B. Braun Aesculap MINOP InVent trocar, Инструкция по эксплуатации / Техническое описание

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9. Validated reprocessing procedure
9.1 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.
9.2 General information
Dried and hardened or clotted surgical residues can
complicate cleaning or render it ineffective and cause
corrosion. Therefore, do not exceed a period of 1h
between use and processing, make sure pre-cleaning
temperatures are <45°C to prevent clotting, and do not
use disinfectants that can cause clotting (active ingre-
dient: aldehyde, alcohol).
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.
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 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:
■
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 detailed information on hygienically safe and
material-friendly/careful processing, please refer to
www.a-k-i.org Header "AKI-Brochures", "Red
brochure".
9.3 Reusable products
There are no known effects of processing that result in
damage to the product.
The product can be re-used up to 75 times with proper
care and if it is undamaged and clean. The user shall be
responsible for any further reuse.
Careful visual and functional testing prior to next use
is the best way to identify a malfunctioning product.
9.4 Disassembling the product before
carrying out the reprocessing pro-
cedure
►
Disassemble the product immediately after use, as
described in the respective instructions for use.
9.5 Preparations at the place of use
►
If applicable, rinse surfaces that are not accessible
to visible inspection (preferably with demineralized
water), using a disposable syringe, for example.
►
Remove any visible surgical residues as much as
possible with a damp, lint-free cloth.
►
Place the wet product in a sealed waste container
and take it to be cleaned and disinfected within 1h.
9.6 Preparation before cleaning
►
Disassemble the product prior to cleaning, see Tro-
car disassembly.