Appendix A: Guidance And Manufacturer's Declaration - Electromagnetic Compatibility - Nutricia Flocare Infinity Instructions For Use Manual

APPENDIX A: GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC
Electromagnetic emissions may affect the operation of any electronic medical device, including enteral feeding pumps.
The Flocare® Infinity™ Pump will not be affected by electromagnetic emissions in most environments. However, some electromagnetic fields
produced by personal communication equipment, household appliances, or occupational 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 telep-
hones, 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 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.
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® Infinity™ enteral feeding pump should assure that it is used in 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 inter-
ruptions and voltage
variations on power sup-
ply lines.
IEC 61000-4-11
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COMPATIBILITY
Compliance
Group 1
Class B
Class A
Complies
IEC 60601 test level Compliance level
± 8 kV contact ± 8 kV contact
± 15 kV air ± 15 kV air
+/- 2 kV @ PRR +/- 2 kV @ PRR
100kHz for power 100kHz for power
supply lines supply lines
± 1 kV @ PRR ± 1 kV @ PRR
100kHz for input/ 100kHz for input/
output lines output line
± 1 kV line to line ± 1 kV line to line
70 % UT; 25/30 70 % UT; 25/30
cycles single phase: at 0° cycles single phase: at 0°
0 % UT; 1 cycle at 0° 0 % UT; 1 cycle at 0°
0 % UT; 0,5 cycle at 0 % UT; 0,5 cycle at
0°, 45°, 90°, 135°, 0°, 45°, 90°, 135°,
180°, 225°, 270° and 180°, 225°, 270° and
315° 315°
0 % UT; 250/300 cycle 0 % UT; 250/300 cycle
(5s) (5s)
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 sup-
plies 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 humi-
dity should be at least 30%.
Mains power quality should be that of a typical commer-
cial or hospital environment.
Mains power quality should be that of a typical commer-
cial or hospital environment.
Mains power quality should be that of a typical com-
mercial or hospital environment. The Flocare® Infinity™
allows continued operation during power mains interrupti-
ons via the internal battery.
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