Omron Healthcare HEM6232T User Manual
Introduction
Important Safety Information
1. Know Your Monitor
2. Preparation
3. Using Your Monitor without a Smart Device
4. Using Your Monitor with a Smart Device
5. Using Memory Function
6. Other Settings
7. Error Messages and Troubleshooting
8. Maintenance
9. Specifications
10. FCC/IC Statement
11. Limited Warranty
12. Guidance and Manufacturer’s Declaration
Important Safety Information
1. Know Your Monitor
2. Preparation
3. Using Your Monitor without a Smart Device
4. Using Your Monitor with a Smart Device
5. Using Memory Function
6. Other Settings
7. Error Messages and Troubleshooting
8. Maintenance
9. Specifications
10. FCC/IC Statement
11. Limited Warranty
12. Guidance and Manufacturer’s Declaration
Thank you for purchasing the
OMRON BP4350 Wrist Blood
Pressure Monitor. This blood pressure monitor is to be worn on your
wrist.
This new blood pressure monitor uses the oscillometric method of
blood pressure measurement. When the cuff inflates, this monitor
senses the pressure pulsations of the artery underneath the cuff.
The pulses are called oscillometric pulses. The electronic pressure
sensor displays a digital reading of blood pressure.
wrist.
This new blood pressure monitor uses the oscillometric method of
blood pressure measurement. When the cuff inflates, this monitor
senses the pressure pulsations of the artery underneath the cuff.
The pulses are called oscillometric pulses. The electronic pressure
sensor displays a digital reading of blood pressure.
Safety Instructions
This instruction manual provides you with important information
about the OMRON BP4350 Wrist 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.
about the OMRON BP4350 Wrist 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 with wrist
circumference ranging from 5.3 inches to 8.5 inches (13.5 cm to
21.5 cm). The device detects the appearance of irregular heartbeats
during measurement and gives a warning signal with readings.
pressure and pulse rate in adult patient population with wrist
circumference ranging from 5.3 inches to 8.5 inches (13.5 cm to
21.5 cm). The device detects the appearance of irregular heartbeats
during measurement and gives a warning signal with readings.
Environments of Use: Home
Patient Population: Adult
Patient Population: Adult
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.
this monitor is damaged, DO NOT USE and contact 1-800-634-
4350.
Symbols Glossary
For symbol information, visit:
OmronHealthcare.com/symbols-glossary
OmronHealthcare.com/symbols-glossary
Contraindications
• This monitor is contraindicated for use in ambulatory
environments.
• This monitor is contraindicated for use on aircraft.
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.
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
Indicates a potentially hazardous situation
which, if not avoided, could result in death or
serious injury.
• DO NOT use this monitor on infants, toddlers, children or
persons who cannot express themselves.
• 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.
physician. ONLY a physician is qualified to diagnose and treat
high blood pressure.
• DO NOT use this monitor on an injured wrist or a wrist under
medical treatment.
• DO NOT apply the wrist cuff on your wrist while on an
intravenous drip or blood transfusion.
• DO NOT use this monitor in areas containing high frequency
(HF) surgical equipment, magnetic resonance imaging (MRI)
equipment, computerized tomography (CT) scanners or in
oxygen rich environments. This may result in incorrect
operation of the monitor and/or cause an inaccurate reading.
equipment, computerized tomography (CT) scanners or in
oxygen rich environments. This may result in incorrect
operation of the monitor and/or cause an inaccurate reading.
• 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.
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.
• NEVER diagnose or treat yourself based on your readings.
ALWAYS consult with your physician.
• This product contains small parts that may cause a choking
hazard if swallowed by infants, toddlers or children.
Wrist Blood Pressure
Monitor
Model BP4350
Instruction Manual
2829250-8A
Table of Contents
Introduction
Important Safety Information
Data Transmission
• 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
restricted, such as on an aircraft or in hospitals. Turn off the
Bluetooth feature in this monitor and remove batteries when
in RF restricted areas. For further information on potential
restrictions refer to documentation on the Bluetooth usage by
the FCC/IC.
in RF restricted areas. For further information on potential
restrictions refer to documentation on the Bluetooth usage by
the FCC/IC.
Battery Handling and Usage
• Keep batteries out of the reach of infants, toddlers or
children.
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.
• Stop using this monitor and consult with your physician if
you experience skin irritation or discomfort.
• Consult with your physician before using this monitor on a
wrist where intravascular access or therapy, or an arterio-
venous (A-V) shunt, is present because of temporary
interference to blood flow which could result in injury.
venous (A-V) shunt, is present because of temporary
interference to blood flow which could result in injury.
• 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.
inflation can cause bruising.
• DO NOT take measurements more often than necessary
because bruising, due to blood flow interference, may occur.
• ONLY inflate the wrist cuff when it is applied on your wrist.
• Remove the wrist cuff if it does not start deflating during a
• Remove the wrist cuff if it does not start deflating during a
measurement.
• DO NOT use this monitor for any purpose other than
measuring blood pressure.
• During measurement, make sure that no mobile device or any
other electrical device that emit electromagnetic fields is
within 12 inches (30 cm) of this monitor. This may result in
incorrect operation of the monitor and/or cause an inaccurate
reading.
within 12 inches (30 cm) of this monitor. This may result in
incorrect operation of the monitor and/or cause an inaccurate
reading.
• 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.
• 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
• 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
9.
• Ensure this monitor is not impairing blood circulation by
observing the wrist while measurement is occurring.
• DO NOT use this monitor in high-use environments such as
medical clinics or physician offices.
• DO NOT use this monitor with other medical electrical (ME)
equipment simultaneously. This may result in incorrect
operation of the monitor and/or cause an inaccurate reading.
operation of the monitor and/or cause an inaccurate reading.
• Avoid bathing, drinking alcohol or caffeine, smoking,
exercising and eating for at least 30 minutes before taking a
measurement.
measurement.
• Rest for at least 5 minutes before taking a measurement.
• Remove tight-fitting, thick clothing and any accessories from
• Remove tight-fitting, thick clothing and any accessories from
your wrist while taking a measurement.
• Remain still and DO NOT talk while taking a measurement.
• ONLY use this monitor on persons whose wrist
• ONLY use this monitor on persons whose wrist
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.
extreme temperature change could lead to an inaccurate
reading.
• DO NOT crease the wrist cuff excessively.
Data Transmission
• DO NOT replace batteries while your reading is being
transferred to your smart device. This may result in the
incorrect operation of this monitor and failure to transfer your
blood pressure data.
incorrect operation of this monitor and failure to transfer your
blood pressure data.
Battery Handling and Usage
• DO NOT insert batteries with their polarities incorrectly
aligned.
• ONLY use 2 “AAA” alkaline batteries with this monitor. DO
NOT use other types of batteries. DO NOT use new and used
batteries together.
batteries together.
• Remove batteries if this monitor will not be used for a long
period of time.
• If battery fluid should get in your eyes, immediately rinse with
plenty of clean water. Consult with your physician
immediately.
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.
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
• Periodically check batteries to ensure they are in good
working condition.
• ONLY use batteries specified for this monitor. Use of
unsupported batteries may damage and/or may be hazardous
to this monitor.
1.1
Contents
Monitor, 2 “AAA” alkaline batteries, storage case, instruction manual,
quick start guide
quick start guide
1.2
Monitor
a. Wrist cuff
(Wrist circumference 5.3" to 8.5" (13.5 cm to 21.5 cm))
b. Display
c. Battery compartment
d. [User ID selection] switch
e. [Memory] button
f. [Morning average] button
g. [START/STOP] button
h. [Connection] button
c. Battery compartment
d. [User ID selection] switch
e. [Memory] button
f. [Morning average] button
g. [START/STOP] button
h. [Connection] button
1.3
Display
1.4
Display Symbols
1. Know Your Monitor
A
Date and time display
B
Average value symbol
Appears when viewing the average readings of the
latest 2 or 3 readings taken within 10 minutes span.
latest 2 or 3 readings taken within 10 minutes span.
C
Memory symbol
Appears when viewing readings stored in the memory.
D
Systolic blood pressure reading
E
Diastolic blood pressure reading
F
Pulse display / Memory number
Pulse rate appears after the measurement.
When pressing the
When pressing the
button, the memory number appears
for approximately one second before the pulse rate appears on
the display.
the display.
G
Deflation symbol
Flashes during cuff deflation.
H
Heartbeat symbol
Flashes while taking a measurement.
I
Sync symbol
Flashes when your data needs to be transferred
because the stored memory is either almost, or
completely full. Once you pair your monitor with a smart
device, transfer your readings immediately before your
monitor deletes the oldest readings. Up to 100 readings
can be stored in the internal memory per user.
because the stored memory is either almost, or
completely full. Once you pair your monitor with a smart
device, transfer your readings immediately before your
monitor deletes the oldest readings. Up to 100 readings
can be stored in the internal memory per user.
J
OK symbol
Flashes when your monitor is connected to the smart
device or readings are transferred successfully.
device or readings are transferred successfully.
K
Morning average symbol
Appears when viewing the weekly average readings
taken in the morning.
Weekly averages for the measurement taken in the
morning within 4 weeks appear on the display.
taken in the morning.
Weekly averages for the measurement taken in the
morning within 4 weeks appear on the display.
L
User ID symbol
The user ID number appears when selecting the user
with [User ID selection] switch.
with [User ID selection] switch.
M
Hypertension symbol
The “
” symbol appears if your systolic blood
pressure is 135 mmHg or above and/or the diastolic
blood pressure is 85 mmHg or above.
blood pressure is 85 mmHg or above.
Morning hypertension symbol
The “
” symbol appears when the morning weekly
average is 135/85 mmHg or above.
a
b
c
d
e
f
g
h
C
D
E
G
H
I
J
F
L
K
B
A
M
O
S
N
P
Q
R
2013 ESH/ESC* Guidelines for the management of
arterial hypertension
Definitions of hypertension by office and home blood pressure levels
These are from statistical values for blood pressure.
* European Society of Hypertension (ESH) and European Society of
Cardiology (ESC).
* European Society of Hypertension (ESH) and European Society of
Cardiology (ESC).
Warning
• NEVER diagnose or treat yourself based on your readings.
ALWAYS consult with your physician.
2.1
Installing Batteries
1.
Push down the hook of the
battery cover and pull
downward.
2.
Insert 2 “
AAA” alkaline batteries
as indicated in the battery
compartment.
3.
Close the battery cover.
Note
• When the “
” symbol appears on the display, it is
recommended you replace batteries.
• To replace batteries, turn your monitor off and remove all batteries.
Then replace with 2 new alkaline batteries at the same time.
• As soon as batteries are correctly installed, the year flashes on the
date and time display to set the date and time.
• Replacing batteries will not delete previous readings.
• The supplied batteries may have a shorter life than new batteries.
• Disposal of used batteries should be carried out in accordance
• The supplied batteries may have a shorter life than new batteries.
• Disposal of used batteries should be carried out in accordance
with local regulations.
2.2
Setting the Date and Time
Note
• Set your monitor to the correct date and time before taking a
measurement for the first time.
• As soon as batteries are correctly installed, the year flashes on the
display of your monitor.
• The date and time will automatically be set when the monitor is
paired with
OMRON connect US/CAN app. Refer to section 4.1.
1.
Press the
or
button once to adjust the year.
Press and hold down the
button to quickly advance the
years.
N
Heart zone indicator
The “
” symbol lights in blue when your monitor is at
the correct position relative to your heart during a
measurement. When your monitor is higher or lower
position relative to your heart, the heart position locator
bar will appear up above, or below the heart symbol to
guide correct wrist positioning.
measurement. When your monitor is higher or lower
position relative to your heart, the heart position locator
bar will appear up above, or below the heart symbol to
guide correct wrist positioning.
O
Irregular heartbeat symbol
Appears along with
readings when an
irregular rhythm is
detected 2 or more
times during a
measurement.
An irregular heartbeat
rhythm is defined as a
rhythm that is 25%
less or 25% more
than the average rhythm detected while your monitor is
measuring the systolic and diastolic blood pressure. If it
continues to appear, we recommend you to consult with
and follow the directions of your physician.
readings when an
irregular rhythm is
detected 2 or more
times during a
measurement.
An irregular heartbeat
rhythm is defined as a
rhythm that is 25%
less or 25% more
than the average rhythm detected while your monitor is
measuring the systolic and diastolic blood pressure. If it
continues to appear, we recommend you to consult with
and follow the directions of your physician.
P
Movement error symbol
Appears along with readings when your body is moving
during a measurement. If it appears, remove the wrist
cuff, and wait for 2 to 3 minutes. Then, remain still and
take another measurement.
during a measurement. If it appears, remove the wrist
cuff, and wait for 2 to 3 minutes. Then, remain still and
take another measurement.
Q
Cuff wrap guide symbol
Appears if the wrist cuff is not wrapped around the wrist
correctly while taking a measurement. It also appears
when viewing past readings.
correctly while taking a measurement. It also appears
when viewing past readings.
R
Battery symbol (low)
Appears when batteries are low.
Battery symbol (depleted)
Appears when batteries are depleted.
S
Bluetooth ON symbol
Appears when Bluetooth is enabled.
Bluetooth OFF symbol
Appears when Bluetooth is disabled.
Office
Home
Systolic Blood
Pressure
≥ 140 mmHg
≥ 135 mmHg
Diastolic Blood
Pressure
≥ 90 mmHg
≥ 85 mmHg
2. Preparation
Irregular Heartbeat
Normal Heartbeat
Pulse
Blood pressure
Blood pressure
Short Long
Pulse
2
1
Press and hold down the
button to quickly go backwards
through the years.
2.
Press the [
START/STOP] button to confirm the year and
the month will flash. Repeat the same steps to adjust
the month, day, hour, and minute.
3.
Press the [
START/STOP] button to store the setting.
It automatically turns off after 3 seconds.
Note
• If you need to reset the date and time, replace batteries or press
the
button until the year flashes, and set the date and time as
above steps.
2.3
Blood Pressure Measurement Tips
To help ensure an accurate reading, follow these directions:
• Stress raises blood pressure. Avoid taking measurements during
stressful times.
• Measurements should be taken in a quiet place.
• It is important to take measurements at same times each day.
• It is important to take measurements at same times each day.
Taking measurements in the morning and in the evening is
recommended.
recommended.
• Remember to have 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.
provide an accurate indication of your true blood pressure. You
need to take and record several readings over a period of time.
Caution
• 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.
2.4
Applying the Wrist Cuff
Note
• Following steps are for applying the wrist cuff to your left wrist.
When you take a measurement on the right wrist, apply the wrist
cuff using the same steps as on the left wrist.
cuff using the same steps as on the left wrist.
• The blood pressure can differ between the right wrist and the left
wrist, and the measured blood pressure values can be different.
OMRON recommends to always use the same wrist for
measurement. If the values between both wrists differ
substantially, please check with your physician as to which wrist to
use for your measurements.
measurement. If the values between both wrists differ
substantially, please check with your physician as to which wrist to
use for your measurements.
Caution
• Remove tight-fitting, thick clothing and any accessories from your
wrist while taking a measurement.
1.
Apply the wrist cuff to your left
wrist.
Roll up sleeve. Make sure your
sleeve is not rolled up too tightly on
your arm. This may constrict the flow
of blood in your arm.
sleeve is not rolled up too tightly on
your arm. This may constrict the flow
of blood in your arm.
2.
Put your wrist through the cuff loop.
Your palm and monitor display should both
face upward.
face upward.
3.
Position the wrist cuff leaving a
clearance of 0.5 inch (1 to 2 cm)
between the cuff and the bottom
of your palm.
4.
Wrap the wrist cuff firmly around your wrist. Do not apply
over clothing.
Check to make sure that there is no gap between your wrist
and the cuff.
and the cuff.
Note
• Make sure your wrist cuff does not
cover the protruding part of the wrist
bone on the outside of your wrist.
bone on the outside of your wrist.
• If the wrist cuff comes
out of the metal ring,
slide it back through as
shown in the figure to
the right.
slide it back through as
shown in the figure to
the right.
Year
Month
Day
Hour
Minute
Wrist cuff
0.5 inch
(1 to 2cm)
(1 to 2cm)
1
2
2.5
Sitting Correctly
To take a measurement, you need
to be relaxed and comfortably
seated in a room with a
comfortable temperature. Place
your elbow on the table to support
your arm.
to be relaxed and comfortably
seated in a room with a
comfortable temperature. Place
your elbow on the table to support
your arm.
• Sit in a chair with your legs
uncrossed and your feet flat on
the floor.
the floor.
• Sit with your back and arm
being supported.
• The distance from the top of
your seat measuring to the top
of the table you are sitting at,
should be 12 plus or minus 2 inches (30 ± 5 cm). If the distance
measured between the top of your seat and table do not fall within
this parameter, correct your seat or table height.
If you are unable to make any seat or table adjustments, please
turn off the heart zone indicator and position your wrist at heart
level by yourself. Refer to section 6.1.
of the table you are sitting at,
should be 12 plus or minus 2 inches (30 ± 5 cm). If the distance
measured between the top of your seat and table do not fall within
this parameter, correct your seat or table height.
If you are unable to make any seat or table adjustments, please
turn off the heart zone indicator and position your wrist at heart
level by yourself. Refer to section 6.1.
• Your monitor must be approximately the same level as your heart.
If the monitor is too high above your heart, your blood pressure will
be artificially low. If the monitor is too low below your heart, your
blood pressure will be artificially high.
be artificially low. If the monitor is too low below your heart, your
blood pressure will be artificially high.
• Relax your wrist and hand. Do not bend your wrist back, clench
your fist, or bend your wrist forward.
2.6
Selecting a User ID
Your monitor is designed to take measurements and store the
readings in the memory for 2 people using the [user ID selection]
switch.
readings in the memory for 2 people using the [user ID selection]
switch.
1.
Select your user ID (1 or 2).
3.1
Taking a Measurement
You can use your monitor without pairing to a smart device. To pair
your monitor with a smart device, refer to section 4.1.
your monitor with a smart device, refer to section 4.1.
Note
• To stop the measurement, press the [
START/STOP] button once
to deflate the wrist cuff.
Caution
• DO NOT use this monitor with other medical electrical (ME)
equipment simultaneously. This may result in incorrect operation
of the monitor and/or cause an inaccurate reading.
of the monitor and/or cause an inaccurate reading.
• Remain still and DO NOT talk while taking a measurement.
1.
Press the [
START/STOP] button.
All symbols appear on the display before starting the
measurement.
measurement.
2.
Check the Heart Zone Indicator.
Your monitor has a built-in heart zone indicator that is used as
an aid in determining if the monitor is at the correct height. It
has been designed to work with most people so that when your
an aid in determining if the monitor is at the correct height. It
has been designed to work with most people so that when your
wrist is at the correct position relative to your heart, the “
”
symbol will light in blue. When your wrist is higher or lower
position relative to your heart, a locator bar will appear
according to the wrist position. Due to difference in individual
size and physique, this feature may not be helpful in all cases
and you may wish to disable this feature. If you feel the position
of the wrist according to heart zone indicator's guidance does
NOT match your heart level, disable this feature and follow
your judgement. To disable it, refer to section
position relative to your heart, a locator bar will appear
according to the wrist position. Due to difference in individual
size and physique, this feature may not be helpful in all cases
and you may wish to disable this feature. If you feel the position
of the wrist according to heart zone indicator's guidance does
NOT match your heart level, disable this feature and follow
your judgement. To disable it, refer to section
6.1.
Note
• After 5 seconds from pressing the [
START/STOP] button,
even if your monitor is not positioned properly, your monitor
will start the measurement and the wrist cuff will start to
inflate.
will start the measurement and the wrist cuff will start to
inflate.
3. Using Your Monitor without a Smart Device
Monitor height
Heart Zone Indicator
Wrist is too high
Any locator bar (-) above
the “
” symbol appears.
Proper position
The “
” symbol lights in blue.
Wrist is too low
Any locator bar (-) below
the “
” symbol appears.