inhealth Blom-Singer HME/HumidiFilter User manual

R1
37602-01E
USER Instructions For Use
Blom-Singer®
HME/HumidiFilter®
System

2| 37602-01E
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-Singer ist eine eingetragene Handelsmarke der Hansa Medical Products, Inc.
InHealth Technologies ist eine eingetragene Handelsmarke von Helix Medical, LLC.
© 2014 Helix Medical, LLC (InHealth Technologies)
Blom-Singer es una marca registrada de Hansa Medical Products, Inc.
InHealth Technologies es una marca registrada de Helix Medical, LLC.
© 2014 Helix Medical, LLC (InHealth Technologies)
Blom-Singer est une marque déposée de Hansa Medical Products, Inc.
InHealth Technologies est une marque déposée de Helix Medical, LLC.
© 2014 Helix Medical, LLC (InHealth Technologies)
Blom-Singer è un marchio registrato di Hansa Medical Products, Inc.
InHealth Technologies è un marchio registrato di Helix Medical, LLC.
© 2014 Helix Medical, LLC (InHealth Technologies)
Blom-Singer is een geregistreerd handelsmerk van Hansa Medical Products, Inc.
InHealth Technologies is een geregistreerd handelsmerk van Helix Medical, LLC.
© 2014 Helix Medical, LLC (InHealth Technologies)
Blom-Singer é uma marca registrada da Hansa Medical Products, Inc.
InHealth Technologies é uma marca registrada da Helix Medical, LLC.
© 2014 Helix Medical, LLC (InHealth Technologies)
Blom-Singer je registrovaná ochranná známka společnosti Hansa Medical Products, Inc.
InHealth Technologies je registrovaná ochranná známka společnosti Helix Medical, LLC.
© 2014 Helix Medical, LLC (InHealth Technologies)
Blom-Singer jest zastrzeżonym znakiem towarowym rmy Hansa Medical Products, Inc.
InHealth Technologies jest zastrzeżonym znakiem towarowym rmy Helix Medical, LLC.
© 2014 Helix Medical, LLC (InHealth Technologies)
37602-01E Eective March 2014 / Gültig ab März 2014 / Efectivo a partir de marzo de
2014 / Date d’entrée en vigueur : mars 2014 / Valido da marzo 2014 / Met ingang van
maart 2014 / Vigente em de março de 2014 / V platnosti od března 2014 / Wchodzi w
życie w marcu 2014 r.

TABLE OF CONTENTS
37602-01E | 3
5
USER Instructions For Use
Gebrauchsanweisung für BENUTZER
Instrucciones para el USUARIO
Instructions d’utilisation destinées à L’UTILISATEUR
Istruzioni per l’uso destinate ALL’UTENTE
Gebruiksaanwijzing voor de GEBRUIKER
Instruções de uso para o USUÁRIO
Návod k použití pro UŽIVATELE
Instrukcja użytkowania dlaUŻYTKOWNIKA
Sistema de TCU/HumidiFilter® Blom-Singer®
Systém Blom-Singer®HME / HumidiFilter®
System HME/HumidiFilter®Blom-Singer®
Blom-Singer® HME/HumidiFilter®Systeem
HME/Systéme HumidiFilter®Blom-Singer®
Sistema HME/HumidiFilter® Blom-Singer®
Blom-Singer® HME/HumidiFilter®System
Sistema HME/HumidiFilter® Blom-Singer®
Blom-Singer®HME/HumidiFilter®System
19
36
52
68
84
100
116
131
Inhaltsverzeichnis / Índice / Sommaire / Sommario / Inhoud / Obsah / Spis treści
Blom-Singer jest zastrzeżonym znakiem towarowym rmy Hansa Medical Products, Inc.
InHealth Technologies jest zastrzeżonym znakiem towarowym rmy Helix Medical, LLC.
© 2014 Helix Medical, LLC (InHealth Technologies)
ENG
DEU
SPA
FRA
ITA
NLD
CES
POR
POL

4| 37602-01E

ENGLISH
37602-01E | 5
BLOMSINGER® HME/HUMIDIFILTER® SYSTEM
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.
Prior to having a laryngectomy, the air you breathe is warmed,
moistened and ltered by tissues in your nose and throat (heat
and moisture exchange) before it reaches your trachea and lungs.
The Blom-Singer HME System is designed to help laryngectomees
regain some of these lost functions. When placed over your
tracheostoma, the heat and moisture exchanger (HME) captures
warm and moist air as it is exhaled from your body. The cool, dry
air you breathe in passes through the HME where it is warmed
and moistened as it enters your body. To maintain a healthy
respiratory tract, it’s critical to breathe in air that is ltered and
contains the proper heat and moisture content. Clinical studies
report that using an HME provides improvements in shortness
of breath, fatigue and listlessness, sleep problems, anxiety and
depression. 3, 4, 5
Health Benets of the Blom-Singer HME/HumidiFilter
System
Daily, consecutive use of the Blom-Singer HME/HumidiFilter
System contributes to a healthier respiratory tract, restores airway
resistance, and helps to maintain optimal lung ventilation.1The
HME should be used every day for as long as possible to receive
the following benets from its use:
Reduced Mucus and Coughing
Studies indicate that patients who use a Blom-Singer HME
have experienced a 60% reduction in mucus when using the
device for at least seven consecutive days. This amount of time
is needed to allow the airway sucient time to recognize the
benets of the HumidiFilter. 1, 2
Increased Airway Resistance
Using an HME aids in resistance to the airway, a role normally
played by your nose. It is important for your lungs to benet

6| 37602-01E
from good airway resistance to supply your body with oxygen
eectively and eliminate carbon dioxide from your blood.
Daily use of an HME has been demonstrated to have a positive
eect on these important functions. 6, 7
Antibacterial Inhibition on the Filter
The HumidiFilter foam lter is treated with an agent to reduce
bacterial growth on the lter for a more hygienic environment.
Improved Quality of Life
Reduced mucus, less coughing, and improved voice quality
can increase your self-condence, and give you more freedom
in social situations by reducing the discomfort that comes
with feeling as though your condition is drawing unwanted
attention. 3, 4, 5
Your doctor will discuss with you the risks and benets of using
an HME System. The information in this manual is not intended
to be used in place of consultation or instructions of a medical
professional.
These devices should only be used by individuals who have
received proper training in the eective management and care
of Blom-Singer tracheostomal prosthetic devices. Management
includes, but is not limited to, handling of the device,
dislodgement of the device, and cleaning of the device.
These products are intended for use by a single patient only.
Note: the HME Cartridge may be used only once by one
patient. It may not be reused. See Warnings, Precautions and
Complications.
INDICATIONS
The Blom-Singer HME/HumidiFilter System is designed to provide
the laryngectomee with humidied, warmed, and ltered air
whether the patient is in dry or humid surroundings, indoor or
outside.
CONTRAINDICATIONS
The Blom-Singer HME/HumidiFilter System is a medical device
intended for use by individuals trained in the use of tracheostomal
prosthetic devices. These devices should not be placed over a
tracheostomal airway if their presence obstructs respiration.

Blom-Singer® HME / HumidiFilter® System
37602-01E | 7
HOW SUPPLIED
The Blom-Singer products for HME are available in several
options: as a HME Cartridge, a preassembled, daily, one-time
use, disposable device in a package of 30 HME cartridges; as
a HumidiFilter® Holder with HumidiFilter®foam lters that
requires assembly and is reusable (replacement HumidiFilter
foam lters available separately); and as an ASTV HumidiFilter®
Cap with ATSV HumidiFilter Cap foam lters for ASTV hands-free
device users that requires assembly and is reusable (replacement
ASTV HumidiFilter foam lters available separately).
Attachment of the HME/HumidiFilter System to the tracheostoma
is achieved through the use of a Blom-Singer tracheostoma
housing, supplied separately.
PRODUCT DESCRIPTION
The Blom-Singer HME/HumidiFilter System may be used by all
laryngectomees: esophageal speakers, electrolarynx users, and
tracheoesophageal voice prosthesis users.
Blom-Singer
HME System Pre-
assembled
One-
time
use
Use with
Tracheostoma
Housing 24 hr
HME Cartridge • • • •
Blom-Singer
HumidiFilter System
HumidiFilter Holder •
ATSV HumidiFilter Cap •
HumidiFilter Foam Filters •
HME Cartridge
The HME Cartridge (diagram 1) is a daily-disposable device,
designed for one-time use, that comes fully assembled and
attaches to a tracheostoma housing (TruSeal® adhesive housing
style recommended). It contains a HumidiFilter foam lter for heat
and moisture exchange (top view, diagram 1A-a); an EasyTouch
speech button (top view, diagram 1A-b) that makes stoma

8| 37602-01E
occlusion simple for talking; a MucusShield occluder (bottom
view, diagram 1B-a) to protect the HumidiFilter from mucus
secretions and provide an airtight seal closure (occlusion) for
speech; a nger-lip (side view, diagram 1C-a) for easy removal of
the HME cartridge from the tracheostoma housing for coughing
or cleaning. Front and side airow vents maximize airow for
unrestricted, easy breathing (side view, diagram 1C-b).
HumidiFilter Holder
The HumidiFilter Holder (diagram 4) is a reusable, lightweight
plastic holder that holds a HumidiFilter foam lter (diagram 5)
and attaches to a tracheostoma housing. Assembly required.
ATSV HumidiFilter Cap
The ATSV HumidiFilter Cap (diagram 7) is a reusable, twist-on
plastic cap that holds a HumidiFilter foam lter and ts over the
Blom-Singer Adjustable Tracheostoma Valve (ATSV) hands-free
device. Assembly required.
HumidiFilter Foam Filters
The disposable, one-time use HumidiFilter foam lter (diagram 5)
helps to create the exchange for heat and moisture. It is specially
treated with an antibacterial agent to reduce bacterial growth
on the HumidiFilter and a salt to hold heat and moisture. Consult
with your physician as individual reactions to these materials
may occur.
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.
If there are tears, cracks, or structural damage to the device,
discontinue use.
Extreme care should be used to avoid adhesive, adhesive remover,
protective skin barrier or fumes from entering the tracheostoma.
Breathing
Breathing through the HME device should be comfortable and
easy. If breathing is not easy, remove the HME device and consult
your medical professional for assistance.

Blom-Singer® HME / HumidiFilter® System
37602-01E | 9
When you begin using the Blom-Singer HME device, a slight
increase in airow resistance will be felt. This resistance is a
normal function of the HME device that may require some
getting used to.
Coughing
It is highly recommended that the HME Cartridge be removed
prior to coughing. The HumidiFilter Holder and ATSV with
HumidiFilter Cap must be removed prior to coughing.
Cleaning
Do not use solvents or petroleum-based products for cleaning
the device. These materials may damage the device.
Never clean or remove the HumidiFilter from the HME cartridge.
If the device should become heavily soiled, remove it and replace
it with a new HME cartridge. Never wash an HME cartridge with
water, soap, or cleaning agents.
Do not wash the specially treated HumidiFilter foam lter. It is
designed for single use only; do not reuse.
Never use facial or toilet tissue to dry a HME device as particles
of lint or fabric may be deposited onto the device that can be
inhaled into the airway upon reinsertion.
HumidiFilter Holder/ ATSV HumidiFilter Cap: Never clean the
HumidiFilter Holder/ ATSV HumidiFilter Cap, or replace the
HumidiFilter foam lter while the device is in position in the neck.
Always clean the HumidiFilter Holder/ ATSV HumidiFilter Cap, or
replace the HumidiFilter foam lter, after the device has been
removed from the stoma. The HumidiFilter foam lter should be
replaced daily.
Device Handling
Always handle the device with clean hands.
Be sure to wash hands after handling the HumidiFilter as it
contains substances that may be irritating to skin and eyes.
The package containing the HME cartridges and HumidiFilter
foam lters must be resealed after every opening to preserve the
eectiveness of the HumidiFilter.

10 | 37602-01E
Sleeping
The Blom-Singer HumidiFilter System must be removed before
sleeping to avoid the potential for airway obstruction.
COMPLICATIONS
The following complications have been identied to occur with
devices of this type, but are infrequent. They include:
• stoma contamination or infection which may require use of
appropriate antibiotics;
• skin irritation around the stoma;
• labored breathing, which may occur if the HumidiFilter foam
lter is clogged or if the HME cartridge/foam lter is not
changed regularly.
HME/HUMIDIFILTER SYSTEM DAILY USE AND CARE
INSTRUCTIONS
Please refer to the diagrams located at the back of this instruction manual.
Your clinician will instruct you on the routine use and care of the
Blom-Singer HME device.
Care should be exercised when inserting or removing HME
devices to avoid accidental displacement of the voice prosthesis
which could result in aspiration (inhalation) of the 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 HME device and user’s hands should always be thoroughly
clean to prevent contaminants from entering into the
tracheostoma, puncture, or esophagus.
Removal and attachment of any devices worn over the
tracheostoma should only be done with the user positioned in
front of a mirror with a bright light focused directly on the stoma.
Do not use solvents or petroleum-based products for cleaning
the device. These materials may damage the device.
A properly attached HME/HumidiFilter system provides an
airtight seal around the stoma. Before inserting an HME device,
a Blom-Singer tracheostoma housing must rst be attached to

Blom-Singer® HME / HumidiFilter® System
37602-01E | 11
the skin surrounding the tracheostoma. Follow the attachment
steps described in the Blom-Singer Tracheostoma Housings
Instructions For Use provided with the product.
The following procedural instructions are provided by Eric D. Blom, Ph.D.
HME Cartridge
The disposable HME cartridge is designed for daily, one-time
use. The HME cartridge should be replaced at least once a day to
maintain proper function of the HME system.
Before inserting an HME Cartridge apply a Blom-Singer
tracheostoma housing (TruSeal housing style recommended) to
the tracheostomal skin according to product instructions. Verify
that the housing is providing an airtight seal around the stoma.
1. With clean hands remove an HME Cartridge from its packaging.
Always reseal the package containing the HME Cartridges after
every opening to preserve the eectiveness of the HumidiFilters.
Should your hands come in contact with the HumidiFilter, be sure
to wash them as it contains substances that may be irritating to
skin and eyes.
Inspect the HME Cartridge for any structural damage, such as
cracks or tears; do not use a device that is damaged. Press down
on the top of the speech button to test that it is fully functional.
The speech button should depress when held down with a nger
and then instantly return to its open, breathing position when
released (diagram 3).
2. Insert the HME cartridge into the previously applied
tracheostoma housing and gently push the HME cartridge until
it snaps into place (diagram 2). A properly inserted HME cartridge
will sit ush and t snugly inside the housing.
Breathing through the HME cartridge should be comfortable
and easy. If breathing is not easy, remove the HME system and
consult your medical professional for assistance. When you begin
using the HME, a slight increase in airow resistance will be felt.
However, this resistance is a normal function of the device that
may initially require some getting use to. The HME cartridge also
contains side and top airow vents to maximize airow for easy
breathing and prevent breathing obstruction.

12 | 37602-01E
3. Tracheoesophageal speech is produced by pressing down
on the EasyTouch speech button (diagram 3a) with minimal,
manual force so that it closes to enable voicing. The ngertip
tactile response is immediate. You will feel the speech button is
completely closed, so you can speak with more condence. Upon
manual release, the EasyTouch speech button instantly returns to
its open, breathing position (diagram 3b). Users of other voicing
methods should follow the voicing instructions provided by their
medical professional.
Coughing/HME Cartridge Removal
It is highly recommended that the HME cartridge be removed
from the tracheostoma housing prior to coughing. To remove
the HME cartridge, hold down the housing with one hand while
grasping the nger-lip (diagram 1C-a) on the HME cartridge with
your other hand. Pull the HME cartridge carefully until it releases
from the housing. Be careful not to separate the housing from the
skin, which will cause air leakage around the stoma.
Cleaning
The HME cartridge may be wiped with a dry cloth if cleaning
is necessary. Never use facial or toilet tissue to dry the HME
cartridge as particles of lint or fabric may be deposited onto the
device that can be inhaled into the airway upon reinsertion. If
a HME cartridge should become heavily soiled, remove it and
replace with a new HME cartridge. Never wash an HME cartridge
with water, soap, or cleaning agents. Never clean or remove the
HumidiFilter from the HME cartridge.
HumidiFilter Holder
The HumidiFilter Holder is designed for repeated use. The
HumidiFilter foam lter should be replaced daily to maintain
proper function of the HumidiFilter system.
Before inserting a HumidiFilter Holder apply a Blom-Singer
tracheostoma housing to the tracheostomal skin according to
product instructions. Verify that the housing is providing an
airtight seal around the stoma.

Blom-Singer® HME / HumidiFilter® System
37602-01E | 13
HumidiFilter Holder Assembly
1. With clean hands remove the HumidiFilter Holder and
HumidiFilter foam lter from its packaging. Always reseal the
package containing the HumidiFilter foam lters after every
opening to preserve the eectiveness of the HumidiFilters.
Inspect the HumidiFilter Holder for any structural damage, such
as cracks or tears; do not use a device that is damaged.
2. Insert the HumidiFilter foam lter into the holder. The
HumidiFilter should lie at in the holder (diagram 6). Be sure
to wash hands after handling the HumidiFilter as it contains
substances that may be irritating to skin and eyes.
3. Insert the assembled HumidiFilter Holder into the previously
applied tracheostoma housing and gently push the holder until
it snaps into place. A properly inserted HumidiFilter Holder will
sit ush and t snugly inside the housing. You should be able
to breathe normally through the HumidiFilter. A slight increase
in airway resistance will be felt. Tracheoesophageal speech is
produced by temporarily blocking the stoma with a nger or
thumb. Users of other voicing methods should follow the voicing
instructions provided by their medical professional.
Removal and Cleaning
Remove the HumidiFilter Holder from the tracheostoma housing.
Pull the HumidiFilter out with forceps and discard. Retain the
HumidiFilter Holder for repeated use.
The HumidiFilter Holder should be cleaned with mild soap and
warm water on a regular basis and rinsed with water. It should be
dried with a lint-free material or air-dried. Never use facial or toilet
tissue to dry the HumidiFilter Holder as particles of lint or fabric
may be deposited onto the device that can be inhaled into the
airway upon reinsertion. Never clean the HumidiFilter Holder
while the HumidiFilter System is in position in the neck.
Always clean the HumidiFilter Holder after the Holder has been
removed from the tracheostoma housing.
Note: The HumidiFilter Holder must be removed from the
tracheostoma housing prior to coughing. Hold down the
housing with one hand while pulling the unit carefully until it
releases from the housing. Be careful not to separate the housing
from the skin, which will cause air leakage around the stoma.

14 | 37602-01E
Sleeping
The HumidiFilter Holder must be removed before sleeping in
order to avoid the potential for airway obstruction.
Replacing Foam Filters
First, remove the HumidiFilter Holder from the tracheostoma
housing. Pull the HumidiFilter out with forceps and discard. Refer
to HumidiFilter Holder assembly instructions. Do not wash the
specially treated foam lter! It is designed for single use only.
Be sure to wash hands after handling the HumidiFilter as
it contains substances that may be irritating to skin and eyes.
The HumidiFilter should be replaced daily. Never replace the
HumidiFilter while the HumidiFilter System is in position in
the neck. Always replace the HumidiFilter after the Holder has
been removed from the tracheostoma housing.
ATSV HumidiFilter Cap
The ATSV HumidiFilter Cap is designed for repeated use. The
HumidiFilter foam lter should be replaced daily to maintain
proper function of the HumidiFilter system.
Before inserting an ATSV HumidiFilter Cap apply a Blom-Singer
tracheostoma housing to the tracheostomal skin according
to product instructions. Verify that the housing is providing an
airtight seal around the stoma.
ATSV HumidiFilter Cap Assembly
1. With clean hands remove the ATSV HumidiFilter Cap and
HumidiFilter foam lter from its packaging. Always reseal the
package containing the HumidiFilter foam lters after every
opening to preserve the eectiveness of the HumidiFilters.
Inspect the HumidiFilter Cap for any structural damage, such as
cracks or tears; do not use a device that is damaged.
2. Insert the HumidiFilter foam lter (diagram 8a) under the
crossbar (diagram 8b) of the ATSV Diaphragm/Faceplate so
that one of the slits on the lter is lined up with one end of the
crossbar. Pull the HumidiFilter through so that the second slit is
lined up with the opposite end of the crossbar. Be sure to wash
hands after handling the HumidiFilter as it contains substances
that may be irritating to skin and eyes.

Blom-Singer® HME / HumidiFilter® System
37602-01E | 15
3. Place the ATSV HumidiFilter Cap (diagram 8c) over the crossbar
(diagram 8b) and rotate counterclockwise to lock it into position.
4. Insert the assembled ATSV/HumidiFilter Cap into the
previously applied tracheostoma housing and gently push
the unit until it snaps into place. A properly inserted ATSV/
HumidiFilter Cap will t squarely inside the housing (diagram 9).
You should be able to breathe normally through the device. A
slight increase in airway resistance may be felt. If breathing is not
easy, remove the HumidiFilter Cap and replace the HumidiFilter
foam if necessary. Refer to the Adjustable Tracheostoma Valve,
User Instruction For Use manual, for complete instructions on
how to properly use the ATSV for hands-free speech.
Removal and Cleaning
Remove the ATSV/HumidiFilter Cap from the tracheostoma
housing, then remove the HumidiFilter Cap by rotating the cap
clockwise and lifting it o from the diaphragm/faceplate. Pull the
HumidiFilter out with forceps and discard. Retain the HumidiFilter
Cap for repeated use.
The HumidiFilter Cap should be cleaned with mild soap and
warm water on a regular basis and rinsed with water. It should be
dried with a lint-free material or air-dried. Never use facial or toilet
tissue to dry the HumidiFilter Cap as particles of lint or fabric may
be deposited onto the device that can be inhaled into the airway
upon reinsertion. Never clean the HumidiFilter Cap while the
ATSV/HumidiFilter Cap is in position in the neck. Always clean
the HumidiFilter Cap after it has been removed from the ATSV.
Note: The ATSV and HumidiFilter Cap assembly must be
removed from the tracheostoma housing prior to coughing.
Hold down the housing with one hand while pulling the unit
carefully until it releases from the housing. Be careful not to
separate the housing from the skin, which will cause air leakage
around the stoma.
Sleeping
The ATSV and HumidiFilter Cap must be removed before
sleepingin orderto avoidthepotential forairwayobstruction.
Replacing Foam Filters
First, remove the ATSV/HumidiFilter Cap from the tracheostoma

16 | 37602-01E
housing. Then remove the HumidiFilter Cap by rotating the
cap clockwise and lifting it o from the diaphragm/faceplate.
Pull the HumidiFilter out with forceps from under the crossbar
and discard. Refer to HumidiFilter Cap assembly instructions.
Do not wash the specially treated foam lter! It is designed
for single use only. Be sure to wash hands after handling the
HumidiFilter as it contains substances that may be irritating to
skin and eyes. The HumidiFilter should be replaced daily. Never
replace the HumidiFilter while the ATSV/HumidiFilter Cap is
in position in the neck. Always replace the HumidiFilter after
the HumidiFilter Cap has been removed from the ATSV.
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, 9:30am–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 distributor
referral.
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]
RETURNED GOODS POLICY
All returned merchandise must have a Return Merchandise
Authorization number (RMA), and must be unopened and

Blom-Singer® HME / HumidiFilter® System
37602-01E | 17
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
Airway
The air passage by which air reaches the lungs.
Candida albicans
A yeast fungus that is a commonly occurring condition that can
infect the mouth or the skin and may multiply and overgrow on
to the voice prosthesis.
Clinician
A health professional, such as a physician, licensed speech-
language pathologist, or nurse who is involved in clinical practice.

18 | 37602-01E
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.
Respiration
The act or process of inhaling and exhaling; breathing; moving air
into and out of the lungs. Also called ventilation.
Respiratory Tract (laryngectomee)
The air passage from the tracheostoma to the air sacs of the
lungs, including the trachea, and bronchi through which air
passes during breathing.
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.

DEUTSCH
37602-01E | 19
BLOMSINGER® HME//HUMIDIFILTER® SYSTEM
Einführung
Siehe Diagramme auf der Rückseite dieser Gebrauchsanweisung.
Am Ende dieses Kapitels bendet sich ein Glossar.
Vor einer Laryngektomie wird die Atemluft durch Gewebe in
der Nase und im Rachen angewärmt, angefeuchtet und geltert
(Wärme- und Feuchtigkeitsaustausch), bevor sie die Luftröhre
und die Lunge erreicht. Das Blom-Singer HME-System dient
dazu, laryngektomierten Patienten wieder zu einigen dieser
eingebüßten Funktionen zu verhelfen. Wenn der Wärme- und
Feuchtigkeitsaustauscher (HME) über demTracheostoma platziert
wird, fängt er die warme und feuchte Luft auf, die aus dem Körper
ausgeatmet wird. Die eingeatmete kühle, trockene Luft strömt
durch den HME, wo sie beim Eintritt in den Körper angewärmt
und angefeuchtet wird. Damit die Atemwege gesund bleiben, ist
es entscheidend, gelterte Luft mit der richtigen Wärme und dem
richtigen Feuchtigkeitsgehalt einzuatmen. Klinischen Studien
zufolge bewirkt ein HME Verbesserungen bei Kurzatmigkeit,
Fatigue und Apathie, Schlafstörungen, Angst und Depression. 3, 4, 5
Gesundheitlicher Nutzen des Blom-Singer HME/
HumidiFilter Systems
Die tägliche, fortlaufende Benutzung des Blom-Singer HME/
HumidiFilter Systems trägt zu einem gesünderen Atemtrakt bei,
verbessert die Widerstandskraft der Atemwege und unterstützt
eine optimale Lungenatmung.1Der HME sollte täglich so lange
wie möglich angewandt werden, um folgenden Nutzen zu
erhalten:
Weniger Schleimbildung und Husten
Studien zufolge wurde bei Patienten, die einen HME
mindestens sieben Tage hintereinander verwendeten, ein
Rückgang der Schleimbildung von 60% festgestellt. Diese Zeit
ist notwendig, damit sich die Atemwege auf die Vorteile des
HumidiFilters einstellen können. 1, 2

20 | 37602-01E
Erhöhte Widerstandskraft der Atemwege
Ein HME erhöht die Widerstandsfähigkeit der Atemwege,
indem er die normalerweise durch die Nase gespielte Rolle
übernimmt. Für die Lunge ist eine gute Widerstandsfähigkeit
der Atemwege wichtig, damit sie den Körper eektiv mit
Sauersto versorgen und Kohlendioxid aus dem Blut
entfernen kann. Es hat sich erwiesen, dass die tägliche
Nutzung eines HMEs eine positive Auswirkung auf diese
wichtigen Funktionen hat. 6, 7
Antibakterielle Wirkung des Filters
Der HumidiFilter Schaumsto-Filter ist mit einem Wirksto
behandelt, der das Bakterienwachstum auf dem Filter hemmt
und so für ein hygienischeres Umfeld sorgt.
Verbesserte Lebensqualität
Verminderte Schleimbildung, weniger Husten und eine
verbesserte Stimmqualität können das Selbstbewusstsein
heben und mehr Freiheit in gesellschaftlichen Situationen
verschaen, indem das unangenehme Gefühl reduziert wird,
dass der Gesundheitszustand möglicherweise unerwünschte
Aufmerksamkeit auf sich zieht. 3, 4, 5
Ihr Arzt wird mit Ihnen über die Risiken und Vorteile der
Verwendung eines HME-Systems sprechen. Die Informationen in
diesem Handbuch sollen keine Konsultation oder Anweisungen
einer medizinischen Fachkraft ersetzen.
Diese Produkte dürfen nur durch Personen benutzt werden, die
eine ordnungsgemäße Schulung für den eektiven Umgang
mit und die eektiven Pege von Blom-Singer prothetischen
Vorrichtungen erhalten haben. Unter Umgang sind insbesondere
der Gebrauch, die Dislokation und das Reinigen des Produkts zu
verstehen.
Diese Produkte sind nur für den Gebrauch durch einen
einzigen Patienten bestimmt. Hinweis: die HME-Kassette ist
nur für den Einmalgebrauch durch einen einzigen Patienten
vorgesehen. Sie darf nicht wiederverwendet werden. Siehe
Warnhinweise, Vorsichtsmaßnahmen und Komplikationen.