Atos Medical ProTrach DualCare User manual

Instructions for Use
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Figure 4bFigure 3
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Figure 5a Figure 5b
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Figure 10 Figure 11
Figure 12a Figure 12b
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Figure 15bFigure 15a
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2 h
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15 min
10 min
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Prescription information
CAUTION: United States Federal law restricts this device
to sale, distribution and use by or on order of a physician or a
licensed practitioner. The availability of this product without
prescription outside the United States may vary from country
to country.
Disclaimer
Atos Medical offers no warranty – neither expressed nor
implied – to the purchaser hereunder as to the lifetime of the
product delivered, which may vary with individual use and
biological conditions. Furthermore, Atos Medical offers no
warranty of merchantability or tness of the product for any
particular purpose.
Patent and trademarks
ProTrach®is a registered trademark and DualCare™is a trademark
of Atos Medical AB. The products are protected by US patent
no. US 6,921,417, JP patent no. 4,156,832 as well as other patents.
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Contents
ENGLISH..........................................................................9
DEUTSCH ..................................................................... 24
NEDERLANDS............................................................. 41
FRANÇAIS .................................................................... 58
ITALIANO...................................................................... 75
ESPAÑOL...................................................................... 92
PORTUGUÊS..............................................................109
SVENSKA ....................................................................127
DANSK.........................................................................142
NORSK.........................................................................158
SUOMI.........................................................................173
ORDERING INFORMATION..................................189
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The Instructions for Use, which accompanies this product, may
be revised from time to time and must therefore be reviewed
prior to each procedure in which the product is used.
ENGLISH
Symbol explanation
Keep away from direct sunlight and heat.
Keep dry and away from rain and other moisture.
Contents
1. Descriptive information............................................................10
1.1 Intended use..........................................................................10
1.2 CONTRAINDICATIONS ........................................................10
1.3 Description of the devices................................................11
1.4 WARNINGS..............................................................................14
1.5 PRECAUTIONS .......................................................................16
2. Instructions for use.....................................................................17
2.1 Preparation and assembly of the speaking
devices............................................................................................17
2.2 Insertion and usage of Speaking Valve
with HME 15 / 22.........................................................................18
2.3 Insertion and usage of HME DigiTop and HME
DigiTop O2......................................................................................19
2.4 Removal of the HME from the speaking devices......20
2.5 Pediatric Use..........................................................................20
2.6 Cleaning and disinfection ................................................21
2.6.1 Cleaning of the speaking devices..........................21
2.6.2 Disinfection of the speaking devices....................22
2.7 Storage instructions............................................................23
2.8 Device lifetime......................................................................23
2.9 Disposal...................................................................................23
2.10 Accessories ..........................................................................23
3. Additional information.............................................................23
3.1 Compatibility with MRI Examination............................23
3.2 Ordering information.........................................................23
3.3 User assistance information.............................................23
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1. Descriptive information
1.1 Intended use
ProTrach DualCare is a combined Speaking Valve and Heat
and Moisture Exchanger (HME) intended for spontaneously
breathing tracheostomized patients using a tracheostomy
tube with a deated cuff, or a tracheostomy tube without cuff.
In HME-mode the device conditions inhaled air by retaining
heat and moisture from the exhaled air.
By turning the lid of the Speaking Valve into speaking mode
air is re-directed to enable speech.
The entire device is for single patient use and the HME-part
is for single use.
Patient Population: For spontaneously breathing tracheostomized
patients (adults and pediatric patients greater than 10 kg in
weight) using a tracheostomy tube with a deated cuff, or a
tracheostomy tube without cuff.
Environment of Use: Hospitals, ICU, sub-acute care institutions
and home.
1.2 CONTRAINDICATIONS
General
ProTrach HME 15 or 22 in combination with either ProTrach
DualCare Speaking Valve or ProTrach HME DigiTop are
contraindicated for:
- Use in combination with an in-line ventilator.
- Patients who are unable to handle or remove the device
themselves when needed, unless the patient is under
constant supervision of a clinician or a trained caregiver.
For example, patients who are unable to move their arms,
patients with decreased levels of consciousness, or patients
with diseases that put them at risk for unpredictable periodic
loss of consciousness.
- Patients who cannot tolerate the added dead space of 5 ml,
or who cannot tolerate the added breathing resistance
of 170 Pa / 1.7 cm H2O. This should be evaluated by a
clinician.
- Unresponsive or sedated patients. The patient must be
responsive and attempting to communicate in order to use
the device. The patient should be able to follow instructions.
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The HME 15 or 22 in combination with either Speaking Valve
or HME DigiTop must NOT be used on a single lumen tube
(tube without an inner tube), unless the patient or caregiver is
able to reinsert the tube themselves after emergency removal.
Speaking Valve specic
The use of Speaking Valve (in combination with HME 15 or 22)
is additionally contraindicated for the following patient groups:
- Laryngectomized patients since the device will prevent the
ability to exhale if the Speaking Valve is unintentionally set
to speaking mode.
- Patients suffering from severe aspiration.
- Patients with severe obstruction in the area of the
tracheostomy tube or in the upper airways, such as tracheal
and/or laryngeal stenosis, since this may cause air trapping.
- Patients with very thick and copious secretions which might
block the device.
DO NOT use the Speaking Valve:
- In combination with a tracheostomy tube with the cuff
inated. The cuff must be completely deated before
placing and during all use of the Speaking Valve.
- In combination with a tracheostomy tube with a foam cuff.
- In combination with a tracheostomy tube with a self-
inating cuff.
- When the size of the tracheostomy tube does not allow for
airow through the upper airways.
- In combination with an endotracheal tube.
Use of the Speaking Valve in these circumstances can restrict
exhalation through the upper airways and cause suffocation!
DO NOT use the Speaking Valve during sleep since the airway
could be blocked unintentionally. During sleep the HME
DigiTop (in combination with HME 15 or 22) should be used
instead (Figure 2a or 2b).
1.3 Description of the devices
The Speaking Valve, the HME DigiTop, and the HME
DigiTop O
2
are all used to enable speaking. In this Instructions
for Use they will therefore be referenced to as “speaking devices”.
Speaking Valve and HME 15 / 22
The reusable Speaking Valve is used with a single use 15 mm
or 22 mm Heat and Moisture Exchanger (HME). The HME is
placed so that it prevents direct contact between the Speaking
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Valve and the airways. This prevents the Speaking Valve from
being clogged or soiled by mucus.
The Speaking Valve has two modes: speaking mode and
HME mode.
In speaking mode, a exible membrane is positioned in
the airow openings and acts as a one way valve. It opens
during inhalation so the patient can inhale through the device.
During exhalation, the membrane remains closed and the air
is re-directed through the upper airways and the vocal folds.
Thereby the patient is able to speak. In speaking mode the
inhaled air does not get conditioned since the exhaled air goes
out through the upper airways.
In HME mode the membrane is moved out of the way of the
airow so that the patient both inhales and exhales through the
device. The inhaled air is conditioned by the heat and moisture
that is retained from the exhaled air in the impregnated HME
media. In HME mode, speaking is not possible.
The device is switched between the modes by rotating the lid
of the Speaking Valve until it clicks into the desired position.
The ProTrach HME 15 is available in two versions: the XtraMoist
with better humidication properties and the Regular with lower
breathing resistance. The XtraMoist should be used when the
slightly higher breathing resistance is tolerated. The Regular
should be used when lower breathing resistance is required,
for example when rst getting used to HME use or during
physical activity.
HME DigiTop and HME DigiTop O2
The HME DigiTop and the HME DigiTop O
2
enable use of
the HME without the Speaking Valve, and can manually be
occluded to enable speaking.
The HME DigiTop O
2
provides possibility to connect
oxygen tubing of 1/8 inch (3.2 mm) diameter to the Oxygen port
connector for patients requiring additional Oxygen (Figure 16).
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ProTrach DualCare Set 15 / Set 22 include:
See Figure 3
(a) 1 pc ProTrach DualCare Speaking Valve
(b1 or b2) 30 pcs (b1) ProTrach HME 15 Regular or
(b2) ProTrach HME 22 Regular
(c) 1 pc ProTrach Connection Strap clip
(d) 1 pc ProTrach Connection Strap string
(e) 1 pc ProTrach HME DigiTop
(f) 1 pc Removal Aid
1 pc ProTrach DualCare Instructions for Use
ProTrach DualCare Speaking Valve / Speaking Valve
Blue package include:
See Figure 3
(a) 1 pc ProTrach DualCare Speaking Valve
or Speaking Valve Blue
(c) 1 pc ProTrach Connection Strap clip
(d) 1 pc ProTrach Connection Strap string
(e) 1 pc ProTrach HME DigiTop or DigiTop Blue
1 pc ProTrach DualCare Instructions for Use
Technical data ProTrach DualCare
Speaking Valve with HME 15 Speaking Valve with HME 22
Pressure drop at 30 l/min in
speaking mode, HME 15 Regular: 125 Pa Pressure drop at 30 l/min in
speaking mode: 136 Pa
Pressure drop at 30 l/min in HME
mode, HME 15 Regular: 35 Pa Pressure drop at 30 l/min in
HME mode: 48 Pa
Pressure drop at 60 l/min in HME
mode, HME 15 Regular: 123 Pa Pressure drop at 60 l/min in
HME mode: 166 Pa
Pressure drop at 30 l/min
in speaking mode, HME 15
XtraMoist: 166 Pa
Pressure drop at 30 l/min in HME
mode, HME 15 XtraMoist: 78 Pa
Pressure drop at 60 l/min in HME
mode, HME 15 XtraMoist: *
Dead space:
(Speaking Valve incl HME) 4.05 ml Dead space:
(Speaking Valve incl HME) 4.62 ml
* During increased physical activity that requires lower breathing resistance the Regular HME
is recommended. Therefore, the XtraMoist is not tested in these conditions.
Oxygen concentration measured at:
Tidal volume 1 L, breathing frequency 10/min, O2ow 10 L/min
DigiTop O2with HME 15 70%
DigiTop O2with HME 22 71%
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1.4 WARNINGS
Speaking Valve specic
(Speaking Valve in combination with HME 15 or 22).
WARNING
If a tracheostomy tube with a cuff is used, the cuff must
be completely deated before placing, and during all use
of the Speaking Valve. The patient cannot breathe if the
cuff is not completely deated. There should be sufcient
airow around the tracheostomy tube and the deated cuff.
DO NOT use the Speaking Valve for patients who use a
tracheostomy tube with a self-inating or foam-lled cuff.
Use of Warning Labels: Attach warning labels provided
with Speaking Valve to the tracheostomy tube pilot balloon
ination line (Figure 1).
Monitoring: Patients with a tracheostomy tube with a cuff
using the Speaking Valve must be monitored according to
physician direction. Continuous observation is needed to make
sure that the patient can exhale through the upper airway.
Education: To ensure correct use of the Speaking Valve,
the patient, family, caregivers, and all personnel working
with the patient must be instructed on how to use Speaking
Valve, including contraindications, warnings, warning labels
and precautions.
Do
- Do make sure the patient has the respiratory ability to
exhale around the tracheostomy tube and out of the nasal
and oral cavities.
- Do make sure the patient has been cleared by the physician
for cuff deation. Cuff deation is mandatory with the
Speaking Valve to allow exhaled air to pass around the
tracheostomy tube and upper airways.
- Do make sure the tracheostomy tube is sized to allow
for sufcient airow around the tracheostomy tube to
facilitate speech. The cuff on the tube can also generate an
obstruction even when deated and this should be taken
into consideration during airway patency assessment.
- Do evaluate, per physician direction, if changing to a
smaller tracheostomy tube is indicated to provide sufcient
airow to allow use of the Speaking Valve.
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- Do evaluate patients with thick unmanageable secretions
that may cause airway obstructions for use of the Speaking
Valve.
- Do evaluate patient experiencing difculty utilizing the
Speaking Valve, as the patient may have airway obstructions
due to stenosis, tissue mass, tracheomalacia, granulation,
vocal cord paralysis in the midline position, secretions,
or a tracheostomy tube that is oversized for the patient’s
trachea. If obstruction is corrected, the patient should be
re-evaluated for the Speaking Valve.
General
(HME 15 and 22 in combination with either Speaking Valve
or HME DigiTop).
Do
- Do make sure that patients with severe pulmonary diseases,
e.g. lung emphysema, severe asthma etc. are examined and
evaluated by a clinician to ensure suitability before they
start using the device.
- Do make sure that the patient or caregiver always has the
ability to remove the device quickly from the tracheostomy
tube if needed. Coughing up a lot of mucus may suddenly
block or nearly block the tube or HME.
- Do make sure that the patient, caregiver and others
understand the closing function and the use of the holes.
Do explain that blocking the holes in the Speaking Valve
or the HME DigiTop by clothing, for example, may cause
difculty in breathing or suffocation.
Do not
- Do not bathe or swim with the device (Figure 4a or 4b).
This could cause water to enter the airways. The speaking
devices do not prevent this in any mode.
- Donot use the deviceif it has beendamaged or contaminated.
- Do not remove the foam from the HME. Using the
device without the foam increases the risk of aspiration
of small device parts, it may also negatively impact valve
functionality due to direct mucus contact, and also without
the foam the important HME function is lost.
- Do not reuse the HME, e.g. by washing it. By washing the
HME the important HME function is lost. Reuse can also
increase the risk of infection.
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- Do not use any part of the device for more than one patient
since this may cause cross contamination. The device is
intended for single patient use only.
HME 22 specic
(HME 22 in combination with either Speaking Valve or HME
DigiTop).
Do
- If the Speaking Valve comes loose from the HME 22
during the removal of the device, always remove the inner
tracheostomy tube or the single lumen tube together with
the HME instead of trying to remove the HME from the
tube connector.
Attempts to remove the HME 22 from the connector
while the tube is still in place is difcult, and the airways
may become blocked by mucus.
1.5 PRECAUTIONS
Do
- Do always check before each use that the Speaking Valve
rotates properly between the two modes. The Speaking
Valve may get stuck in one of the modes due to the presence
of mucus. If this occurs, clean the device thoroughly and if
the problem persists stop using the device and replace it.
- Do check the device if you experience increased breathing
resistance as this might be a sign of blockage by (e.g., by
mucus).
- Do consult your clinician if there is a problem in connection
with the device.
Do not
- Do not use humidiers or heated humidied oxygen via a
mask over the tracheostoma while using the device since it
will cause the HME to become too wet. If oxygen therapy
is required, use only non-heated humidied oxygen.
- Do not administer medicated nebulizer treatment over
the tracheostoma while using the device. The medication
can become deposited in the HME and medications may
also adversely affect the Speaking Valve membrane. If the
device is inadvertently used during a medicated nebulizer
treatment, the device must be removed immediately. The
HME must be discarded, and the Speaking Valve and the
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HME DigiTop must be cleaned thoroughly to remove all
medication residues.
2. Instructions for use
The speaking devices (Speaking Valve, HME DigiTop and HME
DigiTop O2) are reusable. The HME cassettes are disposable
and must be exchanged at least every 24 hours.
2.1 Preparation and assembly of the
speaking devices
CAUTION: Use only original accessories with the device.
Use of other accessories may cause product malfunction and
harm the patient.
When the Speaking Valve in combination with a HME is not
advisable, evaluate the possibility of using the ProTrach HME
DigiTop in combination with a HME.
Before each use, please check that the speaking device (Speaking
Valve, HME DigiTop, or HME DigiTop O
2
) and HME are
undamaged and that the Speaking Valve functions as intended,
e.g., it clicks into the HME mode and speaking mode. If the
device does not function as intended or seems damaged, do
not use the device and replace it.
Attach the ProTrach Connection Strap
The ProTrach Connection Strap can be used to secure the
Speaking Valve to the neckband (optional). This is done to avoid
that the device is lost, for example, when coughing or sneezing.
1. Insert the string of the Connection Strap into the clip
(Figure 5a and 5b).
2. Insert the string of the Connection Strap to the Speaking
Valve (Figure 5c).
Note: If the Connection Strap is pulled with a certain force,
the string will loosen from the clip. This is a security feature to
prevent injury if the string accidentally is caught up somewhere.
If this occurs, just insert the string again in the clip (Figure
5a and 5b).
CAUTION: Do not attempt to glue or otherwise permanently
attach the string to the clip or Speaking Valve.
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Assemble speaking device and HME
CAUTION: Always assemble the HME with the speaking
device (Speaking Valve, HME DigiTop, or HME DigiTop O2)
before use (Figure 6a, 6b, 6c, 6d, 7a, and 7b). If the device is
not properly assembled, the ProTrach HME 22 can get stuck
in the tracheostomy tube and be difcult to remove in case
of blockage.
1. Place the HME on a at surface:
For ProTrach HME 15 with the narrow part down and the
open foam surface up (Figure 6a or 6c).
For HME 22 with the plastic grid down and the open foam
surface up (Figure 6b or 6d).
2. Put the speaking device on top of the HME and push it
down until it clicks in place.
3. Check that the speaking device is rmly attached to the
HME.
2.2 Insertion and usage of Speaking Valve
with HME 15 / 22
If the Connection Strap is used, attach the clip to the neckband
(Figure 8).
Attach the combined Speaking Valve and HME to the
connector of the tracheostomy tube (Figure 9). Caution:
HME 15 users should always attach the combined Speaking
Valve and HME 15 to the connector gently, using a 1/4 twist
in a clockwise motion. If the device is pushed too hard it can
get stuck on the tracheostomy tube and be difcult to remove
in case of blockage.
If you have not used HMEs previously, you should be aware
that the device may increase breathing resistance to some extent.
You can now switch between speaking mode and HME
mode based on your speaking needs, humidication needs,
and breathing resistance needs (Figure 10). Caution: When
changing modes, make sure that you only rotate the lid of
the Speaking Valve, not the entire device. Rotation of the
whole device might cause uncomfortable movement of the
tracheostomy tube.
In case you feel increased breathing resistance after coughing,
take out the device and wipe off the mucus, or replace the
HME with a new one. Also clear the tracheostomy tube from
mucus when necessary. If you feel the need to cough heavily,
it is recommended that you try to remove the device from the
tube prior to coughing. This prevents the device from falling
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off and prevents the HME from getting clogged by mucus. If the
membrane pops out through the holes in the lid of the Speaking
Valve when coughing, rotate the lid, and the membrane will
get back to the correct position.
Speaking mode
The Speaking Valve is put in speaking mode by rotating the
lid until it clicks into the speaking mode position (the exible
membrane covers the openings of the lid). In speaking mode
the membrane only opens when you breathe in. It is closed
when you breathe out, so you will breathe out through your
mouth and nose, and you will be able to speak. You may feel
a somewhat higher breathing resistance in speaking mode
than in HME mode due to the membrane. You can now try to
speak some words, beginning with low volume and pressure.
HME mode
The Speaking Valve is put in HME mode by rotating the lid
until it clicks into the HME mode position (i.e., the exible
membrane does NOT cover the openings of the lid). HME
mode allows you to both breathe in and out through the HME,
thereby conditioning the inhaled air.
Note that increased mucus production may appear during
the rst weeks of HME use.
With Speaking Valve Blue (REF 7755), the colored membrane
makes it easier to see whether the valve is in speaking mode
or in HME mode.
2.3 Insertion and usage of HME DigiTop
and HME DigiTop O2
Assemble and insert the speaking device as described in 2.1.
If you use the HME DigiTop O
2
always assemble and
disassemble the oxygen tubing while the device is disconnected
from the trach-tube. This is to avoid uncomfortable movement
of the trach-tube.
Make sure that the oxygen tubing is securely attached; it
should be assembled beyond the conical edge (Figure 15).
If you have not used HMEs previously, you should be aware
that the device may increase breathing resistance to some extent.
When you occlude the two holes on the sides with your
ngers, exhaled air will be redirected through your upper
airways and you will be able to speak (Figure 11). Releasing
the nger occlusion will allow you to inhale again through the
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device. The two openings in the HME DigiTop / HME DigiTop
O2 allow you to breathe in and out through the device, thereby
conditioning the inhaled air continuously.
Note that increased mucus production may appear during
the rst weeks of HME use.
2.4 Removal of the HME from the speaking
devices
If you use the HME DigiTop O2remove the oxygen tubing as
described above before you start to remove the HME. The HME
is intended for single use, and must be replaced at least every
24 hours, or more often if needed. It should be removed before
cleaning the speaking devices and should also be replaced if
it becomes clogged by mucus.
CAUTION: Do not wash the HME since the important HME
function then is lost.
HME 15
1. Remove the combined speaking device and HME 15
(without separating them) from the tracheostomy tube
with a gentle pulling twist in a clockwise motion.
2. Hold the speaking device with one hand, and pull the
Removal Aid over the HME with the other hand (Figure
12a).
3. Pull the speaking device apart from the HME with a steady
grip (Figure 12b or 12c).
4. Discard the HME 15 (Figure 12d).
HME 22
1. Remove the combined speaking device and HME 22
(without separating them) from the tracheostomy tube.
2. Hold the speaking device with one hand, and pull the
Removal Aid over the HME with the other hand (Figure
13a)
3. Press the handles together (Figure 13b) and the HME 22
will crack and loosen from the speaking device (Figure
13c or 13d).
4. Discard the HME 22 (Figure 13e).
2.5 Pediatric Use
If selected properly, ProTrach DualCare can be used by children
of all ages, provided that it ts the local anatomy. This can
change as the child grows. In children with a short neck or a
high tracheostomy site, the device may contact the chin which
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