Introduction; General Description; Indications For Use; Contraindications - Samsung ARM BPM User Manual

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INTRODUCTION

General Description

Thank you for selecting arm type SAMSUNG ARM BPM ( EI-B5000 ). The
monitor features blood pressure measurement, pulse rate measurement and
the result storage. The design provides you with two years of reliable
service.
Readings taken by the EI-B5000 are equivalent to those obtained by a
trained observer using the cuff and stethoscope auscultation method.
This manual contains important safety and care information, step-by-step
instructions for using the product, please read it thoroughly before using.
Features:
Up to 60 pieces of record stored for each user
3rd technology: Measuring during inflation

Indications for Use

The SAMSUNG ARM BPM is digital monitors intended for use
in measuring blood pressure and heartbeat rate with arm circumference
ranging from 22cm to 42cm(about 8¾˝-16½˝).
It is intended for adult indoor use only.

Contraindications

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.
Before every measurement, the unit establishes a "zero point" equivalent to the
atmospheric pressure. Then it starts inflating the cuff. Meanwhile, the unit detects
pressure oscillation generated by beat-to-beat pulsatile, which is used to deter-
mine the systolic pressure and diastolic pressure as well as pulse rate.

Safety Information

The signs below might be in the user manual, labeling or other components.
They are the requirement of standard and using.
2
Symbol for "THE OPERATION
GUIDE MUST BE READ"
Symbol for "MANUFACTURER"
Symbol for "SERIAL NUMBER"
SN
Symbol for "DIRECT CURRENT"
Symbol for "RECYCLE"
Caution: These notes must
be observed to prevent any
damage to the device.
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 with pre-eclampsia, premature ventricular beats,
atrial fibrillation, peripheral, arterial disease and patients undergoing intravascular therapy or
arterio-venous shunt or people who received a mastectomy. Please consult your doctor prior
to using the unit if you suffer from illnesses.
* The device is not suitable for measuring the blood pressure of children. Ask your doctor
before using it on older children.
* The device is not intended for patient transport outside a healthcare facility.
* The device is not intended for public use.
* 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 without asking a 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.
* Do not take any therapeutic measures on the basis of a self measurement. Never alter the
dose of a medicine prescribed by a doctor. Consult your doctor if you have any question
about your blood pressure.
* When the device is used to measure patients who have common arrhythmias such as atrial
or ventricular premature beats or atrial fibrillation, the best result may occur with deviation.
Please consult your physician about the result.
* Don't kink the connection tube during use, otherwise, the cuff pressure may continuously
increase which can prevent blood flow and result in harmful injury to the PATIENT.
INTRODUCTION
Symbol for "TYPE BF APPLIED
PARTS"
Symbol for "ENVIRONMENT
PROTECTION - Electrical waste
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 "Authorised Representative
EC REP
in the European Community
3

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