OU9TMB1491BJBlood Pressure Monitor

User Manual Arm Blood Pressure Monitor Model: TMB-1491-BHJ Arm Type Thank you for selec�ng Transtek Blood Pressure Monitor. Please read the user manual carefully and thoroughly so as to ensure the safe usage of this product. Keep this manual for further reference in case any issues arise. Version: 1.0 Guangdong Transtek Medical Electronics Co., Ltd. Zone B, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China INTRODUCTION.......................................................................................................................................2 General Descrip�on Indica�ons for Use Contraindica�ons Measurement Principle Safety Informa�on LCD Display Signal Monitor Components BEFORE YOU START..................................................................................................................................9 The Choice of Power Supply Installing and Replacing the Ba�eries Se�ng Date and Time Select the user ID Install the App and Pair-Up Search your Test Informa�on MEASUREMENT.....................................................................................................................................16 Tie the Cuff Start the Measurement DATA MANAGEMENT.............................................................................................................................19 Recall the Records Delete the Records INFORMATION FOR USER......................................................................................................................21 Tips for measurement Maintenance ABOUT BLOOD PRESSURE.....................................................................................................................23 What are systolic pressure and diastolic pressure? What is the standard blood pressure classifica�on? Irregular heartbeat detector Why does my blood pressure fluctuate throughout the day? Why do I get a different blood pressure at home compared to the hospital? Is the result the same if measuring on the right arm? TROUBLE SHOOTING.............................................................................................................................25 SPECIFICATIONS.....................................................................................................................................26 AUTHORIZED COMPONENT ..................................................................................................................27 CONTACT INFORMATION.......................................................................................................................27 FCC STATEMENT.....................................................................................................................................28 COMPLIED STANDARDS LIST..................................................................................................................29 EMC GUIDANCE.....................................................................................................................................30 Table of Contents List CATALOGUE 1 This product features blood pressure measurement, pulse rate measurement and the result storage. The design provides you with two years of reliable service. Readings taken by this blood pressure monitor TMB-1491-BHJ is equivalent to those obtained by a trained observer using the cuff and stethoscope ausculta�on method. This manual contains important safety and care informa�on, and provides step by step instruc�ons for using this blood pressure monitor. Read the manual thoroughly before using this product. Features: Maximum storage of 60 records per user General Description Up-to-date measuring-during-infla�on technology 60 mm × 40.5 mm Digital LCD display Indications for Use This Blood Pressure Monitor TMB-2080 is a digital monitor intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22 cm to 32 cm (about 8¾ ̋-12½ ̋), 22 cm to 42 cm (about 8¾ ̋-16½ ̋). It is intended for indoor, adult use only. Measurement Principle 1. The device is not suitable for use on the women who are or may be pregnant. 2. The device is not suitable for use on pa�ents with implanted, electrical devices, such as cardiac pacemakers, defibrillators. Contraindications This product uses the Oscillometric Measuring method to detect blood pressure. Before every measurement, the unit establishes a “zero pressure” equivalent to the atmospheric pressure. Then it starts infla�ng the arm cuff, meanwhile, the unit detects pressure oscilla�ons generated by beat-to-beat pulsa�le, which is used to determine the systolic and diastolic pressure, and also pulse rate. Safety Information The signs below might be in the user manual, labeling or other component. They are the requirement of standard and using. Symbol for “THE OPERATION GUIDE MUST BE READ” Symbol for “MANUFACTURER” Symbol for “SERIAL NUMBER” Symbol for “TYPE BF APPLIED PARTS” Symbol for “DIRECT CURRENT” Symbol for “ENVIRONMENT PROTECTION - Electrical waste products should not be disposed of with household waste. Please recycle where facili�es exist. Check with your local authority or retailer for recycling advice” Symbol for “MANUFACTURE DATE” For indoor use only F1 T1A/250V Φ3.6*10CCCSymbol for “Class II Equipment” SN Symbol for “Recycle” INTRODUCTIONINTRODUCTION 2 3 Indicates the need for the user to consult the instruc�ons for use for important cau�onary informa�on such as warnings and precau�ons that cannot, for a variety of reasons , be presented on the medical device itself. CAUTION * This device is intended for adult use in homes only. * The device is not suitable for use on neonatal patients, pregnant women, patients with implanted, electronical devices, patients with pre-eclampsia, premature ventricular beats, atrial fibrillation, peripheral, arterial disease and patients undergoing intravascular therapy or arterio-venous shunt or people who received a mastectomy. Please consult your doctor prior to usin…

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

Guangdong Transtek Medical Electronics Co.,Ltd Date: 2021-04-20 Federal Communications Commission 7435 Oakland Mills Road Columbia MD 21046 To whom it may concern: I, the undersigned, hereby authorize UL Verification Services Inc. to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters. Any and all acts carried out by UL Verification Services Inc. on our behalf shall have the same effect as acts of our own. I, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). In authorizing UL Verification Services Inc. as our representative, we still recognize that we are responsible to: a) comply with the relevant provisions of the certification program; b) make all necessary arrangements for the conduct of the evaluation, including provision for examining documentation and access to all areas, records (including internal audit reports) and personnel for the purposes of evaluation (e.g. testing, inspection, assessment, surveillance, reassessment) and resolution of complaints; c) make claims regarding certification only in respect of the scope for which certification has been granted; d) do not use our product certification in such a manner as to bring the Certification Division into disrepute and not make any statement regarding our product certification which the Certification Division may consider misleading or unauthorized; e) upon suspension or cancellation of certification, discontinue use of all advertising matter that contains any reference thereto and return any certification documents as required by the Certification Division; f) use certification only to indicate the products are certified as being in conformity with specified standards; g) endeavor to ensure that no certificate or report nor any part thereof is used in a misleading manner; h) ensure that any reference to our product certification in communication media such as documents, brochures or advertising, complies with the requirements of the Certification Division; i) keep a record of all complaints made known to us relating to the product’s compliance with requirements of the relevant standard and to make these records available to the when requested; j) take appropriate action with respect to such complaints and any deficiencies found in products or services that affect compliance with the requirements for certification; k) document the actions taken. This authorization is valid until further written notice from the applicant. Sincerely Yours, Signed by: Company Name: Guangdong Transtek Medical Electronics Co.,Ltd Contact Name: Kevin Tan Title of Person：R&D Director Address: Zone A, No. 105 , Dongli Road, Torch Development District, Zhongshan,528437, Guangdong, China

Guangdong Transtek Medical Electronics Co.,Ltd Federal Communications Commission 7435 Oakland Mills Road Columbia MD 21046 Subject: Request for Confidentiality FCC ID: OU9TMB1491BJ To Whom It May Concern: Pursuant to the provisions of Sections 0.457 and 0.459 of the Commission’s rules (47 CFR §§ 0.457, 0.459), we are requesting the Commission to withhold the following attachments as confidential document from public disclosure indefinitely. Schematic Diagram Block Diagram Theory of Operation Above mentioned document contains detailed system and equipment description are considered as proprietary information in operation of the equipment. The public disclosure of above documents might be harmful to our company and would give competitor an unfair advantage in the market. It is our understanding that all measurement test reports, FCC ID label format and correspondent during certification review process cannot be granted as confidential documents and those information will be available for public review once the grant of equipment authorization is issued. Best Regards Company Name: Guangdong Transtek Medical Electronics Co.,Ltd Contact Name: Kevin Tan Title of Person：R&D Director Address: Zone A, No.105 , Dongli Road, Torch Development District, Zhongshan,528437, Guangdong ,China Date:2021-04-20

Appendix I External Photographs Page 2 of 4 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch. View of EUT-1 View of EUT-2 Page 3 of 4 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch. View of EUT-3 View of EUT-4 Page 4 of 4 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch. View of EUT-5

Dimension：49.70X19.70mm,Thickness：0.05mm PO#2BEBS0884 TMB-1491-BHJ FDA SN:BS0884210500018D 材质：25#哑银咪钠不干胶 颜色：单黑+Pantone Reflex Blue 表面处理：哑膜 Location: : TMB-1491-BHJ Model 2021-05 Rating: 4×AAA batteries, 6V Guangdong Transtek Medical Electronics Co., Ltd. Zone B, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China AC adaptor powered mode: 6V 1A (21)BS0884210500018D SN (01)XXXXXXXXXXXXXX GS1 Datamatrix (UDI) (Please use the AC adaptor which authorized by the manufacturer!) IP Degree: IP20 Made in China FCC ID OU9TMB1491BJ

Appendix II Internal Photographs Page 2 of 4 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch. Internal View of EUT-1 Internal View of EUT-2 Page 3 of 4 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch. Internal View of EUT-3 Internal View of EUT-4 Antenna Page 4 of 4 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch.

FCC ID: OU9TMB1491BJ According to KDB 447498 D01 General RF Exposure Guidance v06, section 4.3.1 At 100 MHz to 6 GHz and for test separation distances ≤ 50 mm, the SAR test exclusion threshold is determined according to the following [(max. power of channel, including tune-up tolerance, mW) / (min. test separation distance, mm)] x [√f(GHz)] ≤ 3.0 1. SAR test exclusion threshold Frequency: 2480MHz (min. separation distances = 5 mm) SAR test exclusion thresholds (5 mm) = 1 x 5 / (√ 2.480) = 3.18 mW Max. Tune-up Tolerance (mW) SAR Test Exclusion Thresholds (5mm) (mW) 1 3.18 Calculation Value: 1 (mW) / 5 (mm) x √ 2.480 = 0.31 So, Calculation value ≤ 3.0 Remark: -Max. conducted power 0.79 mW is closet 1 mW, so 1 mW was calculated. -When the minimum test separation distance is < 5 mm, a distance of 5 mm is applied to determine SAR test exclusion. 2. Conclusion: No SAR is required.

The results reported herein have been performed in accordance with the laboratory’s terms of accreditation. This report shall not be reproduced except in full without the written approval of the Laboratory. The results in this report apply to the test sample(s) mentioned above at the time of the testing period only and are not to be used to indicate applicability to other similar products. CFR 47 FCC PART 15 SUBPART C CERTIFICATION TEST REPORT For Blood Pressure Monitor MODEL NUMBER: TMB-1491-BHJ FCC ID: OU9TMB1491BJ REPORT NUMBER: 4789906490-1 ISSUE DATE: May 12, 2021 Prepared for Guangdong Transtek Medical Electronics Co., Ltd Zone A,No.105,Dongli Road,Torch Development District,Zhongshan,528437,Guangdong,China Prepared by UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch Building 10, Innovation Technology Park, No. 1, Li Bin Road, Song Shan Lake Hi- Tech Development Zone Dongguan, 523808, People’s Republic of China Tel: +86 769 22038881 Fax: +86 769 33244054 Website: www.ul.com REPORT NO.: 4789906490-1 Page 2 of 86 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch FORM No.: 10-SL-F0087 This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch. Revision History Rev. Issue Date Revisions Revised By V0 05/12/2021 Initial Issue REPORT NO.: 4789906490-1 Page 3 of 86 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch FORM No.: 10-SL-F0087 This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch. Summary of Test Results Clause Test Items FCC/ISED Rules Test Results 1 6dB Bandwidth and 99% Occupied Bandwidth FCC Part 15.247 (a) (2) Pass 2 Peak Conducted Output Power FCC Part 15.247 (b) (3) Pass 3 Power Spectral Density FCC Part 15.247 (e) Pass 4 Conducted Bandedge and Spurious Emission FCC Part 15.247 (d) Pass 5 Radiated Bandedge and Spurious Emission FCC Part 15.247 (d) FCC Part 15.209 FCC Part 15.205 Pass 6 Conducted Emission Test for AC Power Port FCC Part 15.207 Pass 7 Antenna Requirement FCC Part 15.203 Pass Note: 1.This test report is only published to and used by the applicant, and it is not for evidence purpose in China. 2. The measurement result for the sample received is <Pass> according to < CFR 47 FCC PART 15 SUBPART C > when <Accuracy Method> decision rule is applied. REPORT NO.: 4789906490-1 Page 4 of 86 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch FORM No.: 10-SL-F0087 This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch. TABLE OF CONTENTS 1. ATTESTATION OF TEST RESULTS ................................................................................. 6 2. TEST METHODOLOGY ..................................................................................................... 7 3. FACILITIES AND ACCREDITATION ................................................................................. 7 4. CALIBRATION AND UNCERTAINTY ................................................................................ 8 4.1. MEASURING INSTRUMENT CALIBRATION .............................................................. 8 4.2. MEASUREMENT UNCERTAINTY ............................................................................... 8 5. EQUIPMENT UNDER TEST ............................................................................................... 9 5.1. DESCRIPTION OF EUT .............................................................................................. 9 5.2. CHANNEL LIST ........................................................................................................... 9 5.3. MAXIMUM PEAK OUTPUT POWER ........................................................................... 9 5.4. TEST CHANNEL CONFIGURATION ..........................................................................10 5.5. THE WORSE CASE POWER SETTING PARAMETER ..............................................10 5.6. DESCRIPTION OF AVAILABLE ANTENNAS .............................................................10 5.7. DESCRIPTION OF TEST SETUP ...............................................................................11 6. MEASURING INSTRUMENT AND SOFTWARE USED ....................................................12 7. ANTENNA PORT TEST RESULTS ...................................................................................13 7.1. ON TIME AND DUTY CYCLE .....................................................................................13 7.2. 6 dB DTS BANDWIDTH AND 99 % OCCUPIED BANDWIDTH ..................................14 7.3. CONDUCTED OUTPUT POWER ...............................................................................16 7.4. POWER SPECTRAL DENSITY ..................................................................................17 7.5. CONDUCTED BANDEDGE AND SPURIOUS EMISSIONS ........................................19 8. RADIATED TEST RESULTS .............................................................................................21 8.1. RESTRICTED BANDEDGE ........................................................................................26 8.1.1. LE 1M MODE .......................................................................................................26 8.1.2. LE 2M MODE .......................................................................................................32 8.2. SPURIOUS EMISSIONS (1 GHz ~ 3 GHz) .................................................................36 8.2.1. LE 2M MODE .......................................................................................................36 8.3. SPURIOUS EMISSIONS (3 GHz ~ 18 GHz) ...............................................................42 8.3.1. LE 1M MODE ....................................................................................…

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

Appendix III Setup Photographs Conducted Disturbance Radiated Disturbance below 1 GHz and above 30 MHz Radiated Disturbance below 30 MHz Radiated Disturbance above 1 GHz