General Information; Dismantling Prior To Carrying Out The Reprocessing Procedure; Preparations At The Place Of Use; Preparation Before Cleaning - Aesculap PV481 Instrucciones De Manejo

6.1

General information

Dried or affixed surgical residues can make cleaning more difficult or inef-
fective and lead to corrosion. Therefore the time interval between appli-
cation and reprocessing 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 in case of non stainless steel.
Residues containing chlorine or chlorides, e.g., in surgical residues, medi-
cines, saline solutions, and in the service water used for cleaning, disin-
fection, and sterilization, will cause corrosion damage (pitting, stress cor-
rosion) and result in damage to the products in case of non stainless steel.
These must be removed by rinsing 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 reprocessing the product. All the chemical manufacturer's
application specifications must be strictly observed. Failure to do so can
result in the following problems:
■
Optical material changes (e.g. fading or discoloration) in titanium or
aluminum. For aluminum, the application/process solution only needs
to be pH >8 to cause visible surface changes.
■
Material damage (e.g. corrosion, cracks, fracturing, premature aging, or
swelling)
►
Do not use metal cleaning brushes or other abrasives that would dam-
age the product surface and could cause corrosion.
►
For further detailed information on hygienically safe and material-pre-
serving/ value-preserving reprocessing, see www.a-k-i.org link to Pub-
lications, Red Brochure – Proper maintenance of instruments.
Damage to the product due to improper reprocess-
ing!
►
Do not, under any circumstances, clean or disin-
WARNING
fect the product in an ultrasonic cleaning bath.
►
Use cleaning and disinfecting agents which are
suitable and approved for the present product.
►
Observe the manufacturer's cleaning and disin-
fecting instructions regarding concentration,
temperature and exposure time.
►
Only reconnect the system to power when all
cleaned parts are completely dry.
►
Never autoclave the product.
6.2 Dismantling prior to carrying out the reprocessing
procedure
►
Unplug the camera plug from the camera control unit.
►
Remove the sterile cover from the camera head and dispose of it
according to regulations. The sterile cover is only intended for single
use.
►
Remove the endoscope, light guide and all detachable parts.
6.3

Preparations at the place of use

►
Remove any visible surgical residues as much as possible with a damp,
lint-free cloth. Use a soft cloth for this to avoid scratching the optical
lens.
►
Pre-clean all used parts of the fully disassembled product at the oper-
ating table at the conclusion of the surgery by wiping with a lint-free
wipe wetted with an enzymatic cleaning solution until visibly clean.
►
Place the dry product in a sealed waste container and forward it on for
cleaning and disinfection within 6 hours.
6.4

Preparation before cleaning

►
Non-fixating/NaCl-free pre-cleaning is mandatory immediately after
use.
6.5

Cleaning/disinfection

The effectiveness of the following procedures:
■
Manual cleaning and manual disinfection
■
Automated cleaning and thermal disinfection
■
Sterilization
as described in this document, has been fully validated.
It is the operator's responsibility to introduce, document, implement, and
maintain a validated reprocessing procedure. Make sure that the equip-
ment used for reprocessing is properly maintained.
The reprocessing procedure described in this document consists of the fol-
lowing steps:
■
Pre-cleaning immediately after use
■
Cleaning and disinfection (manual or automated) and
■
Sterilization.
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