Validated Processing Procedure; Single-Use Products; General Notes - Braun Acculan 3Ti Instructions For Use/Technical Description

Aesculap Power Systems
Acculan® 3Ti Dermatome GA670
5. Validated processing
procedure
Note
Adhere to national statutory regulations, international
standards and guidelines, and local, clinical hygiene
instructions for sterile processing.
Note
For patients with Creutzfeldt-Jakob disease (CJD),
suspected CJD or possible variants of CJD, observe the
relevant national regulations
reprocessing of the products.
Note
Mechanical processing should be preferred over
manual cleaning, as mechanical processing produces
better and more reliable cleaning results.
Note
Up-to-date information on processing can be found on
the Aesculap Extranet at www.aesculap-extra.net
Note
Successful processing of this medical product can only
be ensured if processing is performed through a
validated processing procedure. The user/processor is
responsible for the validation.
Due to process tolerances, the manufacturer's
specifications can only serve as an approximate guide
for assessing the processing procedures applied by the
individual operator/processors.
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5.1 Single-use products

WARNING
Designation
concerning the Dermatome blade

5.2 General notes

Encrusted or fixated residues from surgery can make
the cleaning process more difficult or ineffective, and
can cause corrosion of stainless steels. To avoid this,
the time interval between application and processing
should not exceed 6 h, and neither fixating pre-
cleaning temperatures >45 °C nor any fixating
disinfecting agents (active ingredient: aldehyde,
alcohol) be used.
Excessive doses of neutralizers or basic detergents can
cause chemical degradation and/or fading and
obliteration of laser inscriptions on stainless steel
surfaces, regarding visual reading and machine-
readability of the inscriptions.
Risk to patients due to damaged,
broken or contaminated products!
These products are intended for
single use only!
Do not reprocess the product.
Art. no.
GB228R