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: