9. Some Useful Information about Blood Pressure ...........28
2
Introduction
The OMRON M6 Comfort is a compact, fully automatic blood
pressure monitor, operating on the oscillometric principle. It
measures your blood pressure and pulse rate simply and
quickly. For comfortable controlled inflation without the need of
pressure pre-setting or re-inflation the devices uses its
advanced “IntelliSense” technology.
The device also stores up to 90 measurements in memory and
calculates an average value based on the last three
measurements taken within 10 minutes. Each measurement is
stored along with the date and time of measurement.
Please read this instruction manual thoroughly before
using the unit. Please keep for future reference.
For specific information about your own blood pressure,
CONSULT YOUR DOCTOR.
EN
3
Important Safety Information
• Blood pressure measurement is not suitable in cases of
serious arteriosclerosis (hardening of the arteries).
• The pulse display is not suitable for monitoring the frequency
of cardiac pacemakers.
• Pregnant women should only measure their own blood
pressure in consultation with their doctor, since the readings
can be changed by pregnancy.
• Do not use the monitor on babies, young children or persons
who cannot express their consent.
• Do not use the monitor for any purpose other than measuring
blood pressure.
• The battery liquid may leak and damage the monitor. Please
observe the following points.
- When you are not going to use the unit for a long period of time
(approximately three months or more), take out the batteries.
- Replace old batteries with new ones immediately.
- Do not use old and new batteries together.
- Do not insert the batteries with their polarities incorrectly aligned.
• Please remember: Self-measurement is not the same as
medical treatment.
• You should never change the dose of medicines prescribed
by your doctor but you can help your doctor to optimize the
treatment by documenting the measured values. If there are
unusual values, please inform your doctor immediately.
• Never unplug the power cord with wet hands.
• Use only the original AC adapter designed for this unit. Use of
unsupported adapters may damage the device.
Read and follow the “Important information regarding Electro
Magnetic Compatibility (EMC)” in the Technical Data Section.
4
1. Overview
Monitor
1.Overview
A
E
B
D
C
A. Display
B. O/I START button
C. Memory () buttons
D. Date/Time () setting
button
F
E. Battery compartment
F. Air j ack
G. AC adapter jack (for optional
AC adapter)
G
EN
5
1.Overview
Display
H. Systolic blood pressure
I. Diastolic blood pressure
J. Memory symbol
K. Average value symbol
L. Movement error symbol
M. Irregular heartbeat symbol
N. Battery low symbol
Package contents
S
H
I
J
K
L
M
N
O. Heartbeat symbol
P. Pulse display
Q. Deflation symbol
R. Date/Time display
O
P
Q
R
1. Flashes during measurement
2. If flashing after measurement
complete indicates blood
pressure out of recommended
range
S. Arm cuff (Arm circumference
22-42 cm)
T. Air p lug
U. Air tube
6
V
UT
W
V. Storage case
W. Four “AA” alkaline (LR6)
batteries
2. Preparation
2.1Installing/Replacing the Batteries
1. Remove the battery cover.
2. Insert four “AA” batteries as
indicated in the battery compartment
and then replace the battery cover.
Notes:
• If the battery low symbol () appears on the display, replace
all four batteries at the same time.
- When the battery low symbol () starts to blink, you will still
be able to use the unit for a short while. You should replace
the batteries with new ones ahead of time. Long-life alkaline
batteries are recommended.
- When the symbol () remains lit, the batteries are
exhausted. You should replace the batteries with new ones
at once. Turn the unit off before replacing the batteries.
• Remove the batteries if the monitor will not be used for three
months or more.
• If the batteries are removed for 30 seconds or more, the Date/
Time setting will need to be reset. See “Setting the Date and
Time” for details.
• Disposal of used batteries should be carried out in accordance
with the national regulations for the disposal of batteries.
2.Preparation
EN
7
2.Preparation
2.2Setting the Date and Time
Your blood pressure monitor automatically stores up to 90
measurements values in its memory and calculates an average
reading based on the measurements from the last three
readings taken within 10 minutes.
• Set the monitor to the correct date and time before taking a
measurement for the first time.
• If the batteries have been removed for 30 seconds or more,
the date and time setting will need to be reset.
1. When the batteries are installed, the
year digits will flash in the display
when you turn on the monitor.
Note: If you need to reset the date
and time for some reason,
hold down the button while the power is off.
2. Press the button to advance
the digits one at a time.
To change the digits to a lower
number, press the button to
lower the digits one at a time.
If you hold down the or
button, the digits will advance (or lower) rapidly.
3. Press the button to confirm the
setting when the desired number
appears on the display.
8
2.Preparation
4. Repeat steps 2 and 3 to set the month and date (day).
or
or
5. Repeat steps 2 and 3 to set the hour and minutes for the time.
or
or
EN
6. Press the O/I START button when
you have finished setting the date
and time.
9
3.Using theUnit
3. Using the Unit
3.1How to Sit Correctly When Taking a Measurement
You can take a measurement on either your left or right arm.
Notes:
• Measurements should be taken in a quiet place and you
should be in a relaxed, seated position. Make sure that the
room is not too hot or cold.
• Avoid eating, smoking, or exercising for at least 30 minutes
before taking a measurement.
• Do not move or talk during measurement.
10
Correct
Posture
Sit upright
with your
back straight.
The gap between the
chair and the top of the
table should be between
25cm to 30cm.
Remove tight fitting clothing from
your upper arm, and any thick
clothing such as a sweater.
Do not place the cuff over thick
clothes and do not roll up your sleeve
if it is too tight.
Place your arm on a table so
that the cuff will be at the same
level as your heart.
3.Using the Unit
Notes:
• Correct posture during measurement is necessary to get
accurate results.
• You should also try to measure your blood pressure at the
same time each day. (Within 1 hour after waking up is
recommended.)
Incorrect Posture
• Arched back (leaning
forwards)
• Sitting cross-legged
• Sitting on a sofa or at a low
table so that you tend to lean
forward
These situations could lead to higher blood pressure values due to
strain or the arm cuff being lower than the heart.
If the arm cuff is at a lower position than your heart use cushions
etc., to adjust the height of your arm.
EN
11
3.Using the Unit
3.2Applying the Arm Cuff
You can wrap the cuff either on your right or left arm.
• Remove tight-fitting clothing from
your upper arm.
• Do not place the cuff over thick
clothes and do not roll up your
sleeve if it is too tight.
1. Insert the air plug into the air jack (on the left side of the
device).
Air jack
Air plug
The cuff must be fully deflated when it is inserted into the air
jack.
2. Sit in a chair with your feet flat on the floor and place your arm
on a table so that the cuff will be at the same level as your
heart.
12
1) Hold the grip on the cuff securely with
r
your hand.
2) Turn the palm of your hand upward.
3. Turn the palm of your hand upward.
Bottom edge 1 to 2cm
Blue strip
3.Using the Unit
Grip
Fabric fastene
Air tube
Apply the cuff to your upper arm so that the blue strip is centred
on the middle of your inner arm and points down the inside of
the arm. The air tube should run down the inside of your
forearm and be in line with your middle finger.
The bottom of the cuff should be approximately 1 to 2 cm
above the elbow.
13
EN
3.Using the Unit
4. When the cuff is positioned correctly,
close the fabric fastener FIRMLY.
Notes:
• Make certain the cuff fits snugly around your arm.
• The cuff should make good contact with your skin. You should
be able to fit your index finger between the cuff and your arm
easily, so you can pull the cuff off and on.
• Make sure that there are no kinks in the air tubing.
Taking measurements on the right arm
Please note the following points
when applying the cuff to your right
arm. Apply the cuff so that the air
tube is at the side of your elbow.
Notes:
• Be careful not to rest your arm on
the air tube, or otherwise restrict
the flow of air to the cuff.
• Apply the arm cuff so that no part
of the cuff is positioned over the
elbow joint. The cuff should be 1 to
2 cm above the elbow.
• If used 2 times per day, the cuff will last for 3 years.
14
3.Using the Unit
3.3Taking a Reading
1. Press the O/I START button and remain still, the cuff will start
to inflate automatically.
As the cuff begins to inflate, the monitor automatically
determines your ideal inflation level. Remain still and do not
talk until measurement is completed.
Note: Do not inflate the cuff if it is not wrapped around your
arm.
2. Inflation stops automatically
and measurement is started.
As the cuff slowly deflates,
decreasing numbers appear
on the display and the
Heartbeat display flashes at every heartbeat.
In rare circumstances, the monitor might re-inflate the cuff to
continue with the measurement.
EN
3. When the measurement is complete, the arm
cuff completely deflates and your blood
pressure and pulse rate are displayed.
Note: The monitor automatically stores the
blood pressure readings and pulse rate
along with date and time of measurement in its memory.
15
3.Using the Unit
4. Press the O/I START button to turn
the monitor off.
Note: If you forget to turn the
monitor off, it will
automatically shut itself off after five minutes.
Important:
• Wait 2-3 minutes before taking another blood pressure
measurement. Waiting between readings allows the arteries
to return to the condition prior to taking the blood pressure
measurement.
• If you move during measurement, the movement display
( ) may appear. Repeat the measurement and remain still
until the measurement is complete.
• Your blood pressure monitor includes an irregular heartbeat
feature. Irregular heartbeats can influence the results of the
measurement. The irregular heartbeat algorithm automatically
determines if the measurement is usable or needs to be
repeated. If the irregular heartbeat display ( ) is shown
after you have taken a measurement, repeat the
measurement. If the irregular heartbeat display ( ) is
shown frequently, please make your doctor aware of it.
• If your systolic blood pressure is above
135 mmHg or your diastolic blood pressure is
above 85 mmHg, the heartbeat symbol will blink
when the measurement result is displayed.
Recent research suggests that the following
values can be used as a guide to high blood
pressure for measurements taken at home.
This criteria is for home blood pressure measurement.
For professional office blood pressure measurement criteria,
please refer to Chapter 9 “Some Useful Information about
Blood Pressure”. Also in special cases (such as diabetics,
16
3.Using the Unit
N
heart- or circulation-disease) a lower limit of blood pressure
might be necessary and that it is recommended to consult the
doctor in such cases.
What is Irregular Heartbeat?
An irregular heartbeat is a
heartbeat rhythm that varies
Pulse
by more than 25% from the
average heartbeat rhythm
Blood pressure
detected while the unit is
measuring the systolic and
diastolic blood pressure.
If such an irregular rhythm is
detected more than twice
Blood pressure
Pulse
during measurement, the irregular heartbeat symbol ( )
appears on the symbol when the measurement results are
displayed.
What is Arrhythmia?
A heartbeat is stimulated by electrical signals that cause the
heart to contract.
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. This can be caused by heart disease,
aging, physical predisposition, stress, lack of sleep, fatigue etc.
Arrhythmia can only be diagnosed by a doctor through a
special examination.
Whether the appearance of the irregular heartbeat symbol
() in the results indicates arrhythmia or not can only be
determined by an examination and diagnosis by your doctor.
If the irregular heartbeat symbol () is shown frequently,
please make your doctor aware of it. Conducting self-diagnosis
and treatment based on measurement results is dangerous. Be
sure to follow the instructions of your doctor.
ormal Heartbeat
Irregular Heartbeat
Short
Long
EN
17
3.Using the Unit
3.4Instructions for Special Conditions
If your systolic pressure is known to
be more than 220 mmHg, after the
cuff starts to inflate, press and hold
the O/I START button until the
monitor inflates 30 to 40 mmHg
higher than your suspected systolic pressure.
Important:
• The monitor will not inflate above 300 mmHg.
• Do not apply more pressure than necessary.
18
3.5Using the Memory Function
This monitor has a memory capable of storing 90 sets of
readings. Every time you complete the measurement, the
monitor automatically stores blood pressure and pulse rate with
the date and time. The monitor also calculates an average
reading based on the measurements from the last three
readings taken within 10 minutes.
If there are three readings within 10 minutes of the last reading,
the average of the three readings is displayed. (If there are only
two readings in memory for that period, the average will be
based on two readings. If there is only one reading in memory
for that period, that reading will be displayed as the average
value.)
Note: When 90 sets of readings are stored in memory, the
oldest set will be deleted to store a new set.
To View the Average Value
Press the memory button.
The average value, based on the last three measurements, is
displayed.
3.Using the Unit
EN
19
3.Using the Unit
To View Previous Readings Stored in Memory
1. Press the button, while the average reading is displayed,
to view reading stored in memory from the most recent to the
oldest.
Alternating display
2. Press the or button repeatedly to cycle through the
previous measurement values
( button: from the most recent to the oldest,
button: from the oldest to the most recent)
Keep the button pressed down to cycle rapidly through the
previous values.
To Delete All the Values Stored in Memory
Caution!
You cannot delete the stored readings partially, all the reading
in the monitor will be deleted.
To delete stored readings, press the memory button and
the O/I START button simultaneously, then all the readings will
be deleted.
20
4.Quick Reference Guide
4. Quick Reference Guide
To help ensure a reliable reading, avoid eating, smoking, or
exercising for at least 30 minutes before taking a
measurement.
Note: Remove any tight-fitting clothing from your upper arm.
1. Sit on a chair with your feet flat on the floor and place your arm
on a table so that the arm cuff will be at the same level as your
heart.
2. Secure the cuff around your arm using the fabric fastener strip.
3. Press the O/I START button.
When measurement is complete,
the monitor displays your blood
pressure and pulse rate, and
automatically deflates the cuff.
Notes:
• Always wait at least 2-3 minutes before taking another blood
pressure measurement.
• Please note that all measurement results are stored in the
memory. If different people take measurements using the
same device, make sure that you are aware of this fact.
EN
21
5.Handling Errors and Problems
5. Handling Errors and Problems
5.1Error Messages
Error DisplayCauseRemedy
Cuff is under inflated.
Blinks or appears
22
continuously.
Movement during
measurement
Cuff over inflated.
This icon indicates irregular
or weak pulses are
detected, but result can be
considered reliable.
This icon indicates that the
systolic blood pressure is
above 135 mmHg or
diastolic blood pressure is
above 85 mmHg.
Batteries have run down.
Carefully read and repeat the steps
listed under section 3.3.
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.
These criteria are for home blood
pressure measurement. For
professional criteria, please refer to
Chapter 9.
Replace all four “AA” batteries with
new ones.
Refer to section 2.1
5.2Troubleshooting
ProblemCauseRemedy
No display appears
when the O/I START
button is pressed.
Cannot measure or
readings are too high.
The blood pressure is
different each time. The
reading is extremely low
(or high).
The batteries are empty.Replace the batteries.
Is the cuff wrapped firmly
around the arm?
The cuff pressure does
not rise although the
pump motor can be
heard.
Blood pressure readings constantly vary with time of
measurement and nervous condition. Take deep
breaths to relax before taking a measurement.
5.Handling Errors and Problems
Attach the arm cuff
correctly.
Check that the air plug is
properly connected to the
monitor. Push the air plug
firmly into the air jack.
EN
23
6.Maintenance and Storage
6. Maintenance and Storage
To protect your monitor from damage, please observe the
following:
• Do not subject your monitor and cuff to extreme temperatures,
humidity, moisture or direct sunlight.
• Do not fold the cuff or tubing tightly.
• Do not disassemble the monitor.
• Do not carry out repairs of any kind yourself. If a defect occurs,
consult the OMRON distributor or Customer Services as
mentioned on the packaging, or seek the advice of your surgical
appliance stockist or pharmacist.
• The OMRON M6 Comfort is a precision measuring device. It is
important that the accuracy remains within the specifications. It is
recommended that you have the monitor inspected every two
years to ensure it is accurate and functioning correctly. Consult
the OMRON distributor or Customer Services as mentioned on
the packaging for further details.
• Do not subject the monitor to strong shocks or vibrations (for
example, dropping the monitor on the floor.)
• Do not use volatile liquids to clean the monitor. THE MONITOR
SHOULD BE CLEANED WITH A SOFT, DRY CLOTH.
• Do not wash the arm cuff or immerse it in water.
24
Storage
Keep the monitor in its storage case
when not in use.
Note: If you are using the optional AC
adapter, make sure that the
adapter is placed under the cuff
and monitor so that it does not
damage the display.
7. Optional Parts
AC Adapter (Q-adapter)
Order No. 1098336-8
Using the Optional AC Adapter
Insert batteries into the battery compartment even when using
the AC adapter.
Notes:
• Never unplug the power cord with wet hands.
• Use only the original AC adapter designed for this unit. Use of
unsupported adapters may damage the unit.
• When storing the optional AC adapter with the main unit, be
careful not to damage the main unit or cuff.
1. Insert the AC adapter plug
into the AC adapter jack on
the rear side of the main unit.
7.Optional Parts
Arm Cuff
Order No. 9956685-4
EN
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 immediately remove the AC
adapter plug from the main unit.
InflationFuzzy-logic controlled by electric pump
DeflationAutomatic pressure release valve
Pressure DetectionCapacitive pressure sensor
Memory90 Measurements with date and time
Power Source
Battery Life
Operating temperature/
Humidity
Storage temperature/
Humidity
Console WeightApproximately 350g without batteries
Cuff WeightApproximately 240g
Outer DimensionsApproximately 131 (l) mm × 155 (w) mm × 84(h) mm
Cuff Dimensions
Package Content
Note: Subject to technical modification without prior notice.
Pressure: 0 mmHg to 299 mmHg
Pulse: 40 to 180/min.
Pressure: ±3mmHg
Pulse: ± 5% of display reading
4 “AA” batteries 1.5V or AC/ DC adapter
(optional, 6V = 4W)
Capacity of new alkaline batteries is approx. 1500
measurements
+10°C to +40°C
Maximum: 30 to 90% RH
-20°C to +60°C
Maximum: 10 to 95% RH
Approximately 152 mm × 600 mm
(Cuff: arm circumference 22 to 42 cm)
This device fulfils the previsions of EC directive 93/42/EEC (Medical Device Directive).
26
8.Technical Data
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 IEC60601-1-2 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
IEC60601-1-2:2001 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 unit 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 IEC60601-1-2:2001 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 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 from
other types of wastes and recycle it responsibly to promote the
sustainable reuse of material resources.
EN
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 take 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.
This product does not contain any hazardous substances.
27
9.SomeUsefulInformation about Blood Pressure
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 pressure readings, the Systolic and Diastolic, are
necessary to enable a doctor to evaluate the status of a
patient’s blood pressure.
Why is it a Good Thing to measure Blood Pressure at
Home?
Having your blood pressure measured by a doctor can cause
anxiety which is itself a cause of high blood pressure. As a
variety of conditions affect blood pressure, a single
measurement may not be sufficient for an accurate diagnosis.
Many factors such as physical activity, anxiety, or the time of
day, can influence your blood pressure. 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.
Blood pressure is measured in millimetres of mercury (mmHg)
and measurements are written with the systolic pressure
before the diastolic e.g. A blood pressure written as 140/90, is
referred to as 140 over 90 mmHg.
28
9.Some Useful Information about Blood Pressure
200
150
mmHg
100
50
61218 24
Example: fluctuation within a day (male, 35 years old)
Classification of Blood Pressure by the World Health
Organization
The World Health Organization (WHO) and the International
Society of Hypertension (ISH) developed the Blood Pressure
Classification shown in this figure.
Systolic blood pressure
(mmHg)
180
160
140
130
120
Optimal blood
(target value)
Normal systolic value
Normal blood
pressure
Severe hypertension
Moderate hypertension
Mild hypertension
pressure
80
85 90 100 110
Diastolic
blood
pressure
(mmHg)
This classification is based on the blood pressure values
measured on people in a sitting position in outpatient
departments of hospitals.
EN
Note: There is no universally accepted definition of
hypotension. However, those having the systolic
pressure below 100 mmHg are assumed as
hypotensive.
29
9.Some Useful Information about Blood Pressure
Subsidiary
Subsidiary
Subsidiary
Manufacturer
EU-representative
OMRON HEALTHCARE UK LTD.
Opal Drive
Fox Milne, Milton Keynes MK 15 0DG, United Kingdom
OMRON Medizintechnik Handelsgesellschaft m.b.H.
Windeckstraße 81a, D-68163 Mannheim, Germany
www.omron-medizintechnik.de
OMRON SANTÉ FRANCE
14, rue de Lisbonne, F-93561 Rosny-sous-Bois Cedex,
France
OMRON HEALTHCARE CO., LTD.
24, Yamanouchi Yamanoshita-cho, Ukyo-ku,
Kyoto, 615-0084 Japan
OMRON HEALTHCARE EUROPE BV
Kruisweg 577, 2132 NA Hoofddorp,
The Netherlands
www.omron-healthcare.com
ECREP
30
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