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Operative Manual 

MO079-IT 

15/06/12 

Rev.0 

Pag. 12 di 16 

 

 

 

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. 
The Product is intended for use in the electromagnetic environment specified below. The customer or the user of 
the Product should assure that these are used in such an environment. 

 

Emissions test 

Compliance 

Electromagnetic environment-guidance 

RF emissions 
CISPR 11 

Group 1 

The Product uses RF energy only for its internal 
function. Therefore, its RF emissions are very low 
and are not likely to cause any interference in nearby 
electronic equipment.  

RF emissions 
CISPR 11 

Class A 

The Product is suitable for use in all establishments 
other than domestic, and may be used in domestic 
establishments and those directly connected to the 
public low-voltage power supply network that 
supplies buildings 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 interference or 
may disrupt the operation of nearby equipment. It 
may be necessary to take mitigation measures, such 
as re-orienting or relocating the Product or shielding 
the location  

Harmonic emissions  
IEC 61000-3-2 

Class A 

Voltage fluctuations/ 
flicker emissions  
IEC 61000-3-3 

Compliance 

      
 

 

Immunity test 

 

IEC 60601-1-2 

 test level 

Compliance level 

Electromagnetic environment-

guidance 

Electrostatic discharge 
(ESD) 
 IEC 61000-4-2 

+/- 6 kV contact 
+/- 8 kV air 

+/- 6 kV contact 
+/- 8 kV air 

Floors should be wood, concrete 
or ceramic tile. 
If floors are covered with 
synthetic material, the relative 
humidity should be at least 30% 

Electrical fast transient / 
burst IEC 61000-4-4 

+/- 2 kV  
for power supply unit 
+/- 1 kV  
for input/output lines 

+/- 2 kV  
for power supply 
lines 
+/- 1 kV  
for input/output lines 

Mains power quality should be 
that of a typical commercial or 
residential  environment.  

Surge 
IEC 61000-4-5 

+/- 1 kV  
differential mode 
+/- 2 kV  
common mode 

+/- 1 kV  
differential mode 
+/- 2 kV  
common mode 

Mains  power  quality  should  be 
that  of  a  typical  commercial  or 
hospital environment. 

Содержание PRIMALED

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

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