2AAS7-BW6004BArm Automatic Blood Pressure Monitor

Rev. A1 1 Arm Automatic Blood Pressure Monitor Instruction Manual BW6004B Table of Contents 1. Safety Information ................................................................................................... 2 1.1 Warning .............................................................................................................................. 2 1.2 Precaution .......................................................................................................................... 2 2. Product Feature ....................................................................................................... 3 3. Pre Measurement ..................................................................................................... 5 3.1 Battery ................................................................................................................................ 5 3.2 Power Adapter（Optional） ............................................................................................ 5 3.3 System Setting ................................................................................................................... 6 4 Take a measurement ................................................................................................. 7 4.1 Important Noted ................................................................................................................ 7 4.2 Fitting the cuff ................................................................................................................... 7 4.3 Body posture during measurement .................................................................................. 8 4.4 Take Measurement ............................................................................................................ 8 4.5 Data Transmission ............................................................................................................. 9 4.6 Memory ............................................................................................................................ 10 5. Error Indication ..................................................................................................... 10 6. Trouble Shooting .................................................................................................... 11 7. Specification ........................................................................................................... 11 8．About Blood Pressure .......................................................................................... 15 8.1 What is Blood Pressure? ................................................................................................. 15 8.2 What is high blood pressure? ......................................................................................... 15 8.3 What is morning hypertension (morning surge)? ........................................................ 16 Reference Standard .................................................................................................... 16 Blood Pressure Measurement Chart ........................................................................ 17 Guarantee Card ......................................................................................................... 17 Product label............................................................................................................... 18 Explanation of Symbols ............................................................................................. 18 After-Sale Service ....................................................................................................... 18 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. • 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. • 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. • 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 AC adapter and 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. 1.2 Precaution • Do not attempt to disassemble, repair or modify the blood pressure monitor or hand cuff. • Avoid high temperature, moisture, dust and direct sunlight. • Clean the body with soft dry …

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Ersteller: U. Rodemeier Revision: 03 Erstelldatum: 03.08.01 Datum: 16.01.08 Seite 1 von 1 SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. PHOENIX TESTLAB GmbH Product Certification Königswinkel 10 D 32825 Blomberg RE : LETTER OF AGENCY AUTHORIZATION To Whom It May Concern: We, the undersigned, hereby authorize Hans Hu,RF Manager of Shenzhen Huatongwei International Inspection Co., Ltd to act on our behalf in all matters relating to application for equipment authorization, including the signing of all documents relating to these matters. 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, 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. This agreement is valid for one year or until further notice. Sincerely, Signatory Connect name: Xiaofeng Wang Applicant / Company Stamp: SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. Date: Sept 11, 2014

Ersteller: D. Brandhorst Revision: 00 Erstelldatum: 02.01.2012 Datum: 00.00.0000 Seite 1 von 1 Long/Short-term Confidentiality Request PHOENIX TESTLAB GmbH Date: 18 September 2014 Product Certification Königswinkel 10 D 32825 Blomberg FCC ID: 2AAS7-BW6004B To Whom it may concerns, Pursuant to sections 0.457(d) and 0.459 of CFR 47 and to avoid premature release of sensitive information prior to marketing or release of the product to the public, we hereby requests long-term confidential treatment of information accompanying this application as outlined below: Schematics Parts List Block Diagram Tune-Up Info Operational Description In addition we hereby request the following exhibits contained in this application to be temporarily (short-term confidentilality) withheld from the public disclosure for an initial period of days until: not applicable External Photos Test Setup Photos Internal Photos Users Manual 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), disclosure of this application and all accompanying documentation will not be made before the date of the GRANT for this application. Thank you for your attention in this matter. Signatory Connect name: Xiaofeng Wang Applicant / Company Stamp: SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. Date: Sept 11, 2014

Report No:TRE1407014201 Page 33 of 40 6. External and Internal Photos of the EUT External photos of the EUT Report No:TRE1407014201 Page 34 of 40 Report No:TRE1407014201 Page 35 of 40

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Report No:TRE1407014201 Page 36 of 40 Internal photos of the EUT Report No:TRE1407014201 Page 37 of 40 Report No:TRE1407014201 Page 38 of 40 Report No:TRE1407014201 Page 39 of 40 Report No:TRE1407014201 Page 40 of 40 .......................End of Report......................... BT Antenna

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Reference No .................... t’s name ..... .................... urer.............. .................... m description ark ................ pe reference odel(s) .......... d ................... eceipt of test esting............ sue............ .............. ...... by +printednam ed by +printedname by +printedname Laboratory N .................... n Huatongw cation may b wei Internatio n Huatongwe ges resulting o. ................. .................... .................... .................... .................... .................... n ................. .................... e ................... .................... .................... sample...... .................. ..................... .................. e+signature) e+signature) e+signature) Name .......... .................... wei Internatio be reproduce onal Inspectio ei Internation from the rea TES ... : TRE1 ... : 2AAS ... : Shen .... : 2/F W Indus .....: Shen ......: 2/F W Indus ... : Arm .... : / .... : BW 6 .... : BW80 BW61 BW61 BW61 BE21 BE6 0 BE61 ... : FCC .....: Jul 2 ......: Jul 2 ......: Aug ......: PASS ) ... : File a .... : Proje .... : RF M ... : Shen .... : Keji N onal Inspec ed in whole o on Co., Ltd is nal Inspection ader's interpr ST RE 1407014201 S7-BW6004 nzhen Pump West, M-7 Si strial Park, N nzhen Pump West, M-7 Si strial Park, N Automatic 6004B 000B/ BW810 103B/ BW611 105B/ BW600 108B/ BW600 01B/ BE6002 014B/ BE6114 07B/ BE6008 CFR Title 4 4, 2014 5, 2014- Aug 18, 2014 S administrator ect Engineer Manager Han nzhen Huato Nan No.12 R ction Co., Ltd or in part for s acknowledg n Co., Ltd tak retation of th EPOR B p Medical Sy nosteel Build Nanshan Dist Medical Sys nosteel Build Nanshan Dist Blood Press 0B/ BW2001B 3B/ BW6104B 6B/ BW6106B 9B/ BW6109B B/ BE6102B/ B/ BE6005B/ B/ BE6108B/ 47 Part 15 Su g 18, 2014 rs Any Yang Lion Cai ns Hu ongwei Inter Road, Hi-tech d. All rights non-commer ged as copy kes no respo e reproduce RT R/C......... ystem Co.,L ding, Maquel trict, Shenzh stem Co.,Ltd ding, Maquel trict, Shenzh sure Monito B/ BW2101B/ B/ BW6014B/ B/ BW6007B/ B/ BE8000B/ B BE6103B/ BE BE6105B/ BE BE6009B/ BE ubpart C Se rnational Ins h Park, Shen reserved. rcial purpose right owner a onsibility for a d material du ....:70908 Ltd. ling Estate, H en, 518057,C . ling Estate, H en, 518057,C or BW6002B/ BW BW6114B/ BW BW6107B/ BW BE8100B/ BE2 E6113B/ BE60 E6006B/ BE61 E6109B ection 15.247 spection Co nzhen, China es as long as and source o and will not a ue to its plac Hi-Tech China Hi-Tech China W6102B/ W6005B/ W6008B/ 2001B/ 004B/ BE6104 06B/ BE6007 7 o., Ltd a s the Shenzh of the materia assume liabil cement and B/ B/ hen al. lity Report No:TRE1407014201 Page 2 of 40 Contents 1. TEST STANDARDS AND TEST DESCRIPTION 3 1.1. Test Standards 3 1.2. Test Description 3 2. SUMMARY 4 2.1. Client Information 4 2.2. Product Description 4 2.3. EUT operation mode 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. Environmental conditions 7 3.4. Statement of the measurement uncertainty 7 3.5. Equipments Used during the Test 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 13 4.4. Power Spectral Density 15 4.5. 6dB bandwidth 17 4.6. Band Edge 19 4.7. Spurious Emission (conducted) 22 4.8. Spurious Emission (radiated) 25 5. TEST SETUP PHOTOS OF THE EUT 3 2 6. EXTERNAL AND INTERNAL PHOTOS OF THE EUT 3 3 Report No:TRE1407014201 Page 3 of 40 1. TEST STANDARDS ANDTEST DESCRIPTION 1.1. 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 :AmericanNationalStandardforTestingUnlicensedWirelessDevices KDB558074 D01 V03R02: Guidance for Performing Compliance Measurements on Digital Transmission Systems (DTS) Operating Under §15.247 1.2. Test Description Test Item Section in CFR 47 Result Antenna requirement 15.203/15.247 (c) Pass Line Conducted Emission (ACMain) 15.207 Pass Conducted Peak Output Power 15.247 (b)(3) Pass Power Spectral Density 15.247 (e) Pass 6dB Bandwidth 15.247 (a)(2) Pass Band Edge 15.247(d) Pass Spurious Emission 15.205/15.209 Pass Remark: The measurement uncertainty is not included in the test result. Report No:TRE1407014201 Page 4 of 40 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, Shenzhen, 518057, China 2.2. Product Description Name of EUT Arm Automatic Blood Pressure Monitor Trade Mark: / Model No.: BW6004B Listed Model(s): BW8000B/ BW8100B/ BW2001B/ BW2101B/ BW6002B/ BW6102B/ BW6103B/ BW6113B/ BW6104B/ BW6014B/ BW6114B/ BW6005B/ BW6105B/ BW6006B/ BW6106B/ BW6007B/ BW6107B/ BW6008B/ BW6108B/ BW6009B/ BW6109B/ BE8000B/ BE8100B/ BE2001B/ BE2101B/ BE6002B/ BE6102B/ BE6103B/ BE6113B/ BE6004B/ BE6104B/ BE6014B/ BE6114B/ BE6005B/ BE6105B/ BE6006B/ BE6106B/ BE6007B/ BE6107B/ BE6008B/ BE6108B/ BE6009B/ BE6109B Power supply: DC 6.0V From battery Adapter information: Model:UE08WCP-060050SPA Input: 100-240VAC, 50-60HZ, 400mA Output: 6VDC, 0.5A Bluetooth Version: Supported BT4.0 Modulation: GFSK Operation frequency: 2402MHz~2480MHz Channel number: 40 Channel separation: 2MHz Antenna type: Internal Antenna Antenna gain: 0.0dBi Note: The product m…

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Report No:TRE1407014201 Page 32 of 40 5. Test Setup Photos of the EUT Conducted Emission Radiated Emission (30MHz-1GHz) Radiated Emission (Above 1GHz)