Omron Healthcare HEM-7360-E Manuel utilisateur
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- Manuel utilisateur
Instruction Manual 1
EN
FR
DE
IT
ES
NL
RU
TR
AR
Symbols
Automatic Upper Arm Blood Pressure Monitor
ωέΫϟϰϠϋ΄ΑΕϳΑΛΗϠϟϝΑΎϘϟϲϟϵϡΩϟρϐοαΎϳϗίΎϬΟ
M6 Comfort (HEM-7360-E) Εέϭϔϣϭϛ6ϡ·
X6 Comfort (HEM-7360-EO) Εέϭϔϣϭϛ6αϛ
Read Instruction manual and before use.
FR Lire le mode d’emploi et avant l’utilisation.
DE Lesen Sie vor der Verwendung Gebrauchsanweisung und .
IT Leggere il manuale di istruzioni e prima dell’uso.
ES Lea el manual de instrucciones y antes del uso.
NL Lees gebruiksaanwijzing en voor gebruik.
RU .
TR Kullanmadan önce, kullanım kılavuzu ve 'yi okuyun.
.ϡΩΧΗγϻϝΑϗ ϭ ΕΩΎηέϹϝϳϟΩέϗ AR
Symboles/ Symbole/ Simboli/ Símbolos/
Symbolen/ / Semboller/
ίϣέϟ
EN1
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
The 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 indicates this via a symbol
with the measurement results. It is mainly designed for general household use.
The device can detect an irregular pulse suggestive of Atrial Fibrillation (Afib).
Please note that the device is not intended to diagnose Afib. A diagnosis of
Afib can only be confirmed by an Electrocardiogram (ECG). If the Afib symbol
appears, consult with your physician.
1.3 Receiving and Inspection
Remove this monitor and other components from the packaging and inspect
for damage. If this monitor or any other components 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 and Afib.
• DO NOT use this monitor on an injured arm or an arm under medical treatment.
• DO NOT 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.
• Consult 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.
• NEVER 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.
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 cause 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
and/or detecting the possibility of Afib.
EN
EN2
EN
• 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 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, thick clothing and any accessories 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.
• 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
210mmHg” in section 11 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.
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
• To stop a measurement, press the [START/STOP] button while taking a
measurement.
• 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.
• When using an optional AC adapter, make sure not to place your monitor in
a location where it is difficult to plug and unplug the AC adapter.
Battery Handling and Usage
• Disposal of used batteries should be carried out in accordance with local
regulations.
• The supplied batteries may have a shorter life span than new batteries.
EN3
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 5 of instruction manual .
Air is leaking from the arm cuff. Replace the arm cuff to the new one. Refer to section 12 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 40mmHg above your previous
readings. Refer to section 11 of instruction manual .
Due to the systolic pressure is above
210mmHg, 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 11 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 5 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
appears
Blood pressure measurements were
not taken correctly in an Afib mode
measurement.
Apply the arm cuff correctly, then take another measurement.
Refer to section 5 of instruction manual . Remain still and
sit correctly during a measurement. Refer to section 6 of
instruction manual .
EN4
EN
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.
flashes Batteries are low. Replacing all 4 batteries with new ones is recommended.
Refer to section 3 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 3 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 3 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 .
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.
Troubleshooting for Afib indicator function:
What is different between the
Afib indicator function and
ECG?
The Afib indicator function and ECG use completely different technologies. An ECG measures the
electrical activity of the heart and can be used to diagnose Afib. The Afib indicator function detects
irregular heartbeat and can suggest the possibility of Afib with a sensitivity of 95.5 % and specificity of
93.8 %. Refer to section 11 for details.
If the “ ” symbol does not
appear, it means there is no
possibility of Afib?
Even if the “ ” symbol does not appear, there is still a possibility of Afib.
Should I consult with my
physician if the “ ” symbol
appears?
We recommend you to consult with your physician because there is a possibility of Afib. However, the
“ ” symbol may be displayed for other reasons, such as other heart arrhythmias.
What is different between Afib
indicator function and irregular
heart beat function?
The irregular heartbeat function detects irregularities in the pulse waves in one measurement. The Afib
indicator function suggests the possibility of Afib when blood pressure is measured 3 consecutive times.
What should I do if the “ ”
symbol sometimes appears?
Afib does not always have symptoms. We recommend you to consult with and follow the directions of
your physician.
EN5
Display/Problem Possible Cause Solution
I have been diagnosed with Afib
by the physician, but the
“ ”
symbol does not appear.
Afib may not occur at the time of specific blood pressure measurements. We recommend you to consult
with your physician regularly.
Is the blood pressure reading
reliable when the “ ” symbol
appears?
Afib or an irregular heartbeat can influence your blood pressure measurements and make it difficult to
get an accurate reading. Repeated measurements may be required to overcome variabilities.* In Afib
mode, the blood pressure measurement is taken 3 times, and the average is displayed. The monitor
will indicate an error message (E5/E6) if the influence of the irregular heartbeat is too severe to give a
measurement result. If this occurs repeatedly, we recommend that you consult with your physician.
* Prof. Roland Asmar et al. European Society of Hypertension Recommendations for Conventional, Ambulatory and Home Blood Pressure Measurement
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 5 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.
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.
Caution
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.
EN6
EN
• To protect your monitor during storage, an optional LCD cover is available as
accessory. Refer to section 13 of Instruction Manual .
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.
6. Specications
Product Category Electronic Sphygmomanometers
Product description Automatic Upper Arm Blood Pressure
Monitor
Model (Code) M6 Comfort (HEM-7360-E) /
X6 Comfort (HEM-7360-EO)
Display LCD digital display
Cuff pressure range 0 to 299mmHg
Blood pressure
measurement range
SYS: 60 to 260mmHg
DIA: 40 to 215mmHg
Pulse measurement range
40 to 180 beats / min.
Accuracy Pressure: ±3mmHg
Pulse: ±5 % of display reading
Inflation Automatic by electric pump
Deflation Automatic pressure release valve
Measurement method Oscillometric method
Operation mode Continuous operation
IP classification Monitor: IP20
Optional AC adapter: IP21 (HHP-CM01)
or IP22 (HHP-BFH01)
Rating DC6V 4.0W
Power source 4 “AA” batteries 1.5V or optional AC
adapter (INPUT AC 100 - 240V
50/60Hz 0.12 - 0.065A)
Battery life Approximately 1000 measurements
(using new alkaline batteries)
The number of times may decrease when
using Afib mode because one Afib indication
consists of 3 regular measurements.
Durable period (Service
life)
Monitor: 5 years / Cuff: 5 years /
Optional AC adapter: 5 years
Operating conditions +10 to +40°C / 15 to 90% RH
(non-condensing) / 800 to 1060hPa
Storage / Transport
conditions
-20 to +60°C / 10 to 90% RH
(non-condensing)
Contents Monitor, arm cuff (HEM-FL31), 4 “AA”
batteries, Instruction Manual and
, storage case
Protection against
electric shock
Internally powered ME equipment
(When using only batteries)
Class II ME equipment (Optional AC
adapter)
Weight Monitor: approximately 460g
(notincluding batteries)
Arm cuff: approximately 163g
Dimensions
(approximately value)
Monitor: 191mm (W) × 85mm (H)
× 120mm (L) / Arm cuff:145mm ×
532mm (air tube: 750 mm)
Cuff circumference
applicable to the monitor
220 to 420mm
Memory Stores up to 100 readings per user
Applied part Type BF (arm cuff)
EN7
Note
• These specifications are subject to change without notice.
• This monitor is clinically investigated according to the requirements
of ENISO 81060-2:2014 and complies with EN ISO 81060-2:2014 and
ENISO81060-2:2019 + A1:2020. 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 IEC60529. This monitor and optional AC adapter are
protected against solid foreign objects of 12.5mm diameter and greater
such as a finger. The optional AC adapter HHP-CM01 is protected against
vertically falling water drops which may cause issues during a normal
operation. Theoptional AC adapter HHP-BFH01 is protected against oblique
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
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-7360-E/EO conforms to the EN60601-1-2:2015 Electromagnetic
Compatibility (EMC) standard.
Further documentation in accordance with this EMC standard is available at
OMRON HEALTHCARE EUROPE at the address mentioned in this instruction
manual or at: www.omron-healthcare.com.
9. Guidance and Manufacturer’s Declaration
• This blood pressure monitor is designed according to the European Standard
EN1060, Non-invasive sphygmomanometers Part 1: General Requirements
and Part 3: Supplementary requirements for electromechanical blood
pressure measuring systems.
• This OMRON product is produced under the strict quality system of OMRON
HEALTHCARE Co., Ltd., Japan. The Core component for OMRON blood
pressure monitors, which is the Pressure Sensor, is produced in Japan.
• Please report to the manufacturer and the competent authority of the
Member State in which you are established about any serious incident that
has occurred in relation to this device.
10. How to Calculate Weekly Averages
Morning Weekly Average Calculation
This is the average for the measurements taken during the morning (4:00 - 9:59)
between Sunday and Saturday. The 2 or 3 readings taken within the first
10minute timeframe in the morning between 4:00 - 9:59 will be used to
calculate the morning average for each day.
Evening Weekly Average Calculation
This is the average for the measurements taken during the evening (19:00 - 1:59)
between Sunday and Saturday. The 2 or 3 readings taken within the last
10minute timeframe in the evening between 19:00 - 1:59 will be used to
calculate the evening average for each day.
Within 10 min.
Measurements
in the morning
Measurements
in the evening
Within 10 min.
EN8
EN
11. Useful Information
What is Blood Pressure?
Blood pressure is a measure of the force of blood flowing against the walls of
the arteries. Arterial blood pressure is constantly changing during the course of
the heart’s cycle.
The highest pressure in the cycle is called the Systolic Blood Pressure; the lowest
is the Diastolic Blood Pressure. Both pressures, the Systolic and Diastolic, are
necessary to enable a physician to evaluate the status of a patient’s blood pressure.
What is Arrhythmia?
Arrhythmia is a condition where the heartbeat rhythm is abnormal due to flaws in
the bio-electrical system that drives the heartbeat. Typical symptoms are skipped
heartbeats, premature contraction, an abnormally rapid (tachycardia) or slow
(bradycardia) pulse.
What is Afib?
Atrial fibrillation (also called Afib or AF) is a quivering or irregular heartbeat
(arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-
related complications. During atrial fibrillation, the heart’s two upper chambers (the
atria) beat chaotically and irregularly — out of coordination with the two lower
chambers (the ventricles) of the heart. Episodes of atrial fibrillation can come and
go, or you may develop atrial fibrillation that doesn’t go away and may require
treatment.
Afib indicator function detects the possibility of Afib with an accuracy of 94.2%
(with sensitivity of 95.5% and specificity of 93.8%) as demonstrated in the study*
with Single-lead ECG as reference measurement.
*M. Ishizawa, T. Noma, T. Minamino et al., Multiple measurements with
automated blood pressure monitor can detect atrial fibrillation with high
sensitivity and specificity in general cardiac patients, ESC Congress 2018
SD1
Symbols Description
FR Description des symboles NL Beschrijving van symbolen
DE Beschreibung der Symbole RU
IT Descrizione dei simboli TR Simgelerin Açıklaması
ES Descripción de los símbolos
Applied part - Type BF Degree of protection against
electric shock (leakage current)
FR Partie appliquée - Type BF
Degré de protection contre
les chocs électriques
(courant de fuite)
DE
Anwendungsteil– TypBF
Schutz vor Stromschlägen
(Ableitstrom)
IT Parti applicate - Tipo BF
Livello di protezione contro
le folgorazioni (corrente di
dispersione)
ES Partes en contacto: TipoBF
Grado de protección
contra descargas eléctricas
(corriente de fuga)
NL Toegepast
onderdeel - Type BF-
beschermingsgraad tegen
elektrische schokken
(lekstroom)
RU
- BF
( )
TR Uygulanan parça - TipBF
Elektrik çarpmasına karşı
koruma derecesi (kaçak
akım)
Class II equipment. Protection against electric shock
FR Équipement de classe II.
Protection contre les chocs
électriques
DE
Gerät der Klasse II. Schutz
vor Stromschlägen
IT Apparecchiatura di Classe
II. Protezione contro le
folgorazioni
ES Equipo de Clase II.
Protección contra
descargas eléctricas
NL Apparatuur van Klasse
II. Bescherming tegen
elektrische schokken
RU
II.
TR Sınıf II ekpman. Elektrk
çarpmasına karşı koruma
IP XX Ingress protection degree provided by IEC 60529
FR Degré de protection selon
CEI60529
DE
Grad des Eindringschutzes
gemäß IEC60529
IT Livello di protezione IP in
base a IEC 60529
ES Grado de protección según
la norma internacional
IEC60529
NL Beschermingsklasse
volgens IEC60529
RU
,
,
IEC 60529
TR Su grmesne karşı koruma
dereces IEC 60529
tarafından verlmştr
CE Marking
FR Marquage CE
DE CE-Kennzeichnung
IT Contrassegno CE
ES Marcado CE
NL CE-merkteken
RU
TR CE İşaret
UKCA marking
FR Marquage UKCA
DE UKCA-Kennzeichnung
IT Marchio UKCA
ES Marcado UKCA
NL UKCA-markering
RU UKCA
TR UKCA işareti
Serial number
FR Numéro de série
DE Seriennummer
IT Numero di serie
ES Número de serie
NL Serienummer
RU
TR Ser numarası
LOT number
FR Numéro de LOT
DE LOT-Nummer
IT Numero di lotto
ES Número de lote
NL Partijnummer
RU
TR Part numarası
ΔΟέΩ%)ωϭϧϟϥϣϖΑρϣ˯ίΟAR
ΔϳΎΑέϬϛϟΕΎϣΩλϟΩοΔϳΎϣΣϟ
ΏέγΗϣϟέΎϳΗϟ
ΩοΔϳΎϣΣϟIIΔϔϟϥϣίΎϬΟAR
ΔϳΎΑέϬϛϟΕΎϣΩλϟ
ΔϠϳϐηΗϟϡϗέ AR
ϝγϠγΗϣϟϡϗέϟ AR
ΔϳΑϭέϭϷΔϧΟϠϟϊϣϖϓϭΗϟΔϣϼϋAR
CE)
ιΎΧϟϖϓϭΗϟϡϳϳϘΗΔϣϼϋAR
ΓΩΣΗϣϟΔϛϠϣϣϟΎΑ
Ύ˱ϘϓϭΏέγΗϟϥϣΔϳΎϣΣϟΔΟέΩ AR
,(&έΎϳόϣϟ
ίϭϣέϟϑλϭ AR
SD2
UDI Unique device identifier
FR Identifiant unique des
dispositifs
DE Produktidentifizierungs-
nummer
IT Identificatore univoco del
dispositivo
ES Identificador único del
producto
NL Unieke apparaat-ID
RU
TR Benzersiz cihaz
tanımlayıcısı
Medical device
FR Dispositif médical
DE Medizinprodukt
IT Dispositivo medico
ES Producto sanitario
NL Medisch apparaat
RU
TR Tıbb chaz
Indicates the manufacturer’s catalogue number
FR Indique le numéro de
catalogue du fabricant
DE
Angabe der Hersteller-
Katalognummer
IT Indica il numero di
catalogo del produttore
ES Indica el número de
catálogo del fabricante
NL Geeft het
catalogusnummer van de
fabrikant aan
RU
TR Üretcnn katalog
numarasını belrtr
Temperature limitation
FR Limitation de température
DE Temperaturbegrenzung
IT Limite di temperatura
ES Limitación de la
temperatura
NL Temperatuurbegrenzing
RU
TR Sıcaklık sınırlaması
Humidity limitation
FR Limitation d’humidité
DE
Luftfeuchtigkeits-
begrenzung
IT Limite di umidità
ES Limitación de la humedad
NL Vochtigheidsbegrenzing
RU
TR Nem sınırlaması
Atmospheric pressure limitation
FR Limitation de pression
atmosphérique
DE Luftdruckbegrenzung
IT Limite di pressione
atmosferica
ES Limitación de la presión
atmosférica
NL Luchtdrukbegrenzing
RU
TR Atmosferk basınç
sınırlaması
Indication of connector polarity
FR Indication de la polarité
des connecteurs
DE
Anzeige der
Steckerpolarität
IT Indicazione della polarità
dei connettori
ES Indicación de la polaridad
del conector
NL Indicatie van polariteit van
aansluiting
RU
TR Bağlantı polarte
gösterges
For indoor use only
FR Pour un usage à l’intérieur
uniquement
DE
Nur für die Nutzung in
Innenbereichen
IT Solo per uso in interni
ES Para uso solo en interiores
NL Alleen voor gebruik
binnenshuis
RU
TR Sadece ç mekanda
kullanım çn
ϲΑρίΎϬΟ AR
ΏγΎϧϣϟϱϭΟϟρϐοϟΩϭΩΣ AR
ΔΑγΎϧϣϟΔΑϭρέϟΩϭΩΣ AR
ΔΑγΎϧϣϟΓέέΣϟΔΟέΩΩϭΩΣ AR
ιΎΧϟΔϣΎϘϟϡϗέϰϟ·ΓέΎηϺϟ AR
ΔόϧλϣϟΔϛέηϟΎΑ
ΩϳέϔϟίΎϬΟϟϑ ˷
έόϣ AR
ϝλϭϣϟΔϳΑρϗϰϟ·έϳηΗΔϣϼϋ AR
ϥϛΎϣϷϲϓϡΩΧΗγϼϟϟΎλ AR
ρϘϓΔϘϠϐϣϟ
SD3
OMRON’s trademarked technology for blood
pressure measurement
FR Technologie brevetée
OMRON pour la mesure de
la pression artérielle
DE
Markenrechtlich
geschützte Technologie
von OMRON zur
Blutdruckmessung
IT Tecnologia brevettata
OMRON per la misurazione
della pressione arteriosa
ES La tecnología de OMRON
para medir la presión
arterial
NL Technologie voor
bloeddrukmeting onder
handelsmerk van OMRON
RU
OMRON
TR OMRON'un kan basıncı
ölçümü çn tcar markalı
teknolojsdr
Identifier of cuffs compatible for the device
FR Identificateur des brassards
compatibles avec l’appareil
DE
Kennzeichnung der mit
dem Gerät kompatiblen
Manschetten
IT Identifica i bracciali
compatibili con il
dispositivo
ES Identificador para
manguitos compatibles
con el dispositivo
NL Identificatie van
manchetten die
compatibel zijn met het
apparaat
RU
,
TR Chaz le uyumlu
kollukların tanıtım şaret
Marker on the cuff to be positioned above the
artery
FR Repère sur le brassard, à
positionner au-dessus de
l’artère
DE
Markierung auf der
Manschette, die oberhalb
der Arterie liegen muss
IT Contrassegno sul bracciale
da posizionare al di sopra
dell’arteria
ES La marca del manguito
debe colocarse sobre la
arteria
NL Markering op de manchet
die boven de slagader
moet worden geplaatst
RU
TR Kolluk üzerndek şaretn
konumu artern üzerne
gelmeldr
,
Manufacturer’s quality control mark
FR Marque de contrôle de la
qualité du fabricant
DE
Qualitätskontrollzeichen
des Herstellers
IT Contrassegno controllo
qualità del produttore
ES Marca del control de
calidad del fabricante
NL Symbool voor
kwaliteitscontrole van
fabrikant
RU
TR Üretcnn kalte kontrol
şaret
Not made with natural rubber latex
FR Ne contient pas de latex de
caoutchouc naturel
DE
Enthält kein Naturlatex
IT Non contiene lattice di
gomma naturale
ES No contiene látex de
caucho natural
NL Bevat geen
natuurrubberlatex
RU
TR Doğal kauçuk lateksten
üretlmemştr
ΔρϏΎοϟρέηϟΩϳΩΣΗΕΎϣϼϋ AR
ίΎϬΟϟϊϣΔϘϓϭΗϣϟ
αϛϳΗϻϡΩΧΗγϥϭΩϊϳϧλΗϟϡΗ AR
ϲόϳΑρϟρΎρϣϟ
ΓέΎηϺϟρϏΎοϟρϳέηϟΎΑΔϣϼϋAR
ϥΎϳέηϟϕϭϓϪόοϭΏϭΟϭϰϟ·
ΔλΎΧϟΓΩϭΟϟϲϓϡϛΣΗϟΔϣϼϋ AR
ΔόϧλϣϟΔϛέηϟΎΑ
OMRONΔϳέΎΟΗϟΔϣϼόϟΔϳϧϘΗ AR
ϡΩϟρϐοαΎϳϘϟ
SD4
Arm circumference
FR Circonférence du bras
DE Armumfang
IT Circonferenza del braccio
ES Perímetro de brazo
NL Armomtrek
RU
TR Kol çevres
Necessity for the user to consult this instruction manual
FR L’utilisateur doit consulter
le mode d’emploi
DE
Der Benutzer muss diese
Gebrauchsanweisung
lesen
IT L’utente deve consultare
il presente manuale di
istruzioni
ES Es necesario que el usuario
consulte este manual de
instrucciones
NL De gebruiker dient deze
gebruiksaanwijzing te
raadplegen
RU
TR Kullanıcı, bu kullanım
kılavuzuna başvurmalıdır
Need for the user to follow this instruction manual
thoroughly for your safety.
FR L’utilisateur doit suivre
attentivement ce mode
d’emploi pour votre
sécurité.
DE
Damit die Sicherheit
gewährleistet ist, muss
der Benutzer diese
Gebrauchsanweisung
sorgfältig befolgen.
IT Per la propria sicurezza,
l’utente deve seguire
attentamente il presente
manuale di istruzioni.
ES Es necesario que el usuario
siga rigurosamente este
manual de instrucciones
para su seguridad.
NL Voor de eigen veiligheid
dient de gebruiker zich
zorgvuldig aan deze
gebruiksaanwijzing te
houden.
RU
.
TR Güvenlk açısından
kullanıcının bu kullanım
kılavuzuna dkkatle
uyması gerekr.
Direct current
FR Courant continu
DE Gleichstrom
IT Corrente diretta
ES Corriente directa
NL Gelijkstroom
RU
TR Doğru akım
Alternating current
FR Courant alternatif
DE Wechselstrom
IT Corrente alternata
ES Corriente alterna
NL Wisselstroom
RU
TR Alternatf akım
Date of manufacture
FR Date de fabrication
DE Herstellungsdatum
IT Data di fabbricazione
ES Fecha de fabricación
NL Productiedatum
RU
TR Üretm tarh
Prohibited action
FR Action interdite
DE Verbotene Aktion
IT Operazione proibita
ES Acción prohibida
NL Verboden handeling
RU
TR Yasaklanmış eylem
ϝϳϟΩωΎΑΗϰϟ·ϡΩΧΗγϣϟΔΟΎΣ AR
ϰϠϋυΎϔΣϠϟϝϣΎϛϟΎΑΕΩΎηέϹ
Δϣϼγϟ
έηΎΑϣϟέΎϳΗϟ AR
έϭυΣϣ˯έΟ· AR
ΏϭΎϧΗϣϟέΎϳΗϟ AR
ϊϳϧλΗϟΦϳέΎΗ AR
ϝϳϟΩϰϟ·ϡΩΧΗγϣϟωϭΟέΓέϭέο AR
ΫϫΕΩΎηέϹ
ωέΫϟρϳΣϣ AR
Issue Date:
2022-06-16
Date de publication:
Ausgabedatum:
Data di pubblicazione:
Fecha de publicación:
Uitgiftedatum
Дата выпуска:
Teslim Tarihi:
έΩλϹΦϳέΎΗ
IM1-HEM-7360-E-06-01/2022
2897001-8E
Instruction Manual 2
Automatic Upper Arm Blood Pressure Monitor
ωέΫϟϰϠϋ΄ΑΕϳΑΛΗϠϟϝΑΎϘϟϲϟϵϡΩϟρϐοαΎϳϗίΎϬΟ
M6 Comfort (HEM-7360-E)
Εέϭϔϣϭϛ6ϡ·
X6 Comfort (HEM-7360-EO)
Εέϭϔϣϭϛ6αϛ
Read Instruction manual and before use.
FR Lire le mode d’emploi et avant l’utilisation.
DE Lesen Sie vor der Verwendung Gebrauchsanweisung und .
IT Leggere il manuale di istruzioni e prima dell’uso.
ES Lea el manual de instrucciones y antes del uso.
NL Lees gebruiksaanwijzing en voor gebruik.
RU .
TR Kullanmadan önce, kullanım kılavuzu ve 'yi okuyun.
AR
ϡΩΧΗγϻϝΑϗ ϭ ΕΩΎηέϹϝϳϟΩέϗ
1Package Contents...........................................3
FR Contenu de l’emballage NL Inhoud van de verpakking
DE Packungsinhalt RU
IT Contenuto della confezione TR Paketin İçindekiler
ES Contenido del envase ΔΑϠόϟΕΎϳϭΗΣϣAR
2Preparing for a Measurement........................4
FR Préparation pour une prise
de mesure
NL Een meting voorbereiden
DE Vorbereiten einer Messung RU
IT Preparazione per la
misurazione
TR Ölçüm Hazırlığı
ES Preparación para una
medición αΎϳϘϟΔϳϠϣόϟίϳϬΟΗϟAR
3Inserting Batteries..........................................5
FR Mise en place des piles NL De batterijen plaatsen
DE Einlegen von Batterien RU
IT Inserimento delle batterie TR Pilleri Takma
ES Introducción de las pilas ΕΎϳέΎρΑϟϝΎΧΩ·AR
4Setting Date and Time....................................6
FR Réglage de la date et de
l’heure
NL Datum en tijd instellen
DE Einstellen von Datum und
Uhrzeit
RU
IT Impostazione di data e ora TR Tarih ve Saatin Ayarlanması
ES Ajuste de la fecha y la hora ΦϳέΎΗϟϭΕϗϭϟρΑοAR
5Applying the Cuff on the Left Arm.................7
FR Pose du brassard sur le bras
gauche
NL De manchet op de linkerarm
aanbrengen
DE Anbringen der Manschette
am linken Arm
RU
IT Applicazione del bracciale
sul braccio sinistro
TR Kolluğun Sol Kola Takılması
ES Colocación del manguito en
el brazo izquierdo
έγϳϷωέΫϟϰϠϋρϏΎοϟρϳέηϟϑϟ
AR
6Sitting Correctly..............................................9
FR Position assise correcte NL Correct zitten
DE Korrekte Körperhaltung RU
IT Come sedersi nel modo
corretto
TR Düzgün Oturma
ES Cómo sentarse
correctamente ϳΣλϝϛηΑαϭϠΟϟAR
7Selecting User ID (1 or 2)................................11
FR Sélection de l’ID Utilisateur
(1 ou 2)
NL Gebruikers-ID selecteren
(1of 2)
DE Auswahl der Benutzer-ID
(1oder 2)
RU
(1 2)
IT Selezione dell’ID utente
(1o2)
TR Kullanıcı Kimliğini Seçme
(1veya 2)
ES Selección de ID de usuario
(1o 2) ˻ϭ˺ϡΩΧΗγϣϟΔϳϭϫΩϳΩΣΗAR
8Taking a Measurement...................................12
FR Réalisation d’une mesure NL Een meting verrichten
DE Eine Messung vornehmen RU
IT Misurazione TR Bir Ölçüm Yapma
ES Obtención de una lectura αΎϳϗ˯έΟ·AR
1
9Checking Readings in Comparison Mode......16
FR Vérification des mesures en
mode de comparaison
NL Metingen bekijken in
vergelijkingsmodus
DE Überprüfen von Messwerten
im Vergleichsmodus
RU
IT Controllo dei risultati in
modalità Confronto
TR Karılatırma Modunda
Ölçüm Değerlerini Kontrol
Etme
ES Comprobación de
las lecturas en modo
comparativo
ΔϧέΎϘϣϟϊοϭϲϓΕ˯έϘϟϥϣϖϘΣΗϟ
AR
10
Using Memory Functions...............................21
FR Utilisation des fonctions de
mémoire
NL Geheugenfuncties
gebruiken
DE Verwendung der
Speicherfunktionen
RU
IT Uso delle funzioni di
memoria
TR Hafıza Fonksiyonunun
Kullanılması
ES Uso de las funciones de
memoria ΓέϛΫϟϑΎυϭϡΩΧΗγAR
11
Other Settings.................................................24
FR Autres réglages NL Andere instellingen
DE Weitere Einstellungen RU
IT Altre impostazioni TR Diğer Ayarlar
ES Otros ajustes ϯέΧϷΕΩΩϋϹAR
12
Optional Medical Accessories........................26
FR Accessoires médicaux en
option
NL Optionele medische
accessoires
DE Medizinisches optionales
Zubehör
RU
IT Accessori medicali opzionali TR Opsiyonel Tıbbi Aksesuarlar
ES Accesorios médicos
opcionales ΔϳέΎϳΗΧϻΔϳΑρϟΕΎϘΣϠϣϟAR
13
Other Optional Parts.......................................27
FR Autres pièces en option NL Overige optionele
onderdelen
DE Weitere optionale Teile RU
IT Altri componenti opzionali TR Diğer Aksesuarlar
ES Otras piezas opcionales ϯέΧΔϳέΎϳΗΧ˯ίΟAR
2
3
1 Package Contents
FR Contenu de l’emballage NL Inhoud van de verpakking
DE Packungsinhalt RU Комплект поставки
IT Contenuto della confezione TR Paketin İçindekiler
ES Contenido del envase ΔΑϠόϟΕΎϳϭΗΣϣ AR
1
Instruction Manual
2
Instruction Manual
4
2Preparing for a Measurement
FR Préparation pour une prise de mesure NL Een meting voorbereiden
DE Vorbereiten einer Messung RU Подготовка к измерению
IT Preparazione per la misurazione TR Ölçüm Hazırlığı
ES Preparación para una medición αΎϳϘϟΔϳϠϣόϟίϳϬΟΗϟAR
30 minutes before
FR 30minutes avant
DE 30 Minuten vorher
IT 30 minuti prima
ES 30minutos antes
NL 30 minuten ervoor
RU 30
TR 30 dakika önce
AR
5 minutes before: Relax and rest.
FR 5minutes avant: détente et repos.
DE 5 Minuten vorher: ruhig hinsetzen.
IT 5 minuti prima: rilassarsi e stare a riposo.
ES 5minutos antes: relájese y descanse.
NL 5 minuten ervoor: ontspan en rust.
RU 5 : .
TR 5 dakika önce: Geveyin ve dinlenin.
AR
ΔϘϳϗΩ˼˹ώϠΑΗΓΩϣΑαΎϳϘϟϝΑϗ
˶ΥέΗγϭΡέΗγϖΎϗΩ˾ώϠΑΗΓΩϣΑαΎϳϘϟϝΑϗ
5
3Inserting Batteries
FR Mise en place des piles NL De batterijen plaatsen
DE Einlegen von Batterien RU Установка элементов питания
IT Inserimento delle batterie TR Pilleri Takma
ES Introducción de las pilas ΕΎϳέΎρΑϟϝΎΧΩ·AR
AA, 1.5V × 4
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Omron Healthcare HEM-7360-E Manuel utilisateur
- Catégorie
- Unités de pression artérielle
- Taper
- Manuel utilisateur
dans d''autres langues
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