Braun Aesculap S4 User manual

Aesculap Spine
Gebruiksaanwijzing
S4percutaan-instrumenten
Инструкция по примению
S4инструменты для чрескожных
вмешательств
Návod k použití
S4Perkutánní nástroje
Instrukcja u¿ytkowania
S4Instrumenty przezskórne
Instructions for use
S4percutaneous instruments
Gebrauchsanweisung
S4perkutan-Instrumente
Mode d’emploi
Instruments percutanés S4
Instrucciones de manejo
Instrumentos percutáneos S4
Istruzioni per l’uso
S4strumenti percutanei
Instruções de utilização
Instrumentos percutâneos S4

6
7
5
4
3
2
1

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percutaneous instruments
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Legend
1Cleaning instrument FW692R
2Clamping sleeve FW693R
3Inner sleeve FW694R
4Screwdriver FW695R
(for polyaxial S4screws)
5Screwdriver FW696R
(for monoaxial S4screws)
6Axial spacer FW143P
7Insertion instrument for locking screws FW697R
Symbols on product and packages
Intended use
S4percutaneous instruments are used for the implan-
tation of cannulated S4implants of the S4Spinal Sys-
tem in percutaneous operating technique.
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 for its intended purpose, see
Intended use.
¾Remove the transport packaging and thoroughly
clean the new product, either manually or mechan-
ically, 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 compo-
nents.
¾Do not use the product if it is damaged or defec-
tive. Set aside the product if it is damaged.
¾Replace any damaged components immediately
with original spare parts.
¾Read, observe and keep the operating manuals for
S4Spinal System Instrumentation, S4FRI and, if
applicable, S4SRI.
Safe operation
Symbol Explanation
Caution, general warning symbol
Caution, see documentation sup-
plied with the product
Date of manufacture DANGER
Danger of death of the patient
caused by pushing the guide wire
into the aorta!
¾When inserting the S4implants
or S4instruments with the
guide wire, always observe the
markings on the guide wire.
¾Hold the guide wire with a for-
ceps.
¾Remove the guide wire at the
right moment.
WARNING
Risk of injury and/or malfunction!
¾Always carry out a function
check prior to using the prod-
uct.

3
Cleaning instrument FW692R
The cleaning instrument is used for cleaning/clearing
the cannulation, if a cannulated instrument becomes
blocked intra-operatively with soft tissue or bone
chips.
¾Disassemble the instrument as far as possible on a
separate sterile table, if applicable, see Disassem-
bling.
¾Carefully insert the cleaning instrument into the
cannulation from the handle side in the direction
of the working end.
¾Remove the obstruction by applying mild pressure
with the handle part. Ensure that the cannulation
does not become occluded.
¾Assemble the instrument, if applicable, see Assem-
bling.
Clamping sleeve FW693R and screwdriver
FW695R/FW696R
Screwdrivers facilitate the percutaneous application of
pedicle screws from the S4Spinal System. Depending
on the type of screw, the corresponding screwdriver for
monoaxial or polyaxial screws must be chosen.
¾Assemble the clamping sleeve, see Assembling.
Inserting the pedicle screws in the clamping sleeve
¾Turn fixing screw Cin the direction of the arrow
until the thread in the direction of the working end
becomes visible, see Fig. 1.
Fig. 1
¾Pull back outer sleeve Aas far as possible in the
direction of fixing screw C, see Fig. 2.
Fig. 2
¾Insert screwdriver Finto clamping sleeve 2from
the rear end. Ensure that the lateral lugs slide into
the grooves right to the bottom, see Fig. 3.
Fig. 3
WARNING
Risk of injury if cannulated instru-
ments are punctured with the
cleaning instrument!
¾Remove the obstruction care-
fully with mild pressure.
¾Always insert the cleaning
instrument in the direction of
the working end.
¾Do not obstruct the outlet with
your hand.
CAUTION
Damage to cannulated instruments
if the cleaning instrument is incor-
rectly applied!
¾Always insert the cleaning
instrument in the direction of
the working end.
¾Check the cleaning instrument
for bending, kinks and other
damage before use.
C
CA
F

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percutaneous instruments
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¾Insert the working ends of the pedicle screws into
tension sleeve B, see Fig. 4.
When using polyaxial pedicle screws: Ensure that
the hexagon of the screwdriver is fully inserted in
the hexagon of the polyaxial pedicle screw.
When using monoaxial pedicle screws: Ensure
that the dihedron sits securely in the screw head.
Fig. 4
¾Slide outer sleeve Ain the direction of the pedicle
screw and with fixing screw Cclamp pedicle screw
in clamping sleeve 2, see Fig. 5.
¾Check to ensure that the implant is properly seated
in the clamping sleeve 2.
Fig. 5
¾For implanting the pedicle screw and inserting the
rod, see operating technique or operating manual
for the S4Spinal System, S4FRI and S4SRI.
Removing the clamping sleeve from the applied
pedicle screw
¾Turn fixing screw Cin the direction of the arrow
until the thread in the direction of the working end
becomes visible, see Fig. 6.
Fig. 6
¾Pull back outer sleeve Ain the direction of fixing
screw C.
¾Completely remove clamping sleeve 2, see Fig. 7.
Fig. 7
Disassembling
Clamping sleeve FW693R
¾Remove outer sleeve Aover collet Bin the direc-
tion of the working end.
¾Unscrew fixing screw Cfrom the rear end and
remove from collet B, see Fig. 8.
Fig. 8
Inner sleeve FW694R
¾Unscrew nut Dfrom inner sleeve E, see Fig. 9.
Fig. 9
B
C
C
CA
CB
BA
E D

5
Assembling
Clamping sleeve FW693R
¾Screw fixing screw Conto collet Buntil the thread
of the collet is no longer visible.
¾Push on outer sleeve Afrom the front end over col-
let B, see Fig. 10. Ensure that the slots are aligned
with the slot nuts. The grooved end of the clamping
sleeve should point in the direction of fixing
screw Cfor improved usability.
Fig. 10
Inner sleeve FW694R
¾Screw nut Donto inner sleeve E, see Fig. 11.
Fig. 11
Validated reprocessing procedure
Note
National laws, national and international standards
and directives, and product-specific hygiene regula-
tions for reprocessing 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 products.
Note
Mechanical reprocessing should be favored over man-
ual 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 method. The operator/
sterile processing technician is responsible for this.
Note
Up-to-date information on reprocessing can be found
on the Aesculap Extranet at www.aesculap-extra.net
B
CB
A
E D

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percutaneous instruments
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General information
To prevent increased contamination of loaded instru-
ment trays during use, please ensure that contami-
nated 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. Consequently, the time interval
between application and processing should not exceed
6 hours, pre-cleaning fixating temperatures >45 °C
should not be used, and no fixating disinfectants (con-
taining aldehydes/alcohols) should be used.
Excessive measures of neutralizing agents or basic
cleaners may result in a chemical attack and/or to fad-
ing and the laser marking becoming unreadable visu-
ally or by machine for stainless steel.
Residues containing chlorine or chloride - e.g. in surgi-
cal 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
demineralized water and then drying.
Only use process chemicals that have been tested and
approved (with VAH, DGHM or FDA approval, for
instance, or feature a CE mark) and are recommended
by the chemical manufacturer as being compatible
with the materials. All the chemical manufacturer's
application specifications regarding temperature, con-
centration 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 corrosion, cracks, frac-
tures, premature deterioration or swelling.
¾Do not use process chemicals that cause stress
cracks or brittleness in plastics.
¾Clean the product immediately after use.
Please see www.a-k-i.org for more detailed informa-
tion on hygienically safe reprocessing which is protec-
tive of materials and retains their value.
¾Use 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 disinfection, rinse the product thoroughly with
running water.

7
Preparation at the place of use
¾Disassemble the product immediately after use, as
described in the respective instructions for use.
¾Rinse non-visible surfaces such as those in instru-
ments with concealed crevices, lumens or complex
geometries, preferably with distilled water, using a
disposable syringe for instance.
¾Remove any visible surgical residues to the extent
possible with a damp, lint-free cloth.
¾Transport the dry product in a sealed waste con-
tainer for cleaning and disinfection within 6 hours.
Preparation before cleaning
¾Disassemble the product prior to cleaning, see Dis-
assembling.
Cleaning/disinfection
¾Carry out ultrasound cleaning:
– as an effective mechanical supplement to man-
ual cleaning/disinfection.
– as a pre-cleaning procedure for products with
encrusted residues, in preparation for mechanical
cleaning/disinfection.
– as an integrated mechanical support measure for
mechanical cleaning/disinfection.
– for additional cleaning of products with residues
left after mechanical cleaning/disinfection.
Manual cleaning/disinfection
¾Prior to manual disinfecting, allow water to drip off
for a sufficient length of time to prevent dilution of
the disinfecting solution.
¾After manual cleaning/disinfection, check visible
surfaces visually for residues.
¾Repeat the cleaning process if necessary.
CAUTION
Damage to the product due to
inappropriate cleaning/disinfecting
agents and/or excessive tempera-
tures!
¾Use cleaning and disinfecting
agents approved for aluminum,
plastics, and high-grade
steel, for example, according to
the manufacturer's instructions.
¾Observe specifications regarding
concentration, temperature and
exposure time.

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Manual cleaning with immersion disinfection
D–W: Drinking water
FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at
least)
RT: Room temperature
Phase I
¾Fully immerse the product in the cleaning/disin-
fecting solution for at least 15 minutes. Ensure
that all accessible surfaces are moistened.
¾Clean the instrument under running tap water with
a suitable cleaning brush where necessary for as
long as it takes to remove all discernable residues.
¾Brush through all surfaces not accessible to visual
inspection, e.g. in products with hidden crevices,
lumens or complex geometries, for at least 1 min or
until no more residues can be removed, using a
suitable cleaning brush (TA007747 or TE654202).
¾Maneuver non-rigid components, such as adjust-
able screws, hinges etc during cleaning.
¾Then flush these areas thoroughly at least five
times with the cleaning solution using a disposable
syringe (20 ml).
¾Do not use metal cleaning brushes or other abra-
sives that would damage the product surfaces and
could cause corrosion.
Phase II
¾Rinse/flush the instrument thoroughly (all accessi-
ble surfaces) under running water.
¾Maneuver non-rigid components, such as adjust-
able screws, hinges, etc. during rinsing.
¾Drain any remaining water fully.
Phase Step T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemical
ICleaning RT
(cold)
>15 2 D–W BBraun Stabimed; aldehyde-free,
phenol-free and QUAT-free
II Intermediate
rinse
RT
(cold)
1-D–W-
III Disinfection RT
(cold)
15 2 D–W BBraun Stabimed; aldehyde-free,
phenol-free and QUAT-free
IV Final rinse RT
(cold)
1-FD-W-
VDrying RT - - - -

9
Phase III
¾Fully immerse the instrument in the disinfectant
solution.
¾Maneuver non-rigid components, such as adjust-
able screws, hinges, etc. during disinfection.
¾Rinse the lumens at least five times at the begin-
ning of the contact period using a disposable
syringe (20 ml) and a suitable irrigation adapter.
Ensure that all accessible surfaces are moistened.
¾Drain any remaining water fully.
Phase IV
¾Rinse/flush the instrument thoroughly (all accessi-
ble surfaces).
¾Maneuver non-rigid components, such as adjust-
able screws, hinges, etc. during final rinse.
¾Rinse the lumens at least five times using a dispos-
able syringe (20 ml) and a suitable irrigation
adapter.
¾Drain any remaining water fully.
Phase V
¾Dry the instrument with a lint-free cloth or medical
compressed air.
Mechanical cleaning/disinfecting
Cleaning instrument FW692R and insertion instru-
ment for locking screws FW697R only
Note
The disinfector must be of proven effectiveness
(e.g. DGHM or FDA approval or CE mark).
Note
For thermal disinfection, always use fully desalinated
water (demineralized, low microbial contamination:
drinking water quality at least) and ensure that Ao is
>3 000 for the process.
Note
The disinfector used for processing must be serviced
and checked at regular intervals.
¾Place the instrument in a tray that is suitable for
cleaning (avoiding rinsing blind spots).
¾Connect components with lumens and channels
directly to the rinsing port of the injector carriage.
¾Keep working ends open for cleaning.
¾Place instruments in the tray with their hinges
open.

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Mechanical alkaline cleaning and thermal disinfection
Machine type: Single-chamber cleaning/disinfection device without ultrasound
D–W: Drinking water
FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at
least)
Mechanical cleaning/disinfection with manual pre-cleaning
Clamping sleeve FW693R, inner sleeve FW694R, screwdriver FW695R and FW696R and axial spacer
FW143P
Note
The disinfector must be of tested and approved effec-
tiveness (e.g. DGHM or FDA approval or CE mark
according to DIN EN ISO 15883).
Note
For thermal disinfection, always use fully desalinated
water (demineralized, low microbial contamination:
drinking water quality at least) and ensure that Ao is
>3 000 for the process.
Note
The disinfector used for processing must be serviced
and checked at regular intervals.
Phase 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 alcaline
with tensides, application solution 0.5%
III Intermediate rinse >10/50 1 FD-W -
IV Thermal disinfec-
tion
90/194 5 FD-W -
VDrying - - - According to disinfector program

11
Manual pre-cleaning with a brush
D–W: Drinking water
RT: Room temperature
Phase I
¾Fully immerse the product in the cleaning/disin-
fecting solution for at least 15 minutes. Ensure
that all accessible surfaces are moistened.
¾Clean the product with a suitable cleaning brush
until all discernable residues have been removed.
¾Brush through all surfaces not accessible to visual
inspection, e.g. in products with hidden crevices,
lumens or complex geometries, for at least 1 min or
until no more residues can be removed, using a
suitable cleaning brush (TA007747 or TE654202).
¾Maneuver non-rigid components, such as adjust-
able screws, hinges 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 abra-
sives that would damage the product surfaces and
could cause corrosion.
Phase II
¾Rinse/flush the instrument thoroughly (all accessi-
ble surfaces) under running water.
¾Maneuver non-rigid components, such
as adjustable screws, hinges, etc. during rinsing.
Phase Step T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemical
IDisinfectant
Cleaning
RT
(cold)
>15 2 D–W BBraun Stabimed; aldehyde-free,
phenol-free and QUAT-free
II Rinsing RT
(cold)
1-D–W-

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Mechanical alkaline cleaning and thermal disinfection
Machine type: Single-chamber cleaning/disinfection
device without ultrasound
¾Place the instrument in a tray that is suitable for
cleaning (avoiding rinsing blind spots).
¾Connect components with lumens and channels
directly to the rinsing port of the injector carriage.
¾Keep working ends open for cleaning.
¾Place instruments in the tray with their hinges
open.
D–W: Drinking water
FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at
least)
Phase 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
disinfection
90/194 5 FD-W -
VDrying - - - According to disinfector program

13
Inspection, maintenance and checks
¾Allow the product to cool down to room tempera-
ture.
¾After each complete cleaning, disinfecting and dry-
ing cycle, check that the instrument is dry, clean,
operational, and free of damage (e.g. broken insu-
lation or corroded, loose, bent, broken, cracked,
worn or fractured components).
¾Dry the product if it is wet or damp.
¾Repeat cleaning and disinfection of products that
still show impurities or contamination.
¾Check that the product functions correctly.
¾Immediately put aside damaged or inoperative
products and send them to Aesculap Technical Ser-
vice, see Technical Service.
¾Assemble dismountable instruments, see Assembly.
¾Check for compatibility with associated products.
Packaging
¾Place the product in its holder or on a suitable tray.
Ensure 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 pro-
tection against recontamination of the product
during storage (DIN EN ISO 11607).
Sterilization
Note
The product may only be sterilized when dismantled.
¾Ensure that the sterilant can reach all external and
internal surfaces (e.g. by opening valves and stop-
cocks).
¾Validated sterilization process
– Disassemble the instrument.
– Steam sterilization through fractionated vacuum
process
– Steam sterilizer specified in DIN EN 285 and val-
idated in accordance with DIN EN ISO 17665
– Sterilization using fractionated vacuum process
at 134 °C/holding time 5 min
¾When sterilizing several instruments at the same
time in a steam sterilizer, ensure that the maxi-
mum permitted load specified by the manufacturer
for the steam sterilizer is not exceeded.
CAUTION
Damage (metal seizure/friction cor-
rosion) to the product caused by
insufficient lubrication!
¾Prior to function checks, lubri-
cate moving parts (e.g. joints,
pusher components and
threaded rods) with mainte-
nance oil suitable for the
respective sterilization process
(e.g. for steam sterilization:
Aesculap STERILIT® I oil spray
JG600 or STERILIT® I drip lubri-
cator JG598).

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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 sterile container 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.
Storage
¾Store sterile products in germ-proof packaging,
protected from dust, in a dry, dark, temperature-
controlled area.
Technical Service
¾For service and repairs, please contact your
national B. Braun/Aesculap agency.
Modifications carried out on medical technical equip-
ment 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 Implant Systems LLC
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.
Disposal
¾Adhere to national regulations when disposing of
or recycling the product, its components and its
packaging!
Aesculap Orga Tray/sterile container (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.

15
Distributor in the US/Contact in Canada
for product information and complaints
Aesculap Implant Systems LLC
3773 Corporate Parkway
Center Valley, PA 18034
USA

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perkutan-Instrumente
16
Legende
1Reinigungsinstrument FW692R
2Klemmhülse FW693R
3Innenhülse FW694R
4Schraubendreher FW695R
(für polyaxiale S4Schrauben)
5Schraubendreher FW696R
(für monoaxiale S4Schrauben)
6Abstandshalter axial FW143P
7Einsetzinstrument für Verriegelungsschrauben
FW697R
Symbole an Produkt und Verpackung
Verwendungszweck
S4perkutan-Instrumente werden zur Implantation von
kanülierten S4-Implantaten des S4Spinal Systems in
perkutaner Operationstechnik verwendet.
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
Verwendungszweck.
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.
¾OP-Manuals S4Spinal System-Instrumentierung,
S4FRI und ggf. S4SRI lesen, einhalten und aufbe-
wahren.
Bedienung
Symbol Erklärung
Achtung, allgemeines Warnzei-
chen
Achtung, Begleitdokumente
beachten
Herstelldatum
GEFAHR
Lebensgefahr für den Patienten
durch Vorschieben des Führungs-
drahts in die Aorta!
¾Beim Einbringen von S4-Implan-
taten bzw. S4-Instrumenten
über den Führungsdraht Mar-
kierungen am Führungsdraht
beachten.
¾Führungsdraht mit einer Zange
festhalten.
¾Führungsdraht rechtzeitig ent-
nehmen.
WARNUNG
Verletzungsgefahr und/oder Fehl-
funktion!
¾Vor jedem Gebrauch Funktions-
prüfung durchführen.

17
Reinigungsinstrument FW692R
Das Reinigungsinstrument wird zum Reinigen/Freiräu-
men der Kanülierung verwendet, wenn ein kanüliertes
Instrument intra-operativ mit Weichteilgewebe oder
Knochenspänen verstopft ist.
¾Instrument auf separatem Steriltisch so weit mög-
lich demontieren, ggf. siehe Demontage.
¾Reinigungsinstrument von Handgriffseite in Kanü-
lierung vorsichtig in Richtung Arbeitsende einfüh-
ren.
¾Verstopfung durch leichten Druck mit dem Griff-
stück entfernen. Dabei darauf achten, dass die
Kanülierung nicht verschlossen wird.
¾Instrument montieren, ggf. siehe Montage.
Klemmhülse FW693R und Schraubendreher
FW695R/FW696R
Schraubendreher erleichtern das perkutane Einbringen
von Pedikelschrauben aus dem S4Spinal System. Je
nach Schraubenart muss der entsprechende Schrau-
bendreher für mono- oder polyaxiale Schrauben
gewählt werden.
¾Klemmhülse zusammensetzen, siehe Montage.
Pedikelschrauben in Klemmhülse einsetzen
¾Klemmschraube Cso weit in Pfeilrichtung zurück-
drehen, bis das Gewinde Richtung Arbeitsende
sichtbar wird, siehe Abb. 1.
Abb. 1
¾Außenhülse Aso weit wie möglich Richtung
Klemmschraube Czurückziehen, siehe Abb. 2.
Abb. 2
¾Schraubendreher Fvon hinten in Klemmhülse 2
einführen. Dabei darauf achten, dass die seitlichen
Zapfen in die Nuten bis zum Grund gleiten, siehe
Abb. 3.
Abb. 3
WARNUNG
Verletzungsgefahr beim Durchstos-
sen von kanülierten Instrumenten
mit dem Reinigungsinstrument!
¾Verstopfung vorsichtig mit
leichtem Druck lösen.
¾Reinigungsinstrument immer
Richtung Arbeitsende einführen.
¾Austrittsöffnung nicht mit der
Hand verschließen.
VORSICHT
Beschädigung von kanülierten
Instrumenten durch fehlerhafte
Anwendung des Reinigungsinstru-
ments!
¾Reinigungsinstrument immer
Richtung Arbeitsende einführen.
¾Reinigungsinstrument vor der
Anwendung auf Biegung,
Knickung oder anderweitige
Beschädigung untersuchen.
C
CA
F

Aesculap Spine
S
4
perkutan-Instrumente
18
¾Pedikelschrauben am Arbeitsende in Spannhülse B
einführen, siehe Abb. 4.
Bei polyaxialen Pedikelschrauben: Sicherstellen,
dass der Sechskant des Schraubendrehers vollstän-
dig im Sechskant der polyaxialen Pedikelschraube
eingeführt ist.
Bei monoaxialen Pedikelschrauben: Sicherstellen,
dass der Zweiflach sicher im Schraubenkopf sitzt.
Abb. 4
¾Außenhülse ARichtung Pedikelschraube schieben
und mit Klemmschraube CPedikelschraube in
Klemmhülse 2festklemmen, siehe Abb. 5.
¾Sicheren Sitz des Implantats in der Klemmhülse 2
prüfen.
Abb. 5
¾Zum Implantieren der Pedikelschraube und Einset-
zen des Stabs, siehe OP-Technik bzw. OP-Manual
des S4Spinal Systems, S4FRI und S4SRI.
Klemmhülse von gesetzter Petikelschraube abneh-
men
¾Klemmschraube Cso weit in Pfeilrichtung zurück-
drehen, bis das Gewinde Richtung Arbeitsende
sichtbar wird, siehe Abb. 6.
Abb. 6
¾Außenhülse ARichtung Klemmschraube Czurück-
ziehen.
¾Kpl. Klemmhülse 2abnehmen, siehe Abb. 7.
Abb. 7
Demontage
Klemmhülse FW693R
¾Außenhülse Aüber die Spannzange Bin Richtung
Arbeitsende abziehen.
¾Klemmschraube Cnach hinten abschrauben und
von Spannzange Bentfernen, siehe Abb. 8.
Abb. 8
Innenhülse FW694R
¾Mutter Dvon Innenhülse Eabschrauben, siehe
Abb. 9.
Abb. 9
B
C
C
CA
CB
BA
E D