2ABAFMD20XYSERIESDigital Automatic Blood Pressure Monitor

DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR USER MANUAL MODEL : MD2020/MD2030/MD2060/MD2070/ MD2021/MD2031/MD2061/MD2071/MD2080 INTRODUCTION Thank you for purchasing this Blood Pressure Meter. This fully automatic instrument measures blood pressure and pulse rate promptly and easily. This device is intended for the non-invasive measurement of systolic and diastolic arterial blood pressure and pulse rate in adults (age 15 and above). Please read this manual thoroughly before use. Contact your physician if you have any query about your blood pressure. This device conforms to the European Directive 93/42 EEC for Medical Products. This is made evident by the CE mark of conformity accompanied by the reference number of the designated authority. This device complies with EN1060 standard relating to non-invasive blood pressure monitors Part 1/1995 : General requirements and Part 3/1997 : Additional requirements for electromechanical blood pressure measuring systems. This completely automatic instrument quickly measures your blood pressure and pulse rate and displays on a large digital panel. This unit 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 cuff fills with air the push of a button and automatically deflates when the measurement is complete. The arm cuff has been treated as Applied Part (clause 3.8 in IEC 60601-1:2005) PRECAUTIONS • This device will detect the atmospheric pressure first after power on each time, so atmospheric pressure is not a factor at this monitor. • Precision components are used in the construction of this device. Extremes in temperature, humidity, direct sunlight, shock or dust should be avoided. • To share the cuff, it need to disinfect by UV light before using and user should cover the LCD screen of the device from the UV light. • If no UV light for disinfection, a mild soap and water (and drying afterwards) to be used for cleaning the surface of the cuff before using. Make sure that no liquid enters into the bladder inside the cuff. • Avoid folding the cuff or storing the hose tightly twisted for long periods, as such treatment may shorten the life of the components. • The device and cuff are not water-resistant. Prevent rain, sweat and water from soiling the device and cuff. • Measurements may be distorted if the device is used close to a television, microwave oven, cellular telephone, X-ray or other devices with strong electrical fields. • Used equipment, parts and batteries are not treated as ordinary household waste, and must be disposed of according to the applicable local regulations. Do not use the equipment where flammable gas (such as anesthetic gas, oxygen or hydrogen) or flammable liquid (such as alcohol) are present. User should not make any clinical decision based on the device’s results alone, unless he/she consults with a medical doctor. • WARNING: No use-serviceable parts inside, before servicing to authorized representation or manufacturer! • WARNING: No modification of this equipment is allowed MAINTENANCE Do not open the device. It uses delicate electrical components and an intricate air unit that could be damaged. If you cannot fix the problem using the troubleshooting instructions, request service from your dealer. The device was designed and manufactured for a long service life. However it is generally recommended to have the monitor inspected every 2 years, to ensure proper functioning and accuracy. Please contact your dealer for maintenance. Avoid dropping the device. If the device is dropped, especially on a hard surface, and the user suspects damage, please contact your dealer for inspection. 1 INSTALL / CHANGE BATTERIES 1. Pull out the battery cover on the back side of the unit as directed. 2. Battery door will pop up instantly. Remove the used batteries and insert new ones as shown. Make sure the polarities (+) and (-) are correct. 3. Push battery cover down to close it. 4. Use only R6P, LR6 or AA alkaline batteries, do not use rechargeable batteries. 5. Only same type batteries are allowed to use together. CAUTION • Insert the batteries as shown in the battery compartment. If not, the device will not work or even be damaged. • When [ ] blinks and "E6" appears in the display, replace all batteries with new ones. Do not mix old and new batteries. It may shorten the battery life, or cause the device to malfunction. • [ ] appears when batteries are new. When battery power becames weak, [ ] and "E6" will appear on display. • Battery life varies with the ambient temperature and may be shorter at low temperature. • Remove the batteries if the device is not to be used for a long time. Batteries may leak and cause a malfunction. • If the battery leaks: - Do not allow the leaking fluid to come in contact with skin or clothing. If already in contact, flush the affected are immediately with clean water and seek medical advice. - Do not allow the leaking fluid to come in contact with eyes. If already in contact, DO NOT rub; rinse with clean water immediately and seek medical advice. - Take extra precautions to keep a leaking battery away from fire as there is a danger of ignition or explosion. To open: Pull out from here To close: Insert the battery cover to the 3 lock first, and then push down to close it 2 USE OPTIONAL AC ADAPTOR (Accessory item sold separately) 1. When optional AC adaptor should comply with the requirement of IEC 60601-1:2005. Furthermore all configurations shall comply with the requirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3Ed. of IEC 60601-1, respectively). Anybody connecting additional equipment to medical electrical equipment configures a medical system and is therefore responsible that the system complies with the requirements for medical electrical systems.…

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Grandway Technology (Shenzhen) Limited Date (14/02/2014) BABT TCB Balfour House, Churchfield Road, Walton-on-Thames, Surrey, KT12 2TD Dear Sir or Madam, We, Grandway Technology (Shenzhen) Limited Block 6 and 7, Zhu Keng Industrial Zone, Ping Shan, Long Gang District, Shenzhen. Hereby authorize TUV-SUD China Shenzhen Branch 6/F, H Hall, Century Craftwork Culture Square, No. 4001 Fuqiang Road, Futian District, Shenzhen 518048 P. R. China Felix Li Phone: +86-755-88286998-3243 e-mail: [email protected] to act as our agent in all matters relating to applications for equipment authorization, including the signing of all documents relating to these matters. We also hereby certify that neither we nor any party to this application are subject to denial of U.S Federal benefits, which include FCC benefits, pursuant to section 5301 of Anti-Drug Abuse Act of 1988, U.S.C 862 because of conviction for possession or distribution of controlled substance. This authorization is application to product: Type of equipment: Digital Automatic Blood Pressure Monitor Model name: MD2020, MD2030, MD2060, MD2070, MD2080, MD2021, MD2031, MD2061, MD2071 FCC ID: 2ABAFMD20XYSERIES This authorization expires one year from the current date. Sincerely, Title: General Manager Contact name: Patrick Chow Telephone Number: 0852-28516789 E-mail: [email protected]

Grandway Technology (Shenzhen) Limited Date (14/02/2014) BABT TCB Balfour House, Churchfield Road, Walton-on-Thames, Surrey, KT12 2TD Confidentiality Request FCC ID: 2ABAFMD20XYSERIES Pursuant to Sections 0.457(d)(1)(ii) and 0.459 of the Commission’s Rules, we Velodyne Acoustics, Inc., 345 Digital Drive Morgan Hill, California 95037 United States hereby requests permanent confidential treatment of information accompanying this application as outlined below: Schematics Parts List Block Diagrams Operational Description 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, February-14-2014 ___________ __________________________________________ (Date) (Applicant’s authorized signature and company Chop)

Grandway Technology (Shenzhen) Limited file: declaration letter-template Page 1 of 1 To: TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Attention: Mr Felix Li From: Date: February 21, 2014 Fax No: Total Page (Cover Included): 1 Project No.: 68.730.13.003.01 Subject: Declaration letter We: Grandway Technology (Shenzhen) Limited Block 6 and 7, Zhu Keng Industrial Zone, Ping Shan, Long Gang District, 518118, Shenzhen, People’s Republic of China. Officially notify TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch that the product<< Digital Automatic Blood Pressure Monitor >>, models<< MD2070 >> and << MD2020, MD2030, MD2060, MD2080, MD2021, MD2031, MD2061, MD2071 >> have the same technical construction including circuit diagram, PCB Layout, components and component layout, all electrical construction and mechanical construction. The difference lies only in Backlight, LCD Type, WHO LED, DC Jack of the different models. << Additional Model >>: MD2020, MD2030, MD2060, MD2080, MD2021, MD2031, MD2061, MD2071 << Main Test Model >>: MD2070 <<Product>>: Digital Automatic Blood Pressure Monitor February-14-2014 ___________ __________________________________________ (Date) (Applicant’s authorized signature and company Chop)

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  !"!#$% &'()*+,*) -./01230-234567783 9-:123;<=>?@A6<BBC-::01.DE;7BFGHI Grandway Technology (Shenzhen) Limited Block 6 and 7, Zhu Keng Industrial Zone,3LQJ6KDQ¬ Long Gang District, Shenzhen, Guang Dong, P.R.C. Shanghai International Trading Corp. GmbH (Hamburg) Eiffestrasse 80, 20537 Hamburg, Germany.

 
 
   !"!#$% &'()*+,*) -./01230-234567783 9-:123;<=>?@A6<BBC-::01.DE;7BFGHI Grandway Technology (Shenzhen) Limited Block 6 and 7, Zhu Keng Industrial Zone,3LQJ6KDQ¬ Long Gang District, Shenzhen, Guang Dong, P.R.C. Shanghai International Trading Corp. GmbH (Hamburg) Eiffestrasse 80, 20537 Hamburg, Germany. MD2070 FCC Label

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Jiangsu TÜV Product Service Ltd. – Shenzhen Branch 6 floor, H Hall, Culture Creative Park, No. 4001, Fuqiang Road, Futian District, Shenzhen 518048, P. R. China, Tel. +86 755 8828 6998, Fax: +86 755 8828 5299 RF exposure Estimation for 2ABAFMD20XYSERIES 1. Introduction FCC ID: 2ABAFMD20XYSERIES, MD2070 is a Digital Automatic Blood Pressure Monitor, which contain Bluetooth function inside. Note: models<< MD2070 >> and << MD2020, MD2030, MD2060, MD2080, MD2021, MD2031, MD2061, MD2071 >> have the same technical construction including circuit diagram, PCB Layout, components and component layout, all electrical construction and mechanical construction. The difference lies only in Backlight, LCD Type, WHO LED, DC Jack of the different models. MD2070 was selected as representative models to perform RF exposure estimation, other models are deemed to fulfill RF exposure estimation. 2. Limit and Guidelines on Exposure to Electromagnetic Fields According to§15.247(e)(i) and §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 Mobile Portable RF Exposure v05r01, 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. 3. 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 = 0.69mW Distance = 5 mm f = 2.402 GHz [0.69/5] * SQRT(2.402) =0.214 0.214 ≤ 3.0 Therefore, excluded from SAR testing. Jiangsu TÜV Product Service Ltd. – Shenzhen Branch 6 floor, H Hall, Culture Creative Park, No. 4001, Fuqiang Road, Futian District, Shenzhen 518048, P. R. China, Tel. +86 755 8828 6998, Fax: +86 755 8828 5299 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Reviewed by: Prepared By: Ken Li/EMC Project Manager Felix Li/EMC Project Engineer Date: 2014-01-21 Date: 2014-01-21

Report Number: 68.730.13.003.01 Page 1 of 30 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch 6 floor, H Hall, Culture Creative Park, No. 4001, Fuqiang Road, Futian District, Shenzhen 518048, P. R. China, Tel. +86 755 8828 6998, Fax: +86 755 8828 5299 FCC- TEST REPORT Report Number : 68.730.13.003.01 Date of Issue: 10 January 2014 Model : MD2020, MD2030, MD2060, MD2070, MD2080, MD2021, MD2031, MD2061, MD2071 Product Type : Digital Automatic Blood Pressure Monitor Applicant : Grandway Technology(Shenzhen) Limited Address : Block 6 and 7, Zhu Keng Industrial Zone, Ping Shan, Long Gang District, 518118, Shenzhen, People’s Republic of China Production Facility : Grandway Technology(Shenzhen) Limited Address : Block 6 and 7, Zhu Keng Industrial Zone, Ping Shan, Long Gang District, 518118, Shenzhen, People’s Republic of China Test Result :  Positive  Negative Total pages including Appendices : 30 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: 68.730.13.003.01 Page 2 of 30 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch 6 floor, H Hall, Culture Creative Park, No. 4001, Fuqiang Road, Futian District, Shenzhen 518048, P. R. China, Tel. +86 755 8828 6998, Fax: +86 755 8828 5299 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 List of Test Instruments ...................................................................................................................................................... 9 9 Systems test configuration ............................................................................................................................................... 10 10 Technical Requirement ................................................................................................................................................ 11 10.1 Conducted Emission ................................................................................................................................................ 11 10.2 Conducted peak output power................................................................................................................................ 14 10.3 6dB bandwidth .......................................................................................................................................................... 15 10.4 Power spectral density ............................................................................................................................................. 17 10.5 Spurious RF conducted emissions ........................................................................................................................ 18 10.6 Band edge compliance of RF emissions............................................................................................................... 23 10.7 Spurious radiated emissions for transmitter ......................................................................................................... 28 11 System Measurement Uncertainty ............................................................................................................................. 30 Report Number: 68.730.13.003.01 Page 3 of 30 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch 6 floor, H Hall, Culture Creative Park, No. 4001, Fuqiang Road, Futian District, Shenzhen 518048, P. R. China, Tel. +86 755 8828 6998, Fax: +86 755 8828 5299 2 Details about the Test Laboratory Details about the Test Laboratory Test Site 1 Company name: TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch 6th Floor, H Hall,Culture Creative Park, N…

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Conducted emission AC power port Spurious radiated emission (30MHz-1000MHz) Spurious radiated emission (1GHz-18GHz)