OMRON HEALTHCARE HEM6232T Blood Pressure Monitor User Manual

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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
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.
Wrist Blood Pressure
Monitor
1.1
Contents
Monitor, 2 “AAA” alkaline batteries, storage case, instruction manual,
quick start guide
1.2
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.
Monitor
• Keep batteries out of the reach of infants, toddlers or
children.
Table of Contents
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
Introduction
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.
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.
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.
Environments of Use: Home
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 1-800-6344350.
Symbols Glossary
For symbol information, visit:
OmronHealthcare.com/symbols-glossary
Contraindications
• This monitor is contraindicated for use in ambulatory
environments.
• This monitor is contraindicated for use on aircraft.
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.
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.
• 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.
• 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.
• 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.
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 arteriovenous (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.
• 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
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.
• 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
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.
• 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, 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
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 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.
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.
• 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.
• 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.
• ONLY use batteries specified for this monitor. Use of
unsupported batteries may damage and/or may be hazardous
to this monitor.
button to quickly go backwards
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.
Irregular heartbeat symbol
2829250-8A
Press and hold down the
through the years.
Heart zone indicator
Battery Handling and Usage
Model BP4350
Instruction Manual
Warning
1. Know Your 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
1.3
Year
Normal Heartbeat
Appears along with
Pulse
readings when an
irregular rhythm is
Blood pressure
detected 2 or more
times during a
measurement.
Irregular Heartbeat
Short Long
An irregular heartbeat
Pulse
rhythm is defined as a
Blood pressure
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.
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.
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.
Display
Battery symbol (low)
Appears when batteries are low.
Battery symbol (depleted)
Bluetooth ON symbol
Appears when Bluetooth is enabled.
Bluetooth OFF symbol
2013 ESH/ESC* Guidelines for the management of
arterial hypertension
Definitions of hypertension by office and home blood pressure levels
1.4
Display Symbols
A Date and time display
Average value symbol
Appears when viewing the average readings of the
latest 2 or 3 readings taken within 10 minutes span.
Memory symbol
Appears when viewing readings stored in the memory.
D Systolic blood pressure reading
E Diastolic blood pressure reading
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.
Flashes when your monitor is connected to the smart
device or readings are transferred successfully.
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.
The user ID number appears when selecting the user
with [User ID selection] switch.
Hypertension symbol
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
The “
” symbol appears if your systolic blood
pressure is 135 mmHg or above and/or the diastolic
blood pressure is 85 mmHg or above.
Morning hypertension symbol
The “
” symbol appears when the morning weekly
average is 135/85 mmHg or above.
• Sit in a chair with your legs
uncrossed and your feet flat on
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.
• 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.
• Relax your wrist and hand. Do not bend your wrist back, clench
your fist, or bend your wrist forward.
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.
Taking measurements in the morning and in the evening is
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.
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.
1. Select your user ID (1 or 2).
≥ 135 mmHg
Diastolic Blood
Pressure
≥ 90 mmHg
≥ 85 mmHg
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.
• 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.
Caution
• Remove tight-fitting, thick clothing and any accessories from your
wrist while taking a measurement.
1. Apply the wrist cuff to your left
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.
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.
• Remain still and DO NOT talk while taking a 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
battery cover and pull
downward.
Wrist cuff
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.
as indicated in the battery
compartment.
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.
All symbols appear on the display before starting the
measurement.
Your palm and monitor display should both
face upward.
2. Insert 2 “AAA” alkaline batteries
3.1
1. Press the [START/STOP] button.
2. Put your wrist through the cuff loop.
Installing Batteries
3. Using Your Monitor without a Smart Device
wrist.
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 6.1.
0.5 inch
(1 to 2cm)
Flashes while taking a measurement.
User ID symbol
Minute
Heartbeat symbol
Morning average symbol
≥ 140 mmHg
1. Push down the hook of the
Flashes during cuff deflation.
OK symbol
Systolic Blood
Pressure
2. Preparation
Deflation symbol
Sync symbol
Home
Warning
• NEVER diagnose or treat yourself based on your readings.
ALWAYS consult with your physician.
Pulse display / Memory number
Pulse rate appears after the measurement.
F When pressing the
button, the memory number appears
for approximately one second before the pulse rate appears on
the display.
Office
These are from statistical values for blood pressure.
* European Society of Hypertension (ESH) and European Society of
Cardiology (ESC).
2.1
Hour
2.4
Appears when Bluetooth is disabled.
Day
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.
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.
Appears when batteries are depleted.
Month
2.5
3. Close the battery cover.
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.
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
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
Press and hold down the
years.
button once to adjust the year.
button to quickly advance the
Monitor height
Wrist is too high
Note
• Make sure your wrist cuff does not
cover the protruding part of the 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.
Proper position
Wrist is too low
Note
Heart Zone Indicator
Any locator bar (-) above
the “
The “
” symbol appears.
” symbol lights in blue.
Any locator bar (-) below
the “
” symbol appears.
• 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.
• When the Bluetooth is
disabled, the following symbol
appears.
3. Remain still and do not move or talk until the entire
measurement process is completed.
As the cuff inflates, your monitor automatically determines your
ideal inflation level. This monitor detects your blood pressure
and pulse rate during inflation.
The “
6. Other Settings
6.1
1. Select your user ID.
Note
INFLATING
• Your monitor will
automatically turn off
after 3 seconds from the completion.
• To enable the heart zone indicator, follow the same steps as
above.
5. Using Memory Function
Viewing the Readings Stored in Memory
2. Press the
6.2
Alternating
date/time
display
COMPLETED
2. Press the
The Memory number appears for one second before the pulse
rate is displayed. The most recent reading set is numbered “1”.
• If the heart zone indicator is enabled before the
measurement, the heart zone indicator is displayed with the
readings.
• If the reading is high (refer to section
1.4), the “
” symbol appears.
• If there are no readings stored in the
memory, the screen to the right is
displayed.
• If the memory is full, the monitor will
delete the oldest readings.
The date and time on your monitor will automatically be set when
you pair your monitor with your smart device.
Review the list of compatible smart devices at
OmronHealthcare.com.
1. Enable Bluetooth on your smart device.
CAN” app onto your smart device.
3. Press the
button repeatedly to scroll through the
previous readings stored in the memory.
5.2
If you already have the “OMRON connect US/CAN” app and
have created your account, open the app and add your new
monitor.
3. Open the app on your smart device. Press the [
button (found on the back of your monitor) for more than
2 seconds to start pairing. Then follow the instructions.
Viewing the Average Reading
Your monitor can calculate an average reading based on the latest 2
or 3 readings taken within 10 minutes span.
1. Select your User ID.
2. When your monitor is off, press and hold the
for more than 2 seconds.
• If there are only 2 readings in the
memory for that period, the
average will be based on these 2
readings.
• If the average reading is high (refer
to section1.4), the “
” symbol
appears.
• Make sure that your monitor is turned off. If it is on, press the
[START/STOP] button to clear the LCD screen.
4. Confirm that your monitor is
connected successfully.
5.3
• If the “Err” symbol appears, follow the
message of the app.
• Your monitor automatically turns off
after 10 seconds without any
operations.
• Your monitor can store 2 user's
readings, however the app can only store 1 user's readings.
Each user will need his/her own OMRON connect account to
transfer their readings.
• 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 in the app.
• Read the utilization method and usage instruction within the
app for details.
4.2
Taking a Measurement
Refer to section 3.1 to start a measurement. The readings will be
transferred to your smart device.
button once.
The morning weekly average for the
current week “THIS WEEK” appears on
the display.
If the morning weekly average is high
(refer to section 1.4), the “
appears.
Restoring Your Monitor to the Default Settings
3. Continue to press the
for the previous weeks.
1. While holding the
4. Press the [START/STOP] button to turn off your monitor.
Morning Weekly Average Calculation
This is the average for the measurements taken during the morning
(4:00am - 9:59am) between Sunday and Saturday. Only the first 3
measurements taken in the morning between 4:00am - 9:59am will
be used to calculate the morning average for each day.
Disabling/Enabling Bluetooth
Sunday
Note
• Reverting to its default
setting of your monitor does
not delete the information in
the app.
• Your monitor will
automatically turn off after 3 seconds.
• You will need to re-pair your monitor when using the monitor
again. Without re-pairing, your readings will not be
transferred to your app.
Monday
Tuesday
Possible Cause
The wrist cuff is not
applied correctly.
appears or the
wrist cuff does
Air is leaking from the
not inflate.
wrist cuff.
Wednesday
Thursday
Bluetooth is enabled as default.
Contact customer
service. Refer to
chapter 11.
appears
appears
You move or talk during
a measurement.
Vibrations disrupt a
measurement.
Remain still and do not
talk during a
measurement.
Refer to chapter 3.
appears
appears
The pulse rate is not
detected correctly.
The first 3 measurements
appears
Disposal
Dispose of your monitor and other components according to
applicable local regulations.
Unlawful disposal may cause environmental pollution.
9. Specifications
Model
Display
Cuff pressure range
Blood pressure
measurement range
Pulse measurement
range
Batteries are low.
appears or the
monitor is
Batteries are depleted.
turned off
unexpectedly
during a
measurement
Enable the “heart zone
indicator”. Refer to
section 6.1.
Immediately replace all
batteries with 2 new
alkaline batteries. Refer
to section 2.1.
Batteries are completely
depleted.
No power.
Nothing
Check the battery
appears on the
Battery polarities are not installation for proper
display of the
properly aligned.
placement. Refer to
monitor.
section 2.1.
Blood pressure varies constantly. Many factors
Readings
including stress, time of day, and/or how you
appear too high apply the wrist cuff, may affect your blood
or too low.
pressure. Review sections 2.3 - 2.5 and chapter
3.
Any other
Follow the instructions shown in the smart device.
communication If the problem still persists, contact customer
issue occurs.
service. Refer to chapter 11.
Any other
problems
occurs.
Press the [START/STOP] button to turn the
monitor off, then press it again to take a
measurement. If the problem continues, remove
all batteries and wait for 30 seconds. Then reinstall batteries.
If the problem still persists, contact customer
service. Refer to chapter 11.
8. Maintenance
8.1
Inflation
Deflation
Measurement method
Transmission method
Bluetooth® low energy technology
IP classification
Rating
Power source
Battery life
Note
• 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.
• IP classification is degrees of protection provided by enclosures in
accordance with IEC 60529. This monitor is protected against
solid foreign objects of 12.5 mm diameter and greater such as a
finger, and against oblique falling water drops which may cause
issues during a normal operation.
Storage
Keep your monitor and other components in the storage case when
not in use.
• Store your monitor and other components in a clean, safe location.
Do not store your monitor and other components:
• If your 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.
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).
11. Limited Warranty
Your BP4350 Wrist Blood Pressure Monitor, excluding batteries, is
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
above warranty extends only to the original retail purchaser.
We will, at our option, replace without charge any monitor covered
by the above warranty. Replacement is our only responsibility and
your only remedy under the above warranty.
To obtain warranty service contact Customer Service by calling 1800-634-4350 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:
For USA - OmronHealthcare.com
For Canada - OmronHealthcare.ca
Call toll free:
1-800-634-4350
12. Guidance and Manufacturer’s Declaration
OMRON Battery-operated Blood Pressure Monitor
Information for Accompanying Documents in the Scope of
IEC60601-1-2:2014
Important information regarding Electro Magnetic Compatibility
(EMC)
BP4350 manufactured by OMRON HEALTHCARE Co., Ltd. conforms to
IEC60601-1-2:2014 Electro Magnetic Compatibility (EMC) standard.
Further documentation in accordance with this EMC standard is available at
OmronHealthcare.com/emc. Refer to the EMC information for BP4350 on the
website.
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.
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.
10. FCC/IC Statement
The monitor is
malfunctioned.
This device complies with part 15 of the FCC Rules. Operation is
subject to the following two conditions: (1) This device may not
cause harmful interference, and (2) this device must accept any
interference received, including interference that may cause
undesired operation.
Note
The monior cannot
connect to a smart
device or transmit data
correctly.
Follow the instructions
shown in the “OMRON
connect US/CAN” app.
If the “Err” symbol still
appears after checking
the app, contact
customer service. Refer
to chapter 11.
• “oFF” appears on the display.
This transmitter must not be co-located or operated in conjunction
with any other antenna or transmitter.
Indicates the correct positioning for the monitor
on the wrist.
Press the [START/
STOP] button again. If
“Er” still appears,
contact customer
service. Refer to
chapter 11.
button for more than 10 seconds.
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.
Pictogram on the Product
To protect your monitor from damage, please follow the directions
below:
• Changes or modifications not approved by the manufacturer will
void the user warranty.
8.2
Frequency range: 2.4 GHz (2400 2483.5 MHz)
Modulation: GFSK
Effective radiated power: <20 dBm
IP 22
DC3 V 3.0 W
2 “AAA” alkaline batteries 1.5V
Approximately 300 measurements (using
new alkaline batteries)
Durable period (Service
5 years
life)
+50°F to +104°F (+10°C to +40°C) / 15 to
Operating conditions
90% RH (non-condensing) / 800 to 1060
hPa
Storage / Transport
-4°F to +140°F (-20°C to +60°C) / 10 to
conditions
90% RH (non-condensing)
Approximately 3.2 oz. (90 g) not
Weight
including batteries
Approximately 3.6” (w) × 2.5” (h) × 0.5” (l)
Dimensions
(91.0 mm × 63.4 mm × 13.4 mm) (not
including the wrist cuff)
Measurable wrist
5.3” to 8.5” (13.5 to 21.5 cm)
circumference
Memory
Stores up to 100 readings per user
Monitor, storage case, 2 “AAA” alkaline
Contents
batteries, instruction manual, quick start
guide
Protection against
Internally powered ME equipment
electric shock
Applied part
Type BF (wrist cuff)
Maintenance
Caution
• DO NOT disassemble or attempt to repair this monitor or other
components. This may cause an inaccurate reading.
40 to 180 beats / min.
Pressure: ±3 mmHg
Pulse: ±5% of display reading
Automatic by electric pump
Automatic rapid deflation
Oscillometric method
Wireless communication
Replacing all batteries
with 2 new alkaline
batteries is
recommended. Refer to
section 2.1.
BP4350
HEM-6232T-Z
LCD digital display
0 to 299 mmHg
SYS: 60 to 260 mmHg
DIA: 40 to 215 mmHg
Your wrist is moved up
and down during a
measurement.
1. When your monitor is off, press and hold onto the [ ]
appears
8.4
Do not move your wrist,
then take another
measurement.
Refer to chapter 3.
9:59
appears
Apply the wrist cuff
correctly, then take
another measurement.
Refer to section 2.4.
Remain still and sit
correctly during a
measurement. Refer to
section 2.5.
If the “
” symbol
continues to appear, we
recommend you to
consult with your
physician.
Saturday
Apply the wrist cuff
correctly, then take
another measurement.
Refer to section 2.4.
Do not touch the wrist
cuff while taking a
measurement.
appears
Friday
Solution
The wrist cuff is
overinflated exceeding
300 mmHg.
4:00
Warning
• 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 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.
flashes
button down, press and
hold the [START/STOP]
button for more than 5
seconds.
button to display the average
Your monitor displays “-1 WEEK” for the previous week's
average, to “-3 WEEK” for the oldest set of averages.
The “heart zone
The heart
indicator” is disabled.
symbol in the
heart zone
indicator does
not light and a
locator bar does
not appear.
To delete all the information stored in your monitor, follow the
instructions below. Make sure that your monitor is turned off.
” symbol
Measurements of the morning
4.3
6.3
Viewing Morning Weekly Averages
2. Press the
Note
• All readings will be deleted.
You cannot partially delete
the readings stored in the
memory.
Display/
Problem
1. Select your User ID.
Pair or transfer your
This monitor is ready for readings to the
“OMRON connect US/
pairing or transferring
CAN” app so you can
your readings.
keep them in memory in
the app, and this error
100 readings are not
symbol disappears.
transferred.
heart symbol
In case of any of the below problems occur during measurement,
first check that no other electrical device is within 12 inches (30 cm).
If the problem persists, please refer to the table below.
Your monitor calculates and displays weekly averages for the
measurements taken in the morning for 4 weeks per user.
Flashes when
transferring your
The [ ] button is
pressed to transfer your readings to the
“OMRON connect US/
readings.
CAN” app.
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 wrist cuff, and then wipe them with a dry
cloth.
• Do not wash or immerse your monitor and wrist cuff or other
components in water.
• Do not use gasoline, thinners or similar solvents to clean your
monitor and wrist cuff or other components.
Accuracy
7. Error Messages and Troubleshooting
Note
Note
When your monitor is connected
successfully to your smart device, the
“OK” symbol flashes.
button
appears
” symbol appears.
Note
Note
Pairing Your Monitor with a Smart Device
2. Download and install the free “OMRON connect US/
button, then the “
The [ ] button is
Appears when pairing
pressed and held to pair
to the smart device.
with a smart device.
3. While holding the
Note
4. Using Your Monitor with a Smart Device
flashes
Deleting All Readings Stored in Memory
button down, press
and hold the [START/
STOP] button for more
than 2 seconds.
• Your monitor will automatically turn off after 2 minutes.
• Wait 2-3 minutes between measurements. The wait time
allows the arteries to decompress and return to their premeasurement form. You may need to increase the wait time
depending on your individual physiological characteristics.
Solution
More than 80 readings
are not transferred.
1. Select your user ID.
button.
4. Press the [START/STOP] button to turn your monitor off.
4.1
flashes
Note
Your monitor automatically stores up to 100 readings per user.
1. Select your User ID.
START
off, press and hold the
button for more
than 10 seconds.
• To enable the Bluetooth, press and hold on the [ ] button for
more than 2 seconds. “on” appears on the display.
• Your monitor will automatically turn off within 3 seconds after
the completion.
5.1
flashes
2. When your monitor is
Note
• When the “
” symbol is displayed, the wrist cuff is not
applied correctly. Press the [START/STOP] button to turn
your monitor off, then apply the cuff correctly.
8.3
Possible Cause
Disabling/Enabling Heart Zone Indicator
The heart zone indicator is enabled as default.
” symbol flashes at every heartbeat.
After your monitor has detected your blood pressure and pulse
rate, the cuff automatically deflates. Your blood pressure and
pulse rate are displayed.
If either the Systolic or the Diastolic reading is high (refer to
section 1.4), the “
” symbol appears.
Display/
Problem
FCC CAUTION
Changes or modifications not expressly approved by the party
responsible for compliance could void the user's authority to operate
the equipment.
• 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
Apple, the Apple logo, iPad and iPhone are trademarks of Apple
Inc., registered in the U.S. and other countries. App Store is a
service mark of Apple Inc., registered in the U.S and other
countries.
iOS is a trademark or registered trademark of Cisco in the U.S. and
other countries and is used under license.
Android and the Google Play logo are trademarks of Google Inc.
Manufactured for:
OMRON HEALTHCARE Co., Ltd
53, Kunotsubo, Terado-cho, Muko, Kyoto, 617-0002 JAPAN
Distributed by:
OMRON HEALTHCARE, INC.
1925 West Field Court Lake Forest, IL 60045 U.S.A.
For USA - OmronHealthcare.com
For Canada - OmronHealthcare.ca
© 2018 OMRON HEALTHCARE, INC.
Made in Vietnam

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