UroShield® User Manual
20-100-0022 Ver. 02
29
Table 2: UroShield® Electromagnetic Immunity
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® should assure that it is used in such an environment.
Immunity test
IEC 60601 level
Compliance level
Electromagnetic environment -
guidance
Electrostatic
discharge (ESD),
IEC 61000-4-2
8 kV contact
15 kV air
8 kV contact
15 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
Electrical fast
transient/burst,
IEC 61000-4-4
2 kV for power
supply lines
1 kV for SIP/SOP
lines
2 kV for power
supply lines
Mains power quality should be that of a
typical commercial or hospital
environment
Surge, IEC
61000-4-5
1 kV line to line
2 kV line to earth
1 kV line to line
(Class II ME
equipment)
Mains power quality should be that of a
typical commercial or hospital
environment.
Voltage dips and
interruptions on
power supply
input lines
IEC 61000-4-11
0 % UT for 0,5
cycle
0 % UT for 1 cycle
70 % UT for
25/30 cycles
0 % UT for
250/300 cycles
0 % UT for 0,5 cycle
0 % UT for 1 cycle
70 % UT for 25/30
cycles
0 % UT for 250/300
cycles
Mains power quality should be that of a
typical commercial or hospital
environment. During system charging is
recommended that the UroShield be
powered from an uninterruptible
power supply.
Power frequency
magnetic field,
IEC 61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
NOTE: UT is the AC mains voltage prior to application of the test level.
