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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

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

Содержание M6W

Страница 1: ...ct 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 Mainten...

Страница 2: ...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 ...

Страница 3: ...es 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 ...

Страница 4: ...tient 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 i...

Страница 5: ...oints 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 ...

Страница 6: ...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 ...

Страница 7: ...GP HEM 7213 E V 01 11 2011 Part 6 Instruction Manual Design ...

Страница 8: ... 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 m...

Страница 9: ...ric 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 Storag...

Страница 10: ...onitrile 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 Acryl...

Страница 11: ...ium Cuff Item Material Grade Bias Tape Polyester EX3001 Cloth covering Polyester P165T Air Tube PVC DIC G 261 Hook and Loop fastener Hook PVC Loop Nylon Hook 1991 Loop Pantone Cool Gray 7C Metal Ring SWRM Air plugs to device ABS Air plug to cuff PVC DIC G 263 ...

Страница 12: ... with a soft dry cloth Use a soft moistened cloth and soap 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 authorised OMRON dealer or the OMRON Customer Servi...

Страница 13: ...Optional Accessories 1 Cuffs Wide Range Arm Cuff Medium Arm Cuff Large Arm Cuff Arm Circumference 22 42 cm Arm Circumference 22 32 cm Arm Circumference 32 42cm Small Arm Cuff Arm Circumference 17 22 cm 2 AC Adapter S Adapter S 9515336 9 ...

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