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Guangdong Transtek Medical Electronics Co., Ltd.
Document
文件名称：
Document
文件编号：
版本号：
页码：
Prepared 编制
Revision History 修订履历
◆
Date
NO.
日期
A/0
2023/07/27
A/1
2023/09/07
广东乐心医疗电子股份有限公司
Name:
No
Rev.:
Page:
Update Description
变更描述
Initial release
Update EC-Representative
User manual
LS-IFU-TMB-2296-B
A/1
共29页
Reviewed 审核
Approved 批准
Prepared
Reviewed
编制
审核
李鑫
胡婉
Celia Li
Nicole Hu
李鑫
胡婉
Celia Li
Nicole Hu
Approved
批准
罗志强
Zhiqiang Luo
罗志强
Zhiqiang Luo
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Summary of Contents for TRANSTEK TMB-2296-B
- Page 1 Guangdong Transtek Medical Electronics Co., Ltd. 广东乐心医疗电子股份有限公司 Document Name: User manual 文件名称： Document LS-IFU-TMB-2296-B 文件编号： Rev.: 版本号： Page: 共29页 页码： Prepared 编制 Reviewed 审核 Approved 批准 Revision History 修订履历 ◆ Date Update Description Prepared Reviewed Approved 日期 变更描述 编制 审核...
- Page 2 Model: TMB-2296-B Blood Pressure Monitor Arm Type Guangdong Transtek Medical Electronics Co., Ltd. Thank you very much for selecting TRANSTEK Blood Pressure Monitor Zone A, No.105, Dongli Road, Torch Development TMB-2296-B. District, 528437 Zhongshan, Guangdong, China Please do read the user manual carefully and thoroughtly so as to ensure...
- Page 3 CATALOGUE Table of Contents INTRODUCTION........................2 General Description Indications for Use Measurement Principle Receiving and Inspecting your Monitor Safety Information LCD Display Signal Name of Each Part Contents/Product Includes BEFORE YOU START......................8 Power Supply and Charge Power Activate Your Blood Pressure Monitor Pair a smart device with the monitor MEASUREMENT........................13 Tie the Cuff...
- Page 4 They are the requirement of standard and using. The monitor features blood pressure measurement, pulse rate measurement and the result storage. The warranty period is two years. Readings taken by the TMB-2296-B are equivalent to those obtained by Type BF applied part Manufacturer a trained observer using the cuff and stethoscope auscultation method.
- Page 5 INTRODUCTION INTRODUCTION Precaution Warning * This device is intended for indoor, home use and is not intended for self-use in public areas. * This device is portable, but it is not intended for use during patient transport. * Do not apply the cuff on an arm that has an intravenous drip or a blood transfusion attached. * Taking blood pressure measurements too frequently could disrupt blood circulation and cause injuries.
- Page 6 The cuff is secured. Pulse rate Pulse rate dectetion during measurement Contents/Product Includes Hand shaking Hand shaking makes results inaccurate • Blood Pressure Monitor (TMB-2296-B) Battery Indicator Indicate the current battery • Cuff (Type BF applied part) Irregular pulse rate Irregular pulse rate...
- Page 7 When powering on the monitor, the LCD doesn’t light up. Activate Your Blood Pressure Monitor CAUTION The battery of TMB-2296-B is built-in rechargeable lithium-ion battery, When you get the Blood Pressure Monitor, the first thing you must do please do not disassemble it by the unauthorized maintenance personel.
- Page 8 When the monitor is off, press and hold the “START/STOP” button to 2. Interference may occur in the vicinity of equipment marked with the following symbol And TMB-2296-B may interfere the vicinal electrical equipment. start pair-up, the bluetooth symbol will flash.
- Page 9 MEASUREMENT BEFORE YOU START Tie the Cuff Setting a user ID Only use a cuff that has been approved by the manufacturer for this device model. There are 2 user ID available. User 1 and User 2, each with 199 memory Before use, please confirm if it fits your arm circumference.
- Page 10 MEASUREMENT MEASUREMENT Start the Measurement You can use your monitor without pairing to a smart device. To pair your 2. Press the button to turn off the monitor, or it will shut off within monitor with a smart device refer to the foregoing chapters. about 1 minute.
- Page 11 MEASUREMENT MEASUREMENT Tips for Measurement 4. About the irregular pulse rate and excessive body motion during the measurement. Measurements may be inaccurate if taken in the following During a measurement, If an irregular pulse rate is detected, the symbol circumstances. will display in the measurement result.
- Page 12 INFORMATION FOR USER ABOUT BLOOD PRESSURE What are systolic pressure and diastolic pressure? Maintenance When ventricles contract and pump blood out of the Systolic Diastolic heart, the blood pressure reaches its maximum value In order to get the best performance, please follow the blood discharging blood entering vein...
- Page 13 TROUBLESHOOTING ABOUT BLOOD PRESSURE Why does my blood pressure If any abnormality arises during use, please check the following points: fluctuate throughout the day? PROBLEM SYMPTOM CHECK THIS REMEDY 1. Individual blood pressure varies multiple times everyday. It is also affected by the Batteries are depleted.
- Page 14 Mode of operation Continuous operation Degree of protection Manufactured by: Guangdong Transtek Medical Electronics Co., Ltd. Type BF applied part Protection against Company: IP22 It means the device could be protected against Guangdong Transtek Medical Electronics Co., Ltd.
- Page 15 Pulse: ±5% RF emissions Group 1 CISPR 11 The Basis Safety of the Blood Pressure Monitor (TMB-2296-B) is as following: RF emissions Deviation from normal operation that poses an unacceptable risk to the patient or Class [ B ] CISPR 11 operator.
- Page 16 EMC GUIDANCE EMC GUIDANCE Table 3 Table 2 Guidance and manufacturer’s declaration – electromagnetic Immunity Guidance and manufacturer’s declaration - electromagnetic Immunity Compliance IEC 60601-1-2 Immunity Test Radiated RF Test Band Service Modulation Distance Maximum Compliance level 60601-1-2 level Test level IEC61000-4-3 Frequency (MHz)
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