Given Imaging Limited CAPSH-3 Manual De Usuario
PillCam Capsule Endoscopy
226
Guidance and Manufacturer's Declarations
Guidance and manufacturer’s declaration - electronic immunity
The PillCam capsules are intended for use in the electromagnetic environment specified below.
The customer or the user of the PillCam capsules should assure that it is used in such an
environment.
The customer or the user of the PillCam capsules should assure that it is used in such an
environment.
Immunity test
IEC 60601 test level
Compliance
level
level
Electromagnetic environment -
guidance
guidance
Electrostatic
discharge (ESD)
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%.
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30%.
Electrical fast
transient/burst
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
supply lines
±1 kV for input/output
lines
lines
Not applicable Not applicable
Surge
IEC 61000-4-5
±1 kV line(s) to line(s)
±2 kV line(s) to earth
Not applicable Not applicable
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
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 Not applicable
Power frequency
(50/60 Hz) magnetic
field
(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.
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.