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Maintenance
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steam sterilization process (according to EN 285/EN 13060/EN ISO
17665) under consideration of the respective country requirements.
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. 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
to ensure that the processing, as actually performed using equipment,
materials and personnel in the processing facility, achieves the
desired result. This requires verification and/or validation and routine
monitoring of the process. Likewise, any deviation by the processor
from the instructions provided should be properly evaluated for
effectiveness and potential adverse consequences.
