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Guidance and manufacturer's declaration according to IEC 60601-1-2,
The device intended for use in an electromagnetic environment as specified below. The customer or the
user must assure that it is used in such an environment.
Immunity test
Electrostatic
discharge (ESD)
according to
IEC 61000-4-2
Fast electrical
transients / bursts
according to
IEC 61000-4-4
Surge according to
IEC 61000-4-5
Voltage dips,
short power
interruptions and
supply voltage
fluctuations
according to
IEC 61000-4-11
Power frequency
(50 / 60 Hz)
magnetic field
according to
IEC 61000-4-8
NOTE
86
clause 6.8.3.201 a) 3)
Table 201: Electromagnetic emissions
IEC 60601
test level
±6 kV contact
discharge
±8 kV air discharge
± 2 KV
for power supply lines
± 1 KV
for input / output lines
± 1 kV voltage
phase – phase
± 2 kV voltage
phase – earth
<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 seconds
3 A/m
U
is the a. c. mains voltage prior to application of the test level.
T
Compliance level
±6 kV contact
±8 kV air
± 2 KV
for power supply lines
± 1 KV
for input / output lines
± 1 KV
common mode
± 2 KV
differential 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
for 25 cycles
<5% U
T
(>95% dip in U
)
T
for 5 seconds
3 A/m
Instructions for Use
Surgical Laser Unit Limax
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%.
Mains power quality shall be
that of a typical industrial or
hospital environment.
Mains power quality shall be
that of a typical industrial or
hospital environment.
Mains power quality shall be
that of a typical industrial or
hospital environment. If the
user requires continued
operation during mains power
interruptions, it is
recommended to power the
device from an uninterruptible
power supply.
Power frequency magnetic
fields shall be at levels
characteristic of a typical
location in a typical industrial
or hospital environment.
®
60
V. 1.0
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