Product Description And Indication For Use; Important Information For Users - Acelity KCI PREVENA PLUS Mode D'emploi

PREVENA PLUS™ INCISION MANAGEMENT SYSTEM
KCI CUSTOMER CONTACT INFORMATION IS LOCATED

PRODUCT DESCRIPTION AND INDICATION FOR USE

The PREVENA PLUS™ Incision Management System is intended to manage the environment of
surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed
environment and removing exudate via the application of negative pressure wound therapy.
The system consists of:
A PREVENA™ 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. FREEDOM™ Therapy Unit
•
V.A.C.ULTA™ Therapy Unit
• V.A.C.RX4™ Therapy Unit
•
V.A.C. SIMPLICITY™ 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™ and V.A.C.RX4™ Therapy Units are only indicated for use in
acute care settings. Before transitioning the patient to home care, these therapy units must
be replaced with one for home use, such as the PREVENA PLUS™ 125, ACTIV.A.C.™, V.A.C.
SIMPLICITY™ or V.A.C. FREEDOM™ 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.
INSTRUCTIONS FOR USE
IN THE BACK OF THIS GUIDE.
5