5
ENGLISH
Security
specification
It is recommended to use password protection on wireless network.
Connectivity
specification
RJ45, IEEE 802.3 10/100 /1000BASE-T, CAT5
(When in combination with TRIOS MOVE+)
All RJ45 sockets provide galvanic isolation between the device
and IT Networks by a network isolator.
IEEE 802.11ac
IMPORTANT NOTICE
The device can be connected to an IT Network to transmit and receive
data via the network. Integration of the device into an IT Network may
lead to unknown IT security risks for users of the device or risk
of compromising the stability or ability to use the device.
Network security is the responsibility of the customer’s organization.
IMPORTANT NOTICE
If the TRIOS intraoral scanner system is connected to IT Network equipment,
it is strongly recommended to apply network security measures and to analyze,
evaluate, and control the IT network.
Analysis of IT Network security measures is recommended for:
• Changes to network configuration
• Addition of new devices
• Removal of devices
• Updates and Upgrades to devices
4.13 Electromagnetic Compability
The TRIOS MOVE+ has been tested according to Medical electrical equipment – Part 1-2:
General requirements for basic safety and essential performance – Collateral Standard:
Electromagnetic disturbances – Requirements and tests, EN 60601-1-2 ed. 4.0, 2015 and
EN 60601-1-2 ed. 4.1, 2020 .
WARNING
Medical electrical equipment needs special precautions regarding
EMC and needs to be installed and put into service according to the
EMC information provided in this document.
IMPORTANT NOTICE
Portable and mobile RF communications equipment can affect medical
electrical equipment.
4.14 Declaration – Electromagnetic Emissions
The TRIOS MOVE+ complies with the requirements EN 60601-1-2 (Ed. 4.0 and Ed. 4.1)
clause 7 Emissions.
The TRIOS MOVE+ is intended for use in the electromagnetic environment specified below.
The user or users of the TRIOS MOVE+ should assure that it is used in such an environment.
Emission
measurement
Conformity
E
lectromagnetic
environment – guidelines
RF emission
CISPR11
Group 1
The TRIOS MOVE+ uses RF energy only for its
internal functions. Therefore, Its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emission
CISPR11
Class B
Harmonic
emission
EN 61000-3-2
Class A
The TRIOS MOVE+ is intended for use in
dental clinical settings, including domestic
establishments and those directly connected
to the public low-voltage power supply
network that supplies buildings used for
domestic purposes.
Voltage
fluctuation and
flicker
EN 61000-3-3
Complies
4.15 Electromagnetic Immunity
The TRIOS MOVE+ complies with the requirements EN 60601-1-2 (Ed. 4.0 and Ed. 4.1)
clause 8 Immunity. The test levels for immunity to RF electromagnetic fields are selected
according to general test conditions for medical equipment.
The TRIOS MOVE+ is intended for use in a Professional Healthcare Facility Environment with
the electromagnetic environment specified below. The user of The TRIOS MOVE+ should
assure that it is used in such an environment.
Immunity test
EN 60601 test
level
Compliance
level
Electromagnetic
environment – guidelines
Electrostatic
discharge ESD
EN 61000-4-2
Contact
+/-8kV.
Air:
+/-15kV.
Contact
+/-8kV.
Air:
+/-15kV.
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic materials, the
relative humidity should
be at least 30 %.
The TRIOS MOVE+ is allowed
to have a temporary loss
of function, which requires
operator intervention or
system reset.
Electrical fast
transients/burst
EN 61000-4-4
+/- 2 kV
for power
supply lines
+/-1 kV
for input/
output lines
+/- 2 kV
for power
supply lines
+/-1 kV
for input/
output lines
Mains power quality should be
that of a typical commercial
or hospital environment.
During electrical fast transient/
burst the TRIOS MOVE+ is
allowed to have a temporary
loss of function, which requires
operator intervention
or system reset.
Surge
EN 61000-4-5
+/-1 kV
Line(s) to earth:
+/-2 kV.
Line to line.
+/-1 kV
Line(s) to earth:
+/-2 kV.
Line to line.
Mains power quality should
be that of a typical commercial
or hospital environment.
Voltage
dips, short
interruption
and voltage
variations
EN 61000-4-11
0 % U
T
for 0.5 cycle
(1 phase)
0 % U
T
for 1 cycle
70 % U
T
for 25/30 cycles
(50/60 Hz)
0 % U
T
for 0.5 cycle
(1 phase)
0 % U
T
for 1 cycle
70 % U
T
for 25/30 cycles
(50/60 Hz)
During the testing the
TRIOS MOVE+ is allowed
to have a temporary loss
of function which requires
operator intervention or reset.
Power frequency
(50/60Hz)
Magnet field
EN 61000-4-8
30 A/m.
30 A/m.
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical domestic
or hospital environment.
Proximity
magnetic fields
9 kHz – 13.56 MHz
EN IEC
61000-4-39
134.2 kHz:
65 A/m, 2.1
kHz pulse
modulation
13.56 MHz:
7.5 A/m, 50
kHz pulse
modulation
CT for
transmitters
CR for receivers
Portable and mobile
RF communications
equipment should be used
no closer to the device than
a recommended separation
distance of 30 cm
Note:
U
T
is the ac mains voltage prior to application of the test level
Immunity test
EN 60601 test level
Compliance level
Conducted RF
EN 61000-4-6
3 Vrms
150 kHz to 80 MHz.
6 Vrms in ISM bands
between 0,15 MHz and
80 MHz (Note b)
[V1] 3 Vrms
[V2] 6 Vrms (Note b)
Radiated RF
EN 61000-4-3
3 V/m
80 MHz to 2.7 GHz.
[E1] 3 V/m
80 MHz to 2.7 GHz.
Electromagnetic environment – guidelines
Portable and mobile RF communications equipment should be used no closer to any part
of the TRIOS MOVE+, including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of transmitter.
Recommended separation distance
d = 1,2 √P
d = 1,2 √P 80 MHz to 800 MHz
d = 2,3 √P 800 MHz to 2,7 GHz
where
P
is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacture and
d
is the recommended separation distance in meter
(m),
V1
is the conducted RF compliance level, and
E1
is the RF radiated compliance level.
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,
(note a, b and c) should be less than the compliance level in each frequency range.
Interference may occur in the vicinity of equipment.
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, object and people.
