Non-clinical testing under these same conditions produced a temperature rise of <0.4°C.
MR image quality may be compromised if the area of interest is in the same area or relatively close
to the position of the V.A.C. GranuFoam Silver
Hyperbaric Oxygen Therapy (HBO): Do not take the V.A.C.Ulta™ Therapy Unit into a
hyperbaric oxygen chamber. The V.A.C.Ulta™ Therapy Unit is not designed for this environment
and should be considered a fire hazard. After disconnecting the V.A.C.Ulta™ Therapy Unit, either
(i) replace the V.A.C.
®
material during the hyperbaric treatment, or (ii) cover the unclamped end of the V.A.C.
with moist cotton gauze and completely cover the V.A.C.
Dressing (including tubing) with a moist towel throughout the treatment in the chamber. For HBO
therapy, the V.A.C.
Tubing or V.A.C. VeraFlo™ Therapy Tubing must not be clamped. Never leave
®
a V.A.C.
Dressing in place without active V.A.C.
®
to the Keep V.A.C.
Therapy On section.
®
ADDITIONAL WARNINGS FOR V.A.C. VERAFLO™ THERAPY
Topical Wound Solutions: Topical wound solutions or suspensions may enter
internal body cavities if the wound is open to such cavities. They should not be
infused into wounds with unexplored tunnels or unexplored undermining as they
may enter into unintended cavities.
Pauses in Negative Pressure: Application of V.A.C. VeraFlo™ Therapy will result
in pauses of negative pressure wound therapy, which is not recommended on
wounds requiring continuous V.A.C.
over unstable structures, such as unstable chest wall or non-intact fascia, on
patients at increased risk of bleeding, highly exudating wounds, on flaps, grafts or
wounds with acute enteric fistulae.
Bioengineered Tissue: V.A.C. VeraFlo™ Therapy is not intended for use with
cellular or accellular bioengineered tissues.
Hemostasis: Patients with difficult or fragile wound hemostasis are at increased
risk of bleeding associated with V.A.C. VeraFlo™ Therapy due to the potential
for disruption of clots or dilution of clotting factors. Do not use V.A.C. VeraFlo™
Therapy where hemostatic agents have been used in the wound bed.
V.A.C.ULTA™ THERAPY SYSTEM PRECAUTIONS
Standard Precautions: To reduce the risk of transmission of bloodborne pathogens, apply
standard precautions for infection control with all patients, per institutional protocol, regardless
of their diagnosis or presumed infection status. In addition to gloves, use gown and goggles if
exposure to body fluids is likely.
Dressing or V.A.C. VeraFlo™ Therapy Dressing with another HBO compatible
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.
Dressing.
®
Dressing or V.A.C. VeraFlo™ Therapy
®
Therapy for more than two hours; please refer
®
Therapy. Do not use V.A.C. VeraFlo™ Therapy
®
10
Tubing
®