Kulzer Translux Wave Instrucciones De Uso página 62

Guidance and manufacturer's declaration – Electromagnetic immunity
Enclosure port
The Translux Wave device is designed to work in the electromagnetic environment specifi ed below.
The client or user of the Translux Wave device should always make sure that it is used only in such environment.
Phenomenon
Electrostatic
discharge (ESD)
Radiated
a)
RF EM fi elds
Rated power
frequency magnetic
d) e)
fi elds
GB
a) The interface between the PATIENT physiological signal simulation, if used, and the Translux Wave shall be located within 0,1 m of the vertical plane of the
uniform fi eld area in one orientation of the Translux Wave.
- 24 -
b) Translux Wave that intentionally receive RF electromagnetic energy for the purpose of their operation shall be tested at the frequency of reception. Testing
may be performed at other modulation frequencies identifi ed by the RISK MANAGEMENT PROCESS. This test assesses the BASIC SAFETY and ESSENTIAL
PERFORMANCE of an intentional receiver when an ambient signal is in the passband. It is understood that the receiver might not achieve normal reception
during the test.
c) Testing may be performed at other modulation frequencies identifi ed by the RISK MANAGEMENT PROCESS.
d) Applies only to Translux Wave with magnetically sensitive components or circuitry.
e) During the test, the Translux Wave may be powered at any NOMINAL input voltage, but with the same frequency as the test signal.
f) Before modulation is applied.
g) This test level assumes a minimum distance between the Translux Wave and sources of power frequency magnetic fi eld of at least 15 cm. If the RISK ANALY-
SIS shows that the Translux Wave will be used close than 15 cm to sources of power frequency magnetic fi eld, the IMMUNITY TEST LEVEL shall be adjusted as
appropriate for the minimum expected distance.
Basic EMC standard Immunity test levels
or test method
IEC 61000-4-2 ±8 kV contact
±2 kV, ±4 kV, ±8 kV,
±15 kV air
IEC 61000-4-3 3 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
IEC 61000-4-8 30 A/m
50 Hz or 60 Hz
Electromagnetic environment – Guidance
Floors must be wood, concrete or ceramic. If the fl oor
is lined with synthetic materials, the relative humidity
should be at least 30 %
f) Portable or mobile RF communication device must
b)
not be used in close proximity of the product, includ-
c)
ing its cables, except when these respect the dis-
tances of separation recommended and calculated
from the equation applicable to the frequency of the
transmitter.
g)
Grid frequency magnetic fi elds should have levels
characteristic of a typical commercial or hospital
environment.