Acelity V.A.C.ULTA, Safety Information And Application Instructions

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Foam Removal: V�A�C�® Foam Dressings and V�A�C� VeraFlo™ Therapy 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 V.A.C.Ulta™ 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 or V.A.C. VeraFlo™ Therapy
until adequate hemostasis has been achieved, and the patient is not at risk for continued
bleeding.
Keep V.A.C.® Therapy and V.A.C. VeraFlo™ Therapy On: Never leave a V�A�C�® Dressing or V�A�C�
VeraFlo™ Therapy Dressing in place without active V�A�C�® Therapy or V�A�C� VeraFlo™ Therapy for more
than two hours� 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 or V�A�C� VeraFlo™ Therapy 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 (supplied with V�A�C�® Dressings) and the V�A�C�® Advanced Drape
(supplied with V�A�C� VeraFlo™ Therapy Dressings) have 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 V�A�C�Ulta™ 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 V�A�C�® Dressing or 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�
Magnetic Resonance Imaging (MRI) – Therapy Unit: The V�A�C�Ulta™ Therapy Unit is MR Unsafe. Do
not take the V�A�C�Ulta™ Therapy Unit into the MR environment�
Magnetic Resonance Imaging (MRI) – V.A.C.® Dressings: V�A�C�® Dressings and V�A�C� VeraFlo™
Therapy Dressings can typically remain on the patient with minimal risk in an MR environment, assuming
that use of the V�A�C�Ulta™ Therapy System is not interrupted for more than two hours (refer to
Keep
V.A.C.® Therapy On above)�
NOTE: If using V.A.C. VeraFlo™ Therapy ensure that irrigation fluid or treatment
solutions are fully removed from the dressing prior to stopping negative pressure
wound therapy.
The V�A�C� GranuFoam Silver® Dressing has been shown to 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 3 W / kg for 15 minutes of
scanning�