V.A.C. FREEDOM™ System

• LCD with menu interface allows for efficient selection of negative pressure wound therapy
• SensaT.R.A.C.™ Technology monitors and maintains wound site target pressure
• Smart Alarms help ensure patient safety and assist staff in providing care
• 300ml canister minimizes canister changes and is easily removed and replaced
• Long battery life (~12 hours) and lightweight design enable patients to be mobile and active
• Carrying case allows discreet delivery of therapy on the go
• Adjustable rate of dressing draw down intensity for increased comfort

The V.A.C. FREEDOM™ System is an integrated wound management system for use in acute, extended and home care settings. When used on open wounds, 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. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.

When used on closed surgical incisions, the V.A.C. FREEDOM™ System is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled 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. FREEDOM™ 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 fistulas
• 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.

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.

Environmental conditions:
Storage/transport conditions
Temperature range: -4°F (-20°C) to 140°F (60°C)
Relative humidity range: 10%-95% non-condensing
Atmospheric pressure: 700hpa to 1060hpa

Operating conditions
Temperature range: 50°F (10°C) to 85°F (30°C)
Relative humidity range: 30%-75% non-condensing
Atmospheric pressure: 50kpa to 106kpa