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
enteral feeding pump should assure that it is used in such an environment.
Immunity test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
Proximity fields
from RF
wireless
communications
equipment 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 elec-
tromagnetic site survey should be considered. If the measurement field strength in the location in which the Flocare
compliance level above, the Flocare
necessary, such as re-orienting or relocating the Flocare
b. Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.
ZMNL900907_AW.indd 33
ZMNL900907_AW.indd 33
IEC 60601 test level
Compliance level
3 Vrms
3 Vrms
150 KHz TO 80
MHz outside ISM and amateur
radio bands
80% AM at 1 kHz
6 Vrms
6 Vrms
50 kHz to 80 MHz
in ISM and amateur
radio bands
80% AM at 1 kHz
10 V/m
10 V/m
80 MHz to 2.7 GHz
80% AM at 1 kHz
9 V/m to 28 V/m
9 V/m to 28 V/m
15 specific frequencies up to
5,785 GHz
75 V/m
No equipment
100 MHz to 8 GHz
Category specified
(75 V/m)
®
™
Infinity
should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
®
™
Infinity
.
Electromagnetic environment – guidance
Portable and mobile RF communications equipment should be
used no closer to any part of the Flocare
cables, than the 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 recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey,
level in each frequency range.
Interference may occur
in the vicinity of equipment
marked with the following
symbol:
®
Infinity
-32-
®
™
Infinity
®
™
Infinity
, including
80 MHz to 800 MHz
800 MHz to 6 GHz
should be less than the compliance
a
b
™
is used exceeds the applicable RF
12.05.21 15:59
12.05.21 15:59