INSTRUCTION MANUAL
7 Series Wrist
Blood Pressure Monitor
Model BP6350
®
ENGLISH
Table of Contents
Introduction ..................................................................................................3
Important Safety Information........................................................................5
1. Know Your Monitor ................................................................................9
2. Preparation ..........................................................................................15
3. Using Your Monitor without a Smart Device ........................................21
4. Using Your Monitor with a Smart Device .............................................24
5. Using Memory Function .......................................................................27
6. Other Settings ......................................................................................29
7. Error Messages and Troubleshooting..................................................31
8. Maintenance ........................................................................................35
9. Specifications.......................................................................................36
10. FCC Statement ....................................................................................39
11. Limited Warranty..................................................................................40
12. Guidance and Manufacturer’s Declaration...........................................42
2
Introduction
Thank you for purchasing the OMRON BP6350 Wrist Blood Pressure Monitor. This
blood pressure monitor is to be worn on your wrist. This monitor can be used by
multiple users.
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
BP6350 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 1800-634-4350 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
1-800-634-4350.
Symbols Glossary
For symbol information, visit:
OmronHealthcare.com/symbols-glossary
3
Contraindications
• This monitor is contraindicated for use in ambulatory environments.
• This monitor is contraindicated for use on aircraft.
4
Important Safety Information
Warning
Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
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.
• 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. This may result in incorrect operation of the
monitor and/or cause an inaccurate reading.
• DO NOT use this monitor in oxygen rich environments or near flammable
gas.
• 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; preeclampsia 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.
5
Data Transmission
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.
• 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.
Battery Handling and Usage
• Keep batteries out of the reach of infants, toddlers or children.
• 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.
• 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 emits 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.
6
• 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.
• During measurement, observe the arm to ensure that the monitor is not
causing prolonged impairment to blood circulation.
• 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 this monitor has acclimated to room temperature before taking
a measurement. Taking a measurement after an extreme temperature
change could lead to an inaccurate reading. OMRON recommends waiting
for approximately 2 hours for the monitor to warm up or cool down when
the monitor is used in an environment within the temperature specified as
operating conditions after it is stored either at the maximum or at the
minimum storage temperature. For additional information of operating and
storage/transport temperature, refer to chapter 9.
• DO NOT crease the wrist cuff excessively.
• DO NOT use this monitor after the durable period has ended. Refer to
chapter 9.
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.
7
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. DO NOT
use different brands of 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.
8
1. Know Your Monitor
a
b
c
f
d
e
g
1.1 Contents
Monitor, 2 “AAA” alkaline batteries, storage case, instruction manual, 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. [Memory] button
d. [Date/Time setting] button
e. [START/STOP] button
f. [Connection] button
g. Battery compartment
9
1.3 Display and Symbols
C
D
E
G
H
I
J
F
B
A
M
Q
L
K
N
O
P
10
A
Date and time display
B
C
D
E
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.
Systolic blood pressure reading
Diastolic blood pressure reading
Pulse display / Memory number
Average value symbol
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.
G
H
Deflation symbol
Appears during cuff deflation.
Heartbeat symbol
Flashes while taking a measurement.
Sync symbol
Flashes/appears when your data needs to be transferred because the
I
stored memory is either almost, or completely full. Once you pair your
monitor with a smart device, transfer your readings immediately before
the monitor deletes the oldest readings. Up to 90 readings can be
stored in the internal memory per user.
OK symbol
J
Flashes when your monitor is connected to the smart device or
readings are transferred successfully.
11
K
Irregular Heartbeat
Normal Heartbeat
Pulse
Blood pressure
Blood pressure
Short
Long
Pulse
L
M
N
O
High symbol
Appears if your systolic blood pressure is 130 mmHg or above and/or
the diastolic blood pressure is 80 mmHg or above. Refer to section 1.4
for more information.
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.
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.
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 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 wrapped around the wrist too loosely while
taking a measurement. It also appears when viewing past readings.
12
Battery symbol (low)
P
Flashes when batteries are low.
Battery symbol (depleted)
Appears when batteries are depleted.
Bluetooth ON symbol
Q
Appears when Bluetooth is enabled.
Bluetooth OFF symbol
Appears when Bluetooth is disabled.
13
1.4 Classification of BP (Blood Pressure)
Warning
ACC/AHA 2017 Hypertension guidelines define categories of BP in adults as below.
Categories of BP in Adults*
BP Category Systolic BP Diastolic BP
Normal < 120 mmHg and < 80 mmHg
Elevated 120 - 129 mmHg and < 80 mmHg
Hypertension
Stage 1 130 - 139 mmHg or 80 - 89 mmHg
Stage 2 ≥ 140 mmHg or ≥ 90 mmHg
* Individuals with Systolic BP and Diastolic BP in 2 categories should be
designated to the higher BP category.
BP indicates blood pressure (based on an average of ≥ 2 careful readings obtained
on ≥ 2 occasions).
Source: ACC/AHA 2017 High Blood Pressure Clinical Practice Guideline
• NEVER diagnose or treat yourself based on your readings. ALWAYS consult with
your physician.
14
2. Preparation
Note
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.
• When the “ ” symbol flashes 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.
15
2
1
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 the button to quickly advance the years.
Press and hold 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.
Year
Month
Day
Hour
Minute
16
3. Press the [START/STOP] button to store the setting.
Note
Caution
It automatically turns off after 3 seconds.
• If you need to reset the date and time, replace batteries or press and hold 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. 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.
• 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.
17
2.4 Applying the Wrist Cuff
Note
Caution
• Following steps are for applying the wrist cuff to your left wrist. When you take a
measurement on your right wrist, apply the wrist cuff using the same steps as on
your 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.
• 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.
2. Put your wrist through the cuff loop.
Your palm and monitor display should both face upward.
Wrist cuff
18
3. Position the wrist cuff leaving a clearance of
Note
0.5 inch
(1 to 2cm)
1 2
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.
• Make sure the 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.
19
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.
• 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.
20
3. Using Your Monitor without a Smart Device
Note
Caution
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.
• To stop the measurement, press the [START/STOP] button once to deflate the
wrist cuff.
• 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.
1. Press the [START/STOP] button.
All symbols appear on the display before starting the 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 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.
21
Note
Monitor height Heart Zone Indicator
Wrist is too high
Proper position
Wrist is too low
• 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.
Any locator bar (-) above the “ ” symbol
appears.
The “ ” symbol lights in blue.
Any locator bar (-) below the “ ” symbol
appears.
22
3. Remain still and do not move or talk until the entire measurement
Note
Note
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 “ ” symbol flashes at every heartbeat.
• 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.
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 1.3), the
“ ” symbol appears.
INFLATINGSTART COMPLETED
4. Press the [START/STOP] button to turn your monitor off.
• 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 pre-measurement form. You may need to
increase the wait time depending on your individual physiological
characteristics.
23
4. Using Your Monitor with a Smart Device
4.1 Pairing Your Monitor with a Smart Device
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.
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, open the app and add your new monitor.
3. Open the app on your smart device and follow the instructions.
24
4. Confirm that your monitor is connected
Note
successfully.
When your monitor is connected successfully to your
smart device, the “OK” symbol flashes.
• If the “Err” symbol appears, follow the instructions in
the “OMRON connect US/CAN” app
• Your monitor automatically turns off after 10 seconds
without any operations.
• 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.
• “OMRON connect US/CAN” is the only app that we recommend to use with
your monitor to transfer data correctly.
4.2 Taking a Measurement
Refer to section 3.1 to start a measurement. The readings will be transferred to your
smart device.
25
4.3 Disabling/Enabling Bluetooth
Warning
Note
• 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.
Bluetooth is enabled as default.
1. When your monitor is off, press and hold the [ ] button for more than
10 seconds.
• “oFF” appears on the display.
• When the Bluetooth is disabled, the following
symbol appears.
• To enable the Bluetooth, press and hold the [ ] button for more than 2
seconds. “on” appears on the display.
• Your monitor will automatically turn off within 3 seconds after the completion.
26
5. Using Memory Function
Note
Note
Your monitor automatically stores up to 90 readings.
• This monitor can be used by multiple users. When you use memory function with
other users, track (or manage) your own readings appropriately.
5.1 Viewing the Readings Stored in Memory
1. Press the button.
Alternating
date/time
display
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, the heart zone indicator is displayed
with the readings.
• If the reading is high (refer to section 1.3), 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.
2. Press the button repeatedly to scroll through the previous
readings stored in the memory.
27
5.2 Viewing the Average Reading
Note
Your monitor can calculate an average reading based on the latest 2 or 3 readings
taken within 10 minutes span.
1. When your monitor is off, press and hold the button 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 section 1.3),
the “ ” symbol appears.
28
6. Other Settings
Note
Note
6.1 Disabling/Enabling Heart Zone Indicator
The heart zone indicator is enabled as default.
1. When your monitor is off, press and hold the button for more than
10 seconds.
• Your monitor will automatically turn off after 3 seconds from the completion.
• To enable the heart zone indicator, follow the same steps as above.
6.2 Deleting All Readings Stored in Memory
1. Press the button, then the “ ” symbol appears.
2. While holding the button down,
press and hold the [START/STOP]
button for more than 2 seconds.
• All readings will be deleted. You cannot
partially delete the readings stored in the
memory.
29
6.3 Restoring Your Monitor to the Default Settings
Note
To delete all the information stored in your monitor, follow the instructions below.
Make sure that your monitor is turned off.
1. While holding the button down,
press the [START/STOP] button within
2 seconds. Hold both buttons for more
than 5 seconds.
• 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.
30
7. Error Messages and Troubleshooting
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.
Display/Problem Possible Cause Solution
appears or the
wrist cuff does not
inflate.
appears
appears
appears
/
appears
appears
The wrist cuff is not applied
correctly.
Air is leaking from the wrist
cuff.
The wrist cuff is overinflated
exceeding 300 mmHg.
You move or talk during a
measurement. Vibrations
disrupt a measurement.
The pulse rate is not detected
correctly.
31
Apply the wrist cuff correctly,
then take another
measurement. Refer to
section 2.4.
Contact customer service.
Refer to chapter 11.
Do not touch the wrist cuff
while taking a measurement.
Remain still and do not talk
during a measurement.
Apply the wrist cuff correctly,
then take another
measurement. Refer to
section 2.4.
Remain still and sit correctly
during a measurement.
If the “ ” symbol continues
to appear, we recommend you
to consult with your physician.
Display/Problem Possible Cause Solution
appears
appears
appears
flashes
flashes
Your wrist is moved up and
down during a measurement.
The monitor is malfunctioned.
The monitor cannot connect to
a smart device or transmit data
correctly.
The [ ] button is pressed and
held to pair with a smart
device.
The [ ] button is pressed to
transfer your readings.
Do not move your wrist, then
take another measurement.
Refer to chapter 3.
Press the [START/STOP]
button again. If “Er” still
appears, contact customer
service. Refer to chapter 11.
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.
Flashes when pairing to the
smart device. Visit the “Help”
section in the “OMRON
connect US/CAN” app for
pairing.
Flashes when transferring your
readings to the “OMRON
connect US/CAN” app.
32
Display/Problem Possible Cause Solution
More than 70 readings are not
transferred.
flashes
This monitor is ready for
pairing or transferring your
readings.
Pair or transfer your readings
to the “OMRON connect US/
CAN” app so you can keep
them in memory in the app,
and this error symbol
disappears.
appears
90 readings are not
transferred.
heart symbol
The heart symbol
in the heart zone
indicator does not
light and a locator
bar does not
appear.
flashes
The heart zone indicator is
disabled.
Batteries are low.
33
Enable the heart zone
indicator. Refer to section 6.1.
Replacing all batteries with 2
new alkaline batteries is
recommended. Refer to
section 2.1.
Display/Problem Possible Cause Solution
appears or the
monitor is turned
off unexpectedly
during a
measurement
No power.
Nothing appears
on the display of
the monitor.
Readings appear
too high or too
low.
Batteries are depleted.
Batteries are completely
depleted.
Battery polarities are not
properly aligned.
Blood pressure varies constantly. Many factors including
stress, time of day, and/or how you apply the wrist cuff, may
affect your blood pressure. Review sections 2.3 - 2.5 and
chapter 3.
Immediately replace all
batteries with 2 new alkaline
batteries. Refer to section 2.1.
Check the battery installation
for proper placement. Refer to
section 2.1.
Any other
communication
issue occurs.
Any other
problems occur.
Follow the instructions shown in the smart device, or visit the
“Help” section in the “OMRON connect US/CAN” app for further
help.
If the problem still persists, contact customer service. Refer to
chapter 11.
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 re-install
batteries.
If the problem still persists, contact customer service. Refer to
chapter 11.
34
8. Maintenance
Caution
8.1 Maintenance
To protect your monitor from damage, please follow the directions below:
• 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.
8.2 Storage
Keep your monitor in the storage case when not in use.
• Store your monitor in a clean, safe location.
Do not store your monitor:
• If your monitor is wet.
• In locations exposed to extreme temperatures, humidity, direct sunlight, dust or
corrosive vapors such as bleach.
• In locations exposed to vibrations or shocks.
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 wrist cuff, and then wipe them with a dry cloth.
• Do not wash or immerse your monitor and wrist cuff in water.
• Do not use gasoline, thinners or similar solvents to clean your monitor and wrist
cuff.
8.4 Disposal
Dispose of your monitor and other components according to applicable local
regulations.
Unlawful disposal may cause environmental pollution.
35
9. Specifications
Model
Display LCD digital display
Cuff pressure range 0 to 299 mmHg
Blood pressure measurement
range
Pulse measurement range 40 to 180 beats / min.
Accuracy
Inflation Automatic by electric pump
Deflation Automatic rapid deflation
Measurement method Oscillometric method
Transmission method
Wireless communication
Operation mode Continuous operation
IP classification IP 22
Rating DC3 V 3.0 W
Power source 2 “AAA” alkaline batteries 1.5 V
Battery life
Durable period (Service life) 5 years
Operating conditions
Storage / Transport conditions
Weight
BP6350 HEM-6231T-Z
SYS: 60 to 260 mmHg
DIA: 40 to 215 mmHg
Pressure: ±3 mmHg
Pulse: ±5% of display reading
®
Bluetooth
Frequency range: 2.4 GHz (2400 - 2483.5 MHz)
Modulation: GFSK
Effective radiated power: < 20 dBm
Approximately 300 measurements (using new
alkaline batteries)
+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)
Approximately 3.2 oz. (91 g) not including
batteries
low energy technology
36
Note
Dimensions
Measurable wrist
circumference
Memory Stores up to 90 readings
Contents
Protection against electric
shock
Applied part Type BF (wrist cuff)
Maximum temperature of the
applied part
* thinnest part
• These specifications are subject to change without notice.
• This monitor is clinically investigated according to the requirements of ISO 810602:2013. In the clinical validation study, K5 was used on 85 subjects for
determination of diastolic blood pressure.
• 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 is protected against solid foreign objects of 0.5
inches (12.5 mm) diameter and greater such as a finger, and against oblique
falling water drops which may cause issues during a normal operation.
Approximately 3.6" (w) × 2.5" (h) × 0.5" (l)*
(91 mm × 63 mm × 13 mm) (not including the wrist
cuff)
5.3" to 8.5" (13.5 to 21.5 cm)
Monitor, storage case, 2 “AAA” alkaline batteries,
instruction manual, quick start guide
Internally powered ME equipment
Lower than +118.4°F (+48°C)
37
Pictogram on the Product
Indicates the correct positioning for the monitor on the wrist.
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.
38
10. FCC Statement
Note
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 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.
• 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 radiation exposure limits set forth for an
uncontrolled environment and meets the FCC radio frequency (RF) Exposure
Guidelines. This equipment has very low levels of RF energy that are deemed to
comply without testing of specific absorption ratio (SAR).
39
11. Limited Warranty
Your BP6350 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 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.
40
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: OmronHealthcare.com
Call toll free: 1-800-634-4350
41
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)
BP6350 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 BP6350 on the website.
42
The Bluetooth® word mark and logos are
registered trademarks owned by the 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.
App Store is a service mark of Apple Inc., registered in the U.S and
other countries.
Google Play and the Google Play logo are trademarks of Google
LLC.
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.
OmronHealthcare.com
© 2019 OMRON HEALTHCARE, INC.
Made in Vietnam 2829249-4B
Loading...