COOK Medical DP-M350 Instrucciones De Uso página 10

TABLE 2 Guidance and Manufacturer's declaration - electromagnetic emissions
The Cook Doppler Blood Flow Monitor (DP-M350) is intended for use in the electromagnetic environment specifi ed
below. The customer or the user of the Cook Doppler Blood Flow Monitor (DP-M350) should assure that it is used in
such an environment.
Emissions Test
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions IEC
61000-3-2
Voltage Fluctuations/Flicker
emissions IEC 61000-3-3
TABLE 3 Guidance and Manufacturer's declaration - electromagnetic immunity
The Cook Doppler Blood Flow Monitor (DP-M350) is intended for use in the electromagnetic environment specifi ed
below. The customer or the user of the Cook Doppler Blood Flow Monitor (DP-M350) should assure that it is used in
such an environment.
Immunity Test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical Test
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
fi eld
IEC 61000-4-8
NOTE: U is the a.c. mains voltage prior to application of the test level.
1
Compliance Electromagnetic environment - guidance
Group 1 The Cook Doppler Blood Flow Monitor (DP-M350) uses RF energy only
for its internal function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic equipment.
Class A The Cook Doppler Blood Flow Monitor (DP-M350) is suitable for use in
all establishments other than domestic and those directly connected to
Class A
the public low-voltage power supply network that supplies buildings
used for domestic purposes.
Complies
IEC 60601 Test Level
±6kV contact
±8kV air
±2kV for power supply
lines
±1kV for input/output
lines
±1kV diff erential mode
±2kV common mode
<5% U1
(>95% dip in U1)
for 0.5 cycles
40% U1 (60% dip in U1)
for 5 cycles
70% U1 (30% dip in UT)
for 25 cycles
<5% U1 (>95% dip in
U1) for 5 sec
3 A/m
Compliance Level
±6kV contact
±8kV air
±2kV for power supply
lines
±1kV for input/output
lines
±1kV diff erential mode
±2kV common mode
<5% U1
(>95% dip in U1)
for 0.5 cycles
40% U1 (60% dip in
U1) for 5 cycles
70% U1 (30% dip in
UT) for 25 cycles
<5% U1 (>95% dip in
U1) for 5 sec
3 A/m
10
Electromagnetic environment - guid-
ance
Floors should be wood, concrete or
ceramic tile. If fl oors are covered with
synthetic material, the relative humidity
should be at least 30%
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the Cook
Doppler Blood Flow Monitor (DP-
M350) requires continued operation
during power mains interruptions, it is
recommended that the Cook Doppler
Blood Flow Monitor (DP-M350) be
powered from an uninterruptible power
supply or a battery.
Power frequency magnetic fi elds should
be at levels characteristic of a typical
location in a typical commercial or hospital
environment.