OU9TMB207401SAMSUNG ARM BPM

Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China EC REP version:1.0 User Manual SAMSUNG ARM BPM EI-B5000 Thank you very much for selecting SAMSUNG ARM BPM EI-B5000. To use the monitor correctly and safely, please read the manual thoroughly. Please keep well this manual in order to reference in future. Arm Type CATALOGUE Table of Contents INTRODUCTION...................................................................................................................2 General Description Indications for Use Contraindications Measurement Principle Safety Information LED Display Signal Components of the Device List BEFORE YOU START...........................................................................................................8 The Choice of Power Supply Installing and Replacing the Batteries Install the App and Pair-Up Search your test information D MEASUREMENT..................................................................................................................11 Tie the Cuff Taking a Measurement INFORMATION FOR USER.................................................................................................14 Tips for measurement Maintenances ABOUT BLOOD PRESSURE...............................................................................................16 What are systolic pressure and diastolic pressure? What is the standard blood pressure classification? 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? TROUBLESHOOTING.........................................................................................................18 SPECIFICATIONS................................................................................................................19 CONTACT INFORMATION...................................................................................................20 FCC STATEMENT................................................................................................... COMPLIED STANDARDS LIST...........................................................................................21 EMC GUIDANCE.................................................................................................................22 CATALOGUE 1 Thank you for selecting arm type SAMSUNG ARM BPM ( EI-B5000 ). The monitor features blood pressure measurement, pulse rate measurement and the result storage. The design provides you with two years of reliable service. Readings taken by the EI-B5000 are equivalent to those obtained by a trained observer using the cuff and stethoscope auscultation method. This manual contains important safety and care information,step-by-step instructions for using the product, please read it thoroughly before using. Features: Up to 60 pieces of record stored for each user 3rd technology: Measuring during inflation General Description 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 deter- mine the systolic pressure and diastolic pressure as well as pulse rate. Measurement Principle Indications for Use Contraindications 1.The device should not be used by any person who may be suspected of, or is pregnant. 2.The device is not suitable for use on patients with implanted, electrical devices, such as cardiac pacemakers, defibrillators. The signs below might be in the user manual, labeling or other components. They are the requirement of standard and using. Safety Information The SAMSUNG ARM BPM is digital monitors intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22cm to 42cm(about 8¾ ̋-16½ ̋). It is intended for adult indoor use only. Symbol for “RECYCLE” 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 facilities exist. Check with your local authority or retailer for recycling advice” Caution: These notes must be observed to prevent any damage to the device. SN Symbol for “MANUFACTURE DATE” Symbol for “Authorised Representative in the European Community EC REP 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 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 arm 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 wit…

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GuangdongTranstekMedicalElectronicsCo.,Ltd Date:2020-10-21 FederalCommunicationsCommission 7435OaklandMillsRoad ColumbiaMD21046 Towhomitmayconcern: I,theundersigned,herebyauthorizeULVerificationServicesInc.toactonourbehalfinallmanners relatingtoapplicationforequipmentauthorization,includingsigningofalldocumentsrelatingtothese matters.AnyandallactscarriedoutbyULVerificationServicesInc.onourbehalfshallhavethesame effectasactsofourown. I,theundersigned,herebycertifythatwearenotsubjecttoadenialoffederalbenefits,that includesFCCbenefits,pursuanttoSection5301oftheAnti-DrugAbuseActof1988,21U.S.C. 853(a). InauthorizingULVerificationServicesInc . asourrepresentative,westillrecognizethatweare responsibleto: a)complywiththerelevantprovisionsofthecertificationprogram; b)makeallnecessaryarrangementsfortheconductoftheevaluation,including provisionforexaminingdocumentationandaccesstoallareas,records(including internalauditreports)andpersonnelforthepurposesofevaluation(e.g.testing, inspection,assessment,surveillance,reassessment)andresolutionofcomplaints; c)makeclaimsregardingcertificationonlyinrespectofthescopeforwhich certificationhasbeengranted; d)donotuseourproductcertificationinsuchamannerastobringtheCertification Divisionintodisreputeandnotmakeanystatementregardingourproduct certificationwhichtheCertificationDivisionmayconsidermisleadingor unauthorized; e)uponsuspensionorcancellationofcertification,discontinueuseofalladvertising matterthatcontainsanyreferencetheretoandreturnanycertificationdocuments asrequiredbytheCertificationDivision; f)usecertificationonlytoindicatetheproductsarecertifiedasbeinginconformity withspecifiedstandards; g)endeavortoensurethatnocertificateorreportnoranypartthereofisusedina misleadingmanner; h)ensurethatanyreferencetoourproductcertificationincommunicationmediasuchas documents,brochuresoradvertising,complieswiththerequirementsofthe CertificationDivision; i)keeparecordofallcomplaintsmadeknowntousrelatingtotheproduct’s compliancewithrequirementsoftherelevantstandardandtomaketheserecords availabletothewhenrequested; j)takeappropriateactionwithrespecttosuchcomplaintsandanydeficienciesfoundin productsorservicesthataffectcompliancewiththerequirementsforcertification; k)documenttheactionstaken. SincerelyYours, Signedby: CompanyName:GuangdongTranstekMedicalElectronicsCo.,Ltd ContactName:KevinTan TitleofPerson：R&DDirector Address:ZoneA,No.105,DongliRoad,TorchDevelopmentDistrict, Zhongshan,528437,Guangdong,China

GuangdongTranstekMedicalElectronicsCo.,Ltd FederalCommunicationsCommission 7435OaklandMillsRoad ColumbiaMD21046 Subject:RequestforConfidentiality FCCID:OU9TMB207401 ToWhomItMayConcern: PursuanttotheprovisionsofSections0.457and0.459oftheCommission’srules(47CFR§§ 0.457,0.459),wearerequestingtheCommissiontowithholdthefollowingattachmentsas confidentialdocumentfrompublicdisclosureindefinitely. SchematicDiagram BlockDiagram TheoryofOperation Abovementioneddocumentcontainsdetailedsystemandequipmentdescriptionareconsidered asproprietaryinformationinoperationoftheequipment.Thepublicdisclosureofabove documentsmightbeharmfultoourcompanyandwouldgivecompetitoranunfairadvantagein themarket. Itisourunderstandingthatallmeasurementtestreports,FCCIDlabelformatandcorrespondent duringcertificationreviewprocesscannotbegrantedasconfidentialdocumentsandthose informationwillbeavailableforpublicreviewoncethegrantofequipmentauthorizationis issued. BestRegards CompanyName:GuangdongTranstekMedicalElectronicsCo.,Ltd ContactName:KevinTan TitleofPerson ： R&DDirector Address:ZoneA,No.105,DongliRoad,TorchDevelopmentDistrict, Zhongshan,528437,Guangdong,China Date:2020-10-22

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: TMB-2074 Model Digital Blood Pressure Monitor Guangdong Transtek Medical Electronics Co., Ltd. Zone B, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China Measuring range: 40-230 mmHg FCC ID: OU9TMB207401 IP Classification:IP21 Designed by Samsung www.samsung.com Rating: Battery powered mode: 4xAAA batteries, 6V (01)00853553005059 (21)BA1234201100001 EI-B5000 Model: Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China FCC ID: OU9TMB207401 IP Classification:IP22 Designed by Samsung www.samsung.com Rating: Battery powered mode: 4xAAA batteries, 6V Label: BA0712200900001 SN SAMSUNG ARM BPM

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. Internal View of EUT-5

FCC ID: OU9TMB207401 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) = 3 x 5 / (√ 2.480) = 9.525 mW Max. Tune-up Tolerance (mW) SAR Test Exclusion Thresholds (5mm) (mW) 2 9.525 Calculation Value: 2 (mW) / 5 (mm) x √ 2.480 = 0.63 So, Calculation value ≤ 3.0 Remark: -Max. conducted power 1.26 mW is closet 2 mW, so 2 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 SAMSUNG ARM BPM MODEL NUMBER: EI-B5000 FCC ID: OU9TMB207401 REPORT NUMBER: 4789696495-4 ISSUE DATE: October 23, 2020 Prepared for Guangdong Transtek Medical Electronics Co., Ltd Zone A, No.105 ,Dongli Road, Torch Development District 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.: 4789696495-4 Page 2 of 81 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 10/23/2020 Initial Issue REPORT NO.: 4789696495-4 Page 3 of 81 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 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 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.: 4789696495-4 Page 4 of 81 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 .................................................................................... 14 7.1. ON TIME AND DUTY CYCLE ...................................................................................... 14 7.2. 6 dB DTS BANDWIDTH AND 99 % OCCUPIED BANDWIDTH ................................... 15 7.3. CONDUCTED OUTPUT POWER ................................................................................ 17 7.4. POWER SPECTRAL DENSITY ................................................................................... 18 7.5. CONDUCTED BANDEDGE AND SPURIOUS EMISSIONS ........................................ 20 8. RADIATED TEST RESULTS .............................................................................................. 22 8.1. RESTRICTED BANDEDGE ......................................................................................... 27 8.1.1. LE 1M MODE ........................................................................................................ 27 8.1.2. LE 2M MODE ........................................................................................................ 31 8.2. SPURIOUS EMISSIONS (1 GHz ~ 3 GHz) .................................................................. 33 8.2.1. LE 1M MODE ........................................................................................................ 33 8.3. SPURIOUS EMISSIONS (3 GHz ~ 18 GHz) ................................................................ 35 8.3.1. LE 1M MODE ........................................................................................................ 35 8.3.2. LE 2M MODE .....…

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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)