Gima PRIMALED SO, Operator'S Manual

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Operator
’
s Manual
MO080-IT 12/09/2017
Rev.3 Page 2 of 20
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 Directive 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 marking.
The Product is classified in risk group 1 according to IEC 62471 standard (Photobiological Safety of Lamps). This
operator’s manual is valid for the
PRIMALED SO model.
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: gima@gimaitaly.com
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 and translation, including partial, 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 EM (Electro-Medical) DEVICE to which this manual refers is a LAMP for diagnosis or observation. For ease of
description, in this manual this EM EQUIPMENT will be called “Product”.
This manual is an integral part of the Product as indicated by European Directives 93/42/EEC and 2007/47/EC.
Always keep this operator’s manual close to the lamp.
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. GIMA does not authorize third parties to perform special maintenance jobs. Should a problem
arise, contact GIMA.
The end user is entirely responsible for Product installation activities; no costs or responsibilities relating to the
installation and/or commissioning of the Product may therefore be traced back and/or in any case attributed to GIMA.
The ceiling or wall masonry works for Products to be installed on ceilings or walls, and the electrical works for
supplying power to the Product shall be carried out in a workmanlike manner by suitably qualified personnel to ensure
these are sturdy and safe.
By way of example only, the following professional figures are deemed as suitably qualified:

Construction Engineer, Draughtsman, Building firm duly registered in the professional Register (for the masonry
works)

Electrical Engineer Electro-technical expert qualified to work as an electrician (for the electrical works)
In case of problematic drilling, e.g., drilling into a reinforced concrete iron rod, for safety reasons, inform the technical
manager of the building inasmuch as the latter’s stability could be affected.
The ceiling must be able to withstand a weight of at least 300 kg/m
2
and have a thickness of at least 250 mm.