Invia Foam Dressing Kit consists of a foam pad, a suction interface (Invia FitPad) and Transparent Film (one or more pieces depending on the kit size).
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 additional safety information and instruction for use. To help ensure safe and effective use, the Invia Foam Dressing Kits with FitPad 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 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 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 andremoving exudates via the application of Negative Pressure Wound Therapy.
The Invia Foam Dressing Kit with FitPad is appropriate for use for the following indications:
- Pressure ulcers
- Flaps and grafts
- Chronic wounds
- Dehisced wounds
- Traumatic wounds
- Partial thickness burns
- Closed surgical incisions
- Venous insufficiency ulcers
- Acute or sub-acute wounds
- Diabetic/neuropathic ulcers
Contraindications
- Exposed nerves
- Exposed organs
- Exposed vasculature
- Untreated osteomyelitis
- Necrotic tissue with eschar present
- Non-enteric and unexplored fistulas
- Exposed anastomotic site of blood vessels or bypasses
- Malignancy in wound (with exception of palliative care to enhance quality of life)
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