Sonotrode And Fork Wrench; Cleaning And Disinfection; Sonicweld Rx Device: Manual Cleaning And Disinfection; Handpiece, Sonotrode, And Fork Wrench: Machine Cleaning And Disinfection - Kls Martin Group Sonicweld Rx Gebrauchsanweisung

Ultrasonic Unit SonicWeld Rx®
Instructions for Use
5.2.2

Sonotrode and fork wrench

• Remove any visible contamination immediately after use.
• Rinse the product for 1 minute under running water (water temperature <35°C).
- Rinse the blind hole on the sonotrode three times with 5 ml water using a syringe and cannula
attachment.
• Then place the products in cleaning solution for 10 minutes (e.g. 0.5% neodisher MediClean).
- When using the sonotrode, take care to ensure that the cleaning solution also enters the blind hole
and that the sonotrode does not come into contact with other sonotrodes or instruments.
• Remove any visible contamination using a soft plastic brush.
- Clean the blind hole intensively using a conical interdental brush.
• Then rinse the product again for one minute under running water and rinse the blind hole three times
with 5 ml water using a syringe and cannula attachment.
5.3

Cleaning and Disinfection

5.3.1

SonicWeld Rx device: Manual Cleaning and Disinfection

Clean the SonicWeld Rx® using a clean, lint-free cloth moistened with a commercial, ethanol- or methanol-
based disinfectant approved for use on surfaces (e.g. neoform MED AF from Dr. Weigert).
5.3.2

Handpiece, sonotrode, and fork wrench: Machine Cleaning and Disinfection

An automated process (W/D) should be used for cleaning and disinfection.
The cleaning process must be carried out using a validated procedure, e.g. in a washer-disinfector (W/D)
according to ISO 15883.
When selecting the W/D, it must be ensured that
• the W/D always has a verified effectiveness (e.g. DGHM or FDA approval/clearance/registration or CE
marking in accordance with DIN EN ISO 15883),
• a tested thermal disinfection program (A0 value > 3000 or - in the case of older devices - at least 5 min
at 90°C/194°F) is used wherever possible (danger of disinfectant residues on the products in the case of
chemical disinfection),
• the program used is suitable for the products and includes a sufficient number of flushing cycles.
Detergent residues can be effectively prevented with one of the following measures: carry out at least
three removal steps after cleaning or neutralization, or conductivity value control of the W/D,
• using only sterile or low-germ (max. 10 germs/ml) as well as low endotoxin load (max. 0.25 endotoxin
units /ml) water (e.g. purified water/highly purified water)
• the air used for drying is filtered (oil-free, low in germs and particles), and
If, in the context of national recommendations (e.g. in Germany KRINKO/RKI/BfArM recommendation on processing), a lower water quality
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is considered sufficient, this is the sole responsibility of the processor.
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