2A3QXFCBP110Upper Arm Electronic Blood Pressure Monitor

Instruction Manual Upper Arm Electronic Blood Pressure Monitor Model No.: FC-BP110 Please read this instruction manual carefully before using your unit. Please keep this instruction manual well for future use. Thanks for choosing the Digital Blood Pressure Monitor. The PATIENT is an intended OPERATOR. Manual Ver.: 1.0 Software Ver.: FC-BP110-V1.0 Issuing Date: 2021/09/28 Contents Contents.......................................................................................2 1. Before Using the Unit.......................................................2 1.1 Introduction.........................................................................2 1.2 Important safety notices.................................................3 1.3 Warning and safety notices............................................3 2. Operating Instruction.....................................................4 2.1 Know your unit...................................................................4 2.2 Battery Installation / Replacement.............................6 2.3 Settings................................................................................6 2.4 Proper Use of the Arm Cu...........................................9 2.5 Take a Measurement......................................................12 2.6 Use the Memory function............................................13 2.7 About Blood Pressure....................................................15 2.8 About Blood Pressure....................................................16 3. Care and Maintenance.................................................17 3.1 Care and Maintenance..................................................17 3.2 Calibration and Service.................................................18 3.3 Error Indicators................................................................18 3.4 Troubleshooting.............................................................18 3.5 Technical Data.................................................................19 3.6 Warranty Information...................................................25 1. Before Using the Unit 2 1.1 Introduction Thank you for purchasing Upper Arm Electronic Blood Pressure Monitor. The unit uses the oscillometric method of blood pressure measurement. It means the unit detects the movement of your blood through your brachial artery, and converts your blood pressure into a digital reading. The unit is simple to use because a stethoscope is not needed while using an oscillometric monitor. The unit stores automatically 2*90 sets of measurement values. You can read the stored data conveniently by pressing the memory button. The unit comes with the following components: • Main Unit • Arm Cuff • Instruction Manual printed in English SYMBOLS USED IN THIS INSTRUCTION MANUAL Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the equipment or other property. Please read this instruction manual thoroughly before using the unit. Please keep for future reference. For specic information about your own blood pressure, CONSULT YOUR DOCTOR. Transport package shall be kept away from rain. AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY Refer to instruction manual/booklet MANUFACTURER SERIAL NUMBER Type BF applied part Device used within the Magnetic Resonance (MR) environment is prohibited. The marking of electrical and electronics devices according to Directive 2002/96/EC. The device accessories and the packaging have to be disposed of waste correctly at the end of the usage. Please follow Local Ordinances or Regulations for disposal. SN EU REP 3 1.2 Important safety notices To assure the correct use of the product basic safety measures should always be followed including the precautions listed as below: Please read all information in the instruction manual and any other literature included in the box before using the unit. Please contact your physician for specic information about your blood pressure. Self-diagnosis and treatment by measure results may be dangerous. Follow the instructions of your health care provider. Operate the unit only as intended. Don't use for any other purpose. The unit is intended to use in measuring blood pressure and pulse rate for adult only, not recommended using for neonatal baby at home or medical centre. Do not use a cellular phone near the unit. It may result in operational failure. Please avoid using in high radiant area in order to make your measuring data correctly. Do not disassemble or attempt to repair the unit or components. Do not use the equipment in places where there are flammable gas (such as anesthetic gas, oxygen or hydrogen) or flammable liquid (such as alcohol) . Do not use a mobile phone or other devices that emit electromagnetic elds near the unit. This may result in incorrect operation of the unit. Indicating that too frequent measurements can cause injury to the PATIENT due to blood flow interference; Please remove the batteries if the unit will not be used for Three months or More. Please do not put CUFF over a wound, as this can cause further injury; Regarding the effect of blood flow interference and resulting harmful injury to the PATIENT caused by continuous CUFF pressure due to connection tubing kinking; StatementRegarding the requirements of the adapter, it should meet the following conditions, output voltage: DC 5V, Current: 1000mA, and comply with IEC 60601-1 and IEC 60601-1-11, provide two MOPP insulation between ac input and dc output. Do not install the wrong battery polarity. After the battery is exhausted, please replace four new batteries. If over three months do not use the device, please remove the battery as it may cause leakage, overheat, rupture and damage the blood pressure monitor body. 2. Operating Instruction 4 2.1 Know your unit Body 1.3 Warning…

Text truncated - open the document above for the full version.

COMPANY LETTERHEAD Date (April 05, 2022) TUV SUD BABT UNLIMITED TCB Octagon House, Segensworth North, Fareham, Hampshire, PO15 5RL, United Kingdom Confidentiality Request FCC ID: 2A3QXFCBP110 Pursuant to Sections 0.457(d)(1)(ii) and 0.459 of the Commission’s Rules, (Shenzhen Finicare Co., Ltd) hereby requests permanent confidential treatment of information accompanying this application as outlined below: Schematics Bill of Materials/Parts List Block Diagrams Theory of Operation] (Shenzhen Finicare Co., Ltd) also hereby requests short-term confidential treatment of information accompanying this application as outlined below for a period of (180) days: Internal Photos External Photos User Manual Test Set-up Photographs 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, Company Officer: Chao Li Telephone Number: 86-0755-23013503 Fax Number: 86-0755-27574425 Email: [email protected]

Details of: Overall view 1 (M/N: FC-BP110) Details of: Overall view 2 (M/N: FC-BP110) Details of: External view 1 of main unit (M/N: FC-BP110) Details of: External view 2 of main unit (M/N: FC-BP110) Details of: External view 3 of main unit (M/N: FC-BP110) Details of: External view 4 of main unit (M/N: FC-BP110) Details of: Battery compartment view (M/N: FC-BP110) Details of: Cuff view

Details of: Internal view 1 of main unit (M/N: FC-BP110) Details of: Internal view 2 of main unit (M/N: FC-BP110) Details of: Internal view 3 of main unit (M/N: FC-BP110) Details of: PCB view 1 of main unit (M/N: FC-BP110) Details of: PCB view 2 of main unit (M/N: FC-BP110) Details of: PCB view 3 of main unit (M/N: FC-BP110) Details of: PCB view 4 of main unit (M/N: FC-BP110) Details of: PCB view 5 of main unit (M/N: FC-BP110) Details of: PCB view 6 of main unit (M/N: FC-BP110) Details of: Bluetooth view of main unit (M/N: FC-BP110) RF Antenna Details of: Speaker view of main unit (M/N: FC-BP110) Details of: Air pump of main unit (M/N: FC-BP110) Details of: Solenoid valve of main unit (M/N: FC-BP110)

Report Number: 68.930.21.0024.01 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 RF exposure Estimation Introduction M/N: FC-BP110 (FCC ID: 2A3QXFCBP110) is a Upper Arm Electronic Blood Pressure Monitor, which supports 2.4GHz Bluetooth functions inside. 1. Limit and Guidelines on Exposure to Electromagnetic Fields According to §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 General RF Exposure Guidance v06, Mobile Portable RF Exposure, 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. 2. Calculation method [(max. power of` channel, including tune-up tolerance, mW)/(min. test separation distance, mm)] ·[√f(GHz)] ≤ 3.0 Conducted Power + tune up tolerance = 2.7606mW Distance = 5 mm f = 2.480 GHz [2.7606/5] * SQRT(2.440) =0.8695 0.8695 ≤ 3.0 Therefore, excluded from SAR testing. TUV SUD China, Shenzhen Branch Reviewed by: Prepared By: Trevor You/ EMC Project Manager Nick Huang/EMC Project Engineer Date: 2022-05-12 Date: 2022-05-12

Report Number: 68.930.21.0024.01 EMC_SZ_FR_23.02 FCC Release 2017-06-20 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 33 FCC - TEST REPORT Report Number : 68.930.21.0024.01 Date of Issue: May 12, 2022 Model : FC-BP110 Product Type : Upper Arm Electronic Blood Pressure Monitor Applicant : Shenzhen Finicare Co., Ltd. Address : 201, No. 50, the 3rd Industrial Park, Houting Community, Shajing Street, Bao’an District, Shenzhen, China Production Facility : Shenzhen Finicare Co., Ltd. Address : 201, No. 50, the 3rd Industrial Park, Houting Community, Shajing Street, Bao’an District, Shenzhen, China Test Result : ◼ Positive  Negative Total pages including Appendices : 33 Any use for advertising purposes must be granted in writing. This technical report may only be quoted in full. This report is the result of a single examination of the object in question and is not generally applicable evaluation of the quality of other products in regular production. For further details, please see testing and certification regulation, chapter A-3.4. Report Number: 68.930.21.0024.01 EMC_SZ_FR_23.02 FCC Release 2017-06-20 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 33 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 Emission ................................................................................................................................................ 10 9.2 Conducted Peak output power ............................................................................................................................... 13 9.3 6 dB Bandwidth ......................................................................................................................................................... 15 9.4 Power spectral density ............................................................................................................................................. 17 9.5 Spurious RF conducted emissions ........................................................................................................................ 19 9.6 Band edge ................................................................................................................................................................. 23 9.7 Spurious radiated emissions for transmitter ......................................................................................................... 25 10 Test Equipment List ...................................................................................................................................................... 32 11 System Measurement Uncertainty ............................................................................................................................. 33 Report Number: 68.930.21.0024.01 EMC_SZ_FR_23.02 FCC Release 2017-06-20 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 33 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, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P. R. China FCC Registration Number: 514049 FCC Designation Number: CA5009 Telephone: 86 755 8828 6998 Fax: 86 755 8828 5299 Report Number: 68.930.21.0024.01 EMC_SZ_FR_23.02 FCC Release 2017-06-20 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 4 of 33 3 Description of the Equipment under Test Product: Upper Arm Electronic Blood Pressure Monitor Model no.: FC-BP110 FCC ID: 2A3QXFCBP110 Ratings: Input: 6VDC (4x1.5V AA batteries) or 5.0Vdc, 1.0A (supplied by a separate approved…

Text truncated - open the document above for the full version.

Conducted emission test of 0.15-30MHz Radiated Emission test of 30MHz-1GHz Radiated Emission test of 1-18GHz Radiated Emission test 18-25GHz