Omron M6 Comfort Manual

OMRON HEALTHCARE EUROPE B.V.
Scorpius 33 2132 LR Hoofddorp
The Netherlands
P.O. Box 2050 2130 GL Hoofddorp The Netherlan
ds
Phone: [phone] fax +3
1 (0)23 55 44 701
www.omron.healthcar
e.com
BANKERS BANK OF TOKYO-
MITUSBISHI (HOLLAND) N.V.
ACC. NR. 063.56.15.320 IBAN NL95BOTK0635615320
SWIFT BOTKNL2X
CHAMBER OF COMMERCE
NR. 342.10306
BTW/VAT NR. NL8132.86.281.B01
PM-1826-01-07/2019
New Product Information Sheet
Specifications subject to change
© OMRON HEALTHCARE EUROPE B.V.
Model (code):
M6 Comfort (HEM-7360-E)
X6 Comfort (HEM-7360-EO)
Versions
Remark
Date
1
Logistics and Harmonized
Standards info not
complete;
31.07.2019
2
Full NPIS
Expected date – end
of August

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Intelli Wrap Cuff
The easy way to get accurate results
Product Name: M6 Comfort (HEM-7360-E), X6 Comfort (HEM-7360-EO)
Product Description: Automatic Upper Arm Blood Pressure Monitor
Product Category: Electronic Sphygmomanometers
Logistic information
Features
Packaging content
- Intelli wrap cuff
- Afib indicator function
- Monitor
- Arm Cuff (HEM-FL31)
- Clinically validated in general
populations, and for people who are
pregnant or have diabetes
- 4 “AA” batteries
- Storage Case
- Instruction Manual 1 & 2
- 2 Users, 100 memories, and Guest
Mode
- 3x consecutive measurement
functionality
- Cuff Wrap Guide
- Setup Instructions
Package Amount Approximate weight
Approximate
dimensions
Main Unit 1 460g (w/o batteries) 191 mm (w) x 85
mm (h) x 120 mm (l)
Single Package 1 Xxxg 157 mm x 120 mm x
223 mm
Master Carton 10 Xxxkg 633 mm x 340 mm x
263 mm
EAN code M6 Comfort : 401567211174 5 , X6 Comfort : 401567211215 5
Storage & transport
Temperature: - 20 to +60°C
Humidity: 10% to 90%

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Technical data
Product description
Automatic Upper Arm Blood Pressure Monitor
Product Category
Electronic Sphygmomanometers
Model (code) M6 Comfort (HEM-7360-E)
X6 Comfort (HEM-7360-EO)
Measurement method
Oscillometric method
Display
LCD digital display
Cuff Pressure range
0 to 299 mmHg
Pulse measurement
range
40 - 180 beats/min
Blood pressure
measurement range
SYS 60 to 260 mmHG, DIA: 40 to 215 mmHG.
Accuracy Pressure +- 3mmHg, Pulse +-5% of display
reading
Inflation
Automatic by electric pump
Deflation
Automatic pressure release valve
Operating mode
Continuous operation
IP classification
Monitor: IP 20/ Optional AC adapter: IP21
Rating
DC6 V 4.0 W
Applied part
Type BF (arm cuff)
Power Source 4 "AA" batteries 1.5 V or optional AC adapter
(input AC 100-240 V 50-60 Hz 0.12 -0.065 A)
Battery life Approximately 1000 measurements (using new
alkaline batteries) The number of times may
decrease when using Afib mode because one
Afib indication consists of 3 regular
measurements.
Durable period
(Service life)
Monitor: 5 years / Cuff: 5 years / Optional AC
adapter: 5 years

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Operating conditions +10 to +40 °C / 15 to 90% RH (non-
condensing)/ 800 to 1060 hPA
Storage / Transport
conditions
-20 to +60 °C / 10 to 90% RH (non-
condensing)
Protection against
electric shock
Internally powered ME equipment (when using
only batteries) Class II ME equipment (optional
AC adapter)
Cuff circumference
applicable to the
monitor
220 to 420 mm
Memory
Stores up to 100 readings per user
Warranty
3 years
Weight Monitor: approximately 460 g (not including
batteries) / Arm cuff: approximately 163 g
Dimensions
(approximate value)
Monitor: 191 mm (W)× 85 mm (H)× 120 mm
(L), Arm cuff: 145 mm × 532 mm (air tube: 750
mm)
Contents Monitor, arm cuff (HEM-FL31), 4 “AA” batteries,
Instruction Manual 1 and 2, setup instructions,
storage case.
Optional accessories AC Adapter (HHP-CM01), AC Adapter UK
version (HHP-BFH01), Arm cuff (HEM-FL31).
General description
The device is a digital monitor intended for use in measuring blood
pressure and pulse rate in adult patient population. The device detects
the appearance of irregular heartbeats during measurement and gives a
warning signal with readings. It is mainly designed for general household
use. The device can detect an irregular pulse suggestive of Atrial
Fibrillation (Afib).

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Please note that the device is not intended to diagnose Afib. A diagnosis
of Afib can only be confirmed by an Electrocardiogram (ECG). If the Afib
symbol appears, consult with your physician.
Packaging content
The manufacturer produces M6 Comfort / X6 Comfort with the applicable
accessories included, necessary for the application of its intended
purpose.
1. Monitor
2. Arm cuff (HEM-FL31)
3. 4 “AA” batteries
4. Instruction Manual 1 and 2
5. Setup instructions
6. Storage case
The complete set of the medical device is specified in the Instruction
Manual 1 in the Specifications section.
Purpose
The device is intended for use in measuring blood pressure and pulse
rate in adult patient population. It detects the appearance of irregular
heartbeats during measurement and gives a warning signal with readings.
Application field
It is mainly designed for general household use.
Intended User
This unit is intended to be operated by adults who can understand this
instruction manual.
Before using this device please refer to ‘Important Safety Information”
section of the Instruction Manual 1 and 2.
This device shouldn’t be used by people mentioned in these sections.

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Indications for use
This device is a digital monitor intended for use in measuring blood
pressure and pulse rate in adult patient population.
Features (Particularities)
The M6 Comfort Automatic Upper Arm Blood Pressure Monitor is a
clinically validated device.
Key features:
•Afib indicator function
•Intelli Wrap Cuff
•2 users x 100 memories, + guest mode
•3x consecutive measurement functionality
•CuffWrap Guide
Description of operating principle
The device operates on the oscillometric principle. It detects blood
movement through the brachial artery and converts the movements into
a digital reading.
How to use the device
Follow IM2 for detailed instructions!
Main steps:
1. Prepare for a measurement. 30 mins before it you shouldn’t drink
alcohol, smoke, have a hot shower, consume hot beverages, eat or
exercise. 5 minutes before the measurement relax and rest.
2. Install the batteries.
3. Set the date and time.
4. Apply the arm cuff on the left arm. (On using the right arm instead,
consult Chapter 2.3 of IM1).
5. Sit correctly and place your arm at your heart’s level. Remain still
and don’t talk.
6. Select user ID (1 or 2).
7. Take the measurement by pressing the START/STOP button.
In the Afib mode, your monitor automatically takes 3 consecutive
readings at 30-second intervals and display the average.
8. Check the readings. Consult Section 9 of IM2 on the symbols that
may appear.

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9. After selecting your used ID, you can use the memory functions
(readings stored, average of the latest 2-3 readings, clear memory).
Please, review Instruction Manual 1 and 2 for the full details on the
application of this product.
Materials used in main device
Parts Name
Material
Housing
ABS (acrylonitrile butadiene styrene)
Battery Cover
ABS (acrylonitrile butadiene styrene)
Front Panel
ABS (acrylonitrile butadiene styrene)
Button
ABS (acrylonitrile butadiene styrene)
Package
Coated board
Instruction Manual
Paper
Materials for accessories
Parts name
Material
Cuff
Cloth, fabric
Nylon, PVC (Polyvinyl Chloride)
Air Tube
PVC (Polyvinyl Chloride)
Air plug to device
ABS (acrylonitrile butadiene styrene)
Air plug to cuff
PC (Polycarbonate)
AC
Adapter
DC Cord
PVC (Polyvinyl Chloride)
Print case
PPE (Polyphenylene Ether)

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Title page of Instruction Manuals
IM1:
IM2:

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Unfolded package design of main device and accessories
Main device:

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Accessories: Arm Cuff (HEM-FL31)
AC Adapter (HHP-CM01)

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AC Adapter (HHP-BFH01)
Other optional parts: Protective LCD Cover
(HEM-CACO-734)
List of Harmonized EN Standards
Applicable Directives: Medical Device Directive (MDD) 93/42/EEC
Full list of Harmonized standards will be included in the next revision of
the document.
Cleaning of the device
• Do not use any abrasive or volatile cleaners.

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• Use a soft dry cloth or a soft cloth moistened with mild (neutral)
detergent to clean your monitor and arm cuff, and then wipe them with a
dry cloth.
• Do not wash or immerse your monitor and arm cuff or other
components in water.
• Do not use gasoline, thinners or similar
Maintenance
This device does not require any regular maintenance.
Storage
Keep your monitor in the storage case when not in use.
1. Remove the arm cuff from the monitor.
Caution! To unplug the air plug, pull on the plastic air plug at the base of
the tube, not the tube itself.
2. Gently fold the air tube into the arm cuff. Note: Do not bend or crease
the air tube excessively.
3. Place your monitor and other components in the storage case.
• Store your monitor and other components in a clean, safe location.
Do not store your monitor and other components:
• If your monitor and other components are wet.
• In locations exposed to extreme temperatures, humidity, direct sunlight,
dust or corrosive vapors such as bleach.
• In locations exposed to vibrations or shocks.
Warnings
(Warning indicate a potentially hazardous situation which, if not avoided,
could result in death or serious injury.)
It is important that you read all the warnings and precautions included in
this instruction manual because they are intended to keep you safe,
prevent injury and avoid a situation that could result in damage to the
unit!
• DO NOT use this monitor on infants, toddlers, children or persons who
cannot express themselves.

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• 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 arm or an arm under medical
treatment.
• DO NOT apply the arm cuff on your arm 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.
• To help avoid strangulation, keep the air tube and AC adapter cable
away from infants, toddlers and children.
• This product contains small parts that may cause a choking hazard if
swallowed by infants, toddlers and children.
AC Adapter (optional accessory) Handling and Usage
• DO NOT use the AC adapter if this monitor or the AC adapter cable is
damaged. If this monitor or the cable is damaged, turn off the power and
unplug the AC adapter immediately.
• Plug the AC adapter into the appropriate voltage outlet. DO NOT use in
a multi-outlet plug.
• NEVER plug in or unplug the AC adapter from the electric outlet with
wet hands.
• DO NOT disassemble or attempt to repair the AC adapter.

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Battery Handling and Usage
• Keep batteries out of the reach of infants, toddlers and children.
Cautions
(Cautions indicate a potentially hazardous situation which, if not avoided,
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 your physician if you
experience skin irritation or discomfort.
• Consult with your physician before using this monitor on an arm where
intravascular access or therapy, or an arteriovenous (A-V) shunt, is
present because of temporary interference to blood flow and 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 arm cuff when it is applied on your upper arm.
• Remove the arm 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 emit 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 or on an
aircraft.
• DO NOT drop or subject this monitor to strong shocks or vibrations.

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• DO NOT use this monitor in places with high or low humidity or high or
low temperatures. Refer to section 6.
• During measurement, observe the arm to ensure that the monitor is not
causing prolonged impairment to blood circulation.
• 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 or thick clothing from your arm while taking a
measurement.
• Remain still and DO NOT talk while taking a measurement.
• ONLY use the arm cuff on persons whose arm 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 on operating and storage/transport temperature, refer to
section 6.
• DO NOT use this monitor after the durable period has ended. Refer to
section 6.
• DO NOT crease the arm cuff or the air tube excessively.
• DO NOT fold or kink the air tube while taking a measurement. This may
cause an injury by interrupting blood flow.
• To unplug the air plug, pull on the plastic air plug at the base of the
tube, not the tube itself.
• ONLY use the AC adapter, arm cuff, batteries and accessories specified
for this monitor. Use of unsupported AC adapters, arm cuffs and batteries
may damage and /or may be hazardous to this monitor.

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• ONLY use the approved arm cuff for this monitor. Use of other arm cuffs
may result in incorrect readings.
• Inflating to a higher pressure than necessary may result in bruising of
the arm here the cuff is applied. NOTE: refer to “If your systolic pressure is
more than 210 mmHg” in section 11 of instruction manual 2 for
additional information.
• Read and follow the “Correct Disposal of This Product” in section 7
when disposing of the device and any used accessories or optional parts.
AC Adapter (optional accessory) Handling and Usage
• Fully insert the AC adapter into the outlet.
• When unplugging the AC 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 adapter cable:
Do not damage it. / Do not break it. / Do not tamper with it.
DO NOT pinch it. / Do not forcibly bend or pull it. / Do not twist it.
DO NOT use it if it is gathered in a bundle.
DO NOT place it under heavy objects.
• Wipe any dust off of the AC adapter.
• Unplug the AC adapter when not in use.
• Unplug the AC adapter before cleaning this monitor.
Battery Handling and Usage
• DO NOT insert batteries with their polarities incorrectly aligned.
• ONLY use 4 “AA” alkaline or manganese 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.

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General precautions:
When you take a measurement on the right arm, the air tube should be
at the side of your elbow. Be careful not to rest your arm on the air tube.
• Blood pressure may differ between the right and left arm and may
result in a different measurement value. Always use the same arm for
measurements. If the values between both arms differ substantially, check
with your physician on which arm to use for your measurements.
• 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.
Disposal
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.
Transportation and storage conditions
Do not store the device in the following situations:
• If the device is wet.
• Locations exposed to extreme temperatures, humidity, direct
sunlight, dust or corrosive vapors such as bleach.
• Locations exposed to vibrations, shocks or where it will be at an
angle.
Storage and transportation conditions:
1. Temperature range: -20 to +60°C
2. Humidity range: 10 to 90% RH
Warranty and lifetime
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.

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Warranty
Lifetime (Service Life)
Monitor:
3 years
5 years
Cuff:
1 year
5 year
AC Adapter:
1 year
5 years
Repair
During the period of warranty OMRON will, without charge for labour or
parts, repair or replace the defect product or any defective parts. Repair
or replacement under the warranty does not give rise to any extension or
renewal of the warranty period.
Servicing
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 authorized OMRON dealer or the
OMRON Customer Service at the address given on the packaging or
attached literature.
Should warranty service be required please apply to the dealer whom the
product was purchased from or an authorized OMRON distributor. For
the address refer to the product packaging / literature or to your
specialized retailer. If you have difficulties in finding OMRON customer
services, contact us for information:
www.omron-healthcare.com.
LEGAL MANUFACTURER
OMRON HEALTHCARE Co., Ltd
53, Kunotsubo, Terado-cho, Muko, KYOTO,
617-0002 Japan
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

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EU-REPRESENTATIVE
OMRON HEALTHCARE EUROPE B.V.
Scorpius 33, 2132 LR Hoofddorp,
THE NETHERLANDS