ACUTRONIC fabian User Manual

18 Electromagnetic compatibility statement 102
fabian Therapy evolution | SW V5.1.x
Ref: 121003.EN / Date: 26Jan2021
Device with SN up to AT-04000
Guideline and manufacturer declaration – electromagnetic emission
The device "fabian Therapy evolution" is intended for operation in the environment described below. The
customer or user of the "fabian Therapy evolution" apparatus should ensure it is operated in this type of
environment.
EMI measurement
Compliance
Electromagnetic environment – guideline
HF emission CISPR 11
Group 1
The device "fabian Therapy evolution" uses HF energy solely for
internal operation. Its HF emission is thus very low and
interference with adjacent apparatuses is unlikely.
HF emission CISPR 11
Class A
The device fabian Therapy evolution is suitable for use in all other
areas except residential areas and areas directly connected to a
public mains supply which also supplies buildings used for
residential purposes.
Emission of harmonics
IEC 61000-3-2
Not
applicable
Emission of voltage
fluctuations / flickers
IEC 61000-3-3
Not
applicable
Guideline and manufacturer declaration – electromagnetic immunity
The device fabian Therapy evolution is intended for operation in the environment described below. The
customer or user of the fabian Therapy evolution apparatus should ensure it is operated in this type of
environment.
Immunity
testing
IEC 60601 test
level
Compliance level
Electromagnetic environment –
guideline
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wooden or concrete or
tiled with ceramic tiles. For flooring made
from synthetic materials the relative air
humidity must not be less than 30%.
Quick electric
transients/burst
IEC 610004-4
± 2kV for power
cords
± 1kV for in-/output
cables
± 2kV for power
cords
± 1kV for in-/output
cables
The mains quality should correspond to
typical business or hospital
environments.
Surges
IEC 61000-4-5
± 1 kV lead to lead
± 2 kV lead to ground
± 1 kV lead to lead
± 2 kV lead to ground
The mains quality should correspond to
typical business or hospital
environments.
Voltage drops,
temporary power
failures and
fluctuations
IEC 61000-4-11
<5% UT
(>95% drop of UT)
for ½ period
40% UT
(60% drop of UT) for
5 periods
70% UT
(30% drop of UT) for
25 periods
<5% UT
(>95% drop of UT)
for 5 seconds
<5% UT
(>95% drop of UT)
for ½ period
40% UT
(60% drop of UT) for
5 periods
70% UT
(30% drop of UT) for
25 periods
<5% UT
(>95% drop of UT)
for
5 seconds
The mains quality should correspond to
typical business or hospital
environments. If the operator of the
fabian Therapy evolution requires
continued use in the event of a power
failure we recommend connecting the
fabian Therapy evolution to an
uninterruptible mains supply or a
battery.

ACUTRONIC fabian Specifications

General

Brand	ACUTRONIC
Model	fabian
Category	Medical Equipment
Language	English