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Usage
EN-
10.1
Clean and disinfect the
US
accessories
The sensor holder surface, the cable and the
USB connector can be disinfected with disinfec-
tant wipes.
Wipe the surface with a soft, lint-free cloth
❯
soaked in disinfectant or with a disinfection
wipe. Comply with the operating instructions of
the disinfectant.
26
11 Reprocessing
11.1
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 all national directives, stand-
ards and specifications such as e.g. the "Guide-
lines for Infection Control in Dental Health-Care
Settings from the Centers for Disease Control
and 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
changed skin.
The operator is responsible for correct classifica-
tion of the medical products, defining the reproc-
essing steps and performing the reprocessing.
11.2
Reprocessing procedures
Perform the reprocessing procedure after each
patient treatment and according to the reproc-
essing procedure:
– Pre-cleaning and manual cleaning in accord-
ance with AAMI TIR 30
– Manual disinfection in accordance with USFDA
(21 CFR sections 58, 201, 211 and 820)
2121100020L29 2101V007
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