B. Braun Aesculap Spine activC FW647R Gebrauchsanweisung/Technische Beschreibung Seite 3

Fin bed reaming
Assembling the reamer guide
Note
The handle and the reamer guide are fitted with identical locking mechanisms.
►
Turn locking pipes 11 of reamer guide 3 to "open" position
►
Mount the reamer guide 3 onto the trial implant in the intervertebral space. Note the "CRANIAL" and "CAUDAL"
markings on the reamer guide and on the trial implant.
►
Turn locking pipes 11 of reamer guide 3 to "closed" position .
Reamer guide 3 is fixed to the trial implant.
►
Check again, by X-ray imaging, the position of the trial implant.
Assembling the reamer handpiece
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.
►
Only use reamer handpiece Hi-Line XS XL-1 (GB771R).
►
Only use activC reamer (GE700SU).
WARNING
►
Prior to mounting, verify that the safety stop of the pneumatic motor is in position "0".
►
Assemble the compressed-air tube, the HiLAN pneumatic motor and reamer handpiece 6 as described and illus-
trated in the respective instructions for use, see Fig. 2.
►
Hold locking clip 13 of mounting block 4 pressed down and push the mounting block over the reamer
handpiece 6 see Fig. 3.
►
Slide on mounting block 4 as far as it will go and release locking clip 13, see Fig. 4.
►
Pull at the mounting block 4 to check whether it is engaged properly. The arrow marking on the locking clip 13
must point to the "closed" pictogram.
►
Mount reamer 5 as described in the instructions for use of reamer handpiece 6.
Risk of injury to blood vessels, nerves, spinal cord or other tissue if wrong reamer
is used!
►
Only use the activC reamer GE700SU.
►
Check for technical faults prior to use.
WARNING
►
Do not use bent reamers.
►
Do not reuse reamers after first use.
Risk of infection for patients and/or users and impairment of product functional-
ity due to reuse. Risk of injury, illness or death due to contamination and/or
impaired functionality of the product!
►
Do not reprocess the product.
DANGER
Note
The reaming of the fin bed determines the position and orientation of the disk prosthesis in the plane of the interver-
tebral disk. The fin bed must only be prepared for the inferior implant plate.
Malpositioning of the intervertebral disk prosthesis due to failure to observe the
midline!
►
Check the central position of the trial implant by means of the midline mark-
ing and on the AP-view X-ray image.
WARNING
►
Make certain that the position of the trial implant does not change during
reaming.
Risk of injury caused by sharp chisel!
►
To 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.
WARNING
►
Do 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.
►
A: Insert the reamer handpiece 6 with the reamer clamped in into the front guide hole of the reamer guide 3,
see Fig. 5.
►
B: Insert the laterally protruding pins of the mounting block 4 into the rear guide slots of the reamer guide 3,
see Fig. 5.
►
With the hand control not actuated, push the safety stop to
The system is ready for operation.
Note
The reaming of the fin bed determines the position and orientation of the disk prosthesis in the plane of the interver-
tebral disk.
Malpositioning of the intervertebral disk prosthesis due to failure to observe the
midline!
►
Check the central position of the trial implant by means of the midline mark-
ing and on the AP-view X-ray image.
WARNING
►
Make certain that the position of the trial implant does not change during
reaming.
Risk of injury to nerves and spinal cord caused by too deep insertion of the reamer!
►
Use activC instruments only.
►
Use the instruments according to their intended use.
►
WARNING For reaming the holes, apply the reamer only in combination with a correctly
selected and positioned trial implant and with the reamer guide coupled.
►
Take care that the depth stop of the trial implant abuts the anterior edge of
the vertebral body.
►
Always maintain lateral X-ray control while reaming the holes.
►
To 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.
►
Pull back reamer handpiece 6 and, after moving the pins of mounting block 4 in the second guiding slot, repeat
the reaming procedure under lateral X-ray control.
The reaming depth will be limited by the stop on the reamer guide 3.
►
With the hand control not actuated, shift the safety stop on the pneumatic motor to position "0".
►
Cautiously pull out reamer handpiece 6 first from the rear and then from the front reamer guide 3.
►
Remove reamer guide 3 and the trial implant from the vertebral disk space. Clean the fin bed with nerve hooks
from the discectomy set.
.
.
Chiseling the fin bed
Assembling the chisel guide
Note
The handle and the chisel guide are fitted with identical locking mechanisms.
►
Turn locking pipes 11 of chisel guide 10 to "open" position
►
Mount the chisel guide 10 onto the trial implant in the intervertebral space. Note the "CRANIAL" and "CAUDAL"
markings on the handle and on the trial implant.
►
Turn locking pipes 11 of chisel guide 10 to "closed" position .
Chisel guide 10 is fixed to the trial implant.
►
Check again, by X-ray imaging, the position of the trial implant.
Damage to nerves, spinal cord and other tissue because of fin bed reamed too
deeply due to using too long a chisel.
►
Only use chisel holder FW786R.
►
Only use chisel FW787R.
WARNING
►
Mount the chisel onto the chisel holder 9, see Fig. 6.
►
To do this mount the chisel sideways onto the chisel holder and push it backwards until it engages. Pull at the
chisel, to check that it is engaged properly.
Risk of injury to blood vessels, nerves, spinal cord or other tissue if wrong chisel
is used!
►
Only use chisel FW787R.
►
Do not use bent chisels. Do not reuse chisels after first use.
WARNING
Note
The chiseling of the fin bed determines the position and orientation of the disk prosthesis in the plane of the interver-
tebral disk. The fin bed must only be prepared for the inferior implant plate.
Malpositioning of the intervertebral disk prosthesis due to failure to observe the
midline!
►
Check the central position of the trial implant by means of the midline mark-
ing and on the AP-view X-ray image.
WARNING
►
Make certain that the position of the trial implant does not change during
reaming.
Risk of injury caused by sharp chisel!
►
To 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
chisel is clamped in the chisel holder.
WARNING
►
A: Carefully push the chisel holder 9 with the chisel through the rear chisel guide, see Fig. 7.
►
B: Carefully push the chisel holder 9 with the chisel through the front chisel guide, see Fig. 7.
Note
The chiseling of the fin bed determines the position and orientation of the disk prosthesis in the plane of the interver-
tebral disk.
Malpositioning of the intervertebral disk prosthesis due to failure to observe the
midline!
►
Check the central position of the trial implant by means of the midline mark-
ing and on the AP-view X-ray image.
WARNING
►
Make certain that the position of the trial implant does not change during
chiseling.
Risk of injury to nerves and spinal cord caused by too deep insertion of the reamer!
►
Use activC instruments only.
►
Use the instruments according to their intended use.
►
WARNING Only use the fin in combination with a correctly selected and positioned trial
implant and with the chisel guide coupled.
►
Take care that the depth stop of the trial implant abuts the anterior edge of
the vertebral body.
►
Always maintain lateral X-ray control while chiseling the fin.
►
Carefully mount the chisel guide with chisel on the vertebral body.
►
With slight pressure and at an even speed, chisel under lateral X-ray control. The chiseling depth is limited by
the stop on the chisel guide 10.
►
Carefully pull the chisel backwards out of the chisel guide.
►
Remove chisel guide 10 and the trial implant from the vertebral disk space.
►
Clean the fin bed with nerve hooks from the discectomy set.
Disassembling
Uncoupling the reamer guide/handle from the trial implant
►
Turn locking pipes 11 of reamer guide 3 or of handle 2 to "open" position
►
Pull off the trial implant in axial direction.
►
Decouple reamer 5 from reamer handpiece 6 as described in instructions for use TA011267.
Detaching the mounting block from the reamer handpiece
►
Hold locking clip 13 of mounting block 4 pressed down (arrow marking points to "open" position ) and pull off
the mounting block from reamer handpiece 6.
Uncoupling the chisel guide/handle from the trial implant
►
Turn locking pipes 11 of chisel guide 10 or of handle 2 to "open" position
►
Pull off the trial implant in axial direction.
►
Raise the chisel by the tip on the instrument and push out forwards.
.
.
.