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TL®
®
Aesculap
MACS
Anterior Stabilization System
Intended use
The MACS TL® implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar and tho-
racic spine. They comprise:
■
Anchoring screws for the vertebral bodies
■
Tensioning elements
■
Fixation nuts and clamping screws
■
Connecting plates and, if necessary, rods of the Aesculap SPINE-System® Evolution with a diameter of 5.2 mm
as connecting elements
System configurations:
■
Polyaxial twin-screw system with plate or 2 rods (see Fig. 1)
■
Polyaxial HMA system with plate or 2 rods (see Fig. 2)
■
Monoaxial HMA single-rod system (see Fig. 3)
Materials
The materials used in the implant are listed on the packaging:
■
ISOTAN®
Titanium forged alloy Ti6Al4V acc. to ISO5832-3
F
The titanium implants are anodized with a colored oxide layer. Slight changes in coloration may occur, but do not
affect the implant quality.
ISOTAN® and MACS TL® are registered trademarks of Aesculap AG, 78532 Tuttlingen / Germany.
System configurations
System incompatibility may result in increased operating time or abortion of the
procedure!
►
Follow only instructions for use TA013373 when using the pre-assembled
retaining bolt SX804T.
CAUTION
Indications
Surgically installed implants serve to support normal healing processes. They are not intended for use either as
replacements for natural body parts or to bear loads over the long term if healing does not occur.
Use polyaxial twin-screw system in case of:
■
Fractures
■
Spinal tumor
■
Degenerative disc disorder (spondylolisthesis, spondylolysis, spinal stenosis)
■
Post-trauma instability
Use polyaxial HMA system, with intact posterior column, in case of:
■
Spinal tumor
■
Degenerative disc disorder (spondylolisthesis, spondylolysis, spinal stenosis)
■
Post-trauma instability
Use monoaxial HMA system in case of:
■
Anterior correction of spinal deformities
Contraindications
This system is not licensed to be screwed onto, or fastened to, the posterior elements (pedicles) of the cervical, tho-
racic or lumbar spine.
Do not use in the presence of:
■
Fever
■
Acute or chronic vertebral infections of a local or systemic nature
■
Pregnancy
■
Severe osteoporosis or osteopenia
■
Medical or surgical conditions that could negatively affect the outcome of the implantation
■
Severely damaged bone structures that could prevent stable implantation of implant components
■
Bone tumors in the region of implant fixation
■
Wound healing disorders
■
Inadequate patient compliance
■
Foreign body sensitivity to the implant materials
■
Cases not listed under indications
Side effects and interactions
The application or improper use of this system entails the following risks:
■
Implant failure resulting from excessive load
– Warping or bending
– Loosening
– Breakage
■
Inadequate fixation
■
Failed or delayed fusion
■
Infection
■
Fractured vertebral body or bodies
■
Injuries to
– Nerve roots
– Spinal cord
– Blood vessels
– Organs
Safety notes
CAUTION
Federal law restricts this device to sale by, or on order of a physician!
To prevent corrosion, do not use this system in conjunction with other materials.
■
It is the operating surgeon's responsibility to ensure that the surgical procedure is performed properly.
■
General risk factors associated with surgical procedures are not described in in the present instructions for use.
■
The operating surgeon must have a thorough command of both the hands-on and conceptual aspects of the
established operating techniques.
■
The operating surgeon must be fully conversant with bone anatomy, including the pathways of nerves, blood ves-
sels, muscles, and tendons.
■
It is the operating surgeon's responsibility to ensure the correct combination of implant components and their
implantation.
■
Aesculap is not responsible for any complications arising from wrong indication, wrong choice of implant, incor-
rect combination of implant components and operating technique, the limitations of the treatment method, or
inadequate asepsis.
■
The instructions for use for individual Aesculap implant components must be followed.
■
The implant components were tested and approved in combination with Aesculap components. If other combi-
nations are used, the responsibility for such action lies with the operating surgeon.
■
Do not, under any circumstances, combine implant components from different manufacturers.
■
Do not, under any circumstances, use damaged or surgically removed components.
■
Implants that have been used before must not be reused.
■
Damage to load-bearing bone structures can result in loosening of the components, bone or implant fractures
or other acute complications.
■
To ensure the earliest possible detection of such causes of dysfunction, the implant must be checked periodically,
using appropriate techniques.
Interactions between MRI and implant components!
■
MRI examinations using magnetic fields of 1.5 and 3.0 tesla do not present an
additional risk to implant bearers.
■
MRI causes non-critical, localized heat development.
■
Implants produce moderate MRI artifacts.
■
Delayed healing can cause implant breakage due to material fatigue.
■
The attending physician shall make any decision with regard to the removal of implant components that have
been used.
■
Damage to the load-bearing structures of the implant can lead to loosening of components, dislocation, migra-
tion, and other severe complications.
■
The implant components applied, along with their article numbers, the name of the implant, as well as the batch
number and serial number (if available) must be documented in all patient records.
■
Postoperatively, individual patient information, as well as mobility and muscle training, is of particular impor-
tance.
Sterility
■
The implant components are supplied in an unsterile condition.
■
The implant components are packaged individually.
►
Store the implant components in their original packaging and only remove them from their original and protec-
tive packaging immediately prior to application.
►
Use a suitable tray for cleaning/disinfection.
►
Ensure that the implant components are not damaged in any way.
Prior to initial sterilization and subsequent resterilization, the implant components must be cleaned using the fol-
lowing validated reprocessing procedure:
Note
Adhere to national statutory regulations, national and international standards and directives, and local, clinical
hygiene instructions for sterile processing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant
national regulations concerning the reprocessing of products.
Note
Successful processing of this medical device can only be ensured if the processing method is first validated. The oper-
ator/sterile processing technician is responsible for this.
The recommended chemistry was used for validation.
Note
If there is no final sterilization, then a virucidal disinfectant must be used.
Note
For the latest information on reprocessing and material compatibility see also the Aesculap extranet at
www.extranet.bbraun.com
The validated steam sterilization procedure was carried out in the Aesculap sterile container system.
Validated reprocessing procedure
Mechanical alkaline cleaning and thermal disinfection
►
Place the implants on a tray that is suitable for cleaning (avoiding rinsing blind spots).
Machine type: single-chamber cleaning/disinfection device without ultrasound
Phase
Step
T
[°C/°F]
I
Prerinse
<25/77
II
Cleaning
55/131
III
Intermediate rinse
>10/50
IV
Thermal disinfection
90/194
V
Drying
-
D–W:
Drinking water
FD–W:
Fully desalinated water (demineralized, low microbiological contamination: drinking water quality
at least)
*Recommended: BBraun Helimatic Cleaner alkaline
Inspection, maintenance and checks
►
Allow the product to cool down to room temperature.
►
Inspect the product after each cleaning and disinfecting cycle to be sure it is: clean, functional, and undamaged.
►
Immediately set aside damaged or inoperative products.
Packaging
►
Place the product in its holder or on a suitable tray.
►
Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers).
►
Make sure that the packaging will prevent a recontamination of the product during storage.
t
Water
Chemical/Note
quality
[min]
3
D–W
-
■
10
FD-W
Concentrate, alkaline:
– pH = 13
– < 5 % anionic surfactant
■
0.5 % working solution
– pH = 11*
1
FD-W
-
5
FD-W
-
-
-
According to the program for cleaning
and disinfection device
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