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Safety And Performance Tests - Philips M8102A Instructions For Use Manual

Patient monitor.
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Safety and Performance Tests

The monitor should not be used next to or stacked with other equipment. If you must stack the
WARNING
monitor, you must check that normal operation is possible in the necessary configuration before you
start monitoring patients.
Electromagnetic Immunity
The monitor is suitable for use in the specified electromagnetic environment. The user must ensure
that it is used in the appropriate environment as described below.
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-
11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
In this table, U
Recommended Separation Distance
The monitor, equipped with a wireless network interface, intentionally receives RF electromagnetic
WARNING
energy for the purpose of its operation. Therefore, other equipment may cause interference, even if that
other equipment complies with CISPR emission requirements.
In the following table, P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer and d is the recommended separation distance in metres
(m). The values given in brackets are for respiration.
IEC 60601-1-2
test level
±
6 kV contact
±8 kV air
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV differential mode
±2 kV common mode
U
<5%
T
U
(>95% dip in
) for
T
0.5 cycles
U
40%
T
U
(60% dip in
) for 5 cycles
T
U
70%
T
U
(30% dip in
) for 25 cycles
T
U
<5%
T
U
(>95% dip in
) for 5 sec
T
3 A/m
is the a.c. mains voltage prior to application of the test level.
T
Compliance level
±
6 kV contact
±8 kV air
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV differential mode
±2 kV common mode
U
<5%
T
U
(>95% dip in
) for
T
0.5 cycles
U
40%
T
U
(60% dip in
) for 5 cycles
T
U
70%
T
U
(30% dip in
) for 25 cycles
T
U
<5%
T
U
(>95% dip in
) for 5 sec
T
3 A/m
24 Specifications
Electromagnetic environment
guidance
Floors should be wood, concrete, or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
Mains power quality should be that
of a typical commercial and/or
hospital environment
Mains power quality should be that
of a typical commercial and/or
hospital environment
Mains power quality should be that
of a typical commercial and/or
hospital environment. If the user of
the monitor requires continued
operation during power mains
interruptions, it is recommended
that the monitor is equipped with
an internal battery or is powered
from an uninterruptible power
supply.
Power frequency magnetic fields
should be a t levels characteristic of
a typical location in a typical
commercial and/or hospital
environment
267

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