Product Description And Indication For Use; Important Information For Users - Acelity PREVENA INCISION Manual De Uso

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 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.
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
•
V.A.C. SIMPLICITY™ Therapy Unit
•
V.A.C. FREEDOM™ Therapy Unit
•
V.A.C.ULTA™ Therapy Unit
•
V.A.C.RX4™ 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: The V.A.C.ULTA™, INFOV.A.C.™ and RX4™ Therapy Units are only indicated for use
in acute care settings. Before transitioning the patient to home care, this therapy unit must
be replaced with one indicated for home use, such as the PREVENA™ 125, ACTIV.A.C.™,
V.A.C. FREEDOM™ or V.A.C. SIMPLICITY™ Therapy Unit.
CAUTION: The PREVENA™ Therapy 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™ Therapy 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.
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.
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.
INSTRUCTIONS FOR USE
5