8
7
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.
Summary of Contents for ICEROSS POST-OP TF
Page 1: ...Instructions for Use ICEROSS POST OP TT TF...
Page 3: ...3 Please continue with Treatment Chart 1 2 3 4 5 6...
Page 69: ...69 IFU ISO 21065 2017 Iceross Post Op EasyGlide 5 7 ssur ORD ssur Rigid Dressing 5 7...
Page 72: ...72 1 2 3 4 5 6 7 1 2 3 4 4 4 4 1 2 3 4 4 4 4 ORD 3 4 3...
Page 73: ...73 1 2 1 2 3 10 a b 3 4...
Page 74: ...74 1 90 C 5 2 6 3 1 2 3 4 1 2 3 134 C 5 4cm...
Page 75: ...75 Iceross Curvemaster Loctite 410 411 ssur 4Nm 3 ft lb Iceross...
Page 76: ...76 pH 100 pH 100 pH 100 ssur ssur ssur...
Page 77: ...77 6...
Page 126: ...126 ISO 21065 2017 Iceross Post Op EasyGlide 5 7 ssur Rigid Dressing ORD 5 7...
Page 127: ...127 Iceross Post Op 0 6 Post Op Iceross 6 6 1 2 4 3 1 4...
Page 129: ...129 1 2 3 4 5 6 7 1 2 3 4 4 4 4 1 2 3 4 4 4 4 ORD 3 4 1 2...
Page 130: ...130 1 2 3 10 a b a b 3 4 1 90 C 5 2 6 3...
Page 131: ...131 1 2 3 4 1 2 3 134 C 5 4 Iceross Curvemaster...
Page 132: ...132 Loctite 410 411 ssur 4 Iceross pH...
Page 133: ...133 pH pH ssur ssur ssur 6...
Page 135: ...135 Iceross Post Op 6 6 1 2 4cm 3 1 4 24 5cm 25 23 5 2 Iceross Curvemaster...
Page 137: ...137 3 3 4 1 2 1 2 1 2 3 10 2 a...
Page 138: ...138 b a b 1 2 1 90 5 2 6 3 1 2 3 4 1 2 3 134 5 4cm...
Page 139: ...139 Iceross Curvemaster lanyard lanyard Loctite 410 411 ssur 4Nm 3 Iceross 1 pH...
Page 140: ...140 pH pH ssur ssur ssur 6...
Page 142: ...142 Iceross Post Op 6 6 1 2 4cm 3 1 4 24 5cm 23 5 25 2 Iceross Curvemaster...
Page 144: ...144 3 3 4 1 2 1 2 3 10 a b...
Page 145: ...145 a b 1 2 1 90 C 5 2 6 3 1 2 3 4 1 2 3 134 5 4...
Page 146: ...146 Iceross Curvemas ter Loctite 410 411 ssur 4Nm 3 ft lb Iceross Socks pH 100...
Page 147: ...147 pH 100 pH 100 ssur ssur ssur 6...
Page 149: ...149 PAOD 0 6 Iceross Post Op 6 6 1 2 4cm 3 1 4 24 5cm 25 23 5 2...
Page 151: ...151 ORD 1 3 1 2 1...
Page 152: ...152 2 3 10 a a b a b 1 2 1 90 C 5 2 6 3 1 2 3...
Page 153: ...153 4 1 2 3 134 C 5 4cm Iceross Curvemaster Loctite 410 411 ssur 4Nm 3ft lb...
Page 154: ...154 Iceross...
Page 155: ...155 ssur ssur ssur 6...