Omron M6W Handbuch

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

TOC

-NEW PRODUCT INFORMATION SHEETS-

Specifications subject to change

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

Part 1

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 Approx dimensions

W x D x H mm

Main unit without

batteries 1 380 g 123 x 158 x 85

Sales Package 1 1150 g 175 x 115 x 221

Master Carton 10 13.15 Kg 612 x 375 x 262

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

Part 2

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

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

Part 3

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.

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

Part 4

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

GP-HEM-7200-E2(V)-03-10/2011

Part 5

Package Design

Packaging Information:

Carton QTY Approx. Weight Approx. Dimensions

(W) x (D) x (H)

Single unit

340 g

123 x 141 x 85

Master carton

9.5 Kg

587 x 292 x 216

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

Part 6

Instruction Manual Design

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

Part 7

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 controlled by electric pump

Deflation Automatic pressure release valve

Rating DC6V 4W

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

Battery life Capacity of new alkaline batteries is approximately 1000 measurements

Applied Part = Type B

Protection Against Electric

Shock Internally powered ME equipment (When using only the batteries)

= Class II ME equipment (Optional AC adapter)

Operating temperature /

Humidity +10C to +40C

Maximum: 30% to 85% RH

Storage Temperature /

humidity -20C to +60C

Maximum: 10% to 95% RH / 700-1060hPa

Console Weight Approximately 380g without batteries

Cuff Weight Approximately 170g

Outer dimensions Approximately 123 (w) mm x 85 (h) mm x 158 (l) mm

Cuff dimensions Approximately 151 mm x 635 mm

(Cuff: arm circumference 22 to 42 cm)

Cuff material Nylon and polyester

Package Content Main unit, cuff, instruction manual, storage case, battery set, guarantee card,

blood pressure pass, quick guide

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 HEALTHCARE

Co. Ltd., Japan. The Core component for OMRON blood pressure monitors, which is the

Pressure Sensor, is produced in Japan.

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

Part 8

Comparison Table

New model Predecessor

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

Measurement

Method Oscillometric Same as new model

Measurement

range Pressure: 0mmHg to 299mmHg

Pulse: 40 to 180/min. Same as new model

Memory 100 measurements

with date and time for each user (A and B) 90 measurements

with date and time for one user

Accuracy Pressure: ±3mmHg

Pulse: ±5% of display reading Same as new model

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

Protection

Against Electric

Shock

Internally powered ME equipment

(When using only the batteries)

= Class II ME equipment

(Optional AC adapter)

Same as new model

Operating

temperature/

Humidity

+10C to +40C

Maximum: 30% to 85% RH Same as new model

Storage

temperature/

humidity

-20C to +60C

Maximum: 10% to 95% RH / 700-1060hPa 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.

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

Part 9

List of Materials (Main unit)

Item Material Grade

Front Housing Acrylonitrile butadiene

styrene UMG EX-120 or

Techno polymer 130

Ground Housing Acrylonitrile butadiene

styrene UMG EX-120 or

Techno polymer 130

Battery Cover Acrylonitrile butadiene

styrene UMG EX-120 or

Techno polymer 130

Start Button Acrylonitrile butadiene

styrene UMG EX-120 or

Techno polymer 130

Memory Button Acrylonitrile butadiene

styrene UMG EX-120 or

Techno polymer 130

Clock Button Acrylonitrile butadiene

styrene UMG EX-120 or

Techno polymer 130

Arrow Button Acrylonitrile butadiene

styrene UMG EX-120 or

Techno polymer 130

Slide Button Acrylonitrile butadiene

styrene UMG EX-120

Front Panel Polycarbonate ―

Air Connector Cap Acrylonitrile butadiene

styrene UMG EX-120

Foot Rubber Polyurethane 3M SJ-5816

Battery Contact SWC-CU

or CP wire 15LSCD Ep-Fe/Ni

or 15CP Ep-FE/Ni

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