NSK Ti-Max NLX nano Manuel D'utilisation page 12

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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 B 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.
Guidance and manufacturer's declaration - electromagnetic emissions
The NLX nano is intended for use in the electromagnetic environment specified below. The customer or the user of the NLX nano and manual should assure that is
used in such an environment.
Emissions test
RF emissions CISPR
Group 
RF emmissions CISPR
class B
Harmonic emissions
class A
IEC6000-3-2
Voltage fluctuations/flicker
Complies
emissions IEC6000-3-3
Guidance and manufacturer's declaration - electromagnetic immunity
The NLX nano is intended for use in the electromagnetic environment specified below. The customer or the user of the NLX nano and manual should assure that it is
used in such an environment.
Immunity test
IEC6060 test level
Electrostatic discharge (ESD)
±6kV contact
IEC6000-4-2
±8kV air
Electrical fast transient/burst
±2kV for power supply
IEC6000-4-4
lines
±kV for input/output
Surge IEC6000-4-5
±kV line(s) to line(s)
±2kV line(s) to earth
Voltage dips, short
<5% Ut
interruptions and voltage
(>95% dip in Ut) for 0.5
variations on power supply
cycle 40% Ut
input lines IEC6000-4-
Power frequency (50/60Hz)
3 A/m
magnetic field IEC6000-4-8
NOTE: Ut is the a.c. mains voltage prior to application of the test level.
Manufacturer.
Emissions test
The NLX nano 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.
The NLX nano is suitable for use in all establishments, including domestic estabilishments and those directly
connected to the public low-voltage power supply network that supplynetwork that spplies buidings used for
domestic purposes.
(*)This applies to the AC230V system. For AC20V system, this is "Not applicable".
Compliance level
±6kV contact
±8kV air
±2kV for power supply lines
No input/output line
±kV line to line
±2kV lines 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
Class II Equipment.
Autoclavable up to Max.35°C. *for detail see Sterilization.
Electromagnetic environment - guidance
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 NLX nano requires continued operation
during power mains interruptions, it is recommended that the NLX nano
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.


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