Validated Reprocessing Procedure; General Safety Notes; General Information - B. Braun Aesculap MINOP InVent Gebrauchsanweisung/Technische Beschreibung

®
Aesculap
MINOP InVent trocar 30°

Validated reprocessing procedure

General safety notes

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
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/reprocessing technician is responsible for this.
The specified chemistry was used for validation.
Note
For up-to-date information about 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.

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 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.
14
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 damage to metallic products.
These must be removed by rinsing thoroughly with
demineralized water and then drying.
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 processing 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
of pH >8 to cause visible surface changes.
■
Material damage such as corrosion, cracks, fractur-
ing, premature aging, or swelling.
►
Do not use metal cleaning brushes or other abra-
sives that would damage the product surface and
could cause corrosion
►
For further detailed information on hygienically
safe and material-preserving/value-preserving
reprocessing, see www.a-k-i.org, link to Publica-
tions, Red Brochure – Proper maintenance of
instruments.