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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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Содержание Phoniq Stoma Button

Страница 1: ...Stoma Button INSTRUCTIONS FOR USE 0123...

Страница 2: ...e 16 OD18 5 mm L14 2 mm 16 18 5 14 2 Recommended Accessories and Consumables 7 Product Code 1 Description 2 LAPFT0001 Phoniq DigiClose Comfort HME Filter LAPFT0002 Phoniq DigiClose Active HME Filter L...

Страница 3: ...a 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 Stom...

Страница 4: ...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...

Страница 5: ...zapo nite umetanje UKLANJANJE Dr e i vanjsku povr inu su eljnog prstena vidjeti Sliku A palcem i ka iprstom nje no povucite i izvucite plo icu Phoniq Stoma Button iz traheostome I ENJE Phoniq Stoma B...

Страница 6: ...ters en lengtes vanwege de verschillen in de menselijke fysiologie De juiste maat is gebaseerd op de lengte en diameter van de stoma van de pati nt Om een goede pasvorm en luchtdichte afdichting te ve...

Страница 7: ...nkele Phoniq Stoma Button niet langer dan 28 dagen Gebruik de Phoniq Stoma button niet na de houdbaarheidsdatum die op de verpakking vermeld staat Gebruik de Phoniq Stoma Button niet als de verpakking...

Страница 8: ...t l aide de la m thode recommand e Dans ce cas mettre le Phoniq Stoma Button au rebut et le remplacer par un neuf INDICATIONS Le Phoniq Stoma Button est indiqu pour des patients ayant subi une larynge...

Страница 9: ...Merkmale des jeweiligen Patienten in verschiedenen Durchmessern und L ngen erh ltlich Die richtige Gr e richtet sich nach der L nge und dem Durchmesser des Stomas des Patienten Damit der Button richti...

Страница 10: ...stattdessen die Vorrichtung und ersetzen Sie sie durch einen neuen Phoniq Stoma Button Setzen Sie die Kan le gem den oben beschriebenen Anweisungen wieder ein ENTSORGUNG Entsorgen Sie klinische Abf ll...

Страница 11: ...oma Button Phoniq HME Filter Phoniq Stoma Button 10 Phoniq Stoma Button Trachi Swab 2 2 Phoniq Stoma Button Phoniq Stoma Button Phoniq Stoma Button Phoniq Stoma Button A B Phoniq Stoma Button Phoniq S...

Страница 12: ...a je pogodna za postavljanje unutar hirur ki kreirane traheostome Ona poseduje interfejs prsten za Phoniq HME Filter i sigurnosnu tipaljku za u vr ivanje Phoniq Stoma Button na mestu pogledajte Sliku...

Страница 13: ...oniq Stoma Button jer to mo e dovesti do postavljanja Phoniq Stoma Button preko otvora stome i ulaska u disajni put Izbegavajte da koristite Phoniq Stoma Button koja je suvi e mala ili previ e velika...

Страница 14: ...k ponovno namestite z upo tevanjem zgornjih navodil za vstavitev INDIKACIJE ZA UPORABO Stoma gumb Phoniq Stoma Button je predviden za uporabo pri bolnikih ki so prestali laringektomijo in ki sedaj dih...

Страница 15: ...DRAVSTVENIM DELAVCEM e pride med uporabo do dra enja ali po kodb na ko i ali na traheostomi e se stoma gumbPhoniq Stoma Button ne prilega ve dobro e se pripomo ek premakne in zaide v dihalno pot PRIJA...

Страница 16: ...30 31...

Страница 17: ...are Ltd Catalogue number Batch code Use by date Caution Keep out of direct sunlight Device has not been subject to sterilisation process Do not use if package is damaged or opened Single use Consult i...

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