11
User Manual
14.
ELECTROMAGNETIC COMPATIBILITY
Declaration regarding electromagnetic compatibility in accordance with EN ISO 60601-1-2 is available on
request at the manufacturer’s premises.
The PLASMA IQ device has been tested for compliance with EN ISO 60601-1-2.
The PLASMA IQ device has been classified by EN ISO 60601-1-2 as Group 2, Class B.
The Plasma IQ has an essential performance which is that there shall be no change in operating mode or false alarm , the
delivered power shall not be higher than +20% of the set power.
The PLASMA IQ device is intended for use only in professional healthcare facilities.
The PLASMA IQ device is intended for use in the electromagnetic environment described below. The user is
responsible for ensuring that the environment in which the device is used has met the following requirements.
The PLASAM IQ device is only used with the active electrode.
Description
Comments
Emission of radiated disturbances in accordance with
PN-EN 55011: 2012
Range 30 -1000MHz
Conducted disturbance emission - disturbance voltage
according to PN-EN 55011:2012
Range 0.15 - 30 MHz
Resistance to electrostatic discharge ESD according to
PN-EN 61000-4-2:2011
Air discharge voltage:
2,4,8,15; po/-
Contact -8kV, + 8kV
Resistance to electromagnetic fields with radio frequencies in
accordance with PN-EN 61000-4-3: 2007 + A1; 2008 + A2: 2011
Range 80-2700 mHz 3V/m
Proximity field: 385, 450, 710, 745, 780, 810,
870, 930, 1720, 1845, 1970, 2450, 5240, 5500,
5785 mHz
Resistance to rapid transient (BURST) in accordance with
PN-EN 61000-4-4:2013-05
+/- 2kV, 100Hz
Resistance strokes (SURGE) in accordance with PN-EN
61000-4-5:2014-10
Line to line: 0.5 and 1.0kV
Line to earth: 0.5, 1.0 and 2.0kV
Resistance to conducted disturbances induced by a radio
frequency field in accordance with PN-EN 61000-4-6: 2014-04
0,15 – 80 MHz
3V r.m.s.
Resistance to sags, short breaks and voltage changes
according to PN-EN 61000-4-11:2007
Warning: Avoid using this device in close proximity to other devices or setting the device on or under another
device because it can cause interference with proper device functions. If close proximity of devices can not be
avoided, observe that both devices are work properly.
Warning: The use of accessories, cables or applicators other than those specified in this manual or supplied
with the product may lead to an increase in electromagnetic radiation generated by the device or to reduce
the electromagnetic immunity of the device and, as a result, to improper device operation. The device is to
be used only with the active electrode.
Warning: Portable devices using wireless communication (including external antennas or antenna cables)
should be used at a distance of not less than 30 cm from the PLASMA IQ.
