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Related Manuals for TRANSTEK Medel Soft TMB-1581-S
Summary of Contents for TRANSTEK Medel Soft TMB-1581-S
- Page 1 USER MANUAL Wrist blood pressure monitor MEDEL SOFT Model: TMB-1581-S...
- Page 2 SYSTOLIC LCD DISPLAY DIASTOLIC GRADE PULSE RATE MEM BUTTON START/STOP BUTTON SET BUTTON...
- Page 6 )DISPLAY SYMBOL )PIC. 3 SYMBOL DESCRIPTION EXPLANATION Systolic blood pressure High blood pressure Dystolic blood pressure Low blood pressure Pulse display Pulse in bests per minutes Excessive Body Motion Motion may result in an inaccura- Detector te measurement Low battery Batteries are running low and need to be replaced mmHg...
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Page 7: Measurement Principle
CONTRAINDICATION 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. MEASUREMENT PRINCIPLE This product uses the Oscillometric Measuring Method to detect blood pressure. - Page 8 * The device doesn’t need to be calibrated within two years of reliable service. * 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...
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Page 9: List Of Accessories
The device must only be serviced, repaired and opened by individuals at authorized sales/service centers. * Please report to Transtek if any unexpected operation or events occur. * Keep the unit out of reach of infants, young children or pets to avoid inhalation or swallowing of small parts. -
Page 10: Before You Start
3. BEFORE YOU START 3.1 INSTALLING AND REPLACING THE BATTERIES )PIC. 2) Slide off the battery cover. Install the batteries by matching the correct polarity, as show pic. 2. Always use the correct battery type (2 x AAa batteries). Replace the battery cover. 3.2 SETTING DATE, TIME AND MEASUREMENT UNIT )PIC. -
Page 11: Start The Measurement
3.3 TIE THE CUFF Remove all accessories (watch, bracelet,etc) from your wrist. If your physician has diagnosed you with poor circulation in your wrist, use the other one. Roll or push up your sleeve to expose the skin. Apply the cuff to your wrist with your palm facing up. Position the edge of the cuff about 1cm~1.5cm from wrist joints. -
Page 12: Delete The Records
next record,and so on. During the process of displaying the results, if there is no operation, the blood pressure monitor will turn off in one minute. Or you can press “START/STOP” button to turn it off. (pic. 6.B). It means the total The corresponding The corresponding records is 5, the... - Page 13 6. ABOUT BLOOD PRESSURE 6.1 WHAT ARE SYSTOLIC PRESSURE AND DIASTOLIC PRESSURE? When ventricles contract and pump blood out of Systolic Diastolic the heart, blood pressure reaches its maximum blood entering blood discharging vein artery value, the highest pressure in the cycle is known as systolic pressure.
- Page 14 6.3 IRREGULAR HEARTBEAT DETECTOR An irregular heartbeat is detected when a heartbeat rhythm varies while the device is measuring systolic pressure and diastolic pressure. During each measurement, blood pressure monitor will keep a record of all the pulse intervals and calculate the average value of them. If there are two or more pulse intervals , the difference between each interval and the average is more than the average value of ±25% , or there are four or more pulse intervals ,the difference between each interval and the average is more...
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Page 15: Specification
8. SPECIFICATION Power supply Battery powered mode: 2*AAA batteries Display mode Digital LCD V.A.32mmx45mm Measurement mode Oscillographic testing mode Rated cuff pressure: 0mmHg~299mmHg)0kPa ~ 39.9kPa( Measurement range Measurement pressure: SYS: 60mmHg~230mmHg )8.0kPa~30.7kPa( DIA: 40mmHg~130mmHg )5.3kPa~17.3kPa( Pulse value: )40-199(beat/minute Pressure:5°C-40°C within±3mmHg)0.4kPa( Accuracy Pulse value:±5% A temperature range of :+5°C to +40°C... -
Page 16: Warranty Conditions
9.WARRANTY CONDITIONS • The device is guaranteed for 5 years from the date of original purchase against any defect in materials or workmanship. • The warranty consists in the replacement and/or repair, free of charge, of originally defective components. • The warranty does not cover the accessories supplied and the parts subject to normal wear and tear. - Page 17 10. REFERENCE TO STANDARD 10.1 COMPLIED LIST EN ISO 14971:2012 / ISO 14971:2007 Medical devices - Risk management Application of risk management to medical devices EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices. Symbols to be used with medical device labels, labelling and Labeling information to be supplied.
- Page 18 12. EMC Guidance 1)This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information pro- vided, and this unit can be affected by portable and mobile RF communications equipment. 2)* Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit.
- Page 19 Table 2 Guidance and manufacturer’s declaration – electromagnetic immunity 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 . Electromagnetic Immunity test IEC 60601 test level...
- Page 20 Table 3 Guidance and manufacturer’s declaration – electromagnetic immunity 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. Immunity test IEC 60601 Compliance Electromagnetic environment - guidance...
- Page 21 Table 4 Recommended separation distances between portable and mobile RF communications equipment and the device. The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment )transmittters( and the device as recommended below, according to the maximum output power of the communications equipment.
- Page 22 Table 5 Guidance and manufacturer’s declaration - electromagnetic immunity 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. IMMUNITY Radiated RF Test Band a(...
- Page 24 Manufacturer: Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105 ,Dongli Road, Torch Deve- lopment District, Zhongshan,528437 Guang- dong,China MDSS - Medical Device Safety Service GmbH EC REP Schiffgraben 41, 30175 Hannover- Germany Distributed by: Medel International Srl Via Villapizzone 26 - 20156 Milano / Italy...
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