Omron X2 Essential Bedienungsanleitung
Omron
Blutdruckmessgerät
X2 Essential
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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.
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 these 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.
Intended Use
Intended Purpose
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 indicates this via a symbol with the measurement result.
Intended Patients
Adult patient population
Intended Users
Adult population (may include patients themselves) who can
understand this instruction manual.
Clinical Benefit
Patient’s blood pressure can be measured non-invasively and simply
in the home environment.
Type of Use
This monitor is intended to be multiple patient multiple use.
Limitation
Patient’s arm circumference must be 17 - 42 cm.
Indication
This device is used by healthy individuals, patients with hypertension,
patients with health-conscious individuals, in a general household
situation for measuring blood pressure and pulse rate.
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.
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.
Contraindications
• 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 on infants, toddlers, children or persons
who cannot express themselves.
Side Effects
• Taking measurements more often than necessary may cause
bruising due to blood flow interference.
• 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 the end of instruction manual
2 for additional information.
• Stop using this monitor and consult with your physician if you
experience skin irritation or discomfort.
Warning
Indicates a potentially hazardous
situation which, if not avoided, could
result in death or serious injury.
• DO NOT adjust medication (including altering your use of any drug
or treatment) 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 heart
related conditions.
• NEVER diagnose or treat yourself based on your readings. ALWAYS
consult with your physician.
• If you are experiencing any symptoms or concerns, consult with
your physician.
• DO NOT postpone/stop regular checkups or physician visits based
on the results that you are getting from this monitor.
• 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.
• 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 the batteries out of the reach of infants, toddlers and children.
Precaution
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.
• Consult with your physician before using this monitor on an arm
where intravascular access or therapy, or an arterio-venous (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 or lymph node clearance.
• Consult with your physician before using this monitor if you have
severe blood flow problems or blood disorders as cuff inflation can
cause bruising.
• 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 emits 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 4.
• During measurement, observe the arm to ensure that the monitor
is not causing prolonged impairment to blood circulation.
• DO NOT use this monitor with other medical electrical (ME)
equipment simultaneously. This may result in incorrect operation
of the devices 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.
It is recommended that you wait 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 4.
• DO NOT use this monitor after the durable period has ended. Refer
to section 4.
• 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.
• Read and follow the “Correct Disposal of This Product” in section 5
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 wiping 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 the 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 the batteries to ensure they are in good working
condition.
General Notices
• 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.
• Replacing batteries will not delete previous readings.
If any of the below problems occur during measurement, check to
make sure that no other electrical device is within 30 cm of the
monitor. If the problem persists, refer to the table below.
Instruction Manual 1: Safety and Other Information
For symbols information, refer to “Symbols Description” section.
X2 Essential (HEM-7188-EO)
IM1-HEM-7188-EO-EN/DA-02-11/2024
Automatic Upper Arm Blood Pressure Monitor
English
A
B
C
Display
[Memory] button
[START/STOP] button
Battery compartment
Air jack
Arm cu
Air plug
Air tube
AC adapter jack
(for optional AC adapter)
A
B
C
D
E
F
G
H
I
D
F
E
G
H
I
Introduction
Important Safety Information
1 Error Messages and Troubleshooting
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.
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 4 of
instruction manual 2.
Air is leaking from
the arm cuff.
Replace the arm cuff
with a new one. Refer
to section 10 of
instruction manual 2.
appears or a
measurement
cannot be
completed after the
arm cuff inflates.
Moving or talking
during a
measurement causes
the arm cuff to 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 the
end of instruction
manual 2.
The systolic pressure
is above 210 mmHg
and 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 the
end of instruction
manual 2.
appears
Moving or talking
during a
measurement results
in vibrations that
disrupt the
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 4 of
instruction manual 2.
Remain still and sit
correctly during a
measurement.
appears
The monitor has
malfunctioned.
Press the [START/STOP]
button again. If “Er”
still appears, contact
your OMRON retail
outlet or distributor.
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 a high level of comfort,
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, visit our website (www.omron-healthcare.com) for contact
information.
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.
3.1 Maintenance
To protect your monitor from damage, follow the directions below:
Changes or modifications not approved by the manufacturer will void
the user warranty.
Precaution
DO NOT disassemble or attempt to repair this monitor or other
components. This may cause an inaccurate reading.
3.2 Storage
• Store your monitor and other components in a clean, safe location.
• Gently fold the air tube into the arm cuff. Note: Do not bend or
crease the air tube excessively.
• 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.
3.3 Wiping the Monitor
• Do not use any abrasive or volatile cleaners.
• Use a soft dry cloth or a soft cloth moistened with mild (neutral)
detergent to wipe 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 wipe your
monitor and arm cuff or other components.
3.4 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.
Note
• These specifications are subject to change without notice.
• This monitor is clinically investigated according to the
requirements of EN ISO 81060-2:2014 and complies with
EN ISO 81060-2:2019+A1:2020+A2:2024 (excluding pregnant and
pre-eclampsia patients). In the clinical validation study, K5 was
used on 85 subjects for determination of diastolic blood pressure.
• 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 monitor and optional AC adapter
HHP-CM01 are protected against vertically falling water drops
which may cause issues during a normal operation. The optional
AC adapter HHP-BFH01 is protected against oblique falling water
drops which may cause issues during a normal operation.
• Operation mode classification complies with IEC 60601-1.
This device conforms to the EN 60601-1-2:2015+A1:2021
Electromagnetic Compatibility (EMC) standard.
Further documentation in accordance with this EMC standard is
available at
https://healthcare.omron.com/electro-magnetic-compatibility
Refer to the EMC information for this device on the website.
• 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.
appears
The pulse rate is not
detected correctly.
Apply the arm cuff
correctly, then take
another measurement.
Refer to section 4 of
instruction manual 2.
Remain still and sit
correctly during a
measurement.
If the irregular
heartbeat symbol
“” continues to
appear, it is
recommended that
you consult with your
physician.
/
appears
does not flash during
a measurement
flashes
Batteries are low.
Replacing all 4
batteries with new
ones is recommended.
Refer to section 3 of
instruction manual 2.
and
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 2.
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 2.
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 sections 2, 4 and 5 of
instruction manual 2.
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 the batteries. If the problem
still persists, contact your OMRON retail outlet
or distributor.
2 Limited Warranty
3 Maintenance
4 Specifications
Product Category Electronic Sphygmomanometers
Product description Automatic Upper Arm Blood
Pressure Monitor
Model (Code) X2 Essential (HEM-7188-EO)
Display LCD digital display
Cuff pressure range 0 to 299 mmHg
Blood pressure measurement
range
SYS: 60 to 260 mmHg
DIA: 40 to 215 mmHg
Pulse measurement range 40 to 180 beats / min.
Accuracy Pressure: ±3 mmHg
Pulse: ±5 % of display reading
Measurement method Oscillometric method
Operation mode Continuous operation
IP classification Monitor: IP21
Optional AC adapter:
IP21 (HHP-CM01) or IP22
(HHP-BFH01)
Rating DC6V 4W
Power source 4 “AA” batteries 1.5 V or optional
AC adapter (INPUT AC 100 - 240 V
50 - 60 Hz 0.12 - 0.065 A)
Battery life Approx. 900 measurements (Using
new alkaline batteries and
included arm cuff. Depending on
the type of battery and arm cuff.)
Durable period (Service life) Monitor: 5 years or the time when
reaching 30000 times of use. /
Cuff: 5 years or the time when
reaching 10000 times of use. /
Optional AC adapter: 5 years
Operating conditions +10 to +40 °C / 15 to 90 % RH
(non-condensing) /
800 to 1060 hPa
Storage / Transport conditions -20 to +60 °C / 10 to 90 % RH
(non-condensing)
Weight Monitor: approx. 260 g
(not including batteries)
Arm cuff: approx. 110 g
Dimensions Monitor: approx. 98 mm (W) ×
79 mm (H) × 138 mm (L) / Arm
cuff: approx. 146 mm × 466 mm
(air tube: 610 mm)
Cuff circumference applicable
to the monitor
17 to 42 cm (included arm cuff:
22 to 32 cm)
Memory Stores up to 30 readings
Contents Monitor, arm cuff (HEM-CR24),
4 “AA” batteries,
Instruction Manual 1 and 2
Protection against electric
shock
Internally powered ME equipment
(when using only batteries)
Class II ME equipment (when
using optional AC adapter)
Applied part Type BF (arm cuff)
Display/Problem Possible Cause Solution
5 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.
6 Important Information regarding
Electromagnetic Compatibility (EMC)
7 Guidance and Manufacturer’s
Declaration
Produktspezifikationen
| Marke: | Omron |
| Kategorie: | Blutdruckmessgerät |
| Modell: | X2 Essential |
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