Inspection, Maintenance, And Checks - B. Braun Aesculap Spine MACS II Gebrauchsanweisung

Phase I
Clean the product in an ultrasonic cleaning bath (frequency 35 kHz). Ensure that all accessible surfaces are
immersed and acoustic shadows are avoided.
Do not use brushes or other abrasives that would damage the product surfaces and could cause corrosion.
To prevent internal stresses on, and weakening of the implants: avoid scoring or scratching of the implant
components.
Stage II
Rinse/flush the instrument thoroughly (all accessible surfaces) under running water.
Allow water to drip off for a sufficient length of time.
Phase III
Fully immerse the instrument in the disinfectant solution. Ensure that all accessible surfaces are moistened.
Phase IV
Rinse/flush the instrument thoroughly (all accessible surfaces) under running water.
Phase V
Rinse/flush the instrument thoroughly (all accessible surfaces) under running water.
Allow water to drip off for a sufficient length of time.
Stage VI
Dry the instrument thoroughly with a lint-free cloth or medical compressed air.
For implant components that are to be resterilized:
Intraoperative contamination with blood, secretions, and other fluids may render the
affected component unsuitable for resterilization!
Handle the implants with new gloves only.
Keep implant system storage devices covered or closed.
WARNING
Process implant system storage devices separately from instrument trays.
Clean implants must not be processed together with contaminated implants.
Process the implant components individually and separately if no implant system
storage devices are available, ensuring that the implant components are not
damaged in the process.
Do not reuse implants contaminated in the course of surgery!
Direct or indirect contamination may render implants unsuitable for resterilization!
Do not reprocess implants that have been directly or indirectly contaminated with
blood.
WARNING

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 sort out damaged or inoperative products.
Packaging
Place the product into its holder or put it on a suitable screen basket.
Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers).
Ensure that the packaging provides sufficient protection against recontamination of the product during storage
(DIN EN ISO 11607).
Sterilization
Validated sterilization process for the anchoring screws for the vertebral bodies, tensioning elements, locknuts,
connecting plates, and rods:
– Steam sterilization through fractionated vacuum process
– Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665
– Sterilization through 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
capacity of the steam sterilizer, as 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
Risk of injury caused by incorrect operation of the product!
Attend appropriate product training before using the product.
For information about product training, please contact your national B. Braun/
Aesculap agency.
WARNING
The MACS II 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
Risk of injury due to unsuitable selection and incorrect position of anchoring screws!
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.
WARNING
The following conditions must be fulfilled prior to application:
• All requisite implant components are ready to hand.
• Operating conditions are highly aseptic.
• The implantation instruments, including the special Aesculap implant system instruments, are complete and in
working condition.
• The surgeon and operating team are fully conversant with the surgical technique, range of implants, and
instrument set; complete information materials on these subjects are readily available at the workplace.
• 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.
• The manufacturer has been consulted if the preoperative situation was unclear and if implants were found in the
spine region being operated on.
The surgical procedure has been explained to the patient and their agreement concerning the following information
has been recorded:
• 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 fusion failure.
• The patient must undergo regular medical follow-up examinations of the implant components.
Implantation of the MACS II system requires the following steps:
Select the appropriate MACS II system variant and anchoring implants according to indication, preoperative
planning, and the bone situation found intraoperatively.
Determine the optimum implant position of the MACS II system:
Preposition the implant with Kirschner wires under X-ray control.
Risk of injury if Kirschner wires are positioned incorrectly!
Always use X-ray control when positioning Kirschner wires.
Use X-ray control to constantly monitor the position of the Kirschner wires
throughout the operation.
WARNING
Risk of injury due to use of unsuitable instruments!
Never use the screw revision instrument to apply counterforce at the Kirschner
wires.
Only use the counter holder to apply counterforce at the Kirschner wires.
WARNING
Prepare the bone correctly, using cannulated instruments.
To avoid internal stress on, and weakening of, the implant: avoid scoring or scratching of the implant
components.
Do not bend or warp any metal implants with the exception of the rods of the Aesculap Spine System Evolution.
Do not re-bend the rods or bend them excessively.
Use only the bending instruments from the Spine MACS TL® instrument set to bend the rods.
Mount the pre-assembled retaining bolt on the polyaxial elements using the special mounting instrument.
Risk of injury due to inability to apply the necessary counter torque when tightening
the locknuts or retaining bolt!
Make sure the retaining lugs of the centralizer engage fully in the appropriate
grooves in the tensioning element.
WARNING
Risk of injury if centralizer is loosened intraoperatively!
Mount the pre-assembled retaining bolt using the mounting block and mounting
torque wrench and tighten to a torque of 1.8 Nm
WARNING
Insert the implant components using the special insertion instruments.
Do not tighten or screw in the polyaxial screw completely; ensure that the tensioning 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 tensioning
elements.
Risk of injury to use of MACS TL® distraction and/or compression instruments!
Do not use any MACS TL® distraction and/or compression instruments!
WARNING
Insert placeholder.
Insert stabilizing plate or rods.
Implant stabilizing plate and fixation nut in such a way that the inscribed side (top side) is visible for the user.
Injury can result from nuts with insufficient clamping stability.
Set locknuts in place correctly.
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!
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 locknuts!
Always tighten the locknuts to the exact torque specified for this purpose.
WARNING
Use a ballpoint screwdriver to evenly tighten polyaxial anchoring screws further.
Risk of jammed ballpoint screwdriver in the polyaxial anchoring screw!
When further tightening the polyaxial anchoring screws, rotate each one no more
than one full turn.
Remove the ballpoint screwdriver from the rear section of the polyaxial anchoring
WARNING
screw by lightly rotating it left and right.
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!
Use the thoracic aiming sleeve when using the thoracic tensioning element (see
handle geometry).
WARNING
Use the lumbar aiming sleeve when using the lumbar tensioning element (see
handle geometry).
Ensure that the aiming sleeve is positioned above the hole for the stabilization
screw in the tensioning element.
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!
A lumbar stabilization screw can be used to unscrew and remove a jammed aiming
sleeve in a controlled manner.
WARNING
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.