6
7
•
Do not use the Phoniq Stoma Button for any other
purpose than the intended use specified in this
document.
USE OF THE DEVICE DURING DIAGNOSTIC
INVESTIGATIONS, EVALUATIONS OR
TREATMENT
The Phoniq Stoma Button can be used safely during
an MRI Scan.
STORAGE AND HANDLING
The Phoniq Stoma Button should be kept dry and
stored in the carton away from direct sunlight.
WHEN TO CONTACT A HEALTHCARE
PROFESSIONAL
•
If there is any irritation or trauma to the skin or the
tracheostoma during use.
•
If the recommended Phoniq Stoma Button is no
longer a good fit.
•
If the device becomes dislodged and enters the
airway.
REPORTING A SERIOUS INCIDENT
If use of the device results in a serious incident, as
defined in Medical Device Regulation (EU) 2017/745,
please contact either Kapitex Healthcare Ltd or the
Competent Authority in your country of use (see
https://ec.europa.eu/growth/sectors/medical-devices/
contacts; Vigilance contact points menu).
properly cleaned using the recommended cleaning
method. Instead, dispose of the device and replace
with a new Phoniq Stoma Button.
Refit following the Insertion instructions above.
DISPOSAL
•
Dispose of as clinical waste in a healthcare
environment.
•
Dispose of as general household waste in a home
environment.
WARNINGS AND PRECAUTIONS
•
Do not re-use a Phoniq Stoma Button on more than
one patient, since this presents a risk of infection.
•
Do not clean a Phoniq Stoma Button using any
other method than that recommended in this
document.
•
Do not use an individual Phoniq Stoma Button for
more than 28 days.
•
Do not use the Phoniq Stoma Button beyond the
expiry date shown on the device packaging.
•
Do not use the Phoniq Stoma Button if the
packaging is open, or the device or packaging
are damaged.
•
Do not attempt to sterilize the Phoniq Stoma
Button.
•
Do not apply excessive force during Phoniq Stoma
Button insertion, as this could result in the Phoniq
Stoma Button being placed beyond the stoma
opening and entering the airway.
•
Avoid using a Phoniq Stoma Button that is too small
or too large for the size of the tracheostoma.
•
An incorrectly fitted or oversized Phoniq Stoma
Button may cause skin irritation, in which case the
device should be removed immediately, and the
stoma allowed to recover before another Phoniq
Stoma Button is fitted.
•
The Phoniq Stoma Button is designed specifically
for use with the Phoniq HME Filter. Do not use with
HME Filters from other manufacturers.
-
If not held in place, repeat the Insertion
instructions. If still unsuccessful, please refer to
the ‘When to Contact a Healthcare Professional’
section.
•
Should the Phoniq Stoma Button be accidentally
forced too far into the stoma opening, gently pull
the Phoniq Stoma Button out of the stoma and start
the Insertion process again.
REMOVAL
•
Holding the outer surface of the interface ring (see
Figure A) with thumb and forefinger, gently pull
and ease out the Phoniq Stoma Button from the
tracheostoma.
CLEANING
The Phoniq Stoma Button should be removed and
cleaned daily. It is suggested to clean the button at the
same time as the Phoniq HME Filter is changed.
•
Soak the Phoniq Stoma Button in a container of
warm water for 10 minutes.
•
Transfer the Phoniq Stoma Button to a container
of fresh warm water and clean with a specifically
designed cleaning swab (Trachi-Swab - see
Recommended Accessories and Consumables)
for 2 minutes.
•
During the 2 minute clean:
-
Clean inside and out with the swab, making
physical contact with all surfaces using a
backwards/ forwards/twisting motion.
•
Rinse inside and out under cold running tap water
for 1 minute. Shake off excess water from the device.
Allow to air dry.
INSPECTION AND REFITTING
•
Prior to refitting, inspect the device to ensure it is
clean, free from blockages and any signs of damage
or deterioration.
•
Do not continue to use a Phoniq Stoma Button that
shows signs of damage, or wear, or that cannot be
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ENGLISH
EN
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