Guidance And Manufacturer's Declaration - Electromagnetic Compatibility - Nutricia flocare Infinity Mode D'emploi

APPENDIX A: GUIDANCE AND MANUFACTURER'S DECLARATION -
Electromagnetic emissions may affect the operation of any electronic medical de-vice, including enteral feeding
pumps.
The Flocare Infinity Pump will not be affected by electromagnetic emissions in most environments. However,
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some electromagnetic fields produced by personal communication equipment, household appliances, or occu-
pational tools may cause electromagnetic interference (EMI) which can affect the pump.
Possible sources of electromagnetic interference with electronic medical devices include, but are not limited to:
cellular phones, cordless telephones, microwave ovens, anti-theft/security systems, blenders, and high-powered
tools (i e drills, saws, chain saws). If electromagnetic emitting devices are operated within one yard/meter of
the Flocare ® Infinity ™ Pump, the pump may automatically shut off and settings may return to their default values.
Check the pump regularly if operating near sources of electromagnetic emissions.
The Flocare Infinity Pump can safely be operated on commercial aircraft and is designed in accordance with
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EN 60601-1-2, EN 60601-1-4 and RT CA DO160D standards for electromagnetic emissions and immunity.
Guidance and manufacturer's Declaration – Electromagnetic emissions
The Flocare Infinity enteral feeding pump is intended for use in the electromagnetic environment specified below.
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The customer or the user of the Flocare
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
® ™
below. The customer or the user of the Flocare
such an environment.
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 61000-4-11
ZMNL900908_AW.indd 32
ELECTROMAGNETIC COMPATIBILITY
® Infinity™ enteral feeding pump should assure that it is used in such an
Compliance
Group 1
Class B
Class A
Complies
enteral feeding pump is intended for use in the electromagnetic environment specified
Infinity
®
IEC 60601 test level Compliance level
± 8 kV contact ± 8 kV contact
± 15 kV air ± 15 kV air
± 2 kV @ PRR 100kHz ± 2 kV @ PRR 100kHz
for power supply lines for power supply lines
± 1 kV @ PRR 100kHz ± 1 kV @ PRR 100kHz
for input/ output lines for input/ output lines
± 1 kV line to line ± 1 kV line to line
70 % U ; 25/30 cycles 70 % U
T
single phase: at 0° single phase: at 0°
0 % U 0 % U
; 1 cycle at 0°
T
0 % U ; 0,5 cycle at 0 % U
T
0°, 45°, 90°, 135°, 0°, 45°, 90°, 135°,
180°, 225°, 270° and 315° 180°, 225°, 270° and 315°
0 % U 0 % U
; 250/300 cycle (5s)
T
Electromagnetic environment – guidance
The Flocare Infinity
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nal function. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby
electronic equipment.
The Flocare Infinity
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establishments, including domestic establishments
and those directly connected to the public low-voltage
power supply network that supplies buildings used for
domestic purposes.
enteral feeding pump should assure that it is used in
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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 typi-
cal commercial or hospital environment.
Mains power quality should be that of a typi-
cal commercial or hospital environment.
; 25/30 cycles Mains power quality should be that of a
T
typical commercial or hospital environment.
The Flocare
; 1 cycle at 0°
T
ration during power mains interruptions via
; 0,5 cycle at
T
the internal battery.
; 250/300 cycle (5s)
T
-30-
uses RF energy only for its inter-
is suitable for use in all
Infinity™ allows continued ope-
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