Omron M6W Manual

GP-HEM-7213-E(V)-01-11/2011
TOC
-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
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
1 340 g 123 x 141 x 85
Master carton 10 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