OU9TMB1583-BBlood Pressure Monitor

MEM SET START STOP version:1.0 User Manual Blood Pressure Monitor TMB-1583-BT Arm Type Thank you very much for selecting TRANSTEK Blood Pressure Monitor TMB-1583-BT. 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. Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China Table of Contents INTRODUCTION...................................................................................................................2 General Description Indications for Use Safety Information LCD Display Signal Monitor Components BEFORE YOU START...........................................................................................................8 The Choice of Power Supply Installing and Replacing the Batteries Measurement Principle Setting Date, Time, Measurement Unit and Clock Mode Select the User Pair-up the Blood Pressure Monitor with Your Device MEASUREMENT...................................................................................................................14 Tie the Cuff Start the Measurement DATA MANAGEMENT...........................................................................................................17 Recall the Records Delete the Records SPECIAL FUNCTION............................................................................................................19 About the Clock Mode About the Lock Button INFORMATION FOR USER..................................................................................................20 Tips for measurement Maintenances ABOUT BLOOD PRESSURE................................................................................................22 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 arm? TROUBLESHOOTING..........................................................................................................24 SPECIFICATIONS................................................................................................................25 AUTHORIZED COMPONENT .............................................................................................26 CONTACT INFORMATION...................................................................................................26 COMPLIED STANDARDS LIST............................................................................................27 FCC STATEMENT.................................................................................................................28 EMC GUIDANCE..................................................................................................................29 CATALOGUECATALOGUE 1 Safety Information The signs below might be in the user manual, labeling or other component. They are the requirement of standard and using. 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” Thank you for selecting TRANSTEK arm type blood pressure Monitor (TMB-1583-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-1583-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. Features: Maximum 60 records General Description For indoor use only F1T1A/250V Φ3.6*10CCC Symbol for “Class II Equipment” 3rd technonoly: Measuring during inflation (The updated technology in the world) 84mm×73 mm Digital LCD display 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 arm circumference ranging from 22 cm to 32 cm ( about 8¾ ̋-12½ ̋ ) or 22cm to 42cm(about 8¾ ̋-16½ ̋). It is intended for adult indoor use only. 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 suitable for use on pregnant women, patients with implanted, electrocical devices, patients with pre-elcampsia, 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 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. Please keep the unit out of reach of infants, children or pets, since inhalation or swallowing of small parts is dangerous or even fatal. CAUTION Caution: These notes must be observed to prevent any damage to the device. INTRODUCTION INTRODUCTION 2 3 LCD display signal SYMBOLDESCRIPTION Systolic blood pressureHigh pressure result Diastolic blood pressureLow pressure result EXPLANATION Pulse per minuteBeats per minute, BPM Memory The displayed measurement values is from the memory. mmHg kPa Measurement Unit of the blood pressure Measurement Unit of the blood pressure L…

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TMB-1583-BT Model IP Classification:IP21 2015-06 SN Rating: 4×AAA batteries, 6V AC adaptor powered mode: 6V 1A (Can be supplied by AC adaptor model KH0601000UW !) Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China Dimension：50X20mm label TMB-1583-BT Colour：black text + Pantone Reflex Blue C with silver background Material：adhesive label with water proof FCC ID:OU9TMB1583-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. TMB-1583-BT Model IP Classification:IP21 2015-06 SN Rating: 4×AAA batteries, 6V AC adaptor powered mode: 6V 1A (Can be supplied by AC adaptor model KH0601000UW !) Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China FCC ID:OU9TMB1583-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.

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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 RF exposure Estimation for TMB-1583-BT 1. Introduction TMB-1583-BT is a 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 = 0.60mW Distance = 5 mm f = 2.480 GHz [0.60/5] * SQRT(2.480) =0.16 0.16 ≤ 3.0 Therefore, excluded from SAR testing. TUV SUD China, Shenzhen Branch Reviewed by: Prepared By: Phoebe Hu/ EMC Project Manager Calvin Weng/EMC Project Engineer Date: 2015-09-25 Date: 2015-09-25

Report Number: 68.930.15.021.01 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 27 FCC- TEST REPORT Report Number : 68.930.15.021.01 Date of Issue: 25 September 2015 Model : TMB-1583-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 : 27 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: 68.930.15.021.01 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 27 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 Emission ................................................................................................................................................ 10 9.2 Conducted peak output power................................................................................................................................ 13 9.3 6dB bandwidth .......................................................................................................................................................... 14 9.4 Power spectral density ............................................................................................................................................. 16 9.5 Spurious RF conducted emissions ........................................................................................................................ 17 9.6 Band edge ................................................................................................................................................................. 21 9.7 Spurious radiated emissions for transmitter ......................................................................................................... 23 10 Test Equipment List ...................................................................................................................................................... 26 11 System Measurement Uncertainty ............................................................................................................................. 27 Report Number: 68.930.15.021.01 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 27 2 Details about the Test Laboratory Details about the Test Laboratory Test Site…

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Radiated Emission Test below 1GHz Radiated Emission Test above 1GHz Conducted Emission Test