Omron M6W Information Sheet

-NEW PRODUCT INFORMATION SHEETS-

Specifications subject to change

© OMRON HEALTHCARE EUROPE B.V.

Sales Name: M6W

Item Number: HEM-7213-E(V)

Table of Contents

Part

General Information

Sales name and Item number of product 1
Model/Category of the product 1
Legal Manufacturer, production Facilities 1
Photo of Product 1

Packaging Content 1
List of Harmonized EN standards` 2
Intended Use 3
Particularity’s (design, specifications, functional peculiarities) 4
Package design – unfolded 5
Instruction Manual – front page 6
Basic Technical Specifications (same as IM) 7
Comparative table – similarities 8
List of used materials 9
Maintenance and Storage 10
Optional Accessories 11

GP-HEM-7213-E(V)-01-11/2011

TOC

General Information:

Sales Name M6W
Item number HEM-7213-E(V)
Model Category Blood Pressure Monitor
Legal Manufacturer

Production Facilities

Photo of Product

Packaging Content Main unit, wide range cuff (22-42 cm), instruction manual,

storage case, battery set, guarantee card, blood pressure
pass, quick guide

EAN Code

4015672106000

Packaging Information:

Carton Qty Approx

Weight
Main unit without
batteries
Sales Package 1 1150 g 175 x 115 x 221
Master Carton 10 13.15 Kg 612 x 375 x 262

1 380 g 123 x 158 x 85

Approx dimensions
W x D x H mm

GP-HEM-7213-E(V)-01-11/2011

Part 1

List of Harmonized EN Standards

Directives

General applicable directives: Medical Device Directive (MDD) 93/42/EEC

Standards:

EN 980: 2008
EN 1041: 2008
EN 1060-1:1995+A2:2009
EN 1060-3:1997+A2:2009
EN ISO 10993-1: 2009
EN ISO 10993-5: 2009
EN ISO 10993-10: 2009
EN ISO 14971: 2009

EN 60601-1:1990+A1:1993+A2:1995

EN 60601-1-2: 2007
EN 60601-1-4:1996+A1:1999
EN 62304:2006
EN 62366:2008

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Part 2

Intended Use

Medical Purpose
This product is intended for use to measure and/or monitor patients to
record their blood pressure levels.

Intended User

• Legally certified medical experts, such as doctor, nurse and therapist,
or healthcare personnel or patient under the guidance of qualified
medical experts.

• The user should also be capable of understanding general operation of
this device and the content of instruction manual.

Intended Patients
This product should not be used by patients, who are unconscious or are
not breathing spontaneously, unattended children or persons who cannot
express their intent.

Environment
This product is intended for use in a medical facility, clinic and doctor’s
office, and in a room of general household.

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Part 3

Particularities

M6W (HEM-7213-E(V)) is an automatic blood pressure monitor that has

the unique selling points as noted:

 Two users with memory
 100 memories with date and time for each user (A and B)
 Optimal speed and pressure for gentle inflation/deflation
 Measurement quality confirmation by Dual Sensor
 Irregular heartbeat detection
 Wide range cuff – 22 – 42 cm
 Correct cuff wrapping guide
 Blood pressure level indicator bar
 Movement error symbol

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Part 4

Packaging Information:

Package Design

Carton QTY Approx. Weight Approx. Dimensions

Single unit

Master carton

1

10

340 g

9.5 Kg

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Part 5

(W) x (D) x (H)

123 x 141 x 85

587 x 292 x 216

Instruction Manual Design

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Part 6

Technical Specifications

Product Description Automatic Blood Pressure Monitor
Model OMRON M6W (HEM-7213-E(V))

Display LCD Digital Display
Measurement Method Oscillometric method
Languages EN, DE, FR, IT, ES, NL, RU, AR
Measurement Range Pressure: 0mmHg to 299mmHg

Pulse: 40 to 180/min.
Memory 100 measurements with date and time for each user (A and B)
Accuracy Pressure: ±3 mmHg

Pulse: ±5% of display reading
Inflation Fuzzy-logic co nt rolled by electric pump
Deflation Automatic pressure release valve
Rating DC6V 4W
Power Source
Battery life Capacity of new alkaline batteries is approximately 1000 measurements
Applied Part

Protecti on Against Electric
Shock

4 “AA” batteries 1.5V or optional AC Adapter (6V = 4W)

= Type B

Internally powered ME equipment (When using only the batteries)

= Class II ME equipment (Optional AC adapter)
Operating temperature /
Humidity
Storage Temperature /
humidity
Console Weight
Cuff Weight
Outer dimensions Approximately 123 (w) mm x 85 (h) mm x 158 (l) mm
Cuff dimensions Approximately 151 mm x 635 mm

Cuff material Nylon and polyester
Package Content Main unit, cuff, instruction manual, storage case, battery set, guarantee card,

EAN code 4015672106000
Note: Subject to technical modification without prior notice.

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, Noninvasive
sphygmomanometers Part 1: General Requirements and Part 3: Supplementary
requirements for electromechanical blood pressure measuring systems.

• This OMRON product is produced under the strict quality system of OMRON HEALTHCA RE
Co. Ltd., Japan. The Core component for OMRON blood pressure monitors, which is the
Pressure Sensor, is produced in Japan.

+10C to +40C
Maximum: 30% to 85% RH

-20C to +60C
Maximum: 10% to 95% RH / 700-1060hPa
Approximately 380g without batteries
Approximately 170g

(Cuff: arm circumference 22 to 42 cm)

blood pressure pass, quick guide

GP-HEM-7200-E2(V)-01-10/2011

Part 7

Comparison Table

New model Predecessor

Model M3W (HEM 7213-E(V)) M6 (HEM 7211-E / E8)
Measurement

Method
Measurement

range
Memory

Accuracy
Inflation Fuzzy-logic controlled by electric pump Same as new model

Deflation Automatic pressure release valve Same as new model
Power source 4 “AA” batteries 1.5V or AC/DC adapter Same as new model

Oscillometric Same as new model
Pressure: 0mmHg to 299mmHg

Pulse: 40 to 180/min.
100 measurements

with date and time for each user (A and B)
Pressure: ±3mmHg

Pulse: ±5% of display reading

Same as new model
90 measurements

with date and time for one user
Same as new model

Protection
Against Electric
Shock

Operating
temperature/
Humidity
Storage
temperature/
humidity

Internally powered ME equipment
(When using only the batteries)

= Class II ME equipment

(Optional AC adapter)
+10C to +40C

Maximum: 30% to 85% RH

-20C to +60C
Maximum: 10% to 95% RH / 700-1060hPa

Same as new model

Same as new model

Same as new model

Conclusion of Comparison

The new model is a substantial equivalent of both of its predecessor in terms of Technology,
Functionality, Safety, Reliability, Performance and general application.

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Part 8

List of Materials (Main unit)

Item Material Grade

Front Housing
Ground Housing
Battery Cover
Start Button
Memory Button
Clock Button
Arrow Button
Slide Button

Acrylonitrile butadiene

styrene

Acrylonitrile butadiene

styrene

Acrylonitrile butadiene

styrene

Acrylonitrile butadiene

styrene

Acrylonitrile butadiene

styrene

Acrylonitrile butadiene

styrene

Acrylonitrile butadiene

styrene

Acrylonitrile butadiene

styrene

Front Panel Polycarbonate
Air Connector Cap

Acrylonitrile butadiene

styrene

UMG EX-120 or

Techno polymer 130

UMG EX-120 or

Techno polymer 130

UMG EX-120 or

Techno polymer 130

UMG EX-120 or

Techno polymer 130

UMG EX-120 or

Techno polymer 130

UMG EX-120 or

Techno polymer 130

UMG EX-120 or

Techno polymer 130

UMG EX-120

―

UMG EX-120

Foot Rubber Polyurethane 3M SJ-5816

Battery Contact

SWC-CU

or CP wire

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Part 9

15LSCD Ep-Fe/Ni
or 15CP Ep-FE/Ni

List of Materials (Medium Cuff)

Item Material Grade

Bias Tape Polyester #EX3001

Cloth covering Polyester #P165T

Air Tube PVC DIC G-261

Hook and Loop

fastener

Hook: PVC

Loop: Nylon

Hook: 1991#

Loop: Pantone Cool Gray 7C

Metal Ring SWRM

Air plugs to device ABS

Air plug to cuff PVC DIC G-263

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Part 9.2

Maintenance and storage

Maintenance

To protect your unit from damage, please observe the following:

• Do not subject the main unit and the cuff to extreme temperatures, humidity, moisture or direct
sunlight.

• Do not fold the cuff or tubing tightly.

• Do not disassemble the unit.

• Do not subject the unit to strong shocks or vibrations (for example, dropping the unit on the floor).

• Do not use volatile liquids to clean the main unit.

• Do not wash the arm cuff or immerse it in water.

• Do not use petrol, thinners or similar solvents to clean the arm cuff.

• Do not carry out repairs of any kind yourself. If a defect occurs, consult your OMRON retail outlet or
distributor as mentioned on the packaging.

• The unit should be cleaned with a soft, dry cloth.

• Use a soft, moistened cloth and soap to clean the arm cuff.

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.

Storage

Keep the unit in its storage case when not in use.

1. Unplug the air plug from the air jack.

2. Gently fold the air tube into the arm cuff.

Note: Do not bend the air tube excessively.

3. Place the arm cuff and main unit in the storage case.

Do not store the unit in the following situations:

• If the unit is wet.

• Locations exposed to extreme temperatures, humidity, direct sunlight, dust or corrosive vapours.

• Locations exposed to vibrations, shocks or where it will be at an angle.

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Part 10

Optional Accessories

1. Cuffs
Wide Range Arm Cuff Medium Arm Cuff Large Arm Cuff

Arm Circumference
22-42 cm

Arm Circumference
22-32 cm

Arm Circumference
32-42cm

Small Arm Cuff

Arm Circumference
17-22 cm

2. AC Adapter S

Adapter S – 9515336-9

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Part 11