Warnings - Atos Provox ActiValve Manual Del Usuario

The device is available in lengths 4.5, 6, 8, 10, and 12,5 mm and the outer diameter is 7.5 mm (22.5Fr). It comes in three
different opening pressures - Light, Strong and XtraStrong (See graph on inner back cover). Magnets in the ring and valve
flap determine the opening force. The magnetic force applies only in the closed and nearly closed position of the valve flap.
Once the valve flap has opened, the airflow resistance drops. Therefore a higher opening pressure does not mean more air
pressure is required during speaking.
The device body is made of medical grade silicone rubber and radio-opaque fluoroplastic. No part of the device is manufactured
with natural rubber latex. The nickel coated magnets are completely sealed in epoxy glue with no detectable release of
nickel. The device can therefore also be used in patients with hypersensitivity to nickel. Care should however be taken not
to physically damage the epoxy seal during removal or other manipulation of the device.
Provox ActiValve Voice Prosthesis package
The Provox ActiValve comes with the following:
Clinician items (Fig. 1a)
Provox ActiValve Voice Prosthesis
(1) Valve flap, fluoroplastic (radio-opaque); silicone hinge.
(2) Esophageal flange.
(3) Tracheal flange.
(4) Valve seat, fluoroplastic (radio-opaque)
(5) Interacting magnets in valve seat and in valve flap (radio-opaque).
(6) Safety strap.
(7) Direction identification knobs.
(8) Size information.
(9) Outer diameter: 7.5 mm (22.5 Fr).
Insertion tool (for anterograde insertion)
(10) Inserter
(11) Loading Tube
Clinicians Instructions for Use
Patient items (shall be given to the patient) (Fig. 1b)
• 1 bottle (8 ml) Provox ActiValve Lubricant for maintenance,
• 2 reusable Provox Brushes. One for cleaning of the inside of the prosthesis and one for application of Provox ActiValve
Lubricant and for inserting the Provox Plug,
• 1 Provox Plug (first aid tool for leakage),
• 2 Provox ActiValve User Cards to be filled in by the clinician,
• 1 Emergency Card,
• 1 Patient's Instructions for Use.
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. Please complete the user cards using a water resistant
permanent marking pen, and provide the cards to the patient.
The Emergency Card provides important information about emergency airway management. Advise the patient to carry a
user card and the emergency card with them at all times in case of emergency, consultation with healthcare providers (e.g.
radiology), or during travel. If your patient needs to replace any of the cards, you can order a new one by contacting Atos Medical.

1.4 WARNINGS

Re-use and re-processing may cause cross- contamination and damage to the device, which could cause patient harm.
Dislodgement or extrusion of the Provox ActiValve voice prosthesis from the TE puncture and subsequent ingestion, aspiration
or tissue damage may occur (See also Section 3).
To reduce the risk of dislodgment/extrusion:
• Select proper prosthesis size.
• If laryngectomy tubes or stoma buttons are used, choose devices that do not exert pressure on the prosthesis or catch onto
the tracheal flange during insertion and removal.
• Instruct the patient to consult a physician immediately if there are any signs of tissue edema and /or inflammation /infection.
• Inform the patient to use only original Provox accessories of corresponding size for maintenance and to avoid all other kinds
of manipulation of the voice prosthesis.
Do not modify the Provox ActiValve voice prosthesis or any of its accessories.
8