Manufacturer's declaration of electromagnetic compatibility (EMC)
ARveo / Ref. 10 747 384 / Version 04 75
15.2 Table 2 from EN 60601-1-2
Guidance and manufacturer's declaration – electromagnetic immunity
The ARveo surgical microscope is intended for operation in an environment as specified below.
The customer or the user of the ARveo surgical microscope should make sure that it is used in such an environment.
When the ARveo surgical microscope is exposed to any of the disturbances below, you might notice one of the following effects:
- flickering/noise on the HD Monitor
- interruptions on the HD Montior
Non of the listed effects above have an impact on the essential performance or safety and effectiveness of the ARveo surgical microscope. Its no
unacceptable risk for User, Patient or environment to be expected.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment – guidance
Discharge of static
electricity (ESD) according
to IEC 61000-4-2
± 8 kV contact discharge
± 15 kV air discharge
± 8 kV contact discharge
± 15 kV air discharge
Floors should be of wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30 %.
Electrical fast transient/
burst immunity according
to IEC 61000-4-4
± 2 kV for power supply line
± 1 kV for input and output
lines
± 2 kV for power supply line
± 1 kV for input and output
lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surges according to
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
commercial or hospital environment.
Voltage dips, short
interruptions and power
supply voltage fluctuations
IEC 61000-4-11
<5 % UT (>95 % dip in UT)
for ½ cycle
40 % UT (60 % dip in UT)
for 5 cycles
70 % UT (30 % dip in UT)
for 25 cycles
<5 % UT (>95 % dip in UT)
for 5 sec
70% UT 25/30 cycles
40% UT 10/12 cycles
40% UT 5/6 cycles
0% UT 0.5/0.5 cycles
0% UT 1/1 cycles
0% UT 250/300 cycles
Mains power quality should be that of a typical
commercial or hospital environment.
When short interruptions of 5 % UT for 5
seconds occur, the ARveo surgical microscope
will cease operation and restart automatically. It
can be brought back to the state it was before
with user intervention.
If the user of the ARveo surgical microscope
requires that the instrument remain functional
even after power interruptions, it is
recommended that the ARveo surgical
microscope be provided with an auxiliary power
source such as an uninterruptible power supply
(UPS) or battery back-up.
Magnetic fields at mains
frequency (50/60 Hz)
according to IEC 61000-4-8
3 A/m
30 A/m
Note
UT is the AC voltage prior to application of the test level.
