NanoVibronix UroShield User Manual page 25

UROSHIELD
IMMUNITY
Table 2
Guidance and Manufacturer's Declaration –
Electromagnetic Immunity
UroShield is intended for use in the electromagnetic environment
®
specified below. The customer or user of the UroShield
assure that it is used in such an environment.
Immunity
test
Electrostatic
discharge
(ESD), IEC
61000-4-2
Electrical fast
transient / burst,
IEC 6100-4-4
Surge, IEC
61000-4-5
Voltage
dips and
interruptions
on power
supply input
lines
IEC 61000-
4-11
Power
frequency
magnetic
field, IEC
61000-4-8
NOTE: UT is the AC mains voltage prior to application of the test level.
ELECTROMAGNETIC
®
IEC 60601 Compliance
level level
8 kV contact 8 kV contact
15 kV air 15 kV air
2 kV for 2 kV for
power power
supply lines supply lines
1 kV for SIP/
SOP lines
1 kV line to 1 kV line
line 2 kV line to line
to earth (Class II ME
equipment)
0 % UT for 0 % UT for
0.5 cycle 0.5 cycle
0 % UT for 0 % UT for
1 cycle 70 % 1 cycle 70 %
UT for 25/30 UT for 25/30
cycles cycles
0 % UT for 0 % UT for
250/300 250/300
cycles cycles
30 A/m 30 A/m
should
®
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.
During system charging, it
is recommended that the
UroShield is powered from an
®
uninterruptible power supply.
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment.
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