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Operative Manual 

MO079-IT 

15/06/12 

Rev.0 

Pag. 3 di 16 

 

 

 

1.1

 

Qualification of operators

 

This paragraph describes the requirements and qualifications which the operators involved in the various stages of 
Product life and use must possess. 

 

Installation 

Qualified Installer and/or Technician 

Use 

Professional medical personnel

 

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. 

 

1.2 Packaging, transport, Storage and characteristic of the installation site 

Boxes containing the whole structure, with installation manual and user manual.  
Transport is carried out by any road haulage contractor as long as they respect the following characteristics: 
Temperature (°C): -15 / +60; Humidity: 10 / 75 %; Atmospheric pressure (h/Pa): 500 / 1060. 
The devices packaged must be stored (warehoused) in a dry place and at the following temperature: 
Temperature (°C): +10 / +40;

  

Humidity: 10 / 75 %;

  

Atmospheric pressure (h/Pa): 500 / 1060. 

The site appointed for the installation of the equipment must have the following characteristics:

 

Temperature (°C): +10 / +40;

  

Humidity: 30 / 75 %;

  

Atmospheric pressure (h/Pa): 700 / 1060.

 

 

1.3 Graphic symbols used on the Product and packaging 

Description symbols present on labels, on product, and manual: 

 

 

Graphic  symbol  proving  the  CE  marking 
of the product

 

 

RECYCLING!  Product  must  be  recycled 
separately

 

 

Symbol  indicating  the  manufacture  date 
(month and year) 

 

B-Type  device.  Indicates  the  level  of 
protection  against  direct  and  indirect 
contact

 

 

Consult accompanying document

 

 

Attention 

 

Address of the Manufacturer  

 

Maximum number of packages stackable

 

 

Maximum number of packages stackable

 

 

Breakable package

 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Summary of Contents for PRIMALED

Page 1: ...ation mobile version 6 2 2 Installation wall version S 12MED fixing 6 2 3 Installation wall version rail bar fixing 6 2 4 Installation table version S11 fixing 6 2 5 First starting 6 2 6 Installation...

Page 2: ...alian edition of this operator s manual 1 General information The ME Medical Electrical EQUIPMENT to which this manual refers is a LAMP for diagnosis or observation For easier description such ME EQUI...

Page 3: ...tion manual and user manual Transport is carried out by any road haulage contractor as long as they respect the following characteristics Temperature C 15 60 Humidity 10 75 Atmospheric pressure h Pa 5...

Page 4: ...ential performance Collateral standard Electromagnetic compatibility Requierements and tests Classification with reference to article 9 and Annex IX of Directives 93 42 EEC and 2007 47 EC DURATION Sho...

Page 5: ...ot above 40 of the net value of the product as indicated on the buyer s invoice GIMA s liability is expressly ruled out for indirect damages or consequential damages including cases of the lamp not be...

Page 6: ...the bar and tighten the handle 3 Insert the lamp into the upper hole of the rail clamp 4 Follow points 2 and 3 of paragraph 2 1 2 4 Installation table version S11 fixing 1 Fix the clamp S 11 to the ta...

Page 7: ...ions could cause glare and potential damage to the retina Never place and or hang anything on the Product Unless this precaution is taken positioning will not be reliable and the danger exists of such...

Page 8: ...ic parts becoming fragile use only disinfectants with low alcohol content Dose the disinfectants so no liquids penetrate inside the lamp bodies and into the support arm system Clean the Product with a...

Page 9: ...tch on Check the INPUT and OUTPUT 24V power supply voltage and the voltage of the electronic board terminal 24V 2 The Product does not remain in position See the attached instructions 3 The light flic...

Page 10: ...240 Frequency Hz 50 60 Absorbed power VA 30 Light source N 12 Led x 1 4W LED light source duration h this datum can vary according to voltage peaks and the frequency of use 50 000 Light intensity con...

Page 11: ...Operative Manual MO079 IT 15 06 12 Rev 0 Pag 11 di 16 8 Electrical diagram...

Page 12: ...ngs used for domestic purposes provided the following warning is heeded Warning This equipment system is intended for use by healthcare professionals only This equipment system may cause radio interfe...

Page 13: ...cial or hospital environment NOTE UT is the a c main voltage prior to application of the test level Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Conducted R...

Page 14: ...transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 24 0 1 0 38 0 38 0 73 1 1 2 1...

Page 15: ...to adjust the friction force in correspondence of rotational joints and therefore the consequent movement of movable arms ROTATION JOINTS Depending on the version of the device there is a different n...

Page 16: ...Operative Manual MO079 IT 15 06 12 Rev 0 Pag 16 di 16 Note...

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