CASPARevolution implants for anterior cervical fusion

Sterility ®

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 established. 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

Designation

ISOTAN®F titanium forged alloy Ti6AI4V acc. to ISO 5832-3

Unscrew screws

ISOTAN®P pure titanium acc. to ISO 5832-2

Bone plates

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 immediately 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 instruments. ► 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 reprocessing procedure: Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing. Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations concerning 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 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.

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

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

Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical/Note

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline: – pH = 13 – <5 % anionic surfactant

■ 0.5 % working solution

Contraindications

– pH = 11*

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

III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfection

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

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:

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-

WARNING

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. ► 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. To achieve a sterility assurance level of 10-6, Aesculap recommends the following parameters:

niques.

■ The operating surgeon must be fully conversant with bone anatomy, including the pathways of nerves, blood vessels, muscles, and tendons. ■ 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. ■ 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.

Aesculap Orga Tray/Sterile container (perforated bottom) Minimum cycle parameters* Sterilization method

Temp.

Time

Minimum drying time

Prevacuum

270 °F/275 °F

4 min

20 min

*Aesculap has validated the above sterilization cycle and has the data on file. The validation was accomplished in an Aesculap sterile container 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.