Fysic B26 User manual

Fully Automatic Upper Arm
Blood Pressure Monitor
Model Number: B26 / FB150
USER’S MANUAL

CONTENTS
1Introduction and Intended Use..............................................................................................................2
2Important Information on Blood Pressure and its Measurement..........................................................3
3Components of your blood pressure monitor.......................................................................................5
4Using your Monitor for the First Time...................................................................................................6
5Measurement Procedure ......................................................................................................................8
6Care and Maintenance........................................................................................................................ 14
7Warranty/Service.................................................................................................................................14
8Certifications .......................................................................................................................................14
9Technical Specifications .....................................................................................................................15
10 EMC Declaration.................................................................................................................................15

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1 Introduction and Intended Use
It enables reliable measurement of systolic and diastolic blood pressure as well as pulse through the
oscillometric method.
Before using, please read this instruction manual carefully and then keep it in a safe place.
1.1 Remember…
⚫Only a health-care professional is qualified to interpret blood pressure measurements.
⚫This device is NOT intended to replace regular medical checkups.
⚫Blood pressure readings obtained by this device should be verified before prescribing or making
adjustments to any medications used to control hypertension. Under no circumstances should YOU
alter the dosages of any drugs prescribed by your physician.
⚫This monitor is intended for use by adults only. Consult with a physician before using this instrument
on a child.
⚫In cases of irregular heartbeat, measurements made with this instrument should only be evaluated
after consultation with a physician.
⚫Host products, including accessories, shall be processed in accordance with local regulations after
reaching the life cycle.
1.2 Warnings and Precautions
Warning:
The use of other accessories other than those specified or provided by the equipment
manufacturer may cause electromagnetic radiation to increase or decrease
electromagnetic immunity resulting in operational failure
Warning:
This system may fail to yield specified measurement accuracy if operated or stored in
temperature or humidity conditions outside the limits stated in the specifications section
of this manual.
Warning:
The separate ac adapter which is intended to connect USB interface of Blood Pressure
Monitor has not been evaluated according to IEC 60601-1. The safety of the product
shall be reappraised when it power supply by a separate ac adapter.
Warning:
The user must check that the equipment functions safely and see that it is in proper
working condition before being used.
Warning:
The device is not suitable for use in the presence of flammable anesthetic mixtures with
air or with oxygen or nitrous oxide.
Warning:
The patient is an intended operator, the functions of monitoring blood pressure and pulse
rate can be safely used by patient. The routine clean and changing batteries can be
performed by the patient.
Warning:
This device can not be used together with hf surgical equipment.
Warning:
Use of power adapters
1. Adapter: input 100-240V, 50/60hz output DC 5V 1A
2. Do not to position the device to make it difficult to operate the disconnection device
while using adaptor.
3. Avoid usage in wet, moisture, high temperature, corrosive gas environments and in
direct sunlight.
Warning:
Too frequent measurements can cause injury to the PATIENT due to blood flow
interference.

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Warning:
Don’t place the cuff over wound part.
Warning:
Pressurization of the CUFF can temporarily cause loss of function of simultaneously
used monitoring EQUIPMENT on the same limb.
Caution:
To avoid any possibility of accidental strangulation, keep this unit away from children and
do not drape tubing around your neck.
Caution:
To avoid damaging the device, keep this unit away from children and pets.
Caution:
The standard material used for the bladder and tubing is latex-free.
Attention:
Self-measurement means control, not diagnosis or treatment. Unusual values must
always be discussed with a physician. Under no circumstances should you alter the
dosages of any drugs prescribed by a physician.
Attention:
The pulse display is not suitable for checking the frequency of heart pacemakers!
Attention:
In cases of irregular heartbeat, measurements made with this instrument should only be
evaluated after consultation with a physician.
Note:
To obtain the greatest accuracy from your blood pressure instrument, it is recommended
that the instrument be used within the specified temperature and the relative humidity,
please see the Technical Specifications.
Note:
The cuff is treated as the applied part. The user should contact the manufacturer for
assistance, if needed, in setting up, using or maintaining the device.
Note:
This device contains sensitive electronic components. Avoid strong electrical or
electromagnetic fields in the direct vicinity of the device (e.g. mobile telephones,
microwave ovens) during use. These can lead to erratic results.
Note:
Do not attempt to service or repair this device yourself. Should a malfunction occur, refer
to local distributor or the manufacturer.
2 Important Information on Blood Pressure and its Measurement
2.1 How does high or low blood pressure arise?
Your level of blood pressure is determined in the circulatory center of the brain and adjusts to a variety of
situations through feedback from the nervous system. To adjust blood pressure, the strength and speed
of the heart (Pulse), as well as the width of circulatory blood vessels is altered. Blood vessel width is
controlled by fine muscles in the blood vessel walls.
Your level of arterial blood pressure changes periodically during heart activity: During the “blood ejection”
(Systole) the value is highest (systolic blood pressure value). At the end of the heart’s “rest period”
(Diastole) pressure is lowest (diastolic blood pressure value).

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2.2 Which values are normal?
Please refer to the diagram below (Picture-01)
Picture-01
There are six grids in the display of device. Please refer to the picture-01-01. Different grids represent
different interval scales of WHO.
Blood pressure value
WHO grids in device
WHO Classification
DIA<80 & SYS<120
1
Optimal blood pressure
DIA<85 & SYS<130
2
Normal blood pressure
DIA<90 & SYS<140
3
High normal value
DlA<100 & SYS<160
4
Mild hypertension
DIA<110 8<SYS<180
5
Moderate hypertension
DIA>= 110 or SYS>= 180
6
Severe hypertension
Picture-01-01