6
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: Invia NPWT Systems are not for use in the Magnetic Resonance (MR) Environment, so do not take an 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 Invia NPWT Systems into HBOT Chamber
– Dressings: After disconnecting the Invia NPWT System from the dressing, either (i) replace the Invia Foam 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 Foam 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 interruption. If the-
rapy is discontinued for more than 2 hours, the dressing should be replaced and therapy restarted by a healthcare professio-
nal. If the therapy needs to be interrupted, the tubing should be clamped and the ends of the tubing protected.
CAUTIONS
The following statements describe conditions that may require special care for the safe and effective use of the Invia
Foam Dressing Kit with FitPad.
– Patients receiving anticoagulant therapy or platelet aggregation inhibitors, actively bleeding or have weakened
blood vessels or organs.
– Patients suffering from difficult wound hemostasis.
– Patients untreated for malnutrition.
– Noncompliant or combative patients.
– Patients suffering from wounds in close proximity to blood vessels or delicate fascia.
– Patients with infected wound or osteomyelitis.
– Patients with Spinal Cord Injury (sympathetic nervous system stimulation): in the event a patient experiences auto-
nomic dysreflexia (sudden changes in blood pressure or heart rate in response to stimulation in response to stimu-
lation of the sympathetic nervous system), discontinue Invia NPWT therapy to help minimize sensory stimulation
and seek immediate medical assistance.
– Wounds that involve an enteric fistula.
– Use near vagus nerve (bradycardia).
– Circumferential dressing application.
– The device has not been studied on pediatric patients.
– Patient size and weight should be considered when prescribing this device.
– The use of negative pressure presents a risk of tissue ingrowth into the foam. Tissue ingrowth may be reduced by
reducing therapy pressure, using a wound contact layer or by increasing the frequency of dressing changes.
– As a condition of use, this device should only be used by qualified and authorized personnel. The user must have
the necessary knowledge of the specific medical application for which Invia Foam Dressing Kit with FitPad is being
used.
– Ensure that tubing is installed completely and without any kinks to avoid leaks or blockages in the suction circuit.
– Underlying structures, such as tendons, ligaments and nerves should be covered with natural tissue or a non-ad-
herent dressing layer prior to applying the foam dressing.
– Maintain regular monitoring of the wound site during therapy to ensure therapeutic treatment and patient comfort.
– Upon dressing changes, ensure that all pieces of foam are removed from the wound.
– As with all adhesive products apply and remove the dressing carefully from sensitive or fragile skin to avoid skin
tripping, especially after frequent dressing changes.
– Do not use if packaging is breached or damaged.
– For maximum benefit on closed surgical incision, the Invia negative pressure therapy should be applied immedi-
ately post-surgery to clean surgically closed wounds. It is to be continuously applied for a minimum of two days up
to a maximum of seven days, with regular dressing changes everty 48 to 72 hours. All dressing changes should be
applied under direct medical supervision. The Invia therapy system will not be effective in addressing complica-
tions associated with the following:
