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Instruction Manual Model HCG-801

This document is the instruction manual for the OMRON Portable ECG Monitor Model HCG-801. It introduces the intended use of the device to record electrocardiographic waveforms when a patient feels arrhythmia symptoms. The manual emphasizes that measurement results are for monitoring purposes only and should not replace a medical examination. It also lists important safety warnings, such as not using the device for self-diagnosis, in intensive care units, or with a defibrillator.

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0% found this document useful (0 votes)
105 views

Instruction Manual Model HCG-801

This document is the instruction manual for the OMRON Portable ECG Monitor Model HCG-801. It introduces the intended use of the device to record electrocardiographic waveforms when a patient feels arrhythmia symptoms. The manual emphasizes that measurement results are for monitoring purposes only and should not replace a medical examination. It also lists important safety warnings, such as not using the device for self-diagnosis, in intensive care units, or with a defibrillator.

Uploaded by

Metalbet
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 56

HCG801-E.

fm Page 1 Thursday, April 29, 2010 4:56 PM

Portable, cordless, single-channel ECG Monitor


Model HCG-801

• Instruction Manual EN

Thank you for purchasing the OMRON Portable ECG Monitor.


Before using this unit for the first time, please be sure to read this
instruction manual carefully and use the unit properly.
Please keep this instruction manual on hand for future reference.
OMRON assumes no responsibility for personal injury or damage
sustained by or through use of this product.
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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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1. Know Your Unit


Main Unit
K

A J

B I

C
D H
E G
F

A. (Power/Cancel) button G. OK button


Turns the power on/off and cancels measurement. Selects the highlighted menu option or ECG
data.
B. Chest electrode
Clears error messages.
Place this against your chest when taking a
measurement. H. Battery cover
Open this cover to insert batteries.
C. Display
Displays the wave pattern after measurement, and I. Finger electrodes
displays menus and setting options. Place your right index finger over these when
taking a measurement.
D. MENU button
Displays or closes the menu screen. J. START button
Starts measurement.
E. button
Moves the desired menu or wave pattern to the left or K. SD memory card slot cover
up and decreases the number of the selected field. Open this cover to insert the SD memory card.
F. button
Moves the desired menu or wave pattern to the right
or down and increases the number of the selected
field.

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1. Know Your Unit

Replacements Parts

L M

L. SD memory card M. Storage pouch

EN

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1. Know Your Unit

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.

N. GRAPH menu Q. Back


This allows you to view ECG readings stored This option takes you back to the previous
on the SD memory card or in unit memory. screen, from the SET menu.
(p. 28)
R. Close
O. SET menu This option closes the menu screen.
This allows you to set the date and time, and
adjust other settings. (p. 30)
P. GUIDE
This displays the guidance screens that
show you how to take a measurement.

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1. Know Your Unit

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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2. Inserting and Replacing Batteries

1. Slide the battery cover in the direction of the arrow,


and lift the end of the cover upwards.
Note: Do not pull too hard on the cover.

2. Insert two LR03 (AAA) batteries as indicated.


Always use LR03 (AAA) batteries.
Note: Make sure that the polarity of the batteries is
correct.

3. Close the battery cover.


Lower the battery cover (1), then while gently 2
pressing the cover down, slide it in the direction of
the arrow (2).
1

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2. Inserting and Replacing Batteries

Battery life and replacement


When the “Please insert new batteries.” message appears, replace both batteries
with new ones.
• Always turn the unit off before replacing the batteries.
• Dispose of the used batteries according to applicable local regulations.

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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2. Inserting and Replacing Batteries

• 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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3. Setting the Date and Time


Always set the date and time before using the unit for the first time.
Check the date and time are correct before using the unit, reset them if necessary.
The date and time are important indicators of when a measurement was taken.
Note: The date and time format can be changed to different territorial standards.
(Refer to “8.7 Date Format” on p. 36)

1. Press the (Power/Cancel) button to turn the


unit on.

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

2. Press the or button to set the day.


Press the button to increase the number.
Press the button to decrease the number.

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3. Setting the Date and Time

3. Press the OK button to confirm the day setting.


The day setting is set and the month setting is
highlighted.
The display cycles through the settings,
day -> month -> year -> hour -> minute, with each
press of the OK button.
Note: If the setting for the date format has been
changed (refer to “8.7 Date Format” on p. 36), the order in which items are
highlighted may differ from the example above.

4. In the same way, press the or button to


set the month, year, hour, and minute.
After you have confirmed the last item on the date
and time setting, press the OK button to complete
the date and time setting.
Note: If you need to set the date and time again,
refer to p. 30 - 32.

5. Press the button for two seconds to turn off


Press for two seconds.
the power.
The unit beeps, then the power is turned off.
Note: If you forget to turn off the power, the unit will
turn itself off automatically after five minutes.

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4. Using SD Memory Card


The unit includes an SD memory card for storing ECG data, which can then be
viewed by your doctor later. This section describes how to insert and eject an SD
memory card, and how to format a card so it can be used to store ECG data.

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.

4.1 Inserting and Ejecting SD Memory 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.

Inserting the SD memory card

1. Check that the unit is turned off.

Caution!
Never insert an SD memory card while the unit is turned on.
EN

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4. Using SD Memory Card

2. Open the SD memory card slot cover and insert the


SD memory card into the slot.

Notes:
• Check that the card is correctly aligned and insert
it into the slot as shown.

Back to front Upside down Back to front and


upside down

• Insert the card until it clicks into position.

Write Protection (Locking the SD Memory Card)


• Make sure that the write-protect switch is not locked, before
inserting the SD memory card. If the write-protect switch is
locked (down), you will not be able to store new ECG data on
the SD memory card.

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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4. Using SD Memory Card

3. Close the SD memory card slot cover.

EN

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4. Using SD Memory Card

To eject the SD memory card

1. Check that the device is turned off.

Caution!
Only eject an SD memory card when the unit is turned off.

2. Open the SD memory card slot cover and press the


memory card.
The lock is released and the card is ejected slightly.

3. Remove the memory card.

4. Close the SD memory card slot cover.

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4. Using SD Memory Card

4.2 Formatting an SD Memory Card


You will need to format the SD memory card before you use it for the first time, and
in the following circumstances.
• If you use an SD memory card that has been used by other devices.
• If a memory card error occurs.

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.

1. Press the MENU button, press the button to


select SET menu, then press the OK button.

2. Press the button to scroll through the settings EN


and select Formatting SD.

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4. Using SD Memory Card

3. Press the OK button.


The message “All data in SD will be deleted. Format
SD?” is displayed.

4. Press the button to select YES, then press


the OK button.
If you press the OK button while NO is selected, the
SD memory card will not be formatted. * By default, NO is high-
lighted.

5. Press the OK button.


A message warning you not to remove the SD
memory card while it is being formatted is displayed
and the SD memory card is formatted.
Formatting can take up to eight seconds to
complete.

Caution!
Never remove an SD memory card while it is
being formatted.

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5. Important Notes on Taking a Measurement


In order to obtain a good ECG reading, it is important that measurements are taken
correctly.
Before taking a measurement for the first time, read these instructions carefully
and make sure you observe the following points each time you take a
measurement.
• Make sure that the electrodes are directly touching your skin.
• If your hands or skin are dry, wipe them with a damp towel so that they are
slightly moist.
• If the electrodes are dirty, wipe any dirt off with a soft cloth moistened with
disinfectant alcohol or a cotton swab.
- Take care not to use too much disinfectant alcohol when cleaning the electrodes.
- Do not wipe or get disinfectant alcohol on parts other than the electrodes.
• Do not move during measurement.
- Movement, including talking, coughing, or sneezing, during measurement can affect the
measurement results.
• If the position of your finger or arm is inappropriate during measurement, the
results may be unreliable, so be sure to check their position before taking a
measurement. (Refer to p. 22 and p. 23.)
• After taking a measurement, disinfect the electrodes by wiping them with a soft
cloth or cotton swab moistened with disinfectant alcohol. If you do not disinfect
the electrodes there is a risk of skin disease. EN

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

1. Press the button to turn the unit on.


The unit displays a reminder that self-measurement
is not the same as medical diagnosis and then the
guidance screens are displayed. (The guidance
screens are displayed twice.)
Note: You can press the START button to begin a
measurement even while the guidance
screens are being displayed.

2. Make sure that you are in a relaxed position.


The ideal posture is one where you are seated comfortably with your back straight.
Note: You can also take a measurement while you are standing or while lying
down.

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.

Do not press START button


until ready to take
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

Press closely to your chest.


EN

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

5. While maintaining the same posture, press the START button.

Measurement starts During measurement Measurement ends

The unit beeps every second.

About 30 seconds

The measurement ends


automatically, indicated
by 4 rapid beeps.

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

A measurement result message is displayed when


the measurement has been completed. (Refer to p.
27 for details.)
If you press the OK button while the result message
is displayed, the list of ECG data stored on the SD
memory card or unit is displayed.
Note: If the “Please insert new batteries.” error
message is displayed immediately after
measurement, the ECG data may not be Example result message
stored. If this happens, please repeat the
measurement after replacing the batteries.

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

Common Causes of Inaccurate Measurement Results


The following situations can result in inaccurate measurement results or errors.

• The index finger is not placed • The unit is held incorrectly.


closely on the electrode.

• 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.

Recommendation on measurement result


In addition to the above messages the device will display the heart rate in beats per minute.
Finally, the device will display one of the following messages:
EN
Store data? Yes/No
This message will be displayed when the unit can find none or only sleight deviations from
normal. This data can be saved by selecting Yes and pressing the OK button.
Data is stored.
This message will be displayed when the unit can find moderate deviation from normal.
The unit will automatically store the data for future analysis by your doctor.
Data is stored. Please show your Dr.
This message will be displayed when the unit can find significant deviation from normal.
The unit will automatically store the data for future analysis by your doctor.
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7. Displaying ECG Data


The GRAPH menu is used to display the list of ECG data stored on the SD
memory card or in unit memory.

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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7. Displaying ECG Data

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.

3. If you press the button, you can scroll through


the ECG waveform.
Press the button to return to the previous
waveform display.
Two waveforms are displayed (the lower, smaller,
waveform being a view of the whole 30-second
measurement.)
At the bottom of the screen is a bar indicating the
progress of the measurement. The current heart
rate is shown in the lower right corner of the screen.
The shaded area in the progress bar indicates the section of the ECG waveform
being displayed.
EN
4. Press the OK button again to view the measurement
comments and heart rate.
Note: You can specify whether a result message is
displayed or not. (Refer to p. 37 for details.)

5. Press the OK button once more to return to the


GRAPH menu list.

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8. Adjusting the Settings


You can use the SET menu to adjust various settings.
You can press the START button to begin measurement even while the SET menu
is displayed.

8.1 Basic Operation


The following procedure describes how to select and adjust a setting. Refer to the
following pages for details of the options available for each setting.

1. Press the MENU button, while the unit is on, to display the
menu screen.

* Initially, GRAPH
menu is highlighted.

2. Press the button to select SET menu.

3. Press the OK button.


Initially, the Date and Time setting is highlighted.

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8. Adjusting the Settings

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. Adjusting the Settings

8.2 Date and Time


Select this item if you need to reset the date and time for some reason. For details
on setting the date and time, refer to p. 13.
Note: You will be prompted to set the date and time when you first insert the
batteries.

8.3 Volume

The current volume level is displayed The mark indicates the


at the bottom of the screen. volume level.
* The default setting is the maximum
volume level.

Press the button or button to adjust the volume.


The volume increases as the mark moves to the right.
The sound is muted (off) when the mark is to the far left.

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8. Adjusting the Settings

8.4 Brightness

The current brightness level is displayed The mark indicates the


at the bottom of the screen. brightness level.
* The default setting is the maximum
brightness level.

Press the button or button, to adjust the brightness.


The brightness can be set to one of nine levels.
The brightness increases as the marker moves to the right.

EN

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8. Adjusting the Settings

8.5 Contrast

The current contrast level is displayed The mark indicates the


at the bottom of the screen. contrast level.
* The default setting is medium
contrast level.

Press the button or button to adjust the contrast.


The contrast can be set to one of nine levels.
The contrast increases as the marker moves to the right.

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8. Adjusting the Settings

8.6 Language
This setting specifies the language to be used for the screen display.

The currently selected language is * The default language is English.


displayed at the bottom of the screen.

Press the button or button to select the desired language, then press
the OK button to confirm your selection.

EN

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8. Adjusting the Settings

8.7 Date Format


You can select one of four formats, DD/MM/YY HH:MM (24 hour clock), DD/MM/YY
HH:MM (AM/PM), MM-DD-YY HH:MM (AM/PM), or YY/MM/DD HH/MM (AM/PM).

The date is displayed at the bottom of the


* The default date format is
screen using the currently selected format. DD/MM/YY HH:MM (24 hour clock).

Press the button or button to select the desired format, then press the
OK button to confirm your selection.

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8. Adjusting the Settings

8.8 Messages
This setting specifies whether to display or hide the message that appears after a
measurement has been completed.

The current setting is displayed at the


* The default setting is Display.
bottom of the screen.

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. Adjusting the Settings

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.)

The current setting is displayed at the


bottom of the screen.

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.

About the Overwrite message


If you select Display, the unit will display a message before
you take a measurement, asking if you want to overwrite
existing data with the new measurement data.
Select Yes to overwrite the oldest ECG data with the
results of the new measurement.
If you select No, measurement is cancelled.

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9. Managing ECG Data

9.1 Erasing ECG Data

Erasing All ECG Data


You can use the SET menu to erase all the ECG data stored on the SD memory
card or in unit memory.
Note: If an SD memory card is inserted in the unit, all data on the card will be
erased.

1. Press the button to scroll through the settings and


select Erase all data.

2. Press the OK button.


The message “Erase all data in SD memory?” is
displayed.
EN
Note: If the SD memory card is not inserted and
measurements are being stored in unit memory, the
message “Erase all data in the device?” is
displayed. * By default, NO is
highlighted.

39
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9. Managing ECG Data

3. Press the button and select YES, then press the OK


button.
The number of sets of data to be deleted is displayed.

4. Press the button and select YES, then press the OK


button.
All the ECG data is erased and the screen from step 1 appears.
Note: If you press the OK button after selecting NO, the screen from step 1
appears.

Erasing Selected ECG Data


Use the GRAPH menu if you only want to delete a selected set of ECG data.
For details on displaying the GRAPH menu, follow step 1 in “7. Displaying ECG
Data” on p. 28.

1. Press the button to highlight the data you want to erase.

2. Press the MENU button.


The menu screen is displayed.

3. Press the button and select Erase data.

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9. Managing ECG Data

4. Press the OK button.


The confirmation message “Erase selected data?” is
displayed.

5. Press the button and select YES, then press the OK


button.
* By default, NO is
The ECG data is erased and the screen from step 1 highlighted.
appears.
Note: If you press the OK button after selecting NO, the screen from step 1
appears.
Important: Never remove an SD memory card while data is being erased.

EN

41
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9. Managing ECG Data

9.2 Copying Data to an SD Memory Card


You can copy ECG data from the unit’s internal memory to an SD memory card.
This allows you to copy data to the SD memory card if measurements have been
taken while the SD memory card was not inserted.
Note: The unit’s internal memory can only store a maximum of five measurement
results.

1. Press the button and select Data copy to SD.

2. Press the OK button.


The conformation message “Copy data into SD?” is
displayed.

3. Press the button to select YES.

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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9. Managing ECG Data

4. Press the OK button.


The ECG data is copied to the SD memory card.

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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9. Managing ECG Data

9.3 Copying data from the SD memory card to a PC

Copying data from the SD memory card to a PC


Please follow these instructions to copy data from the SD memory card to a PC.

1. Make sure the PC is equipped with an SD memory card port or connect a


commercially available SD memory card reader/writer to your PC.

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).

5. When copying is finished, remove the SD memory card.

6. The SD memory card can now be formatted as described in “4.2 Formatting an SD


Memory Card” on p. 19, if you wish to delete the data.

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9. Managing ECG Data

Copying data from a PC to the SD memory card


Please follow these instructions to copy data from a PC to the SD memory card.

1. Make sure the PC is equipped with an SD memory card port or connect a


commercially available SD memory card reader/writer to your PC.

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)

4. When copying is finished, insert the SD memory card in the HCG-801 as


described in “4.1 Inserting and Ejecting SD Memory Card” on p. 15.

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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10. Care and Maintenance

10.1 Lists and Explanations of Messages


This section includes a list of all messages that may appear on the display. Refer
to these if you are not sure what a displayed message means.

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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10. Care and Maintenance

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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10. Care and Maintenance

Message Cause Remedy


Refer to the instruction supplied
The unit is unable to access data
with the memory card and insert
SD is write-protected. because the SD memory card
the SD memory card with write-
inserted is write-protected.
protection turned off.
Insert new batteries and reset the
The battery power has run low Date and Time and other
No saved data. and the ECG data stored on the settings. Any ECG data that was
unit has disappeared. stored on the unit cannot be
recovered.
The battery power has run low Insert new batteries and reset the
Set clock. and the Date and Time setting on Date and Time from the SET
the unit has disappeared. menu.
The battery power has run low
No saved data. Insert new batteries and reset the
and the ECG data stored on the
Date and Time and other
Set clock. unit has disappeared or the clock
settings.
has been reset.

Error Messages
Error # Message Cause Remedy
Please insert new Replace both batteries with new
01 The batteries are worn out.
batteries. ones.

Device memory error An error occurred while


11 trying to read ECG data
Cannot read data. stored in unit memory.
Try again.
Device memory error An error occurred while
12 trying to erase ECG data If the error still occurs, consult
Cannot erase data. stored in unit memory. your OMRON service
representative.
Device memory error An error occurred while
13 trying to save ECG data to
Cannot write data. unit memory.

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10. Care and Maintenance

Error # Message Cause Remedy


An error occurred while
SD memory error trying to read ECG data Format the SD memory card.
21
Cannot read data. stored on the SD memory Refer to p. 19.
card. *Copy any important data to a PC
An error occurred while before formatting the SD memory
SD memory error trying to erase ECG data card as all data on the card will be
22 erased.
Cannot erase data. stored on the SD memory
Use a new/different SD memory
card. card. (Always turn off the unit before
An error occurred while removing or inserting SD memory
SD memory error cards.)
23 trying to save ECG data on
Cannot write data. the SD memory card.
Use a new/different SD memory
An error occurred when
Error formatting SD card. (Always turn off the unit
24 formatting the SD memory
memory. before removing or inserting SD
card.
memory cards.)
Format the SD memory card.
Refer to p. 19.
*Copy any important data to a PC
The SD memory card may before formatting the SD memory
SD memory error. card as all data on the card will be
25 be damaged.
SD memory unknown. erased.
Use a new/different SD memory
card. (Always turn off the unit before
removing or inserting SD memory
cards.)

SD memory full. The SD memory card is full


and there is not enough
26 Please delete Either delete unnecessary data EN
space to save new ECG
unnecessary data. data. or use a new SD memory card.
(Always turn off the unit before
The number of data in The SD memory card is full removing or inserting SD
SD is over the limit. and there is not enough memory cards.)
27
Please delete space to save new ECG
unnecessary data. data.
Turn the unit off, then on again.
The unit may have been If this error still occurs, consult
91 Device error. damaged or is otherwise your Omron Customer Service
unable to operate normally. Department (Tel. 0870-
7502771).

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10. Care and Maintenance

10.2 Troubleshooting
Refer to this table for problems that do not result in a message on the display.

Problem Cause Solution


Replace both batteries with new ones.
Nothing happens when you press the The batteries are worn out.
button. The batteries are inserted incorrectly. Insert the batteries with their polarities
correctly aligned.
Measurement starts but the message
“Analysis impossible. Please The measurement data could not be Check the instructions and repeat
measure again.” appears. analysed. measurement.

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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11. Maintenance and Storage

11. Maintenance and Storage


• Clean the unit with a cloth lightly dampened with
water, disinfectant alcohol or detergent, then wipe
it dry with a dry cloth. Do not wipe the SD memory
card slot cover.
• Wipe the electrodes using a cloth dampened with
disinfectant alcohol.
• Do not wipe the unit with benzene, gasoline, paint
thinner, concentrated alcohol, or other volatile
detergents.

• Do not place objects on top of the unit. This could


damage the unit.

• Do not disassemble the unit. There are no user


serviceable parts. Repairs should only be carried
out by authorized personnel.
EN
• Do not sterilise this unit in an autoclave, ultraviolet
steriliser or gas steriliser (EOG, formaldehyde,
high density ozone etc.)
• This device does not require calibration during the
expected life cycle of five years.

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12. Technical Data


Model HCG-801
Induction system Bipolar single channel
Heart rate range 2 to 200 beats/min.
Accuracy Bandwidth: 0.05 to 40Hz
Sampling Rate: 125Hz
Enclosure ingress IP20
protection
Display Graphic LCD
Memory 5 measurements (using the unit’s internal memory)
300 measurements (using the supplied SD memory card)
Type of protection
against electric shock INTERNALLY POWERED

Classification of Applied TYPE BF


Parts

Power Supply 2 LR03 (AAA) batteries


Battery life Approximately 400 measurements with alkaline batteries
(When measurements are taken once a day at room temperature (22 °C).)
Operating Temperature +10 to +40 °C
and Humidity
30 to 85%RH
Storage Temperature -20 to +60 °C
and Humidity
10 to 95%RH
Weight Approximately 130g (including batteries)
Dimensions 121 mm (W) × 67 mm (H) × 24 mm (D)
Attachments Batteries 2 × LR03(AAA), SD memory card, Storage pouch, Instruction
manual, Quick reference card, Registration card, Guarantee card.
Other Symbol Mark
Please be sure to read this instruction manual carefully.

Note: Specifications may be changed without prior notice.

• This device supports SDA standard SD memory cards.


• OMRON Healthcare Inc. is a member of the SD Card Association.
• Uses bitmap font from Ricoh Co., Ltd.
• The SD logo is a registered trademark.
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12. Technical Data

This device fulfills the provisions of EC directive 93/42/EEC (Medical Device Directive).

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
potential 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 standard has been implemented. This standard defines
the levels of immunity to electromagnetic interferences as well as maximum levels of electromagnetic
emissions for medical device.
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 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 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, EN
please separate this 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 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.
Disposal of used batteries should be carried out in accordance with the national regulations for the
disposal of batteries.

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13. General Information About the Heart and ECG Measurements


The heart is a muscular pump controlled by electrical impulses generated by the
body. It is divided into two by the septa and each side has two chambers – an
atrium and a ventricle – linked by a one-way valve. The left atrium and ventricle
control oxygenated blood, and the right atrium and ventricle de-oxygenated
(“used”) blood.
The electrical impulse that causes the heart to beat spreads across the atria,
causing the left and right atrium to contract and pump blood into the left and right
ventricles respectively. The two ventricles then contract and pump blood out of the
heart. The heart muscle then relaxes, or re-polarises, allowing blood to fill up the
heart again.

Left atrium

Right atrium
Left ventricle

Right ventricle Septa

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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13. General Information About the Heart and ECG Measurements

About the ECG Waveform


The ECG waveform shows the rhythm of your heartbeat during the 30-second
measurement and displays the electrical activity causing the heart to beat. The
waveform for each heartbeat shows the progress of the electrical impulse across
and through the heart.
Ventrcular contraction
(QRS complex)

Atrial contraction (P wave) Re-polarization (T wave)

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.

55
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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

OMRON HEALTHCARE UK LIMITED


Opal Drive, Fox Milne Milton Keynes, MK15 0DG U.K.

OMRON MEDIZINTECHNIK HANDELSGESELLSCHAFT mbH


Subsidiary John-Deere-Str. 81a 68163 Mannheim GERMANY
www.omron-medizintechnik.de

OMRON Santé France SAS


14, rue de Lisbonne 93561 Rosny-sous-Bois Cedex, FRANCE

OMRON MATSUSAKA Co., Ltd.


Production facility 1855-370, Kubo-cho, Matsusaka-city, Mie-prefecture, 515-8503
JAPAN

Made in Japan IM-HCG-801-04-03/2010


1647415-5D

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