17
Manufacturer standards and declaration - Electromagnetic Immunity - for every Therapy EC [IEC
60601-1-2 / 2007 - subcl. 6.8.3.201 a) 6)]
Therapy EC is designated to be used in electromagnetic environment specified below. Therapy EC’ customer
or user shall ensure it will be used in such environment.
Immunity test
ABNT NBR IEC60601
test level
Compliance level
Electromagnetic
Environment - Standard
Electrostatic discharge
(ESD) IEC 61000-4-2
± 6 kV per contact
± 8 kV by the air
Compliance
It shall be wood, concrete or ce-
ramic floor. If floor is covered by
synthetic material, the relative hu-
midity should be at least 30%.
Fast electrical tran-
sients/pulse train
(“burst”) IEC 610004-4
± 2 kV in power lines
± 1 kV in input/output
lines
Compliance
Quality of energy supply should be
like a hospital or typical commer-
cial environment.
Power surge
IEC 61000-4-5
± 2 kV line to ground
± 1 kV line to line
Compliance
Quality of energy supply should be
like a hospital or typical commer-
cial environment.
Voltage drop, short in-
terruptions and voltage
variation in input sup-
ply line
IEC 61000-4-11
<5%
U
t
(>95% of voltage drop
in Ut) for 0.5 cycles.
40%
U
t
(60% of voltage drop
in Ut) for 5 cycles.
70%
U
t
(30% of voltage drop
in Ut) for 25 cycles.
<5%
U
t
(>95% of voltage drop
in Ut) for 5 seconds.
Compliance
Quality of energy supply should
be like a hospital or typical com-
mercial environment. If Therapy
EC user requires a continuous
operation during energy drop, it’s
recommended that Therapy EC be
feed by continuous power supply
or by battery.
Magnetic field in power
frequency (50/60 Hz)
IEC 61000-4-8
3 A/m
Compliance
The magnetic fields in power fre-
quency shall be into levels of a
typical hospital or commercial en-
vironment.
Note:
U
t is CA supply voltage before application of test level.
Table 2: Information regarding compliance to the requirements for electromagnetic immunity based
on Table 202 – 60601-1-2, 2007.
