time 5 minutes; or steam sterilization, 121°C, hold time 20 minutes. To dry the products/
individual components, the drying cycle of the autoclave should be configured accord-
ingly. Please observe the autoclave manufacturer’s usage instructions.
STORAGE
To maintain sterility, products must be stored in standardized sterilization bags in a dry,
clean place until they are used. If the sterile packaging is damaged, the products must be
processed again before they are used.
ADDITIONAL INFORMATION
Mark the sterilized products according to the legal and national regulations. The recom-
mended storage duration for sterile medical devices is described in the DIN 58953-8
standard and depends on external influences and effects during storage, transport and
handling. The user must ensure within their quality management system that any speci-
fied processing cycles that might apply (see Limitations in the processing) are not ex-
ceeded. The manufacturer and the competent authority of your member state must be
immediately notified of all serious incidents occurring in connection with the product.
For disposal of products, recommendations and regulations differ according to region.
Ask your disposal company for the current regulations in your region.
CONTACT TO THE MANUFACTURER
Tel.: (+49) 203/99269-0 Fax.: (+49) 203/299283 Email: [email protected]
The instructions specified above are validated by the medical device manufacturer as
suitable for the preparation of a medical device for its reuse. The processor is responsible
for ensuring that the processing performed in practice, including the equipment used,
materials and personnel in the preparation facility, achieves the desired result. To this
end, verification and/or validation and routine monitoring of the procedure are required.
MIRAHOLD
®
-BLOCK
F Mode d´emploi
• Cale-bouche en silicone élastique
• On place le bloc en silicone entre le max. sup. et le max. inf., celui-ci maintient bien la
bouche ouverte grâce à son élasticité
• On peut le fixer aux lèvres avec l´écarte-joue
• Autoclavables
Le cale-bouche Mirahold-Block est un cale-bouche avec écarte-joue. On le met en place
en suivant les figures de 1 à 4.
4
1
2
3
