Medela Invia Gauze Instrucciones De Uso página 8

CAUTIONS
The following statements describe conditions that may require special care for the safe and effective use of the Invia
Gauze 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 medi-
cal 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 gauze. 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 Gauze 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 gauze 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 gauze 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 every 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:
– Ischemia to the incision or the incision area
– Untreated or inadequately treated infection
– Inadequate hemostasis of the incision
– Cellulitis of the incision area
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