Ivoclar Vivadent UTS 3D Instrucciones De Limpieza Y Esterilizado página 6

6. Dry and pack the components immediately after the
removal (see chapter "Packaging"), if necessary after
additional post-drying at a clean place.
Validation was carried out on an equivalent product by an
independent accredited and recognized test laboratory by
application of the cleaning detergent Cidezyme/Enzol and
the disinfectant Cidex OPA (Johnson & Johnson GmbH,
Norderstedt) according to the specified procedure.
CHECK
Check all components after cleaning or cleaning/disinfection,
respectively, for corrosion, damaged surfaces, and impuri-
ties. Do not further use damaged components (for limitation
of the numbers of re-use cycles see chapter "Reusability").
Components which are still contaminated are to be cleaned
and disinfected again.
MAINTENANCE
Instrument oils or grease must not be used.
Do not mount prior to packaging and sterilization (no
sterilization of the other components without contact
to the patient admitted).
PACKAGING
Please insert the cleaned and disinfected components into
single-use sterilized packages (single packaging), which
fulfill the following requirements (material/process):
– EN ISO/ANSI AAMI ISO 11607 (for USA: FDA clearance)
– suitable for steam sterilization (temperature resistance up
to at least 142 °C (288 °F), sufficient steam permeability)
– sufficient protection of the components as well as of the
sterilized packages to mechanical damage
at least three vacuum steps
3
The less effective gravity displacement procedure must not be used in case of availability of the fractionated vacuum procedure.
4
5 The required drying time depends directly on parameters for which the user has the sole responsibility (load configuration and density,
sterilizer conditions ...), therefore, the drying time is to be determined by the user. Nevertheless, drying times shorter than 20 min must not
be applied.
respectively 18 min (inactivation of prions, not relevant for USA)
6
6
STERILIZATION
Please only perform listed sterilization procedures for sterili-
zation; other sterilization procedures must not be applied.
Do not sterilize the other components without contact
to the patient.
Steam sterilization
– fractionated vacuum/dynamic air removal procedure
gravity displacement procedure
drying )
5
– steam sterilizer according to EN 13060/EN 285 or ANSI
AAMI ST79 (for USA: FDA clearance)
– validated according to EN ISO 17665 (valid IQ/OQ
(commissioning) and product specific performance
qualification (PQ))
– maximum sterilization temperature 138 °C (280 °F);
plus tolerance according to EN ISO 17665
– sterilization time (exposure time at the sterilization
temperature):
Area fractionated
vacuum/dynamic
air removal
USA at least 4 min at
132 °C (270 °F),
drying time at
least 20 min
5
other at least 3 min
6
countries 132 °C (270 °F) /
134 °C (273 °F)
3
(with sufficient product
4
gravity
displacement
at least 30 min
at 121 °C (250 °F),
drying time at
least 20 min
5
at at least 20 min
at 121 °C (250 °F)
or