Taking Skin Grafts; Validated Reprocessing Procedure; General Safety Notes; General Information - B. Braun Aesculap Acculan 4 GA340 Gebrauchsanweisung/Technische Beschreibung

6.3.4

Taking skin grafts

Note
To familiarize with the operation of the Dermatome prior to its first surgical
application, the user should carry out some test cuts on a specimen.
►
Stretch flabby skin.
►
With the sliding surface in level contact with the skin, push product 1
forward in a smooth movement, applying gentle pressure. Be careful
not to cant the product 1.
►
For very thin grafts, use a forceps, from time to time, to lay up the
resected portion of the graft on surface 21, see Fig. C.
►
Turn off the motor and pull the freshly cut skin graft out of the device
- or -
►
Lower the handle and cut off the skin graft with the product 1.
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 (dermatome blade,
battery, accessories).
►
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 Disassembling the product before carrying out the
reprocessing procedure
►
Remove battery 7 from the product 1, see Removing the rechargeable
battery.
►
Open the clamping levers 15 to remove the dermatome blade 11, see
Removing the dermatome blade.
►
Disassemble the product 1 immediately after use, according to instruc-
tions.
7.5.1

Removing the flap rod of the dermatome

►
Loosen nut 26 by turning it clockwise (left-handed thread).
►
Screw the nut 26 back to the end of the visible surface.
►
Press on nut 26 and push flap rod 23 approx. 4 mm to one side.
►
Twist flap rod 23 until it can be removed.
►
Remove flap rod 23.
►
Slide off the flaps 24 from flap rod 23.
The flap rod 23 has been dismantled.
7.6

Preparation before cleaning

►
Prior to first mechanical cleaning/disinfection: Mount the ECCOS
holders in a suitable basket (e.g. JC254R) or use the ECCOS basket
GB256R equipped with holders.
►
Insert the products in the correct position into the ECCOS holders, see
Fig. G.
7.7

Single-use products

Dermatome blade GB228R
WARNING
Risk of infection for patients and/or users and impairment of product
functionality due to reuse. Risk of injury, illness or death due to con-
tamination and/or impaired functionality of the product!
►
Do not reprocess the dermatome blade GB228R.
en
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