iTero Element - APPENDIX A: EMC Declaration

iTero
®
Element
™
Operation Manual
ENGLISH
2017 Align Technology, Inc. Publication 109797
14
APPENDIX A:
EMC Declaration
Guidance and Align Technology‘s Declaration – Electromagnetic Emissions – for iTero Element
iTero Element is intended for use in the electromagnetic environment specied below.
The customer or the user of iTero Element should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment – Guidance
RF emissions CISPR 11 Group 1
iTero Element 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.
RF emissions CISPR 11 Class B
Harmonic emissions IEC
61000-3-2
Complies, class A
Voltage uctuations/
icker emissions IEC
61000-3-3
Complies
iTero Element is suitable for use in all establisments, Includ-
ing domestic establishments and those directly connected to
the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Guidance and Align Technology’s Declaration – Electromagnetic Immunity – for iTero Element
iTero Element is intended for use in the electromagnetic environment specied below.
The customer or the user of iTero Element should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level
Electromagnetic Environment –
Guidance
Electrostatic dis-
charge (ESD) IEC
61000-4-2
± 6 kV contact ± 8
kV air
± 6 kV contact ± 8 kV
air
Floors should be wood, concrete
or ceramic tile. If oors are covered
with synthetic material, the relative
humidity should be at least 30%.
Electrical fast tran-
sient/burst IEC
61000-4-4
± 2 kV for power
supply lines ± 1 kV for
input/output lines
± 2 kV for power supply
lines NA
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge IEC 61000-
4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 1 kV line(s) to line(s) ±
2 kV line(s) to earth
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines IEC 61000-4-11
<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 s
<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 s
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the iTero
Element system requires continued
operation during power mains inter-
ruptions, it is recommended that the
iTero Element system be powered
from an uninterruptible power supply
or a battery.
Power frequency
(50/60 Hz) magnetic
eld IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic elds
should be at levels characteristic of a
typical location in a typical commer-
cial or hospital environment.
NOTE: UT is the A.C. mains voltage prior to application of the test level.