ACUTRONIC fabian User Manual

18 Electromagnetic compatibility statement 100
fabian Therapy evolution | SW V5.1.x
Ref: 121003.EN / Date: 26Jan2021
Guideline and Manufacturer Declaration – Electromagnetic Immunity
The fabian Therapy evolution device is intended for operation in the environment described below. The
customer or operator of the fabian Therapy evolution apparatus should ensure it is operated in this type of
environment.
Immunity
Testing
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.
Conducted
Disturbances
Induced RF Fields
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz (a)
Recommended Safety Distance (d)
d = 0.35√P
d = 1.2√P
10 Vrms (ISM bands)
150 kHz to 80 MHz (b)
Radiated RF
Electromagnetic
Fields
IEC 61000-4-3
10 V/m
Sweep from 80 MHz to 2.7 GHz
27 V/m
385 MHz
d = 1.2√P 80 MHz to 800 MHz
d = 2.3√P 800 MHz to 2.7 GHz
28 V/m
450, 810, 870, 930, 1720, 1845,
1970, 2450 MHz
9 V/m
710, 745, 780, 5240, 5500, 5785
MHz
(P) being the transmitter’s nominal rating in Watts (W)
per manufacturer specifications and (d) being the
recommended safety distance (b) in meters (m).
The area strength of stationary radio transmitters
should be below the compliance level (d) on all
frequencies as tested on site c.
Interference could 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 case. The propagation of electromagnetic quantities is
influenced by absorption and reflection 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
b
The compliance levels in ISM frequency bands between 150 kHz and 80 MHz and between 80 MHz and
2.5 GHz are defined as such to decrease the probability of mobile/portable transmitters causing
interference in the event they are accidentally brought into the vicinity of the patient. For this reason,
an additional factor of 10/3 is used when calculating the recommended safety distance of transmitters
in this frequency range.
c
In theory the area intensity of stationary transmitters, as for example: base units of radio telep hones
(mobile/cordless) and mobile land radio devices, amateur radio stations, AM and FM radio stations and

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