identifier Medical Device This way up Fragile, handle with care Keep dry Indicates the temperature limits to which the medical device can be safely exposed Indicates the range of humidity to which the medical device can be safely exposed Indicates the range of atmospheric pressure to which the medical device can be safely exposed CE Mark:conforms to essential requirements of EU MDR 2017/745 DISPOSAL:Do not dispose this product as unsorted municipal waste.Collection of such waste separately for special treatment is necessary. IP43 Safe waterproof and dustproof level, use in a relatively dry environment 1. Notes 1. This blood pressure monitor is suitable for home use and is not recommended for use in public places as a public blood pressure monitor. 2. This device is not suitable for newborns or infants. 3. Long-term high blood pressure values are harmful to health, and consultation with a doctor and treatment are necessary. If abnormal values are detected, consult a doctor, but do not rely solely on a single measurement. 4. Please use the device in the environment as stated in this manual, otherwise, it may not measure correctly. 5. Blood pressure values can vary depending on your physical condition. Therefore, please measure your blood pressure in a quiet, relaxed environment. 6. Pregnant women should be extra cautious when measuring blood pressure, as their blood pressure fluctuations are more significant …

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External Photos

External Photos

Internal Photos

Internal Photos

RF Exposure Info

FCC ID:2AK5KU16H25008 RF Exposure Evaluation REQUIREMENT KDB 447498 D04 Interim General RF Exposure Guidance v01 Appendix B Exemptions for Single RF Sources B.3 MPE-based Exemption and B.4 SAR-based Exemption: f is in GHz, d is the separation distance (cm), and ERP20cm is per Formula (B.1). TEST RESULT Passed Not Applicable Radio Type Frequency (MHz) Conducted Power (dBm) Conducted Power (mW) Minimum Separation Distance(mm) Pth (mW) Bluetooth 2402-2480 -0.48 0.895 0 3 Note: The safety distance for body exposure assessment is 0mm.

Test Report

2.4 GHz Antenna Radiation Pattern 1.2 Antenna S11 1.3 Antenna Pattern (3-D) 1.3.1 XY plane 1.3.2 YZ plane 1.3.3 XZ plane Antenna Efficiency Freqency(MHz) Gain(dBi) Efficiency(dB) Efficiency(%) 2400 -14.06 -17.64 1.72 2450 -14.1 -17.21 1.9 2500 -13.11 -16.71 2.13 1.4 Antenna Dimension

Test Report

Page: 1 of 34 TEST REPORT For Bluetooth-LE Report No. ...................................... : CHTW25030001 Report Verification: Project No.................................: SHT2409018615W FCC ID ............................................. : 2AK5KU16H25008 Applicant’s name ........................... : Shenzhen Urion Technology Co.,Ltd. Address ............................................. : Floor 4-6th of Building D, Jiale Science&Technology Industrial Zone, No.3, ChuangWei Road, Heshuikou Community, MaTian Street, GuangMing New District, 518106 Shenzhen, PEOPLE'S REPUBLIC OF CHINA Product Name ................................ : Wrist Electronic Blood Pressure Monitor Trade Mark ....................................... : - Model No. ......................................... : U16H Listed Model(s) ................................. : U16L, U16P, U16W, U19M, U19R, U19S, U19T Standard ......................................... : FCC CFR Title 47 Part 15 Subpart C § 15.247 Date of receipt of test sample..........: Dec. 25, 2024 Date of testing.............................: Jan. 10, 2025- Feb. 27, 2025 Date of issue...............................: Mar. 03, 2025 Result .................. ........................: PASS Compiled by ( Position+Printed name+Signature): File administrator Xiaodong Zhao Supervised by (Position+Printed name+Signature): Project Engineer Xiaodong Zhao 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.: CHTW25030001 Page: 2 of 34 Date of issue: 2025-03-03 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V06(2023-09) Contents 1. TEST S T A N D A R D S A N D 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 29 7. EXTERNAL AND INTERNAL PHOTOS 31 7.1. External Photos 31 7.2. Internal Photos 33 8. APPENDIX REPORT 34 Report No.: CHTW25030001 Page: 3 of 34 Date of issue: 2025-03-03 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 2025-03-03 Original Report No.: CHTW25030001 Page: 4 of 34 Date of issue: 2025-03-03 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 Xiaodong Zhao 5.2 AC Conducted Emission 15.207 PASS Yating Chen 5.3 Peak Output Power 15.247(b)(3) PASS Xiangyu Wei 5.4 Power Spectral Density 15.247(e) PASS Xiangyu Wei 5.5 6dB Bandwidth 15.247(a)(2) PASS Xiangyu Wei 5.6 99% Occupied Bandwidth - PASS *1 Xiangyu Wei 5.7 Duty cycle - PASS *1 Xiangyu Wei 5.8 Conducted Band Edge and Spurious Emission 15.247(d)/15.205 PASS Xiangyu Wei 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 Junxu Lin Note: ‒ The measurement uncertainty is not included in the test result. ‒ *1: No requirement on standard, only report these test data. Report No.: CHTW25030001 Page: 5 of 34 Date of issue: 2025-03-03 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V06(2023-09) 3. SUMMARY 3.1. Client Information Applicant: Shenzhen Urion Technology Co., Ltd. Address: Floor 4-6th of Building D, Jiale Science&Technology Industrial Zone, No.3, ChuangWei Road, Heshuikou Community, MaTian Street, GuangMing New District, 518106 Shenzhen, PEOPLE'S REPUBLIC OF CHINA Manufacturer: Shenzhen Urion Technology Co., Ltd. Address: Floor 4-6th of Building D, Jiale Science&Technology Industrial Zone, No.3, ChuangWei Road, Heshuikou Community, MaTian Street, GuangMing New District, 518106 Shenzhen, PEOPLE'S REPUBLIC OF CHINA Factory: Shenzhen U…

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Test Setup Photos

Test setup photos-Part15.247 Radiated Emission AC Conducted Emission

Contact Information

Applicant

Joanna Guo(Director)
[email protected]Fax: 0755-27493959

Technical Contact

Shenzhen Huatongwei International Inspection Co.,Xiaodong Zhao
[email protected]

Building 7, Baiwang Idea Factory, No.1051, Songbai · Shenzhen · China

Test Firm

Shenzhen Huatongwei International Inspection Co.,Tony Jiang
[email protected]

Technical Specifications

#Rule PartsFrequency RangePower Output
115C2.40 GHz - 2.48 GHz900.00 µW
Confidentiality
Long Term
Grant Notes
Output power listed is conducted.