Warnings; Precautions; Adverse Events; Instructions For Use - Atos Medical Provox ActiValve Patient Manual

2.4 WARNINGS

• Accidental aspiration (entering the windpipe) of the
Provox ActiValve voice prosthesis or other components
of the Provox voice rehabilitation system may occur.
Immediate symptoms may include coughing, wheezing,
difficulty to breathe or inability to breathe, which can
be life-threatening. If this occurs seek immediate
medical treatment. A foreign object in your airway
may cause severe complications, and has to be removed
by a clinician.
• Accidental swallowing of the Provox ActiValve voice
prosthesis may occur. If this occurs, contact your
clinician immediately.
• 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.
• Re-use and re-processing may cause cross-contamination
and damage to the device, which could cause patient
harm.
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.

2.5 PRECAUTIONS

DO
• Clean and lubricate the voice prosthesis as directed
to help maintaining its functionality.
• Only use Provox ActiValve Lubricant for lubrication
of the Provox ActiValve prosthesis. Other lubricants
may damage the prosthesis.
• Make sure that your hands are thoroughly clean
and dry before using your hands in the area of your
tracheostoma, and before cleaning your voice prosthesis
and/or accessories.
• Keep all devices that may enter, or make any contact
with your tracheostoma and voice prosthesis clean.
• Always inform medical personnel about your Provox
ActiValve and show them your Provox ActiValve User
Card before undergoing any kind of medical treatment
or examination. Also see section Contraindications.
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• Keep the Provox ActiValve Lubricant and other
accessories out of reach of children and pets that may
be harmed by inhaling or swallowing them.
DO NOT
• Do not try to change the Provox ActiValve at home
or by yourself. The device should only be removed
and replaced by a healthcare professional.
• Do not enlarge the bottle opening of the Provox
ActiValve Lubricant.
• Do not apply the Provox ActiValve Lubricant directly
from the bottle to the prosthesis [Fig. 2] since this
could deposit the liquid in the lungs and cause severe
coughing, pneumonia or serious breathing problems.

2.6 Adverse events

Consult your clinician if:
• Any changes occur in the appearance of the material
of the prosthesis or the way it fits in the puncture.
• You frequently suffer from coughing during drinking,
and cleaning the prosthesis does not resolve it.
This may be an early sign of leakage through or around
the prosthesis.
• Speaking becomes difficult (requires higher effort)
and cleaning the prosthesis does not resolve it.
• There are any signs of inflammation or tissue change
at or near the puncture tract. Symptoms may include,
but are not limited to, pain, heat, redness, and swelling.
• 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.

3. Instructions for Use

3.1 How to use Provox ActiValve for
speaking
Using Provox ActiValve is similar to using any other
Provox voice prosthesis. However, you may need to use
slightly more pressure to overcome the initial resistance