AVM Microclips System

■ Aesculap is not responsible for any complications arising from incorrect diagnosis, choice of incorrect implant, incorrectly combined implant components and/or operating techniques, the limitations of treatment methods, or lack of 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 combi-

Aesculap® AVM microclips

nations are used, the responsibility for such action lies with the operating surgeon.

Legend Legend microclip AVMmicroclip 1 AVM point Measuringpoint AAMeasuring Force FFForce part jawpart thejaw Lengthofofthe LLLength microclip AVMmicroclip appliedAVM Correctlyapplied 22Correctly microclip AVMmicroclip appliedAVM Incorrectlyapplied 33Incorrectly

■ Do not, under any circumstances, combine implant components from different manufacturers. ■ Do not, under any circumstances, use damaged or surgically removed components. ■ Implants that have been used before must not be reused. ■ 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. Each AVM microclip is supplied with additional labels indicating the article number and order number (BATCH) of the AVM microclip. These labels can be attached to the patient records. The implants used, along with their article numbers, the name of the implant and the order number (BATCH) must be documented in all patient records.

Symbols on product and packages Sterilization using irradiation Not for reuse in intended applications as defined by the manufacturer

Use by

Patient ID Important information about the implanted AVM microclip and the surgical procedure can be noted on the patient ID. To facilitate the postoperative radiological examination, each patient should receive a patient ID. ■ Contents of the patient ID – Patient data – Hospital data – Date of operation – Name of surgeon and hospital – Article number and order number (LOT) of the implanted AVM microclip The patient ID can be ordered separately from Aesculap.

Sterility Caution, general warning symbol Caution, see documentation supplied with the product

■ The implant components come individually packed in protective packaging that is labeled according to its contents.

■ The implant components are provided sterile by gamma irradiation. ► Store implant components in their original packaging. Remove them from their original protective packaging

only just prior to application. Date of manufacture

► Prior to use, check the product expiry date and verify the integrity of the sterile packaging. ► Do not use implant components that are past their expiration date or whose packaging is damaged.

Damage to implants caused by processing and resterilization! Do not use if the packaging is damaged WARNING

►Do not reprocess or resterilize the implants. ►If the packageing is open during surgery and the clip is not used, the clip must be discarded.

Application Materials ■ Phynox® Cobalt-based alloy according to ISO 5832-7

Available sizes The AVM microclips are available in various lengths and in straight and curved designs. Information on the geometry and dimensions can be found in the AVM microclip brochure. AVM microclips are supplied in sterile packaging. The closing force range indicated on the label is measured at 1 mm from the distal clip end of the contact surfaces of the jaw parts, see Fig. 1.

The operating surgeon shall devise an operation plan that specifies and accurately documents the following: ■ Selection of the implant components and their dimensions ■ Location of intraoperative landmarks The following conditions must be fulfilled prior to application: ■ All components are available. ■ Operating conditions are highly aseptic. ■ Aesculap-AVM applying forceps must be in good working order ■ The 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 available.

■ 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.

Intended use

■ The manufacturer has been consulted if the preoperative situation was unclear and if implants were found in the

The implant is used for the temporary or permanent occlusion of small vessels in cases of intracranial arteriovenous malformations (AVM).

■ The patient must have been informed about the procedure and the characteristics of the AVM microclip.

Indications for Use

The Aesculap AVM Microclips are intended for intracranial vascular occlusion (permanent or temporary) of small vessels.

area operated on.

Note Risk for the patient due to accelerated galvanic activity in connection with other implanted clips! AVM microclip must only be implanted if it has been ruled out that this will come into contact with implants (e.g. clips) made from other metals.

Side effects and interactions

Damage to the AVM microclip due to incorrect handling, restriction of the functionality and changing of the closing force! ► AVM microclip must only be taken out of the sterile packaging for its application. ► AVM microclip must only be removed and applied with the Aesculap-AVM applying forceps. ► AVM microclip must never be manipulated with the fingers. ► Avoid repeated opening and closing of the AVM microclip.

Side effects, risks and complications include infections, sensitivity to the implant materials, nerve damage, vascular damage possibly resulting in hematomas or bleeding, organ and other tissue damage, wound healing disturbances, and other types of surgical complications. The following risks may occur in connection with the use of AVM microclips: ■ The AVM microclip may slip out of place or migrate ■ Crossing over of the jaw parts

Damage to the AVM microclip from it slipping out of place, breaking or snapping out! ► Use only the Aesculap-AVM applying forceps, under no circumstances use products from other manufacturers. ► Ensure that the AVM microclip is positioned correctly in the applying forceps.

CAUTION

MRI Safety Information

The clips are non-ferromagnetic, which makes them MRI safe. This means that the clips do not interact with magnetic fields up to 1.5 tesla of magnetic resonance imaging, although larger artifacts can be generated.

CAUTION

► AVM microclip is taken out of the double sterile packaging. ► Check to make certain that the surfaces of AVM microclips are not bent or damaged. ► AVM microclip must be carefully grasped with the Aesculap-AVM applying forceps and removed, see Fig. 2. ► AVM microclip is then to be applied. When doing so, ensure that the occlusion of the blood vessel is achieved. ► Check the position of the AVM microclip and if necessary correct it or use further AVM microclips.

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

■ The surgeon decides, based on the size of the vessel, whether the AVM microclips are to be used, or whether larger clips such as Aesculap-Yasargil aneurysm clips need to be used.

■ The surgeon decides whether the AVM microclips are to be used only for the duration of the operation and removed before closing up the patient (temporary use), or whether the AVM microclips will remain in the patient after the operation (permanent use). Both uses are possible with the AVM microclips. ■ 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 techniques. ■ The operating surgeon must be fully conversant with bone anatomy, including the pathways of nerves, blood vessels, muscles, and tendons. ■ It is the operating surgeon's responsibility to ensure the correct combination of implant components and their implantation.

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

Distributor in the US/Contact in Canada for producct information and complaints Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 SOP-AIC-5001635 Ver. 1 11/16