3
en
1.
About this document
Note
General risk factors associated with surgical procedures are not described
in these instructions for use.
1.1
Scope
These instructions for use apply for S
4
Cervical – Navigated Instruments.
Note
The applicable CE mark for the product can be seen on the label or packag-
ing of the product.
►
For article-specific instructions for use as well as information on mate-
rial compatibility and lifetime see B. Braun eIFU at eifu.bbraun.com
1.2
Safety messages
Safety messages make clear the dangers to patient, user and/or product
that could arise during the use of the product. Safety messages are labeled
as follows:
DANGER
Indicates a possible threat of danger. If not avoided, death or serious
injury may result.
WARNING
Indicates a possible threat of danger. If not avoided, minor or moder-
ate injury may result.
CAUTION
Indicates a possible threat of material damage. If not avoided, the
product may be damaged.
2.
Clinical use
2.1
Areas of use and limitations of use
2.1.1
Intended use
The S
4
Cervical system (S
4
C system) is used for posterior occipital cervical
and thoracic stabilization and fusion.
2.1.2
Indications
Note
The manufacturer is not responsible for any use of the product against the
specified indications and/or the described applications.
Indications are specified in the instruction for use for the implants
(TA011796).
2.1.3
Contraindications
Contraindications are specified in the instruction for use for the implants
(TA011796).
2.2
Safety information
2.2.1
Clinical user
General safety information
To prevent damage caused by improper setup or operation, and to not
compromise the manufacturer warranty and liability:
►
Use the product only according to these instructions for use.
►
Follow the safety and maintenance instructions.
►
Ensure that the product and its accessories are operated and used only
by persons with the requisite training, knowledge and experience.
►
Store any new or unused products in a dry, clean, and safe place.
►
Prior to use, check that the product is in good working order.
►
Keep the instructions for use accessible for the user.
Note
The user is obligated to report all severe events in connection with the prod-
uct to the manufacturer and the responsible authorities of the state in
which the user is located.
Notes on surgical procedures
It is the user's responsibility to ensure that the surgical procedure is per-
formed correctly.
Appropriate clinical training as well as a theoretical and practical profi-
ciency of all the required operating techniques, including the use of this
product, are prerequisites for the successful use of this product.
The user is required to obtain information from the manufacturer if there
is an unclear preoperative situation regarding the use of the product.
2.2.2
Product-specific safety information
►
Observe the surgical technique of the S
4®
Cervical system O34202.
The instruments listed in the key form part of this system. They are used
for the individual adaptation, positioning and insertion of S
4
C implants in
patients. For safe usage, follow instructions for use for S
4
C System Instru-
ments (TA011984) and Operating Techniques (O34202/O83002)
The instruments listed in the key may only be used with the Brainlab nav-
igation system. For safe handling prior to the operation, read Spine &
Trauma user manual for Brainlab instruments and the corresponding soft-
ware manual for the Brainlab spine application used.
Combination specifications
Note
Aesculap and Brainlab accept absolutely no responsibility if instruments,
centering tools or drills other than those named below are used with the
corresponding drill guides and guide sleeves.
■
Only combine S
4
C navigated drill guide
F
with:
– S
4
C centering tool
P
for S
4
C drill guide
F
– S
4
C drill
R
Ø
2.4 mm for
Ø
3.5 mm screws
■
Only combine S
4
C navigated drill guide
G
with:
– S
4
C centering tool
Q
for drill guide
G
– S
4
C drill
S
Ø
2.9 mm for
Ø
4.0 mm screws
■
Only combine S
4
C navigated guide sleeve
Ø
4.0 mm
I
for smoothshank
screws with:
– Smooth-shaft screw bone awl (FW085R)
– Drill for
Ø
2.9 mm smooth-shaft screws (FW086SU)
– Smooth-shaft (Shank) screw tapper (Tap) (FW087R)
– Polyaxial screwdriver (FW070R/FW131R)
– Navigated screwdriver for polyaxial screw (FW656R)
– Apfelbaum ball head screwdriver, short (FJ968R)
Содержание Aesculap S4 Cervical
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