inhealth Blom-Singer Indwelling TEP Occluder User manual

37720-03F
R3
Blom-Singer®Indwelling
TEP Occluder
MEDICAL PROFESSIONAL Instructions For Use

2| 37720-03F
37720-03F Eective October 2017 / Ekim 2017’de Yürürlüğe
Girdi / Cu intrare în vigoare din octombrie 2017 / Stupa na snagu
u listopadu 2017 / Stupa na snagu u oktobru 2017 / Velja od
oktobra 2017 / Вступает в силу с октября 2017
Blom-Singer and InHealth Technologies are registered
trademarks of Freudenberg Medical, LLC

TABLE OF CONTENTS
37720-03F | 3
5
Medical Professional Instructions For Use
Tıp Uzmanı Kullanım Talimatları
Instrucţiuni de utilizare pentru CADRU medicale specializate
Upute za korištenje za zdravstvene stručnjake
Uputstva za korišćenje za medicinske stručnjake
Navodila za uporabo za ZDRAVSTVENI DELAVEC
Инструкция по эксплуатации для ПРОФЕССИОНАЛЬНЫХ
МЕДРАБОТНИКОВ
   Blom-Singer®
Notranje zapiralo Blom-Singer® TEP
Blom-Singer® trajni TEP okluder
Obturator TEP permanent Blom-Singer®
Blom-Singer® Kalıcı TEP Tıkacı
Blom-Singer® trajni TEP okluder
Blom-Singer® Indwelling TEP Occluder
17
29
42
54
66
78
İçindekiler / Cuprins / Sadržaj / Vsebina / Содержание
ENG
TUR
RON
HRV
SRP
SLV
RUS

4| 37720-03F

ENGLISH
37720-03F | 5
BLOMSINGER® INDWELLING TEP OCCLUDER
The Blom-Singer Indwelling TEP (Tracheoesophageal Puncture)
Occluder is a non-valved silicone device designed for placement
in and maintenance of the TE (tracheoesophageal) puncture
following total laryngectomy.
The Indwelling TEP Occluder is intended to:
1. Maintain the TEP stula by keeping the puncture tract open.
2. Prevent leakage of esophageal contents into the trachea
during swallowing.
This Blom-Singer medical device may be used only once by
one patient. It may not be reused. See Warnings, Precautions
and Complications.
Do not use the device if it becomes contaminated; discard and
replace it with a newly packaged device.
This device is for anterograde placement only. Not intended for
retrograde placement.
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.
INDICATIONS
The Blom-Singer Indwelling TEP Occluder is indicated for
anterograde placement in and maintenance of the TE puncture
following total laryngectomy when placement, or replacement,
of the indwelling silicone prosthesis is performed by a qualied,
trained medical professional. This device is for use with healed,
intact tracheoesophageal puncture stulas only.
CONTRAINDICATIONS
The Blom-Singer Indwelling TEP Occluder is a medical product
that should be used only by a qualied, medical professional with
experience and training in its use and care.

6| 37720-03F
This device should not be placed in a small tracheostomal airway if
its presence obstructs breathing. This device is not a valved voice
prosthesis and does not function like one. Tracheoesophageal
speech is not possible with an Indwelling TEP Occluder.
Placement of the Indwelling prosthesis is contraindicated in a TE
puncture that has dilated substantially beyond the diameter of
a conventional 16 French or 20 French Blom-Singer Indwelling
prosthesis.
HOW SUPPLIED
The Indwelling TEP Occluder is available by special order in 16
French or 20 French diameters. It is supplied nonsterile; do not
sterilize or place in an autoclave as damage to the device may
occur. Provided in each package is the appropriately sized gel
caps and inserters.
WARNINGS AND PRECAUTIONS
The Blom-Singer Indwelling TEP Occluder is a medically
prescribed device. Initial sizing and instructions for use must be
provided by a qualied medical professional trained in the use of
this particular device.
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.
If the device is not functioning properly, the patient should have
it evaluated by a qualied, trained medical professional soon as
possible.
If there are tears, cracks, or structural damage to the device or
accessories, discontinue use. Signs of a defective device include,
but are not limited to,
• occluder degradation due to patient chemistry caused by
microbial growth colonization on device;
• improper sizing caused by a compromised tracheoesophageal
wall status;
• device pushed through TEP caused by improper use of inserter
tool, improper sizing, or a compromised tracheoesophageal
wall status;

Blom-Singer® Indwelling TEP Occluder
37720-03F | 7
• leakage around the device;
• tissue reaction or infection of puncture tract.
Handle the device and the gel cap loading tool carefully to avoid
damaging the products.
Use only the specially sized gel caps provided by InHealth
Technologies. The Gel Cap Insertion System is designed for use
with Blom-Singer devices only.
Do not use petroleum-based products such as Vaseline® to
lubricate the device as these products can damage silicone.
Changes in the anatomy or medical status of the patient may
lead to improper tting and/or function of the device. It is
recommended that the device and TEP be evaluated by the
clinician at regular intervals.
Device Dislodgement
Care must be exercised during device insertion or removal to
avoid injury to the TEP or accidental displacement of the device
which could result in aspiration of the device into the trachea.
Should aspiration occur, the patient should attempt to cough
the device out of the trachea. Further medical attention may be
necessary if coughing the device out is unsuccessful.
Conrm gel cap dissolution and deployment of the esophageal
retention ange per procedures provided to ensure that the
device is securely retained in the TEP.
If the device is accidentally dislodged from the puncture, the
patient should immediately place a Blom-Singer puncture dilator,
of the appropriate diameter, in the puncture to keep it from
closing and leaking uids. The device should be reinserted within
24 hours.
Foreign objects should never be inserted into the device by the
patient.
Management of Indwelling TEP Occluder During Planned or
Unplanned Airway Events
During a planned (e.g., elective) or unplanned (e.g., emergency)
airway event that involves stomal manipulation, the device
should not be removed.

8| 37720-03F
If the device becomes dislodged, it should be replaced as soon as
possible with an all-purpose catheter of a compatible diameter
to prevent aspiration of esophageal contents, and to maintain
the opening between the trachea and the esophagus so that an
Indwelling occluder can be inserted at a later time.
Standard resuscitation procedures for neck breathers should be
utilized in a medical emergency.
Please instruct your patient to consider obtaining a medical alert
bracelet or card to identify them as a neck breather. This should
be kept in a clearly visible location.
Device Removal
The attached neck strap on an Indwelling occluder should only
be removed after the esophageal retention ange position within
the esophagus has been veried. Never attempt to insert or
reinsert an Indwelling occluder that has the neck strap removed.
Never remove one Indwelling occluder and insert another
occluder without rst dilating the TE puncture and remeasuring
the tract to conrm correct device length.
The patient should never attempt to remove the device or allow
anyone other than a qualied, trained medical professional to
remove the device.
The Indwelling occluder is not a permanent device and requires
replacement periodically. Many clinicians recommend routine
follow-up evaluations not longer than 6 months. InHealth
Technologies makes no warranty, either expressed or implied, as
to the lifetime of the Indwelling TEP Occluder. The device lifetime
may vary with individual use and biological conditions.
Removal of the Indwelling occluder should only be done by
grasping the outer tracheal ange of the device securely with a
locking hemostat. Pull gently and rmly until the device is fully
withdrawn.
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 devices of the Blom-Singer type. They include:

Blom-Singer® Indwelling TEP Occluder
37720-03F | 9
stoma contamination or sepsis, which may require removal of the
device and/or appropriate antibiotics; accidental aspiration of the
device into the airway, which may require removal by a physician;
occasional extrusion of the device, requiring replacement after
dilation of the TE puncture and additional supervision of the
stoma care regimen; puncture dilation resulting in leakage of
uids around the device; inammatory reaction around the
puncture site and formation of granulation tissue; dislodgment of
the device and subsequent closure of theTE puncture; intractable
leakage around the device, requiring surgical revision or closure
of the puncture; diculty swallowing; tearing or other damage to
the device from improper use; accidental ingestion of the device
into the esophagus and/or GI tract.
PRODUCT DESCRIPTION
The Blom-Singer Indwelling TEP Occluder is oered nonsterile.
Nonsterile product is not intended for primary placement
procedures.
The Blom-Singer Indwelling TEP Occluder is made of silicone,
a biocompatible material used in many medical products. This
device is latex-free.
The gel cap used for insertion of the device is made of a vegetable
base gelatin. Individual patient reactions to these materials may occur.
The Blom-Singer Indwelling Occluder, (diagram 1) consists of an
esophageal retention ange (diagram 1a), a tracheal retention
ange (diagram 1b), and a neck strap (diagram 1c).
Note: Since this is a non-speaking device, cleaning of the device
is not necessary. However, on the portion of the device that
shows out of the puncture, the patient may need to remove dried
mucus secretions using a tweezer.
In order to manage dryness and secretions of the airway, a heat
and moisture exchange system is recommended. If dry secretions
persist and require removal, it is recommended that the area of
crusting be humidied to prevent trauma to the tracheal tissue.
INSTRUCTIONS FOR USE
The following procedure is provided by Eric D. Blom, Ph.D. Please
refer to the diagrams located at the back of this instruction manual.

10 | 37720-03F
Use of gloves, protective eye wear, and a respiratory face mask is
recommended for the following procedure.
The Indwelling Occluder and its accessories should always be
thoroughly clean and dry to help avoid introducing contaminants
into the tracheostoma, TE puncture, or esophagus.
Note: Insertion or removal of the device in the TE puncture
should only be done with a bright light focused directly on the
stoma.
Have the following Blom-Singer items prepared for aseptic
insertion of the device:
• Blom-Singer Indwelling Occluder
• Blom-Singer Gel Cap Insertion System
• Blom-Singer Dilator-Sizer
• Blom-Singer Voice Prosthesis Sizer (or Dilator-Sizer)
• Blom-Singer Puncture Dilator (or Dilator-Sizer)
• Blom-Singer Prosthesis Inserter
Dilate and Measure
Please refer to the Blom-Singer Dilation/Sizing System Instructions
For Use for complete product details.
Optional: The Blom-Singer Sizer or Puncture Dilator may be used
as an alternate procedure. Refer to the instructions for use supplied
with the product.
1. Dilate the TEP with a Blom-Singer Dilator-Sizer of the
appropriate diameter. Gently insert the Dilator-Sizer into the
puncture completely to the neck strap (diagram 2) and leave in
place for ve minutes.
2. Carefully withdraw the Dilator-Sizer until very gentle
resistance is detected indicating that the esophageal wings are
seated against the anterior wall of the esophagus (diagram 2a).
Note: Pulling too rmly on the Dilator-Sizer may squeeze or
compress the TE tract resulting in an erroneous measurement
that indicates it is shorter than it actually is.
3. Note the marker that is closest to the entrance of the TE
puncture. Read the size number on the Dilator-Sizer and select
a Blom-Singer Indwelling Occluder of corresponding size. If the

Blom-Singer® Indwelling TEP Occluder
37720-03F | 11
measurement is between two markers, select the longer one.
4. Fully insert the Dilator-Sizer and fasten the neck strap with
adhesive tape on to the patient’s neck. Leave the Dilator-Sizer in
the puncture to dilate 5 minutes, or longer if necessary, in order
to allow for easy insertion of the selected Indwelling Occluder.
Prior to insertion of the Blom-Singer Indwelling Occluder, remove
the tape from the neck strap, grasp the dilator securely, and
carefully withdraw it from the puncture. Immediately insert the
Indwelling Occluder.
Device Preparation
1. Prepare the device for easy, atraumatic insertion by utilizing the
Blom-Singer Gel Cap Insertion System. Use only the specially sized
gel caps provided with this product.
The Gel Cap Insertion System is designed for use with Blom-
Singer Prostheses only; do not use with any other type devices.
The following steps describe the hand folding method of gel cap
insertion.
a. Remove the device from the package. Always handle the
device with clean, gloved hands. Be certain that your gloves
and the device are completely dry before loading the gel cap.
Failure to do so may cause premature dissolving of the gel
cap.
b. Remove the Gel Cap Insertion System items from the package:
gel cap, ange introducer, and inserter tool.
c. Fold and load the device into the unprinted gel cap (discard
the printed end) according to the following steps.
d. Fold the esophageal retention ange tightly in half toward the
center of the device (diagram 4a).
e. Fold the two outer edges of the esophageal retention ange
tightly against the folded ange (diagram 4b) and hold the
device in this folded position.
f. Insert the folded portion of the esophageal retention ange
into the gel cap (diagram 4c). Gently tuck and push the folded
device as far as possible into the gel cap.
g. Use the ange introducer to gently tuck the remaining
portion of the folded esophageal retention ange completely

12 | 37720-03F
into the gel cap (diagram 4d). Do not use any sharp or serrated
instruments to avoid damaging the device.
h. The esophageal retention ange should be folded toward the
center of the device and completely enclosed inside the gel
cap (diagram 4e).
Device Insertion
Warning: Caution should be exercised to avoid accidental
displacement of the device which could result in aspiration of
the device into the trachea. Should aspiration occur, the patient
should attempt to cough the device out of the trachea. Further
medical attention may be necessary if coughing the device out
is unsuccessful.
1. Place the device on the inserter and lock the neck strap onto
the safety peg (diagram 3).
2. Caution the patient not to swallow as you remove the
previously inserted Dilator-Sizer to avoid aspiration of saliva into
the trachea prior to inserting the device.
3. Apply a light coating of water-soluble lubricant (oil-free) to
the tip of the gel-capped end of the device and immediately
insert the device completely into the TE puncture by aligning
the tip of the device partially in the puncture with the neck strap
oriented upwards (diagram 5). Note: Do not use petroleum-
based products such as Vaseline® to lubricate the device as these
products can damage silicone.
4. Hold the device in this position of complete insertion for at
least three minutes. This allows ample time for the gel cap to
dissolve and release the esophageal retention ange (diagram
1a) within the esophagus. Patients should be instructed to swallow
their saliva or warm water to facilitate dissolving the gel cap.
Caution: If the device does not insert easily on the rst attempt,
do not continue to try to insert it. Instead, insert a clean puncture
dilator, of the appropriate diameter, for a few minutes to dilate the
TE tract, and then try again.
5. Detach the device neck strap (diagram 1c) from the safety
peg on the inserter. Place a nger against the neck strap and
carefully withdraw the inserter from the device with a twisting
motion. Warning: Caution should be exercised when removing

Blom-Singer® Indwelling TEP Occluder
37720-03F | 13
the inserter to avoid accidental displacement of the device which
could result in aspiration of the device. Secure the device with
adhesive tape across the neck strap. It is recommended to orient
the device with the neck strap up.
NECK STRAP DETACHMENT
The Indwelling Occluder is designed to include the optional
detachment of the neck strap following conrmation that the
device esophageal retention ange is securely positioned within
the esophageal lumen against the anterior wall of the esophagus.
Removal of the neck strap is an optional procedure.
The neck strap should not be detached from the Indwelling
Occluder if:
• use of a laryngectomy tube may potentially dislodge the
device;
• a patient has previously been wearing a device that is larger
in diameter than the Indwelling Occluder currently being
inserted;
• the diameter of the TE puncture is dilated signicantly larger
than the device diameter;
• the health of the stoma tissue or physical condition of the
patient is in question; or,
• direct exible endoscopy is not utilized for conrmation of
esophageal ange deployment.
Note: It is important not to detach the neck strap from the
device in the instances cited above. Tape the neck strap to the
peristomal skin and observe security of device retention for an
extended period of time.
The following procedure for conrming deployment of the
esophageal retention ange is recommended by Eric D. Blom, Ph.D.
After insertion of the device in the puncture tract and completion
of the 3-minute waiting period for gel cap dissolution and
esophageal retention ange deployment, repeatedly rotate the
device on the inserter while it is in the puncture. If the esophageal
retention ange has deployed and has properly seated against
the mucosa of the anterior esophageal wall, the device on the
inserter will rotate easily in the puncture tract. If the gel cap has

14 | 37720-03F
dissolved and incorrectly deployed the esophageal retention
ange inside the puncture tract rather than inside the lumen of
the esophagus, considerable resistance to device rotation will
be felt.
A second method for conrming esophageal retention ange
deployment is to utilize direct exible endoscopy conrmation
of deployment.
If the assessment methods described above fail to provide
satisfactory verication of correct esophageal retention ange
deployment, remove the device, dilate and remeasure the
puncture tract, and repeat the device insertion and conrmation
process.
Once deployment of the esophageal retention ange has been
conrmed, detach the neck strap from the tracheal retention
ange (diagram 1b) at the area of reduced neck strap width,
where it meets the tracheal ange, by cutting carefully with
scissors (diagram 6).
Note: if you are uncertain that the esophageal retention ange
has properly unfolded, and the device is in place inside the
esophageal lumen, after using the steps described above, do
not detach the neck strap from the device. Securely tape the
neck strap to the neck and observe the patient for a few days for
retention ability.
Removal of the Device
The Indwelling Occluder is not a permanent device and requires
replacement periodically. Many clinicians recommend routine
follow-up evaluations not longer than 6 months. InHealth
Technologies makes no warranty, either expressed or implied, as
to the lifetime of the Indwelling TEP Occluder. The device lifetime
may vary with individual use and biological conditions.
Removal of the Indwelling Occluder should only be done by
grasping the outer tracheal ange of the device securely with
a locking hemostat. Pull gently and rmly until the device is fully
withdrawn.
Insert a Dilator-Sizer of the appropriate diameter, and tape it in
position for ve minutes prior to inserting a new Indwelling Occluder .

Blom-Singer® Indwelling TEP Occluder
37720-03F | 15
Warning: Clearly inform the patient never to attempt to remove
the device or allow anyone other than a qualied, trained medical
professional to remove the Indwelling Occluder.
Never remove one device and insert another device without rst
dilating the TE puncture and remeasuring the tract to conrm
device length.
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 ecacy 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, 9:30am–7:00pm, Eastern Standard Time.
FAX: Toll-Free [phone] or [phone]. EMAIL: order@
inhealth.com 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 list of
international distributors.
Consumer Aairs
If you have any questions or dissatisfaction with a product please
contact our customer service department via telephone, fax, post,
or Email: [email protected]

16 | 37720-03F

TÜRKÇE
37720-03F | 17
BLOMSINGER® KALICI TEP TIKACI
Blom-Singer Kalıcı TEP (Trakeoözofajeal Ponksiyon) Tıkacı, total
larenjektomi sonrasında TE (Trakeoözofajeal) ponksiyon içine
yerleştirilerek ponksiyonun devamını sağlamak üzere tasarlanmış
bir valfsız silikon cihazdır.
Kalıcı TEP Tıkacının kullanım amacı:
1. Ponksiyon yolunu açık tutarak TEP stülünü devam ettirmek.
2. Yutma sırasında özofajeal içeriklerin trakeaya sızmasını
engellemek.
Bu Blom-Singer tıbbi cihazı, tek hastada sadece bir kez
kullanılabilir. Yeniden kullanılmamalıdır. Bkz. Uyarılar,
Önlemler ve Komplikasyonlar.
Kontamine olan cihazı kullanmayın; cihazı atın ve yerine yeni
ambalajlı bir cihaz kullanın.
Bu cihaz sadece anterograd yerleştirmeye yöneliktir. Retrograd
yerleştirmeye uygun değildir.
InHealth, bu cihazın kullanımı ve bakımı hakkında hastalara
gerekli talimatların verilmesi ve hastalara ürünle birlikte verilen
Blom-Singer kullanım talimatlarının temin edilmesi konusunda
eğitimli ve nitelikli sağlık uzmanlarına güvenmektedir.
ENDİKASYONLAR
Blom-Singer Kalıcı TEP Tıkacı, kalıcı silikon protezin yerleştirilmesi
veya yeniden yerleştirilmesi işleminin eğitimli ve nitelikli bir
sağlık uzmanı tarafından gerçekleştirilmesi şartıyla, total
larenjektomi sonrasında TE ponksiyonunun anterograd
yerleştirilmesi ve ponksiyonun devam ettirilmesine yöneliktir.
Bu cihaz sadece iyileşmiş, sağlam trakeoözofajeal ponksiyon
stülleri ile kullanıma yöneliktir.
KONTRAENDİKASYONLAR
Blom-Singer Kalıcı TEP Tıkacı, sadece bu cihazın kullanımı ve
bakımı konusunda deneyimi olan nitelikli bir sağlık uzmanı
tarafından kullanılması gereken bir tıbbi cihazdır.

18 | 37720-03F
Bu cihazın varlığı nefes alıp vermeyi engelliyorsa, cihaz küçük bir
trakeostomal hava yoluna yerleştirilmemelidir. Bu cihaz bir valı
ses protezi değildir ve böyle bir işlev gerçekleştiremez. Kalıcı TEP
Tıkacı ile trakeoözofajeal konuşma mümkün değildir.
Geleneksel 16 Fr. veya 20 Fr. Blom-Singer Kalıcı protezin çapına
göre çok daha fazla genişlemiş bulunan bir TE ponksiyonuna
Kalıcı protezin yerleştirilmesi kontrendikedir.
TEDARİK EKLİ
Kalıcı TEP Tıkacı, özel sipariş yoluyla 16 Fr. veya 20 Fr. çaplarında
temin edilebilir. Cihaz steril değildir; cihaza zarar verebileceği için
sterilize etmeyin veya otoklav uygulamayın. Her paketin içinde
uygun ebatlarda jel kapaklar ve yerleştiriciler mevcuttur.
UYARILAR VE ÖNLEMLER
Blom-Singer Kalıcı TEPTıkacı tıbbi olarak reçete edilen bir cihazdır.
İlk ebatlar ve kullanım talimatları, bu cihazın kullanımı konusunda
eğitim almış nitelikli bir sağlık uzmanı tarafından sağlanmalıdır.
InHealth, bu cihazın kullanımı ve bakımı hakkında hastalara
gerekli talimatların verilmesi ve hastalara ürünle birlikte verilen
Blom-Singer kullanım talimatlarının temin edilmesi konusunda
eğitimli ve nitelikli sağlık uzmanlarına güvenmektedir.
Cihaz düzgün biçimde çalışmıyorsa, hasta cihazın en kısa
zamanda eğitimli ve nitelikli bir sağlık uzmanı tarafından
değerlendirilmesini sağlamalıdır.
Cihazda yırtık, çatlak veya yapısal hasar varsa, kullanımı durdurun.
Kusurlu cihazın belirtileri şunları içerir:
• cihaz üzerinde mikrobiyal büyüme kolonizasyonundan
kaynaklanan hasta kimyası nedeniyle tıkacın bozulması;
• bozulmuş trakeoözofajeal duvar durumu nedeniyle yanlış
boyutlandırma;
• yerleştirici aracının yanlış kullanılması, yanlış boyutlandırma
veya bozulmuş trakeoözofajeal duvar durumu nedeniyle
cihazın TEP içinden itilmesi;
• cihaz etrafında sızıntı;
• ponksiyon yolunda doku reaksiyonu veya enfeksiyon.
Ürünlere zarar vermemek için cihazı ve jel kapağı yükleme aracını
dikkatli bir şekilde kullanın.

Blom-Singer® Kalıcı TEP Tıkacı
37720-03F | 19
Sadece InHealth Technologies tarafından sağlanan özel ebatlı jel
kapakları kullanın. Jel Kapak Takma Sistemi, sadece Blom-Singer
cihazlarda kullanım için tasarlanmıştır.
Bu ürünler silikona zarar verebileceği için, cihazı yağlamak için
Vaseline® gibi petrol bazlı ürünler kullanmayın.
Hastanın anatomisi veya tıbbi durumundaki değişiklikler, cihazın
yanlış takılması ve/veya çalışmasına neden olabilir. Cihazın ve
TEP’in klinisyen tarafından düzenli aralıklarla değerlendirilmesi
tavsiye edilir.
Cihazın Yerinden Çıkması
Cihazın takılması veya çıkarılması sırasında TEP’e zarar
gelmemesi veya cihazın yanlışlıkla yerinden çıkarak trakeaya
kaçmasını önlemek için dikkatli olunmalıdır. Böyle bir aspirasyon
durumunda, hasta öksürerek cihazı trakea dışına çıkarmaya
çalışmalıdır. Cihazın öksürük yoluyla dışarı atılması başarısız
olursa, başka tıbbi müdahale gerekli olabilir.
Jel kapak çözünmesi ve özofajiyal tutma anşı yerleştirme
işleminin, cihazın TEP içinde güvenli bir şekilde tutulmasını
sağlamayı amaçlayan prosedürlere uygun olarak gerçekleştiğini
doğrulayın.
Cihaz yanlışlıkla ponksiyondan çıkarsa, hasta ponksiyonun
kapanmasını ve sıvıların sızmasını engellemek için derhal uygun
çapta bir Blom-Singer ponksiyon dilatörü yerleştirmelidir. Cihaz
24 saat içinde yeniden yerleştirilmelidir.
Hasta tarafından cihaza asla yabancı nesneler sokulmamalıdır.
Planlı veya Plansız Hava Yolu İşlemleri Sırasında Kalıcı TEP
Tıkacının Yönetimi
Stomal manipülasyon içeren bir planlı (örn, isteğe bağlı) veya
plansız (örn, acil) hava yolu işlemi sırasında, cihaz çıkarılmamalıdır.
Cihaz yerinden çıkarsa, özofajeal içeriklerin aspirasyonunu
önlemek ve Kalıcı tıkacın daha sonraki bir zamanda takılabilmesini
sağlamak bakımından trakea ve özofagus arasındaki deliğin
korunması için, uyumlu çaptaki bir çok amaçlı kateter ile en kısa
zamanda değiştirilmelidir.
Bir tıbbi acil durumda boyundan nefes alıp verenler için standart
resusitasyon prosedürleri uygulanmalıdır.

20 | 37720-03F
Lütfen hastanızın boyundan nefes aldığını göstermek için bir tıbbi
uyarı bileziği veya kartı almasını sağlayın. Bu bilezik veya kart
açıkça görünen bir yerde tutulmalıdır.
Cihazın Çıkarılması
Kalıcı tıkaç üzerindeki ekli boyun bandı ancak özofagus
içindeki özofajiyal tutma anşı pozisyonu doğrulandıktan sonra
çıkarılmalıdır. Boyun bandı çıkarılmış bir Kalıcı tıkacı asla takmaya
veya yeniden takmaya çalışmayın.
İlk önce TE ponksiyonunu genişletmeden ve doğru cihaz
uzunluğunu teyit etmek için yolu yeniden ölçmeden, asla bir
Kalıcı tıkacı çıkarmayın ve başka bir tıkaç takmayın.
Hasta asla cihazı çıkarmaya çalışmamalı veya eğitim almış
nitelikli bir sağlık uzmanı dışında hiç kimsenin cihazı çıkarmasına
izin vermemelidir.
Kalıcı tıkaç, süresiz bir cihaz değildir ve periyodik olarak
yeniden yerleştirilmesi gerekir. Çoğu klinisyen 6 aydan uzun
olmamak üzere rutin takip değerlendirmeleri yapılmasını tavsiye
etmektedir. InHealth Technologies, Kalıcı TEP Tıkacının kullanım
ömrü ile ilgili olarak açık veya zımni herhangi bir garanti vermez.
Cihazın kullanım ömrü, kişisel kullanım ve biyolojik koşullara göre
farklılık gösterebilir.
Kalıcı tıkacın çıkarılması ancak cihazın dış trakeal anşının bir
kilitleme hemostatı ile güvenli bir şekilde kavranması suretiyle
yapılmalıdır. Cihaz tam olarak çıkana kadar hafçe ve sıkıca çekin.
Dikkat: Federal (ABD) kanunlar uyarınca, bu cihaz sadece bir
hekim veya lisanslı konuşma patoloğu tarafından veya bunların
talimatı ile satılabilir.
KOMPLİKASYONLAR
Blom-Singer tipi silikon cihazlarda nadir olsa da aşağıdaki
komplikasyonların ortaya çıktığı saptanmıştır. Bunlar: cihazın
çıkarılmasını ve/veya uygun antibiyotiklerin kullanımını
gerektirebilecek stoma kontaminasyonu veya sepsis; cihazın bir
hekim tarafından çıkarılmasını gerektirebilecek şekilde yanlışlıkla
hava yoluna aspirasyonu; cihazın TE ponksiyonunun dilatasyonu
ve stoma bakım rejiminin ek gözetiminden sonra yeniden
yerleştirilmesini gerektirecek şekilde zaman zaman yerinden