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elexxion claros pico - Sterilisation

elexxion claros pico
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claros pico user manual V 2.1 page 24 of 34
Remove instruments from the cleaning solution and rinse them with clean water for at least a minute.
Thoroughly rinse lumina, blind holes and other difficult-to-reach areas.
Place the instruments in a suitable basket for the cleaning/disinfecting machine such that they can be
reached unhindered by water and cleaning agents and undergo a standard cleaning cycle for instruments.
The following minimum parameters are extremely important for thorough cleaning and disinfection:
Step Description
1 Pre-rinse with cold water for at least one minute
2 Clean with 0.3% Neodisher MediClean cleaner at 55°C for at least five minutes
3 Rinsing 1: at least two minutes with water
4 Rinsing 2: at least one minute with water
The automated reprocessing of cannulated parts or hollow bodys (e.g. handpieces) is done by the specifications and
with the tools of the manufacturer of the cleaning unit (e.g. Thermaldisinfectors). They are mandatory to adhere.
Note: The instructions from the manufacturer of the cleaning/disinfecting machine must be strictly observed. Use only
cleaning agents recommended for this particular type of automatic cleaning/disinfecting machine. A
cleaning/disinfecting machine with verified effectiveness must be used (e.g. CE marking and valid validation as per EN
ISO 15883-1).
If residual contamination is still visible on the instrument following manual preparation, repeat cleaning and chemical
disinfection process until contamination is no longer visible (a visual inspection using a magnifier is recommended
according to the RKI).
8.1.1 Packaging
Packaging that is suitable for the instrument (application fibres/glass rod) and the sterilisation procedure should be
selected. Instruments with restrictions in terms of their frequency of use should be labelled accordingly in order to
ensure clear allocation for the purpose of the QM system. The packaging must be labelled, at the latest after their
treatment in the steam steriliser, with usage-relevant markings. The following must be visible: the sterilisation date
or sterile storage period, the contents, the sterilisation procedure and, if multiple sterilisers are used, the device
used.
8.2
Sterilisation
For dental practices, devices with cycle B or cycle S are specifically prescribed.
In order to ensure effective
sterilisation, it is vital that steam can reach all parts of the product being sterilised, especially in the event of stricter
preparation requirements (critical B / e.g. hollow parts, handpieces). Based on the risk assessment for the instruments
(application fibers/glass rod = critical A) (handpiece= critical B), all detachable parts must be sterilised. The autoclave
procedure using a fractioned pre-vacuum method is validated in accordance with DIN EN ISO 13060. The person
preparing the instruments is responsible for ensuring that the reprocessing actually carried out using the equipment,
materials and staff available in the reprocessing facility achieves the desired results.
Temperature: 134°C Temperature: 121°C
Pressure: 2,1 bar Pressure: 1,1 bar
Time: 5 minutes Time: 20 minutes
We recommend that after repeated sterilisations a suitable optical inspection is carried out (for visual damage etc.).
! PLEASE NOTE