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Idiomas disponibles
Idiomas disponibles
Aesculap
®
Double pedal foot switch
5.
Validated reprocessing pro-
cedure
5.1
General safety instructions
Note
Adhere to national statutory regulations, national and
international standards and directives, and local, clini-
cal hygiene instructions for sterile processing.
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
Successful processing of this medical device can only
be ensured if the processing method is first validated.
The operator/sterile processing technician is responsi-
ble for this.
The recommended chemistry 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.extranet.bbraun.com
The validated steam sterilization procedure was carried
out in the Aesculap sterile container system.
8
5.2
General information
Dried or affixed surgical residues can make cleaning
more difficult or ineffective and lead to corrosion.
Therefore the time interval between application and
processing should not exceed 6 h; also, neither fixating
pre-cleaning temperatures >45 °C nor fixating disin-
fecting agents (active ingredient: aldehydes/alcohols)
should be used.
Excessive measures of neutralizing agents or basic
cleaners may result in a chemical attack and/or to fad-
ing and the laser marking becoming unreadable visu-
ally or by machine for stainless steel.
Residues containing chlorine or chlorides e.g. in surgi-
cal residues, medicines, saline solutions and in the ser-
vice water used for cleaning, disinfection and steriliza-
tion will cause corrosion damage (pitting, stress
corrosion) and result in the destruction of stainless
steel products. These must be removed by rinsing thor-
oughly with demineralized water and then drying.
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' recommendations may be used for
processing the product. All the chemical manufac-
turer's application specifications must be strictly
observed. Failure to do so can result in the following
problems:
■
Optical changes of materials, e.g. fading or discol-
oration of titanium or aluminum. For aluminum,
the application/process solution only needs to be
of pH >8 to cause visible surface changes.
■
Material damage such as corrosion, cracks, fractur-
ing, premature aging or swelling.
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