Gima SIMPLEX User manual

Operative Manual
MO076-GB
19/01/14
Rev.2
Pag. 1 di 8
Observation lamp with flexible support
SIMPLEX
Via Marconi, 1 –20060 GESSATE (MI) ITALIA
Tel. [phone] Fax [phone]
http://www.gimaitaly.com e-mail: [e-mail]
CONTENTS
Pag.
General information
2
1.1
Identification data of the apparatus, EC marking and re-traceability
2
1.2
Classification and destination of use of the device
2
1.3
Declaration of EC conformity
3
1.4
Warranty Certificate
3
1.5
Technical assistance
4
1.6
Packing, Transport, Stockage, Characteristics of the installation premises, Dismantling
4
Using the apparatus
5
2.1
Safety considerations (undesirable secondary effects)
5
2.2
Description of the apparatus, working principle and lighting
5
2.3
Cleaning
5
2.4
Technical data and performance of the apparatus
6
Maintenance
7
3.1
Repairing faults and anomalies
7
3.2
Bulb sostitution
7
3.3
Electrical diagram
8
Introduction
Dear Client,
GIMA congratulates you for having purchased a product from its range and invites you to read carefully every part
of the present Operative Manual, subdivided into installation, use and maintenance phases.
You will find all the necessary instructions for a correct use of the product within. Please observe the warnings
contained carefully, keep it unaltered and easy to find and be accessible to the operator. In the case of sale or
transfer of the used apparatus, this manual and its attachments must always accompany it.
GIMA can modify the content of the present Manual, without previous notice or further obligations, in order to
include variations and improvements.
The reproduction or translation of any part of the present manual is forbidden without the written agreement of
GIMA.
We inform you that our Company remains completely available to you for further information and clarifications of
everything concerning the installation, use and maintenance of the product.

The symbol to the side and used in the present manual means that when it is shown it is to
be considered “compulsory” in order to install and use the device correctly.
The symbol to the side and used in the present manual means that when it is shown it is
to be considered “compulsory” in order to install and use the device correctly.

Operative Manual
MO076-GB
19/01/14
Rev.2
Pag. 2 di 8
General information
GIMA does not assume any responsibility for eventual damage to people or things as a result of
failure to respect the safety regulations and recommendations contained in the present document.
1.1 Identification data of the apparatus, EC marking and re-traceability
Conformity is documented by the plate with the EC mark (portrayed below) and by the declaration of conformity
accompanying the present manual.
Device SIMPLEX: re-traceability plate
Model SIMPLEX 230Vac 35W 12V 10° IRC GU5,3 50/60
Hz
Halogen
The plate is positioned on the device on the basement. The re-traceability of the SIMPLEX is guaranteed by the
series number positioned on the label in fulfilment of the internal company PO 7.5 Operative Procedure.
Description of the symbols on the plate, the product and in the present manual:
Graphic symbol confirming the EC
product mark
All electrical and electronic products should be
disposed of separately from the municipal
waste stream
Symbol indicating the manufacturing date
(year).

Attention → ADVICE
Fragile package
Warning → COMPULSORY
Read enclosed warning
1.2 Classification and destination of use of the device
Classification according to a general regulation (CEI EN 60598-1 section 2)
On the basis of the type of protection against electrical danger: class I apparatus
On the basis of protection against penetration of water: IP20
On the basis of the level of safety of use in the presence of an inflammable anaesthetic mixture with air or
oxygen or hydrogen protoxide: apparatus considered not suitable for use with the above described elements.
On the basis of the conditions of use: apparatus for continuous functioning.
The device can’t be used in surgical rooms.

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MO076-GB
19/01/14
Rev.2
Pag. 3 di 8
1.3 Manufacturer’s declaration of conformity
The Company:
RIMSA P. LONGONI S.r.l. Via Monterosa, 18/20/22 - 20831 SEREGNO (MB) - ITALY
declares on its own responsibility that the Light Fitting Devices for :
SIMPLEX
APPLICARE
ETICHETTA
constructed by RIMSA P.LONGONI S.r.l., conforms to Dierctive Low Tension 2006/95/EC. It is also in
conformity with the following safety regulation:
IEC 60598-1
IEC 60598-2-4
EN 60598-2-25
Technical reference file Code RIM-FTI015.
The RIMSA Quality System conforms to the UNI EN ISO 9001 and UNI EN ISO 13485 regulations and is
certified by the CSQ (certified CSQ n.9120.RMS1 and 9124.RMS2).
Name: Paolo Longoni
Position: Managing Director
1.4 Warranty Certificate
1. The appliance 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 the instruction 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 machine is
installed is not in compliance with International or local 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

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Pag. 4 di 8
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 the
instruction 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.
1.5 Technical assistance and qualification of the personnel
For any requests, clarifications or interventions contact the numbers below.
Telephonic assistance is guaranteed from Monday to Friday, from 8.30 a.m. to 5.30 p.m.
GIMA TECHNICAL ASSISTANCE OFFICE FOR CLIENTS
Via Marconi, 1 –20060 GESSATE (MI) ITALY
Tel. [phone] Fax [phone]
http://www.gimaitaly.com e-mail: [e-mail]
1.6 Packing, Transport, Stockage, Characteristics of the installation premises, Dismantling
The packing for the SIMPLEX model consists of one box:
Packing
Content
Dimensions LxWxH
Weight
(Kg)
1
Medical device + Operative Manual
60x47x12
3,300
Transport is carried out by GIMA or by any carrier as long as the following characteristics are respected:
Temperature
(-15/+60)°C
Humidity
(10/75) %
Atmospheric pressure
(500/1060) h/Pa
Stockage (storage) of the packaged devices must take place in a dry place and at the following temperature:
Temperature
(-15/+60)°C
Humidity
(10/75) %
Atmospheric pressure
(500/1060) h/Pa

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Pag. 5 di 8
The premises designated for setting up the apparatus must have the following characteristics:
Temperature
(+10/+40) °C
Humidity
(30/75) %
Atmospheric pressure
(700/1060) h/Pa
Method for dismantling product at the end of life:
dismantle Medical Device separing plastic parts from glass, electric wires and iron dismantling following
national laws.

Before proceeding with installation, check that all the packages are present and in good
condition, without damage due to transportation and that the contents coincide with what has
been reported above.
Complaints will be considered only if the vendor or the forwarder is immediately advised. Every
complaint must be made in written form. The goods always travel at the risk and danger of the
purchaser.
Keep the original packing in case there is the need to return the lamp.
Using the apparatus
2.1 Safety indications (undesired secondary effects)
The lamp is not designed to function in a zone with a risk of explosion.
Do not look directly at the lit lamp and do not insert reflecting objects in the way of the rays. There exists the
danger of blinding in view of the high potency of illumination.
The distance between the surface of emission of the light of the lamp and the surface of the patient should not
be less than 10 cm so as to guarantee an efficient illumination.
Do not place any objects on the body of the lamp nor hang objects on the arm or the body of the lamp.
Avoid collisions with the body of the lamp. The lamp might be damaged with a violent collision or
pieces of magnifying glass might break off and fall into the operating field of the patient zone.
The alimentation wire cannot be substituted. In case of damage you have to contact GIMA.
2.2 Description of the apparatus, working principle and lighting
The lamp in constituted of a lamp of 35W 12V 10° IRC settled inside the reflector end protected by a
temperate glass. The reflector is little in order to give more freedom for the movement. There’s a flexible
arm (70cm).
2.3 Cleaning and disinfecting

Before proceeding to the operations of cleaning removing feeding to the lamp parading the thorn
from the net electrical worker
All the parts of the lamp can be cleaned up with common detergents on all the superficial ones and can be
disinfected with common disinfectants in use passing a humid soft cloth to you with frequency of 3 months or
before if famous that the reflector is being opacified or the lamps cover of one powder layer.
Not to pour never directly the content of bottle the detergents and disinfectants on the lamp also
through atomizer and not to spray never the liquids to the inside of the device.

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Rev.2
Pag. 6 di 8
2.4 Technical data and performance of the apparatus
Technical data
Mod.SIMPLEX
Maximum radiation at 50cm [Lux]
30.000
Technical data on power supply
Nominal voltage [Volt ac]
230
Frequency [Hz]
50/60
Absorbed power [W]
35
General data
Lamp
35W
Life fluorescent bulbs [h]
(this data can vary in base to a tension advanced supply to that one
indicated, from tension peaks and from the frequency of use)
5.000 c.ca
Dimension
Measures of block[mm]
1000x110x110
Weight [Kg]
2,0
Colour
White
Marks

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MO076-GB
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Rev.2
Pag. 7 di 8
Maintenance
3.1 Repairing faults and anomalies
n
Problem
Solve problem
1
Device do not light
To verify the presence of tension to the net of feeding (taken
electrical worker), the presence of the lamps and their
condition
3.2 Bulb sostitution
First of all you have to unscrew the screw (1). Taking out the washer (2), you have the opportunity to rotate the
cover (3). Now you can take out the dicroric bulb and substituted it (4).

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MO076-GB
19/01/14
Rev.2
Pag. 8 di 8
3.3 Electric diagram