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Operative Manual 

MO082-IT 

22/04/13 

Rev.0 

Pag. 2 di 12 

 

 

 

Introduction 

Dear user You are kindly invited to read this manual carefully before proceeding to use the Product in order to 
safeguard yourself and other people from any injuries. 
This appliance is a Class 1 medical device pursuant to European Directives on medical devices (MDD) 93/42/EEC, 
Annex IX, and 2007/47/EC

The  manufacturer  declares  that  this  product  is  in  compliance  with  Annex  I  (essential  requirements  of  Directive 
93/42/EEC and certifies such conformity by affixing the CE mark. 
This operator’s manual refers to the product 

GIMANORD

The customer service is at your disposal in case of Product details, information concerning its use, identification of 
spare parts being required and for any other queries you might have concerning the appliance, for ordering spares 
and for matters relating to assistance and warranty.

  

GIMA TECHNICAL ASSISTANCE OFFICE FOR CLIENTS  
Via Marconi, 1 – 20060 GESSATE (MI)  ITALY 

Tel. +39 02 953854209   Fax +39 02 95381167 

http://www.gimaitaly.com    e-mail: [email protected] 

 

The contents of this Manual may be amended by GIMA, without prior notice or any further obligations, in order to 
make  changes  and  improvements.  The  reproduction,  including  partial,  or  translation  of  any  part  of  this  manual  is 
forbidden without the written permission of GIMA. 
GIMA reserves the right to change, cancel or otherwise amend the data contained in this document at any time and 
for  any  reason without prior notice inasmuch as  GIMA is constantly seeking new solutions which lead to product 
evolution.  GIMA  therefore  reserves  the  right  to  make  changes  to  the  supplied  Product  in  terms  of  shape,  fittings, 
technology and performances. 
With regard to translations into languages other than Italian, reference shall always be made to the Italian edition of 
this operator’s manual. 

 

 

1.

 

General information 

The  ME  (Medical-Electrical)  EQUIPMENT  to  which  this  manual  refers  is  a

 

LAMP

 

for  diagnosis  or  observation. 

For easier description such ME EQUIPMENT will be indicated in this manual with the name of “Product”. 
This  manual  is  an  integral  part  of  the  Product  as  required  by  European  directive  93/42/EEC  and  2007/47/EC. 
Always keep this installation manual close to the Product.

 

The Product is not suitable for use in explosion-risk areas 

The Product is not suitable for use in the presence of inflammable mixtures of anaesthetics with air, oxygen or 

NO

2

 (laughing gas) 

 

GIMA  disclaims  all  liability  for  any  injuries  to  persons  or  damage  to  things  caused  by  the  installation, 

maintenance or use of the Product by unqualified operators. By qualified operator is meant whosoever has attended 
a  course  relating  to  the  installation,  maintenance  and  use  of  the  product  organised  by  GIMA  or,  alternatively, 
whosoever has carefully read this installation manual. 
The only party responsible for Product installation is the buyer’s customer itself; no cost or responsibility relating to 
installation and/or commissioning of the Product shall therefore be traced back and/or in any case attributed to 
GIMA. 
The masonry works involving the preparation of the ceiling or wall, for Products to be installed on the ceiling or 
wall respectively, and the electric works for preparing the power supply system for the Product shall be of a sturdy 
and safe nature and completed in a workmanlike manner by suitably trained personnel. 
By way of example only, without limitation, the following professional figures are deemed adequately trained:  

 

Building Engineer, Draughtsman, Building firm duly registered in the professional Register (for masonry works) 

 

Electro-technician qualified to exercise the profession of electrician (for the electrical works) 

The Product is a ME EQUIPMENT and consequently falls within the field of application of the EN:62353 standard. 
Consequently, any operation performed on the Product must be carried out in compliance with the EN:62353 
standard, where applicable. 
 
 
 

 

Summary of Contents for GIMANORD

Page 1: ...2 1 Installation mobile version 6 2 2 Installation wall version S 12MED fixing 6 2 3 Installation wall version rail bar fixing 6 2 4 Installation table version S11 fixing 6 2 5 First starting 6 2 6 In...

Page 2: ...n The ME Medical Electrical EQUIPMENT to which this manual refers is a LAMP for diagnosis or observation For easier description such ME EQUIPMENT will be indicated in this manual with the name of Prod...

Page 3: ...tion manual and user manual Transport is carried out by any road haulage contractor as long as they respect the following characteristics Temperature C 15 60 Humidity 10 75 Atmospheric pressure h Pa 5...

Page 4: ...and essential performance Collateral standard Electromagnetic compatibility Requierements and tests Classification with reference to article 9 and Annex IX of Directives 93 42 EEC and 2007 47 EC DURAT...

Page 5: ...ot above 40 of the net value of the product as indicated on the buyer s invoice GIMA s liability is expressly ruled out for indirect damages or consequential damages including cases of the lamp not be...

Page 6: ...ion screws 2 Put the clamp on the bar and tighten the handle 3 Insert the lamp into the upper hole of the rail clamp 4 Follow points 2 and 3 of paragraph 2 1 2 4 Installation table version S11 fixing...

Page 7: ...autions could cause glare and potential damage to the retina Never place and or hang anything on the Product Unless this precaution is taken positioning will not be reliable and the danger exists of s...

Page 8: ...therefore be checked during inspection and maintenance intervals 6 Adjustments 6 1 Yearly inspections by the operator Keep to the yearly inspection schedules and inspect the product according to IEC...

Page 9: ...year Check the condition of the Product paint Make sure there are no paint pieces that could fall on the operating field 7 Technical data Technical data GIMANORD Illumination Ec at a distance of 50cm...

Page 10: ...d indirect contacts B type device Dimensions Overall dimension mm 1200x300x100 Lamp weight Kg 3 Certificate Complying with directive 93 42 EEC included 2007 47 EC All lighting values are subject to a...

Page 11: ...sions IEC 61000 3 3 Compliance Immunity test IEC 60601 1 2 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact...

Page 12: ...nications equipment and the Product The Product is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Product can help...

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