Ca-Mi New Askir 118 Basic Manual De Instrucciones página 23

UNDER NEW EUROPEAN RULES, CA-MI REQUIRES THE FOLLOWING PROCEDURES TO BE CARRIED OUT TO PROTECT THE
INSTRUMENT AND THE SAFETY OF ALL WHO COME IN CONTACT WITH IT.
Before returning an instrument for repair, the external surfaces and all accessories MUST be carefully disinfected with a cloth
soaked in methylated spirits or hypochlorite-based solution. The instrument and accessories should then be placed in a bag with a
note outlining the disinfection undertaken.
Failure to follow this procedure will result in the instrument being returned to the purchaser unrepaired.
Instruments returned for repair MUST be accompanied by a description of the problem. CA-MI will not be responsible for damage
caused through improper use. To avoid such damage, please read the instruction carefully.
Where CA-MI determines that an instrument is faulty, a replacement will be provided only if a SALES RECEIPT and STAMPED
GUARANTEE are provided. CA-MI will not be responsible for damage accessories. These may be replaced at the customer's
expence.
RISK OF ELECTROMAGNETIC INTERFERENCE AND POSSIBLE REMEDIES
This section contains information regarding the conformity of the compliance with the EN 60601-1-2 (2015) Standard.
The NEW ASKIR 118 BASIC surgical aspirator is an electro-medical device that requires particular precautions regarding
electro-magnetic compatibility and which must be installed and commissioned according to the electro-magnetic compatibility
information supplied. Portable and mobile radio communication devices (mobile phones, transceivers, etc.) may interfere with
the medical device and should not be used in close proximity with, adjacent to or on top of the medical device.
If such use is necessary and unavoidable, special precautions should be taken so that the electro-medical device functions
properly in its intended operating configuration (for example, constantly and visually checking for the absence of anomalies or
malfunctions). The use of accessories, transducers and cables different to those specified, with the exception of transducers and
cables sold by the appliance and system manufacturer as spare parts, can lead to an increase in emissions or in a decrease of the
immunity of the device or system..
The surgical aspirator NEW ASKIR 118 BASIC is intended for use in the electromagnetic environment specified below.
The customers or the user of the surgical aspirator NEW ASKIR 118 BASIC should assure that it's used in such an environment.
Emissions test
Irradiated / Conducted emissions
CISPR11
Irradiated / Conducted emissions CISPR11
Harmonic emissions EN 61000-3-2
Voltage fluctuations / flicker emissions
EN 61000-3-3
The surgical aspirator NEW ASKIR 118 BASIC is intended for use in the electromagnetic environment specified below.
The customers or the user of the surgical aspirator NEW ASKIR 118 BASIC should assure that it's used in such an
Immunity Test
Electrostatic
discharge (ESD)
EN 61000-4-2
Electrical fast
transient / burst
EN 61000-4-4
Surge
EN 61000-4-5
Loss of voltage, brief
voltage interruptions
and variations
EN 61000-4-11
Magnetic field
EN 61000-4-8
Nota U is the value of the power supply voltage
T
RULES FOR RETURNING AND RAPAIRING
Guidance and manufacturer's declaration – electromagnetic Emissions
Compliance
Group 1
Class [B]
Class [A]
Complies
Guidance and manufacturer's declaration – Immunity Emissions
Level indicated by the
EN 60601-1-2
± 8kV on contact
± 15kV in air
± 2kV power supply
lines
± 1kV for input /
output lines
± 1kV differential mode
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
30A/m
Electromagnetic environment - guidance
The surgical aspirator ASKIR 36BR 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 ASKIR 118 BASIC 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.
environment.
Compliance Level Electromagnetic environment - guidance
The device doesn't Floors should be wood, conceret or ceramic tile.
change its state If floors are covered with synthetic material, the
relative humidity should be at least 30%.
The device doesn't Mains power quality should be that of a typical
change its state commercial environment or hospital.
The device doesn't Mains power quality should be that of a typical
change its state 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 ASKIR 118 BASIC
request that the appliance operates continuously,
the use of a continuity unit is recommended.
The device doesn't The power frequency magnetic field should be
change its state measured in the intended installation location to
assure that it's sufficiently low.
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