inhealth Blom-Singer Gebrauchsanweisung Seite 7

Caution: Federal (USA) law restricts this device to sale by or on
the order of a physician.
Complications
Although rare, the following complications have been identified
to occur with Blom-Singer Plug Inserts. They include:
• stoma or device contamination or bacterial infection, which
may require removal of the prosthesis and or treatment with
appropriate antibiotics;
• accidental aspiration of the voice prosthesis into the airway,
which may require removal by a physician;
• aspiration of liquids through the prosthesis into the airway,
which may cause the patient to cough;
• occasional movement out of position by the voice prosthesis,
requiring replacement after enlargement of the TE puncture
and additional supervision of the stoma care regimen;
• dislodgment of the voice prosthesis and subsequent closure
of the TE puncture;
• tearing or other damage to the voice prosthesis from improper
use;
• accidental swallowing of the voice prosthesis into the
esophagus and/or gastrointestinal (GI) tract.
INSTRUCTIONS FOR USE
Your clinician will instruct you on the routine use and care of this
Blom-Singer device.
Changes in your anatomy or medical status may lead to improper
fitting and/or function of the device. It is recommended that your
voice prosthesis and TEP be evaluated by your clinician at regular
intervals.
If there are tears, cracks, or structural damage to the device,
discontinue use.
The indwelling accessory device should always be cleaned to
prevent contaminants from entering into the tracheostoma,
puncture, or esophagus, see below for cleaning instructions.
The user's hands should always be washed with soap and water
prior to cleaning the Plug Insert.
Blom-Singer ® Plug Insert
37582-01G | 7