St. Jude Medical Merlin@home EX1150, Руководство пользователя

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12
Table 5. Guidance and manufacturer's declaration - electromagnetic immunity
Test IEC 60601 Test Level (Actual
Level)
1F
2
Electromagnetic Environment -
Guidance
Electrostatic
Discharge (ESD)
IEC 61000-4-2 ±8 kV contact
(±8 kV contact)
±15 kV air
(±15 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
(±2 kV for power supply lines)
±2 kV for input/output lines
(±2 kV for input/output 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]
(±1 kV line[s] to line[s])
±2 kV line[s] to earth
(±2 kV line[s] to 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
(<5% U
T;
>95% dip in U
T
for 0.5
cycle)
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
; >95% dip in U
T
for 5 s
(<5% U
T
; >95% dip in U
T
for 5 s)
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
Merlin@home transmitter requires
continued operation during power
mains interruptions, it is
recommended that the Merlin@home
transmitter be powered from an
uninterruptible power supply or a
battery.
Power Frequency
(50/60 Hz)
Magnetic Field
IEC 61000-4-8
30 A/m
(30 A/m)
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical
commercial or hospital environment.
* U
T
is the AC mains voltage prior to application of the test level.
2
Figures in parentheses are the immunity compliance levels for each test.