Validated Reprocessing Procedure; General Safety Notes; General Information; Reusable Products - Aesculap Acculan 4 GA334 Instrucciones De Manejo

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.
Note
If there is no final sterilization, then a virucidal disinfectant must be used.
Note
See also B.Braun eIFU at eifu.bbraun.com for current information on pro-
cessing and compatibility of material
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:
■
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
►
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".
7.3

Reusable products

The service life of the product is limited by damage, normal wear, type and
duration of the application, handling, storage and transportation of the
product.
Careful visual and functional testing prior to next use is the best way to
identify a malfunctioning product.
7.4

Preparations at the place of use

►
Remove all attached components from the product (tool an 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.
7.5

Preparation before cleaning

►
Prior to first mechanical cleaning/disinfection: Assemble ECCOS hold-
ers in a suitable basket (e.g. GB243800).
►
Insert product 1 in the correct position into the ECCOS holders, see
Fig. B.
7.6 Product-specific safety instructions for the pro-
cessing procedure
CAUTION
Damage to the product due to inappropriate cleaning/disinfecting
agents and/or excessive temperatures!
►
Use cleaning and disinfecting agents according to the manufac-
turer's instructions which
– are approved for plastic material and high-grade steel,
– and which do not affect softeners (e.g., in silicone).
►
Do not use cleaning agents that contain acetone.
►
Observe information concerning concentration, temperature and
exposure time.
►
Do not exceed the maximum temperature of 60 °C in chemical
cleaning and/or disinfection.
►
Do not exceed maximum temperature during thermal disinfection
using 96 °C DI water.
►
Dry the product for at least 10 minutes at a maximum of 120 °C.
CAUTION
Damage or destruction of the batteries due to processing!
►
Protect battery from moisture.
Note
The drying time listed is only indicative. It has to be checked taking into
account the specific conditions (e.g. load) and adjusted if necessary.
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