Tracoe 650-S Instructions D'utilisation page 12

Instructions for Use for
EN
TRACOE
1. General Information
TRACOE phon assist I valves are adjustable speaking valves devel-
oped for tracheostomy patients. The valves are manufactured with
or without an oxygen supply port for TRACOE grid buttons and
stoma buttons, TRACOE adhesive carriers and for tracheostomy
tubes with a 15 mm connector.
CAUTION: the following instructions are for the use of doctors,
nursing staff and the patient. The instructions refer exclusively
to TRACOE phon assist I valves and must be read carefully
before use.
sterile only if the packaging and all seals are intact.
Materials: the materials used in the manufacture of TRACOE phon
assist I satisfy all international requirements for medical devices; they
contain no latex.
Packaging Contents: each pack REF 650-S /-SO /-T or /-TO
/-TO-C contains one TRACOE phon assist I valve.
2. Product Description
TRACOE phon assist I valves were developed as adjustable speak-
ing valves with or without an oxygen supply port for tracheostomy
patients.
The head of the valve can be rotated on the base and contains a
silicone membrane. The head and base sections each contain two
lateral wedge-shaped apertures located opposite each other, which
may be closed by rotating through 90 degrees clockwise and
opened by turning anticlockwise. When the side apertures are
closed, the valve operates as a one-way valve, i.e. it allows air to
flow in only during inhalation, allowing voice production in the larynx
during exhalation. After rotating to the left (anticlockwise), the patient
can breathe in and out through the lateral valve apertures without
obstruction. The lateral slot-shaped apertures are infinitely adjusta-
ble and can be opened wider or less wide as required.
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phon assist I Speaking Valves
®
Sterilisation: TRACOE phon assist I valves are
sterilised with ethylene oxide. The contents are