BIOMET 2001A, Руководство пользователя

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The Model 2001 Bone Healing System is intended for use in the electromagnetic environment specified
below. The customer or the user of the Model 2001 Bone Healing System should assure that it is used
in such an environment.
Immunity test
Electrostatic
discharge (ESD)
IEC 610004-2
IEC 60601 test level Compliance level
Electromagnetic environment -
guidance
± 6 kV contact
± 8 kV air
Electrical fast
transient/burst
IEC 61000-4-4
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
± 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 for
differential mode
± 2 kV for common
mode
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 Model
2001 Bone Healing System requires
continued operation during power
mains interruptions, it is
recommended that the Model 2001
Bone Healing System be powered
from an uninterruptible power supply
(UPS).
Voltage dips,
short
interruptions and
voltage varia-
tions on
power supply
input lines
IEC 61000-4-11
< 5% U
T
( > 95% dip in U
T
)
for 0.5 cycle
40% U
T
( 60% dip in U
T
)
for 5 cycles
70% U
T
( 30% dip in U
T
)
for 25 cycles
< 5% U
T
(> 95% dip in U
T
) for
5 sec
Power frequency
( 50/60 Hz )
magnetic field
IEC 61000-4-8
3 A/m Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
Table 2
69
Guidance and manufacturer’s
declaration - electromagnetic immunity