Omron RS3 Intelli IT Bedienungsanleitung

Omron Blutdruckmessgerät RS3 Intelli IT

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Introduction
Important Safety Information
1. Know Your Monitor
2. Preparation
3. Using Your Monitor
4. Other Settings
5. Error Messages and Troubleshooting
6. Maintenance
7. Specifications
8. Limited Warranty
9. Guidance and Manufacturer’s Declaration
Thank you for purchasing the RS3 Intelli IT Automatic Wrist Blood
Pressure Monitor. This blood pressure monitor is to be worn on your
wrist.
This 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 RS3 Intelli IT Automatic 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 OMRON retail outlet or distributor 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
OMRON retail outlet or distributor.
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.
Warning
Indicates a potentially hazardous situation
which, if not avoided, could result in death or
serious injury.
• 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.
Data Transmission
• This product emits radio frequencies (RF) in the 2.4 GHz
band. DO NOT use this product in locations where RF is
restricted, such as on an aircraft or in hospitals. Turn off the
Bluetooth feature in this monitor and remove batteries when
in RF restricted areas.
Battery Handling and Usage
• Keep batteries out of the reach of infants, toddlers or
children.
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.
• Stop using this monitor and consult with your physician if
you experience skin irritation or discomfort.
Automatic Wrist Blood
Pressure Monitor
RS3 Intelli IT (HEM-6161T-E)
Instruction Manual
IM-HEM-6161T-E-EN-01-09/2018
4602352-2A
Table of Contents
Introduction
Important Safety Information
• Consult with your physician before using this monitor on a
wrist where intravascular access or therapy, or an arterio-
venous (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 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 7.
• 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 7.
• 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 7.
Data Transmission
• DO NOT replace batteries while your reading is being
transferred to your smart device. This may result in the
incorrect operation of this monitor and failure to transfer your
blood pressure data.
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.
1.1 Contents
Monitor, 2 “AAA” alkaline batteries, storage case, instruction manual,
setup instructions
1.2 Monitor
a. Wrist cuff
(Wrist circumference 13.5 cm to 21.5 cm)
b. Display
c. Battery compartment
d. [Connection] button
e. [START/STOP] button
1. Know Your Monitor
a
c
b
d
e
1.3 Display and Symbols
2013 ESH/ESC* Guidelines for the management of
arterial hypertension
Definitions of hypertension by office and home blood pressure levels
These ranges are from statistical values for blood pressure.
Warning
• NEVER diagnose or treat yourself based on your readings.
ALWAYS consult with your physician.
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.
ASystolic blood pressure reading
BDiastolic blood pressure reading
C
Cuff wrap guide symbol (OK)
Appears if the wrist cuff is wrapped around the wrist
correctly while taking a measurement. It also
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.
D
Heartbeat symbol
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.
EDeflation symbol
Appears during cuff deflation.
F
Bluetooth ON symbol
Appears when Bluetooth is enabled.
Bluetooth OFF symbol
Appears when Bluetooth is disabled.
G
Sync symbol
Flashes/appears when your data needs to be
transferred because the stored memory is either
almost, or completely full. Once you pair your
monitor with a smart device, transfer your readings
immediately before the monitor deletes the oldest
readings. Up to 30 readings can be stored in the
internal memory.
H
Battery symbol (low)
Flashes when batteries are low.
Battery symbol (depleted)
Appears when batteries are depleted.
I
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. If it continues to appear,
we recommend you to consult with and follow the
directions of your physician.
JPulse display / Memory number
Pulse rate appears after the measurement.
Office Home
Systolic Blood
Pressure ≥ ≥ 140 mmHg 135 mmHg
Diastolic Blood
Pressure ≥ ≥ 90 mmHg 85 mmHg
off
B
A
C
E
D
H
F
G
I
J
Irregular Heartbeat
Normal Heartbeat
Pulse
Blood pressure
Blood pressure
Short Long
Pulse
* European Society of Hypertension (ESH) and European Society
of Cardiology (ESC).
2. Preparation
3. Close the battery cover.
Note
• 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.
• As soon as batteries are correctly installed, “P” flashes on the
display to start pairing. To pair your monitor, refer to section 2.2. If
your monitor has already been paired with your smart device when
batteries are installed, "O" will flash. If it flashes, transfer your
readings.
2.2 Pairing Your Monitor with a Smart Device
Review the list of compatible smart devices at
www.omronconnect.com/devices/
1. Enable Bluetooth on your smart device.
2. Download and install the free “OMRON connect” app
onto your smart device.
If you already have the “OMRON connect” app, open the app
and add your new monitor.
3. Open the app on your smart device and follow the
instructions.
4. Confirm that your monitor is
connected successfully.
When your monitor is connected
successfully to your smart device, the
“OK” symbol appears.
Note
• If the “Err” symbol appears, follow the
instructions in the “OMRON connect”
app.
• Your monitor automatically turns off
after 10 seconds without any
operations.
• Any readings currently saved in the memory of your monitor
are automatically transferred to the app after successful
completion of the pairing process.
• Please be aware that OMRON will not be responsible for the
loss of data and/or information in the app.
• “OMRON connect” is the only app that we recommend to use
with your monitor to transfer data correctly.
2.3 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.
Please use the Blood Pressure Diary to keep records of several
readings over a certain period of time. To download PDF files of
the diary, visit www.omron-healthcare.com.
Caution
• 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.
2.4 Applying the Wrist Cuff
Note
• 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.
Caution
• 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.
1
2
Wrist cuff
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.
Note
• Make sure the wrist cuff does not
cover the protruding part of the wrist
bone on the outside of your wrist.
2.5 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.
3.1 Taking a Measurement
Note
• To stop the measurement, press the [START/STOP] button once
to deflate the wrist cuff.
Caution
• 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.
Note
• 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.
Note
• 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 pre-
measurement form. You may need to increase the wait time
depending on your individual physiological characteristics.
1 to 2 cm
3. Using Your Monitor
3.2 Disabling/Enabling Bluetooth
Disable Bluetooth in your monitor in the following areas where use of
wireless equipment is prohibited.
• On aircraft • In hospitals • While abroad
Bluetooth is enabled as default.
1. When your monitor is off, press and hold the button
for more than 10 seconds.
• “oFF” appears on the display.
• When the Bluetooth is
disabled, the following symbol
appears.
Note
• To enable the Bluetooth, press and hold the button for
more than 2 seconds. “on” appears on the display.
• Your monitor will automatically turn off within 3 seconds after
the completion.
Transferring Data Automatically/Manually
• The readings will be transferred to your smart device within 1 hour
after taking a measurement.
• To transfer the readings manually, press the button.
4.1 Restoring Your Monitor to the Default Settings
To delete all the information stored in your monitor, follow the
instructions below. Make sure that your monitor is turned off.
1. While holding the button down, press and hold the
[START/STOP] button for more than 2 seconds.
The following display flashes.
2. While holding the button down, press and hold the
[START/STOP] button for more than 2 seconds.
Note
• Reverting to its default setting of your monitor does not
delete the information in the app.
• Your monitor will automatically turn off after 3 seconds.
• You will need to re-pair your monitor when using the monitor
again. Without re-pairing, your readings will not be
transferred to your app.
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.
off
4. Other Settings
5. Error Messages and Troubleshooting
Display/
Problem Possible Cause Solution
appears or the
wrist cuff does
not inflate.
The wrist cuff is not
applied correctly.
Apply the wrist cuff
correctly, then take
another measurement.
Refer to section 2.3.
Air is leaking from the
wrist cuff.
Contact your OMRON
retail outlet or
distributor.
appears
The wrist cuff is
overinflated exceeding
300 mmHg.
Do not touch the wrist
cuff while taking a
measurement.
appears
You move or talk during
a measurement.
Vibrations disrupt a
measurement.
Remain still and do not
talk during a
measurement.
appears
The pulse rate is not
detected correctly.
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.
appears
appears
6.1 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.
Caution
• DO NOT disassemble or attempt to repair this monitor or other
components. This may cause an inaccurate reading.
6.2 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.
6.3 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.
6.4 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 the OMRON Customer Service
at the address given on the packaging or attached literature.
appears
The monitor is
malfunctioned.
Press the [START/
STOP] button again. If
“Er” still appears,
contact your OMRON
retail outlet or
distributor.
appears
The monitor cannot
connect to a smart
device or transmit data
correctly.
Follow the instructions
shown in the “OMRON
connect” app. If the
“Err” symbol still
appears after checking
the app, contact your
OMRON retail outlet or
distributor.
flashes
The button is
pressed and held to pair
with a smart device.
Flashes when pairing to
the smart device. Visit
the “Help” section in the
“OMRON connect” app
for pairing.
flashes
The button is
pressed to transfer your
readings.
Flashes when
transferring your
readings to the
“OMRON connect” app.
flashes
More than 24 readings
are not transferred. Pair or transfer your
readings to the
“OMRON connect” app
so you can keep them
in memory in the app,
and this error symbol
disappears.
Your monitor is not
paired or not connected
with your smart device.
appears
30 readings are not
transferred.
flashes
Batteries are low.
Replacing all batteries
with 2 new alkaline
batteries is
recommended. Refer to
section 2.1.
appears or the
monitor is
turned off
unexpectedly
during a
measurement
Batteries are depleted. Immediately replace all
batteries with 2 new
alkaline batteries. Refer
to section 2.1.
No power.
Nothing
appears on the
display of the
monitor.
Batteries are completely
depleted.
Battery polarities are not
properly aligned.
Check the battery
installation for proper
placement. Refer to
section 2.1.
Readings
appear too high
or too low.
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 2.3 - 2.5 and chapter
3.
Any other
problems occur.
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 re-
install batteries.
If the problem still persists, contact your OMRON
retail outlet or distributor.
6. Maintenance
Display/
Problem Possible Cause Solution
Note
• 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 EN ISO 81060-2:2014.
• 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.
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 3 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 difficulties in finding
OMRON customer services, contact us for information.
www.omron-healthcare.com
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.
7. Specifications
Product category Electronic Sphygmomanometers
Product description Automatic Wrist Blood Pressure Monitor
Model (Code) RS3 Intelli IT (HEM-6161T-E)
Display LCD digital display
Cuff pressure range 0 to 299 mmHg
Blood pressure
measurement range
SYS: 60 to 260 mmHg
DIA: 40 to 215 mmHg
Pulse measurement
range 40 to 180 beats / min.
Accuracy Pressure: ±3 mmHg
Pulse: ±5% of display reading
Inflation Automatic by electric pump
Deflation Automatic rapid deflation
Measurement method Oscillometric method
Transmission method Bluetooth® low energy technology
Wireless communication
Frequency range: 2.4 GHz (2400 -
2483.5 MHz)
Modulation: GFSK
Effective radiated power: < 20 dBm
Operation mode Continuous operation
IP classification IP 22
Rating DC3 V 3.0 W
Power source 2 “AAA” alkaline batteries 1.5V
Battery life Approximately 300 measurements (using
new alkaline batteries)
Durable period (Service
life) 5 years
Operating conditions +10°C to +40°C / 15 to 90% RH (non-
condensing) / 800 to 1060 hPa
Storage / Transport
conditions
-20°C to +60°C / 10 to 90% RH (non-
condensing)
Weight Approximately 85 g not including
batteries
Dimensions
Approximately 84 mm (w) × 62 mm (h) ×
21 mm (l)
(not including the wrist cuff)
Measurable wrist
circumference 13.5 to 21.5 cm
Memory Stores up to 30 readings
Contents
Monitor, 2 “AAA” alkaline batteries,
storage case, instruction manual, setup
instructions
Protection against
electric shock Internally powered ME equipment
Applied part Type BF (wrist cuff)
Maximum temperature
of the applied part Lower than +48°C
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.
8. Limited Warranty
• 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.
• Hereby, OMRON HEALTHCARE Co., Ltd., declares that the radio
equipment type HEM-6161T-E 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. The Core component
for OMRON blood pressure monitors, which is the Pressure
Sensor, is produced in Japan.
Important information regarding Electro Magnetic Compatibility
(EMC)
Correct Disposal of This Product (Waste Electrical & Electronic
Equipment)
9. Guidance and Manufacturer’s Declaration
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
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.
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
HEM-6161T-E 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
www.omron-healthcare.com. Refer to the EMC information for HEM-6161T-E on
the website.
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.
IP XX
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.
A
pp Store and the App Store logo are service marks of Apple Inc.,
registered in the U.S and other countries.
iPhone is a trademark of Apple Inc., registered in the U.S. and other
countries.
A
ndroid, Google Play and the Google Play logo are trademarks of
Google LLC.
Made in Vietnam
Manufacturer
53, Kunotsubo, Terado-cho, Muko, KYOTO,
617-0002 JAPAN
EU-representative OMRON HEALTHCARE EUROPE B.V.
OMRON HEALTHCARE Co., Ltd.
OMRON HEALTHCARE UK LTD.
Scorpius 33, 2132 LR Hoofddorp,
THE NETHERLANDS
www.omron-healthcare.com
Production
facility
OMRON HEALTHCARE MANUFACTURING
VIETNAM CO., LTD.
No.28 VSIP II, Street 2, Vietnam-Singapore
Industrial Park II, Binh Duong
Industry-Services-Urban Complex,
Hoa Phu Ward, Thu Dau Mot City,
Binh Duong Province, Vietnam
Subsidiaries
Opal Drive, Fox 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
14, rue de Lisbonne, 93561 Rosny-sous-Bois
Cedex, FRANCE
www.omron-healthcare.com

Produktspezifikationen

Marke: Omron
Kategorie: Blutdruckmessgerät
Modell: RS3 Intelli IT

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