Sterilization - KLS Martin group marCut Mode D'emploi

5.4

Sterilization

Perform a visual check for intact insulation, cleanliness and potential damage of the
•
instruments before the sterilization.
If required, repeat the reprocessing until all visible dirt has been removed from the
•
instrument.
WARNING
Danger of infection due to non-sterile handling!
Improper sterilization and non-sterile handling of the forceps 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 ST79, 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 operator/user is responsible for cleaning, disinfecting and sterilizing the instruments.
It is essential that national regulations and restrictions be observed.
Use appropriate and approved sterilization packing (e.g. in accordance with EN 868,
ISO 11607) or sterilization containers for sterilization, subsequent transport and storage.
WARNING
Peril to life or danger of serious physical injury by to prion infection!
Destroy instruments immediately after potential contact with prions
(risk of CJD contamination!) and do not use again under any circumstances!
The scissors must be sterilized in opened state.
Sterilization of the instruments is done using a fractionated pre-vacuum process according to
ISO 13060/ISO 17665 and in compliance with the respective national requirements.
Method
Fractionated pre-
vacuum process
Sterilization at high temperature or long sterilization times reduce the lifespan of the
•
bipolar scissors.
30
Number of pre-
vacuum phases
3
at a minimum of
60 mbar
Exposure
temperature
min. 132°C (270°F)
max. 137°C (278°F)
Instructions for Use
®
marCut bipolar scissors
Exposure time
min. 3 min
Drying time
min. 10 min
V. 4