2ABAFMD5990Digital Automatic Blood Pressure Monitor with Bluetooth Low Energy

DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR USER MANUAL MODEL : MD5900 / MD5910 / MD5920 / MD5930 MD5940 / MD5950 / MD5960 / MD5970 MD5980 / MD5990 1 INTRODUCTION Thank you for purchasing this blood pressure monitor. Please read this manual thoroughly before use. Contact your physician if you have any queries about your blood pressure. This fully automatic instrument utilizes the non-invasive oscillometric method, which detects your blood movement through you brachial artery, for measuring your blood pressure and pulse rate, and the result will display on a digital panel. Without using a stethoscope, you can get the readings promptly and easily. This device conforms to European Council Directive 93/42/EEC concerning medical devices. This is made evident by the CE mark of conformity accompanies by the reference number of the designated authority. This device complies with : • EN ISO 81060 standard relating to non-invasive sphygmomanometers Part 1: Requirements and test methods for non-automated measuremnt types and EN 1060 standard relating to non-invasive sphygmomanometers Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems. • EN 60601 standard relating to medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests. • EN 1060-4:2004 standard relating to non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers. • ISO 81060-2:2013 standard relating to non-Invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. • IEC 80601-2-30:2009+A1:2013 standard relating to medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated type non-invasive sphygmomanometers. Indication for Use This device is for use by medical professional or home users. It is intended to measure the systolic and diastolic blood pressure of an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm. The patient is an intended operator. 2 WARNING indicates a hazardous situation which, if not avoided, could result in death or serious injury. • Consult your physician before starting to measure your blood pressure. • Like any oscillometric blood pressure measurement devices, certain medical conditions can affect the measurement accuracy, among others: - Disorder of the cardiac rhythm - Very low blood pressure - Very low blood perfusion - Patients in shock - Diabetes - Vessel anomalies - People with electrical implants such as a cardiac pacemaker - Women who are pregnant - Patient who are pre-eclamptic - Patient motion during measurement Due to their condition the oscillometric measurement method can produce incorrect readings. This represents a risk for your health, since values may be interpreted incorrectly. Always consult your physician to determine what will be suitable for you. • This product does not and is not intended to provide a medical diagnosis. Measurement results are for reference only. Self-diagnosis and treatment, e.g. regarding medication, using measured results represents a risk for your health. Always consult with a licensed physician for determination of appropriate medication and dosage thereof. Follow the instructions of your physician or licensed healthcare provider. SAFETY NOTES WARNING WARNING CAUTION indicates a hazardous situation which, if not avoided, may result in minor or moderate injury. CAUTION 3 • Please note that technically related measuring tolerances are possible. Please see the section “TECHNICAL SPECIFICATION”. • Any cuf f related blood pressure measurement in high repetition rates, can lead to severe measurement side effects, e.g. - A nerve compression with temporary wrist/ hand paralysis - The release of an arterial or venous thrombus, which can cause a life threatening situation. Please contact your physician about the specific risks of cuff pressure in your specific case. • The “irregular heartbeat” function does not replace a cardiac examination, but may help to detect potential heart rate irregularities at an early stage. Always consult your physician to determine what will be suitable for you. • The “irregular heartbeat” function is not designed for diagnosing or treating an arrhythmic disorder. Arrhythmia can only be ascertained by a licensed physician. • The “WHO BLOOD PRESSURE CLASSIFICATION” chart is not intended to replace a medical diagnosis. This chart is only for reference for dif ferent classifications of blood pressure. • If you notice abnormal or suspicious variations in blood pressure measurements, consult your physician immediately . • Women who underwent a breast or axillaries lymph node removal operation should consult a physician or licensed healthcare provider before starting blood pressure measurements. • This device must be used in accordance to the specified ambient conditions, otherwise the accuracy of readings might be affected. See “TECHNICAL SPECIFICATION” for details. • Do not wrap the cuff around body parts other than your upper left arm. Misuse represents a risk to your health. • This product is not intended for use by or on children, toddlers and infants or on persons who cannot express their consent, e.g. persons with mental disorders or the like. Consult your physician for alternative methods of measuring a child’s blood pressure. • Packaging materials are a deadly hazard for children and can cause suffocation. Remove all packaging materials immediately and keep them away from children at all times. • This product contains small parts that may present a choking hazard to children. Keep the unit and all parts out of reach of children. SAFETY NOTES 4 • Proper cuff size is important for accurate measurements. Only use the device on adults wh…

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COMPANY LETTERHEAD Date (January 13, 2021) TUV SUD BABT UNLIMITED TCB Octagon House, Segensworth North, Fareham, Hampshire, PO15 5RL, United Kingdom Confidentiality Request FCC ID: 2ABAFMD5990 Pursuant to Sections 0.457(d)(1)(ii) and 0.459 of the Commission’s Rules, (Grandway Technology (Shenzhen) Limited) hereby requests permanent confidential treatment of information accompanying this application as outlined below: Schematics Bill of Materials/Parts List Block Diagrams Theory of Operation] (Grandway Technology (Shenzhen) Limited) also hereby requests short-term confidential treatment of information accompanying this application as outlined below for a period of (180) days: Internal Photos External Photos User Manual Test Set-up Photographs The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to the Applicant and provide unjustified benefits to its competitors. The Applicant understands that pursuant to Rule 0.457(d)(1)(ii), disclosure of this Application and all accompanying materials will not be made before the date of the Grant for this Application. Yours sincerely, Company Officer: Eric Wong Telephone Number: 852-28516789 Fax Number: 852-28516278 Email: [email protected]

file: declaration letter-template Page 1 of 1 To: TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Attention: Nick Huang From: Grandway Technology (Shenzhen) Limited Date: November 04, 2020 Fax No: Total Page (Cover Included): 1 Project No.: 68.730.20.0066.01 68.930.20.0017.01 Quo#: Subject: Declaration letter We: Company Name: Grandway Technology (Shenzhen) Limited Address: No. 5, the Second Industrial Zone, Zhukeng Community, Longtian Street, Pingshan District, 518118 Shenzhen, China Officially notify TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch that the << MD5980 >> have the same technical construction including circuit diagram, PCB Layout, components and component layout, all electrical construction and mechanical construction, with << Digital Automatic Blood Pressure Monitor >>, << MD5990 >>. The difference lies only in < the voice function > of the different models. The differences details are listed below. Model Voice function Bluetooth function Backlight Dimension Power supply Critical components MD5980 Without With With Same Same Same MD5990 With With With Same Same Same << Additional model >>: MD5980 << Main Model >>: MD5990 <<Product Name >>: Digital Automatic Blood Pressure Monitor Applicant: Grandway Technology (Shenzhen) Limited November-04, 2020 ___________ __________________________________________ (Date) (Applicant’s authorized signature and company Chop)

Details of: Overall view (M/N: MD5990) Details of: External view 1 of main unit (M/N: MD5990) Details of: External view 2 of main unit (M/N: MD5990) Details of: External view 3 of main unit (M/N: MD5990) Details of: External view 4 of main unit (M/N: MD5990) Details of: External view 5 of main unit (M/N: MD5990) Details of: Overall view (M/N: MD5980) Details of: External view 1 of main unit (M/N: MD5980) Details of: External view 2 of main unit (M/N: MD5980) Details of: External view 3 of main unit (M/N: MD5980) Details of: External view 4 of main unit (M/N: MD5980) Details of: External view 5 of main unit (M/N: MD5980) Details of: Cuff – 22~32cm Details of: Cuff – 22~44cm Details of: Accessories (USB cable) Details of: External view 1 of Medical Adapter Details of: External view 2 of Medical Adapter Details of: Label view of Medical Adapter

Part No. Bottom Cabinet - Silk Screen Printing MD5990 [A] INJECTION: Pantone No. WHITE Size: 59 x 20mm Background: WHITE Printing: (1) BLACK (2) Pantone No. 294c (Blue) 0123 Digital Automatic Blood Pressure Monitor Model: MD5990 FCC ID: 2ABAFMD5990 Rating: 6V (4 x 1.5V AAA batteries) , 600mA Grandway Technology (Shenzhen) Limited No. 5, the Second Industrial Zone, Zhukeng Community, Longtian Street, Pingshan District, Shenzhen, 518118 The People’s Republic of China. Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537 Hamburg, Germany. 0123 Digital Automatic Blood Pressure Monitor Model: MD5990 FCC ID: 2ABAFMD5990 Rating: 6V (4 x 1.5V AAA batteries) , 600mA Grandway Technology (Shenzhen) Limited No. 5, the Second Industrial Zone, Zhukeng Community, Longtian Street, Pingshan District, Shenzhen, 518118 The People’s Republic of China. Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537 Hamburg, Germany.

Details of: Battery compartment view (M/N: MD5990) Details of: Internal view 1 of main unit (M/N: MD5990) Details of: Internal view 2 of main unit (M/N: MD5990) Details of: Screen view 1 of main unit (M/N: MD5990) Details of: Screen view 2 of main unit (M/N: MD5990) Details of: Speaker view of main unit (M/N: MD5990) Details of: PCB view 1 of main unit (M/N: MD5990) Details of: PCB view 2 of main unit (M/N: MD5990) Details of: Bluetooth module of main unit (M/N: MD5990) Details of: Solenoid valve of main unit (M/N: MD5990) RF Antenna Details of: Air pump of main unit (M/N: MD5990) Details of: Battery compartment view (M/N: MD5980) Details of: Internal view 1 of main unit (M/N: MD5980) Details of: Internal view 2 of main unit (M/N: MD5980) Details of: Screen view 1 of main unit (M/N: MD5980) Details of: Screen view 2 of main unit (M/N: MD5980) Details of: PCB view 1 of main unit (M/N: MD5980) Details of: PCB view 2 of main unit (M/N: MD5980) Details of: Bluetooth module of main unit (M/N: MD5980) Details of: Solenoid valve of main unit (M/N: MD5980) RF Antenna Details of: Air pump of main unit (M/N: MD5980) Details of: Internal view 1 of Medical Adapter Details of: Internal view 2 of Medical Adapter Details of: PCB view 1 of Medical Adapter Details of: PCB view 2 of Medical Adapter

Report Number: 68.930.20.0017.01 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P. R. China Tel. +86 755 8828 6998, Fax: +86 755 8828 5299 RF exposure Estimation Introduction M/N: MD5980 and MD5990 (FCC ID: 2ABAFMD5990) is a Digital Automatic Blood Pressure Monitor, which supports 2.4GHz Bluetooth Low Energy functions. 1. Limit and Guidelines on Exposure to Electromagnetic Fields According to §1.1307(b)(1), systems operating under the provisions of this section shall be operated in a manner that ensure that the public is not exposed to radio frequency energy level in excess of the Commission’s guideline. According to KDB 447498 D01 General RF Exposure Guidance v06, Mobile Portable RF Exposure, no SAR required if power is lower than the flowing threshold: 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 calculation25 • The result is rounded to one decimal place for comparison • 3.0 and 7.5 are referred to as the numeric thresholds in the step 2 below 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 5) in section 4.1 is applied to determine SAR test exclusion. 2. Calculation method [(max. power of` channel, including tune-up tolerance, mW)/(min. test separation distance, mm)] ·[√f(GHz)] ≤ 3.0 Conducted Power + tune up tolerance = 2.081434mW Distance = 5 mm f = 2.440 GHz [2.081434/5] * SQRT(2.440) =0.65 0.65 ≤ 3.0 Therefore, excluded from SAR testing. TUV SUD China, Shenzhen Branch Reviewed by: Prepared By: Trevor You/ EMC Project Manager Nick Huang/EMC Project Engineer Date: 2020-11-04 Date: 2020-11-04

Report Number: 68.930.20.0017.01 EMC_SZ_FR_23.02 FCC Release 2017-06-20 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P. R. China Tel. +86 755 8828 6998, Fax: +86 755 8828 5299 Page 1 of 37 FCC - TEST REPORT Report Number : 68.930.20.0017.01 Date of Issue: November 4, 2020 Model : MD5980, MD5990 Product Type : Digital Automatic Blood Pressure Monitor Applicant : Grandway Technology (Shenzhen) Limited Address : No. 5, the Second Industrial Zone, Zhukeng Community, Longtian Street, Pingshan District, 518118 Shenzhen, China Production Facility : Grandway Technology (Shenzhen) Limited Address : No. 5, the Second Industrial Zone, Zhukeng Community, Longtian Street, Pingshan District, 518118 Shenzhen, China Test Result : ◼ Positive  Negative Total pages including Appendices : 37 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch is a subcontractor to TÜV SÜD Product Service GmbH according to the principles outlined in ISO 17025. TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch reports apply only to the specific samples tested under stated test conditions. Construction of the actual test samples has been documented. It is the manufacturer's responsibility to assure that additional production units of this model are manufactured with identical electrical and mechanical components. The manufacturer/importer is responsible to the Competent Authorities in Europe for any modifications made to the production units which result in non-compliance to the relevant regulations. TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch shall have no liability for any deductions, inferences or generalizations drawn by the client or others from TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch issued reports. This report is the confidential property of the client. As a mutual protection to our clients, the public and ourselves, extracts from the test report shall not be reproduced except in full without our written approval. Report Number: 68.930.20.0017.01 EMC_SZ_FR_23.02 FCC Release 2017-06-20 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P. R. China Tel. +86 755 8828 6998, Fax: +86 755 8828 5299 Page 2 of 37 1 Table of Contents 1 Table of Contents ................................................................................................................................................................ 2 2 Details about the Test Laboratory ..................................................................................................................................... 3 3 Description of the Equipment under Test ........................................................................................................................ 4 4 Summary of Test Standards .............................................................................................................................................. 5 5 Summary of Test Results ................................................................................................................................................... 6 6 General Remarks ................................................................................................................................................................ 7 7 Test Setups .......................................................................................................................................................................... 8 8 Systems test configuration ................................................................................................................................................. 9 9 Technical Requirement .................................................................................................................................................... 10 9.1 Conducted Emission ................................................................................................................................................ 10 9.2 Conducted Peak output power ............................................................................................................................... 13 9.3 6 dB Bandwidth ......................................................................................................................................................... 15 9.4 Power spectral density ............................................................................................................................................. 17 9.5 Spurious RF conducted emissions ........................................................................................................................ 19 9.6 Band edge ................................................................................................................................................................. 23 9.7 Spurious radiated emissions for transmitter ......................................................................................................... 25 10 Test Equipment List ...................................................................................................................................................... 35 11 System Measurement Uncertainty ............................................................................................................................. 37 Report Number: 68.930.20.0017.01 EMC_SZ_FR_23.02 FCC Release 2017-06-20 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P. R. China Tel. +86 755 8828 6998, Fax: +86 755 8828 5299 Page 3 of 37 2 Details about the Test Laboratory Details about the Test Laboratory Te…

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Radiated Emission test of 30MHz-1GHz Radiated Emission test of 1-18GHz Test Setup Photos Radiated Emission test 18-25GHz Conducted Emission test