2AAEEE10B4Blood Pressure Meter

Edition：AO VBPA Blood Pressure Meter user manual shenzhen belter health measurement and analysis technology co.,ltd Thank you for purchasing the BELTER electronic Blood Pressure Meter This product is a sphygmomanometer which uses noninvasive method to measure human blood pressure.Please be sure to read the instructions before use.After reading, please safekeeping for inspection at any time, reference. Scope of application: used for blood pressure and pulse measurement of human body. Referent Standards and Documents Edition：AO No Standard Name Reference No. 1 Standard Name Reference No. 2 Medical Device Quality System for the regulation requirement EN ISO13485: 2012 3 Medical device risk management to medical devices application EN ISO14971: 2012 4 Symbol for the label of medical devices EN 980: 2008 5 Term, symbol and information of medical device— information of medical device manufacturer offering EN 1041: 2008 6 Medical electrical equipment – Part 1: General requirements for safety EN60601-1: 2005/AC:2012 7 Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests EN 60601-1-2: 2007 8 Clinical investigation of medical devices for human subjects. General requirements EN ISO 14155-1:2009 9 Clinical investigation of medical devices for human subjects. Clinical investigation plans EN ISO 14155-2:2009 10 Medical device software – Software life-cycle processes EN 62304: 2006/AC: 2008 11 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability EN 60601-1-6: 2010 12 Medical electrical equipment. Part 1-11:General requirements for basic safety and essential performance. Collateral standard:Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment EN 60601-1-11：2010 13 Medical devices – Application of usability engineering to medical devices EN62366: 2008 14 Council Directive 93/42/EECof 14 June 1993 concerning medical devices OJ L 169 of 12 July 1993 (including Directive 2007/47/EC ) MDD 93/42/EEC 15 Non-invasive sphygmomanometers —Part 1: General requirements EN 1060-1 16 Non-invasive sphygmomanometers.Part 3:Supplementary requirements for electro-mechanical blood pressure measuring systems EN 1060-3 17 Secondary cells and batteries containing alkaline IEC62133:2012 Edition：AO or other non-acid electrolytes – Safety requirem ents for portable sealed secondary cells, and for batteries made from them, for use in portable a pplications 18 User Manual Version:1.0 Important safety notes SIGNS AND SYMBOLS The following signs appear in this manual. READ THE SAFETY SECTION AND ALL INSTRUCTIONS AND WARNINGS COMPLETELY AND CAREFULLY BEFORE USING THIS PRODUCT. FOLLOW ALL SAFETY INSTRUCTIONS AND WARNINGS TO AVOID HAZARDOUS SITUATIONS AND TO MAKE CORRECT USE OF THIS PRODUCT. symbol Description WARNING WARNING indicates a hazardous situation which, if not avoided, could Result in death or serious injury CAUTION CAUTION indicates a hazardous situation which, if not avoided, may result in minor or moderate injury NOTICE addresses practices not related to personal injury, such as product and/or property damage Type BF Do not dispose this product as unsorted municipal waste. Collection of such waste separately for special treatment is necessary This item is compliant with Medical Device Directive 93/42/EEC of June 14,1993, a directive of the European Economic community Refer to instruction manual / booklet IP22 Degree of protection against harmful ingress of particulate matter and water DISPOSAL NOTICE Edition：AO Manufacturer Authorized representative in the European Community Date of manufacture Serial number SYS systolic DIA diastolic PUL pulse Bluetooth connection symbol warning Do not use this product in the mixed gas of flammable gas with air or wih oxygen or with nitrous oxide conditions. Do not dispose of electrical appliances as unsorted municipal waste, use separate collection facilities. Contact you local government for information regarding the collection systems available. If electrical appliances are disposed of in landfills or dumps, hazardous substances can leak into the groundwater and get into the food chain, damaging your health and well-being. The device is not suitable for use in the presence of flammable anesthetic mixtures with air or with oxygen or nitrous oxide. The device requires no calibration. The device is not repairable and contains no user serviceable parts. No modification of this equipment is allowed. Remove batteries if equipment is not likely to be used for some time. The user must check that the equipment functions safely and see that it is in proper working condition before being used. The manufacturer does not require such preventive inspections by other persons. . It is dangerous to carry on self judgment and self treatment by the sufferer himself,so please follow doctor’s instruction. Self judgment may lead to exacerbation of disease . Get a serious blood circulation obstacle, blood paroxysm sufferer, please use under the doctor's instruction, while measuring because the arm is squeezed may cause impatient internal bleeding Edition：AO . Infant and person not be able to express himself,please do not use . Please control the add pressue to the armband in the range of 300 mmHgs(40 kpas) , otherwise the arm may appear blood clot, benumbed symptom . This product is only used for human body blood pressure measurement and used outside the purpose of measuring human body blood pressure, may take place accident . Please don't use a cell phone in the neighborhood of this product and have the danger to make product mistake action . Please don't dismantle to unload or fix by yourself, reformation of the blood pressure account of essence or armband, otherwise can not measure correctly Please use special arm band, otherwise may not be able to measure corre…

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file: declaration letter-template Page 1 of 1 Declaration letter for model difference We: Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd 702,704,block C, tsinghua unis science park, hi-tech industrial park north, nanshan Shenzhen China Officially notify TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch that the Models ePA-09B4, PA-10, IVBPA have the same technical construction including circuit diagram, PCB Layout, components and component layout, all electrical construction and mechanical construction. The difference are the motherboard compared with IVBPA is to remove LED display and display driver for ePA-09B4, and the main board compared with IVBPA is to remove the Bluetooth transmission part for PA-10.

Date (07/06/2015) BABT TCB Balfour House, Churchfield Road, Walton-on-Thames, Surrey, KT12 2TD Confidentiality Request FCC ID: 2AAEEE10B4 Pursuant to Sections 0.457(d)(1)(ii) and 0.459 of the Commission’s Rules, we Guangdong Transtek Medical Electronics Co., Ltd hereby requests permanent confidential treatment of information accompanying this application as outlined below: Schematics Parts List PCB Layout 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, Project Engineer: Ming Pang Telephone Number: +86-0769-89893000 E-mail: [email protected]

Date (07/06/2015) BABT TCB Balfour House, Churchfield Road, Walton-on-Thames, Surrey, KT12 2TD Dear Sir or Madam, We, Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd 702,704,block C, tsinghua unis science park, hi-tech industrial park north, nanshan Shenzhen China hereby authorize TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District 518052, Shenzhen, 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: Blood Pressure Meter Model name: ePA-09B4, IVBPA. FCC ID: 2AAEEE10B4 This authorization expires one year from the current date. Yours sincerely, Project Engineer: Ming Pang Telephone Number: +86-0769-89893000 E-mail: [email protected]

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Belter Health Measurement and Analysis Technology Co., Ltd OTC Blood Pressure Meter Model: ePA-09B4 Rated input Voltage:DC 5V FCC ID: 2AAEEE10B4 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 undesirable operation.

Belter Health Measurement and Analysis Technology Co., Ltd OTC Blood Pressure Meter Model: IVBPA Rated input Voltage:DC 5V FCC ID: 2AAEEE10B4 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 undesirable operation.

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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 1. Introduction The EUT is Blood Pressure Meter, which contain Bluetooth function inside. 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 BT4.0： Conducted Power + tune up tolerance = -6.69dBm=0.2mW Distance = 5 mm f = 2.402 GHz [0.2/5] * SQRT(2.402) =0.06 0.06 ≤ 3.0 Therefore, excluded from SAR testing. TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch eviewed by: Prepared By: Phoebe Hu/EMC Project Manager Felix Li/EMC Project Engineer Date: 2015-08-11 Date: 2015-08-11

Report Number: 68.930.15.002.01 EMC_SZ_FR_21.00 FCC Release 2014-03-20 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 23 FCC - TEST REPORT Report Number : 68.930.15.002.01 Date of Issue: June 23, 2015 Model : ePA-09B4, IVBPA Product Type : Blood Pressure Meter Applicant : Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. Address : 702, 704, Block C, Tsinghua Unis Science Park, Hi-Tech Industrial Park North, Nanshan Production Facility : Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. Address : 702, 704, Block C, Tsinghua Unis Science Park, Hi-Tech Industrial Park North, Nanshan Test Result :  Positive  Negative Total pages including Appendices : 23 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: 68.930.15.002.01 EMC_SZ_FR_21.00 FCC Release 2014-03-20 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 23 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 peak output power ..................................................................................................................................... 10 9.2 Power spectral density ................................................................................................................................................. 11 9.3 6 dB Bandwidth .......................................................................................................................................................... 12 9.4 Spurious RF conducted emissions ............................................................................................................................... 14 9.5 Band edge testing ........................................................................................................................................................ 18 9.6 Spurious radiated emissions for transmitter ................................................................................................................ 20 10 Test Equipment List ............................................................................................................................................................. 22 11 System Measurement Uncertainty ....................................................................................................................................... 23 Report Number: 68.930.15.002.01 EMC_SZ_FR_21.00 FCC Release 2014-03-20 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 23 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 Building 12&13, Zhihen…

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Page 1 of 1 Test setup photos Transmitting spurious emission (below 1GHz) Transmitting spurious emission (Above 1GHz)