Precautions - KCI Prevena Intrucciones 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™ Dressings. If any signs of allergic reaction, irritation or
hypersensitivity develop, such as redness, swelling, rash, hives, blisters 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, remove the dressing 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
and PREVENA PLUS™ 125 Therapy Units, 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 the
PREVENA™ 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 ionic 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 PREVENA™ 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™ 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™ 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.

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.
Pediatric Use: The PREVENA™ Incision Management System has not been studied in patients under
22 years of age.
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