Electromagnetic Compatibility - Nutricia flocare infinity Instructions D'utilisation

APPENDIX A: GUIDANCE AND MANUFACTURER'S DECLARATION -

ELECTROMAGNETIC COMPATIBILITy

Guidance and manufacturer's Declaration – Electromagnetic emissions
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.
Emissions test Compliance
RF Emissions
Group 1
CISPR 11
RF Emissions Class B
CISPR 11
Harmonic emissions Class A
IEC 61000-3-2
Voltage fluctuations/ Complies
Flicker emissions
IEC 61000-3-3
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 ® Infinity ™ enteral feeding pump should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level
Electrostatic ≤ 6 KV contact ≤ 6 KV contact
discharge (ESD)
IEC 61000-4-2 ≤ 8 KV air ≤ 8 KV air
Electric fast ≤ 2 KV for power sup- ≤ 2 KV for power sup-
transient/burst ply lines ply lines
IEC 61000-4-4 ≤ 1 KV for input/ out- ≤ 1 KV for input/ out-
put lines put lines
Surge ≤ 1 KV differential ≤ 1 KV differential
IEC 61000-4-5 mode mode
Voltage dips, short 161 V for 0,5 s 161 V
ac
interruptions and 95 V for 100 ms 95 V
ac
0 V for 10 ms 0 V
voltage variations on
ac
0 V for 5 s 0 V
power supply lines.
ac
IEC 61000-4-6
ZMNL900048_AW.indd 82-83
Electromagnetic environment – guidance
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.
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.
Electromagnetic environment – guidance
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30%.
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment.
for 0,5 s
Mains power quality should be that of a typical
ac
for 100 ms
commercial or hospital environment. If the user
ac
for 10 ms
ac of the Flocare ® Infinity ™ requires continued
for 5 s
ac operation during power mains interruptions, it is
recommended that the Flocare ® Infinity
feeding pump be powered from an uninterrupti-
ble power supply of battery.
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Recommended separation distances between portable and mobile RF communications equipment and the
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
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)
0,01
0,1
1
10
100
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.
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 IEC 60601 test level
Conducted RF 3 Vrms
IEC 61000-4-6 150 KHz to 80 MHz
Radiated RF 3 V/m
IEC 61000-4-3 80 Mhz to 2,5 GHz
™ enteral
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 above, the Flocare
mance is observed, additional measures may be necessary, such as reorienting or relocating the Flocare
b. Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.
Flocare Infinity enteral feeding pump
® ™
® Infinity ™ can help prevent electromagnetic interference
Separation distance according to frequency of transmitter (m)
150 KHz to 80 MHz 80 MHz to 800 MHz
d = 0,12 CD d = 0,12 CD
P P
0,01 0,01
0,04 0,04
0,12 0,12
0,37 0,37
1,17 1,17
Infinity enteral feeding pump should assure that it is used in such an environment.
® ™
Compliance level 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
3 Vrms d = 1,17CD P
150 KHz to 80 MHz
30 V/m d = 0,12CD P 80 MHz to 800 MHz
d = 0,23CD P
80 Mhz to 2,5 GHz 800 MHz to 2,5 GHz
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 ™
® Infinity ™ should be observed to verify normal operation. If abnormal perfor-
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800 MHz to 2,5 GHz
d = 0,23 CD
P
0,02
0,07
0,23
0,74
2,33
, including cables, than the
™
a
b
is used exceeds the appli-
® Infinity ™ .
7/2/11 10:06 AM