Ca-Mi NEW HOSPIVAC 400 Mode D'emploi page 11

The surgical aspirator The surgical aspirator NEW HOSPIVAC 400 / NEW HOSPIVAC 350
The customers or the user of the The customers or the user of the surgical aspirator
Emissions Test Emissions
Power disturbance Power disturbance
CISPR11 CISPR11
Irradiated Irradiated / / Conducted Conducted emissions
Harmonic emissions Harmonic emissions IEC/EN
Voltage fluctuations / Voltage fluctuations /
flicker emissions IEC/EN 61000-3-3 flicker emissions IEC/EN 61000-3-3
The surgical aspirator The surgical aspirator NEW HOSPIVAC 400 / NEW HOSPIVAC 350
The customers or the user of the The customers or the user of the surgical aspirator
Immunity Test Immunity
Electrostatic discharge (ESD) Electrostatic discharge (ESD)
IEC/EN 61000-4-2 IEC/EN 61000-4-2
Electrical fast transient / burst Electrical fast transient / burst
IEC/EN 61000-4-4 IEC/EN 61000-4-4
Surge Surge IEC/EN IEC/EN 61000-4-5 61000-4-5
Loss of voltage, brief v Loss of voltage, brief voltage
interruptio interruptions ns and variations and variations
IEC/EN 61000-4-11 IEC/EN 61000-4-11
Magnetic field Magnetic field
IEC/EN 61000-4-8 IEC/EN 61000-4-8
Conducted Immunity Conducted Immunity
IEC/EN 61000-4-6 IEC/EN 61000-4-6
Irradiated Conducted Irradiated Conducted
IEC/EN 61000-4-3 IEC/EN 61000-4-3
Note U Note U is the value of the power supply voltage is the v alue of the power supply voltage
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Replacing the antibacterial filter: Replacing the antibacterial filter:
The filter is made of hydrophobic material that stops the passage of liquids into the same filter. The filter is made of hydrophobic material that stops the passage of liquids into the same filter.
If you suspect the filter may If you s uspect the filter may have been contaminated and/or got wet or
If the equipment is to be used If the equipment is to be used on patients with unknown pathological conditions or should you
replace the filter after each utilization replace the filter after
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 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 contaminati o n risks, we recommend to remove and replace the filter at the end of known and not implying any indirect contaminati
even if the equipment has not been used. 4000cc complete tank versions are available on request. even if the equipment has not been used. 4000cc complete tank versions are available on request.
Versions fitted with FLOVAC® 2000ml or 3000ml disposable collecti Versions fitted with FLOVAC® 2000ml or
are also available on request. 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 WARNING: Suction tubes for insertion in the human body purchased separately from the machine should comply with ISO 10993-1 standards on
material biocompatibility. material biocompatibility.
Guidance and manufacturer's declaration – Electromagnetic Emissions Guidance and manufacturer's declaration – Electromagnetic Emissions
NEW HOSPIVAC 400 / NEW HOSPIVAC 350 is intended for use
surgical aspirator NEW HOSPIVAC 400 / NEW HOSPIVAC 350 NEW HOSPIVAC 400 / NEW HOSPIVAC 350 should assure that it's used in
Test Compliance Compliance
Group Group 1 1
emissions CISPR11 CISPR11 Class [B] [B] Class
IEC/EN 61000-3-2 61000-3-2 Class [A] [A] Class
Complies Complies
Guidance and manufacturer's declaration – Electromagnetic Immunity Guidance and manufacturer's declaration – Electromagnetic Immunity
NEW HOSPIVAC 400 / NEW HOSPIVAC 350 is intended for use
surgical aspirator NEW HOSPIVAC 400 / NEW HOSPIVAC 350 NEW HOSPIVAC 400 / NEW HOSPIVAC 350 should assure that it's used in such
Test Compliance Compliance
± 6kV on contact ± 6kV on contact
± 8kV in air ± 8kV in air
± ± 2kV 2kV power power supply
± ± 1kV 1kV differentia differential l mode
oltage 5%U 5%U for 0.5 cycle for 0.5 cycle
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40%U 40%U
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70%U 70%U
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<5%U <5%U
3Vrms 150kHz to 80MHz 3Vrms 150kHz to 80MHz
(for appliances that aren't (for appliances that aren't
life - life - supporting) supporting)
3V/m 80MHz to 2.5 GHz 3V/m 80MHz to 2.5 GHz
(for appliances that aren't (for appliances that aren't
life - equipment) life - equipment)
N°2 COMPLETE ASPIRATION JAR 2000cc N°2 COMPLETE ASPIRATION JAR 2000cc
ANTIBACTERIAL AND HYDROFOBIC FILTER ANTIBACTERIAL AND HYDROFOBIC FILTER
FOOTSWITCH CONTROL cod. 52130 (for FOOTSWITCH CONTROL cod. 52130 (for versions equipped with footswitch control)
have been contaminated and/or got wet or discoloured, always remove and replace the filter.
on patients with unknown pathological conditions or should you evaluate the possibility of indirect contamination, remove and
each utilization . The filter is not designed for decontamination, disassembly and/or sterilization. If you suspect the filter may have . The filter is not designed for decontamination, disassembly and/or sterilization. If you suspect the filter may have
on risks, we recommend to remove and replace the filter at the end of each work shift or else every month,
3000ml disposable collecti o n systems
is intended for use in the electromagnetic environment specifie
Electromagnet Electromagnetic ic environment
The surgical The surgical aspirator aspirator NEW
energy only for its internal functioni energy only for its internal functioni n g. Therefore its RF
are not cause are not cause interferen interference in proximity
The The surgical surgical aspirator aspirator NEW
all environments, including domestic and those connected directly to the public mains all environments, including domestic and those connected directly to the public mains
distribution that supplies power to environments used for domestic scopes. distribution that supplies power to environments used for domestic scopes.
is intended for use in the electromagnetic environment specifie
Floors should be wood, conceret or ceramic tile. If floors are coverei with Floors should be wood, conceret or ceramic tile. If floors are coverei with
synthetic material, the relative humidity should be at synthetic material, the relative humidity should be at least 30%.
supply Mains Mains power power quality quality should
hospital hospital
mode Mains power Mains power quality quality should
hospital hospital
Mains power quality should be that Mains power quality should be that of a typical
for 05 cycle for 05 cycle hospital If the user of the surgical aspirator NEW HOSPIVAC 400 / NEW hospital If the user of the surgical aspirator NEW HOSPIVAC 400 / NEW
for 25 cycle for 25 cycle HOSPIVAC 350 request that the appliance operates continuously, the use of HOSPIVAC 350 request that the appliance operates continuously, the use of
for 5 sec for 5 sec a continuity unit is recommended. a continuity unit is recommended.
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3A/m 3A/m The power The power frequency frequency magnetic
installati o n location to assure installati on location to assure that it's sufficiently low.
ACCE ACCESSOR SSORIES IES SUPPL SUPPLIED
DESCRIPTION DESCRIPTION
CONICAL FITTING CONICAL FITTING
TUBES SET 8 mm x 14 mm TUBES SET 8 mm x 14 mm
versions equipped with footswitch control)
discoloured, always remove and replace the filter.
on systems (including a re-usable rigid polycarbonate contai (including a re-usable rigid polycarbonate contai n er and a
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in the electromagnetic environment specified below.
should assure that it's used in such an environment.
environment - - guidance guidance
NEW HOSPIVAC HOSPIVAC 400 400 / / NEW NEW HOSPIVAC HOSPIVAC 350
ng. Therefore its RF emissions are very low emissions are very low and
ce in proximity of any Electronic appliances. of any Electronic appliances.
NEW HOSPIVAC HOSPIVAC 400 400 / / NEW NEW HOSPIVAC HOSPIVAC 350
in the electromagnetic environment specified below.
should assure that it's used in such an environment.
Electromagne Electromagnetic tic environments environments - - guidance
should be be that that of of a a typical typical commercial commercial environment
should be be that that of of a a typical typical commercial commercial environment
of a typical commercial environment or commercial environment or
magnetic field field should should be be measured measured in in the the intended
that it's sufficiently low.
- -
- -
IED
evaluate the possibility of indirect contamination, remove and
each work shift or else every month,
d below.
such an environment.
350 only only used used RF RF
and
350 can can be be used used in in
d below.
an environment.
guidance
least 30%.
environment or or
environment or or
intended
ner and a disposable Liner) disposable Liner)