Guidance And Manufacturer's Declaration - Electromagnetic Compatibility - Nutricia Flocare Infinity Instrucciones De Uso

APPENDIX A: GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC
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, some electromagnetic fields
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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
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
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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 enteral feeding pump is intended for use in the electromagnetic environment specified below. The customer or the user
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of the Flocare Infinity enteral feeding pump should assure that it is used in such an environment.
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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
ZMNL900911_AW.indd 85 ZMNL900911_AW.indd 85
COMPATIBILITY
Infinity
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Infinity enteral feeding pump should assure that it is used in such an
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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/ output lines 100kHz for input/ output lines
± 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 315° 180°, 225°, 270° and 315°
0 % UT; 250/300 cycle (5s) 0 % UT; 250/300 cycle (5s)
Pump, the pump may automatically shut off and settings may return to their
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Electromagnetic environment – guidance
The Flocare Infinity uses RF energy only for its internal function.
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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
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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 commer-
cial or hospital environment. The Flocare
continued operation during power mains interruptions via
the internal battery.
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Infinity allows
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