Safety Messages; Clinical Use; Areas Of Use And Limitations Of Use; Intended Use - Braun Aesculap TSPACE PEEK Instructions For Use/Technical Description

en
►
For article specific instructions for use and material
compatibility and
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:
WARNING
Indicates a possible threat of danger. If not avoided,
minor or moderate 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 TSPACE PEEK/TSPACE
are used to insert TSPACE PEEK (third generation),
XP
TSPACE and TSPACE 3D trial implants and implants
into the thoracolumbar spine.
The SN305R insertion instrument 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
XP
TSPACE PEEK/TSPACE
are used to hold the implants on the surgical table
while filling the inner window with bone material.

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.
For indications, see Intended use.

2.1.3 Contraindications

No known contraindications.
4
lifetime information,
XP
/TSPACE 3D instruments
holders SN304R
) and SN704R (for TSPACE 3D)
2.2

Safety information

see

2.2.1 Clinical user

General safety information
To prevent damage caused by improper setup or oper-
ation, and to not compromise the manufacturer war-
ranty and liability:
►
Use the product only according to these instruc-
tions for use.
►
Follow the safety and maintenance instructions.
►
Ensure that the product and its accessories are
operated and used only by persons with the requi-
site 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 work-
ing order.
►
Keep the instructions for use accessible for the
user.
Note
The user is obligated to report all severe events in con-
nection with the product 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 performed correctly.
Appropriate clinical training as well as a theoretical
and practical proficiency of all the required operating
techniques, including the use of this product, are pre-
requisites for the successful use of this product.
(for
The user is required to obtain information from the
manufacturer if there is an unclear preoperative situa-
tion regarding the use of the product.

2.2.2 Product

Product-specific safety information
►
Only use the product with visual control.

2.2.3 Sterility

The product is delivered in an unsterile condition.
►
Clean the new product after removing its transport
packaging and prior to its initial sterilization.