ACUTRONIC fabian +nCPAP evolution User Manual

20 Electromagnetic compatibility statement 133
fabian +nCPAP evolution | SW V5.1.x
Ref: 122003.EN / Date : 26Jan2021
20.2 Devices with SN up to AN-03999
Guideline and manufacturer declaration – electromagnetic emission
The device " fabian +nCPAP evolution " is intended for operation in the environment described below. The
customer or user of the " fabian +nCPAP 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 +nCPAP 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 +nCPAP 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
NA
Emission of voltage
fluctuations / flickers IEC
61000-3-3
NA
Guideline and manufacturer declaration – electromagnetic immunity
The device "fabian +nCPAP evolution" is intended for operation in the environment described below. The
customer or user of the " fabian +nCPAP 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 be no 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
½ period
40% UT
(60% drop of UT) for
5 periods
70% UT
(30% drop of UT) for
25 periods
The mains quality should correspond to
typical business or hospital
environments. If the operator of the
"fabian +nCPAP evolution" requires
continued use in the event of a power
failure we recommend connecting the
"fabian +nCPAP evolution " to an
uninterruptible mains supply or a
battery.

ACUTRONIC fabian +nCPAP evolution Specifications

General

Brand	ACUTRONIC
Model	fabian +nCPAP evolution
Category	Medical Equipment
Language	English