Validated Processing Procedure; Single-Use Products; Reusable Products - Aesculap GB740R Instrucciones De Manejo

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
concerning the 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.

5.1 Single-use products

Possible damage to/or destruction of products, due
to processing!
Intended use: These products have been designed
CAUTION
for single use only.
Do not reprocess these products.
Designation
Craniotome reamer
Spiral burr
Ball reamer "Twin Cut"
Diamond reamer
Pin reamer
Spray nozzle
Art. no.
GE420SU, GE520SU, GE620SU
GE429SU, GE529SU, GE629SU
GE389SU, GE390SU, GE391SU,
GE395SU
GE396SU, GE397SU
GE394SU, GE398SU, GE399SU
GE392SU
GB767SU

5.2 Reusable products

Reusable products supplied in sterile condition
Designation
Craniotome reamer
Spiral burr
Ball reamer "Twin Cut"
Diamond reamer
Pin reamer
Do not use products from open or damaged sterile packaging.
Do not use the product after its use-by date.
Reusable products supplied in unsterile condition
Designation
Craniotome handpiece
Dura protector (fixed)
Depth stop
Holding sleeve
Dura protector (pivoted)
Carry out sterile processing of the product prior to first use.
Art. no.
GE420R, GE520R, GE620R
GE389R, GE390R, GE391R, GE395R
GE396R, GE397R
GE394R, GE398R, GE399R
GE392R
Art. no.
GB740R
GB741R, GB742R, GB743R
GB744R
GB745R
GB746R, GB747R, GB748R
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