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Operative Manual 

MO082-IT 

22/04/13 

Rev.0 

Pag. 11 di 12 

 

 

 

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. 

Voltage dips, short 
interruptions and voltage 
variations on power supply 
input lines  
IEC 61000-4-11 

<5% U

T

 

(>95% dip in U

T

For 0,5 cycle 
 
40% of U

(60% dip in U

T

For 5 cycles 
 
70% of U

(30% dip in U

T

For 25 cycles 
 
<5% U

(>95% dip in U

T

For 5 sec 

<5% U

T

 

(>95% dip in U

T

For 0,5 cycle 
 
40% of U

(60% dip in U

T

For 5 cycles 
 
70% of U

(30% dip in U

T

For 25 cycles 
 
<5% U

(>95% dip in U

T

For 5 sec 

Mains  power  quality  should  be  that 
of  a  typical  commercial  or  hospital 
environment. 
If  the  user  of  the  Product  requires 
continued  operation  during  power 
mains 

interruptions, 

it 

is 

recommended  that  the  Product  be 
powered  from  an  uninterruptible 
power supply or battery. 

Power frequency (50/60Hz)   
magnetic field  
IEC 61000-4-8 
 

3 A/m   

3 A/m 

Power  frequency  magnetic  fields 
should be at levels characteristic of a 
typical 

location 

in 

typical 

commercial or hospital environment. 

NOTE U

T

 is the a.c. main voltage prior to application of the test level. 

Summary of Contents for GIMANORD

Page 1: ...2 1 Installation 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 In...

Page 2: ...n The ME Medical Electrical EQUIPMENT to which this manual refers is a LAMP for diagnosis or observation For easier description such ME EQUIPMENT will be indicated in this manual with the name of Prod...

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: ...and essential 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 DURAT...

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: ...ion screws 2 Put the clamp on 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...

Page 7: ...autions 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 s...

Page 8: ...therefore be checked during inspection and maintenance intervals 6 Adjustments 6 1 Yearly inspections by the operator Keep to the yearly inspection schedules and inspect the product according to IEC...

Page 9: ...year Check the condition of the Product paint Make sure there are no paint pieces that could fall on the operating field 7 Technical data Technical data GIMANORD Illumination Ec at a distance of 50cm...

Page 10: ...d indirect contacts B type device Dimensions Overall dimension mm 1200x300x100 Lamp weight Kg 3 Certificate Complying with directive 93 42 EEC included 2007 47 EC All lighting values are subject to a...

Page 11: ...sions 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...

Page 12: ...nications 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...

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