AtriCure ASU2-115, Руководство пользователя

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USER’S MANUAL
Page 8 of 39 P000463.F
1.4.3. Electromagnetic Immunity
Guidance and manufacturer’s declaration – electromagnetic immunity
The AtriCure Ablation and Sensing Unit (ASU) is intended for use in the electromagnetic environment specified
below. The customer or the user of the ASU unit should assure that it is used in such an environment.
IMMUNITY test IEC 60601 test level Compliance level
Electromagnetic environment –
guidance
Electrostatic
discharge (ESD) IEC
61000-4-2 ± 6 kV contact
± 8 kV air ± 6 kV contact
± 8 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
± 1 kV for input/output
lines ± 2 kV for power
supply lines
± 1 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)
± 2 kV line(s) to earth
± 1 kV differential
mode
± 2 kV common mode
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 UT)
for 0,5 cycle
40 % U
T
(60 % dip in UT)
for 5 cycles
70 % U
T
(30 % dip in UT)
for 25 cycles
<5 % U
T
(>95 % dip in UT)
for 5 s
<5 % U
T
(>95 % dip in UT)
for 0,5 cycle
40 % U
T
(60 % dip in UT)
for 5 cycles
70 % U
T
(30 % dip in UT)
for 25 cycles
<5 % U
T
(>95 % dip in UT)
for 5 s
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the ASU
unit requires continued operation
during power mains interruptions, it is
recommended that the ASU unit be
powered from an uninterruptible
power supply or a battery.
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic fields
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.