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Intended use and therapy safety information
The Invia Foam 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 addi-
tional safety information and instruction for use. To help ensure safe and effective use, the Invia Foam Dressing Kits with Fit-
Pad are to be used only with the approved therapy units.
The components of the Invia Foam 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 Foam 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 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 Foam 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 Ther-
apy) 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 Foam 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.
The Invia Foam Dressing Kit with FitPad is appropriate for use for 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
