Product Description And Indication For Use; Important Information For Users - KCI Prevena Intrucciones De Uso

PREVENA™ INCISION MANAGEMENT SYSTEM
KCI CUSTOMER CONTACT INFORMATION IS LOCATED

PRODUCT DESCRIPTION AND INDICATION FOR USE

The PREVENA™ 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™ 125 Therapy Unit
•
• PREVENA PLUS™ 125 Therapy Unit
ACTIV.A.C.™ 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 indicated for home use, such as the PREVENA™ 125, PREVENA PLUS™ 125,
ACTIV.A.C.™ or V.A.C. SIMPLICITY™ Therapy Unit.
For pressure settings and connection information for use of the PREVENA™ Dressings with the V.A.C.®
Therapy Units listed in the Product Description and Indication for Use section above, see the
Using the PREVENA™ Dressing with KCI V.A.C.® Therapy Units section.
CAUTION: The PREVENA™ 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 and could result in failure of the
wound to heal.
The PREVENA™ 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 and/
or infection.
INSTRUCTIONS FOR USE
IN THE BACK OF THIS GUIDE.
5