Optimum Use Conditions; Contraindication; Warnings - KCI PREVENA PLUS DUO Manual Del Usuario

As with any prescription medical device, failure to carefully read and follow all instructions and safety
information prior to use may lead to improper product performance.
The PREVENA PLUS DUO™ Incision Management System dressings and therapy unit canisters are
disposable and are for single use only. Re-use of disposable components may result in wound
contamination, infection and/or failure of the wound to heal.

OPTIMUM USE CONDITIONS

For maximum benefit the PREVENA PLUS DUO™ System should be applied immediately post surgery
to clean surgically closed wounds. It is to be continuously applied for a minimum of two days up to a
maximum of seven days. It can transition home with the patient.
The PREVENA PLUS DUO™ Incision Management System will not be effective in addressing
complications associated with:
• ischemia to the incision or incision area
• untreated or inadequately treated infection
• inadequate hemostasis of the incision
• cellulitis of the incision area
The PREVENA PLUS DUO™ Incision Management System should not be used to treat open or
dehisced surgical wounds.
The V.A.C.® Therapy System should be considered for treatment of these wounds.
Consider using the smallest available canister for the selected V.A.C.® Therapy Unit.
The PREVENA PLUS DUO™ Incision Management System should be used with caution in the following
patients:
• patients with fragile skin surrounding the incision as they may experience skin or tissue
damage upon removal of the PREVENA™ Dressing
• patients who are at an increased risk of bleeding from the incision associated with the use of
anticoagulants and/or platelet aggregation inhibitors

CONTRAINDICATION

• sensitivity to silver

WARNINGS

PREVENA PLUS DUO™ Incision Management System is not intended to manage open or
dehisced wounds.
DO NOT use with V.A.C. VERAFLO™ Therapy (Instillation) provided by the V.A.C.ULTA™ Therapy
Unit. Instillation into the incision site may result in pooling of fluid which may result in
maceration.
Bleeding: Before applying the PREVENA PLUS DUO™ Incision Management System to patients
who are at risk of bleeding complications due to the operative procedure or concomitant therapies
and/or co-morbidities, ensure that hemostasis has been achieved and all tissue planes have been
approximated. If active bleeding develops suddenly or in large amounts during therapy, or if frank
blood is seen in the tubing or in the canister, the patient should leave the PREVENA™ Dressings in
place, turn off the therapy unit and seek immediate emergency medical assistance.
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