Warnings - Medela Invia Instrucciones Para Uso

WARNINGS

– Do not modify this equipment without authorization from the manufacturer.
– This manual provides general guidelines for the use of the Invia NPWT system.
– The safe and effective operation of this device requires specific instruction from a physician.
– No modification of this equipment is allowed.
– For use only by healthcare professionals who have been adequately trained in suction procedures,
wound care, negative pressure wound therapy and in the use of aspirators or adequately trained
lay users. Healthcare professionals are responsible to train lay users according to the patient inst-
ructions for use and explain all related safety information.
Caution: Incorrect use can cause pain and injury to the patient.
– Consult the indications for use, cautions and contraindications when using the Invia Liberty as a
vacuum source with the Invia NPWT system. Failure to read and follow all instructions in this
manual prior to use may result in death or injury of the patient.
– Failure to obtain consent and any additional instructions from the treating physician prior to use,
may lead to death or injury of the patient.
– Before you plug in the device, please check that your local power supply is the same as the voltage
given on the specification plate.
– The device is not for use while bathing or showering
– Do not dry Invia Liberty in a microwave.
– Data transfer via USB is not possible in the running mode.
– A patient undergoing NPWT requires frequent supervision. Objective indications or signs of possi-
ble infection or complication must be addressed immediately (e.g. fever, pain, redness, increased
warmth, swelling or purulent drainage). Monitor the device, wound, surrounding skin and patient
status and comfort level frequently to ensure efficient, safe treatment and patient comfort.
– Do not place the foam/gauze dressing directly on exposed blood vessels, organs, nerves, tendons,
bones or ligaments. When using the Invia Liberty NPWT system in close proximity to these struc-
tures a protective barrier, such as a non-adherent wound contact layer, must be used.
– Serious or fatal injury can result from bone fragments or sharp edges (e.g. staples or hardware)
that could puncture protective barriers, vessels or organs.
– Patient must be closely monitored for bleeding. If sudden or increased bleeding is observed, imme-
diately stop use of the pump, apply pressure on wound dressing and seek immediate Emergency
Medical Attention.
– Should a spinal cord injury patient experience autonomic hyperreflexia, discontinue treatment with
the Invia Liberty NPWT system and consult a physician immediately.
– Never place the Invia Liberty pump in water or liquids. Clamp the drain and disconnect from the
dressing prior to bathing or showering.
– Consider the use of a protective barrier on skin that may come in contact with the tubing, espe-
cially in patients with fragile skin.
– Invia NPWT instructions advise 24 hours therapy without interruption. If therapy is discontinued for
more than 2 hours using foam or gauze, the dressing should be replaced and therapy restarted by
a healthcare professional.
– This device has not been studied in pediatric patients.
– Clamp the drain and disconnect the Invia Liberty pump prior to patient entering hyperbaric oxygen
chamber (HBO) or Positron Emission Tomography (PET).
– The Invia Liberty NPWT system is not for use in the Magnetic Resonance (MR) environment, so do
not take the Invia Liberty NPWT system into this environment.
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