2AAS7-BFZArm Automatic Blood Pressure Monitor

Rev. A1 1 Arm Automatic Blood Pressure Monitor Instruction Manual BF1204B Table of Contents 1. Safety Information ................................................................................................... 2 1.1 Warning .............................................................................................................................. 2 1.2 Contraindications .............................................................................................................. 3 1.3 Care and maintenance ...................................................................................................... 3 2. Product Feature ....................................................................................................... 4 3. Pre Measurement ..................................................................................................... 5 3.1 Battery ................................................................................................................................ 5 3.2 Power Adapter（Optional） ............................................................................................ 6 3.3 System Setting ................................................................................................................... 6 4 Take a measurement ................................................................................................. 7 4.1 Important Noted ................................................................................................................ 7 4.2 Fitting the cuff ................................................................................................................... 8 4.3 Body posture during measurement .................................................................................. 8 4.4 Take Measurement ............................................................................................................ 9 4.5 Data Transmission ........................................................................................................... 10 4.6 Memory ............................................................................................................................ 10 5. Error Indication ..................................................................................................... 11 6. Trouble Shooting .................................................................................................... 11 7. Specification ........................................................................................................... 12 8．About Blood Pressure .......................................................................................... 16 8.1 What is Blood Pressure? ................................................................................................. 16 8.2 What is high blood pressure? ......................................................................................... 16 8.3 What is morning hypertension (morning surge)? ........................................................ 17 Reference Standard ................................................................................................... 17 Blood Pressure Measurement Chart ........................................................................ 18 Guarantee Card ......................................................................................................... 18 Explanation of Symbols ............................................................................................. 19 After-Sale Service ....................................................................................................... 19 Rev. A1 2 1. Safety Information 1.1 Warning  Self diagnosis and treatment which use measured results may be dangerous. Follow the instructions of your physician or licensed healthcare provider.  If cuff inflation doesn’t stop, remove the cuff or power off the unit, otherwise, it may result in a hazard condition.  Only take measurement with the manufacturer supplied cuff or AC adapter, or else it will lead to inaccurate results.  Do not use the blood pressure monitor when you are close proximity to strong static electricity or electromagnetic fields, and avoid using the mobile during measurement.  Do not use in combination with a hyperbaric oxygen therapy device, or in an environment where combustible gas may be generated.  Do not install the unit in the following locations: - Locations subject to vibration such as ambulances and emergency helicopters. - A location where there is gas or flame. - A location where there is water or steam. - A location where chemicals are stored. - A location where the unit may easily fall.  Measurements or stores need to take into account environment variables, or else it would lead to the inaccurate measurement.  When using AC adapter or replacing the batteries, the operator not to touch those parts and the patient simultaneously.  The battery has positive/negative polarity. If the battery does not connect well to the unit, do not forcibly connect it.  Do not use Luer lock. If Luer lock connectors are used in the construction of tubing, there is a possibility that they might be inadvertently connected to intravascular fluid systems, allowing air to be pumped into a blood vessel.  This product is suitable for use to self- monitoring of blood pressure in home or used by the licensed healthcare per sonnel in hospital.  Blood pressure measurements determined with the device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultatory method, within the limit prescribed by the American National Standard, Manual, electronic or automated sphygmomanometers.  Keep out of reach of infants, small children, and compromised people who cannot express their consent. Playing the air tube may result in suffocate children, and Children may swallow small parts and lead to suffocation.  Children must be supervised to ensure that they are not play …

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SCS-F18: Project and Product Certification Representative Authorization Letter Page 1 of 3 Rev 5.0 775 Montague Expressway Milpitas, CA 95035 Tel: 408-526-1188 Fax: 408-526-1088 Email: [email protected] Project and Product Certification Representative Authorization Letter Reason for Amendment (current / obsolete) Revision History Approved Date From To Initial Release (obsolete) 1.0 1.0 Nov-14-2006 Revised wording (obsolete) 1.0 2.0 Sept–25-2007 Updated company template (obsolete) 2.0 3.0 Jan-31-2012 Updated letter information (obsolete) 3.0 4.0 May-23-2014 Added FCC ID field (current) 4.0 5.0 Sept 16 2014 SCS-F18: Project and Product Certification Representative Authorization Letter Page 2 of 3 Rev 5.0 (Shenzhen Pump Medical System Co., Ltd.) (Aug 26, 2015) To: SIEMIC, INC. 775 Montague Expressway, Milpitas, CA 95035 USA Dear Sir/Madam, Re: Product Certification Representative Authorization Letter We, _Shenzhen Pump Medical System Co., Ltd. hereby authorize SIEMIC, Inc. to act as a Certification Body for certifying for the following project(s): (Arm Automatic Blood Pressure Monitor, BF1204B, BF1100B,BF1110B,BF1102B,BF1112B,BF1205B,BF1215(0B), BF1206B,BF1216(0B), BF1207B,BF1217(0B),BF3203B,BF3213(0B), BF1214(0B),BF6004B,BF6104B, BF6002B,BF6102B,BF6023A, BF6123A,BF6023B,BF6123B,BF6025A,BF6125A, BF6025B, BF6125B,BF6026A,BF6126A,BF6026B,BF6126B,BF6027A, BF6127A, BF6027B,BF6127B,BF6028A,BF6128A,BF6028B, BF6128B, BF6032B,BF6132B, BF6032A,BF6132A,BF6033B,BF6133B,BF6033A,BF6133A,BF6042B,BF6142B,BF6042A, BF6142A,BF6043A,BF6143A,BF6043B,BF6143B, BF6012C,BF6112C,BF6012I,BF6112I, BF6015C,BF6115C, BF6015I,BF6115I,BF6018C,BF6118C,BF6018I,BF6118I,BF6019C, BF6119C,BF6019I,BF6119I,BF6022C,BF6122C,BF6022I,BF6122I, BF1115(0B),BF1113(0B), BF3201B,BF3211(0B),BF6024A,BF6124A,BF6024B,BF6124B,BF6039B,BF6139B,BF6039A, BF6139A,BA2311,BF6020I,BF6120I,BF6020C,BF6120C,BF6021I,BF6121I,BF6021C, BF6121C) FCC ID: 2AAS7-BFZ Sincerely, Client’s signature: Client’s name / title: Xiaofeng Wang Contact information / address: +86-0755-26710795/2F West, M7 Sinosteel Building, Maqueling Estate, High Technology Industrial Park, Nanshan District, Shenzhen, China.

SCS-F19: Confidentiality Request Letter Page 1 of 4 Rev 4.0 775 Montague Expressway Milpitas, CA 95035 Tel: 408-526-1188 Fax: 408-526-1088 Email: [email protected] Confidentiality Request Letter Reason for Amendment (current / obsolete) Revision History Approved Date From To Initial Release (obsolete) 1.0 1.0 Nov-14-2006 Adding CFR 2.459 (obsolete) 1.0 2.0 August – 11 - 2008 Updated company template & Added text box (obsolete) 2.0 3.0 Jan-31-2012 Added IC confidentiality letter form (current) 3.0 4.0 March-26-2015 SCS-F19: Confidentiality Request Letter Page 2 of 4 Rev 4.0 (Shenzhen Pump Medical System Co., Ltd.) (Aug 26, 2015) To: Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD Subject: Permanent Confidentiality Request for FCC ID: 2AAS7-BFZ We hereby request confidential treatment of information accompanying this application as outlined below: - e.g. Block Diagram - e.g. Schematics - e.g. Operational Description The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these materials may be harmful to the applicant and provide unjustified benefits to its competitors. The applicant understands that pursuant to Section 0.457 & 0.459 of the Rules, disclosure of this application and all accompanying documentation will not be made before the date of the Grant for this application. Sincerely, Client’s signature: Client’s name & title: Xiaofeng Wang & General manager Contact information / address: +86-0755-26710795/2F West, M7 Sinosteel Building, Maqueling Estate, High Technology Industrial Park, Nanshan District

Report No: TRE1507003101 Page: 30 of 37 Issued: 2015-08-11 6. External and Internal Photos of the EUT External Photos of the EUT Report No: TRE1507003101 Page: 31 of 37 Issued: 2015-08-11 Report No: TRE1507003101 Page: 32 of 37 Issued: 2015-08-11

Report No: TRE1507003101 Page: 35 of 39 Issued: 2015-08-11 Internal Photos of EUT Report No: TRE1507003101 Page: 36 of 39 Issued: 2015-08-11 BT ANT Report No: TRE1507003101 Page: 37 of 39 Issued: 2015-08-11 Report No: TRE1507003101 Page: 38 of 39 Issued: 2015-08-11 Report No: TRE1507003101 Page: 39 of 39 Issued: 2015-08-11 .........End of Report.......

Report No.: TRE1405010303 Page 1 of 8 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. RF EXPOSURE REPORT Report Reference No. ...............................TRE1507003102 R/C..........: 89374 FCC ID. .......................................................2AAS7-BFZ Applicant’s name ......................................Shenzhen Pump Medical System Co.,Ltd. Address .......................................................2/F West, M-7 Sinosteel Building, Maqueling Estate, Hi-Tech Industrial Park, Nanshan District, Shenzhen 518057, China Manufacturer......................................: Shenzhen Pump Medical System Co.,Ltd. Address...............................................: 2/F West, M-7 Sinosteel Building, Maqueling Estate, Hi-Tech Industrial Park, Nanshan District, Shenzhen 518057, China Test item description ................................Arm Automatic Blood Pressure Monitor Trade Mark ..................................................- Model/Type reference .................................BF1204B Listed Model(s) ...........................................BF1100B,BF1110B,BF1102B,BF1112B,BF1205B,BF1215(0B), BF1206B,BF1216(0B), BF1207B,BF1217(0B),BF3203B,BF3213(0B), BF1214(0B),BF6004B,BF6104B, BF6002B,BF6102B,BF6023A, BF6123A,BF6023B,BF6123B,BF6025A,BF6125A, BF6025B, BF6125B,BF6026A,BF6126A,BF6026B,BF6126B,BF6027A, BF6127A, BF6027B,BF6127B,BF6028A,BF6128A,BF6028B, BF6128B, BF6032B,BF6132B, BF6032A,BF6132A,BF6033B,BF6133B,BF6033A,BF6133A,BF6042B,BF6142B,BF6042A, BF6142A,BF6043A,BF6143A,BF6043B,BF6143B, BF6012C,BF6112C,BF6012I,BF6112I, BF6015C,BF6115C, BF6015I,BF6115I,BF6018C,BF6118C,BF6018I,BF6118I,BF6019C, BF6119C,BF6019I,BF6119I,BF6022C,BF6122C,BF6022I,BF6122I, BF1115(0B), BF1113(0B),BF3201B,BF3211(0B),BF6024A,BF6124A,BF6024B,BF6124B,BF6039B, BF6139B,BF6039A,BF6139A,BA2311,BF6020I,BF6120I,BF6020C,BF6120C,BF6021I, BF6121I, BF6021C, BF6121C Standard ....................................................FCC Per 47 CFR 2.1093(d) Date of receipt of test sample .....................Aug 04, 2015 Date of testing .............................................Aug 04, 2015- Aug 11, 2015 Date of issue... ...........................................Aug 11, 2015 Result ................................ .....................PASS Compiled by ( position+printed name+signature) ........... . File administrators Yingchun Shan Supervised by ( position+printed name+signature) ........... . Project Engineer Yingchun Shan Approved by ( position+printed name+signature) ........... . RF Manager Hans Hu Testing Laboratory Name .........................Shenzhen Huatongwei International Inspection Co., Ltd Address .......................................................Keji Nan No.12 Road, Hi-tech Park, Shenzhen, China 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. Report No.:TRE1507003102 Page 2 of 8 Issued:2015-08-11 Contents 1. SUMMARY ............................................................................... 3 1.1. Client Information 3 1.2. Product Description 3 1.3. EUT operation mode 4 1.4. EUT configuration 4 1.5. Modifications 4 2. TEST ENVIRONMENT .................................................................. 5 2.1. Address of the test laboratory 5 2.2. Test Facility 5 2.3. Environmental conditions 6 2.4. Statement of the measurement uncertainty 6 3. METHOD OF MEASUREMENT ...................................................... 7 3.1. Applicable Standard 7 3.2. Limit 8 3.3. MPE Calculation Method 8 3.4. TEST RESULS 8 4. CONCLUSION ........................................................................... 8 Report No.:TRE1507003102 Page 3 of 8 Issued:2015-08-11 1. SUMMARY 1.1. Client Information Applicant: Shenzhen Pump Medical System Co.,Ltd. Address: 2/F West, M-7 Sinosteel Building, Maqueling Estate, Hi-Tech Industrial Park, Nanshan District, Shenzhen 518057, China Manufacturer: Shenzhen Pump Medical System Co.,Ltd. Address: 2/F West, M-7 Sinosteel Building, Maqueling Estate, Hi-Tech Industrial Park, Nanshan District, Shenzhen 518057, China 1.2. Product Description Name of EUT Arm Automatic Blood Pressure Monitor Trade Mark: - Model No.: BF1204B Listed Model(s): BF1100B,BF1110B,BF1102B,BF1112B,BF1205B,BF1215(0B), BF1206B,BF1216(0B), BF1207B,BF1217(0B),BF3203B,BF3213(0B), BF1214(0B),BF6004B,BF6104B, BF6002B,BF6102B,BF6023A, BF6123A,BF6023B,BF6123B,BF6025A,BF6125A, BF6025B, BF6125B,BF6026A,BF6126A,BF6026B,BF6126B,BF6027A, BF6127A, BF6027B,BF6127B,BF6028A,BF6128A,BF6028B, BF6128B, BF6032B,BF6132B, BF6032A,BF6132A,BF6033B,BF6133B,BF6033A,BF6133A,BF6042B,BF6142B,BF6042A, BF6142A,BF6043A,BF6143A,BF6043B,BF6143B, BF6012C,BF6112C,BF6012I,BF6112I, BF6015C,BF6115C, BF6015I,BF6115I,BF6018C,BF6118C,BF6018I,BF6118I,BF6019C, BF6119C,BF6019I,BF6119I,BF6022C,BF6122C,BF6022I,BF6122I, BF1115(0B),BF1113(0B), BF3201B,BF3211(0B),BF6024A,BF6124A,BF6024B,BF6124B,BF6039B,BF6139B,BF6039A, BF6139A,BA2311,BF6020I,BF6120I,BF6020C,BF6120C,BF6021I,BF6121I,BF6021C, BF6121C Power supply: AC120V/60Hz Adapter information: Model:BPE001 Input:100-240Vac ,50/60Hz,400mA Output: 6.0Vd.c.,0.5A Bluetooth Version: Supported BT4.0+BLE Modulation: GFSK Operation frequency: 2402MHz~2480MHz Channel number: 40 Channel separation: 2MHz Antenna type: Internal Antenna Antenna gain: 1.60dBi Report No.:TRE1507003102 Page 4 of 8 Issued:2015-08-11 Test Frequency: Channel Frequency (MHz) 00 2402 01 2404 ... ... 19 2440 ... ... 38 2478 39 2480 Note:In section 15.31(m), re…

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All rights re r non-commercia and source of th for damages re out the writte EPORT R ystem Co.,Ltd. ding, Maqueling stem Co.,Ltd. ding, Maqueling sure Monitor B,BF1112B,BF12 03B,BF3213(0B A, BF6123A,BF6 A,BF6126A,BF6 A,BF6128A,BF6 B,BF6133B,BF6 A,BF6043B,BF6 I,BF6115I,BF60 BF6022C,BF612 24A,BF6124A,B BF6120I,BF6020 ubpart C Sectio 5 Shan han rnational Inspe rial Park, Genyu eserved. al purposes as e material. She esulting from the en permission T R/C..........:8937 Estate, Hi-Tech Estate, Hi-Tech 205B,BF1215(0 ), BF1214(0B),B 6023B,BF6123B 6026B,BF6126B 028B, BF6128B 033A,BF6133A 143B, BF6012C 018C,BF6118C, 22C,BF6022I,B F6024B,BF612 0C,BF6120C,BF on 15.247 ection Co., Ltd u Road, Shenzh long as the She nzhen Huatong e reader's interp n of the test l 74 h Industrial Park h Industrial Park 0B), BF1206B,B BF6004B,BF610 B,BF6025A,BF6 B,BF6027A, BF6 B, BF6032B,BF6 A,BF6042B,BF61 C,BF6112C,BF6 BF6018I,BF611 F6122I, BF1115 4B,BF6039B,B F6021I,BF6121I hen, China enzhen Huatong wei Internationa pretation of the r laboratory. k, Nanshan Dis k, Nanshan Dis BF1216(0B), 04B, 6125A, 6127A, 6132B, 142B,BF6042A 6012I,BF6112I, 18I,BF6019C, 5(0B),BF1113(0 F6139B,BF6039 I,BF6021C, gwei Internation al Inspection Co reproduced trict, trict, , 0B), 9A, al o., Report No: TRE1507003101 Page: 2 of 39 Issued: 2015-08-11 Contents 1. APPLICABLE STANDARDS AND TEST DESCRIPTION 3 1.1. Applicable Standards 3 1.2. Test Description 3 2. SUMMARY 4 2.1. Client Information 4 2.2. Product Description 4 2.3. Operation state 5 2.4. EUT configuration 5 2.5. Modifications 5 3. TEST ENVIRONMENT 6 3.1. Address of the test laboratory 6 3.2. Test Facility 6 3.3. Equipments Used during the Test 7 3.4. Environmental conditions 8 3.5. Statement of the measurement uncertainty 8 4. TEST CONDITIONS AND RESULTS 9 4.1. Antenna requirement 9 4.2. Conducted Emission (AC Main) 10 4.3. Conducted Peak Output Power 15 4.4. Power Spectral Density 16 4.5. 6dB bandwidth 18 4.6. Restricted band (Conducted) 20 4.7. Band edge and Spurious Emission (conducted) 22 4.8. Spurious Emission (radiated) 26 5. TEST SETUP PHOTOS OF THE EUT 3 1 6. EXTERNAL AND INTERNAL PHOTOS OF THE EUT 3 2 Report No: TRE1507003101 Page: 3 of 39 Issued: 2015-08-11 1. APPLICABLE STANDARDS AND TEST DESCRIPTION 1.1. Applicable 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 C63.10-2013 : American National Standard for Testing Unlicensed Wireless Devices KDB558074 D01 V03R02: Guidance for Performing Compliance Measurements on Digital Transmission Systems (DTS) 1.2. Test Description Report Section Test Item FCC Rule Result 4.1 Antenna requirement 15.203/15.247 (c) Pass 4.2 Line Conducted Emission (AC Main) 15.207 Pass 4.3 Conducted Peak Output Power 15.247 (b)(3) Pass 4.4 Power Spectral Density 15.247 (e) Pass 4.5 6dB Bandwidth 15.247 (a)(2) Pass 4.6 Restricted band 15.247(d)/15.205 Pass 4.7/4.8 Spurious Emission 15.247(d)/15.209 Pass Remark: The measurement uncertainty is not included in the test result. Report No: TRE1507003101 Page: 4 of 39 Issued: 2015-08-11 2. SUMMARY 2.1. Client Information Applicant: Shenzhen Pump Medical System Co.,Ltd. Address: 2/F West, M-7 Sinosteel Building, Maqueling Estate, Hi-Tech Industrial Park, Nanshan District, Shenzhen 518057, China Manufacturer: Shenzhen Pump Medical System Co.,Ltd. Address: 2/F West, M-7 Sinosteel Building, Maqueling Estate, Hi-Tech Industrial Park, Nanshan District, Sh…

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Report No: TRE1507003101 Page: 31 of 39 Issued: 2015-08-11 5. Test Setup Photos of the EUT Radiated Emission 30MHz-1GHz: Above 1GHz: Conducted Emission (AC Mains)