NSK Surgic XT Plus Operación Manual página 19

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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.
This product is designed not to become the ignition source in air and flammable anesthetic gas.
The EU directive 93/42/EEC was applied in the design and production of this medical device.
Protected against the effects of continuous immersion in dust and water.
Dispose of this device and its accessories via methods approved for electronic device and in compliance with the Directive
2002/96/CE
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.
Guidance and manufacturer's declaration - Electromagnetic Emissions.
Surgic XT Plus is intended for use in the electromagnetic environment specified below.
The customer or the user of the Surgic XT Plus should assure that is used in such an environment.
Guidance and manufacture's declaration electromagnetic emissions.
Emissions test
RF emissions
CISPR11
RF emissions
CISPR11
Harmonic emissions
IEC61000-3-2
Voltage fluctuations/flicker emissions
IEC61000-3-3
Guidance and manufacturer's declaration - Electromagnetic Immunity
Surgic XT Plus is intended for use in the electromagnetic environment specified below.
The customer or the user of the Surgic XT Plus should assure that it is used in such an environment.
Immunity test IEC60601 test level
Electrostatic discharge (ESD) ± (2, 4) 6 kV contact
IEC61000-4-2 ± (2, 4) 8 kV air
Electrical fast transient/burst ± 2kV for power supply lines
IEC61000-4-4 ± 1kV for input/output lines
Surge ± 1kV differential mode
IEC61000-4-5 ± 2kV common mode
Voltage dips, short <5% Ut (>95% dip in Ut)
interruptions and voltage for 0.5 cycle
variations on power supply
40% Ut (60% dip in Ut)
input lines
for 5 cycles
IEC61000-4-11
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
NOTE 'Ut' is the AC mains voltage prior to application of the test level.
See Operation Manual
Compliance Electromagnetic environment - guidance
Group 1 Surgic XT Plus 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 XT Plus 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
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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 XT Plus
requires continued operation during power mains
interruptions, it is recommended that the Surgic XT Plus 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.