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Copyright The reproduction and translation, including partial, of any part of this manual is forbidden without the written permission of TECNO-GAZ. Translations The original language of this manual is ITALIAN. For all translations, reference must be made to the original manual language.
Operation and MU_010_IT 15/06/15 maintenance manual Rev.4 Pag. 3 di 29 List of Contents KEY ....................5 1 WARNINGS AND SAFETY NOTICES ........6 2 Importance of personal safety ..........6 2.1 Intended use ..................6 2.2 Safety conditions (secondary effects) ..........7 2.3 Environmental conditions ..............
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Operation and MU_010_IT 15/06/15 maintenance manual Rev.4 Pag. 4 di 29 7.7 Spare parts list ................21 8 Technical properties ..............22 Declaration of Conformity of the Manufacturer ....24 10 Warranty Certificate ..............29...
Operation and MU_010_IT 15/06/15 maintenance manual Rev.4 Pag. 5 di 29 PRODUCT THE EM (Electro-Medical) EQUIPMENT to which this manual refers is a SECONDARY SURGICAL LAMP (TREATMENT LAMP). For ease of description, in this manual this EM EQUIPMENT will be called “Product”.
NO (laughing gas). WARNING TECNO-GAZ disclaims all liability for any injury to persons or damage to things caused by the Product having been used and services by persons who are not OPERATORS or SERVICE PERSONNEL.
Operation and MU_010_IT 15/06/15 maintenance manual Rev.4 Pag. 7 di 29 WARNING – Possibility of tissue dehydration and damage Undesired effects of In the event of overlapping lamps, a temperature increase would ensue overlapping light fields in the patient area with consequent risk of dehydration and tissue damage.
Operation and MU_010_IT 15/06/15 maintenance manual Rev.4 Pag. 8 di 29 2.3 Environmental conditions - 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 (laughing gas).
Operation and MU_010_IT 15/06/15 maintenance manual Rev.4 Pag. 9 di 29 PERSONNEL, RESPONSIBLE ORGANIZATION PRODUCT could be exposed. DANGER indicates an immediately hazardous situation which could result in death or serious injuries. WARNING indicates a potentially hazardous situation that could result in death or serious injuries.
The instructions must be provided in written form on the basis of this manual. 4.3 Warranty and liabilities TECNO-GAZ disclaims all liability as regards unreliable Product operation in the following cases: - The Product has not been used for its intended purpose and in conformity with the operating instructions.
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Operation and MU_010_IT 15/06/15 maintenance manual Rev.4 Pag. 11 di 29 See drawing 120 WALL version: wall plate (1), power supply unit (2), wall box (3), horizontal arm (4), oscillating arm (5), fork (6), lamp head (7), function control keyboard (8), sterilizable handle (9), power supply plug (10). See drawing 121 CEILING SINGLE version: ceiling cover (1), ceiling anchorage tube (2), power supply unit (3), horizontal arm (4), oscillating arm (5), fork (6),...
Operation and MU_010_IT 15/06/15 maintenance manual Rev.4 Pag. 12 di 29 5.2 Description of operation Control keyboard Product control is by means of the control keyboard positioned on the fork. By pressing the keys, the following functions are started: - On/Off button (1) - Sun button (2): light intensity adjustment.
Operation and MU_010_IT 15/06/15 maintenance manual Rev.4 Pag. 13 di 29 5.3 Product handling SINGLE ceiling model ∞ ∞ DOUBLE ceiling model ∞ ∞ ∞...
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Operation and MU_010_IT 15/06/15 maintenance manual Rev.4 Pag. 14 di 29 Wall model ∞ 180° Floor model 10°...
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Operation and MU_010_IT 15/06/15 maintenance manual Rev.4 Pag. 15 di 29 The Product can be moved using the sterilisable grip (fig. A) or by means of the side handles (fig.B) Fig.B Fig.A By pressing the keys on the membrane keyboard, the previously described control functions are started (fig.
Operation and MU_010_IT 15/06/15 maintenance manual Rev.4 Pag. 16 di 29 6 Cleaning and disinfecting 6.1 Cleaning the Product Frequency The Product is best cleaned every time before use. WARNING – Electric shock hazard Before cleaning the product, make sure it is off and cannot be switched back on.
Operation and MU_010_IT 15/06/15 maintenance manual Rev.4 Pag. 17 di 29 6.2 Product disinfecting Frequency The Product is best disinfected daily. WARNING – Electric shock hazard Before proceeding to clean the Product, make sure it is off and cannot be switched back on. Allow the lamp to cool down and only clean it when it is cold.
Operation and MU_010_IT 15/06/15 maintenance manual Rev.4 Pag. 18 di 29 6.3 Sterilizing hand-pieces Frequency The hand-pieces must be sterilized before use and can withstand up to 200 cycles. The operator must comply with the rules of the national commission for hygiene, disinfection and sterilization.
Operation and MU_010_IT 15/06/15 maintenance manual Rev.4 Pag. 19 di 29 7 Adjustments and maintenance 7.1 Setting the swinging arm See drawing 123 The Product is sold already balanced and does not require further adjustment. In the event of the spring swinging arm becoming stiff or loose over time, mechanical intervention is possible by regulating the compression of the internal spring.
Operation and MU_010_IT 15/06/15 maintenance manual Rev.4 Pag. 20 di 29 7.3 Periodical checks to be performed on the Product CAUTION – Product electrical check At the time of start up and after each maintenance job, perform electrical tests and jobs indicated in the IEC 62353 standard. 7.4 Routine maintenance CAUTION –...
Operation and MU_010_IT 15/06/15 maintenance manual Rev.4 Pag. 21 di 29 7.5 Repairs CAUTION – Unsuitable repairs The Product must only be opened and repaired by the Service Personnel. 7.6 Disposal after use Disposal at the end of The used Product contains valuable materials which can be recycled. life cycle Dispose of the used Product in an environment-friendly way and in compliance with applicable national directives on waste disposal.
Operation and MU_010_IT 15/06/15 maintenance manual Rev.4 Pag. 22 di 29 8 Technical properties Technical details of light ORION 40 ORION 40DS (a 80cm) Illumination E ± 10% (5.000°K) [Lux] 130.000 130.000 Illumination E ± 10% (4.500°K) [Lux] 80.000 100.000 Illumination E at 80 cm ±...
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Operation and MU_010_IT 15/06/15 maintenance manual Rev.4 Pag. 23 di 29 Light source N°30 Led x 1.4W Duration of LED diode light source [hr] (this figure can vary according to power peaks and 50.000 operating frequency) 50 – 100 Light intensity control [%] General data Colour RAL 9003...
Declaration of Conformity of the Manufacturer The company: TECNO-GAZ S.P.A. Strada Cavalli n. 4 - CAP 43038 - Sala Baganza – Parma – ITALY Declares under its own responsibility that the Product (Medical lighting device for surgical and diagnosis use):...
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Operation and MU_010_IT 15/06/15 maintenance manual Rev.4 Pag. 25 di 29 EMC Declaration The Product has been tested according to EN60601-1-2 standard to ensure correct electromagnetic compatibility. Portable and mobile communication appliances can affect the Product. Other appliances used in the proximity of the product must also be in conformity with this standard.
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Operation and MU_010_IT 15/06/15 maintenance manual Rev.4 Pag. 26 di 29 IEC 60601-1-2 Electromagnetic Immunity test Compliance level test level environment-guidance Electrostatic +/- 6 kV contact +/- 6 kV contact Floors should be wood, discharge +/- 8 kV air +/- 8 kV air concrete or ceramic tile.
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Operation and MU_010_IT 15/06/15 maintenance manual Rev.4 Pag. 27 di 29 IEC 60601 test Compliance Electromagnetic environment- Immunity test level level guidance Portable and mobile RF communications equipment should be used no closer to any part of the Product, included cables, than the recommended separation distance calculated from the equation applicable to the frequency of the...
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Operation and MU_010_IT 15/06/15 maintenance manual Rev.4 Pag. 28 di 29 Recommended separation distance between portable an mobile RF communications 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 prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Product as recommended below, according to the maximum output power of the communications equipment.
2. La garanzia ha inizio dalla data di installazione della lampada presso il cliente solo ed esclusivamente se l’installazione è effettuata da personale TECNO-GAZ. In tutti gli altri casi la garanzia decorre dalla data di spedizione della lampada dal magazzino TECNO-GAZ al cliente.
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19. I prodotti che rientrano in TECNO-GAZ, devono avere allegata la documentazione d’autorizzazione al rientro e un documento in cui sia descritto il guasto. Spedizione reso 20. Tutti i prodotti in riparazione devono essere spediti a TECNO-GAZ in porto franco e adeguatamente imballati (è obbligo utilizzare l’imballo originale). Non responsabilità...
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Operation and MU_010_IT 15/06/15 maintenance manual Rev.4 Pag. 31 di 29 Note...
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