SMQSAEDANAmbulatory Blood Pressure Monitor

I About this Manual P/N: 01.54.458314 MPN: 01.54. 458314012 Release Date: December 2020 © Copyright EDAN INSTRUMENTS, INC. 2020. All rights reserved. Statement This manual will help you understand the operation and maintenance of the product better. It is reminded that the product shall be used strictly complying with this manual. User’s operation failing to comply with this manual may result in malfunction or accident for which EDAN INSTRUMENTS, INC. (hereinafter called EDAN) cannot be held liable. EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any materials contained in this manual shall not be photocopied, reproduced or translated into other languages. Materials protected by the copyright law, including but not limited to confidential information such as technical information and patent information are contained in this manual, the user shall not disclose such information to any irrelevant third party. The user shall understand that nothing in this manual grants him, expressly or implicitly, any right or license to use any of the intellectual properties of EDAN. EDAN holds the rights to modify, update, and ultimately explain this manual. Product Information Product Name: Ambulatory Blood Pressure Monitor Model: SA-10, SA-05, SA-06, SA-08, and SA-09 Responsibility of the Manufacturer EDAN only considers itself responsible for any effect on safety, reliability and performance of the equipment if: Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorized by EDAN, and II The electrical installation of the relevant room complies with national standards, and The instrument is used in accordance with the instructions for use. Terms Used in this Manual This guide is designed to give key concepts on safety precautions. WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death. CAUTION A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure. NOTE A NOTE provides useful information regarding a function or a procedure. III Table of Contents Chapter 1 Safety Guidance ........................................................................................................... 1 1.1 Indications for Use/Intended Use ........................................................................................ 1 1.2 Warnings and Cautions ....................................................................................................... 1 1.2.1 General Warnings ...................................................................................................... 1 1.2.2 Protecting Personal Information ............................................................................... 5 1.2.3 Battery Care Warnings .............................................................................................. 6 1.2.4 General Cautions ....................................................................................................... 7 1.2.5 Contraindications ...................................................................................................... 8 1.3 List of Symbols ................................................................................................................... 9 Chapter 2 Introduction ................................................................................................................ 12 2.1 About ABPM .................................................................................................................... 12 2.2 ABP Monitor at a Glance .................................................................................................. 13 Chapter 3 Setting up ABPM ........................................................................................................ 15 3.1 Powering the Monitor for Use........................................................................................... 15 3.2 Installing Analysis Software ............................................................................................. 15 3.3 Logging in to Analysis Software ...................................................................................... 15 3.4 Connecting the Monitor to PC .......................................................................................... 16 Chapter 4 Main Screen of Analysis Software ............................................................................ 18 Chapter 5 Conducting an Ambulatory BP Study ...................................................................... 20 5.1 Programming the Monitor ................................................................................................. 20 5.2 Fitting Patient with the Monitor and Cuff ......................................................................... 21 5.3 Preparing the Patient ......................................................................................................... 23 5.4 Measurement Limitations ................................................................................................. 23 5.5 Starting the Study .............................................................................................................. 24 5.6 Finishing the Study ........................................................................................................... 24 Chapter 6 Retrieving ABP Data .................................................................................................. 25 Chapter 7 Analyzing and Editing ABP Data .............................................................................. 26 7.1 Editing Patient Information ............................................................................................... 26 7.2 Data Table ......................................................................................................................... 26 7.3 Day & Night BP Profile ................…

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Edan Instruments, Inc Agent Authorization Company: Edan Instruments, Inc Address: #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District,518122 Shenzhen P.R.China Product Name: Ambulatory Blood Pressure Monitor Model Number(s): SA-08, SA-10, SA-05, SA-09, SA-06 Product Description: Ambulatory Blood Pressure Monitor We authorize MiCOM Labs Inc., 575 Boulder Court, Pleasanton, California 94566, USA, to act on our behalf on all matters concerning the certification of above named equipment. We declare that MiCOM Labs Inc. is allowed to forward all information related to the approval and certification of equipment to the regulatory agencies as required and to discuss any issues concerning the approval application. Any and all acts carried out by MiCOM Labs on our behalf shall have the same effect as acts of our own. Signature: Date: 2021-02-01 Name: Huanhuan Xia Title: Manager Company: Edan Instruments, Inc

Edan Instruments, Inc Date: 26 Jan，2021 To: Federal Communications Commission, Authorization & Evaluation Division, 7435 Oakland Mills Road, Columbia, MD 21046 To Whom It May Concern: The Edan Instruments, Inc , the undersigned, hereby authorizes Mr. Wu Xuewen from Shenzhen BALUN Technology Co., Ltd., to act on the behalf of the Edan Instruments, Inc solely in matters relating to the application for an FCC equipment authorization for FCC ID: SMQSAEDAN including the signing of documents in connection with this Application. Necessary acts carried out by Shenzhen BALUN Technology Co., Ltd. in connection with the Application shall have the same effect as acts of the Edan Instruments, Inc. The Edan Instruments, Inc also hereby certify that no party to this application is subject to a denial of benefits, including FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. Section 862. Yours Sincerely, Print name: Huanhuan Xia Edan Instruments, Inc

Edan Instruments, Inc. Date: 26 Jan，2021 To: Federal Communications Commission, Authorization & Evaluation Division, 7435 Oakland Mills Road, Columbia, MD 21046 RE: Edan Instruments, Inc. FCC ID: SMQSAEDAN FCC Certification Confidentiality Request Gentlemen: This letter is to comply with 47 CFR 0.457 and 0.459 pertaining to confidentiality material. Edan Instruments, Inc. requests that the following documents regarding this submission for FCC ID : SMQSAEDAN be kept Long-Term confidential: Exhibit Type File Name Block Diagram Block Diagram.pdf Schematics Schematics.pdf Operational Description Operational Description.pdf And below exhibit kept short-term confidential (180 days): Exhibit Type File Name External Photos External Photo.pdf Internal Photos Internal Photo.pdf Test Setup Photos Test Setup Photos.pdf Users Manuals Users Manual.pdf Those documents contain detailed system and equipment description and related information about the product which Edan Instruments, Inc. considers to be confidential proprietary, a custom design and, otherwise, not releasable to the general public. Since this design is a basis form which future technological products will evolve, Edan Instruments, Inc. considers this information would be of benefit to its competitors, and that the disclosure of the information in these documents would give competitors an unfair advantage in the market. Thank you for your attention to this matter. Yours Sincerely, Print name: Huanhuan Xia Edan Instruments, Inc.

Edan Instruments, Inc DECLARATION OF IDENTITY Hereby we: Edan Instruments, Inc (Name of Manufacturer) Basic Model Number: SA-08 Basic Brand Name: EDAN Basic Product Name: Ambulatory Blood Pressure Monitor Basic Certificate Number： Declare the Circuit, PCB Layout, Electrical Parts and Outlook of the following product(s) are identical to the basic model: New / Additional Model Number(s): SA-10，SA-05，SA-09，SA-06 New / Additional Brand Name(s): New / Additional Product Name(s): Except the following(s) : 1. Hardware of all models is same，only the software function configuration is different, which does not affect the test 2. N/A Remarks: Signature: Printed Name: Huanhuan Xia Date: Jan 26, 2021

Annex No.: BL-SZ20C0197-AW 1 / 3 EUT EXTERNAL PHOTOS FRONT VIEW OF EUT b REAR VIEW OF EUT Annex No.: BL-SZ20C0197-AW 2 / 3 LEFT SIDE VIEW OF EUT RIGHT SIDE OF EUT X Annex No.: BL-SZ20C0197-AW 3 / 3 TOP VIEW OF EUT c BOTTOM VIEW OF EUT

Label Label location

Annex No.: BL-SZ20C0197-AI 1 / 2 EUT INTERNAL PHOTOS EUT UNCOVER VIEW MAIN BOARD TOP VIEW (WITH SHIELDING) Annex No.: BL-SZ20C0197-AI 2 / 2 MAIN BOARD REAR VIEW (WITHOUT SHIELDING) MAIN BOARD TOP VIEW (WITHOUT SHIELDING)

RF Exposure Evaluation for FCC ID: SMQSAEDAN Refer user manual this device is a Ambulatory Blood Pressure Monitor, and this device was designed used in portable devices that the minimum distance between human’s body is 5mm. Based on the 47CFR 2.1093, this device belongs to portable device. The definition of the category as following: Portable Derives: CFR Title 47 §2.1093(b) (b) For purposes of this section, a portable device is defined as a transmitting device designed to be used so that the radiating structure(s) of the device is/are within 20 centimeters of the body of the user. FCC KDB 447498 D01 General RF Exposure Guidance v06 Limit Unless specifically required by the published RF exposure KDB procedures, standalone 1‐g head or body and 10‐g extremity SAR evaluation for general population exposure conditions, by measurement or numerical simulation, is not required when the corresponding SAR Test Exclusion Threshold condition, listed below, is satisfied. These test exclusion conditions are based on source‐based time‐averaged maximum conducted output power of the RF channel requiring evaluation, adjusted for tune‐up tolerance, and the minimum test separation distance required for the exposure conditions. The minimum test separation distance is determined by the smallest distance from the antenna and radiating structures or outer surface of the device, according to the host form factor, exposure conditions and platform requirements, to any part of the body or extremity of a user or bystander. 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 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 is applied to determine SAR test exclusion. Test data Bluetooth Mode BR+EDR GFSK π/4-DQPSK 8-DPSK Peak Power (dBm) 1.81 0.96 1.13 Note: This report listed the worst case peak power value, please refer to RF test report for more details. Turn-up power Mode Power Range (dBm) Bluetooth 0.00-2.00 RF Exposure Evaluation Result Mode Tune-up limit power (dBm) Distance (mm) Calculation Frequency (MHz) Calculation Results Threshold Value Verdict Bluetooth 2.00 5 2480 0.498 3.0 Compliance ‐‐END OF REPORT‐‐

Report No.: BL-SZ20C0197-601 2 / 72 Revision History Version Issue Date Revisions Content Rev. 01 Jan. 29, 2021 Initial Issue TABLE OF CONTENTS 1 ADMINISTRATIVE DATA (GENERAL INFORMATION) .......................................................................... 5 1.1 Identification of the Testing Laboratory ....................................................................................... 5 1.2 Identification of the Responsible Testing Location ...................................................................... 5 1.3 Laboratory Condition ................................................................................................................... 5 1.4 Announce .................................................................................................................................... 5 2 PRODUCT INFORMATION ...................................................................................................................... 6 2.1 Applicant Information ................................................................................................................... 6 2.2 Manufacturer Information ............................................................................................................ 6 2.3 Factory Information ..................................................................................................................... 6 2.4 General Description for Equipment under Test (EUT) ................................................................ 6 2.5 Technical Information .................................................................................................................. 7 2.6 Additional Instructions ................................................................................................................. 8 3 SUMMARY OF TEST RESULTS .............................................................................................................. 9 3.1 Test Standards ............................................................................................................................ 9 3.2 Verdict ......................................................................................................................................... 9 4 GENERAL TEST CONFIGURATIONS ................................................................................................... 10 4.1 Test Environments .................................................................................................................... 10 4.2 Test Equipment List ................................................................................................................... 10 4.3 Measurement Uncertainty ......................................................................................................... 12 4.4 Description of Test Setup .......................................................................................................... 12 4.4.1 For Antenna Port Test ............................................................................................................... 12 4.4.2 For AC Power Supply Port Test ................................................................................................ 13 4.4.3 For Radiated Test (Below 30 MHz) ........................................................................................... 13 4.4.4 For Radiated Test (30 MHz-1 GHz) .......................................................................................... 14 4.4.5 For Radiated Test (Above 1 GHz) ............................................................................................. 14 4.5 Measurement Results Explanation Example ............................................................................. 15 4.5.1 For conducted test items: .......................................................................................................... 15 5 TEST ITEMS ........................................................................................................................................... 16 Report No.: BL-SZ20C0197-601 3 / 72 5.1 Antenna Requirements .............................................................................................................. 16 5.1.1 Relevant Standards ................................................................................................................... 16 5.1.2 Antenna Anti-Replacement Construction .................................................................................. 16 5.1.3 Antenna Gain ............................................................................................................................ 16 5.2 Frequency Hopping Systems .................................................................................................... 17 5.2.1 Relevant Standards ................................................................................................................... 17 5.2.2 Description of the systems ........................................................................................................ 17 5.3 Number of Hopping Frequencies .............................................................................................. 19 5.3.1 Limit ........................................................................................................................................... 19 5.3.2 Test Setup ................................................................................................................................. 19 5.3.3 Test Procedure .......................................................................................................................... 19 5.3.4 Test Result ................................................................................................................................ 19 5.4 Peak Output Power ................................................................................................................... 20 5.4.1 Test Limit ..........................................................…

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Annex No.: BL-SZ20C0197-AR 1 / 3 TEST SETUP PHOTOS 1 Radiated Test Photo Below 30MHz Close-up Annex No.: BL-SZ20C0197-AR 2 / 3 30MHz-1GHz Above 1GHz Annex No.: BL-SZ20C0197-AR 3 / 3 Close-up 2 Conducted Test Photo Conducted Test-BT3.0