MediWorks S360 - Important Information Regarding Electronic Magnetic Compatibility (EMC)

Slit Lamp Microscope USER MANUAL
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Important information regarding Electronic Magnetic Compatibility (EMC)
Slit Lamp Microscope S360/S390L WDR needs special precautions regarding EMC and put into service
according to the EMC information provided in the user manual and other documents; Slit Lamp Microscope
S360 /S390L WDR conforms to this EN 60601-1-2:2007+AC:2010/IEC 60601-1-2 standard for both immunity
and emissions.
Nevertheless, special precautions need to be observed:
●The use of accessories and cable other than those specified, with the exception of accessories and cables sold
of Slit Lamp Microscope S360 /S390L WDR as replacement parts for internal components, may result in
increased EMISSIONS or decreased IMMUNITY or decreased LIFESPAN of the Slit Lamp Microscope S360/
S390L WDR.
●Slit Lamp Microscope S360/ S390L WDR should not be used adjacent to or stacked with other equipment. In
case adjacent or stacked use is necessary, The Slit Lamp Microscope S360/ S390L WDR should be observed to
verify normal operation in the configuration in which it will be used.
EMC Information
Guidance and manufacturer’s declaration - electromagnetic emissions - for all ME EQUIPMENT and
ME SYSTEM.
Table 1:Guidance and manufacturer’s declaration – electromagnetic emissions
The S360/ S390L WDR is intended for use in the electromagnetic environment specified below. The
customer or the user of the S360/ S390L WDR should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The S360/ S390L WDR 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
RF emissions
CISPR 11
Class A
The S360/ S390L WDR is suitable for use in all
establishments other than domestic and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
Flicker emissions
IEC 61000-3-3
Complies
Guidance and manufacturer’s declaration - electromagnetic immunity - for all ME EQUIPMENT and
ME SYSTEM.
Table 2:Guidance and manufacturer’s declaration – electromagnetic immunity
The S360/ S390L WDR is intended for use in the electromagnetic environment specified below. The customer
or the user of the S360/ S390L WDR 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
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative 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 commercial or hospital
environment
Surge
IEC 61000-4-5
±1 kV lines to lines
±2 kV lines to earth
±1 kV lines
to lines
Mains power quality should be that of a
typical commercial or hospital