Braun Aesculap activ C Manual

Aesculap Spine
activ C
Instructions for use/Technical description
Distraction set with lockable distraction screws
Gebrauchsanweisung/Technische Beschreibung
Distraktions-Set mit verriegelbaren Distraktions-
schrauben
Mode d’emploi/Description technique
Kit de distraction avec vis de distraction verrouillables
Instrucciones de manejo/Descripción técnica
Juego de distracción con tornillos de distracción
bloqueables
Istruzioni per l’uso/Descrizione tecnica
Set da distrazione con viti da distrazione bloccabili
Instruções de utilização/Descrição técnica
Kit de distracção com parafusos de distracção
bloqueáveis
Gebruiksaanwijzing/Technische beschrijving
Distractieset met vergrendelbare distractieschroeven
Návod k použití/Technický popis
Distrakèní set se zamykatelnými distrakèními šrouby

Aesculap Spine
Distraction set with lockable distraction screws
2
Legend
1activ C distractor for lockable distraction screws,
right
2activ C distractor for lockable distraction screws,
left
3activ C screwdriver for lockable distraction screws
4activ C lockable offset distraction screw
5Hexagon
6Sheath
7activ C lockable distraction screw
8Flap screw
9Ratchet lever
10 Toothed rack
11 Guide
12 Distraction arm (at guide)
13 Buttons (for locking and release)
14 Distraction arm (at toothed rack)
Figure captions
AIllustration on fold-out page
BIllustration on fold-out page
CIllustration on fold-out page
Symbols on product
Intended use
The activ C distractor for lockable distraction screws is
used in combination with the corresponding activ C
lockable distraction screws for parallel distraction of
adjacent vertebral bodies in the cranial section for the
purpose of extending the height of the intervertebral
space.
Sterilization using irradiation
Not for reuse in intended appli-
cations as defined by the manu-
facturer
Use by
Attention, see instructions for
use

3
Available sizes Safe handling and preparation
CAUTION
Federal law restricts this device to sale by or on
order of a physician!
¾Read, follow and keep the instructions for use.
¾Follow the instructions for use of activ C interver-
tebral disk prosthesis TA011995.
¾Follow the operating manual (O31302).
¾Use the product only in accordance with its
intended use, see Intended use.
¾Clean the new product either manually or mechan-
ically prior to the 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.
¾To avoid damage to the working tip: Exercise cau-
tion when passing products through the working
channel (e.g. trocars).
The product is gamma-sterilized and supplied in sterile
packaging.
The product must not be reused.
¾Do not use products from open or damaged sterile
packaging.
¾Do not re-sterilize the product.
¾Do not use the product after its use-by date.
Art.-no. Designation
FW848R activ C distractor for lockable
distraction screws, right
FW849R activ C distractor for lockable
distraction screws, left
FW850R activ C distraction screwdriver
for lockable distraction screws
FW851SU activ C lockable offset distrac-
tion screw, 12 mm
FW852SU activ C lockable offset distrac-
tion screw, 14 mm
FW853SU activ C lockable offset distrac-
tion screw, 16 mm
FW854SU activ C lockable offset distrac-
tion screw, 18 mm
FW855SU activ C lockable
distraction screw, 16 mm
FW856SU activ C lockable
distraction screw, 18 mm
FW861SU activ C lockable
distraction screw, 12 mm
FW862SU activ C lockable
distraction screw, 14 mm

Aesculap Spine
Distraction set with lockable distraction screws
4
Safe operation
In the text below, the following short designations are
used for the product components:
• activ C distractor for lockable distraction screws is
referred to as “distractor”
• activ C distraction screwdriver for lockable distrac-
tion screws is referred to as “distraction screw-
driver”
• activ C lockable distraction screws are referred to
as “distraction screws”
• activ C lockable offset distraction screws are
referred to as “offset distraction screws”
Note
Any application of the distraction screw includes the
application of the offset distraction screw, if the latter
is not mentioned explicitly!
Applying the distraction screw
Fig. 1 Distraction screwdriver with distraction screw
and offset distraction screw

5
Note
For very small vertebral bodies, offset distraction
screws must be used to ensure that there is sufficient
space for the implantation instruments!
¾Choose distraction screw 7or offset distraction
screw 4.
¾Insert distraction screw 7or offset distraction
screw 4in distraction screwdriver 3.
¾Place distraction screwdriver 3on hexagon 5of
distraction screw 7and make sure it engages.
¾Check the self-holding function of distraction
screw 7in distraction screwdriver 3.
- or -
¾Install distraction screwdriver 3on hexagon 5of
offset distraction screw 4, making sure that it
engages.
Inserting the distraction screw into the vertebral
body under X-ray control
Fig. 2
Note
For very small vertebral bodies, offset distraction
screws must be used to ensure that there is sufficient
space for the implantation instruments!
¾Position and screw in distraction screw 7/offset
distraction screw 4at the center of the vertebral
body.
¾Remove distraction screwdriver 3from distraction
screw 7/offset distraction screw 4.
WARNING
Compression of, or damage to the
spinal canal due to selection of a
distraction screw of excessive
length!
¾Use the radiographic image to
determine the correct length of
the distraction screw according
to the vertebral body.
¾Always maintain x-ray control
when applying the distraction
screw.

Aesculap Spine
Distraction set with lockable distraction screws
6
¾Apply second distraction screw 7/offset distraction
screw 4, ensuring the parallel positioning of dis-
traction screw 7/offset distraction screw 4.
Mounting the distractor and applying the distrac-
tion, see Fig. A/B
¾Select distractor right 1or distractor left 2.
¾Turn flap screw 8to transfer the distance of paral-
lel distraction screws 4/7to distraction arms 12/
14.
The distance of distraction arms 12/14 corre-
sponds to the distance of distraction screws 4/7.
¾Mount distractor right 1or distractor left 2on par-
allel distraction screws 4/7 so that they click into
position.
¾Distract with the distraction forceps.
¾While distracting with the distraction forceps,
extend distractor right 1or distractor left 2by
turning flap screw 8.
¾Once the distraction process carried out with the
distraction forceps is complete, lock distractor
right 1or distractor left 2and hold the vertebrae
in the distracted position.
Removing the distractor, see Fig. C
¾To release the distraction after the implantation in
the intervertebral space, press ratchet lever 9at
the distractor.
Distraction arms 12/14 move towards each other.
The distractor is fully released from any load.
¾Press buttons 13 at the side of distraction arm 12/
14 and slide off the distractor from distraction
screws 4/7.
¾Remove distraction screws 4/7 from the vertebrae,
using distraction screwdriver 3.
Disassembling
Disassembling the distractor, see Fig. C
¾Pull distraction arm 12 (labeled "RIGHT/LEFT")
along toothed rack 10 until toothed rack 10 is not
seated in guide 11 anymore.
Assembling
Assembling the distractor, see Fig. C
Note
Combine distraction arm
12 labeled "RIGHT" only with
distraction arm
14 labeled "FW848R"!
Combine distraction arm
12 labeled "LEFT" only with
distraction arm
14 labeled "FW849R"!
¾Push the ratchet lever 9.
¾Mount distraction arm 12 (labeled "RIGHT/LEFT")
with guide 11 on the toothed rack, ensuring the
correct orientation of distraction arms 12/14.
WARNING
Risk of loosening/tear-out of the
distraction screws when distracting
with the distractor and the distrac-
tion screws!
¾Use the distraction forceps for
the distraction process.
¾Do not use the distractor and
the distraction screws for the
actual distraction process.
¾Lock the distractor in extended
condition.
WARNING
Irritation of the facet joints/strain
on spinal cord and nerve roots due
to excessive distraction!
¾Extend the distraction forceps
slowly and carefully under X-ray
control.
¾Observe the tactile response.
¾Use the heights of adjacent
(healthy) disks as a guide for
the required degree of distrac-
tion.

7
Validated processing procedure
Note
Observe all relevant national regulations and standards
with regard to 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 through a validated processing procedure.
The user/processor is responsible for the validation.
Due to process tolerances, manufacturer’s
specifications can only serve as guide values for the
processing procedures applied by the individual user.
Note
Up-to-date information on processing can be found on
the Aesculap Extranet at www.aesculap-extra.net
Single-use products
General notes
Encrusted or fixated residues from surgery can make
the cleaning process more difficult or ineffective, and
can cause corrosion of “stainless” steels. Consequently
the time interval between application and processing
should not exceed 6 h, and neither potentially fixating
pre-cleaning temperatures > 45 °C nor any fixating
disinfecting agents (active ingredient: aldehyde,
alcohol) should be used.
Excessive doses of neutralizers or basic detergents can
cause chemical deterioration and/or fading of the laser
engraving on stainless steel.
Residues containing chlorine or chlorides, as found e.g.
in surgical residues, tinctures, medicines, saline
solutions, service water used for cleaning, and in
cleaning/disinfecting agents, cause corrosion damage
(pitting, stress corrosion) and thereby destruction of
stainless steel products. To remove such residues, the
products must be rinsed sufficiently with fully
desalinated water and dried thoroughly.
Only use process chemicals recommended by the
chemicals’ manufacturers as effective cleaning/
disinfecting agents compatible with the materials used
in the respective product. Strictly observe all
application instructions, e.g. regarding temperatures,
concentrations, exposure times, etc. Failure to do so
can result in the following problems:
• Optical changes to the material, e.g. fading or
discoloration of titanium or aluminum. For
aluminum, the application/process solution only
needs to be of pH > 8 to cause visible surface
changes or
• Material damage, e.g. corrosion, cracks, fracturing,
premature aging or swelling.
• Do not use oxidizing process chemicals, which
could cause bleaching/layer loss of the product.
WARNING
Breakage of distraction screws/
offset distraction screws due to
reuse!
¾The distraction screws/offset
distraction screws are intended
for single use only.
CAUTION
Possible damage to or destruction
of products, due to processing!
Intended use: These products have
been designed for single use only.
¾Do not reprocess these products.

Aesculap Spine
Distraction set with lockable distraction screws
8
• Do not use process chemicals that cause stress
cracking of plastics such as PPSU, or attack and
cause brittleness e.g. of silicone softeners.
¾Clean the product immediately after use.
Encrusted debris on HF instruments is softened
most effectively and conservatively by a 5 minutes
immersion treatment in a 3 % H2O2solution.
Encrustations can be removed by hand, with a soft
brush and/or in an ultrasound bath. After that
treatment, proceed through the normal steps of
processing.
¾Further detailed advice on hygienically safe and
material-/value-preserving reprocessing can be
found at www.a-k-i.org, Publications, Red
Brochure – Proper maintenance of instruments.
¾Use suitable cleaning/disinfecting agents if the
product is put away in wet condition. Prior to
mechanical cleaning and disinfecting, rinse the
product thoroughly with running water.
Preparations at the place of use
¾Disassemble the product immediately after use, as
described in the respective instructions for use.
¾Remove visible residues as completely as possible,
using a lint-free, single-use cleaning tissue.
Preparation prior to cleaning
¾Have the product dry in a disposal container and
ready for immediate cleaning and disinfecting
within 30 min after use.
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.
Manual cleaning/disinfecting
¾Clean hinged or jointed products in open and
closed positions.
¾Check visible surface for residues 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 a cleaning and disinfecting
agent according to the
manufacturer’s instructions. The
cleaning and disinfecting agent
- must be approved for the
product materials (e.g.
aluminum, plastics, high-grade
steel)
- must not attack softeners (e.g.
silicone).
¾Observe specifications regarding
concentration, temperature and
exposure time.
¾Do not exceed the maximum
allowable cleaning temperature
of 60 °C.

9
Manual cleaning with immersion disinfecting and cleaning with brush
FW848R–FW850R
D–W: Drinking water
FD–W: Fully desalinated water (demineralized)
RT: Room Temperature
Stage I
¾Fully immerse the product in the disinfecting
solution. Make certain that all accessible surfaces
are moistened.
¾Clean the product under running tap water, using
a suitable cleaning brush if necessary, 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 geometries, for at
least 5 min or until no more residues can be
removed. Mobilize non-rigid components, e.g. set
screws, links, etc. during cleaning.
¾After that, thoroughly rinse (at least 5 times) with
the cleaning solution these difficult to access areas
of the product, using a single-use syringe (20 ml).
¾To avoid the risk of corrosion, do not use a metal
brush or other abrasives, which would damage the
surfaces, for cleaning the product.
Stage II
¾Rinse the product completely (all accessible
surfaces) under running water.
Stage III
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 IV
¾Dry the product completely with compressed air.
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; pH = 9
II Intermediate rinse RT
(cold)
1-D–W-
III Final rinse RT
(cold)
0.5 - FD–W -
IV Drying RT - - - -

Aesculap Spine
Distraction set with lockable distraction screws
10
Mechanical cleaning/disinfecting with manual pre-cleaning
FW848R–FW850R
Manual pre-cleaning with brush
D–W: Drinking water
RT: Room Temperature
Stage I
¾Fully immerse the product in the disinfecting
solution. Make certain that all accessible surfaces
are moistened.
¾Clean the product with a suitable cleaning brush
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 geometries, for at
least 5 min or until no more residues can be
removed. Mobilize non-rigid components, e.g. set
screws, links, etc. during cleaning.
¾After that, thoroughly rinse (at least 5 times) with
the cleaning solution these difficult to access areas
of the product, using a single-use syringe (20 ml).
¾To avoid the risk of corrosion, do not use a metal
brush or other abrasives that would damage the
surfaces for cleaning the product.
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; pH = 9
II Intermediate rinse RT
(cold)
1-D–W-

11
Mechanical alkaline cleaning and thermal disinfecting
Machine type: Single-chamber cleaning/disinfecting
machine without ultrasound
¾Place the product on a tray that is suitable for
cleaning (avoid rinsing blind spots).
¾Connect components with lumens and channels
directly to the injector carriage attachment.
¾Store products with hinges or joints on the tray in
such a way that the joints are kept open.
D–W: Drinking water
FD–W: Fully desalinated water (demineralized)
Stage Step T
[°C/°F]
t
[min]
Water
quality
Chemical
IPrerinse < 25/77 3 D–W -
II Cleaning 55/131 10 FD–W - Concentrate, alkaline:
pH = 10.9
< 5 % anionic tensides
- 1 % solution:
pH = 10.5
III Neutralization 20/68 2 FD–W - Concentrate, acid:
pH = 2.6
Basis: Citric acid
- 0.2 % solution:
pH = 3.0
IV Intermediate rinse 70/158 1 FD–W -
VThermal
disinfecting
94/201 10 FD–W -
VI Drying 90/194 40 - -

Aesculap Spine
Distraction set with lockable distraction screws
12
Control, care and inspection
¾Allow the product to cool down to room
temperature.
¾Lightly lubricate moving parts (e.g. joints and links)
with a maintenance oil suitable for the respective
sterilization process (e.g. Aesculap STERILIT® spray
JG600 or maintenance oil JG598).
¾Assemble the separable product, see Assembling.
¾Inspect the product after each cleaning and
disinfecting cycle to be sure it is clean, functioning
properly, not damaged, has intact insulation and
does not have any loose, bent, broken, cracked,
worn, or fractured components.
¾Check for compatibility with associated products.
¾Set aside the product if it is damaged.
Packaging
¾Appropriately protect products with fine working
tips.
¾Secure product with retractor in the first notch.
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).
¾Pack the product in such a way that the packaging
will prevent recontamination of the product in the
period between reprocessing and reuse.
Sterilization method and parameters
Note
The product can be sterilized either in disassembled or
in assembled condition.
Note
To prevent breakage due to stress crack corrosion,
sterilize the instruments with the locking mechanism
open, or locked on the first ratchet tooth.
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
– Disassemble the product
– Steam sterilization through fractionated vacuum
process
– Steam sterilization acc. to EN 285/ANSI/AAMI/
ISO 11134-1993, ANSI/AAMI ST 46-1993,
validated acc. to EN ISO 17665 or EN 554/
ISO 13683
– 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.

13
Sterilization for the US market
• Sterilization of the device may be accomplished by
steam.
• Aesculap does not recommend the device be ster-
ilized by “Flash” or chemical sterilization.
• Surgical instruments may also be placed within an
Aesculap rigid sterilization container (sterile con-
tainer) for processing under generally accepted
hospital in-use conditions.
The recommended sterilization parameters are as fol-
lows:
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 cross-contamination!
Storage
¾Store processed products in germ-proof packaging
in a dust-protected, dry, dark and temperature-
controlled room.
Technical Service
For service, maintenance 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 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 Implant Systems Inc.
3773 Corporate Parkway
Center Valley, PA 18034
USA
Sterilization
method Temp.
Minimum exposure time
Wrapped
In a sterile
container
system
Pre-vacuum 270—
275 °F
4 min 4 min

Aesculap Spine
Distraktions-Set mit verriegelbaren Distraktionsschrauben
14
Legende
1activ C-Distraktor für verriegelbare Distraktions-
schrauben, rechts
2activ C-Distraktor für verriegelbare Distraktions-
schrauben, links
3activ C-Schraubendreher für verriegelbare Distrak-
tionsschrauben
4activ C-verriegelbare Offset-Distraktionsschraube
5Sechskant
6Schaft
7activ C-verriegelbare Distraktionsschraube
8Lappenschraube
9Rasthebel
10 Zahnstange
11 Führung
12 Distraktionsarm (an der Führung)
13 Knöpfe (zur Ver- und Entriegelung)
14 Distraktionsarm (an der Zahnstange)
Bildlegende
AAbbildung in Ausklappseite
BAbbildung in Ausklappseite
CAbbildung in Ausklappseite
Symbole am Produkt
Einsatzgebiet
Der activ C-Distraktor für verriegelbare Distraktions-
schrauben wird in Verbindung mit den dazugehörigen
activ C- verriegelbaren Distraktionsschrauben verwen-
det, um benachbarte Wirbelkörper im Halswirbel-
bereich parallel zu distrahieren und damit die Höhe des
Bandscheibenraums zu vergrößern.
Sterilisation durch Bestrahlung
Nicht zur Wiederverwendung im
Sinne des vom Hersteller festge-
legten bestimmungsgemäßen
Gebrauchs
Verwendbar bis
Gebrauchsanweisung einhalten

15
Lieferbare Größen Sichere Handhabung und Bereitstellung
¾Gebrauchsanweisung lesen, einhalten und aufbe-
wahren.
¾Gebrauchsanweisung activ C-Bandscheibenpro-
these TA011995 einhalten.
¾OP-Manual Nr. 031301 einhalten.
¾Produkt nur bestimmungsgemäß verwenden, siehe
Einsatzgebiet.
¾Fabrikneues Produkt 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.
¾Um Schäden am Arbeitsende zu vermeiden: Pro-
dukt vorsichtig durch den Arbeitskanal (z. B. Tro-
kar) einführen.
Das Produkt ist strahlensterilisiert und steril verpackt.
Das Produkt darf nicht wieder verwendet werden.
¾Kein Produkt aus offenen oder beschädigten Steril-
verpackungen verwenden.
¾Produkt nicht resterilisieren.
¾Produkt nach Ablauf des Verfallsdatums nicht mehr
verwenden.
Art.-Nummer Bezeichnung
FW848R activ C-Distraktor für verriegel-
bare Distraktionsschrauben,
rechts
FW849R activ C-Distraktor für verriegel-
bare Distraktionsschrauben,
links
FW850R activ C-Distraktionsschrauben-
dreher für verriegelbare Distrak-
tionsschrauben
FW851SU activ C-verriegelbare Offset-
Distraktionsschraube, 12 mm
FW852SU activ C-verriegelbare Offset-
Distraktionsschraube, 14 mm
FW853SU activ C-verriegelbare Offset-
Distraktionsschraube, 16 mm
FW854SU activ C-verriegelbare Offset-
Distraktionsschraube, 18 mm
FW855SU activ C-verriegelbare
Distraktionsschraube, 16 mm
FW856SU activ C-verriegelbare
Distraktionsschraube, 18 mm
FW861SU activ C-verriegelbare
Distraktionsschraube, 12 mm
FW862SU activ C-verriegelbare
Distraktionsschraube, 14 mm

Aesculap Spine
Distraktions-Set mit verriegelbaren Distraktionsschrauben
16
Bedienung
Im weiteren Text werden folgende Komponenten
umbenannt:
• activ C-Distraktor für verriegelbare Distraktions-
schrauben in Distraktor
• activ C-Distraktionsschraubendreher für verriegel-
bare Distraktionsschrauben in Distraktionsschrau-
bendreher
• activ C-verriegelbare Distraktionsschrauben in Dis-
traktionsschrauben
• activ C-verriegelbare Offset-Distraktionsschrauben
in Offset-Distraktionsschrauben
Hinweis
Jeder Einsatz der Distraktionsschraube schließt den
Einsatz der Offset-Distraktionsschraube mit ein, sofern
diese nicht explizit erwähnt wird!
Distraktionsschraube setzen
Abb. 1 Distraktionsschraubendreher mit Distraktions-
schraube und Offset-Distraktionsschraube

17
Hinweis
Bei sehr kleinen Wirbelkörpern müssen Offset-Distrak-
tionsschrauben verwendet werden, um ausreichend
Platz für das Implantationsinstrumentarium sicherzu-
stellen!
¾Distraktionsschraube 7oder Offset-Distraktions-
schraube 4wählen.
¾Distraktionsschraube 7oder Offset-Distraktions-
schraube 4in Distraktionsschraubendreher 3set-
zen.
¾Distraktionsschraubendreher 3auf Sechskant 5der
Distraktionsschraube 7setzen, bis sie einrastet.
¾Selbsthaltefunktion der Distraktionsschraube 7im
Distraktionsschraubendreher 3prüfen.
- oder -
¾Distraktionsschraubendreher 3auf Sechskant 5der
Offset-Distraktionsschraube 4setzen, bis sie ein-
rastet.
Distraktionsschraube unter Röntgenkontrolle in den
Wirbelkörper einschrauben
Abb. 2
Hinweis
Bei sehr kleinen Wirbelkörpern müssen Offset-Distrak-
tionsschrauben verwendet werden, um ausreichend
Platz für das Implantationsinstrumentarium sicherzu-
stellen!
¾Distraktionsschraube 7/Offset-Distraktionsschraube 4
in der Mitte des Wirbelkörpers positionieren und
einschrauben.
¾Distraktionsschraubendreher 3von der Distrakti-
onsschraube 7/Offset-Distraktionsschraube 4ent-
fernen.
WARNUNG
Kompression bzw. Beschädigung des
Spinalkanals durch zu lang
gewählte Distraktionsschraube!
¾Länge der Distraktionsschraube
mit dem Wirbelkörper auf Rönt-
genbild abgleichen.
¾Distraktionsschraube nur unter
Röntgenkontrolle setzen.

Aesculap Spine
Distraktions-Set mit verriegelbaren Distraktionsschrauben
18
¾Zweite Distraktionsschraube 7/Offset-
Distraktionsschraube 4setzen und dabei die paral-
lele Positionierung der Distraktionsschraube 7/Off-
set-Distraktionsschraube 4sicherstellen.
Distraktor montieren und Distraktion durchführen,
siehe Abb. A/B
¾Distraktor rechts 1oder Distraktor links 2wählen.
¾Lappenschraube 8drehen, um den Abstand der
parallelen Distraktionsschrauben 4/7auf die Dis-
traktionsarme 12/14 zu übertragen.
Der Abstand der Distraktionsarme 12/14 ent-
spricht dem der Distraktionsschrauben 4/7.
¾Distraktor rechts 1oder Distraktor links 2auf par-
allele Distraktionsschrauben 4/7setzen, bis sie
einrasten.
¾Über die Spreizzange distrahieren.
¾Distraktor rechts 1oder Distraktor links 2während
der Distraktion mit der Spreizzange mit der Lap-
penschraube 8aufspreizen.
¾Distraktor rechts 1oder Distraktor links 2nach der
Distraktion mit der Spreizzange arretieren und die
Wirbel in distrahierter Position halten.
Distraktor entfernen, siehe Abb. C
¾Um Distraktion nach der erfolgten Implantation im
Bandscheibenraum zu lösen, Rasthebel 9am Dis-
traktor drücken.
Die Distraktionsarme 12/14 bewegen sich aufein-
ander zu.
Der Distraktor ist völlig entlastet.
¾Knöpfe 13 seitlich am Distraktionsarm 12/14 drü-
cken und Distraktor von den Distraktionsschrauben 4/
7abziehen.
¾Distraktionsschrauben 4/7aus den Wirbeln mit
Distraktionsschraubendreher 3entfernen.
WARNUNG
Gefahr der Lockerung/des Ausrei-
ßens der Distraktionsschrauben bei
Spreizung über Distraktor und Dis-
traktionsschrauben!
¾Spreizzange zum Spreizen ein-
setzen.
¾Nicht über Distraktor und Dis-
traktionsschrauben spreizen.
¾Distraktor im gespreizten
Zustand arretieren.
WARNUNG
Irritation der Facettengelenke/
Spannung auf Rückenmark und
Nervenwurzeln durch Überdistrak-
tion!
¾Spreizzange langsam und vor-
sichtig unter Röntgenkontrolle
aufspreizen.
¾Taktile Rückmeldung beachten.
¾Höhe benachbarter (gesunder)
Bandscheiben als Maß für die
Spreizung heranziehen.