KCI PREVENA PLUS, Instructions For Use Manual

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INSTRUCTIONS FOR USE
PREVENA PLUS™ INCISION MANAGEMENT SYSTEM
KCI CUSTOMER CONTACT INFORMATION IS LOCATED IN THE BACK OF
THIS GUIDE.
PRODUCT DESCRIPTION AND INDICATION FOR USE
The PREVENA PLUS™ Incision Management System is intended to manage the environment of
closed 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.
The system consists of:
A PREVENA PLUS™ Dressing and a source of negative pressure, which may be one of the following
KCI therapy units:
• PREVENA PLUS™ 125 Therapy Unit
• ACTIV.A.C.™ Therapy Unit
• V.A.C.ULTA™ Therapy Unit
Clinical studies have been conducted on KCI Negative Pressure Incision Management Systems. Refer
to the Bibliography of Published Studies in the back of this guide.
IMPORTANT INFORMATION FOR USERS
WARNING: 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.
WARNING: The V.A.C.ULTA™ Therapy Unit is only indicated for use in acute care settings. Before
transitioning the patient to home care, this therapy unit must be replaced with one for home
use, such as the PREVENA PLUS™ 125 or ACTIV.A.C.™ Therapy Unit.
For pressure settings and connection information for use of the PREVENA PLUS™ Dressings with the
V.A.C.® Therapy Units listed above, see the Using the PREVENA PLUS™ Dressing with KCI V.A.C.®
Therapy Units section.
CAUTION: The PREVENA PLUS™ Incision Management System should be applied and removed
only by qualified physicians or nurses.
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™ 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.