2AAS7-BFWBlood Pressure Monitor

Rev. A3 1 Blood Pressure Monitor Instruction Manual BF2204B Table of Contents 1. Safety Information ................................................................................................ 2 1.1 Warning .............................................................................................................................. 2 1.2 Precaution .......................................................................................................................... 2 2. Product Feature .................................................................................................... 3 3. Pre Measurement .................................................................................................. 4 3.1 Battery ................................................................................................................................ 4 3.2 System Setting ................................................................................................................... 5 4. Take a Measurement ............................................................................................ 5 4.1 Important Notes ................................................................................................................ 6 4.2 Applying the Wrist Cuff ................................................................................................... 6 4.3 Body Posture during Measurement ................................................................................. 6 4.4 Taking a Measurement ..................................................................................................... 7 4.5 Data Transmission ............................................................................................................. 8 4.6 Memory .............................................................................................................................. 9 5. Error Indication .................................................................................................... 9 6. Trouble Shooting ................................................................................................... 9 7. Specification ........................................................................................................ 10 8．About Blood Pressure .......................................................................................... 14 8.1 What is Blood Pressure? ................................................................................................. 14 8.2 What is High Blood Pressure? ....................................................................................... 14 8.3 What is Morning Hypertension (Morning Surge)? ...................................................... 15 Reference Standard .................................................................................................... 15 Blood Pressure Measurement Chart ........................................................................ 15 Guarantee Card ......................................................................................................... 16 Explanation of Symbols ............................................................................................. 17 After-Sale Service ....................................................................................................... 17 Rev. A3 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.  Those who have arrhythmia, diabetes, blood circulation or apoplexy problem, please use under the physician’s instruction.  If cuff inflation doesn’t stop, remove the cuff or power off the unit, otherwise, it may result in a hazard condition.  This equipment is not suitable for the neonate, infant and who can't communicate or interact independently.  Do not use the blood pressure monitor for any other purpose except measuring the blood pressure of human body.  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.  The common arrhythmia such as atrial premature beats, premature ventricular and atrial fibrillation will lead to inaccurate results or error.  Measurements or stores need to take into account environment variables, or else it would lead to the inaccurate measurement.  When using or replacing the batteries, the operator should not 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. 1.2 Precaution  Do not attempt to disassemble, repair or modify the blood pressure monitor.  Avoid high temperature, moisture, dust and direct sunlight.  Clean the body with soft and clean wet cloth. Do not clean the unit with alcohol and other corrosive liquids.  Do not wet or clean the cuff with water.  Clean the cuff with soft dry cloth after measurement.  Do not use at extremely high temperature, high humidity, or high altitude. Use only within the Rev. A3 3 required ambient conditions.  Do not drop or expose the device to heavy shock.  Do not use the unit near large equipment that uses a switching relay for po…

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SHENZHEN PUMP MEDICAL SYSTEM CO., LTD 022311 – 6 Authority to Act as Agent Date: 2016-01-14 American Certification Body, Inc. 6731 Whittier Avenue Suite C110 McLean, VA 22101 To Whom It May Concern: Shenzhen Huatongwei International Inspection Co., Ltd / Hans Hu is authorized to act on our behalf, until otherwise notified, for applications to American Certification Body, Inc. (ACB). We certify that we are not subject to denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862. Further, no party, as defined in 47 CFR 1.2002 (b), to the application is subject to denial of federal benefits, that includes FCC benefits. Thank you, Agency Agreement Expiration Date: _____2016-06-01_____ By: Xiaofeng Wang (Signature 1 ) (Print name) Title: On behalf of: SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. (Company Name) Telephone: +86-0755-26710795 1 - Must be signed by applicant contact given for applicant on the FCC site, or by the authorized agent if an appropriate authorized agent letter has been provided. Letters should be placed on appropriate letterhead. 022311 – 6

Differences Declaration To whom concern, We company SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. hereby declares: The product model(s) : BF2210(0B)/BF2211(0B)/BF2212(0B)/BF2213(0B)/BF2214(0B)/BF2215(0B) /BF2216(0B)/BF2217(0B)/BF2205B/BF2206B/BF2207B; BF2002B/BF2102B/BF2003B/BF2103B/BF2004B/BF2104B/BF2005B/ BF2105B/BF2006B/BF2106B/BF2008B/BF2108B/BF2009B/BF2109B/ BF2010B/BF2110B/BF2011B/BF2111B are identical in the same PCB layout, interior structure and electrical circuits with the model BF2204B which tested in Shenzhen Huatongwei International Inspection Co., Ltd, the only differences are the model name for commercial purpose. Sincerely yours, Signatory: Name: Xiaofeng Wang Position: General manager Company/Adress: SHENZHEN PUMP MEDICAL SYSTEM CO., LTD./ 2/F, M-7 Sinosteel Building, Maqueling Estate, Hi-Tech Industrial Park, Nanshan District, Shenzhen, People's Republic of China Tel/Fax: +86 755 26710795/+86 755 26498210 E-Mail: [email protected]

SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. Request for Confidentiality Date: 2016-01-14 Subject: Confidentiality Request for: FCC ID: 2AAS7-BFW Pursuant to FCC 47 CRF 0.457(d) and 0.459 and IC RSP-100, Section 10, the applicant requests that a part of the subject FCC application be held confidential. Type of Confidentiality Requested Exhibit Short Term Permanent Block Diagrams Short Term External Photos Short Term Permanent* 1 Internal Photos Short Term Permanent Operation Description/Theory of Operation Short Term Permanent Parts List & Placement/BOM Short Term Permanent Tune-Up Procedure Short Term Permanent Schematics Short Term Test Setup Photos Short Term Permanent* User’s Manual *Note: ______(Insert Explanation as Necessary)______ SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. has spent substantial effort in developing this product and it is one of the first of its kind in industry. Having the subject information easily available to "competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. Permanent Confidentiality: The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality: The applicant requests the exhibits selected above as short term confidential be withheld from public view for a period of ___(specify number of days not to exceed 180 ) 2 ___ days from the date of the Grant of Equipment Authorization and prior to marketing. This is to avoid premature release of sensitive information prior to marketing or release of the product to the public. Applicant is also aware that they are responsible to notify ACB in the event information regarding the product or the product is made available to the public. ACB will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-1705. NOTE for Industry Canada Applications: The applicant understands that until such time that IC distinguishes between Short Term and Permanent Confidentiality, either type of marked exhibit above will simply be marked Confidential when submitted to IC. Sincerely, Xiaofeng Wang By: (Signature3) (Print name) 1 - The asterisked items (*) require further justification before permanent confidentiality will be allowed. These also currently require review by the FCC under their Permit-But-Ask policy before the grant is issued and can delay completion of an application. Further justification should be added to the note above. One such example for a potted device would be: “The EUT is FULLY potted using a non-removable epoxy based material. Removal of potting material causes irreparable damage to internal circuitry. See photographs exhibits that outline the device before and after potting.” 2 - Please refer to http://acbcert.com/documents/misc-docs/Memo-Short-Term-Vs-Standard-Confidentiality.pdf for complete details. 3 - Must be signed by applicant contact given for applicant on the FCC site, or by the authorized agent if an appropriate authorized agent letter has been provided. Letters should be placed on appropriate letterhead.

Report No: TRE1512004101 Page: 28 of 33 Issued: 2015-12-18 6. External and Internal Photos of the EUT External Photos of the EUT Report No: TRE1512004101 Page: 29 of 33 Issued: 2015-12-18

Label location FCC ID: 2AAS7‐ BFW 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 undesired operation.

Report No: TRE1512004101 Page: 30 of 34 Issued: 2015-12-18 Internal Photos of EUT Report No: TRE1512004101 Page: 31 of 34 Issued: 2015-12-18 Report No: TRE1512004101 Page: 32 of 34 Issued: 2015-12-18 Report No: TRE1512004101 Page: 33 of 34 Issued: 2015-12-18 Report No: TRE1512004101 Page: 34 of 34 Issued: 2015-12-18 .........End of Report.......

Report No.: TRE1512004102 Page 1 of 8 Issued:2015-12-18 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. ...............................TRE1512004102 R/C..........: 78306 FCC ID. .......................................................2AAS7- BFW Applicant’s name ......................................Shenzhen Pump Medical System Co.,Ltd. Address .......................................................2/F, M-7 Sinosteel Building, Maqueling Estate, Hi-Tech Industrial Park, Nanshan District, Shenzhen, People's Republic of China Manufacturer......................................: Shenzhen Pump Medical System Co.,Ltd. Address...............................................: 2/F, M-7 Sinosteel Building, Maqueling Estate, Hi-Tech Industrial Park, Nanshan District, Shenzhen, People's Republic of China Test item description ................................Blood Pressure Monitor Trade Mark ..................................................- Model/Type reference .................................BF2204B Listed Model(s) ...........................................BF2210(0B),BF2211(0B),BF2212(0B),BF2213(0B),BF2214(0B),BF2215(0B),BF2216(0B), BF2217(0B),BF2205B,BF2206B,BF2207B,BF2002B,BF2102B,BF2003B,BF2103B,BF2004B, BF2104B,BF2005B,BF2105B,BF2006B,BF2106B,BF2008B,BF2108B,BF2009B,BF2109B, BF2010B,BF2110B,BF2011B,BF2111B Standard ....................................................FCC Per 47 CFR 2.1093(d) Date of receipt of test sample .....................Dec 03, 2015 Date of testing .............................................Dec 04, 2015- Dec 18, 2015 Date of issue... ...........................................Dec 18, 2015 Result ................................ .....................PASS Compiled by ( position+printed name+signature) ........... .File administrators Shayne Zhu Supervised by ( position+printed name+signature) ........... . Project Engineer Cary Luo Approved by ( position+printed name+signature) ........... . RF Manager Hans Hu Testing Laboratory Name .........................Shenzhen Huatongwei International Inspection Co., Ltd Address .......................................................Bldg3, Hongfa Hi-tech Industrial Park, Genyu Road, 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.:TRE1512004102 Page 2 of 8 Issued:2015-12-18 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.:TRE1512004102 Page 3 of 8 Issued:2015-12-18 1. SUMMARY 1.1. Client Information Applicant: Shenzhen Pump Medical System Co.,Ltd. Address: 2/F, M-7 Sinosteel Building, Maqueling Estate, Hi-Tech Industrial Park, Nanshan District, Shenzhen, People's Republic of China Manufacturer: Shenzhen Pump Medical System Co.,Ltd. Address: 2/F, M-7 Sinosteel Building, Maqueling Estate, Hi-Tech Industrial Park, Nanshan District, Shenzhen, People's Republic of China 1.2. Product Description Name of EUT Blood Pressure Monitor Trade Mark: - Model No.: BF2204B Listed Model(s): BF2210(0B),BF2211(0B),BF2212(0B),BF2213(0B),BF2214(0B),BF2215(0B),BF2216(0B), BF2217(0B),BF2205B,BF2206B,BF2207B,BF2002B,BF2102B,BF2003B,BF2103B,BF2004B, BF2104B,BF2005B,BF2105B,BF2006B,BF2106B,BF2008B,BF2108B,BF2009B,BF2109B, BF2010B,BF2110B,BF2011B,BF2111B Power supply: DC 3.0V From internal battery Adapter information: - 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.:TRE1512004102 Page 4 of 8 Issued:2015-12-18 Test Frequency: Channel Frequency (MHz) 00 2402 01 2404 ... ... 19 2440 ... ... 38 2478 39 2480 Note:In section 15.31(m), regards to the operating frequency range over 10 MHz, the Lowest frequency, the middle frequency, and the highest frequency of channel were selected to perform the test, please see the above gray bottom. 1.3. EUT operation mode The EUT has been tested under test mode condition. The Applicant provides software to control the EUT for staying in continous transmitting and receiving mode for testing. Test mode:GFSK Modulation 1.4. 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. : / 1.5. Modifications No modifications were implemented to meet testing criteria. Report No.:TRE1512004102 Page 5 of 8 Issued:2015-12-18 2. TEST ENVIRONMENT 2.1. Address of the test laboratory Laboratory:Shenzhen Huatongwei International Inspection Co., Ltd. Address: 1/F, Bldg 3, Hongfa Hi-tech Industrial Park, Genyu Road, Tianliao, Gongming, Shenzhen, China Phone: 86-755-26748019 Fax: 86-755-…

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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. TEST REPORT Report Reference No. ..............................TRE1512004101 R/C..........: 78306 FCC ID ....................................................... 2AAS7- BFW Applicant’s name .....................................Shenzhen Pump Medical System Co.,Ltd. Address ..................................................... 2/F, M-7 Sinosteel Building, Maqueling Estate, Hi-Tech Industrial Park, Nanshan District, Shenzhen, People's Republic of China Manufacturer......................................: Shenzhen Pump Medical System Co.,Ltd. Address...............................................: 2/F, M-7 Sinosteel Building, Maqueling Estate, Hi-Tech Industrial Park, Nanshan District, Shenzhen, People's Republic of China Test item description ...............................Blood Pressure Monitor Trade Mark ................................................ - Model/Type reference ............................... BF2204B Listed Model(s) ......................................... BF2210(0B),BF2211(0B),BF2212(0B),BF2213(0B),BF2214(0B),BF2215(0B),BF2216(0B), BF2217(0B),BF2205B,BF2206B,BF2207B,BF2002B,BF2102B,BF2003B,BF2103B,BF2004B, BF2104B,BF2005B,BF2105B,BF2006B,BF2106B,BF2008B,BF2108B,BF2009B,BF2109B, BF2010B,BF2110B,BF2011B,BF2111B Standard ...................................................FCC CFR Title 47 Part 15 Subpart C Section 15.247 Date of receipt of test sample...........: Dec 03, 2015 Date of testing..............................: Dec 04, 2015- Dec 18, 2015 Date of issue.................................: Dec 18, 2015 Result ................................ .....................PASS Compiled by ( position+printedname+signature) ........... File administrators Shayne Zhu Supervised by ( position+printed name+signature) .......... Project Engineer Cary Luo Approved by ( position+printed name+signature) .......... RF Manager Hans Hu Testing Laboratory Name ........................Shenzhen Huatongwei International Inspection Co., Ltd Address ..................................................... Bldg3, Hongfa Hi-tech Industrial Park, Genyu Road, 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: TRE1512004101 Page: 2 of 37 Issued: 2015-12-18 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 11 4.4. Power Spectral Density 12 4.5. 6dB bandwidth 14 4.6. Restricted band (Conducted) 16 4.7. Band edge and Spurious Emission (conducted) 18 4.8. Spurious Emission (radiated) 25 5. TEST SETUP PHOTOS OF THE EUT 3 0 6. EXTERNAL AND INTERNAL PHOTOS OF THE EUT 3 1 Report No: TRE1512004101 Page: 3 of 37 Issued: 2015-12-18 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 N/A 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: TRE1512004101 Page: 4 of 37 Issued: 2015-12-18 2. SUMMARY 2.1. Client Information Applicant: Shenzhen Pump Medical System Co.,Ltd. Address: 2/F, M-7 Sinosteel Building, Maqueling Estate, Hi-Tech Industrial Park, Nanshan District, Shenzhen, People's Republic of China Manufacturer: Shenzhen Pump Medical System Co.,Ltd. Address: 2/F, M-7 Sinosteel Building, Maqueling Estate, Hi-Tech Industrial Park, Nanshan District, Shenzhen, People's Republic of China 2.2. Product Description Name of EUT Blood Pressure Monitor Trade Mark: - Model No.: BF2204B Listed Model(s): BF2210(0B),BF2211(0B),BF2212(0B),BF2213(0B),BF2214(0B),BF2215(0B),BF2216(0B), BF2217(0B),BF2205B,BF2206B,BF2207B,BF2002B,BF2102B,BF2003B,BF2103B,BF2004B, BF2104B,BF2005B,BF2105B,BF2006B,BF2106B,BF2008B,BF2108B,BF2009B,BF2109B, BF2010B,BF2110B,BF2011B,BF2111B Power supply: DC 3.0V From internal battery Adapter information: - 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: TRE1512004101 Page: 5 of 37 Issued: 2015-12-18 2.3. Operation state  Test frequency list According to section 15.31(m), regards to the operating frequency range over 10 MHz, must select three channel which were te…

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Report No: TRE1512004101 Page: 27 of 33 Issued: 2015-12-18 5. Test Setup Photos of the EUT Radiated Emission 30MHz-1GHz: Above 1GHz: