Precautions - KCI PREVENA PLUS Instrucciones De Uso

headache, dizziness, fainting, sore throat with swelling of the mucus membranes, disorientation,
high fever, refractory and/or orthostatic hypotension or erythroderma (a sunburn-like rash). Silver in
the interface layer of the PREVENA PLUS™ Dressing is not intended to treat infection, but to reduce
bacterial colonization in the fabric. If infection develops, PREVENA PLUS™ Therapy should be
discontinued until the infection is treated.
Allergic Response: The PREVENA PLUS™ Dressing has an acrylic adhesive coating and a skin interface
layer with silver, which may present a risk of an adverse reaction in patients who are allergic or
hypersensitive to acrylic adhesives or silver. If a patient has a known allergy or hypersensitivity to
these materials, do not use the PREVENA PLUS™ Dressings. If any signs of allergic reaction, irritation
or hypersensitivity develop, such as redness, swelling, rash, urticaria or significant pruritus, patient
should consult a physician immediately. If bronchospasm or more serious signs of allergic reaction
appear, the patient should turn off the therapy unit and seek immediate emergency medical
assistance.
Defibrillation: Remove the PREVENA PLUS™ Dressing if defibrillation is required in the area of
dressing placement. Failure to remove the dressing may inhibit transmission of electrical energy and/
or patient resuscitation.
Magnetic Resonance Imaging (MRI): All KCI Therapy Units, including the PREVENA PLUS™ 125
Therapy Unit, are MR unsafe. Do not take therapy units into the MR environment. The PREVENA
PLUS™ Dressings can typically remain on the patient with minimal risk in an MR environment.
Interruption of PREVENA PLUS™ Therapy during MRI may reduce the effectiveness of the PREVENA
PLUS™ Incision Management System. The PREVENA PLUS™ Dressings pose no known hazards in an
MR environment with the following conditions of use: static magnetic field of 3 Tesla or less, spatial
gradient field of 720 Gauss/cm or less and maximum whole-body-averaged specific absorption rate
(SAR) of 3W/kg for 15 minutes of scanning.
Diagnostic Imaging: The PREVENA PLUS™ Dressing contains metallic silver that may impair
visualization with certain imaging modalities.
Hyperbaric Oxygen Therapy (HBO): Do not take the PREVENA PLUS™ 125 Therapy Unit, V.A.C.®
Therapy Units or PREVENA PLUS™ Dressings into a hyperbaric oxygen chamber. They are not
designed for this environment and should be considered a fire hazard. If PREVENA PLUS™ Therapy is
reinitiated after HBO treatment, do not readhere the same dressing; a new dressing must be applied.
Canister Full: If at any time while using the PREVENA PLUS™ Incision Management System the
canister becomes full of fluid, indicated by a therapy unit alert or visual inspection, the patient should
turn off the therapy unit and contact the treating physician for additional instruction.
Standard Operation: Do not use accessories or materials not provided with the PREVENA PLUS™
Incision Management System. For a list of acceptable therapy units with which PREVENA PLUS™
Dressings may be used, see the Product Description and Indications for Use section.

PRECAUTIONS

Standard Precautions: To reduce the risk of transmission of bloodborne pathogens, apply standard
precautions for infection control with all patients, per institutional protocol, regardless of their
diagnosis or presumed infection status.
Circumferential Dressing Application: Avoid applying the PREVENA PLUS™ Dressing
circumferentially. In cases where the clinician determines that the benefits of applying the PREVENA
PLUS™ Dressing circumferentially outweigh the risk of circulatory compromise, extreme care should
be taken not to stretch or pull the dressing when securing it. Attach the dressing loosely and stabilize
7