Braun Aesculap TSPACE PEEK Manual

Aesculap®
Aesculap Spine
Instructions for use/Technical description
TSPACE PEEK/TSPACEXP instruments
Gebrauchsanweisung/Technische Beschreibung
TSPACE PEEK/TSPACEXP Instrumente
Mode d’emploi/Description technique
Instruments TSPACE PEEK/TSPACEXP
Instrucciones de manejo/Descripción técnica
Instrumental TSPACE PEEK/TSPACEXP
Istruzioni per l’uso/Descrizione tecnica
Strumenti TSPACE PEEK/TSPACEXP
Instruções de utilização/Descrição técnica
Instrumental TSPACE PEEK/TSPACEXP
Gebruiksaanwijzing/Technische beschrijving
TSPACE PEEK/TSPACEXP Instrumenten
Bruksanvisning/Teknisk beskrivning
TSPACE PEEK/TSPACEXP instrument
Инструкция по примению/Техническое опи-
сание
Инструменты TSPACE PEEK/TSPACEXP
Návod k použití/Technický popis
Nástroje TSPACE PEEK/TSPACEXP
Instrukcja użytkowania/Opis techniczny
Instrumenty TSPACE PEEK/TSPACEXP
Návod na použivanie/Technický opis
Nástroje TSPACE PEEK/TSPACEXP
Kullanım Kılavuzu/Teknik açiklama
TSPACE PEEK/TSPACEXP el aletleri

A
C
DE
1 2 3 4
567
B

2
Aesculap®
TSPACE PEEK/TSPACEXP instruments
Aesculap® TSPACE PEEK/TSPACEXP instruments
Legend
AInsertion instrument SN305R (assembled)
BInsertion instrument SN305R (disassembled):
1Tube
2Switch
3Rotary nut
4Irrigation connector
5Pin
6Rod
7Dihedron
CImpact cylinder SN320R
DTrial implant
EFilling holder SN304R
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
The TSPACE PEEK/TSPACEXP instruments are used to
insert TSPACE PEEK (third generation) and TSPACEXP
trial implants and implants into the thoracolumbar
spine.
The insertion instrument SN305R is used for implant-
ing implants and for determining the implant size by
inserting trial implants into the intervertebral space.
The impact cylinder SN320R is coupled to the insertion
instrument. The impact cylinder is used to expel the
trial implants from the intervertebral space or to revise
the implants.
The filling holder SN304R is used to hold the implants
on the operating table while the inner window is filled
with bone material.
Available sizes
Caution, general warning symbol
Caution, see documentation sup-
plied with the product
Date of manufacture
Implant coupled
Implant uncoupled
Art. no. Designation
SN304R TSPACE PEEK/TSPACEXP filling holder
SN305R TSPACE PEEK/TSPACEXP insertion
instrument
SN320R TSPACE PEEK/TSPACEXP impact cylinder

3
TSPACE PEEK/TSPACEXP trial implants
26 mm
TSPACE PEEK/TSPACEXP trial implants
30 mm
TSPACE PEEK/TSPACEXP trial implants
34 mm
Safe handling and preparation
CAUTION
Federal law restricts this device to sale by, or on
order of a physician!
►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.
Art. no. Designation
SN322R Trial implant 5° 26 x 11.5 x 7 mm
SN323R Trial implant 5° 26 x 11.5 x 8 mm
SN324R Trial implant 5° 26 x 11.5 x 9 mm
SN325R Trial implant 5° 26 x 11.5 x 10 mm
SN326R Trial implant 5° 26 x 11.5 x 11 mm
SN327R Trial implant 5° 26 x 11.5 x 12 mm
SN328R Trial implant 5° 26 x 11.5 x 13 mm
SN329R Trial implant 5° 26 x 11.5 x 14 mm
SN330R Trial implant 5° 26 x 11.5 x 15 mm
SN332R Trial implant 5° 26 x 11.5 x 17 mm
Art. no. Designation
SN352R Trial implant 5° 30 x 11.5 x 7 mm
SN353R Trial implant 5° 30 x 11.5 x 8 mm
SN354R Trial implant 5° 30 x 11.5 x 9 mm
SN355R Trial implant 5° 30 x 11.5 x 10 mm
SN356R Trial implant 5° 30 x 11.5 x 11 mm
SN357R Trial implant 5° 30 x 11.5 x 12 mm
SN358R Trial implant 5° 30 x 11.5 x 13 mm
SN359R Trial implant 5° 30 x 11.5 x 14 mm
SN360R Trial implant 5° 30 x 11.5 x 15 mm
SN362R Trial implant 5° 30 x 11.5 x 17 mm
Art. no. Designation
SN382R Trial implant 5° 34 x 11.5 x 7 mm
SN383R Trial implant 5° 34 x 11.5 x 8 mm
SN384R Trial implant 5° 34 x 11.5 x 9 mm
SN385R Trial implant 5° 34 x 11.5 x 10 mm
SN386R Trial implant 5° 34 x 11.5 x 11 mm
SN387R Trial implant 5° 34 x 11.5 x 12 mm
SN388R Trial implant 5° 34 x 11.5 x 13 mm
SN389R Trial implant 5° 34 x 11.5 x 14 mm
SN390R Trial implant 5° 34 x 11.5 x 15 mm
SN392R Trial implant 5° 34 x 11.5 x 17 mm

4
Aesculap®
TSPACE PEEK/TSPACEXP instruments
►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
Preparing the implant bed
►Resect the facet joint.
►Open the intervertebral disk space.
►Restore the height of the intervertebral disk using
distractors.
►Clear the intervertebral disk space using rongeurs,
sharp spoons and curettes.
►If necessary, apply bone material.
Determining the implant height with the
trial implant
Pick up the trial implant with the insertion
instrument
►Turn the rotary nut 3on the insertion instrument A
counterclockwise (“loosen” direction) to push the
rod 6forward, see Fig.1.
Fig.1 Close-up view of the insertion instrument,
switch open
►Couple the trial implant Dto the dihedron 7on the
insertion instrument A, see Fig.2. When doing so,
pay attention to the orientation of the trial implant
(orientation according to the marking on the inser-
tion instrument).
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.
WARNING
Risk of injury to nerves, blood
vessels, and tissue caused by
sharp instruments!
►To avoid injuries, proceed
with extreme care during
the operation.
25 36

5
Fig.2 Coupling the trial implant to the insertion
instrument
Note
The switch 2can only be turned when the rod is in the
front position and the pin 5is fully visible in the switch.
►Turn the switch 2to the right ( direction), see
Fig.3.
Fig.3 Close-up view of the insertion instrument,
switch closed
►Hold the trial implant Dat 0° position on the inser-
tion instrument A, see Fig.8.
►Turn the rotary nut 3on the insertion instrument A
clockwise (“fix” direction) until the trial implant is
clamped, see Fig.4.
Fig.4 Close-up view of the insertion instrument,
trial implant/implant clamped
►Check manually that the trial implant is securely in
place.
Inserting the trial implant
►Insert the trial implant Dwith the insertion
instrument 1straight (0° position) into the pre-
pared implant bed. To do so, carefully hit with a
hammer on the impact surface of the rotary nut 3.
►To turn the trial implant D:
– Gently turn the rotary nut 3counterclockwise
(“loosen” direction). When doing so, make cer-
tain that the pin 5remains outside of the
switch 2.
– Impact the trial implant Dfurther with the
hammer until the required end position is
reached.
►Check the position of the trial implant Dusing
intraoperative X-ray control.
D
7 A
2 35
32 5

6
Aesculap®
TSPACE PEEK/TSPACEXP instruments
Removing the trial implant
►Mount the impact cylinder Conto the insertion
instrument A, see Fig.5.
Fig.5 Mounting the impact cylinder onto the inser-
tion instrument
►Carefully expel the trial implant Dusing the impact
cylinder Cout of the intervertebral space, see
Fig.6.
Fig.6 Expelling the trial implant/implant with the
impact cylinder
►Uncouple the impact cylinder Cfrom the insertion
instrument A.
Uncoupling the trial implant from the inser-
tion instrument
►Turn the rotary nut 3counterclockwise ("loosen"
direction), until the pin 5is fully in the switch 2,
see Fig.3. When doing so, ensure that the pin 5
does not jam the switch 2.
►Turn the switch 2to the left ( direction), see
Fig.1.
►Remove the trial implant.
►If necessary, repeat the process with the next big-
gest trial implant, until the correct implant size is
determined.
Inserting the implant in the implant bed
Picking up the implant with the insertion
instrument
►Select an implant according to the size of the trial
implant.
►Remove the implant with protective packaging
from the sterile packaging.
►Mount the implant ain the protective packaging
onto the dihedron 7of the insertion instrument A,
see Fig.7. When doing so, pay attention to the ori-
entation of the implant (orientation according to
the marking on the insertion instrument).
Fig.7 Coupling the implant to the insertion instru-
ment
Legend
aImplant
►Turn the switch 2to the right ( direction), see
Fig.3.
►Hold the implant at 0° position, see Fig.8.
Fig.8 Implant at 0° position
►Turn the rotary nut 3on the insertion instrument A
clockwise (direction: “fix”), until the implant is
clamped, see Fig.4.
A
C
C
a 7a
A
a 7 A

7
►Remove the protective packaging from the
implant.
►Check manually that the implant is securely in
place.
Filling the implant with bone material
(optional)
►Place the implant ain the filling holder E, see
Fig.9. When doing so, observe the implant length
(marking on the filling holder: L26/L30/L34).
Fig.9 Implant in filling holder
►Compress the bone grafts or bone replacement
material in the inner window of the implant a
using the pestle provided in the set. When doing so,
ensure that the pestle does not damage the surface
of the implant.
Inserting the implant
►Insert the implant awith the insertion
instrument Astraight (0° position) into the pre-
pared implant bed. To do so, carefully hit with a
hammer on the impact surface of the rotary nut 3.
Fig.10 Inserting the implant into the implant bed
►To turn the implant a:
– Gently turn the rotary nut 3counterclockwise
(“loosen” direction). When doing so, make cer-
tain that the pin 5remains outside of the
switch 2.
– Impact the implant afurther with the hammer
until the required end position is reached.
►Check the position of the implant ausing intraop-
erative X-ray control.
►As soon as the end position (see Fig.11) is reached:
Turn the rotary nut 3counterclockwise ("loosen"
direction), until the pin 5is fully in the switch 2,
see Fig.3. When doing so, ensure that the pin 5
does not jam the switch 2.
Fig.11 Implant in end position
►Turn the switch 2to the left ( direction), see
Fig.1.
a
E
A
a
a
A
A
a
a
A

8
Aesculap®
TSPACE PEEK/TSPACEXP instruments
►Carefully remove the insertion instrument Afrom
the implant a. Avoid any tilting or canting of the
instrument when doing so.
►Place bone or bone replacement material around
the implant a.
Removing the implant intraoperatively
If, in the opinion of the surgeon, it becomes necessary
to remove the implant intraoperatively, carry out the
following steps:
►Check the position for coupling the insertion
instrument A, see Fig.1.
►Couple insertion instrument Ato implant ain situ,
see Fig.7.
►Turn the switch 2to the right ( direction), see
Fig.3.
►Mount the impact cylinder Bonto the insertion
instrument A, see Fig.5.
►Carefully expel the implant ausing the impact
cylinder Cout of the intervertebral space, see
Fig.6.
Disassembling
Insertion instrument SN305R
►Turn the rotary nut 3counterclockwise (“loosen”
direction).
►Turn the switch 2to the left ( direction), see
Fig.1.
►Turn the rotary nut 3clockwise (“fix“ direction),
until the rod 6is out of the thread.
►Remove the rod 6from the tube 1, see Fig.12.
Fig.12 Insertion instrument disassembled
Assembling
►Turn the switch 2to the left ( direction).
►Insert the rod 6into the tube 1, see Fig.12.
►Turn the rotary nut 3counterclockwise (“loosen”
direction) to push the rod 6forward, see Fig.1.
6
1