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6.4 The cleaning, disinfection and sterilization of contra-angle,lip
hook, file clip,protective silicon cover,touch probeare as follow.
Unless otherwise stated, they will be hereinafter referred to as
“products”.
Warnings:
The use of strong detergent and disinfectant (alkaline pH>9 or acid
pH <5) will reduce the life span of products. And in such cases, the
manufacturer takes no responsibility.
The products may not be exposed to 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 products is 250 times.
6.4.1 Initial processing
6.4.1.1 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.
6.4.1.2Post-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 products from the base, and rinse away the dirt on the
surface of handpiece with pure water (or distilled water/deionized water);
2. Dry the products 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.
6.4.2 Preparation before cleaning
Steps:
Tools: tray, soft brush, clean and dry soft cloth.
1. Remove the shanks/files.
2. Remove the file clip, isolation sleeve,Contra-angle and connecting
wire from the handpiece in sequence, and then put them into a clean tray;
3. Use a clean soft brush to carefully brush lip hook, file
clip,protective silicon cover,touch probe, head and back cover of the
contra-angle until the dirt on surface is not visible. Then use soft cloth to
dry the products and put them into a clean tray. The cleaning agent can
be pure water, distilled water or deionized water.
Disassembling steps
a) Press the push-button and pull out the shank/file.
b) When removing the protective silicon cover, pull it straight out
slowly.
c) When inserting and removing the contra-angle, turn thehandpiece
power off beforehand.
6.4.3 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.
6.4.3.1Automated cleaning
• The cleaning device is proved to be valid by CE certification in
accordance with EN ISO 15883.
• There should be a flushing connector connected to the inner cavity
of the product.
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