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Operative manual for diagnosis lamp
TABLE OF CONTENTS
1.1
1.2
1.3
1.4
1.5
2.1
2.2
2.3
2.4
2.5
2.6
3.1
3.2
3.3
5.1
5.2
5.3
6.1
6.2
6.3
Adjustments
6.4
6.5
6.6
Operative Manual
PRIMALED
PRIMALED-FLEX
Via Marconi, 1 - 20060 GESSATE (MI) ITALIA
http://www.gimaitaly.com e-mail: gima@gimaitaly.com
MO079-IT
15/06/12
Rev.0
Pag. 1 di 16
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Summary of Contents for Gima PRIMALED
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Page 1: Table Of Contents
Pag. 1 di 16 Operative manual for diagnosis lamp PRIMALED PRIMALED-FLEX Via Marconi, 1 – 20060 GESSATE (MI) ITALIA Tel. +39 02 953854209 Fax +39 02 95381167 http://www.gimaitaly.com e-mail: gima@gimaitaly.com TABLE OF CONTENTS Pag. Introduction 1. General information Qualification of operators... -
Page 2: Tel. +39 02 953854209 Fax +39 02 95381167
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. -
Page 3: Qualification Of Operators
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. -
Page 4: Ce Declaration Of Conformity Of The Manufacturer
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): PRIMALED/ PRIMALED-FLEX 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: ... -
Page 5: Warranty Certificate
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. -
Page 6: Product Installation
MO079-IT 15/06/12 Operative Manual Rev.0 Pag. 6 di 16 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. -
Page 7: Importance If Personal Safety
MO079-IT 15/06/12 Operative Manual Rev.0 Pag. 7 di 16 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. -
Page 8: Cleaning And Disinfection
MO079-IT 15/06/12 Operative Manual Rev.0 Pag. 8 di 16 5. Cleaning and disinfection 5.1 Cleaning the Product Switch the Product off by means of the operating theatre main switch 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. -
Page 9: Adjustments
MO079-IT 15/06/12 Operative Manual Rev.0 Pag. 9 di 16 6. Adjustments 6.1 Yearly inspections by the operator Keep to the yearly inspection schedules and inspect the product according to IEC 62353 standard. 6.2 Repairs The Product must only be opened and repaired by a technician who has attended a course on the Product organised by the manufacturer or by a qualified technician in possession of the necessary technical skills. -
Page 10: Technical Data
Protection against direct and indirect contacts B-type device Dimensions Lamp body diameter [cm] 19,5 Diameter of the poly-elliptical reflector [cm] Light emission surface [cm Lamp weight (Primaled / Primaled-Flex) [Kg] 3,5 / 3,3 Certificate Complying with directive 93/42/EEC (included 2007/47/EC) -
Page 11: Electrical Diagram
MO079-IT 15/06/12 Operative Manual Rev.0 Pag. 11 di 16 Electrical diagram... -
Page 12: Emc Declaration
MO079-IT 15/06/12 Operative Manual Rev.0 Pag. 12 di 16 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. - Page 13 MO079-IT 15/06/12 Operative Manual Rev.0 Pag. 13 di 16 Voltage dips, short <5% U <5% U Mains power quality should be interruptions and voltage (>95% dip in U (>95% dip in U that of a typical commercial or variations power For 0,5 cycle For 0,5 cycle hospital environment.
- Page 14 MO079-IT 15/06/12 Operative Manual Rev.0 Pag. 14 di 16 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.
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Page 15: Friction Regulation
MO079-IT 15/06/12 Operative Manual Rev.0 Pag. 15 di 16 10. Friction regulation The device is provided already balanced and no further adjustments are required; however, if over time the movement of arms around their rotation joints should became too rigid or too soft, so as to not allow the maintenance in position of the device itself, it is possible to act on the different friction systems in order to restore the correct balance. - Page 16 MO079-IT 15/06/12 Operative Manual Rev.0 Pag. 16 di 16 Note...
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