3M™ ActiV.A.C.™ Therapy System

3M™ ActiV.A.C.™ Therapy System is indicated for use as an integrated wound management system in acute, extended, and home care settings. It is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. 3M™ ActiV.A.C.™ Therapy System is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers(such as diabetic or pressure), flaps, and grafts.

Do not place foam dressings of the V.A.C.® Therapy System directly in contact with exposed blood vessels, anastomotic sites, organs, or nerves.NOTE: Refer to Warnings section for additional information concerning bleeding or osteomyelitis.V.A.C.® Therapy is contraindicated for patients with:
• Malignancy in the wound
• Untreated osteomyelitis
• Non-enteric and unexplored fistula
• Necrotic tissue with eschar present
• Sensitivity to silver (V.A.C.® Granufoam Silver Dressing only)

NOTE: After debridement of necrotic tissue and complete removal of eschar, V.A.C.® Therapy may be used.

CONSIDERATIONS FOR TRANSITIONING V.A.C.® THERAPY INTO HOME CARE WARNING:

Patients having an increased risk of bleeding complications should be treated and monitored in a care setting deemed appropriate by the treating physician.In addition to the contraindications, warnings and precautions for use of V.A.C.® Therapy, consider the following before prescribing V.A.C.® Therapy for use in the home care setting.

• The Patient's Situation:
• Clinical condition (adequate hemostasis, and a low risk of active and/or large amounts of bleeding at the wound site)

Home environment (patient or family member/caregiver able to read and understand safety labeling, able to respond to alarms, able to follow instructions for use)

• The Patient's Wound:
• Must be assessed for exposed vessels, anastomotic sites, organs, and nerves. Adequate protection must be present without the need for a protective, non-adherent layer placed between the V.A.C.® Dressing and the exposed structure for the sole purpose of protection of these structures (Refer to Protect Vessels and Organs in the Warnings section)
• The V.A.C.® Therapy System Canister Size: • The 1000ml canister is NOT intended for use in the home.

• Labeling:

• The prescribing physician and health care clinician should be familiar with the V.A.C. Therapy labeling materials that accompany the therapy unit and dressing cartons into the home• An information folder is provided with the therapy unit. The prescribing physician and/or health care clinician should carefully review these materials with the patient

• 3M offers in-service and training programs for use of V.A.C.® Therapy. Contact your local 3M account representative.In the U.S., call 1-800-275-4524 for scheduling. If there are any questions regarding the proper placement or usage of V.A.C.® Therapy, please refer to the V.A.C.® Therapy Clinical Guidelines for more detailed instructions, or contact your local 3M clinical representative. For additional and most current information, please see 3M's website at3M.com/Medical.CAUTION: U.S. Federal law restricts this device to sale/rental by or on the order of a physician. Bleeding: With or without using V.A.C.® Therapy, certain patients are at high risk of bleeding complications. The following types of patients are at increased risk of bleeding, which, if uncontrolled, could be potentially fatal.

• Patients who have weakened or friable blood vessels or organs in or around the wound as a result of, but not limited to:
• Suturing of the blood vessel (native anastamoses or grafts)/organ
• Infection
• Trauma
• Radiation
• Patients without adequate wound hemostasis

• Patients who have been administered anticoagulants or platelet aggregation inhibitors

• Patients who do not have adequate tissue coverage over vascular structures.If V.A.C.® Therapy is prescribed for patients who have an increased risk of bleeding complications, they should be treated and monitored in a care setting deemed appropriate by the treating physician. If active bleeding develops suddenly or in large amounts during V.A.C.® Therapy, or if frank (bright red) blood is seen in the tubing or in the canister, immediately stop V.A.C.® Therapy, leave dressing in place, take measures to stop the bleeding, and seek immediate medical assistance. The V.A.C.® Therapy Units and dressings should not be used to prevent, minimize, or stop vascular bleeding.

• Protect Vessels and Organs: All exposed or superficial vessels and organs in or around the wound must be completely covered and protected prior to the administration of V.A.C.® Therapy.Always ensure that V.A.C.® Foam Dressings do not come in direct contact with vessels or organs. Use of a thick layer of natural tissue should provide the most effective protection. If a thick layer of natural tissue is not available or is not surgically possible, multiple layers of fine-meshed, non-adherent material, or bio-engineered tissue may be considered as an alternative, if deemed by the treating physician to provide a complete protective barrier. If using non-adherent materials, ensure that they are secured in a manner as to maintain their protective position throughout therapy. Consideration should also be given to the negative pressure setting and therapy mode used when initiating therapy. Caution should be taken when treating large wounds that may contain hidden vessels, which may not be readily apparent. The patient should be closely monitored for bleeding in a care setting deemed appropriate by the treating physician.

• Infected Blood Vessels: Infection may erode blood vessels and weaken the vascular wall which may increase susceptibility to vessel damage through abrasion or manipulation. Infected blood vessels are at risk of complications,including bleeding, which, if uncontrolled, could be potentially fatal. Extreme caution should be used when V.A.C.®Therapy is applied in close proximity to infected or potentially infected blood vessels. (Refer to Protect Vessels and Organs section above.)

• Hemostasis, Anticoagulants and Platelet Aggregation Inhibitors: Patients without adequate wound hemostasis have an increased risk of bleeding, which, if uncontrolled, could be potentially fatal. These patients should be treated and monitored in a care setting deemed appropriate by the treating physician. Caution should be used in treating patients on doses of anticoagulants or platelet aggregation inhibitors thought to increase their risk for bleeding (relative to the type and complexity of the wound). Consideration should be given to the negative pressure setting and therapy mode used when initiating therapy.

• Hemostatic Agents Applied at the Wound Site: Non-sutured hemostatic agents (for example, bone wax, absorbable gelatin sponge, or spray wound sealant) may, if disrupted, increase the risk of bleeding, which, if uncontrolled, could be potentially fatal. Protect against dislodging such agents. Consideration should be given to the negative pressure setting and therapy mode used when initiating therapy.

• Sharp Edges: Bone fragments or sharp edges could puncture protective barriers, vessels, or organs causing injury.Any injury could cause bleeding, which, if uncontrolled, could be potentially fatal. Beware of possible shifting in the relative position of tissues, vessels or organs within the wound that might increase the possibility of contact with sharp edges. Sharp edges or bone fragments must be eliminated from the wound area or covered to prevent them from puncturing blood vessels or organs before the application of V.A.C.® Therapy. Where possible, completely smooth and cover any residual edges to decrease the risk of serious or fatal injury, should shifting of structures occur. Use caution when removing dressing components from the wound so that wound tissue is not damaged by unprotected sharp edges. 1000mL Canister: DO NOT USE the 1000mL canister on patients with a high risk of bleeding or on patients unable to tolerate a large loss of fluid volume, including children and the elderly. Consider the size and weight of the patient,patient condition, wound type, monitoring capability and care setting when using this canister. This canister is recommend for acute care (hospital) use only. The 3M™ ActiV.A.C.™ Therapy System is a medical device, not a toy. Keep away from children, pets, and pests as they can damage the dressing and therapy unit and affect performance. Keep the therapy unit free of dust and lint as they can also damage the dressing and therapy unit and affect performance. Cell phones or similar products could affect the therapy unit. Move the therapy unit away from these devices if interference is suspected. Small Parts - Choking Hazard Allergic Reaction - The V.A.C.® Dressing may cause an allergic reaction if you are sensitive to acrylic adhesives or to silver. The following symptoms may mean you are having an allergic reaction. Call your doctor right away if you:
• notice redness
• notice swelling
• develop a rash
• develop hives
• develop itching If you feel short of breath, your allergic reaction may be more serious. Immediately call your local emergency service. Do not modify the therapy unit or dressing. Do not connect the therapy unit or dressing to other devices that you might be using. Do not operate the therapy unit if it has a damaged power cord, power supply or plug. If these items are worn or damaged, call 3M. Do not drop or insert any object into any opening or tubing on the therapy unit. Keep the therapy unit away from heated surfaces. Do not spill fluids on any part of the therapy unit. If spills do occur, unplug the unit immediately if plugged in. Clean the fluid from the therapy unit. Ensure there is no moisture on the unit and power supply before plugging in. If the unit does not work correctly, call 3M. Do not use the therapy unit in the bath or shower. Do not place the therapy unit where it can fall or be pulled into a tub, shower, or sink. Do not reach for a therapy unit that has fallen into water. Unplug the unit immediately if plugged in. Disconnect the unit from the dressing and call 3M.