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Warning: Do not use an automated procedure or ultrasonic bath to clean or
disinfect the accessories.
4.2 Cleaning, Disinfection and Sterilization (according to DIN EN ISO 17664)
The procedure for cleaning, disinfection and Sterilization applies only to the accessories lip clip,
file clip.
4.2.1 Pre-treatment
Pulp and dentin residues must be removed immediately from the accessories (within maximum 2
hrs). Do not let them dry! After the accessories have been used on patients, place the accessories
for cleaning, pre-disinfection and interim storage directly into a bowl filled with an appropriate
cleaning and disinfecting solution (for max. 2 hrs). Then clean the accessories under running water
or clean in a disinfecting solution to remove all visible contamination. The disinfectant should be
aldehyde-free (aldehyde fixes blood stains), tested for effectiveness (e.g. CE mark), suitable for
accessories disinfection and compatible with the accessories.
Only use clean, soft brushes to manually remove contamination or a clean, soft cloth which you
only use for this purpose. Do not use metal brushes or steel wool. For better cleaning of the inner
parts, the file clip must be pressed and released five times during cleaning process. Please note that
disinfectants used for pre-treatment are only for personal protection and do not replace disinfection
when cleaning is completed. The pre-treatment process should be performed in every case.
4.2.2 Manual Cleaning and Disinfection
Step-by-step-process
Cleaning
• Place the pre-cleaned accessories into the cleaning bath for the prescribed contact time, the
accessories must be sufficiently covered
(if necessary careful brushing with a soft brush). For better cleaning of the inner parts, the file clip
must be pressed and released five times during cleaning process.
• Then remove the instruments from the cleaning bath and rinse them thoroughly with water for at
least three times for 1 min. and press and release the file clip five times.
Disinfection
• Place the cleaned and inspected accessories into the disinfection bath for the prescribed contact
time; the accessories must be sufficiently covered. For better disinfection of the inner parts, the file
clip must be pressed and released five times during disinfection process.
• 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 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.
4.2.3 Inspection/Maintenance
Check all accessories after cleaning or cleaning / 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.
4.2.4 Packing
Please pack the accessories into disposable Sterilization packages (single disposable packaging)
meeting the following requirements:
• Compliant with DIN EN ISO/ANSI AAMI ISO 11607
• Suitable for steam Sterilization
4.2.5 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 sterilizer according to DIN EN 13060 or DIN EN 285
• The Sterilization validation has been performed in compliance with DIN EN ISO 17665 (Valid
installation and operation qualification (IQ and OQ) and product-specific performance qualification
(PQ))
• Maximum Sterilization temperature 134 ºC (273 ºF); plus tolerance according to ISO DIN EN ISO
17665
• Sterilization time (exposure time at Sterilization temperature) at least 18 min. at 134 ºC (273 ºF)
The rapid Sterilization method or the Sterilization method of unpacked accessories is not permitted.
Also do not use any hot air Sterilization, no radiation Sterilization, no formaldehyde or ethylene
oxide Sterilization and no plasma Sterilization.
4.2.6 Storage
After Sterilization, the instruments must be stored in the Sterilization package and kept dry and
dust-free.
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