Operation Manual

3.4 Turning “OFF” Bluetooth
®
Turn off the Bluetooth
®
in your monitor in the following areas where use
of wireless equipment is prohibited.
• On aircraft • In hospitals • While abroad
Your blood pressure monitor comes with the Bluetooth
®
already turned
on.
1. Turn your monitor power off if it is turned on.
2. Press and hold the connection button for more than
10 seconds.
3. Release the connection button when “ ” appears on
the display.
4. Press the [START/STOP] button to turn the monitor off.
Note: The monitor will automatically turn off after 2 minutes.
How to turn “ON” Bluetooth
®
Operate the following step when the power has been off.
Press and hold the connection button for more than 2 seconds and
then release the connection button when
“” appears on the
display.
3.5 Restoring Your Monitor to the Default Settings
To delete all the information stored in your monitor, follow the instructions
below. Make sure that your monitor is turned off. It will be off when the
screen is not showing numbers or symbols.
1. While holding the connection button down, the Connection
symbol “ ” and “P” appear on the display, and then press
the [START/STOP] button for more than 5 seconds.
2. When the “Clr” symbol appears on the display, release the
connection button and [START/STOP] button.
The “Clr” will appear on the display when your monitor settings have
reverted back to their original.
3. Press the [START/STOP] button to turn the monitor off.
Notes:
• The monitor will automatically turn off after 2 minutes.
• Reverting to initial settings of this monitor will not delete the information
in the app.
• When using this monitor again, please delete the registration of the
monitor in the app first, and then pair your monitor.
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 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 device is clinically investigated according to the requirements of
ISO81060-2:2013.
• 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 is protected against solid foreign objects of 12 mm
diameter and greater such as a finger, and against oblique falling water drops
which may cause issues during a normal operation.
• 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.
• 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.
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
®
Smart 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.
* : “XX” will change to
display an error
number, 6 and
higher.
Device error.
Contact your local OMRON
representative.
(2 sec.) (8 sec.)
*
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
transmission 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
Product category
Electronic Sphygmomanometers
Product description
Automatic Upper Arm Blood Pressure Monitor
Model (code)
EVOLV (HEM-7600T-E)
Display OLED display
Cuff pressure range Pressure: 0 to 299 mmHg
Measurement range Pressure: 40 to 260 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 rapid deflation
Measurement method Oscillometric method
Transmission method
Bluetooth Smart
Wireless communication Frequency range: 2.4 GHz (2400 - 2483.5 MHz)
Modulation: GFSK
Effective radiated power: <20 dBm
IP classification IP 22
Power source
4 “AAA” batteries 1.5V
Battery life Approximately 300 measurements
(using new alkaline batteries)
Durable period (Service life) Monitor: 5 years
Operating conditions 10°C to 40°C / 15 to 90% RH (non-condensing) /
800 to 1060 hPa
Storage / Transport
conditions
-20°C to 60°C / 10 to 90% RH (non-condensing)
Weight Monitor: Approximately 240 g
(not including batteries)
Dimensions Monitor: Approximately 85 mm × 120 mm × 20 mm
(not including the arm cuff)
Arm circumference 22 to 42 cm
Contents Monitor, battery set, instruction manual, setup instructions,
storage case
Applied part Type BF
Protection against electric
shock
Internally powered ME equipment
®
®
®
®
®
®
Symbol descriptions
Please consult this instruction manual
Applied part - Type BF
Degree of protection against electric shock (leakage
current)
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.
Temperature limitation
Humidity limitation
Atmospheric pressure limitation
Artery mark
Product production date is integrated in a Serial or LOT number, which placed
on the Rating Label and sales package: the first 2 digits mean year of
production, the next 2 digits - month of production.
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 omron-healthcare.com
.
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.
or
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 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
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
Made in Japan
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