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Operative Manual 

MO079-IT 

15/06/12 

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.

  

The Product, in compliance with the standard IEC 60601-2-41,

 

is assesses as luminaire for diagnosis: 

-

 

Luminaire to illuminate the body of the patient locally in order to support diagnosis or treatment which could 

be interrupted without any hazard for the patient in case of failure of the light. (Is not intended to be used in 
operating rooms) 

 

 

3.2

 

Enviromental conditions 

-

 

The Product is not suitable for use in explosion-risk areas. 

-

 

The Product is not suitable for use in the presence of inflammable mixtures of anaesthetics with air, oxygen or 
NO

2

 (laughing gas). 

-

 

During operation, the ambient temperature must be between 10°C and 40°C. 

-

 

Relative humidity must be between 30% and 75%. 

-

 

Atmospheric pressure must be between 700 and 1060hPa. 

 

3.3

 

Other secondary conditions (secondary effects) 

-

 

Do not direct the light source into the patient’s and/or operator’s eyes. 

-

 

Obligation to adequately protect the patient’s eyes. 
Failure to follow such precautions 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 objects falling in 
the operating area. 

-

 

Never hang on the Product with the body weight of a person. 
Unless this precaution is taken, mechanical parts of the Product could be damaged. 

-

 

Never cover the head of the Product during operation. 
Failure to comply could prevent heat exchange with the environment and the Product could overheat. 

-

 

Avoid knocking the rocker arms and Product head. 
A violent knock could damage the Product and pieces of paint could chip off and fall onto the operating field in 
the patient area. 

 

4.

 

Description of the operations 

The membrane keyboard is fitted to the light head and grants the following functions:  

-

 

On/off switch by means of the membrane key I/O (1) 

-

 

Light intensity adjustment by pressing the keys (2) and (3), with display of intensity reached by means of  3 

green position micro LEDs 

-

 

Colour temperature selection by pressing the key with the letter “K” (3) while the set value is displayed by 

means of the lighting up of one of the 2 green micro LEDs 

-

 

Courtesy light selection by pressing the key with the letter “C”, three leds without lens offer a soft light not 

suitable for examination (5).  Courtesy light is available only when lamp is switched-off, it can be adjusted the 
light intensity but not the color temperature. Press key I/O (1) to have the standard functioning.

 

 

 

 

 

The light field is not adjustable. 

 

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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