5
cases, the manufacturer takes no responsibility.
This device shall not be exposed to high temperature above
138℃.
Processing limit
The products have been designed for a large number of
sterilization cycles.
The materials used in manufacture were selected accordingly.
However with every renewed preparation for use, thermal and
chemical stresses will result in ageing of the products. The
maximum number of sterilizations for optical fiber is 500 times.
7.1 Initial processing
7.1.1 Processing principles
It is only possible to carry out effective sterilization after the
completion of effective cleaning and disinfection. Please ensure
that, as part of your responsibility for the sterility of products
during use, only sufficiently validated equipment and product-
specific procedures are used for cleaning/disinfection and
sterilization, and that the validated parameters are adhered to
during every cycle.
Please also observe the applicable legal requirements in your
country as well as the hygiene regulations of the hospital or
clinic,especially with regard to the additional requirements for
the inactivation of prions.
7.1.2 Post-operative treatment
The post-operative treatment must be carried out immediately,
no later than 30 minutes after the completion of the operation.
The steps are as follows:
1. Remove the optical fiber from the Curing light Device,and
rinse away the dirt on the surface of product with pure water (or
distilled water/deionized water);
2. Dry the product with a clean, soft cloth and place it in a
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