Electromagnetic Compatibility; Electromagnetic Emissions; Electromagnetic Immunity - Ultradent Genius Bedienungsanleitung

Damaged PCB
Damaged motor
Damaged connector pins and/
or cord
Observed problem: Motor suddenly stops
Possible Cause
Damaged motor/cord
Improper voltage
Damaged PCB
Observed problem: Motor does not turn off
Possible Cause
Internal disconnections
Damaged PCB
Improper voltage
X - ELECTROMAGNETIC COMPATIBILITY
Important:
The power cord, the endodontic motor cord, and the pedal cord must be kept away from one another.
The Genius endodontic motor requires special precautions with regard to electromagnetic compatibility. It should be installed
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and set up as described in Chapter IV.
Some types of mobile telecommunications devices, like cellphones, may interfere with the Genius
separation distances recommended in this section must be followed.
The Genius endodontic motor should not be used near or on another device. If this cannot be avoided, ensure that it works
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properly under operating conditions prior to use.
Using replacement part other than those specified or sold by the manufacturer may result in Genius
increased emissions or decreased immunity.
To avoid any risk of electromagnetic interference, do not use any other similar electromedical instrument near the
Genius endodontic motor. The unit complies with radiation standards.
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This device was tested for emissions and declared compliant with IEC 60601-1-2 requirements. These standards
were designed to ensure reasonable protection against the harmful interference that can occur in a typical
medical setting. High levels of radiofrequency (RF) emitted by electrical devices, such as cellphones, can disrupt
the operation of this device. To limit disruptive electromagnetic interference, position this device away from RF
emitters and any other source of electromagnetic energy.
Risks associated with electromagnetic fields: Implanted system operation (such as pacemakers) may be disrupted
by electromagnetic fields. Before using the motors, ask patients and operators whether they are wearing an
implanted system and check their operation. Do not bring motors close to such systems. Take appropriate emergency
precautions and respond immediately to any change in health status.

10.1 ELECTROMAGNETIC EMISSIONS

The device is intended for use in the electromagnetic environment described in the table below. The operator and/or installer
should make sure the device is used in the environment described below:
Emission Test
RF Emission - CISPR 11
RF Emission - CISPR 11
Harmonic current
emission IEC61000-3-2
Voltage fluctuation and
flicker IEC61000-3-3

10.2 ELECTROMAGNETIC IMMUNITY

The device is intended for use in the electromagnetic environment described in the table below. The operator and/or installer
should make sure the device is used in such an electromagnetic environment.
Test Level as per
Immunity Test
Electrostatic
± 6 kV in contact
discharge (ESD)
± 8 kV in the air
IEC61000-4-2
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Operating Manual ● Genius
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Stop using the device immediately and contact Ultradent's customer service.
Solution
Verify that the motor cord is properly connected to the front right of the unit. If not,
disconnect and reconnect it.
Verify that the voltage matches the power. If it does not, try turning it off and then
turning the unit back on or connect the device to another electrical outlet.
If you cannot identify the cause of the problem, stop using the device immediately and
contact Ultradent customer service.
Solution
Stop using the device immediately and contact Ultradent's customer service.
Verify that the voltage matches the power. If it does not, try turning it off and then
turning the unit back on or connect the device to another electrical outlet.
Conformity
The device uses RF energy for its internal operation. As a result, its
Group 1 radiofrequency emissions are very weak and unlikely to create any
interference with neighboring equipment.
Class B
The medical device is suitable for use in all establishments, including
Class A
domestic and those directly connected to the low voltage energy supply
public network supplying buildings used for domestic purposes.
Complying
Compliance Level
IEC60601
± 6 kV in contact
± 8 kV in the air
Endodontic Motor ● J28629 ● V4 ● (16) ● 10/2016 ● NO69US010F
Electromagnetic Environment - Comments
Electromagnetic Environment - Comments
Floors must be wood, concrete, cement or tiled. If floors
are covered with synthetic materials (carpet, etc.), the
relative humidity must be 30% minimum.
endodontic motor. The
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endodontic motor
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