Product Description - Molnlycke Avance Solo Adapt Manual Del Usuario

Avance Solo Adapt Foam, Film and Transfer Port
®
Avance Solo Adapt Film
®
Avance Solo Adapt Foam, Film and Transfer Port and Avance Solo
Adapt Film are products within the Avance Solo Adapt Negative
Pressure Wound Therapy (NPWT) System.
Avance Solo Adapt NPWT System consists of Avance Solo Adapt
Pump, Avance Solo Canister 50 ml, Avance Solo Adapt Foam,
Avance Solo Adapt Film and Avance Solo Adapt Transfer Port which
together form a system for wound management via the application
of negative pressure.
These instructions for use contain information relevant to the
Avance Solo Adapt Foam, Film and Transfer Port and Avance Solo
Adapt Film for Health Care Professionals. Avance Solo Adapt Foam,
Film and Transfer Port and Avance Solo Adapt Film are intended
for use by healthcare professionals for therapy on patients in
healthcare facilities and home care settings.
For complete list of warnings, precautions and instructions
regarding the Avance Solo Adapt NPWT System, including those
relevant to the Avance Solo Adapt Pump and Avance Solo Canister
see HEALTH CARE PROFESSIONAL Instructions for use provided
with Avance Solo Adapt NPWT System.
1.

Product description

Avance Solo Adapt Foam, Film and Transfer Port consists of
Avance Solo Adapt Foam, a single use polyurethane foam
wound filler, distributing negative pressure to the wound bed
and facilitating transport of exudate
Avance Solo Adapt Film, a single use breathable soft silicone
film, to fixate the foam and a to achieve a seal
Avance Solo Adapt Transfer Port, a single use polyolefin/
polyurethane transfer port, for transporting exudate
Avance Solo Adapt Film consists of
Avance Solo Adapt Film, a single use breathable soft silicone
film, to fixate the foam and a to achieve a seal
Avance Solo Adapt Foam, Film and Transfer Port and Avance Solo
Adapt Film are applicable for use on low to moderately exuding
wounds up to the size of the Avance Solo Adapt Foam.
Avance Solo Adapt Foam, Film and Transfer Port and Avance Solo
Adapt Film are intended for adults.
Material content
Film: polyethylene, polyurethane, soft silicone, polyacrylate adhesive
Foam: polyurethane
Transfer Port and tubing with clamp: Polyurethane, polyester,
polyacrylate adhesive, polyolefin based thermoplastic elastomer,
polyethylene
Connectors: acrylonitrile butadiene styrene copolymer,
thermoplastic olefin, polyethylene
2. Indications for use
The Avance Solo Adapt NPWT System is indicated for patients
who would benefit from wound management via the application of
negative pressure, particularly as the device may promote wound
healing through the removal of exudate, infectious material.
Avance Solo Adapt NPWT System is indicated for removal of low to
moderate amounts of exudate from pressure ulcers.
3. Contraindications
Avance Solo Adapt NPWT System is contraindicated for patients with
the following conditions:
• Malignancy in the wound or margins of the wound
• Untreated and previously confirmed osteomyelitis
• Non-enteric and unexplored fistulas
• Necrotic tissue with eschar present
• Exposed nerves, arteries, veins or organs
• Exposed anastomotic site
4. Warnings
• Application of NPWT may increase the risk of bleeding. If sudden
or increased bleeding is observed, immediately take appropriate
action to stop bleeding and seek emergency medical attention.
• Patients at high risk of bleeding, such as patients receiving
anticoagulant therapy or with altered hemostasis, must be
monitored closely during therapy. Ensure to establish hemostasis
before applying therapy.
• Patients at risk of bleeding complications due to e.g. a history of
vascular anastomosis or friable, irradiated, sutured or infected
blood vessels, shall be monitored carefully during therapy.
• Patients undergoing NPWT need frequent supervision. Routinely
check that the negative pressure therapy is active, the dressing
should be contracted and firm to the touch. If it is necessary to
discontinue therapy, the time elapsed without negative pressure
must comply with instructions from healthcare professional.
• During therapy, make sure that the pump and tubing are
positioned to eliminate the risk of
- imprints
- contamination
- entrapment or strangulation
- kinking or blocking of tubing
- being exposed to sources of heat
• Cover or remove sharp edges or bones in the wound prior to the
application of the dressing due to the risk of puncturing of organs
and blood vessels.
• Tendons, ligaments and nerves shall be protected from direct
contact with Avance Solo Adapt Foam.
• Do not place Avance Solo Adapt Foam into unexplored or blind
tunnels.
• If defibrillation is required, disconnect Avance Solo Adapt Pump
and remove the dressing if the dressing positioning interferes.
• Avance Solo Adapt Pump is Magnetic Resonance (MR) unsafe, do
not take into a Magnetic Resonance Imaging (MRI) environment.
Avance Solo Adapt Foam, Avance Solo Adapt Film and Avance Solo
Adapt Transfer Port are MR safe. The impact of the foam, film
and transfer port on Magnetic Resonance Tomography (MRT)/
Magnetic Resonance Imaging (MRI) imaging artifacts is unknown.
• If the patient experiences sudden elevation in blood pressure or
heart rate in response to stimulation of the sympathetic nervous
system, immediately stop the therapy to help minimize sensory
stimulation and seek emergency medical attention.
• To minimize the risk of bradycardia, do not apply the dressing
close to the vagus nerve.
• Do not use oxidizing agents such as hypochlorite solutions or
hydrogen peroxide prior to use of the Avance Solo Adapt Foam.