ACUTRONIC fabian User Manual

103 18 Electromagnetic compatibility statement
fabian Therapy evolution | SW V5.1.x
Ref: 121003.EN / Date: 26Jan2021
Magnetic field at
supply frequency
(50/60 Hz)
IEC 61000-4-8
3 A / m
3 A / m
Magnetic fields at the mains frequency
should correspond to typical values in
business and hospital environments.
Remark UT is the mains alternating voltage prior to applying the test level.
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
Never use portable or mobile radio devices closer to
the fabian Therapy evolution, including cables, than
the recommended safety distance calculated using
the equation applicable to the transmission
frequency.
Recommended safety distance
HF interference
currents
IEC 61000-4-6
3 Veff
150 kHz to 80 MHz
beyond ISM bands
a
10 Veff
150 kHz to 80 MHz
within ISM bands b
10 V
10 V
d = 0.35√P
d = 1.2√P
HF interference
radiation
IEC 61000-4-3
10 V/m
80 MHz to 2.5 GHz
10 V/m
d = 1.2√P 80 MHz to 800 MHz
d = 2.3√P 800 MHz to 2.5 GHz
P being the transmitter’s nominal rating in Watts (W)
per manufacturer specifications and being the
recommended safety distance in metres (m).
The field strength of stationary radio transmitters
should be below the compliance level d on all
frequencies as tested on site c.
Interference may occur in proximity of apparatuses
bearing
the following symbol:
REMARK 1 At 80 MHz and 800 MHz the higher frequency range applies.
REMARK 2 These guidelines may not apply to all cases. The propagation of electromagnetic quantities is
influenced by absorption and reflexion of buildings, objects and people.
a
The ISM bands (industrial, scientific and medical) between 150 kHz and 80 MHz are:
6.765
to
6.795
MHz
13.553
to
13.567
MHz
26.957
to
27.283
MHz
40.66
to
40.7
MHz

ACUTRONIC fabian Specifications

General

Type	Neonatal and Pediatric Ventilator
Manufacturer	ACUTRONIC Medical Systems AG
Model	fabian
Respiratory Rate	1 - 150 bpm
FiO2 Range	21 - 100%
HFOV Frequency	5 - 20 Hz
Power Supply	100-240 V AC, 50/60 Hz
Modes of Ventilation	SIMV, CPAP, HFOV
Tidal Volume Range	2 to 300 ml
PEEP/CPAP	0-20 cmH2O
Inspiratory Time	0.1 to 3 seconds
Flow Rate	2 - 30 L/min
Flow Sensor	Integrated
Pressure Limit	10-80 cmH2O