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TUV Rhineland of North America is a Nationally Recognized Testing Laboratory (NRTL) in the United States and is accredited by
the Standards Council of Canada to certify electro-medical products with Canadian National Standards.
Follow the waste of electric and electronic equipment (WEEE) Directive (2002/96/EC) to dispose of the product and
accessories.
Consult operation instructions.
Manufacturer.
This conforms to CE European Directive of “Medical equipment directive 93/42/EEC.”
Type BF applied part.
Authorised representative in
the European community.
Protected against vertically falling water
drops.
Autoclavable up to Max.35°C. *for detail see
Sterilization.
Marking on the outside of Equipment or Equipment parts that include RF transmitters or that apply RF electromagnetic energy
for diagnosis or treatment.
Guidance and manufacturer's declaration - electromagnetic immunity
The Varios 370 / Varios 370 Lux is intended for use in the electromagnetic environment specified below. The customer or the user of the Varios 370 / Varios 370 Lux
should assure that it is used in such an environment.
Immunity test
EN/IEC60601 test level
Compliance level
Electromagnetic environment - guidance
Electrostatic discharge (ESD)
EN/IEC6000-4-2
±6kV contact
±8kV air
±6kV contact
±8kV 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
EN/IEC6000-4-4
±2kV for power supply lines
±kV for input/output
±2kV for power supply lines
±kV for input/output
Mains power quality should be that of a typical commercial or
hospital environment.
Surge
EN/IEC6000-4-5
±kV line(s) to line(s)
±2kV line(s) to earth
±kV line(s) to line(s)
±2kV line(s) to earth
Mains power quality should be that of a typical commercial or
hospital environment.
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
EN/IEC6000-4-
<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 secs
<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
Mains power quality should be that of a typical commercial
or hospital environment. If the user of the Varios 370 / Varios
370 Lux requires continued operation during power mains
interruptions, it is recommended that the Varios 370 / Varios
370 Lux be powered from an uninterruptible power supply or
a battery.
Power frequency (50/60Hz)
magnetic field
EN/IEC6000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial or
hospital environment.
NOTE
: Ut is the a.c. mains voltage prior to application of the test level.
Class II Equipment.
Guidance and manufacturer's declaration - electromagnetic emissions
The Varios 370 / Varios 370 Lux is intended for use in the electromagnetic environment specified below. The customer or the user of the Varios 370 / Varios 370 Lux
should assure that is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR/EN550
Group
The Varios 370 / Varios 370 Lux 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 emmissions
CISPR/EN550
class B
The Varios 370 / Varios 370 Lux is suitable for use in all establishments, including domestic establishments
and those directly connected to the public low-voltage power supply network that supply network that
supplies buildings used for domestic purposes.
Harmonic emissions
EN/IEC6000-3-2
class A
Voltage fluctuations/flicker emissions
EN/IEC6000-3-3
Complies
This product can be cleaned and disinfected with a
Thermo-Disinfector.
