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Omni ow® II Biosynthetic Vascular Prosthesis
Instructions For Use - English
STORED IN
50% ETHANOL
Description
Omni ow® II Vascular Prosthesis is constructed of polyester mesh within an ovine brocollagenous tissue matrix. The prosthesis is
sterilised in a glutaraldehyde solution.
The prosthesis is supplied sterile and nonpyrogenic in a solution of 50% ethanol. The prosthesis remains sterile unless the primary
package is opened or damaged.
The Omni ow II Straight Vascular Prosthesis is mounted on a glass mandrel contained in a glass tube. The mandrel design prevents
the prosthesis slipping o the mandrel when it is removed from the glass tube. The diameter and minimum length of the prosthesis is
speci ed on the label applied to the glass tube.
The Omni ow II Curved Vascular Prosthesis is contained in a sterile exible inner bag within an outer bag. The diameter and minimum
length of the prosthesis is speci ed on the label applied to the outer surface of the outer bag.
The Omni ow II Vascular Prosthesis is considered MR safe.
Indications for Use
The Omni ow II vascular prosthesis is indicated for the replacement, reconstruction, bypassing or patching of diseased vessels in patients
su ering occlusive or aneurismal diseases, in trauma patients requiring vascular replacement or for patients requiring vascular access
such as for haemodialysis.
The Omni ow II Straight Vascular Prosthesis is intended:
1.
To bypass, replace or reconstruct diseased or injured blood vessels
2.
To patch and repair peripheral vessels
3.
For arteriovenous access when a straight con guration is required.
The Omni ow II Curved Vascular Prosthesis is intended for arteriovenous access when a looped con guration is required.
Warnings
1.
Do NOT re-sterilise the Omni ow II prosthesis. It is supplied sterile and pyrogen free. Use the prosthesis immediately after
opening the package and discard any unused portions.
2.
Do NOT use the prosthesis if the primary package is damaged as sterility may be compromised.
3.
Do NOT use the prosthesis if the glass mandrel is broken.
4.
Do NOT use the prosthesis if it is not completely covered by the storage solution.
5.
Do NOT attempt to reposition the prosthesis after removal of the tunnelling instrument.
6.
Do NOT straighten the curved prosthesis during preparation or implantation, as this will cause disruption of the mesh tissue
interface.
7.
Do NOT use the straight prosthesis to fashion a looped arteriovenous access as this may cause kinking.
8.
Do NOT pull, stretch, twist, squeeze or pinch the body of the prosthesis.
9.
Do NOT use ablation techniques such as cutting balloons, laser, or radio frequency ablation with the Omni ow II prosthesis.
10.
Do NOT attempt to dilate the prosthesis with balloon angioplasty or stenting procedures.
11.
The Omni ow II prosthesis should only be implanted by trained surgeons.
12.
The use of the Omni ow II prosthesis in the coronary artery has not been evaluated.
Technical Information/Precautions
1.
Ensure the rinsing procedure has been performed to remove the storage solution prior to implanting the prosthesis. Failure
to do so may cause occlusion. Keep the prosthesis moist with sterile physiological saline during the procedure.
2.
The use of a hollow tunnelling instrument for the passage of the prosthesis is essential. Failure to do so may cause disruption
to the biosynthetic material and lead to occlusion, dilatation or aneurysm formation. The inner diameter of the tunneler
should be at least 3mm larger than the indicated inner diameter of the prosthesis.
3.
Ensure that the prosthesis does not become twisted when passing through the tunnelling instrument as this may lead to
occlusion.
4.
Avoid cross clamping with metal instruments as this may damage the prosthesis and cause occlusion, dilatation or aneurysm
formation. If clamping is necessary use only a-traumatic clamps and avoid repeated or excessive clamping in the same
position on the prosthesis.
5.
The prosthesis has minimal longitudinal elasticity. Ensure the prosthesis is cut to the correct length. If it is too short it may
cause suture pullout with a risk of anastomotic aneurysm. If it is too long it may kink and cause occlusion.
6.
Cut o the sections of the prosthesis which were clamped during rinsing. Ensure that the full wall thickness and a mesh
eyelet are incorporated with each stitch when performing the anastomosis. Failure to do so may result in stitch pullout and
anastomotic aneurysm formation.
7.
Do not implant Omni ow II into a site with an active infection unless the surgeon determines there is not a more suitable
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