Pag. 1 di 12 Operative manual for diagnosis lamp GIMANORD Via Marconi, 1 – 20060 GESSATE (MI) ITALIA Tel. +39 02 953854209 Fax +39 02 95381167 http://www.gimaitaly.com e-mail: gima@gimaitaly.com Itroduction Pag. 1. General information Qualification of operators. Packaging, Transport, Storage, and Characteristic of the installation site Graphic symbols used on the Product and packaging CE declaration of Conformity of the Manufacturer.
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, including partial, or translation of any part of this manual is forbidden without the written permission of GIMA.
Routine maintenance (about every year) Qualified technician in possession of professional technical requirements Special maintenance (in case of necessity) Qualified technician in possession of professional technical requirements Assistance GIMA or authorized dealer Cleaning Properly trained medical and paramedical personnel Demolition In compliance with the national directives applicable to waste disposal.
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 lighting device for surgical and diagnosis use): GIMANORD APPLICARE ETICHETTA made by RIMSA P.LONGONI S.r.l., complies with Annex VII of Directive 93/42/EEC dated 14/05/1993, and subsequent amendments (including Directive 2007/47/EC dated 05/09/2007) and the following standards: ...
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.
MO082-IT 22/04/13 Operative Manual Rev.0 Pag. 6 di 12 2. Product Installation Before installing the Product, make sure that all the packages are present and in good condition, without any transport-related damage, and that the contents correspond to what is specified above. Claims will be considered only if the seller or the forwarder are informed immediately.
MO082-IT 22/04/13 Operative Manual Rev.0 Pag. 7 di 12 3. Importance of personal safety 3.1 Intended use The Product is made to light up the area occupied by the patient undergoing diagnostic or observation, and has been designed for use in medical surgeries. The Product correctly lights up the field of work from a minimum distance of 40cm to a maximum distance of 70cm from the point of light emission.
MO082-IT 22/04/13 Operative Manual Rev.0 Pag. 8 di 12 5.2 Disinfecting Switch the Product off by means of the removing of plug and make sure it cannot be switched back on. Protect the Product against water spray and do not clean it/disinfect it with liquids. Leave the lamp body to cool down.
Check the condition of the Product paint. Make sure there are no paint pieces that could Once a year fall on the operating field. 7. Technical data Technical data GIMANORD Illumination Ec at a distance of 50cm [Lux] ± 10% Data on electrical connection Primary alternating voltage [Volt ac] 220-240...
MO082-IT 22/04/13 Operative Manual Rev.0 Pag. 10 di 12 Protection against direct and indirect contacts B-type device Dimensions Overall dimension [mm] 1200x300x100 Lamp weight [Kg] Certificate Complying with directive 93/42/EEC (included 2007/47/EC) All lighting values are subject to a tolerance of ± 6% due to manufacturing and metrological reasons. 8.
MO082-IT 22/04/13 Operative Manual Rev.0 Pag. 11 di 12 9. EMC declaration The Product has been tested in accordance to EN60601-1-2 to ensure proper electromagnetic compatibility. Portable and mobile RF-communications equipment can affect the Product. Other products used in the vicinity of Product should also comply with this standard.
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MO082-IT 22/04/13 Operative Manual Rev.0 Pag. 12 di 12 Compliance Immunity test IEC 60601 test level Electromagnetic environment-guidance level 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 transmitter.
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