User Manual

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The SmartPill GI Monitoring System is intended for use in the electromagnetic environment specified below.
The customer or the user of the SmartPill GI Monitoring System 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
±2 kV on AC
mains
±1 kV on
measurement I/O
lines
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
±1 kV on Line to
Neutral
±2 kV on Line or
Neutral to
protected earth
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
N/A
N/A
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m @ 50 Hz
and 60 Hz
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 a.c. mains voltage prior to application of the test level.