Omron HeartGuide BP8000-L User manual

Model BP8000-L
Instruction Manual
2872436-0B
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
©2021 OMRON HEALTHCARE, INC.
Made in Japan

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TABLE OF CONTENTS
Introduction .............................................................................. 3
Safety Instructions ....................................................................................................... 3
Intended Use .................................................................................................................. 4
Receiving and Inspection.......................................................................................... 4
Symbols Glossary.......................................................................................................... 4
Important Safety Information................................................. 5
1. Know Your Monitor............................................................. 13
1.1 Contents ..................................................................................................................13
1.2 Monitor....................................................................................................................14
1.3 Display and Symbols ..........................................................................................15
1.4 Classification of BP (Blood Pressure)............................................................18
2. Preparation.......................................................................... 19
2.1 Charging the Battery..........................................................................................19
2.2 Installing the Cuff Sleeve..................................................................................21
2.3 Wearing the Monitor on the Left Wrist.......................................................21
2.4 Turn Your Monitor On ........................................................................................23
3. Using Your Monitor without a Smart Device ................... 24
3.1 Taking a Blood Pressure Measurement.......................................................25
4. Using Your Monitor with a Smart Device ......................... 32
4.1 Pairing Your Monitor with a Smart Device.................................................32
4.2 Taking a Blood Pressure Measurement ......................................................33
4.3 Taking Activity Measurements ......................................................................34
4.4 Taking Sleep Measurements...........................................................................38
4.5 Receiving Notification from Your Smart Device .....................................40
4.6 Receiving a Reminder........................................................................................41

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5. Recording an Event............................................................. 42
6. Viewing the Readings Stored in Memory......................... 43
Readings Details..........................................................................................................45
Sleep Mode Details ....................................................................................................46
7. Settings ................................................................................ 47
7.1 Function Settings.................................................................................................47
7.2 Bluetooth Settings ..............................................................................................49
7.3 Restoring Your Monitor to the Default Settings......................................51
7.4 Turning Off Your Monitor..................................................................................52
8. Error Messages and Troubleshooting .............................. 53
8.1 Error Messages......................................................................................................53
8.2 Troubleshooting ..................................................................................................57
9. Maintenance........................................................................ 59
9.1 Maintenance..........................................................................................................59
9.2 How to Replace the Cuff Sleeve.....................................................................59
9.3 Storage.....................................................................................................................60
9.4 Cleaning ..................................................................................................................60
9.5 Disposal ...................................................................................................................61
10. Optional Accessories ........................................................ 62
11. Specifications .................................................................... 63
12. FCC Statement................................................................... 68
13. Limited Warranty .............................................................. 69
14. Guidance and Manufacturer’s Declaration.................... 70

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Introduction
Thank you for purchasing the OMRON BP8000-L Wrist Blood Pressure
Monitor. This blood pressure monitor is to be worn on your wrist. This
blood pressure monitor uses the oscillometric method of blood pressure
measurement. When the band inflates, the monitor senses the pressure
pulsations of the artery underneath the band. The pulses are called
oscillometric pulses. The electronic pressure sensor displays a digital
reading of blood pressure.
This monitor can also track measurements such as steps, calories burned,
hours slept and awake time.
Safety Instructions
This instruction manual provides you with important information about
the OMRON BP8000-L Wrist Blood Pressure Monitor. To ensure the safe and
proper use of your 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
your monitor. For specific information about your own blood pressure,
contact your physician.

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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 7.1 to 8.5 inches (18 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
Contraindications
Blood Pressure Measurement Usage
• The monitor is contraindicated for use in ambulatory environments.
• The monitor is contraindicated for use on aircraft.
Introduction

Important Safety Information
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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.
Warning
• DO NOT use this monitor on infants, toddlers, children or persons who
cannot express themselves.
• DO NOT adjust medication based on blood pressure 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 wear this monitor 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.
Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.

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Important Safety Information
• 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 blood pressure
measurement reading.
• NEVER diagnose or treat yourself based on your readings. ALWAYS consult
with your physician.
• To help avoid strangulation, keep the charging cable away from infants,
toddlers or children.
• This product contains small parts that may cause a choking hazard if
swallowed by infants, toddlers or children.
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 when in RF restricted
areas. For further information on potential restrictions refer to
documentation on the Bluetooth usage by the FCC.
AC Adapter / Charging Cable Handling and Usage
• DO NOT use the AC adapter if the monitor or the charging cable is
damaged. If this monitor or the charging cable is damaged, turn off the
power and unplug the AC adapter immediately.

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• Plug the AC adapter into the appropriate voltage outlet. DO NOT use in a
multi-outlet plug.
• NEVER plug in or unplug the AC adapter from the electric outlet with wet
hands.
• DO NOT disassemble or attempt to repair the AC adapter.
• DO NOT touch (with wet hands) or wet the charging port of the band,
terminal of the charging clip and plugs of cables.
Rechargeable Battery Handling and Usage
• The rechargeable battery has been specifically designed for this monitor.
DO NOT use it in any other devices.
• DO NOT recharge the rechargeable battery once it has been removed
from this monitor.
• DO NOT dispose of the battery in a fire.
• DO NOT crush or puncture the battery because it may cause spontaneous
flames.
• DO NOT disassemble or modify the battery.
• DO NOT connect the + and – poles using a piece of metal or other
conductive objects.
• DO NOT carry it or store it together with item such as necklaces and hair
pins.
• DO NOT recharge, use, or leave the battery in any high temperature
environment such as in a location near a fire or in direct sunlight. Doing so
may cause the battery to overheat, ignite or rupture.
Important Safety Information

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Important Safety Information
• DO NOT leave the battery that has been removed within the reach of
infants, toddlers, children or pets. Doing so may result in an injury or an
accident. If liquid comes in contact with the battery, a fire or an accident
may occur.
• This monitor has a built-in rechargeable battery. To prevent the risk
of overheating, fire or explosion, DO NOT throw into fire, apply heat,
puncture or crush, use or leave in a high temperature environment.
Caution
• Stop using this monitor and consult with your physician if you experience
skin irritation or discomfort.
• DO NOT use this device if you have a metal allergy.
• Keep this monitor clean. If this monitor is causing skin irritation
due to sweat or contamination, stop using it and consult with your
dermatologist.
• Prolonged rubbing and pressure may irritate the skin. Give your wrist a
break by removing the monitor for a while after extended wear.
• DO NOT let chemical products such as lotions, oils, skin creams or
cosmetics collect on the band. To avoid damage to the band material,
make sure to wipe off any chemical products that have collected on the
band.
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.

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• 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 blood pressure measurements more often than necessary
because bruising, due to blood flow interference, may occur.
• ONLY inflate the cuff when the band is applied to your wrist.
• Remove the band if it does not start deflating during a blood pressure
measurement.
• 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.
Important Safety Information

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Important Safety Information
• The monitor, AC adapter and charging cable are not designed for use in
water or wet environments.
• 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 section 11.
• Ensure this monitor is not impairing blood circulation by observing the
wrist while blood pressure 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 blood pressure
measurement.
• Rest for at least 5 minutes before taking a blood pressure measurement.
• Remove tight-fitting and thick clothing and any accessories from your
wrist while taking a blood pressure measurement.
• Remain still and DO NOT talk while taking a blood pressure measurement.
• ONLY use this monitor on persons whose wrist circumference is within the
specified range of the cuff.

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Important Safety Information
• 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
s e c ti o n 11.
• DO NOT use this monitor after the durable period has ended. Refer to
s e c ti o n 11.
• DO NOT crease the band excessively.
• DO NOT use the blood pressure measuring function for any other purpose.
• DO NOT use this monitor to diagnose sleep disorders.
• Consult with your physician or healthcare provider if you begin a weight
reduction or exercise program.
AC Adapter / Charging Cable Handling and Usage
• DO NOT plug the charging cable into any device other than this monitor.
• Fully insert the AC adapter into the outlet.
• When unplugging the AC adapter from the outlet, be sure to safely pull
from the AC adapter. DO NOT pull from the charging cable.

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Important Safety Information
• When handling the charging cable:
- DO NOT damage it. -DO NOT break it.
- DO NOT tamper with it. -DO NOT forcibly bend or pull it.
- DO NOT twist it. -DO NOT use it if it is gathered in a bundle.
- DO NOT pinch it. -DO NOT place it under heavy objects.
• Wipe any dust off of the AC adapter.
• Unplug the AC adapter when not in use.
• Unplug the AC adapter before cleaning this monitor.
• ONLY use the AC adapter and charging cable specified for this monitor.
Use of unsupported AC adapters or cables may damage and/or may be
hazardous to this monitor.
Rechargeable Battery Handling and Usage
• DO NOT charge the battery when the AC adapter is wet.

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Monitor Charging clip
Model: HEM-CLIP-01
AC adapter
Model: HHP-AM02
Charging cable
Model: HHX-CB07U
Replacement cuff
sleeve
Model: HEM-CUCV-01L
(2 pcs.)
Instruction manual
Quick start guide
Paper sizing guide
1. Know Your Monitor
1.1 Contents

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aDisplay
b[START/STOP] button
c[FORWARD] button
d[HOME] button
Press this button from any screen
to go back to HOME screen.
eBand
fCharging port
gCuff
1.2 Monitor
1. Know Your Monitor
a
b
c
d
e
g
f

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A
Sleep mode symbol
Appears when your monitor
is in sleep mode. Refer to
sub-section 4.4 (page 38).
B
Bluetooth symbol
Appears when your
readings are being
transferred.
C
Reminder symbol
Appears when a reminder is
set. Refer to sub-section 4.6
(page 41).
D
Battery symbol
Appears when any button is
pressed or battery is low.
Refer to page 17.
E
Sync symbol
Appears when your data
needs to be transferred
because the stored memory
is either almost or completely
full. Once you pair your
monitor with your smart
device, transfer your readings
immediately before the
monitor deletes the oldest
reading. Refer to page 17
for each internal memory.
F
Bluetooth OFF symbol
Appears when Bluetooth is
disabled.
Disconnect symbol
Appears when your monitor is
not connected with your smart
device and Bluetooth is enabled.
1.3 Display and Symbols
1. Know Your Monitor
A
B
CEFD
WED 4
12: 35
Date
T
ime
<HOME screen>

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Movement error symbol
Appears along with a blood pressure reading when your body is moving during a
blood pressure measurement. If it appears, check if the band is applied correctly.
Refer to sub-section 2.3 (page 21). After applying the band correctly, wait for 2
to 3 minutes. Then, remain still and take another measurement.
Heart zone error symbol
Appears when your monitor is not positioned at heart level during a
measurement. Refer to page 30 for more information about heart zone
indicator.
Irregular heartbeat symbol
Appears along with readings when an irregular rhythm is detected 2 or more
times during a blood pressure measurement. An irregular heartbeat rhythm
is defined as a rhythm that is 25 % less or 25 % more than the average rhythm
detected while your monitor is measuring the blood pressure. The irregular
heartbeat symbol may be displayed when the monitor detects arm movements.
Refer to section 8 to solve the problem.
If it continues to appear, we recommend you consult with and follow the
directions of your physician.
Heartbeat symbol
Flashes while taking a blood pressure measurement.
Blood pressure level indicator (color)
When your systolic or diastolic blood pressure is above the AHA guideline, the number
will be shown in red. Refer to sub-section 1.4 (page 18) for more information.
1. Know Your Monitor

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Storable Readings of Each Measurement
Your monitor can store readings in its internal memory as follows:
Blood pressure measurements Up to 100 readings
Activity data Up to 7 days
Sleep data Up to 7 times
Event data Up to 100 items
Battery Symbols
Indicates current battery remaining.
Remaining
LowFull
Symbols
Depleted
1. Know Your Monitor

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1.4 Classification of BP (Blood Pressure)
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
Hypertensive crisis > 180 mmHg and/or > 120 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
Warning
NEVER diagnose or treat yourself based on your readings. ALWAYS consult
with your physician.
1. Know Your Monitor

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2.1 Charging the Battery
We recommend charging the battery to a full 100 % charge. Once fully charged,
the battery will last for approximately 2 days. It takes about 2.5 hours to fully
charge once the battery is empty.
When the charging clip is powered using the AC adapter, it may malfunction if
the electrode terminal of the charging clip touches a metal object such as the
body of the monitor or the buckle.
FOLLOW the steps below when charging the battery.
1. Plug the smaller end of the
charging cable into the charging
clip.
2. Lift the band and connect the
clip to the charging port of your
monitor.
Make sure the cuff sleeve does not cover
the charging port.
Charging clip
Charging port
Band
3. Plug the larger end of the charging
cable into the AC adapter.
AC adapter
2. Preparation