Distributor In The Us/Contact In Canada For Product Information And Complaints - B. Braun Aesculap Spine MACSTL Gebrauchsanweisung/Technische Beschreibung

Sterilization
►
Validated sterilization process
– Steam sterilization through fractionated vacuum process
– Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665
– Sterilization using fractionated vacuum process at 134 °C/holding time 5 min
►
When sterilizing several instruments at the same time in a steam sterilizer, ensure that the maximum load capac-
ity of the steam sterilizer specified by the manufacturer is not exceeded.
Storage
►
Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.
Application
The MACS TL® system is described in detail in the OR manual. Detailed user instructions can be found in the product
documentation.
The OR manual can be ordered from the manufacturers at any time.
The operating surgeon shall devise an operation plan that specifies and accurately documents the following:
■
Selection of the implant components and their dimensions
■
Positioning of the implant components in the bone
■
Location of intraoperative landmarks
Note
For a secure implantation of the anchoring screws, careful measurement of the vertebral body's diameter at the
planned screw position and direction is crucial. A screw length smaller than the measured diameter has to be chosen.
The following conditions must be fulfilled prior to application:
■
All requisite implant components are ready to hand.
■
Operating conditions are highly aseptic.
■
All requisite implantation instruments must be available and in working order, including specialized Aesculap
implantation systems.
■
The operating surgeon and operating room team are thoroughly familiar with the operating technique and with
the available range of implants and instruments; information materials on these subjects must be complete and
ready to hand.
■
The operating surgeon is fully conversant with the rules governing medical practice, the current state of scientific
knowledge, and the contents of relevant scientific articles by medical authors.
■
Information has been obtained from the manufacturer in the event of an ambiguous preoperative situation and
if implants are present in the area to be treated
The surgical procedure and following information has been explained to the patient, and the patient's consent has
been documented:
■
In the case of delayed or incomplete fusion, the implants can break and loosen due to high loads.
■
The life-span of the implant depends on the patient's body weight.
■
The implant components must not be overloaded by extreme strains, hard physical labor or sports.
■
Corrective surgery may be necessitated by implant loosening, fracture or loss of correction.
■
Smokers present an increased risk of bone fusion failure.
■
The patient must undergo medical check-ups of the implant components at regular intervals.
The implantation of the MACS TL® system requires the following application steps:
►
Select the suitable MACS TL® system version and anchoring screws on the basis of the indication, the preopera-
tive planning and the bone situation found during the operation.
►
Determine the optimum implant position of the MACS TL® system:
– Preposition the implant with Kirschner wires and
– Prepare the bone correctly, using cannulated instruments.
►
Apply the implantation instruments in the correct way.
►
To avoid internal stress on, and weakening of, the implant: avoid scoring or scratching of the implant compo-
nents.
►
Do not bend metal implants, except for the rods of the Aesculap SPINE-System® Evolution.
►
Do not bend the rods back or bend them excessively.
►
Use only the bending instruments from the MACS TL® instrument set to bend the rods.
►
Mount the centralizer on the polyaxial elements using the special mounting instrument.
►
Insert the implant components using the special insertion instruments.
►
Do not tighten or screw in the polyaxial screw completely; ensure that the tensioner element can still be moved.
►
Prior to unlocking the insertion instrument, remove the Kirschner wire through the cannulated insertion element,
using the appropriate removal instrument.
►
Remove the insertion instrument.
►
When using a polyaxial element, ensure that the centralizers remain temporarily mounted on the tensioner ele-
ments.
►
Distract and insert placeholder, if necessary.
►
Insert stabilizing plate or rods. Implant stabilizing plate and locknut in such a way that the inscribed side (top
side) is visible for the user.
Risk of injury caused by insufficiently tightened clamping screws of the polyaxial
elements!
►
Set clamping screws in place correctly.
►
Using a torque wrench, tighten the clamping screws to a torque of 10 Nm.
WARNING
►
Remove centering devices.
►
Tighten the polyaxial anchoring screws evenly.
►
When using the Twin-Screw system, insert the stabilization screw through a suitable centralizer.
►
When using a polyaxial element, insert a clamping screw.
Injury can result from nuts with insufficient clamping stability!
►
Set nuts in place correctly.
►
Using a torque wrench, tighten the nuts to a torque of 15 Nm.
WARNING
Further information on Aesculap implant systems is always available from B. Braun/Aesculap or the appropriate
B. Braun/Aesculap office.
Distributor in the US/Contact in Canada for product information and
complaints
Aesculap Implant Systems LLC
3773 Corporate Parkway
Center Valley, PA, 18034,
USA
TA-Nr. 010220 03/14 V6 Änd.-Nr. 48365