Descriptive Information; Indications For Use; Contraindications; Description Of The Device - Atos Provox ActiValve Manual Del Paciente

2. Descriptive information

2.1 Indications for use

The Provox ActiValve is an unsterile indwelling voice prosthesis intended for anterograde insertion in a healed puncture
for voice rehabilitation after total laryngectomy. The device is intended for patients who are experiencing early leakage
with previous voice prostheses (device life less than 4-8 weeks). The device reduces the need for frequent replacements in
a majority of users, but not in all.

2.2 CONTRAINDICATIONS

The Provox ActiValve is NOT intended:
• for insertion in a freshly made puncture,
• to be in place during MRI-examination (Magnetic Resonance Imaging), or during Radiation Therapy.

2.3 Description of the device

The Provox ActiValve Voice Prosthesis [Fig. 1] is an unsterile single use one-way valve that keeps a TE-puncture open for
speech, while reducing the risk of fluids and food entering the windpipe. It has two retention flanges [A] and a blue ring [B]
that adds stability and an even sealing surface for the valve flap [C]. The prosthesis is not a permanent implant and needs
periodic replacement.
The device is made of medical grade silicone rubber and radio-opaque fluoroplastic. No part of the device is manufactured
with natural rubber latex. The outer diameter is 7.5 mm (22.5Fr). The Provox ActiValve is available in lengths 4.5, 6, 8, 10,
and 12,5 mm and comes in different opening forces of the valve. The magnets [D] in the ring and valve flap determine the
opening force (the magnets are not adjustable). Since the opening forces are not apparent upon simple visual inspection the
device comes with Provox ActiValve User Cards that also provide important information about the voice prosthesis. If you
have lost the user cards contact your clinician who can arrange for a replacement.
The following items in the package are intended for patient use and should be handed over to you by your clinician:
2 Provox Brushes,
1 Provox Plug,
1 Provox ActiValve Lubricant,
1 Emergency Card.
2 Provox ActiValve User Cards.

2.4 WARNINGS

Accidental swallowing of the Provox ActiValve voice prosthesis may occur. If this occurs, contact your physician who will
advise you further.
Accidental aspiration (i.e. the device falls into the windpipe) of the Provox ActiValve voice prosthesis or other components
of the Provox ActiValve voice rehabilitation system may occur. Immediate symptoms may include coughing, choking or
wheezing. If this occurs seek immediate medical treatment. A foreign body in your airways may cause severe complications
and has to be removed by a clinician.
Caution: You may aspirate or swallow the device without having immediate symptoms, or only mild coughing. If the device
is not visible in the puncture contact the clinician immediately whether you have severe, mild, or no symptoms.
Re-use and re-processing may cause cross- contamination and damage to the device, which could cause patient harm.
Do not modify the Provox ActiValve voice prosthesis or any of its accessories. This may increase the risk of aspiration or
ingestion of the device.
Do not modify the Provox ActiValve voice prosthesis or any of its accessories.

2.5 PRECAUTIONS

Consult your clinician if:
• There is leakage through or around the prosthesis (coughing and/or change of mucus color).
• Speaking becomes difficult (higher effort and/or voice sounds more strained).
• There are signs of inflammation or tissue changes at the puncture region (pain, heat, swelling, traces of blood on the brush
after brushing).
• You see changes in the appearance of the material of the voice prosthesis or the way it fits in the puncture.
• You frequently suffer from coughing during drinking, and cleaning the voice prosthesis does not resolve it. This may be an
early sign of leakage through or around the voice prosthesis.
• You have bleeding or overgrowth of tissue around the device.
• You have persistent pain or discomfort in the region of the Provox ActiValve.
• You experience chronic cough, trouble breathing, or blood in the mucus. These can be signs of a serious health condition
that requires medical attention.
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