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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 

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 

6 - 8 

Instruction Manual – front page 

Basic Technical Specifications (same as IM) 

10 

Comparative table – similarities 

11 

List of used materials 

12 

Maintenance and Storage 

13 

Optional Accessories 

14 

 

Summary of Contents for HEM-6121-E

Page 1: ...ry 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...

Page 2: ...RON 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 2...

Page 3: ...evice 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: ...he 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 f...

Page 5: ...e 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: ...Page 6 Packaging ...

Page 7: ...Page 7 Expanded View Front Panel Expanded View Back Panel ...

Page 8: ...Page 8 Expanded View Side Panel 1 Expanded View Side Panel 2 ...

Page 9: ...Page 9 Instruction Manual Design ...

Page 10: ...perature 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 manua...

Page 11: ...as Predecessor Deflation Automatic rapid deflation Same as Predecessor Power Source 2 AAA alkaline LR03 batteries 1 5V Same as Predecessor Protection against Electric Shock Internally powered ME equipment When using only the batteries Same as Predecessor Operating temperature Humidity 10 C to 40 C Maximum 30 to 85 RH Same as Predecessor Storage Temperature humidity 20 C to 60 C Maximum 10 to 95 RH...

Page 12: ...er 130 Battery Cover Acrylonitrile butadiene styrene UMG EX 120 or Techno polymer 130 LCD Holder Acrylonitrile butadiene styrene UMG EX 120 or Techno polymer 130 Hard Case Polypropylene PP6019 Front Panel Polyethylene terephthalate PET t 0 188mm Outer Cloth Polyester P165T Inner Cloth Nylon G4028FF 2C Fastener hook Nylon A9663Y Fastener Loop Nylon Polyester PVC PVC95F Bias Polyester TC8864H 1 CGR ...

Page 13: ...p to clean the arm cuff Calibration and Service The accuracy of this blood pressure monitor has been carefully tested and is designed for a long service life 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 lite...

Page 14: ...Page 14 Optional Accessories Not applicable ...

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