Instruction Manual Model HCG-801
Instruction Manual Model HCG-801
• Instruction Manual EN
Contents
Before Using the Unit
Introduction .............................................................................................................. 3
Intended Use........................................................................................................... 3
Notes on Safety ........................................................................................................ 4
1. Know Your Unit ................................................................................................ 6
Operating Instructions
2. Inserting and Replacing Batteries................................................................ 10
3. Setting the Date and Time ............................................................................. 13
4. Using SD Memory Card ................................................................................. 15
4.1 Inserting and Ejecting SD Memory Card..................................................................................... 15
4.2 Formatting an SD Memory Card ................................................................................................. 19
5. Important Notes on Taking a Measurement................................................. 21
6. Taking a Measurement................................................................................... 22
7. Displaying ECG Data ..................................................................................... 28
8. Adjusting the Settings................................................................................... 30
8.1 Basic Operation .......................................................................................................................... 30
8.2 Date and Time ............................................................................................................................ 32
8.3 Volume ........................................................................................................................................ 32
8.4 Brightness ................................................................................................................................... 33
8.5 Contrast ...................................................................................................................................... 34
8.6 Language .................................................................................................................................... 35
8.7 Date Format ................................................................................................................................ 36
8.8 Messages.................................................................................................................................... 37
8.9 Overwrite..................................................................................................................................... 38
9. Managing ECG Data....................................................................................... 39
9.1 Erasing ECG Data ...................................................................................................................... 39
9.2 Copying Data to an SD Memory Card ........................................................................................ 42
9.3 Copying data from the SD memory card to a PC........................................................................ 44
Care and Maintenance
10. Care and Maintenance................................................................................... 46
10.1 Lists and Explanations of Messages........................................................................................... 46
10.2 Troubleshooting .......................................................................................................................... 50
11. Maintenance and Storage.............................................................................. 51
12. Technical Data ................................................................................................ 52
13. General Information About the Heart and ECG Measurements................. 54
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Introduction
Your OMRON HCG-801 is an easy-to-use electrocardiograph unit that can record and store
electrocardiogram (ECG) measurements of your heart rhythm. Each ECG reading records
about 30-second measurement and these ECG readings can help your doctor monitor your
condition. It also includes guidance screens to help you obtain good results when taking
measurements.
The monitor is supplied with an SD memory card that can store up to 300 measurements,
which include the ECG data along with the date and time of measurement. Storing ECG data
on the SD memory card, or in unit memory, allows you or your doctor to view them later.
Intended Use
Medical Purpose The device is used for recording electrocardiographic
waveform when patient feels symptoms of arrhythmia.
Intended User Self-recording by patient
Patient Population It is not intended to use for infants weighing less than 10 kg.
Environment The device can be used anytime except in the cases
stated in the sections of warnings and cautions in the
instruction manual.
Measurement Parameter Electrocardiograph (ECG)
Precautions for use Warnings and cautions described in the instruction manual
should be observed.
Important: Please note that while the measurements from an ECG monitor are a
useful guide for your doctor, they cannot detect all changes in heart EN
conditions. Always consult your doctor if you notice any change in
your condition, regardless of the measurement results. Consult a
doctor even if “Stable waveform.” is displayed as the measurement
result, if you have been diagnosed with a heart condition.
* The illustrations used in this manual may differ slightly from the appearance of the actual product.
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Notes on Safety
This unit is designed for monitoring the ECG waveform. Never use the unit
to monitor vital signs and acute events.
- Self-diagnosis and treatment is dangerous.
The measurement results are for monitoring purposes only, and should never be
used as a basis for starting or modifying treatment without independent
confirmation by medical examination.
- The values displayed by the unit are the values at the time of measurement.
Medical conditions can change suddenly. If you notice any change in your
condition, consult your doctor, regardless of the measurement results.
- This unit has no function to detect pacing spikes.
For a person with a cardiac pacemaker, there are cases where pacing spikes are
recorded or not recorded.
Warning!
• Do not use the unit in intensive care units or operating rooms.
• When using this unit in hospitals or other medical facilities, use the unit under the
supervision of your doctor.
This unit may affect the other medical devices, and vice versa.
• Do not use with a defibrillator.
• Do not use in the presence of flammable anesthetics, drugs or pressurised
oxygen (such as in a hyperbaric chamber, ultraviolet steriliser or oxygen tent).
• Do not attempt self-diagnosis of the measurement results and analysis, always
consult your doctor.
- Self-diagnosis may lead to a deterioration in your condition.
• Do not use on people with sensitive skin or allergies.
- This may result in exanthema, skin irritation, or eczema.
• Keep out of reach of small children and people who can not express their
consent.
• Do not use for any purpose other than obtaining an electrocardiograph.
• Do not expose the unit to strong shocks or vibrations, or drop or step on the unit.
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Notes on Safety
• Do not use batteries of a type other than that specified in this manual.
• Do not apply over clothing or touch the electrodes with your left hand.
• Do not take measurements when there are drops of water on your skin, such as
from sweat or after bathing.
• Do not take measurements where the unit will be exposed to strong
electromagnetic forces.
Caution!
• Do not expose the unit to static electricity. Always disperse any static electricity
from your body before handling the unit.
• Do not take measurements in a moving vehicle.
• Do not use a cellular phone near the unit.
• Do not disassemble, repair, or modify the unit.
• Do not insert batteries with their polarities reversed.
• The chest electrode will be impeded by excessive body hair, regularly remove
hair at the electrode contact point. Omron does not recommend the use of
contact gel.
General
• Avoid extremes in temperature and humidity. Do not use this unit in locations
subject to high or low temperatures or humidity.
Use at a temperature within 10 to 40°C and between 30 and 85% RH.
• Do not sterilise this unit in an autoclave or gas steriliser (EOG, formaldehyde,
high density ozone etc.) EN
• Do not wash this unit with water.
• Do not store the unit in the following ambient conditions:
- Locations exposed to direct sunlight.
- Locations subject to high temperatures and high humidity.
- Wet or damp locations where water may get on the unit.
- Dusty locations.
- Near fires or open flames.
- Locations exposed to strong vibration.
- Locations exposed to strong electromagnetic fields.
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A J
B I
C
D H
E G
F
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Replacements Parts
L M
EN
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Display
The screen is used to display the guidance screens and results of ECG readings,
adjust settings, and manage ECG data stored on the SD memory card or in unit
memory.
Menus
N
O
P
Q
R
Menu screen Settings (SET menu) screen
The main menu screen is The setting menu screen is displayed
displayed when you press the when you select the SET menu and
MENU button. press the OK button.
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ECG Graph
This screen is displayed when you use the GRAPH menu to select ECG data
stored on the unit.
V
S W
X
T
Y
U
S. Calibration guide V. SD memory card indicator
Serves as a guide when your doctor Displayed when the SD memory card is in
analyses the stored ECG data. the card slot.
T. Full 30-second waveform W. Battery level indicator
U. Measurement time indicator X. ECG waveform
Y. Heart rate
(*bpm=beats per minute)
Note: During measurement, the screen displays the ECG waveform and the
progress bar at the bottom of the screen displays measurement progress
and a guide to the heart rate. EN
Depending on the waveform, situations can occur in which the device
cannot assess and display the heart rate during the measurement.
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Battery life
• Two new LR03 (AAA) batteries will last for approximately 400 measurements. (If
measurements are taken once a day at room temperature (22 °C).)
• The batteries enclosed in the package are used for demonstration purpose. It is
possible these batteries will therefore not last for 400 measurements.
• If the batteries are removed for more than one hour, the settings and any ECG
data stored in the unit may be erased. If the date and time setting is erased, be
sure to reset it before using the unit again. Any ECG data erased from the unit
cannot be recovered.
• The battery life can be confirmed in the upper right of the display.
Remaining power is low.
Full power. Half remaining.
Replace the batteries with new ones.
Warning!
If battery fluid should get in your eyes, immediately rinse with plenty of clean
water. Consult a doctor immediately. EN
Caution!
• Do not use batteries not specified for this unit. Do not insert the batteries
with the polarities in the wrong direction.
• Do not dispose of batteries in fire.
• If battery fluid should get on your skin or clothing, immediately rinse with
plenty of clean water.
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• Remove the batteries from this unit when you are not going to use it for a
long period of time (approximately three months or more).
• Do not use batteries of a different type together.
• Do not use new and used batteries together.
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When the unit is used for the first time, or if the Date
and Time setting has been reset, the Date and Time
setting screen is automatically displayed, and the
day digits are highlighted.
EN
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Notes:
• If you need to purchase a new SD memory card, consult your Omron Customer
Service Department (Tel. 0870-7502771).
• Do not store data other than ECG data from the unit on the card.
The SD ( ) mark is displayed in the top right corner of the screen while the SD
memory card is inserted, and the unit is turned on.
Caution!
Never insert an SD memory card while the unit is turned on.
EN
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Notes:
• Check that the card is correctly aligned and insert
it into the slot as shown.
Caution!
When inserting the SD memory card, do not try to force the card into the slot
if it is upside down, back to front etc. This could damage the card or the unit
itself.
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EN
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Caution!
Only eject an SD memory card when the unit is turned off.
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Notes:
• When you format an SD memory card, any data stored on the card is erased.
Always copy any data you wish to keep to a computer before formatting an SD
memory card.
• When you format an SD memory card, format it with the unit. Do not format an
SD memory card with a computer.
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Caution!
Never remove an SD memory card while it is
being formatted.
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Note: If you have problems applying the unit so that the chest electrode is flat
against your chest, please ask your doctor for advice.
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6. Taking a Measurement
3. Place your finger so that it fits closely over the two Fit finger closely on the
finger electrodes. electrodes.
Notes:
• Even if you are left-handed, use your right hand to
take a measurement.
• Take care not to press the START button until you
are ready to take the measurement.
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6. Taking a Measurement
4. Place the chest electrode on bare skin about 5 cm below your left nipple.
Notes:
• Make sure that you are relaxed and that your chest is free of tension.
• Press the chest electrode close against your bare chest. Do not place the
electrode on clothing as this will result in an inaccurate measurement.
Chest electrode
About 5 cm
Female:
Locate the ECG monitor at the lower end of the breastbone
and move horizontally to the left to the middle of the left part
of the chest. If necessary, gently lift the breast and place the
Chest Electrode under the left breast. Unless the chest
electrode comes in contact with the brassiere, it is not
necessary to remove it; if you are unsure please consult
your doctor.
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6. Taking a Measurement
About 30 seconds
The measurement takes about 30 seconds to complete. The unit beeps every
second during measurement.
During measurement, the screen displays the ECG waveform and the progress
bar at the bottom of the screen displays measurement progress and a guide to the
heart rate.
Depending on the waveform, situations can occur in which the device cannot
assess and display the heart rate during the measurement.
Notes:
• During measurement the device will only respond to the button to
discontinue the measurement.
• If the contact of the electrodes becomes loose, or the conditions change during
measurement, the measurement may not be correct.
Important: Keep still and do not move until the measurement is complete.
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6. Taking a Measurement
6. Press the button for two seconds, to turn the unit off.
The unit beeps, then the power is turned off.
Note: If you forget to turn the unit off, it will automatically shut itself off after five
minutes.
EN
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6. Taking a Measurement
• The unit is being held in the left hand. • Unit placed on clothing.
Always use your right hand to hold
the unit when taking a measurement.
• The rear of the unit is placed • The chest electrode is against the
against the chest. finger and the finger electrode is
against the chest.
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6. Taking a Measurement
Measurement Result
There are 13 messages regarding the measurement result.
A letter of the alphabet indicates each of the 13 possible messages. This letter is
displayed together with the time and date of the measurement when the GRAPH
menu is displayed.
Important: Do not interpret measurement results yourself, consult your doctor.
a Stable waveform.
b Fast heart rate.
c Fast and irregular heart rate.
d Fast heart rate and deviating waveform.
e Fast and irregular heart rate, deviating waveform.
f Slow heart rate.
g Slow and irregular heart rate.
h Slow heart rate and deviating waveform.
i Slow and irregular heart rate, deviating waveform.
j Irregular heart rate.
k Irregular heart rate and deviating waveform.
l Deviating waveform.
m Analysis impossible. Please measure again.
1. Press the MENU button while the unit is turned on, the GRAPH menu is
highlighted. If you then press the OK button, the list of ECG data is displayed.
2. Select the ECG data you wish to view from the GRAPH menu list, then press the
OK button to display the detailed view of the waveform.
Each stored ECG data is displayed by date, time and a character representing the
measurement result, refer to p. 27 for the overview of character and measurement
result.
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Press the button to move down the list, and the button to move up.
The most recent measurement result is displayed at the top of the list and is
automatically highlighted, with any previous measurement results listed below it in
chronological order.
When the SD memory card is in the SD memory card slot, the list of ECG data
stored on the card is displayed.
If there is no SD memory card in the card slot, the ECG data stored in unit memory
is displayed.
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1. Press the MENU button, while the unit is on, to display the
menu screen.
* Initially, GRAPH
menu is highlighted.
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4. Press the or button to select the desired setting, then press the OK
button to see the options for that setting.
5. Adjust the settings then press the OK button to confirm the changes.
The SET menu can be used to adjust the following settings or manage ECG data
stored on the SD memory card or unit:
Date and Time, Volume, Brightness, Contrast, Language, Date Format, Message,
Overwrite, Erase all data, Data copy to SD, Formatting SD.
Notes:
Refer to “9. Managing ECG Data” on p. 39 for details on Erase all data and Data
copy to SD.
Refer to “4. Using SD Memory Card” on p. 15 for details on Formatting SD.
• To return to the menu screen from the SET menu screens, press the MENU
button. To return to the previous screen, highlight Back, then press the OK button
or MENU button. EN
• If you press the MENU button without first pressing the OK button, after making
the changes to a setting, the changes to the setting will not be implemented.
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8.3 Volume
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8.4 Brightness
EN
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8.5 Contrast
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8.6 Language
This setting specifies the language to be used for the screen display.
Press the button or button to select the desired language, then press
the OK button to confirm your selection.
EN
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Press the button or button to select the desired format, then press the
OK button to confirm your selection.
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8.8 Messages
This setting specifies whether to display or hide the message that appears after a
measurement has been completed.
1. Press the button or button to highlight the Display or Hide, then press
the OK button to confirm your selection.
Note: Even if Hide is selected, results messages are saved by the unit.
EN
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8.9 Overwrite
The unit will overwrite the oldest stored reading when the SD memory card or unit
memory is full. A message will warn that this will happen, you can choose to hide
or display this message. (The default setting is to hide the message.)
1. Press the button or button to highlight Display or Hide, then press the
OK button to confirm your selection.
Caution!
While Hide is selected, the unit will overwrite (erase and replace) the oldest
measurement data with the results of the new measurement without displaying a
message, when the SD memory card or unit memory are full.
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EN
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Notes: * By default, NO is
• If the SD memory card is full, the “Overwrite data” highlighted.
message may appear. Refer to p. 38 for details.
• ECG data stored on an SD memory card can be damaged by static electricity and
other causes. Copy data to PC or other device for additional safety.
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Caution!
Never remove the SD memory card while data is being
copied to it. If the SD memory card is removed while
data is being copied, the data may be lost or damaged.
Notes:
• The copied data is displayed and the screen from step 1 appears.
• If the same ECG data already exists on the SD memory card, the data is not
copied.
EN
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2. Create a new folder on your PC where you want to save a copy of the ECG data.
3. Insert the SD memory card and browse to the SD memory card data as explained
in the instruction manual of your PC and /or software. The ECG data is located in
the *:\hcg801\data\ folder (where * stands for the character of a removable disk).
4. Select all files and copy them in the folder you have created earlier (2).
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2. Insert the SD memory card in the SD port of your PC and confirm that there is an
“hcg801” folder in the SD memory card. If there is not, format the SD memory card
in the HCG-801 as described in section 4.2 of the HCG-801 instruction manual.
3. Browse to the folder where you saved the ECG data in the PC. Select all files and
copy them to the SD memory card in the *:\hcg801\data\ folder (where * stands for
the character of a removable disk)
5. Do not store more than 300 measurement files in this folder on the SD memory
card. When more than 300 files are copied in this folder, the HCG-801 will display
an error message when activated.
EN
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Notice Messages
Message Description Action
No action required. Wait until
Analysing. The ECG data is being analysed.
analysis ends.
Can not measure.
A ECG wave-pattern could not Check the instructions and
Please follow the instructions be detected. repeat measurement.
for use.
Measurement was stopped.
The measurement was Press START to resume the
Push START to begin interrupted or cancelled. measurement.
measurement again.
The indicated number of ECG
Copied *1
data into SD. data has been copied to an SD No action required.
memory card. Wait until the message
*2 The indicated number of ECG disappears.
Erased data. data has been erased.
*1: Number of readings from 0 to 5. The number displayed represents the amount of copied ECG data.
*2: Number of readings from 1 to 300. The number displayed represents the amount of erased ECG
data.
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Warning Messages
Message Cause Remedy
Wait until the message
disappears.
Formatting SD memory. The SD memory card is being
formatted. Do not remove the SD memory
DO NOT REMOVE SD
card until formatting has been
completed.
Wait until the message
disappears.
Storing on SD memory. ECG data is being written
(saved) to the SD memory card. Do not remove the SD memory
DO NOT REMOVE SD
card until data storage has been
completed.
Wait until the message
disappears.
Copying SD memory. ECG data is being copied to the
SD memory card. Do not remove the SD memory
DO NOT REMOVE SD
card until data copying has been
completed.
Data in device memory is ECG data stored on the unit is Wait until the message
being erased. being erased. disappears.
Wait until the message
Data in SD is being erased. disappears.
ECG data stored on the SD
DO NOT REMOVE SD until memory card is being erased. Do not remove the SD memory
erasing finishes. card until data erasing has been
completed.
Wait until the message
disappears. EN
Reading data... The unit is loading ECG data
stored on the SD memory card. Do not remove the SD memory
DO NOT REMOVE SD.
card until the data has been
loaded by the unit.
Turn off the power and insert the
There is no SD memory card in SD memory card.
No SD is inserted.
the card slot. Never insert the SD memory card
while the power is turned on.
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Error Messages
Error # Message Cause Remedy
Please insert new Replace both batteries with new
01 The batteries are worn out.
batteries. ones.
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10.2 Troubleshooting
Refer to this table for problems that do not result in a message on the display.
The electrodes are not making good Check the instructions and repeat
contact with your finger or chest. measurement.
Your body is too tense. Relax and repeat the measurement.
Electrode contact was broken before Make sure that your finger and chest
30 seconds of data has been maintain contact with the electrodes for
recorded. the full 30 seconds of the measurement.
Measurement finishes but no result is
shown. The chest electrode has been applied
Apply the chest electrode to bare skin.
over clothing.
Your skin is dry. Moisten your skin with a damp towel.
Make sure that the electrodes are
applied correctly. However, for some
The ECG signal is too weak. individuals measurement may not be
possible.
The unit will not be able to store data if
left with worn batteries for an extended
ECG data has disappeared. The batteries are worn out or have period. Replace the batteries with new
been removed for over one hour.
ones as soon as possible after the
warning message appears.
The card was exposed to a strong
ECG data has disappeared from an electromagnetic field. electric noise or Erased data cannot be recovered.
SD memory card. static, damaging the data stored on Format the SD memory card again.
the card. Or the card is defective.
Turn off the unit and try again.
Other problems If the data and time or other settings
have been reset to their default values,
set them again.
If the problem still occurs, consult your Omron Customer Service Department
(Tel. 0870-7502771)
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This device fulfills the provisions of EC directive 93/42/EEC (Medical Device Directive).
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Left atrium
Right atrium
Left ventricle
An ECG monitor is able to measure the electrical impulse as it passes across and
through the heart, causing the heart to beat. An ECG does not measure the
movement of your heartbeat, but rather the electrical activity that causes the heart
to beat. The measurements recorded by an ECG monitor, when combined with a
medical examination, can help your doctor monitor your heart condition.
Conditions such as arrhythmia and Ischemia can only be diagnosed by a doctor
through a special examination.
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The first peak indicates the spread of the impulse over the atria and the beginning
of their contraction. This is known as the P wave. The second peak indicates the
spread of the impulse over the ventricles and the beginning of their contraction.
This is known as the QRS complex. The third peak indicates the activity as the
heart relaxes (re-polarization), and is known as the T wave.
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. This can be caused by heart disease, ageing, physical EN
predisposition, stress, lack of sleep, fatigue etc.
Arrhythmia can only be diagnosed by a doctor through a special examination.
What is Ischemia?
Ischemia is a condition in which insufficient oxygen is supplied to parts of the heart
or other parts of the body. This is usually due to a blockage or partial blockage of
an artery.
Ischemia can only be diagnosed by a doctor through a special examination.
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Manufacturer
OMRON HEALTHCARE Co., Ltd.
24, Yamanouchi Yamanoshita-cho, Ukyo-ku, Kyoto, 615-0084 JAPAN
EU-representative
OMRON HEALTHCARE EUROPE B.V.
Kruisweg 577, 2132 NA Hoofddorp, THE NETHERLANDS
EC REP www.omron-healthcare.com