Given Imaging Limited CAPSH-3 User Manual
PillCam Capsule Endoscopy
230
Guidance and Manufacturer's Declarations
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
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
<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
Mains power quality should
be that of a typical
commercial or hospital
environment. If the user of
the PillCam recorder DR2
requires continued
operation during power
mains interruptions, it is
recommended that the
PillCam recorder DR2 be
powered from an
uninterruptible power
supply or a battery.
be that of a typical
commercial or hospital
environment. If the user of
the PillCam recorder DR2
requires continued
operation during power
mains interruptions, it is
recommended that the
PillCam recorder DR2 be
powered from an
uninterruptible power
supply or a battery.
Power
frequency (50/
60 Hz)
magnetic field
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.
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.
Guidance and manufacturer’s declaration - electronic immunity
The PillCam recorder DR2 is intended for use in the electromagnetic environment specified
below. The customer or the user of the PillCam recorder DR2 should assure that it is used in
such an environment.
Immunity test
IEC 60601 test
level
level
Compliance
level
level
Electromagnetic environment -
guidance
guidance
Portable and mobile RF
communications equipment should be
used no closer to any part of PillCam
recorder DR2, including cables, than
the recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
communications equipment should be
used no closer to any part of PillCam
recorder DR2, including cables, than
the recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6
3 VRMS
150 kHz to
80 MHz
80 MHz
3V
ms
d = 1.2 P
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
2.5 GHz
3 V/m
d = 1.2 P 80 MHz to 800 MHz range
d = 2.3 P 800 MHz to 2.5 GHz
range
range
Guidance and manufacturer’s declaration - electronic immunity