Moretti LEM Aspimed 2.2 Manual De Instrucciones página 13

This section contains information regarding the conformity of the compliance with the IEC 60601-1-2 Standard.
The ASPIMED 2.2 surgical aspirator is an electro-medical device that requires particular precautions regarding electro-magnetic
compatibility and which must be installed and commissioned according to the electro-magnetic compatibility information supplied.
Mobile and portable RF communication appliances (mobile phones, transceivers, etc..) can affect the medical system.
The use of accessories, transducers and cables different to those specified, with the exception of transducers and cables sold by the
appliance and system manufacturer as spare parts, can lead to an increase in emissions or in a decrease of the immunity of the device
or system.
The surgical aspirator ASPIMED 2.2 is intended for use in the electromagnetic environment specified below.
Emissions test
Irradiated / Conducted emissions
CISPR11
Irradiated / Conducted emissions CISPR11
Harmonic emissions IEC/EN 61000-3-2
Voltage fluctuations / flicker emissions
IEC/EN 61000-3-3
The surgical aspirator ASPIMED 2.2 is intended for use in the electromagnetic environment specified below.
The customers or the user of the surgical aspirator ASPIMED 2.2 should assure that it's used in such an environment.
Immunity Test
Electrostatic discharge
(ESD)
IEC/EN 61000-4-2
Electrical fast transient
/ burst
IEC/EN 61000-4-4
Surge
IEC/EN 61000-4-5
Loss of voltage, brief
voltage interruptions
and variations
IEC/EN 61000-4-11
Magnetic field
IEC/EN 61000-4-8
Nota U is the value of the power supply voltage
T
Guidance and manufacturer's declaration – electromagnetic Emissions
Compliance
Group 1
Class [B]
Class [A]
Complies
Guidance and manufacturer's declaration – Immunity Emissions
Level indicated by the
IEC 60601-1-2
± 6kV on contact
± 8kV in air
± 2kV power supply
lines
± 1kV for input / output
lines
± 1kV differential mode
5%U (>95% dip U ) for
T T
0.5 cycle
40%U (>60% dip U )
T T
for 5 cycle
70%U (>30% dip U )
T T
for 25 cycle
<5%U (>95% dip U )
T T
for 5 sec
3A/m
Electromagnetic environment - guidance
The surgical aspirator ASPIMED 2.2 only used RF energy only
for its internal functioning. Therefore, its RF emissions are very
low and are not cause interference in proximity of any
Electronic appliances.
The surgical aspirator ASPIMED 2.2 can be used in all
environments, including domestic and those connected directly
to the public mains distribution that supplies power to
environments used for domestic scopes.
Compliance Level
The device doesn't Floors should be wood, conceret or ceramic tile. If
change its state floors are covered with synthetic material, the
relative humidity should be at least 30%.
The device doesn't Mains power quality should be that of a typical
change its state commercial environment or hospital.
The device doesn't Mains power quality should be that of a typical
change its state commercial environment or hospital.
- Mains power quality should be that of a typical
commercial environment or hospital If the user of
the surgical aspirator ASPIMED 2.2 request that the
appliance operates continuously, the use of a
continuity unit is recommended.
The device doesn't The power frequency magnetic field should be
change its state measured in the intended installation location to
assure that it's sufficiently low.
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Electromagnetic environment - guidance