Omron HEM-6161-D User Manual

Warning

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

Caution

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

Wrist Blood Pressure

a

c

b

d

e

B

A

D

C

G

E

F

H

I

Warning

Note

Irregular Heartbeat

Normal Heartbeat

Pulse

Blood pressure

Blood pressure

Short

Long

Pulse

1

2

Caution

Note

Caution

Note

Wrist cuff

1 to 2 cm

Monitor

HEM-6161

Instruction Manual

2829548-5B

Table of Contents

Introduction
Important Safety Information

1. Know Your Monitor

2. Preparation

3. Using Your Monitor

4. Using Memory Function

5. Other Settings

6. Error Messages and Troubleshooting

7. Maintenance

8. Specifications

9. Guidance and Manufacturer’s Declaration

Introduction

Thank you for purchasing the OMRON HEM-6161 Wrist Blood
Pressure Monitor. This blood pressure monitor is to be worn on your
wrist.
This new blood pressure monitor uses the oscillometric method of
blood pressure measurement. When the cuff inflates, this monitor
senses the pressure pulsations of the artery underneath the cuff.
The pulses are called oscillometric pulses. The electronic pressure
sensor displays a digital reading of blood pressure.

Safety Instructions

This instruction manual provides you with important information
about the OMRON HEM-6161 Wrist Blood Pressure Monitor. To
ensure the safe and proper use of this monitor, READ and
UNDERSTAND all of the safety and operating instructions. If you do
not understand these instructions or have any questions, contact
your local OMRON representative 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 with wrist
circumference ranging from 13.5 cm to 21.5 cm. This monitor
detects the appearance of irregular heartbeats during measurement
and gives a warning signal with readings. It is mainly designed for
general household use.

Receiving and Inspection

Remove this monitor from the packaging and inspect for damage. If
this monitor is damaged, DO NOT USE and consult with your local
OMRON representative.

Important Safety Information

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

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

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

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

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

• DO NOT apply the wrist cuff on your wrist while on an
intravenous drip or blood transfusion.

• DO NOT use this monitor in areas containing high frequency
(HF) surgical equipment, magnetic resonance imaging (MRI)
equipment, computerized tomography (CT) scanners. This
may result in incorrect operation of the monitor and/or cause
an inaccurate reading.

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

• Consult with your physician before using this monitor if you
have common arrhythmias such as atrial or ventricular
premature beats or atrial fibrillation; arterial sclerosis; poor
perfusion; diabetes; pregnancy; 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.

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

Battery Handling and Usage

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

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

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

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

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

• During measurement, make sure that no mobile device or any
other electrical device that emits electromagnetic fields is
within 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.

• DO NOT use this monitor in places with high or low humidity
or high or low temperatures. Refer to chapter 8.

• Ensure this monitor is not impairing blood circulation by
observing the wrist while 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
measurement.

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

• Remove tight-fitting, thick clothing and any accessories from
your wrist while taking a measurement.

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

• ONLY use this monitor on persons whose wrist
circumference is within the specified range of the cuff.

• Ensure that this monitor has acclimated to room temperature
before taking a measurement. Taking a measurement after an
extreme temperature change could lead to an inaccurate
reading. OMRON recommends waiting for approximately 2
hours for the monitor to warm up or cool down when the
monitor is used in an environment within the temperature
specified as operating conditions after it is stored either at
the maximum or at the minimum storage temperature. For
additional information of operating and storage/transport
temperature, refer to chapter 8.

• DO NOT crease the wrist cuff excessively.

• Read and follow the “Correct Disposal of This Product” in
chapter 9 when disposing of the device and any used
accessories or optional parts.

• DO NOT use this monitor after the durable period has ended.
Refer to chapter 8.

Battery Handling and Usage

• DO NOT insert batteries with their polarities incorrectly
aligned.

• ONLY use 2 “AAA” alkaline batteries with this monitor. DO
NOT use other types of batteries. DO NOT use new and used
batteries together. DO NOT use different brands of batteries
together.

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

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

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

• DO NOT use batteries after their expiration date.

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

• ONLY use batteries specified for this monitor. Use of
unsupported batteries may damage and/or may be hazardous
to this monitor.

1. Know Your Monitor

1.1 Contents

Monitor, 2 “AAA” alkaline batteries, storage case, instruction manual

1.2 Monitor

a. Wrist cuff

(Wrist circumference 13.5 cm to 21.5 cm)
b. Display
c. Battery compartment
d. [Memory] button
e. [START/STOP] button

1.3 Display and Symbols

A

Systolic blood pressure reading

B

Diastolic blood pressure reading

Heartbeat symbol

C

Flashes while taking a measurement.
Appears if your systolic blood pressure is 135
mmHg or above and/or the diastolic blood pressure
is 85 mmHg or above.

Cuff wrap guide symbol (OK)

Appears if the wrist cuff is wrapped around the wrist
correctly while taking a measurement. It also

D

appears when viewing past readings.

Cuff wrap guide symbol (loose)

Appears if the wrist cuff is not wrapped around the
wrist correctly while taking a measurement. It also
appears when viewing past readings.

Memory symbol

E

Appears when viewing readings stored in the
memory.

Irregular heartbeat symbol

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

F

measurement.
An irregular
heartbeat rhythm
is defined as a
rhythm that is 25% less or 25% more than the
average rhythm detected while your monitor is
measuring blood pressure. If it continues to appear,
we recommend you to consult with and follow the
directions of your physician.

Battery symbol (low)

flashes

G

Flashes when batteries are low.

Battery symbol (depleted)

appears

H

Appears when batteries are depleted.

Deflation symbol

Appears during cuff deflation.

Pulse display / Memory number

Pulse rate appears after the measurement.

I

When pressing the button, the memory number appears
for approximately one second before the pulse rate appears on
the display.

2013 ESH/ESC* Guidelines for the management of
arterial hypertension

Definitions of hypertension by office and home blood pressure levels

Office Home

Systolic Blood

Pressure

Diastolic Blood

Pressure

These ranges are from statistical values for blood pressure.

* European Society of Hypertension (ESH) and European Society

of Cardiology (ESC).

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

≥ 140 mmHg ≥ 135 mmHg

≥ 90 mmHg ≥ 85 mmHg

2. Preparation

2.1 Installing Batteries

1. Push down the hook of the battery

cover and pull downward.

2. Insert 2 “AAA” alkaline batteries as

indicated in the battery compartment.

3. Close the battery cover.

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

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

2.3 Applying the Wrist Cuff

• Following steps are for applying the wrist cuff to your left wrist.
When you take a measurement on your right wrist, apply the wrist
cuff using the same steps as on your left wrist.

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

• Remove tight-fitting, thick clothing and any accessories from your
wrist while taking a measurement.

1. Apply the wrist cuff to your left

wrist.

Roll up sleeve. Make sure your
sleeve is not rolled up too tightly on
your arm. This may constrict the flow
of blood in your arm.

2. Put your wrist through the cuff loop.

Your palm and monitor display should both
face upward.

3. Position the wrist cuff leaving a

clearance of 1 to 2 cm between
the cuff and the bottom of your
palm.

4. Wrap the wrist cuff firmly around

your wrist. Do not apply over
clothing.

Check to make sure that there is no gap
between your wrist and the cuff.

• Make sure the wrist cuff does not
cover the protruding part of the wrist
bone on the outside of your wrist.

2.4 Sitting Correctly

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

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

• Sit with your back and arm
being supported.

• Your monitor must be
approximately the same level
as your heart. 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.

• Relax your wrist and hand. Do not bend your wrist back, clench
your fist, or bend your wrist forward.

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

• Consult with your physician before using this monitor on a
wrist where intravascular access or therapy, or an 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.

• When the “ ” symbol flashes on the display, it is recommended
you replace batteries.

• To replace batteries, turn your monitor off and remove all batteries.
Then replace with 2 new alkaline batteries at the same time.

• Replacing batteries will not delete previous readings.

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

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

Note

Caution

Note

Note

Note

Note

3. Using Your Monitor

START

INFLATING COMPLETED

Caution

Note

IP XX

Made in Vietnam

Manufacturer

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

EU-representative OMRON HEALTHCARE EUROPE B.V.

OMRON HEALTHCARE Co., Ltd.

Scorpius 33, 2132 LR Hoofddorp,
THE NETHERLANDS
www.omron-healthcare.com

www.omron-healthcare.com

Asia Pacific HQ OMRON HEALTHCARE SINGAPORE PTE

LTD.

438A Alexandra Road, #05-05/08
Alexandra Technopark, Singapore 119967
www.omronhealthcare-ap.com

Production
Facility

OMRON HEALTHCARE
MANUFACTURING VIETNAM CO., LTD.

Binh Duong Province, Vietnam

3.1 Taking a Measurement

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

• 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 measurement.

1. Press the [START/STOP] button.

All symbols appear on the display before starting the
measurement.

2. 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. This monitor detects your blood pressure
and pulse rate during inflation.

The “ ” symbol flashes at every heartbeat.

• The “ ” symbol appears if the wrist cuff is wrapped
around the wrist correctly.

• When the “ ” symbol is displayed, the wrist cuff is not
applied correctly. Press the [START/STOP] button to turn
your monitor off, then apply the cuff correctly.

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

section 1.3), the “ ” symbol appears.

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

• Your monitor will automatically turn off after 2 minutes.

• Wait 2-3 minutes between measurements. The wait time
allows the arteries to decompress and return to their pre­measurement form. You may need to increase the wait time
depending on your individual physiological characteristics.

4. Using Memory Function

Your monitor automatically stores up to 30 readings.

4.1 Viewing the Readings Stored in Memory

1. Press the button.

The Memory number appears for one second before the pulse
rate is displayed. The most recent reading set is numbered “1”.

• If there are no readings stored in the
memory, the screen to the right is displayed.

• If the reading is high (refer to section 1.3),

the “ ” symbol appears.

• If the memory is full, the monitor will delete the oldest
readings.

2. Press the button repeatedly to scroll through the

previous readings stored in the memory.

5. Other Settings

5.1 Deleting All Readings Stored in Memory

1. Press the button, then the “ ” symbol appears.

2. While holding the button down, press and hold the

[START/STOP] button for more than 2 seconds.

• All readings will be deleted. You cannot partially delete the
readings stored in the memory.

6. Error Messages and Troubleshooting

In case of any of the below problems occur during measurement,
first check that no other electrical device is within 30cm. If the
problem persists, please refer to the table below.

Display/
Problem

appears or the
wrist cuff does

not inflate.

appears

appears

appears

appears

appears

appears

flashes

appears or the

monitor is
turned off

unexpectedly

during a

measurement

No power.
Nothing
appears on the
display of the
monitor.

Readings
appear too high
or too low.

Any other
problems occur.

Possible Cause Solution

The wrist cuff is not
applied correctly.

Air is leaking from the
wrist cuff.

The wrist cuff is
overinflated exceeding
300 mmHg.

You move or talk during
a measurement.
Vibrations disrupt a
measurement.

The pulse rate is not
detected correctly.

The monitor is
malfunctioned.

Batteries are low.

Batteries are depleted.

Batteries are completely
depleted.

Battery polarities are not
properly aligned.

Blood pressure varies constantly. Many factors
including stress, time of day, and/or how you
apply the wrist cuff, may affect your blood
pressure. Review sections 2.2 - 2.4 and chapter

3.

Press the [START/STOP] button to turn the
monitor off, then press it again to take a
measurement. If the problem continues, remove
all batteries and wait for 30 seconds. Then re­install batteries.
If the problem still persists, contact local OMRON
representative.

Apply the wrist cuff
correctly, then take
another measurement.
Refer to section 2.3.

Contact local OMRON
representative.

Do not touch the wrist
cuff while taking a
measurement.

Remain still and do not
talk during a
measurement.

Apply the wrist cuff
correctly, then take
another measurement.
Refer to section 2.3.
Remain still and sit
correctly during a
measurement.

If the “ ” symbol
continues to appear, we
recommend you to
consult with your
physician.

Press the [START/
STOP] button again. If
“Er” still appears,
contact local OMRON
representative.

Replacing all batteries
with 2 new alkaline
batteries is
recommended. Refer to
section 2.1.

Immediately replace all
batteries with 2 new
alkaline batteries. Refer
to section 2.1.

Check the battery
installation for proper
placement. Refer to
section 2.1.

7. Maintenance

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

7.2 Storage

Keep your monitor in the storage case when not in use.

• 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.

7.3 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 wrist cuff, and then wipe them with a dry
cloth.

• Do not wash or immerse your monitor and wrist cuff in water.

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

7.4 Calibration and Service

• The accuracy of this blood pressure monitor has been carefully
tested and is designed for a long service life.

• It is generally recommended to have the unit inspected every two
years to ensure correct functioning and accuracy. Please consult
your authorised OMRON dealer or local OMRON representative at
the address given on the packaging or attached literature.

8. Specifications

Product description Wrist Blood Pressure Monitor

Model HEM-6161

Display LCD digital display

Cuff pressure range 0 to 299 mmHg

Blood pressure
measurement range

Pulse measurement
range

Accuracy

Inflation Automatic by electric pump

Deflation Automatic rapid deflation

Measurement method Oscillometric method

Operation mode Continuous operation

IP classification IP 22

Rating DC3 V 3.0 W

Power source 2 “AAA” alkaline batteries 1.5V

Battery life

Durable period (Service
life)

Operating conditions

Storage / Transport
conditions

Weight

Dimensions

Measurable wrist
circumference

Memory Stores up to 30 readings

Contents

Protection against
electric shock

Cuff Material Nylon and polyester

Applied part Type BF (wrist cuff)

Maximum temperature
of the applied part

• 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.

• 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, and against oblique falling water drops which may cause
issues during a normal operation.

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

SYS: 60 to 260 mmHg
DIA: 40 to 215 mmHg

40 to 180 beats / min.

Pressure: ±3 mmHg
Pulse: ±5% of display reading

Approximately 300 measurements (using
new alkaline batteries)

5 years

+10°C to +40°C / 15 to 90% RH (non­condensing) / 800 to 1060 hPa

-20°C to +60°C / 10 to 90% RH (non­condensing)

Approximately 85 g not including
batteries

Approximately 84 mm (w) × 62 mm (h) ×
21 mm (l)
(not including the wrist cuff)

13.5 to 21.5 cm

Monitor, storage case, 2 “AAA” alkaline
batteries, instruction manual

Internally powered ME equipment

Lower than +48°C

9. Guidance and Manufacturer’s Declaration

• This device fulfils the provisions of EC directive 93/42/EEC
(Medical Device Directive).

• This blood pressure monitor is designed according to the
European Standard EN1060, Non-invasive sphygmomanometers
Part 1: General Requirements and Part 3: Supplementary
requirements for electromechanical blood pressure measuring
systems.

• This OMRON product is produced under the strict quality system
of OMRON HEALTHCARE Co., Ltd., Japan. The Core component
for OMRON blood pressure monitors, which is the Pressure
Sensor, is produced in Japan.

Symbols description

Applied part - Type BF
Degree of protection against electric
shock (leakage current)

Ingress protection degree provided by
IEC 60529

CE Marking

Serial number

Temperature limitation

Humidity limitation

Atmospheric pressure limitation

Need for the user to consult this
instruction manual.

Indicates the correct positioning for the
monitor on the wrist
Measurable wrist circumference

Battery

Direct current

Important information regarding Electro Magnetic Compatibility
(EMC)

HEM-6161 manufactured by OMRON HEALTHCARE Co., Ltd. conforms to
EN60601-1-2:2015 Electro Magnetic Compatibility (EMC) standard.
Further documentation in accordance with this EMC standard is available at
http://www.omronhealthcare-ap.com/emc-information. Refer to the EMC
information for HEM-6161 on the website.

Correct Disposal of This Product (Waste Electrical & Electronic
Equipment)

This marking shown on the product or its literature, indicates that it
should not be disposed of, with other household wastes at the end
of its working life.
To prevent possible harm to the environment or human health from
uncontrolled waste disposal, please separate this product from
other types of wastes and recycle it responsibly to promote the
sustainable reuse of material resources.

Household users should contact either the retailer where they purchased this
product, or their local government office, for details of where and how they can
return this item for environmentally safe recycling.
Business users should contact their supplier and check the terms and conditions of
the purchase contract. This product should not be mixed with other commercial
waste for disposal.