English; Descriptive Information; Intended Use; Contraindications - Atos Medical PROVOX XtraHME Gebrauchsanweisung

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 humidifies 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 fistula it may also facilitate voicing.

1.2 CONTRAINDICATIONS

The Provox XtraHME Cassette is not intended to be used by patients unable to
remove or operate the device, 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.
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

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 finger to close the
cassette and redirect air through the voice prosthesis to enable speech. After
releasing the finger, 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

(carbon dioxide) retention at too low tidal volume.
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