Amann Girrbach artex gesichtsbogen Instructions page 14

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
5. Then, remove the components of the disinfectant
solution and post-rinse them at least five times in-
tensively (at least 1 min) with water.
EN
If applicable (see chapter Specific aspects): Rinse
all lumens of the components at least five times at
the beginning and at the end of the soaking time
by application of a single-use syringe (minimum
volume 5 ml).
6. Dry and pack the components immediately after
the removal (see chapter „packaging„, if necessary
after additional post-drying at a clean place).
The fundamental suitability of the components for an
effective cleaning and disinfection was demonstrated
by an independent accredited and recognized (§ 15 (5)
MPG) test laboratory by application of the cleaning
detergent Cidezyme/Enzol and the disinfectant Cidex
OPA (Johnson & Johnson GmbH, Norderstedt) consid-
ering the specified procedure.
CHECK
Check all components after cleaning or cleaning/disin-
fection, respectively, on corrosion, damaged surfaces,
and impurities. Do not further use damaged compo-
nents (for limitation of the numbers of re-use cycles
see chapter „reusability„). Still dirty components are
to be cleaned and disinfected again.
MAINTENANCE
Do not mount prior to packaging and sterilization (no
sterilization of the other components without contact
to the patient admitted)
Ball bearings, threads and attachments must be lubri-
cated regularly with Ballistol oil or a food-safe silicone
grease!
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Only hand-tighten screws. If too much force is
applied, the precision instrument may be damaged!
PACKAGING
Please insert the cleaned and disinfected components
single-use sterilization packagings (single packaging),
which fulfill the following requirements (material/
process):
- EN ISO/ANSI AAMI ISO 11607
(for USA: FDA clearance)
- suitable for steam sterilization (temperature resist-
ance up to at least 142 °C (288 °F), sufficient steam
permeability)
- sufficient protection of the components as well
as of the sterilization packagings to mechanical
damage
STERILIZATION
Please use for sterilization only the listed sterilization
procedures; 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 proce-
dure or gravity displacement procedure
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sufficient product drying
- 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)
(with
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)
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