Cautions - Medela Invia Instrucciones Para Uso

– Explosion hazard – the Invia Liberty pump is not for use in potentially explosive environments inclu-
ding oxygen enriched environments and in areas of flammable anesthetics.
– In the event that defibrillation is required, disconnect the pump from the wound dressing before the
patient is defibrillated.
– Special care is advised for dressing placement and removal in order to avoid situations such as
unintentional gauze or foam retention.
– This product contains lithium-ion batteries which bear risk of fire, explosion and burns.
Do not disassemble, crash, heat above 100 °C (212 °F), incinerate or dispose of in fire.
Contact your local Medela customer service representative for assistance with product operations.

CAUTIONS

– The following statements describe medical conditions that may require special care for the safe
and effective use of the Invia NPWT system.
– Patients at high risk for bleeding and hemorrhage.
– Patients taking anticoagulants or platelet aggregation inhibitors, or with patients experiencing
active bleeding or difficult wound hemostasis.
– Wounds that involve a fistula.
– Using Invia NPWT system in close proximity to blood vessels and organs or exposed organs, ves-
sels, nerves, tendons, or ligaments. Provide necessary protection of all vessels and organs using a
protective barrier.
– Patients with a history of vascular anastomosis or friable, irradiated, sutured or infected blood ves-
sels.
– Use near vagus nerve (bradycardia) or use on patients with a history of spinal cord injury (stimula-
tion of sympathetic nervous system).
– Circumferential dressing application.
– For maximum benefit on closed surgical incision, the Invia negative pressure therapy should be
applied immediately 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 complications associated with the fol-
lowing:
– Ischemia to the incision or the incision area
– Untreated or inadequately treated infection
– Inadequate hemostasis of the incision
– Cellulitis of the incision area
Incorrect use may cause pain and injury to the patient. Excessive negative pressure,
a too tight adhesive cover dressing, or an infection of the wound may cause pain to the patient. In eit-
her case, the dressing must be removed and the wound assessed.
The patient should be monitored regularly according to physician instructions and facility guidelines to
monitor patient comfort, therapy compliance and signs of wound infection.
Do not use an Invia Liberty canister or tubing if the sterile packaging is damaged.
The Negative Pressure Wound Therapy must be used 24 hours per day without interruption. If the
pump is stopped for more than two hours, the dressing must be changed and therapy restarted.
Consider the patient's size and weight when prescribing this device.
Consider mode of therapy – intermittent versus continuous.
CAUTION: U.S. Federal law restricts this device for sale or rental by or on the order of a physician.
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