OU9-TMB-2266Blood Pressure Monitor

User Manual Blood Pressure Monitor TMB-2266 Arm Type Thank you very much for selecting TRANSTEK Blood Pressure Monitor TMB-2266 Please do read the user manual carefully and thoroughtly so as to ensure the safe usage of this product, and keep the manual well for further reference in case you have problems. version:1.0 Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105 ,Dongli Road, Torch Development District, 528437 Zhongshan, Guangdong,China INTRODUCTION..................................................................................................................2 General Description Indications for Use Contraindications Measurement Principle Safety Information LCD Display Signal Monitor Components List BEFORE YOU START..........................................................................................................8 The Choice of Power Supply Installing and Replacing the Batteries Setting DateTime and Voice Pair a smart device with the monitor MEASUREMENT................................................................................................................15 Applying the Cuff Start the Measurement DATA MANAGEMENT........................................................................................................20 Recall the Records Delete the Records INFORMATION FOR USER...............................................................................................24 Tips for measurement Maintenances ABOUT BLOOD PRESSURE.............................................................................................26 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.......................................................................................................28 SPECIFICATIONS..............................................................................................................29 AUTHORIZED COMPONENT ...........................................................................................30 CONTACT INFORMATION.................................................................................................30 EMC GUIDANCE................................................................................................................31 FCC STATEMENT..............................................................................................................34 1 Table of Contents CATALOGUE 23 Thank you for selecting TRANSTEK blood pressure monitor (TMB-2266). 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 TMB-2266 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. Features: Maximum 199 records per each user General Description 3rd technonoly: Measuring during inflation 71mm×82 mm Digital LCD display with white backlight INTRODUCTION INTRODUCTION Indications for Use The Transtek Blood Pressure Monitor is digital monitors intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22cm to 32cm, 22cm to 42cm, 22cm to 45cm. It is intended for adult indoor use only. Safety Information The signs below might be in the user manual, labeling or other component. They are the requirement of standard and using. Measurement Principle 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 inflating the arm cuff, meanwhile, the unit detects pressure oscillations generated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure, and also pulse rate. MR Unsafe To identify an item which poses unacceptable risks to the patient, medical staff or other persons within the MR environment. Manufacturer Serial Number Type BF applied part Direct Current The symbol indicates that the product should not be discarded as unsorted waste but must be sent to separate collection facilities for recovery and recycling. Recyclable Caution Indicates that caution is necessary when operating the device or control close to where the symbol is placed, or that the current situation needs operator awareness or operator action in order to avoid undesirable consequences. Refer to instruction manual/booklet To signify that the instruction manual/ booklet must be read. Date and Country of manufacture For indoor use only Symbol for “Class II Equipment” 1.The device is not suitable for use on may be pregnant women or pregnant women. 2.The device is not suitable for use on patients with implanted,electrical devices, such as cardiac pacemakers, defibrillators. Contraindications 45 INTRODUCTION INTRODUCTION CAUTION * This device is intended for indoor, home use. * This device is not intended for public use. * This device is portable, but it is not intended for use during patient transport. * This device is not suitable for continuous monitoring during medical emergencies or operations. * 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 any purpose other than obtaining a blood pressure measurement. * This device is for adults. Do not use this device on neonates or infants. Do not use it on children unless otherwise instructed by a medical professional. * Do not use on the women in pregnant, including pre-eclamptic, patients. * The device i…

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Guangdong Transtek Medical Electronics Co.,Ltd Date: 2022/07/28 TO: Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Regarding: FCC ID: OU9-TMB-2266 To whom it may concern: We, the undersigned, hereby authorize Compliance Certification Services (Kunshan) Inc to act on our behalf in all manners relating to application for equipment authorization with respect to the FCC ID above, including signing of all documents relating to these matters. Any and all acts carried out by the agent on our behalf shall have the same effect as acts of our own. We, 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). Where our 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 SGS North America, Inc., still resides with Guangdong Transtek Medical Electronics Co., Ltd. This authorization is valid until further written notice from the applicant. Print Name: Jerry Fan Title: RA Manager Signature: On behalf of Company: Guangdong Transtek Medical Electronics Co., Ltd. Telephone: +86-760-85166220 E-mail: [email protected]

GuangdongTranstekMedicalElectronicsCo.,Ltd TO:FederalCommunicationCommission EquipmentAuthorizationBranch 7435OaklandMillsRoad Columbia,MID21046 Regarding:ConfidentialityRequestregardingapplicationforFCCID:OU9-TMB-2266 LONGTERMCONFIDENTIALITY Pursuantto47CFRSection0.459and0.457ofthecommission’srules,theapplicantherebyrequest confidentialtreatmentofthedocumentslistedbelow,associatedwiththecertificationapplication referencedabove. Schematic(s) BlockDiagrams OperationalDescriptions Thedocumentsabovecontainproprietaryinformationnotreleasedtothepublic.Publicdisclosureofthis informationmayproveharmfultothebusinessoftheapplicant. SHORTTERMCONFIDENTIALITY Additionally,theapplicantrequeststhefollowingdocumentsbeheldconfidentialuntilthedeviceis marketedor180daysfromthegrantdate,whicheverisless.Ifthedeviceismarketedwithinconfidential period,theapplicantwillnotifytheTCBperFCCKDB726920D01ConfidentialityRequestProcedures. ExternalPhotos InternalPhotos TestSetupPhotos Usermanual(s) Sincerely, PrintName:JerryFanTitle:RAManager Signature: OnbehalfofCompany:GuangdongTranstekMedicalElectronicsCo.,Ltd Telephone:+86-760-85166220 E-mail:[email protected]

Compliance Certification Services (Kunshan) Inc. Shenzhen Branch SZCCS-TRF-A02 Rev. A/0 Page: 1 of 5 External Photos for FYCR2207000280ME FCC ID: OU9-TMB-2266 Compliance Certification Services (Kunshan) Inc. Shenzhen Branch SZCCS-TRF-A02 Rev. A/0 Page: 2 of 5 EUT Constructional Details (EUT Photos) Compliance Certification Services (Kunshan) Inc. Shenzhen Branch SZCCS-TRF-A02 Rev. A/0 Page: 3 of 5 Compliance Certification Services (Kunshan) Inc. Shenzhen Branch SZCCS-TRF-A02 Rev. A/0 Page: 4 of 5 Compliance Certification Services (Kunshan) Inc. Shenzhen Branch SZCCS-TRF-A02 Rev. A/0 Page: 5 of 5

TMB-2266 label SN：2BS1096220700001-2BS1096220700050 Dimension：50.0 x 19.0 mm Model: TMB-2266IP Classification: IP21 Made in China FCC ID: OU9-TMB-2266 Blood Pressure Monitor Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105, Dongli Road, Torch Development District, 528437 Zhongshan, Guangdong, China Rating: Battery powered mode: 4x AAA batteries, 6V AC adapter powered mode: 5V 1A (Please use the AC adapter authorized by the manufacturer!) SN (21) 2BS1096220700001 (01) xxxxxxxxxxxxxx GS1 Datamatrix (UDI) Colour： Pantone Reflex Blue C Material：60# paper with white background 2022-07 FCC Statement: This device complies with Part 15 of the FCC Rules. Operation is subject to 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.

Compliance Certification Services (Kunshan) Inc. Shenzhen Branch SZCCS-TRF-A03 Rev. A/0 Page: 1 of 4 Internal Photos for FYCR2207000280ME FCC ID: OU9-TMB-2266 Compliance Certification Services (Kunshan) Inc. Shenzhen Branch SZCCS-TRF-A03 Rev. A/0 Page: 2 of 4 EUT Constructional Details (EUT Photos) Compliance Certification Services (Kunshan) Inc. Shenzhen Branch SZCCS-TRF-A03 Rev. A/0 Page: 3 of 4 Antenna Compliance Certification Services (Kunshan) Inc. Shenzhen Branch SZCCS-TRF-A03 Rev. A/0 Page: 4 of 4

Compliance Certification Services (Kunshan) Inc. Shenzhen Branch SZCCS-TRF-01 Rev. A/0 Aug01,2022 Report No.: FYCR220700028003 Page: 1 of 9 Winkey Wang EMC Technical Manager 1 Cover Page RF Exposure Report Application No.: FYCR2207000280ME Applicant: Guangdong Transtek Medical Electronics Co., Ltd. Address of Applicant: Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China Manufacturer: Guangdong Transtek Medical Electronics Co., Ltd. Address of Manufacturer: Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China Factory: Guangdong Transtek Medical Electronics Co., Ltd. Address of Factory: Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China Equipment Under Test (EUT): EUT Name: Blood pressure monitor Model No.: TMB-2266 Trade Mark: Transtek FCC ID: OU9-TMB-2266 Standard(s) : FCC Rules 47 CFR §2.1093 KDB 447498 D04 interim General RF Exposure Guidance v01 Date of Receipt: 2022-07-22 Date of Test: 2022-07-28 to 2022-08-08 Date of Issue: 2022-08-09 Test Result: Pass* * In the configuration tested, the EUT complied with the standards specified above. Compliance Certification Services (Kunshan) Inc. Shenzhen Branch SZCCS-TRF-01 Rev. A/0 Aug01,2022 Report No.: FYCR220700028003 Page: 2 of 9 Revision Record Version Chapter Date Modifier Remark 01 2022-08-09 Original Authorized for issue by: Tree Zhan/Project Engineer Winkey Wang/Reviewer Compliance Certification Services (Kunshan) Inc. Shenzhen Branch SZCCS-TRF-01 Rev. A/0 Aug01,2022 Report No.: FYCR220700028003 Page: 3 of 9 2 Contents Page 1 COVER PAGE .................................................................................................................................... 1 2 CONTENTS ........................................................................................................................................ 3 3 GENERAL INFORMATION ................................................................................................................ 4 3.1 GENERAL DESCRIPTION OF E.U.T. ................................................................................................ 4 3.2 DETAILS OF E.U.T. ....................................................................................................................... 4 3.3 SEPARATION DISTANCE ................................................................................................................ 5 3.4 TEST LOCATION ............................................................................................................................ 5 3.5 TEST FACILITY .............................................................................................................................. 5 4 FCC RADIOFREQUENCY RADIATION EXPOSURE LIMITS .......................................................... 6 4.1 BLANKET 1 MW BLANKET EXEMPTION ........................................................................................... 6 4.2 MPE-BASED EXEMPTION .............................................................................................................. 6 4.3 SAR-BASED EXEMPTION ............................................................................................................... 7 5 MEASUREMENT AND CALCULATION ............................................................................................ 9 5.1 MAXIMUM TRANSMIT POWER ......................................................................................................... 9 5.2 RF EXPOSURE CALCULATION ........................................................................................................ 9 Compliance Certification Services (Kunshan) Inc. Shenzhen Branch SZCCS-TRF-01 Rev. A/0 Aug01,2022 Report No.: FYCR220700028003 Page: 4 of 9 3 General Information 3.1 General Description of E.U.T. Product Type: Portable device Mobile device Fixed device 3.2 Details of E.U.T. Power supply: AC Adapter Model: BLJ06L060100P-U Input: AC 100-240V, 50/60Hz, 0.2A Max Output: DC 5.0V, 1.0A 6.0V DC(4 x 1.5V "AAA" Size Battery) Test Voltage: AC 120V, 60Hz Note: Both nominal AC 120V, 60Hz and AC 240 V, 60Hz are required for testing in accordance with FCC KDB174176, this report only shows the results of the worst test result(AC 120V, 60Hz); Cable(s): DC cable:140cm unshielded Operation Frequency: 2402MHz to 2480MHz Bluetooth Version: V5.0 Modulation Type: GFSK Number of Channels: 40 Channel Spacing: 2MHz Antenna Type: PCB Antenna Antenna Gain: 2.89dBi Remark:The information in this section is provided by the applicant or manufacturer, SGS is not liable to the accuracy, suitability, reliability or/and integrity of the information. Compliance Certification Services (Kunshan) Inc. Shenzhen Branch SZCCS-TRF-01 Rev. A/0 Aug01,2022 Report No.: FYCR220700028003 Page: 5 of 9 3.3 Separation Distance Minimum test separation distance: 5mm Remark: This minimum test separation distance is determined by the smallest distance from the antenna and radiating structures or outer surface of the device, according to the host form factor, exposure conditions and platform requirements, to any part of the body or extremity of a user or bystander. 3.4 Test Location All tests were performed at: Compliance Certification Services（Kunshan）Inc. Shenzhen branch. Fuyong lab. Xinlong TechnoPark,Fengtang Road, Fuyong Subdistrict, Bao’an, Shenzhen, China Tel: +86 755 8866 3988 Fax: +86 755 2671 0594 No tests were sub-contracted. 3.5 Test Facility The test facility is recognized, certified, or accredited by the following organizations: • A2LA (Certificate No. 6606.01) Compliance Certification Services（Kunshan）Inc. Shenzhen branch is accredited by the American Association for Laboratory Accreditation(A2LA). Certificate No. 6606.01. • FCC –Designation Number: CN1322 Compliance Certification Services（Kunshan）Inc. Shenzhen branch has been recognized as an accredited testing laboratory. Designation Number: CN1322. Test Firm Registration…

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Compliance Certification Services (Kunshan) Inc. Shenzhen Branch SZCCS-TRF-01 Rev. A/0 Aug01,2022 Report No.: FYCR220700028002 Page: 1 of 54 Winkey Wang EMC Technical Manager TEST REPORT Application No.: FYCR2207000280ME Applicant: Guangdong Transtek Medical Electronics Co., Ltd. Address of Applicant: Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China Manufacturer: Guangdong Transtek Medical Electronics Co., Ltd. Address of Manufacturer: Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China Factory: Guangdong Transtek Medical Electronics Co., Ltd. Address of Factory: Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China Equipment Under Test (EUT): EUT Name: Blood Pressure Monitor Model No.: TMB-2266 Trade Mark: Transtek FCC ID: OU9-TMB-2266 Standard(s) : 47 CFR Part 15, Subpart C 15.247 Date of Receipt: 2022-07-22 Date of Test: 2022-07-28 to 2022-08-08 Date of Issue: 2022-08-09 Test Result: Pass* * In the configuration tested, the EUT complied with the standards specified above. Compliance Certification Services (Kunshan) Inc. Shenzhen Branch SZCCS-TRF-01 Rev. A/0 Aug01,2022 Report No.: FYCR220700028002 Page: 2 of 54 Revision Record Version Chapter Date Modifier Remark 01 2022-08-09 Original Authorized for issue by: Tree Zhan/Project Engineer Winkey Wang/Reviewer Compliance Certification Services (Kunshan) Inc. Shenzhen Branch SZCCS-TRF-01 Rev. A/0 Aug01,2022 Report No.: FYCR220700028002 Page: 3 of 54 2 Test Summary Radio Spectrum Technical Requirement Item Standard Method Requirement Result Antenna Requirement 47 CFR Part 15, Subpart C 15.247 N/A 47 CFR Part 15, Subpart C 15.203 & 15.247(b)(4) Pass Radio Spectrum Matter Part Item Standard Method Requirement Result Conducted Emissions at AC Power Line (150kHz-30MHz) 47 CFR Part 15, Subpart C 15.247 ANSI C63.10 (2013) Section 6.2 47 CFR Part 15, Subpart C 15.207 Pass Conducted Peak Output Power ANSI C63.10 (2013) Section 11.9.1 47 CFR Part 15, Subpart C 15.247(b)(3) Pass Minimum 6dB Bandwidth ANSI C63.10 (2013) Section 11.8.1 47 CFR Part 15, Subpart C 15.247a(2) Pass Power Spectrum Density ANSI C63.10 (2013) Section 11.10.2 47 CFR Part 15, Subpart C 15.247(e) Pass Conducted Band Edges Measurement ANSI C63.10 (2013) Section 11.13.3.2 47 CFR Part 15, Subpart C 15.247(d) Pass Conducted Spurious Emissions ANSI C63.10 (2013) Section 11.11 47 CFR Part 15, Subpart C 15.247(d) Pass Radiated Emissions which fall in the restricted bands ANSI C63.10 (2013) Section 6.10.5 47 CFR Part 15, Subpart C 15.205 & 15.209 Pass Radiated Spurious Emissions Below 1GHz ANSI C63.10 (2013) Section 6.4,6.5 47 CFR Part 15, Subpart C 15.205 & 15.209 Pass Radiated Spurious Emissions Above 1GHz ANSI C63.10 (2013) Section 6.6 47 CFR Part 15, Subpart C 15.205 & 15.209 Pass Compliance Certification Services (Kunshan) Inc. Shenzhen Branch SZCCS-TRF-01 Rev. A/0 Aug01,2022 Report No.: FYCR220700028002 Page: 4 of 54 3 Contents Page 1 COVER PAGE ............................................................................................................................................ 1 2 TEST SUMMARY ....................................................................................................................................... 3 3 CONTENTS ................................................................................................................................................ 4 4 GENERAL INFORMATION ........................................................................................................................ 6 4.1 DETAILS OF E.U.T. ............................................................................................................................... 6 4.2 DESCRIPTION OF SUPPORT UNITS ......................................................................................................... 6 4.3 MEASUREMENT UNCERTAINTY .............................................................................................................. 6 4.4 TEST LOCATION .................................................................................................................................... 7 4.5 TEST FACILITY ...................................................................................................................................... 7 4.6 DEVIATION FROM STANDARDS ............................................................................................................... 7 4.7 ABNORMALITIES FROM STANDARD CONDITIONS ..................................................................................... 7 5 EQUIPMENT LIST ...................................................................................................................................... 8 6 RADIO SPECTRUM TECHNICAL REQUIREMENT ............................................................................... 11 6.1 ANTENNA REQUIREMENT .................................................................................................................... 11 6.1.1 Test Requirement: ....................................................................................................................... 11 6.1.2 Conclusion ................................................................................................................................... 11 7 RADIO SPECTRUM MATTER TEST RESULTS ..................................................................................... 12 7.1 CONDUCTED EMISSIONS AT AC POWER LINE (150KHZ-30MHZ) ........................................................... 12 7.1.1 E.U.T. Operation .......................................................................................................................... 12 7.1.2 Test Mode Description ................................................................................................................. 12 7.1.3 Test Setup Diagram ..........................................................................…

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Project NameTest byDate Project StageHW versionSW versio n Instruments 测试暗室 Test Lab FreqEffiEffiGain (MHz)(%)(dB)(dBi) 2400 43.92 -3.572.08 1.S11 2 . 天线效率Antenna efficiency 需要Free Space、On Wrist两种状态下的效率，增益值；效率需要有百分比和dB两组值 Need Free Space, On Wrist two states of efficiency, gain value; efficiency needs to have percentage and dB two groups of values 测试结论 Test Result 备注 Remark Antenna Test Report 2022/8/12 整机Complete unit 5071CETS 2410 47.85-3.22.47 2420 45.01 -3.472.03 2430 53.3-2.732.89 2440 48.09 -3.182.54 2450 55.07 -2.592.82 2460 48.41 -3.151.84 2470 53.76-2.71.84 2480 51.19 -2.911.02 2490 54.99-2.61.61 2500 50.09-31.16 3.待测产品Test sample: Antenna，15mm*5mm

Compliance Certification Services (Kunshan) Inc. Shenzhen Branch Page: 1 of 3 Appendix Photographs of Test Setup for FYCR2207000280ME FCC ID: OU9-TMB-2266 Compliance Certification Services (Kunshan) Inc. Shenzhen Branch Page: 2 of 3 Test Setup Photos Conducted Emissions at AC Power Line (150kHz-30MHz) Radiated Emissions which fall in the restricted bands Compliance Certification Services (Kunshan) Inc. Shenzhen Branch Page: 3 of 3 Radiated Spurious Emissions Below 1GHz Radiated Spurious Emissions Above 1GHz