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

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 ® IFU Infinity ™
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 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
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 ® IFU Infinity ™
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
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
ZMNL900616_AW.indd 27
ELECTROMAGNETIC COMPATIBILITY
Pump will not be affected by electromagnetic emissions in most environments. However, some
Pump can safely be operated on commercial aircraft and is designed in accordance with EN
Compliance
Group 1
Class B
Class A
Complies
Infinity enteral feeding pump should assure that it is used in such an environment.
® ™
IEC 60601 test level Compliance level
± 6 kV contact ± 6 kV contact
± 8 kV air ± 8 kV air
± 2 kV for power sup- ± 2 kV for power sup-
ply lines ply lines
± 1 kV for input/ out- ± 1 kV for input/ out-
put lines put lines
± 1 kV lin(s) to line(s) ± 1 kV differential
mode
<5 % U (>95 % dip in U ) <5 % U
T T
for 0.5 cycle for 0.5 cycle
40 % U (60 % dip in U ) 40 % U
T T
for 5 cycles for 5 cycles
70 % U (30 % dip in U ) 70 % U
T T
for 25 cycles for 25 cycles
<5 % U (>95 % dip in U ) <5 % U
T T
for 5 s for 5 s
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 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
relative 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.
(>95 % dip in U ) Mains power quality should be that of a typi-
T T
cal commercial or hospital environment. The
(60 % dip in U ) Flocare Infinity™ allows continued operation
®
T T
during power mains interruptions via the internal
(30 % dip in U ) battery.
T T
(>95 % dip in U )
T T
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® IFU Infinity ™
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