NPWT (Wound Vacuum Systems) Indications / Contraindications
Indications:
Medela® Invia® Wound Therapy is indicated to help promote wound
healing through means including drainage and removal of infectious
material or other fluids, under the influence of continuous and/or
intermittent negative pressures, particularly for patients with
chronic, acute, traumatic, subacute and dehisced wounds,
partial-thickness burns, ulcers (such as diabetic or pressure),
flaps and grafts.
The types of wounds indicated are:
• Diabetic/Neuropathic ulcers
•
Pressure ulcers
• Chronic wounds
• Acute wounds
• Dehisced wounds
Contraindications:
Contraindicated for patients with:
• Malignancy of the wound
•
Untreated osteomyelitis
• Non-enteric and unexplored fistula
•
Necrotic tissue with eschar present
• Do not place Invia® Wound Therapy
dressing over exposed blood vessels or organs
Warnings:
The following Warning statements describe the potential for serious
consequences to the patient, such as death, injury or adverse reactions.
• The Instructions for Use provides general guidelines for the use of
Invia® Wound Therapy; the safe and effective operation of this device
requires specific instruction from a qualified healthcare provider.
•
Consult the indications for use, precautions and contraindications when
using the Invia Liberty as a vacuum source with the Invia Wound Therapy.
• Serious injury or death can result from bone fragments or sharp edges
(e.g., staples of hardware) that could puncture protective barriers,
vessels, or organs.
• Please consider using a protective barrier where
drain tubing comes in contact with patients with fragile or pliable skin.
• Patients undergoing NPWT need frequent supervision. Objective indications
or signs of possible infection of the patient or complication must be met
immediately, such as e.g. fever, pain, redness, increased warmth, swelling
or purulent discharge.
Precautions:
The following statements describe medical conditions that may require
special care for the safe and effective use of Invia® Wound Therapy.
Additional precautions must be used with:
• Patients taking
anticoagulants or platelet aggregation inhibitors, or in patients
experiencing active bleeding or difficult wound hemostasis
• Wounds that
involve a fistula (excluding contraindicated fistulae)
• Using Invia®
Wound Therapy in close proximity to blood vessels and organs (provide
necessary protection of all vessels and organs using a protective barrier)
• Patients with a history of irradiated or sutured blood vessels or organs.
Contact the Medela® customer assistance department for help with product
operations.
Not available in all countries.
Federal law restricts this device to sale or rental by or on the
order of a physician.
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