Nutricia Flocare Infinity Instrucciones De Uso página 33

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 electromagne-
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tic 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 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
shut off and settings may return to their default values. Check the pump regularly if operating near sources of electromagnetic emis-
sions.
The Flocare Infinity Pump can safely be operated on commercial aircraft and is designed in accordance with EN 60601-1-2, EN
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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® 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 inter-
ruptions and voltage
variations on power sup-
ply lines.
IEC 61000-4-11
403259675_r0.indd 31 403259675_r0.indd 31
COMPATIBILITY
Compliance
Group 1
Class B
Class A
Complies
Infinity enteral feeding pump should assure that it is used in such an environment.
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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)
Infinity Pump, the pump may automatically
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Electromagnetic environment – guidance
The Flocare Infinity uses RF energy only for its internal func-
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tion. 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 net-
work 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 rela-
tive 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.
Mains power quality should be that of a typical
commercial or hospital environment. The Flocare
Infinity™ allows continued operation during power
mains interruptions via the internal battery.
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