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Omniflow® II Vascular Prosthesis
Instructions For Use - English
STORED IN
50% ETHANOL
Description
Omniflow® II Vascular Prosthesis is constructed from a composite biosynthetic material comprised of polyester mesh incorporated within
a cross-linked ovine fibrocollagenous 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 Omniflow II Straight Vascular Prosthesis is mounted on a glass mandrel contained in a glass tube. The mandrel design prevents
the prosthesis slipping off the mandrel when it is removed from the glass tube. The diameter and minimum length of the prosthesis is
specified on the label applied to the glass tube.
The Omniflow II Curved Vascular Prosthesis is contained in a sterile flexible inner bag within an outer bag. The diameter and minimum
length of the prosthesis is specified on the label applied to the outer surface of the outer bag.
Indications for Use
The Omniflow II vascular prosthesis is indicated for the replacement, reconstruction, bypassing or patching of diseased vessels in patients
suffering occlusive or aneurismal diseases, in trauma patients requiring vascular replacement or for patients requiring vascular access
such as for haemodialysis.
The Omniflow 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 configuraiton is required.
The Omniflow II Curved Vascular Prosthesis is intended for arteriovenous access when a looped configuration is required.
Warnings
1.
Do NOT re-sterilise the Omniflow 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 Omniflow II prosthesis.
10.
Do NOT attempt to dilate the prosthesis with balloon angioplasty or stenting procedures.
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 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.
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 off 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.
When the prosthesis is used for arteriovenous access some redness and swelling may be present over the implant area for a
few days following implant.
8.
Insufficient data is available on which to base any conclusions regarding the use of the Omniflow II vascular prosthesis for
aortocoronary bypass procedures.
9.
It is recommended that the Omniflow II prosthesis not be implanted into an area with an ongoing infection.
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