Warnings - Medela Invia Liberty Mode D'emploi

Warnings

WARNINGS
– Do not modify this equipment without authorization from the manufacturer.
– This manual provides general guidelines for the use of the Invia Wound Therapy.
– The safe and effective operation of this device requires specific instruction from
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 Patients Instructions for Use and explain all
related safety information.
CAUTION: Incorrect use can cause pain and injury to the patient.
– Consult the indications for use, precautions and contraindications when using the
Invia Liberty as a vacuum source with the Invia Wound Therapy. 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, showering or suitable for a hazardous
explosive environment.
– Do not dry Invia Liberty with microwaves.
– Data transfer via USB is not possible in the running mode.
– A patient undergoing NPWT requires frequent supervision. Objective indications or
signs of possible 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 structures 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, immediately 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.
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