Braun Aesculap Spine User manual

Aesculap Spine
Instructions for use
activ C handle, reamer guide, trial implants
Gebrauchsanweisung
activ C-Handgriff, Fräserführung, Probeimplantate
Mode d’emploi
Poignée, guidage de fraise, implants d’essai activ C
Instrucciones de manejo
Mango, guía de fresado, implantes de prueba activ C
Istruzioni per l’uso
Impugnatura, guida per la fresa, impianti di prova activ C
Instruções de utilização
Cabo, guia de fresa, implantes de ensaio activ C
Gebruiksaanwijzing
Activ C-handgreep, freesgeleider, proefimplantaten
Návod k použití
activ C-rukojet’, vedení frézy, zkušební implantáty

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Aesculap Spine
activ C handle, reamer guide, trial implants
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Legend
1Trial implant
2Handle
3Reamer guide
4Mounting block (for reamer handpiece)
5Reamer
6Reamer handpiece
7HiLAN pneumatic motor
Symbols on product
Intended use
The trial implants are used in conjunction with the
handpiece to verify the size, height and shape of the
activ C intervertebral disk prosthesis to be implanted,
and in conjunction with the reamer guide to prepare
the fin bed for the inferior implant plate of the activ C
intervertebral disk prosthesis.
Available sizes
Attention, see instructions for use
Position "closed"
Position "open"
Ready
Art. no. Designation
FW789R Trial implant flat size XS, H5
FW790R Trial implant flat size XS, H6
FW791R Trial implant flat size S, H5
FW792R Trial implant flat size S, H6
FW793R Trial implant flat size M, H5
FW794R Trial implant flat size M, H6
FW795R Trial implant flat size L, H5
FW796R Trial implant flat size L, H6
FW797R Trial implant flat size XL, H5
FW798R Trial implant flat size XL, H6
FW799R Trial implant flat size XXL, H5
FW800R Trial implant flat size XXL, H6
FW870 Handle
FW871R Reamer guide (with mounting block)
FW874R Trial implant size XS, H5
FW875R Trial implant size XS, H6
FW876R Trial implant size S, H5
FW877R Trial implant size S, H6
FW878R Trial implant size M, H5
FW879R Trial implant size M, H6
FW880R Trial implant size L, H5
FW881R Trial implant size L, H6
FW882R Trial implant size L, H7
FW883R Trial implant size XL, H5

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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.
¾Use the product only in accordance with its
intended use, see Intended use.
¾Clean the new product either manually or
mechanically 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
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.
¾To avoid damage to the working tip: Carefully
insert the product through the working channel
(e.g. trocar).
FW884R Trial implant size XL, H6
FW885R Trial implant size XL, H7
FW886R Trial implant size XXL, H5
FW887R Trial implant size XXL, H6
FW888R Trial implant size XXL, H7
GB771R Hi-Line XS handpiece angled XL-I
GA529 HiLAN pneumatic motor short with
hand control
GA505R Compressed-air tube Aesculap-Dräger/
Aesculap small
GA506R Compressed-air tube Schrader
+ diffuser/Aesculap small
GA507R Compressed-air tube DIN-union/
Aesculap small
GE700SU Hi-Line XS activ C drill XL-I D1, 5
Art. no. Designation

Aesculap Spine
activ C handle, reamer guide, trial implants
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Safe operation
Note
Follow OP manual no. O31302 and instructions for use
"activ C intervertebral disk prosthesis" TA011995.
Mounting the trial implant of the selected size on
the handle
Note
Height 5 and height 6 trial implants are also available
as flat implants marked with the inscription "FLAT".
Fig. 1 Handle for trial implants in open (left) and
closed (right) position
¾Turn locking pipes 8of handle 2to position "open"
.
¾Mount the trial implant of the selected size, height
and shape on handle 2.
Note markings "CRANIAL" and "CAUDAL" on the
handle and on the trial implant.
¾Turn locking pipes 8of handle 2to position
"closed" .
¾Check the trial implant for firm seating.
¾Use adjusting wheel 10 to set the depth stop of the
trial implant to minimum insertion depth.
¾Insert the trial implant in the intervertebral space
under X-ray control. Ensure correct cranial and
caudal alignment of the trial implant.
¾Align the markings of the trial implant center to
the midline marking.
¾If necessary, correct the position of the depth stop
with adjusting wheel 10 until the intended
position is reached.
Ensure that depth stop abuts the anterior edge of
the vertebral body.
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WARNING
Compression of the spinal canal and
of other posterior elements caused
by trial implants inserted too
deeply!
¾Prior to insertion of trial
implants, adjust the depth stop
to minimum insertion depth.
¾Insert trial implants in the
intervertebral space under X-ray
control.

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¾On the intraoperative X-ray image, in AP and
lateral view, check the size, height and position of
the trial implant.
¾With the trial implant properly positioned, turn
locking pipes 8to position "open" and pull off
handle 2carefully in axial direction from the trial
implant.
The trial implant remains in the intervertebral
space.
Reaming the fin bed/ Mounting the reamer guide
Note
The handle and the reamer guide are fitted with
identical locking mechanisms.
¾Turn locking pipes 8of reamer guide 3to position
"open" .
¾Mount reamer guide 3on the trial implant sitting
in the intervertebral space.
Note markings "CRANIAL" and "CAUDAL" on the
reamer guide and on the trial implant.
¾Turn locking pipes 8of reamer guide 3to position
"closed" .
Reamer guide 3is fixed to the trial implant.
¾Check again, by X-ray imaging, the position of the
trial implant.
WARNING
Increased risk of migration if the
selected implant size is too small!
¾Select the trial implant or
implant size, respectively, to
achieve maximum coverage of
the vertebral body endplates.
¾On the X-ray, in AP and lateral
view, check to ensure that the
size, position and alignment of
the trial implant are correct.
WARNING
Irritation of the facet joints and
strain on spinal cord and nerve
roots due to excessive or
insufficient distraction!
¾Select the correct trial implant/
implant height.
¾Check for correct height of the
trial implant in a lateral X-ray.

Aesculap Spine
activ C handle, reamer guide, trial implants
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Reaming the fin bed/Mounting the reamer
handpiece
¾Prior to mounting, verify that the safety stop of the
pneumatic motor is in position "0".
¾Assemble the compressed-air tube, the HiLAN
pneumatic motor and reamer handpiece 6as
described and illustrated in the respective
instructions for use supplied with the products.
Fig. 2
¾Keep pressed locking clip 9of mounting block 4and
push the clip over reamer handpiece 6, see Fig. 3.
Fig. 3 Mounting block with pressed locking clip
¾Slide on mounting block 4as far as it will go and
release locking clip 9, see Fig. 4.
Fig. 4 Mounting block with locking clip engaged
¾Pull at mounting block 4to check whether it is
engaged properly.
The arrow marking on locking clip 9has to point to
the pictogram "closed" .
¾Mount reamer 5as described in the instructions for
use of reamer handpiece 6.
WARNING
Damage to nerves, spinal cord and
other tissue because of fin bed
reamed too deeply due to using too
long a reamer handpiece or reamer.
¾Only use reamer handpiece Hi-
Line XS XL-1 (GB771R).
¾Only use activ C reamer
(GE700SU).
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Note
The reaming of the fin bed determines the position and
orientation of the disk prosthesis in the plane of the
intervertebral disk. The fin bed must only be prepared
for the inferior implant plate. ¾A: Position reamer handpiece 6with the coupled
reamer through the frontal guide hole of reamer
guide 3, see Fig. 5.
¾B: Position the laterally protruding pins of
mounting block 4through the rear guiding slots of
reamer guide 3, see Fig. 5.
Fig. 5 Sliding the reamer handpiece into the reamer
guide
¾With the hand control not actuated, push the
safety stop to .
The system is ready for operation.
WARNING
Risk of injury to blood vessels,
nerves, spinal cord or other tissue if
wrong reamer is used!
¾Only use activ C reamer
GE700SU.
¾Check for technical faults prior
to use.
¾Do not use bent reamers.
¾Do not reuse reamers after first
use.
WARNING
Mispositioning of the intervertebral
disk prosthesis due to failure to
observe the midline!
¾Check the central position of
the trial implant by means of
the midline marking and on the
AP-view X-ray image.
¾Make certain that the position
of the trial implant does not
change during reaming.
WARNING
Risk of injury caused by sharp
chisel!
¾To avoid injuries to critical
blood vessels, nerves and other
tissue, as well as injuries to the
operating surgeon, always work
with appropriate care when a
reamer is clamped in the
machine.
¾Do not activate the motor
before the handpiece with the
coupled reamer is properly
positioned in the guide hole and
the guiding slot of the reamer
guide.
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A

Aesculap Spine
activ C handle, reamer guide, trial implants
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Note
The reaming of the fin bed determines the position and
orientation of the disk prosthesis in the plane of the
intervertebral disk.
¾To ream the first hole under lateral X-ray control:
With the motor running, push reamer handpiece 6
at an even speed and with mild forward pressure
into the first guiding slot down to the stop.
¾Pull back reamer handpiece 6and, after moving
the pins of mounting block 4to the second guiding
slot, repeat the reaming procedure.
The reaming depth will be limited by the stop at
reamer guide 3.
¾With the hand control not actuated, shift the
safety stop at the pneumatic motor to position "0".
¾Cautiously pull out reamer handpiece 6first from
the rear and then from the frontal reamer guide 3.
¾Remove reamer guide 3and the trial implant from
the vertebral disk space.
¾Clean the fin bed with nerve hooks from the
discectomy set.
Disassembling
Uncoupling the reamer guide/handle from the trial
implant
¾Turn locking pipes 8of reamer guide 3or handle 2,
respectively, to position "open" .
¾Pull off the trial implant in axial direction.
¾Decouple reamer 5from reamer handpiece 6as
described in instructions for use TA011267.
Detaching the mounting block from the reamer
handpiece
¾Hold locking clip 9of mounting block 4pressed
down (arrow marking points to position "open" )
and pull off the mounting block from reamer
handpiece 6.
WARNING
Mispositioning of the intervertebral
disk prosthesis due to failure to
observe the midline!
¾Check the central position of
the trial implant by means of
the midline marking and on the
AP-view X-ray image.
¾Make certain that the position
of the trial implant does not
change during reaming.
WARNING
Risk of injury to nerves and spinal
cord caused by too deep insertion
of the reamer!
¾Only use activ C instruments.
¾Use the instruments according
to their intended use.
¾For reaming the holes, apply the
reamer only in combination with
a correctly selected and
positioned trial implant and
with the reamer guide coupled.
¾Take care that the depth stop of
the trial implant abuts the
anterior edge of the vertebral
body.
¾Always maintain lateral X-ray
control while reaming the holes.