Precautions - Acelity PREVENA INCISION Manual De Uso

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.

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™ Dressing
circumferentially. In cases where the clinician determines that the benefits of applying the
PREVENA™ 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 edges with an elastic wrap if necessary. It is crucial to systematically and recurrently
palpate distal pulses and assess distal circulatory status. If circulatory compromise is suspected,
discontinue therapy and remove dressing.
Electrodes or Conductive Gel: Do not allow the PREVENA™ Dressing to come in contact
with EKG or other electrodes or conductive gels during electronic monitoring or when taking
electronic measurements.
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