Operating The Product; Validated Reprocessing Procedure; General Safety Notes; General Information - Aesculap Acculan 4 GA334 Instrucciones De Manejo

6.3.1

Operating the product

Note
The slight whistling noise when the product is starting up is due to the con-
struction.
►
Activate trigger 2.
The oscillation frequency of the product 1 is continuously variable.
7.

Validated reprocessing procedure

7.1

General safety notes

Note
Adhere to national statutory regulations, national and international stan-
dards and directives, and local, clinical hygiene instructions for reprocess-
ing.
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
It should be noted that successful reprocessing of this medical device can
only be guaranteed following prior validation of the reprocessing method.
The operator/reprocessing technician is responsible for this.
The recommended chemistry was used for validation.
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 also the Aesculap Extranet at https://extranet.bbraun.com
The validated steam sterilization procedure was carried out in the Aesculap
sterile container system.
7.2

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 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.
On stainless steel, residues containing chlorine or chloride (such as surgi-
cal residues, drugs, saline solutions in water for cleaning, disinfection and
sterilization) may lead to corrosion (pitting corrosion, tensile corrosion)
and thus to the destruction of the product. These must be removed by rins-
ing 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' 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:
■
Visual material changes (such as fading or color changes in 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, breaks, premature aging or
swelling).
►
Do not use metal cleaning brushes or other abrasives that would dam-
age the product surface and could cause corrosion
►
For further detailed information on hygienically safe and material-pre-
serving/value-preserving reprocessing, see www.a-k-i.org, link to Pub-
lications, Red Brochure – Proper maintenance of instruments.
7.3

Preparations at the place of use

►
Remove all attached components from the product (tool and accesso-
ries).
►
Remove any visible surgical residues as much as possible with a damp,
lint-free cloth.
►
Place the dry product in a sealed waste container and forward it on for
cleaning and disinfection within 6 hours.
7.4

Preparation before cleaning

►
Prior to the first mechanical cleaning/disinfection process, mount the
ECCOS fixations in a suitable tray (e.g. GB243800).
►
Insert product 1 in the correct position in the ECCOS fixations, see
Fig. B.
7