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Maintenance
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Minimum requirements: 3 min at 134 °C (in EU: 5
min at 134 °C)
Maximum sterilization temperature: 137°C
Flash sterilization is not allowed on lumen
instruments!
WARNING
1. Use only approved autoclave devices
according to EN 13060 or EN 285.
2. Use a validated sterilization procedure
according to EN ISO 17665.
3. Respect the maintenance procedure of the
autoclave device given by the manufacturer.
4. Use only this recommended sterilization
procedure.
5. Control the efficiency (packaging integrity, no
humidity, color change of sterilization
indicators, physicochemical integrators, digital
records of cycles parameters).
6. The sterilization procedure must comply with
EN ISO 17665.
7. Wait for cooling before touching.
Storage
Storage of sterilized instruments in a dry, clean
and dust free environment at modest
temperatures, refer to label and instructions for
use.
WARNING
1. Sterility cannot be guaranteed if packaging is
open, damaged or wet.
2. Check the packaging and the contra angle
before using it (packaging integrity, no humidity
and validity period).
NOTE
The instructions provided above have been validated by the
manufacturer of the medical device as being capable of preparing a
medical device for use. It remains the responsibility of the processor