UV3BPA-2282BArm Type Blood Pressure Monitor

Arm Type Blood Pressure Monitor Model: BPM82B INSTRUCTION MANUAL PLEASE READ THIS INSTRUCTION MANUAL COMPLETELY BEFORE OPERATING THIS UNIT EN RoHS REACH MDSS GmbH Schiffgraben 41 30175 Hannover Germany AViTA Corporation 9F., No. 78, Sec. 1, Kwang Fu Rd., San Chung Dist., New Taipei City 24158, Taiwan China, AViTA(WUJIANG) Importer Distributor Contents Intended Use .................................................................................................................. 1 Type of Use/ Reuse ....................................................................................................... 1 Intended User ................................................................................................................ 1 Important Information before Use ........................................................................ 3 Product Identification ................................................................................................. 7 Description of LCD Display ....................................................................................... 8 Battery Installation ....................................................................................................... 9 Setting the Date and Time ...................................................................................... 10 Placement of the Pressure Sleeve ........................................................................ 11 Measurement of Pulse Rate and Blood Pressure ............................................ 13 Hypertension Indicator ............................................................................................ 15 Irregular Heartbeat Detector ................................................................................. 15 Atrial Fibrillation (AFIB) ............................................................................................. 16 Memory Function ....................................................................................................... 18 Data Transferring ........................................................................................................ 20 Error Codes ................................................................................................................... 21 Troubleshooting .......................................................................................................... 22 Cleaning and Disinfecting ....................................................................................... 23 Technical Specification ............................................................................................. 24 EMC Tables .................................................................................................................... 25 Explanation of Symbols ............................................................................................ 27 1 Intended Use The product automatically measures human being’s Systolic, Diastolic blood pressure and pulse rate by oscillometric method. The measurement results are displayed on the LCD. Measurement position is at human being’s upper arm. The intended use of this over-the-counter device is for adults with upper arm circumference ranging from 220 mm to 420 mm (Approx.8.7 ~ 16.5 inches) and for home use. When the device detects the appearance of irregular heartbeats such as atrial or ventricular premature beats during measurement, an indicated symbol will appear with measuring readings. This device is designed only for adults. Type of Use/ Reuse Multiple patient multiple use Intended User The Arm type blood pressure monitor is intended or both professional and consumer, and the patient is the intended operator. Patient selection criteria: Handicapped persons and children are the exception, as of handicapped persons and children need assistance by another person to use the device. Contra-indications Do not use in these cases (e.g. common arrhythmias such as atrial or ventricular premature beats, atrial fibrillation, arterial sclerosis, poor perfusion, diabetes, age, renal diseases, patient motion, trembling, shivering). 2 CAUTION: • Beware of blood flow interference and resulting harmful injury to the patient caused by continuous cuff pressure. • Pressurization of the cuff can temporarily cause loss of function of monitoring ME equipment simultaneously being used on the same limb. • Reading can be affected by the measurement site, the position of the patient, exercise, or patient's physiologic condition. • Automated sphygmomanometer can be affected by extremes of temperature, humidity and altitude. • Frequent measurements can cause injury to the patient due to blood flow interference. • Check that operation of the automated sphygmomanometer does not result in prolonged impairment of patient blood circulation. • Retake the measurement if unexpected readings are obtained • Ensure that the cuff is not placed on an arm in which the arteries or veins are undergoing medical treatment, e.g., intravascular access or therapy, or an arteriovenous (AV) shunt. • This product is suitable for use in the home healthcare environment. • Keep this device out of the reach of children. Strangulation may result from baby or child entanglement in cables. • Please keep this device away from pets, pests, and children. • Preventing potential allergic reaction, please avoid the device in direct contact to patient's wound. 3 • Do not use the cuff on people who have undergone a mastectomy. • Do not apply the cuff over a wound, as this can cause further injury. • Do not apply the cuff other then the original manufacturer provided. • Do not use in these cases (e.g. Device for use in an ambulance, helicopter or professional environment) • Cuff pressure 0 – 300 mmHg • Reduction rate: ≦30S Refer to IEC 80601-2-30 • No modification of this equipment is allowed. • High BMI health condition users may result varied. • Users shall notify serious adverse event to the central competent authority or its…

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

AViTA Corporation * the applicant must designate a contact located in the United States for purposes of acting as the applicant’s agent for service of process, regardless of whether the applicant is a domestic or foreign entity. An applicant located in the United States may designate itself as the agent for service of process. U.S. Agent Designation for Service of Process - Certification Attestation Letter DATE:6/14/2023 Nemko North America, Inc. 303 River Road Ottawa K1V 1H2 Canada ATTN.: Reviewing Engineer FCC ID: UV3BPA-2282B Per section 2.911(d)(7) of the FCC rules, AViTA Corporationcertifies that the equipment for which authorization is sought is designated to the following U.S. Designated agent* for service of process: Company Name: TianHeng Consulting, LLC Physical U.S. Company Address: 392 Andover Street, Wilmington, MA 01887, United States Agent name: Hualing Dong Agent Email Address: [email protected] FRN: 0033401258 The above contact person accepts the obligation for service of process. The applicant accepts to maintain an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any Commission-related proceeding involving the equipment. Applicant Signed: Designated Agent Signed: (Required, if different to Applicant): Signed: Signed: Printed name: Terry yang Printed name: Hualing Dong Title: Deputy Manager Title: President Company Name: Deputy Manager Company Name: TianHeng Consulting, LLC Date: 6/14/2023 Date: 6/14/2023

AViTA Corporation Covered Equipment Certification Attestation Letter DATE: 2/2/2023 Nemko North America, Inc. 303 River Road Ottawa K1V 1H2 Canada ATTN.: Reviewing Engineer FCC ID: UV3BPA-2282B AViTA Corporation certifies that the equipment for which authorization is sought is not “covered” equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. Note: If the equipment for which the applicant seeks authorization is produced by any of the entities identified on the current Covered List, the applicant should include an explanation on why the equipment is not “covered” equipment. AViTA Corporation certifies that, as of the date of the filing of the application, the applicant is not identified on the Covered List as an entity producing “covered” equipment. Signed: Printed name: Terry yang Title: Deputy Manager Company Name: AViTA Corporation Date: 2/2/2023

Nemko Canada Inc 303 River Road Ottawa, Ontario, Canada K1V 1H2 Attn: Director of Certification (FCC ID: UV3BPA-2282B) Authority to Act as Agent On our behalf, I appoint Chenz Ker (MRT Technology (Taiwan) Co., Ltd./ No.38 Fuxing 2 nd Road, Guishan Dist., Taoyuan City, Taiwan 33377). to act as our agent in the preparation of this application for equipment certification. I certify that submitted documents properly describe the device or system for which equipment certification is sought. I also certify that each unit manufactured, imported or marketed, as defined in the Federal Communications Commission’s regulations will have affixed to it a label identical to that submitted for approval with this application. For instances where our authorized agent signs the application for certification on our behalf, I acknowledge that all responsibility for complying with the terms and conditions for certification, as specified by Nemko Canada Inc, still resides with AViTA Corporation / 9F, No.78, Sec. 1,Kwang-Fu Road, San-Chung District, New Taipei City 241,Taiwan(R.O.C) Dated this 2023/2/2 Agency agreement expiration date: 2023/7/30 By: Terry yang Signature Printed Title: Deputy Manager On behalf of : AViTA Corporation

AViTA Corporation June 20, 2023 Nemko North America, Inc. 303 River Road Ottawa, Ontario, Canada K1V 1H2 REQUEST FOR CONFIDENTIALITY - FCC FCC ID: UV3BPA-2282B Pursuant to Sections 0.457(d) and 0.459 of the Commission’s Rules and FCC Guidance document 726920, we hereby request permanent confidential treatment of exhibits identified as such in the table below and request they are permanently withheld from public review based on the documents containing trade secrets and proprietary information not customarily released to the public. The public disclosure of this information might be harmful to the applicant and provide unjustified benefits to its competitors. We also request short-term confidentiality on certain exhibits until the intended date of marketing as outlined below. We request the exhibits be withheld from public view for a period of insert number of days (cannot exceed 180 days) days. We attest marketing of the product will only commence after the period of short-term confidentiality expires, or if marketing is to commence before the requested number of days listed above, the grantee will inform Nemko to release the Short-Term Confidentiality information withheld on the FCC equipment authorization website. Exhibit Type of Confidentiality Requested Block Diagrams ☒ Permanent ☐ Short Term External Photos ------------------ ☐ Short Term Internal Photos ☐ Permanent* ☐ Short Term Operation Description ☒ Permanent ☐ Short Term Parts List & Placement/BOM ☒ Permanent ☐ Short Term Tune-Up Procedure ☐ Permanent ☐ Short Term Schematic Diagrams ☒ Permanent ☐ Short Term Test Setup Photos ------------------ ☐ Short Term User’s Manual ☐ Permanent* ☐ Short Term The asterisked items (*) require further information to be provided in this justification letter before permanent confidentiality will be extended to these exhibits. Please refer to FCC KDB 726920 D01 found at: https://apps.fcc.gov/oetcf/kdb/forms/FTSSearchResultPage.cfm?switch=P&id=41731 and review section II, 3) regarding specific information that must accompany these requests. Note: any documents held under the Short-Term confidentiality will automatically become public after the requested time if an appropriate extension request has not been received. Any exhibits (i.e., schematic diagrams) that may have already been requested to have “Permanent” confidentiality as shown above need not be repeated under Short-Term confidentiality request. Sincerely, Signed: Printed name: Terry yang Title: Deputy Manager Company Name: AViTA Corporation

Report No.: 2211TW8601-U2~U3 Product: Arm Type Blood Pressure Monitor Brand Name: AViTA Model Number: BPM82B 1 of 8 External Photograph (1) EUT Photo (2) EUT Photo Report No.: 2211TW8601-U2~U3 2 of 8 (3) EUT Photo (4) EUT Photo Report No.: 2211TW8601-U2~U3 3 of 8 (5) EUT Photo (6) EUT Photo Report No.: 2211TW8601-U2~U3 4 of 8 (7) EUT Photo (8) Adapter Photo Report No.: 2211TW8601-U2~U3 5 of 8 (9) Adapter Photo (10) Adapter Photo Report No.: 2211TW8601-U2~U3 6 of 8 (11) Adapter Photo (12) Adapter Photo Report No.: 2211TW8601-U2~U3 7 of 8 (13) Adapter Photo (14) Adapter Photo Report No.: 2211TW8601-U2~U3 8 of 8 (15) Adapter Photo

Label Label location

Report No.: 2211TW8601-U2~U3 Product: Arm Type Blood Pressure Monitor Brand Name: AViTA Model Number: BPM82B 1 of 5 Internal Photograph (1) EUT Photo (2) EUT Photo Report No.: 2211TW8601-U2~U3 2 of 5 (3) EUT Photo (4) EUT Photo Report No.: 2211TW8601-U2~U3 3 of 5 (5) EUT Photo (6) EUT Photo Report No.: 2211TW8601-U2~U3 4 of 5 (7) EUT Photo (8) EUT Photo Report No.: 2211TW8601-U2~U3 5 of 5 (9) EUT Photo (10) EUT Photo

Report No.: 2211TW8601-U2~U3 Product: Arm Type Blood Pressure Monitor Brand Name: AViTA Model Number: BPM82B 1 of 3 Test Photograph Test Mode: Mode 1 Description: Front View of Conducted Emission Test Setup Test Mode: Mode 1 Description: Back View of Conducted Emission Test Setup Report No.: 2211TW8601-U2~U3 2 of 3 Test Mode: Mode 1/ Mode 2 Description: Radiated Emission Test Setup for below 1GHz Test Mode: Mode 1/ Mode 2 Description: Radiated Emission Test Setup for above 1GHz Report No.: 2211TW8601-U2~U3 3 of 3 Test Mode: Mode 1 Description: Conducted Emission Test Setup