The surgical aspirator NEW HOSPIVAC 400 / NEW HOSPIVAC 350 is intended for use in the electromagnetic environment specified below.
The customers or the user of the surgical aspirator NEW HOSPIVAC 400 / NEW HOSPIVAC 350 should assure that it's used in such an environment.
Emissions Test
Power disturbance
CISPR11
Irradiated / Conducted emissions CISPR11
Harmonic emissions IEC/EN 61000-3-2
Voltage fluctuations /
flicker emissions IEC/EN 61000-3-3
The surgical aspirator NEW HOSPIVAC 400 / NEW HOSPIVAC 350 is intended for use in the electromagnetic environment specified below.
The customers or the user of the surgical aspirator NEW HOSPIVAC 400 / NEW HOSPIVAC 350 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
Conducted Immunity
IEC/EN 61000-4-6
Irradiated Conducted
IEC/EN 61000-4-3
Note U
is the value of the power supply voltage
T
Replacing the antibacterial filter:
The filter is made of hydrophobic material that stops the passage of liquids into the same filter.
If you suspect the filter may have been contaminated and/or got wet or discoloured, always remove and replace the filter.
If the equipment is to be used on patients with unknown pathological conditions or should you evaluate the possibility of indirect contamination, remove and
replace the filter after each utilization. The filter is not designed for decontamination, disassembly and/or sterilization. If you suspect the filter may have
been contaminated and/or got wet or discoloured, always remove and replace the filter. If the equipment is to be used on patients whose pathologies are
known and not implying any indirect contamination risks, we recommend to remove and replace the filter at the end of each work shift or else every month,
even if the equipment has not been used. 4000cc complete tank versions are available on request.
Versions fitted with FLOVAC® 2000ml or 3000ml disposable collection systems (including a re-usable rigid polycarbonate container and a disposable Liner)
are also available on request.
WARNING: Suction tubes for insertion in the human body purchased separately from the machine should comply with ISO 10993-1 standards on
material biocompatibility.
Guidance and manufacturer's declaration – Electromagnetic Emissions
Compliance
Group 1
Class [B]
Class [A]
Complies
Guidance and manufacturer's declaration – Electromagnetic Immunity
Compliance
± 6kV on contact
± 8kV in air
± 2kV power supply
± 1kV differential mode
5%U
for 0.5 cycle
T
40%U
for 05 cycle
T
70%U
for 25 cycle
T
<5%U
for 5 sec
T
3A/m
3Vrms 150kHz to 80MHz
(for appliances that aren't
life - supporting)
3V/m 80MHz to 2.5 GHz
(for appliances that aren't
life - equipment)
ACCESSORIES SUPPLIED
N°2 COMPLETE ASPIRATION JAR 2000cc
TUBES SET 8 mm x 14 mm
ANTIBACTERIAL AND HYDROFOBIC FILTER
FOOTSWITCH CONTROL cod. 52130 (for versions equipped with footswitch control)
Electromagnetic environment - guidance
The surgical aspirator NEW HOSPIVAC 400 / NEW HOSPIVAC 350 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 NEW HOSPIVAC 400 / NEW HOSPIVAC 350 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 coverei 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 NEW HOSPIVAC 400 / NEW
HOSPIVAC 350 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.
DESCRIPTION
CONICAL FITTING
11
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