B. Braun Aesculap Spine MACS II Gebrauchsanweisung/Technische Beschreibung Seite 3

Manual cleaning/disinfection
Manual cleaning with ultrasound and immersion disinfection
Phase Step T
[°C/°F]
I Ultrasonic cleaning RT
(cold)
II Intermediate rinse RT
(cold)
III Disinfection RT
(cold)
IV Final rinse RT
(cold)
V Drying RT
D–W: Drinking water
FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality
at least)
RT: Room temperature
*Recommended: BBraun Stabimed
►
Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
infection procedure.
Phase I
►
Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible
surfaces are immersed and acoustic shadows are avoided.
►
Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed
from the surface.
►
If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min.
►
Mobilize non-rigid components, such as set screws, links, etc. during cleaning.
►
Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a
disposable syringe.
Phase II
►
Rinse/flush the product thoroughly (all accessible surfaces) under running water.
►
Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.
►
Drain any remaining water fully.
Phase III
►
Fully immerse the product in the disinfectant solution.
►
Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.
►
Rinse lumens at least five times at the beginning of the exposure time with an appropriate disposable syringe.
Ensure that all accessible surfaces are moistened.
Phase IV
►
Rinse/flush the product thoroughly (all accessible surfaces) under running water.
►
Mobilize non-rigid components, such as set screws, joints, etc. during final rinse.
►
Rinse lumens with an appropriate disposable syringe at least five times.
►
Drain any remaining water fully.
Phase V
►
Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning
and disinfection procedure.
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 the implant system storage devices covered or closed.
WARNING
►
Process implant system storage devices separately from instrument trays.
►
Clean implants must not be cleaned together with contaminated implants.
►
Reprocess 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.
►
Mechanically clean and disinfect the implant components.
►
Do not reuse surgically contaminated implants.
Direct or indirect contamination may render implants unsuitable for resteriliza-
tion!
►
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 in its holder or on a suitable tray.
►
Pack trays appropriately for the intended sterilization process (e.g. in Aesculap sterile containers).
►
Ensure that the packaging provides sufficient protection against recontamination of the product during storage.
Sterilization
►
Validated sterilization process
– Steam sterilization using 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 products at the same time in a steam sterilizer, ensure that the maximum load capacity
of the steam sterilizer specified by the manufacturer is not exceeded.
t Conc. Water Chemical
[%] quality
[min]
>15 2 D–W Aldehyde-free, phenol-free,
and QUAT-free concentrate,
pH ~ 9*
1 - D–W -
15 2 D–W Aldehyde-free, phenol-free,
and QUAT-free concentrate,
pH ~ 9*
1 - FD-W -
- - - -
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 cru-
WARNING
cial.
►
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
■
The implantation instruments, including the special Aesculap implant system instruments, are complete and in
working condition.
■
The operating surgeon and operating room team are thoroughly conversant 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.
■
The manufacturer has been consulted if the preoperative situation was unclear and if implants were found in the
area operated on.
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 regular medical follow-up examinations of the implant components.
The implantation of the MACS II system requires the following application steps:
►
Select the suitable MACS II system version and anchoring implant on the basis of the indication, the preoperative
planning and the bone situation found during the operation.
►
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 if incorrect instruments are used!
►
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 compo-
nents.
►
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 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 tight-
ening 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 comes loose during the procedure!
►
Mount the pre-assembled retaining bolt using the mounting block and mount-
ing 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 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.
Risk of injury due to use of MACS TL® distraction and/or compression instruments!
►
Do not use any MACS TL® distraction and/or compression instruments!
WARNING