Acteon X-MIND trium - Electromagnetic Immunity Guidance

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USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M
Emission test Conformity Electromagnetic environment guidance
RF emissions
CISPR 11
Group 1
The medical device uses RF energy only for internal operation. RF
emissions are extremely reduced and are not likely to generate
interference with electronic equipment in the vicinity.
RF emissions
CISPR 11
Class A
The medical device is suitable for use in all establishments other
than domestic establishments and those directly connected to the
public low-voltage power supply network that supplies buildings
used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage uctuations/icker emissions
IEC 61000-3-3
Complies
11.17.3 ELECTROMAGNETIC IMMUNITY
The medical device is designed for use in the magnetic and electromagnetic environment described in the table below. The
user and/or installer must ensure conformity of the electromagnetic environment.
Immunity test CEI EN 60601 test level Compliance level Electromagnetic environment guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
+/- 6 kV contact
+/- 8 kV air
IEC 60601-1-2
Test level
Floors should be wood, concrete or ceramic tile.
If oors are covered with synthetic material, the
relative humidity must be at least 30%
Electrical fast
transient/burst
IEC 61000-4-4
+/- 2 kV for power supply
lines
+/- 1 kV for input/output
lines
IEC 60601-1-2
Test level
Mains power quality should conform to that of
typical commercial or hospital applications.
Surge
IEC 61000-4-5
+/- 1 kV differential mode
+/- 2 kV common mode
IEC 60601-1-2
Test level
Mains power quality should conform to that of
typical commercial or hospital applications.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5 % UT for 0.5 cycles
(>95 % dip in UT)
40 % UT for 5 cycles
(60 % dip in UT)
70 % UT for 25 cycles
(30 % dip in UT)
<5 % UT for 5 onds
(>95 % dip in UT)
IEC 60601-1-2
Test level
Mains power quality should conform to that of
typical commercial or hospital applications. If the
operator requires continued operation even during
mains power outage, we recommend powering the
system using a UPS.
Mains frequency
(50/60 Hz)
magnetic eld
IEC 61000-4-8
3 A/m
IEC 60601-1-2
Test level
Power frequency magnetic elds must be at the
typical level of standard mains for commercial or
hospital use.
Note: Ut is the AC mains voltage prior to the application of the test level.