Kapitex Phoniq Stoma Button, Instructions For Use Manual

Page: 3 / 17

4 5
[A]
Interface ring
(8)
Interface ring(8) (EN) Interface ring, (HR) Sučeljni prsten, (NL) Interface-ring,
(FR) Anneau d’interface, (DE) Verbindungsring, (EL) Δακτύλιος διασύνδεσης,
(SR) Interfejs prsten, (SL) Vmesni obroček
Retaining lip(9)
(EN) Retaining lip, (HR) Zaporna brtva, (NL) Borglipje, (FR) Lèvre de retenue,
(DE) Haltelippe, (EL) Χείλος συγκράτησης, (SR) Sigurnosna štipaljka,
(SL) Pritrdilna zaponka
Recommended Accessories
(EN) Recommended Accessories and Consumables, (HR) Preporučeni dodaci
and Consumables(7)
i potrošni materijal, (NL) Aanbevolen accessoires en verbruiksartikelen,
(FR) Accessoires et consommables recommandés, (DE) Empfohlene
Zubehörteile und Verbrauchsmaterialien, (EL) Συνιστώμενα αξεσουάρ και
αναλώσιμα, (SR) Preporučena dodatna oprema i potrošni materijal,
(SL) Priporočeni dodatki in potrošni material
Retaining lip
(9)
[B]
Stoma Button
INDICATIONS FOR USE
The Phoniq Stoma Button is indicated for use in
patients who have undergone a laryngectomy
procedure and who now breathe through a
tracheostoma.
CONTRA-INDICATIONS
There are no specific contra-indications identified for
the Phoniq Stoma Button.
INSTRUCTIONS FOR USE
•
Assistance should be provided with insertion,
removal, cleaning and re-fitting the device
for patients who are unable to carry this out
themselves.
•
Initial selection and fitting of the Phoniq Stoma
Button should be carried out by a healthcare
professional.
PREPARATION
•
It is optional to lubricate the Phoniq Stoma Button
with a medical grade, water based lubricant gel,
to aid insertion (please seek the advice of your
healthcare professional).
INSERTION
•
Compress and fold the retaining lip between
thumb and forefinger before inserting into the
tracheostoma (see Figure A & B).
•
After partially inserting the Phoniq Stoma Button,
allow the device to unfold to fit the shape of the
tracheostoma.
•
Gently push into place in the tracheostoma.
•
Check placement of the Phoniq Stoma Button.
-
A gentle pull of the interface ring followed by
a forceful cough from the user will confirm that
the Phoniq Stoma Button is held in place by the
retaining lip.
DISCLAIMER
The instructions for use for this device may be
periodically reviewed and revised and must therefore
be consulted by the user prior to each use.
DESCRIPTION
The Phoniq Stoma Button is a transparent, silicone
tracheostoma button (sometimes referred to as a
tracheostoma stud) suitable for placement within
a surgically created tracheostoma. It features an
interface ring for a Phoniq HME Filter and retaining
lip to secure the Phoniq Stoma Button in place (see
Figure A).
The Phoniq Stoma Button is available in a range
of different diameters and lengths to account for
differences in patient physiology. Correct sizing is
based on the length and diameter of the patient’s
stoma. To obtain a good fit and an airtight seal with
the tracheostoma, it is sometimes necessary to try a
number of Phoniq Stoma Button sizes.
The Phoniq Stoma Button is for single-patient use only
and is supplied non-sterile. The Phoniq Stoma Button
can be worn in the shower if fitted with a Phoniq HME
Filter and the recommended shower shield.
The Phoniq Stoma Button is intended to be worn for
up to 28 days with daily cleaning. Replacement earlier
than 28 days is recommended if the device shows
signs of deterioration or damage.
INTENDED USE
The Phoniq Stoma Button is intended to keep
the tracheostoma open and the airway clear. It is
intended to be used with a Phoniq HME Filter which
warms, moistens and filters inhaled air and can
facilitate speech for those patients fitted with a voice
prosthesis.
It is intended that laryngectomy patients will use
these devices following instruction and guidance from
a healthcare professional.
ENGLISH
EN
INSTRUCTIONS FOR USE