Terumo Vascutek ePTFE, Инструкция по эксплуатации

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Configuration
Graft Characteristic
Typical Applications
Supported Unsupported
Step Taper ----------------- High Strength
Arteriovenous conduit for blood access. Stepped
taper and short taper configurations minimise the risk
of steal syndrome and high cardiac output
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Step Taper - Central
Support
High Strength &
Compression Resistant
-----------------
Arteriovenous conduit for blood access. Stepped
taper and short taper configurations minimise the risk
of steal syndrome and high cardiac output
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matched to the inside diameter of the graft.
Failure to size the catheter correctly or the over-
inflation of the balloon may result in rupture of
either the graft or the balloon.
(c) Cut the graft long enough to ensure that no
stress exists on the anastomosis. The patient’s
body mass and likely extremes of their posture
must be considered when determining the length
of the graft to be implanted, otherwise stress
may be placed on the anastomosis. Failure to
consider these aspects may cause anastomotic
disruption, resulting in excessive bleeding, loss
of function or possible amputation of limb and in
the worst case death.
(d) The graft must not be filled with blood before
it has been passed through the tunnel. Exerting
pressure may cause blood components to be
passed through the graft wall leading to the
possible formation of seroma
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5. Never cut or open a graft to form a surgical
patch.
6. The outer ePTFE wrap on wrapped grafts is
NOT designed to be removed.
Precautions
1. DO NOT PRECLOT. No preclotting
required.
2. DO NOT USE BEYOND THE INDICATED
EXPIRY DATE. The gelatin sealant may not
meet the design specification after the
expiration date because of hydrolytic action.
3. DO NOT RESTERILISE. FOR SINGLE USE
ONLY. Do not reuse, reprocess or resterilise.
Reuse, reprocessing or resterilisation may
compromise the structural integrity of the device
and/or lead to device failure which, in turn, may
result in deterioration of health or death of
patients. Reuse, reprocessing or resterilisation
may also create a risk of contamination of
the device and/or cause patient infection or
cross infection, including, but not limited to the
transmission of infectious disease(s) from one
patient to another. Contamination of the device
may lead to injury, illness or death of the patient
end-user.
Contraindications
1.
Grafts only to be implanted by Vascular
Surgeons who are experienced with the specific
techniques required by these medical devices.
2. Thin wall grafts are not recommended
for axillo-femoral or axillo-bifemoral bypass
reconstruction because of the potential for
anastomotic disruption during extreme body
movement.
3. Unsupported grafts must not be implanted in
such areas where total or partial occlusion can
occur as a result of the movement of a patient’s
body.
4. These prostheses should not be implanted
in patients who exhibit sensitivity to ePTFE or
materials of bovine origin.
5.
These prostheses should not be implanted
in the Central Circulatory System as defined
by Annex IX, 1.7 of the Medical Device
Directive 93/42/EEC with the exception of
prostheses implanted using the Blalock-Taussig
procedure
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Warnings
1. Grafts with an external support over the entire
length are NOT recommended for blood access
purposes, however it has been demonstrated
that ePTFE (Unity) supported grafts maybe
used for such applications
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2. For blood access applications, do NOT
cannulate the portion of the graft with central
spiral support, however it has been demonstrated
that this is not applicable for ePTFE (Unity)
supported grafts
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3. Do NOT remove central spiral support.
Attempts to remove this support may damage
the graft. If damage occurs, discard the graft.
4.
The following precautions should be taken:
Point (a) is particularly important as gelatin
sealed ePTFE grafts feature a degree of
longitudinal elasticity :-
(a) Excessive tension on the prosthesis must be
avoided
but moderate tension is essential.
(b) When using embolectomy or balloon
angioplasty catheters within the lumen of a
graft, the inflated balloon size must be carefully