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Revision 5.5
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Sterilization
WARNING
Danger of infection due to non-sterile handling!
Improper sterilization and non-sterile handling of components of the CO
2
Laser System
MCO 25 plus can lead to serious health hazards for patients.
Sterilization must be carried out according to a validated steam sterilization process, for
example in a sterilizer complying with EN 285:2009 and ANSI/AAMI ST 79, validated in
accordance with ISO 17665-1:2006.
ANSI/AAMI ST79 recommends a minimum cycle time of 4 min at 132°C (270°F) for dynamic
air removal steam sterilization cycles.
Please follow the instructions of the user manual of your steam sterilizer.
NOTICE
•
The responsibility for proper cleaning, disinfection and sterilization of components of the
CO
2
Laser System MCO 25 plus rests with the operator/user. Be sure to observe your
national/local regulations, including potential restrictions.
•
Use appropriate and approved sterile packaging (e.g. in accordance with EN 868,
ISO 11607) for sterilization, subsequent transportation and storage.
•
Cleaning and sterilization must take into account the aging effects of the material.