Ossur ICEROSS POST-OP TT Gebrauchsanweisung Seite 8

STERILIZATION
WARNING: Always sterilize the liner before use on another patient.
PRECAUTIONS:
– Sterilization is limited to max. 10 cycles.
– Always wash and disinfect the liner before sterilization.
Preparation for Sterilization
Track the number of sterilization cycles on a chart. Mark the number
directly on the liner. Identify the liner using the serial number at the distal
end.
Prepare the liner for sterilization by performing only one of the two
following methods:
a. Manual cleaning and disinfection (see "Manual Cleaning and
Disinfection" below)
OR
a. By use of a washing disinfector (see "Washing Disinfector" below).
Inspect the liner (see "Liner Inspection" below) after performing a) or b).
Manual Cleaning and Disinfection
1. Turn the liner inside out and wipe the surface with alcohol-
impregnated wipes until completely wet. Allow to dry.
2. Turn the liner back to normal shape and repeat the procedure on the
outer surface.
Washing Disinfector
1. Clean and disinfect using a washing disinfector at 90 °C and an
exposure time of 5 min.
2. Place the liner in the washing disinfector, with the distal end at the
top (Fig. 6). Make sure the stand is long enough to keep the proximal
end open.
3. Add cleaning agent and start the washing disinfector.
PRECAUTION: After using a washing disinfector the liner is required to
be sterilized before reuse (see "Sterilization Process" below).
Liner Inspection
1. Check the liner for visible contamination and tears in the silicone
layer.
2. Dispose liner if any tears are visible in the silicone layer.
3. If any contamination is visible, repeat cleaning and disinfection (see
"Preparation for Sterilization" above).
4. If neither tears nor contamination are visible, sterilize the liner (see
"Sterilization Process" below).
Sterilization Process
1. Place the liner in a sterilization film and seal both ends.
2. Apply the necessary labeling.
3. Sterilize in an autoclave with fractionated pre-vacuum and moist heat
at 134 °C and an exposure time of at least 5 min.
PRECAUTION: Do not use other media for sterilization, as silicone can
absorb the substances it is exposed to.
8