inhealth Blom-Singer User manual

R3
USER Instructions For Use
37531-03E
Blom-Singer®
Patient-changeable
Voice Prostheses

2| 37531-03E
Blom-Singer is a registered trademark of Hansa Medical Products, Inc.
InHealth Technologies is a registered trademark of Helix Medical, LLC.
© 2014 Helix Medical, LLC (InHealth Technologies)
Blom-Snger, Hansa Medcal Products, Inc.’n kayıtlı tcar markasıdır.
InHealth Technologes, Helx Medcal, LLC’nn kayıtlı tcar markasıdır.
© 2014 Helix Medical, LLC (InHealth Technologies)
Blom-Singer este o marcă înregistrată a Hansa Medical Products, Inc.
InHealth Technologies este o marcă înregistrată a Helix Medical, LLC.
© 2014 Helix Medical, LLC (InHealth Technologies)
Blom-Singer registrirani je zaštitni znak tvrtke Hansa Medical Products, Inc.
InHealth Technologies registrirani je zaštitni znak tvrtke Helix Medical, LLC.
© 2014 Helix Medical, LLC (InHealth Technologies)
Blom-Singer je registrovani robni žig kompanije Hansa Medical Products, Inc.
InHealth Technologies je registrovani robni žig kompanije Helix Medical, LLC.
© 2014 Helix Medical, LLC (InHealth Technologies)
Blom-Singer je registrirana blagovna znamka Hansa Medical Products, Inc.
InHealth Technologies je registrirana blagovna znamka Helix Medical, LLC.
© 2014 Helix Medical, LLC (InHealth Technologies)
Blom-Singer     
Hansa Medical Products, Inc.
InHealth Technologies    
 Helix Medical, LLC.
© 2014 Helix Medical, LLC (InHealth Technologies)
37531-03E Eective March 2014 / Mart 2014’da Yürürlüğe Grd / Cu intrare în
vigoare din martie 2014 / Stupa na snagu uožujku 2014 / Stupa na snagu u martu
2014 / Velja od marca 2014 /    2014

TABLE OF CONTENTS
37531-03E | 3
5
USER Instructions For Use
KULLANICI Kullanım Talimatları
Instruciuni de folosire pentru UTILIZATOR
Upute za korištenje za KORISNIKE
Uputstva za korišćenje za KORISNIKE
UPORABNIŠKA navodila za uporabo
    
   
Govorne proteze, ki jih lahko zamenja bolnik
Glasovne proteze koje može mijenjati pacijent
Proteze fonatorii înlocuibile de către pacient
Hasta Tarafından Değiştirilebilen Ses Protezleri
Glasovne proteze koje može menjati pacijent
Patient-changeable Voice Prostheses
18
31
45
58
72
85
İçindekiler / Cuprins / Sadržaj / Vsebina / 
ENG
TUR
RON
HRV
SRP
SLV
RUS

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ENGLISH
37531-03E | 5
BLOMSINGER® PATIENTCHANGEABLE
VOICE PROSTHESES
Introduction
Please refer to the diagrams located at the back of this instruction
manual. A glossary of terms appears at the end of this chapter.
The Blom-Singer voice prosthesis has helped thousands
of laryngectomees worldwide to speak again. The original
tracheoesophageal voice prosthesis was developed by Dr. Eric
Blom and Dr. Mark Singer in 1978. Today, their method of TEP,
tracheoesophageal puncture, is still recognized throughout the
world as the leading standard for voice restoration following total
laryngectomy.
With persistence, a laryngectomee can learn from a clinician or
speech therapist new ways of speaking. One option, described in
this manual, enables voice restoration using a tracheoesophageal
voice prosthesis (diagram 1). The voice prosthesis (1A) is inserted
into the TE puncture which allows air to enter from the lungs
into the trachea (1B) and esophagus (1C) to produce sound (1D).
Voice is produced by temporarily blocking the stoma, either with
a nger or a hands-free Blom-Singer Adjustable Tracheostoma Valve.
This voice prosthesis is a patient-changeable device; the patient
may insert, remove and clean the prosthesis independently.
The voice prosthesis and accessory items should only be
used by individuals who have received proper training in the
eective management and care of Blom-Singer voice prostheses.
Management includes, but is not limited to, handling of the
device, dislodgement of the device, and cleaning of the device.
Your doctor will discuss with you the risks and benets of using a
voice prosthesis. The information in this manual is not intended
to be used in place of consultation or instructions of a medical
professional.
This product is intended for use by a single patient only. See
Warnings, Precautions and Complications.

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INDICATIONS
The Blom-Singer voice prosthesis is indicated for
tracheoesophageal voice restoration following total
laryngectomy.
CONTRAINDICATIONS
The Blom-Singer voice prosthesis is a medical product that
should be used only by individuals with experience and training
in its use and care.
HOW SUPPLIED
The Blom-Singer patient-changeable voice prosthesis is supplied
as a complete voice restoration system. Special order sizes/styles
are available. Accessory products for each prosthesis are available
separately.
PRODUCT DESCRIPTION
The Blom-Singer patient-changeable voice prosthesis is available
in a Low Pressure style (diagram 2A) or a Duckbill style (diagram
2B). Each prosthesis consists of a one-way valve (diagram 2a), an
esophageal retention ange (diagram 2b), a body that holds the
valve assembly (diagram 2c), a tracheal retention ange (diagram
2d), and a neck strap with safety hole (diagram 2e).
Blom-Singer®
Patient-changeable Voice Prostheses 16 Fr. 20 Fr.
Low Pressure Voice Prosthesis, with apper valve • •
Duckbill Voice Prosthesis, with slit valve •
Accessory Item (supplied separately)
18 Fr. Blom-Singer Puncture Dilator, use with: •
22 Fr. Blom-Singer Puncture Dilator, use with: •
The Blom-Singer voice prosthesis is made of silicone, a
biocompatible material used in many medical products.
The gel cap used for insertion of the Low Pressure voice prosthesis
is made of a vegetable base gelatin. Consult with your physician
as individual reactions to these materials may occur.

Blom-Singer® Patient-changeable Voice Prostheses
37531-03E | 7
BLOMSINGER ACCESSORIES
Blom-Singer accessories are available separately; please refer to
the InHealth website, www.inhealth.com or contact customer
service for product details.
Dilation/Sizing System (Clinician)
The Blom-Singer Dilation/Sizing System is designed for the
clinician to facilitate dilating and measuring of the TE puncture
tract in preparation for insertion of a Blom-Singer voice
prosthesis. The clinician should always measure the TE puncture
tract before inserting a voice prosthesis to conrm correct voice
prosthesis length.
Voice Prosthesis Cleaning System
The voice prosthesis cleaning system contains the necessary
cleaning device for careful cleaning of the voice prosthesis while
in the TE puncture.
Puncture Dilator
The Blom-Singer Puncture Dilator is used to help prevent the
TE puncture from closing when a voice prosthesis has been
removed; prevent leakage of esophageal contents into the
trachea; and, to slightly expand the puncture, making prosthesis
reinsertion easier. It is recommended that you always have on
hand a puncture dilator, of the appropriate diameter, or a suitable
device recommended by your doctor that serves the same
function. The Blom-Singer Puncture Dilator should only be used
by individuals with experience and training in the use and care of
TEP prosthetic devices.
Gel Cap Insertion System
The Gel Cap Insertion System provides an optional method for
easy and comfortable insertion of a Blom-Singer Low Pressure
voice prosthesis into the TE puncture. Each package contains a
loading tool, pushrods, gel caps and lubricant. Replacement gel
caps available.
WARNINGS AND PRECAUTIONS
InHealth relies on the qualied, trained medical professional to
instruct patients on the use and care of this device and to provide
patients with the Blom-Singer instructions for use supplied with
the product.

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Should the voice prosthesis show signs of malfunction, contact
your physician/clinician as soon as possible to have the device
performance evaluated.
If there are tears, cracks, or structural damage to the voice
prosthesis or cleaning devices, discontinue use.
Handle the voice prosthesis, cleaning device and the gel cap
loading tool carefully to avoid damaging the prosthesis.
Changes in your anatomy or medical status may lead to improper
tting and/or function of the device. It is recommended that your
voice prosthesis and TEP be evaluated by your clinician at regular
intervals.
Initial sizing of the voice prosthesis must be provided by a
qualied medical professional trained in the use of this particular
device.
In some users the inability to relax the muscles of the throat may
account for their inability to speak uently and, to speak with
minimal eort. This problem requires assessment.
Users with a voice prosthesis who undergo postoperative
radiation may experience transient interruption of voice in the
third or fourth week of treatment. The prosthesis can be left in
place throughout radiation treatments.
When using the Blom-Singer Gel Cap Insertion System, always
wait at least two minutes following insertion of the Low Pressure
voice prosthesis into the TE puncture before detaching the strap
from the safety peg and withdrawing the inserter.
The tip of the Low Pressure Voice Prosthesis, the gel cap loading
tool, the gel cap, the pushrod, and the user’s hands must be
completely dry prior to using the Gel Cap Insertion System in
order to prevent premature dissolving of the gel cap.
The Blom-Singer Gel Cap Insertion System is designed for use
with Blom-Singer Low Pressure Voice Prostheses only. Do not use
this product with any other type devices.
Voice Production
To prevent post-operative complications, do not begin speaking
with the voice prosthesis until your doctor has informed you that
it is safe for you to do so.

Blom-Singer® Patient-changeable Voice Prostheses
37531-03E | 9
The voice prosthesis must be kept clean of mucus and organic
matter in order for it to function properly and to help you speak
with a good quality of voice.
Voice Prosthesis Dislodgement
If the voice prosthesis is accidentally dislodged from the TE
puncture, immediately place a Blom-Singer puncture dilator,
or a suitable device as recommended by your doctor, of the
appropriate diameter, in the puncture to keep it from closing
and leaking uids. Contact your doctor immediately. The voice
prosthesis should be reinserted within 24 hours.
Care should be exercised when inserting or removing cleaning
devices to avoid accidental displacement of the prosthesis which
could result in aspiration (inhalation) of the voice prosthesis. In
the unlikely event that this should occur, you should attempt
to cough the voice prosthesis out of the windpipe. Immediately
seek medical attention if unsuccessful.
Never insert foreign objects into the voice prosthesis. The
cleaning device is designed for only cleaning dried mucus and
organic matter from the voice prosthesis. Inserting objects other
than the supplied cleaning device may cause dislodgment of the
voice prosthesis or its components and may cause these objects
to be swallowed or inhaled.
Voice Prosthesis Leakage
Recurrent leakage of uids through the voice prosthesis should
be evaluated by your clinician soon after it is noticed. When the
valve (diagram 2a) fails to close completely a few drops of uid
may pass back through the valve from the esophagus to the
trachea, which may cause coughing.
Candida species
Most users have a yeast (Candida albicans) in their mouth,
throat, or esophagus; this is a commonly occurring condition.
However, if the prosthesis is not properly cleaned in users who
have this condition, the yeast may grow on the valve of the
voice prosthesis. The yeast is identied by discolored spots on
the prosthesis. Yeast deposits can cause valve deformation and
failure, i.e., liquid leakage through the prosthesis and an increase
in the pressure necessary to voice. Replacement of the prosthesis

10 | 37531-03E
may be required more frequently. Some patients can be treated
successfully for yeast with oral medication or mouth rinses.
Device Removal
The voice prosthesis may be used until it ceases to function
correctly, that is, until it leaks or is not providing adequate
voice for speech. Many clinicians recommend routine follow-up
evaluations not longer than 6 months.
Caution: Federal (USA) law restricts this device to sale by or on
the order of a physician or a licensed speech pathologist.
COMPLICATIONS
Although rare, the following complications have been identied
to occur with silicone prostheses of the Blom-Singer type. They
include:
• stoma contamination or bacterial infection, which may require
removal of the prosthesis and/or appropriate antibiotics;
• accidental inhalation of the voice prosthesis into the airway,
which may require removal by a physician;
• inhalation of liquids through the prosthesis into the airway,
which may cause the patient to cough;
• occasional movement out of position by the voice prosthesis,
requiring replacement after enlargement of the TE puncture
and additional supervision of the stoma care regimen;
• puncture enlargement resulting in leakage of uids around
the prosthesis;
• inammatory reaction around the puncture site and formation
of scar tissue;
• dislodgment of the voice prosthesis and subsequent closure
of the TE puncture;
• chronic and persistent leakage around the voice prosthesis,
requiring surgical revision or closure of the puncture;
• diculty speaking or swallowing;
• tearing or other damage to the voice prosthesis from improper use;
• yeast deposits causing leakage through the prosthesis or
inability of the valve to function properly;
• accidental swallowing of the prosthesis into the esophagus
and/or gastrointestinal (GI) tract.

Blom-Singer® Patient-changeable Voice Prostheses
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INSTRUCTIONS FOR USE
Please refer to the diagrams located at the back of this instruction
manual.
Your clinician will instruct you on the use and routine care of the
Blom-Singer voice prosthesis.
The voice prosthesis will continue to function and may last longer
if it is cleaned daily with the supplied cleaning device per the
recommended instructions.
Caution: Use only supplied cleaning device. Do not insert
foreign objects into voice prosthesis. Inserting objects other than
the supplied cleaning device may cause dislodgment of the voice
prosthesis or its components.
Warning: Care should be exercised when inserting or removing
cleaning devices to avoid accidental displacement of the
prosthesis which could result in aspiration (inhalation) of the
voice prosthesis. In the unlikely event that this should occur,
you should attempt to cough the voice prosthesis out of the
windpipe. Immediately seek medical attention if unsuccessful.
The cleaning device, puncture dilator, and user’s hands should
always be thoroughly clean to prevent contaminants from
entering into the tracheostoma, puncture, or esophagus.
Cleaning of the voice prosthesis should only be done in front of
a mirror with a bright light focused directly on the stoma so that
the open end of the prosthesis is clearly visible.
Never use facial or toilet tissue to dry a voice prosthesis, puncture
dilator, or cleaning device as particles of lint or fabric may be
deposited onto the device that can be inhaled into the airway
upon reinsertion.
Do not use solvents or petroleum-based products for cleaning or
lubricating the device. These materials may damage silicone or
cause the device to not work properly.
The following procedural instructions are provided by Eric D. Blom, Ph.D.
Voice Prosthesis Removal
Once the user has been instructed by a qualied, trained medical
professional on how to remove, clean and reinsert the voice
prosthesis, a maintenance schedule is selected. Some users prefer

12 | 37531-03E
to remove and clean their voice prosthesis once a week, while
others may leave it in for a considerably longer period of time. It
is suggested that users alternate between two prostheses.
Each time the prosthesis is removed for cleaning, a Blom-
Singer Puncture Dilator, of the appropriate diameter, should be
inserted into the puncture to help prevent leakage of esophageal
contents into the trachea; and, to slightly expand the puncture,
making prosthesis reinsertion easier. For instructions on using the
puncture dilator, refer to the Blom-Singer Dilation-Sizing System
instructions for use.
After removing the tape from the prosthesis neck strap, grasp the
prosthesis securely and withdraw it gently out of the puncture.
Immediately insert a clean puncture dilator, of the appropriate
diameter, by positioning the tapered tip into the puncture. Avoid
touching the portion of the dilator that will enter the puncture.
Gently push the dilator into the puncture completely to the neck
strap (diagram 3). Secure the dilator near the edge of the stoma
with adhesive tape across the strap so it will not slide out.
Voice Prosthesis Cleaning
Please refer to the Voice Prosthesis Cleaning System instructions
for use supplied with the cleaning device.
1. The visible portion of the prosthesis may be cleaned carefully
with blunt-tipped, long handled tweezers to remove obvious
organic matter while the prosthesis is in the puncture.
2. When the prosthesis has been removed for cleaning, wash
the prosthesis thoroughly with a mild detergent and rinse
under a strong ush of tap water. Dry the prosthesis with sterile
gauze. Once a prosthesis or dilator has been cleaned and dried
completely, it should be stored in a clean, resealable plastic bag.
Always handle with clean hands and avoid touching portions of
the prosthesis or dilator that will enter the puncture.
3. Inspect the voice prosthesis routinely for structural damage.
Warning: When the valve fails to close completely a few drops
of uid may pass back through the valve from the esophagus to
the trachea, which may cause coughing. The valve closure can be
veried by looking at it with a mirror, while it is still positioned in
the puncture, to see if uids leak through it during swallowing.

Blom-Singer® Patient-changeable Voice Prostheses
37531-03E | 13
4. Candida species: Most users have a yeast (Candida albicans) in
their mouth, throat, or esophagus; this is a commonly occurring
condition. However, if the prosthesis is not properly cleaned in
users who have this condition, the yeast may grow on the valve of
the voice prosthesis. The yeast is identied by discolored spots on
the prosthesis. Yeast deposits can cause valve deformation and
failure, i.e., liquid leakage through the prosthesis and an increase
in the pressure necessary to voice. Replacement of the prosthesis
may be required more frequently. Some patients can be treated
successfully for yeast with oral medication or mouth rinses.
If it is determined that the user has a Candida condition, routine
cleaning of the voice prosthesis will retard the development
of yeast deposits. After removing the prosthesis, inserting the
dilator, and after following the cleaning instructions above, place
the prosthesis in a small container of fresh 3% hydrogen peroxide
overnight. After soaking, the prosthesis should be thoroughly
rinsed again with tap water, dried completely, and then placed in
a clean, resealable plastic bag until its next use. It is suggested
that users alternate between two prostheses every two days.
Note: Soaking in hydrogen peroxide will not remove yeast that is
already present on the prosthesis. It is a recommended cleaning
measure only. If yeast is present on the prosthesis and causing it
to leak, the prosthesis should be replaced.
Precaution: Never insert any cleaning device deep inside the
prosthesis while the prosthesis is in position in the neck.
Do not use solvents or petroleum-based products for cleaning or
lubricating the device. These materials may damage silicone or
cause the device to not work properly.
Insertion of the Voice Prosthesis
Please refer to the diagrams located at the back of this instruction
manual.
Note: Prior to use of the Voice Prosthesis, check the valve
mechanism to be sure it is intact and working properly. The
valve on the Low Pressure prosthesis should close at inside the
prosthesis. The slit valve on the Duckbill prosthesis should be
closed without evidence of gapping.
1. Insert the voice prosthesis only while using a close-up mirror

14 | 37531-03E
and a bright light focused directly into the stoma. Be certain
that your hands are clean. Place the tip of the inserter into the
open end of the prosthesis (see diagram 4). Avoid squeezing or
damaging the valve on the voice prosthesis. Handle the voice
prosthesis by the base of the strap to avoid touching the portion
that inserts into the puncture.
2. Attach the strap on the prosthesis securely over the safety
peg on the inserter as shown in diagram 5. This should prevent
inadvertent dislodgment of the prosthesis o the inserter during
insertion into the puncture.
3. Hold the end of the inserter as shown in diagram 6, and align
the top of the voice prosthesis partially in the puncture with
the neck strap oriented upwards. Firmly insert the prosthesis
until the esophageal ange can be felt to “snap” within the
esophagus. It should be noted that insertion or removal of
the voice prosthesis occasionally may cause slight bleeding at
the puncture. You should consult a qualied, trained medical
professional if bleeding is persistent.
4. While rmly holding the inserter, lift the strap o the safety
peg on the inserter (see diagram 7). Gently withdraw the inserter
with a twisting motion from the fully inserted voice prosthesis.
Warning: Caution should be exercised when removing the
inserter to avoid accidental displacement of the prosthesis, which
could result in aspiration (inhaling) of the voice prosthesis. Should
aspiration occur, attempt to cough the prosthesis out of the
windpipe. Seek medical attention immediately if unsuccessful.
5. Apply a strip of hypo-allergenic adhesive tape over the
neck strap to prevent strap movement as shown in diagram
8. Caution: If the prosthesis does not insert easily on the rst
attempt, do not continue to try to insert it. Instead, reinsert a
clean puncture dilator, of the appropriate diameter, for a few
minutes to dilate the TE puncture, then try again. In cases where
there is repeated diculty managing the prosthesis, consult
the qualied, trained medical professional who provided initial
instruction in the prosthesis use.
Alternate Method of Insertion
An alternate method of inserting the Low Pressure Voice
Prosthesis is also available. The esophageal ange of the voice

Blom-Singer® Patient-changeable Voice Prostheses
37531-03E | 15
prosthesis can be enclosed in a gel cap, using the Blom-Singer Gel
Cap Insertion System. The function of the gel cap is to:
1. Decrease the prole of the tip of the voice prosthesis by
folding and enclosing the esophageal ange in a forward position
inside the gel cap, so that the prosthesis tip is fully encapsulated.
This eliminates its presence during insertion of the prosthesis into
the TE puncture.
2. Reduce the trauma and force that may be associated with
Low Pressure voice prosthesis insertion by providing a smooth,
rounded shape to the tip end of the voice prosthesis, thus
enabling easy entry into the esophagus.
For instructions on using the gel caps, refer to the Instructions for
Use packaged with the Blom-Singer Gel Cap Insertion System. It
is recommended that the user discuss the use of this device with
a qualied, trained medical professional.
SPECIAL ORDER PRODUCTS
If this instruction manual accompanies a Special Order Product,
there may be dierences in the physical characteristics between
the product and the product descriptions described in this
instruction manual. These dierences will not aect the safety
or desired benecial eect of the special order product. Special
Order products are nonreturnable.
ORDERING INFORMATION
USA
Blom-Singer products may be ordered directly from InHealth
Technologies. TELEPHONE: Toll-Free [phone] or (805)684-
9337, Monday — Friday, 9:30 am — 7:00 pm, Eastern Standard
Time. FAX: Toll-Free [phone] or [phone]. EMAIL:
[email protected] ORDER ON-LINE: www.inhealth.com POST:
InHealth Technologies, 1110 Mark Avenue, Carpinteria, CA 93013-
2918, USA, Attention: Customer Service.
International
Please contact our customer service department for a distributor referral.
Consumer Aairs
If you have any questions or dissatisfaction with a product please

16 | 37531-03E
contact our customer service department via telephone, fax,
post, or Email: [email protected]om
RETURNED GOODS POLICY
All returned merchandise must have a Return Merchandise
Authorization number (RMA), and must be unopened and
undamaged. RMA numbers are obtained from InHealth Customer
Service. Returns without an RMA will not be accepted. Products
must be returned in unopened packages, with manufacturer’s
tamper evident seals intact to be accepted for replacement or
credit. Products will not be accepted for replacement or credit if
they have been in possession of the customer for more than 14
days. Special order products are nonreturnable. There is a 20%
restocking fee on all returned merchandise.
LIMITED WARRANTY, LIMITED REMEDY AND
LIMITATION OF LIABILITY
InHealth Technologies, a Division of Helix Medical, LLC, warrants
that the Product will be free from defects in workmanship
and materials on the date of purchase. THE FOREGOING
WARRANTY IS EXCLUSIVE AND IN LIEU OF ALL OTHER
WARRANTIES OR REPRESENTATIONS, EXPRESS OR IMPLIED,
ARISING BY LAW OR CUSTOM, INCLUDING IMPLIED WARRANTIES
OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR
PURPOSE, SAID IMPLIED WARRANTIES BEING HEREBY EXPRESSLY
DISCLAIMED. Purchaser’s sole and exclusive remedy for a valid
warranty claim is replacement of the Product. This remedy does
not include the cost of installation, removal, dismantling, delivery
or reinstallation. InHealth shall have no liability to the extent
Products are or have been modied or subject to misuse, abuse
or improper storage, installation or maintenance or damaged
in transit. No returns will be accepted without prior approval
and authorization. INHEALTH SHALL NOT BE LIABLE FOR ANY
SPECIAL, INCIDENTAL, INDIRECT, CONSEQUENTIAL, PUNITIVE, OR
EXEMPLARY DAMAGES OF ANY KIND.
GLOSSARY
Candida albicans
A yeast fungus that is a commonly occuring condition that can
infect the mouth or the skin and may multiply and overgrow on
to the voice prosthesis.

Blom-Singer® Patient-changeable Voice Prostheses
37531-03E | 17
Clinician
A health professional, such as a physician, licensed speech-
language pathologist, or nurse who is involved in clinical practice.
Contraindications
A reason that makes it inadvisable to prescribe a particular
procedure or treatment.
Esophagus
The muscular membranous tube for the passage of food from the
pharynx to the stomach; the “food pipe.”
Fistula; TE-stula
An abnormal duct or passage that connects an abscess or cavity
to the body surface; a small opening between the trachea and
the esophagus.
Indications
A reason to prescribe a drug or perform a procedure.
Tracheoesophageal puncture (TEP)
An opening made by a surgeon between the trachea and the
esophagus. The opening is made at the time of initial surgery or
later so that a voice prosthesis can be placed into this passage.
Trachea
The airway through which respiratory air passes to and from the
lungs (windpipe).
Tracheoesophageal (TE)
Pertaining to the trachea and esophagus.
Tracheostoma
An opening through the neck and into the trachea. It is through
this opening that the laryngectomee breathes.
Voice prosthesis
A one-way speech valve that is inserted into the TEP to allow
air to pass from the trachea through the prosthesis and into the
esophagus to produce sound.

TÜRKÇE
18 | 37531-03E
BLOMSINGER® HASTA TARAFINDAN
DEĞİŞTİRİLEBİLEN SES PROTEZLERİ
Grş
Lütfen kullanım kılavuzunun arkasında bulunan dyagramlara
başvurun. Bu bölümün sonunda br termler sözlüğü yer almaktadır.
Blom-Snger ses protez, dünya çapında gırtlak nakl yapılan
bnlerce knn yenden konumasına yardımcı olmutur. Orjnal
trakeoözofajeal ses protez 1978’de Dr. Erc Blom ve Dr. Mark
Snger tarafından geltrlmtr. Bugün onların trakeoözofajeal
ponksyon yöntem TEP hala tüm dünyada toplam larngektom
sonrası ses restorasyonunda önde gelen standart olarak kabul
edlmektedr.
Gırtlak nakl yapılan br k kararlı olduğu taktrde br klnsyen
ya da konuma terapstnden yen konuma yollarını öğreneblr.
Bu kılavuzda açıklanan br seçenek, trakeoözofajeal ses protez
kullanarak ses restorasyonunu sağlamaktadır (dyagram 1). Ses
protez (1A) TE ponksyonuna yerletrlr, bu protez ses üretmek
(1D) çn havanın akcğerlerden trakeaya (1B) ve özofagusa (1C)
grmesne zn verr. Ses, br parmak veya ellern serbest olduğu
Blom-Snger Ayarlanablr Trakeostoma Valfı le stomanın geçc
olarak kapatılmasıyla elde edlr.
Bu ses protez hasta tarafından değtrleblr br chazdır; hasta
protez özgürce takablr, çıkarablr ve temzleyeblr.
Ses protez ve aksesuar öğeler, yalnızca Blom-Snger ses
protezlernn etkl yönetm ve bakımına dar uygun eğtm almı
kler tarafından kullanılmalıdır. Yönetm, chazın kullanımını,
yernden çıkarılmasını ve temzlenmesn çerr ancak bunlarla
sınırlı kalmaz.
Doktorunuz sze ses proteznn kulanım rsklern ve faydalarını
anlatacaktır. Bu kılavuzdak blgler br tıbb uzmanın
konsültasyonu veya talmatlarının yerne kullanılmak çn
tasarlanmamıtır.
Bu ürün yalnızca tek br hastada kullanıma yönelktr. Bkz.
Uyarılar, Önlemler ve Komplkasyonlar.

Blom-Singer® Hasta Tarafından Değiştirilebilen Ses Protezleri
37531-03E | 19
ENDİKASYONLAR
Blom-Snger ses protez, toplam larngektomy takben
trakeoözofajeal ses restorasyonu çn endkedr.
KONTRAENDİKASYONLAR
Blom-Snger ses protez yalnızca kullanımı ve bakımı konusunda
deneyml ve eğtml kler tarafından kullanılması gereken tıbb
br üründür.
TEDARİK ŞEKLİ
Blom-Snger hasta tarafından değtrleblen ses protez komple
ses restorasyon sstem olarak sunulur. Özel spar boyutları/
stller mevcuttur. Her protezn aksesuar ürünler ayrı olarak satın
alınablr.
ÜRÜN TANIMI
Blom-Snger hasta tarafından değtrleblen ses protez Düük
Basınçlı stlyle (dyagram 2A) veya Duckbll stlyle (dyagram 2B)
mevcuttur. Her protez tek yönlü valf (dyagram 2a), br özofugal
tutma anı (dyagram 2b) kapak düzeneğn tutan br gövde
(dyagram 2c), br trakeal tutma anı (dyagram 2d) ve br boyun
bandından (dyagram 2e) oluur.
Blom-Snger®
Hasta tarafından değştrleblr Ses Protez 16 Fr. 20 Fr.
Düük Basınçlı Ses Protez kanatlı valf le brlkte • •
Duckbll Ses Protez, yarık valf le brlkte •
Aksesuar Öğes (ayrı tedark edlr)
18 Fr. Blom-Snger Ponksyon Dlatörü le kullanılacak öğe:
•
22 Fr. Blom-Snger Ponksyon Dlatörü le kullanılacak öğe:
•
Blom-Snger ses protez, brçok tıbb üründe kullanılan
byouyumlu br ürün olan slkondan üretlmtr.
Düük Basınçlı ses proteznn takılması çn kullanılan jel kapsülü
sebze bazlı jelatnden üretlmtr. Breylern bu materyallere karı
reaksyon göstermes htmalne karı doktorunuza danıın.

20 | 37531-03E
BLOMSINGER AKSESUARLARI
Blom-Snger aksesuarları ayrı olarak satın alınablr; lütfen ürün
ayrıntıları çn www.nhealth.com adresndek InHealth web
stesne bakın ya da müter hzmetler le görüün.
Dlatasyon/Boyutlandırma Sstem (Klnsyen)
Blom-Snger Dlatasyon/Boyutlandırma Sstem, Blom-Snger ses
proteznn yerletrlmes çn hazırlıklar sırasında TE ponksyon
alanının genletlmesn ve ölçülmesn kolaylatırmak amacıyla
klnsyen çn tasarlanmıtır. Klnsyen ses protezn takmadan
önce doğru ses protez uzunluğunu doğrulamak çn her zaman
TE ponksyon alanını ölçmeldr.
Ses Protez Temzleme Sstem
Ses protez temzleme sstem, TE ponksyonu çndeyken ses
proteznn dkkatl br eklde temzlenmes çn gerekl temzlk
chazlarını çerr.
Ponksyon Dlatörü
Blom-Snger Ponksyon Dlatörü, ses protez çıkarılırken TE
ponksyonunun kapanmasını önlemeye yardımcı olmak,
özofagus çerğnn trakeaya sızıntısını engellemek ve protezn
tekrar takılmasını kolaylatırmak üzere poksyonu haffçe
genletmek çn kullanılır. Elnzn altında her zaman uygun çapta
br ponksyon dlatörü ya da doktorunuzun önerdğ aynı lev
gören br chaz bulundurmanız önerlr. Blom-Snger Ponksyon
Dlatörü yalnızca TEP prostetk chazlarının kullanımı ve bakımı
konusunda deneyml ve eğtml klerce kullanılmalıdır.
Jel Kapsülü Takma Sstem
Jel Kapsülü Takma Sstem, Blom-Snger Düük Basınçlı
ses proteznn TE ponksyonuna kolay ve rahat br eklde
yerletrlmes çn opsyonel br yöntem sunar. Her paket,
yükleme aracı, tc çubuklar, jel kapaklar ve yağlayıcı çerr. Yedek
jel kapakları mevcuttur.
UYARILAR VE ÖNLEMLER
InHealth, hastaları bu chazın kullanımı ve bakımı konusunda
blglendrmek ve hastalara bu ürünle brlkte verlen Blom-Snger
kullanım talmatlarını sağlamak konusunda kalfye, eğtml tıp
uzmanlarına güvenmektedr.