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Automatic Upper Arm Blood Pressure Monitor
M4 Intelli IT (HEM-7155T-EBK)
X4 Smart (HEM-7155T-ESL)
Instruction Manual
Symboles/ Symbole/ Simboli/ Símbolos/
Symbolen/ Символы/ Semboller/
ίϣέϟ΍
Read Instruction manual and before use.
FR
Lire le mode d’emploi et avant l’utilisation.
DE
Lesen Sie vor der Verwendung die Gebrauchsanweisung und .
IT
Leggere il manuale di istruzioni e prima dell’uso.
ES
Lea el manual de instrucciones y antes del uso.
NL
Lees de gebruiksaanwijzing en voor gebruik.
RU
Прочтите руководство по эксплуатации и перед использованием.
TR
Kullanmadan önce, kullanım kılavuzu ve 'yi okuyun.
ϡ΍ΩΧΗγϻ΍ϝΑϗ
ϭ Ε΍ΩΎηέϹ΍ϝϳϟΩ΃έϗ΍
AR
EN1
EN
1. Introduction
Thank you for purchasing the OMRON Automatic Upper Arm Blood
Pressure Monitor. This blood pressure monitor uses the oscillometric
method of blood pressure measurement. This means this monitor
detects your blood movement through your brachial artery and
converts the movements into a digital reading.
1.1 Safety Instructions
This instruction manual provides you with important information
about the OMRON Automatic Upper Arm Blood Pressure Monitor.
To ensure the safe and proper use of this monitor, READ and
UNDERSTAND all of the safety and operating instructions. If you do
not understand these instructions or have any questions, contact
your OMRON retail outlet or distributor before attempting to
use this monitor. For specific information about your own blood
pressure, consult with your physician.
1.2 Intended Use
This device is a digital monitor intended for use in measuring blood
pressure and pulse rate in adult patient population. The device detects
the appearance of irregular heartbeats during measurement and
gives a warning signal with readings. It is mainly designed for general
household use.
1.3 Receiving and Inspection
Remove this monitor from the packaging and inspect for damage. If
this monitor is damaged, DO NOT USE and consult with your OMRON
retail outlet or distributor.
2. Important Safety Information
Read the Important Safety Information in this instruction manual
before using this monitor. Follow this instruction manual thoroughly
for your safety.
Keep for future reference. For specific information about your own
blood pressure, CONSULT WITH YOUR PHYSICIAN.
2.1 Warning
Indicates a potentially hazardous
situation which, if not avoided, could
result in death or serious injury.
DO NOT use this monitor on infants, toddlers, children or persons
who cannot express themselves.
DO NOT adjust medication based on readings from this blood
pressure monitor. Take medication as prescribed by your physician.
ONLY a physician is qualified to diagnose and treat high blood
pressure.
DO NOT use this monitor on an injured arm or an arm under medical
treatment.
DO NO
T apply the arm cuff on your arm while on an intravenous
drip or blood transfusion.
DO NOT use this monitor in areas containing high frequency (HF)
surgical equipment, magnetic resonance imaging (MRI) equipment,
computerized tomography (CT) scanners. This may result in incorrect
operation of the monitor and/or cause an inaccurate reading.
DO NOT use this monitor in oxygen rich environments or near
flammable gas.
C
onsult with your physician before using this monitor if you have
common arrhythmias such as atrial or ventricular premature beats
or atrial fibrillation; arterial sclerosis; poor perfusion; diabetes;
pregnancy; pre-eclampsia or renal disease. NOTE that any of these
conditions in addition to patient motion, trembling, or shivering
may affect the measurement reading.
NE
VER diagnose or treat yourself based on your readings. ALWAYS
consult with your physician.
To help avoid strangulation, keep the air tube and AC adapter cable
away from infants, toddlers and children.
This product contains small parts that may cause a choking hazard if
swallowed by infants, toddlers and children.
Data Transmission
This product emits radio frequencies (RF) in the 2.4GHz band.
DO NOT use this product in locations where RF is restricted, such as
on an aircraft or in hospitals. Turn off the Bluetooth® feature in this
monitor, remove batteries and/or unplug the AC adapter when in
RFrestricted areas.
EN2
EN
AC Adapter (optional accessory) Handling and Usage
DO NOT use the AC adapter if this monitor or the AC adapter cable is
damaged. If this monitor or the cable is damaged, turn off the power
and unplug the AC adapter immediately.
Plug the AC adapter into the appropriate voltage outlet. DO NOT
use in a multi-outlet plug.
NEVER plug in or unplug the AC adapter from the electric outlet
with wet hands.
DO NOT disassemble or attempt to repair the AC adapter.
Battery Handling and Usage
Keep batteries out of the reach of infants, toddlers and children.
2.2 Caution
Indicates a potentially hazardous
situation which, if not avoided,may
result in minor or moderate injury to
the user or patient or damage to the
equipment or other property.
Stop using this monitor and consult with your physician if you
experience skin irritation or discomfort.
Consult with your physician before using this monitor on an arm
where intravascular access or therapy, or an arteriovenous (A-V)
shunt, is present because of temporary interference to blood flow
and could result in injury.
Consult with your physician before using this monitor if you have
had a mastectomy.
Consult with your physician before using this monitor if you have
severe blood flow problems or blood disorders as cuff inflation can
cause bruising.
DO NOT take measurements more often than necessary because
bruising, due to blood flow interference, may occur.
ONLY inflate the arm cuff when it is applied on your upper arm.
Remove the arm cuff if it does not start deflating during a
measurement.
DO NOT use this monitor for any purpose other than measuring
blood pressure.
During measurement, make sure that no mobile device or any other
electrical device that emit electromagnetic fields is within 30 cm of
this monitor. This may result in incorrect operation of the monitor
and/or cause an inaccurate reading.
DO NOT disassemble or attempt to repair this monitor or other
components. This may cause an inaccurate reading.
DO NOT use in a location where there is moisture or a risk of water
splashing this monitor. This may damage this monitor.
DO NOT use this monitor in a moving vehicle such as in a car or on
an aircraft.
DO NOT drop or subject this monitor to strong shocks or vibrations.
DO NOT use this monitor in places with high or low humidity or high
or low temperatures. Refer to section 6.
During measurement, observe the arm to ensure that the monitor is
not causing prolonged impairment to blood circulation.
DO NOT use this monitor in high-use environments such as medical
clinics or physician offices.
DO NOT use this monitor with other medical electrical (ME)
equipment simultaneously. This may result in incorrect operation of
the monitor and/or cause an inaccurate reading.
Avoid bathing, drinking alcohol or caffeine, smoking, exercising and
eating for at least 30 minutes before taking a measurement.
Rest for at least 5 minutes before taking a measurement.
Remove tight-fitting or thick clothing from your arm while taking a
measurement.
Remain still and DO NOT talk while taking a measurement.
ONLY use the arm cuff on persons whose arm circumference is
within the specified range of the cuff.
Ensure that this monitor has acclimated to room temperature before
taking a measurement. Taking a measurement after an extreme
temperature change could lead to an inaccurate reading. OMRON
recommends waiting for approximately 2 hours for the monitor to
warm up or cool down when the monitor is used in an environment
within the temperature specified as operating conditions after
it is stored either at the maximum or at the minimum storage
temperature. For additional information on operating and storage/
transport temperature, refer to section 6.
DO NOT use this monitor after the durable period has ended. Refer
to section 6.
DO NOT crease the arm cuff or the air tube excessively.
DO NOT fold or kink the air tube while taking a measurement. This
may cause an injury by interrupting blood flow.
To unplug the air plug, pull on the plastic air plug at the base of the
tube, not the tube itself.
EN3
ONLY use the AC adapter, arm cuff, batteries and accessories
specified for this monitor. Use of unsupported AC adapters, arm
cuffs and batteries may damage and/or may be hazardous to this
monitor.
ONLY use the approved arm cuff for this monitor. Use of other arm
cuffs may result in incorrect readings.
Inflating to a higher pressure than necessary may result in bruising
of the arm where the cuff is applied. NOTE: refer to “If your systolic
pressure is more than 210mmHg in section 13 of instruction
manual
for additional information.
Read and follow the “Correct Disposal of This Product” in section 7
when disposing of the device and any used accessories or optional
parts.
Data Transmission
DO NOT replace batteries or unplug the AC adapter while your
readings are being transferred to your smart device. This may result
in incorrect operation of this monitor and failure to transfer your
blood pressure data.
AC Adapter (optional accessory) Handling and Usage
Fully insert the AC adapter into the outlet.
When unplugging the AC adapter from the outlet, be sure to safely
pull from the AC adapter. DO NOT pull from the AC adapter cable.
When handling the AC adapter cable:
Do not damage it. / Do not break it. / Do not tamper with it.
DO NOT pinch it. / Do not forcibly bend or pull it. / Do not twist it.
DO NOT use it if it is gathered in a bundle.
DO NOT place it under heavy objects.
Wipe any dust off of the AC adapter.
Unplug the AC adapter when not in use.
Unplug the AC adapter before cleaning this monitor.
Battery Handling and Usage
DO NOT insert batteries with their polarities incorrectly aligned.
ONLY use 4 “AA alkaline or manganese batteries with this monitor.
DO NOT use other types of batteries. DO NOT use new and used
batteries together. DO NOT use different brands of batteries
together.
Remove batteries if this monitor will not be used for a long period of
time.
If battery fluid should get in your eyes, immediately rinse with
plenty of clean water. Consult with your physician immediately.
If battery fluid should get on your skin, wash your skin immediately
with plenty of clean, lukewarm water. If irritation, injury or pain
persists, consult with your physician.
DO NOT use batteries after their expiration date.
Periodically check batteries to ensure they are in good working
condition.
2.3 General Precautions
When you take a measurement on the right arm, the air tube should
be at the side of your elbow. Be careful not to rest your arm on the
air tube.
Blood pressure may differ between the right and left arm, and
may result in a different measurement value. Always use the same
arm for measurements. If the values between both arms differ
substantially, check with your physician on which arm to use for
your measurements.
Remember to have a record of your blood pressure and pulse
readings for your physician. A single measurement does not provide
an accurate indication of your true blood pressure.
Please use the Blood Pressure Diary to keep records of several
readings over a certain period of time. To download PDF files of the
diary, visit www.omron-healthcare.com.
EN4
EN
3. Error Messages and Troubleshooting
If any of the below problems occur during measurement, check to make sure that no other electrical device is within 30 cm. If the problem persists,
please refer to the table below.
Display/Problem Possible Cause Solution
appears or the arm
cuff does not inflate.
The [START/STOP] button was pressed
while the arm cuff is not applied.
Press the [START/STOP] button again to turn the monitor off.
After inserting the air plug securely and applying the arm cuff
correctly, press the [START/STOP] button.
Air plug is not completely plugged into
the monitor.
Insert the air plug securely.
The arm cuff is not applied correctly. Apply the arm cuff correctly, then take another measurement.
Refer to section 7 of instruction manual
.
Air is leaking from the arm cuff. Replace the arm cuff to the new one. Refer to section 14 of
instruction manual
.
appears or a
measurement
cannot be
completed after the
arm cuff inflates.
You move or talk during a measurement
and the arm cuff does not inflate
sufficiently.
Remain still and do not talk during a measurement. If “E2”
appears repeatedly, inflate the arm cuff manually until the
systolic pressure is 30 to 40 mmHg above your previous
readings. Refer to section 13 of instruction manual
.
Due to the systolic pressure is above
210mmHg, a measurement cannot be
taken.
appears
The arm cuff is inflated exceeding the
maximum allowable pressure.
Do not touch the arm cuff and/or bend the air tube while taking
a measurement. If inflating the arm cuff manually, refer to
section 13 of instruction manual
.
appears
You move or talk during a measurement.
Vibrations disrupt a measurement.
Remain still and do not talk during a measurement.
appears
The pulse rate is not detected correctly. Apply the arm cuff correctly, then take another measurement.
Refer to section 7 of instruction manual . Remain still and sit
correctly during a measurement.
If the
symbol continues to appear, we recommend you to
consult with your physician.
/ /
appears
does not flash during
a measurement.
EN5
Display/Problem Possible Cause Solution
appears
The monitor has malfunctioned. Press the [START/STOP] button again. If “Er still appears, contact
your OMRON retail outlet or distributor.
appears
The monior cannot connect to a smart
device or transmit data correctly.
Follow the instructions shown in the “OMRON connect” app.
If the “Err symbol still appears after checking the app, contact
your OMRON retail outlet or distributor.
flashes
The monitor is waiting for pairing with
the smart device.
Refer to section 5 of instruction manual
for pairing your
monitor with your smart device, or press [START/STOP] button
to cancel pairing and turn your monitor off.
flashes
The monitor is ready to transfer your
readings to the smart device.
Open the “OMRON connect” app to transfer your readings.
flashes
More than 48 readings are not
transferred.
Pair or transfer your readings to the “OMRON connect app so
you can keep them in memory in the app, and this error symbol
disappears.
The date and time is not set.
appears
There are 60 readings in memory to be
transferred
flashes
Batteries are low. Replacing all 4 batteries with new ones is recommended. Refer
to section 4 of instruction manual
.
appears or the
monitor is turned
off unexpectedly
during a
measurement
Batteries are depleted. Immediately replace all 4 batteries with new ones. Refer to
section 4 of instruction manual
.
Nothing appears on the
display of the monitor.
Battery polarities are not properly
aligned.
Check the battery installation for proper placement. Refer to
section 4 of instruction manual
.
Readings appear too high or
too low.
Blood pressure varies constantly. Many factors including stress, time of day, and/or how you apply the arm
cuff, may affect your blood pressure. Review section 2 of instruction manual
.
EN6
EN
Display/Problem Possible Cause Solution
Any other communication
issue occurs.
Follow the instructions shown in the smart device, or visit the “Help” section in the “OMRON
connect" app for further help. If the problem still persists, contact your OMRON retail outlet or
distributor.
Any other problem occurs.
Press the [START/STOP] button to turn the monitor off, then press it again to take a measurement.
If the problem continues, remove all batteries and wait for 30 seconds. Then re-install batteries.
If the problem still persists, contact your OMRON retail outlet or distributor.
4. Limited Warranty
Thank you for buying an OMRON product. This product is constructed of high quality materials and great care has been taken in its manufacturing.
It is designed to give you every satisfaction, provided that it is properly operated and maintained as described in the instruction manual.
This product is warranted by OMRON for a period of 3 years after the date of purchase. The proper construction, workmanship and materials of
this product is warranted by OMRON. During this period of warranty OMRON will, without charge for labour or parts, repair or replace the defect
product or any defective parts.
The warranty does not cover any of the following:
A. Transport costs and risks of transport.
B. Costs for repairs and / or defects resulting from repairs done by unauthorised persons.
C. Periodic check-ups and maintenance.
D. Failure or wear of optional parts or other attachments other than the main device itself, unless explicitly warranted above.
E. Costs arising due to non-acceptance of a claim (those will be charged for).
F. Damages of any kind including personal caused accidentally or from misuse.
G. Calibration service is not included within the warranty.
H. Optional parts have a one (1) year warranty from date of purchase. Optional parts include, but are not limited to the following items: cuff and
cuff tube.
Should warranty service be required please apply to the dealer whom the product was purchased from or an authorised OMRON distributor. For
the address refer to the product packaging / literature or to your specialised retailer. If you have difficulties in finding OMRON customer services,
contact us for information:
www.omron-healthcare.com
Repair or replacement under the warranty does not give rise to any extension or renewal of the warranty period.
The warranty will be granted only if the complete product is returned together with the original invoice / cash ticket issued to the consumer by the
retailer.
EN7
5. Maintenance
5.1 Maintenance
To protect your monitor from damage, follow the directions below:
Changes or modifications not approved by the manufacturer will void the user warranty.
DO NOT disassemble or attempt to repair this monitor or other components. This may cause an inaccurate reading.
5.2 Storage
Keep your monitor in the storage case when not in use.
1. Remove the arm cuff from the monitor.
Caution
To unplug the air plug, pull on the plastic air plug at the base of the tube, not the tube itself.
2. Gently fold the air tube into the arm cuff. Note: Do not bend or crease the air tube excessively.
3. Place your monitor and other components in the storage case.
Store your monitor and other components in a clean, safe location.
Do not store your monitor and other components:
If your monitor and other components are wet.
In locations exposed to extreme temperatures, humidity, direct sunlight, dust or corrosive vapors such as bleach.
In locations exposed to vibrations or shocks.
5.3 Cleaning
Do not use any abrasive or volatile cleaners.
Use a soft dry cloth or a soft cloth moistened with mild (neutral) detergent to clean your monitor and arm cuff, and then wipe them with a dry
cloth.
Do not wash or immerse your monitor and arm cuff or other components in water.
Do not use gasoline, thinners or similar solvents to clean your monitor and arm cuff or other components.
5.4 Calibration and Service
The accuracy of this blood pressure monitor has been carefully tested and is designed for a long service life.
It is generally recommended to have the unit inspected every two years to ensure correct functioning and accuracy. Please consult your
authorised OMRON dealer or the OMRON Customer Service at the address given on the packaging or attached literature.
Caution
EN9
Note
These specifications are subject to change without notice.
This monitor is clinically investigated according to the requirements of ISO 81060-2:2013. In the clinical validation study, K5 was used on
85subjects for determination of diastolic blood pressure.
This device has been validated for use on pregnant and pre-eclampsia patients according to the Modified European Society of Hypertension
Protocol*.
This device has been validated for use on diabetic (Type II) population**.
IP classification is degrees of protection provided by enclosures in accordance with IEC 60529. This monitor and optional AC adapter are
protected against solid foreign objects of 12.5 mm diameter and greater such as a finger. The optional AC adapter is protected against vertically
falling water drops which may cause issues during a normal operation.
* Topouchian J et al. Vascular Health and Risk Management 2018:14 189–197
** Chahine M.N. et al. Medical Devices: Evidence and Research 2018:11 11–20
About a wireless communication interference
This product operates in an unlicensed ISM band at 2.4 GHz. In the event this product is used near other wireless devices such as microwave and
wireless LAN, which operate on the same frequency band as this product, there is a possibility that interference may occur. If interference occurs,
stop the operation of the other devices or relocate this product away from other wireless devices before attempting to use it.
7. Correct Disposal of This Product (Waste Electrical & Electronic Equipment)
This marking shown on the product or its literature, indicates that it should not be disposed of, with other household wastes at the
end of its working life.
To prevent possible harm to the environment or human health from uncontrolled waste disposal, please separate this product from
other types of wastes and recycle it responsibly to promote the sustainable reuse of material resources.
Household users should contact either the retailer where they purchased this product, or their local government office, for details of
where and how they can return this item for environmentally safe recycling.
Business users should contact their supplier and check the terms and conditions of the purchase contract. This product should not be mixed with
other commercial waste for disposal.
8. Important Information Regarding Electromagnetic Compatibility (EMC)
HEM-7155T-EBK and HEM-7155T-ESL conform to EN60601-1-2:2015 Electromagnetic Compatibility (EMC) standard.
Further documentation in accordance with this EMC standard is available at
www.omron-healthcare.com
Refer to the EMC information for HEM-7155T-EBK and HEM-7155T-ESL on the website.
19

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