Denstply Sirona X-Smart IQ Protocole D'utilisation page 6

Warnings
Environmental conditions
• The X-Smart IQ
environments: physician offices, dental offices, clinics and hospitals (except near HF
surgical equipment, outside of RF shield room of an ME system for magnetic
resonance imaging).
• The device must not be used in home healthcare environments or in special
environments.
• The device must not be placed in moist surroundings or in contact with liquids.
• Do not expose the device to direct or indirect heat sources.
• The device must be operated and stored in a safe environment (follow labeling
indications).
• The device can be operated to a maximum ambient temperature of 35°C (95°F) and
up to an altitude of 2 000 m (approximately 6561 ft) above sea level.
• Do not use the device in the presence of free oxygen, anesthetics or flammable
substances.
• The device can cause radio interference or disrupt the operation of equipment in its
vicinity. If this happens, the interference should be reduced by reorienting or
repositioning the device or by screening off its immediate environment. The
electromagnetic radiations emitted by the X-Smart IQ
recommended limits specified by the applicable relevant provisions
(ref. IEC 60601-1-2, EN 60601-1-2). For more details, refer to applicable standards
IEC 60601-1-2, EN 60601-1-2.
• Use of the X-Smart IQ
should be avoided because it could result in improper operation. If such use is
necessary, the proper functioning of the devices shall be checked before use.
• The device requires special precautions with regard to electromagnetic compatibility
(EMC) and must be installed and operated in strict compliance with the EMC
Directive.
• The use of any accessories or components other than those specified or provided by
the manufacturer of this device could result in increased electromagnetic emissions
or decreased electromagnetic immunity and in improper operation. Refer to sections
6.2, 6.3
details.
• The X-Smart IQ
affect the normal functioning of pacemakers, implanted heart defibrillators and
hearing aid devices. Do not place the accessories or any other object sensitive to
static magnetic fields near the X-Smart IQ
• Do not charge, operate or store at high temperatures. Comply with the specified
operating and storage conditions.
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Handpiece is intended for use in professional healthcare facility
®
Handpiece adjacent to, or stacked with other equipment
and Appendix A: Electromagnetic Emissions and Immunity
®
Handpiece Case contains permanent magnets. Magnets could
®
Handpiece Case.
END-IFU-X-SMART-IQ-V16-WEB-EUR-Multilingual-2021-01
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Handpiece are below the
for further