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Omron HeartGuide - HEM-6411T-MAE Manual

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Problem
Cause Solution
•
Your wrist is moved
up and down during
a measurement.
Take another measurement making sure not to
move your wrist.
•
Temperature error is
detected.
Wait for few minutes, then take another
measurement in a place with moderate room
temperature. If the error appears again, contact
your OMRON retail outlet or distributor. Refer
to “www.omron-healthcare.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 step 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 temperature,
contact your OMRON retail outlet or distributor.
Refer to “www.omron-healthcare.com” for
contact information.
Error
xxx
The monitor has
malfunctioned.
Turn o your monitor, then turn on your
monitor again. To turn 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. Refer to step 2 of Instruction
Manual
.
Your monitor is turned o. Refer to step 3 of
Instruction Manual
to turn on your monitor.
Readings appear too high or too
low.
Blood pressure varies constantly. Many factors
including stress, time of day, and/or how
you apply the band, may aect your blood
pressure.
Any other communication issue
occurs.
Follow the instructions shown in the smart device,
or visit the “Help” section in the “HeartAdvisor”
app for further help. If the problem still persists,
contact your OMRON retail outlet or distributor.
Refer to “www.omron-healthcare.com” for contact
information.
The monitor or the AC adapter is
abnormally hot when charging the
battery.
The monitor or the AC adapter may be damaged.
Unplug the AC adapter from the outlet immediately
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, even
when the battery is fully charged.
This may be due to the life of the rechargeable
battery. The battery cannot be replaced. Contact
your OMRON retail outlet
or dispose of your
monitor.
Refer to “www.omron-healthcare.com”
for contact information.
6. Useful Functions
The HeartGuide has some useful functions other than taking blood pressure/activity/
sleep measurements. These functions can be set using “HeartAdvisor” app. Refer to the
app for more detail about these functions.
6.1 Receiving Notication from Your Smart Device
Your monitor receives a notication (phone call, message and email) from your smart device.
When your monitor receives a notication, your monitor vibrates.
Press any button to close the notication.
6.2 Receiving a Reminder
The reminder function will alert you at a specic time of day with vibration and the
“Reminder” icon on the display.
6.3 Recording an Event
You can record the time of your action or activity as an “Event”, such as time you ate,
took a medicine, exercised or had another event.
Press and hold the button (
)
for more than 3 seconds, then “check” mark appears.
7. Limited Warranty
Thank you for buying an OMRON product. This product is constructed of high quality
materials and great care 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 for 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 defect product or any defective parts. The warranty does not cover
any of the following:
A. Transport costs and risks of transport.
B. Costs for repairs and / or defects resulting from repairs done by unauthorised persons.
C. Periodic check-ups and maintenance.
D. Failure 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 for).
F. Damages of any kind 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 refer to the product
packaging / literature or to your specialised retailer. If you have diculties in nding
OMRON customer services, contact us for information: www.omron-healthcare.com
Error 7
Error 8
Error 9
Error
Repair or replacement under the warranty does not give rise to any extension or renewal
of the warranty period. The warranty will be granted only if the complete product is
returned together with the original invoice / cash ticket issued to the consumer by
the retailer.
8. Maintenance
8.1 Maintenance
Changes or modications not approved by the manufacturer will void the user warranty.
Caution
DO NOT disassemble or attempt to repair this monitor or other components.
8.2 How to Replace the Cu Sleeve
Replace the cu sleeve when it becomes dirty. It is recommended to replace the cu
sleeve after six months of use.
See illustration below to detach the cu sleeve and install another cu sleeve. Refer to
foreside of Instruction Manual
.
8.3 Storage
• 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.
8.4 Cleaning
Clean the cu sleeve when it becomes dirty (once-a-week cleaning is recommended).
• Do not use any abrasive 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 dry cloth.
• Do not wash or immerse your monitor and wrist cu in water.
• Do not use gasoline, thinners or similar solvents to clean your monitor and wrist cu.
• Do not use a wet cloth on the plugs of the AC adapter, the AC adapter cable, or the
terminal of the charging clip.
• Hand-wash with neutral (mild) detergent and air-dry the cu sleeve. Do not soak it in
water for long periods of time. Do not use any sterilization chemicals, disinfectants, or
softeners.
Caution
• Stop using this monitor and consult with your physician if you experience skin
irritation or discomfort.
• Prolonged rubbing and pressure may irritate the skin. Give your wrist a break by
removing your monitor for a while after extended wear.
• Be careful not to let chemical products such as lotions, oils, skin creams or cosmetics
collect on the band. If this happens, wipe them immediately, otherwise it may impact
the material and lifetime of product.
8.5 Calibration and Service
• The accuracy of this blood pressure monitor has been carefully tested and is designed
to last for the full service life.
• The maintenance is limited to replacement of cu sleeve.
9. Specications
Product description Wearable Blood Pressure Monitor
Model (code) HeartGuide (HEM-6411T-MAE)
Product Category Electronic Sphygmomanometers
Display Transective memory-in-pixel LCD
Memory Blood pressure measurement: Up to 100 times
Activity measurement: Up to 7 days
Sleep measurement: Up to 7 times
Event: Up to 100 items
Transmission
method
Bluetooth® Low Energy
Wireless
communication
Frequency range: 2.4 GHz (2400 - 2483.5 MHz)
Modulation: GFSK
Eective radiated power: <20 dBm
Operation mode Continuous operation
IP classication Monitor: IP22 / AC adapter: IP22
Rating DC 3.8 V 3.0 W
Power source Built in Lithium ion polymer rechargeable battery (3.8V;
Approximately 164mAh)
AC adapter (INPUT AC100-240V, 50-60Hz 0.12-0.065A)
Battery lifespan Will last for approximately 500 cycles, 8 times/day
measurements in normal temperatures of 25 °C when new
battery fully charged.
Battery Life Up to 2 days (48 hours) battery 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 sleeve: 0.5 years
Operating
conditions
+5 to +40 °C / 15 to 90 % RH (non-condensing) /
800to1060hPa
Charging / data
transmission
conditions
+10 to +35 °C / 15 to 90 % RH (non-condensing) /
800to1060hPa
Storage conditions -20 to +40 °C / 10 to 90 % RH (non-condensing)
Transport
conditions
-20 to +60 °C / 10 to 90 % RH (non-condensing)
Weight Approximately 115 g
Dimensions Case diameter: Approximately 48 mm
Case thickness: Approximately 14 mm
Band width: Approximately 30 mm
Measurable wrist
circumference
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 Type 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 following use: in 23°C
environment, 170 mm wrist circumference, 8 times of blood pressure measurement
(inates 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 day.
The battery life depends on the terms of use and the environment of storage.
Blood pressure measurement
Cu pressure range 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 / Pulse: ±5 % of display reading
Ination Automatic by electric pump
Deation Automatic rapid deation
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 to 23:59
Weight: 9.97 to 136.08kg (in increments of 0.01kg) /
22 to 300lb (in increments of 1lb)
Height: 100.00 to 199.00cm (in increments of 0.01cm) /
3'4
"
to 6'6
"
(in increments of 1inch)
Stride length: 30.00 to 121.92cm (in increments of 0.01cm) /
12
"
to 48
"
(in increments of 1inch)
Note
• These specications are subject to change without notice.
• This monitor is clinically investigated according to 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 classication is degrees of protection provided by enclosures in accordance with
IEC 60529. This monitor and AC adapter protected against solid foreign objects of
12.5mm diameter and greater 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 your monitor in a location where it is dicult to plug and
unplug the AC adapter.
About a wireless communication interference
This product operates in an unlicensed ISM band at 2.4GHz. In the event this Product
is used near other wireless devices such as microwave and wireless LAN, which operate
on the same frequency band as this Product, there is a possibility that interference may
occur. If interference occurs, stop the operation of the other devices or relocate this
Product away from other wireless devices before attempting to use it.
10. 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 oce, 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 pur-
chase contract. This product should not be mixed with other commercial waste for disposal.
To dispose this monitor, refer to www.omron-healthcare.com.
11. Important Information regarding Electromagnetic
Compatibility (EMC)
This device is manufactured by OMRON HEALTHCARE Co., Ltd. and conforms to the
EN60601-1-2:2015 Electromagnetic Compatibility (EMC) standard.
Further documentation in accordance with this EMC standard is available at
OMRON HEALTHCARE EUROPE at the address mentioned in this instruction manual
or at: www.omron-healthcare.com.
12. Guidance and Manufacturer’s Declaration
• 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.
• Hereby, OMRON HEALTHCARE Co., Ltd., 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 conformity is available at the following internet
address:
www.omron-healthcare.com
• This OMRON product is produced under the strict quality system of
OMRONHEALTHCARECo., Ltd., 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 occurred in relation
to this device.
13. Optional Accessories
Medical Accessory Other Accessories
Cu Sleeve
HEM-CUCV-01
AC Adapter
HHP-CH03 (for Europe)
Charging Clip
HEM-CLIP-01
HHP-BFH03 (for UK)
14. Symbols Description
Applied part - Type BF Degree
of protection against electric
shock (leakage current)
Class II equipment. Protection
against electric shock
Ingress protection degree
provided by IEC60529
CE marking
Serial number Medical device
Direct current Alternating current
Indication of connector
polarity
Temperature 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
To indicate generally elevated,
potentially hazardous, levels
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.
Eciency level of power
supply
Prohibited action
For indoor use only
The Bluetooth® word mark and logos are registered trademarks owned by the
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.
App Store and App Store logo are service marks of Apple Inc., registered in the U.S and
other countries.
Google Play and Google Play logo are trademarks of Google LLC.
https://www.omron-healthcare.com/
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