DEFIBRILLATOR MONITOR
Mod. 3850B-BIPHASIC - USER MANUAL
Page 60 of 63
6.11. MANUFACTURER’S GUIDANCE AND DECLARATION REGARDING ELECTROMAGNETIC
COMPATIBILITY
Electromagnetic emissions
The
feas
ELECTRÓNICA
’s DEFIBRILLATOR Monitor Mod. 3850B-Biphasic REC/TPM/SpO
2
is intended for use in the
electromagnetic environment specified below. The customer or the user of the Defibrillator should assure that it is
used in such an environment.
Emissions test
Compliance
Electromagnetic environment
–
guidance
RF emissions CISPR 11
Group 1
The
feas
ELECTRÓNICA
’s DEFIBRILLATOR Monitor Mod.
3850B-Biphasic REC/TPM/SpO
2
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.
RF emissions CISPR 11
Class B
The
feas
ELECTRÓNICA
’s DEFIBRILLATOR Monitor Mod.
3850B-Biphasic REC/TPM/SpO
2
is suitable for use in all
establishments, including domestic establishments and those
directly connected to the public low-voltage power that supplies
buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
Complies
Electromagnetic Immunity
The
feas
ELECTRÓNICA
’s DEFIBRILLATOR Monitor Mod. 3850B-Biphasic REC/TPM/SpO
2
is intended for use in the
electromagnetic environment specified below. The customer or the user of the Defibrillator should assure that it is
used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment
– guidance
Electrostatic discharge
(ESD)
±6kV by contact
±6kV by contact
Floors should be wood,
concrete or ceramic tile. If floors
are covered with synthetic
material, the relative humidity
should be at least 30%.
IEC 61000-4-2
±8kV by air
±8kV by air
Electrical fast transient/burst
IEC 61000-4-4
±2kV for power supply
lines
±1kV for input/output
lines
±2kV for power supply
lines
±1kV for input/output
lines
Power supply quality should be
typical of commercial or hospital
environment.
Surge
IEC 61000-4-5
±1kV line(s) to line(s)
±2kV line(s) to earth
±1kV line(s) to line(s)
±2kV line(s) to earth
Power supply quality should be
typical of commercial or hospital
environment.
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
<5%
U
T
(dip >95% in
U
T
)
for 0.5 cycles
<5%
U
T
(dip >95% in
U
T
)
for 0.5 cycles
Power supply quality should be
typical of commercial or hospital
environment. If the user of the
feas
ELECTRÓNICA
’s
DEFIBRILLATOR Monitor Mod.
3850B-Biphasic
REC/TPM/SpO
2
requires
continuous operation during
power supply interruptions, it is
recommended that the
feas
ELECTRÓNICA
’s
DEFIBRILLATOR Monitor Mod.
3850B-Biphasic
REC/TPM/SpO
2
be powered
from an uninterruptible power
supply or an internal battery.
IEC 61000-4-11
40%
U
T
(60% dip in
U
T
)
for 5 cycles
40%
U
T
(60% dip in
U
T
)
for 5 cycles
70%
U
T
(30% dip in
U
T
)
for 25 cycles
70%
U
T
(30% dip in
U
T
)
for 25 cycles
<5%
U
T
(dip >95% in
U
T
)
for 5s
<5%
U
T
(dip >95% in
U
T
)
for 5s
Power frequency (50/60Hz)
magnetic field
IEC 61000-4-8
3A/m 3A/m
Magnetic fields at power
frequency 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.
