OU9TMB2085-KBlood Pressure Monitor

Wrist Type Version:1.0 Guangdong Transtek Medical Electronics Co., Ltd.Zone B, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China Thank you for selecting Transtek Blood Pressure Monitor. Please read theuser manual carefully and thoroughly so as to ensure the safe usage of thisproduct. Keep this manual for further reference in case any issues arise. User Manual Arm Blood Pressure Monitor Model: TMB-2085 CATALOGUE INTRODUCTION   2 Safety InformationLCD Display SymbollMonitor Components BEFOREYOU START   13 Installing and Replacing the BatteriesSetting Date, Time and Measurement Unit MEASUREMENT   24 Tie the CuffStart the Measurement DATA MANAGEMENT 27 Deleting the RecordsRecalling the Records INFORMATION FOR USER   30 Tips for MeasurementMaintenance ABOUT BLOOD PRESSURE   32 What are systolic pressure and diastolic pressure?What is the standard blood pressure classification? Irregular heartbeat detectorWhy 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 wrist? TROUBLESHOOTING   35 SPECIFICATIONS   37 FCC STATEMENT   39 COMPLIED STANDARDS LIST   40 EMC GUIDANCE   41   General Description Indications for Use Measurement Principle List Contraindications  Select the User ID Search your test information Install the App and Pair-Up   INTRODUCTION INTRODUCTION Features: Systolic blood pressureDiastolic blood pressurePulse rate120 records for one user General Description Indications for Use This product uses the Oscillometric Measuring Method to detect blood pressure. Before every measurement, the unit establishes a “zero point” equivalent to the atmospheric pressure. Then it starts inflating the cuff. Meanwhile, the unit detects pressure oscillation generated by beat-to-beat pulsatile, which is used to determine the systolic pressure and diastolic pressure as well as pulse rate. Measurement Principle 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-2085 is equivalent to those obtained by a trained observer using the cuff and stethoscope auscultation method.This manual contains important safety and care information, and provides step by step instructions for using this blood pressure monitor. Read the manual thoroughly before using this product. This Transtek Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and heartbeat rate with a wrist circumference ranging from 13.5 cm to 21.5 cm or 13.5 cm to 23 cm. It is intended for indoor, adult use only. Contraindications 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 patients with implanted, electrical devices, such as cardiac pacemakers, defibrillators.  INTRODUCTION INTRODUCTION  The signs below might be in the user manual, labeling or other component. They are the requirement of standard and using. Safety Information * 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 using the unit if you suffer from illnesses.* The device is not suitable for measuring the blood pressure of children. Ask your doctor before using it on older children.* The device is not intended for patient transport outside a healthcare facility.* The device is not intended for public use.* This device is intended for no-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than the wrist or for functions other than obtaining a blood pressure measurement.* Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure.Do not begin or end medical treatment without asking a physician for treatment advice.* If you are taking medication,consult your physician to determine the most appropriate time to measure your blood pressure. Never change a prescribed medication without consulting your physician.* Do not take any therapeutic measures on the basis of a self measurement. Never alter the dose of a medicine prescribed by a doctor. Consult your doctor if you have any question about your blood pressure.* When the device is used to measure patients who have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, the best result may occur with deviation. Please consult your physician about the result.* Warning: Do not apply the cuff over a wound;otherwise it can cause further injury.*Do not inflate the cuff on the same limb which other monitor…

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Guangdong Transtek Medical Electronics Co.,Ltd Date: 2021-01-14 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: OU9TMB2085-K 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 BOM List 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:2020-01-14

Guangdong Transtek Medical Electronics Co.,Ltd Address: Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China Confirmation Letter We, Guangdong Transtek Medical Electronics Co.,Ltd The product: Blood Pressure Monitor And model No.: TMB-2085 TMB-2085-K have the same technical construction including circuit diagram, PCB Layout, components and component layout, all electrical construction and mechanical construction with TMB-2085.The difference lies only the model number, Face shell and key shape. 2021.01.14 Company Name: Guangdong Transtek Medical Electronics Co.,Ltd On behalf of: Kevin Tan Address: Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China

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 View of EUT-6

Location: 30 FCC ID: OU9TMB2085-K (01) 00000000000000 (21) BA52872001000001D SN Label

Appendix II Internal Photographs Page 2 of 5 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 5 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 5 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-5 Internal View of EUT-6 Page 5 of 5 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-7

FCC ID: OU9TMB2085-K 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, i ncluding 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) = 3.18mW Max. Tune-up Tolerance (mW) SAR Test Exclusion Thresholds (5mm) (mW) 13.18 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-2085, TMB-2085-K FCC ID: OU9TMB2085-K REPORT NUMBER: 4789795650-2 ISSUE DATE: January 21, 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.: 4789795650-2 Page 2 of 77 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 01/21/2021 Initial Issue REPORT NO.: 4789795650-2 Page 3 of 77 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 Rules Test Results 1 6dB 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 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 >< ISED RSS-247 > when <Accuracy Method> decision rule is applied. REPORT NO.: 4789795650-2 Page 4 of 77 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 ..................................15 7.2.1. LE 1M MODE .......................................................................................................16 7.2.1. LE 2M MODE .......................................................................................................20 7.3. CONDUCTED OUTPUT POWER ...............................................................................24 7.3.1. LE 1M MODE .......................................................................................................25 7.3.2. LE 2M MODE .......................................................................................................25 7.4. POWER SPECTRAL DENSITY ..................................................................................26 7.4.1. LE 1M MODE .......................................................................................................27 7.4.2. LE 2M MODE .......................................................................................................29 7.5. CONDUCTED BANDEDGE AND SPURIOUS EMISSIONS ........................................31 7.5.1. LE 1M MODE .......................................................................................................32 7.5.2. LE 2M MODE .......................................................................................................36 8.R…

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Appendix III Setup Photographs Radiated Disturbance below 1GHz Radiated Disturbance above 1GHz RADIATED RF MEASUREMENT SETUP (Above 1G – X axis) RADIATED RF MEASUREMENT SETUP (Above 1G – Y axis) RADIATED RF MEASUREMENT SETUP (Above 1G – Z axis)