Braun Aesculap S4 FW225R Manual

Aesculap®
Aesculap Spine
Instructions for use/Technical description
S4-Spondylolisthesis reduction instrument (SRI)
FW225R
Gebrauchsanweisung/Technische Beschreibung
S4-Spondylolisthesis-Reduktionsinstrument (SRI)
FW225R
Mode d’emploi/Description technique
Instrument de réduction pour spondylolisthésis (SRI)
S4FW225R
Instrucciones de manejo/Descripción técnica
Instrumento de reducción para espondilolistesis S4
(SRI) FW225R
Istruzioni per l’uso/Descrizione tecnica
Strumento di riduzione della spondilolistesi (SRI) S4
FW225R
Instruções de utilização/Descrição técnica
Instrumento redutor para espondilolistese S4 (SRI)
FW225R
Gebruiksaanwijzing/Technische beschrijving
S4-Spondylolisthesis-reductie-instrument (SRI)
FW225R
Bruksanvisning/Teknisk beskrivning
S4-spondylolistes-reduktionsinstrument (SRI) FW225R
Инструкция по примению/Техническое опи-
сание
S4инструмент для редукции спондилолистеза
(SRI) FW225R
Návod k použití/Technický popis
Redukční nástroj spondylolistézy (SRI) S4FW225R
Instrukcja użytkowania/Opis techniczny
Przyrząd redukcyjny do kręgozmyku (SRI) S4FW225R
Návod na použitie/Technický opis
Nástroj na redukciu spondylolistézy (SRI) S4FW225R
Kullanım Kılavuzu/Teknik açiklama
S4Spondilolistezis redüksiyon ekipmanı (SRI) FW225R
사용 설명서 /기술 설명
S4척추전방전위증 교정 기구 (SRI) FW225R

5
4
3
1
2
FW232R
FW 231R

9
7
11
8
10
12
6
FG322R
FG321R

2
Aesculap®
S4-Spondylolisthesis reduction instrument (SRI) FW225R
Aesculap® S4-Spondylolisthesis reduction instrument (SR I) FW225R
Legend
1Cylinder piece
2Polyaxial screw body
3Mounting post
4Outer T-handle
5Inner T-handle
6Distraction spindle
7Articular head of mounting post
8Distraction spindle nut
9Tightening key
10 Reduction lever
11 Positioning screws
12 Rod
Symbols on product and packages
About this document
Note
General risk factors associated with surgical proce-
dures are not described in this documentation.
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 S4Spondylolisthesis Reduction Instrument (SRI) is
used for reduction of spondylolisthesis or dislocated
vertebrae in the region of the lumbar spine.
Indications
Indications are described in the relevant chapter of the
instructions for use TA011187.
Absolute contraindications
Absolute contraindications are described in the rele-
vant chapter in the instructions for use TA011187.
Relative contraindications
Relative contraindications are described in the rele-
vant chapter in the instructions for use TA011187.
Components required for use
Caution, general warning symbol
Caution, see documentation sup-
plied with the product
Art. no. Designation
FG321R SOCON Hook wrench for spindle dis-
tractor
FG322R SOCON Quick wrench, angled
FW231R S4SRI T-wrench
FW232R S4SRI T-wrench with hex chuck

3
Safe handling and preparation
CAUTION
Federal law restricts this device to sale by, or on
order of a physician!
The S4Spondylolisthesis reduction instrument requires
the surgeon to have practical experience with spine
stabilization systems and a good biomechanical
knowledge of the unstable spine. The decision as to
whether, and to what extent reduction is required is
dependent on the indication and is the responsibility of
the treating surgeon. In order to ensure safe reduction,
the force may only be applied in small doses and the
spread may not exceed the height of the physiological
disc space.
The S4Spondylolisthesis reduction instrument should
be used exclusively with implants of the Aesculap
S4Spinal System. For specific information about
S4implants and instruments, please contact your Aes-
culap Service Agency or Aesculap directly.
►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.
►Clean the new product after removing its transport
packaging and prior to its initial sterilization (auto-
matic).
►Store any new or unused products in a dry, clean,
and safe place.
►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
Screw placement
Note
Screw placement is critical. It is recommended to place
the screws parallel in the saggital plane and to make
sure the screws are not too laterally deviated.
►Within the limits of the patient's anatomy, place
the screws in the cephalad vertebral body parallel
to its superior endplate and as parallel to each
other as possible.
►Place the caudal vertebra screws so that they are
parallel to the cephalad vertebra screws in both
planes (contrary to the standard convergent man-
ner).
Placement of screws in this way allows for optimal
operation of the reduction instrument and provides
for easier rod placement.
WARNING
Trauma to the spinal columns
and nerve roots due to incor-
rect application!
►Monitor under image
intensifier control and/or
monitor spinal cord.
►Avoid over-distraction or
overreduction.
►Avoid over-tightening the
repositioning device to the
pedicular screws.
WARNING
Risk of injury and/or malfunc-
tion!
►Always carry out a func-
tion check prior to using
the product.