9 Reprocessing of the
device
9.1 Risk analysis and categorisa-
tion
A risk analysis and categorisation of medical
products often used in dentistry must be per-
formed before their reprocessing by the operator.
Comply with all national directives, standards and
specifications such as e. g. the "Recommenda-
tions from the Commission for Hospital Hygiene
and Infection Prevention".
Accessories of the medical device are also sub-
ject to reprocessing.
Classification recommendation based on proper
use of the product: Semi-critical A
Semi-critical medical product:
A medical product which comes into contact
with mucous membrane or pathologically
affected skin.
The operator is responsible for correct classifica-
tion of the medical products, defining the repro-
cessing steps and performing the reprocessing.
9.2 Reprocessing procedure in
accordance with EN ISO
17664
The reprocessing procedure after each patient
treatment is carried out according to the repro-
cessing procedure established by EN ISO 17664.
Important information!
The reprocessing notes in accordance
with EN ISO 17664 have been indepen-
dently tested by Dürr Dental for the
preparation of the device and its compo-
nents for their reuse.
The person conducing the reprocessing is
responsible for ensuring the reprocessing
performed using the equipment, materials
and personnel achieves the desired
results. This requires validation and rou-
tine monitoring of the reprocessing pro-
cess. Any deviation from the instructions
described herein by the staff preparing
the equipment could lead to lower effec-
tiveness and possible negative conse-
quences: these lie solely with the staff
responsible.
Frequent reprocessing has little effect on
the device components. The end of the
product life cycle is especially 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.
The validation of the reprocessing method was
performed based on the assumption that, in the
worst case scenario, a disposable protective
cover could be damaged while it is being pulled
on or during use.
In accordance with IEC 80601-2-60, the applica-
tion part of the intraoral camera is limited to a
length of 80 mm, starting with the tip of the inter-
changeable head. During the validation of the
reprocessing method, only the application part
was looked at for this reason.
The reprocessing method was validated as fol-
lows:
–
Pre-cleaning
– FD multi wipes compact (Dürr Dental)
–
Manual cleaning
– FD 333 forte wipes (Dürr Dental)
–
Manual disinfection
– FD 333 forte wipes (Dürr Dental)
Usage
9000-618-176/30 1812V009 25
EN
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