User Manual

PillCam Platform
52 Chapter 5
Guidance and manufacturer’s declaration - electromagnetic immunity for all
equipment and systems
The PillCam COLON 2 capsules are intended for use in the electromagnetic environment specified below.
The customer or the user of the PillCam COLON 2 capsules should assure that it is used in such an
environment.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic
environment - guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 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 input/output
lines
Not applicable
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
Not applicable
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
<5 % U
T
(>95 % dip in U
T
)
for 0.5 cycle
40 % U
T
(60 % dip in U
T
)
for 5 cycles
70 % U
T
(30 % dip in U
T
)
for 25 cycles
<5 % U
T
(>95 % dip in U
T
)
for 5 sec
Not applicable
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the
equipment requires continued
operation during power mains
interruptions, it is recommended that
the equipment be powered from an
uninterruptible power supply or a
battery.
Power frequency (50/
60 Hz) magnetic field,
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
NOTE: U
T
is the AC mains voltage prior to application of the test level.