• Easy to use
• Features SensaT.R.A.C.^™ Technology, a real-time pressure feedback system that adjusts pump output, compensating for wound distance, wound position, exudate characteristics, and patient movement
• Simple user interface minimizes device training time
• Quick release canisters
• Multi-orientational canister allows for patient mobility and product position flexibility
• 300mL canister minimizes canister changes
• Long battery life (8+ hours) with fast recharge time (6 hours)
• Lightweight and portable

The V.A.C.^® Simplicity Therapy System is an integrated wound management system for use 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. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps, and grafts.
When used on closed surgical incisions, it is intended to manage the environment of surgical incisions that continue to drain following sutured or staple closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

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 (Note: Refer to Warnings section for Osteomyelitis information.)
• Non-enteric and unexplored fistulas
• Necrotic tissue with eschar present (NOTE: After debridement of necrotic tissue and complete removal of eschar, V.A.C.^® Therapy may be used.)
• Sensitivity to silver (V.A.C.^® Granufoam^™ Silver Dressing only)

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 anastomoses 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.)

• 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 recommended for acute care (hospital) use only.
Infected Wounds: Infected wounds should be monitored closely and may require more frequent dressing changes than non-infected wounds, dependent upon factors such as wound conditions and treatment goals. Refer to dressing application instructions for details regarding dressing change frequency. As with any wound treatment, clinicians and patients/caregivers should frequently monitor the patient’s wound, periwound tissue, and exudate for signs of infection, worsening 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 there are any signs of the onset of systemic infection or advancing infection at the wound site, contact a physician immediately to determine if V.A.C.^® Therapy should be discontinued. For wound infections relating to blood vessels, please also refer to the section titled Infected Blood Vessels.

Osteomyelitis: V.A.C.^® Therapy should NOT be initiated on a wound with untreated osteomyelitis. Consideration should be given to thorough debridement of all necrotic, non-viable tissue, including infected bone (if necessary), and appropriate antibiotic therapy.

Circulatory Compromise: V.A.C.^® Therapy should not be initiated on wounds with untreated, underlying circulatory compromise (eg, acutely ischemic wounds). Consideration should be given to both treatment of the underlying cause(s) and therapy settings before using the ActiV.A.C.^™ Therapy System.

Protect Tendons, Ligaments, and Nerves: Tendons, ligaments, and nerves should be protected to avoid direct contact with V.A.C.^® Foam Dressings. These structures may be covered with natural tissue or meshed non-adherent material to help minimize risk of desiccation or injury.

Foam Placement: Always use V.A.C.^® Dressings from sterile packages that have not been opened or damaged. Do not place any foam dressing into blind/unexplored tunnels. The V.A.C. Whitefoam^™ Dressing may be more appropriate for use with explored tunnels. Do not force foam dressings into any area of the wound, as this may damage tissue, alter the delivery of negative pressure, or hinder exudate and foam removal. Always count the total number of pieces of foam used in the wound and the dressing change date and document that number on the drape, in the patient’s chart and on the foam quantity label attached to the pad tubing (if provided).

Foam Removal: V.A.C.^® Foam Dressings are not bioabsorbable. Always count the total number of pieces of foam removed from the wound and ensure the same number of foam pieces was removed as placed. Foam left in the wound for greater than the recommended time period may foster ingrowth of tissue into the foam, create difficulty in removing foam from the wound, or lead to infection or other adverse events. If significant bleeding develops, immediately discontinue the use of the ActiV.A.C.^™ Therapy System, take measures to stop the bleeding, and do not remove the foam dressing until the treating physician or surgeon is consulted. Do not resume the use of the V.A.C.^® Therapy until adequate hemostasis has been achieved and the patient is not at risk for continued bleeding.

Keep V.A.C.^® Therapy On: Never leave a V.A.C.^® Dressing in place without active V.A.C.^® Therapy for more than two hours. This may cause maceration, wound infection, or failure to heal. If therapy is off for more than two hours, remove the old dressing and irrigate the wound. Either apply a new V.A.C.® Dressing from an unopened sterile package and restart therapy; or apply an alternative dressing at the direction of the treating clinician.

Acrylic Adhesive: The V.A.C.^® Drape has an acrylic adhesive coating, which may present a risk of an adverse reaction in patients who are allergic or hypersensitive to acrylic adhesives. If a patient has a known allergy or hypersensitivity to such adhesives, do not use the ActiV.A.C.^™ Therapy System. If any signs of allergic reaction or hypersensitivity develop, such as redness, swelling, rash, urticaria or significant pruritus, discontinue use and consult a physician immediately. If bronchospasm or more serious signs of allergic reaction appear, seek immediate medical assistance.

Defibrillation: Remove the Solventum^™ V.A.C.^® Dressing or 3M^™ V.A.C. Veraflo^™ Therapy 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.

Flammable Environment: Equipment not suitable for use in the presence of a flammable anesthetic mixture of air, oxygen, or nitrous oxide, or in an oxygen enriched environment.

Magnetic Resonance Imaging (MRI)—Therapy Unit: The ActiV.A.C.^™ Therapy Unit is MR Unsafe. Do not take the ActiV.A.C.™ Therapy Unit into the MR environment.

Magnetic Resonance Imaging (MRI)—V.A.C.^® Dressings: V.A.C.^® Dressings can typically remain on the patient with minimal risk in an MR environment, assuming that use of the ActiV.A.C.^™ Therapy System is not interrupted for more than two hours (refer to Keep V.A.C.^® Therapy On above).

Hyperbaric Oxygen Therapy (HBO): Do not take the ActiV.A.C.^™ Therapy Unit into a hyperbaric oxygen chamber. The ActiV.A.C.^™ Therapy Unit is not designed for this environment and should be considered a fire hazard. After disconnecting the ActiV.A.C.^™ Therapy Unit, either (i) replace the V.A.C.^® Dressing with another HBO compatible material during the hyperbaric treatment, or (ii) cover the unclamped end of the V.A.C.^® Tubing with dry gauze. For HBO therapy, the V.A.C.^® Tubing must not be clamped. Never leave a V.A.C.^® Dressing in place without active V.A.C.^® Therapy for more than two hours; please refer to the Keep V.A.C.^® Therapy On section.

Considerations for Transitioning V.A.C.® Therapy Into Home Care

WARNING: Patients with 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.
• 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 into the home. The prescribing physician and/or healthcare clinician should carefully review these materials with the patient and patient’s caregiver.
   • Solventum offers in-service and training programs for use of V.A.C.^® Therapy. Contact your local Solventum representative. In the U.S., call 1-800-275-4524 for scheduling. For additional and most current information, please see Solventum's website at Solventum.com.

Storage Conditions:
Storage Temperature Range: -20°C–60°C
Relative Humidity Range: 0% to 95% non-condensing
Operating Conditions:
Operational Temperature Range: 5°C–40°C
Relative Humidity Range: 0% to 95% non-condensing