OU9TMB1580-BBlood Pressure Monitor

User Manual Blood Pressure Monitor TMB-1580-BT To use the monitor correctly and safely, please read the manual thoroughly. Thank you very much for selecting TRANSTEK Blood Pressure Monitor TMB-1580-BT. Please keep this manual well in order to reference in future. Wrist Type Version:1.0 Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China INTRODUCTION...............................................................2 Safety Information LCD Display Signal Monitor Components BEFORE YOU START ..........................................................5 Installing and Replacing the Batteries Setting Date, Time and Measurement Unit MEASUREMENT ...............................................................12 Tie the Cuff Pair-up the Blood Pressure Monitor with Your Device Start the Measurement Select the User ID DATA MANAGEMENT16 Recall the Records Delete the Records INFORMATION FOR USER .....................................................18 Tips for Measurement Maintenance ABOUT BLOOD PRESSURE ....................................................20 What are systolic pressure and diastolic pressure? What is the standard blood pressure classification? 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 .........................................................22 SPECIFICATIONS ............................................................. ............................................................. 23 CONTACT INFORMATION ......................................................24 24 COMPLIED STANDARDS LIST FCC STATEMENT .....................................................................26 EMC GUIDANCE ......................................................27 .......................................................... General Description Indications for Use 1 CATALOGUECATALOGUE The signs below might be in the user manual, labeling or other component. They are the requirement of standard and using. Safety Information Features: Systolic blood pressure Diastolic blood pressure Pulse rate 60 records per each user Symbol for “THE OPERATION GUIDE MUST BE READ” Symbol for “MANUFACTURER” Symbol for “SERIAL NUMBER” Symbol for “TYPE BF APPLIED PARTS” Symbol for “DIRECT CURRENT” Symbol for “ENVIRONMENT PROTECTION - Electrical waste products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice” Symbol for “MANUFACTURE DATE” General Description Thank you for selecting TRANSTEK Blood Pressure Monitor (TMB-1580-BT). 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-1580-BT 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 Bluetooth Combination Mark Symbol for “Including RF transmitter” Indications for Use The Transtek Blood Pressure Monitor is digital monitors intended for use in measuring blood pressure and heartbeat rate with wrist circumference ranging from 13.5 cm to 21.5 cm ( about 5⅓ ̋-8½ ̋ ). It is intended for adult indoor use only. CAUTION This device is intended for adult use only. 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. If the cuff pressure exceeds 40 kPa (300 mmHg),the unit will automatically deflate. Should the cuff not deflate when pressures exceeds 40 kPa (300 mmHg), detach the cuff from the wrist and press the START/STOP button to stop inflation. To avoid measurement errors, carefully read this manual before using the product. The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable anesthetic mixture with air of with oxygen or nitrous oxide. The operator shall not touch output of batteries and the patient simultaneously. Do not use the monitor under the conditions of strong electromagnetic field (e.g. medical RFequipment) that radiates interference signal or electrial fast transient/ burst signal. The user must check that the equipment functions safely and see that it is in proper working condition before being used. Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the user/patients. Manufacturer will make available on request circuit diagrams, component parts list etc. This unit is not suitable for continuous monitoring during medical emergencies or operations. Otherwise, the patient’s wrist and fingers will become anaesthetic, swollen and even purple due to a lack of blood. Please use the device under the environment which was provided in the user manual. Otherwise, the performance and lifetime of the device will be impacted and reduced. During use, the patient will be in contact with the cuff. The materials of the cuff have been tested and found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any potential alergic reaction or contact injury. The device doesn’t need to be calibrated wh…

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Page 1 of 2 External Photos Details of: Overall view 1 for model TMB-1580-BT Details of: Overall view 2 for model TMB-1580-BT Page 2 of 2 Details of: Overall view 3 for model TMB-1580-BT

TMB-1580-BT Dimension：35X15mm Colour：black text with silver background Material：adhesive label with water proof 材质：25#哑银咪纳不干胶（强胶+光胶） TMB-1580-BT Model Rating:2×AAA batteries,3V Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China SN:BAXXXXXXXXXXXXD 2015-01 FCC ID: OU9TMB1580-B 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. 35.00 TMB-1580-BT Model Rating:2×AAA batteries,3V Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China SN:BAXXXXXXXXXXXXD 2015-01 FCC ID: OU9TMB1580-B 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.

TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng W isdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P. R. China Tel. +86 755 8828 6998, Fax: +86 755 8828 5299 RF exposure Estimation for TMB-1580-BT 1.Introduction TMB-1580-BT is wrist blood pressure monitor, which contain Bluetooth function inside. 2.Limit and Guidelines on Exposure to Electromagnetic Fields According to §15.247(e)(i) and §1.1307(b)(1), systems operating under the provisions of this section shall be operated in a manner that ensure that the public is not exposed to radio frequency energy level in excess of the Commission’s guideline. According to KDB 447498 D01 Mobile Portable RF Exposure v05r02, no SAR required if power is lower than the flowing threshold: The 1-g and 10-g SAR test exclusion thresholds for 100 MHz to 6 GHz at test separation distances ” 50 mm are determined by: [(max. power of channel, including tune-up tolerance, mW)/(min. test separation distance, mm)] [¥f(GHz)] ” 3.0 for 1-g SAR and ” 7.5 for 10-g extremity SAR, where • f(GHz) is the RF channel transmit frequency in GHz • Power and distance are rounded to the nearest mW and mm before calculation25 • The result is rounded to one decimal place for comparison • 3.0 and 7.5 are referred to as the numeric thresholds in the step 2 below The test exclusions are applicable only when the minimum test separation distance is ” 50 mm and for transmission frequencies between 100 MHz and 6 GHz. When the minimum test separation distance is < 5 mm, a distance of 5 mm according to 5) in section 4.1 is applied to determine SAR test exclusion. 3.Calculation method [(max. power of` channel, including tune-up tolerance, mW)/(min. test separation distance, mm)] ·[¥f(GHz)] ” 3.0 Conducted Power + tune up tolerance = 0.824mW Distance = 5 mm f = 2.480 GHz [0.824/5] * SQRT(2.480) =0.26 0.26 ” 3.0 Therefore, excluded from SAR testing. TUV SUD China,Shenzhen Branch Reviewed by: Prepared By: Phoebe Hu / EMC Project Manager Trevor You/EMC Project Engineer Date: 2015-07-06 Date: 2015-07-06

Report Number: 68.730.15.039.01 EMC_SZ_FR_21.00 FCC Release 2014-03-20 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P. R. China Tel. +86 755 8828 6998, Fax: +86 755 8828 5299 Page 1 of 24 FCC- TEST REPORT Report Number : 68.730.15.039.01 Date of Issue: 06 July 2015 Model : TMB-1580-BT Product Type : Blood Pressure Monitor Applicant : Guangdong Transtek Medical Electronics Co., Ltd Address : Zone A, No. 105 Dongli Road, Torch Development District, 528437 Zhongshan, Guangdong, PEOPLE'S REPUBLIC OF CHINA Production Facility : Guangdong Transtek Medical Electronics Co., Ltd Address : Zone B, No. 105 Dongli Road, Torch Development District, 528437 Zhongshan, Guangdong, PEOPLE'S REPUBLIC OF CHINA Test Result :  Positive  Negative Total pages including Appendices : 24 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch is a subcontractor to TÜV SÜD Product Service GmbH according to the principles outlined in ISO 17025. TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch reports apply only to the specific samples tested under stated test conditions. Construction of the actual test samples has been documented. It is the manufacturer's responsibility to assure that additional production units of this model are manufactured with identical electrical and mechanical components. The manufacturer/importer is responsible to the Competent Authorities in Europe for any modifications made to the production units which result in non-compliance to the relevant regulations. TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch shall have no liability for any deductions, inferences or generalizations drawn by the client or others from TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch issued reports. This report is the confidential property of the client. As a mutual protection to our clients, the public and ourselves, extracts from the test report shall not be reproduced except in full without our written approval. Report Number: 68.730.15.039.01 EMC_SZ_FR_21.00 FCC Release 2014-03-20 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P. R. China Tel. +86 755 8828 6998, Fax: +86 755 8828 5299 Page 2 of 24 1 Table of Contents 1 Table of Contents ................................................................................................................................................................ 2 2 Details about the Test Laboratory ..................................................................................................................................... 3 3 Description of the Equipment under Test ........................................................................................................................ 4 4 Summary of Test Standards .............................................................................................................................................. 5 5 Summary of Test Results ................................................................................................................................................... 6 6 General Remarks ................................................................................................................................................................ 7 7 Test Setups .......................................................................................................................................................................... 8 8 Systems test configuration ................................................................................................................................................. 9 9 Technical Requirement .................................................................................................................................................... 10 9.1 Conducted peak output power................................................................................................................................ 10 9.2 6dB bandwidth .......................................................................................................................................................... 11 9.3 Power spectral density ............................................................................................................................................. 13 9.4 Spurious RF conducted emissions ........................................................................................................................ 14 9.5 Band edge ................................................................................................................................................................. 18 9.6 Spurious radiated emissions for transmitter ......................................................................................................... 20 10 Test Equipment List ...................................................................................................................................................... 23 11 System Measurement Uncertainty ............................................................................................................................. 24 Report Number: 68.730.15.039.01 EMC_SZ_FR_21.00 FCC Release 2014-03-20 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P. R. China Tel. +86 755 8828 6998, Fax: +86 755 8828 5299 Page 3 of 24 2 Details about the Test Laboratory Details about the Test Laboratory Test Site 1 Company name: TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan Distric…

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Page 1 of 1 Test Setup Photo Radiated Emission Test (below 1G) Radiated EmissionTest(above 1G)