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APPENDIX A: GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC
COMPATIBILITY
Emissions test Compliance Electromagnetic environment – guidance
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.
RF Emissions
CISPR 11
Group 1 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.
RF Emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
Flicker emissions
IEC 61000-3-3
Complies
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.
Immunity test IEC 60601 test level Electromagnetic environment – guidance
Guidance and manufacturer’s Declaration – Electromagnetic immunity
Compliance level
70 % UT; 25/30 cycles single
phase:at 0°
0 % UT; 1 cycle at 0°
0 % UT; 0,5 cycle at
0°, 45°, 90°, 135°,
180°, 225°, 270° and
315°
0 % UT; 250/300
cycle (5s)
70 % UT; 25/30
cycles single phase:
at 0°
0 % UT; 1 cycle at 0°
0 % UT; 0,5 cycle at
0°, 45°, 90°, 135°,
180°, 225°, 270° and 315°
0 % UT; 250/300
cycle (5s)
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.
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 15 kV air
Floors should be wood, concrete or ceramic tile. If floors are
covered with synthetic material, the relative humidity should be
at least 30%.
± 8 kV contact
± 15 kV air
Electric fast
transient/burst
IEC 61000-4-4
+/- 2 kV @ PRR
100kHz for power supply lines
± 1 kV @ PRR
100kHz for input/ output lines
Mains power quality should be that of a typical commercial or
hospital environment.
+/- 2 kV @ PRR
100kHz for power supply lines
± 1 kV @ PRR
100kHz for input/ output lines
Surge
IEC 61000-4-5
± 1 kV line to line Mains power quality should be that of a typical commercial or
hospital environment.
± 1 kV line to line
Voltage dips, short interrupti-
ons and voltage variations on
power supply lines.
IEC 61000-4-11
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.
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 produced by personal com-
munication 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
®
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.
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