Medela Invia Vario 18 AC/DC c/i Instrucciones De Uso página 16

Invia Wound Therapy indications for use
XXIV
System components
The Invia Wound Therapy consists of the Vario 18 AC/DC c/i suction pump with automatic vacu-
um control, which provides the vacuum intensity (75-413 mmHg) and vacuum mode (constant
or intermittent), with a wound dressing kit, consisting of wound dressing material, tubing system
and wound closing material (see the individual components in chapter XXV).
Wound Healing Indication
The Vario 18 AC/DC c/i is intended to be used to create localized topical negative pressure when
used with a wound sealing kit based on the publications and teachings of Mark Chariker, MD and
Katherine Jeter, EdD, ET to promote wound healing and drainage of fluids and infected materials
from the wound into a disposable or reusable canister.
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 or malnutrition
• 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.
• Failure to read and follow all instructions in this manual prior to use may
result in death or injury of the patient.
• This manual provides general guidelines for the use of the Invia Wound Therapy; however,
the safe and effective operation of this device requires specific instruction from a physician.
• Failure to obtain consent and any additional instructions from the treating physician prior
to use may lead to death or injury of the patient.
• Serious injury or death can result from bone fragments or sharp edges (e.g., staples or
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.
• NPWT should not be interrupted for more than 120 minutes at a time, because this may
lead to increased bacteria and a higher risk of infection.
• Patients undergoing NPWT need constant supervision. Objective indications or signs of
a possible infection of the patient or complication must be met immediately, such as e.g.
fever, pain, redness, increased warmth, swelling or purulent discharge.
• Excessive vacuum, a too tight adhesive dressing or an infection of the wound can cause
the patient pain. In each case the dressing must be changed and the wound inspected
in detail.
Precautions:
The following statements describe medical conditions that may require special care for the
safe and effective use of the 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
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