Gima SATURNO WALL Operative Manual
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Gima SATURNO WALL Operative Manual

Gima SATURNO WALL Operative Manual

Secondary scialytic lamp
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MO003-GB
18/05/06
Operative Manual
Rev.0
Page 1 of 34
Operative Manual
Installation – Use – Maintenance
Secondary Scialytic Lamp
for surgery
SATURNO WALL
This manual is an integral part of the lamp according to the provisions
envisaged
by
the
93/42/CEE
European
Directive
and
successive
modifications and integrations.
The present manual must always accompany the Medical Device.
Via Monza, 102 – 20060 GESSATE (MI) ITALIA
Tel. +39 02 9538541 Fax +39 02 95381167
http://www.gimaitaly.com e-mail: gima@gimaitaly.com

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Summary of Contents for Gima SATURNO WALL

  • Page 1 Operative Manual Rev.0 Page 1 of 34 Operative Manual Installation – Use – Maintenance Secondary Scialytic Lamp for surgery SATURNO WALL This manual is an integral part of the lamp according to the provisions envisaged 93/42/CEE European Directive successive modifications and integrations.
  • Page 2 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.

  • Page 3: Table Of Contents

    MO003-GB 18/05/06 Operative Manual Rev.0 Page 3 of 34 Page CONTENTS Chapter 1 – General Information Manufacturer identification data Identification data of the apparatus, EC marking and re-traceability Classification and destination of use of the device Safety considerations (undesirable secondary effects) Declaration of EC conformity Guarantee Technical assistance...
  • Page 4 MO003-GB 18/05/06 Operative Manual Rev.0 Page 4 of 34 Changing the bulb Changing fuses Technical data and performance of the apparatus Chapter 5 – Maintenance Calibrating the oscillating arm and horizontal arm Extraordinary maintenance Repairing faults and anomalies Spare parts list Chapter 6 –...

  • Page 5: Chapter 1 - General Information

    ITALIA 1.2 Identification data of the apparatus, EC marking and re-traceability The SATURNO wall secondary scialytic lamp for surgery is designed and constructed according to the provisions of the 93/42/CEE directive. Conformity is documented by the plate with the EC mark (portrayed below) and by the declaration of conformity accompanying the present manual.
  • Page 6 MO003-GB 18/05/06 Operative Manual Rev.0 Page 6 of 34 Type B apparatus. Indicates the level of protection against direct and indirect contact. Graphic symbol confirming the EC product mark. Symbol indicating the manufacturing date (month and year). Protection device: fuses employed in the device. Upper side of the packing.

  • Page 7: Classification And Destination Of Use Of The Device

    MO003-GB 18/05/06 Operative Manual Rev.0 Page 7 of 34 1.3 Classification and destination of use of the device Classification according to a particular regulation (CEI EN 60601-2-41 regulation section 2) Secondary scialytic lamp for surgery (treatment lamp): single lamp in the patient zone that assures an adequate illumination at the centre to illuminate the patient’s body locally.

  • Page 8: Safety Considerations (Undesirable Secondary Effects)

    MO003-GB 18/05/06 Operative Manual Rev.0 Page 8 of 34 1.4 Safety indications (undesired secondary effects) • The incorrect use and non-observance of the precautionary measures reported here can provoke serious accidents. You must, therefore, understand the functions of the SATURNO scialytic lamp using these instructions for installation, use and maintenance.

  • Page 9: Declaration Of Ec Conformity

    RIMSA P. LONGONI S.r.l. Via Monterosa, 18/20/22 - 20038 SEREGNO (MI) - ITALIA declares on its own responsibility that the Medical Illumination Device for surgical and diagnostic use: SATURNO WALL APPLICARE ETICHETTA constructed by RIMSA P.LONGONI S.r.l., conforms to the Attachment VII of the 93/42 EEC Directive of June 14 1993 and applied in Italy by the Legislative Decree N°...

  • Page 10: Guarantee

    15. GIMA does not accept returns from the final users. 16. Returns to GIMA for repair must be managed by the retailer or the assistance centre chosen by the final user in conformity with the Company PO 7.2 Operative Procedure.

  • Page 11: Technical Assistance

    GIMA or authorised dealer Demolition GIMA, qualified Installer/ Maintenance operator GIMA does not accept any responsibility for eventual damage to people or things as a result of employing unqualified operators. Qualified Installer/Maintenance operator means a male or female person/or male or female people who has/have completed a course at the GIMA...

  • Page 12: Packing, Transport, Stockage And Characteristics Of The Installation Premises

    Packing Content LxDxH (Kg) Scialytic lamp + Operative Manual 73x143x43 22,5 Transport is carried out by GIMA or by any carrier as long as the following characteristics are respected: Temperature (-20/+60)°C Humidity (30/90) % (including condensation) Atmospheric pressure (500/1060) h/Pa...

  • Page 13: Chapter 2 - Mechanical And Electrical Preparation Of The Premises

    MO003-GB 18/05/06 Operative Manual Rev.0 Page 13 of 34 Chapter 2 – Mechanical and electrical preparation of the premises The preparatory masonry and electrical work for installing the Product is at the total expense of the Final Client. 2.1 Mechanical preparation of the premises The preparatory masonry work of the slab for installing the product must be carried out in a solid and safe way according to good rules by qualified personnel.

  • Page 14: Wall Plate Anchorage With Reinforced Concrete Slab

    MO003-GB 18/05/06 Operative Manual Rev.0 Page 14 of 34 2.1.1 Plate anchorage with wall in CONCRETE (reinforced concrete) Mechanical anchorage: fix the plate with n° 4 Hilti HSL-G-TZ M12/25 mod. expansion dowels, scrupulously following the indications issued by the Hilti manufacturing company and reported here for information: Anchorage stays (mm)

  • Page 15: Wall Plate Anchorage With Secondary Concrete Slab

    MO003-GB 18/05/06 Operative Manual Rev.0 Page 15 of 34 With the hexagonal dynamometric wrench tighten with the wrench calibrated to the value given by the manufacturer of the dowels and make the anchorage open. The anchorage stay will immediately take the weight. Perforate the other 3 remaining holes and insert the anchorage stays as in previous points 2-5.

  • Page 16: Chapter 3 - Installing The Product

    MO003-GB 18/05/06 Operative Manual Rev.0 Page 16 of 34 Before installing the scialytic lamp make sure of the following conditions: • The electrical plant of the environment (premises) in which the installation will be carried out must conform to the CEI 64-8 regulations (regulations for electrical plant for premises designated for medical use) and the national laws and/or regulations in force.

  • Page 17: Installing Oscillating Arm

    MO003-GB 18/05/06 Operative Manual Rev.0 Page 17 of 34 3.2 Installation oscillating arm Unscrew the three screws TSCE M4x8 from the circular metal ring of the oscillating arm (1). Join the electrical connectors (2) respecting the colours of the electrical cables: •...

  • Page 18: Setting The Correct Tension

    MO003-GB 18/05/06 Operative Manual Rev.0 Page 18 of 34 It is necessary now block the spin of the contact crawling through the insertion of the screw TSCE M3x15 to the arm. With the aid of a screwdriver of the maximum diameter of 2mm, find the hole of the crawling contact moving with small rotating movements the oscillating arm until the screwdriver penetrates at least in order of 8mm in the hole of the contact.

  • Page 19: Setting The Correct Tension To The Transformer

    MO003-GB 18/05/06 Operative Manual Rev.0 Page 19 of 34 Every time you intervene on the transformer ends in both entry and exit to carry out the adjustment of tension, REMOVE the electrical supply to the lamp using the main switch envisaged for the plant of the premises to the scialytic lamp.
  • Page 20 MO003-GB 18/05/06 Operative Manual Rev.0 Page 20 of 34 Checking installation: 1 Check the suitability of the wall on installing the lamp 2 The wall must guarantee a load of 10 Kg to 200cm distance 3 Check that the arrangement of the wall anchorage is suitable for fixing the lamp 4 The lamp must be fixed to the wall with 4 nuts and 4 counter-nuts at each point.

  • Page 21: Chapter 4 - Using The Apparatus

    MO003-GB 18/05/06 Operative Manual Rev.0 Page 21 of 34 Chapter 4 – Using the apparatus 4.1 Description of the apparatus The SATURNO scialytic wall lamp consists of an optical unit (superficially vacuum treated reflecting paraboloid in glass, lamp-holder and one bulb with main functions, upper closure dome in aluminium and lower in tempered glass, external joining ring in aluminium too between the lower glass and upper cap cover and electric cabling).

  • Page 22: Cleaning, Disinfecting, Sterilising

    MO003-GB 18/05/06 Operative Manual Rev.0 Page 22 of 34 4.2 Cleaning, disinfecting, sterilisation 4.2.1 Cleaning and disinfecting the lamp Before proceeding to the cleaning operations, remove the supply to the lamp from the main line switch dedicated to the scialytic lamp All the parts of the lamp can be cleaned with ordinary detergents on all the external surfaces and can be disinfected with ordinary disinfectants in use in the operating department (no corrosive liquids and containing chlorine) using a soft wet cloth.

  • Page 23: Changing The Bulb

    200 cleaning cycles. Damaged handles can no longer be used. The user must take account of the demands of the competent national body on hygiene and disinfection. The GIMA Company does not advise hot air sterilisation. If, however, it becomes necessary, the handle must be sterilised, unpacked, at 134°C for 3 minutes.

  • Page 24: Changing Fuses

    N.B: closing the porthole make attention to insert the three springs of support in the 3 appropriate rabbet and rotate clockwise until the lock of detention. Remove the burnt-out halogen bulb and insert a new GIMA 75W 12V original halogen bulb in the holder. Attention! Do not hold the bulb of the halogen lamp with your bare hands.

  • Page 25: Technical Data And Performance Of The Apparatus

    MO003-GB 18/05/06 Operative Manual Rev.0 Page 25 of 34 4.5 Technical data and performance of the apparatus Technical data on the light Wall SATURNO Technology of the reflecting mirror Reflector in vacuum treated (glass) Warehouse thin layers of SiO (silicon Elimination of heat from the bulb oxide) and Ti O (titanium oxide)

  • Page 26: Chapter 5 - Maintenance

    MO003-GB 18/05/06 Operative Manual Rev.0 Page 26 of 34 Dimensions Lamp body diameter [cm] Internal reflector diameter [cm] Light emission surface [cm Maximum head vertical movement [cm] Scialytic lamp weight [Kg] 22,5 Certificates In conformity with the 93/42/CEE directive Chapter 5 – Maintenance Ordinary maintenance of the apparatus consists of: •...

  • Page 27: Extraordinary Maintenance

    MO003-GB 18/05/06 Operative Manual Rev.0 Page 27 of 34 To adjust the rotation of the horizontal arm and vertical arm, work on the four nuts placed on the bent tube, rotating them with equal intensity Rotate clockwise to have greater frictional force and vice versa to loosen the force for rotating the arm.

  • Page 28: Spare Parts List

    MO003-GB 18/05/06 Operative Manual Rev.0 Page 28 of 34 The lamp flickers The central rotor charcoal does not have good surface contact on the electrical tracks. Open the inspection cover and check the condition visually. Clean the tracks and position the charcoal so that it adheres perfectly to the collector.

  • Page 29: Chapter 6 - Diagrams

    MO003-GB 18/05/06 Operative Manual Rev.0 Page 29 of 34 Chapter 6 – Electrical diagrams 5.1 General electrical diagram...

  • Page 30: Exploded Drawing

    MO003-GB 18/05/06 Operative Manual Rev.0 Page 30 of 34 6.2 Explode drawing...
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  • Page 34 MO003-GB 18/05/06 Operative Manual Rev.0 Page 34 of 34...

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