Wearable Blood Pr essure Monitor
Hear tGuide (HEM-6411T -M AE)
Read the instruction manuals before use.
Important safety information is in Instruction Manual
.
How to set up the wrist monitor is in Instruction Manual
.
IM1-HEM-6411T -MAE-01-06/2019
2893297-3A
Issue Date: 2019-08-08
1. Introduction
Thank you for pur chasing the OMR ON HEM-6411T -MAE Automatic Wrist Blood Pressure
Monitor . This blood pressur e monitor is to be worn on your wrist. This blood pressure
monitor uses the oscillometric method of blood pressure measuremen t. When the band
in ates, the monitor senses the pressur e pulsations of the ar tery underneath the band.
The pulses are called oscillometric pulses. The electronic pressure sensor displays a
digital reading of blood pressur e.
This monitor can also track other measurements .
Activity measurement
This monitor tracks steps and calculates calories burned and distance .
Sleep measurement
This monitor measures hours slept and awake time .
1.1 Safety Instructions
This instruction manual provides you with important information about the OMRON
HEM-6411T -MAE Automatic Wrist Blood Pr essure Monitor . T o ensur e the safe and
proper use of your monitor , READ and UNDERST AND all of the safety and operating
instructions. If you do not understand these instructions or have any questions, con tact
your OMRON retail outlet or distributor befor e attempting to use this monitor . For
speci c information about your own blood pr essure, consult with y our physician.
1.2 Intended Use
The device is a digital monitor intended f or use in measuring blood pressure and pulse
rate in adult patient population with wrist circumf erence ranging from 16 to 19 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 .
1.3 Receiving and Inspection
Remove this monitor from the packaging and inspect for damage. If this monitor is
damaged, DO NOT USE and c onsult with your OMRON retail outlet or distributor .
2. Know Y our Monitor
a
b
c
d
g
f
e
a Display e Charging port
b [ST ART/STOP] button f C u ff
c [FORW ARD] button g Band
d
[HOME] button
Press this button fr om any screen to
go back to HOME screen.
h i j
h Charging clip
j
Cuff sleeve
T o use your monitor comfortably, install the
cu sleeve to the cu of the monitor .
i AC adapter
2018 ESH/ESC
*
Guidelines for the management of arterial hypertension
De nitions of hypertension by o ce and home blood pressure levels
O ffi c e Home
Systolic Blood P ressure ≥ 140 mmHg ≥ 135 mmHg
Diastolic Blood Pressur e ≥ 90 mmHg ≥ 85 mmHg
These ranges are from sta tistical values for blood pressur e.
* European Society of Hypertension (ESH) and European Society of Cardiology (ESC).
Blood pressure level indicat or (color)
When your systolic or diastolic blood pr essure is above the ESC/ESH Guidelines, the
number will be shown in red . Refer to “2018 ESH/ESC Guidelines for the management
of arterial hypertension” for mor e information.
3. Important Safety Information
Read the Impor tant Safety Information in this instruction manual before using this
monitor . Follow this instruction manual thoroughly for y our safety. Keep for future
referenc e. F or speci c information about your own blood pressure, C ONSUL T WITH
Y OUR PHYSICIAN.
3.1 W arning
Indicates a potentially hazardous situation which, if not a voided,
could result in death or serious injury .
• DO NO T use this monitor on infants, toddlers , children or persons who cannot express
themselves.
• DO NOT adjust medica tion based on readings from this blood pressur e monitor . T ake
medication as prescribed by your ph ysician. ONL Y a physician is quali ed to diagnose
and treat high blood pressure .
• DO NO T use this monitor on an injured arm or an arm under medical treatment.
• DO NO T wear this monitor on your wrist while on an intra venous drip or blood
transfusion.
• DO NO T use this monitor in areas containing high fr equency (HF) surgical equipment,
magnetic resonance imaging (MRI) equipment, c omputerized tomograph y (C T )
scanners. This may result in incorrect operation of the monitor and/or cause an
inaccurate reading .
• DO NO T use this monitor in oxygen rich environmen ts or near ammable gas.
• Consult with your ph ysician before using this monitor if you have c ommon
arrhythmias such as atrial or ventricular prematur e beats or atrial brillation; arterial
sclerosis; poor perfusion; diabetes; pregnancy ; preeclampsia or renal disease . NOTE
that any of these conditions in addition to patient motion, tr embling, or shivering may
a ect the blood pressure measurement reading .
• NEVER diagnose or treat y ourself based on your readings. AL W A YS consult with your
physician.
• T o help avoid strangulation, keep the A C adapter cable away from infants, toddlers or
children.
• This product contains small parts that may cause a choking hazard if swallowed b y
infants, toddlers or children.
Data T ransmission
• This product emits radio frequencies (RF) in the 2.4 GHz band. DO NO T use this
product in locations where RF is restricted, such as on an aircraft or in hospitals. T ur n
o the Bluetooth® feature in this monitor , remove batteries and/or unplug the A C
adapter in those areas.
AC A dapter Handling and Usage
• DO NO T use the AC adapter if the monitor or the A C adapter cable is damaged. If this
monitor or the AC adapter cable is damaged, turn o the power and unplug the AC
adapter immediately .
• Plug the AC adapter into the appropriate v oltage outlet. DO NOT use in a multi-outlet plug.
• NEVER plug in or unplug the AC adapter fr om the electric outlet with wet hands.
• DO NO T disassemble or attempt to repair the A C adapter.
• Dry your hands before touching the A C Adapter, the char ging clip and the the device
charging electrodes.
• Keep the AC adapter , the charging clip and the device charging electrodes dry at all times.
Rechargeable Battery Handling and Usage
• The rechargeable battery has been speci cally designed for this monitor . DO NOT use it in
any other devices.
• DO NOT recharge the rechargeable batt ery once it has been removed from this monitor .
• DO NOT dispose of the battery in a re.
• DO NOT crush or puncture the battery because it may cause spontaneous ames.
• DO NOT disassemble or modify the battery.
• DO NOT connect the + and – poles using a piece of metal or other conductive objects.
< HOME screen >
• DO NOT carry it or store it together with item such as necklaces and hair pins.
• DO NOT rechar ge, use, or leav e the batter y in any high temperature en vironment such as
in a location near a re or in direct sunlight. Doing so may cause the battery to overheat,
ignite or rupture.
• DO NOT leave the battery that has been removed within the r each of infants, toddlers,
children or pets. Doing so may result in an injury or an accident. If liquid comes in contact
with the battery, a re or an accident ma y occur .
• This monitor has a built-in rechargeable battery. T o prevent the risk of overheating, re
or explosion, DO NOT thr ow into re, apply heat, puncture or crush, use or leav e in a high
temperature en vironment.
3.2 Caution
Indicates a potentially hazardous situation which, if not a voided, may
result in minor or moderate injury to the user or patient or damage to
the equipment or other property.
• Stop using this monitor and consult with y our physician if you experience skin irritation
or discomfort.
• DO NO T use this device if you have a metal aller gy.
• Keep this monitor clean. If this monitor is causing skin irritation due to sweat or
contamination, stop using it and consult with your dermat ologist.
• Pr olonged rubbing and pressure may irritate the skin. Give your wrist a break by
removing the monitor for a while after extended wear .
• DO NOT let chemical products such as lotions, oils, skin creams or cosmetics collect on the
band. T o avoid damage to the band material, make sure to wipe o an y chemical products
that have collected on the band.
• Consult with your ph ysician before using this monitor on an arm where intravascular
access or therapy , or an ar teriovenous ( A-V ) shunt, is present because of tempor ary
interference to blood ow and could result in injury .
• Consult with your ph ysician before using this monitor if you have had a mast ectomy .
• Consult with your ph ysician before using this monitor if you have sev ere blood ow
problems or blood disorders as cu in ation can cause bruising.
• DO NO T take measurements more often than necessary because bruising, due to
blood ow interference, may occur .
• ONL Y in ate the cu when it is applied on y our wr ist.
• Remove the band if it does not start de ating during a blood pressure measurement.
• During measurement, make sure tha t no mobile device or any other electrical device
that emits electromagnetic elds is within 30 cm of this monitor . This may r esult in
incorrect operation of the monitor and/or cause an inaccurate r eading.
• DO NO T disassemble or attempt to repair this monitor or other c omponents. This may
cause an inaccurate reading .
• DO NO T use in a location where there is moisture or a risk of wa ter splashing this
monitor . This may damage this monit or.
• The monitor and A C adapter are not designed for use in water or wet envir onments.
• DO NO T use this monitor in a moving vehicle such as in a car or on an aircr aft.
• DO NO T 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 tempera tures.
Refer to section 9.
• Ensure this monitor is not impairing blood circulation by observing the arm while
measurement is occurring.
• DO NOT use this monitor in high-use environme nts such as medical clinics or phy sician o c es.
• 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 inac curate reading .
• ONL Y use this monitor on persons whose wrist circumf erence is within the speci ed
range of the cu .
• Ensure that this monitor has ac climated to room temperature before taking a
measurement. T ak ing 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 do wn when the monitor is used in an environment
within the temperature speci ed as operating conditions after it is stor ed either at
the maximum or at the minimum storage temperatur e. F or additional information of
operating and storage/transport temperature , refer to section 9.
• DO NO T use this monitor after the durable period has ended. Refer to section 9.
• DO NO T crease the band excessiv ely.
• DO NO T use the blood pressure measuring function for any other purpose .
• DO NO T use this monitor to diagnose sleep disorders .
• Consult with your physician or healthcar e provider if you begin a weight reduction or
exercise pr ogram.
• Keep the product out of the reach of infants, toddlers and children.
• Av oid bathing, drinking alcohol or ca eine, smoking, exercising and eating for at least
30 minutes before taking a measurement.
• Rest for at least 5 minutes bef ore tak ing a measurement.
• Remove tight - tting, thick clothing and any accessories from y our ar m while taking a
blood pressure measurement.
• Remain still and DO NO T talk while taking a measurement.
AC A dapter Handling and Usage
• DO NO T plug the AC adapter cable into an y device other than this monitor.
• F ully inser t the AC adapter into the outlet.
• When unplugging the A C adapter from the outlet, be sure to safely pull from the AC
adapter . DO NOT pull from the AC adapter cable .
• When handling the AC adapt er cable:
DO NOT damage it. / DO NO T break it. / DO NOT tamper with it. / DO NO T pinch it. /
DO NOT f orcibly bend or pull it. / DO NO T twist it.
DO NOT use it if it is gather ed in a bundle.
DO NOT place it under hea vy objects.
• Wipe an y dust o of the A C adapter.
• Unplug the AC adapt er when not in use.
• Unplug the AC adapt er before cleaning this monitor .
• ONL Y use the AC adapt er speci ed for this monitor . Use of unsupported AC adapters
may damage and/or may be hazardous to this monit or .
Rechargeable Battery Handling and Usage
• DO NO T charge the battery when the AC adapter is wet.
4. T urn Y our Monitor O ff
Press and hold the middle and low er button at the same time for more than 7 seconds
to turn o y our monitor .
THU 17
8
:
38
Continue to the back side
5. Error Messages and T roubleshooting
If any of the below problems occur during measuremen t, check to make sure that no other
electrical device is within 30 cm. If the problem persists, please refer to the table belo w .
Display/
Problem
Cause Solution
•
Irregular heartbeat
detected.
Remove your monitor . Wait for 2 - 3 minutes
and then take another measurement. Repeat
the steps in Instruction Manual
. If this error
continues to appear , we recommend that you
consult with your physician.
•
Y our body
moved during a
measurement.
Carefully read and r epeat the steps in
Instruction Manual
.
•
Y our monitor is
not at the correct
height.
Adjust the height of your wrist follo wing the hear t
zone indicator . Refer to step 8
of Instruction
Manual
.
Due to di erences in individual size and
physique, this f eature may not be helpful in
all cases. If you feel the position of the wrist
does NOT match y our hear t level, turn o this
feature and f ollow your judgment. T o disable
this feature , refer to back side of Instruction
Manual
.
•
The battery is
depleted.
Charge the battery. Ref er to step 2 of
Instruction Manual
.
The monitor cannot
connect to a smart
device or transmit
data correctly .
Follo w the instructions shown in the
“HeartAdvisor ” app . I f it still appears after checking
the app, contact your OMRON r etail outlet or
distributor . Refer to “www.omron-healthcare .com”
for contact information.
•
The band is not
applied correctly .
Apply the band correctly , then take another
measurement. Refer to st ep 7 of Instruction
Manual
.
Air is leaking from
the cu .
Contact your OMRON retail
outlet or distributor . Refer to
“www.omron-healthcare .com” for c ontact
information.
Clothing is
interfering with the
band.
Remove any clothing int erfering with the
band.
•
The band may be
applied too loosely .
Apply the band correctly , then take another
measurement. Refer to st ep 7 of Instruction
Manual
.
•
The cu was in ated
exceeding the
maximum allowable
pressure.
Do not touch your monitor while taking a
measurement.
•
Y ou move or
talk during a
measurement.
Vibrations disrupt a
measurement.
Remain still and do not talk during a
measurement.
•
The band was not
applied correctly or
was moved during a
measurement.
Apply the band correctly , then take another
measurement. Refer to st ep 7 of Instruction
Manual
.
Remain still and sit correctly during a
measurement.
12
:
35
Error 1
Error 2
Error 3
Error 4
Error 5
The detailed user manual for the HeartGuide is now
available on the w eb. Scan the QR code below using
your smartphone or t ype the URL below to acc ess our
web instruction manual.
https://www.omron-healthcar e.com/manuals/heartguide
Instruc tion Manual
Manufacturer
OMRON HEAL THCARE Co ., Ltd.
53, Kunotsubo, T erado-cho, Muko, KY OTO , 617-0002 JAP AN
EU-
representativ e
OMRON HEAL THCARE EUROPE B.V .
Scorpius 33, 2132 LR Hoofddorp, THE NETHERLANDS
www.omron-healthcare .com
Importer in EU
Production facility OMRON HEAL THCARE Co., Lt d.
Matsusaka F actory
1855-370, Kubo-cho, Matsusaka-shi, Mie, 515-8503 Japan
Subsidiaries OMRON HEAL THCARE UK L TD.
Opal Drive, F ox Milne, Milton Keynes,
MK15 0DG, UK
www.omron-healthcare .com
OMRON MEDIZINTECHNIK HANDELSGESELLSCHAFT mbH
Konrad-Zuse-Ring 28, 68163 Mannheim, GERMANY
www.omron-healthcare .com
OMRON SANTÉ FRANCE SAS
3, Parvis de la Gare, 94130 Nogent-sur-Marne, FRANCE
www.omron-healthcare .com
Made in Japan
①EN ②FR ③DE ④IT ⑤ES
⑥NL
19G1627