Medela Invia Gauze Instrucciones De Uso página 7

bleeding may be observed and considered expected. However, patients with increased risk of bleeding, as described
in the Warnings section under Bleeding, have a potential for more serious bleeding from the wound site. If signifi-
cant bleeding develops, immediately discontinue the use of the therapy system, take measures to stop the
bleeding and do not remove the gauze dressing until the treating physician or surgeon is consulted. Do not
resume the use of the therapy system until adequate hemostasis has been achieved and the patient is not at
risk for continued bleeding.
Sensitivity to PHMB (Polyhexamethylene biguanide):
The Kerlix™AMD™ Antimicrobial gauze contains PHMB, which may present a risk of an adverse reaction in patients
who are allergic or hypersensitive to PHMB. If a patient has a known allergy or hypersensitivity to PHMB, do not use
Invia Gauze Dressings. If any signs of allergic reaction or hypersensitivity develop, such as redness, swelling, rash,
urticarial or signification pruritus, discontinue use and consult a physician immediately. If bronchospasm or more
serious signs of allergic reaction appear, seek immediate medical assistance.
Acrylic adhesive: The Invia Transparent Film 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 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 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 Invia NPWT Systems are not for use in the Magnetic Resonance (MR) Environment, so do
not take the Invia NPWT device into this environment.
– Dressings: After disconnecting from the Invia NPWT system, dressings can typically remain on the patient with
no risk in a MR environment (all components are electrically nonconductive and nonmagnetic items).
Hyperbaric Oxygen Therapy (HBOT):
– Therapy Unit: Do not bring the Invia NPWT Systems into HBOT Chamber
– Dressings: After disconnecting the Invia NPWT System from the dressing, either (i) replace the Invia Gauze
Dressing with another HBOT compatible material during the hyperbaric treatment or (ii) cover the unclamped
end of the tubing with moist cotton gauze and completely cover the Invia Gauze Dressing (including tubing)
with a moist towel throughout the treatment in the chamber. For Hyperbaric Oxygen Therapy, the tubing must
not be clamped
Course of therapy: Invia Negative Pressure Wound Therapy Instructions advise 24 hours therapy without interrup-
tion. If therapy is discontinued for more than 2 hours, the dressing should be replaced and therapy restarted by a
healthcare professional. If the therapy needs to be interrupted, the tubing should be clamped and the ends of
the tubing protected.
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