ACUTRONIC fabian HFO User Manual

170 Electromagnetic compatibility statement
fabian HFO | SW 5.1.x
Ref: 113003.EN / Date 2020-02-10
Guideline and manufacturer declaration – electromagnetic immunity
The device "fabian HFO" is intended for operation in the environment described below. The customer or
user of the "fabian HFO" 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 HFO", 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 (d) being
the recommended safety distance (b) in meters.
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 case. 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 MHz to 6.795 MHz;
13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz 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 so as to decrease the probability of mobile/portable transmitters causing interference
in the event they are accidentally brought in to 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 field intensity of stationary transmitters, as e.g. base units of radio telephones (mobile/cordless)
and mobile land radio devices, amateur radio stations, AM and FM radio stations and television stations cannot
be predefined precisely. A study of the location should be conducted to determine the electromagnetic
environment with regard to stationary transmitters. If the field intensity at the location where the "fabian HFO" is
used exceeds the above compliance levels, "fabian HFO" should be monitored for proper function. If unusual
performance characteristics are observed, additional measures may be required, as e.g. changing the direction
or location of the "fabian HFO".
d
Above a frequency range of 150kHz to 80MHz the field intensity should be below 10 V/m.

ACUTRONIC fabian HFO Specifications

General

Brand	ACUTRONIC
Model	fabian HFO
Category	Medical Equipment
Language	English