Indications For Use; Contraindications; Warnings, Cautions And Safety Instructions - Medela Invia Instrucciones Para Uso

Indications for use

The Invia Liberty Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would
benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds it creates
an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by pre-
paring the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion,
and by removing exudate and infectious material.
When used on closed surgical incisions, the Invia Liberty NPWT system is also intended to manage the
environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining
a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.
The Invia Liberty NPWT system is appropriate for use for the following indications:
– Acute or subacute wounds
– Chronic wounds
– Dehisced wounds
– Pressure ulcers
– Diabetic/Neuropathic ulcers

Contraindications

The Invia Liberty NPWT system is contraindicated in the presence of:
– Necrotic tissue with eschar present
– Untreated osteomyelitis
– Non-enteric and unexplored fistulas
– Malignancy in the wound
– Exposed vasculature

Warnings, cautions and safety instructions

WARNINGS
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
CAUTIONS
Indicates a potentially hazardous situation which, if not avoided, could result in minor or moder-
ate injury.
Safety related tip
Indicating useful information about the safe use of the device.
The Invia Liberty Negative Pressure Wound Therapy system (Invia Liberty NPWT system) is intended for
the use described in these instructions for use.
Medela is only responsible for the effect on BASIC SAFETY, reliability and performance of the Invia
Liberty NPWT system if it is used in accordance with the instructions for use.
Please read and observe these warnings and safety instructions before operation.
These instructions for use must be kept with the device.
Please note that these instructions for use are a general guide for the use of the product. Medical
situations must be addressed by a physician.
– Venous insufficiency ulcers
– Traumatic wounds
– Partial thickness burns
– Flaps and grafts
– Closed surgical incisions
– Exposed nerves
– Exposed anastomotic site of blood vessels
or bypasses
– Exposed organs
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