2
Indications
for
use
C·SMART
·I
Pro
Usar
Manual
C-SMART-1
Pro User
Manual
o
Then
remove
the
accessories
from the
disinfection
bath and rinse
them
thoroughly
with water for at least five times for 1
min.and
press and
release
The
device
is the
supplementary root-cana
l
treatment
device which can
assist
the
dentists
to shape more
standard root-canal
in the
process
of
root-canal
treatment
based on the
micro-electronic
control
technology.
This
instrument
contributes
to
alleviate
the
dentist's working intensity.
This
device
must only be used in
hospital
environments,
clinics
or dental
offices
by
qualified
dental
personnel.
3
Contraindication&
o
In cases where a
patient
has been fitted with an
implanted
heart
pacemaker
(or other
electrical equipment)
and has been
cautione
d
against
the use of
small
electrical
appliances
(such as
electric shavers,
hair
dryers,
etc.)
it is
recommended
not to use the
device.
o The
device
should not be used for
severely curved
root canal
preparation.
o
Do not use the
device
for
implant
or any other
dentist procedure outside
endodontics.
f4
Warnings
The
device
must only be used in
suitable locations
and only by
specialized
physicians licensed
to
practice dentistry.
In this
chapter,
a
description
of
serious adverse reactions
and
potential safety
hazards
for the
product
or the
user/patient
is
included.
Read the
followin
g
warnings
before
use.
WARNINGS
o The device must only be used in
suitable locations
and only by
specialized
physicians licensed
to
practic
e
dentistry.
o Confirm that the
operating
voltage and the mains voltage are
compatible.
•
Use the specified battery for this
product.
Never use a battery other
than
those
specified
by
manufacturer.
o
Use the
manufacture
r
AC adapter for this
product.
Never use any other
AC
adapters.
o
If you do not use the device for a long period of
time,remove
the battery
to
avoid fluid
leak.
o
If you
should
notice battery fluid leak,
deformation
of the motor
handpiece
casing or partial
discoloring, immediately
stop use and contact your
distributor
II
the file clip five
times. Inspect,
dry and pack the
accessories
as
quickly as
possible
after
removal(see chapter INSPECTION,
and
PACKING).
Please
make sure that the
accessories
do not have direct
contact.
9.2.3
Inspection/Maintenance
Check all
accessories
after
cleaning
or
cleaning
I
disinfection.
Defective
accessories
should
be
immediately discarded.
These
defects include:
• Plastic
deformation
·Corrosion
Accessories
which are still
contaminated
must be
cleaned
and
disinfected
again.
Maintenance
is not
required.
Instruments
oil must not be
used.
9.2.4
Packing
Please
pack the
accessories
into
disposable Sterilization packages
(single
disposable packaging) meeting
the
following requirements:
•Compliant
with DIN EN
ISOIANSIAAMIISO 11607
·Suitable
for steam
Sterilization
9.2.5
Sterilization
Use only the
Sterilization methods
listed
below
;
other
Sterilization
methods
are
not
permitted.
• Steam
Sterilization
•
Fractional
vacuum/pre-vacuum
(at
least
three
vacuum cycles)
method
or
gravity displacement
method
(product
must be
sufficiently
dry).
The less
effective gravitational
method should only be used if the
fractional
vacuum
method is not
available.
·Steam
sterilize
r
according
to DlN EN 13060 or DIN EN
285.
·The Sterilization validation
has been
performed
in
compliance
with DIN
EN
ISO 17665 (Valid
installatio
n
and
operation qualification
(IQ and OQ)
and
product-specific performance qualification (PQ).
•
Maximum Sterilization temperature
134
ac
(273
GF);
plus tolerance
according to
ISO DIN EN ISO
17665.
·Sterilization
time (exposure time
at
Sterilization
temperatura
)
at
least
18
min.at
134 •c (273
aF).
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