OMRON BP8000-M HeartGuide Wearable Blood Pressure Monitor Instruction Manual

: October 27, 2023
: Omron

Table of Contents

BP8000-M HeartGuide Wearable Blood Pressure Monitor
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

BP8000-M HeartGuide Wearable Blood Pressure Monitor

Model BP8000-M Instruction Manual

EN
4615954-8E

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 ………………………………………………34 4.3 Taking Activity Measurements …………………………………………………………….35 4.4 Taking Sleep Measurements…………………………………………………………………38 4.5 Receiving Notification from Your Smart Device ……………………………….40 4.6 Receiving a Reminder…………………………………………………………………………….41
1

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
2

Introduction
Thank you for purchasing the OMRON BP8000-M 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-M 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.
3

Introduction
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 6.3 to 7.5 inches (16 to 19 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.
4

Important Safety Information

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

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 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.

5

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; preeclampsia 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.
6

Important Safety Information
· 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. 7

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.
Indicates a potentially hazardous situation which, if not
Caution 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.
· 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.
8

Important Safety Information
· 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.
9

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 section 11.
· DO NOT use this monitor after the durable period has ended. Refer to section 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.
11

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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1. Know Your Monitor

1.1 Contents

Monitor

Charging clip

AC adapter

Model: HEM-CLIP-01

Model: HHP-AM02

Charging cable Model: HHX-CB07U

Replacement cuff sleeve Model: HEM-CUCV-01
(2 pcs.)

Instruction manual Quick start guide Paper sizing guide

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1.2 Monitor

1. Know Your Monitor
f

b

a

c

g

d

e

a Display

e Band

b

[START/STOP] button

f Charging port

c

[FORWARD] button

g Cuff

[HOME] button

d

Press this button from any screen

to go back to HOME screen.

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1. Know Your Monitor

1.3 Display and Symbols

AD

Date

WED 4

Time 12:35 B

F E DC

E

Sleep mode symbol

A

Appears when your monitor

is in sleep mode. Refer to

sub-section 4.4 (page 38).

Bluetooth symbol

B

Appears when your

readings are being

transferred.

Reminder symbol

F

C

Appears when a reminder is

set. Refer to sub-section 4.6

(page 41).

15

Battery symbol Appears when any button is pressed or battery is low. Refer to page 17.
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.
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. Know Your Monitor
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.
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1. Know Your Monitor

Storable Readings of Each Measurement

Your monitor can store readings in its internal memory as follows:

Blood pressure measurements Activity data Sleep data

Up to 100 readings Up to 7 days Up to 7 times

Event data

Up to 100 items

Battery Symbols Indicates current battery remaining.

Remaining

Full

Low

Depleted

Symbols

17

1. Know Your Monitor
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 Normal Elevated

Systolic BP < 120 mmHg 120-129 mmHg

Diastolic BP and < 80 mmHg and < 80 mmHg

Hypertension Stage 1 130-139 mmHg or Stage 2 140 mmHg or

80-89 mmHg 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.

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2. Preparation
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.

Band

Charging clip

Charging port

3. Plug the larger end of the charging cable into the AC adapter.
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AC adapter

2. Preparation

4. Plug the AC adapter into an

electrical outlet. The charging screen shown as the image

–: —

on the right will appear.

When the power is off, the screen on the right will not be displayed. Refer to sub-section 2.4 to turn the power on. When charging is complete, remove the AC adapter from the outlet BEFORE removing the charging clip.

Note
· If you cannot charge the battery, try the steps of this section again. · If your monitor has not been used for 3 months, recharge it. Do not charge the
battery in environments where there is high heat or cold temperatures.
Charging Status

Remaining Low

Full

Symbols FULL
Battery Life
Your monitor will last up to 2 days per charge, depending on use and storage condition. Refer to “Battery Life Information” (page 65) for the terms of the battery life.
Note · The battery life will eventually get shorter due to recharging the monitor
repeatedly. When the battery life becomes extremely short, it is coming to the end of its service life. For disposal information, refer to sub-section 9.5 (page 61). · Temperature during the battery charging should be 50 to 95 °F (10 to 35 °C).
20

2. Preparation
2.2 Installing the Cuff Sleeve
To use your monitor comfortably, install the cuff sleeve to the cuff of the monitor. Note · Install the cuff sleeve correctly, otherwise the blood pressure readings may not be
accurate.
1. Insert the longer side of the cuff to the
replacement cuff sleeve’s hole from inside as the illustration shown on the right.

2. Cover the cuff by pulling the cuff sleeve toward
the charging port.
3. Cover the charging port.

Charging port

2.3 Wearing the Monitor on the Left Wrist
Blood pressure can differ between the right and left wrists, and readings can be different. OMRON recommends always using the same wrist when measuring blood pressure. Consult with your physician to determine which wrist you should use for your measurements.
Caution
Remove tight-fitting and thick clothing and any accessories from your wrist while taking a blood pressure measurement.
21

(2.15i-n3chcm)

2. Preparation
Note · Your monitor does not have water-resistant functionality. Do not immerse your
monitor in water.
Position the monitor and leave approximately 1 inch (2.5 – 3 cm) between the band and the bottom of your palm. Use your forefinger and middle finger as a guide. If you cannot determine which hole is appropriate, use the “paper sizing guide”.
Note · Your monitor must have a snug fit prior to measuring; not
too tight, not too loose. Your index finger should NOT easily slide between the band and your wrist.

· Make sure that the cuff is positioned correctly. When the upper and lower sides of the cuff are overlapped, the lower side should be positioned under the upper side. Refer to the illustration.

Upper side Lower side

Wearing the Monitor on the Right Wrist Your monitor can also be worn on your right wrist. Configure the Right / Left Wrist setting. Refer to sub-section 7.1.2 (page 48).
22

2. Preparation
2.4 Turn Your Monitor On
Press and hold the [FORWARD] button for more than 3 seconds. The monitor turns on and the screen below appears on the display.
Connect to the Smart device app
for pairing.
Note · You can use your monitor without pairing to your smart device. Refer to section 3
(page 24). · To take activity measurements and sleep measurements, pair your monitor with
your smart device. Refer to sub-section 4.1 (page 32). · If the monitor does not turn on or the screen below appears on the display, charge
the battery. Refer to sub-section 2.1 (page 19).
–:–
23

3. Using Your Monitor without a Smart Device
You can use your monitor as a blood pressure monitor without pairing to a smart device. To pair your monitor with a smart device, refer to sub-section 4.1.
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 blood pressure measurement. Note · When using your monitor without a smart device, you can take only blood pressure measurements. · When using your monitor without a smart device, you will not be able to view your prior readings that have been stored in memory.
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3. Using Your Monitor without a Smart Device
3.1 Taking a Blood Pressure Measurement 3.1.1 Blood Pressure Measurement Tips
To help ensure an accurate reading, be aware of the following: · 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 the 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.
Caution · 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.
25

3. Using Your Monitor without a Smart Device
3.1.2 Positioning the Band To take an accurate blood pressure measurement, the position of the band is important.

1. Find the positioning mark on the band.

Positioning mark

2. Position the positioning mark on the center of your wrist (align with your middle finger).
The positioning mark may be covered by the buckle, depending on your wrist size.

Positioning mark

26

3. Using Your Monitor without a Smart Device

3.1.3 Sitting Correctly To take a blood pressure measurement, you need to be relaxed and comfortably seated in a room with a comfortable temperature. · Keep your upper arm next to the body. · Sit in a comfortable chair with your back supported. · Keep your feet flat and your legs uncrossed. · Relax your wrist and hand. Do not bend your wrist back, clench your fist
or bend your wrist forward.

3.1.4 Taking a Blood Pressure Measurement

Note · To stop the measurement, press the [START/STOP] button once to deflate
the cuff.

1. Press the [START/STOP] button.
The heart zone indicator will appear.

Connect to the Smart device app
for pairing.

Place the monitor over your heart.

27

3. Using Your Monitor without a Smart Device

2. Adjust the position of your wrist.
Place your monitor over your heart while a measurement. Once the heart zone indicator appears, raise or lower your wrist until it is at heart level. Make sure your wrist is about 2 inches apart from your chest. When your wrist is in the proper position, your monitor will vibrate once. After approximately 2 seconds, the monitor will start a measurement and the cuff will start to inflate. 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.

2 inches space

Note · DO NOT make the band and your body touch while taking a measurement. · After approximately 5 seconds your monitor will start a measurement
and the cuff will start to inflate, even when your monitor is not positioned properly. · For more information about the heart zone indicator, refer to “Heart Zone Indicator” on page 30.
28

3. Using Your Monitor without a Smart Device
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. Your monitor detects your blood pressure and pulse rate during inflation. The heartbeat 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 sub-section 1.4), the number and indicator will be shown in red.

Place the monitor over your heart.

67
mmHg

118 SYS
mmHg
78 DIA
mmHg
70 PULSE
/min 5/17 8:38AM

Note · To stop a measurement, press any button. · Wait 2-3 minutes between measurements. The wait time allows the arteries
to decompress and return to their pre-measurement state. You may need to increase the wait time depending on your individual physiological characteristics.

29

3. Using Your Monitor without a Smart Device
Heart Zone Indicator Your monitor has a built-in heart zone indicator that is used as an aid in determining if your monitor is at the correct height and position. It has been designed to work with most people so that when your wrist is at the correct position relative to your heart, your monitor will vibrate once. If it does not vibrate, your monitor may not be at the correct height and position relative to your heart. Due to differences in individual size and physique, this feature may not be helpful in all cases and you may wish to turn off this feature. If you feel the position of the wrist, according to the heart zone indicator’s guidance, does NOT match your heart level, please turn off this feature and follow your judgment. To disable this feature, refer to sub-section 7.1 (page 47).
30

3. Using Your Monitor without a Smart Device
Error Symbols If the error screens below are displayed, please take another measurement. Refer to sub-section 1.3 (page 16).

· Your monitor is not at the correct height.

Position device at heart-level.

· Your body moved during measurement.

Do not move and take another measurement.

· Irregular heartbeats are detected.

Irregular heartbeat

Warning · DO NOT adjust medication based on your readings from this blood
pressure monitor. Take medication only as prescribed by your physician. ONLY a physician is qualified to diagnose and treat high blood pressure. · NEVER diagnose or treat yourself based on your readings. ALWAYS consult with your physician.
31

4. Using Your Monitor with a Smart Device 4.1 Pairing Your Monitor with a Smart Device
Pairing your monitor with the compatible OMRON app on your smart device will set the date and time on the monitor. Once you have paired with the app, all future measurements will include the date and time when you transfer. If you do not pair the monitor, any measurements you take will not include the date and time. Review the list of compatible smart devices at OmronHealthcare.com.
1. Enable Bluetooth on your smart device. 2. Scan the code below with your smart phone camera or visit
OmronHealthcare.com/app to find the OMRON compatible app for this product.
3. Download, then open the app and follow the pairing instructions shown on your smart device.
32

4. Using Your Monitor with a Smart Device

4. Confirm that your monitor is connected successfully.

If your monitor is connected

successfully to your smart device, “OK”

flashes on the display.

OK

If “Error” flashes on the display, follow the instructions in the app. If it still appears after checking the app, contact customer service. Refer to section 13 (page 69).

Error

Note · Only compatible OMRON apps should be used with this monitor to help
ensure correct data transfer. · Be aware that OMRON will not be responsible for the loss of data and/or
information in the app. · If you change your smart device that was paired with your monitor,
delete the pairing information from your old smart device to avoid communication issue.

33

4. Using Your Monitor with a Smart Device
4.2 Taking a Blood Pressure Measurement 1. Take a measurement.
Refer to sub-section 3.1 (page 25) to start a measurement.
2. Your reading will be transferred to your smart device automatically.
Past readings cannot be viewed on either of the monitor’s displays. Open the app on your smart device and follow the instructions. Note · Make sure your monitor is within 16 ft. (5 m) of your smart device. · When the Bluetooth OFF symbol ( ) appears on the display of your
monitor, enable Bluetooth. Refer to sub-section 7.2 (page 49). · When the sync symbol ( ) appears on the display, the stored memory is
almost full. Transfer the data immediately before your readings are deleted. · Once you transfer your readings to the app, your readings cannot be sent
again to any app or smart device.
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4. Using Your Monitor with a Smart Device
4.3 Taking Activity Measurements
Your monitor automatically measures your activities when you are wearing your monitor. The following items will be measured: · Steps · Calories burned · Distance · Aerobic steps Refer to “Readings Details” in section 6 (page 45) for more information.
Note Do not wear your monitor other than on your wrist.
1. Pair your monitor with your smart device.
Refer to sub-section 4.1 (page 32). The personal information you are asked to provide on the app is to help calculate measurements accurately. You can also set your daily target steps on the app.
2. Set your stride length.
The initial stride length displayed on the app is an estimated value calculated by your height setting. You may choose to adjust your stride length by adding the new value in the app. For instructions on calculating your stride manually, refer to the instructions below. 1. Walk 10 steps with your normal stride as illustrated below. 2. Measure the distance from START to END in inches. 3. Calculate your stride length by dividing the total distance by 10.
35

4. Using Your Monitor with a Smart Device

Example: Total distance = 320” 320 ÷ 10 = 32” (2 feet 8 inches) Conversion Chart 12 inches = 1 foot 24 inches = 2 feet 36 inches = 3 feet 48 inches = 4 feet

END
9
10

3 2
320 inches

START
1

3. Wear your monitor wherever you go.
When your target steps are achieved, the achievement screen appears.

Congratulations!
5000 steps

4. Press the [FORWARD] button to view the readings stored in the memory.
Refer to section 6 (page 43) for more information.

118 SYS
mmHg
78 DIA
mmHg
70 PULSE
/min 5/17 8:38AM

10217 5.1mile 328kcal

7h 26
80% /8h12
5/17-5/18

8:38 THU 17
<Date/time>

36

4. Using Your Monitor with a Smart Device Your monitor may not track your activity data correctly: Improperly Wearing · Wearing your monitor somewhere other than your wrist. · Putting your monitor inside a bag or pocket. Moving Irregularly · Placing your monitor inside or attached to a bag and the bag moves irregularly. · Moving your arm continuously when not walking. · Carrying a bag · Extremely slow arm movements. · Doing housework without walking. Walking at an Inconsistent Pace · Shuffling or wearing sandals. · Constantly starting and stopping walking or moving at some other inconsistent pace. · Walking extremely slowly. Moving Up and Down · Standing up and sitting down. · Playing sports other than walking. · Going up or down stairs or a steep slope. Vibrations from a Moving Vehicle · When you are on a bicycle, automobile, train or bus.
37

4. Using Your Monitor with a Smart Device
4.4 Taking Sleep Measurements
Your monitor measures your sleep by detecting movement of your body while you sleep. The following items will be measured: · Sleep period time · Awake time Refer to “Readings Details” in section 6 (page 45) for more information. Note · Only wear your monitor on your wrist. · During the sleep mode, your monitor does not count your steps. · If you set the sleep mode manually, you cannot take a blood pressure
measurement or change settings. 1. Pair your monitor with your smart device.
Before taking a measurement, pair your monitor with your smart device. Refer to sub-section 4.1 (page 32). You can also set your target sleep period time on the app.
38

4. Using Your Monitor with a Smart Device

2. Go to sleep with your monitor on.
To detect and track your sleep automatically, set your approximate daily bedtime and wake-up time on the app first.

Note

· When you take a measurement, do not

place your monitor on the floor, bed or

shelf.

· To enable the sleep mode manually, refer to

the app.

Sleep mode

· If the “Auto sleep” function is disabled, press

and hold the [START/STOP] button to start

the sleep measurement.

Sleep mode : ON

3. Get up.

Your monitor will detect rising and disable the sleep mode automatically.

Note · If the “Auto sleep” function is disabled, press and hold the [START/STOP] button
to stop the sleep measurement.

Your monitor may not track your sleep data in the following instances: · Wearing your monitor somewhere other than your wrist. · Wearing your monitor too loosely, so that you can insert more than one pointer
finger in between your wrist and the band. · Sleeping in a chair or on a couch
39

4. Using Your Monitor with a Smart Device
4.5 Receiving Notification from Your Smart Device
Your monitor receives a notification (phone call, message and email) from your smart device. When your monitor receives a notification, your monitor vibrates. Press any button to close the notification.

Call from 1-847-555-1212

Message from Brian

Mail from mail@omron.com

Phone call

Message

Email

Note

· Refer to the app for compatible email apps or any other information.

· Your monitor cannot receive a notification from your smart device during

the following:

– When taking a blood pressure measurement.

– When the Bluetooth function of your monitor or smart device is disabled.

· Only English alphabets and digits can be displayed correctly on your

monitor.

· Your monitor may not able to receive a notification for any reason other

than your monitor or the app.

· For more details, refer to the app.

40

4. Using Your Monitor with a Smart Device
4.6 Receiving a Reminder
The reminder function will alert you at a specific time of day with vibration and the “Reminder” icon on the display. The reminder can only be set on the app.

11:30AM

Note · To stop the vibration, press any button. · If the reminder time comes while taking a blood pressure measurement,
the alert will start after the measurement. · The reminder will not alert you when the monitor is being charged or the
battery is depleted.

41

5. Recording an Event

You can record the time of your action or activity as an “Event”, such as time you ate, took a medicine, exercised or had another event. Note · The recorded time of your events can be viewed on the app only. · An event cannot be recorded during transferring the data to the app.

1. Press and hold the [FORWARD] button for

more than 3 seconds.

THU 17
8:38

2. “Record” appears on the display.
Record

42

6. Viewing the Readings Stored in Memory
Only your latest reading can be viewed on the monitor’s display. Use the app to view all the readings stored in the memory.
1. Press the [FORWARD] button.
THU 17
8:38

2. Press the [FORWARD] button one by one.
The display of your readings changes as below. For activities and sleep, the ring around the reading describes the level of achievement against your target.

118 SYS
mmHg
78 DIA
mmHg
70 PULSE
/min 5/17 8:38AM

10217 5.1mile 328kcal

7h 26
80% /8h12
5/17-5/18

8:38 THU 17
<Date/time>

43

6. Viewing the Readings Stored in Memory

If this monitor detects any errors during a measurement, the following symbols will appear on the display.

Alternating pulse/symbols
display

118 SYS
mmHg
78 DIA
mmHg
70 PULSE
/min
5/17 8:38AM

118 SYS
mmHg
78 DIA
mmHg
5/17 8:38AM

Symbol

Meaning

This monitor is not at the correct height.

Irregular heartbeats are detected.

Movement during measuring.

Meaning of each display item

Total steps

Sleep period time

10217 5.1mile 328kcal

Distance

Calories burned

7h 26
80% /8h12
5/17-5/18

Percent achieved

Target sleep period time

44

6. Viewing the Readings Stored in Memory

Readings Details

Calories burned Indicates the amount of calories burned by

measuring the intensity of your activity.

Distance

Indicates you distance traveled by using your step

count.

Note

If you have jogged, climbed up or down stairs, or walked at brisk

walking pace, some errors may occur in the value.

Aerobic steps

Aerobic steps are the physical exercise that helps us

stay healthy. Aerobic steps are counted separately

when walking more than 60 steps per minute and

more than 10 minutes successively. If a rest of less

than 1 minute is taken after a continuous walk of

more than 10 minutes, this will be regarded as part of

“a continuous walk”.

Note

Aerobic steps can be viewed on the app only.

Sleep period time Indicates your actual time asleep.

Awake time

Indicates the time of movement at “restless level 2”

after you fell asleep.

For more information on restless levels, refer to

“Sleep Mode Details” on the next page.

Note

Awake time can be viewed on the app only.

45

Sleep Mode Details

6. Viewing the Readings Stored in Memory

Bedtime Fall asleep time

Wake up time

Time until you fall asleep

Sleep period time
Total amount of sleep period time is from when the time sleep mode is enabled to the time sleep mode is disabled, except the awake time.

Sleep mode
enabled Awake time
Time of movement at restless level 2
during sleep period time.

Restless level 2 1 0
Sleep mode disabled

46

7. Settings

7.1 Function Settings

To change the function settings

on your monitor, press and hold

ON / OFF

both the [START/STOP] button

THU 17
8:38

L / R

and the [FORWARD] button for

more than 3 seconds.

7.1.1 Enabling/Disabling Heart Zone Indicator ( ) 1. Press the [START/STOP] button for heart zone indicator setting.
ON / OFF
L / R

2. Press the [START/STOP] button to enable,

or press the [HOME] button to disable.

[ ON ]

Note

OFF

The heart zone indicator is enabled by default.

The current setting is shown in the bracket.

47

7.1.2 Selecting Your Wrist to Wear ( Left 1. Press the [HOME] button for wrist setting.

or Right
ON / OFF L / R

7. Settings
)

2. Press the [START/STOP] button if you

wear your monitor on the left wrist, or

press the [HOME] button if you wear the

[ L ]

monitor on the right wrist.

R

Note Left is set by default. Current setting is indicated in the bracket.

48

7. Settings
7.2 Bluetooth Settings
To enter the pairing mode or change Bluetooth setting, follow the instructions below.

7.2.1 Entering Pairing Mode Press and hold the [HOME] button for more than 3 seconds. Refer to sub-section 4.1 (page 32) to pair your monitor with your smart device.

THU 17
8:38

Connect to the Smart device app
for pairing.

Note Bluetooth will be enabled automatically after pairing with your smart device successfully.

49

7.2.2 Disabling/Enabling Bluetooth

7. Settings

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 those areas. For further information on potential restrictions refer to documentation on the Bluetooth usage by the FCC.

Press and hold the [HOME] button for at

least 3 seconds when your monitor is in

the pairing mode.

When Bluetooth is enabled, this operation

will make it disabled. When Bluetooth is disabled, this operation

Connect to the Smart device app
for pairing.

will make it enabled.

Note · Bluetooth is enabled by default.

ON OFF OFF ON

50

7. Settings
7.3 Restoring Your Monitor to the Default Settings
To delete all the information stored in your monitor, follow the instructions below.
Press and hold both the [START/STOP] button and the [HOME] button for at least 7 seconds. When the confirmation screen appears, press the [START/STOP] button to restore your monitor.

THU 17
8:38

Clear All Cancel

Cleared

Note · Reverting to its default setting of your monitor does not delete the information in
the app. · You will need to re-pair your monitor when using the monitor again. Without
repairing, your readings will not be transferred to your app. Refer to sub- section 4.1 (page 32).

51

7.4 Turning Off Your Monitor

Press and hold both the

[FORWARD] button and the [HOME] button for more than 7 seconds.

THU 17
8:38

7. Settings

Turn off and restart your monitor if either of the following occurs: · When “Error” with a number other than 1 to 9 appears on the display. · Your monitor cannot be operated even though you pressed a button.
Note · Turning off your monitor will not delete your reading or any information
in the monitor and the app, however; your step numbers from the past hour may be lost. · After restarting, open the app. The date and time will be set automatically. When using your monitor without a smart device, you can only take blood pressure measurements. When using your monitor without a smart device, you will not be able to view your prior readings that have been stored in memory. · If the “Error” with a number other than 1 to 9 appears on the display after restarting, refer to section 13 (page 69).
52

8. Error Messages and Troubleshooting

In case 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.
8.1 Error Messages

Display

Cause

Solution

Irregular heartbeat

Irregular heartbeat detected.

Remove your monitor. Wait for 2 – 3 minutes and then take another measurement. Repeat the steps in sub-section 3.1 (page 25). If this error continues to appear, we recommend that you consult with your physician.

Do not move and take another measurement.

Your body moved during a measurement.

Carefully read and repeat the steps in subsection 3.1 (page 25).

Position device at heart-level.

Your monitor is not at the correct height.

Adjust the height of your wrist following the heart zone indicator. Refer to sub-section 3.1 (page 25).

53

Display
12:35

Cause
The battery is depleted.

8. Error Messages and Troubleshooting
Solution Charge the battery. Refer to sub-section 2.1 (page 19).

The monitor cannot Follow the instructions shown in the app. If it

connect to a smart still appears after checking the app, contact

device or transmit customer service. Refer to section 13 (page

data correctly.

69).

Please see the manual.
Error 1

The band is not applied correctly.

Apply the band correctly, then take another measurement. Refer to sub-section 2.3 (page 21).

Air is leaking from Contact customer service. Refer to section 13

the cuff.

(page 69).

Clothing is

Remove any clothing interfering with the band.

interfering with the Refer to sub-section 2.3 (page 21).

band.

54

8. Error Messages and Troubleshooting

Display
Please see the manual.
Error 2

Cause

Solution

The band may be Apply the band correctly, then take another applied too loosely. measurement. Refer to sub-section 2.3
(page 21).

Please see the manual.
Error 3

The cuff was inflated Do not touch your monitor while taking a

exceeding the

measurement.

maximum allowable

pressure.

Please see the manual.
Error 4

You move or

Remain still and do not talk during a

talk during a

measurement.

Vibrations disrupt a

measurement.

Please see the manual.
Error 5
55

The band was not Apply the band correctly, then take another

applied correctly or measurement. Refer to sub-section 2.3

was moved during a (page 21).

measurement.

Remain still and sit correctly during a

measurement. Refer to sub-section 3.1

(page 25).

Display
Please see the manual.
Error 7

8. Error Messages and Troubleshooting

Cause

Solution

Your wrist is moved Take another measurement making sure not up and down during to move your wrist. Refer to sub-section 3.1 a measurement. (page 25).

Please see the manual.
Error 8

Temperature error is Wait for few minutes, then take another

detected.

measurement in a place with moderate room

The monitor has malfunctioned.

temperature. If the error appears again, contact customer service. Refer to section 13 (page 69).

Please see the manual.
Error 9

The band may be Apply the band correctly, then take another applied too tightly. measurement. Refer to sub-section 2.3
(page 21).

Room temperature Charge the battery at a moderate room

is too high to charge temperature.

the battery.

Error

The monitor has If the error appears in moderate temperature,

malfunctioned. contact customer service. Refer to section 13

(page 69).

56

8. Error Messages and Troubleshooting

Display
Error 123

Cause
The monitor has malfunctioned.

Solution
Turn off and restart your monitor. Refer to subsection 7.4 (page 52). If the error still appears, contact customer service. Refer to section 13 (page 69).

8.2 Troubleshooting

Problem

Cause and Solution

Nothing appears on the display of the monitor.

· Charge the battery. Refer to sub-section 2.1 (page 19). · Your monitor is turned off. Refer to sub-section 2.4 (page
23) to turn on your monitor.

Readings appear too high or too low.

Blood pressure varies constantly. Many factors including stress, time of day, and/or how you apply the band, may affect your blood pressure. Review sub- section 3.1 (page 25).

Any other communication issue occurs.

Follow the instructions shown in the smart device, or visit the “Help” section in the app for further help. If the problem still persists, contact customer service. Refer to section 13 (page 69).

The monitor cannot be Turn off and restart your monitor. Refer to sub-section 7.4

operated.

(page 52).

If your monitor still does not operate, contact customer

service. Refer to section 13 (page 69).

57

8. Error Messages and Troubleshooting

Problem

Cause and Solution

The monitor or the AC The monitor or the AC adapter may be damaged. Unplug adapter is abnormally the AC adapter from the outlet immediately and contact hot when charging the customer service. Refer to section 13 (page 69). battery.

The operating time is This may be due to the life of the rechargeable battery. The short, or the monitor battery cannot be replaced. Contact customer service (refer does not operate, even to section 13 (page 69)) or dispose of your monitor. Refer when the battery is to sub-section 9.5 (page 61). fully charged.

58

9. Maintenance 9.1 Maintenance
To protect this monitor from damage, please follow the directions below: · Changes or modifications not approved by the manufacturer will void the
user warranty. Caution
DO NOT disassemble or attempt to repair this monitor or other components.
9.2 How to Replace the Cuff Sleeve
Clean the cuff sleeve when it becomes dirty (once-a-week cleaning is recommended). Replace the cuff sleeve to new one in half a year.
1. Detach the cuff sleeve.
2. Refer to sub-section 2.2 (page 21) to install the cuff sleeve.
59

9. Maintenance
9.3 Storage
· 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.
9.4 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 then wipe them with a dry cloth. · Do not wash or immerse your monitor in water. · Do not use gasoline, thinners or similar solvents to clean your monitor. · Do not use a wet cloth on the plugs of the AC adapter. The charging cable,
or the terminal of the charging clip. · Hand-wash with mild detergent and air- dry the cuff sleeve. Do not soak
it in water for long periods of time. Do not use any sterilization chemicals, disinfectants, or softeners.
60

9. Maintenance Caution
· Stop using this monitor and consult with your physician if you experience skin irritation or discomfort.
· Prolonged rubbing and pressure may irritate the skin. Give your wrist a break by removing your monitor for a while after extended wear.
· Be careful not to let chemical products such as lotions, oils, skin creams or cosmetics collect on the band. If this happens, wipe them immediately, otherwise it may impact the material and lifetime of product.
9.5 Disposal
Dispose of your monitor and other components according to applicable local regulations. Unlawful disposal may cause environmental pollution.
61

10. Optional Accessories

Charging clip

AC adapter

Model: HEM-CLIP-01 Charging cable

Model: HHP-AM02 Cuff sleeve

Model: HHX-CB07U
Model: HEM-CUCV-01 For further information, visit our website at OmronHealthcare.com.

62

11. Specifications

Model Display Memory
Transmission method Wireless communication Operation mode IP classification Rating Power source
Battery lifespan

BP8000-M REF HEM-6411T-ZM
Transflective memory-in-pixel LCD
Blood pressure measurement: Up to 100 times Activity measurement: Up to 7 days Sleep measurement: Up to 7 times Event: Up to 100 items
Bluetooth® low energy technology
Frequency range: 2.4 GHz (2400 – 2483.5 MHz) Modulation: GFSK Effective radiated power: <20 dBm
Continuous operation
Monitor: IP22 AC adapter: IPX0
DC 3.8 V 3.0 W
1 Lithium ion polymer rechargeable battery (3.8 V; Approximately 164 mAh) AC adapter (INPUT AC100-240 V, 50-60 Hz 0.2-0.13 A)
Will last for approximately 500 cycles, 8 times/day measurements in normal temperatures of 77.0 °F (25 °C) when new battery fully charged.

63

11. Specifications

Battery Life

Up to 2 days (48 hours) battery life per charge. Refer to “Battery Life Information” (page 65) for the
terms of the battery life.

Durable period (Service life)

Monitor: 2 years AC adapter: 2 years Cuff sleeve: 0.5 years

Operating conditions 41 to 104 °F (5 to 40 °C) / 15 to 90 % RH (non- condensing) / 800 to 1060 hPa

Charging / data

50 to 95 °F (10 to 35 °C)

transmission conditions

Storage conditions

-4 to 104 °F (-20 to 40 °C) / 10 to 90 % RH (non-condensing)

Transport conditions -4 to 140 °F (-20 to 60 °C) / 10 to 90 % RH (non- condensing)

Weight

Approximately 4.1 oz. (115 g)

Dimensions

Case diameter: Approximately 1.89″ (48 mm) Case thickness: Approximately 0.55″ (14 mm) Band width: Approximately 1.18″ (30 mm)

Measurable wrist circumference

6.3″ to 7.5″ (160 to 190 mm)

Contents

Monitor, charging clip (HEM-CLIP-01), charging cable (HHX-CB07U), AC adapter (HHP-AM02), paper sizing guide, replacement cuff sleeve (HEM-CUCV-01), instruction manual, quick start guide

64

11. Specifications

Applied part

Type BF (cuff)

Protection against electric shock

Internally powered ME equipment Class II ME equipment (AC adapter)

Maximum temperature Lower than +118.4 °F (+48 °C) of the applied part

Battery Life Information
The battery life is based on 2 days (48 hours) with the following use: in 23°C environment, 170 mm wrist circumference, 8 times of blood pressure measurement (inflates to 150 mmHg) per day, 16-hour step counting per day, 8-hour sleep measurement per day, 96 times of button pressing per day, 16 times of incoming call per day, 1 time of ringing alarm per day, 16hour Bluetooth communication per day.
The battery life depends on the terms of use and the environment of storage.

Blood pressure measurement

Cuff pressure range Blood pressure

0 to 299 mmHg SYS: 60 to 230 mmHg

measurement range Pulse measurement range Accuracy

DIA: 40 to 160 mmHg 40 to 180 beats / min.
Pressure: ±3 mmHg

Inflation Deflation Measurement method

Pulse: ±5 % of display reading Automatic by electric pump Automatic rapid deflation Oscillometric method

65

11. Specifications

Activity / Sleep measurement

Measurement range Setting range

Steps: 0 to 99,999 steps Distance: 0.0 to 621.3 mile Time: 12:00 AM to 11:59 PM Calories burned: 0 to 59,999 kcal Time: 12:00 AM to 11:59 PM (0:00 to 23:59) Weight: 22 to 300 lb (in increments of 1 lb) Height: 3′ 4″ to 6′ 6″ (in increments of 1 inch) Stride length: 12″ to 48″ (in increments of 1 inch)

Notes · 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 comply with the requirements of ISO 81060-2:2013. · 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 ingress of dust which would cause issues during a normal operation, and against splashing water which may cause issues during a normal operation. · This AC adapter is not protected against water. · Rating indication is printed on the cuff.

66

11. Specifications
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.
Pictogram on the Product Indicates the correct positioning for the band on the wrist. Indicates the correct positioning for the monitor on the wrist.
67

12. FCC Statement
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.
Note 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 with 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).
68

13. Limited Warranty

Your BP8000-M Wrist Blood Pressure Monitor, excluding AC adapter and charging cable, is warranted to be free from defects in materials and workmanship appearing within 1 year 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, and only to products purchased from an Omron authorized seller who is subject to and follows Omron’s quality control standards, unless otherwise prohibited by law. We will, at our option, replace without charge any monitor or band 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. 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

69

14. 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 Electromagnetic Compatibility (EMC) BP8000-M manufactured by OMRON HEALTHCARE Co., Ltd. conforms to IEC60601-1-2:2014 Electromagnetic Compatibility (EMC) standard. Further documentation in accordance with this EMC standard is available at OmronHealthcare.com/emc. Refer to the EMC information for BP8000-M on the website.
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.
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OMRON HEALTHCARE Co., Ltd. 53, Kunotsubo, Terado-cho, Muko, Kyoto, 617-0002 JAPAN
Distributed by: OMRON HEALTHCARE, INC. 2895 Greenspoint Pkwy. Hoffman Estates, IL 60169 USA

Made in Japan