Atos Medical Provox XtraFlange, Руководство пользователя

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The device is supplied sterile and is intended
for single use only.
The Provox XtraFlange is put in place with
the help of two non-toothed hemostats while
the prosthesis remains in situ (for appropriate
Provox XtraFlange sizes, see order information).
In order to prevent accidental aspiration during
placement the Provox XtraFlange has a safety
medallion. After proper placement, the safety
medallion is cut off.
The Provox XtraFlange is intended to stay in
place until the voice prosthesis is removed. The
washer has to be discarded when the prosthesis
is replaced.
WARNINGS
- Instruct the patient to seek immediate medical
attention if the washer and/or prosthesis
dislodges from the puncture. Immediate
symptoms of aspiration may include coughing,
wheezing or difficulty breathing. A foreign
body in the airways may cause severe
complications and has to be removed by a
physician.
- A too tight fit may cause tissue necrosis and
extrusion of the prosthesis. The washer is
neither intended nor designed to make a too
long prosthesis shorter. Instruct the patient to
consult their clinician immediately if there are
any signs of tissue edema and/or inflammation/
infection. Treatment may require antibiotic
therapy, temporary insertion of a prosthesis
with a longer shaft, removal of the prosthesis
and/or surgical closure of the puncture (with
later possibly a repuncture).
- Provox XtraFlange is for single use; i.e. the
washer has to be discarded when the prosthesis
is replaced. Do not reuse the washer. Re-use and
re-processing may cause crosscontamination
and damage to the device, which could cause
patient harm.