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6 CLEANING, DISINFECTION AND STERILIZATION
In accordance with EN ISO 17664, this section provides users with instructions for cleaning, disinfection, and sterilization of
SOPRO reusable medical devices. All cleaning, disinfection and sterilization instructions provided by SOPRO for the company's
medical devices and accessories have been validated. This section is applicable only to devices manufactured by SOPRO.
In countries where the reprocessing requirements are more stringent than those detailed in these Instructions for Use, the
user must always comply with national guidelines, laws, and regulations.
Always follow the recommendations of the manufacturers of the products and equipment used.
Cleaning is defined as the removal of visible soil (e.g., organic and inorganic material). Cleaning reduces the initial population
of microorganisms, preventing blood proteins and other contaminants from drying on the devices, facilitating subsequent
processing steps and protecting personnel who handle medical devices, in addition to preventing contamination of the
environment. Disinfection reduces the number of pathogenic microorganisms, except bacterial spores. The sterilization
process is used to render product free of viable microorganisms with a Sterility Assurance Level (SAL) of 10
-6
.
6.1 DEVICES AND PROCESS TO APPLY
SOPROTIPS & C50TIPS intraoral tips are reusable medical devices that are supplied non-sterile. They must be cleaned, and
steam sterilized before first use and after each use thereafter.
Handpiece and docking station must be disinfected before first use and after each use with a disinfecting wipe only. Do not
immerse in a disinfecting liquid. Handpiece and docking station are not autoclavable.
The device must always be decontaminated before sending it to the after-sales service department.
6.2 CLEANING OF INTRAORAL TIPS (C50TIPS AND SOPROTIPS)
Only SOPROTIPS and C50TIPS are concerned by the cleaning procedure described hereafter:
Wash hands using correct technique and mild foam soap and dry with disposable paper towels.
Wear appropriate PPE (disposable gloves, goggles, surgical mask, face shield etc.). Immediately after use, rinse the intraoral
tip for 1 minute with warm (not hot) tap water at 20-25°C taking care to brush the inside surface of the tip with a small nylon
brush.
CAUTION: Do not use steel wool or wire brushes. Be sure to remove all blood, fluids, and tissue.
Submerge the SOPROTIPS or C50TIPS in a detergent and disinfectant solution freshly prepared with ANIOS’s Clean Excel D
diluted to 0.5 %, which was used for cleaning validation. If ANIOS Clean Excel D is not available, be sure to select a detergent
and disinfectant designed to reduce the risk of surface biofilm formation on medical device, possessing demonstrated
antimicrobial efficacity and a pH of 7.4 at 0.5% dilution in mains water.
Leave the device to soak for at least 15 minutes. Please refer to the detergent manufacturer's instructions for use. This step is
intended to reduce the risk of surface biofilm formation on the medical device.
Manual cleaning: Brush the intraoral tip with a stiff plastic (nylon) cleaning brush in a detergent solution prepared in
accordance with the manufacturer's instructions (for instance, a 0.5% solution of ANIOS’s Clean Excel D).
CAUTION: Do not use steel wool or wire brushes.
Visually inspect the device to ensure that all contamination has been removed.
Let it dry completely, then package the SOPROTIPS or C50TIPS in a single sterilization pouch compatible with steam sterilization
and complying with the ISO 11607-1 and EN 868-5 standards in force. If possible, proceed immediately to sterilization.
6.3 STERILIZATION OF INTRAORAL TIPS (C50TIPS AND SOPROTIPS)
Only SOPROTIPS and C50TIPS are concerned by the steam sterilization procedure describer hereinafter.
6.3.1 CAUTION
SOPROTIPS and C50TIPS must be carefully cleaned prior to sterilization (all visible organic material, blood and cleaning solution
must be completely eliminated).
SOPROTIPS and C50TIPS must be packaged in an individual single-use sterilization pouch. The approved sterilisation settings
apply only to sterilisation equipment which is properly serviced and calibrated.
Any deviation from the recommended sterilisation settings must be validated by the user.
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