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Guangdong Transtek Medical Electronics Co., Ltd.
Zone B, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
User Manual
Wrist Blood Pressure Monitor TMB-1014-BS
Thank you very much for selecting TRANSTEK Wrist Blood Pressure Monitor
TMB-1014-BS.
To use the monitor correctly and safely, please read the manual thoroughly.
Please keep this manual well in order to reference in future.
Version:1.0
Wrist Type
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Summary of Contents for TRANSTEK TMB-1014-BS
- Page 1 Version:1.0 User Manual Wrist Blood Pressure Monitor TMB-1014-BS Wrist Type Thank you very much for selecting TRANSTEK Wrist Blood Pressure Monitor Guangdong Transtek Medical Electronics Co., Ltd. TMB-1014-BS. Zone B, No.105 ,Dongli Road, Torch Development District, To use the monitor correctly and safely, please read the manual thoroughly.
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Page 2: Table Of Contents
CATALOGUE INTRODUCTION ..................... General Description Indications for Use Contraindications Measurement Principle Safety Information LCD Display Symboll Monitor Components List BEFOREYOU START ..................Installing and Replacing the Batteries Setting Date, Time and Measurement Unit Select the User ID Pair-up the Blood Pressure Monitor with Your Device MEASUREMENT .................... -
Page 3: Introduction
The design provides you with two years of reliable such as cardiac pacemakers, defibrillators. service. Readings taken by the TMB-1014-BS are equivalent to those obtained by a Measurement Principle trained observer using the cuff and stethoscope auscultation method. -
Page 4: Safety Information
INTRODUCTION INTRODUCTION Safety Information CAUTION The signs below might be in the user manual, labeling or other component. * This device is intended for adult use in homes only. They are the requirement of standard and using. * 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, Symbol for “THE OPERATION Symbol for “TYPE BF APPLIED... - Page 5 INTRODUCTION INTRODUCTION CAUTION CAUTION * The patient can measure data and change batteries under normal circumstances and maintain the device *On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, open the cuff and its accessories according to the user manual. immediately.
- Page 6 * If you have any problems with this device, such as setting up, maintaining or using, please contact the SERVICE PERSONNEL of Transtek. Don’t open or repair the device by yourself in the event of malfunctions. The device must only be serviced, repaired and opened by individuals at authorized sales/service centers.
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Page 7: Lcd Display Symboll
INTRODUCTION INTRODUCTION Monitor Components SYMBOL DESCRIPTION EXPLANATION Time Hour:Minute (Month/Day/Year) Blood pressure monitor is detecting an IHB Detector irregular heartbeat during measurement. Bluet ooth Successful Bluetooth Connection MEM/UP Error Data communication has failed SYSTOLIC BUTTON User ID The selected User ID DIASTOLIC Memory Indicate it is in the memory mode... -
Page 8: List
• Replacing the battery door. 5. Cuff. BATTERY COMPARTMENT List 1) Wrist Blood Pressure Monitor TMB-1014-BS 2) 2×AAA Batteries 3) User manual The typical service life of the new and unused batteries is 138 measurements for the operation time is 60s. - Page 9 BEFORE YOU START BEFORE YOU START Setting Date and Time Replace the batteries whenever the below happen Please proceed to time setting before your initial use so as to ensure each piece of record are labled with a time stamp. shows (Year Range: 2018-2058;...
- Page 10 BEFORE YOU START BEFORE YOU START 3.When you get the right hour,Press “SET” button again to confirm [HOUR]. Then it will 5.Repeat step 2 and 3 to confirm [MONTH], [DAY] and [YEAR]. turn to the next step. 4.Repeat step 2 and 3 to confirm [MINUTE]. 6.After confirming [YEAR], the LCD will display “donE”...
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Page 11: Select The User Id
BEFORE YOU START BEFORE YOU START Pair-up the Blood Pressure Monitor Select the User ID with Your Device Before you start the measurement, please select the suitable user ID first. 1.When the blood pressure monitor is off, press the 1.Turn on Bluetooth and the app. Make sure both are ON when pair-up is proceeding. MEM button for 3 seconds, then the user ID will blink. -
Page 12: Measurement
BEFORE YOU START MEASUREMENT Tie the Cuff Remove all accessories (watch, bracelet,etc) from your wrist. If your physician has diagnosed you with If FAIL , the symbol “ ” will be shown on the LCD. poor circulation in your wrist, use the other one. Roll or push up your sleeve to expose the skin. -
Page 13: Start The Measurement
MEASUREMENT MEASUREMENT Start the Measurement 2.This device will proceed to data transmission after measurement. The Bluetooth symbol 1.When the monitor is off, press the START/STOP button START will blink. to turn on the monitor, and it will finish the whole STOP measurement.(Take user 1 for example.) Adjust to zero. -
Page 14: Data Management
Interference may occur in the vicinity of equipment marked with the following symbol . And 2. Press “MEM” button or “SET” button to rotate the history TMB-1014-BS may interfering vicinity electrical equipment. records.“MEM” to go forward;“SET” to go backward. Sensitive people, including pregnant women pre-eclamptic and those who implanted medical electronic instruments, should avoid using the unit whenever possible. -
Page 15: Deleting The Records
INFORMATION FOR USER DATA MANAGEMENT Deleting the Records Tips for Measurement ABOUT BLOOD PRESSURE If you did not get the correct measurement, you can delete all results Measurements may be inaccurate if taken in the following circumstances. by following steps below. 1.Hold pressing “MEM”... -
Page 16: What Are Systolic Pressure And Diastolic Pressure
ABOUT BLOOD PRESSURE INFORMATION FOR USER What are systolic pressure and diastolic pressure? Maintenance When ventricles contract and pump blood out of the heart, blood pressure reaches its maximum To obtain the best performance, please follow the instructions below. value, the highest pressure in the cycle is known as systolic pressure. When the heart relaxes between heartbeats, the lowest blood pressure is diastolic pressure. - Page 17 ABOUT BLOOD PRESSURE ABOUT BLOOD PRESSURE Why does my blood pressure fluctuate throughout the day? Irregular Heartbeat Detector 1. Individual blood pressure varies multiple times everyday. It is also An irregular heartbeat is detected when a heartbeat rhythm varies while the device is measuring affected by the way you tie your cuff and your measurement position, so systolic pressure and diastolic pressure.
- Page 18 TROUBLESHOOTING TROUBLESHOOTING This section includes a list of error messages and frequently PROBLEM SYMPTOM CHECK THIS REMEDY asked questions for problems you may encounter with your blood pressure monitor. If the products not operating as you think it Make sure that phone’s Bluetooth is on or Data communication Error + should, check here before arranging for servicing.
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Page 19: Specifications
EMC GUIDANCE SPECIFICATIONS SPECIFICATIONS Power supply Battery powered mode: 2*AAA batteries Mode of operation Continuous operation Display mode Digital LCD V.A.36mmx41mm Degree of protection Type BF applied part Measurement mode Oscillographic testing mode Device Classification Internally Powered ME Equipment Rated cuff pressure: 0mmHg~299mmHg(0kPa ~ 39.9kPa) Measurement range IP22: The first number 2: Protected against solid foreign... -
Page 20: Contact Information
FCC Statement FCC ID:OU9TMB1014BS For more information about our products, please visit www.transtek.cn.you can get customer service, usual problems and customer download, transtek will serve you anytime. 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. -
Page 21: Complied Standards List
COMPLIED STANDARDS LIST COMPLIED STANDARDS LIST Complied Standards List EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood EN ISO 14971:2012 / ISO 14971:2007 Medical devices - Risk management pressure measuring systems Application of risk management to medical devices IEC 80601-2-30:2009+A1:2013 Medical electrical equipment- Part 2-30: Particular requirements for the basic safety and EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices. -
Page 22: Emc Guidance
EMC GUIDANCE EMC GUIDANCE Table 1 EMC Guidance Guidance and manufacturer’s declaration – electromagnetic emissions 1)This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. - Page 23 EMC GUIDANCE EMC GUIDANCE Table 2 Guidance and manufacturer’s declaration – electromagnetic immunity Voltage dips, 0.5 cycle 0% U ; 0.5 cycle Mains power quality should be short interruptions At 0°, 45°, 90°, 135°, At 0°, 45°, 90°, 135°, that of a typical commercial or 180°,225°,270°...
- Page 24 EMC GUIDANCE EMC GUIDANCE Table 5 Table 3 determined by an Guidance and manufacturer’s declaration – electromagnetic immunity electromagnetic site The device is intended for use in the electromagnetic environment specified below. The customer or the survey, should be less user of the device should assure that it is used in such an environment.
- Page 25 Table 5 EMC GUIDANCE EMC GUIDANCE Table 4 Recommended separation distances between portable and mobile RF communications Guidance and manufacturer’s declaration - electromagnetic immunity equipment and the device. The device is intended for use in an electromagnetic environment in which radiated RF disturbances are The device is intended for use in the electromagnetic environment specified below.
- Page 26 Table 5 EMC GUIDANCE GSM 1800; Pulse 1720 1700- CDMA 1900; modulation b) 1990 GSM 1900; 217Hz 1845 DECT; LTE Band 1, 3, 1970 4,25; UMTS Pulse Bluetooth, 2450 2400- modulation b) WLAN, 2570 217 Hz 802.11 b/g/n, RFID 2450, LTE Band 7 5240 5100-...
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