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

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

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.

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

Part 3