• Helps hold incision edges together
• Acts as a barrier to external contamination
• Removes fluids and infectious materials from the surgical site
• Lightweight and portable
• Expanded coverage area delivers therapy to the incision and surrounding soft tissue

3M™ Prevena Restor™ Incision Management System is intended to manage the environment of closed surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.

Sensitivity to silver: Note: the interface layer of the 3M™ Prevena Restor™ Dressings contains 0.019% silver to help reduce bacterial colonization in the fabric. It is not intended for treating infection at the incision site.

The 3M™ Prevena Restor™ Incision Management System is not intended to manage open or dehisced wounds.

Do not use with 3M™ Veraflo™ Therapy (Instillation) provided by the V.A.C.Ulta™ Therapy Unit. Instillation into the incision site may result in pooling of fluid which may result in maceration.

Bleeding: Before applying the 3M™ Prevena Restor™ 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 homeostasis 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 canister, the patient should leave the 3M™ Prevena Restor™ Dressing in place, turn off 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). If infection develops, Prevena Restor™ Therapy should be discontinued until the infection is treated.
 
Allergic Reaction: Prevena™ Dressing has an acrylic coating, hydrocolloid adhesive and skin interface layer with silver, which may present at 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, 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 3M™ V.A.C.® Therapy Units, including 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 to the MR environment. Interruption of Prevena Restor™ Therapy during MRI may reduce the effectiveness of the Prevena Restor™ Incision Management System. The Prevena™ Dressings pose no known hazard in an MR environment with the following conditions: 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 iconic 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 Restor™ Therapy is reinitiated after HBO treatment, do not re-adhere the same dressing; a new dressing must be applied.

Canister Full: If at any time while using the Prevena Restor™ Incision Management System 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 instructions.

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™ dressings 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 recurrent palpate distal pulses and assess distal circulatory status. If circulatory compromise is suspected, discontinue therapy and remove dressing.

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

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.

Dressing Components:
• The Prevena™ Dressing contains ionic silver (0.019%). Application of products containing silver may cause temporary tissue discoloration.
• Always use Prevena™ Dressings and canisters from sterile packages that have not been opened or damaged.
• All dressing components and canisters of the Prevena Resor™ Incision Management System are for single use only. Do not re-use any component of this system.
• To avoid trauma to the skin, do not pull or stretch the adhesive border of the dressing during application.
• To avoid tension or irritation on intact skin use Prevena™ Patch Strips under the Prevena™ Dressing for protection.

Compressive Garments or Dressings: Avoid tight compressive garments or dressings (such as surgical bras, elastic bandage wraps or abdominal binders) to prevent forcibly pressing the Prevena™ Dressing into soft tissue.

Allergic Response: The Prevena Restor™ Dressing has an acrylic adhesive coating, hydrocolloid adhesive 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, hydrocolloid adhesive or silver.
If a patient has a known allergy or hypersensitivity to these materials, do not use the Prevena Restor™ Dressing. 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.

3M™ Prevena Restor™ Dressings
Operating temperature range: 41°F (5°C) to 104°F (40°C)
Altitude range for optimum performance: -1,253ft to 9,878ft (-381.9m to 3010m)
Relative humidity range: 15%-93%, non-condensing