KCI PREVENA PLUS DUO Manual Del Usuario página 7

Infected Wounds: As with any wound treatment, clinicians and patients/caregivers should
frequently monitor the patient's wound, periwound tissue and exudate for signs of infection or
other complications. Some signs of infection are fever, tenderness, redness, swelling, itching, rash,
increased warmth in the wound or periwound area, purulent discharge or strong odor. Infection
can be serious, and can lead to complications such as pain, discomfort, fever, gangrene, toxic shock,
septic shock and/or fatal injury. Some signs or complications of systemic infection are nausea,
vomiting, diarrhea, 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™ Dressing is not intended to treat infection, but
to reduce bacterial colonization in the fabric. If infection develops, PREVENA PLUS DUO™ Therapy
should be discontinued until the infection is treated.
Allergic Response: The PREVENA™ 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™ 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™ 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™
Dressings can typically remain on the patient with minimal risk in an MR environment. Interruption
of PREVENA PLUS DUO™ Therapy during MRI may reduce the effectiveness of the PREVENA PLUS
DUO™ Incision Management System. The PREVENA™ 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™ 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™ Dressings into a hyperbaric oxygen chamber. They are not designed
for this environment and should be considered a fire hazard. If PREVENA PLUS DUO™ 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 DUO™ 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
DUO™ Incision Management System. For a list of acceptable therapy units with which PREVENA™
Dressings may be used, see the Product Description and Indication for Use section.
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