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Safety Information

The below signs might be in the user manual, labeling or other component. 

They are the requirement of standard and using.

INTRODUCTION

INTRODUCTION

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General Description

Thank you for selecting TRANSTEK arm type blood pressure Monitor (TMB-986). 

The monitor features blood pressure measurement, pulse rate measurement and the 

result storage. The design provides you with two years of reliable service.

Reading taken by the TMB-986 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 instruction for using the product.

Read the manual thoroughly before using the product.

Features:

128*50mm Digital LCD display

Touch sensor key

Two users for choice

Maximum 60 records per user

Measuring during inflation technology

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 arm 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 based solely 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.

When the device was used to measure patients who have common arrhythmias such as atrial or 

ventricular premature beats or artrial fibrillation, the best result may occure deviation. Please 

consult your physician about the result.

If the cuff pressure exceeds 300 mmHg, the unit will automatically deflate. Should the cuff not 

deflate when pressures exceeds 300 mmHg, detach the cuff from the armand press the 

START/STOP button to stop inflation.

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.

To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated 

interference signal or electrical 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.

This device is contraindicated for any female who may be suspected of, or is pregnant. Besides 

provided inaccurate readings, the affects of this device on the fetus are unknown.

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 arm 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 been impacted and reduced.

During using, the patient will 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 sensization or irritation reaction.

Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE. 

Otherwise, it may cause damage to the unit or danger to the user/patients.

The device doesn’t need to be calibrated in two years of reliable service.

Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the 

local guidelines.

If you have any problems with this device, such as setting up, maintaining or using, please 

contact with SERVICE PERSONNEL of Transtek. Don’t open or repair the device by yourself. 

Please report to Transtek if any unexpected operation or events occur.

Please use the soft cloth to clean the whole unit. Don’t use any abrasive or volatile cleaners. 

CAUTION

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 - Wast electrical 

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”

Symbol for “COMPLIES WITH

MDD 93/42/EEC REQUIREMENTS”

EC REP

Symbol for “Authorised Representative 

in the European Community

Caution: These notes must be observed 

to prevent any damage to the device

Summary of Contents for TMB-986

Page 1: ...ual carefully and thoroughly so as to ensure the safe usage of this product and keep the manual well for further refer ence in case you have problems GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO LTD Address Zone A No 105 Dongli Road Torch Development District Zhongshan 528437 Guangdong China EC REP IFU TRANSTEK TMB986EN 2016_02 TMB 986 英文说明书 A0 印色 单黑 材质 80G书纸 尺寸 170 120mm ...

Page 2: ...ATION FOR USER 14 Tips for measurement Maintenances ABOUT BLOOD PRESSURE 16 What are systolic pressure and diastolic pressure What is the standard blood pressure classification Why does my blood pressure fluctuate throughout the day Why the blood pressure I get from the hospital is different from home If the result is the same if measuring on the right arm TROUBLESHOOTING 18 SPECIFICATIONS 19 CONT...

Page 3: ...ent errors please avoid the condition of strong electromagnetic field radiated interference signal or electrical 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 This device is contraindicated for any female who may be suspected of or is pregnant Besides provided inaccurate readings the affects of t...

Page 4: ...ime hour minute Currently time Memory If M shows the displayed measurement values is from the memory mmHg Measurement Unit of the blood pressure 1mmHg Low battery Batteries are low and need to be replaced Shocking remainding Shocking will result in inaccurate Average The average of blood pressure Recalling The erecords will be showed Irregular heartbeat Irregular heartbeat User A The User A is cho...

Page 5: ...e off the battery cover 2 Install the batteries by matching the correct polarity as shown 3 Replace the cover Remove batteries if the device is not likely to be used for some time The old batteries are harmful to the environment so please disposal with other daily trash Remove the old batteries from the device and follow your local recycling guidelines CAUTION Replace the batteries whenever the be...

Page 6: ...Repeat step 2 and 3 to set the HOUR and MINUTE START STOP START STOP START STOP START STOP START STOP START STOP START STOP START STOP BEFORE YOU START BEFORE YOU START 6 After confirming the minute the LCD will display dOnE and the monitor will shut off ...

Page 7: ...ke daily measurements at approximately the same time on the same arm or as directed by a physician Tie the Cuff 1 Tie the cuff on your upper arm the position the tube off center toward the inner side of arm in line with the little finger 2 The cuff should be sung but not too tight You should be able to insert one fingers between the cuff and your arm 3 Sit comfortably with your arm resting on a fl...

Page 8: ...s 1 Please choose the user A or user B when the blood pressure monitor turns off and press the MEM to show the average of the last 3 records The sign of AVG will show in the right corner 2 Press the MEM or SET to get the record you want The most recent record 1 is shown first Each new measurement is assigned to the first 1 record All other records are pushed back one digit e g 2 becomes 3 and so o...

Page 9: ... or moving your fingers When you want to discharge urine 15 14 Maintenance In order to get the best performance please follow the below instructions Put in a dry place and avoid the sunshine Avoid the intense shaking and collision Using the wet clothing to remove the dirt Avoid touching water clean it with a dry cloth in case Avoid the dusty and unstable temperature environment Avoid washing the c...

Page 10: ...y a physician could tell whether your blood pressure value has reached a dangerous point The blood pressure classification published by World Health Organization WHO and International Society of Hypertension ISH in 1999 is as follows SYS DIA 120 80 120 129 80 84 130 139 85 89 140 159 90 99 160 179 100 109 180 110 Level Blood Pressure mm Hg Optimal Normal High normal Mild Moderate Severe CAUTION 1 ...

Page 11: ...shows on the display A calibration error occurred Retake the measurement If the problem persists contact the retailer or our customer service department for further assistance Refer to the warranty for contact information and return instructions E21 shows The treatment of the measurement failed Relax for a moment and then measure again Display is dim or shows Power supply Battery powered mode 4 AA...

Page 12: ...s Part 4 Test procedures to determine the overall system accuracy of automated non invasive sphygmomanometers EN 60601 1 6 2010 Medical electrical equipment Part 1 6 General requirements for basic safety and essential performance Collateral standard Usability EN 62366 2008 Medical devices Application of usability engineering to medical devices EN 62304 2006 AC 2008 Medical device software Software...

Page 13: ...NG Guidance and manufacturer s declaration electromagnetic immunity IMMUNITY test Not applicable 3 V m Compliance level IEC 60601 TEST LEVEL Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 Vrms 150 kHz to 80 MHz Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the device including cables than...

Page 14: ...ters and the device as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of th...

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