Guidance and manufacturer's Declaration – Electromagnetic immunity
The Flocare
Infinity
enteral feeding pump is intended for use in the electromagnetic environment specified below. The
®
™
customer or the user of the Flocare
Immunity test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
Radiated RF
RTCA/DO-160E
Section 20
NOTE 1
At 80 Mhz and 800 MHz, the higher frequency range applies.
NOTE 2
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measurement field strength in the location in which the Flocare
cable RF compliance level above, the Flocare
performance is observed, additional measures may be necessary, such as re-orienting or relocating the Flocare
Infinity
™
.
b. Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.
ZMNL900616_AW.indd 29
Infinity
enteral feeding pump should assure that it is used in such an environment.
®
™
IEC 60601 test level
Compliance level
3 Vrms
3 Vrms
150 KHz to 80 MHz
3 V/m
30 V/m
80 Mhz to 2,5 GHz
75 V/m
No Equipment
100 MHz to 8 GHz
Category specified
(75 V/m)
®
Infinity
Electromagnetic environment – guidance
Portable and mobile RF communications equi-
pment should be used no closer to any part of
the Flocare
Infinity
®
recommended separation distance calculated
from the equation applicable toe the frequency
of the transmitter:
Recommended separation distance
d = 1.2CD P
d = 1.2CD P
d = 2.3CD P
Where P is the maximum output power rating
of the transmitter in watts (W) according to the
transmitter manufacturer and d is the recom-
mended separation distance in metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
should be less than the compliance level in
each frequency range.
Interference may occur
in the vicinity of equipment
marked with the following
symbol:
®
Infinity
™
should be observed to verify normal operation. If abnormal
-29-
, including cables, than the
™
80 MHz to 800 MHz
800 MHz to 2,5 GHz
a
b
™
is used exceeds the appli-
®
10/11/16 16:07