Acelity Prevena Incision Management System, Application Instructions

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INSTRUCTIONS FOR USE
PREVENA™ INCISION MANAGEMENT SYSTEM
KCI customer contact information is located in the back of this guide.
Product Description and Indication for Use
The Prevena™ Incision Management System is intended to manage the environment of
surgical incisions and surrounding intact skin in patients at risk for developing post-operative
complications, such as infection, by maintaining a closed environment via the application of a
negative pressure wound therapy system to the incision. The Prevena™ Dressing skin interface
layer with silver reduces microbial colonization in the fabric.
It consists of:
A Prevena™ Peel & Place™ Dressing and a source of negative pressure, which may be one of the
following KCI therapy units:
•
Prevena™ 125 Therapy Unit
•
ActiV.A.C.® Therapy Unit
•
InfoV.A.C.® Therapy Unit
Important Information for Users
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.
All of the Prevena™ Incision Management System components 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.
CAUTION: Prevena™ Therapy should be applied and removed only by qualified physicians,
nurses or caregivers.
Optimum Use Conditions
For maximum benefit the Prevena™ 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; however, all Prevena™
Dressing changes should be performed under direct medical supervision.
Prevena™ Therapy will not be effective in addressing complications associated with the
following:
•
ischemia to the incision or incision area
•
untreated or inadequately treated infection
•
inadequate hemostasis of the incision
•
cellulitis of the incision area
Prevena™ Therapy 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.
Prevena™ Therapy 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
•
V.A.C.ATS® Therapy Unit
•
V.A.C. Freedom® Therapy Unit
•
V.A.C.Ulta™ Therapy Unit