The 3M™ Prevena Restor™ Incision Management System features Prevena Plus™ 125 Therapy Units that manage the environment of closed surgical incisions and remove fluid away from the surgical incision via the application of -125mmHg continuous negative pressure.
• 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
• Dressing may be connected directly to a 3M™ V.A.C.® Therapy Unit
3M™ Prevena™ 125 and 3M™ Prevena Plus™ 125 Therapy Units manage the environment of closed surgical incisions and remove fluid away from the surgical incision via the application of -125mmHg continuous negative pressure.
Sensitivity to silver: Note: the interface layer of the Prevena Restor™ Dressings contains 0.019% silver, added to control bacterial growth in the dressing. It is not for treating infection at the incision site.
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. 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 Restor™ Dressing is not intended to treat infection, but to reduce bacterial colonization in the fabric. If infection develops, Prevena Restor™ Therapy should be discontinued until the infection is treated. Remove the Prevena Restor™ Dressing if defibrillation is required in the area of the dressing placement. Failure to remove the dressing may inhibit transmission of electrical energy and/or patient resuscitation. All therapy units, including the 3M™ 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 in an MR environment. Interruption of Prevena Restor™ Therapy during MRI may reduce the effectiveness of the 3M™ Prevena Restor™ 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. The Prevena Restor™ Dressing contains metallic silver that may impair visualization with certain imaging modalities. Do not take therapy units or Prevena Restor™ 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 readhere the same dressing; a new dressing must be reapplied. If at any time while using the Prevena Restor™ 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.
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
Moderately Exudating Wounds
For maximum benefit the Prevena Restor™ Incision Management System should be applied immediately post surgery to clean surgically closed wounds. It is to be continuously applied for a minimum of 2 days up to a maximum of 7 days. It can transition home with the patient; however, all Prevena Restor™ Dressing changes should be performed under direct medical supervision.
Indicated for up to 14 days of use. Dressing change required after 7 days.
Prevena Plus™ 125 Therapy Unit
Negative Pressure Options: Pre-set, continuous NPWT at -125mmHg
Weight with empty canister: 0.64lb (0.29kg)
Dimensions: Approximately 16cmx9cmx5.5cm
Prevena Plus™ 150ml Canister
150ml canister with connecting tubing
Single use, sterile, disposable
Canister dimensions: 15.5cmx9cmx2.5cm
Prevena Plus™ Connector Tube length: 45cm
3M™ Prevena Restor™ Axio•Form™ Incision Management System: 29cmx28cm
3M™ Prevena Restor™ Roto•Form™ Incision Management System: 31cmx29cm
3M™ Prevena Restor™ Adapti•Form™ Incision Management System: 49cmx28cm
3M™ Prevena Restor™ Arthro•Form™ Incision Management System: 33cmx30cm, 46cmx30cm
3M™ Prevena Restor™ Bella•Form™ Incision Management System: 21cmx19cm, 24cmx22cm, 29cmx27cm
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