H i k o n e b | 9 0 8 D C
Us e r Ma n ua l
13. Electromagnetic Conformity
The nebulizer can operate without being affected by electromagnetic frequencies at a
certain level. Ultrasonic Nebulizers Electromagnetic Conformity Directive (89/336/AT).
The device has been tested and manufactured conforming to the Medical Devices
EEC/93/42 Medical Devices Rules and EN 60601-1 and EN60601-1-2 Electromagnetic
conformity. EMC Test
Test
TS EN 61000-4-2
Electrostatic Discharge
Immunity
TS EN 61000-4-3
Beaming, RF, Electro
Magnetic Area Immunity
TS EN 61000-4-4
Electrical Rapid Temporary
Regime/ Explosion
İmmunity
TS EN 61000-4-5
Immunity Against Sudden
Increases
TS EN 61000-4-6
Its Immunity Against
Inducted and Transmitted
Breaks by RF Areas
TS EN 61000-4-8
Main frequency magnetic
area immunity
32
Level
With contact: ± 8 kV
From air: ± 2 – 4 – 8 -
15 kV
10V
±2 kV 100 kHz
L-N: ± 0,5 - 1 - 2 kV
L-PE: ± 0,5 - 1 - 2 kV
3 V
30 mA
Ambient
Laying where the device is placed,
should be wooden, concrete or
ceramic. If laying is synthetic, relative
humidity should be 30% at least.
Portable and movable RF devices
should not be approached to our
device. Required distances have been
given below.
Power feeding should be on mains or
hospital installation quality, in building
power input, Leakage Current Protective
Relay should be plugged if there is not.
Power feeding should be on mains or
hospital installation quality, in building
power input, Leakage Current Protective
Relay should be plugged if there is not.
Portable and movable RF devices
should not be approached to our
device. Required distances have been
given below.
Its power frequency magnetic area
should be in hospital or mains quality.
Our devices have no magnetic break
effect on power network.