Boston Scientific MAESTRO 4000 Manual De Instrucciones página 25

Guidance and manufacturer's declaration – electromagnetic immunity
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Electrical fast ±2 kV for power
transient/burst supply lines
IEC 61000-4-4 ±1 kV for input/
output lines
Surge ±1 kV differential
mode
IEC 61000-4-5
±2 kV common
mode
Voltage dips, short <5% U
interruptions and (>95% dip in U
voltage variations on for 0.5 cycles
power supply input
40% U
lines
(60% dip in U
IEC 61000-4-11 for 5 cycles
70% U
(30% dip in U
for 25 cycles
<5% U
(>95% dip in U
for 5 seconds
Power frequency 3 A/m
(50/60 Hz) magnetic
field
IEC 61000-4-8
NOTE: U is the AC mains voltage prior to application of the test level.
T
Maestro 4000™ Cardiac Ablation System Operator's Manual, Global
±2 kV for power
supply lines
±1 kV for input/
output lines
±1 kV differential
mode
±2 kV common
mode
<5% U
T T
) (>95% dip in U
T
for 0.5 cycles
40% U
T T
) (60% dip in U
T
for 5 cycles
70% U
T T
) (30% dip in U
T
for 25 cycles
<5% U
T T
) (>95% dip in U
T
for 5 seconds
3 A/m
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the Maestro 4000™
Controller requires continued operation
during electrical disturbances on the
power mains, it is recommended that
the MetriQ™ Pump be connected to an
uninterruptible power supply with surge
and electrical fast transient-suppression
filtering/device embedded or connected
in series.
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the Maestro 4000 Controller
requires continued operation during
electrical disturbances on the power
mains, it is recommended that the MetriQ
Pump be connected to an uninterruptible
power supply with surge and electrical
fast transient-suppression filtering/device
embedded or connected in series.
Mains power quality should be that of a
) typical commercial or hospital environment.
T
If the user of the Maestro 4000 RF
Generator requires continued operation
) during electrical disturbances on the
T
power mains, it is recommended that
the MetriQ Pump be connected to an
uninterruptible power supply with surge
)
T
and electrical fast transient-suppression
filtering/device embedded or connected
in series.
)
T
Power frequency magnetic fields should
be at levels characteristic of typical
location in a typical commercial or
hospital environment.
25
Black (K) ∆E ≤5.0