Gima TOBI CLINIC, Руководство пользователя

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Guidance and manufacturer’s declaration – Electromagnetic Emissions
(as request by regulation EN 60601-1-2:2001)
The surgical aspirator TOBI HOSPI PLUS is intended for use in the electromagnetic environment specified
below. The customers or the user of the surgical aspirator TOBI HOSPI PLUS should assure that it’s used in
such an environment.
Emissions Test Compliance Electromagnetic environment -
guidance
Irradiated / Conducted emissions
CISPR11 Group 1 The surgical aspirator
TOBI HOSPI PLUS 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.
Irradiated / Conducted emissions
CISPR11 Class [B]
Harmonic emissions
IEC/EN 61000-3-2 Class [A]
Voltage fluctuations /
flicker emissions
IEC/EN 61000-3-3 Complies
The surgical aspirator
TOBI HOSPI PLUS 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.
Guidance and manufacturer’s declaration – Electromagnetic Emissions
(as request by regulation EN 60601-1-2:2001)
The surgical aspirator TOBI HOSPI PLUS is intended for use in the electromagnetic environment specified
below. The customers or the user of the surgical aspirator TOBI HOSPI PLUS should assure that it’s used in
such an environment.
Immunity Test Compliance Electromagnetic environments -
guidance
Electrostatic discharge (ESD)
IEC/EN 61000-4-2
± 6kV on contact
± 8kV in air
Floors should be wood, conceret or
ceramic tile. If floors are coverei with
synthetic material, the relative
humidity should be at least 30%.
Electrical fast transient / burst
IEC/EN 61000-4-4
± 2kV power supply Mains power quality should be that of a
typical commercial environment or
hospital
Surge
IEC/EN 61000-4-5
± 1kV differential mode Mains power quality should be that of a
typical commercial environment or
hospital
Loss of voltage, brief voltage
interruptions and variations
IEC/EN 61000-4-11
5%U
T
for 0.5 cycle
40%U
T
for 05 cycle
70%U
T
for 25 cycle
<5%U
T
for 5 sec
Mains power quality should be that of a
typical commercial environment or
hospital If the user of the surgical
aspirator TOBI HOSPI PLUS
request that the appliance operates
continuously, the use of a continuity
unit is recommended.
Magnetic field
IEC/EN 61000-4-8
3A/m The power frequency magnetic field
should be measured in the intended
installation location to assure that it’s
sufficiently low.
Conducted Immunity
IEC/EN 61000-4-6
3Vrms 150kHz to 80MHz
(for appliances that aren’t life -
supporting)
-
Irradiated Conducted
IEC/EN 61000-4-3
3V/m 80MHz to 2.5 GHz
(for appliances that aren’t life -
equipment)
-
Note U
T
is the value of the power supply voltage