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Operative Manual 

MO079-IT 

15/06/12 

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. Only clean the lamp body when it is cold. 
Clean with appropriate detergent with low alkaline content and chlorine free.  
Do not use abrasive products, petrol, paint thinners, alkaline detergents, acids, containing alcohol or aldehydes;  
Dose the detergents so no liquids penetrate into the lamp bodies and into the support arm system. 
Clean the Product with a damp but not wet cloth. 

 

5.2

 

Disinfecting 

 

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. Only disinfect the lamp body when it is cold. 
Disinfectants can contain substances which are harmful for the health: only use disinfectants in accordance with the 
rules on hygiene established by the hospital. 
The  Product  operator  must  comply  with  the  rules  established  by  the  national  commission  for  hygiene  and 
disinfection. 
To  prevent  damaging  parts  in  stainless  steel  or  aluminum,  only  use  disinfectants  which  are  chlorine  and  halogen 
free.  
To prevent the plastic 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 damp but not wet cloth. 

 

5.3

 

Sterilizing the handpieces 

 

Replace the handpieces as soon as these become cracked or deformed, as these could fall in the wound area. 
The Product operator must comply with the rules of the national commission for hygiene and disinfection.

 

Handpiece fitting / removal: 
- rotate counter clockwise the handpiece for remove it. 
- rotate clockwise the handpiece, until it to beat the head lamp and the rotation result impossible. 
Cleaning, disinfecting and sterilizing the handpiece: 
The handpieces are made of plastic material resistant to heat and knocks (PPSU). 
They can be cleaned with a neutral or lightly-alkaline detergent free of active chlorine.  
To  disinfect  the  handpieces,  we  suggest  using  alcohol  or  aldehyde-based  products.  The  disinfectants  must  be 
approved by the manufacturer for use on polyphenylsulfone (PPSU). 
Before sterilizing, rinse the handpieces. 
The handpieces can withstand about 300 steam sterilization cycles as follows: 
-

 

steam sterilization at 121°C  1.3bar from 25 to 30 minutes, 

or 
-

 

steam sterilization at 134°C  2.3 bar for 4 minutes. 

Position the handpieces straight with open side downwards. 
Do not exceed a sterilization temperature of 134°C. 
Avoid the handpieces coming into contact with other objects during the sterilizing process. 

 
Each Product, over time, is subject to a certain amount of wear. Product safety and operation must therefore 
be checked during inspection and maintenance intervals.  

 
 
 
 
 
 
 

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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