Braun Aesculap activ L User manual

Aesculap®activ L
Aesculap Spine
Instructions for use
activ L chisel and chisel guides
Gebrauchsanweisung
activ L-Meißel und Meißelführungen
Mode d'emploi
Burin activ L et guidages de burin
Instrucciones de manejo
Cincel y guías de cincel activ L
Istruzioni per l'uso
Scalpello activ L e relative guide
Instruções de utilização
Cinzel e guias de cinzel activ L
Gebruiksaanwijzing
activ L-beitel en beitelgeleiders
Bruksanvisning
activ L-mejsel och mejselhållare
Инструкция по применению
Резец и направляющие резца activ L
Návod k použití
Dláto a vedení dláta activ L
Instrukcja użytkowania
Dłuto activ L i prowadnice dłuta
Návod na používanie
activ L-dláto a vedenia dláta
Kullanım Kılavuzu
activ L keskisi ve keski kılavuzları

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Aesculap®activ L
activ L chisel and chisel guides
Aesculap®activ Lact iv L c hisel and chisel guides
Legend
1Handle (for chisel guide)
2Chisel guide
3Double chisel
4Single chisel
Symbols on product and packages
Applicable to
►For item-specific instructions for use and informa-
tion on material compatibility, see also the
Aesculap Extranet at www.aesculap-extra.net
Intended use
activ L chisels and chisel guides are used to prepare the
keel bed in one or two vertebral bodies for anchoring
the activ L disk prosthesis with keel.
A double or single chisel is required depending on
whether the keel or combined version is being used.
Available sizes
Caution, general warning symbol
Caution, see documentation sup-
plied with the product
Designation Size Art. no.
activ L handle for chisel
guide
- FW980R
activ L chisel guide 8.5 mm, 6° FW981R
10 mm, 6° FW982R
12 mm, 6° FW983R
14 mm, 6° FW984R
8.5 mm, 11° FW993R
10 mm, 11° FW994R
12 mm, 11° FW995R
14 mm, 11° FW996R
activ L double chisel 8.5 mm FW985R
10 mm FW986R
12 mm FW987R
14 mm FW988R
activ L single chisel 8.5 mm FW989R
10 mm FW990R
12 mm FW991R
14 mm FW992R

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Safe handling and preparation
CAUTION
Federal law restricts this device to sale by, or on
order of a physician!
Use of the activ L chisels and chisel guides requires
precise knowledge about spine surgery and the stabili-
zation and biomechanical situation at the spine.
Surgical application of the activ L chisels and chisel
guides is described in detail in the respective Operating
Manual.
►Ensure that the product and its accessories are
operated and used only by persons with the requi-
site training, knowledge, or experience.
►Read, follow, and keep the instructions for use.
►Use the product only in accordance with its
intended use, see Intended use.
►Remove the transport packaging and clean the new
product, either manually or mechanically, prior to
its initial sterilization.
►Store any new or unused products in a dry, clean,
and safe place.
►Prior to each use, inspect the product for loose,
bent, broken, cracked, worn, or fractured compo-
nents.
►Do not use the product if it is damaged or defec-
tive. Set aside the product if it is damaged.
►Replace any damaged components immediately
with original spare parts.
Safe operation
►Mount chisel guide 2with the desired implant
height and angle onto the handle 1,seeFig.1.
►Turn wheel bclockwise and adjust safety stop ato
the shortest chisel length, see Fig. 1.
►Insert chisel guide 2centrally into the disk space
and adjust safety stop ato the desired chisel depth
while monitoring radiographically,see Fig. 1.
Fig. 1
WARNING
Risk of injury and/or malfunc-
tion!
►Always carry out a func-
tion check prior to using
the product.
WARNING
Risk of injury when using the
product beyond the field of
view!
►Apply the product only
under visual control.
►Handle the chisel with
utmost care in order to
prevent injuries to the ves-
sels and nerve structures,
as well as to surgical staff.
WARNING
Damage to the implant from
bone residues!
►Prior to inserting the
implant, ensure that no
residual bone can be found
in the intervertebral space
and slits.
1
2
ba