PARTICULAR CARE SHOULD BE TAKEN TO ENSURE THAT THE INTERNAL PARTS OF THE EQUIPMENT DO NOT GET IN TOUCH
During all clearing operations use protection gloves and apron (if need be, also wear a face mask and glasses) to avoid getting in contact with
contaminating substances (after each utilization cycle of the machine).
The surgical aspirator TOBI CLINIC is intended for use in the electromagnetic environment specified below. The customers or the user of the
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 CLINIC is intended for use in the electromagnetic environment specified below.
The customers or the user of the surgical aspirator TOBI CLINIC 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
The surgical aspirator TOBI CLINIC is intended for use in the electromagnetic environment specified below.
The customers or the user of the surgical aspirator TOBI CLINIC should assure that it's used in such an environment.
Immunity Test
Conducted Immunity
IEC / EN 61000-4-6
Radiated Immunity
IEC / EN 61000-4-3
WITH LIQUIDS. NEVER CLEAN THE EQUIPMENT WITH WATER.
Guidance and manufacturer's declaration – Electromagnetic Emissions
surgical aspirator TOBI CLINIC should assure that it's used in such an environment.
Compliance
Group 1
Class [B]
Class [A]
Complies
Guidance and manufacturer's declaration – Immunity Emissions
Level indicated by the
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
<5%U
(>95% dip U
)
T
T
for 5 sec
3A/m
The device doesn't
change its state
Guidance and manufacturer's declaration – Immunity Emissions
Level indicated by the
Compliance level
IEC 60601-1-2
3Vrms 150kHz to
80Mhz
(for non life-supporting
devices)
3V/m 80MHz to
2.5GHz
(for non life-supporting
devices)
Electromagnetic environment - guidance
The surgical aspirator TOBI CLINIC 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 CLINIC 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 CLINIC 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.
V
= 3 V rms
The portable and mobile RF communication devices, including
1
cables, must not be used closer to the TOBI CLINIC device, than
the separation distance calculated by the equation applicable to the
transmitter frequency. Recommended separation distance
E
= 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
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