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Table of Contents

INTRODUCTION...................................................................................................................2

General Description

Indications for Use

Contraindications

Measurement Method

Safety Information

LCD Display

Monitor Components

List

BEFORE YOU START...........................................................................................................9

Power Supply

Installing and Replacing the Batteries

MEASUREMENT...................................................................................................................10

Tie the Cuff

Start the Measurement

DATA MANAGEMENT..........................................................................................................12

Recall the records

Pair up the Blood Pressure Monitor with Your Device

Data Transmission

INFORMATION FOR USER................................................................................................ 15

Tips for measurement

Maintenances

ABOUT BLOOD PRESSURE..............................................................................................17

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........................................................................................................19

SPECIFICATIONS...............................................................................................................20

AUTHORIZED COMPONENT ............................................................................................21

CONTACT INFORMATION..................... ...........................................................................21

COMPLIED STANDARDS LIST...........................................................................................22

FCC STATEMENT................................................................................................................23

EMC GUIDANCE.................................................................................................................24

CATALOGUE

Содержание TMB-995-BT

Страница 1: ...Monitor TMB 995 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 ...

Страница 2: ...th Your Device Data Transmission INFORMATION FOR USER 15 Tips for measurement Maintenances ABOUT BLOOD PRESSURE 17 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 TR...

Страница 3: ... 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 The Transtek Blood Pressure Monitor is digital monitors intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22cm to 42cm about 8 16 It...

Страница 4: ...ecome anaesthetic swollen and even purple due to a lack of blood When not in use store the device with the adapter in a dry room and protect it against extreme moisture heat lint dust and direct sunlight Never place any heavy objects on the storage case This device may be used only for the purpose described in this booklet The manufacturer cannot be held liable for damage caused by incorrect appli...

Страница 5: ...luer lock connectors are used in the construction of tubing there is a possibility that they might be inadvertently connected to intravascular fluid systems allowing air to be pumped into a blood vessel Please use the device under the environment which was provided in the user manual Otherwise the performance and lifetime of the device will be impacted and reduced 6 7 INTRODUCTION LCD display sign...

Страница 6: ...uff Type BF applied part 22cm 42cm 3 4 AA batteries Please use TRANSTEK authorized cuff The size of the actual cuff please refer to the label on the attached cuff Component list of pressure measuring system 1 Cuff 2 Air pipe 3 PCBA 4 Pump 5 Valve AIR HOSE AIR CONNECTOR PLUG LCD DISPLAY START STOP 5 AC Adaptor KH0601000UW CUFF The Choice of Power Supply 1 Battery powered mode 6VDC 4 AA batteries 2 ...

Страница 7: ...and take 5 6 deep breaths Rest for 5 minutes before first measuring Wait at least 3 minutes between measurements This allows your blood circulation to recover The patient must relax as much as possible and do not move and talk during the measurement procedure For a meaningful comparison try to measure under similar conditions For example take daily measurements at approximately the same time on th...

Страница 8: ...cord 1 is shown first Each new measurement is assigned to the first 1 record All other records are pushed one digit e g 2 becomes 3 and so on and the last record 60 CAUTION Pair up the Blood Pressure Monitor with Your Device 1 Turn on Bluetooth and the app Make sure both are on when pair up is proceeding 2 When the monitor is off press and hold the START STOP button to start pair up The symbol and...

Страница 9: ... 20 centimeters away from the human body especially the head when the data transmission is proceeding after measurement To enable the data transmission function this product should be paired to Bluetooth end at 2 4 GHz How to mitigate possible interference The range between the device and BT end should be reasonably close from 1 meter to 10 meters Please ensure no obstacles between the device and ...

Страница 10: ...ac examination but serves to detect pulse irregularities at an early stage Only a physician can tell your normal BP range Please contact a physician if your measuring result falls out of the range Please note that only a physician can tell whether your blood pressure value has reached a dangerous point The chart on the right is the standard blood pressure classification published by American Heart...

Страница 11: ...ed questions for problems you may encounter with your blood pressure monitor If the products not operating as you think it should check here before arranging for servicing TROUBLESHOOTING PROBLEM SYMPTOM CHECK THIS REMEDY No power Low batteries Error message Display will not light up Batteries are exhausted Replace with new batteries Insert the batteries correctly Replace with new batteries Batter...

Страница 12: ...ly Powered ME Equipment AC Adaptor Powered Mode Class II ME Equipment IP21 It means the device could protected against solid foreign objects of 12 5mm and greater and protect against vertically falling water drops Pressure 5 40 within 3mmHg 0 4kPa pulse value 5 A temperature range of 5 C to 40 C A relative humidity range of 15 to 90 non condensing but not requiring a water vapour partial pressure ...

Страница 13: ... 1 General requirements IEC 80601 2 30 2013 Medical electrical equipment Part 2 30 Particular requirements for the basic safety and essential performance of automated non invasive sphygmomanometers ISO 81060 2 2013 Non invasive sphygmomanometers Part 2 Clinical validation of automated measurement type EN 60601 1 2 2007 IEC 60601 1 2 2007 Medical electrical equipment Part 1 2 General requirements f...

Страница 14: ...will be used Guidance and manufacturer s declaration electromagnetic immunity IMMUNITY test 6 kV contact 8 kV air 6 kV contact 8 kV air 2 kV for power supply lines 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 3A m NOTE UT is the a c mains voltage prior to application of the test level Table 2 Guidance and MANUFACTURER ...

Страница 15: ... RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the device Over the frequency range 150 kH...

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