Validated Reprocessing Procedure - B. Braun Aesculap Spine Quintex Gebrauchsanweisung/Technische Beschreibung

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
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.
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Keep the implant system storage devices covered or closed.
WARNING
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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 sys-
tem storage devices are available, ensuring that the implant components are
not damaged in the process.
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Mechanically clean and disinfect the implant components.
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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
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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 whilst in storage.
Sterilization
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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.
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
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 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
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 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 operating surgeon has detailed knowledge of cervical-spine stabilization and the biomechanical principles
of the cervical spine.
The surgical procedure and following information has been explained to the patient, and the patient's consent has
been documented:
■
The patient is aware of the risks involved in neurosurgery, general surgery, orthopedics, and general anesthesia.
■
The patient has been informed of the advantages and drawbacks of implants and has been made aware of pos-
sible alternative methods of treatment.
■
In cases of delayed or incomplete fusion, the implants may break or loosen as a result of excessive strains.
■
The life-span of the implant depends on the patient's body weight.
■
The implant components must not be overloaded by excessive 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 Quintex® system requires the following application steps:
►
Only use Quintex® instruments from Aesculap.
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Comply with the information contained in the instructions for use for Quintex® instruments (TA013377) and the
operating manual (brochure number O91702).
►
Select implant components according to the indication, preoperative planning, and the bone situation found
intraoperatively.
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Make sure that high-grade steel and titanium components are not combined in one and the same spinal con-
struct.
►
In order to prevent internal stresses on, and weakening of the implants: do not notch or scratch implant compo-
nents.
The two types of Quintex® plate are marked with the following color coding:
■
Gold = dynamic Quintex® plate
■
Blue = hybrid Quintex® plate (constrained/semiconstrained)
►
Select the correct Quintex® plate in terms of type and length.
►
Select the length of the Quintex® plate according to the following criteria:
– as short as possible
– enclosing the area to be fixed
– allowing for axial settling
Note
The length of the implant is usually finally determined during the operation. The curvature of the Quintex® plates can
be adapted to circumstances or the intended curvature of the spine, if applicable.
Note
In order to prevent excessive or insufficient lordosation, long Quintex® plates should only be bent gradually.
Damage to or breakage of the Quintex® plate caused by an impermissible load on
the implant material!
►
Always bend the Quintex® plate in one direction only.
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Do not bend back the Quintex® plate.
CAUTION
►
Always use the Quintex® plate bender to bend a Quintex® plate.
Damage to the locking mechanism of the plate holes caused by incorrect bending
of the plates.
►
Only bend the plate in the area of the bone chip window.
►
Never bend the plate right next to or on the plate holes.
CAUTION
►
Only bend the plate longitudinally and in the area of the bone chip window.
►
Avoid small bending radii, bending back, notching, and scratching of the Quintex® plate.
The various types of screw are marked with the following color coding:
■
Blue screw = ∅ 4.0 mm constrained screw, self-locking
■
Blue screw head, purple screw shaft = ∅ 4.5 mm constrained screw, self-locking
■
Green screw = ∅ 4.0 mm semiconstrained screw, self-locking
■
Green screw head, purple screw shaft = ∅ 4.5 mm semiconstrained screw, self-locking
■
Gold screw = ∅ 4.0 mm dynamic screw, self-locking
■
Gold screw head, purple screw shaft = ∅ 4.5 mm dynamic screw, self-locking
►
Select the correct Quintex® screws in terms of type, diameter, and length.
►
Check the length of the Quintex® screw.