Atos Provox Vega Puncture Set Instrucțiuni de utilizare

Marca: Atos

Model: Provox Vega Puncture Set

Tip: Instrucțiuni de utilizare

Vega

™Puncture Set

Vega™Puncture Set

IFU

Prescription 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



the lifetime of the product delivered, which may vary with individual use and biological conditions.



particular purpose.

Patents and trademarks





Vega

™

is a trademark

of Atos Medical AB. For information about protective rights (e.g. patents), please refer to our web page

www.atosmedical.com/patents.

Contents

EN- ENGLISH .............................................................................4

DE - DEUTSCH ..........................................................................9

NL - NEDERLANDS............................................................... 15

FR - FRANÇAIS ....................................................................... 21

IT - ITALIANO ......................................................................... 26

ES - ESPAÑOL ......................................................................... 32

PT - PORTUGUÊS .................................................................. 38

SV - SVENSKA ........................................................................ 44

DA - DANSK ............................................................................ 49

NO - NORSK ............................................................................ 55

FI - SUOMI ............................................................................... 60

IS - ÍSLENSKA ......................................................................... 69

ET - EESTI ................................................................................. 71

LT - LIETUVIŲ KALBA .......................................................... 76

CS - ČESKY................... ................. ...........................................81

HU - MAGYAR................... .......... ...........................................87

SK - SLOVENČINA ................................................................. 92

SL - SLOVENŠČINA......................... . ....................................97

PL - POLSKI......................... .............. ....................................103

RO - ROMÂNĂ .....................................................................109

HR - HRVATSKI................... .............. ....................................115

SR - SRPSKI ...........................................................................120

EL - ΕΛΛΗΝΙΚΑ ....................................................................126

KA -ქართული ...............................................................132

HY - ......................... ..... ....................................139

TR - TÜRKÇE..........................................................................146

RU - РУССКИЙ................... .............. ....................................151

ID - BAHASA INDONESIA ................................................158

MS - BAHASA MELAYU ....................................................163

JA - 日本語................................ ...........................................169

KO - 한국어............................... ...........................................174

ZHTW - 繁體中文.............................. .................................180

HE - ......................................... .................................190

AR - ..................................... ................... ...................195

ENGLISH

Please see accompanying Illustration manual for illustrations referenced in this Instructions

for Use.

Stomal airway management

Emergency situations

It is important that emergency personnel knows that you are a neck breather. This will help them



your mouth or nose.

We recommend that you and your clinician download the guidelines for rescue breathing from

www.atosmedical.com/rescuebreathing

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



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.

1. Descriptive information

1.1 Indications for use









is performed by the patient while it remains in situ.

1.2 CONTRAINDICATIONS











puncture may lead to unintended trauma of the pharyngeal/ esophageal tissue.

1.3 Description of the device







is part of the device.



sterile items in a blister package (Fig. 1):

 

• 1 Puncture Needle (Fig. 1.2) made of surgical stainless steel,

 

 

is made of thermoplastic elastomer and polypropylene; and the Vega voice prosthesis is made of



The preloaded Puncture Dilator contains the following functional characteristics and components:

 

 

 

 

Guidewire,

                

               

towards the Wirelock.











 

(including 1 Illustration manual)

 

 

 

1.4 WARNINGS

Pre-surgery

• DO NOT use the product if the package is damaged or opened. Unsterile product may cause

infection.

• DO NOT REUSE and DO NOT RESTERILIZE by any method. This device is intended for

            

structural damage to the device.

• DO proceed with great care if the patient has received radiotherapy with or without concurrent

         





During surgery

General

• DO



Protector may cause tissue damage.

• DO



• DO            



• DO ensure that the Puncture Dilator is mounted on the esophageal end of the Guidewire and not

the tracheal. The dilatation should be performed in the posteroanterior direction. Dilatation in the

wrong direction causes reversed placement of the voice prosthesis, which causes aspiration and

inability to speak.

• DO NOT withdraw the Guidewire back through the Puncture Needle. Damage, shearing and/or

scraping of the Guidewire may occur. If the Guidewire must be withdrawn, remove the Guidewire

and the Puncture Needle simultaneously, as one unit, to prevent the Puncture Needle from damaging

the Guidewire.

• DO NOT use toothed hemostats or other instruments that may damage the product.

Secondary puncture

• DO NOT

used during Primary punctures.

• DO ensure that the pharyngeal/esophageal tissue is adequately protected, e.g., by use of a rigid



Post surgery

Use of the voice prosthesis



ingestion, aspiration or tissue damage may occur. For further information about these events and how





• DO



• DO

(e.g., Brush, Flush, Plug) for maintenance and to avoid all other kinds of manipulation.

• DO instruct the patient to consult a physician immediately if there are any signs of tissue edema



• DO

 

insertion and removal of the tube or button.

1.5 PRECAUTIONS







• DO carefully assess patients with bleeding disorders or patients undergoing anticoagulant treatment

for the risk of bleeding or hemorrhage, prior to secondary puncture and prosthesis placement.

• DO always use aseptic technique when handling the Puncture Set in order to reduce risk for

infection.

• DO



Protector.

• DO ensure that the Guidewire is adequately threaded and locked in position in the Wirelock.

If proper locking is not achieved, the Guidewire may come loose from the Wirelock, causing failure

to complete procedure.

• DO

the prosthesis. Tissue damage may otherwise occur.

• DO





• DO NOT

in that case has been compromised, with risk for dislocation of the voice prosthesis during the

procedure.

1.6 Adverse events and troubleshooting information

1.6.1 During use of the Puncture Set

(Sub-) mucosal injury

During puncture, the Puncture Needle or the Guidewire could cause a (sub) mucosal injury if the



of suspicion of (sub)mucosal damage, it is recommended that the patient receives a prophylactic

course of postoperative antibiotics and is fed through a nasogastric tube or similar to allow healing.

Re-puncture







Forgot to remove the Pharynx Protector



procedure cannot be completed. If this occurs, detach the Puncture Dilator from the Guidewire and



Reloading

In some cases, reloading of the Puncture Dilator may be necessary; e.g., if the voice prosthesis is

pulled completely through the puncture during prosthesis placement. The reloading procedure is



1.6.2 During use of the voice prosthesis

Dislodgement of the voice prosthesis– Dislodgement can be caused by infection and/or edema of



Dislodgement might lead to aspiration or ingestion of the prosthesis. See below.

Aspiration of the prosthesis – Accidental aspiration of the voice prosthesis or other components

of the voice rehabilitation system may occur. As with any other foreign body, complications from

aspiration of a component may cause obstruction or infection. Immediate symptoms may include

coughing, wheezing or other abnormal breathing sounds, dyspnea, and respiratory arrest, partial or





If the patient can breathe, coughing may remove the foreign body. Partial airway obstruction or

complete airway obstruction requires immediate intervention for removal of the object. If aspiration









and during endoscopy, the device may appear as a oval shape with an opening in the middle with an





light source on the clear silicone rubber may be seen. Also, in prostheses that have been in situ for



Ingestion of the prosthesis – Accidental ingestion of the voice prosthesis, or other components of

the voice rehabilitation system, may occur. As with any other foreign body, the symptoms caused by

ingestion of the prosthesis or a component of the voice rehabilitation system depends largely on size,

location, degree of obstruction (if any) and the length of time it has been present. Ingested components

that have remained in the lower esophagus may be removed by esophagoscopy or observed for a short

period of time. The object may pass spontaneously into the stomach. Foreign bodies that pass into

the stomach usually pass through the intestinal tract. Surgical removal of foreign bodies from the

intestinal tract must be considered when bowel obstruction occurs, bleeding is present, perforation

occurs or the object fails to pass through the intestinal tract.



to observe the stools for the ingested device. If the device does not pass spontaneously, or if there

are signs of obstruction (fever, vomiting, abdominal pain) a gastroenterologist should be consulted.

The silicone housing of the Vega voice prosthesis can be located and retrieved endoscopically. The

device may be retrieved by using a non toothed grasping forceps. During endoscopy, the device may









be visible on the device.

Infection and/or edema of the TE-puncture – Infection, granulation formation and/or edema of the

puncture may increase the length of the puncture tract. This may cause the prosthesis to be drawn



mucosa may also cause the prosthesis to protrude from the puncture. Temporary replacement of the

prosthesis by a prosthesis with a longer shaft is then advisable. If standard medical treatment does

not resolve the infection, the prosthesis should be removed. In some cases stenting the puncture with



new prosthesis may be required.

Granulation around the puncture



granulation may be considered.

Granulation/Hypertrophic scarring around the puncture – Bulging of the tracheal mucosa over



by using a laser. Alternatively, a prosthesis with a longer shaft can be used.

Protrusion/extrusion of the prosthesis – Protrusion of the prosthesis and subsequent spontaneous



required to avoid dislodgement into the trachea. The puncture may close spontaneously secondary



Tissue damage – If the prosthesis is too short, too long, or is pushed frequently against the esophageal



and/or esophageal tissues may occur. Inspect the conditions regularly to avoid severe damage.

Leakage through the valve – Leakage through the prosthesis may occur because:

                

     

rehabilitation and an indication to replace the voice prosthesis.

            



Leakage around the prosthesis – Transient leakage around the prosthesis may occur and may resolve

spontaneously. The most common reason is that the prosthesis is too long, which is solved by inserting

a shorter prosthesis. If the problem is not solved by inserting the correct length prosthesis, other







(e.g., collagen) or temporary removal of the voice prosthesis, should be considered. If the leakage

around the voice prosthesis is intractable, more conservative measures, such as surgical closure of

the puncture may be necessary.

2. Instructions for use

Please see accompanying Illustration manual for illustrations referenced in this Instructions

for Use.



section headings below.

Caution: The videos do not replace nor do they set forth the complete contents of the Instructions

for Use and /or Prescriber Information, and are not a substitute for reviewing the entire contents of

the Instructions for Use. The videos are only intended to further enhance the understanding of the

procedure after review of the Instructions for Use.

2.1 Preparation

Prior to the puncture always determine what size and diameter of voice prosthesis to use. The appropriate

size and diameter depends on the anatomy of the patient, local medical practice and preference of

the surgeon.

2.2 Operating instruction



Unsterile product may cause infection.

2.2.1 Primary puncture and prosthesis placement



 



 



depending on surgical technique) should be felt during palpation (Fig. 2.2).

 



(Fig. 2.3).

If an endotracheal tube is in situ, this tube should be removed if it obstructs proper dilatation

and integral placement of the voice prosthesis.

 



WARNING:





of the Puncture Set).

 

CAUTION:

for damaging the esophageal tissue otherwise.

 



 





 

9. Tighten the Guidewire by pulling it from the narrow end of the Puncture Dilator and verify that

it is secured to the Puncture Dilator (Fig. 2.9).

10. Using a continuous, smooth motion; dilate the puncture site by carefully pulling the Guidewire





Dilator (Fig. 2.10).

CAUTION: Dilatation and integral placement of the voice prosthesis should be carried out in

the anterior/caudal direction with limited lateral movement in order to limit the force applied to



11. In the same continuous, smooth motion, carefully pull the Guidewire, Puncture Dilator and the







 



hemostats.

 

in the correct position, and cut the safety strap (Fig. 2.12).

2.2.2 Secondary puncture and prosthesis placement





secondary puncture.

 

  

  

  

and out of the mouth.

Introduce the instrument into the esophagus (Fig. 3.1). If an endotracheal tube is in situ, this tube

should be removed if it obstructs proper dilatation and integral placement of the voice prosthesis.

CAUTION:



2. Verify the correct location of the instrument by palpating the trachea at the intended puncture



(Fig. 3.2).

tracheostoma) until the tip of the needle reaches the inside wall of the instrument (Fig. 3.3).

 





WARNING: Always verify that the Guidewire comes out through the lumen of the instrument





as Instructions for Reload of the Puncture Set).

 

CAUTION: Always remove the needle before removing the instrument. There is a risk for

damaging the esophageal tissue otherwise.

 



 



 

(Fig. 3.8).

9. Tighten the Guidewire by pulling it from the narrow end of the Puncture Dilator and verify that

it is secured to the Puncture Dilator (Fig. 3.9).

CAUTION:

Dilator. If the Guidewire is not securely locked into the Wirelock, the Guidewire could separate

from the Puncture Dilator and the Puncture Dilator may end up in the esophagus requiring

retrieval using additional instruments (e.g., laryngeal forceps).

10. Using a continuous, smooth motion; dilate the puncture site by carefully pulling the Guidewire

through the puncture site until the thick end of the Puncture Dilator has passed the puncture.





CAUTION: Dilatation and integral placement of the voice prosthesis should be carried out in

the anterior/caudal direction with limited lateral movement in order to limit the force applied to



11. In the same continuous, smooth motion, carefully pull the Guidewire, Puncture Dilator and the





hemostats.

 

and cut the safety strap (Fig. 3.12).

2.2.3 Reload of the Puncture Set



CAUTION:





In order to reload the system:

1. Push the Guidewire from the narrow end of the Puncture Dilator until the Guidewire loosens



 

 

WARNING:

the Puncture Dilator strap and the Wirelock when it is inserted into the Puncture Dilator loop



 

 

2.3 Cleaning and sterilization





After placement, the voice prosthesis requires regular cleaning by the patient while the prosthesis

remains in situ (see prosthesis maintenance below).

2.4 Important patient information

Inform the patient that:

• After a prosthesis placement traces of blood may be found in the sputum.

         

insertion of a prosthesis. This often resolves spontaneously and does not require immediate

replacement of the prosthesis.

• Speech training sessions with a speech language pathologist are advised in order to acquire optimal



Ensure that the patient understands to contact their clinician if:

 

occur.

 

Vega Plug can be used for temporary preventing leakage during eating and drinking until the device

can be replaced.

 

 

• Bleeding or overgrowth of tissue around the device.

• Persistent pain or discomfort in the region of the Vega voice prosthesis.

             

conditions that requires medical attention.

Prosthesis maintenance:

CAUTION:

cleaning the prosthesis.



Brush by inserting the brush into the prosthesis and moving it gently back and forth with a twisting

movement. After the brush is removed it should be wiped with a gauze. The procedure can be repeated

as often as necessary. For details and how to clean the brush see Instructions for Use that come with







Compatibility with antifungal substances

In most cases treatment with antifungal agents should not be indicated but may be considered as a







of the voice prosthesis should be carefully assessed.



components when using the following antifungal medications: Nystatin, Fluconazole and Mikonazol.

Cleaning and disinfection of the accessories

The accessories should be cleaned after each use and disinfected at least once a day according to their

Instructions for Use. During hospitalization there is an increased risk of device contamination and

patient infection. Therefore, during hospitalization, it is important to clean and disinfect the accessories

immediately after use and again just before use, and rinse using sterile water, rather than tap water.





2.5 Device lifetime of the Provox Vega voice prosthesis

Depending on individual biological circumstances the device life varies, and it is not possible to

predict the integrity of the device over a longer period of time. The material of the device will be







leakage through the prosthesis or other incompetence of the valve. Also see; Prosthesis maintenance



The prosthesis is not a permanent implant, and requires periodic replacement. Depending on

individual biological circumstances the device life varies, and it is not possible to predict the integrity

of the device over a longer period of time. The prosthesis and especially the silicone material of the



eventually deteriorate.



blockage of the prosthesis, bacterial and candidal overgrowth leading to degradation of the materials







2.6 Disposal

Always follow medical practice and national requirements regarding biohazard

when disposing of a used medical device.

2.7 Accessories



Do not use other devices since they may cause patient harm or product malfunction.

Accessories to maintain the device function (for patient use)

Provox Brush/Provox Brush XL: is used by the patient to clean the inside of the prosthesis.

Provox Flush:

Provox Plug: A tool for patient use that temporarily blocks the voice prosthesis.

Please see www.atosmedical.com or contact your local distributor for more info.

3. Reporting

Please note that any serious incident that has occurred in relation to the device shall be reported

to the manufacturer and the national authority of the country in which the user and/or patient

resides.



beilegenden Broschüre „Abbildungen“.

Wichtige Informationen für Patienten mit Tracheostoma

Notfallsituationen









www.atosmedical.com/rescuebreathing herunterzuladen.

Besondere Situationen















Stimmprothese nicht verschoben wird oder herausrutscht.

1. Beschreibende Informationen

1.1 Indikationen









Stimmrehabilitation nach der operativen Kehlkopfentfernung (Laryngektomie) dient. Die Reinigung

der Stimmprothese wird vom Patienten in situ vorgenommen.

1.2 GEGENANZEIGEN

















1.3 Produktbeschreibung







angebracht, der Teil des Produkts ist.



sterilen Teile in einer Blisterpackung (Abb. 1):

 

 

 

 

         



DEUTSCH

Der Punktionsdilatator mit Stimmprothese umfasst die folgenden Funktionsmerkmale und Bestandteile:

 

            

verbindet,

 

 



           

            

Stimmprothese zur Drahtverriegelung gerichtet ist.













 

 

 

 

 

1.4 WARNHINWEISE

Vor der Operation

• Das Produkt NICHT



• NICHT WIEDERVERWENDEN und NICHT RESTERILISIEREN, egal mit welchem

Verfahren. Dieses Produkt ist nur zum einmaligen Gebrauch. Wiederverwendung kann eine

    



• BESONDERS vorsichtig vorgehen, wenn der Patient eine Strahlenbehandlung mit oder ohne

         

         





Während der Operation

Allgemeines

• DARAUF ACHTEN







• DARAUF ACHTEN            



• DARAUF ACHTEN         

         



• DARAUF ACHTEN



Bei Dilatation in die falsche Richtung wird die Stimmprothese falsch herum positioniert, was zu



   NICHT       

        





• KEINE         



Sekundäre Punktion

 NICHT



• DAFÜR SORGEN        



Nach der Operation

Gebrauch der Stimmprothese









• WÄHLEN SIE           



• WEISEN SIE





• WEISEN SIE



• Falls verwendet, WÄHLEN SIE





1.5 VORSICHTSMASSNAHMEN







zu viel Kraft erfordert.

 

sorgfältig



• VERWENDEN SIE bei der Handhabung des Punktionssets stets die aseptische Technik, um das

Infektionsrisiko zu reduzieren.

            

  



• ACHTEN SIE DARAUF         





• GEHEN SIE



• STÜTZEN SIE          

            



nach ordentlicher Heilung des Gewebes wiederholt werden.

• Befestigen Sie die Stimmprothese NICHT WIEDER am Dilatator, nachdem der Sicherheitsfaden





1.6 Unerwünschte Ereignisse und Problemlösungen

1.6.1 Während der Verwendung des Punktionssets

Verletzung der Mukosa bzw. Submukosa











Punktionswiederholung





Verletzung der Submukosa zu untersuchen und das Punktionsverfahren mit richtig eingesetztem



Entfernung des Pharynxprotektors wurde vergessen







Neuladen







1.6.2 Während des Gebrauchs der Stimmprothese

Verschiebung der Stimmprothese



Vernarbung um die Punktionsstelle herum verursacht werden. Bei einer Verschiebung kann es zu

versehentlicher Aspiration oder Ingestion der Prothese kommen. Siehe unten.

Aspiration der Prothese











Atelektase, Bronchitis, Lungenabszess, bronchopulmonale Fistel und Asthma.











gezahnten Greifzange geborgen werden.















Ingestion der Prothese



die durch Ingestion der Prothese oder eines Bestandteils des Stimmrehabilitationssystems verursachten











aus dem Darmtrakt muss in Betracht gezogen werden, wenn ein Darmverschluss, Blutung oder





den Stuhl auf die ingestierte Prothese hin zu beobachten. Wenn die Prothese nicht spontan abgeht oder





bergen. Die Prothese kann mit einer nicht gezahnten Greifzange geborgen werden. Die Prothese stellt













Infektion und/oder Ödem an der TE-Punktionsstelle

















Prothese erforderlich sein.







gezogen werden.

 – Wenn die Prothese







Protrusion/Extrusion der Prothese







kann eine erneute Punktion erforderlich sein.

Gewebeschäden







Leckage durch das Ventil

auftreten:

            

Schließung der Ventilklappe verhindern, sodass es zur Leckage durch die Prothese kommt. Dieses



gewechselt werden sollte.

 



Leckage um die Prothese herum   











und reduzierter Haltekraft sind andere konventionelle Behandlungsmethoden wie z.B. die Injektion







2. Bedienungsanleitung

beilegenden Broschüre „Abbildungen“.





Vorsicht:







beitragen.

2.1 Vorbereitung







2.2 Verfahrensanleitung





2.2.1 Primäre Punktion und Einsetzen der Prothese



 



 





 



 



 





WARNHINWEIS:







 

VORSICHT: 



 



 





 

(Abb. 2.8).

 

kontrollieren, ob er fest am Punktionsdilatator befestigt ist (Abb. 2.9).

 







VORSICHT:





 







entfaltet sich in der Trachea, sobald die Schleife den Flansch freigibt (Abb. 2.11).

Sofort nachdem die Schleife des Punktionsdilatators den trachealen Flansch nicht mehr umgibt,





 

Prothese in die richtige Position drehen und den Sicherheitsfaden zerschneiden (Abb. 2.12).

2.2.2 Sekundäre Punktion und Einsetzen der Prothese





Punktion nicht verwendet.

 

  

  

  

und aus dem Mund heraus.

 





VORSICHT:



Mukosa bzw. Submukosa.

 



verwendet werden (Abb. 3.2).



 





WARNHINWEIS:



einer Verletzung der Mukosa bzw. Submukosa, und das Verfahren muss neu begonnen werden



 

VORSICHT:



 



 





 



kontrollieren, ob er fest am Punktionsdilatator befestigt ist (Abb. 3.9).

VORSICHT:















Kontrolle dicht am Punktionsdilatator festhalten (Abb. 3.10).



entfaltet sich in der Trachea, sobald die Schleife den Flansch freigibt (Abb. 3.11).

Sofort nachdem die Schleife des Punktionsdilatators den trachealen Flansch nicht mehr umgibt,



 

Position drehen und den Sicherheitsfaden zerschneiden (Abb. 3.12).

2.2.3 Neuladen des Punktionssets



VORSICHT:





Um das System neu zu laden:

 



 

 

WAR NHINWEIS:





 

 

2.3 Reinigung und Sterilisierung









2.4 Wichtige Informationen für den Patienten

Der Patient ist auf Folgendes hinzuweisen:

 

 



sofortigen Wechsel der Prothese.

 



Der Patient ist anzuweisen, in den folgenden Fällen einen Arzt zu konsultieren:

 

 

           



          



 

• Blutung oder Gewebewucherung um die Prothese herum.

• Anhaltende Schmerzen oder Beschwerden im Bereich der Vega Stimmprothese.

 





VORSICHT:





















Kompatibilität mit Antimykotika













Stimmprothese und ihrer Bestandteile bei Verwendung der folgenden Antimykotika: Nystatin,

Fluconazol und Mikonazol.

Reinigung und Desinfektion des Zubehörs















2.5 Lebensdauer der Provox Vega Stimmprothese







































2.6 Entsorgung





Vorschriften des jeweiligen Landes zu befolgen.

2.7 Zubehör







Zubehör zur Erhaltung der Funktionsfähigkeit des Produkts (für den Patientengebrauch)

Provox Brush /Provox Brush XL: 

Provox Flush:



Provox Plug:

werden kann.



3. Meldung







In de begeleidende illustratiehandleiding kunt u de illustraties vinden waarnaar in deze

gebruiksaanwijzing wordt verwezen.

Luchtwegmanagement bij patiënten met een tracheostoma

Spoedeisende situaties

Het is belangrijk dat eerstehulpverleners weten dat u stembandloos bent. Ze kunnen dan eerder







www.atosmedical.com/rescuebreathing

Niet-urgente situaties

Als u een ingreep moet ondergaan waarvoor intubatie (het inbrengen van een beademingsbuis in uw

luchtpijp) nodig is, is het heel belangrijk dat de anesthesist en de arts die de ingreep uitvoert ervan

op de hoogte zijn dat u stembandloos bent en een stemprothese gebruikt. Het is van belang dat ze

begrijpen dat de stemprothese op haar plaats moet blijven. Als de prothese wordt verwijderd, kunnen



Het is heel belangrijk dat de intubatiebuis voorzichtig wordt ingebracht en verwijderd, zodat de

stemprothese niet losraakt of naar buiten komt.

1. Beschrijving

1.1 Indicaties voor gebruik









De stemprothese wordt in situ door de patiënt gereinigd.

1.2 CONTRA-INDICATIES







dit weefselbeschadiging kan veroorzaken.





puncteren niet goed beschermd is, kan onbedoeld letsel van faryngeaal/oesofageaal weefsel ontstaan.

1.3 Beschrijving van het hulpmiddel







voorgeladen op de punctiekanaaldilatator, die deel uitmaakt van het hulpmiddel.



de volgende steriele materialen in een blisterverpakking (afb. 1):

 

• 1 punctienaald (afb. 1.2), vervaardigd van chirurgisch roestvrij staal,

 

          

De punctiekanaaldilatator is vervaardigd van thermoplastisch elastomeer en polypropyleen, de



De voorgeladen punctiekanaaldilatator heeft de volgende functionele eigenschappen en onderdelen:

 

 

 

 

de voerdraad,

 

  

draadgrendel wijst.



praten en het risico verkleint dat er vloeistof en voedsel in de trachea komt.



De prothese is verkrijgbaar in verschillende diameters en diverse maten.



 

(inclusief 1 illustratiehandleiding),

 

 

 

NEDERLANDS

1.4 WAARSCHUWINGEN

Voorafgaand aan de ingreep

• Gebruik het product NIET

een infectie veroorzaken.

• NIET HERGEBRUIKEN en NIET OPNIEUW STERILISEREN met welke methode dan ook.

Dit hulpmiddel is uitsluitend bestemd voor eenmalig gebruik. Hergebruik kan kruisbesmetting

veroorzaken. Door reiniging en hersterilisatie kan het hulpmiddel structureel beschadigd raken.

• GA UITERST VOORZICHTIG te werk als de patiënt bestraald is met of zonder gelijktijdige

chemotherapie. Deze omstandigheden vergroten het risico van punctiegerelateerde complicaties





Tijdens de ingreep

Algemeen

• CONTROLEER

         



• CONTROLEER              



• CONTROLEER



• CONTROLEER of de punctiekanaaldilatator op het oesofageale en niet op het tracheale uiteinde

van de voerdraad geplaatst is. Dilatatie dient in posteroanterieure richting plaats te vinden.

Bij dilateren in de verkeerde richting wordt de stemprothese achterstevoren geplaatst, wat aspiratie

en onvermogen tot praten veroorzaakt.

• Trek de voerdraad NIET terug door de punctienaald. Gebeurt dat wel dan kan dat tot beschadiging,

scheuren en/of afschrapen van de voerdraad leiden. Als de voerdraad teruggetrokken moet worden,

verwijder de voerdraad en de punctienaald dan samen als één geheel om te voorkomen dat de

voerdraad door de punctienaald wordt beschadigd.

• Gebruik GEEN getande vaatklemmen of andere instrumenten die het product kunnen beschadigen.

Secundaire punctie

      NIET     

Protector is uitsluitend bedoeld voor gebruik tijdens primaire puncties.

• CONTROLEER

beschermd is, bijvoorbeeld met een starre endoscoop.

Na de ingreep

Gebruik van de stemprothese









• SELECTEER



• INSTRUEER           

bijpassende maat en diameter (bijvoorbeeld Brush, Flush, Plug) mag gebruiken, en alle andere

vormen van manipulatie moet vermijden.

• INSTRUEER de patiënt dat hij/zij onmiddellijk een arts moet raadplegen bij verschijnselen van

oedeem en/of ontsteking/infectie van weefsels.

• KIES toepasselijk gevormde laryngectomie canules of stomabuttons (indien gebruikt) die tijdens

gebruik geen druk uitoefenen op de prothese, en die tijdens inbrengen of verwijderen niet aan de



1.5 VOORZORGSMAATREGELEN







te veel kracht vergt.

• CONTROLEER patiënten met een bloedingsstoornis of patiënten op anticoagulantia vóór



• PAS ALTIJD een aseptische techniek toe bij het hanteren van de punctieset om het infectierisico

te verkleinen.

• VERWIJDER





• CONTROLEER of de voerdraad adequaat opgevoerd en in positie vastgezet is in de draadgrendel.

Als de voerdraad niet goed vergrendeld is, kan de draad loskomen van de draadgrendel, waardoor

de procedure niet kan worden voltooid.

• GA ALTIJD langzaam te werk en zonder overmatige kracht te gebruiken tijdens het dilateren en

het plaatsen van de prothese. Anders kan weefselbeschadiging ontstaan.

• ONDERSTEUN          

         



het weefsel goed genezen is.

• NIET herladen nadat de veiligheidsband van de prothese doorgeknipt is omdat het

veiligheidsmechanisme in dat geval niet meer werkt, waardoor tijdens de procedure risico op

dislocatie van de stemprothese bestaat.

1.6 Complicaties en oplossen van problemen

1.6.1 Tijdens gebruik van de punctieset

(Sub)mucosaal letsel

Tijdens het puncteren kan de punctienaald of de voerdraad (sub)mucosaal letsel veroorzaken als de



op (sub)mucosaal letsel wordt aanbevolen de patiënt postoperatief profylactisch antibiotica te geven



Opnieuw puncteren



reden opnieuw moet worden gepuncteerd, dan dient het weefsel te worden onderzocht op mogelijk



De Pharynx Protector is niet verwijderd



verwijderd is dan kan de procedure niet worden voltooid. Koppel de punctiekanaaldilatator in



Herladen

In sommige gevallen kan het nodig zijn om de punctiekanaaldilatator te herladen, bijvoorbeeld als de

stemprothese tijdens het plaatsen helemaal door het punctiekanaal getrokken is. De herlaadprocedure

 

1.6.2 Tijdens gebruik van de stemprothese

Losraken van de stemprothese – De stemprothese kan losraken als gevolg van infectie en/of



rond het punctiekanaal. Losraken kan tot aspiratie of ingestie van de prothese leiden. Zie hieronder.

Aspiratie van de prothese – De stemprothese of andere onderdelen van het stemrevalidatiesysteem

kunnen per ongeluk worden geaspireerd. Net als bij andere lichaamsvreemde voorwerpen kan aspiratie

van een onderdeel obstructie of infectie veroorzaken. Acute symptomen zijn onder meer hoesten, een







Als de patiënt kan ademen, kan het vreemde voorwerp mogelijk door hoesten worden verwijderd.

Bij gedeeltelijke of gehele luchtwegobstructie moet onmiddellijk worden ingegrepen om het vreemde



de longen te worden gemaakt om aspiratie te bevestigen en het hulpmiddel te lokaliseren. Als de



een ongetande grijptang worden verwijderd.











siliconenrubber te zien zijn. Bij protheses die al enige tijd in situ zijn, kunnen ook witte of gele

candida afzettingen op het hulpmiddel te zien zijn.

Ingestie van de prothese – De stemprothese of andere onderdelen van het stemrevalidatiesysteem

kunnen per ongeluk worden ingeslikt. Net als bij andere lichaamsvreemde voorwerpen zijn de symptomen

veroorzaakt door ingestie van de prothese of een onderdeel van het stemrevalidatiesysteem grotendeels

afhankelijk van de grootte, de plaats, de mate van obstructie (indien aanwezig) en de tijdsduur dat

het lichaamsvreemde voorwerp aanwezig is. Ingeslikte onderdelen die onderin de oesofagus zijn

blijven zitten, kunnen oesofagoscopisch worden verwijderd of korte tijd worden geobserveerd. Het

voorwerp kan uit zichzelf in de maag terechtkomen. Lichaamsvreemde voorwerpen die in de maag



voorwerpen uit het darmkanaal moet worden overwogen wanneer darmobstructie, bloeding of

perforatie optreedt, of wanneer het voorwerp het darmkanaal niet passeert.





hulpmiddel niet spontaan wordt geloosd of als er obstructieverschijnselen ontstaan (koorts, braken,



Vega stemprothese kan endoscopisch worden gelokaliseerd en verwijderd. Het hulpmiddel kan met

een ongetande grijptang worden teruggehaald. Tijdens endoscopie kan het hulpmiddel eruitzien als







op het doorzichtige siliconenrubber te zien zijn. Bij protheses die al enige tijd in situ zijn, kunnen

ook witte of gele candida afzettingen op het hulpmiddel te zien zijn.

Infectie en/of oedeem van de TE-punctie – Door infectie, granulatie en/of oedeem van het

punctiekanaal kan het tracé langer worden. Daardoor kan de prothese inwaarts en onder de tracheale





een prothese met een langere schacht is dan raadzaam. Als de infectie niet met een medicamenteuze

standaardbehandeling geneest dan dient de prothese te worden verwijderd. In sommige gevallen

kan stenten van het punctiekanaal met een katheter worden overwogen. Als het punctiekanaal zich

spontaan sluit, kan opnieuw puncteren voor het inbrengen van een nieuwe prothese nodig zijn.

Granulatie rond het punctiekanaal



granulatiegebied kan worden overwogen.

 – Bij een relatief korte





langere schacht.

Protrusie/extrusie van de prothese



verwijderd om losraken in de trachea te voorkomen. Het punctiekanaal kan zich na verwijdering van



Weefselbeschadiging – Als de prothese te kort of te lang is, of regelmatig door een laryngectomie

canule, een stomabutton of een vinger van de patiënt tegen de oesofaguswand wordt gedrukt dan



omstandigheden regelmatig om ernstige beschadiging te voorkomen.

Lekkage door de klep – Lekkage door de prothese kan ontstaan als gevolg van:

 

waardoor lekkage door het hulpmiddel ontstaat. Dit is een normale gebeurtenis bij prothetische

stemrevalidatie en een indicatie dat de stemprothese moet worden vervangen.

 

dient tijdens het slikken een transstomale inspectie van de klep van de prothese te worden

uitgevoerd.

Lekkage rond de prothese – Voorbijgaande lekkage rond de prothese kan ontstaan en vanzelf weer

verdwijnen. De meest voorkomende oorzaak is dat de prothese te lang is, wat opgelost kan worden door

het inbrengen van een kortere prothese. Als het probleem niet wordt opgelost door het inbrengen van

een prothese met de juiste lengte, dienen andere factoren die de integriteit van weefsel in het gebied



schildklier functie) te worden overwogen, onderzocht en behandeld. In vergrote punctiekanalen met

afgenomen retentiekracht dienen andere conventionele behandelmethoden, zoals het injecteren van



Als de lekkage rond de stemprothese onbehandelbaar is, kunnen conservatievere maatregelen, zoals

operatieve sluiting van het punctiekanaal, noodzakelijk zijn.

2. Gebruiksaanwijzing

In de begeleidende illustratiehandleiding kunt u de illustraties vinden waarnaar in deze

gebruiksaanwijzing wordt verwezen.

Voor een visueel overzicht van de verschillende procedures kunt u de links naar videoanimaties

volgen die hieronder zijn opgenomen onder de titels van de hoofdstukken.

Let op:

de gebruiksaanwijzing en/of de informatie voor de voorschrijver, en vormen geen vervanging voor



om het inzicht in de procedure na het doorlezen van de gebruiksaanwijzing verder te vergroten.

2.1 Voorbereiding

Bepaal voorafgaand aan de punctie altijd welke maat en diameter de te gebruiken stemprothese

moet hebben. De juiste maat en diameter hangen af van de anatomie van de patiënt, de plaatselijke

medische praktijk en de voorkeur van de chirurg.

2.2 Gebruiksinstructies





2.2.1 Primaire punctie en protheseplaatsing



1. Breng na de laryngectomie en het aanleggen van het tracheostoma en vóór het sluiten van de



 



gleuf in de bovenkant, afhankelijk van de chirurgische techniek) moet tijdens het palperen worden

gevoeld (afb. 2.2).

3. Breng de punctienaald op de juiste punctieplaats (ongeveer 8 – 10 mm van de rand van het



(afb. 2.3).

Als er een endotracheale tube in situ is, moet deze worden verwijderd als de tube goede dilatatie

en integrale plaatsing van de stemprothese hindert.

 



WAARSCHUWING: 

naar buiten komt. Anders bestaat het risico op (sub)mucosaal letsel en moet de procedure worden





 

LET OP:

bestaat er risico op beschadiging van het oesofagusweefsel.

 



 

punctiekanaaldilatator en duw de voerdraad door de punctiekanaaldilatator tot de draad ongeveer

 

8. Pak de tip van voerdraad vast en steek die in de opening naast de uitgangsopening (afb. 2.8).

 

te trekken en controleer of de draad goed aan de punctiekanaaldilatator vastzit (afb. 2.9).

10. Dilateer de punctieplaats door de voerdraad voorzichtig met een continue, vloeiende beweging



dilateren (bijvoorbeeld met twee vingers) om de dilatatiekracht te verkleinen. Pak de voerdraad

stevig vlakbij de punctiekanaaldilatator vast om het dilateren zo goed mogelijk te kunnen sturen

(afb. 2.10).

LET OP: 



wand uitgeoefende kracht te beperken.

11. Trek in dezelfde continue, vloeiende beweging voorzichtig de voerdraad, punctiekanaaldilatator







uit de lus (afb. 2.11).

 



verdraaid worden met behulp van twee ongetande vaatklemmen.



tot in de juiste stand en knip de veiligheidsband door (afb. 2.12).

2.2.2 Secundaire punctie en protheseplaatsing





secundaire punctie niet gebruikt.

1. Kies een instrument (bijvoorbeeld een starre endoscoop) dat kan functioneren als:

  

  

  

mond wordt gevoerd.

Introduceer het instrument in de oesofagus (afb. 3.1).Als er een endotracheale tube in situ is, moet

deze worden verwijderd als de tube goede dilatatie en integrale plaatsing van de stemprothese

hindert.

LET OP:

voor het veilig doorvoeren van de voerdraad. Anders bestaat er risico op (sub)mucosaal letsel.

 



worden gebruikt (afb. 3.2).

3. Breng de punctienaald op de juiste punctieplaats (ongeveer 8 – 10 mm van de rand van het

tracheostoma) in tot de tip van de naald de binnenwand van het instrument bereikt (afb. 3.3).

 

door het lumen van het instrument tot de draad ongeveer 20 cm uit het distale uiteinde van het



WAARSCHU WI NG:

gekozen instrument naar buiten komt. Anders bestaat er risico op (sub)mucosaal letsel en moet de





 

LET OP: Verwijder altijd de naald voordat het instrument wordt verwijderd. Anders bestaat er

risico op beschadiging van het oesofagusweefsel.

 



 

de voerdraad op tot de draad ongeveer 10 cm uit de uitgangsopening van de punctiekanaaldilatator



8. Pak de tip van voerdraad vast en steek die in de opening naast de uitgangsopening van de

punctiekanaaldilatator (afb. 3.8).

9. Zet de voerdraad vast door aan de draad uit het nauwe uiteinde van de punctiekanaaldilatator te

trekken en controleer of de draad goed aan de punctiekanaaldilatator vastzit (afb. 3.9).

LET OP:

Als de voerdraad niet stevig in de draadgrendel vastzit dan kan de voerdraad loskomen van de

punctiekanaaldilatator. De punctiekanaaldilatator kan dan in de oesofagus terechtkomen en met



10. Dilateer de punctieplaats door de voerdraad voorzichtig met een continue, vloeiende beweging door

de punctieplaats te trekken tot het dikke uiteinde van de punctiekanaaldilatator het punctiekanaal



met twee vingers) om de dilatatiekracht te verkleinen. Pak de voerdraad stevig vlakbij de

punctiekanaaldilatator vast om het dilateren zo goed mogelijk te kunnen sturen (afb. 3.10).

LET OP:

wand uitgeoefende kracht te beperken.

11. Trek in dezelfde continue, vloeiende beweging de voerdraad, punctiekanaaldilatator en de lus







(af b. 3.11).

verdraaid worden met behulp van twee ongetande vaatklemmen.



en knip de veiligheidsband door (afb. 3.12).

2.2.3 Herladen van de punctieset



LET OP:

stemprothese bij de eerste plaatsingspoging doorgeknipt of beschadigd is.



Het systeem herladen:

1. Duw de voerdraad door het nauwe uiteinde van de punctiekanaaldilatator op tot de voerdraad



 

 

WAARSCHUWING:

op de band van de punctiekanaaldilatator en de draadgrendel gericht zijn wanneer de prothese



 

 

2.3 Reiniging en sterilisatie

De chirurgische onderdelen van de punctieset en de stemprothese worden steriel (gesteriliseerd met



of opnieuw worden gesteriliseerd.

Na plaatsing moet de stemprothese regelmatig door de patiënt worden gereinigd, waarbij de



2.4 Belangrijke informatie voor de patiënt

Breng de patiënt van onderstaande op de hoogte:

• Na plaatsing van een prothese kan het sputum spoortjes bloed bevatten.

• Soms kan er in de eerste weken na het inbrengen van een prothese lichte lekkage door of rondom

de prothese plaatsvinden. Dit gaat vaak vanzelf weer over en de prothese hoeft niet onmiddellijk te

worden vervangen.

• Spraaktraining met een logopedist wordt aangeraden om een optimaal stemgeluid, een vloeiende

spraak en optimale verstaanbaarheid te realiseren.

Zorg ervoor dat de patiënt weet dat hij/zij in onderstaande gevallen contact moet opnemen met

zijn/haar arts:

• Wanneer het uiterlijk van het materiaal van de prothese verandert of wanneer er iets verandert in de

manier waarop de prothese in het punctiekanaal past.

• Wanneer er lekkage optreedt tijdens eten en/of drinken en reinigen van de prothese niet helpt.

              

gebruikt tot het hulpmiddel kan worden vervangen.

• Wanneer het spreken moeilijk wordt (meer inspanning vergt) en reinigen niet helpt.

• Bij verschijnselen van ontsteking of weefselverandering bij of in de buurt van het punctiekanaal.

• Bij bloeding of overgroei van weefsel rond het hulpmiddel.

• Bij aanhoudende pijn of ongemak in het gebied met de Vega stemprothese.

• Bij chronisch hoesten, ademhalingsproblemen of bloed in het slijm. Dit kunnen verschijnselen zijn

van een ernstige aandoening waarbij medische hulp nodig is.

Onderhoud van de prothese:

LET OP:







en achterwaarts te bewegen. Nadat de borstel verwijderd is, dient deze met een gaasje te worden

afgeveegd. De procedure kan zo vaak als nodig is worden herhaald. Raadpleeg de gebruiksaanwijzing









Compatibiliteit met antifungale middelen



preventieve maatregel worden overwogen als er overmatige candidagroei op de prothese plaatsvindt.



materiaaleigenschappen van het hulpmiddel. Daarom dient het inbrengen van antifungale geneesmiddelen

rechtstreeks in of in de onmiddellijke nabijheid van de stemprothese zorgvuldig te worden beoordeeld.

Uit laboratoriumonderzoek blijkt geen negatieve invloed op het functioneren van de Vega

stemprothese en de onderdelen wanneer de volgende antifungale geneesmiddelen worden gebruikt:



Reiniging en desinfectie van de accessoires

De accessoires dienen conform de bijbehorende gebruiksaanwijzingen na elk gebruik te worden

gereinigd en minstens eenmaal daags te worden gedesinfecteerd. Tijdens ziekenhuisopnames is er

een verhoogd risico op contaminatie van het hulpmiddel en infectie van de patiënt. Daarom is het

tijdens ziekenhuisopname belangrijk de accessoires onmiddellijk na gebruik en nogmaals vlak vóór

gebruik te reinigen en te desinfecteren, en af te spoelen met steriel water in plaats van kraanwater.





2.5 Levensduur van de Provox Vega stemprothese

De levensduur van het hulpmiddel varieert, afhankelijk van de individuele biologische omstandigheden;

het is niet mogelijk te voorspellen hoe lang het hulpmiddel intact zal blijven. Het materiaal van het

hulpmiddel wordt aangetast door bijvoorbeeld bacteriën en gisten, en de structurele integriteit van

het hulpmiddel zal uiteindelijk achteruitgaan.



speeksel en voedingsgewoonten kunnen van invloed zijn op de snelheid waarmee candida het siliconen

materiaal aantast, waardoor lekkage door de prothese of andere storingen van de klep ontstaan.



De prothese is geen permanent implantaat en moet periodiek worden vervangen. De levensduur

van het hulpmiddel varieert, afhankelijk van de individuele biologische omstandigheden; het is niet

mogelijk te voorspellen hoe lang het hulpmiddel intact zal blijven. De prothese en met name het

siliconen materiaal van het hulpmiddel wordt aangetast door bijvoorbeeld bacteriën en candida, en

de structurele integriteit van het hulpmiddel zal uiteindelijk achteruitgaan.





de materialen en/of het moeten gebruiken van overmatige kracht om te kunnen spreken. Andere

redenen voor vroegtijdige vervanging kunnen onder meer medische indicaties zijn, zoals problemen





2.6 Afvoeren

Na gebruik is het product potentieel biologisch gevaarlijk. Hantering en afvoer dienen te geschieden

overeenkomstig de medische praktijk en geldende nationale wetten en voorschriften.

2.7 Accessoires



Gebruik geen andere hulpmiddelen omdat die letsel van de patiënt of disfunctioneren van het product

kunnen veroorzaken.

Accessoires voor functioneel onderhoud van het hulpmiddel (voor gebruik door de patiënt)

Provox Brush/Provox Brush XL: wordt door de patiënt gebruikt om de binnenkant van de prothese

te reinigen.

Provox Flush: een aanvullend reinigingshulpmiddel waarmee de patiënt de prothese kan schoonspoelen/

schoonblazen.

Provox Plug: een hulpmiddel waarmee de patiënt de stemprothese tijdelijk kan afsluiten.

Ga voor nadere informatie naar www.atosmedical.com of neem contact op met uw plaatselijke

leverancier.

3. Meldingen

Let op: elk ernstig incident dat zich in verband met het hulpmiddel heeft voorgedaan, moet worden

gemeld aan de fabrikant en de nationale autoriteit van het land waar de gebruiker en/of de patiënt woont.

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Atos Provox Vega Puncture Set Instrucțiuni de utilizare

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Model: Provox Vega Puncture Set

Tip: Instrucțiuni de utilizare

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Atos Provox Vega Puncture Set Instrucțiuni de utilizare

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