4. Error Messages and Troubleshooting
4.1 Error Messages
4.2 Troubleshooting
5. Maintenance and Storage
5.1 Maintenance
To protect your device from damage, please observe the following:
• Store the device and the components in a clean, safe
location.
• Do not use any abrasive or volatile cleaners.
• Do not wash the device and any components or immerse
them in water.
• Do not use petrol, thinners or similar solvents to clean the
device.
• Use a soft and dry cloth, or a soft and moistened cloth and
neutral soap to clean on the monitor and the arm cuff.
• Changes or modification not approved by the manufacturer
will void the user warranty. Do not disassemble or attempt to
repair the device or components. Consult your authorised
OMRON retail outlet or distributor.
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 device inspected
every 2 years to ensure correct functioning and accuracy.
Please consult your authorised OMRON retail outlet or
distributor.
5.2 Storage
Keep the device in its storage case when not in use.
1.
Unplug the air plug from the air jack.
2.
Gently fold the air tube into the arm cuff.
Note: Do not bend or crease the air tube excessively.
3.
Place the monitor and the arm cuff in the
storage case.
Do not store the device in the following situations:
• If the device is wet.
• Locations exposed to extreme temperatures,
humidity, direct sunlight, dust or corrosive vapours
such as bleach.
• Locations exposed to vibrations, shocks or where
it will be at an angle.
5.3 Optional Medical Accessories
(within the scope of EC Medical Device Directive 93/42/EEC)
Using the Optional AC Adapter
1.
Insert the AC adapter plug
into the AC adapter jack on
the rear side of the monitor.
2.
Plug the AC adapter into an
electrical outlet.
To disconnect the AC adapter, unplug the AC adapter from the electrical outlet
first and then remove the AC adapter plug from the monitor.
6. Specifications
Notes:
• These specifications are subject to change without notice.
• In the clinical validation study, the 5th phase was used on 85 subjects for
determination of diastolic blood pressure.
• This device is clinically investigated according to the requirements of
ISO 81060-2:2013.
• This device has not been validated for use on pregnant patients.
• IP classification is degrees of protection provided by enclosures in
accordance with IEC 60529.
• This device fulfils the provisions of EC directive 93/42/EEC (Medical Device
Directive).
• 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.
7. 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 guaranteed by OMRON for a period of 3 years after the date of
purchase. The proper construction, workmanship and materials of this product is
guaranteed by OMRON. During this period of guarantee OMRON will, without
charge for labour or parts, repair or replace the defect product or any defective
parts.
The guarantee 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 guaranteed 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 guarantee.
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, AC Adapter.
Should guarantee 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 guarantee does not give rise to any extension or
renewal of the guarantee period.
The guarantee will be granted only if the complete product is returned together with
the original invoice / cash ticket issued to the consumer by the retailer.
8. Some Useful Information about Blood Pressure
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.
Why is it a Good Thing to measure Blood Pressure at Home?
Many factors such as physical activity,
anxiety, or the time of day, can influence your
blood pressure. A single measurement may
not be sufficient for an accurate diagnosis.
Thus it is best to try and measure your blood
pressure at the same time each day, to get
an accurate indication of any changes in
blood pressure. Blood pressure is typically
low in the morning and increases from afternoon to evening. It is lower in the
summer and higher in the winter.
How is Hypertension related to Stroke?
Hypertension (high blood pressure) is the key risk factor for Stroke.
It is estimated that amongst hypertensive patients, effective treatment would
prevent 1 in 4 haemorrhagic strokes (bleeding around the brain).
Hypertension guidelines have endorsed the use of Home Blood Pressure
Monitoring in addition to the measurements in physicians’ offices to help manage
hypertension effectively.
References to above medical claims are available upon request.
Made in Vietnam
Error Display
Cause
Solution
Irregular heartbeats are
detected.
Remove the arm cuff. Wait 2 - 3
minutes and then take another
measurement. Repeat the steps
in section 3.3. If this error
continues to appear, contact
your physician.
Movement during measurement.
Carefully read and repeat the
steps in section 3.3.
Arm cuff is applied too loosely.
Apply the arm cuff tighter.
Refer to section 3.1.
The batteries are low.
Recommend to replace the
batteries with new ones ahead
of time.
Refer to section 2.1.
The batteries are depleted.
Replace 4 batteries with new
ones at once.
Refer to section 2.1.
Air plug disconnected.
Insert the plug securely.
Refer to section 3.1.
Arm cuff is applied too loosely.
Apply the arm cuff tighter.
Refer to section 3.1.
Air is leaking from the arm cuff.
Replace the cuff with a new one.
Refer to section 5.3.
Movement during measurement
and the arm cuff has not been
inflated sufficiently.
Repeat measurement. Remain
still and do not talk during
measurement.
Refer to section 3.3.
If “E2” appears repeatedly,
inflate the cuff manually until it is
30 to 40 mmHg above your
previous measurement result.
Refer to section 3.3.
The arm cuff was inflated
exceeding the maximum
allowable pressure, and then
deflated automatically.
Do not touch the arm cuff and/or
bend the air tube while taking a
measurement. Do not inflate the
arm cuff more than necessary.
Refer to section 3.3.
Movement during measurement. Repeat measurement. Remain
still and do not talk during
measurement.
Refer to section 3.3.
Movement during measurement.
Clothing is interfering with the
arm cuff.
Remove any clothing interfering
with the arm cuff.
Refer to section 3.1.
Device error.
Contact your OMRON retail
outlet or distributor.
Problem
Cause
Solution
The measurement
result is extremely
high (or low).
Arm cuff is applied too
loosely.
Apply the arm cuff tighter.
Refer to section 3.1.
Movement or talking during
measurement.
Remain still and do not talk
during measurement.
Refer to section 3.3.
Clothing is interfering with
the arm cuff.
Remove any clothing
interfering with the arm cuff.
Refer to section 3.1.
Arm cuff pressure
does not rise.
The air connector is not
securely connected into the
air jack.
Make sure that the air tube
is connected securely.
Refer to section 3.1.
Air is leaking from the arm
cuff.
Replace the arm cuff with a
new one.
Refer to section 5.3.
Arm cuff deflates too
soon.
The arm cuff is loose.
Apply the cuff correctly so
that it is firmly wrapped
around the arm.
Refer to section 3.1.
Cannot measure or
the results are too low
or too high.
The arm cuff has not been
inflated sufficiently.
Inflate the cuff so that it is 30
to 40 mmHg above your
previous measurement
result.
Refer to section 3.3.
Nothing happens
when you press the
buttons.
The batteries are depleted.
Replace 4 batteries with
new ones.
Refer to section 2.1.
The batteries have been
inserted incorrectly.
Insert the batteries with the
correct (+/-) polarity.
Refer to section 2.1.
Other problems.
• Press the START/STOP button and repeat
measurement.
• Replace the batteries with new ones.
If the problem continues, contact your OMRON retail outlet
or distributor.
Arm cuff
AC adapter
Arm circumference
22 - 42 cm
HEM-FL31
AC ADAPTER-S
(60240HW5SW)
AC ADAPTER-UK
(60240H7000SW)
Product category
Electronic Sphygmomanometers
Product description
Automatic Upper Arm Blood Pressure Monitor
Model (code)
M3 Comfort (HEM-7134-E)
Display
LCD Digital Display
Measurement
method
Oscillometric method
Measurement range
Pressure: 0 to 299 mmHg
Pulse: 40 to 180 beats/min.
Accuracy
Pressure: ±3 mmHg
Pulse: ±5% of display reading
Inflation
Fuzzy-logic controlled by electric pump
Deflation
Automatic pressure release valve
Memory
60 measurements with date and time for each user (1 and 2)
Rating
DC6V 4W
Power source
4 “AA” batteries 1.5V or optional AC adapter
(AC ADAPTER-S, INPUT AC100-240V 50/60Hz 0.12A)
(AC ADAPTER-UK, INPUT AC100-240V 50/60Hz 15VA)
Battery life
Approx. 1000 measurements (using new alkaline batteries)
Applied part
= Type BF
Protection against
electric shock
Internally powered ME equipment (When using only the
batteries)
= Class II ME equipment (Optional AC adapter)
Operating
temperature /
humidity /
air pressure
+10 to +40°C / 30 to 85% RH / 700 to 1060 hPa
Storage
temperature /
humidity /
air pressure
-20 to +60°C / 10 to 95% RH / 700 to 1060 hPa
IP classification
IP 20
Weight
Monitor: Approx. 300 g without batteries
Arm cuff: Approx. 163 g
Outer dimensions
Monitor: Approx. 107 (w) mm x 79 (h) mm x 141 (l) mm
Arm cuff: Approx. 145 mm x 532 mm
Cuff circumference
22 to 42 cm
Cuff / Tube material
Nylon, polyester, polyvinyl chloride
Package contents
Monitor, arm cuff, instruction manual, storage case,
battery set, blood pressure pass
Important information regarding Electro Magnetic Compatibility (EMC)
With the increased number of electronic devices such as PC’s and mobile (cellular)
telephones, medical devices in use may be susceptible to electromagnetic
interference from other devices. Electromagnetic interference may result in
incorrect operation of the medical device and create a potentially unsafe situation.
Medical devices should also not interfere with other devices.
In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with
the aim to prevent unsafe product situations, the EN60601-1-2:2007 standard has
been implemented. This standard defines the levels of immunity to
electromagnetic interferences as well as maximum levels of electromagnetic
emissions for medical devices.
This medical device manufactured by OMRON HEALTHCARE conforms to this
EN60601-1-2:2007 standard for both immunity and emissions.
Nevertheless, special precautions need to be observed:
• Do not use mobile (cellular) telephones and other devices, which generate strong
electrical or electromagnetic fields, near the medical device. This may result in
incorrect operation of the device and create a potentially unsafe situation.
Recommendation is to keep a minimum distance of 7 m. Verify correct operation
of the device in case the distance is shorter.
Further documentation in accordance with EN60601-1-2:2007 is available at
OMRON HEALTHCARE EUROPE at the address mentioned in this instruction
manual.
Documentation is also available at www.omron-healthcare.com.
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
wastes for disposal.
Manufacturer
OMRON HEALTHCARE Co., Ltd.
53, Kunotsubo, Terado-cho, Muko, KYOTO,
617-0002 JAPAN
EU-representative
OMRON HEALTHCARE EUROPE B.V.
Scorpius 33, 2132 LR Hoofddorp,
THE NETHERLANDS
www.omron-healthcare.com
Production facility
OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD.
No.28 VSIP II, Street 2, Vietnam-Singapore Industrial Park II,
Binh Duong Industry-Services-Urban Complex,
Hoa Phu Ward, Thu Dau Mot City,
Binh Duong Province, Vietnam
Subsidiaries
OMRON HEALTHCARE UK LTD.
Opal Drive, Fox Milne, Milton Keynes, MK15 0DG, UK
www.omron-healthcare.com
OMRON MEDIZINTECHNIK HANDELSGESELLSCHAFT mbH
Gottlieb-Daimler-Strasse 10, 68165 Mannheim, GERMANY
www.omron-healthcare.com
OMRON SANTÉ FRANCE SAS
14, rue de Lisbonne, 93561 Rosny-sous-Bois Cedex, FRANCE
www.omron-healthcare.com
Example: fluctuation within a day (male, 35 years old)
mmHg
200
150
100
50
6
12
18
24
Upper curve: systolic blood pressure
Lower curve: diastolic blood pressure
Time of day
