OU9TMB1776BSBlood Pressure Monitor

version:1.0 User Manual Blood Pressure Monitor TMB-1776-B Arm Type Thank you very much for selecting TRANSTEK Blood Pressure Monitor TMB-1776-B. Please 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. Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China FCC ID:OU9TMB1776BS Table of Contents 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 Date, Time Select the user MEASUREMENT................................................................................................................12 Tie the Cuff Start the Measurement DATA MANAGEMENT........................................................................................................15 Recall the Records Delete the Records INFORMATION FOR USER...............................................................................................17 Tips for measurement Maintenances ABOUT BLOOD PRESSURE.............................................................................................20 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........................................................................................................21 SPECIFICATIONS..............................................................................................................22 AUTHORIZED COMPONENTS..........................................................................................23 CONTACT INFORMATION.................................................................................................23 FCC STATEMENT............................................................................................................. 23 COMPLIED STANDARDS LIST.........................................................................................24 EMC GUIDANCE................................................................................................................25 1 CATALOGUECATALOGUE Measurement Principle General Description Features: Maximum 60 records 3rd technonoly: Measuring during inflation 80mm×58.5mm Digital LCD display Indications for Use Thank you for selecting TRANSTEK arm type blood pressure monitor (TMB-1776-B). 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-1776-B 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. 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 42cm(about 8¾ ̋-16½ ̋). It is intended for adult indoor use only. * 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 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. * Don't kink the connection tube during use, otherwise, the cuff pressure may continuously increase which can prevent blood flow and result in harmful injury to the PATIENT. CAUTION 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. This product uses the Oscillometric Measuring method to detect blood pressure. Before every measurement, the unit establishes a “zero pressure”…

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Date: 2020/07/13 TO: Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Regarding: FCC ID: OU9TMB1776BS To whom it may concern: We, the undersigned, hereby authorize SGS-CSTC Standards Technical Services Co., Ltd. (SGS) Shenzhen Branch and Keny Xu in SGS-CSTC Standards Technical Services Co., Ltd. (SGS) Shenzhen Branch 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: Kevin Tan Title: R&D Director On behalf of Company: Guangdong Transtek Medical Electronics Co.,Ltd Telephone: +86-760-85166220 E-mail: [email protected] Signature:

To: Federal Communications Commission Office of Engineering and Technology Laboratory Division 7435 Oakland Mills Rd. Columbia MD 21046 From: Guangdong Transtek Medical Electronics Co.,Ltd Zone A, No.105, Dongli Road Torch Development District Zhongshan, Guangdong 528437 China Regarding: Confidentiality Request regarding application for FCC ID: OU9TMB1776BS LONG TERM CONFIDENTIALITY Pursuant to 47 CFR Section 0.459 and 0.457 of the commission’s rules, the applicant hereby requests confidential treatment of the documents listed below, associated with the certification application referenced above. Schematic(s) Block Diagrams Operational Descriptions BOM The documents above contain proprietary information not released to the public. Public disclosure of this information may prove harmful to the business of the applicant. SHORT TERM CONFIDENTIALITY Additionally, the applicant requests the following documents be held confidential for [0] days from the grant date. If the device is marketed within aforementioned days of the Grant Date, the applicant will notify the TCB per FCC KDB 726920 D01 Confidentiality Request Procedures. External Photos Internal Photos Test Setup Photos User manual(s) Sincerely, Print Name: Kevin Tan Title: R&D Director On behalf of Company: Guangdong Transtek Medical Electronics Co.,Ltd Telephone: +86-760-85166220 E-mail: [email protected] Signature:

Applicant Declaration Applicant Declaration Rev:0.0 SGS North America Inc. 620 Old Peachtree Road SUITE 100 Suwanee, Georgia 30024 United States Applicant Legal Business Name Guangdong Transtek Medical Electronics Co.,Ltd Address Zone A, No.105 ,Dongli Road Torch Development District Zhongshan , Guangdong China 528437 Grantee Code OU9 FCC ID OU9TMB1776BS Authorized Contact Name Kevin Tan Contact Email [email protected] Contact Phone +86-760-85166220 I, the undersigned, certify that I am an authorized signatory for the Applicant and therefore declare; a)in accordance with 47CFR2.911(d), all of the statements herein and the exhibits attached hereto are true and correct to the best of my knowledge and belief. b)in accepting a Grant of Equipment Authorization issued by a TCB, under the authority of the FCC, as a result of the representations made in this application, the Applicant is responsible for: (1) labeling the equipment with the exact FCC ID as specified in this application, (2) compliance statement labeling pursuant to the applicable rules, (3) compliance of the equipment with the applicable technical rules, c)if the Applicant is not the actual manufacturer of the equipment, appropriate arrangements have been made with the manufacturer to ensure that production units of this equipment will continue to comply with the FCC’s technical requirements. d)in accordance with 47 CFR 2.909 and KDB394321, the Applicant has read, understood and agrees to accept that they are the responsible party and agree to abide by their responsibilities as specified under 47 CFR 2.909 and KDB394321. e)in accordance with ISO17065, FCC KDB641163, FCC KDB610077, KDB394321 and RSP-100, the Applicant has read, understood, accepts and agrees to abide by the post market surveillance requirements. (1) the Applicant understands, accepts and agrees that a sample may be requested for surveillance testing. (2) the Applicant shall make provisions to always have a production sample available upon request by SGS, FCC and/or ISED. (3) the Applicant shall, upon request by SGS, at the Applicant’s expense, provide a production sample of the requested product to SGS, FCC and/or ISED as instructed. The sample shall include all support devices, cables, software, accessories or other hardware or software required for evaluation, review, certification and audit surveillance of products certified by SGS. f)neither the Applicant nor any party to the application is 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. §862 because of a conviction for possession or distribution of a controlled substance. See 47CFR 1.2002(b) for the definition of a “party” for these purposes. g)the Applicant has read, understood, accepts and agrees to abide by the SGS North America, Inc.(TCB) terms and conditions. Link to CFRs: https://www.fcc.gov/wireless/bureau-divisions/technologies-systems-and-innovation-division/rules-regulations-title-47 Link to KDBs: https://apps.fcc.gov/oetcf/kdb/index.cfm Link to RSP-100: https://www.ic.gc.ca/eic/site/smt-gst.nsf/eng/sf01130.html Applicant Signature: Date: 2020/07/13 Print Name: Kevin Tan Title: R&D Director Applicant Declaration Applicant Declaration Rev:0.0 SGS North America Inc. 620 Old Peachtree Road SUITE 100 Suwanee, Georgia 30024 United States *NOTE: This declaration cannot be signed by an Agent, it shall be signed by an authorized person listed in the FCC database

SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 1 of 5 External Photos for SZEM1912021010CR FCC ID: OU9TMB1776BS 1 EUT Constructional Details Model No.: BLJ06L060100P-U Model No.: KH0601000UW

TMB-1776-B Model IP Classification:IP21 2019-10 Rating: 4×AA batteries, 6V Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China SN BS1008191000001D AC adaptor powered mode: 6V 1A (Please use the AC adaptor which authorized by the manufacturer!) FCC ID:OU9TMB1776BS 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.

SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 1 of 4 Internal Photos for SZEM1912021010CR FCC ID: OU9TMB1776BS SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 2 of 4 1 EUT Constructional Details SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 3 of 4 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 4 of 4 BT Antenna

SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Report No.: SZEM191202101002 Page: 1 of 6 Keny Xu EMC Laboratory Manager 1 Cover page SAR Evaluation Report Application No.: SZEM1912021010CR Applicant: Guangdong Transtek Medical Electronics Co., Ltd. Address of Applicant: Zone A, No.105 Dongli Road, Torch Development District, Zhongshan, Guangdong, China 528437 Manufacturer: Guangdong Transtek Medical Electronics Co., Ltd. Address of Manufacturer: Zone A, No.105 Dongli Road, Torch Development District, Zhongshan, Guangdong, China 528437 Factory: Guangdong Transtek Medical Electronics Co., Ltd. Address of Factory: Zone B, No.105 Dongli Road, Torch Development District, Zhongshan, Guangdong, China 528437 Equipment Under Test (EUT): EUT Name: Blood Pressure Monitor Model No.: TMB-1776-B FCC ID: OU9TMB1776BS Standards: 47 CFR Part 1.1307 47 CFR Part 2.1093 KDB447498D01 General RF Exposure Guidance v06 Date of Receipt: 2019-12-09 Date of Test: 2019-12-10 to 2020-01-14 Date of Issue: 2020-02-13 Test Result : Pass* * In the configuration tested, the EUT complied with the standards specified above. SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Report No.: SZEM191202101002 Page: 2 of 6 2 Version Revision Record Version Chapter Date Modifier Remark 01 2020-02-13 Original Authorized for issue by: Damon Su /Project Engineer Eric Fu /Reviewer SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Report No.: SZEM191202101002 Page: 3 of 6 3 Contents Page 1 COVER PAGE ........................................................................................................................................ 1 2 VERSION ................................................................................................................................................ 2 3 CONTENTS ............................................................................................................................................ 3 4 GENERAL INFORMATION ..................................................................................................................... 4 4.1 GENERAL DESCRIPTION OF EUT ......................................................................................................... 4 4.2 TEST LOCATION ................................................................................................................................ 5 4.3 TEST FACILITY .................................................................................................................................. 5 4.4 DEVIATION FROM STANDARDS ............................................................................................................ 5 4.5 ABNORMALITIES FROM STANDARD CONDITIONS .................................................................................... 5 4.6 OTHER INFORMATION REQUESTED BY THE CUSTOMER .......................................................................... 5 5 SAR EVALUATION ................................................................................................................................. 6 5.1 RF EXPOSURE COMPLIANCE REQUIREMENT ........................................................................................ 6 5.1.1 Standard Requirement ................................................................................................................ 6 5.1.2 Limits .......................................................................................................................................... 6 5.1.3 EUT RF Exposure ....................................................................................................................... 6 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Report No.: SZEM191202101002 Page: 4 of 6 4 General Information 4.1 General Description of EUT Power supply: DC 6V by 4*AA batteries or DC 6V, 1A by AC/DC adapter. Frequency Range: 2402MHz to 2480MHz Bluetooth Version: V4.2 Modulation Type: GFSK Number of Channels: 40 Antenna Type: PCB Antenna Antenna Gain: 0dBi SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Report No.: SZEM191202101002 Page: 5 of 6 4.2 Test Location All tests were performed at: SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch No. 1 Workshop, M-10, Middle section, Science & Technology Park, Shenzhen, Guangdong, China 518057 Telephone: +86 (0) 755 2601 2053 Fax: +86 (0) 755 2671 0594 No tests were sub-contracted. 4.3 Test Facility The test facility is recognized, certified, or accredited by the following organizations: • A2LA (Certificate No. 3816.01) SGS-CSTC Standards Technical Services Co., Ltd., Shenzhen EMC Laboratory is accredited by the American Association for Laboratory Accreditation(A2LA). Certificate No. 3816.01. • VCCI The 3m Fully-anechoic chamber for above 1GHz, 10m Semi-anechoic chamber for below 1GHz, Shielded Room for Mains Port Conducted Interference Measurement and Telecommunication Port Conducted Interference Measurement of SGS-CSTC Standards Technical Services Co., Ltd. have been registered in accordance with the Regulations for Voluntary Control Measures with Registration No.: G-20026, R-14188, C-12383 and T-11153 respectively. • FCC –Designation Number: CN1178 SGS-CSTC Standards Technical Services Co., Ltd., Shenzhen EMC Laboratory has been recognized as an accredited testing laboratory. Designation Number: CN1178. Test Firm Registration Number: 406779. • Innovation, Science and Economic Development Canada SGS-CSTC Standards Technical Services Co., Ltd., Shenzhen EMC Laboratory has been recognized by ISED as an accredited testing laboratory. CAB identifier: CN0006. IC#: 4620C. 4.4 Deviation from Standards None. 4.5 Abnormalities from Standard Conditions None. 4.6 Other Information Requested by the Customer None. SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Report No.: SZEM191202101002 Page: 6 of 6 5 SAR Evaluation 5.1 RF Exposure Compliance Requirement 5.1.1 Standard Requirement According to K…

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SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Report No.: SZEM191202101001 Page: 1 of 61 Keny Xu EMC Laboratory Manager TEST REPORT Application No.: SZEM1912021010CR Applicant: Guangdong Transtek Medical Electronics Co., Ltd. Address of Applicant: Zone A, No.105 Dongli Road, Torch Development District, Zhongshan, Guangdong, China 528437 Manufacturer: Guangdong Transtek Medical Electronics Co., Ltd. Address of Manufacturer: Zone A, No.105 Dongli Road, Torch Development District, Zhongshan, Guangdong, China 528437 Factory: Guangdong Transtek Medical Electronics Co., Ltd. Address of Factory: Zone B, No.105 Dongli Road, Torch Development District, Zhongshan, Guangdong, China 528437 Equipment Under Test (EUT): EUT Name: Blood Pressure Monitor Model No.: TMB-1776-B FCC ID: OU9TMB1776BS Standard(s) : 47 CFR Part 15, Subpart C 15.247 Date of Receipt: 2019-12-09 Date of Test: 2019-12-10 to 2020-01-14 Date of Issue: 2020-02-13 Test Result: Pass* * In the configuration tested, the EUT complied with the standards specified above. SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Report No.: SZEM191202101001 Page: 2 of 61 Revision Record Version Chapter Date Modifier Remark 01 2020-02-13 Original Authorized for issue by: Damon Su /Project Engineer Eric Fu /Reviewer SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Report No.: SZEM191202101001 Page: 3 of 61 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 Minimum 6dB Bandwidth 47 CFR Part 15, Subpart C 15.247 ANSI C63.10 (2013) Section 11.8.1 47 CFR Part 15, Subpart C 15.247a(2) Pass Conducted Peak Output Power 47 CFR Part 15, Subpart C 15.247 ANSI C63.10 (2013) Section 11.9.1 47 CFR Part 15, Subpart C 15.247(b)(3) Pass Power Spectrum Density 47 CFR Part 15, Subpart C 15.247 ANSI C63.10 (2013) Section 11.10.2 47 CFR Part 15, Subpart C 15.247(e) Pass Conducted Band Edges Measurement 47 CFR Part 15, Subpart C 15.247 ANSI C63.10 (2013) Section 11.13.3.2 47 CFR Part 15, Subpart C 15.247(d) Pass Conducted Spurious Emissions 47 CFR Part 15, Subpart C 15.247 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 47 CFR Part 15, Subpart C 15.247 ANSI C63.10 (2013) Section 6.10.5 47 CFR Part 15, Subpart C 15.205 & 15.209 Pass Radiated Spurious Emissions 47 CFR Part 15, Subpart C 15.247 ANSI C63.10 (2013) Section 6.4,6.5,6.6 47 CFR Part 15, Subpart C 15.205 & 15.209 Pass SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Report No.: SZEM191202101001 Page: 4 of 61 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 ............................................................................13 6.1 ANTENNA REQUIREMENT ................................................................................................................13 6.1.1 Test Requirement: ..................................................................................................................13 6.1.2 Conclusion ..............................................................................................................................13 7 RADIO SPECTRUM MATTER TEST RESULTS .................................................................................14 7.1 CONDUCTED EMISSIONS AT AC POWER LINE (150KHZ-30MHZ) ........................................................14 7.1.1 E.U.T. Operation .....................................................................................................................15 7.1.2 Test Setup Diagram ................................................................................................................15 7.1.3 Measurement Procedure and Data .........................................................................................15 7.2 MINIMUM 6DB BANDWIDTH .............................................................................................................18 7.2.1 …

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SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 1 of 4 Setup Photos for SZEM1912021010CR FCC ID: OU9TMB1776BS SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 2 of 4 1 Photographs 1.1 Conducted Emissions at AC Power Line (150kHz-30MHz) Test Setup SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 3 of 4 1.2 Radiated Emissions which fall in the restricted bands Test Setup 1.3 Radiated Spurious Emissions Test Setup SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 4 of 4