B. Braun Aesculap Spine MACS II Gebrauchsanweisung/Technische Beschreibung Seite 4

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Insert placeholder.
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Insert stabilizing plate or rods.
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Implant stabilizing plate and locknut in such a way that the inscribed side (top side) is visible for the user.
Injury can result from nuts with insufficient clamping stability!
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Set locknuts in place correctly.
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Using a torque wrench, tighten the locknuts to a torque of 15 Nm.
WARNING
Risk of injury if no or insufficient counterforce is applied using the counter holder!
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To apply a counterforce, always use the counter holder provided, ensuring that
an absolute minimum of force is transferred to the spine.
WARNING
Damage to the implant caused by overtightening of the locknut!
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Always tighten the locknuts to the exact torque specified for this purpose.
WARNING
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Use a ballpoint screwdriver to evenly tighten polyaxial anchoring screws further.
Ensure that the ballpoint screwdriver is lodged securely in the polyaxial anchoring
screw!
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When further tightening the polyaxial anchoring screws, rotate each one no
more than one full turn.
WARNING
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Remove the ballpoint screwdriver from the rear section of the polyaxial
anchoring screw by lightly rotating it left and right.
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When using the Twin-Screw system, insert the stabilization screw using an appropriate aiming sleeve and screw
in to the positive stop.
Risk of injury due to use of unsuitable aiming sleeve, incorrect placement of the
aiming sleeve, or failure to use an aiming sleeve!
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Use the thoracic aiming sleeve when using the thoracic tensioning element
(see handle geometry).
WARNING
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Use the lumbar aiming sleeve when using the lumbar tensioning element (see
handle geometry).
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Ensure that the aiming sleeve is positioned above the hole for the stabilization
screw in the tensioning element.
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Always use the suitable aiming sleeve to insert the stabilization screw.
Risk of injury if the aiming sleeve becomes jammed in the centralizer as a result
of severe angular misalignment between the approach direction and centralizer
axis!
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A lumbar stabilization screw can be used to unscrew and remove a jammed
WARNING
aiming sleeve in a controlled manner.
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To lock the polyaxial screw, tighten the torque wrench to 10 Nm for two clicks. The first click causes the break-
off collar on the pre-assembled retaining bolt to break off; the second click releases the torque wrench at a
torque of 10 Nm.
Risk of injury caused by insufficiently tightened fixing screws of the polyaxial ele-
ments!
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Using a torque wrench, tighten the fixing screws to a torque of 10 Nm.
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The screwdriver for the retaining bolt must engage fully in the fixing screw to
WARNING
prevent it from slipping.
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The groove on the screwdriver to accommodate the retaining bolt must be
completely covered by the guide tube.
Risk of injury if the centralizer is left in the body!
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In the event of failure of the 10 Nm torque wrench, the retaining bolt can be
locked using a ¼" T-handle grip.
WARNING
Operating time may be increased as a result of incorrect application!
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Do not pull out the insertion instrument after the first click!
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Only pull out the insertion instrument after completion of the second click.
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WARNING Ensure that the insertion instrument does not slip off the tensioning element
after the first click.
Further information on Aesculap implant systems is always available from B. Braun/Aesculap or the appropriate
B. Braun/Aesculap office.
Disposal
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Adhere to national regulations when disposing of or recycling the product, its components and its packaging!
TA-Nr. 013373 2017-12 V6 Änd.-Nr. 57994