B.Braun Aesculap Spine activ L Mode D'emploi page 3

Drive the chisel into the vertebral body, but only down to the bedstop on
the chisel guide, not any further.
Carefully knock the chisel out of the vertebral body, using a slotted ham-
mer.
Remove the chisel guide from the intervertebral space.
If necessary, use a narrow spacer for keeping the vertebral bodies apart.
Inserting the activ L vertebral disc prosthesis
Select the implant components of the size that was determined intraop-
eratively.
Damage to the friction surfaces due to improper
handling!
Handle with caution the friction surfaces of
the prosthesis plates and the polyethylene
inlay.
WARNING
Insert the polyethylene inlay into the depression in the inferior prosthesis
plate, in such a way that the two thinner protrusions of the polyethylene
inlay engage in the undercut of the prosthesis plate. The polyethylene
inlay can be mounted in only one position, without having to exert any
force.
Mount the complete intervertebral disc assembly on the insertion instru-
ment, according to the surgical access, observing the markings. The infe-
rior prosthesis plate must be at the part of the insertion instrument clamp
that is marked "CAUDAL", while the superior prosthesis plate must be at
the "CRANIAL" part.
Turn the clamping sleeve to clamp in the intervertebral disc prosthesis on
the instrument.
Compression of the spinal canal and of other pos-
terior elements caused by the intervertebral disc
prosthesis inserted too deeply!
Introduce the distractor into the interverte-
WARNING bral space under X-ray control.
On the X-ray image, under AP and lateral
irradiation, check to ensure that the position
and alignment of the intervertebral disc
prosthesis are correct.
Note
For prosthesis plates with anchoring fin, the central position is determined the
previously applied slits in the vertebral bodies.
For prosthesis plates without anchoring fin, the intervertebral disc prosthesis
has to be aligned with midline marks. The central anchoring tooth on the supe-
rior and inferior prosthesis plates must be in line with the midline markings.
Carefully introduce the intervertebral disc prosthesis into the interverte-
bral space. When doing this, the superior prosthesis plate must be ori-
ented towards cranial, and the inferior prosthesis plate towards caudal.
Damage to vertebral body end plates when driving
in the intervertebral disc prosthesis!
Apply proper care when driving in the inter-
vertebral disc prosthesis.
WARNING
Vascular damage caused by protruding implants!
Check to make certain that the interverte-
bral disc prosthesis is positioned centrally.
WARNING
Under X-ray control, drive the intervertebral disc prosthesis into the inter-
vertebral space until the posterior edge of the prosthesis is at the poste-
rior edge of the vertebral body, or 1 mm to 2 mm in front of it.
While doing this, check the insertion depth on the lateral X-ray image, for
this depth is not limited by the instrument.
Release the clamping sleeve on the insertion instrument and remove the
insertion instrument.
Check the position of the intervertebral disc prosthesis on the intraoper-
ative X-ray image, in AP and lateral view.
Further information about B. Braun/Aesculap implant systems is available
from B. Braun/Aesculap or the B. Braun/Aesculap office responsible.
Handling of explanted devices
Place explanted device in appropriate biohazard or designated container
for transport to decontamination area (Central Services, etc.). Ensure that
the appropriate documentation accompanies the explant separately to
avoid contamination.
Decontaminate explanted device according to facility procedures or refer-
ence the following:
– Ensure that a pair of rubber, chemical resistant gloves, goggles, and
a facemask (or face shield) is being worn.
– Place contaminated instrumentation into a container with Metricide
or equivalent disinfecting solution.
– Soak the instruments for a minimum of five minutes at room tem-
perature (25 °C).
– Using a soft toothbrush below the surface of the solution removes
all contamination from the instruments or follows the "Manufac-
tures Recommended Procedure".
– Continue to soak the instruments for an additional 15 minutes.
– After a total of 20 minutes, remove instrumentation, rinse thor-
oughly and dry.
– Discard residual solution in the drain and flush thoroughly with
water.
– Rinse the container thoroughly and dry.
Once the explanted device is decontaminated, package it appropriately
along with documentation and contact your Aesculap representative for
further instructions on return of the device.
Distributor in the US/Contact in Canada for
product information and complaints
Aesculap Implant Systems Inc.
3773 Corporate Parkway
Center Valley, PA 18034
USA
TA-Nr.: 011430 02/11 Änd.-Nr.: 32568/32607