OMRON BP4350 Instruction Manual
INSTRUCTION MANUAL
Gold Wrist Blood Pressure Monitor
Model BP4350
®
ENGLISH
Table of Contents
Introduction ..................................................................................................3
Important Safety Information........................................................................4
1. Know Your Monitor ................................................................................8
2. Preparation ..........................................................................................14
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......................................................................................30
7. Error Messages and Troubleshooting..................................................32
8. Maintenance ........................................................................................36
9. Specifications.......................................................................................37
10. FCC/IC Statement................................................................................40
11. Limited Warranty..................................................................................42
12. Guidance and Manufacturer’s Declaration...........................................44
2
Introduction
Contraindications
Thank you for purchasing the OMRON BP4350 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
BP4350 Wrist Blood Pressure Monitor. To ensure the safe and proper use of this
monitor, READ and UNDERSTAND all of these 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.
Receiving and Inspection
Remove this monitor from the packaging and inspect for damage. If this monitor is
damaged, DO NOT USE and contact
Symbols Glossary
For symbol information, visit:
OmronHealthcare.com/symbols-glossary
• This monitor is contraindicated for use in ambulatory environments.
• This monitor is contraindicated for use on aircraft.
1-800-634-4350
.
3
Important Safety Information
Warning
Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
Read the Important Safety Information in this instruction manual before using
this monitor.
Follow this instruction manual thoroughly for your safety.
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 and children.
4
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
batteries when in RF restricted areas. For further information on potential
restrictions refer to documentation on the Bluetooth usage by the FCC/IC.
®
feature in this monitor and remove
Battery Handling and Usage
• Keep batteries out of the reach of infants, toddlers and 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.
5
• 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 or 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.
6
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.
7
1. Know Your Monitor
a
b
c
d
e
f
g
h
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. [User ID selection] switch
d. [Memory] button
e. [Morning average] button
f. [START/STOP] button
g. [Connection] button
h. Battery compartment
8
1.3 Display and Symbols
A
B
K
L
C
M
D
N
E
F
G
H
O
P
Q
R
I
J
S
9
A
Date and time display
B
C
D
E
Appears when viewing the average of the latest 2 or 3 readings taken
within the most recent 10 minute timeframe.
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 100 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.
10
K
Appears when viewing the weekly average readings taken in the
morning over the past 4 weeks.
Morning average symbol
L
The user ID number appears when selecting the user with [user ID
selection] switch.
High symbol
User ID symbol
Appears if your systolic blood pressure is 130 mmHg or above and/or
M
the diastolic blood pressure is 80 mmHg or above. Refer to section 1.4
for more information.
High morning average symbol
Appears when the morning weekly average is 130/80 mmHg or above.
Heart zone indicator
Your monitor has a built-in heart zone indicator which helps determine
if the monitor is at the correct height for your measurement.
N
The “ ” symbol lights in blue when your monitor is at the correct
position relative to your heart. If your wrist is positioned too high, the
black bar will appear above the heart symbol. If your wrist is positioned
too low, the black bar will appear below the heart symbol.
11
O
Irregular Heartbeat
Normal Heartbeat
Pulse
Blood pressure
Blood pressure
Short
Long
Pulse
P
Q
R
S
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 on past readings in the memory
if the cuff was wrapped too loosely during those readings taken.
Low battery symbol
Flashes when batteries are low.
Depleted battery symbol
Appears when batteries are depleted.
Bluetooth ON symbol
Appears when Bluetooth is enabled.
Bluetooth OFF symbol
Appears when Bluetooth is disabled.
12
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.
13
2. Preparation
Note
2.1 Installing Batteries
1. Push down on 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.
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