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OU9LC-BP01-BBlood Pressure Monitor

Guangdong Transtek Medical Electronics Co.,Ltd
Blood Pressure Monitor - FCC ID OU9LC-BP01-B - Guangdong Transtek Medical Electronics Co.,Ltd
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Application Details

Equipment Class
DTS - Digital Transmission System
Date of Grant
May 23, 2021
Application Purpose
Original Equipment
Date of Application
May 23, 2021
Equipment Note
Blood Pressure Monitor
Frequency Range
2402.00000000 - 2480.00000000
Company
Guangdong Transtek Medical Electronics Co.,Ltd
Country
China

Documents & Files

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Users Manual

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Cover Letter(s)

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External Photos

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ID Label/Location Info

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Internal Photos

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RF Exposure Info

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Test Report

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Test Setup Photos

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Document Text

Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.

Users Manual

User Manual Blood Pressure Monitor LC-BP01 Please read the user manual carefully and thoroughly so as to ensure the safe usage of this product, Keep the manual well for your further reference in case you have problems. Thank you very much for selecting moon Blood Pressure Monitor LC-BP01. Arm Type Version:1.0 Guangdong Transtek Medical Electronics Co., Ltd. Zone B, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China INTRODUCTION................................................................ 2 Indications for Use LCD Display Signal Monitor Components List BEFORE YOU START...........................................................9 INFORMATION FOR USER......................................................16 Tips for Measurement Maintenance ABOUT BLOOD PRESSURE.....................................................18 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? TROUBLESHOOTING..........................................................20 SPECIFICATIONS..............................................................21 ATHORIZED COMPONENT................................................22 CONTACT INFORMATION.......................................................22 Safety Information Power Supply and Charge Power Setting the Time,Date and Unit MEASUREMENT Start Measurement ..................................... 14 ...................... COMPLIED EUROPEAN STANDARDS LIST ........................23 ....................................................... 24 ...... Table of Contents ................ Measurement Principle General Description EMC GUDIANCE Tie the Cuff Pair up with Your Device 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? Contraindications Select the User Turn on or turn off the voice .............................................................. 27 1 TABLE OF CONTENTS FCC STATEMENT FEATURES: 52.00mm diameter circular Digital LCD display Measure-during-inflating Technology Up to 99 pieces of record stored per each user General Description The signs below might be in the user manual, labeling or other components. They are the requirement of standard and using. Safety Information T1A/250V Φ3.6*10CCC Indications for Use The moon Blood Pressure Monitor is digital monitors intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22 cm to 32 cm (about 8¾ ̋-12½ ̋) or 22 cm to 42 cm (about 8¾ ̋-16½ ̋). It is intended for adult indoor use only. 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” SN Symbol for “TYPE BF APPLIED PARTS” Symbol for “THE OPERATION GUIDE MUST BE READ” Symbol for “MANUFACTURER” Symbol for “SERIAL NUMBER” Symbol for “DIRECT CURRENT” Symbol for “MANUFACTURE DATE” Caution: These notes must be observed to prevent any damage to the device. Symbol for “RECYCLE” Symbol for “Class II Equipment” For indoor use only F1 Thank you for selecting moon arm type blood pressure monitor (LC-BP01). 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 LC-BP01 are 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 the product. Read the manual thoroughly before using the product. 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. Surface with a soft pillow for user measurement Built-in six speech and the six languages Measurement Principle 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. INTRODUCTIONINTRODUCTION 23 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 without consulting your physician. * Do not take any therapeutic measures on the basis of a self measurement. Never alter the dose of a m…

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Cover Letter(s)

GuangdongTranstekMedicalElectronicsCo.,Ltd Date:03/18/2021 FederalCommunicationsCommission 7435OaklandMillsRoad ColumbiaMD21046 Towhomitmayconcern: I,theundersigned,herebyauthorizeULVerificationServicesInc.toactonourbehalfinall mannersrelatingtoapplicationforequipmentauthorization,includingsigningofalldocuments relatingtothesematters.AnyandallactscarriedoutbyULVerificationServicesInc.onour behalfshallhavethesameeffectasactsofourown. 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. Thisauthorizationisvaliduntilfurtherwrittennoticefromtheapplicant. SincerelyYours, Signedby: CompanyName:GuangdongTranstekMedicalElectronicsCo.,Ltd ContactName:KevinTan TitleofPerson:R&DDirector Address:ZoneA,No.105,DongliRoad,TorchDevelopmentDistrictZhongshanGuangdong528437 China

Cover Letter(s)

GuangdongTranstekMedicalElectronicsCo.,Ltd FederalCommunicationsCommission 7435OaklandMillsRoad ColumbiaMD21046 Subject:RequestforConfidentiality FCCID:OU9LC-BP01-B 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,TorchDevelopmentDistrictZhongshanGuangdong528437 China Date:03/25/2021

External Photos

Appendix I External 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. View of EUT-1 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. View of EUT-3 View of EUT-4 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. View of EUT-5 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. View of EUT-7

ID Label/Location Info

: LC-BP01 Model IP Classification:IP21 2021-03 AC adaptor powered mode: 5V 1A Not Included Rating: Built-in rechargeable li-polymer battery, 3.7V (01)17649998849026 (21)BS0867210300001D (Please use the AC adaptor which authorized by the manufacturer!) Distributed by This device complies with Part 15 of the FCC Rules.Operation is subjectto the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. FCC StatementFCC ID:OU9LC-BP01-B APEMAN INTERNATIONAL CO.LIMITED ROOM 1409 BLOCK C 14/F TAK WING INDUSTRIAL BUILDING 3 TSUN WEN ROAD TUEN MUN NT, HKSAR

Internal Photos

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 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 Internal View of EUT-8 Antenna

RF Exposure Info

FCC ID: OU9LC-BP01-B 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) 4 9.525 Calculation Value: 4 (mW) / 5 (mm) x √ 2.480 = 1.26 So, Calculation value ≤ 3.0 Remark: -Max. conducted power 3.55 mW is closet 4 mW, so 4 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.

Test Report

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: LC-BP01 FCC ID: OU9LC-BP01-B REPORT NUMBER: 4789859486-1 ISSUE DATE: March 26, 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.: 4789859486-1 Page 2 of 67 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 03/26/2021 Initial Issue REPORT NO.: 4789859486-1 Page 3 of 67 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 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.: 4789859486-1 Page 4 of 67 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 ............................................................................. 9 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 8.2. SPURIOUS EMISSIONS (1 GHz ~ 3 GHz) .................................................................. 30 8.2.1. LE 1M MODE ........................................................................................................ 30 8.3. SPURIOUS EMISSIONS (3 GHz ~ 18 GHz) ................................................................ 36 8.3.1. LE 1M MODE ........................................................................................................ 36 8.4. SPURIOUS EMISSIONS (18 GHz ~ 26 GHz) ........…

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Test Setup Photos

Appendix III Setup Photographs Conducted Disturbance Radiated Disturbance Below 1 GHz and Above 30 MHz Radiated Disturbance Below 30 MHz Radiated RF Measurement Setup

Contact Information

Applicant

Jerry Fan(RA Manager)
[email protected]+86-760-85166220Fax: +86-760-86742877

Test Firm

UL Verification Services (Guangzhou) Co., Ltd.Stephen Guo
[email protected]+86 0769 33817120

Technical Specifications

#Rule PartsFrequency RangePower Output
115C2.40 GHz - 2.48 GHz3.40 mW
Confidentiality
Long Term
Grant Notes
Output power listed is conducted.

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