2AAEEEPA46Bsphygmomanometer

Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd ePA-46B sphygmomanometer user manual shenzhen belter health measurement and analysis technology co.,ltd Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd Thank you for purchasing the BELTER electronic sphygmomanometer 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. The sphygmomanometer is able to store up to 100 measurements per user (maximum 2 users) and equipped with the Bluetooth Smart technology to achieve reliable transmission linkage with a mobile device or tablet PC that is with the logo and corresponding application. From now on, you can easily track your health on a daily basis. Referent Standards and Documents 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: 2006/AC:2010 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 EN 60601-1-11 Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd systems used in the home healthcare environment 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 Manual, electronic, or automated sphygmomanometers SP10 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 T ype BF Bluetooth function Do not dispose this product as unsorted municipal waste. Collection of such waste separately for special treatment is DISPOSAL NOTICE Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd 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 Manufacturer Authorized representative in the European Community Date of manufacture Serial number SYS systolic DIA diastolic PUL pulse 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. Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd 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 . 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 outsid…

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Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd FCC ID: 2AAEEEPA46B DATE: Mar 31, 2013 To whom it may concern: We the undersigned, hereby authorize Shenzhen Huatongwei International Inspection Co., Ltd to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters. Any and all acts carried out by Shenzhen Huatongwei International Inspection Co., Ltd on our behalf shall have the same effect as acts of our own. This authorization is valid until further written notice from Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd Sincerely yours, Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd Ming Pang/Enginer Fax: +86 769-89899380 Tel: +86 769-89893000 E-mail: [email protected]

Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd FCC ID: 2AAEEEPA46B DATE: Mar 31, 2013 Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 Gentlemen: This letter is to comply with Sections 0.457 and 0.459 pertaining to confidential material. Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd. would like the following documents regarding this submission for FCC ID:2AAEEEPA46B to be kept confidential. 1. Block Diagram 2. Schematic 3. Theory of Operation The above material contains trade secrets or technical data, which would customarily be guarded from competitors. We do not want these documents to be accessible to the general public. Sincerely yours, Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd Ming Pang/Enginer Fax: +86 769-89899380 Tel: +86 769-89893000 E-mail: [email protected]

Product Similarity Declaration FCC ID: 2AAEEEPA46B DATE: Mar 31, 2013 To Whom It May Concern, We, Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd, hereby declare that our product (sphygmomanometer) Model Number: PA-46,PA-52 and PA-54 are electrically identical with the Model ePA-46B. ePA-46B, PA-46,PA-52 and PA-54 are named differently due to marketing purposes Please contact me if you have any question. Sincerely yours, Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd Ming Pang/Enginer Fax: +86 769-89899380 Tel: +86 769-89893000 E-mail: [email protected]

External photos of the EUT

Internal photos of the EUT

MPE TEST REPORT FCC Per 47 CFR 2.1093(d) Report Reference No. .................... : FCC ID . ........................................... : TRE1303008402 R/C:24854 2AAEEEPA46B Compiled by ( position+printed name+signature) .. : File administrators Eric Zhang Supervised by ( position+printed name+signature) .. : Test Engineer Tim Zhang Approved by ( position+printed name+signature) .. : Manager Wenliang Li Date of issue ..................................... : Mar 31, 2013 Testing Laboratory Name .............. : Shenzhen Huatongwei International Inspection Co., Ltd Address ............................................. : Keji Nan No.12 Road, Hi-tech Park, Shenzhen, China Applicant’s name ............................ : Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd Address ............................................. : 702/704, Block C, Tsinghua Unis Science Park, No.13 Langshan Rd, Hi-Tech Industrial Park(north), Nanshan District, 518057 Shenzhen, People’s Republic of China. Test specification .......................... : Standard ........................................... : FCC Per 47 CFR 2.1093(d) TRF Originator .................................. : Shenzhen Huatongwei International Inspection CO., Ltd Master TRF ....................................... : Dated 2006-06 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. Test item description .................... : sphygmomanometer Trade Mark ....................................... : Model/Type reference ....................... : ePA-46B Modulation ........................................ : GFSK Listed Models .................................. : PA-46, PA-52, PA-54 Manufacturer .................................... : Dongguan Simple Industrial Co., Ltd Operation Frequency ........................ : From 2402MHz to 2480MHz Ratings .............................................. : DC 6.00V Result ................................................ : PASS Report No.: TRE1303008402 Page 2 of 8 Issue Data:2013-03-31 T E S T R E P O R T Test Report No. : TRE1303008402 Mar 31, 2013 ______________________________________________________________________________________________ Date of issue Equipment under Test : sphygmomanometer Model /Type : ePA-46B Listed Models : PA-46; PA-52; PA-54 Applicant : Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd Address : 702/704, Block C, Tsinghua Unis Science Park, No.13 Langshan Rd, Hi-Tech Industrial Park(north), Nanshan District, 518057 Shenzhen, People’s Republic of China. Manufacturer : Dongguan Simple Industrial Co., Ltd Address : No. 192，Shaxin Road, Science Message Park, Tangxia Town, Dongguan, Guangdong, China Test Result: PASS The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test result without the written permission of the test laboratory. Report No.: TRE1303008402 Page 3 of 8 Issue Data:2013-03-31 Contents 1. SUMMARY ............................................................................. 4 1.1. EUT configuration 4 1.2. Power supply system utilised 4 1.3. Description of the test mode 4 1.4. Related Submittal(s) / Grant (s) 5 1.5. Modifications 5 1.6. NOTE 5 2. TEST ENVIRONMENT ............................................................... 6 2.1. Address of the test laboratory 6 2.2. Environmental conditions 6 2.3. Statement of the measurement uncertainty 6 3. METHOD OF MEASUREMENT .................................................... 6 3.1. Applicable Standard 6 3.2. Limit 7 3.3. RF Exposure 7 4. CONCLUSION ........................................................................ 8 Report No.: TRE1303008402 Page 4 of 8 Issue Data:2013-03-31 1. SUMMARY 1.1. EUT configuration The following peripheral devices and interface cables were connected during the measurement: ● - supplied by the manufacturer ○ - supplied by the lab ○ Power Cable Length (m) : / Shield : / Detachable : / ○ Multimeter Manufacturer : / Model No. : / 1.2. Power supply system utilised Power supply voltage : ○ 120V / 60 Hz ○ 115V / 60Hz ○ 12 V DC ○ 24 V DC ● Other (specified in blank below) DC 6.00V From battery 1.3. Description of the test mode The EUT has been tested under typical operating condition. There is BDR (Basic Data Rate) mode with DH1.The Applicant provides communication tools software to control the EUT for staying in continous transmitting and receiving mode for testing. There are 79 channels of EUT, and the test carried out at the lowest channel, middle channel and highest channel . Channel Frequency(MHz) Channel Frequency(MHz) 0 2402 40 2442 1 2403 41 2443 2 2404 42 2444 3 2405 43 2445 4 2406 44 2446 5 2407 45 2447 6 2408 46 2448 7 2409 47 2449 8 2410 48 2450 9 2411 49 2451 10 2412 50 2452 11 2413 51 2453 12 2414 52 2454 13 2415 53 2455 14 2416 54 2456 15 2417 55 2457 16 2418 56 2458 17 2419 57 2459 18 2420 58 2460 19 2421 59 2461 20 2422 60 2462 21 2423 61 2463 22 2424 62 2464 23 2425 63 2465 24 2426 64 2466 25 2427 65 2467 26 2428 66 2468 27 2429 67 2469 28 2430 68 2470 Report No.: TRE1303008402 Page 5 of 8 Issue Data:2013-03-31 29 2431 69 2471 30 2432 70 2472 31 2433 71 2473 32 2434 72 2474 33 2435 73 2475 34 2436 74 2476 35 2437 75 2477 36 2438 76 2478 37 2439 77 2479 38 2440 78 2480 39 2441 1.4. Related Submittal(s) / Grant (s) This submittal(s) (test report) is intended for FCC ID: 2AAEEEPA46B filing to comply with Section 15.247 of the FCC Part 15, Subpart C Rules. 1.5. Modifications No modifications were implemented to meet testing criteria. 1.6. NOTE 1. The funct…

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FCC PART 15 SUBPART C TEST REPORT FCC PART 15.247 Report Reference No. .....................: FCC ID . ............................................: TRE1303008401 R/C:24854 2AAEEEPA46B Compiled by ( position+printed name+signature) .. : File administrators Eric Zhang Supervised by ( position+printed name+signature) .. : Test Engineer Tim Zhang Approved by ( position+printed name+signature) .. : Manager Wenliang Li Date of issue ..................................... : Mar 31, 2013 Testing Laboratory Name .............. : Shenzhen Huatongwei International Inspection Co., Ltd Address ............................................ : Keji Nan No.12 Road, Hi-tech Park, Shenzhen, China Applicant’s name ............................ : Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd Address ............................................ : 702/704, Block C, Tsinghua Unis Science Park, No.13 Langshan Rd, Hi-Tech Industrial Park(north), Nanshan District, 518057 Shenzhen, People’s Republic of China. Test specification ...........................: Standard ........................................... : FCC Part 15.247: Operation within the bands 902-928 MHz, 2400-2483.5 MHz and 5725-5850 MHz Frequency hopping systems TRF Originator .................................. : Shenzhen Huatongwei International Inspection CO., Ltd Master TRF ....................................... : Dated 2006-06 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. Test item description ..................... : sphygmomanometer Trade Mark ....................................... : Model/Type reference ....................... : ePA-46B Listed Models .................................. : PA-46, PA-52, PA-54 Manufacturer .................................... : Dongguan Simple Industrial Co., Ltd Modulation ........................................ : GFSK Operation Frequency ........................ : From 2402MHz to 2480MHz Ratings ............................................. : DC 6.00V Result................................................ : PASS Report No.: TRE1303008401 Page 2 of 50 Issue Data:2013-03-31 T E S T R E P O R T Test Report No. : TRE1303008401 Mar 31, 2013 ______________________________________________________________________________________________ Date of issue Equipment under Test : sphygmomanometer Model /Type : ePA-46B Listed Models : PA-46; PA-52; PA-54 Applicant : Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd Address : 702/704, Block C, Tsinghua Unis Science Park, No.13 Langshan Rd, Hi-Tech Industrial Park(north), Nanshan District, 518057 Shenzhen, People’s Republic of China. Manufacturer : Dongguan Simple Industrial Co., Ltd Address : No. 192，Shaxin Road, Science Message Park, Tangxia Town, Dongguan, Guangdong, China Test Result: PASS The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test result without the written permission of the test laboratory. Report No.: TRE1303008401 Page 3 of 50 Issue Data:2013-03-31 Contents 1. TEST STANDARDS .................................................................. 4 2. SUMMARY ............................................................................. 5 2.1. General Remarks 5 2.2. Equipment Under Test 5 2.3. Short description of the Equipment under Test (EUT) 5 2.4. EUT operation mode 5 2.5. Configuration of Test System 6 2.6. Related Submittal(s) / Grant (s) 6 2.7. Modifications 6 2.8. NOTE 7 3. TEST ENVIRONMENT ............................................................... 8 3.1. Address of the test laboratory 8 3.2. Test Facility 8 3.3. Environmental conditions 9 3.4. Test Description 9 3.5. Statement of the measurement uncertainty 9 3.6. Equipments Used during the Test 9 4. TEST CONDITIONS AND RESULTS ............................................ 11 4.1. AC Power Conducted Emission(Not Applicable) 11 4.2. Radiated Emission 13 4.3. Maximum Peak Output Power 18 4.4. 20dB Bandwidth 20 4.5. Band Edge Compliance of RF Emission 22 4.6. Frequency Separation 30 4.7. Number of hopping frequency 33 4.8. Time Of Occupancy(Dwell Time) 34 4.9. Spurious RF Conducted Emission 36 4.10. Pseudorandom Frequency Hopping Sequence 42 4.11. Antenna Requirement 43 5. TEST SETUP PHOTOS OF THE EUT .......................................... 44 6. EXTERNAL AND INTERNAL PHOTOS OF THE EUT ....................... 46 Report No.: TRE1303008401 Page 4 of 50 Issue Data:2013-03-31 1. TEST STANDARDS The tests were performed according to following standards: FCC Rules Part 15.247: Frequency Hopping, Direct Spread Spectrum and Hybrid Systems that are in operation within the bands of 902-928 MHz, 2400-2483.5 MHz, and 5725-5850 MHz. ANSI C63.10-2009 : American National Standard for Testing Unlicensed Wireless Devices Report No.: TRE1303008401 Page 5 of 50 Issue Data:2013-03-31 2. SUMMARY 2.1. General Remarks Date of receipt of test sample : Nov 15,2012 Testing commenced on : Nov 15,2012 Testing concluded on : Mar 31,2013 2.2. Equipment Under Test Power supply system utilised Power supply voltage : ○ 120V / 60 Hz ○ 115V / 60Hz ○ 12 V DC ○ 24 V DC ● Other (specified in blank below) DC 6.00V From battery/DC12.00V Adapter from AC 120V/60Hz 2.3. Short description of the Equipment under Test (EUT) 2.4GHz (sphygmomanometer (ePA-46B, PA-46; PA-52; PA-54)). For more details, refer to the user’s manual of the EUT 2.4. EUT operation mode The EUT has been tested under typical operating condition. There is BDR (Basic Data Rate) mode with only DH1.The Applicant provides communicatio…

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Test setup photos of the EUT