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Miscellaneous
Guidance and manufacturer’s declaration electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The cus
-
tomer or the user of the device 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
Floor should be wood, concrete, or ceramic tile. If
floors are covered with synthetic material, the rela
-
tive 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 com
-
mercial or hospital environment.
Surge
IEC 61000 -4- 5
±1 kV
differential mode
±2 kV
common mode
±1 kV
differential mode
±2 kV
common mode
Mains power quality should be that of a typical com
-
mercial 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
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
<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
Mains power quality should be that of a typical com
-
mercial or hospital environment. If the user of the
device requires continued operation during power
mains interruptions, it is recommended that the
device 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 com
-
mercial or hospital environment
NOTE: U
T
is the a.c. mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is
used in such an environment.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic environment guidance
Conducted RF
IEC 61000- 4- 6
Radiated RF
IEC 61000 -4- 3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 Vrms
(V1=3)
3 V/m
(E1=3)
Portable and mobile RF communications equip
-
ment should be used no closer to any part of the
device, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
d=1.2
150 kHz to 80 MHz
d=1.2
80 MHz to 800 MHz
d=2.3
800 MHz to 2.5 GHz
where
P
is the maximum output power rating
of the transmitter in watts (W) according to the
transmitter manufacturer and d is the recom
-
mended separation distance in meters (m).
Field strengths from fixed RF transmitters, as deter
-
mined by an electromagnetic site survey,
a
should be less
than the compliance level in each frequency range.
b
Interference may occur in the vicin
-
ity of equipment marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propaga
-
tion is affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mo
-
bile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the device is used exceeds the ap
-
plicable RF compliance level above, the device should be observed to verify normal operation. If abnormal per
-
formance is observed, additional measures may be necessary, such as reorienting or relocating the device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communications
equipment and the device
The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The cus
-
tomer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the
maximum output power of the communications equipment.
Rated maximum output
power of transmitter
W
Separation distance according
to frequency of transmitter
m
150 kHz to 80 MHz
d
=1.2
80 MHz to 800 MHz
d
=1.2
800 MHz to 2.5 GHz
d
=2.3
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d
in
metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where
P
is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propaga
-
tion is affected by absorption and reflection from structures, objects, and people.
Please visit
www.usophthalmic.com
for more information.
