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Guangdong Transtek Medical Electronics Co., Ltd.

Zone A, No.105 ,Dongli Road, Torch Development District, 
Zhongshan,528437,Guangdong,China  

EC REP

version:1.0

User Manual

           SAMSUNG ARM BPM 

EI-B5000

Thank you very much for selecting SAMSUNG  ARM BPM EI-B5000.

To use the monitor correctly and safely, please read the manual thoroughly.

Please keep well this manual in order to reference in future.

Arm Type

CATALOGUE

 

Table of Contents

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

General Description
Indications for Use
Contraindications
Measurement Principle
Safety Information
LED Display Signal
Components of the Device
List

 
BEFORE YOU START...........................................................................................................8

The Choice of Power Supply
Installing and Replacing the Batteries

      Install the App and Pair-Up
     Search your test information 

D

MEASUREMENT..................................................................................................................11

Tie the Cuff
Taking a Measurement

INFORMATION 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?
Irregular heartbeat detector
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.........................................................................................................18
SPECIFICATIONS................................................................................................................19
CONTACT INFORMATION...................................................................................................20
FCC STATEMENT...................................................................................................
COMPLIED STANDARDS LIST...........................................................................................21
EMC GUIDANCE.................................................................................................................22

CATALOGUE

1

Summary of Contents for ARM BPM

Page 1: ...nal Components of the Device List BEFORE YOU START 8 The Choice of Power Supply Installing and Replacing the Batteries Install the App and Pair Up Search your test information D MEASUREMENT 11 Tie the Cuff Taking a Measurement INFORMATION FOR USER 14 Tips for measurement Maintenances ABOUT BLOOD PRESSURE 16 What are systolic pressure and diastolic pressure What is the standard blood pressure class...

Page 2: ...uthority or retailer for recycling advice Caution These notes must be observed to prevent any damage to the device SN Symbol for MANUFACTURE DATE Symbol for Authorised Representative in the European Community EC REP CAUTION This device is intended for adult use in homes only The device is not suitable for use on neonatal patients pregnant women patients with implanted electronical devices patients...

Page 3: ...nd charge power under normal circumstances and maintain the The service life of the cuff may vary by the frequency of washing skin condition and storage state The typical service life is 10000 times It is recommended that the performance should be checked every 2 years and after maintenance and repair by retesting at least the requirements in limits of the error of the cuff pressure indication and...

Page 4: ...OCUMENTS Wireless communications equipment such as wireless home network devices mobile phones cordless telephones and their base stations walkie talkies can affect this equipment and should be kept at least a distance d away from the equipment The distance d is calculated by the MANUFACTURER from the 80MHz to 5 8 GHz column of Table 4 and Table 9 of IEC 60601 1 2 2014 as appropriate Please use AC...

Page 5: ...to the environment Do not dispose with daily garbage Remove the old batteries from the device following your local recycling guidelines Install the App and Pair Up Download the SAMSUNG HEALTH app from APP Store or Google Play Install the APP and register an account Click Manage items add Blood pressure and then click Save Click choose Accessories click Scan for accessories and add Samsung Arm Bpm ...

Page 6: ...y Range 2402MHz to 2480MHz Output Power Range 0 dBm Supply Voltage 4 0 7 2V Transmitting Distance 10 meters Settinging the User 1 When the monitor is off press the START STOP button to turn on the monitor and it will show the current user Long press the START STOP button agin to switch the user There are 3 user intotal and guest mode User mode store 60 grops message guest mode doesn t store messag...

Page 7: ...e daily measurements at approximately the same time on the same arm or as directed by a physician Take the measurement in a silent room The cuff should maintain at the same level as the right atrium of the heart Please sit comfortably Do not cross your legs and keep your feet flat on the ground Keep your back against the backrest of the chair Tip You can press START STOP button at any time to stop...

Page 8: ...g When talking or moving your fingers When you want to discharge urine Maintenance In order to get the best performance please follow the instructions below Put in a dry place and avoid the sunshine Avoid intense shaking and collisions Using wet cloths to remove dirt Avoid touching water clean it with a dry cloth in case Avoid dusty and unstable temperature environment Avoid washing the cuff 15 14...

Page 9: ...me if measuring on the right arm Why do I get a different blood pressure at home compared to the hospital 1 Individual blood pressure varies multiple times everyday It is also affected by the way you tie your cuff and your measurement position so please take the measurement under the same conditions 2 If the person takes medicine the pressure will vary more 3 Wait at least 3 minutes for another me...

Page 10: ... of 93 non condensing at a water vapour pressure up to 50hPa A01 PROBLEM SYMPTOM CHECK THIS REMEDY No power or Low batteries Error message Display will not light up Batteries are exhausted Replace with new batteries Insert the batteries correctly Batteries are inserted incorrectly E 01 shows E 02 shows E 03 shows Movement can affect the measurement Relax for a moment and then measure again E 04 sh...

Page 11: ... for Safety Electromagnetic compatibility Performance requirements Clinical investigation EN ISO 15223 1 2016 ISO 15223 1 2016 Medical devices Symbols to be used with medical device labels labelling and information to be supplied Part 1 General requirements 21 20 Contact Information COMPLIED STANDARDS LIST FCC Statement This device complies with Part 15 of the FCC Rules Operation is subject to the...

Page 12: ...rvice life 2 Guidance and manufacturer s declaration electromagnetic emissions and Immunity Table 1 Guidance and manufacturer s declaration electromagnetic emissions RF emissions CISPR 11 Group 1 Class B Not applicable Compliance Harmonic emissions IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 RF emissions CISPR 11 Emissions test Not applicable Table 2 Guidance and manufacture...

Page 13: ...000 4 8 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Conduced RF IEC61000 4 6 10 V m 80 MHz 2 7 GHz 80 AM at 1 kHz 10 V m 80 MHz 2 7 GHz 80 AM at 1 kHz Radiated RF IEC61000 4 3 Not applicable Not applicable Not applicable Not applicable Table 3 Guidance and manufacturer s declaration electromagnetic Immunity Test Frequency MHz 385 0 3 27 Radiat...

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