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7 CLEANING, DISINFECTION AND N° Operation Operating mode Warning
STERILIZATION
Check the validity period of the
pouch given by the manufacturer
7.1 General Information to determine the shelf life.
7. Packaging Pack the devices in “Sterilization
The measurement cable and the surface of the equipment should be pouches”. Use packaging which are
resistant up to a temperature of
cleaned with a paper towel or soft cloth or wipe that has been wetted 141°C (286°F) and in
with aldehyde-free disinfection and cleaning solution (bactericidal and accordance with EN ISO 11607.
fungicidal). The accessories (lip clip, hook
and fork) must be sterilized
according to the packaging
The lip clip, the hook and the fork must be cleaned, disinfected and labelling.
sterilized before each use to prevent any contamination. This concerns
the first use as well as the subsequent uses. The only way to ensure Use fractionated vacuum or
gravity (less preferred)
that these accessories are effectively sterilized is to thoroughly clean autoclaves (according to
and disinfect them. When doing this, follow the instructions set out in Steam sterilization at: 134°C EN 13060, EN 285).
this chapter. 8. Sterilization (237°F) during 3 min. Use validated sterilization
procedure according to
When you use any of the other equipment that you have in your ISO 17665-1.
practice, make sure you follow the directions for use for this equipment. Respect maintenance procedure
As part of your responsibility for ensuring that the accessories are of the autoclave device given by
sterile, always make sure that only validated cleaning, disinfection and the manufacturer.
sterilization methods are used, that the equipment (sterilizer) is Use only the listed sterilization
regularly maintained and inspected, and that the validated parameters procedures.
are adhered to each time. Keep devices in sterilization Sterility cannot be guaranteed if
9. Storage packaging in a dry and clean packaging is open, damaged or
In addition, ensure that you always comply with the applicable statutory environment. wet (check the packaging before
using the instruments).
rules and regulations with regard to hygiene in your practice or clinic. In
particular, this applies to the directives on effective prion inactivation.
We accept no liability in the event that these instructions are
disregarded or processes that have not been validated are used to
prepare the accessories for reuse.

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