Nutricia Flocare Infinity, Instructions For Use Manual, Page: 41 / 42

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Emissions test Compliance Electromagnetic environment – guidance
Guidance and manufacturer’s Declaration – Electromagnetic emissions
Immunity test IEC 60601 test level Electromagnetic environment – guidance
Guidance and manufacturer’s Declaration – Electromagnetic immunity
Compliance level
161 V
ac
for 0,5 s
95 V
ac
for 100 ms
0 V
ac
for 10 ms
0 V
ac
for 5 s
161 V
ac
for 0,5 s
95 V
ac
for 100 ms
0 V
ac
for 10 ms
0 V
ac
for 5 s
APPENDIX A: GUIDANCE AND MANUFACTURER’S DECLARATION -
ELECTROMAGNETIC COMPATIBILITy
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres
(m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output
power rating of the transmitter in Watts (W) according to the transmitter manufacturer.
NOTE 1
At 80 MHz and 800 MHz, the separation distance for 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.
0,01 0,01 0,01 0,02
0,1 0,04 0,04 0,07
1 0,12 0,12 0,23
10 0,37 0,37 0,74
100 1,17 1,17 2,33
The Flocare ® Infinity ™ enteral feeding pump is intended for use in an electromagnetic environment in which radiated RF dis-
turbances are controlled. The customer or the user of the Flocare
®
Infinity
™
can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the
Flocare ® Infinity ™ as recommended below, according to the maximum output power of the communications equipment.
Rated Maximum output
power of transmitter
(W)
Separation distance according to frequency of transmitter (m)
Recommended separation distances between portable and mobile RF communications equipment and the
Flocare
®
Infinity
™
enteral feeding pump
150 KHz to 80 MHz
d = 0,12
CD
P
80 MHz to 800 MHz
d = 0,12
CD
P
800 MHz to 2,5 GHz
d = 0,23
CD
P
Portable and mobile RF communications equi-
pment should be used no closer to any part of
the Flocare
®
Infinity
™
, including cables, than the
recommended separation distance calculated
from the equation applicable toe the frequency
of the transmitter:
Recommended separation distance
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,
a
should be less than the compliance level in
each frequency range.
b
Interference may occur
in the vicinity of equipment
marked with the following
symbol:
Conducted RF
IEC 61000-4-6 3 Vrms
150 KHz to 80 MHz d = 1,17 CD
P
3 Vrms
150 KHz to 80 MHz
Radiated RF
IEC 61000-4-3 3 V/m
80 Mhz to 2,5 GHz d = 0,12 CD
P
d = 0,23 CD
P
80 MHz to 800 MHz
800 MHz to 2,5 GHz 30 V/m
80 Mhz to 2,5 GHz
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
® Infinity ™ is used exceeds the appli-
cable RF compliance above, the Flocare ® Infinity ™ should be observed to verify normal operation. If abnormal perfor-
mance is observed, additional measures may be necessary, such as reorienting or relocating the Flocare ® Infinity ™ .
b. Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.
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.
The Flocare
®
Infinity
™
enteral feeding pump is intended for use in the electromagnetic environment specified below. The
customer or the user of the Flocare
®
Infinity
™
enteral feeding pump should assure that it is used in such an environment.
Guidance and manufacturer’s Declaration – Electromagnetic immunity
Immunity test IEC 60601 test level Electromagnetic environment – guidance Compliance level
The Flocare
®
Infinity
™
enteral feeding pump is intended for use in the electromagnetic environment specified below.
The customer or the user of the Flocare® Infinity™ enteral feeding pump should assure that it is used in such an
environment.
RF Emissions
CISPR 11
Group 1 The Flocare ® Infinity ™ uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment.
RF Emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
Flicker emissions
IEC 61000-3-3
Complies
The Flocare
®
Infinity
™
is suitable for use in all
establishments, including domestic establishments and
those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic
purposes.
The Flocare ® Infinity ™ enteral feeding pump is intended for use in the electromagnetic environment specified below. The
customer or the user of the Flocare ® Infinity ™ enteral feeding pump should assure that it is used in such an environment.
Electrostatic
discharge (ESD)
IEC 61000-4-2 ≤ 6 KV contact
≤ 8 KV air
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30%.
≤ 6 KV contact
≤ 8 KV air
Electric fast
transient/burst
IEC 61000-4-4 ≤ 2 KV for power sup-
ply lines
≤ 1 KV for input/ out-
put lines
Mains power quality should be that of a typical
commercial or hospital environment.
≤ 2 KV for power sup-
ply lines
≤ 1 KV for input/ out-
put lines
Surge
IEC 61000-4-5 ≤ 1 KV differential
mode
Mains power quality should be that of a typical
commercial or hospital environment.
≤ 1 KV differential
mode
Voltage dips, short
interruptions and
voltage variations on
power supply lines.
IEC 61000-4-6
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the Flocare
®
Infinity
™
requires continued
operation during power mains interruptions, it is
recommended that the Flocare
®
Infinity
™
enteral
feeding pump be powered from an uninterrupti-
ble power supply of battery.
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