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Mode d'emploi/description technique (15 pages)

Table Des Matières

Table des Matières

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Application

Risk to the patient due to inadequate expertise of the operating surgeon!

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Make certain the surgeon possesses detailed knowledge in spine surgery and about the biome-

chanical conditions at the spine.

WARNING

The operating surgeon shall devise an operation plan that specifies and accurately documents the following:

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Selection of the implant components and their dimensions

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Positioning of the implant components in the bone

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Location of intraoperative landmarks

The following conditions must be fulfilled prior to application:

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All requisite implant components are ready to hand.

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Operating conditions are highly aseptic.

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All requisite implantation instruments must be available and in working order, including specialized Aesculap implantation systems.

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The special instrument set must be ready for implanting the implant components and for the distraction, compression, and repositioning

of the cervical spine

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The operating surgeon and operating room team are thoroughly familiar 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.

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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.

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Information has been obtained from the manufacturer in the event of an ambiguous preoperative situation and if implants are present

in the area to be treated

Note

The surgical procedure for implanting the CASPARevolution implants and application advisories for the system components are described in

detail in the operating manual. The operating manual can be ordered under article number O15901 from the address indicated below.

The surgical procedure and following information has been explained to the patient, and the patient's consent has been documented:

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In the case of delayed or incomplete fusion, the implants can break and loosen due to high loads.

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The life-span of the implant depends on the patient's body weight.

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The implant components must not be overloaded by extreme strains, hard physical labor or sports.

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Corrective surgery may be necessitated by implant loosening, fracture or loss of correction.

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The patient must undergo medical check-ups of the implant components at regular intervals.

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We recommend informing the patient about alternative methods of treatment.

Implantation of the CASPARevolution implant requires the following steps:

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Select the appropriate CASPARevolution implants according to the indication, the preoperative planning, and the bone situation found

intraoperatively.

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To avoid internal stress on, and weakening of, the implant: avoid scoring or scratching of the implant components.

CASPARevolution bone plates

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Select bone plates of appropriate length to cover the region to be fixated.

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If necessary adjust the curvature of the bone plates to the individual situation or to the required spine lordosis.

Weakening or breakage of the bone plates due to excessive bending!

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Check that the bone plates are fully intact prior to application.

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For bending the bone plates, only use bending instruments of the CASPARevolution instrument

set.

WARNING

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Bend the bone plates only once at any one place.

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Avoid excessive bending.

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Do not bend back bone plates that have already been bent.

Note

Metal implants other than the bone plates must not be bent.

CASPARevolution screws

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Be certain to choose the correct diameter and length when selecting the CASPARevolution screws to be used.

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Apply the implantation instruments in the correct way.

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Completely screw in the screws into the bone plates.

Incorrect application can result in trauma to the spinal cord and nerve roots!

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Alignment and insertion of the instruments and bone screws may only be carried out under

radiographic control or aided by a navigation system.

WARNING

Further information on Aesculap implant systems is always available from B. Braun/Aesculap or the appropriate B. Braun/Aesculap office.

Disposal

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Adhere to national regulations when disposing of or recycling the product, its components and its packaging!