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.® Therapy or V.A.C. VeraFlo™ Therapy, certain 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.
•
Patients who have weakened or friable blood vessels or organs in or around the wound as a
result of, but not limited to:
•
Suturing of the blood vessel (native anastamoses or grafts) / organ
•
Infection
•
Trauma
•
Radiation
•
Patients without adequate wound hemostasis
•
Patients who have been administered anticoagulants or platelet aggregation inhibitors
•
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 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.® Therapy or 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.® Therapy and V.A.C. VeraFlo™ Therapy) should not be used to prevent,
minimize or stop vascular bleeding.
•
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�
Always ensure that V�A�C�® Foam Dressings and V�A�C� VeraFlo™ Foam Dressings do 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 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�
6