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  9. Omron M2 Compact User manual

Omron M2 Compact User manual

PM-2044-01-08/2021
New Product Information Sheet
Specifications subject to change
© OMRON HEALTHCARE EUROPE B.V.
Model (code):
M2 (HEM-7143-E)
Versions
Remark
Date
1
1st version, without key
market visual
31/08/2021
2
PM-2044-01-08/2021
M2
Accurate measurements in one touch
Product Name
M2 (HEM-7143-E)
Product Description
Automatic Upper Arm Blood Pressure Monitor
Product Category
Electronic Sphygmomanometers
Features
•Intellisense
•Irregular heartbeat detection
•Hypertension indicator
•Body movement detection
•Cuff wrap guide
•30 memories capacity
•Clinically Validated
Packaging contents
•
Monitor
•Arm cuff (HEM-CR24)
•4 “AA” batteries
•Storage case
•
Instruction Manual 1 and 2
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General description
M2 Automatic Upper Arm Blood Pressure Monitor uses the oscillometric
method of blood pressure measurement. This means this monitor detects
your blood movement through your brachial artery and converts the
movements into a digital reading.
Intended use
This device is a digital monitor intended for use in measuring blood
pressure and pulse rate in adult patient population. This monitor detects
the appearance of irregular heartbeats during measurement and
indicates this via a symbol with readings. It is mainly designed for general
household use.
Application field /Environment
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. This device
shouldn’t be used by people mentioned in these sections.
Indications for use
This device is a digital monitor intended for use in measuring blood
pressure and pulse rate in adult patient population.
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.
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How to use the device?
Please refer to the IM1 and IM2 for full details on the application of this
product.
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. Apply the arm cuff on the left arm. (On using the right arm instead,
consult “General Precaution” chapter in IM1).
4. Sit correctly and place your arm at your heart’s level. Remain still
and don’t talk.
5. Take a measurement by pressing the START/STOP button.
6. Check the readings. Consult Section 1 of IM1 on the symbols that
may appear.
Cleaning of the device
•Do not use any abrasive or volatile cleaners.
•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 solvents to clean your
monitor and arm cuff or other components.
Maintenance
To protect your monitor from damage, follow the directions below:
•Changes or modifications not approved by the manufacturer will
void the user warranty.
•DO NOT disassemble or attempt to repair this monitor or other
components. This may cause an inaccurate reading.
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Transportation and storage conditions
•Keep your monitor in the storage case when not in use.
•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.
•Storage and transportation
-Temperature range: -20°C to +60°C
-Humidity range: 15% to 90%RH
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.
•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.
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•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.
Battery Handling and Usage
•Keep batteries out of the reach of infants, toddlers and children.
•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.
•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.
7
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•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.
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.
8
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•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.
•DO NOT use this monitor in places with high or low humidity or
high or low temperatures. Refer to specification chapter in IM1.
•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
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.
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•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 specification chapter in IM1.
•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.
•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 where the cuff is applied. NOTE: refer to “If your systolic
pressure is more than 210 mmHg” in section 6 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:
10
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•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.
Disposal procedure
•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.
•Disposal of used batteries should be carried out in accordance with
local regulations.
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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.
Warranty
Lifetime (Service Life)
Monitor:
3 years
5 years
Cuff:
1 year
5 years
Repair
During the period of warranty OMRON will, without charge for labor 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.
12
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Technical data
Product description Automatic Upper Arm Blood Pressure
Monitor
Product Category
Electronic Sphygmomanometers
Model (code)
M2 (HEM-7143-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 ± 3mmHg, Pulse ±5% of display
reading
Inflation
Automatic by electric pump
Operating mode
Continuous operation
IP classification Monitor: IP20 / Optional AC adapter: IP21
(HHP-CM01) or IP22 (HHP-BFH01)
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 900 measurements (using
new alkaline batteries and included arm
cuff. Depending on the type of battery
and arm cuff.)
Durable period (Service
Monitor: 5 years / Cuff: 5 years / Optional
13
PM-2044-01-08/2021
life)
AC adapter: 5 years
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)
Cuff circumference
applicable to the monitor
17 to 42 cm (included arm cuff: (22 to 32
cm)
Memory
Store up to 30 readings
Weight Monitor: approximately 250 g (not
including batteries) / Arm cuff:
approximately 110 g
Dimensions (approximate
value)
Monitor: 103 mm (W)× 82 mm (H)× 140
mm (L), Arm cuff: 146 mm × 466 mm (air
tube: 610 mm)
Contents Monitor, Arm cuff (HEM-CR24), 4 “AA”
batteries, Storage case, Instruction
Manual 1 and 2
Protection against electric
shock
Internally powered ME equipment (when
using only batteries) Class II ME
equipment (optional AC adapter)
Overview of Accessories
Included Accessory
Product Description
Model
CM2 Medium Cuff
HEM-CR24
Optional Accessories
Product Description
Model
AC Adapter
HHP-CM01 or HHP-BFH01
Easy Cuff
HEM-RML31
14
PM-2044-01-08/2021
CS2 Small Cuff
HEM-CS24
Materials used in main device
Parts name
Material
Housing
HIPS WT (High Impact Polystyrene White)
Battery Cover
HIPS WT (High Impact Polystyrene White)
Front Panel
T0.188 PET
Cuff
Cotton, Polyester
Package
Coated board E/F
Instruction Manual
Wood free paper
Materials for (optional) accessories
Parts name
Material
Cuff
Cloth, fabric
Cotton or 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)
Package specifications/ Logistic information
Package Amount Approximate
weight
Approximate
dimensions
(w*d*h)
Main Unit 1 250 g 103 mm x 140
mm x 82 mm
Sales Package 1 635 g 125 mm x 118
mm x 165 mm
Master Carton 10 7.2 kg 623 mm x 276
mm x 208 mm
15
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Title pages of Instruction Manual
UDI-DI/EAN code
4015672113060
Minimum order
quantity
10
HS/CN custom
commodity code
9018901000
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17
PM-2044-01-08/2021
Unfolded package design of main device and accessories
Main device:
18
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Included Accessory
19
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Optional Accesories
20
PM-2044-01-08/2021

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