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0900‑5005 REV‑00
ELECTROMAGNETIC IMMUNITY
Table 27. Guidance and Manufacturer’s Declaration —Electromagnetic Immunity
The system is intended for use in the electromagnetic environment specified below. The customer or the user
of the system should ensure that it is used in such an environment.
IMMUNITY TESTS
IEC 60601 TEST LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC ENVIRONMENT –
GUIDANCE
Electrostatic
discharge (ESD)
IEC 61000‑4‑2
± 8 kV contact
± 15 kV air
In compliance
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
100 kHz repetition
frequency
In compliance
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000‑4‑5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
In compliance
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000‑4‑11
0% U
T
; 0.5 cycle
At 0˚, 45˚, 90˚, 135˚, 180˚,
225˚, 270˚, and 315˚
0% U
T
; 1 cycle and
70% U
T
; 25/30 cycles
Single Phase: at 0˚
In compliance
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
system requires continued operation
during power mains interruptions,
it is recommended that the system
be powered from an uninterruptible
power supply or a battery.
Rated power
frequency magnetic
fields
IEC 61000‑4‑8
30 A/m
Frequency: 50/60 Hz
In compliance
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital environment.
Conducted RF
IEC 61000‑4‑6
3 Vrms
150 kHz to 80 MHz
6 Vrms in ISM bands
150 kHz to 80 MHz
80% AM at 1 kHz
In compliance
Portable and mobile RF
communications equipment should
be used no closer to any part of the
system, including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation
distance d (m)
d
=1.2 √
P
Summary of Contents for BladderScan i10
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