Omron HEM-6121-E User manual

GP–HEM-6121-E–01-11/2012
NEW PRODUCT INFORMATION SHEETS-
Specifications subject to change
© OMRON HEALTHCARE EUROPE B.V.
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
y
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.