B. Braun Aesculap Spine activ L Manual

Aesculap Spine
activ L
Instructions for use/Technical description
activ L insertion instrument
Gebrauchsanweisung/Technische Beschreibung
activ L-Einsetzinstrument
Mode d’emploi/Description technique
Instrument d’insertion activ L
Instrucciones de manejo/Descripción técnica
Instrumento de inserción activ L
Istruzioni per l’uso/Descrizione tecnica
Impattatore activ L
Instruções de utilização/Descrição técnica
Instrumento introdutor activ L
Gebruiksaanwijzing/Technische beschrijving
activ L-inbrenginstrument
Návod k použití/Technický popis
Nasazovací instrument activ L

12
3
4
a
b
5
6
7
8
9
10 11
a
b

Aesculap Spine
activ L insertion instrument
2
Legend
1Spacer
2Clamp
3Clamping sleeve
4Insertion instrument handle
5Slotted-hole pin
6Coupling pin
7Superior prosthesis plate
8Polyethylene inlay
9Inferior prosthesis plate
10 Unlocking button for spacer
11 Twist cap
Symbols on product and packages
Intended use
The activ L insertion instrument is used for implanting
the intervertebral disc prosthesis through anterior (0°)
or lateral (approx. 45°) approach. Different color-
coded and labeled insertion instruments are used for
implants of different height.
Available sizes
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 by hand or using a
machine, 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
Coupling the implant
¾Select the appropriate insertion instrument
according to the height of the intervertebral disc
prosthesis.
¾Completely assemble the intervertebral disc
prosthesis.
Symbol Explanation
Caution, general warning symbol
Caution, see documentation supplied
with the product
Art. no. Size
FW961R 8.5 mm
FW962R 10 mm
FW963R 12 mm
FW964R 14 mm
WARNING
Risk of injury and/or malfunction!
¾Always carry out a function
check before using the product.

3
¾Extend spacer 1as far as possible. If necessary,
change the position of the spacer by turning twist
cap 11.
Fig. 1 Coupling for anterior access (0°)
Fig. 2 Coupling for lateral access (approx. 45°)
¾Put the intervertebral disc prosthesis onto clamp 2
of the insertion instrument, observing the marking
on the insertion instrument. Inferior prosthesis
plate 9must butt against the part of clamp 2
marked “CAUDAL” of the insertion instrument;
superior prosthesis plate 7must butt against the
part marked as “CRANIAL“.
¾Guide prosthesis plates on spacer 1across to
position pins 5and 6of the clamp 2.
¾Make certain that the coupling pins of the clamp
fully engage in the coupling holes of the prosthesis
plates.
¾Turn clamping sleeve 3clockwise until the
intervertebral disc prosthesis is securely couples.
Decoupling the implant
¾Release clamping sleeve 3.
¾Carefully detach the insertion instrument from the
implant.
¾If the insertion instrument cannot be detached
without applying force: Turn twist cap 11
anticlockwise to move back spacer 1.
Disassembly
¾Turn twist cap 11 counterclockwise until it can be
removed.
¾Hold unlocking button 10 pressed down.
¾Pull out spacer 1to the front.
Assembly
¾Insert spacer 1from the front through clamp 2
and, with unlocking button 10 pressed down, push
in the clamp as far as it will go.
¾Release unlocking button 10.
¾Attach twist cap 11 and screw it on as far as it will
go.
¾To position spacer 1as required: Turn twist cap 11
accordingly.
1
1