Omron BP7100CAN, 3 Instruction Manual

INSTRUCTION MANUAL

3 Series Upper Arm

Blood Pressure Monitor

Model BP7100CAN

®

ENGLISH

Table of Contents

Introduction ..................................................................................................3

Important Safety Information........................................................................4

1. Know Your Monitor ................................................................................8

2. Preparation ..........................................................................................13

3. Using the Monitor.................................................................................14

4. Error Messages and Troubleshooting..................................................20

5. Maintenance ........................................................................................23

6. Specifications.......................................................................................25

7. FCC/ISED Statement...........................................................................27

8. Limited Warranty..................................................................................28

9. Guidance and Manufacturer’s Declaration...........................................30

2

Introduction

Contraindications

Thank you for purchasing the OMRON BP7100CAN Blood Pressure Monitor. This
blood pressure monitor uses the oscillometric method of blood pressure
measurement. This means this monitor detects your blood movement through your
brachial artery and converts the movements into a digital reading.

Safety Instructions

This instruction manual provides you with important information about the OMRON
BP7100CAN Blood Pressure Monitor. To ensure the safe and proper use of this
monitor, READ and UNDERSTAND all of these instructions. If you do not

understand these instructions or have any questions, contact 1-800-634-4350
before attempting to use this monitor. For specific information about your
own blood pressure, consult with your physician.

Intended Use

This device is a digital monitor intended for use in measuring blood pressure and
pulse rate in adult patient population. 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.ca/symbols-glossary

• This monitor is contraindicated for use in ambulatory environments.

• This monitor is contraindicated for use on aircraft.

3

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

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

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

• DO NOT use this monitor on an injured arm or an arm under medical
treatment.

• DO NOT apply the arm cuff on your arm 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 or in oxygen rich environments. This may result
in incorrect operation of the monitor and/or cause an inaccurate reading.

• DO NOT use this monitor in oxygen rich environments or near flammable
gas.

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

• NEVER diagnose or treat yourself based on your readings. ALWAYS consult
with your physician.

• To help avoid strangulation, keep the air tube away from infants, toddlers
and children.

Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.

4

• This product contains small parts that may cause a choking hazard if
swallowed by infants, toddlers and children.

Battery Handling and Usage

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

Indicates a potentially hazardous situation which, if not

Caution

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

• Consult with your physician before using this monitor on an arm where
intravascular access or therapy, or an arteriovenous (A-V) shunt, is present
because of temporary interference to blood flow which could result in injury.

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

• Consult with your physician before using this monitor if you have severe
blood flow problems or blood disorders as cuff inflation can cause bruising.

• DO NOT take measurements more often than necessary because bruising,
due to blood flow interference, may occur.

• ONLY inflate the arm cuff when it is applied on your upper arm.

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

• DO NOT use this monitor for any purpose other than measuring blood
pressure.

• During measurement, make sure that no mobile device or any other
electrical device that emits electromagnetic fields is within 12 inches (30 cm)
of this monitor. This may result in incorrect operation of the monitor and/or
cause an inaccurate reading.

• DO NOT disassemble or attempt to repair this monitor or other components.
This may cause an inaccurate reading.

• DO NOT use in a location where there is moisture or a risk of water
splashing this monitor. This may damage this monitor.

• 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.

avoided, may result in minor or moderate injury to the user
or patient, or cause damage to the equipment or other
property.

5

• DO NOT use this monitor in places with high or low humidity or high or low
temperatures. Refer to section 5.

• During measurement, observe the arm to ensure that the monitor is not
causing prolonged impairment to blood circulation.

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

• DO NOT use this monitor with other medical electrical (ME) equipment
simultaneously. This may result in incorrect operation of the monitor and/or
cause an inaccurate reading.

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

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

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

• Remain still and DO NOT talk while taking a measurement.

• ONLY use the arm cuff on persons whose arm circumference is within the
specified range of the cuff.

• Ensure that this monitor has acclimated to room temperature before taking a
measurement. Taking a measurement after an extreme temperature change
could lead to an inaccurate reading. OMRON recommends waiting for
approximately 2 hours for the monitor to warm up or cool down when the
monitor is used in an environment within the temperature specified as
operating conditions after it is stored either at the maximum or at the
minimum storage temperature. For additional information on operating and
storage/transport temperature, refer to section 5.

• DO NOT use this monitor after the durable period has ended. Refer to
section 6.

• DO NOT crease the arm cuff or the air tube excessively.

• DO NOT fold or kink the air tube while taking a measurement. This may
cause an injury by interrupting air flow.

• To unplug the air plug, pull on the plastic air plug at the base of the tube, not
the tube itself.

• ONLY use the arm cuff, batteries and accessories specified for this monitor.
Use of unsupported arm cuffs and batteries may damage and/or may be
hazardous to this monitor.

• ONLY use the approved arm cuff for this monitor. Use of other arm cuffs may
result in incorrect readings.

6

• Inflating to a higher pressure than necessary may result in bruising of the
arm where the cuff is applied. NOTE: please refer to “If your systolic
pressure is more than 210 mmHg” in section 3 of this instruction manual for
additional information.

Battery Handling and Usage

• DO NOT insert batteries with their polarities incorrectly aligned.

• ONLY use 4 “AA” alkaline or manganese batteries with this monitor. DO NOT
use other types of batteries. DO NOT use new and used batteries together.
DO NOT use different brands of batteries together.

• Remove batteries if this monitor will not be used for a long period of time.

• If battery fluid should get in your eyes, immediately rinse with plenty of
clean water. Consult with your physician immediately.

• If battery fluid should get on your skin, wash your skin immediately with
plenty of clean, lukewarm water. If irritation, injury or pain persists, consult
with your physician.

• DO NOT use batteries after their expiration date.

• Periodically check batteries to ensure they are in good working condition.

7

1. Know Your Monitor

A

B

C

D

E

F

H

G

Arm cuff

(Arm circumference 9" - 17" (22 - 42 cm))

Air plug
Air tube

F

G

H

Contents:

Monitor, arm cuff, instruction manual, quick start guide

Monitor:

A

D

Display
START/STOP button
Memory button

Arm cuff:

C

B

E

Battery compartment
Air jack

8

1.1 Display and Symbols

J

K

L

I

M

P

O

Q

N

I

Systolic blood pressure reading

J

Diastolic blood pressure reading

K

L

M

Memory symbol

Appears when viewing readings stored in the memory.

Low battery symbol

Flashes when batteries are low.

Depleted battery symbol

Appears when batteries are depleted.

Heartbeat symbol

Flashes while taking a measurement.

9

N

Irregular heartbeat symbol

Appears along with readings when an irregular rhythm is detected
2 or more times during a measurement.

An irregular heartbeat rhythm is defined as a rhythm that is 25%
less or 25% more than the average rhythm detected while your
monitor is measuring blood pressure.

Irregular heartbeat symbol may be displayed when the monitor
detects arm movements. Refer to section 4 for more information.
If it continues to appear, we recommend you to consult with and
follow the directions of your physician.

Irregular Heartbeat

Normal Heartbeat

Movement error symbol

Appears with your reading when your body is moving during a

O

measurement. If it appears, remove the arm cuff and wait for 2 to
3 minutes. Then, reapply the cuff, remain still and take another
measurement.

Pulse display / Memory number

P

Pulse rate appears after the measurement.

Q

Deflation symbol

Appears during cuff deflation.

Short

Long

10

Classification of BP (Blood Pressure)

ACC/AHA 2017 Hypertension guidelines define categories of BP in adults as
below.

Categories of BP in Adults*

BP Category Systolic BP Diastolic BP
Normal < 120 mmHg
Elevated 120-129 mmHg
Hypertension

Stage 1
Stage 2

* 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).

130-139 mmHg

≥ 140 mmHg

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.

and < 80 mmHg
and < 80 mmHg

or 80-89 mmHg
or ≥ 90 mmHg

11

1.2 Blood Pressure Measurement Tips

To help ensure an accurate reading, follow these directions:

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

• Measurements should be taken in a quiet place.

• It is important to take measurements at 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.

• Avoid bathing, drinking alcohol or caffeine, smoking,

Caution

exercising and eating for at least 30 minutes before
taking a measurement.

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

12

2. Preparation

2.1 Battery Installation

1. Remove the battery cover.

2. Insert 4 “AA” batteries as

indicated in the battery
compartment.

3. Replace the battery cover.

Notes:

• When the low battery symbol ( ) appears on the display, turn the monitor
off, then replace all batteries at the same time. Long life alkaline batteries
are recommended.

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

• Disposal of used batteries should be carried out in accordance with local
regulations.

13

3. Using the Monitor

0.5 inch
(1 - 2 cm)

Bottom edge

3.1 Applying the Arm Cuff

Caution

1. Insert the air plug into the air jack

securely.

2. Place your hand through the

cuff loop, then pull the cuff
until it reaches your upper left
arm.

The bottom edge of the arm cuff
should be 0.5 inch (1 to 2 cm) above
the elbow. Air tube is on the inside of
your arm and aligned with your middle
finger.

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

14

3. Secure closed with the

fabric fastener.

Notes:

• When you take a measurement on the right
arm, the air tube will be at the side of your
elbow. Be careful not to rest your arm on the
air tube.

• 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 which arm to use
for your measurements.

15

3.2 How to Sit Correctly

To take a measurement, you need to be
relaxed and comfortably seated with a
comfortable room temperature. Place
your arm on the table.

• Sit in a comfortable chair with your back and
arm supported.

• Keep your feet and your legs uncrossed.

• The arm cuff should be placed on your arm at
the same level as your heart, with the arm
resting comfortably on a table.

16

3.3 Taking a Measurement

START INFLATING COMPLETED

If your systolic pressure is more than 210 mmHg

After the arm cuff starts to inflate, press and hold the START/STOP
button until the monitor inflates 30 to 40 mmHg higher than your
expected systolic pressure.

Notes:

•The monitor will not inflate above 299 mmHg.

Caution

Inflating to a higher pressure than necessary may
result in bruising where the arm cuff is applied.

Notes:

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

• Remain still and quiet while taking a measurement.

1. Press the START/STOP button.

The arm cuff will start to inflate automatically.

17

2. Remove the arm cuff.

3.

Press the START/STOP button to turn the monitor off.

The monitor automatically stores the measurement result in its memory.
It will automatically turn off after 2 minutes.

Note: Wait 2-3 minutes before taking another measurement. Waiting between

measurements allows the arteries to return to the condition prior to
taking a measurement.

3.4 Using the Memory Function

The monitor automatically stores the results up to 14 sets.

Note: If the memory is full, the monitor will delete the oldest value.

To View the Measurement Values Stored in Memory

1. Press the button.

The Memory number appears for a second
before the pulse rate is displayed.

The newest set is numbered “1”.

2. Press the button repeatedly to view the values stored in

memory.

18

To Delete All the Values Stored in Memory

1. Press the button, while the memory symbol appears.

2. While holding the button

down, press the START/STOP
button for more than 3 seconds.

Note: You cannot partially delete the values stored in memory.

19

4. Error Messages and Troubleshooting

If any of the below problems occur during measurement, check to make
sure that no other electrical device is within 12 inches (30 cm).
If the problem persists, refer to the table below.

4.1 Error Messages

Error Display Cause Solution

Remove the arm cuff. Wait 2 - 3

Irregular heartbeats are
detected.

minutes and then take another
measurement. Repeat the steps
in section 3.3. If this error
continues to appear, contact
your physician.

Movement during measurement.

The batteries are low.

The batteries are depleted.

20

Carefully read and repeat the
steps in section 3.3.

You should replace the batteries
with new ones ahead of time.
Refer to section 2.1.

You should replace the batteries
with new ones at once.
Refer to section 2.1.

Air plug disconnected.

Insert the plug securely.
Refer to section 3.1.

Arm cuff is applied too loosely.

Air is leaking from the arm cuff.

Movement during measurement
and the arm cuff has not been
inflated sufficiently.

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

Movement during measurement.

Clothing is interfering with the
arm cuff.

Apply the arm cuff tighter.
Refer to section 3.1.

Replace the arm cuff with a new
one.
Refer to section 5.5.

Repeat measurement. Remain
still and do not talk during
measurement.
Refer to section 3.3.

If “E2” appears repeatedly,
inflate the arm cuff manually
until it is 30 to 40 mmHg above
your previous measurement
result.
Refer to section 3.3.

Do not touch the arm cuff and/or
bend the air tube while taking a
measurement. Do not inflate the
arm cuff more than necessary.
Refer to section 3.3.

Repeat measurement. Remain
still and do not talk during
measurement.
Refer to section 3.3.

Remove any clothing interfering
with the arm cuff.
Refer to section 3.1.

21

Device error. Contact Customer Service.

4.2 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 wrap the cuff, may affect your
blood pressure. Review section 1.2 and
section 3.3.

22

5. Maintenance

5.1 Maintenance

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

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

DO NOT disassemble or attempt to repair this

Caution

5.2 Storage

Store your monitor and other components in a clean, safe location.

1. Remove the arm cuff from the monitor.

Caution

2. Gently fold the air tube into the arm cuff.

Note:

• Do not bend or crease the air tube excessively.

Do not store your monitor and other components:

• If your monitor and other components are wet.

• In locations exposed to extreme temperatures, humidity, direct sunlight, dust

or corrosive vapors such as bleach.

• In locations exposed to vibrations or shocks.

monitor or other components. This may cause an
inaccurate reading.

To unplug the air plug, pull on the plastic air plug at
the base of the tube, not the tube itself.

23

5.3 Cleaning

• Do not use any abrasive or volatile cleaners.

• Use a soft dry cloth or a soft cloth moistened with neutral soap to clean your
monitor and arm cuff, and then wipe them with a dry cloth.

• Do not wash or immerse your monitor and arm cuff or other components in water.

• Do not use gasoline, thinners or similar solvents to clean your monitor and arm
cuff or other components.

5.4 Disposal

• Dispose of your monitor, other components and optional accessories according to
applicable local regulations.

• Unlawful disposal may cause environmental pollution.

5.5 Optional Medical Accessories

Arm circumference
7" - 9" (17 - 22 cm)

CD-CS9

(Model: HEM-CS24)

Arm cuff

24

Arm circumference

9" - 17" (22 - 42 cm)

CD-WR17

(Model: HEM-RML31)

6. Specifications

Model
Display LCD digital display
Cuff pressure range Pressure: 0 to 299 mmHg
Measurement range Pressure: 20 to 280 mmHg

Accuracy Pressure: ±3 mmHg

Inflation Fuzzy-logic controlled by electric pump
Deflation Automatic pressure release valve
Measurement method Oscillometric method
IP classification IP 20
Rating DC6 V 4 W
Power source
Battery life Approximately 1000 measurements (using new alkaline batteries)
Durable period

(Service life)
Operating conditions +50 °F to +104 °F (+10 °C to + 40 °C) / 15 to 90% RH

Storage / Transport
conditions

Weight Monitor : Approximately 8.8 oz. (250 g) not including batteries

Dimensions Monitor : Approximately 4.0" (w) × 3.1" (h) × 5.1" (l)

Cuff circumference
applicable to the
monitor

Memory Up to 14 Readings
Contents
Applied part Type BF (arm cuff)
Protection against

electric shock

BP7100CAN HEM-7121-CA2

Pulse: 40 to 180 beats / min.

Pulse: ± 5% of display reading

4 “AA” batteries 1.5 V

Monitor: 5 years
Cuff: 5 years

(non-condensing) / 800 to 1060 hPa

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

Arm cuff : Approximately 6 oz. (170 g)

Arm cuff : Approximately 5.7" × 23.4" (air tube: 29.5")

7" to 17" (170 to 420 mm) (included arm cuff 9” to 17” (220 to
420 mm))

Monitor, arm cuff, instruction manual, quick start guide

Internally powered ME equipment

(103 mm × 80 mm × 129 mm)

(145 mm × 594 mm (air tube: 750 mm))

25

Notes:

• These specifications are subject to change without notice.

• This monitor complies with the requirements of ISO 81060-2:2013. In the
clinical validation study, K5 was used on 85 subjects for determination of
diastolic blood pressure.

• This monitor has not been validated for use on pregnant patients.

• IP classification is degrees of protection provided by enclosures in
accordance with IEC 60529. This monitor is protected against solid foreign
objects of 12.5 mm diameter and greater such as a finger.

Pictogram on the Product

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

Identifies the type of cuff that is compatible with the blood Pressure
Monitor

26

7. FCC/ISED 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 FCC Rules and Innovation, Science and
Economic Development Canada’s licence-exempt RSS(s). 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 the dealer or an experienced radio/TV technician for help.

27

8. Limited Warranty

Your BP7100CAN Automatic Blood Pressure Monitor, excluding the arm cuff, is
warranted to be free from defects in materials and workmanship appearing within 2
years from the date of purchase, when used in accordance with the instructions
provided with the monitor. The arm cuff is warranted to be free from defects in
materials and workmanship appearing within 1 year from the date of purchase when
the monitor is used in accordance with the instructions provided with the monitor.
The above warranty extends only to the original retail purchaser.
We will, at our option, replace without charge any monitor or arm cuff 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 that
may apply.

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.
SOME STATES DO NOT ALLOW LIMITATIONS ON HOW LONG AN IMPLIED
WARRANTY LASTS, SO THE ABOVE LIMITATION MAY NOT APPLY TO YOU.

28

OMRON SHALL NOT BE LIABLE FOR LOSS OF USE OR ANY OTHER SPECIAL,
INCIDENTAL, CONSEQUENTIAL OR INDIRECT COSTS, EXPENSES OR
DAMAGES.
SOME STATES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF
INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATION
OR EXCLUSION MAY NOT APPLY TO YOU.

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: www.OmronHealthcare.ca
Call toll free: 1-800-634-4350

29

9. 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)

BP7100CAN conforms to IEC60601-1-2:2014 Electromagnetic Compatibility
(EMC) standard.
Further documentation in accordance with this EMC standard is available at
OmronHealthcare.ca/emc. Refer to the EMC information for BP7100CAN on the
website.

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OMRON HEALTHCARE Co., Ltd.
53, Kunotsubo, Terado-cho, Muko, Kyoto, 617-0002 JAPAN

Distributed by:
OMRON HEALTHCARE, INC.
1925 West Field Court, Lake Forest, IL 60045 U.S.A.

OmronHealthcare.ca
© 2019 OMRON HEALTHCARE, INC.

Made in Vietnam 2881878-0A