Table 9.5-3 Iec Emc Specifications (Immunity) - Baylis Medical RFP-100A Gebrauchsanweisung

Table 9.5-3 IEC EMC Specifications (Immunity)

Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The BMC Radiofrequency Puncture Generator is intended for use in the electromagnetic
environment specified below. The customer or the user of the BMC Radiofrequency
Puncture Generator should assure that it is used in such an environment.
IEC 60601
Immunity test
test level
Electrostatic ±6 kV contact
discharge
±8 kV air
(ESD)
IEC 61000-4-2
Electrical fast ±2 kV for
transient/burst power supply
lines
IEC 61000-4-4
±1 kV for
input/output
lines
Surge ±1 kV
differential
IEC 61000-4-5
mode
±2 kV common
mode
Voltage dips, <5% U
short dip in U
interruptions 0.5 cycles
and voltage
40% U
variations on
dip in U
power supply
cycles
input lines
70% U
IEC 61000-4-11
dip in U
25 cycles
<5% U
dip in U
seconds
Power
frequency
(50/60 Hz)
3 A/m
magnetic field
IEC 61000-4-8
NOTE U is the a.c. mains voltage prior to application of the test level.
T
Compliance
level
±6 kV contact
±8 kV air
±2 kV for
power supply
lines
±1 kV for
input/output
lines
±1 kV
differential
mode
±2 kV common
mode
(>95% <5% U (>95%
T T
) for dip in U ) for
T T
0.5 cycles
(60% 40% U (60%
T T
) for 5 dip in U ) for 5
T T
cycles
(30% 70% U (30%
T T
) for dip in U ) for
T T
25 cycles
(>95% <5% U (>95%
T T
) for 5 dip in U ) for 5
T T
seconds
3 A/m
36 DMR RFP-100 3.3 V-13 16-Jan-2012_EN.doc
Electromagnetic environment
- guidance
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
BMC Radiofrequency Puncture
Generator requires continued
operation during power mains
interruptions, it is recommended
that the BMC Radiofrequency
Puncture Generator be powered
from an uninterruptible power
supply or battery.
Power frequency magnetic fields
should be at levels characteristic of
typical location in a typical
commercial or hospital
environment.