Reprocessing; Risk Analysis And Classification; Reprocessing Procedure In Accordance With En Iso 17664 - Air Techniques ProVecta 3D Prime Instrucciones De Uso

Usage
9

Reprocessing

The following accessories need to be repro-
cessed:
– Bite block:
- Manual cleaning
EN
- Automatic cleaning and disinfection
US
- 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 classification

A risk analysis and classification of medical de-
vices that are common in dentistry must be per-
formed before they are reprocessed by the op-
erator� Comply with the country-specific guide-
lines, standards and regulations�
Accessories of the medical device are also sub-
ject to reprocessing�
Recommended classification
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
mandibular joint image, chin holder for edentu-
lous jaws, and chin holder for sinus image and
cushions for head supports Plus:
non-critical
The operator is responsible for correct classifi-
cation of the medical products, defining the re-
processing steps and performing the reprocess-
ing�
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9.2 Reprocessing procedure in ac-
cordance with EN ISO 17664
Perform the reprocessing procedure after each
patient treatment and according to the repro-
cessing procedure established by EN ISO
17664�
Important information!
The reprocessing instructions in accor-
dance with EN ISO 17664 have been in-
dependently tested by the manufacturer
for the preparation of the device and its
components for their reuse�
The person conducing the reprocessing
is responsible for ensuring that the repro-
cessing 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 in-
structions 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 influ-
enced by the amount of wear and tear or
damage resulting from its use�
The use of soiled, contaminated and
damaged components is at the sole re-
sponsibility of the person performing the
reprocessing and the operator�
The reprocessing procedure was validated as
follows:
– Pre-cleaning:
- Monarch surface disinfection wipes (Air
Techniques)
- Cleaning brush
– Manual cleaning:
- Monarch enzymatic cleaner 2�0 % (v/v) (Air
Techniques)
– Manual disinfection:
- Monarch surface disinfection wipes (Air
Techniques)
– Automated cleaning and disinfection was
performed in accordance with EN ISO 15883
with tested efficacy:
- Washer-disinfector PG 8536 CD (Miele,
Gütersloh, Germany)
- Cleaning agent: Neodisher MediClean Forte
2210200496L41 1904V004
17.04.2019 14:29:03