ACUTRONIC fabian User Manual

101 18 Electromagnetic compatibility statement
fabian Therapy evolution | SW V5.1.x
Ref: 121003.EN / Date: 26Jan2021
Guideline and Manufacturer Declaration – Electromagnetic Immunity
television stations cannot be predefined precisely. A study of the location should be conducted to
determine the electromagnetic environment regarding stationary transmitters. If the area intensity at
the location where the fabian Therapy evolution is used exceeds the above compliance levels, fabian
Therapy evolution should be monitored for proper function. If unusual performance characteristics are
observed, additional measures could be required, as for example: changing the direction or location of
the fabian Therapy evolution.
d
Above a Frequency Range of 150kHz to 80MHz the area intensity should be below 10 V/m.
Recommended Safety Distances between Portable and Mobile
HF communication devices and the fabian Therapy evolution device.
fabian Therapy evolution is intended to be operated in an electromagnetic environment with controlled HF
interferences. The operator of the fabian Therapy evolution can help avoid electromagnetic interference by
maintaining the minimum distance between portable and mobile HF telecommunication devices
(transmitters) and the fabian Therapy evolution device – depending on the output rating of the
communication device, as listed below.
Maximum
Transmitter Power
Output (W)
Safety Distance depending on transmission Frequency
(meters)
150 kHz to 80 MHz
outside ISM bands
150 kHz to 80 MHz
within ISM bands
80 to 800 MHz
800 MHz to
2.5 GHz
d = 0.35√P
d = 1.2√P
d = 1.2√P
d = 2.3√P
0.01
0.04
0.12
0.12
0.23
0.1
0.13
0.38
0.38
0.73
1
0.40
1.2
1.2
2.3
10
1.3
3.8
3.8
7.3
100
4.0
12
12
23
For transmitters with a maximum power output not listed in the above table the recommended Safety
Distance (d) in meters (m) can be determined using the equation from the corresponding column, with (P)
being the transmitter’s maximum power output Watts (W) per the transmitter’s manufacturer specifications.
REMARK 1
At 80 MHz and 800 MHz the Safety Distance of the Higher frequency applies.
REMARK 2
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
REMARK 3
An additional factor of 10 ∕3 is used when calculating the recommended Safety Distance for
transmitters within the ISM frequency between 150KHz and 80 MHz and between 80MHz and
2.5GHz to reduce the probability of mobile/portable transmitters causing interference if
accidentally brought into the vicinity of the patient.
REMARK 4
These guidelines may not apply to all case. The propagation of electromagnetic quantities is
influenced by Absorption and Reflection of Buildings, Objects and People.

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