Gima SATURNO WALL User Manual Download

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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: [email protected]

Summary of Contents for SATURNO WALL

Page 1: ...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 acco...

Page 2: ...tten 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 th...

Page 3: ...Mechanical and electrical preparation of the premises 2 1 Mechanical preparation of the premises 13 2 1 1 Wall plate anchorage with REINFORCED CONCRETE slab 14 2 1 2 Wall plate anchorage with SECONDA...

Page 4: ...Technical data and performance of the apparatus 25 Chapter 5 Maintenance 5 1 Calibrating the oscillating arm and horizontal arm 26 5 2 Extraordinary maintenance 27 5 3 Repairing faults and anomalies...

Page 5: ...late with the EC mark portrayed below and by the declaration of conformity accompanying the present manual SATURNO wall scialytic lamp re traceability plate MEDICAL EQUIPMENT Seregno Mi Italia MOD a S...

Page 6: ...device fuses employed in the device Upper side of the packing Maximum number of stackable packages Fragile package Unsuitable package in humidity Do not superimpose pallets over the packages Package w...

Page 7: ...achment IX Short term active and not invasive medical device destined for local illumination of the patient In terms of the above the device is considered as falling into class I according to rule 1 C...

Page 8: ...d of the surgical intervention might overheat and dry up There is indeed the danger of necrosis of the tissue with prolonged use over time Do not place any objects on the body of the lamp nor hang obj...

Page 9: ...y regulation EN 60601 2 41 Classification with reference to article 9 and Attachment IX of the 93 42 CEE Directive DURATION Short term Par 1 Definitions art 1 paragraph 1 1 attachment IX DESCRIPTION N...

Page 10: ...duct or upon which ordinary maintenance has not been practised or the elementary principles of good maintenance have been neglected negligence 10 Compensation for the Lamp going out is not recognised...

Page 11: ...ical life phases Responsible operator qualification Installation GIMA or qualified Installer Maintenance operator Use Authorised medical personnel Ordinary maintenance GIMA or company maintenance Extr...

Page 12: ...at the following temperature Temperature 5 40 C Humidity 30 90 including condensation Atmospheric pressure 500 1060 h Pa The premises designated for setting up the apparatus must have the following ch...

Page 13: ...ety because the stability of the structure may be compromised Make sure of the following conditions before installing the lamp the wall must have a capacity to keep 10Kg at 200cm shared out on the pla...

Page 14: ...5 12 18 105 93 125 80 19 25 do Nominal point diameter Mt Moment of tightening twist t Minimum perforation depth Sw Opening the wrench hs Minimum insertion depth x Fixing height l Length of anchorage s...

Page 15: ...s need to be tightened on the threaded bars placing a drop of Loctite code 243 medium thread delay 2 1 2 Anchoring plate with wall in SECONDARY CONCRETE In this case it is compulsory to sandwich the w...

Page 16: ...sted requisites identify which of the following types of electrical plant you are facing Chapter 3 Installing the product 3 1 Installing wall plate The first operation to execute consists in using the...

Page 17: ...ontal arm to 2 Keep aligned on the same axis the parts to couple and align the hole of the contact crawling 3 with the threaded hole of the horizontal arm 4 that will have then to be centred from scre...

Page 18: ...wing the screw is felt to force it means that the hole of the contact has not been cantered from the screw and therefore must re centered following the described modality over If the crawling contact...

Page 19: ...tension to the bulb To supply tension from the predisposed general switch for the scialytic switch on the light and verify that the lamp gives light Now it is necessary to find the tension with a mul...

Page 20: ...and verify that is between 12 0 and 13 0 Volt 10 Check the correct insertion of the halogen bulb flush on the lamp holder and on the vertical 11 Take care not to touch the halogen bulb with your fing...

Page 21: ...there is the command panel that allows turning the lamp on and off and adjusting the luminous intensity The horizontal arm is in its turn connected centrally to a tube join to a flange in aluminium wi...

Page 22: ...e handle Simple cleaning the handles that can be sterilised consist of thermo hardened material resistant to hear and shock resistant They can be cleaned with slightly alkaline cleaners without active...

Page 23: ...le must be sterilised unpacked at 134 C for 3 minutes Handle disposal sterilise the now worn out handle to avoid contamination and eliminate it according to the normal procedures for non biologically...

Page 24: ...the entire guarantee on the maintenance of the technical data of the lamp and the perfect functioning of the product luminous intensity and focus is forfeited 4 4 Changing fuses Before proceeding to...

Page 25: ...adiation visible and IR W m2 190 Irradiation Illumination m W m2 klx 4 75 Index of chromatic yield Ra 94 Diameter of the luminous field d10 and d50 mm d10 150 d50 78 Depth of illumination mm 1280 Data...

Page 26: ...librating the oscillating arm Paragraph 5 1 5 1 Calibrating the oscillating and horizontal arm The lamp is sold already balanced and no further calibration is necessary If over time the oscillating ar...

Page 27: ...f the bulb detachment of parts of the paint from the apparatus due to accidental collision with other objects these fragments can fall onto the patient zone during the use of the device For the cases...

Page 28: ...is faulty 5 The luminous band on the operating field is not in focus Check the correct insertion of the halogen bulb it must be perpendicular to the bulb holder 6 The bulb breakage frequently With a...

Page 29: ...MO003 GB 18 05 06 Operative Manual Rev 0 Page 29 of 34 Chapter 6 Electrical diagrams 5 1 General electrical diagram...

Page 30: ...MO003 GB 18 05 06 Operative Manual Rev 0 Page 30 of 34 6 2 Explode drawing...

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