Intended Use; Indications For Use; Contraindications - Medela Invia Motion Instrucciones De Uso

Intended use

The Invia Motion NPWT system is intended to be used by healthcare professionals or adequately trained lay
users.
Healthcare professionals are responsible to train lay users according to the patient instructions for use and
explain all related safety information.
Intended patient population
The Invia Motion NPWT system is intended to be used on patients only exhibiting conditions as described in
the indications for use. The device has not been studied in pediatric patients.
Intended environment
The Invia Motion NPWT system is intended for use in acute, extended and home care settings.

Indications for use

The Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit
from a suction device (NPWT) 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 Motion NPWT system is also intended to manage the environ-
ment 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 Motion NPWT system is appropriate for the following indications:
– Acute or subacute 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

The Invia Motion 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
– Exposed nerves
– Exposed anastomotic site of blood vessels or bypasses
– Exposed organs
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