Gima SOLESUD 2-LED User Manual
MANUALE OPERATIVO
PER LAMPADA
DA OSSERVAZIONE
USER MANUAL
FOR OBSERVATION LAMP
SOLESUD 2-LED
MO083-EN 14/02/20
EN
Rev.4
Page 1 of 17
USER MANUAL
USER MANUAL FOR OBSERVATION LAMP
SOLESUD 2-LED
Via Marconi, 1 – 20060 GESSATE (MI) ITALY
Tel. +39 02 953854209 Fax +39 02 95381167
http://www.gimaitaly.com e-mail: gima@gimaitaly.com
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.
This User manual is valid for the following model: SOLESUD 2-LED.
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 User manual.
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USER MANUAL
CONTENTS
1 General information 3
1.1 Operator qualification 3
1.2 Packaging, transport, storage and characteristics of installation premises 4
1.3 Graphic symbols used on the Product 4
1.4 Manufacturer's Declaration of Conformity 5
1.5 Warranty Certificate 6
2 Importance of personal safety 7
2.1 Intended use 7
2.2 Environmental conditions 7
2.3 Safety conditions (secondary effects) 7
2.4 Controls to be performed every time before the lamp is used 7
3 Product installation 8
3.1 Installation of wall version (S/12 MED fastening) 8
3.2 Installation of wall version (bar rail fastening) 8
3.3 Installation of 5-spoke floor version (RL) 9
3.4 First switch-on 9
3.5 Check the result of Product installation and testing before use 9
4 Description and operation 10
5 Cleaning and disinfecting 10
5.1 Cleaning the Product 10
5.2 Disinfecting 10
6 Adjustments 11
6.1 Yearly inspections by operator 11
6.2 Repairs 11
6.3 Adjustments 11
6.4 Troubleshooting 11
6.5 Routine maintenance 11
7 Technical properties 12
8 Wiring diagram 13
9 EMC Declaration 14
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Installation
Ins
taller and/or quali
fied technici
an
Use
Profession
al medical personnel
Routine maintenanc
e Qualified technician with required technical
-
professi
onal skills
Spe
cial maintenance
GIMA
or author
i
zed Dealer
Assistance
GIMA
or authorized Dealer
Cleaning
Properly trained me
dica
l and param
edi
cal personnel
Comply with applicable laws on waste disposal. This product must not
ensure correct recycling.
USER 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:
onstruction Engineer, Draughtsman, Building firm duly registered in the professional Register (for
C
the masonry works)
Electrical Engineer Electro-technical expert qualified to work as an electrician (for the electrical
works)
The Product is an EM electro-medical equipment and therefore falls within the field of application of
the IEC 62353 standard. Consequently, any operation performed on the Product must be carried out in
compliance with the IEC 62353 standard, where applicable.
1.1 Operator qualification
This paragraph describes the requirements and qualifications which the operators involved in the
various stages of Product life and use must possess.
be disposed of in standard waste disposal bins. To avoid risks for the
environment and health deriving from the dispersion of polluting
Demolition
substances in the environment, separate the various internal
component parts such as iron, aluminium, plastic and electrical
material, and dispose of these through authorized channels so as to
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CE marking
(month/y
ear)
Limit temperature (indicate max limit
left)
Humidity to b
e co
mplied with (indicate
bottom left)
Pressure to be complied with
(indicate
bottom left)
signal
USER MANUAL
1.2 Packaging, transport, storage and characteristics of installation premises
Boxes containing the Product together with User manual.
Transport is made by GIMA or any road-hauler as long as in compliance with the following
characteristics:
Temperature (°C): -15 / +60; Humidity: 10 / 75 %; Atmospheric pressure (hPa): 500 / 1060.
The packaged Product must be stored (warehoused) in dry premises having the following
characteristics:
Temperature (°C): -15 / +60; Humidity: 10 / 75 %; Atmospheric pressure (hPa): 500 / 1060.
The premises where the Product is started up must have the following characteristics:
Temperature (°C): +10 / +40; Humidity: 30 / 75 %; Atmospheric pressure (hPa): 700 / 1060.
1.3 Graphic symbols used on the Product
Description of the symbols on plates, product and in manual:
Graphic symbol showing product bears
Manual reading obligation
‘I’
Symbol indicating date of manufacture
Manufacturer’s address
RECYCLING! The Product must be
recycled separately
Stand-By
ON power
Top side of packaging
Fragile packaging
Do not stack packaging
max limit at top right and min limit at
General warning signal
‘O’
Model
Serial number
Functional earth
Protection earth
OFF power
Weight of packaging
Protect from rain
at top right and min limit at bottom
max limit at top right and min limit at
General mandatory code of conduct
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I
EC 60
601-1 (Part
1:
General requirements for basic safety and ess
ential per
formance
)
• IEC 60601
-2-41
(Part
1:
Parti
c
ular require
ments
for the safety of surgical luminaires and
IEC 60601
-1-2 (Part 2:
General requirements for basic sa
fet
y and essential performance
-
Collateral Standard: Electrom
agnetic di
sturbances
- Requirements and tests
)
DURAT
ION:
Short term duration (Annex IX, Par.1 “D
efi
nitions”, art.1, subsection 1.1)
DESCRI
PTION
:
Non-invasive
medical d
evice (Annex IX, Par.1
“Definitions”, ar
t
.1, subsecti
on 1.2
)
A
ctive medical device
(Annex
IX,
Par.1 “Defini
tions
”,
art.1,
subsection
1.4)
CLASS I:
(Annex IX, Par.3 “Classification”
, ar
t.3, subsection 3.3, Rule 12) and
USER MANUAL
1.4 Manufacturer's Declaration of Conformity
The company: RIMSA P. LONGONI S.r.l. Via Monterosa, 18/20/22 - 20831 SEREGNO (MB) – ITALY
declares under its own responsibility that the Product (Medical device for observation and diagnosis):
made by RIMSA P.LONGONI S.r.l., complies with Annex VII of Directive 93/42/EEC dated 14/05/1993,
enforced in Italy by Legislative Decree No. 46 dated 24 February 1997 and subsequent amendments
(including Directive 2007/47/EC dated 05/09/2007, enforced in Italy by Legislative Decree No. 37 dated
25 January 2010) and with the following standards:
•
APPLY
LABEL
luminaires for diagnosis)
•
Classification with reference to article 9 and Annex IX of Directives 93/42/EEC and 2007/47/EC
(Annex IX Par.3 “Classification”, art.1, subsection 1.1 Rule 1)
• The conformity assessment is developed with reference to article 11 of Directive 93/42/EEC and
2007/47/EC.
• RIMSA Quality System complies with UNI EN ISO 9001 and UNI CEI EN ISO 13485 standards and is
certified by CSQ (CSQ certificate no. 9120.RMS1 and 9124.RMS2).
• The Medical Device to locally light up the patient’s body is marketed in NON-STERILE form.
Name: Paolo Longoni
Position: Managing Director
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USER MANUAL
1.5 Warranty Certificate
1. The Product is covered by an 18-month warranty, including electrical parts
2. The warranty begins on the date of product shipment from the GIMA warehouse to the buyer.
3. In case of disputes, the date indicated on the “transport document” attached to the goods shall
be deemed valid.
4. The warranty only covers the sending of Product spare parts to the buyer or, in the event of GIMA
considering the replacement of spare parts not feasible, the replacement of the entire product,
after fabrication faults have been properly ascertained at the undisputable judgement of GIMA.
The warranty does not therefore cover any other costs or expenses (including, by way of example
but without limitation, labour costs, packaging costs and transport costs, etc.).
5. The guarantee does not include the components subject to normal wear, such as halogen bulbs,
LEDs, fuses, relays, ball bearings, etc.)
6. The warranty does not cover:
- malfunctions due to failure to comply with user manuals;
- malfunctions due to installation and/or maintenance errors;
- malfunctions or faults caused by carelessness, negligence, incorrect use or other causes not
attributable to GIMA;
- malfunctions or faults due to the fact that the electrical system of the premises where the
device is installed is not in compliance with CEI 64-8 standards (standards for electrical
systems in premises used for medical purposes) and similar standards.
7. GIMA shall repay direct damages suffered by the buyer and which are documented as
attributable to its product, caused within the warranty period, for an amount not 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 being used)
deriving from the supply.
8. This warranty certificate replaces legal warranties for faults and non-conformities and rules out
any other possible liability of GIMA originating from the supplied products.
9. The payment of any damages to persons or things due to product malfunction or faults shall be
limited to the maximum amount of GIMA’s insurance coverage for civil liability.
10. The warranty shall be automatically invalidated in the event of:
- the Product having been tampered with or modified by the buyer or third parties;
- the Product having been repaired by the buyer or third parties, without following the
instructions in user manuals;
- the Product serial number having been cancelled, defaced or removed;
- the buyer not being up to date with payments.
11. For jobs to be done under warranty, the buyer shall contact GIMA only.
12. The component parts replaced under warranty must only be returned to GIMA, if so requested by
GIMA, carriage free and suitably packed.
13. In case of failure to return a part requested by GIMA, the cost of the component part will be
charged.
14. GIMA cannot accept returns from end users or in any case from parties other than the buyer.
15. Products returned to GIMA must be complete with documentation authorising such return and
another document describing the malfunction.
16. For everything not indicated on this warranty certificate, reference shall be made to the laws of
Italy.
17. For all disputes deriving from or related to the orders to which this warranty certificate applies and
which cannot be amicably settled between the parties, the only competent law court shall be that
of Milan.
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