Intraoral Scanner User Manual
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Table 2-4 Guidance and manufacturer’s declaration – electromagnetic immunity
Immunity test
IEC 60601
test levels
Compliance
level
Electromagnetic
environment – guidance
NOTE 1:
At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2:
These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures,
objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/
cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength
in the location in which the
Intraoral Scanner
is used exceeds the applicable RF
compliance level above, the
Intraoral Scanner
should be observed to verify
normal operation. If abnormal performance is observed, additional measures may
be necessary, such as reorienting or relocating the
Intraoral Scanner
.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than
3 V/m.
c
The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz
are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283
MHz; and 40.66 MHz to 40.70 MHz.
To limit exposure to electromagnetic interference from nearby equipment that can
degrade image quality or launch warning messages, it is necessary to position the
Intraoral Scanner
further from sources of electromagnetic interference or install
electromagnetic shielding to block unwanted interference. The customer or the user
of the
Intraoral Scanner
should operate the device under EMI conditions that
minimize power supply transients, mechanical interactions, vibration, and thermal,
optical, and ionizing radiation.
