Braun Aesculap Neurosurgery Manual

Aesculap Neurosurgery
Instructions for use/Technical description
AVM microclip applying forceps
Gebrauchsanweisung/Technische Beschreibung
AVM-Mikroclip-Anlegezange
Mode d’emploi/Description technique
Pince de pose pour microclips AVM
Instrucciones de manejo/Descripción técnica
Pinza de colocación para microclips AVM
Istruzioni per l’uso/Descrizione tecnica
Pinza applicatrice per microclips AVM
Instruções de utilização/Descrição técnica
Pinça de aplicação para microclips AVM
Gebruiksaanwijzing/Technische Beschrijving
AVM-microclips-applicatietang

1 2
3
4 5 7
78
6
9
10

Aesculap Neurosurgery
AVM microclip applying forceps
2
Legend
1Jaw piece with pulling rod
2Sheath outer tube
3Sheath
4Rotary element
5Lock pushbutton
6Locking button
7Branches left/right
8Lock
9Handle part
10 AVM microclip applying forceps
Symbols on product and packages
Intended use
The AVM microclip applying forceps is used for
opening and closing the Aesculap AVM microclips.
AVM microclips are used for temporary or permanent
occlusion of small blood vessels in cases of
arteriovenous malformation (AVM) in the brain.
Available sizes
The AVM microclip applying forceps are available in
various working lengths (see brochure AVM
microclips).
Safe handling and preparation
CAUTION
Federal law restricts this device to sale by or on
order of a physician!
¾Ensure that the product and its accessories are
operated and used only by persons with the requi-
site training, knowledge or experience.
¾Read, follow and keep the instructions for use.
¾Use the product only in accordance with its
intended use, see Intended use.
¾Remove the transport packaging and thoroughly
clean the new product, either by hand or by a
mechanical process, prior to its initial sterilization.
¾Store any new or unused products in a dry, clean
and safe place.
¾Prior to each use, inspect the product for: loose,
bent, broken, cracked, worn, or fractured
components.
¾Do not use the product if it is damaged or
defective. Set aside the product if it is damaged.
¾Replace any damaged components immediately
with original spare parts.
Safe operation
Symbol Explanation
Caution: See documentation
supplied with the product
WARNING
Risk of injury and/or malfunction!
¾Always carry out a function
check before using the product.

3
Engaging the lock and handing over the AVM
microclip
¾Push lock pushbutton 5 while simultaneously
compressing the branches left/right 7.
Lock 8is engaged now. With lock 8engaged, jaw
piece 1 is set in such a way that the AVM microclip
is slightly clamped between jaws 1.
Fig. 1 Engaging the lock
Releasing the lock and applying the AVM
microclip
¾Swivel rotary element 4until the AVM microclip is
in the required position.
¾Compress branches left/right 7.
Jaw piece 1of AVM microclip applying forceps 10
closes and the clamped AVM microclip opens.
Lock 8with lock pushbutton 5 automatically snaps
back into the unlocked position, so that the AVM
microclip can be applied.
¾Apply the AVM microclip on the blood vessel.
Fig. 2 Releasing the lock
Detaching the AVM microclip applying
forceps from the AVM microclip
¾Release the pressure on branches left/right 7.
Jaw piece 1opens and the AVM microclip closes.
¾Detach AVM microclip applying forceps 10 from
the AVM microclip.
Fig. 3 Detaching the AVM microclip applying forceps
5
7
8
1
5
7
8
43
1
1
7

Aesculap Neurosurgery
AVM microclip applying forceps
4
Disassembling
Fig. 4 Turning the locking button
¾Turn locking button 6 until it is in the position
shown in fig. 4.
Fig. 5 Disassembling the sheath
Note
Jaw piece with pulling rod
1 and sheath outer tube 2
cannot be removed from handle part 9 at the same
time!
¾Extract jaw piece with pulling rod 1 from sheath
outer tube 2.
¾Extract sheath outer tube 2 from handle part 9.
Assembling
Fig. 6 Turning the locking button
¾Return locking button 6to its initial position, see
Fig. 6.
CAUTION
Reduced functionality of the AVM
microclip applying forceps caused
by bending of, or damage to a
component!
¾Proceed cautiously when disas-
sembling the AVM microclip
applying forceps.
¾Observe the sequential order of
disassembly.
6
21
9
CAUTION
Reduced functionality of the AVM
microclip applying forceps caused
by bending of, or damage to a
component!
¾Proceed cautiously when assem-
bling the AVM microclip app-
lying forceps.
¾Observe the sequential order of
assembly.
CAUTION
Excessive load on the AVM clips,
caused by using a wrong
combination of jaw piece with
pulling rod, sheath outer tube and
handle part!
¾Make certain the jaw piece with
pulling rod, the sheath outer
tube and the handle part carry
the same code number.
¾Fully insert the sheath outer
tube into the handle part.
6

5
Fig. 7 Checking the code numbers
¾Slide jaw piece with pulling rod 1into sheath outer
tube 2 to the positive stop, see Fig. 7, making sure
that jaw piece with pulling rod 1is in the correct
assembly position.
Fig. 8 Assembly position of the jaw piece with
pulling rod
¾Check AVM microclip applying forceps 10 for
proper functioning, see Safe operation.
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 because of the better and more
reliable cleaning results of mechanical processing.
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.
Note
Up-to-date information on processing can be found on
the Aesculap Extranet at www.aesculap-extra.net
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Aesculap Neurosurgery
AVM microclip applying forceps
6
General notes
To avoid unnecessary, excessive contamination of the
complete instrument tray during operations, take care
that contaminated instruments are collected
separately and not put back into the instrument tray.
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.
Residues containing chlorine or chlorides e.g. in
surgical residues, medicines, saline solutions and in the
service water used for cleaning, disinfection and
sterilization will cause corrosion damage (pitting,
stress corrosion) and result in the destruction of
stainless steel products. To remove such residues, the
products must be rinsed sufficiently with fully
desalinated water and dried thoroughly.
Only process chemicals that have been tested and
approved (e.g. VAH/DGHM 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 processing the
product. All process parameters specified by the
chemical’s manufacturer, such as temperatures,
concentrations and exposure times, must be strictly
observed. Failure to do so can result in the following
problems:
• Optical deterioration, e.g. fading or discoloration of
titanium or aluminum surfaces. For aluminum, pH
>8 in the application/process can already cause
visible surface changes.
• Material damage, e.g. corrosion, cracks, fracturing,
premature aging or swelling.
¾Do not use process chemicals that cause stress
cracking or brittleness of plastics.
¾For further detailed advice on hygienically safe and
material/value-preserving reprocessing, see
www.a-k-i.org, link to Publications, Red Brochure –
Proper maintenance of instruments.
¾Use suitable cleaning/disinfecting agents if the
product is put away in 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.

7
Preparations at the place of use
¾Disassemble the product immediately after use, as
described in the respective instructions for use.
¾Rinse surfaces inaccessible to visual inspection, e.g.
on products with hidden crevices or lumens or
products with complex geometries, preferably with
distilled water, using e.g. a disposable syringe.
¾Remove visible surgical residues as completely as
possible, using a lint-free wet wipe.
¾Put the dry product into a closed disposal container
and have it transferred to cleaning and disinfecting
within 6 h.
Cleaning/Disinfecting
¾Carry out ultrasound cleaning:
– as an effective mechanical supplement to manual
cleaning/disinfecting.
– as a pre-cleaning procedure for products with
encrusted residues, in preparation for mechanical
cleaning/disinfecting.
– as an integrated mechanical support measure for
mechanical cleaning/disinfecting.
– for additional cleaning of products with residues
left after mechanical cleaning/disinfecting.
¾Clean and disinfect microsurgical products
mechanically, provided they can be securely fixed
in machines or storage devices in such a way that
they will be thoroughly cleaned.
Manual cleaning/disinfecting
¾Clean products with movable links with the links
opened or mobilized.
¾Inspect visible surfaces for residual contamination
after manual cleaning/disinfecting.
¾Repeat the cleaning process if necessary.
CAUTION
Damage to the product due to
inappropriate cleaning/disinfecting
agents and/or excessive
temperatures!
¾Use cleaning and disinfecting
agents according to
manufacturers’ instructions. The
cleaning and disinfecting agents
- must be approved for e.g.
aluminum, plastic materials and
high-grade steel.
¾Observe specifications regarding
concentration, temperature and
exposure time.
¾Do not exceed the maximum
allowable cleaning temperature
of 55 °C.

Aesculap Neurosurgery
AVM microclip applying forceps
8
Manual cleaning with immersion disinfection
D–W: Drinking water
FD–W: Fully desalinated water (demineralized)
RT: Room Temperature
Stage I
¾Fully immerse the product in the cleaning/
disinfecting solution. Make certain that all
accessible surfaces are moistened.
¾Clean the product under running tap water, using
a suitable cleaning brush (FM32800) if necessary,
until all visible residues have been removed from
the surfaces.
¾Brush through all surfaces that are not accessible
to visual inspection, e.g. in products with hidden
crevices, lumens or complex geometry, for at least
1 min or until no more residues can be removed.
Mobilize non-rigid components, such as set screws,
links, etc. during cleaning.
¾After cleaning, thoroughly rinse through these
components (at least five times) with the cleaning/
disinfecting solution, using a disposable syringe
(20 ml).
¾Do not use metal cleaning brushes or other
abrasives that would damage the product surfaces
and could cause corrosion.
Stage II
¾Rinse the product completely (all accessible
surfaces) under running water.
¾Allow water to drip off for a sufficient length of
time.
Stage III
¾Fully immerse the product in the disinfecting
solution. Make certain that all accessible surfaces
are moistened.
Stage Step T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemical
ICleaning RT
(cold)
15 2 D–W BBraun Stabimed; aldehyde
phenol and QAV-free
II Intermediate rinse RT
(cold)
1-D–W-
III Disinfecting RT
(cold)
15 2 D–W BBraun Stabimed; aldehyde
phenol and QAV-free
IV Final rinse RT
(cold)
0.5 - FD–W -
VDrying RT - - - -

9
Stage IV
¾Carry out a full rinse of the product (all accessible
surfaces) under running water.
¾Allow water to drip off for a sufficient length of
time.
Stage V
¾Dry the product with lint-free tissue or medical-
quality compressed air.
Mechanical cleaning/disinfecting with
manual pre-cleaning
Note
Categorically, the disinfector must be of tested and
approved effectiveness (e.g. DGHM or FDA approval or
CE mark according to DIN EN ISO 15883).
Note
For thermal disinfection, always use fully desalinated
(demineralized) water. Ensure that Ao is >3 000 for the
process.
Note
The disinfector used for processing must be serviced
and checked at regular intervals.

Aesculap Neurosurgery
AVM microclip applying forceps
10
Manual pre-cleaning with brush
D–W: Drinking water
RT: Room Temperature
Stage I
¾Fully immerse the product in the cleaning/
disinfecting solution. Make certain that all
accessible surfaces are moistened.
¾Clean the product with a suitable cleaning brush
(FM32800) until all visible residues have been
removed from the surface.
¾Brush through all surfaces that are not accessible
to visual inspection, e.g. in products with hidden
crevices, lumens or complex geometry, for at least
1 min or until no more residues can be removed.
Mobilize non-rigid components, such as set screws,
links, etc. during cleaning.
¾After cleaning, thoroughly rinse through these
components (at least five times) with the cleaning
solution, using a disposable syringe (20 ml).
¾Do not use metal cleaning brushes or other
abrasives that would damage the product surfaces
and could cause corrosion.
Stage II
¾Rinse the product completely (all accessible
surfaces) under running water.
Stage Step T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemical
IDisinfecting
cleaning
RT
(cold)
15 2 D–W BBraun Stabimed; aldehyde
phenol and QAV-free
II Irrigation RT
(cold)
1-D–W-

11
Mechanical alkaline cleaning and thermal disinfecting
Machine type: Single-chamber washer/disinfector without ultrasound
¾Place the product on a tray that is suitable for
cleaning (avoid rinsing blind spots).
¾Connect components with lumens and canals
directly to the special rinsing port of the injector
cart.
¾Keep working ends open during cleaning.
¾Place the product on the tray with all product links
and joints open.
D–W: Drinking water
FD–W: Fully desalinated water (demineralized)
Stage Step T
[°C/°F]
t
[min]
Water
quality
Chemical/Note
IPrerinse <25/77 3 D–W -
II Cleaning 55/131 10 FD–W BBRAUN HELIMATIC CLEANER
alkaline with tensides,
application solution 0.5 %
III Intermediate rinse >10/50 1 FD–W -
IV Thermal disinfecting 90/194 5 FD–W -
VDrying - - - According to disinfector
program

Aesculap Neurosurgery
AVM microclip applying forceps
12
Inspection, maintenance and checks
¾Allow the product to cool down to room
temperature.
¾After each complete cleaning, disinfecting and
drying cycle, check that the product is: dry, clean,
operational, and free of damage (e.g. broken
insulation or corroded, loose, bent, broken, cracked,
worn, or fractured components).
¾Dry the product if it is wet or moist.
¾Repeat cleaning and disinfecting of products that
still show impurities or contamination.
¾Check the product for proper functioning.
¾Immediately sort out damaged or inoperative
products and have them sent to Aesculap Technical
Service, see Technical Service.
¾Assemble the separable product, see Assembling.
¾Check for compatibility with associated products.
Packaging
¾Appropriately protect products with fine working
tips.
¾Store products with ratchet locks fully opened or
locked no further than in the first notch.
¾Close the locks so that the jaw tips just touch each
other.
¾Sort the product into its appropriate storage device
or put it on a suitable tray. Make certain that all
cutting edges are protected.
¾Package trays appropriately for the sterilization
process (e.g. in Aesculap sterile containers).
¾Ensure that the packaging provides sufficient
protection against recontamination of the product
during storage (DIN EN ISO 11607).
Sterilization method and parameters
Note
The product can be sterilized either in disassembled or
in assembled condition.
¾Make certain that all external and internal surfaces
will be exposed to the sterilizing agent (e.g. by
opening all valves and faucets).
¾Validated sterilization process
– Steam sterilization through fractionated vacuum
process
– Steam sterilizer according to DIN EN 285 and
validated according to DIN EN ISO 17665
– Sterilization through fractionated vacuum process
at 134 °C/holding time 5 min
¾When sterilizing several products at the same time
in one steam sterilizer: Make certain that the
maximum allowable load capacity of the steam
sterilizer, as specified by the manufacturer, is not
exceeded.
CAUTION
Damage (metal seizure/friction
corrosion) to the product caused by
insufficient lubrication!
¾Prior to function checks,
lubricate moving parts (e.g.
joints, pusher components and
threaded rods) with
maintenance oil suitable for the
respective sterilization process
(e.g. for steam sterilization:
Aesculap STERILIT® spray JG600
or maintenance oil JG598).

13
Sterilization for the US market
• Aesculap does not recommend the device sterilized
by flash or chemical sterilization.
• Sterilization may be accomplished by steam auto-
clave in a standard prevacuum cycle.
To achieve a sterility assurance level of 10-6, Aesculap
recommends the following parameters:
*Aesculap has validated the above sterilization cycle
and has the data on file. The validation was accom-
plished in an Aesculap Sterilcontainer cleared by FDA
for the sterilization and storage of these instruments.
Other sterilization cycles may also be suitable, how-
ever individuals or hospitals not using the recom-
mended method are advised to validate any alternative
method using appropriate laboratory techniques. Use
an FDA cleared accessory to maintain sterility after
processing, such as a wrap, pouch, etc.
WARNING for the US market
If this device is/was used in a patient with, or sus-
pected of having Creutzfeldt-Jakob Disease (CJD),
the device cannot be reused and must be destroyed
due to the inability to reprocess or sterilize to elim-
inate the risk of crosscontamination.
Storage
¾Store sterile products in germ-proof packaging
under dust protection in a dry, dark and
temperature-controlled room.
Technical Service
¾For service and repairs, please contact your
national B. Braun/Aesculap agency.
Modifications carried out on medical technical
equipment may result in loss of guarantee/warranty
rights and forfeiture of applicable licenses.
Service addresses
Aesculap Technischer Service
Am Aesculap-Platz
78532 Tuttlingen / Germany
Phone: [phone]
Fax: [phone]
E-Mail: [e-mail]
Or in the US:
Aesculap Inc.
Attn. Aesculap Technical Services
615 Lambert Pointe Drive
Hazelwood, MO 63042
Aesculap Repair Hotline
Phone: [phone]
Fax: [phone]
Other service addresses can be obtained from the
address indicated above.
Distributor in the US/Contact in Canada
for product information and complaints
Aesculap Inc.
3773 Corporate Parkway
Center Valley, PA 18034
USA
Aesculap Orga Tray/Sterilcontainer (perforated
bottom)
Minimum cycle parameters*
Sterilization
method
Temp. Time Minimum
drying time
Pre-vacuum 270 °F—
275 °F
4 min 20 min
WARNING
Risk of injury and/or malfunction!
¾Do not modify the product.

Aesculap Neurosurgery
AVM-Mikroclip-Anlegezange
14
Legende
1Maulteil mit Zugstange
2Schaft-Außenrohr
3Schaft
4Drehelement
5Sperrendruckknopf
6Sicherungsknopf
7Branchen links/rechts
8Sperre
9Griffteil
10 AVM-Mikroclip-Anlegezange
Symbole an Produkt und Verpackung
Einsatzgebiet
Die AVM-Mikroclip-Anlegezange wird zum Öffnen und
Schließen von Aesculap AVM-Mikroclips eingesetzt.
Die AVM-Mikroclips werden zur temporären oder per-
manenten Okklusion von kleinen Gefäßen bei arterio-
venösen Missbildungen (AVM) im Gehirn eingesetzt.
Lieferbare Größen
Die AVM-Mikroclip-Anlegezangen sind in unterschied-
lichen Arbeitslängen erhältlich, siehe Prospekt AVM-
Mikroclips.
Sichere Handhabung und Bereitstellung
¾Produkt und Zubehör nur von Personen betreiben
und anwenden lassen, die die erforderliche Ausbil-
dung, Kenntnis oder Erfahrung haben.
¾Gebrauchsanweisung lesen, einhalten und aufbe-
wahren.
¾Produkt nur bestimmungsgemäß verwenden, siehe
Einsatzgebiet.
¾Fabrikneues Produkt nach Entfernung der Trans-
portverpackung und vor der ersten Sterilisation
gründlich reinigen (manuell oder maschinell).
¾Fabrikneues oder unbenutztes Produkt an einem
trockenen, sauberen und geschützten Platz aufbe-
wahren.
¾Produkt vor jeder Verwendung visuell prüfen auf:
lose, verbogene, zerbrochene, rissige, abgenutzte
und abgebrochene Teile.
¾Kein beschädigtes oder defektes Produkt verwen-
den. Beschädigtes Produkt sofort aussortieren.
¾Beschädigte Einzelteile sofort durch Originaler-
satzteile ersetzen.
Bedienung
Symbol Erklärung
Achtung, Begleitdokumente
beachten
WARNUNG
Verletzungsgefahr und/oder Fehl-
funktion!
¾Vor jedem Gebrauch Funktions-
prüfung durchführen.

15
Sperre verriegeln und AVM-Mikroclip anrei-
chen
¾Sperrendruckknopf 5 drücken und gleichzeitig
Branchen links/rechts 7 zusammendrücken.
Die Sperre 8ist verriegelt. Das Maulteil 1 ist bei
verriegelter Sperre 8so eingestellt, dass der AVM-
Mikroclip im Maulteil 1 leicht geklemmt wird.
Abb. 1 Verriegelung der Sperre
Sperre entriegeln und AVM-Mikroclip appli-
zieren
¾Drehelement 4drehen, bis der AVM-Mikroclip die
gewünschte Position erreicht hat.
¾Branchen links/rechts 7 zusammendrücken.
Das Maulteil 1der AVM-Mikroclip-Anlegezange 10
schließt sich und der eingespannte AVM-Mikroclip
öffnet sich.
Die Sperre 8springt zusammen mit dem Sperren-
druckknopf 5 automatisch in die entriegelte Posi-
tion zurück, so dass der AVM-Mikroclip appliziert
werden kann.
¾AVM-Mikroclip auf das Gefäß applizieren.
Abb. 2 Entriegelung der Sperre
AVM-Mikroclip-Anlegezange vom AVM-
Mikroclip lösen
¾Branchen links/rechts 7 entspannen.
Das Maulteil 1öffnet sich und der AVM-Mikroclip
schließt sich.
¾AVM-Mikroclip-Anlegezange 10 vom AVM-Mikro-
clip lösen.
Abb. 3 Lösen der AVM-Mikroclip-Anlegezange
5
7
8
1
5
7
8
43
1
1
7

Aesculap Neurosurgery
AVM-Mikroclip-Anlegezange
16
Demontage
Abb. 4 Drehen des Sicherungsknopfs
¾Sicherungsknopf 6 so weit drehen, bis die in Abb. 4
dargestellte Position erreicht ist.
Abb. 5 Demontage des Schafts
Hinweis
Maulteil mit Zugstange
1 und Schaft-Außenrohr 2
können nicht gleichzeitig aus dem Griffteil 9 entnom-
men werden!
¾Maulteil mit Zugstange 1 aus dem Schaft-Außen-
rohr 2 herausziehen.
¾Schaft-Außenrohr 2 aus dem Griffteil 9 ziehen.
Montage
Abb. 6 Drehen des Sicherungsknopfs
¾Sicherungsknopf 6 in seine Ausgangsposition
zurück drehen, siehe Abb. 6.
VORSICHT
Funktionseinschränkung der AVM-
Mikroclip-Anlegezange durch Ver-
biegen oder Beschädigen einer
Komponente!
¾AVM-Mikroclip-Anlegezange
vorsichtig demontieren.
¾Reihenfolge der Demontage ein-
halten.
6
21
9
VORSICHT
Funktionseinschränkung der AVM-
Mikroclip-Anlegezange durch Ver-
biegen oder Beschädigen einer
Komponente!
¾AVM-Mikroclip-Anlegezange
vorsichtig montieren.
¾Reihenfolge der Montage ein-
halten.
6

17
Abb. 7 Prüfung der Code-Nummern
¾Maulteil mit Zugstange 1bis zum Anschlag in
Schaft-Außenrohr 2 schieben, siehe Abb. 7, und
dabei sicherstellen, dass die korrekte Position des
Maulteils mit Zugstange 1eingehalten wird.
Abb. 8 Einbauposition des Maulteils mit Zugstange
¾AVM-Mikroclip-Anlegezange 10 auf Funktion prü-
fen, siehe Bedienung.
Validiertes Aufbereitungsverfahren
Hinweis
Nationale gesetzliche Vorschriften und nationale und
internationale Normen und Richtlinien und die eigenen
Hygienevorschriften zur Aufbereitung einhalten.
Hinweis
Bei Patienten mit Creutzfeldt-Jakob-Krankheit (CJK),
CJK-Verdacht oder möglichen Varianten bezüglich der
Aufbereitung der Produkte die jeweils gültigen natio-
nalen Verordnungen einhalten.
Hinweis
Der maschinellen Aufbereitung ist aufgrund eines bes-
seren und sichereren Reinigungsergebnisses gegenüber
der manuellen Reinigung der Vorzug zu geben.
Hinweis
Es ist zu beachten, dass die erfolgreiche Aufbereitung
dieses Medizinproduktes nur nach vorheriger Validie-
rung des Aufbereitungsprozesses sichergestellt werden
kann. Die Verantwortung hierfür trägt der Betreiber/
Aufbereiter.
Durch Prozesstoleranzen bedingt, dienen die Angaben
des Herstellers nur als Richtwert für die Beurteilung der
beim Betreiber/Aufbereiter vorhandenen Aufberei-
tungsprozesse.
Hinweis
Aktuelle Informationen zur Aufbereitung siehe auch
Aesculap Extranet unter www.aesculap-extra.net
VORSICHT
Überbeanspruchung der AVM-
Mikroclips durch falsche Kombina-
tion von Maulteil mit Zugstange,
Schaft-Außenrohr und Griffteil!
¾Sicherstellen, dass die Code-
Nummern des Maulteils mit
Zugstange, des Schaft-Außen-
rohrs und des Griffteils überein-
stimmen.
¾Schaft-Außenrohr vollständig in
Griffteil stecken.
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Aesculap Neurosurgery
AVM-Mikroclip-Anlegezange
18
Allgemeine Hinweise
Zur Vermeidung einer verstärkten Kontamination des
bestückten Instrumententrays bei der Anwendung
bereits darauf achten, dass verschmutzte Instrumente
getrennt gesammelt und nicht wieder in das Instru-
mententray gelegt werden.
Angetrocknete bzw. fixierte OP-Rückstände können
die Reinigung erschweren bzw. unwirksam machen
und bei nicht rostendem Stahl zu Korrosion führen.
Demzufolge sollten ein Zeitraum zwischen Anwendung
und Aufbereitung von 6 h nicht überschritten, keine
fixierenden Vorreinigungstemperaturen >45 °C ange-
wandt und keine fixierenden Desinfektionsmittel
(Wirkstoffbasis: Aldehyd, Alkohol) verwendet werden.
Überdosierte Neutralisationsmittel oder Grundreiniger
können zu einem chemischen Angriff und/oder zur
Verblassung und visuellen oder maschinellen Unles-
barkeit der Laserbeschriftung bei nicht rostendem
Stahl führen.
Bei nicht rostendem Stahl führen Chlor- bzw. chlorid-
haltige Rückstände, z. B. in OP-Rückständen, Arznei-
mitteln, Kochsalzlösungen, im Wasser zur Reinigung,
Desinfektion und Sterilisation zu Korrosionsschäden
(Lochkorrosion, Spannungskorrosion) und somit zur
Zerstörung der Produkte. Zur Entfernung muss eine
ausreichende Spülung mit vollentsalztem Wasser mit
anschließender Trocknung erfolgen.
Es dürfen nur Prozess-Chemikalien eingesetzt werden,
die geprüft und freigegeben sind (z. B. VAH/DGHM-
oder FDA-Zulassung bzw. CE-Kennzeichnung) und vom
Chemikalienhersteller hinsichtlich Materialverträg-
lichkeit empfohlen wurden. Sämtliche Anwendungs-
vorgaben des Chemikalienherstellers über Temperatur,
Konzentration und Einwirkzeit sind strikt einzuhalten.
Im anderen Fall kann dies zu nachfolgenden Problemen
führen:
• optische Materialveränderungen, wie z. B. Verblas-
sen oder Farbveränderungen bei Titan oder Alumi-
nium. Bei Aluminium können sichtbare Oberflä-
chenveränderungen bereits bei einem pH-Wert von
>8 in der Anwendungs-/Gebrauchslösung auftre-
ten.
• Materialschäden, wie z. B. Korrosion, Risse, Brüche,
vorzeitige Alterung oder Quellung.
¾Keine Prozesschemikalien verwenden, die bei
Kunststoffen zu Spannungsrissen oder Versprö-
dung führen.
¾Weitere detaillierte Hinweise zu einer hygienisch
sicheren und materialschonenden/werterhalten-
den Wiederaufbereitung, siehe
www.a-k-i.org Rubrik Veröffentlichungen Rote
Broschüre - Instrumentenaufbereitung richtig
gemacht.
¾Bei Nassentsorgung geeignete Reinigungs-/Desin-
fektionsmittel verwenden. Um Schaumbildung und
Verschlechterung der Wirksamkeit der Prozessche-
mie zu vermeiden: Vor maschineller Reinigung und
Desinfektion Produkt gründlich mit fließendem
Wasser spülen.