About This Document; Scope; Safety Messages; Clinical Use - B. Braun Aesculap Spine Quintex SC420R Gebrauchsanweisung/Technische Beschreibung

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 the following products: Quintex® ante-
rior cervical plate system - 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:
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 instruments listed in the legend are part of the Quintex® system for
anterior cervical fusion.
The instruments are used for fixating the Quintex® plates and screws. The
surgeon uses the instruments to adapt the Quintex® implants to the indi-
vidual patient and to position and insert them.
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.
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

Product-specific safety information
The surgeon must have extensive and detailed knowledge of the stabiliza-
tion techniques for the cervical spine and its biomechanical properties. The
surgeon must also be familiar with the theory and practice of the relevant
surgical techniques for the Quintex® system.
►
Observe the instructions for use for Quintex® plates and screws
(TA013366) and the corresponding operating manual (brochure no.
O91702).
►
SC431R/SC428R: Only use the product under X-ray vision.
2.2.3

Sterility

Art. no.
FJ833RS
The product is gamma-sterilized and supplied in sterile packaging.
The product must not be reused.
►
Observe the additional handling instructions.
►
Do not use the product if it is damaged or defective. Set aside the prod-
uct if it is damaged.
►
Do not use the product after its use-by date.
►
See TA009932 "ABC temporary fixation pins" for further information.
2.3

Application

WARNING
Risk of injury and/or malfunction!
►
Prior to each use, inspect the product for loose, bent, broken,
cracked, worn, or fractured components.
►
Always carry out a function test prior to each use of the product.
2.3.1 Determining the Quintex® plate length
►
To determine the correct plate length, use caliper B or another appro-
priate means of measuring device.
►
Use the scale to read the distance between the two ends.
The drag indicator stays in its position and indicates the measured plate
length, even if the arms of the caliper are closed again.
Note
The drag indicator must be returned to its initial position before each new
measurement.
Designation
Temporary fixation pin
3