Terumo Vascutek ePTFE, Инструкция по эксплуатации

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to use. Immediate use may increase the risk of
haematoma formation.
• The blood access needle should be inserted
at an angle of 45° (bevel upward) until the graft
has been penetrated. Care must be taken not to
puncture the opposite side of the graft.
• Do not cannulate at the same site. Rotate
areas to reduce chance of graft damage
and the possibility of perigraft haematoma
or pseudoaneurysm formation. If using a
support graft do not cannulate near or within
the supported portion, however it has been
demonstrated that this is not applicable for
ePTFE (Unity) supported grafts
5
.
• Do not cannulate within one inch of proximal
and distal anastomosis.
• To minimize infection, strict adherence to
aseptic techniques is recommended.
• Once the needle has been withdrawn, apply
moderate digital compression to the cannulation
site to assist haemostasis.
Sterilisation
Vascutek Ltd gelatin sealed ePTFE grafts are
sterilised in ethylene oxide, supplied sterile,
and must not be re-sterilised. The Tyvek® seal
on both intermediate and inner trays must be
intact. Any damage to the trays renders the
prosthesis non-sterile. In the event of damage
to the primary packaging, the product must not
be used and should be returned immediately to
the supplier.
Angioaccess
• When implanting an unsupported prosthesis
care must be taken to ensure that a subcutaneous
tunnel is created of similar size to the graft, such
that a snug fit is achieved.
• Best results are achieved by leaving the
graft in place for approximately 2 weeks prior
Figure 3 Rifampicin Bonding (Optional Procedure)
All Vascutek Ltd gelatin sealed ePTFE grafts may be bonded with the antibiotic Rifampicin using the simple 5 stage procedure
outlined below:
Stage 1
Fill syringe
to 40ml with
saline.
Stage 3
Draw up the 10ml
of Rifampicin
solution from (2)
into the 50ml
syringe to give a
total volume of
50ml.
Stage 4
Inject the Rifampicin/saline
solution through the tyvek lid of
the blister containing the graft.
Taking care not to damage the
graft, rock the blister to ensure
complete coverage of the graft.
Stage 5
After 5 minutes, the
graft can be removed
- excess solution
is allowed to drain
before the graft is
implanted.
Stage 2
Reconsttute
600mg of
Rifampicin with
the 10ml of
diluent provided.
Standard operating room practice should be followed throughout this procedure to ensure that the sterility of the graft, and of
any other items involved, is not compromised.
Figure 2b
Do not use this method
Figure 2a
NOTE: The rifampicin/heparin bonding procedure has not been approved by Health Canada.