Gima TOBI Mode D'emploi page 12

The surgical aspirator TOBI HOSPITAL is intended for use in the electromagnetic environment specified below. The customers or the user of the
surgical aspirator TOBI HOSPITAL 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 HOSPITAL is intended for use in the electromagnetic environment specified below.
The customers or the user of the surgical aspirator TOBI HOSPITAL should assure that it's used in such an environment.
Immunity Test Level indicated by the
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
<5%U
Magnetic field
IEC/EN 61000-4-8
Note U is the value of the power supply voltage
T
The surgical aspirator TOBI HOSPITAL is intended for use in the electromagnetic environment specified below.
The customers or the user of the surgical aspirator TOBI HOSPITAL should assure that it's used in such an environment.
Immunity Test Level indicated by the
Conducted Immunity
IEC / EN 61000-4-6
(for non life-supporting
Radiated Immunity
IEC / EN 61000-4-3
(for non life-supporting
Note 1: At 80 MHz and 800 MHz the interval with the highest frequency is applied
Note 2: These guide lines may not be applicable in all situations. The electro-magnetic propagation is influenced by the absorption and by
Guidance and manufacturer's declaration – Electromagnetic Emissions
Compliance
Group 1
Class [B]
Class [A]
Complies
Guidance and manufacturer's declaration – Immunity Emissions
Compliance Level
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
(>95% dip U )
T T
for 5 sec
3A/m The device doesn't
change its state
Guidance and manufacturer's declaration – Immunity Emissions
Compliance level
IEC 60601-1-2
3Vrms 150kHz to V
80Mhz
devices)
3V/m 80MHz to E
2.5GHz
devices)
Electromagnetic environment - guidance
The surgical aspirator TOBI HOSPITAL 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 HOSPITAL 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.
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 HOSPITAL request that the appliance operates continuosly,
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.
= 3 V rms The portable and mobile RF communication devices, including
1
cables, must not be used closer to the TOBI HOSPITAL device,
than the separation distance calculated by the equation applicable
to the transmitter frequency. Recommended separation distance
= 3 V / m
1 d = [3.5 / V
d = [12 / E
d = [23 / E
Where P is the maximum nominal output voltage of the transmitter
in Watt (W) depending on the manufacturer of the transmitter and
the recommended separation distance in metres (m). The intensity
of the field from the fixed RF transmitters, as determined by an
electro-magnetic study of the site
of conformity of each frequency interval
It is possible to check for interference in proximity to devices
identified by the following symbol:
12
Electromagnetic environments - guidance
Electromagnetic environments - guidance
P
]
1
P
] from 80 MHz to 800MHz
1
P
] from 800 MHz to 2.5 GHz
1
a)
, could be lower than the level
b)
.