Gima TOBI Mode D'emploi page 11

This section contains information regarding the conformity of the compliance with the IEC 60601-1-2 Standard. The 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 TOBI is intended for use in the electromagnetic environment specified below.
The customer or the user of the surgical aspirator TOBI should assure that it's used in such an environment.
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 TOBI is intended for use in the electromagnetic environment specified below.
The customer or the user of the surgical aspirator 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
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 – electromagnetic Immunity
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 U )
T T
for 5 cycle
70%U (>30% dip U )
T T
for 25 cycle
<5%U (>95% dip
T
U ) for 5 sec
T
3A/m The device doesn't
change its state
Electromagnetic environment - guidance
The surgical aspirator 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.
The surgical aspirator 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.
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
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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