Validated Reprocessing Procedure; General Information - B. Braun Aesculap Spine activ C FW645R Gebrauchsanweisung/Technische Beschreibung

Aesculap Spine
activ C handle, reamer guide, chisel guide, trial implants

Validated reprocessing procedure

Note
National laws, national and international standards
and directives, and
regulations for processing must be observed.
Note
For patients with Creutzfeldt-Jakob disease (CJD), sus-
pected CJD or possible variants of CJD, observe the rel-
evant national regulations concerning the reprocessing
of the products.
Note
Mechanical processing should be favored over manual
cleaning as it gives better and more reliable results.
Note
It should be noted that successful processing of this
medical device can only be guaranteed following prior
validation of the processing method. The operator/
sterile processing technician is responsible for this.
Note
Up-to-date information on processing can be found on
the Aesculap Extranet at www.aesculap-extra.net
Single-use products
Infection hazard for patients
and/or users and impairment
of product functionality due
to reuse. Risk of injury, illness
DANGER
or death due to contamina-
tion and/or impaired functio-
nality of the product!
Do
product.
10
product-specific hygiene
not reprocess the

General information

To prevent increased contamination of loaded
instrument trays during use, please ensure that
contaminated instruments are collected separately
and not returned to the instrument tray.
Dried or affixed surgical residues can make cleaning
more difficult or ineffective and lead to corrosion of
stainless steel. You should therefore leave no more
than 6 hours between use and cleaning, not use pre-
clean fixing temperatures >45°C, and ensure that non-
fixing disinfectants ( aldehyde-free/alcohol-free) are
used.
Excessive measures of neutralizing agents or basic
cleaners may result in a chemical attack and/or to
fading and the laser marking becoming unreadable
visually or by machine for stainless steel.
Residues containing chlorine or chloride - e.g. in
surgical residues, drugs, saline solutions and water for
cleaning, disinfection and sterilization - may cause
corrosion damage to stainless steel (pinholing, stress
corrosion), thus rendering the products unusable.
These must be removed by rinsing thoroughly with
demineralised water and then drying.
Only use process chemicals which have been tested
and approved (e.g. VAH/DGHM or FDA-certified or CE
marking) and recommended by the chemical
manufacturer as being compatible with the materials.
All the chemical manufacturer's
specifications regarding temperature, concentration
and contact time should be strictly observed. Failure to
do so can result in the following problems:
• Visible changes to materials e.g. fading or changes
in the color of titanium or aluminum. As regards
aluminum, visible changes to the surface may
already occur at a pH level of >8 in the application/
working solution.
• Material damage such as
fractures, premature deterioration or swelling.
Do not use process chemicals which cause stress
cracks or brittleness in plastics.
Clean the product immediately after use.
application
corrosion, cracks,