Atos Medical Provox ActiValve Patient Manual page 6

The Provox ActiValve® Voice Rehabilitation System
Prescriber information
CAUTION: United States Federal law restricts this device to sale, distribution and use by or on order of a
physician or a licensed practitioner. The availability of this product without prescription outside the United
States may vary from country to country.
Disclaimer
Atos Medical offers no warranty - neither expressed nor implied - to the purchaser hereunder as to the lifetime of
the product delivered, which may vary with individual use and biological conditions. Furthermore, Atos Medical
offers no warranty of merchantability or fitness of the product for any particular purpose.
Patents and Trademarks
Provox ActiValve is a trademark owned by Atos Medical AB
Provox ActiValve is protected by US 5.314.470, US 5.976.151, US 7.166.128 and other patents.
This Manual contains information that you may find helpful in considering the use of the Provox ActiValve Voice
Rehabilitation System and in assisting you with the use of the device. It is not intended to provide a comprehensive
discussion of the risks and benefits of the device, nor is it intended to take the place of a discussion about the risks
and benefits of the device for you between you and your physician or clinician.
The Manual, which accompanies this product, may be revised from time to time and must therefore be reviewed
prior to each procedure in which the product is used.
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 Cards. 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.
This product and its packaging are latex-free.
ENGLISH
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