Intended Use And Therapy Safety Information; Indications For Use; Contraindications - Medela Invia Gauze Instrucciones De Uso

Intended use and therapy safety information

Invia Gauze Dressing Kit with FitPad is intended for use in conjunction with the Invia Motion and Invia Liberty Negative
Pressure Wound Therapy (NPWT) Systems. The Invia Motion and Invia Liberty NPWT Systems are intended for use in acute,
extended and home care settings. Users are directed to the Invia Motion and Invia Liberty NPWT System labeling for additio-
nal safety information and instruction for use. To help ensure safe and effective use, the Invia Gauze Dressing Kits with FitPad
are to be used only with the approved therapy units.
The components of the Invia Gauze Dressing Kit with FitPad are packaged sterile and are for single use only. Do not use if
sterile package is damaged or opened prior to use.
To apply Invia Gauze Dressing Kit with FitPad, use clean/aseptic or sterile techniques in accordance with local protocol.
Important: Failure to consult a physician and carefully read and follow all therapy unit and dressing instructions for use and
safety information prior to each use may lead to inadequate performance of the product and/or the potential for serious or
fatal injury. Do not adjust therapy unit settings or use unit without directions from or supervision by the prescribing physician.

Indications for use

The Invia Gauze Dressing Kit with FitPad in conjunction with the Invia Motion and Invia
Liberty Negative Pressure Wound Therapy (NPWT) Systems 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 preparing 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 Gauze Dressing Kit with FitPad 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 exudates
via the application of Negative Pressure Wound Therapy.
Invia Gauze Dressing Kit with FitPad is appropriate for use on the following indications:
– Acute or sub-acute wounds
– Chronic wounds
– Dehisced wounds
– Pressure ulcers
– Diabetic/neuropathic ulcers
– Venous insufficiency ulcers
– Traumatic wounds
– Partial thickness burns
– Flaps and Grafts
– Closed surgical incisions

Contraindications

– Necrotic tissue with eschar present
– Untreated osteomyelitis
– Non-enteric and unexplored fistulas
– Malignancy in wound (with exception of palliative care to enhance quality of life)
– Exposed vasculature
– Exposed nerves
– Exposed anastomotic site of blood vessels or bypasses
– Exposed organs
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