PROCESSING (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 required as well for
the first use after delivery of the unsterile compo-
nents (cleaning and disinfection after removal of the
protective packaging, sterilization after packaging).
An effective cleaning and disinfection is an indispensa-
ble requirement for an 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 only sufficiently device and prod-
uct specifically validated procedures will be used for
cleaning, disinfection, and sterilization, that the used
devices (WD, sterilizer) will be maintained and checked
regularly, as well as that the validated parameters will
be applied for each cycle.
Additionally, please pay attention to the legal provi-
sions valid for your country as well as to the hygienic
instructions of the doctor´s practice or of the hospital.
This applies particularly 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 content of this reprocessing instruction).
1 In case of application of a cleaning and disinfection detergent for this (e.g. in consequence of personnel´s safety) please consider, that this should
be aldehyde-free (otherwise fixation of blood impurities), possess a fundamentally approved efficiency (for example VAH/DGHM or FDA/EPA ap-
proval/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 serves only the personnel`s safety, but cannot replace the disinfection step
later to be performed after cleaning.
2 Still remaining remnants of registration material easily can be removed after cooling-down in a refrigerator.
I N S T R U C T I O N S F O R C L E A N I N G A N D C A R E
I N S T R U C T I O N S F O R P R O C E S S I N G
CLEANING AND DISINFECTION
Basics
If possible, an automated procedure (WD (Washer-
Disinfector)) should be used for cleaning and disinfec-
tion 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 repro-
ducibility of a manual procedure has to be considered.
The pre-treatment step is to be performed in both
cases.
Pre-treatment
Please remove coarse impurities of the components
directly after application (within a maximum of 2 h).
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
1
(see chapter Specific aspects): Rinse all lumens of
the components five times by application of a sin-
gle-use syringe (minimum volume 5 ml).
3. Remove manually all visible impurities by use of a
clean and soft brush (or a clean, soft, and lint-free
cloth) only to be for this, in no case metal brushes
or steel wool. If applicable (see chapter Specific as-
pects)
: Brush holes by use of a conical interdental
2
brush.
4. Rinse again at least 1 min under running water. If
applicable (see chapter Specific aspects): Rinse all
lumens of the components five times by application
of a single-use syringe (minimum volume 5 ml).
EN
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