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User's Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST-2000
Guidance and manufacturer's declaration – electromagnetic immunity
The model SONOST-2000 is intended for use in the electromagnetic environment specified below. The customer
or the user of the model SONOST-2000 should assure that it is used in such an environment.
Immunity
IEC 60601
test
test level
6 kV contact
Electrostatic
8 kV air
discharge (ESD)
IEC 61000-4-2
2 kV for power
Electrical fast
transient/burst
supply lines
IEC 61000-4-4
input/output lines
1 kV differential
Surge
IEC 61000-4-5
mode
2 kV common
mode
Voltage dips,
< 5 % U
short
(> 95 % dip in U
interruption, and
for 0.5 cycle
voltage
40 % U
variations
on
power supply
(60 % dip in U
input lines
for 5 cycles
IEC 61000-4-11
70 % U
(30 % dip in U
< 5 % U
(> 95 % dip in U
for 5 s
Power frequency
3 A/m
(50/60 Hz)
IEC 61000-4-8
Note :
U
is the a.c. mains voltage prior to application of the test level.
T
Safety consideration about parts of device and compartment
For use safely, you must use parts of device which are supplied or approved from OsteoSys.
NOTE !
If you use parts of device which are not approved from OsteoSys, we do not guarantee
safety to user. Moreover, it become dangerous and prone to producing errors and wrong
results to users or patients. In this case, the user has the sole responsibility.
Compliance
level
6 kV contact
8 kV air
2 kV for power
supply lines
1
kV
for
input/output lines
1 kV differential
mode
2 kV common
mode
< 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
< 5 % U
T
)
(> 95 % dip in U
T
for 5 s
3 A/m
Electromagnetic environment – guidance
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Main power quality should be that of a
typical
environment.
1
kV
for
Main power quality should be that of a
typical
environment.
Main power quality should be that of a
T
)
typical
T
environment. If the user of the model
SONOST-2000
operation during power interruptions, it is
T
)
recommended that the model SONOST-
T
2000 be powered from an uninterruptible
power supply or battery.
T
)
T
T
)
T
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment
12
DOC. No. : OT-IFU-S2K
commercial
or
commercial
or
commercial
or
requires
hospital
hospital
hospital
continued
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