21
eNgLIsh
Guidance and manufacturer’s declaration – Electromagnetic Emissions
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
Compliance
Electromagnetic environment - guidance
Irradiated / Conducted
emissions CISPR11
Group 1
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.
Irradiated / Conducted
emissions CISPR11
Class [B]
The surgical aspirator TOBI HOSPITAL can be used in all en-
vironments, including domestic and those connected directly to
the public mains distribution that supplies power to environments
used for domestic scopes.
Harmonic emissions
EN 61000-3-2
Class [A]
Voltage fluctuations /
flicker emissions EN 61000-
3-3
Complies
Guidance and manufacturer’s declaration – Immunity Emissions
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
EN 60601-1-2
Compliance Level
Electromagnetic environments -
guidance
Electrostatic
discharge
(ESD) EN 61000-
4-2
±
8
kV on contact
±
15
kV in air
The device doesn’t
change its state
Floors should be wood, conceret or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrical fast
transient / burst
EN 61000-4-4
± 2kV power supply
lines
± 1kV for input / output
lines
The device doesn’t
change its state
Mains power quality should be that of
a typical commercial environment or
hospital.
Surge
EN 61000-4-5
±
0.5
kV
+/-
1
kV
differential
mode
The device doesn’t
change its state
Mains power quality should be that of
a typical commercial environment or
hospital.
Loss of voltage,
brief voltage
interruptions and
variations EN
61000-4-11
<5% U
T
(>95% dip U
T
)
for 0,5 cycle
40 % U
T
(> 60% dip U
T
)
for 5 cycle
70 % U
T
(> 30% dip
UT) for 25 cycle
<5 % U
T
(>95% dip U
T
)
for 5 sec
- -
Mains power quality should be that of a
typical commercial environment or hos-
pital If the user of the surgical aspirator
TOBI HOSPITAL request that the appli-
ance operates continuosly, the use of a
continuity unit is recommended.
Magnetic field
(50/60 Hz)
EN 61000-4-8
3
0
A/m
The device doesn’t
change its state
The power frequency magnetic field
should be measured in the intended
installation location to assure that it’s
sufficiently low.
Note UT is the value of the power supply voltage.
