V.a.c.ulta™ Therapy System Warnings - Acelity V.A.C.ULTA Mode D'emploi

V.A.C.ULTA™ THERAPY SYSTEM WARNINGS
Bleeding: With or without using V.A.C.
patients are at high risk of bleeding complications. The following types of patients are at
increased risk of bleeding, which, if uncontrolled, could be potentially fatal.
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Patients who have weakened or friable blood vessels or organs in or around the wound
as a result of, but not limited to:
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Suturing of the blood vessel (native anastamoses or grafts) / organ
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Infection
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Trauma
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Radiation
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Patients without adequate wound hemostasis
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Patients who have been administered anticoagulants or platelet aggregation inhibitors
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Patients who do not have adequate tissue coverage over vascular structures.
If V.A.C. Therapy or V.A.C. VeraFlo™ Therapy is prescribed for patients who have
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an increased risk of bleeding complications, they should be treated and monitored
in a care setting deemed appropriate by the treating physician.
If active bleeding develops suddenly or in large amounts during V.A.C.
V.A.C. VeraFlo™ Therapy, or if frank (bright red) blood is seen in the tubing or in the
canister, immediately stop therapy, leave dressing in place, take measures to stop
the bleeding, and seek immediate medical assistance. The V.A.C.Ulta™ Therapy
Unit and dressings (both V.A.C.
be used to prevent, minimize or stop vascular bleeding.
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Protect Vessels and Organs: All exposed or superficial vessels and organs in or around
the wound must be completely covered and protected prior to the administration of
V.A.C. Therapy or V.A.C. VeraFlo™ Therapy.
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Always ensure that V.A.C.
not come in direct contact with vessels or organs. Use of a thick layer of natural tissue
should provide the most effective protection. If a thick layer of natural tissue is not
available or is not surgically possible, multiple layers of fine-meshed, non-adherent
material may be considered as an alternative, if deemed by the treating physician to
provide a complete protective barrier. If using non-adherent materials, ensure that they
are secured in a manner as to maintain their protective position throughout therapy.
Consideration should also be given to the negative pressure setting and therapy mode
used when initiating therapy.
Caution should be taken when treating large wounds that may contain hidden vessels,
which may not be readily apparent. The patient should be closely monitored for bleeding
in a care setting deemed appropriate by the treating physician.
Therapy or V.A.C. VeraFlo™ Therapy, certain
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Therapy and V.A.C. VeraFlo™ Therapy) should not
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Foam Dressings and V.A.C. VeraFlo™ Foam Dressings do
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Therapy or
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