Validated Reprocessing Procedure; General Safety Instructions; General Information; Single-Use Products - B. Braun Aesculap Spine Quintex SC420R Gebrauchsanweisung/Technische Beschreibung

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3.

Validated reprocessing procedure

3.1

General safety instructions

Note
Adhere to national statutory regulations, national and international stan-
dards and directives, and local, clinical hygiene instructions for sterile pro-
cessing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possi-
ble variants of CJD, observe the relevant national regulations concerning
the reprocessing of products.
Note
Mechanical reprocessing should be favored over manual cleaning as it gives
better and more reliable results.
Note
Successful processing of this medical device can only be ensured if the pro-
cessing method is first validated. The operator/sterile processing technician
is responsible for this.
Note
If there is no final sterilization, then a virucidal disinfectant must be used.
Note
For up-to-date information about reprocessing and material compatibility,
see B. Braun eIFU at eifu.bbraun.com
The validated steam sterilization procedure was carried out in the Aesculap
sterile container system.
3.2

General information

Dried or affixed surgical residues can make cleaning more difficult or inef-
fective and lead to corrosion. Therefore the time interval between applica-
tion and processing should not exceed 6 h; also, neither fixating pre-
cleaning temperatures >45 °C nor fixating disinfecting 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 fading and the laser marking becoming
unreadable visually or by machine for stainless steel.
Residues containing chlorine or chlorides e.g. in surgical residues, medi-
cines, saline solutions and in the service water used for cleaning, disinfec-
tion and sterilization will cause corrosion damage (pitting, stress corro-
sion) and result in the destruction of stainless steel products. These must
be removed by rinsing thoroughly with demineralized water and then dry-
ing.
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 manufacturer'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 discoloration 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, fracturing, premature aging
or swelling.
►
Do not use metal cleaning brushes or other abrasives that would dam-
age the product surfaces and could cause corrosion.
►
Further detailed advice on hygienically safe and material-/value-pre-
serving reprocessing can be found at www.a-k-i.org, link to "AKI-
Brochures", "Red brochure".
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3.3

Single-use products

Art. no. Designation
FJ833RS Fixation pin
►
Do not reuse the product.
The reprocessing of the product affects its functionality. Risk of injury, ill-
ness or death due to soiling and/or impaired functionality of the product.
►
Do not reprocess the product.
3.4

Reusable products

Influences of the reprocessing which lead to damage to the product are
not known.
A careful visual and functional inspection before the next use is the best
opportunity to recognize a product that is no longer functional, see
Inspection.
3.5

Preparations at the place of use

►
If applicable, rinse non-visible surfaces preferably with deionized
water, with a disposable syringe for example.
►
Remove any visible surgical residues to the extent possible with a
damp, lint-free cloth.
►
Transport the dry product in a sealed waste container for cleaning and
disinfection within 6 hours.
3.6

Preparing for cleaning

►
Disassemble the product prior to cleaning, see Disassembly.
►
Open up product with hinges.