OMRON Evolv Wireless Upper Arm Blood Pressure Monitor USER MANUAL

INSTRUCTION MANUAL

Evolv® Upper Arm Blood Pressure Monitor

Model BP7000

®

9545343-5G

ENGLISH

INTRODUCTION

Thank you for purchasing the OMRON BP7000 Blood Pressure Monitor.
Your new blood pressure monitor uses the oscillometric method of blood pressure
measurement. This means the monitor detects your blood movement through your
brachial artery and converts the movements into a digital reading. An oscillometric
monitor does not need a stethoscope so the monitor is simple to use.

Symbols Glossary

For symbol information, visit:
OmronHealthcare.com/symbols-glossary

2

TABLE OF CONTENTS

INTENDED USE...........................................................................................4

IMPORTANT SAFETY INFORMATION .......................................................5

1. KNOW YOUR MONITOR ......................................................................8

2. PREPARATION ...................................................................................12

3. USING THE MONITOR WITHOUT A SMART DEVICE ......................16

4. USING THE MONITOR WITH A SMART DEVICE..............................18

5. ERROR MESSAGES AND TROUBLESHOOTING .............................25

6. MAINTENANCE, STORAGE AND CLEANING ...................................29

7. DISPOSAL...........................................................................................30

8. SPECIFICATIONS ...............................................................................31

9. FCC STATEMENT...............................................................................33

10. LIMITED WARRANTY .........................................................................34

11. GUIDANCE AND MANUFACTURER’S DECLARATION ....................35

3

INTENDED USE

This device is a digital monitor intended for use in measuring blood pressure and
pulse rate in adult patient population with arm circumference ranging from 9 inches
to 17 inches (22 cm to 42 cm). The device detects the appearance of irregular
heartbeats during measurement and gives a warning signal with readings.

4

IMPORTANT SAFETY INFORMATION

Please read the Important Safety Information in this instruction manual before
using the unit.

Please follow this instruction manual thoroughly for your safety.
Please keep for future reference. For specific information about your own blood
pressure, CONSULT YOUR PHYSICIAN.

Contraindications

• The device is contraindicated for use in ambulatory environments.

• The device is contraindicated for use on aircraft.

Indicates a potentially hazardous situation

Warning

• DO NOT adjust medication based on measurement results 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 arm or an arm under medical treatment.

• DO NOT wear the arm cuff on your arm while on an intravenous drip or blood
transfusion.

• DO NOT apply or inflate the arm cuff around any body parts other than your upper
arm.

• DO NOT use this monitor in areas containing high frequency (HF) surgical
equipment, magnetic resonance imaging (MRI) equipment, computerized
tomography (CT) scanners or in oxygen rich environments.

• DO NOT use this monitor on infants, toddlers, children or persons who cannot
express themselves.

• Consult your physician before using this monitor if you have common arrhythmias
such as atrial or ventricular premature beats or atrial fibrillation; arterial sclerosis;
poor perfusion; diabetes; pregnancy; pre-eclampsia; or renal disease. Note that
any of these conditions in addition to patient motion, trembling, or shivering may
affect the measurement reading.

• Always consult your physician. Self-diagnosis of measurement results and self­treatment are dangerous.

• Contains small parts that may cause a choking hazard if swallowed by children,
toddlers or infants.

• Keep the BATTERY out of the reach of children, toddlers and infants.

which, if not avoided, could result in death or
serious injury.

5

IMPORTANT SAFETY INFORMATION

• 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.
For further information on any potential restrictions refer to documentation on

Bluetooth

• Stop using this monitor and consult your physician if you experience skin irritation
or discomfort.

• Consult your physician before using this monitor on an arm with an arterio-venous
(A-V) shunt.

• Consult your physician before using this monitor if you have had a mastectomy.

• Consult your physician before using the 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.

• Remove the arm cuff if it does not start deflating during the measurement.

• Do not use this monitor for any purpose other than measuring blood pressure.

• Do not use a mobile phone or other electrical devices that emit electromagnetic
fields near this monitor except when transferring your readings to your smart
device. This may result in incorrect operation of this monitor.

• Do not disassemble or attempt to repair the monitor or components. This may
cause an inaccurate reading.

• Do not use in a location where there is moisture or a risk of water splashing the
monitor. This may damage the monitor.

• Do not use this monitor in a moving vehicle such as in a car.

• Do not drop, or subject this monitor to strong shocks or vibrations.

• Do not use this monitor in places with high or low humidity or high or low
temperatures. See the “8. SPECIFICATIONS” section of the manual.

• Please check, by observation of the arm being used, that the monitor is not
causing any impairment of patient blood circulation.

• Do not use this monitor in high-use environments such as medical clinics or
physician offices.

®

usage by the FCC.

Caution

Indicates a potentially hazardous situation
which, if not avoided, may result in minor or
moderate injury to the user or patient or damage
to the equipment or other property.

6

IMPORTANT SAFETY INFORMATION

• Avoid bathing, drinking alcohol or caffeine, smoking, exercising and eating for 30
minutes before taking a measurement.

• Rest for at least 5 minutes before taking the measurement.

• Remove t

• Remain still and do not talk while taking a measurement.

Data Transmission

• Do not replace the battery while your reading is being transferred to your smart
device. This may result in the incorrect operation of your monitor and failure to
transfer your blood pressure data.

• Do not place integrated circuit cards, magnets, metal objects, or other devices that
emit electromagnetic fields near this monitor while your reading is being
transferred to your smart device. This may result in the incorrect operation of your
monitor and failure to transfer your blood pressure data.

Battery Handling and Usage

• Do not insert the batteries with their polarities incorrectly aligned.

• Use only 4 “AAA” alkaline batteries with this monitor. Do not use other types of
batteries. Do not use new and used batteries together.

• Remove the batteries if the 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 a 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 a physician.

• Do not use batteries after their expiration date.

• Periodically check your 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 the monitor.

ight-fitting or thick clothing from your arm while taking a measure

ment.

7

1. KNOW YOUR MONITOR

A

BC

D

E

A. START/STOP button
B. Connection button
C. Display
D. Arm cuff
E. Battery compartment

F. Systolic blood pressure
G. Diastolic blood pressure
H. Pulse display

G

H

F

Display:

Contents:

Monitor, 4 “AAA” batteries, instruction manual, quick start guide

Monitor:

8

1. KNOW YOUR MONITOR

Connection symbol Irregular heartbeat symbol

Connection OFF symbol Battery symbol (low)

Connection ON symbol Battery symbol (depleted)

Movement error symbol Deflation symbol

SYNC symbol

Heartbeat symbol
(Flashes during measurement.)

1.1 Display symbols

Connection symbol ( )

Appears when transferring the data or pairing with your smart device.

Connection OFF symbol ( )

Appears when Bluetooth is off.

Connection ON symbol ( )

Appears when Bluetooth is on.

Movement error symbol ( )

The movement error symbol will display when your body is moving during
measurement. If the movement symbol displays, remove the monitor and wait
for 2 to 3 minutes. After 2 to 3 minutes, remain still and take another
measurement.

SYNC symbol ( )

• When the SYNC symbol appears on the display, make sure that your
monitor has been pairing with the smart device or transfer the data.

• When the SYNC symbol appears on the display, transfer the data before the
measurements are deleted. Maximum internal memory is for 100
measurements. The oldest value will be deleted when this is reached before
transferring.

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1. KNOW YOUR MONITOR

Irregular heartbeat symbol ( )

When the monitor detects an irregular rhythm two
or more times during the measurement, the
irregular heartbeat symbol will appear on the
display along with the measurement values.

Blood pressure

An irregular heartbeat rhythm is defined as a
rhythm that is 25% less or 25% more than the
average rhythm detected while the monitor is
measuring the systolic and diastolic blood

Blood pressure

pressure.
If the irregular heartbeat symbol displays with your measurement results, we
recommend you consult your physician. Follow the directions of your
physician.

Battery symbol (low) ( )

Appears when the batteries are low.

Battery symbol (depleted) ( )

Appears when the batteries are depleted.

Deflation symbol ( )

Flashes while arm cuff is deflating.

Heartbeat symbol ( )

Flashes while taking a measurement.

Normal Heartbeat

Pulse

Irregular Heartbeat

Short

Pulse

Long

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1. KNOW YOUR MONITOR

Avoid bathing, drinking alcohol or caffeine, smoking, exercising and eating for
30 minutes before taking a measurement.

Rest for at least 5 minutes before taking the measurement.

1.2 Classification of BP (Blood Pressure)

ACC/AHA 2017 Hypertension guidelines defines 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

* 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

1.3 Before Taking a Measurement

To help ensure an accurate reading, follow these directions:

• Stress raises blood pressure. Avoid taking measurements during stressful
times.

• Measurements should be taken in a quiet place.

• Keep 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. Try to measure your blood pressure at the same time each day for
consistency.

Stage 1
Stage 2

130 - 139 mmHg or 80 - 89 mmHg

≥140 mmHg or ≥90 mmHg

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2. PREPARATION

2.1 Battery Installation

1. Remove the battery cover.

Insert your fingernail into the slot of
the battery cover, and push
downwards to remove the cover.

2. Insert battery, slide over so it is

secured inside the circular
battery positioner. Then insert
the second battery.

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2. PREPARATION

3. Replace the battery cover.

When the batteries have been securely placed in this monitor, the message
below will appear on the screen:

Notes:

• When the depleted battery symbol “ ” appears on the display, turn the
monitor off and remove all the batteries. Replace with 4 new batteries at the
same time. Long life alkaline batteries are recommended.

• The measurement values continue to be stored in the memory even after the
batteries are replaced.

• The supplied batteries may have a shorter life than new batteries.

• Disposal of used batteries should be carried out in accordance with the
national/local regulations for the disposal of batteries.

• When the batteries are replaced, the words “Please pair this device.” or
“Pairing not completed. No data transfer.” will appear on the display. Press
the [ ] button to pair with the smart device or transfer the data before taking
a measurement.

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2. PREPARATION

Remove tight-fitting or thick clothing from your arm while taking a
measurement.

1/2 inch
(1 - 2 cm)

2.2 Applying the Arm Cuff

1. Apply the arm cuff to your left upper

arm.

The bottom edge of the arm cuff should be 1/2
inch (1 to 2 cm) above the elbow. The display
should be in clear view and easy to read,
positioned slightly on the inside of your arm.

2. Securely close with the fabric

fastener.

Notes:

• The blood pressure can differ between the
right arm and the left arm, and the measured
blood pressure values can be different.
Omron recommends to always use the same arm for measurement. If the
values between both arms differ substantially, please check with your
physician as to which arm to use for your measurements.

• Positioning the monitor with the [START/STOP] button toward the body
makes it easier to use the monitor.

14

2. PREPARATION

2.3 How to Sit Correctly

To take a measurement, you need to be relaxed and
comfortably seated, at a comfortable room temperature.

• Sit in a chair with your legs uncrossed and your feet flat on
the floor.

• Sit upright with your back straight.

• Sit with your back and arm being supported.

• The arm cuff should be placed on your arm at the same level
as your heart.

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3. USING THE MONITOR WITHOUT A SMART DEVICE

START INFLATING

DEFLATING

COMPLETED

Example:

You can use this blood pressure monitor without pairing to a smart device.

3.1 Taking a Measurement

Notes:

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

• Remain still and do not talk while taking a measurement.

• When using this blood pressure monitor without a smart device, you will not
be able to view your prior readings stored in the memory.

• Do not use the monitor with any other electrical device simultaneously. This
may result in incorrect operation of the monitor.

1. Press the [START/STOP] button.

The arm cuff will start to inflate.

The following symbols indicate incorrect measurement

• If “Please remeasure” and any of these symbols below are displayed, please
take another measurement and try again.

2. Remove the arm cuff.

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3. USING THE MONITOR WITHOUT A SMART DEVICE

DO NOT adjust medication based on measurement results from this blood
pressure monitor. Take medication as prescribed by your physician. Only a
physician is qualified to diagnose and treat high blood pressure.

Always consult your physician. Self-diagnosis of measurement results and
self-treatment are dangerous.

3. Write down your SYS/DIA and Pulse readings, along with the

date and time of your measurement on a piece of paper to
keep a record of your history.

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4. USING THE MONITOR WITH A SMART DEVICE

Review the list of compatible smart devices at: OmronHealthcare.com

4.1 Pairing Your Monitor with a Smart Device

The date and time on your monitor will automatically be set when you pair it
with your smart device.

1.

Enable Bluetooth on your smart device.

2. Scan the code below with your smart device camera or visit

OmronHealthcare.com/app to find the OMRON compatible
app for this product.

3. Download and install the compatible OMRON app onto your

smart device.

If you already have the compatible OMRON app and have created your
account, open the app and add your new monitor.

4. Open the app and follow the pairing instructions shown on

your smart device.

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4. USING THE MONITOR WITH A SMART DEVICE

5. Confirm that your monitor is connected successfully.

If the monitor is connected successfully to the smart device, “OK” will appear
on the display.

If “Error” appears, refer to section 5.1 for more detail.

For more information, visit OmronHealthcare.com

Notes:

• If you do not pair this monitor to set the date and time, any blood pressure
readings you take with this monitor will not be transferred.

• The date/time will only be set for future measurements taken after the
measurement that was transferred. It will not be saved to the measurement
that was just transferred.

• Please be aware that OMRON will not be responsible for the loss of data
and/or information.

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4. USING THE MONITOR WITH A SMART DEVICE

START INFLATING

DEFLATING

COMPLETED

Example:

4.2 Taking a Measurement

Notes:

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

• Remain still and do not talk while taking a measurement.

• This monitor will store 100 measurements. Stored measurements cannot be viewed
on the monitor's display. You will need to use the app to view all measurements prior
to the most recent reading taken.

• Do not use a mobile phone or other electrical devices that emit electromagnetic fields
near this monitor except when transferring your readings to your smart device. This
may result in incorrect operation of this monitor.

1. Press the [START/STOP] button.

The arm cuff will start to inflate.

The following symbols indicate incorrect measurement

• If “Please remeasure” and any of these symbols below are displayed, please
take another measurement and try again.

20

4. USING THE MONITOR WITH A SMART DEVICE

®

2. Remove the arm cuff.

3. Transfer your readings.

Make sure your monitor is within 16 ft. (5 m) of your smart device.
As soon as your measurement is complete, open the app on your smart
device to transfer your readings.

Transferring

1. Open the app on your smart device and then follow the instructions.

2. Press [ ] button to transfer your readings.

• If your readings are successfully transferred to your smart device, “OK”
will flash on the display.

If “Error” appears, refer to section 5.1 for more detail.

Notes:

• When the SYNC symbol “ ” appears on the display, transfer the data
immediately before the readings are deleted.

• When the Connection OFF symbol “ ” appears on the display, turn on the

Bluetooth feature of your monitor. (Refer to section 4.3)

your readings later

21

4. USING THE MONITOR WITH A SMART DEVICE

DO NOT adjust medication based on measurement results from this blood
pressure monitor. Take medication as prescribed by your physician. Only a
physician is qualified to diagnose and treat high blood pressure.

Always consult your physician. Self-diagnosis of measurement results and
self-treatment are dangerous.

• Once you send your readings to the app, the data cannot be sent again to
the app or smart device.

4. After your readings have been transferred to the app, press

the [START/STOP] button to turn the monitor off.

Notes:

• The monitor will automatically turn off after 2 minutes.

• Wait 2-3 minutes before taking another measurement. Waiting between
measurements allows the arteries to return to the condition they were prior
to taking the measurement.

• Only compatible OMRON apps should be used with this monitor to help
ensure correct data transfer.

Data Transfer With Multiple Smart Devices

Once you transfer your data to a smart device, that data can no longer be
transferred again to the same smart device, nor to another smart device.

About Multiple Users

To share your blood pressure monitor with other people, please refer to the
“Help” section in the app.

22

4. USING THE MONITOR WITH A SMART DEVICE

4.3 Turning “OFF” Bluetooth

Turn off the Bluetooth
wireless equipment is prohibited.

• On aircraft • In hospitals • While abroad

Your monitor comes with the Bluetooth

®

in your monitor in the following areas where use of

1. Turn your monitor power off if it is on by pressing the [START/

STOP] button on the monitor.

2. Press and hold the [ ] button for more than 10 seconds.

Release the [ ] button when “ ” appears on the
display. When the “ ” is blinking, you have now turned the

®

Bluetooth

off in your monitor.

3. Press the [START/STOP] button to turn the monitor off.

Note: The monitor will automatically turn off after 2 minutes.

How to turn “ON” Bluetooth

Perform the following step when the power has been off.
Press and hold the [ ] button for more than 2 seconds and then release
the [ ] button when
The

“” will blink to show that the Bluetooth

turned on.

“” appears on the display.

®

®

already turned on.

®

®

in your monitor has been

23

4. USING THE MONITOR WITH A SMART DEVICE

4.4 Restoring Your Monitor to the Default Settings

To delete all the information stored in your monitor, follow the instructions
below. Make sure that your monitor is turned off. It will be off when the screen
is not showing numbers or symbols.

1. While holding the [ ] button down, the Connection symbol

“ ” and “P” appear on the display, and then press the
[START/STOP] button for more than 5 seconds.

2. When the “Clear” symbol appears on the display, release the

[ ] button and [START/STOP] button.

The “Clear” will appear on the display when your monitor settings have
reverted back to their original.

3. Press the [START/STOP] button to turn the monitor off.

Notes:

• The monitor will automatically turn off after 2 minutes.

• Reverting to initial settings of this monitor will not delete the information in
the app.

• When using this monitor again, first delete the registration of monitor in the
app and then pair your monitor.

24

5. ERROR MESSAGES AND TROUBLESHOOTING

5.1 Error Messages

Error Display Cause Solution

Remove the arm cuff. Wait 2

- 3 minutes and then take

Irregular heartbeat is
detected.

another measurement.
Repeat the steps in
section 2.2. If this error
continues to appear, contact
your physician.

Movement during
measurement.

The batteries are low.

The batteries are
depleted or battery
polarities are not
properly aligned.

Connection failure. Data
is not being transmitted.

Arm cuff is applied too
loosely.

25

Carefully read and repeat the
steps in section 3.1 or 4.2.

Recommend replacement of
all 4 batteries with new ones.
Refer to section 2.1.

Immediately replace 4
batteries with new ones.
Refer to section 2.1.

Confirm the batteries are
properly inserted with
polarities correctly aligned.
Refer to section 2.1.

Refer to“ Connection failure. /
Data is not being
transmitted.” in section 5.2.

Apply the arm cuff tighter.
Refer to section 2.2.

5. ERROR MESSAGES AND TROUBLESHOOTING

*

Error Display Cause Solution

The arm cuff was
inflated exceeding the
maximum allowable
pressure, and then
deflated automatically.

Movement during
measurement.

Clothing is interfering
with the arm cuff.

Movement during
measurement

Arm cuff is not applied
correctly.

Do not touch the arm cuff
while taking a measurement.
Refer to section 3.1 or 4.2.

Repeat measurement.
Remain still and do not talk
during measurement.
Refer to section 3.1 or 4.2.

Remove any clothing
interfering with the arm cuff.
Refer to section 2.2.

Repeat measurement.
Remain still and do not talk

during measurement.
Refer to section 3.1 or 4.2.

Apply the arm cuff correctly.
Refer to section 2.2.

* : “XX” will change to

display an error
number, 6 and
higher.

Device error.

Please contact customer
service.

26

5. ERROR MESSAGES AND TROUBLESHOOTING

5.2 Troubleshooting

Problem Cause and Solution

No power.
No display appears on the
monitor.

Measurement values appear
too high or too low.

Replace all batteries with new ones.
Check the battery installation for proper
placement of the battery polarities.
Refer to section 2.1.

Blood pressure varies constantly. Many factors
including stress, time of day, and how you apply the
arm cuff, may affect your blood pressure.
Review the section 1.3, 2.3 and 4.2.

27

5. ERROR MESSAGES AND TROUBLESHOOTING

®®®

®

Problem Cause and Solution

The blood pressure monitor might not be
properly placed within the smart device's
transmission range and is too far from the smart
device. If there are no causes of data
transmission interference found near the blood
pressure monitor, move the blood pressure
monitor within 16 ft. (5 m) of the smart device
and try again.

The Bluetooth feature of the smart device is
turned off. Turn on the Bluetooth feature of the
smart device and your monitor, and try sending
the data again.

The Bluetooth feature of the blood pressure

Connection failure. /
Data is not being transmitted.

monitor is turned off.
Refer to “To turn “ON” the Bluetooth ” in “4.3
Turning “OFF” Bluetooth®”.

The blood pressure monitor did not pair
successfully to the smart device. Try to pair the
devices again.
Refer to “Pair Your Monitor with a Smart Device”
in section 4.1. Confirm your smart device
compatibility with this monitor at
OmronHealthcare.com

The app on the smart device is not ready. Check
the app then try sending the data again.
Refer to “Pair Your Monitor with a Smart Device”
in section 4.1. If the “Error” symbol still displays
after checking the app, contact customer
service.

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6. MAINTENANCE, STORAGE AND CLEANING

Do not disassemble or attempt to repair the monitor or components.

6.1 Maintenance

To protect your monitor from damage, please follow the directions below:

• Store the monitor and the components in a clean, safe location.

• Do not wash the monitor and any components or immerse them in water.

• Do not use gasoline, thinners or similar solvents to clean the monitor.

• Changes or modification not approved by the manufacturer will void the user
warranty.

6.2 Storage

Do not store the monitor in the following situations:

• If the monitor is wet.

• Locations exposed to extreme temperatures, humidity, direct sunlight, dust

or corrosive vapors such as bleach.

• Locations exposed to vibrations, shocks or where it will be at an angle.

6.3 Cleaning

• Do not use any abrasive or volatile cleaners.

• Use a soft dry cloth, or a soft cloth moistened with neutral soap to clean on

the monitor and the arm cuff, and then wipe it with a dry cloth.

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7. DISPOSAL

Dispose of the monitor and components according to applicable local regulations.
Unlawful disposal may cause environmental pollution.

30

8. SPECIFICATIONS

®

Model
Display OLED display
Cuff pressure range Pressure: 0 to 299 mmHg
Measurement range Pressure: 40 to 260 mmHg

Accuracy Pressure: ±3 mmHg

Inflation Fuzzy-logic controlled by electric pump
Deflation Automatic rapid deflation
Measurement method Oscillometric method
Transmission method
Wireless communication Frequency range : 2.4 GHz (2400 - 2483.5 MHz)

IP classification IP 22
Power source
Battery life Approximately 300 measurements

Durable period (Service life) Monitor : 5 years
Operating conditions 50°F to 104°F (10°C to 40°C) /

Storage / Transport
conditions

Weight Monitor : Approximately 8 1/2 oz. (240 g)

Dimensions Monitor : Approximately 3 1/2" (w) × 4 5/8" (h) × 1" (l)

Arm circumference 9" to 17" (22 to 42 cm)
Contents Monitor, 4 “AAA” batteries, instruction manual, quick start

Applied part Type BF
Protection against electric

shock

BP7000 HEM-7600T-Z

Pulse: 40 to 180 beats / min.

Pulse: ±5% of display reading

Bluetooth

Modulation : GFSK
Effective radiated power : <20 dBm

4 “AAA” batteries 1.5V

(using new alkaline batteries)

15 to 90% RH (non-condensing) / 800 to 1060 hPa

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

guide

Internally powered ME equipment

low energy technology

not including batteries

(85 mm × 120 mm × 20 mm)
(not including the arm cuff)

31

8. SPECIFICATIONS

or

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 clinically investigated according to 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 device is protected against solid foreign objects of 12 mm
diameter and greater such as a finger, and against oblique falling water drops
which may cause issues during a normal operation.

About a wireless communication interference

This Product operates in the unlicensed ISM band at 2.4GHz. In case this
Product is used around the other wireless devices including microwave and
wireless LAN, which operate same frequency band of this Product, there is a
possibility that interference occurs between this Product and such other devices.
If such interference occurs, please stop the operation of other devices or relocate
this Product before using this Product or do not use this Product around the other
wireless devices.

Pictogram on the Product

Types of marks used to indicate the correct positioning of
the artery for the upper arm.

32

9. 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.

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 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).

33

10. LIMITED WARRANTY

Your BP7000 Upper Arm Blood Pressure Monitor, excluding batteries, is warranted
to be free from defects in materials and workmanship appearing within 5 years from
the date of purchase, when used in accordance with the instructions provided with
the monitor. The above warranty extends only to the original retail purchaser, 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 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

34

11. GUIDANCE AND MANUFACTURER’S DECLARATION

OMRON Blood Pressure Monitor (BPM)
Information for accompanying documents in the scope of IEC60601-1-2:2007

Important information regarding Electromagnetic Compatibility (EMC)

With the increased number of electronic devices such as PCs and mobile (cellular) telephones,
medical devices in use may be susceptible to electromagnetic interference from other devices.
Electromagnetic interference may result in incorrect operation of the medical device and create a
potentially unsafe situation. Medical devices should also not interfere with other devices.

In order to regulate the requirements for EMC (Electromagnetic Compatibility) with the aim to prevent
unsafe product situations, the IEC60601-1-2 standard has been implemented. This standard defines
the levels of immunity to electromagnetic interferences as well as maximum levels of electromagnetic
emissions for medical devices.
Medical devices manufactured by OMRON Healthcare conform to this IEC60601-1-2:2007 standard
for both immunity and emissions.
Nevertheless, special precautions need to be observed:

• The use of accessories and cables other than those specified by OMRON, with
the exception of cables sold by OMRON as replacement parts for internal
components, may result in increased emission or decreased immunity of the
device.

• The medical devices should not be used adjacent to or stacked with other
equipment.
In case adjacent or stacked use is necessary, the medical device should be
observed to verify normal operation in the configuration in which it will be used.

• Refer to further guidance below regarding the EMC environment in which the
device should be used.

• The MEDICAL ELECTRICAL EQUIPMENT BPM needs special precautions
regarding EMC and needs to be installed and put into service according to the
EMC information provided in this documentations.

• The Essential Performance of the BPM is to measure a blood pressure and a
pulse rate and using the memory function.

The BPM may be interfered with by other equipment, even if that other equipment complies with
CISPR EMISSION requirements.

35

11. GUIDANCE AND MANUFACTURER’S DECLARATION

Guidance and manufacturer’s declaration - electromagnetic emissions

OMRON battery-operated BPM is intended for use in the electromagnetic environment specified
below. The customer or the user of this OMRON battery-operated BPM should assure that it is used in
such environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions
CISPR 11

RF emissions
CISPR 11

Harmonic
emissions
IEC 61000-3-2

Voltage
fluctuations/
flicker emissions
IEC61000-3-3

Group 1

Class B

Not Applicable.

Not Applicable.

The OMRON battery-operated BPM uses RF energy only for
its internal function. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby
electronic equipment.

The OMRON battery-operated BPM is suitable for use in all
establishments, including domestic establishments and
those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic
purposes.

36

11. GUIDANCE AND MANUFACTURER’S DECLARATION

Guidance and manufacturer’s declaration - electromagnetic immunity

OMRON battery-operated BPM is intended for use in the electromagnetic environment specified
below. The customer or the user of this OMRON battery-operated BPM should assure that it is used in
such environment.

Immunity test IEC 60601 test level Compliance level

Electrostatic
discharge (ESD)
IEC 61000-4-2

Electrical fast
transient/burst
IEC 61000-4-4

Surge
IEC 61000-4-5

Voltage dips, short
interruptions and
voltage variations
on power supply
inputlines
IEC 61000-4-11

Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8

Note: U

T is the A.C. mains voltage prior to application of the test level.

Contact discharge:
±6 kV
Air discharge:
±8 kV

±2 kV for power
supply lines
±1 kV for input/output
lines

±1 kV line(s) to line(s)
±2 kV line(s) to earth

<5 % U

T (>95 % dip in

U

T)

for 0.5 cycle

40 % U

T (60 % dip in

U

T)

for 5 cycles

T (30 % dip in

70 % U

U

T)

for 25 cycles

T (>95 % dip in

<5 % U

U

T)

for 5 sec.

3 A/m 30 A/m

Contact discharge:
±8 kV
Air discharge:
±15 kV

Not Applicable. Not Applicable.

Not Applicable. Not Applicable.

Not Applicable.

Not Applicable.

Not Applicable.

Not Applicable.

Electromagnetic environment -

The relative humidity should be
at least 5 %.

guidance

Not Applicable.

Magnetic fields from common
appliances are not expected to
affect the device.

37

11. GUIDANCE AND MANUFACTURER’S DECLARATION

P

P

Guidance and manufacturer’s declaration - electromagnetic immunity

OMRON battery-operated BPM is intended for use in the electromagnetic environment specified
below. The customer or the user of this OMRON battery-operated BPM should assure that it is used in
such environment.

Immunity test

Conducted RF
IEC 61000-4-6

IEC 60601

test level

3 V rms
150 kHz to
80 MHz

Compliance

level

Not
Applicable.

Electromagnetic environment - guidance

Portable and mobile RF communications equipment
should be used no closer to any part of the OMRON
battery-operated BPM including cables, than the
recommended separation distance calculated from the
equation appropriate to the frequency of the transmitter.

Recommend separation distance

Not Applicable.

Radiated RF
IEC 61000-4-3

Note1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by

3 V/m

absorption and reflection from structures, objects, and people.

10 V/m

d = 0.35

80 MHz to 800 MHz

d = 0.70

800 MHz to 2.5 GHz

where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters as

determined by an electromagnetic site survey,
be less than the compliance level in each frequency

b

range.
Interference may occur in the vicinity of equipment
marked with the following symbol:

38

a

should

11. GUIDANCE AND MANUFACTURER’S DECLARATION

P

P

a

Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones

and land mobile radio, AM and FM radio broadcast, and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters,
an electromagnetic site survey should be considered. If the measured field strength in the location in
which the OMRON battery-operated BPM is used exceeds the applicable RF compliance level
above, the OMRON battery-operated BPM should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the OMRON battery-operated BPM.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 6 V/m.

Recommended separation distance between portable and mobile RF communications

and the OMRON battery-operated BPM

OMRON battery-operated BPM is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of this OMRON battery-operated
BPM can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the OMRON battery-operated
BPM as recommended below, according to the maximum output power of the communications
equipment.

Output Power of Transmitter in

For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by

Watt

0.01 Not Applicable. 0.035 0.070

0.1 Not Applicable. 0.11 0.22

1 Not Applicable. 0.35 0.70

10 Not Applicable. 1.1 2.2

100 Not Applicable. 3.5 7.0

absorption and reflection from structures, objects, and people.

equipment

Separation distance according to frequency of transmitter

150 kHz to 80 MHz

Not Applicable.

in meter

80 MHz to 800 MHz

d = 0.35

800 MHz to 2.5 GHz

d = 0.70

39

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.

Manufactured by: OMRON HEALTHCARE Co., Ltd.

Distributed by: OMRON HEALTHCARE, INC.

© 2021 OMRON HEALTHCARE, INC.

Made in Japan

53, Kunotsubo, Terado-cho, Muko, Kyoto 617-0002 JAPAN

2895 Greenspoint Pkwy. Hoffman Estates, IL 60169 USA
1-800-634-4350
OmronHealthcare.com