15
Guidance and Align Technology’s Declaration – Electromagnetic Immunity – for iTero Element
that is not Life-Supporting
The iTero Element is intended for use in the electromagnetic environment specied below.
The customer or the user of the iTero Element should assure that it is used in such an environment.
Immunity Test IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment – Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to
2.5 GHz
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2.5
GHz
Portable and mobile RF communications equip-
ment should be used no closer to any part of the
iTero
Element system, Including cables, than the recom-
mended separation distance calculated from the
equation applicable to the frequency of the trans-
mitter.
Recommended separation distance:
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separa-
tion distance in metres (m).
Field strengths from xed RF transmitters, as de-
termined by an electromagnetic site survey, should
be less than the compliance level in each frequency
range.
Interference may occur in the vicinity of equipment
marked with the following symbol:
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 reection from structures, objects and people.
Field strengths from xed 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 xed RF transmitters, an electromagnetic site
survey should be considered. If the measured eld strength in the location in which the iTero Element system
is used exceeds the applicable RF compliance level above, the iTero Element system should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such
as re-orienting or relocating the iTero Element system. Over the frequency range 150 kHz to 80 MHz, eld
strengths should be less than 3 V/m.
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
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