2AM8O-U214-1Arm Blood Pressure Monitor

Page 1 of 16 Arm Blood Pressure Monitor Instruction Manual Model: AES-U214 Version:1.1 Date modified: 2023-05-10 Please read this instruction manual carefully before use Page 2 of 16 Table of Contents 1. Introduction ..................................................................................................................................... 3 2. Indications for Use ........................................................................................................................... 3 3. Product information ........................................................................................................................ 3 4. Classification .................................................................................................................................... 3 5. Safety Information ........................................................................................................................... 4 5.1 General usage ............................................................................................................................ 4 5.2 General precautions .................................................................................................................. 5 6. Explanation of Marks or Symbols .................................................................................................... 5 7. Unit Description .............................................................................................................................. 6 8. Display ............................................................................................................................................. 6 9. Charging the Battery ........................................................................................................................ 6 10. Setting the Measurement Unit ........................................................................................................ 7 11. Precautions for Measurement ......................................................................................................... 8 12. Applying the Arm Cuff ..................................................................................................................... 8 13. Correct Measurement Posture ........................................................................................................ 9 14. Taking A Measurement .................................................................................................................... 9 15. Care and Maintenance .................................................................................................................. 10 15.1 Cleaning the monitor and cuff ............................................................................................... 10 15.2 Maintaining the monitor and cuff ......................................................................................... 10 16. Guarantee ...................................................................................................................................... 11 17. Error Messages .............................................................................................................................. 11 18. Technical Specifications ................................................................................................................. 11 19. Blood Pressure Classification for Adult .......................................................................................... 12 20. Disposal ......................................................................................................................................... 12 21. Electromagnetic Compatibility ...................................................................................................... 12 22. FCC Warning .................................................................................................................................. 16 Page 3 of 16 1. Introduction Thank you for purchasing the Arm Blood Pressure Monitor. The blood pressure monitor uses the oscillometric method of blood pressure measurement. This means the monitor detects your blood’s movement through your brachial artery and converts the movements into a digital reading. An oscillometric monitor does not need a stethoscope so the monitor is simple to use. The Blood Pressure Monitor comes with the following components:  Monitor  Arm Cuff  Instruction Manual Please read this instruction manual thoroughly before using the unit. Please keep for future reference. For specific information about your own blood pressure, please consult your doctor. 2. Indications for Use The Arm Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-42cm. Suitable for adults and adolescents who over the age of 12. 3. Product information Product name: Arm Blood Pressure Monitor , Product model: AES-U214 , Software version: A.01.00.00 Standard: The product is made under the IEC 80601-2-30. Manufacturer Company name: Alicn Medical Shenzhen, Inc Address: Room 410, Building A, 3rd Sub-park, Leibo Zhongcheng Life Science Park, No. 22 Jinxiu East Road, Pingshan District, 518118 Shenzhen, Guangdong, PEOPLE'S REPUBLIC OF CHINA Web: www.alicn-med.com Tel: +86 755 26501548 Fax: +86 755 26504849 4. Classification (1) Internally powered equipment; (2) Type BF applied part; (3) IP classification: IP21; (4) Disinfection of 75% medical alcohol; (5) Not Category AP / APG equipment; (6) Mode of operation: continuous operation. Page 4 of 16 5. Safety Information 5.1 General usage  Do not adjust medication based on measurement values from this blood pressure monitor. Take medication as prescribed by your physician. Only a physician is qualifie…

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Alien Medical Shenzhen, Inc U.S. Agent Designation for Service of Process Certification Attestation Letter July 4, 2023 Nemko North America, Inc. 303 River Road Ottawa K1V 1 H2 Canada ATTN.: Reviewing Engineer FCC ID: 2AM80-U214-1 FRN: 0026737429 Per section 2.911 (d)(7) of the FCC rules, (" Alien Medical Shenzhen, Inc ") certifies that the equipment for which authorization is sought is designated to the following U.S. Designated agent* for service of process: Company Name: Physical U.S. Company Address: Agent name: Agent Email Address: FRN: Global Product Services & Consultation LLC 328 W Palm Ave, Monrovia. CA91016 ChiS.Chan [email protected] 0033406703 The above contact person accepts the obligation for service of process. The applicant accepts to maintain an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any Commission-related proceeding involving the equipment. Applicant Signed: Signed: � Printed name: Renxiong.Huang Title: L&R manager Company Alien Medical Shenzhen, Name: Inc Date: July 4, 2023 Designated Agent Signed: (Required, if different to Applicant): Signed &;p Printed name: Chis.Chan Title: Company Global Product Services Name: Consultation LLC Date: 2023-07-04 & * the applicant must designate a contact located in the United States for purposes of acting as the applicant's agent for service of process, regardless of whether the applicant is a domestic or foreign entity. An applicant located in the United States may designate itself as the agent for service of process. Technical Director S C3078126

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FCC ID: 2AM8O-U214-1

AES-U214

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Page: 1 of 15 TEST REPORT For FCC Part15B Report No. .......................................: CHTEW23060056 Report verification: Project No. ..................................: SHT2304055304EW FCC ID ............................................. : 2AM8O-U214-1 Applicant’s name ........................... : Alicn Medical Shenzhen, Inc Address ............................................. : Room 410, Building A, 3rd Sub-park, Leibo Zhongcheng Life Science Park, No. 22 Jinxiu East Road, Pingshan District, 518118 Shenzhen, Guangdong, PEOPLE'S REPUBLIC OF CHINA Product Name ................................ : Arm Blood Pressure Monitor Trade Mark ....................................... : - Model No. ......................................... : AES-U214 Listed Model(s) ................................. : - Standard ......................................... : FCC CFR Title 47 Part 15 Subpart B Date of receipt of test sample...........: May.04, 2023 Date of testing..............................: May.04, 2023-Jun.27, 2023 Date of issue.................................: Jun.28, 2023 Result .................. ........................: Pass Compiled by ( position+printedname+signature) ... : File administrators Fanghui Zhu Supervised by (position+printedname+signature) .... : Project Engineer Xiaodong Zhao Approved by (position+printed name+signature) ... : RF Manager Hans Hu Testing Laboratory Name ............. : Shenzhen Huatongwei International Inspection Co., Ltd. Address ............................................. : 1/F, Bldg 3, Hongfa Hi-tech Industrial Park, Genyu Road, Tianliao, Gongming, Shenzhen, 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 corresponds to the test sample. Report No.: CHTEW23060056 Page: 2 of 15 Date of issue: 2023-06-28 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V05 (2023-03) Contents 1. TEST STANDARDS AND REPORT VERSION ........................................... 3 1.1. Test Standards 3 1.2. Report version information 3 2. TEST DESCRIPTION .................................................................... 4 3. SUMMARY ............................................................................... 5 3.1. Client Information 5 3.2. Product Description 5 3.3. Testing Laboratory Information 5 4. TEST CONFIGURATION ................................................................. 6 4.1. Descriptions of test mode 6 4.2. Configuration of Tested System 6 4.3. Support unit used in test configuration 6 4.4. Environmental conditions 6 4.5. Statement of the measurement uncertainty 7 4.6. Equipments Used during the Test 7 5. TEST CONDITIONS AND RESULTS ..................................................... 8 5.1. Conducted Emissions 8 5.2. Radiated Emissions 10 6. TEST SETUP PHOTOS OF THE EUT .................................................. 14 7. EXTERNAL AND INTERNAL PHOTOS OF THE EUT .................................. 15 Report No.: CHTEW23060056 Page: 3 of 15 Date of issue: 2023-06-28 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V05 (2023-03) 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 B - Unintentional Radiators ANSI C63.4: 2014 – American National Standard for Methods of Measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40GHz 1.2. Report version information Revision No. Date of issue Description N/A 2023-06-28 Original Report No.: CHTEW23060056 Page: 4 of 15 Date of issue: 2023-06-28 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V05 (2023-03) 2. TEST DESCRIPTION Section Test Item Section in CFR 47 Result #1 Test Engineer 5.1 Conducted Emissions 15.107(a) PASS Yongjin Lin 5.2 Radiated Emissions 15.109(a) PASS Chuanfeng Li Note: #1: The test result does not include measurement uncertainty value Report No.: CHTEW23060056 Page: 5 of 15 Date of issue: 2023-06-28 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V05 (2023-03) 3. SUMMARY 3.1. Client Information Applicant: Alicn Medical Shenzhen, Inc Address: Room 410, Building A, 3rd Sub-park, Leibo Zhongcheng Life Science Park, No. 22 Jinxiu East Road, Pingshan District, 518118 Shenzhen, Guangdong, PEOPLE'S REPUBLIC OF CHINA Manufacturer: Alicn Medical Shenzhen, Inc Address: Room 410, Building A, 3rd Sub-park, Leibo Zhongcheng Life Science Park, No. 22 Jinxiu East Road, Pingshan District, 518118 Shenzhen, Guangdong, PEOPLE'S REPUBLIC OF CHINA 3.2. Product Description Main unit information: Product Name: Arm Blood Pressure Monitor Trade Mark: - Model No.: AES-U214 Listed Model(s): - Power supply: 3.7V, 1100mAh Li-ion battery Hardware version: AES-066-4G-JV01 Software version: A.01.00.00 3.3. Testing Laboratory Information Laboratory Name Shenzhen Huatongwei International Inspection Co., Ltd. Laboratory Location 1/F, Bldg 3, Hongfa Hi-tech Industrial Park, Genyu Road, Tianliao, Gongming, Shenzhen, China Contact information: Tel: 86-755-26715499 E-mail: [email protected] http://www.szhtw.com.cn Qualifications Type Accreditation Number FCC 762235 Report No.: CHTEW23060056 Page: 6 of 15 Date of issue: 2023-06-28 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V05 (2023-03) 4. TEST CONFIGURATION 4.1. Descriptions of test mode Test mode Description O1 EUT shuts down and charges. O2 The EUT works properly when power…

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TEST SETUP PHOTOS OF THE EUT Conducted Emissions (AC Mains) Radiated Emissions (30MHz-1GHz) Radiated Emissions (Above 1GHz)