Omron HEM-6121-E Bedienungsanleitung

GP–HEM-6121-E–01-11/2012

NEW PRODUCT INFORMATION SHEETS-

Specifications subject to change

Sales Name: RS2

Item Number: HEM-6121-E

Table of Contents

Page

General Information

Sales name and Item number of product 2

Model/Category of the product 2

Legal Manufacturer, production Facilities 2

Photo of Product 2

Packaging Content 2

List of Harmonized EN standards` 3

Intended Use 4

Particularity’s (design, specifications, functional peculiarities) 5

Package design – unfolded and separate panels 6 - 8

Instruction Manual – front page 9

Basic Technical Specifications (same as IM) 10

Comparative table – similarities 11

List of used materials 12

Maintenance and Storage 13

Optional Accessories 14

Page 2

General Information:

Product Description Wrist Blood Pressure Monitor

Sales Name RS2

Item number HEM-6121-E

Model Category Wrist Type Blood Pressure Monitor

Legal Manufacturer

Production Facilities OMRON (DALIAN) Co., LTD.

Dalian, China

Photo of Product

Packaging Content Main unit, pre-formed cuff, battery pack (2 x AAA), Instruction

manual, Storage case, Guarantee card

EAN Code 4015672107304

Packaging Information:

Carton Qty Approx

Weight Approx dimensions

W x D x H mm

Main unit without

batteries 1 101g 78 x 21 x 60 (without the wrist cuff)

Sales Package 1 300g 100 x 110 x 110

Master Carton 20 6.87kg 578 x 224 x 267

Page 3

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

EN60601-1:1990+A1:1993+A2:1995

EN 60601-1-2:2007

EN60601-1-4:1996+A1:1999

EN ISO 14971:2007

EN ISO 10993-1:2009

EN ISO 10993-5:2009

EN ISO 10993-10:2009

EN 62304:2006

EN 62366:2008

Page 4

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.

Page 5

Particularities

RS2 (HEM-6121-E) is an automatic wrist type blood pressure

monitor that has the unique selling points as noted:

• Intellisense Technology

• Cuff wrapping guide

• Optimal speed and pressure for gentle inflation/deflation

• Pre-formed easy to fit cuff

• Irregular heartbeat detection

• Hypertension indicator

• 30 x memories

Page 6

Packaging

Page 7

Expanded View – Front Panel

Expanded View – Back Panel

Page 8

Expanded View - Side Panel 1

Expanded View – Side Panel 2

Page 9

Instruction Manual Design

Page 10

TECHNICAL PRODUCT INFORMATION

Product Description Digital Automatic Wrist Blood Pressure Monitor

Model OMRON RS2 (HEM-6121-E)

Display LCD Digital Display

Measurement Method Oscillometric method

Languages EN, DE, FR, IT, ES, NL, RU, AR, TU, SR

Measurement Range Pressure: 0mmHg to 299mmHg

Pulse: 40 to 180/min.

Memory 30 x memory

Applied Part = T

pe B

Protection Against Electric

Shock Internally powered ME equipment

Accuracy Pressure: ±3 mmHg

Pulse: ±5% of display reading

Inflation Automatic inflation by pump

Deflation Automatic rapid deflation

Pressure Detection Capacitive pressure sensor

Power Source 2 “AAA” alkaline (LR03) batteries 1.5V

Battery life Approximately 300 measurements with new alkaline batteries at a room

temperature of 23°C

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

Console Weight Approximately 101g without batteries

Outer dimensions Approximately 78 (w) mm x 60 (h) mm x 21 (d) mm (without the wrist cuff)

Measurable circumference

of wrist Approximately 13.5 to 21.5 cm

Cuff material Nylon and polyester

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

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.

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