Validated Reprocessing Procedure; General Information - B. Braun Aesculap Spine activ L Instructions For Use/Technical Description

Aesculap Spine
activ L insertion instrument

Validated reprocessing procedure

Note
National laws, national and international standards
and directives, and
regulations for reprocessing must be observed.
Note
Machine 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 procedure. 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

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.
4
product-specific hygiene
These must be removed by rinsing thoroughly with
demineralized water and then drying.
Only use process chemicals which have been tested
and approved (e.g. VAH/DGHModer FDA-certified or CE
marking) and recommended by the chemical
manufacturer as being compatible with materials. All
the chemical manufacturers' application specifications
regarding temperature, concentration and contact
time should be strictly observed. Failure to do so may
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
application/working solution.
• Material damage such as corrosion, cracks,
fractures, premature deterioration or swelling.
Do not use process chemicals which cause stress
cracks or brittleness in plastics.
Clean the product immediately after use.
Please see www.a-k-i.org
information on hygienically safe reprocessing which is
protective of materials and retains instruments' value.
Use suitable cleaning/disinfecting agents if the
product is put away in a wet condition. To prevent
foam formation and reduced effectiveness of the
process chemicals: Prior to mechanical cleaning
and disinfecting, rinse the product thoroughly with
running water.
in the
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