15. Symbols
This product is designed not to become the ignition source in air and flammable anesthetic gas.
Type BF applied part
Marking on the outside of Equipment or Equipment parts that include RF transmitters or that apply RF electromagnetic energy for
diagnosis or treatment.
16. EMC Information (Electromagnetic Compatibility Information)
Guidance and manufacturer's declaration - Electromagnetic Emissions.
Surgic Pro series is intended for use in the electromagnetic environment specified below. The customer or the user of the Surgic Pro series should assure that is
used in such an environment. Guidance and manufacture' sdeclaration electromagnetic emissions.
Emissions test
RF emissions
CISPR11/EN55011
RF emissions
CISPR11/EN55011
Harmonic emissions
IEC61000-3-2/EN61000-3-2
Voltage fluctuations/flicker emissions
IEC61000-3-3/EN61000-3-3
Guidance and manufacturer's declaration - Electromagnetic Immunity
Surgic Pro series is intended for use in the electromagnetic environment specified below.
The customer or the user of the Surgic Pro series should assure that it is used in such an environment.
Immunity test
IEC/EN60601 test level
Electrostatic discharge (ESD)
± (2, 4) 6 kV contact
IEC61000-4-2/EN61000-4-2
± (2, 4) 8 kV air
Electrical fast transient/burst
± 2kV for power supply lines
IEC61000-4-4/EN61000-4-4
± 1kV for input/output lines
Surge
± 1kV differential mode
IEC61000-4-5/EN61000-4-5
± 2kV common mode
Voltage dips, short
<5% Ut (>95% dip in Ut)
interruptions and voltage
for 0.5 cycle
variations on power supply
input lines
40% Ut (60% dip in Ut)
IEC61000-4-11/EN61000-4-11
for 5 cycles
70% Ut (30% dip in Ut)
for 25 cycles
<5% Ut (>95% dip in Ut)
for 5 sec
Power frequency
3A/m
(50/60Hz) magnetic Field
IEC61000-4-8/EN61000-4-8
NOTE 'Ut' is the AC mains voltage prior to application of the test level.
See Operation Manual
Compliance
Electromagnetic environment - guidance
Group 1
Surgic Pro series uses RF energy only for its internal function. Therefore, its RF emissions are very
low and are not likely to cause any interference in nearby electronic equipment.
Class B
Surgic Pro series is suitable for use in all establishments, including domestic establishments and
those directly connected to the public low-voltage power supply network that supplies buildings
used for domestic purposes.
Class A
Complies
Compliance level
± (2, 4) 6 kV contact
± (2, 4) 8 kV air
± 2kV for power supply lines
± 1kV for input/output lines
± 1kV differential mode
± 2kV common mode
<5% Ut (>95% dip in Ut)
for 0.5 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
3A/m
21
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 commercial
or hospital environment. If the user of the Surgic Pro series
requires continued operation during power mains
interruptions, it is recommended that the Surgic Pro series
be powered from an uninterruptible power supply or a
battery.
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial
or hospital environment.