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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.
1. Descriptive information
1.1 Intended use
The Provox XtraHME Cassette is a single use, specialized device intended for
patients breathing through a tracheostoma. It is a heat and moisture exchanger
(HME) that heats and humidi
fi
es inhaled air by retaining heat and moister from
exhaled air in the device. It partially restores lost breathing resistance. For patients
with a voice prosthesis or surgical speech
fi
stula it may also facilitate voicing.
1.2 CONTRAINDICATIONS
The product shall not be used by patients with decreased level of consciousness, or
reduced mobility of the arms and/or hands, who are unable to remove the device.
Do not use the Provox XtraHME Cassette in combination with cuffed tracheal
cannula; breathing may be restricted and suffocation may occur.
Do not use on patients with a low tidal volume, as the added dead space
(5 ml) may cause CO
2
(carbon dioxide) retention at too low tidal volume.
1.3 Description of the device
The Provox XtraHME Cassettes are single use devices for pulmonary
rehabilitation. They are a part of the Provox HME System, which consists of
HME cassettes, attachment devices and accessories.
The Provox XtraHME Cassettes have a calcium chloride treated foam in
a plastic housing. The top lid can be pushed down with a
fi
nger to close the
cassette and redirect air through the voice prosthesis to enable speech. After
releasing the
fi
nger, the top lid returns to its rest position.
The Provox XtraHME Cassettes are available in two versions:
• Provox XtraMoist HME is intended for use during normal everyday activity.
• Provox XtraFlow HME is intended for use during physical activities since it
has a lower breathing resistance. It can also be used in a two-step approach to
get adapted to the higher breathing resistance of the Provox XtraMoist HME.
ENGLISH
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