Medizintechnik MASTERLIGHT Serie Instrucciones De Empleo página 37

Table 2: Shell (according to IEC60601-1-2).
Table 2: Shell (according to IEC60601-1-2).
Phenomenon
Static electricity discharge
High-frequency electromagnetic fields
High-frequency electromagnetic fields
in the vicinity of wireless
communication devices
Magnetic fields with rated energy
frequencies d), e)
a) The interface between the patient physiological signal simulator, if used, and ME-DEVICES or ME-SYSTEMS should be located within 0.1 m from the vertical plane of
the uniform field. The simulator must be directed in the same direction as the ME-DEVICE or ME-SYSTEM.
b ) ME-DEVICES and ME-SYSTEMS, which for the purpose of their operation properly receive high-frequency electromagnetic energy, should also be tested at the
receiving frequency. The test may also be conducted at other baseband frequencies as determined by the risk management process. This test evaluates the basic
safety and essential performance of such a receiving ME-DEVICE in the presence of ambient signals at its receiving frequencies. It should be assumed that during
this test, normal reception conditions for the receiver may not be achieved.
c) The test may also be conducted at other baseband frequencies as determined by the risk management process.
d) Applies only to ME-DEVICES with magnetically sensitive elements or connections.
e) When testing the ME-DEVICE, one of the provided rated input voltages can be applied, however, the corresponding mains frequency must correspond to the test
signal frequency (see Table 1).
f) The level before modulation is applied.
g) This test level assumes the distance between the ME-DEVICE or ME-SYSTEM and the power frequency magnetic field sources of minimum 15 cm. If the risk analysis
shows that ME-DEVICE or ME-SYSTEM, when used, turns out to be closer than 15 cm to the power frequency magnetic field sources, the test level of immunity
should be adjusted in accordance with the expected minimum distance.
EMC basic standard or test
method
Professional health care institutions
± 8 kV contact discharge
IEC 61000-4-2
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air discharge
3 V/m
IEC 61000-4-3
a)
80 MHz to 2.7 GHz
IEC 61000-4-3 See Table 9
30 A/m
IEC 61000-4-3
50 Hz or 60 Hz
Immunity test level
f)
b) 80% AM at 1 kHz c)
g)
Home health care environment
10 V/m f)
80 MHz to 2.7 GHz
b)
80% AM at 1 kHz c)
Table 3: A
Electrical f
impulse w
impulse vo
impulse vo
Conducted
frequency
Voltage di
Voltage in
r)
a) The te
teste
b) During
c) The ca
d) If the
all ISM
e) The te
f) ME-DE
transfo
transfo
g) Applie
h) Slash-
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