BP769CAN: Instruction Manual

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Français
Blood Pressure Monitor / Tensiomètre
Model / Modèle BP769CAN
Instruction Manual / Guide de l’utilisateur
3124754-8A
Product includes:
Le produit inclut :
AC Adapter
Adaptateur c.a.
Monitor
Tensiomètre
Easy-Wrap ComFit Cuff
Brassard facile à enrouler
ComFit
GETTING
STARTED
Blood Pressure Monitor
BP769CAN
Quick Start Guide
Guide de démarrage rapide
Instruction Manual
Guide de l’utilisateur
4 “AA” batteries
4 piles “AA”
1
2
b
I
D
I
A
L
c
a
M
Table Of Contents
Introduction ...................................................1
Definitions / Symbols ....................................2
Important Safety Information .......................4
1. Know Your Monitor .............................................9
Display Symbols ...................................... 10
2. Preparation ..........................................................13
2.1 Battery Installation ...............................13
2.2 Using the AC adapter ..........................14
2.3 Setting the Date and Time ..................15
2.4 Applying the Arm Cuff .........................17
2.5 Before Taking a Measurement ............18
2.6 How to Sit Correctly ............................19
3. Using Your Monitor without
a Smart Device ....................................................20
3.1 Taking a Measurement .......................20
4. Using Your Monitor with a Smart Device .....23
4.1 Pairing Your Monitor With
a Smart Device ....................................23
4.2 Taking a Measurement .......................26
5. Using the Memory Function ............................28
5.1 Viewing Your Readings Stored in
the Memory .........................................28
5.2 Viewing the Average Value .................29
5.3 Deleting All the Readings Stored in
the Memory .........................................30
6. Other Settings .....................................................31
6.1 Turning Bluetooth “OFF” ..................... 31
6.2 Turning Bluetooth “ON” ..................... 32
6.3 Restoring Your Monitor to the
Default Setting .................................... 33
7. Error Messages and Troubleshooting .........34
7.1 Error Messages .................................. 34
7.2 Troubleshooting .................................. 36
8. Maintenance ........................................................37
8.1 Maintenance ....................................... 37
8.2 Storage ............................................... 37
8.3 Cleaning ............................................. 38
8.4 Disposal .............................................. 38
9. Optional Accessories .......................................39
10. Specifications .....................................................40
11. FCC/IC Statement ..............................................42
12. Limited Warranty ...............................................43
13. Guidance and Manufacturer’s
Declaration ..........................................................44
Introduction
„ Introduction
Thank you for purchasing the OMRON BP769CAN Blood Pressure Monitor.
This new blood pressure monitor uses the oscillometric method of blood pressure measurement. This
means this monitor detects your blood movement through your brachial artery and converts the movements
into a digital reading. An oscillometric monitor does not need a stethoscope so this monitor is simple to use.
„ Safety Instructions
EN
This instruction manual provides you with important information about the OMRON BP769CAN Blood
Pressure Monitor. To ensure the safe and proper use of this monitor, READ and UNDERSTAND all of the
safety and operating instructions. If you do not understand these instructions or have any questions,
contact 1-800-634-4350 before attempting to use this monitor. For specific information about your
own blood pressure, consult with your physician.
„ Intended Use
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient
population. The device detects the appearance of irregular heartbeats during measurement and gives a
warning signal with readings.
„ Receiving and Inspection
Remove this monitor from the packaging and inspect for damage. If this monitor is damaged, DO NOT USE
and contact 1-800-634-4350.
Contraindications
• This monitor is contraindicated for use in ambulatory environments.
• This monitor is contraindicated for use on aircraft.
1
Definitions / Symbols
2
Warning
Indicates a potentially hazardous
situation, which if not avoided,
could result in death or serious
injury.
Temperature limitation
Caution
Indicates a potentially hazardous
situation, which if not avoided,
may result in minor or moderate
injury to the user or patient, or
cause damage to the equipment
or other property.
Humidity limitation
NOTE
Provides additional information to
clarify a point in the text.
Atmospheric pressure limitation
Follow this instruction manual
thoroughly for your safety.
or
Artery mark
Consult Instructions for Use.
or
Identifier of cuffs compatible for
the monitor
Applied part - Type BF
Degree of protection against
electric shock (leakage current)
Manufacturer
LOT number
Catalogue number
Definitions / Symbols
Class II equipment. Protection
against electric shock
For indoor use only
Indication of connector polarity
Alternating current
Direct current
Efficiency Level of power supply
Serial number
IP20
The device is protected against
solid foreign objects of 12.5 mm
diameter and greater such as a
finger.
IP21
The device is protected against
solid foreign objects of 12.5 mm
diameter and greater such as a
finger, and against vertically falling
water drops which may cause
issues during a normal operation.
EN
To indicate generally elevated,
potentially hazardous, levels of
nonionizing radiation, or to
indicate equipment or systems
e.g. in the medical electrical area
that include RF transmitters or
that intentionally apply RF
electromagnetic energy for
diagnosis or treatment.
3
Important Safety Information
Please read the Important Safety Information in this instruction manual before using this monitor.
Please follow this instruction manual thoroughly for your safety.
Please keep for future reference. For specific information about your own blood pressure, CONSULT WITH YOUR
PHYSICIAN.
Warning
• DO NOT adjust medication based on readings from this blood pressure monitor. Take medication as prescribed
by your physician. ONLY a physician is qualified to diagnose and treat high blood pressure.
• DO NOT use this monitor on an injured arm or an arm under medical treatment.
• DO NOT apply the arm cuff on your arm while on an intravenous drip or blood transfusion.
• ONLY inflate the arm cuff when it is applied on your upper arm.
• Consult with your physician before using this monitor on an arm with an arterio-venous (A-V) shunt.
• DO NOT use this monitor with other medical electrical (ME) equipment simultaneously.
• DO NOT use this monitor in areas of high frequency (HF) surgical equipment, magnetic resonance imaging (MRI)
equipment, computerized tomography (CT) scanners or in oxygen rich environments.
• Consult with your physician before using this monitor if you have common arrhythmias such as atrial or
ventricular premature beats or atrial fibrillation; arterial sclerosis; poor perfusion; diabetes; pregnancy;
pre-eclampsia or renal disease.
NOTE that any of these conditions in addition to patient motion, trembling, or shivering may affect the
measurement reading.
• The air tube or the AC adapter cable may cause accidental strangulation in infants, toddlers or children.
• This product contains small parts that may cause a choking hazard if swallowed by infants, toddlers or children.
• This product emits radio frequencies (RF) in the 2.4 GHz band. DO NOT use this product in locations where RF
is restricted, such as on an aircraft or in hospitals. Turn off the Bluetooth feature in this monitor, remove batteries
and/or unplug the AC adapter in those areas. For further information on potential restrictions refer to
documentation on the Bluetooth usage by the FCC/IC.
4
Important Safety Information
AC Adapter Handling and Usage
• DO NOT use the AC adapter if this monitor or the AC adapter cable is damaged. If this monitor or the cable is
damaged, turn off the power and unplug the AC adapter immediately.
• Plug the AC adapter into the appropriate voltage outlet. DO NOT use in a multi-outlet plug.
• NEVER plug in or unplug the AC adapter from the electric outlet with wet hands.
• DO NOT disassemble or attempt to repair the AC adapter.
Battery Handling and Usage
EN
• Keep batteries out of the reach of infants, toddlers or children.
Caution
•
•
•
•
•
•
•
•
•
•
•
NEVER diagnose or treat yourself based on your readings. ALWAYS consult with your physician.
DO NOT use this monitor on infants, toddlers, children or persons who cannot express themselves.
Stop using this monitor and consult with your physician if you experience skin irritation or discomfort.
Consult with your physician before using this monitor if you have had a mastectomy.
Consult with your physician before using this monitor if you have severe blood flow problems or blood disorders
as cuff inflation can cause bruising.
DO NOT take measurements more often than necessary because bruising, due to blood flow interference, may
occur.
Remove the arm cuff if it does not start deflating during a measurement.
DO NOT use this monitor for any purpose other than measuring blood pressure.
DO NOT use a mobile phone or other electrical devices that emit electromagnetic fields near this monitor except
when transferring your readings to your smart device. This may result in incorrect operation of this monitor.
DO NOT disassemble or attempt to repair this monitor or other components. This may cause an inaccurate
reading.
DO NOT use in a location where there is moisture or a risk of water splashing this monitor. This may damage this
monitor.
5
Important Safety Information
• DO NOT use this monitor in a moving vehicle such as in a car.
• DO NOT drop or subject this monitor to strong shocks or vibrations.
• DO NOT use this monitor in places with high or low humidity or high or low temperatures. Refer to chapter 10,
“Specifications”.
• Ensure this monitor is not impairing blood circulation by observing the arm while measurement is occurring.
• DO NOT use this monitor in high-use environments such as medical clinics or physician offices.
• Avoid bathing, drinking alcohol or caffeine, smoking, exercising and eating for at least 30 minutes before taking a
measurement.
• Rest for at least 5 minutes before taking a measurement.
• Remove tight-fitting or thick clothing from your arm while taking a measurement.
• Remain still and DO NOT talk while taking a measurement.
• ONLY use this monitor on persons whose arm circumference is within the specified range of the cuff.
• Ensure that the monitor has acclimated to room temperature before taking a measurement. Taking a
measurement after an extreme temperature change could lead to an inaccurate reading.
• DO NOT crease the arm cuff or the air tube excessively.
• DO NOT fold or kink the air tube while taking a measurement. This may cause an injury by interrupting blood
flow.
• To unplug the air plug, pull on the plastic air plug at the base of the tube, not the tube itself.
• ONLY use the AC adapter, arm cuff, batteries and accessories specified for this monitor. Use of unsupported AC
adapters, arm cuffs and batteries may damage and/or may be hazardous to this monitor.
• ONLY use the approved arm cuff for this monitor. Use of other arm cuffs may result in incorrect readings.
• Inflating to a higher pressure than necessary may result in bruising of the arm where the cuff is applied.
NOTE: please refer to “What to do if your systolic pressure is more than 210 mmHg” (page 21) of this instruction
manual for additional information.
• Read and follow the “Important information regarding Electro Magnetic Compatibility (EMC)” in chapter 13 of this
manual.
• Dispose of the monitor, other components and optional accessories according to applicable local regulations.
Unlawful disposal may cause environmental pollution.
6
Important Safety Information
Data Transmission
• DO NOT replace batteries or unplug the AC adapter while your readings are being transferred to your smart
device. This may result in incorrect operation of this monitor and failure to transfer your blood pressure data.
• When using this monitor for wireless communications, DO NOT place integrated circuit cards, magnets, metal
objects or other devices that emit electromagnetic fields near this monitor. This may result in incorrect operation
of this monitor or damage to the data.
AC Adapter Handling and Usage
EN
• Fully insert the AC adapter into the outlet.
• When unplugging the AC adapter from the outlet, be sure to safely pull from the AC adapter. DO NOT pull from
the AC adapter cable.
• When handling the AC adapter cable:
DO NOT damage it.
DO NOT break it.
DO NOT tamper with it.
DO NOT forcibly bend or pull it.
DO NOT twist it.
DO NOT use it if it is gathered in a bundle.
DO NOT pinch it.
DO NOT place it under heavy objects.
• Wipe any dust off of the AC adapter.
• Unplug the AC adapter when not in use.
• Unplug the AC adapter before cleaning this monitor.
7
Important Safety Information
Battery Handling and Usage
• DO NOT insert batteries with their polarities incorrectly aligned.
• ONLY use 4 “AA” alkaline or manganese batteries with this monitor. DO NOT use other types of batteries. DO
NOT use new and used batteries together.
• Remove batteries if this monitor will not be used for three months or more.
• If battery fluid should get in your eyes, immediately rinse with plenty of clean water. Consult with your physician
immediately.
• If battery fluid should get on your skin, wash your skin immediately with plenty of clean, lukewarm water. If
irritation, injury or pain persists, consult with your physician.
• DO NOT use batteries after their expiration date.
• Periodically check batteries to ensure they are in good working condition.
8
1. Know Your Monitor
Open the rear cover page to read the following:
The letter identifiers on the rear cover page correspond to those in the body of this page.
„ Monitor
A Air jack
B Blood pressure level indicator (color) *
C Connection button
D User ID selection switch
E Display
F Memory button
G START/STOP button
H Up/Down buttons
I
J
Battery compartment
AC adapter jack
„ Arm cuff
K Arm cuff (Arm circumference
9” - 17” (22 - 42 cm))
L Air plug
M Air tube
EN
* Blood pressure level indicator (color)
If your systolic blood pressure is 135 mmHg or above and/or the diastolic blood
pressure is 85 mmHg or above, the blood pressure level indicator (color) will light in
“orange” with readings. If readings are within the standard range, the blood pressure
level indicator (color) will light in “green”.
2013 ESH/ESC Guidelines for the management of arterial hypertension
Definitions of hypertension for office and home blood pressure levels
Office
Home
Systolic Blood Pressure
• 140 mmHg
• 135 mmHg
Diastolic Blood Pressure
• 90 mmHg
• 85 mmHg
These are from statistical values for blood pressure.
9
1. Know Your Monitor
Display Symbols
N
Memory symbol
Appears when you press the memory button along with the stored readings.
O
User ID symbol
The user ID number appears when selecting the user with user ID selection switch.
P
Average value symbol
Appears when you press and hold the memory button for more than 3 seconds. The
most recent average value appears on the display.
Q
R
S
Systolic blood pressure
Diastolic blood pressure
Connection symbol
Appears when transferring the data or pairing with your smart device.
T
Memory full symbol
Flashes when the data needs transferring because the stored memory is almost full.
When the memory is full, transfer your readings immediately before your monitor deletes
the oldest readings. Maximum internal memory is for 60 readings.
U
OK symbol
Flashes when your monitor is connected or readings are transferred successfully.
V
Heartbeat symbol
Flashes while taking a measurement.
10
1. Know Your Monitor
W
X
Date and Time display
Movement error symbol
Appears when your body is moving during a measurement. If the movement symbol
appears, remove the arm cuff, and wait for 2 to 3 minutes. After 2 to 3 minutes, remain
still and take another measurement.
Y
Irregular heartbeat symbol
Normal Heartbeat
When your monitor detects an irregular rhythm two or
Pulse
more times during a measurement, the irregular
Blood pressure
heartbeat symbol appears on the display along with
readings.
Irregular Heartbeat
Short Long
An irregular heartbeat rhythm is defined as a rhythm
Pulse
that is 25% less or 25% more than the average rhythm
detected while the monitor is measuring the systolic
Blood pressure
and diastolic blood pressure.
If the irregular heartbeat symbol appears with readings, consult with and follow the
directions of your physician.
Z
EN
Blood pressure level indicator (bar)
The blood pressure level indicator (bar) displays the range of your systolic blood
pressure and diastolic blood pressure visually.
AA
Battery symbol (low) (
Appears when batteries are low.
)
Battery symbol (depleted) (
Appears when batteries are depleted.
)
11
1. Know Your Monitor
AB
Deflation symbol
Flashes while your monitor is deflating the arm cuff.
AC
Pulse display / Memory number
Pulse rate appears after the measurement.
When pressing the memory button, the memory number appears for approximately one
second before the pulse rate appears on the display.
12
2. Preparation
2.1 Battery Installation
1. Remove the battery cover.
2. Insert 4 “AA” batteries as
EN
indicated in the battery
compartment.
3. Replace the battery cover.
NOTES:
• When the depleted battery symbol “
” appears on the display, turn your monitor off, then replace all
batteries at the same time. Long life alkaline batteries are recommended.
• After replacing batteries, “-/ - -:--” appears on the date and time display during or after measurement.
Before taking measurements, your monitor needs to be set with the correct date and time.
Measurements taken without date and time settings do not sync. For setting the date and time
manually, refer to section 2.3.
• The readings continue to be stored in memory even after batteries are replaced.
• The supplied batteries may have a shorter life than new batteries.
• Disposal of used batteries should be carried out in accordance with local regulations.
13
2. Preparation
2.2 Using the AC adapter
NOTES:
• Make sure to use an easily accessible power socket when plugging and unplugging the AC adapter.
• We recommend keeping batteries in your monitor at all times, even if you choose to use the AC adapter.
• If only the AC adapter is used without keeping batteries in your monitor, you may need to reset the date
and time each time you unplug and plug back the AC adapter. The readings will not be deleted.
1. Insert the AC adapter plug
into the AC adapter jack on
the rear side of your
monitor.
2. Plug the AC adapter into an
electrical outlet.
To unplug the AC adapter, unplug the AC adapter from the electrical outlet and then
remove the AC adapter plug from the monitor.
ONLY use the AC adapter, the arm cuff, batteries and accessories, specified for this monitor. Use of
unsupported AC adapters, arm cuffs and batteries may damage and/or may be hazardous to this
monitor.
14
2. Preparation
Open the rear cover page to read the following:
The letter identifiers on the rear cover page correspond to those in the body of this page.
2.3 Setting the Date and Time
The date and time are automatically set when you pair with your smart device. To set
manually, follow the instructions below. For pairing instructions, refer to section 4.1.
1. Press the
C
connection button
EN
.
1If your monitor has not been paired with a smart
device, the year flashes on the date and time
display.
2If your monitor has been paired with a smart
device already, the connection symbol “ ” and
“ ” flashes on the display of the monitor. Then
press the
button again, and the year flashes
on the date and time display.
NOTE: When the connection symbol “
” and “ ” flashes on the display of your monitor, you can
transfer your readings. Refer to section 4.2.
15
2. Preparation
2. Press the
or
button to change the year.
Press the
button to confirm the year and then the month flashes. Repeat the
same steps to change the month, day, hour, and minute.
Year
Month
Change Confirm
: Forward
: Back
Change Confirm
Day
Change
Minute
Hour
Confirm
Change
Confirm
Change
Confirm
3. Press the [START/STOP] button to turn the monitor off.
16
2. Preparation
Open both the front and rear covers to read the following:
The letter identifiers on the cover pages correspond to those in the body of this page.
2.4 Applying the Arm Cuff
Remove tight-fitting or thick clothing from your arm while taking a measurement.
EN
1. Insert L the air plug into A the air jack securely.
2. Apply the arm cuff to your left upper arm.
The bottom edge of the arm cuff should be a 1/2 inch (1 to 2 cm) above the elbow.
M Air tube is on the inside of your arm and aligned with your middle finger.
NOTES:
• When you take a measurement on the right arm, the air tube needs to be at the side of your elbow. Be
careful not to rest your arm on the air tube. --- b
• The blood pressure can differ between the right arm and the left arm, and the readings can be different.
OMRON recommends to always use the same arm for measurements. If the readings between both
arms differ substantially, please check with your physician as to which arm to use for your
measurements.
3. Securely close with the fabric fastener.
17
2. Preparation
2.5 Before Taking a Measurement
To help ensure an accurate reading, follow these directions:
Avoid bathing, drinking alcohol or caffeine, smoking, exercising and eating for at least 30 minutes before
taking a measurement.
Rest for at least 5 minutes before taking a measurement.
Remove tight-fitting or thick clothing from your arm while taking a measurement.
• Stress raises blood pressure. Avoid taking measurements during stressful times.
• Measurements should be taken in a quiet place.
• Keep a record of your blood pressure and pulse readings for your physician. A single measurement does not
provide an accurate indication of your true blood pressure. You need to take and record several readings over a
period of time. Try to measure your blood pressure at the same time each day for consistency.
18
2. Preparation
2.6 How to Sit Correctly
To take a measurement, you need to be relaxed and comfortably seated, at a
comfortable room temperature.
• Sit in a chair with your legs uncrossed and your feet flat on the floor.
• Sit with your back and arm being supported.
• The arm cuff should be placed on your arm at the same level as your heart. --- c
EN
19
3. Using Your Monitor without a Smart Device
Taking a Measurement
You can use your monitor without pairing to a smart device. For pairing, refer to
section 4.1.
NOTES:
• Check if the date and time are correct on the display when taking a measurement. For setting the date and
time manually, refer to section 2.3.
• To stop a measurement, press the [START/STOP] button once to deflate the arm cuff.
DO NOT use this monitor with other medical electrical (ME) equipment simultaneously.
Remain still and DO NOT talk while taking a measurement.
Your monitor is designed to take measurements and store readings in the memory
for 2 people using user ID 1 and user ID 2.
1. Select your user ID (1 or 2).
20
3. Using Your Monitor without a Smart Device
2. Press the [START/STOP] button.
The monitor automatically starts to inflate.
START
INFLATING
DEFLATING
COMPLETED
What to do if your systolic
pressure is more than 210 mmHg
After the arm cuff starts to inflate, press and
hold the [START/STOP] button until your
monitor inflates 30 to 40 mmHg higher than
your expected systolic pressure.
EN
NOTE: The monitor does not inflate above
299 mmHg.
Inflating to a higher pressure than
necessary may result in bruising where
the arm cuff is applied.
3. Remove the arm cuff.
4. Press the [START/STOP] button to turn the monitor off.
The monitor automatically stores readings in its memory.
It automatically turns off after 2 minutes.
NOTE: Wait 2-3 minutes before taking another measurement. Waiting between measurements allows
the arteries to return to the condition prior to taking a measurement.
21
3. Using Your Monitor without a Smart Device
„ Using the Guest Mode
Your monitor stores readings for 2 users in the memory. The guest mode can be
used to take a single measurement for another user. No readings are stored in the
memory when the guest mode is selected.
1. Press and hold the [START/STOP]
button for more than 3 seconds.
The user ID symbol and the date and time display disappears.
2. Release the [START/STOP] button when the date and
time display turns off.
The arm cuff automatically starts to inflate.
DO NOT adjust medication based on readings from this blood pressure monitor. Take medication
as prescribed by your physician. ONLY a physician is qualified to diagnose and treat high blood
pressure.
NEVER diagnose or treat yourself based on your readings. ALWAYS consult with your physician.
Inflating to a higher pressure than necessary may result in bruising of the arm where the cuff is
applied.
NOTE: please refer to "What to do if your systolic pressure is more than 210 mmHg" (page 21) of
this instruction manual for additional information.
22
4. Using Your Monitor with a Smart Device
4.1 Pairing Your Monitor With a Smart Device
The date and time on your monitor is automatically set when you pair the monitor
with your smart device.
Review the list of compatible smart devices at: OmronHealthcare.ca/connect.
EN
1. Turn on Bluetooth on your smart device.
2. Download and install the free “OMRON connect
US/CAN” app onto your smart device.
If you already have the “OMRON connect US/CAN” app, and have created your
account, visit “Manage Devices” in the “Profile” section of the “OMRON connect
US/CAN” app to add your new monitor.
3. Open the app on your smart device and follow set-up
and pairing instructions.
NOTE: Please make sure that your monitor is turned off. If the monitor is on, press the [START/STOP]
button to begin for pairing.
23
4. Using Your Monitor with a Smart Device
4. Press and hold the
button for more
than 2 seconds.
The connection symbol “
display of the monitor.
” and “P” flashes on the
5. Follow the pairing instructions shown on
your smart device, while the connection
symbol is flashing on the display of the
monitor.
6. Confirm if the monitor is connected
successfully.
When the monitor is connected successfully to your smart
device, the OK symbol “ ” flashes.
If “Err” appears, refer to “Connection failure. / Data is not
being transmitted.” in section 7.2 for more detail.
The monitor automatically turns off without any operations.
24
4. Using Your Monitor with a Smart Device
NOTES:
• If the Bluetooth feature of your monitor is turned off, turn Bluetooth on. Refer to section 6.2.
• If you use any other app instead of “OMRON connect US/CAN”, the date and time on your monitor may
not automatically be set. For setting the date and time manually, refer to section 2.3.
• Any readings currently saved in the memory of your monitor are automatically transferred to the app
after successful completion of the pairing process.
• Please be aware that OMRON will not be responsible for the loss of data and/or information.
EN
25
4. Using Your Monitor with a Smart Device
4.2 Taking a Measurement
1. Take a measurement.
About how to take a measurement, refer to chapter 3.
2. Transfer your Readings.
Please make sure your monitor is within 16 ft. (5 m) of your smart device and your
“OMRON connect US/CAN” app is active.
As soon as a measurement has completed, tap the “sync” icon in the “OMRON
connect US/CAN” app on your smart device to transfer the readings.
„ Transferring your Readings Later
1. Open the app on your smart device and follow the
instructions.
2. Make sure if your monitor has been turned off. If not,
turn the monitor off by pressing the [START/STOP]
button, and press the
button on the monitor.
3. Tap the “sync” icon in the “OMRON connect US/CAN”
app to start the transfer.
26
4. Using Your Monitor with a Smart Device
4. Confirm that your readings were
successfully transferred.
When your readings are successfully transferred to your smart device,
the OK symbol “
” flashes.
If “Err” appears or the data transfer is not starting, refer to “Connection failure. /
Data is not being transmitted.” in section 7.2 for more detail.
EN
NOTES:
• If the Bluetooth feature of your monitor is turned off, turn Bluetooth on. Refer to
section 6.2.
• The stored readings can be transferred all at once.
• Once you send your readings to the app, the readings cannot be sent again to any app or smart device.
• When the time on your monitor and smart device differ by more than 10 minutes, your smart device
updates the time on the monitor.
• If “-/ - -:--” appears on the date and time display during or after measurement, the readings will not be
transferred. For setting the date and time manually, refer to section 2.3.
• If you use an app other than the “OMRON connect US/CAN” app, the date and time may not be set
automatically on your monitor.
„ Memory Full Notification
When the memory full symbol “ ” flashes on the display, transfer your readings
immediately before the readings are deleted. If the memory is full, your monitor
deletes the oldest readings.
27
5. Using the Memory Function
5.1 Viewing Your Readings Stored in the
Memory
Your monitor automatically stores readings up to 60 for each user (1 and 2).
It can also calculate an average value based on the last 3 readings taken within
10 minutes.
NOTES:
• When there are only 2 readings in the memory for that period, the average is displayed based on these
2 readings.
• When there is 1 set of readings in the memory for that period, it is displayed as the average.
• When the memory is full, your monitor deletes the oldest readings.
• When viewing the readings taken without setting the date and time, “-/ - -:--” is displayed instead of the
date and time.
1. Select your user ID (1 or 2).
2. Press the button.
The memory number appears for approximately one
second before the pulse rate is displayed. The newest
set is numbered “1”.
28
5. Using the Memory Function
3. Press the
or
the memory.
button to view the readings stored in
: To view the older readings
: To view the more recent readings
EN
5.2 Viewing the Average Value
1. Select your user ID (1 or 2).
2. Press and hold the button for more
than 3 seconds.
NOTES:
• If the previous measurement was taken without setting the date and
time, the average value is not calculated.
• If there are no readings stored in the memory, the screen to the right is
displayed.
29
5. Using the Memory Function
5.3 Deleting All the Readings Stored in the
Memory
The readings stored in the memory are deleted by each user ID.
1. Select your user ID (1 or 2).
2. Press the button. The memory symbol “
3. While holding the button down,
press the [START/STOP] button for
more than 3 seconds.
NOTE: You cannot partially delete the readings stored in the
memory. All readings for the user you select will be
deleted.
30
” appears.
6. Other Settings
6.1 Turning Bluetooth “OFF”
This product emits radio frequencies (RF) in the 2.4 GHz band. DO NOT use this product in locations
where RF is restricted, such as on an aircraft or in hospitals. Turn off the Bluetooth feature in this
monitor, remove batteries and/or unplug the AC adapter in those areas. For further information on
potential restrictions refer to documentation on the Bluetooth usage by the FCC/IC.
EN
Your monitor comes with Bluetooth already turned on.
1. Make sure if your monitor has been turned off. If not,
turn the monitor off by pressing the [START/STOP]
button.
2. Press and hold the
button for
more than 10 seconds.
Release the
button when
“oFF” appears on the display.
3. Press the [START/STOP] button to turn the monitor off.
NOTE: Your monitor automatically turns off after 2 minutes.
31
6. Other Settings
6.2 Turning Bluetooth “ON”
1. Make sure if your monitor has been turned off. If not,
turn the monitor off by pressing the [START/STOP]
button.
2. Press and hold the
button for
more than 10 seconds.
Release the
button when “on”
appears on the display.
3. Press the [START/STOP] button to turn the monitor off.
NOTE: Your monitor automatically turns off after 2 minutes.
32
6. Other Settings
6.3 Restoring Your Monitor to the Default
Setting
To delete all the information stored in your monitor, follow the instructions below. Make sure that the
monitor is turned off. It is off when the screen is not showing numbers or symbols.
1. While holding the
button down,
press the [START/STOP] button
for more than 5 seconds.
EN
2. Release the
button and [START/STOP]
button when “CLr” appears on the display.
The “CLr” appears on the display when the monitor setting has
reverted back to its original.
NOTES:
• Your monitor automatically turns off without any operations.
• Reverting to its default setting of your monitor does not delete the information in the app.
• Make sure to re-pair your monitor when using the monitor again. Without re-pairing, your readings are
not transferred to your app.
33
7. Error Messages and Troubleshooting
7.1 Error Messages
Display
Possible Cause
Irregular heartbeats are detected.
Movement during a measurement.
Carefully read and repeat the steps in
chapter 3.
Batteries are low.
Batteries are depleted or battery polarities
are not properly aligned.
The air plug is disconnected.
The arm cuff is applied too loosely.
Air is leaking from the arm cuff.
34
Solution
Remove the arm cuff. Wait 2-3 minutes and
then take another measurement.
Repeat the steps in chapter 3. If this error
continues to appear, contact your physician.
Recommend replacement of all 4 batteries
with new ones.
Refer to section 2.1.
Immediately replace 4 batteries with new
ones.
Refer to section 2.1.
Confirm batteries are properly inserted with
polarities correctly aligned.
Refer to section 2.1.
Insert the air plug securely.
Refer to section 2.4.
Apply the arm cuff tighter.
Refer to section 2.4.
Replace the arm cuff with a new one.
Refer to chapter 9.
7. Error Messages and Troubleshooting
Display
Possible Cause
Movement during measurement and the
arm cuff has not been inflated sufficiently.
The arm cuff was inflated exceeding the
maximum allowable pressure, and then
deflated automatically.
Movement during a measurement.
Movement during a measurement.
Solution
Repeat measurement. Remain still and do not
talk during measurement.
Refer to chapter 3.
If “E2” appears repeatedly, inflate the arm cuff
manually until it is 30 to 40 mmHg above your
previous measurement result.
Refer to chapter 3.
Do not touch the arm cuff and/or bend the air
tube while taking a measurement. Do not
inflate the arm cuff more than necessary.
Refer to chapter 3.
EN
Repeat measurement. Remain still and do not
talk during measurement.
Refer to chapter 3.
Clothing is interfering with the arm cuff.
Remove any clothing interfering with the arm
cuff.
Refer to section 2.4.
Connection failure. /
Data is not being transmitted.
Refer to “Connection failure. / Data is not
being transmitted.” in section 7.2.
Device error.
Contact Customer Service.
35
7. Error Messages and Troubleshooting
7.2 Troubleshooting
Problem
Possible Cause and Solution
No power.
No display appears on the monitor.
Replace all batteries with new ones.
Check the battery installation for proper placement of the battery
polarities. Refer to section 2.1.
Readings appear too high or too
low.
Blood pressure varies constantly. Many factors including stress, time of
day, and how you apply the arm cuff, may affect your blood pressure.
Review sections 2.5, 2.6 and chapter 3.
The monitor might not be properly placed within the transmission range of
the smart device and is too far from the smart device. If there are no
causes of data transmission interference found near the monitor, move
the monitor within 16 ft. (5 m) of the smart device and try sending the data
again.
The Bluetooth feature of the smart device is turned off. Turn on the
Bluetooth feature of the smart device and try sending the data again.
The Bluetooth feature of the monitor is turned off. Refer to section 6.2,
and try sending the data again.
Connection failure. /
Data is not being transmitted.
The monitor did not pair successfully to the smart device. Try to pair the
devices again.
Refer to section 4.1 or visit the “Help” section in the “OMRON connect
US/CAN” app for further help in pairing your smart device.
The monitor is not ready. If the monitor is on, press the [START/STOP]
button to turn the monitor off, and press the
button to allow you to
begin to transfer your readings. Then try sending the data again.
The application on the smart device is not ready. Check the application
then try sending the data again.
If the “Err” symbol still lights after checking the application, contact
customer service.
36
8. Maintenance
8.1 Maintenance
To protect your monitor from damage, please follow the directions below:
• Store your monitor and other components in a clean, safe location.
• Changes or modifications not approved by the manufacturer will void the user warranty.
DO NOT disassemble or attempt to repair this monitor or other components. This may
cause an inaccurate reading.
EN
8.2 Storage
1. Unplug the air plug from the air jack.
2. Gently fold the air tube into the
arm cuff.
NOTE: Do not bend or crease the air tube excessively.
Do not store your monitor and other components:
• If the monitor and other components are wet.
• In locations exposed to extreme temperatures, humidity, direct sunlight, dust or corrosive vapors such
as bleach.
• In locations exposed to vibrations or shocks.
37
8. Maintenance
8.3 Cleaning
• Do not use any abrasive or volatile cleaners.
• Use a soft dry cloth or a soft cloth moistened with neutral soap to clean your
monitor and the arm cuff, and then wipe them with a dry cloth.
• Do not wash or immerse your monitor or other components in water.
• Do not use gasoline, thinners or similar solvents to clean your monitor.
8.4 Disposal
Dispose of the monitor, other components and optional accessories according to
applicable local regulations. Unlawful disposal may cause environmental pollution.
38
9. Optional Accessories
Arm Cuff
AC Adapter
Arm circumference
9” - 17” (22 - 42 cm)
EN
Easy-Wrap ComFit Cuff
Model: CFX-WR17
(HEM-FL31)
Model: HEM-ADPTW5
39
10. Specifications
Model
Display
Cuff pressure range
Measurement range
Accuracy
Inflation
Deflation
Measurement method
Transmission method
Wireless communication
IP classification
Rating
Power source
Battery life
Durable period (Service life)
Operating conditions
Storage / Transport conditions
Weight
Dimensions
40
Cuff circumference
Memory
Contents
BP769CAN
HEM-7320T-CACS
LCD digital display
Pressure: 0 to 299 mmHg
Pressure: 20 to 280 mmHg
Pulse: 40 to 180 beats / min.
Pressure: r3 mmHg
Pulse: r 5% of display reading
Fuzzy-logic controlled by electric pump
Automatic pressure release valve
Oscillometric method
Bluetooth® low energy technology
Frequency range: 2.4 GHz (2400 - 2483.5 MHz)
Modulation: GFSK
Effective radiated power: <20 dBm
Monitor: IP 20
AC adapter: IP21
DC6 V 4 W
4 “AA” batteries 1.5V or AC adapter (INPUT AC100-240V 50/60Hz 0.12-0.065A)
Approximately 1000 measurements (using new alkaline batteries)
Monitor: 5 years
Cuff: 1 year
AC adapter: 5 years
+50°F to +104°F (+10°C to +40°C) / 15 to 90% RH (non-condensing) / 800 to 1060 hPa
-4°F to +140°F (-20°C to +60°C) / 10 to 90% RH (non-condensing)
Monitor: Approximately 13 5/8 oz. (385 g) not including batteries
Arm cuff: Approximately 5 3/4 oz. (163 g)
Monitor: Approximately 4 7/8” (w) u 3 1/2” (h) u 6 3/8” (l)
(124 mm u 90 mm u 161 mm)
Arm cuff: Approximately 5 3/4” u 21” (air tube: 29 1/2”)
(145 mm u 532 mm (air tube: 750 mm))
9” to 17” (22 to 42 cm)
Up to 60 per user
Monitor, Easy-Wrap ComFit Cuff, 4 “AA” batteries, AC adapter, instruction manual, quick start guide
10. Specifications
Applied part
Protection against electric shock
Type BF
Internally powered ME equipment (When using only batteries)
Class II ME equipment (AC adapter)
NOTES:
•
•
•
•
•
These specifications are subject to change without notice.
In the clinical validation study, K5 was used on 85 subjects for determination of diastolic blood pressure.
This monitor is clinically investigated according to the requirements of ISO 81060-2:2013.
This monitor has not been validated for use on pregnant patients.
IP classification is degrees of protection provided by enclosures in accordance with IEC 60529. This monitor and
the AC adapter are protected against solid foreign objects of 12.5 mm diameter and greater such as a finger.
The AC adapter is protected against vertically falling water drops which may cause issues during a normal
operation.
EN
About a wireless communication interference
This product operates in an unlicensed ISM band at 2.4 GHz. In the event this Product is used near other
wireless devices such as microwave and wireless LAN, which operate on the same frequency band as this
Product, there is a possibility that interference may occur.
If interference occurs, stop the operation of the other devices or relocate this Product away from other wireless
devices before attempting to use it.
41
11. FCC/IC Statement
FCC CAUTION
Changes or modifications not expressly approved by the party responsible for compliance could void the user’s
authority to operate the equipment.
NOTE:
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15
of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed
and used in accordance with the instructions, may cause harmful interference to radio communications. However,
there is no guarantee that interference will not occur in a particular installation. If this equipment does cause
harmful interference to radio or television reception, which can be determined by turning the equipment off and on,
the user is encouraged to try to correct the interference by one or more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.
This transmitter must not be co-located or operated in conjunction with any other antenna or transmitter.
This equipment complies with FCC/IC radiation exposure limits set forth for an uncontrolled environment and
meets the FCC radio frequency (RF) Exposure Guidelines and RSS-102 of the IC radio frequency (RF) Exposure
rules. This equipment has very low levels of RF energy that are deemed to comply without testing of specific
absorption ratio (SAR).
42
12. Limited Warranty
Your BP769CAN Blood Pressure Monitor, excluding the arm cuff, AC adapter and batteries are warranted to be
free from defects in materials and workmanship appearing within 5 years from the date of purchase, when used in
accordance with the instructions provided with the monitor. The arm cuff and AC adapter are warranted to be free
from defects in materials and workmanship appearing within 1 year from the date of purchase when the monitor is
used in accordance with the instructions provided with the monitor. The above warranty extends only to the original
retail purchaser.
We will, at our option, replace without charge any monitor, arm cuff or AC adapter covered by the above warranty.
Replacement is our only responsibility and your only remedy under the above warranty.
EN
To obtain warranty service contact Customer Service by calling 1-800-634-4350 for the address of the inspection
center and the return shipping and handling fee.
Enclose the original printed receipt. Include a letter, with your name, address, phone number, and description of
the specific problem. Pack the product carefully to prevent damage in transit. Because of possible loss in transit,
we recommend insuring the product with return receipt requested.
THE FOREGOING IS THE SOLE WARRANTY PROVIDED BY OMRON IN CONNECTION WITH THIS
PRODUCT, AND OMRON HEREBY DISCLAIMS ANY OTHER WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
IMPLIED WARRANTIES AND OTHER TERMS THAT MAY BE IMPOSED BY LAW, IF ANY, ARE LIMITED IN
DURATION TO THE PERIOD OF THE ABOVE EXPRESS WARRANTY.
OMRON SHALL NOT BE LIABLE FOR LOSS OF USE OR ANY OTHER SPECIAL, INCIDENTAL,
CONSEQUENTIAL OR INDIRECT COSTS, EXPENSES OR DAMAGES.
This warranty provides you with specific legal rights, and you may have other rights that vary by jurisdiction.
Because of special local requirements, some of the above limitations and exclusions may not apply to you.
FOR CUSTOMER SERVICE
Visit our web site at:
Call toll free:
OmronHealthcare.ca
1-800-634-4350
43
13. Guidance and Manufacturer’s Declaration
OMRON Blood Pressure Monitor (BPM) including AC-adapter
Information for accompanying documents in the scope of IEC60601-1-2:2007
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.
Medical devices manufactured by OMRON Healthcare conform to this IEC60601-1-2:2007 standard for both immunity and emissions.
Nevertheless, special precautions need to be observed:
• The use of accessories and cables other than those specified by OMRON, with the exception of cables sold by OMRON as replacement
parts for internal components, may result in increased emission or decreased immunity of the device.
• The medical devices should not be used adjacent to or stacked with other equipment.
In case adjacent or stacked use is necessary, the medical device should be observed to verify normal operation in the configuration in
which it will be used.
• Refer to further guidance below regarding the EMC environment in which the device should be used.
• The MEDICAL ELECTRICAL EQUIPMENT BPM including AC-adapter needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided in this documentations.
• The Essential Performance of the BPM including AC-adapter is to measure a blood pressure and a pulse rate and using the memory
function.
The BPM including AC-adapter may be interfered with by other equipment, even if that other equipment complies with CISPR EMISSION
requirements.
Guidance and manufacturer’s declaration - electromagnetic emissions
OMRON BPM including AC-adapter is intended for use in the electromagnetic environment specified below. The customer or the user of this
OMRON BPM including AC-adapter should assure that it is used in such environment.
Emissions test
44
Compliance
RF emissions CISPR 11
Group 1
RF emissions CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC61000-3-3
Complies
Electromagnetic environment - guidance
The OMRON BPM including AC-adapter uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
The OMRON BPM including AC-adapter is suitable for use in all establishments,
including domestic establishments and those directly connected to the public
low-voltage power supply network that supplies buildings used for domestic
purposes.
13. Guidance and Manufacturer’s Declaration
Guidance and manufacturer’s declaration - electromagnetic immunity
OMRON BPM including AC-adapter is intended for use in the electromagnetic environment specified below. The customer or the user of this
OMRON BPM including AC-adapter should assure that it is used in such environment.
Immunity test
IEC 60601 test level
Compliance level
Electrostatic discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
Electrical fast transient/burst
IEC 61000-4-4
Mains power quality should be that of a
±2 kV for power supply lines ±2 kV for power supply lines
typical commercial and/or hospital
±1 kV for input/output lines ±1 kV for input/output lines
environment.
Surge
IEC 61000-4-5
±1 kV line(s) to line(s)
±2 kV line(s) to earth
±1 kV line(s) to line(s)
±2 kV line(s) to earth
<5 % UT (>95 % dip in UT)
for 0.5 cycle
<5 % UT (>95 % dip in UT)
for 0.5 cycle
40 % UT (60 % dip in UT)
for 5 cycles
40 % UT (60 % dip in UT)
for 5 cycles
70 % UT (30 % dip in UT)
for 25 cycles
70 % UT (30 % dip in UT)
for 25 cycles
<5 % UT (>95 % dip in UT)
for 5 sec.
<5 % UT (>95 % dip in UT)
for 5 sec.
3 A/m
3 A/m
Voltage dips, short interruptions
and voltage variations on power
supply inputlines
IEC 61000-4-11
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
±6 kV contact
±8 kV air
Electromagnetic environment - guidance
Floor should be wood, concrete, or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30 %.
EN
Mains power quality should be that of a
typical commercial and/or hospital
environment.
Mains power quality should be that of a
typical commercial and/or hospital
environment. If the user of the OMRON BPM
including AC-adapter requires continued
operation during power mains interruption, it
is recommended that the OMRON BPM
including AC-adapter be powered from an
uninterruptible power supply.
Power frequency magnetic fields should be
at levels characteristic of a typical location in
a typical commercial or hospital environment.
Note: UT is the A.C. mains voltage prior to application of the test level.
45
13. Guidance and Manufacturer’s Declaration
Guidance and manufacturer’s declaration - electromagnetic immunity
OMRON BPM including AC-adapter is intended for use in the electromagnetic environment specified below. The customer or the user of this
OMRON BPM including AC-adapter should assure that it is used in such environment.
Compliance
Immunity test
IEC 60601 test level
Electromagnetic environment - guidance
level
Portable and mobile RF communications equipment should be used no closer to
any part of the OMRON BPM including AC-adapter including cables, than the
recommended separation distance calculated from the equation appropriate to
the frequency of the transmitter.
Recommend separation distance
Conducted RF
IEC 61000-4-6
3 V rms
150 kHz to 80 MHz
3 V rms
d = 1.2 P
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
d = 1.2 P
80 MHz to 800 MHz
d = 2.3 P
800 MHz to 2.5 GHz
where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters as determined by an electromagnetic
site survey,a should be less than the compliance level in each frequency range.b
Interference may occur in the vicinity of equipment marked with the following
symbol:
46
Note1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects, and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radio, AM and FM
radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the
OMRON BPM including AC-adapter is used exceeds the applicable RF compliance level above, the OMRON BPM including AC-adapter
should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the OMRON BPM including AC-adapter.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
13. Guidance and Manufacturer’s Declaration
Recommended separation distance between portable and mobile RF communications equipment
and the OMRON BPM including AC-adapter
OMRON BPM including AC-adapter is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of this OMRON BPM including AC-adapter can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications equipment (transmitters) and the OMRON BPM including AC-adapter
as recommended below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter in meter
Output Power of Transmitter in Watt
150 kHz to 80 MHz
d = 1.2 P
80 MHz to 800 MHz
d = 1.2 P
800 MHz to 2.5GHz
d = 2.3 P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
EN
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated
using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer.
Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects, and people.
47
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W
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D
P
K
L
Q
X
Y
R
M
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S
T
U
V
AA
AB
AC
The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG,
Inc. and any use of such marks by OMRON HEALTHCARE Co., Ltd. is under license. Other
trademarks and trade names are those of their respective owners.
Apple and the Apple logo are trademarks of Apple Inc., registered in the U.S. and other countries.
App Store is a service mark of Apple Inc.
Android and the Google Play logo are trademarks of Google Inc.
Manufactured for / Fabriqué pour :
OMRON HEALTHCARE Co., Ltd.
53, Kunotsubo, Terado-cho, Muko, Kyoto, 617-0002 JAPAN
Distributed by / Distribué par :
OMRON HEALTHCARE, INC.
1925 West Field Court Lake Forest, IL 60045 U.S.A.
OmronHealthcare.ca
© 2017 OMRON HEALTHCARE, INC.
Made in Vietnam / Fabriqué au Vietnam
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