Acelity PREVENA INCISION Manual De Uso página 7

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, the PREVENA™ Therapy System 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™ Therapy System. 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™
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™ Therapy during MRI may reduce the effectiveness of
PREVENA™ Therapy. The PREVENA™ Therapy System 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 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 the PREVENA™ Therapy System 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™ Therapy System the canister becomes
full of fluid other than blood, indicated by a therapy unit alert or visual inspection, the patient
should turn off the therapy unit and contact the treating physician.
Standard Operation: Do not use accessories or materials not provided with the PREVENA™
Therapy 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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