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NEW PRODUCT INFORMATION SHEETS-
Sales Name:
Item Number:
General Information
Sales name and Item number of product
Model/Category of the product
Legal Manufacturer, production Facilities
Photo of Product
Packaging Content
List of Harmonized EN standards`
Intended Use
Particularity's (design, specifications, functional peculiarities)
Package design – unfolded and separate panels
Instruction Manual – front page
Basic Technical Specifications (same as IM)
Comparative table – similarities
List of used materials
Maintenance and Storage
Optional Accessories
GP–HEM-6121-E–01-11/2012
Specifications subject to change
© OMRON HEALTHCARE EUROPE B.V.
HEM-6121-E
Table of Contents
RS2
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Table of Contents
Related Manuals for Omron HEM-6121-E
Summary of Contents for Omron HEM-6121-E
- Page 1 NEW PRODUCT INFORMATION SHEETS- Specifications subject to change © OMRON HEALTHCARE EUROPE B.V. Sales Name: Item Number: HEM-6121-E Table of Contents Page General Information Sales name and Item number of product Model/Category of the product Legal Manufacturer, production Facilities Photo of Product...
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Page 2: Photo Of Product
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... -
Page 3: List Of Harmonized En Standards
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 3... -
Page 4: Intended Use
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. •... - 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 •...
- Page 6 Packaging Page 6...
- Page 7 Expanded View – Front Panel Expanded View – Back Panel Page 7...
- Page 8 Expanded View - Side Panel 1 Expanded View – Side Panel 2 Page 8...
- Page 9 Instruction Manual Design Page 9...
- Page 10 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.
- Page 11 Comparison Table Product Description Predecessor New Model Model OMRON R2 HEM-6113-E OMRON RS2 HEM-6121-E Measurement Method Oscillometric Same as Predecessor Measurement Range Pressure: 0mmHg to 299mmHg Same as Predecessor Pulse: 40 to 180/min Memory 30 x memory Same as Predecessor Accuracy Pressure: ±3 mmHg...
- Page 12 List of Materials Item Material Grade Acrylonitrile butadiene UMG EX-120 or Front Housing styrene Techno polymer 130 Acrylonitrile butadiene UMG EX-120 or Ground Housing styrene Techno polymer 130 Acrylonitrile butadiene UMG EX-120 or Battery Cover styrene Techno polymer 130 Acrylonitrile butadiene UMG EX-120 or LCD Holder styrene...
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Page 13: Maintenance And Storage
It is generally recommended to have the unit inspected every two years to ensure correct functioning and accuracy. Please consult your authorized OMRON dealer or the OMRON Customer Service at the address given on the packaging or attached literature. -
Page 14: Optional Accessories
Optional Accessories Not applicable Page 14...