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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, i.e. it has to be exchanged at least every 24 hours.

1.2 CONTRAINDICATIONS

General
ProTrach HME 15 or 22 in combination with either ProTrach
DualCare Speaking Valve or ProTrach HME DigiTop are
contraindicated for the following patient groups:
- Patients under any form of mechanical ventilation.
- Patients who are unable to handle or remove the device
themselves when needed, or who are not under constant
supervision of a clinician or a trained caregiver.
- 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 H
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.
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 specifi 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
infl ated. The cuff must be completely defl ated before
placing and during all use of the Speaking Valve.
10
O. This should be evaluated by a
2

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