4. Error Messages and Troubleshooting
4.1 Error Messages
4.2 Troubleshooting
In case of any of the below problems occur during measurement, first check that
no other electrical device is within 30cm. If the problem persists, please refer to
the table below.
5. Maintenance and Storage
5.1 Maintenance
To protect your device from damage, please follow the directions below:
• 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 gasoline, thinners or similar solvents to clean the device.
• Use a soft dry cloth, or a soft cloth moistened with neutral soap to clean on
the monitor and the arm cuff, and then wipe it with a dry cloth.
• Changes or modification not approved by the manufacturer will void the
user warranty. Do not disassemble or attempt to repair the device or
components.
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 OMRON
retail outlet or distributor.
5.2 Storage
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 vapors such as bleach.
• Locations exposed to vibrations, shocks or where it will be at an angle.
6. Specifications
Notes:
• These specifications are subject to change without notice.
• In the clinical validation study, K5 was used on 85 subjects for determination of
diastolic blood pressure.
• This monitor is clinically investigated according to the requirements of
EN ISO 81060-2:2014 and complies with EN ISO 81060-2:2014 and
EN ISO 81060-2:2019 + A1:2020 (excluding pregnant and pre-eclampsia
patients).
• This device has been validated for use on pregnant and pre-eclampsia patients
according to the Modified European Society of Hypertension Protocol*.
• IP classification is degrees of protection provided by enclosures in accordance
with IEC 60529. This device is protected against solid foreign objects of 12.5 mm
diameter and greater such as a finger, and against oblique falling water drops
which may cause issues during a normal operation.
• This device can be used for continuous operation.
• 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.
• Hereby, OMRON HEALTHCARE Co., Ltd., declares that the radio equipment
type EVOLV (HEM-7600T-E) is in compliance with Directive 2014/53/EU.
The full text of the EU declaration of conformity is available at the following
internet address: www.omron-healthcare.com
• 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.
Use this monitor only in the member countries of EU or the country you purchased
it in. If you use it elsewhere, you may violate the radio laws or regulations of that
country.
7. Trademarks
The Bluetooth
®
word mark and logos are registered
trademarks owned by Bluetooth SIG, Inc. and any use of such
marks by OMRON HEALTHCARE Co., Ltd. is under license.
Other trademarks and trade names are those of their
respective owners.
Apple and the Apple logo are trademarks of Apple Inc., registered in the U.S. and
other countries. App Store is a service mark of Apple Inc.
Android, the Google Play logo are trademarks of Google Inc.
8. 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 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.
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.
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.
9. 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.
Error Display Cause Solution
Irregular heartbeat is
detected.
Remove the arm cuff. Wait
2 - 3 minutes and then take
another measurement.
Repeat the steps in section
3.1. 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 replacement of
all 4 batteries with new ones.
Refer to section 2.1.
The batteries are
depleted or battery
polarities are not
properly aligned.
Immediately replace
4 batteries with new ones.
Refer to section 2.1.
Confirm the batteries are
properly inserted with
polarities correctly aligned.
Refer to section 2.1.
Connection failure.
Data is not being
transmitted.
Refer to “Connection failure.
Data is not being
transmitted.” in section 4.2.
Arm cuff is applied
too loosely.
Apply the arm cuff tighter.
Refer to section 3.1.
The arm cuff was
inflated exceeding
the maximum
allowable pressure,
and then deflated
automatically.
Do not touch the arm cuff
while taking a measurement.
Refer to section 3.3.
Movement during
measurement.
Repeat 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.
Movement during
measurement.
Repeat measurement.
Remain still and do not talk
during measurement.
Refer to section 3.3.
Arm cuff is not
applied correctly.
Apply the arm cuff correctly.
Refer to section 3.1.
* : “XX” will change to
display an error
number, 6 and
higher.
Device error.
Contact your local OMRON
representative.
Problem Cause and Solution
No power.
No display appears on the
monitor.
Replace all batteries with new ones.
Check the battery installation for proper
placement of the battery polarities.
Refer to section 2.1.
Measurement values appear
too high or too low.
Blood pressure varies constantly. Many
factors including stress, time of day, and how
you apply the arm cuff, may affect your blood
pressure.
Review the section, 3.2 and 3.3.
Connection failure. /
Data is not being transmitted.
The blood pressure monitor might not be
properly placed within the smart device's
t
r
ansmission range and is too far from the
smart device. If there are no causes of data
transmission interference found near the
blood pressure monitor, move the blood
pressure monitor within 5 m (16 ft.) of the
smart device and try again.
The Bluetooth feature of the smart device
is turned off. Turn on the Bluetooth feature
of the smart device and your monitor, and try
sending the data again.
The Bluetooth feature of the blood
pressure monitor is turned off.
Refer to “To turn “ON” the Bluetooth ” in
“3.4 Turning “OFF” the Bluetooth ”.
The blood pressure monitor did not pair
successfully to the smart device. Try to pair
the devices again.
Refer to “Pairing Your Monitor with a Smart
Device” in section 2.2.
For more detail, go to “Help” in the “OMRON
connect” app.
The application on the smart device is not
ready. Check the application then try sending
the data again.
Refer to “Pairing Your Monitor with a Smart
Device” in section 2.2. If the “Err” symbol still
displays after checking the application,
contact your OMRON retail outlet or
distributor. Confirm your smart device
compatibility with this monitor at
omronconnect.com
Symbols description
Applied part - Type BF
Degree of protection against electric shock
(leakage current)
Class II equipment. Protection against
electric shock
Ingress protection degree provided by
IEC 60529
CE Marking
Metrology symbol
Symbol of Eurasian Conformity
Serial number
LOT number
Medical device
Temperature limitation
Humidity limitation
Atmospheric pressure limitation
Indication of connector polarity
For indoor use only
or
OMRON’s trademarked technology for blood
pressure measurement
Identifier of cuffs compatible for the device
Cuff positioning indicator for the left arm
Marker on the cuff to be positioned above the
artery
Range pointer and brachial artery alignment
position
or
Manufacturer's quality control mark
Not made with natural rubber latex
Range indicator of arm circumferences to
help selection of the correct cuff size.
Need for the user to consult this instruction
manual.
Need for the user to follow this instruction
manual thoroughly for your safety.
Direct current
Alternating current
Date of manufacture
Technology by OMRON Healthcare in Japan
To indicate generally elevated, potentially
hazardous, levels of non-ionizing radiation, or
to indicate equipment or systems e.g. in the
medical electrical area that include RF
transmitters or that intentionally apply RF
electromagnetic energy for diagnosis or
treatment.
Arm circumference
Wrist circumference
OMRON connect - App for uploading
measurement data to smart device.
Important information regarding Electromagnetic Compatibility (EMC)
HEM-7600T-E manufactured by OMRON HEALTHCARE Co., Ltd. conforms
to 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
Refer to the EMC information for HEM-7600T-E on the website.
About a wireless communication interference
This Product operates in the unlicensed ISM band at 2.4GHz. In case this
Product is used around the other wireless devices including microwave and
wireless LAN, which operate same frequency band of this Product, there is a
possibility that interference occurs between this Product and such other
devices. If such interference occurs, please stop the operation of other
devices or relocate this Product before using this Product or do not use this
Product around the other wireless devices.
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.
Example: fluctuation within a day (male, 35 years old)
mmHg
200
150
100
50
61218 24
Upper curve: systolic blood pressure
Lower curve: diastolic blood pressure
Time of day
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
Importer in EU
Production facility
OMRON HEALTHCARE Co., Ltd.
Matsusaka Factory
1855-370, Kubo-cho, Matsusaka-shi,
Mie, 515-8503 Japan
Subsidiaries
OMRON HEALTHCARE UK LTD.
Opal Drive, Fox Milne, Milton Keynes, MK15 0DG, UK
www.omron-healthcare.com
OMRON MEDIZINTECHNIK HANDELSGESELLSCHAFT mbH
Konrad-Zuse-Ring 28, 68163 Mannheim, GERMANY
www.omron-healthcare.com
OMRON SANTÉ FRANCE SAS
3, Parvis de la Gare, 94130 Nogent-sur-Marne, FRANCE
www.omron-healthcare.com
Made in Japan
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