Contraindication; Warnings - Acelity Prevena Incision Management System Application Instructions

Contraindication

sensitivity to silver
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Warnings

Bleeding: Before applying the Prevena™ Incision Management System to patients who are at
risk of bleeding complications due to the operative procedure or concomitant therapies and /
or co-morbidities, ensure that hemostasis has been achieved and all tissue planes have been
approximated. If active bleeding develops suddenly or in large amounts during therapy, or
if frank blood is seen in the tubing or in the canister, the patient should leave the Prevena™
Dressing in place, turn off the Prevena™ 125 Therapy Unit and seek immediate emergency
medical assistance.
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™ 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 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): The Prevena™ 125 Therapy Unit is MR unsafe. Do not take
the Prevena™ 125 Therapy Unit 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. 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™ 125 Therapy Unit 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™ System the canister becomes full of fluid,
indicated by a Maximum Capacity Alert or visual inspection, the patient should turn off the
therapy unit and contact the treating physician.
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