25
Recommended Procedure: Manual cleaning/disinfection
•
The components must be placed in a 0.5% solution of Korsolex®-Endo-Cleaner and approx.
50°C warm water, and cleaned thoroughly for 5 minutes.
•
The components are then placed in a 4% disinfectant solution of Korsolex
®
basic for 15 minutes.
•
Then thoroughly rinse the nebuliser components under hygienically tested water and leave
them to dry completely on a clean, dry and absorbent surface (for at least 4 hours).
The effectiveness of this procedure has been proven using the Korsolex
®
-Endo-Cleaner cleaning agent
in combination with the Korsolex
®
basic disinfectant made by BODE CHEMIE HAMBURG.
Possible Alternative: Chemical-thermal Disinfection
•
Place the nebuliser components in the instrument disinfector.
•
Add a suitable cleaner/ disinfectant and select the 60°C program.
7.4
Sterilisation of the Nebuliser
The AKITA JET control unit and the nebuliser are non-sterile products. Sterilisation process as described
below is required in case of multi patient use. Sterilised parts do not need to be stored sterile or applied
sterile to the patient.
After cleaning/disinfection, pack the dismantled nebuliser in sterilisation packaging (disposable
sterilisation packaging, e.g. foil/paper sterilisation bags). The sterilisation packaging must conform to
DIN EN 868/ ISO 11607 and be suitable for steam sterilisation. Then sterilise the nebuliser using the
following sterilisation procedure:
Recommended Procedure: Steam Sterilization
•
Sterilisation temperature:
o
121°C (to be maintained for at least 20min.) or
o
132°C/134°C (to be maintained for at least 3min.)
o
max. 137°C
This procedure has been validated according to EN ISO 17664-1 as well as DGKH guidelines for the
validation and routine monitoring of sterilisation processes using damp heat for medical devices.
The provided process has to be validated according EN ISO 17665.
