Tabla De Contenido; Descriptive Information; Indications For Use; Contraindications - Atos Provox ActiValve Manual Del Usuario

ENGLISH
The Provox ActiValve® Voice Rehabilitation System
It is important that your patient is aware of the consequences of having a tracheostoma. Therefore make sure that the patient is
informed and understands the Stomal airway management information below (extract from the Provox ActiValve patient manual).
Stomal airway management
Emergency situations
It is important that emergency personnel knows that you are a neck breather. This will help them determining that oxygen
and rescue breathing need to be administered to your stoma and not to your mouth or nose.
We recommend that you and your clinician download the guidelines for rescue breathing from
www.atosmedical.com/rescuebreathing
In the package of your Provox ActiValve you will find a bright yellow Emergency card and Provox ActiValve User Card.
We recommend that you keep both the Emergency Card and Provox ActiValve User Card with you at all times.
Elective situations
If you need to undergo a procedure that requires intubation (putting a breathing tube in your windpipe), it is very important
that the anesthesiologist and the doctor who is performing the procedure are aware that you are a neck breather and that
you are using a voice prosthesis. It is important for them to understand that the voice prosthesis should stay in place. If it is
removed, fluids from your mouth, food pipe, or stomach may get into your windpipe.
It is very important that the intubation tube is inserted and removed carefully so that the voice prosthesis does not dislodge
or come out.
1. Descriptive information ..................................................................................................................................................................................... 7
1.1 Indications for use ............................................................................................................................................................................................. 7
1.2 CONTRAINDICATIONS ...................................................................................................................................................................................... 7
1.3 Description of the device ............................................................................................................................................................................... 7
1.4 WARNINGS .......................................................................................................................................................................................................... 8
1.5 PRECAUTIONS ..................................................................................................................................................................................................... 9
2. Instructions for use .............................................................................................................................................................................................. 9
2.1 Voice prosthesis replacement ....................................................................................................................................................................... 9
2.2 Device lifetime ..................................................................................................................................................................................................10
2.3 Prosthesis maintenance ................................................................................................................................................................................10
2.4 Accessories ........................................................................................................................................................................................................11
3. Adverse event/Trouble shooting information.........................................................................................................................................11
4. Additional information ....................................................................................................................................................................................13
4.1 Date of printing and user assistance information ...............................................................................................................................13

1. Descriptive information

1.1 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.

1.2 CONTRAINDICATIONS

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

1.3 Description of the device

The Provox ActiValve Voice Prosthesis is an unsterile single use one-way valve that keeps a TracheoEsophageal (TE)-puncture
open for speech, while reducing the risk of fluids and food entering the windpipe. It has a higher opening pressure than standard
voice prostheses to prevent inadvertent valve opening when the patient breathes or swallows.
The prosthesis is not a permanent implant and needs periodic replacement. It cannot be sterilized.
7