6
Aesculap®
S4-Spondylolisthesis reduction instrument (SRI) FW225R
Validated reprocessing procedure
General safety information
Note
Adhere to national statutory regulations, national and
international standards and directives, and local, clini-
cal hygiene instructions for reprocessing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), sus-
pected CJD, or possible variants of CJD, observe the rel-
evant national regulations concerning the reprocessing
of products.
Note
Mechanical reprocessing should be favored over man-
ual cleaning as it gives better and more reliable results.
Note
It should be noted that successful reprocessing of this
medical device can only be guaranteed following prior
validation of the reprocessing method. The opera-
tor/reprocessor is responsible for this.
The recommended chemical was used for validation.
Note
If there is no final sterilization, then a virucidal disin-
fectant must be used.
Note
For the latest information on reprocessing and material
compatibility see also the Aesculap extranet at
www.aesculap-extra.net
The validated steam sterilization procedure was carried
out in the Aesculap sterile container system.
General notes
Dried or affixed surgical residues can make cleaning
more difficult or ineffective and lead to corrosion.
Therefore, no more than 6 hours should be left
between use and preparation, pre-clean temperatures
>45 °C liable to fusing should not be employed and
disinfectants liable to fusing (aldehyde or alcohol-
based) should not be used.
Excessive neutralizing agents or basic cleaners may
result in a chemical attack and/or fading and the laser
marking becoming unreadable either visually or by
machine in case of non stainless steel.
Residues containing chlorine or chlorides, e.g., in sur-
gical residues, medicines, saline solutions, and in the
service water used for cleaning, disinfection, and ster-
ilization, will cause corrosion damage (pitting, stress
corrosion) and result in damage to the products in case
of non stainless steel. These must be removed by rins-
ing thoroughly with demineralized water and then dry-
ing.
Perform additional drying, if necessary.
Only process chemicals that have been tested and
approved (e.g. VAH or FDA approval or CE mark) and
which are compatible with the product’s materials
according to the chemical manufacturers’ recommen-
dations may be used for reprocessing the product. All
the chemical manufacturer's application specifications
must be strictly observed. Failure to do so can result in
the following problems:
■Optical changes in materials, e.g., fading or discol-
oration of titanium or aluminum. For aluminum,
the application/process solution only needs to be
pH >8 to cause visible surface changes.
■Material damage such as corrosion, cracks, fractur-
ing, premature aging, or swelling.
