OU9TMB1598B2Blood pressure monitor

User Manual Wrist Blood Pressure Monitor TMB-1598-BS Wrist Type Version:1.0 To use the monitor correctly and safely, please read the manual thoroughly. Thank you very much for selecting TRANSTEK Wrist Blood Pressure Monitor TMB-1598-BS. Please keep this manual well in order to reference in future. Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105, Dongli Road, Torch Development District, 528437 Zhongshan, Guangdong, China CATALOGUE INTRODUCTION............................................................................................. 2 Safety Information LCD Display Symbol Monitor Components BEFORE YOU START ......................................................................................13 Installing and Replacing the Batteries Setting Date, Time and Measurement Unit MEASUREMENT ..............................................................................................24 Tie the Cuff Start the Measurement DATA MANAGEMENT28 Delete the Records Recall the Records INFORMATION FOR USER ................................................................................32 Tips for Measurement Maintenance ABOUT BLOOD PRESSURE ...............................................................................34 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 wrist? TROUBLESHOOTING .....................................................................................37 SPECIFICATIONS ...........................................................................................39 CONTACT INFORMATION .................................................................................41 EMC GUIDANCE .............................................................................................42 ...................................................................................... General Description Indications for Use Measurement Principle List Contraindications 1 Select the User ID Pair up the Blood Pressure Monitor with Your Device FCC STATEMENT .................................................................................41 32 INTRODUCTION INTRODUCTION Features: Systolic blood pressure Diastolic blood pressure Pulse rate 60 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 Thank you for selecting TRANSTEK Blood Pressure Monitor (TMB-1598-BS). 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-1598-BS 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. The Transtek Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and heartbeat rate with a wrist circumference ranging from 13.5cm to 21.5 cm ( about 5⅓ ̋-8½ ̋ ). It is intended for adult indoor use only. 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. 4 INTRODUCTION INTRODUCTION 5 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 sam…

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Guangdong Transtek Medical Electronics Co.,Ltd Date: 2022/06/30 TO: Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Regarding: FCC ID: OU9TMB1598B2 To whom it may concern: We, the undersigned, hereby authorize Compliance Certification Services (Kunshan) Inc and Kidd Yang in 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]

Guangdong Transtek Medical Electronics Co.,Ltd TO: Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Regarding: Confidentiality Request regarding application for FCC ID: OU9TMB1598B2 LONG TERM CONFIDENTIALITY Pursuant to 47 CFR Section 0.459 and 0.457 of the commission’s rules, the applicant hereby request confidential treatment of the documents listed below, associated with the certification application referenced above. Schematic(s) Block Diagrams Operational Descriptions 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. Sincerely, 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]

Compliance Certification Services (Kunshan) Inc. Shenzhen Branch Page: 1 of 4 External Photos for FYCR2206000256ME Compliance Certification Services (Kunshan) Inc. Shenzhen Branch Page: 2 of 4 EUT Constructional Details (EUT Photos) Compliance Certification Services (Kunshan) Inc. Shenzhen Branch Page: 3 of 4 Compliance Certification Services (Kunshan) Inc. Shenzhen Branch Page: 4 of 4

TMB-1598-BS Model Rating: 2×AAA batteries, 3V IP Classification: IP22 Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105 ,Dongli Road, Torch Development District, 528437 Zhongshan,Guangdong,China 35.00 SN 2BS0300220600001 ----------------> SN 2BS0300220600050 FCC ID: OU9TMB1598B2 (01)XXXXXXXXXXXXXX GS1 Datamatrix (UDI) (21)2BS0300220600001 FCC STATEMENT This device complies with Part 15 of the FCC Rules. Operation is subjectto the following two conditions: (1) this device may not cause harmfulinterference, and (2) this device must accept any interference received,including interference that may cause undesired operation. SN 2022-06

Compliance Certification Services (Kunshan) Inc. Shenzhen Branch Page: 1 of 4 Internal Photos for FYCR2206000256ME Compliance Certification Services (Kunshan) Inc. Shenzhen Branch Page: 2 of 4 EUT Constructional Details (EUT Photos) Compliance Certification Services (Kunshan) Inc. Shenzhen Branch Page: 3 of 4 Compliance Certification Services (Kunshan) Inc. Shenzhen Branch Page: 4 of 4 Antenna

Compliance Certification Services (Kunshan) Inc. Shenzhen Branch Report No.: FYCR220600025603 Page: 1 of 9 Winkey Wang EMC Technical Manager 1 Cover Page RF Exposure Report Application No.: FYCR2206000256ME 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-1598-BS FCC ID: OU9TMB1598B2 Standard(s) : FCC Rules 47 CFR §2.1093 KDB 447498 D04 interim General RF Exposure Guidance v01 Date of Receipt: 2022-06-28 Date of Test: 2022-07-12 to 2022-07-21 Date of Issue: 2022-07-22 Test Result: Pass* * In the configuration tested, the EUT complied with the standards specified above. Compliance Certification Services (Kunshan) Inc. Shenzhen Branch Report No.: FYCR220600025603 Page: 2 of 9 Revision Record Version Chapter Date Modifier Remark 01 2022-07-22 Original Authorized for issue by: Tree Zhan/Project Engineer Winkey Wang/Reviewer Compliance Certification Services (Kunshan) Inc. Shenzhen Branch Report No.: FYCR220600025603 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............................................................................................................ 4 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 Report No.: FYCR220600025603 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: DC 3V Operation Frequency: 2402MHz to 2480MHz Bluetooth Version: V4.2 Modulation Type: GFSK Channel Spacing: 2MHz Number of Channels: 40 Antenna Type: PCB Antenna Antenna Gain: -3.7dBi 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. Compliance Certification Services (Kunshan) Inc. Shenzhen Branch Report No.: FYCR220600025603 Page: 5 of 9 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 Number: 718073 • Innovation, Science and Economic Development Canada Compliance Certification Services（Kunshan）Inc. Shenzhen branch has been recognized by ISED as an accredited testing laboratory. CAB identifier: CN0129. IC#: 28189. Compliance Certification Services (Kunshan) Inc. Shenzhen Branch Report No.: FYCR220600025603 Page: 6 of 9 4 FCC Radiofrequency radiation exposure limits Test exemptions apply for devices used in general population/uncontrolled exposure environments, according to the SAR-based, or MPE-based exemption thresholds. 4.1 Blanket 1 mW Blanket Exemption The 1 mW Blanket Exemption of §1.1307(b)(3)(i)(A) applies for single fixed, mobile, and portable RF sources with available maximum time-averaged power of no more than 1 mW, regardless of separation distance. The 1-mW blanket exemption a…

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Compliance Certification Services (Kunshan) Inc. Shenzhen Branch Report No.: FYCR220600025602 Page: 1 of 47 Winkey Wang EMC Technical Manager TEST REPORT Application No.: FYCR2206000256ME 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-1598-BS FCC ID: OU9TMB1598B2 Standard(s) : 47 CFR Part 15, Subpart C 15.247 Date of Receipt: 2022-06-28 Date of Test: 2022-07-12 to 2022-07-21 Date of Issue: 2022-07-22 Test Result: Pass* * In the configuration tested, the EUT complied with the standards specified above. Compliance Certification Services (Kunshan) Inc. Shenzhen Branch Report No.: FYCR220600025602 Page: 2 of 47 Revision Record Version Chapter Date Modifier Remark 01 2022-07-22 Original Authorized for issue by: Tree Zhan/Project Engineer Winkey Wang/Reviewer Compliance Certification Services (Kunshan) Inc. Shenzhen Branch Report No.: FYCR220600025602 Page: 3 of 47 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 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 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 Report No.: FYCR220600025602 Page: 4 of 47 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 ............................................................................10 6.1 ANTENNA REQUIREMENT ................................................................................................................10 6.1.1 Test Requirement: ..................................................................................................................10 6.1.2 Conclusion ..............................................................................................................................10 7 RADIO SPECTRUM MATTER TEST RESULTS .................................................................................11 7.1 CONDUCTED PEAK OUTPUT POWER ................................................................................................11 7.1.1 E.U.T. Operation .....................................................................................................................11 7.1.2 Test Mode Description ............................................................................................................11 7.1.3 Test Setup Diagram ................................................................................................................11 7.1.4 Measurement Procedure and Data .........................................................................................12 7.2 MINIMUM 6DB BANDWIDTH .............................................................................................................13 7.2.1 E.U.T. Operation .............................................…

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Compliance Certification Services (Kunshan) Inc. Shenzhen Branch Page: 1 of 3 Appendix Photographs of Test Setup for FYCR2206000256ME Compliance Certification Services (Kunshan) Inc. Shenzhen Branch Page: 2 of 3 Test Setup Photos 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