B. Braun Aesculap activ L Manual

Aesculap®activ L
Aesculap Spine
Instructions for use/Technical description
activ L chisel and chisel guides
Instructions for use/Technical description
activ L chisel and chisel guides
Note for U.S. users
This Instructions for Use is NOT intended for United
States users. Please discard. The Instructions for Use
for United States users can be obtained by visiting our
website at https://www.aesculapimplantsys-
tems.com/products/instructions-for-use. If you wish
to obtain a paper copy of the Instructions for Use, you
may request one by contacting your local Aesculap
representative or Aesculap's customer service at
1-866-229-3002. A paper copy will be provided to you
upon request at no additional cost.
Gebrauchsanweisung/Technische Beschreibung
activ L-Meißel und Meißelführungen
Mode d’emploi/Description technique
Burin activ L et guidages de burin
Instrucciones de manejo/Descripción técnica
Cincel y guías de cincel activ L
Istruzioni per l’uso/Descrizione tecnica
Scalpello activ L e relative guide
Instruções de utilização/Descrição técnica
Cinzel e guias de cinzel activ L
Gebruiksaanwijzing/Technische beschrijving
activ L-beitel en beitelgeleiders
Bruksanvisning/Teknisk beskrivning
activ L-mejsel och mejselhållare
Инструкция по примению/Техническое опи-
сание
Резец и направляющие резца activ L
Návod k použití/Technický popis
Dláto a vedení dláta activ L
Instrukcja użytkowania/Opis techniczny
Dłuto activ L i prowadnice dłuta
Návod na použivanie/Technický opis
activ L-dláto a vedenia dláta
Kullanım Kılavuzu/Teknik açiklama
activ L keskisi ve keski kılavuzları

2
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 https://extranet.bbraun.com
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

3
Safe handling and preparation
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