Acelity V.A.C. Ulta, Информация о безопасности и инструкции по применению

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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 and V.A.C. VeraFlo™ 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