
11
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 clean tray.
Notes
a) The water used here must be pure water, distilled water or deionized water.
7.2 Preparation before cleaning
Steps
Tools: tray, soft brush, clean and dry soft cloth Remove optical fiber from
main unit and put it into the clean tray.
Use a clean soft brush to carefully brush the optical fiber until the dirt on
surface is not visible. Then use soft cloth to dry the optical fiber and put them into
a clean tray. The cleaning agent can be pure water, distilled water or deionized
water.
7.3 Cleaning
The cleaning should be performed no later than 24 hours after the operation.
The cleaning can be divided into automated cleaning and manual cleaning.
Automated cleaning is preferred if conditions permit.
7.3.1 Automated cleaning
•The cleaner is proved to be valid by CE certificationin accordance with
ENISO 15883.
▪
There should be a flushing connector connected to the inner cavity of the
product.
▪
The cleaning procedure is suitable for the product, and the irrigating period
is sufficient.
It is recommended to use a washer-disinfector in accordance with EN
Summary of Contents for O-Star CURING LIGHT
Page 1: ......
Page 23: ...ZMN SM 426 V1 0 20210609 ...