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Idiomas disponibles
Idiomas disponibles
This section contains information regarding the conformity of the compliance with the IEC 60601-1-2 Standard.
The SUPER TOBI 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 SUPER TOBI is intended for use in the electromagnetic environment specified below. The customers or the user of the surgical
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 SUPER TOBI is intended for use in the electromagnetic environment specified below.
The customers or the user of the surgical aspirator SUPER TOBI 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
Note U
is the value of the power supply voltage
T
Guidance and manufacturer's declaration – Electromagnetic Emissions
aspirator SUPER TOBI should assure that it's used in such an environment.
Compliance
Group 1
The surgical aspirator SUPER TOBI 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.
Class [B]
The surgical aspirator SUPER TOBI 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.
Class [A]
Complies
Guidance and manufacturer's declaration – Immunity Emissions
Level indicated by
Compliance Level
the
IEC 60601-1-2
± 6kV on contact
The device doesn't
± 8kV in air
change its state
± 2kV power supply
The device doesn't
lines
change its state
± 1kV for input /
output lines
± 1kV differential
The device doesn't
mode
change its state
5%U
(>95% dip U
)
T
T
for 0.5 cycle
40%U
(>60% dip
T
U
) for 5 cycle
T
70%U
(>30% dip
T
U
) for 25 cycle
T
<5%U
(>95% dip
T
U
) for 5 sec
T
3A/m
The device doesn't
change its state
Electromagnetic environment - guidance
Electromagnetic environments - guidance
Floors should be wood, conceret 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
environment or hospital.
Mains power quality should be that of a typical commercial
environment or hospital.
-
Mains power quality should be that of a typical commercial
environment or hospital If the user of the surgical aspirator
SUPER TOBI request that the appliance operates continuously,
the use of a continuity unit is recommended.
The power frequency magnetic field should be measured in the
intended installation location to assure that it's sufficiently low.
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