Air Techniques Rxonly ProVecta 3D Prime, Operating Instructions Manual

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9 Reprocessing
The following accessories need to be reproc-
essed:
– Bite block:
– Manual cleaning
– Automatic cleaning and disinfection
– Steam sterilization
– Adapter bite block, chin holder for mandibular
joint image, chin holder for edentulous jaws,
and chin holder for sinus image
– Manual cleaning
– Manual disinfection
– Automatic cleaning and disinfection
– Cushion for head supports Plus
– Manual cleaning
– Manual disinfection
– Automatic cleaning and disinfection
In order to prevent damage to the accessories,
only the methods described above must be
used.
9.1 Risk analysis and classifica-
tion
A risk analysis and classification of medical devi-
ces that are common in dentistry must be per-
formed before they are reprocessed by the oper-
ator. Comply with the country-specific guidelines,
standards and regulations.
Accessories of the medical device are also sub-
ject to reprocessing.
Recommended classification according to EN
ISO 17664, Appendix C
Recommended classification given proper use of
the bite block:
semi-critical
Recommended classification given proper use for
the adapter for bite block, chin holder for man-
dibular joint image, chin holder for edentulous
jaws, and chin holder for sinus image and cush-
ions for head supports Plus:
non-critical
The operator is responsible for correct classifica-
tion of the medical products, defining the reproc-
essing steps and performing the reprocessing.
9.2 Reprocessing procedure in
accordance with EN ISO
17664
Perform the reprocessing procedure after each
patient treatment and according to the reproc-
essing procedure established by EN ISO 17664.
Important information!
The reprocessing instructions in accord-
ance with EN ISO 17664 have been inde-
pendently tested by the manufacturer for
the preparation of the device and its com-
ponents for their reuse.
The person conducing the reprocessing is
responsible for ensuring that the reproc-
essing is performed using equipment,
materials and personnel that attains the
desired results. This requires validation
and routine monitoring of the reprocess-
ing process. Any deviation from the
instructions described herein by the staff
reprocessing the equipment could lead to
lower effectiveness and possible negative
consequences: these lie solely with the
staff responsible.
Frequent reprocessing has little effect on
the components of the device. The end of
the product life cycle is mainly influenced
by the amount of wear and tear or dam-
age resulting from its use.
The use of soiled, contaminated and
damaged components is at the sole
responsibility of the person performing the
reprocessing and the operator.
Usage
42 2210200496L41 1911V006
EN-
US