Atos Medical PROVOX FreeHands HME Series User manual

© Atos Medical AB, 200704A, REF 90750
Atos Medical AB
P.O. Box 183, SE-242 22 Hörby, Sweden
Tel: [phone] • Fax: [phone]
[email protected] • www.atosmedical.com
Instructions for use
90750 200704A

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SUOMI.......................................... 126-136
DEUTSCH .................................... 16-29
NEDERLANDS............................. 30-41
FRANÇAIS................................... 42-54
ITALIANO..................................... 55-67
ΕΛΛΗΝΙΚΆ................................... 137-151
TÜRKÇE....................................... 152-162
NORSK......................................... 115-125
DANSK......................................... 104-114
SVENSKA .................................... 93-103
PORTUGUES............................... 81-92
ESPAÑOL .................................... 68-80
ENGLISH...................................... 4-15

4
Contents index
General Information ..................4-8
Clinicians....................................9-11
Patients.......................................12-15
GENERAL
Provox®FreeHands HME®
- Instructions for Use
General Instructions
These Instructions for Use contain information for the
clinician and the user. Read this information carefully
each time a Provox®FreeHands HME®is provided.
There may be new information. This information is
not intended to take the place of discussions between
clinician and user. Make sure any questions you may
have about the use of the Provox®‚ FreeHands HME®
are answered.
Before Use
Before the device can be used for the rst time, the
proper function of the cough-relief valve must be
checked and adjusted if necessary, and the right speech
valve membrane chosen by a clinician trained in voice
and pulmonary rehabilitation. Readjustment to indi-
vidual conditions may be needed from time to time. A
check-up after some weeks of use is recommendable.
Prior to each use, inspect the product to ensure
it is undamaged and that all parts and accessories are
complete and in proper condition. Do not use the prod-
uct if any components show signs of cracking or other
structural damage.
Product description
The product consists of two functional units that work
together:
• a Provox®FreeHands speech valve unit in a reusable
housing, containing two independent valves: an internal,
exchangeable valve membrane (speaking valve) and a
hinged valve on the top (cough-relief valve)
• a disposable Provox®FreeHands HME®Cassette, which
has to be connected to the lower part of the valve hous-
ing before it is ready to use.

5
GENERAL
After proper adjustment and attachment of speech
valve unit and HME cassette, the completed Provox®
FreeHands HME®is inserted into either Provox®
Adhesive base plate or Provox®LaryTube with ring.
(The latter is not included in the package.)Accessories
included with the Provox®FreeHands HME®are:
• five disposable Provox®FreeHands HME®Cas-
settes
• two Provox®XtraBase®Adhesives base plates
• a safety screwdriver for the adjustment of the cough-
relief valve
• a plastic forceps for replacement of the speech valve
membrane
• two extra speech valve membranes: “light” (white
dot) and “strong” (green dot). The “medium” mem-
brane (blue dot) is already mounted in the valve.
• a plastic cleaning and storage box for the reusable
valve unit
• one package of Skin-Prep™wipes
• Instructions for Use
How does the Provox®FreeHands HME®work?
The speech valve unit allows hands-free tracheostoma
occlusion for voice prosthesis users.
The speech valve closes as exhalation pressure is
increased briey, just as it increases when one starts
to talk loudly in normal laryngeal speech. If the ex-
halation pressure does not increase rapidly, the valve
stays open and allows normal breathing.
Once the valve is closed, a small magnet holds it
in the closed position. There is no need to maintain
high air pressure in the trachea/windpipe in order to
keep the valve closed.
When the pressure in the trachea/windpipe drops to
a very low level, or during inhalation, the valve opens
and allows free breathing again.
There are two valve positions, which can be ad-
justed by simple rotation of the valve housing. The
“speaking position” (On) allows the automatic change
between stoma closure and normal breathing as de-
scribed above. The “breathing position” (Off) allows
a higher airow without closing the valve. This is
also achieved by the use of two magnets, which keep
the valve open despite the increased airow during
physical activity.
The cough-relief valve helps reduce the risk of
trauma to the airways, which might occur due to
sudden pressure increases while coughing. The cough-
relief valve also helps to diminish the pressure on the
Adhesive and, thus, premature loosening of the airtight
stoma seal. The pressure (cough intensity) needed to

6
GENERAL
open the cough-relief valve can be adjusted individu-
ally with the included screwdriver before the Provox®
FreeHands HME®is put in place.
The HME unit of the Provox®FreeHands HME®is
a full heat-and-moisture-exchanger, which is used for
partial restoration of the lost upper airway functions.
It also separates the speech valve from direct contact
with the airway and, thus, prevents mucous from being
coughed into the valve part of the device. It also reduces
the risk of inhalation of small particles, e.g. coming from
a defective valve.
Technical Data
Pressure drop at 30 l/min:
81 Pa (0,83 cmH2O)
Pressure drop at 60 l/min:
242 Pa (2,47 cmH2O)
Moisture Loss: at 500 ml tidal volume
19,1 mg/l
(according to ISO 9360-2; 2001)
Indications
The Provox®FreeHands HME®is an accessory to pros-
thetic vocal and pulmonary rehabilitation after a total
laryngectomy. It is designed to allow automatic trache-
ostoma closure (instead of digital stoma occlusion) for
voice prosthesis users (e.g. Provox®‚ Voice Prosthesis),
while providing heat-and-moisture-exchange (HME)
for pulmonary rehabilitation.
The device should be adjusted for the end user by a
clinician trained in voice and pulmonary rehabilitation,
e.g. a speech pathologist, before it can be used without
supervision.
THE PROVOX®FREEHANDS HME®IS INTENDED
FOR SINGLE PATIENT USE.
Contraindications
The device must not be used if there is no properly func-
tioning voice prosthesis in place or if the laryngectomee
is unable to speak with such a device. The user must be
able to produce intelligible voicing by means of digital
stoma occlusion. Consequently, all contraindications
for prosthetic voice rehabilitation also contraindicate
the use of a Provox®FreeHands HME®. Absolute and
relative contraindications for prosthetic voice rehabilita-
tion include, but are not limited to: Radiotherapy doses
greater than 70 Gy in 7 weeks, poor overall physical
condition, heart insuff iciency, coagulopathy or anti-
coagulant therapy, mental diseases, hypersensitivity to
the material of the voice prosthesis.

7
GENERAL
Allergy or hypersensitivity against any of the fol-
lowing materials contraindicates the use of the Provox®
FreeHands HME®: metals, polycarbonate, compound
thermoplastics and silicone.
Lung emphysema, asthma and other pulmonary
diseases, which affect lung capacity, are contraindica-
tions for breath-controlled automatic speech valves.
Patients suffering from such diseases should only use
the Provox®FreeHands HME®if it has been determined
by their physician that the benets of the device clearly
outweigh the risk of its use.
The stoma size and the condition of the peristomal
skin may be factors contraindicating the use of the de-
vice and its required accessories. A stoma, which is too
small can limit the inhaled airow and thereby lead to
too low a tidal volume. Hypersensitive skin may make
it impossible to attach the valve properly.
Warnings
Always assemble the device (HME cassette and valve
unit) before use. Using not properly assembled or single
device components may increase the risk of aspiration
of these components or device fragments, e.g. of lose
magnets in the case of a speech valve unit defect. Us-
ing the Provox®FreeHands HME®Cassette without
the valve unit may lead to aspiration of the cassette
or parts of it.
If the connection between the speech valve
unit and HME cassette becomes loose during use
or removal of the device, the HME cassette must be
removed from the tracheostoma only by removing the
complete Adhesive base plate from the skin. No other
manipulation must be done in such situation, in order
not to increase any risk of aspiration.
Excessive coughing-up of mucus may suddenly
block or nearly block your airway. Make sure you
always have the possibility to remove the device quickly
from your tracheostoma if needed.
Do NOT remove the foam from the Provox®Free-
Hands HME® Cassette. Removal of the foam eliminates
the physiologically needed HME features, damages the
valve due to direct mucus contact and increases risks for
the user, including the risk of incidental loss of small
device parts and the risk of aspiration.
Do NOT reuse the foam, e.g. by washing out.
Doing so eliminates the calcium chloride needed for a
sufcient humidity exchange and can increase the risk
of infection.
Do NOT wear the Provox® FreeHands HME® while
sleeping. Instead, use a Provox®HME Cassette with a
digitally operated speech valve (picture P19) or use the

8
GENERAL
accessory Provox®HME Cap (REF 7730) with a Provox®
FreeHands HME®Cassette (see Accessories).
The device is NOT MRI-compatible and must
NOT be worn during radiotherapy or x-ray.
Precautions
Handle the device with care.
Use only the recommended cleaning solutions/tab-
lets for cleaning and care. We recommend commercially
available denture cleaning tablets.
Never use oil-based detergents, boil or sterilize the
device, since this might destroy the valve.
For adjustment of the valve, i.e. the exchanging the
speech valve membrane or adjusting the cough valve
magnet, only use the Adjustment Kit (plastic forceps
and safety screwdriver) provided with the Provox®
FreeHands HME®.
Adverse Events
The patient should watch for any change in the stoma
tissue, the tissue around the voice prosthesis, increasing
difculties in breathing, or similar symptoms. If any
of these symptoms or any other difculties possibly
related to the use of the device occur, a clinician should
be consulted.
Some patients may experience a reaction to the
Provox®Adhesive. Discontinue use of Adhesive until
the reaction resolves. The use of Provox®OptiDerm
(hydrocolloid) Adhesive, skin protection with Skin-
Prep™or wearing a LaryTube may reduce the risk of
such reactions.
Device Lifetime Expectation
The HME should be replaced at least every 24 hours
or as often as needed when the HME is blocked by
mucous, etc.
Device ageing and long-term usage of the reus-
able valve unit may lead to improper valve function.
Symptoms for a worn-out Speech Valve Membrane can
include delayed closing and / or opening, air leaks and
increased closing sound. Symptoms for a defective valve
housing include mechanical defects and / or changes in
the cough-relief valve function.
Regular conditions provided, the Speech Valve
Membranes withstands a minimum of 6 months use,
and the valve housing of 12 months use. Proper han-
dling, cleaning and storage according to the instructions
further below are important factors to maintain the
device function.
Speech Valve Membranes for replacement are sepa-
rately available (REF 7713, 7714 and 7715).

9
CLINICIANS
Atos Medical makes no warranty as to the lifetime of
the device, which may vary with individual use and
biological conditions.
Instructions for the Clinician
See also the illustrations for clinicians at the back of the
manual [C1 through C17].
If you are a patient, please refer to “Instructions for the
Patient” further below.
Adjustment
STEP 1 – PREPARATION OF THE STOMA
Carefully clean and dry the skin around the stoma
using Provox®Cleaning Towel or water and a mild
soap. Make sure that the skin is dry before proceeding
[picture C1]
Apply Skin-Prep™to the skin around the stoma
before you put on the Adhesive to enhance the stick-
ing properties of the Provox®Adhesive. Let it dry for
about 30 seconds and then apply the Adhesive base
plate. [picture C2]
Provox®Silicone Glue (REF 7720), can be used to
prepare the skin before applying the Adhesive base
plate, thus providing a better seal. (The silicone glue
is not included in the Provox®FreeHands HME®pack-
age.)
STEP 2 – PREPARATION OF THE DEVICE
Place a Provox®FreeHands HME® Cassette on a at
surface, with the plastic grid down and the open foam
surface on top. Place the valve housing on top of the
HME Cassette and push it down until it clicks, and the
Cassette is tightly xed to the housing. Check the proper
t manually. [picture C3]
Hold the device with the HME Cassette facing away
from you. When looking at the top of the speech valve
unit, twist the housing counter-clockwise until it stops.
The valve is now in the “breathing position” (OFF).
[picture C4]
STEP 3 – INSERTION AND ADHESIVE SEAL
Insert the Provox®FreeHands HME®into the Provox®
Adhesive base plate and ask the patient to breathe
normally. [picture C5]
Inspect the Adhesive seal. There should be no leak-
age. This can be achieved by massaging the Adhesive
base plate onto the skin. If there is still leakage, a new
Adhesive base plate should be used and carefully ap-

10
CLINICIANS
plied to the skin. Skin-Prep™and silicone glue can be
used to enhance the seal of the Adhesive base plate.
[picture C6]
STEP 4 – SELECTION OF
THE SPEECH VALVE MEMBRANE
Turn the valve “ON” to the “speaking position” (clock-
wise, if the patient is sitting opposite you), [picture
C7].
After a short time of adaptation and maybe some
attempts, starting with low pressure, the patient should
be able to speak “hands-free” without too much effort,
[picture C8]. If this is achieved, proceed to step 6.
The valve originally comes with the medium (blue
dot) membrane in place, to allow in many cases for
immediate use without further adaptation.
If this fails, consider the following possibilities:
A) The valve closes too late, too briey or not prop-
erly, allowing air to leak along the valve. The voice is
weak and speaking is possible only for a very short
time and much effort: Go to step 5 and chose a valve
membrane with higher exibility, which is easier to
close (light or medium, respectively).
B) The valve closes too easily, e.g., it sometimes
closes as a result of deep breathing. Go to step 5 and
chose a valve membrane with lower exibility (strong
or medium, respectively).
C) The cough-relief valve opens during speech as
might happen with patients used to other, conventional
valve systems. Go to step 6, adjust the cough-relief
valve, and repeat step 4.
STEP 5 – REPLACEMENT OF
THE SPEECH VALVE MEMBRANE
If the membrane has to be replaced, use only the plastic
forceps provided with the device for manipulation, in
order to avoid damaging the membrane. [picture C9
and C10]
Lift the cough-relief valve (lid) with your ngers and
hold it open. [picture C11]
Grasp the membrane next to the xation point and
pull it out. [picture C12]
Hold the cough-relief valve open and insert the new
membrane by grasping it next to the xation point and
pushing it in. [picture C13]
STEP 6 – ADJUSTING THE COUGH-RELIEF VALVE
Once the speech valve membrane has been chosen,
the patient should be asked to cough with increasing
force. The valve should open as soon as the pressure
increases to a level of discomfort during the cough.

11
CLINICIANS
Properly adjusted, it should not open during loud speech.
During both speaking and coughing, the cough-relief
valve should allow the Provox®Adhesive to remain in
an airtight position. [picture C14]
The default setting of the cough-relief valve is at a
medium opening force. However, because of individual
differences, it is adjustable in order to keep the valve
closed even during loud speech and to permit the valve
to open instantly during a sudden cough.
To adjust the cough-relief valve, remove the Provox®
FreeHands HME®from theAdhesive base plate and hold
it with the HME part facing to you. [picture C15]
Locate the position of the cough-relief valve magnet
(below the point on the top of the cough-relief valve)
and, using only the safety screwdriver provided with
the device, push the HME foam to the side, enough to
see and reach the magnet screw in the valve housing.
[picture C16]
The magnetic force of the valve can now be made
stronger (by turning the screw clockwise) or weaker
(by turning the screw counter-clockwise). Start with an
adjustment of about 90°. [picture C17]
Stop immediately if resistance is felt while turn-
ing the screw, otherwise you can damage the valve
irreparably.
STEP 7 – INSTRUCTING THE PATIENT
The patient should be instructed on the proper use and
daily care of this device as described below. This manual
must be given to the patient.
Cleaning the Device
REMOVAL OF THE PROVOX®FREEHANDS
HME CASSETTE
See step 5 in the Instructions for the Patient
NORMAL CLEANING OF THE REUSABLE
SPEECH VALVE UNIT
See step 6 in the Instructions for the Patient
Disinfecting the Device
The Provox®FreeHands HME®is intended for single
patient use. However, should disinfection become
necessary, use the following procedure:
Cleaning prior to disinfection
Use the cleaning container, which comes with the
Provox®FreeHandsHME®.
Remove the speech valve membrane from the valve
unit.

12
PATIENTS
Fit the valve unit onto the holder, the lid must be
open.
Fill the cleaning container with a solution of luke-
warm tap water and a commercially available denture
cleanser tablet.
Immerse the membrane and the valve (attached to
the holder) for 10 to 15 minutes (read instructions of
the denture cleanser). The container may be shaken to
facilitate cleaning.
Rinse the valve, membrane and container carefully
under tap water.
Shake off the water.
Chemical Disinfection
Fill the container with fresh 70% Ethanol, minimum
temperature 18° C / 65° F.
Immerse the valve (with open lid) and membrane.
Shake the container for a short time and let all soak for
a minimum of 30 minutes.
Tip out the Ethanol and let the valve, membrane and
container air-dry.
Storage
Put valve and membrane into the cleaning container and
leave that closed until the next use.
Instructions for the Patient
See also the illustrations for patients at the front of the
manual [P1 through P18].
This patient section of the Instructions for Use de-
scribes the more regular (every-day) use of the Provox®
FreeHands HME®. For all general information, e.g.,
Product Description, Indications, Contraindications,
Warnings andAdverse Events, Device Lifetime Expec-
tation, please review the general information section at
the beginning of this manual.
Please make sure that you are fully instructed and
that your clinician has adjusted the device, prior to
starting to use the Provox®FreeHands HME®. In case of
any problems possibly related to the use of the Provox®
FreeHands HME®, please consult your clinician.
STEP 1 – PREPARATION OF THE STOMA
Carefully clean and dry the skin around the stoma
using Provox®Cleaning Towel or water and a mild
soap. Make sure that the skin is dry before proceeding
[picture P1]
Apply Skin-Prep™to the skin around the stoma

13
PATIENTS
before you put on the Adhesive to enhance the stick-
ing properties of the Provox®Adhesive. Let it dry for
about 30 seconds and then apply the Adhesive base
plate. [picture P2]
Provox®Silicone Glue (REF 7720), can be used to
prepare the skin before applying the Adhesive base
plate, thus providing a better seal.
STEP 2 – PREPARATION OF THE DEVICE
Place a Provox®FreeHands HME® Cassette on a at
surface, with the plastic grid down and the open foam
surface on top. Place the valve housing on top of the
HME Cassette and push it down until it clicks, and the
Cassette is tightly xed to the housing. Check the proper
t manually. [picture P3]
Hold the device with the HME Cassette facing away
from you. When looking at the top of the speech valve
unit, twist the housing counter-clockwise until it stops.
The valve is now in the “breathing position” (OFF).
[picture P4]
STEP 3 – INSERTION AND ADHESIVE SEAL
Insert the Provox®FreeHands HME®into the Provox®
Adhesive base plate (REF 7251-56, 7265) and breathe
normally. [picture P5]
Inspect the Adhesive seal with means of a mirror.
There should be no leakage. This can be achieved by
massaging the Adhesive base plate onto the skin. [pic-
ture P6] If there is still leakage, a new Adhesive base
plate should be used and carefully applied to the skin.
Skin-Prep™and Provox®Silicone Glue can be used to
enhance the seal of the Adhesive base plate. (The sili-
cone glue is not included in the package.)
STEP 4 – USING THE VALVE
ON (= automatic function; i.e., the valve lets you
breathe and talk)
To switch the valve ON, twist the housing of the
device in the opposite direction as in step 2, until you
feel it stop, [picture P7]. You should now try to speak
some words, beginning with low volume and pressure.
In case you feel increased breathing resistance after
coughing, you may have to take out the whole device
for wiping the mucous away, or to replace the HME
cassette with a new one.
OFF (= only breathing possible; for use e.g. during
harder physical activities)
For heavier breathing turn the valve into the OFF
position (like in step 2, you can do that while the valve
is attached to the stoma). [picture P8]. This should avoid
unwanted valve closure and also minimize the breathing

14
resistance as much as possible.
STEP 5 – REMOVAL OF THE
PROVOX®FREEHANDS HME®CASSETTE
The HME cassette should be replaced at least every 24
hours or as often as needed when the HME is blocked
by mucous, etc.
Take the Provox®FreeHands HME®out of the Adhe-
sive base plate. [picture P9]
Hold the housing with one hand and compress the
HME part with a little force, at a place where no crossbar
touches the outer rim. [picture P10] The Provox®Free-
Hands HME®Cassette will be deformed during this step
and come loose from the valve housing. [picture P11]
The cassette must be thrown away. [picture P12] But
the reusable speech valve unit is cleaned and prepared
for its next use (step 6).
STEP 6 – CLEANING THE REUSABLE
SPEECH VALVE UNIT
Use the cleaning container, which comes with the Pro-
vox®FreeHands HME®.[picture P13]
Fit the valve unit onto the holder, the lid must be
open. [pictures P14 and P 15]
Fill the cleaning container with a solution of luke-
warm tap water and a commercially available denture
cleanser tablet.
Immerse the valve (attached to the holder) for 10 to
15 minutes (read instructions of the denture cleanser).
[picture P16] The container may be shaken to facilitate
cleaning.
Rinse the valve and container carefully under tap
water. [picture P17]
Shake off the water.
Leave the valve in the holder of the container lid and
let it air dry before the next use. [picture P18]
Caution: Never use oil-based detergents, do not
boil or sterilize the device, since this might destroy
the valve.
Replacement of the speech valve membrane
If the membrane has to be replaced, please refer to step
5 in “Instructions for Clinicians”. In case you’d like to
change to another type of membrane, please consult
your clinician to adjust the valve properly.
Adjustment of the cough-relief valve
In order to ensure a proper valve function, your clinician
should do this adjustment.
Accessories: Provox®HME Cap (REF 7730)
The Provox HME Cap is a dome-shape titanium
PATIENTS

15
ring that allows you to use the special HME cassettes
of Provox FreeHands HME®(REF 7712) without a
FreeHands valve unit. This is especially of advantage,
if you want to continue HME use during the night but
have no other HME cassettes available than FreeHands
HME® cassettes. Read instructions.
PATIENTS

16
Inhalt
Allgemeine Information.............16-21
Arzt/Logopäde ...........................22-25
Patient.........................................26-29
ALLGEMEINES
Provox®FreeHands HME®
– Anwendungshinweise
Allgemeines
Diese Anwendungshinweise enthalten Informationen
für den Arzt / Logopäden sowie den Patienten. Lesen
Sie bitte diese Informationen jedes Mal vorAnwendung
eines neuen Provox®FreeHands HME®sorgfältig durch.
Sie könnten Angaben zu neuen Erkenntnissen enthal-
ten. Diese Informationen ersetzen nicht das Gespräch
zwischen Arzt / Logopäde und Patient. Klären Sie alle
offenen Fragen über das Provox®FreeHands HME®.
Vor der Verwendung
Vor der ersten Verwendung muss die ordnungsgemäße
Funktion des Hustenventils überprüft und – falls not-
wendig – eingestellt werden. Weiterhin muss durch
medizinisches Personal mit Erfahrung im Bereich
Stimm-/Lungenrehabilitation bestimmt werden, welche
der mitgelieferten Sprechventilmembranen eingesetzt
werden soll.Von Zeit zu Zeit kann es notwendig werden,
diese Einstellung/Entscheidung individuell anzupassen.
Nach einigen Wochen der Verwendung wird eine Kon-
trolle empfohlen.
Überprüfen Sie vor der Verwendung, dass das Pro-
dukt unbeschädigt ist und dass alle Teile und alles Zu-
behör vollständig und in einwandfreiem Zustand sind.
Benutzen Sie das Produkt nicht, falls eine oder mehrere
Komponenten zerbrochen oder beschädigt sind.
Produktbeschreibung
Das Produkt besteht aus zwei Funktionseinheiten, die
zusammenwirken:
• Provox®FreeHands Sprechventil in einem wieder-
verwendbaren Gehäuse mit zwei voneinander unab-
hängigen Ventilen: einer internen, auswechselbaren
Sprechventilmembran und einem an der Oberseite mit
einem Scharnier befestigten Ventil (Hustenventil)

17
ALLGEMEINES
• Provox FreeHands HME®-Cassette (HME: Heat
and Moisture Exchanger = Wärme- und Feuchtig-
keitstauscher) zur einmaligen Verwendung (wird vor
Verwendung des Sprechventils mit dem unteren Teil
des Sprechventilgehäuses verbunden).
Nach bestimmungsgemäßer Anpassung und Zu-
sammensetzen des FreeHands Sprechventils und der
FreeHands HME®-Cassette wird das komplette Provox®
FreeHands HME®entweder in eine Provox Adhesive
Basisplatte oder in eine Provox®LaryTube mit blauem
Ring (nicht im Lieferumfang enthalten) in Verbindung
mit einer Provox-Adhesive Basisplatte.
Folgende Komponenten sind im Lieferumfang des
Provox®FreeHands HME®enthalten:
• fünf Provox®FreeHands HME®-Cassetten zur einma-
ligen Benutzung
• zwei Provox®HME-Adhesive Basisplatten XtraBase®
• ein Sicherheits-Schraubendreher zum Einstellen des
Hustenventils
• eine Kunststoff-Pinzette zum Ersetzen der Sprech-
ventilmembran
• zwei Ersatz-Sprechventilmembranen: „leicht“ (wei-
ße Markierung) und „stark“ (grüne Markierung). Im
Gehäuse bendet sich die „mittlere“ Membran (blaue
Markierung).
• eine Reinigungs- undAufbewahrungsdose aus Kunst-
stoff für das wiederverwendbare Ventil
• eine Packung Skin-Prep™Hautreinigungstücher/Haft-
vermittler
• Anwendungshinweise
Funktionsweise des Provox®FreeHands HME®
Das Provox®FreeHands HME®ermöglicht Stimmpro-
thesenträgern einen ngerfreien Stomaverschluss beim
Sprechen.
Das Sprechventil schließt, wenn der Druck der
Ausatemluft kurzfristig erhöht wird, so wie dies bei der
herkömmlichen Sprache der Fall ist, wenn man lauter
spricht. Wenn der Druck der Ausatemluft nicht schnell
erhöht wird, bleibt das Ventil offen und es kann normal
geatmet werden.
Ist das Sprechventil geschlossen, hält es ein kleiner
Magnet in dieser Position.Dies ermöglicht eine ver-
gleichsweise lange Phonationsdauer, selbst dann noch,
wenn der Ausatemdruck langsam abnimmt. Um das
Ventil geschlossen zu halten, ist es daher nicht nötig
einen hohen Luftdruck aufrechtzuerhalten.
Sobald der Druck in der Trachea auf einen, sehr ge-
ringenWert abfällt, oder während des Einatmens, öffnet
das Ventil und erlaubt wieder freies Atmen.

18
ALLGEMEINES
Das Provox FreeHands HME®kann durch einfaches
Verdrehen des Ventilgehäuses auf zwei verschiedene
Positionen (Sprechposition und Atemposition) einge-
stellt werden. Die „Sprechposition“ ermöglicht den
automatischen Wechsel zwischen Stomaverschluss und
normalerAtmung wie oben beschrieben. Die „Atempo-
sition“ ermöglicht kräftiges Atmen, d.h. der Ventilme-
chanismus wird selbst durch erhöhten Ausatemdruck
nicht aktiviert. Dies wird durch zwei Magnete erreicht,
die das Ventil in dieser Stellung auch während eines
erhöhten Luftdurchusses bei erhöhter körperlicher
Aktivität offen halten.
Das Hustenventil minimiert das Risiko von Ver-
letzungen der Luftwege, die beim Husten aufgrund
einer plötzlichen Erhöhung des Luftdruckes u.U.
entstehen können. Das Hustenventil verhindert auch
übermäßigen Druck auf die Adhesive Basisplatte und
damit eine frühzeitige Ablösung der Stoma-Abdich-
tung. Der Druck (Hustenintensität), der zum Öffnen
des Hustenventils benötigt wird, kann vor Einsetzen
des Provox®FreeHands HME®individuell mit dem im
Lieferumfang enthaltenen Sicherheits-Schraubendreher
eingestellt werden.
Der im Provox®FreeHands enthaltene HME ist ein
vollwertiger Wärme- und Feuchtigkeitstauscher, der zur
teilweisen Wiederherstellung der Funktionen der oberen
Luftwege verhilft. Weiterhin dient er als Barriere zwi-
schen Luftweg und Ventil, wodurch kein Hustensekret in
dasVentil gelangen kann. Ferner minimiert der HME im
Falle eines beschädigten Sprechventils das Risiko einer
versehentlichen Aspiration kleinster Ventilpartikel.
Technische Daten
Druckabfall bei 30 l/min:
81 Pa (0,83 cmH2O)
Druckabfall bei 60 l/min:
242 Pa (2,47 cmH2O)
Feuchtigkeitsverlust: bei 500 ml Atemzugvolumen
19,1 mg/l
(gemäß ISO 9360-2; 2001)
Indikationen
Das Provox®FreeHands HME®ist ein Hilfsmittel zur
prothetischen Stimmrehabilitation und zur pulmo-
nalen Rehabilitation nach totaler Laryngektomie. Es
ermöglicht Stimmprothesenträgern (z.B. Trägern einer
Provox®Stimmprothese) den automatischen anstelle des
manuellen Tracheostomaverschlusses und ist gleichzei-
tig ein Wärme- und Feuchtigkeitstauscher (HME) zur
pulmonalen Rehabilitation.
Für den Patienten muss das Provox®FreeHands