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Guidance and manufacturer’s declaration Electromagnetic Immunity
The surgical aspirator NEW ASPIRET is intended for use in the electromagnetic environment specified below.
The customers or the user of the surgical aspirator NEW ASPIRET should assure that it’s used in such an environment.
Immunity Test Compliance Electromagnetic environments -
guidance
Electrostatic discharge (ESD)
IEC/EN 61000-4-2
± 6kV on contact
± 8kV in air
Floors should be wood, concrete or
ceramic
tile. If floors are covered with synthetic
material,
the relative humidity should be at least
30%.
Electrical fast transient / burst
IEC/EN 61000-4-4
± 2kV power supply
Mains power quality should be that of a
typical
commercial environment or hospital
Surge
IEC/EN 61000-4-5
± 1kV differential mode
Mains power quality should be that of a
typical
commercial environment or hospital
Loss of voltage, brief voltage
interruptions and variations
IEC/EN 61000-4-11
5%U
T
for 0.5 cycle
40%U
T
for 05 cycle
70%U
T
for 25 cycle
<5%U
T
for 5 sec
Mains power quality should be that of a
typical commercial environment or
hospital If
the user of the surgical aspirator NEW
ASPIRET.
request that the appliance operates
continuously, the use of a continuity
unit is
recommended.
Magnetic field
IEC/EN 61000-4-8
3A/m
The power frequency magnetic field
should be
measured in the intended installation
location to
assure that it’s sufficiently low.
Conducted Immunity
IEC/EN 61000-4-6
3Vrms 150kHz to 80MHz
(for appliances that aren’t life -
supporting)
-
Irradiated Conducted
IEC/EN 61000-4-3
3V/m 80MHz to 2.5 GHz
(for appliances that aren’t life -
equipment)
-
Note U
T
is the value of the power supply voltage
ACCESSORIES SUPPLIED
DESCRIPTION
COMPLETE ASPIRATION JAR 1000cc
CONICAL FITTING
TUBES SET 6 mm x 10 mm
ASPIRATION PROBE CH20
ANTIBACTERIAL FILTER
Available under request with different versions with complete jar 2000cc.
Antibacterial Filter: The filter is produced with (PTFE) hydrophobic material witch prevents fluids entering the
pneumatic circuit.
The filter is for a single patient use which will protect patients and machines from cross contamination.
When the filter is wet, it’s not possible to use the unit therefore the filter should be changed immediately.
In case of possible contamination or discolouration, change the filter immediately.
Don’t use the suction unit without the protection filter fitted.
Suction catheter: Single-use device to be used on a single patient. Do not wash or re-sterilize after use. Reuse may
cause cross-infections.
Don’t use after lapse of the sell-by date
WARNING: Suction tubes for insertion in the human body purchased separately from the machine should comply
with ISO 10993-1 standards on material biocompatibility.
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  • Why does my filter repeatedly gets wet? I've just replaced it with a new filter, and now, there's clear fluid in it again. Anybody with this experience? Submitted on 6-2-2020 at 05:04

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