maquet FUSION Bedienungsanleitung Seite 3

FUSION Vascular Graft
3. To avoid disruption of anastomoses, use appropriate anastomotic angles to minimize tension on the suture lines.
4. When clamping is necessary, atraumatic clamps should be used to minimize the risk of damage to the graft. Repeated clamping in the same area
of the graft should be avoided.
5. To minimize the risk of leakage through its walls, the graft should remain free of any blood or fluid prior to passing it through the tissue tunnel.
Tissue tunnels should be properly made to match the diameter of the graft. An oversized tunnel may contribute to seroma formation.
6. When performing embolectomy, or using balloon angioplasty catheters within the lumen of a FUSION Vascular Graft, care should be taken when
selecting the size of the balloon. Oversized or over-inflated balloon catheters could damage the graft.
7. Do not twist graft.
8. Do not attempt to reposition the graft after sheath removal.
OPENING OF STERILE PACKAGE
Prior to removal from the transparent container, the graft may be visually compared with the host vessel for sizing purposes. This will prevent
contamination of the graft with blood. Open the lid only after inspection of the graft, use care when transferring to the sterile field.
INSTRUCTIONS FOR USE
Tunneling Technique: Prior to using a sheath tunneler, verify that the graft fits in the Sheath Lumen. Always follow the instructions for use for the
specific tunneler used to tunnel the graft. Create a tunnel that approximates the diameter of the graft.
Suturing: Use a tapered, noncutting needle with a nonabsorbable monofilament suture. Take 2mm suture bites in the graft following the curve of the
needle and gently pull the suture at a 90 degree angle to the graft.
Thrombectomy: If a thrombectomy is required, utilize either a transverse incision or a longitudinal incision. For the longitudinal incision, position
stay sutures at either end of the incision prior to insertion of the thrombectomy catheter. Select a thrombectomy balloon of the same diameter as the
graft so as not to damage the graft. For the transverse incision, stay sutures are not required. The transverse incision may be closed with a horizontal
mattress suture.
Externally Supported Grafts: After cutting the graft to its proper length, remove as much of the support coil from the graft ends as may be required
(usually 2 or 3 turns) to perform the appropriate proximal and distal anastomoses. The support coil should be carefully removed by peeling at a 90°
angle to the graft.
POTENTIAL ADVERSE EVENTS
Potential adverse events (in alphabetical order) which may be associated with the use of a FUSION Vascular Graft include but are not limited to:
• Bleeding
• Embolism
• Excessive suture hole bleeding
• Hematoma
• Hemorrhage
• Infection
• Mechanical disruption or tearing of the suture line, graft and/or host vessel
• Obstruction
• Occlusion
• Pseudoaneurysm
• Redundancy
• Seroma
• Skin erosion
• Stenosis
• Swelling in the implanted limb
• Thrombosis
HOW SUPPLIED
• FUSION grafts are packaged one per container.
• Store at controlled room temperature.
• Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found call your
MAQUET Cardiovascular LLC representative.
• This product contains no detectable latex.
• Magnetic Resonance Safe
WARRANTY
MAQUET Cardiovascular LLC (MCV) warrants that reasonable care has been used in the design and manufacture of this instrument. This warranty
is in lieu of and excludes all other warranties not expressly set forth herein, whether express or implied by operation of law or otherwise,
including, but not limited to, any implied warranties of merchantability or fitness for a particular purpose. Handling, storage, cleaning and
sterilization of this instrument as well as other factors relating to the patient, diagnosis, treatment, surgical procedures, and other matters beyond
MCV's control directly affect the instrument and the results obtained from its use. MCV's obligation under this warranty is limited to the repair
or replacement of this instrument and MCV shall not be liable for any incidental or consequential loss, damage, or expense directly or indirectly
arising from the use of this instrument. MCV neither assumes, nor authorizes any other person to assume for it, any other or additional liability or
responsibility in connection with this instrument. MCV assumes no liability with respect to instruments reused, reprocessed or resterilized and
makes no warranties, express or implied, including but not limited to merchantability or fitness for a particular purpose, with respect to such
instruments.
ENGLISH
3