Cleaning And Disinfection - Ivoclar Vivadent UTS 3D Instrucciones De Limpieza Y Esterilizado

REPROCESSING (CLEANING, DISINFECTION,
AND STERILIZATION) OF COMPONENTS
(SEMI-CRITICAL CONTACT)
Fundamental points
All components with semi-critical contact to the patient
are to be cleaned, disinfected, and sterilized prior to each
application. This is also necessary for prior to initial use,
after delivery of the unsterile components (cleaning and
disinfection after removal of the protective packaging, steri-
lization after packaging). Effective cleaning and disinfection
are indispensable prerequisites for effective sterilization of
the components.
You are responsible for the sterility of the components
with semi-critical contact to the patient. Therefore please
ensure that cleaning, disinfection and sterilization measures
are used, which are sufficiently validated for the specific
devices and products, that the devices used (WD, sterilizer)
are regularly serviced and inspected and that the validated
parameters are applied to each cycle.
Additionally, please pay attention to the legal provisions
valid for your country as well as to the hygienic instructions
of the doctor's practice or of the hospital. This applies par-
ticularly to the different guidelines regarding the inactivation
of prions (not relevant for USA).
For all further components (without contact to the patient)
standard surface disinfection may be applied (not included in
these instructions).

CLEANING AND DISINFECTION

Basics
If possible, an automated procedure (WD (Washer
Disinfector)) should be used for cleaning and disinfection
of the components. A manual procedure – even in case of
application of an ultrasonic bath – should only be used if
an automated procedure is not available; in this case, the
significantly lower efficiency and reproducibility of a manual
procedure must be taken into consideration.
The pre-treatment step is to be performed in both cases.
Pre-treatment
Please remove coarse impurities from the components
directly after use (within a maximum of 2 h).
In case a cleaning and disinfection detergent is used for this purpose (e.g. for reasons of personnel's safety) please consider that this should
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be aldehyde-free (otherwise fixation of blood impurities), possess a fundamentally approved efficiency (for example VAH/DGHM or FDA/EPA
approval/clearance/registration or CE marking), be suitable for the disinfection of instruments made of metallic or plastic material, and be
compatible with the components (see chapter "Material Resistance").
Please consider that a disinfectant used in the pre-treatment step ensures the personnel's safety only, but cannot replace the disinfection step
later to be performed after cleaning.
Still remaining remnants of registration material can be removed easily after cooling-down in a refrigerator.
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Procedure:
1. Disassemble the components as possible (see chapter
"Specific Aspects").
2. Rinse the components at least 1 min under running
water (temperature < 35 °C/95 °F). If applicable (see
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chapter "Specific Aspects"): Rinse through all cavities
within the components five times using a disposable
syringe (minimum volume 5 ml).
3. Manually remove all visible impurities with a clean and
soft brush (or a clean, soft and fluff-free cloth), which
is only used for this purpose. Never use metal brushes
or steel wool. If applicable (see chapter "Specific
Aspects") : Brush holes clean with a conical interdental
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brush.
4. Rinse again at least 1 min under running water. If appli-
cable (see chapter "Specific Aspects"): Rinse through all
cavities within the components five times using a dispos-
able syringe (minimum volume 5 ml).
Automated cleaning/disinfection
(WD (Washer Disinfector))
Pay attention to following points when selecting the WD:
– fundamentally approved efficiency of the WD (for exam-
ple CE marking according to EN ISO 15883 or DGHM or
FDA approval/clearance/registration)
– possibility for an approved program for thermal disinfec-
tion (A0 value > 3000 or – in case of older devices – at
least 5 min at 90 °C/194 °F; in case of chemical disin-
fection danger of remnants of the disinfectant on the
components)
– fundamental suitability of the program for instruments as
well as sufficient rinsing steps in the program
– post-rinsing only with sterile or low contaminated water
(max. 10 germs/ml, max. 0.25 endotoxin units/ml), for
example purified/highly purified water
– only use filtered air (oil-free, low contamination with
microorganisms and particles) for drying
– regular maintenance and check/calibration of the WD