Omron M6 Comfort Handbuch

OMRON HEALTHCARE EUROPE B.V.

Scorpius 33 2132 LR Hoofddorp

The Netherlands

P.O. Box 2050 2130 GL Hoofddorp The Netherlan

Phone: +31 (0)23 55 44 700 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

Model (code):

M6 Comfort (HEM-7360-E)

X6 Comfort (HEM-7360-EO)

Versions

Remark

Date

Logistics and Harmonized

Standards info not

complete;

31.07.2019

Full NPIS

Expected date – end

of August

PM-1826-01-07/2019

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%

PM-1826-01-07/2019

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

PM-1826-01-07/2019

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).

PM-1826-01-07/2019

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.

PM-1826-01-07/2019

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.

PM-1826-01-07/2019

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)

Adapter

DC Cord

PVC (Polyvinyl Chloride)

Print case

PPE (Polyphenylene Ether)

PM-1826-01-07/2019

Title page of Instruction Manuals

IM1:

IM2:

PM-1826-01-07/2019

Unfolded package design of main device and accessories

Main device:

Andere Handbücher für M6 Comfort

Dieses Handbuch passt für folgende Modelle

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