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26 Guidance and manufacturer's declarations
The 13500 Insight BIO is intended for use in the electromagnetic environment specified below. The customer or the user
of the 13500 Insight BIO should assure that it is used in such an environment.
Immunity test
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
Power frequency (50/
60 Hz) magnetic field
IEC 61000-4-8
Note
®
Welch Allyn
Electromagnetic immunity
IEC 60601 test level
Compliance level
±6 kV contact
± 6 kV contact
± 8 kV air
± 8 kV air
±2 kV for power supply
±2 kV for power supply
lines
lines
±1 kV for input/output
±1 kV for input/output
lines
lines
± 1 kV differential
± 1 kV differential
mode
mode
± 2 kV common mode
± 2 kV common mode
<5 % U
<5 % U
T
(>95 % dip in U
)
(>95 % dip in U
T
for 0,5 cycle
for 0,5 cycle
40 % U
40 % U
T
(60 % dip in U
)
(60 % dip in U
T
for 5 cycles
for 5 cycles
70 % U
70 % U
T
(30 % dip in U
)
(30 % dip in U
T
for 25 cycles
for 25 cycles
<5 % U
<5 % U
T
(>95 % dip in U
)
(>95 % dip in U
T
for 5 s
for 5 s
3 A/m
0,3 A/m
U
is the a.c. mains voltage prior to application of the test level.
T
™
13500 Insight
Wireless LED Binocular Indirect Ophthalmoscope
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 should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
T
commercial or hospital environment. If the user
)
of the 13500 Insight BIO requires continued
T
operation during power mains interruptions, it
is recommended that the 13500 Insight BIO be
powered from an uninterruptible power supply
T
or a battery.
)
T
T
)
T
T
)
T
If image distortion occurs, it may be necessary
to position the 13500 Insight BIO further from
sources of power frequency magnetic fields or
to install magnetic shielding. The power
frequency magnetic field should be measured
in the intended installation location to assure
that it is sufficiently low.
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