NSK Varios 370 Manuel D'utilisation page 16

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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.
This conforms to CE European Directive of "Medical equipment directive 93/42/EEC."
Type BF applied part.
Autoclavable up to Max.135°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 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
RF emissions
CISPR11/EN55011
RF emmissions
CISPR11/EN55011
Harmonic emissions
EN/IEC61000-3-2
Voltage fluctuations/flicker emissions
EN/IEC61000-3-3
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
Electrostatic discharge (ESD) ±6kV contact
EN/IEC61000-4-2 ±8kV air
Electrical fast transient/burst ±2kV for power supply lines
EN/IEC61000-4-4 ±1kV for input/output
Surge ±1kV line(s) to line(s)
EN/IEC61000-4-5 ±2kV line(s) to earth
Voltage dips, short <5% Ut (>95% dip in Ut)
interruptions and voltage for 0.5 cycle
variations on power supply
40% Ut (60% dip in Ut)
input lines
for 5 cycles
EN/IEC61000-4-11
70% Ut (30% dip in Ut)
for 25 cycles
<5% Ut (>95% dip in Ut)
for 5 secs
Power frequency (50/60Hz) 3 A/m
magnetic field
EN/IEC61000-4-8
NOTE: Ut is the a.c. mains voltage prior to application of the test level.
Varios370 EN-140501.indd 15
Manufacturer.
Authorised representative in
the European community.
Compliance Electromagnetic environment - guidance
The Varios 370 / Varios 370 Lux uses RF energy only for its internal function. Therefore, its RF emissions are
Group 1
very low and are not likely to cause any interference in nearby electronic equipment.
The Varios 370 / Varios 370 Lux is suitable for use in all establishments, including domestic establishments
class B
and those directly connected to the public low-voltage power supply network that supply network that
supplies buildings used for domestic purposes.
class A
Complies
Compliance level
±6kV contact
±8kV air
±2kV for power supply lines
±1kV for input/output
±1kV line(s) to line(s)
±2kV line(s) to earth
<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
3 A/m
15
Class II Equipment.
Protected against vertically falling water
drops.
This product can be cleaned and disinfected with a
Thermo-Disinfector.
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 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 magnetic fields should be at levels
characteristic of a typical location in a typical commercial or
hospital environment.
2014/05/07 18:05:20