Contraindications - B.Braun Aesculap Spine Mode D'emploi/Description Technique

®
Aesculap
CASPARevolution implants for anterior cervical fusion
Intended use
CASPARevolution implants are used for anterior mono- and multisegmental stabilization of the cervical spine until bone fusion is estab-
lished.
The implants are available in various shapes and sizes to adapt them to the individual patient and pathology.
CASPARevolution implants include:
■
Bone plates
– of different length from 24 to 90 mm
– factory pre-bent, longitudinally and vertically
– adapting to the anatomic shape of the cervical spine
■
Monocortical screws
– 4.0 mm diameter (green)
■
Bicortical screws
– 3.5 mm diameter (blue)
– 4.5 mm diameter (for cases in which the 3.5 mm screw would shear out)(pink)
Materials
Materials
ISOTAN® titanium forged alloy Ti6AI4V acc. to ISO 5832-3
F
ISOTAN® pure titanium acc. to ISO 5832-2
P
The screws made of titanium forged alloy and the bone plates made of pure titanium are used together.
The titanium implants are coated with a colored oxide. Slight changes in coloration may occur, but do not affect the implant quality.
ISOTAN® is a registered trademark of Aesculap AG, 78532 Tuttlingen / Germany.
Indications
Surgically installed implants serve to support normal healing processes. They are not intended for use either as replacements for natural
body parts or to bear loads over the long term if healing does not occur.
Use for mono- and multisegmental fusions in cases of cervical spine instabilities caused by:
■
Tumors
■
Degenerative diseases of intervertebral discs
■
Fractures

Contraindications

Do not use in the presence of:
■
Acute or chronic infections in the region of the implant fixation or the spine; or systemic infections
■
Severe defects of the bone structures of the affected vertebral bodies, which need to be intact for a stable implantation to be possible.
■
Bone tumors in the region of implant fixation
■
Anticipated overloading of the implant
■
Metal or foreign body sensitivity to the implant materials
■
profound osteopenia, osteoporosis, or other bone loss
■
Pregnancy
■
Generally poor condition
■
Medical or surgical conditions that could negatively affect the outcome of the implantation
■
Dependency on pharmaceutical drugs, drug abuse, or alcoholism
■
Psychosocial problems
■
Lack of patient's cooperation
Side effects and interactions
HWS plating involves the following potential risks:
■
Neurological deficits, hemorrhages and infections
■
Loss of intervertebral disk height due to subsidence or resorption of bone material, or to the removal of healthy bone material
Complications that can generally occur in connection with vertebral surgery:
■
Pseudarthrosis
■
Infections.
■
Spondylolisthesis
■
Incorrect implant position
■
Bone graft resorption
■
Delayed or failed union can lead to implant breakage due to material fatigue
The life span of the implant is affected by the following factors:
■
Body weight of the patient
■
Degree of physical activity
■
Compliance with instructions with regard to carrying loads
The side effects and interactions listed above do not include every unwelcome effect that can generally occur in the context of surgical
interventions. Rather, they are important factors to be considered when using internal fixation devices made of metal.
Safety notes
■
It is the operating surgeon's responsibility to ensure that the surgical procedure is performed properly.
■
General risk factors associated with surgical procedures are not described in the present instructions for use.
■
The operating surgeon must have a thorough command of both the hands-on and conceptual aspects of the established operating tech-
niques.
■
The operating surgeon must be fully conversant with bone anatomy, including the pathways of nerves, blood vessels, muscles, and ten-
dons.
■
Aesculap is not responsible for any complications arising from wrong indication, wrong choice of implant, incorrect combination of
implant components and operating technique, the limitations of the treatment method, or inadequate asepsis.
■
The instructions for use for individual Aesculap implant components must be followed.
■
The implant components were tested and approved in combination with Aesculap components. If other combinations are used, the
responsibility for such action lies with the operating surgeon.
■
Only combine Aesculap modular implant components with each other.
■
Do not, under any circumstances, use damaged or surgically removed components.
■
Implants that have been used before must not be reused.
■
Titanium implants may not be combined with steel implants.
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Always observe the instructions for use of the instruments of the CASPAR-HWS system (TA008349 and TA009343).
The implant has not been evaluated for safety and compatibility in the MR environment. It has not
been tested for heating, migration or image artifact in the MR environment. Scanning a patient
who has this implant may result in patient injury.
WARNING
■
The implant components applied, along with their article numbers, the name of the implant, as well as the batch number and serial
number (if available) must be documented in all patient records.
■
Postoperatively, individual patient information, as well as mobility and muscle training, is of particular importance.
■
Do not combine titanium CASPAR-HWS implants with implant components from other manufacturers.
Designation
Unscrew screws
Bone plates
Sterility
The implants have to be sterilized before they can be used:
■
The implant components are supplied in an unsterile condition.
■
The implant components are packaged individually.
For implant components in original packaging:
►
Store the implant components in their original packaging and only remove them from their original and protective packaging immedi-
ately prior to processing.
►
Use the implant system storage devices for processing, sterilization and sterile setup.
►
Ensure that the implant components in their implant system storage devices do not come into contact with each other or with instru-
ments.
►
Ensure that the implant components are not damaged in any way.
Prior to initial sterilization and subsequent resterilization, the implant components must be cleaned using the following validated repro-
cessing procedure:
Note
Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for ster-
ile processing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations con-
cerning the reprocessing of products.
Note
Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing
technician is responsible for this.
The recommended chemistry was used for validation.
Note
For up-to-date information about reprocessing and material compatibility, see also the Aesculap Extranet at https://extranet.bbraun.com
The validated steam sterilization procedure was carried out in the Aesculap sterile container system.
Validated reprocessing procedure
Mechanical alkaline cleaning and thermal disinfection
►
Process the implant in its system storage device.
►
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.
►
Keep the implant system storage devices covered or closed.
WARNING
►
Process implant system storage devices separately from instrument trays.
►
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.
►
Implant components that are contaminated intraoperatively must be disposed of.
►
Carry out the final rinse with distilled, demineralized, or fully desalinated water.
►
Always observe the applicable hospital guidelines concerning the supply of sterile materials.
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 permitted load specified by the
manufacturer for the steam sterilizer is not exceeded.
Sterilization for the US market
■
Aesculap advises against sterilizing the device by flash sterilization or chemical sterilization.
■
Sterilization may be accomplished by a standard prevacuum cycle in a steam autoclave.
-6
To achieve a sterility assurance level of 10 , Aesculap recommends the following parameters:
Aesculap Orga Tray/Sterile container (perforated bottom)
Minimum cycle parameters*
Sterilization method Temp.
Prevacuum 270 °F/275 °F
*Aesculap has validated the above sterilization cycle and has the data on file. The validation was accomplished in an Aesculap sterile con-
tainer cleared by FDA for the sterilization and storage of these products. Other sterilization cycles may also be suitable, however individuals
or hospitals not using the recommended method are advised to validate any alternative method using appropriate laboratory techniques.
Use an FDA cleared accessory to maintain sterility after processing, such as a wrap, pouch, etc.
WARNING for the US market
If this device is/was used in a patient with, or suspected of having Creutzfeldt-Jakob Disease (CJD), the device cannot be reused and
must be destroyed due to the inability to reprocess or sterilize to eliminate the risk of crosscontamination.
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 disin-
fection device
Time Minimum drying time
4 min 20 min