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AppENdIx A: gUIdANCE ANd MANUFACTURER'S dECLARATION -
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
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
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
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electric fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations on
power supply lines.
IEC 61000-4-6
ZMNL900071_AW.indd 30
ELECTROMAgNETIC COMpATIBILITY
Compliance
Group 1
Class B
Class A
Complies
Infinity
enteral feeding pump should assure that it is used in such an environment.
®
™
IEC 60601 test level
Compliance level
≤ 6 KV contact
≤ 6 KV contact
≤ 8 KV air
≤ 8 KV air
≤ 2 KV for power sup-
≤ 2 KV for power sup-
ply lines
ply lines
≤ 1 KV for input/ out-
≤ 1 KV for input/ out-
put lines
put lines
≤ 1 KV differential
≤ 1 KV differential
mode
mode
161 V
for 0,5 s
161 V
ac
95 V
for 100 ms
95 V
ac
ac
0 V
for 10 ms
0 V
ac
ac
0 V
for 5 s
0 V
ac
ac
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
ac
Mains power quality should be that of a typical
for 100 ms
commercial or hospital environment. If the user
for 10 ms
of the Flocare
for 5 s
operation during power mains interruptions, it is
recommended that the Flocare
feeding pump be powered from an uninterrupti-
ble power supply of battery.
-28-
Infinity
requires continued
®
™
®
Infinity
™
enteral
11/7/11 4:35 PM
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