Display/
Problem
Cause Solution
•
Y our wrist is moved
up and down during
a measurement.
T ake another measurement making sure not to
move your wrist.
•
T emperature error is
detected.
Wait f or few minutes, then take another
measurement in a place with moderate r oom
temperature . If the error appears again, contact
your OMRON retail outlet or distributor . Refer
to “ www.omron-healthcar e.com” for contact
information.
The monitor has
malfunctioned.
•
The band may be
applied too tightly .
Apply the band correctly , then take another
measurement. Refer to st ep 7 of Instruction
Manual
.
•
Room temperature
is too high to charge
the battery.
Charge the battery at a moderate room
temperature .
The monitor has
malfunctioned.
If the error appears in moderate temperatur e,
contact your OMRON retail outlet or distributor .
Refer to “w ww.omr on-healthcare.com” for
contact information.
Error
xxx
The monitor has
malfunctioned.
T urn o your monitor, then turn on y our
monitor again. T o tur n o your monitor , refer
to section 4.
If the error still appears, contact your
OMRON retail outlet or distributor . Refer to
“www.omron-healthcare .com” for contact
information.
If 3 digit number
is displayed.
(“xxx” is 3 digit
number .)
The monitor
cannot be
operated.
Nothing appears on the display of
the monitor .
Charge the battery. Ref er to step 2 of Instruc tion
Manual
.
Y our monitor is turned o. Ref er to step 3 of
Instruction Manual
to turn on your monitor .
Readings appear too high or too
l ow.
Blood pressure varies constantly . Many factors
including stress, time of day , and/or how
you apply the band, may a ec t your blood
pressure.
Any other communication issue
occurs.
Follo w the instructions shown in the smart device,
or visit the “Help ” sec tion in the “Hear tAdvisor”
app for further help. If the problem still persists,
contact your OMRON retail outlet or distributor .
Refer to “w ww.omr on-healthcare.com” for contact
information.
The monitor or the AC adapter is
abnormally hot when charging the
battery.
The monitor or the AC adapter ma y be damaged.
Unplug the AC adapter from the outlet immedia tely
and contact your OMRON retail outlet or
distributor . Refer to “www.omron-healthcare .com”
for contact information.
The operating time is short, or the
monitor does not operate, ev en
when the battery is fully charged.
This may be due to the life of the r echargeable
battery. The battery cannot be replaced. Contact
your OMRON retail outlet
or dispose of your
monitor .
Refer to “w ww .omron-healthcare.c om”
for contact information.
6. Useful F unc tions
The HeartGuide has some useful functions other than tak ing blood pressure/activity/
sleep measurements. These functions can be set using “HeartAdvisor ” app. Ref er to the
app for more detail about these functions.
6.1 Receiving Notication from Y our Smar t Device
Y our monitor receives a notication (phone call , message and email) from your smar t device.
When your monitor rec eives a notication, your monitor vibr ates.
Press an y button to close the notication.
6.2 Receiving a Reminder
The reminder function will alert you at a specic time of day with vibration and the
“Reminder” icon on the display.
6.3 Recording an Ev ent
Y ou can record the time of y our action or activity as an “Event” , such as time you ate ,
took a medicine, ex ercised or had another event.
Press and hold the button (
)
for more than 3 seconds , then “ check” mark appears.
7. Limited W arranty
Thank you for buying an OMRON pr oduct. T his product is constructed of high quality
materials and great car e has been taken in its manufacturing. It is designed to give you
every satisfaction, provided that it is properly operated and maintained as described in
the instruction manual.
This product is warranted by OMRON f or a period of 2 years after the date of purchase.
The proper construction, workmanship and materials of this product is warranted by
OMRON. During this period of warranty OMRON will, without charge for labour or parts,
repair or replace the def ect product or any defective parts. The warranty does not cover
any of the following:
A. T ransport costs and risks of transport.
B. Costs for repairs and / or defects resulting from repairs done by unauthorised persons .
C. Periodic check-ups and maint enance.
D. F ailure or wear of optional parts or other attachments other than the main device itself, unless
explicitly warranted above .
E. Costs arising due to non-acceptance of a claim (those will be charged f or).
F . Damages of any k ind including personal caused accidentally or from misuse .
G. Calibration service is not included within the warranty.
Should warranty service be required please apply to the dealer whom the product was
purchased from or an authorised OMRON distributor . For the address r efer to the product
packaging / literature or to your specialised r etailer . If you have diculties in nding
OMRON customer services, contact us for information: www.omr on-healthcare.com
Error 7
Error 8
Error 9
Error
Repair or replacement under the warranty does not give rise to an y ex tension or renewal
of the warranty period. The warranty will be granted only if the complete product is
returned together with the original inv oice / cash ticket issued to the consumer by
the retailer .
8. Maintenance
8.1 Maintenance
Changes or modications not approved b y the manufacturer will void the user warranty .
Caution
DO NOT disassemble or attempt t o repair this monitor or other components.
8.2 How to Replace the C u Sleeve
Replace the cu sleeve when it becomes dirty. It is recommended to r eplace the cu
sleeve after six months of use.
See illustration below to detach the cu sleeve and install another cu sleev e. Refer to
foreside of Instruction Manual
.
8.3 Storage
• Store y our monitor in a clean, safe location.
• Do not store y our 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.
8.4 Cleaning
Clean the cu sleeve when it becomes dirty (once -a-week cleaning is rec ommended).
• Do not use any abrasiv e or volatile cleaners.
• Use a soft dry cloth or a soft cloth moistened with neutral (mild) detergent to clean
your monitor and wrist cu , and then wipe them with a dr y cloth.
• Do not wash or immerse your monitor and wrist cu in wat er.
• Do not use gasoline, thinners or similar solven ts to clean your monitor and wrist cu .
• Do not use a wet cloth on the plugs of the A C adapter , the AC adapter cable, or the
terminal of the charging clip .
• Hand-wash with neutral (mild) deter gent and air- dry the cu sleeve. Do not soak it in
water for long periods of time. Do not use an y sterilization chemicals, disinfectants, or
softeners.
Caution
• Stop using this monitor and c onsult with your physician if y ou experience skin
irritation or discomfort.
• Pr olonged rubbing and pressure may irritate the skin. Give your wrist a break by
removing your monitor f or a while af ter extended wear .
• Be careful not to let chemical pr oducts such as lotions, oils, skin creams or cosmetics
collect on the band. If this happens, wipe them immediately , other wise it may impact
the material and lifetime of product.
8.5 Calibration and Service
• The accuracy of this blood pressure monit or has been carefully tested and is designed
to last for the full service life.
• The maintenanc e is limited to replacement of cu sleev e.
9. Specications
Product description Wear able Blood Pressur e Monitor
Model (code) HeartGuide (HEM-6411T-MAE)
Product Category Electronic Sphygmomanometers
Display T ransec tive memory-in-pixel L CD
Memory Blood pressure measurement: Up t o 100 times
Activity measurement: Up to 7 days
Sleep measurement: Up to 7 times
Event: Up to 100 items
T ransmission
method
Bluetooth® Low Energy
Wireless
communication
Fr equency range: 2.4 GHz (2400 - 2483.5 MHz)
Modulation: GFSK
Eective radiated pow er : <20 dBm
Operation mode Continuous operation
IP classication Monitor: IP22 / AC adapter: IP22
Rating DC 3.8 V 3.0 W
Pow er source Built in Lithium ion polymer rechargeable battery (3.8 V;
Approximat ely 164mAh)
AC adapter (INPUT A C100-240V , 50-60H z 0.12-0.065A)
Battery lifespan Will last for appr oximately 500 cycles, 8 times/da y
measurements in normal temperatures of 25 °C when new
battery fully charged.
Battery Life Up to 2 days (48 hours) batt er y life* per charge.
* Refer to “Battery Life Information” for the terms of the battery life.
Durable period
(Service life)
Monitor: 2 years / AC adapter: 2 years / Cu sleev e: 0.5 years
Operating
conditions
+5 to +40 °C / 15 to 90 % RH (non-condensing) /
800to1060hPa
Charging / data
transmission
conditions
+10 to +35 °C / 15 to 90 % RH (non-condensing) /
800to1060hPa
Storage conditions -20 to +40 °C / 10 to 90 % RH (non-condensing)
T ranspor t
conditions
-20 to +60 °C / 10 to 90 % RH (non-condensing)
Weigh t Approximat ely 115 g
Dimensions Case diameter: Approximat ely 48 mm
Case thickness: Approximately 14 mm
Band width: Approximat ely 30 mm
Measurable wrist
circumferenc e
160 to 190 mm
Contents Monitor , charging clip (HEM-CLIP-01), AC adapter (HHP-CH03),
2 replacement cu sleeves (HEM-CUCV-01), Instruction Manual
and
Applied part T ype BF (cu )
Protection against
electric shock
Internally powered ME equipment
Maximum
temperature of the
applied part
Lower than +48 °C
Battery Life Information
The battery life is based on 2 days (48 hours) with the follo wing use: in 23°C
environment, 170 mm wrist cir cumference , 8 times of blood pressure measurement
(inates to 150 mmHg) per day , 16-hour step counting per day , 8-hour sleep
measurement per day , 96 times of button pressing per day , 16 times of incoming call
per day , 1 time of ringing alarm per day, 16-hour Bluetooth communication per da y.
The battery life depends on the terms of use and the environment of st orage.
Blood pressure measuremen t
Cu pressure r ange 0 to 299 mmHg
Blood pressure
measurement range
SYS: 60 to 230 mmHg
DIA: 40 to 160 mmHg
Pulse measurement
range
40 to 180 beats / min.
Accuracy Pressure: ±3 mmHg / P ulse: ±5 % of display reading
Ination Automatic by electric pump
Deation Automatic rapid deation
Measurement
method
Oscillometric method
Activity / Sleep measurement
Measurement range Steps: 0 to 99,999 steps
Distance: 0.0 to 999.9 km / 0.0 to 621.3 mile
Time: 0:00 to 23:59
Calories burned: 0 to 59,999 kcal
Setting range Time: 0:00 t o 23:59
Weigh t: 9.97 to 136.08kg (in increments of 0.01kg) /
22 to 300lb (in increments of 1lb)
Height: 100.00 to 199.00cm (in increments of 0.01cm) /
3'4
"
to 6'6
"
(in increments of 1inch)
Stride length: 30.00 to 121.92cm (in increments of 0.01cm) /
12
"
to 48
"
(in increments of 1inch)
Note
• These specications are subject to change without notice .
• This monitor is clinically in vestigated according to the requirements of
ISO81060-2:2013. In the clinical validation study, K5 w as used on 85 subjects for
determination of diastolic blood pressure .
• This monitor has not been valida ted for use on pregnan t patients.
• IP classication is degrees of pr otec tion provided by enclosur es in accordance with
IEC 60529. This monitor and AC adapter pr otec ted against solid for eign objects of
12.5mm diameter and great er such as a nger , and against oblique falling water drops
which may cause issues during a normal operation.
• Rating indication is printed on the cu .
• Make sure not to place y our monitor in a location where it is dicult to plug and
unplug the AC adapter .
About a wireless communication in terference
This product operates in an unlicensed ISM band at 2.4GHz. In the event this P roduct
is used near other wireless devices such as microw ave and wireless LAN, which opera te
on the same frequency band as this Product, there is a possibility that interference may
occur . If inter ference occurs , stop the operation of the other devices or relocate this
Product away fr om other wireless devices before attempting to use it.
10. Correct Disposal of This Product ( W aste Electrical &
Electronic Equipment)
This marking shown on the product or its literature, indicat es that it should
not be disposed of, with other household w astes at the end of its working life.
T o prevent possible harm to the en vironment or human health from uncon trolled
waste disposal, please separate this pr oduc t from other types of wastes and
recycle it responsibly to promote the sustainable r euse of material resources.
Household users should contact either the retailer where they purchased this
product, or their local government oce, f or details of where and how they
can return this item for en vironmentally safe r ecycling.
Business users should contact their supplier and check the terms and conditions of the pur-
chase contract. This product should not be mixed with other commercial waste for disposal .
T o dispose this monitor , refer to www.omron-healthcar e.com.
11. Impor tant Informa tion regarding Elec tromagnetic
Compa tibilit y (EMC)
This device is manufactured by OMRON HEAL THCARE Co., Ltd. and c onforms to the
EN60601-1-2:2015 Electromagnetic Compatibility (EMC) standard.
Further documentation in accor dance with this EMC standard is available at
OMRON HEAL THCARE EUROPE at the address mentioned in this instruction manual
or at: www.omron-healthcar e.com.
12. Guidance and Manufacturer’ s Declaration
• This blood pressur e monitor is designed according t o the European Standard
EN1060, Non-invasive sph ygmomanometers P ar t 1: General Requirements and Part3:
Supplementary requirements for electromechanical blood pressure measuring syst ems.
• Hereby , OMRON HEAL THCARE Co., Lt d., declares that the radio equipments type
HEM-6411T -MAE is in compliance with Directive 2014/53/EU.
• The full text of the EU declaration of conf ormit y is available at the follo wing internet
address:
www.omron-healthcare .com
• This OMRON product is produced under the strict quality system of
OMRONHEAL THCARECo., L td., Japan.
• Please report to the manufacturer and the competent authority of the Member State
in which you are established about any serious incident that has oc cur red in relation
to this device.
13. Optional Acc essories
Medical Accessory Other Accessories
Cu Sleeve
HEM-CUCV-01
AC Adapt er
HHP-CH03 (for Europe)
Charging Clip
HEM-CLIP-01
HHP-BFH03 (for UK)
14. Symbols Description
Applied part - T ype BF Degree
of protection against electric
shock (leakage current)
Class II equipment. Prot ection
against electric shock
Ingress protection degree
provided by IEC60529
CE marking
Serial number Medical device
Direct current Alternating current
Indication of connector
polarity
T emperature limitation
Humidity limitation Atmospheric pressure
limitation
The correct positioning for
the band on the wrist
Necessity for the user to
consult this instruction
manual
The correct positioning for
the monitor on the wrist
Date of manufacture
T o indicate generally elevated ,
potentially hazardous, lev els
of non-ionizing radiation,
or to indicate equipment
or systems. e.g . in the
medical electrical area that
include RF transmitters or
that intentionally apply RF
electromagnetic energy for
diagnosis or treatment.
Eciency level of power
supply
Prohibited action
For indoor use only
The Bluetooth® word mark and logos ar e registered tr ademar ks owned by the
Bluetooth SIG, Inc. and any use of such marks by OMRON HEAL THCARE Co., Ltd. is under
license. Other trademarks and trade names are those of their respective owners .
App Store and App Stor e logo are ser vice marks of Apple Inc., register ed in the U.S and
other countries.
Google Play and Google Play logo are trademarks of Google LL C.
https://ww w .omron-healthcare.com/