Atos Medical Provox GuideWire, Инструкция по эксплуатации

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English
1.5 PRECAUTIONS
Always assess the suitability before using the Provox GuideWire in
the patient. In cases with lacking suitability, do not use the product.
• DO carefully assess patients with bleeding disorders or
patients undergoing anticoagulant treatment for the risk of
bleeding or hemorrhage prior to placement or replacement of
the voice prosthesis.
• DO ensure that in case of known or suspected pharyngeal
stenosis, dilatation of the pharynx should be performed before
using the GuideWire.
• DO always use aseptic technique during the procedure in
order to reduce the risk of infection.
• DO ensure that the safety strap of the voice prosthesis is
adequately attached to the GuideWire. If proper attachment is
not achieved, the voice prosthesis may come loose from the
GuideWire, causing failure to complete the procedure.
• DO NOT load or reload the voice prosthesis if the safety strap
has been cut off or is broken.
1.6 Adverse events and troubleshooting
information
Aspiration of parts of the Provox GuideWire or parts of the
Provox System –
Accidental aspiration of parts of the Provox
GuideWire or parts of the Provox System may occur. As with any
other foreign body, complications from aspiration of a component
may cause obstruction or infection. Immediate symptoms may
include coughing, wheezing or other abnormal breathing sounds,
dyspnea, and respiratory arrest, partial or inadequate air exchange
and/or asymmetrical chest movement with respiration. Complications
may include pneumonia, atelectasis, bronchitis, lung abscess,
bronchopulmonary fistula and asthma. If the patient can breathe,
coughing may remove the foreign body. Partial airway obstruction
or complete airway obstruction requires immediate intervention
for removal of the object. If aspiration of the object is suspected,
the object should be located and retrieved endoscopically using a
non-toothed grasping forceps.
Ingestion of parts of the Provox GuideWire or parts of the
Provox System –
Accidental ingestion of parts of the Provox
GuideWire or parts of the Provox System may occur. As with any
other foreign body, the symptoms caused by ingestion of parts of
the GuideWire or parts of the Provox System, depend largely on
size, location, degree of obstruction (if any) and the length of time
it has been present. Ingested components that have remained in the
esophagus may be removed by esophagoscopy or observed for a
short period of time. The object may pass spontaneously into the
stomach. Foreign bodies that pass into the stomach usually pass
through the intestinal tract. Surgical removal of foreign bodies from
the intestinal tract must be considered when bowel obstruction
occurs, bleeding is present, perforation occurs or the object fails
to pass through the intestinal tract.
Spontaneous passage of the object may be awaited for 4-6 days.
The patient should be instructed to observe the stools for the
ingested object. If the object does not pass spontaneously, or if
there are signs of obstruction (fever, vomiting, abdominal pain) a
gastroenterologist should be consulted. The device may be retrieved
by using a non toothed grasping forceps.
The Provox GuideWire gets stuck in the pharyngeal mucosal
wall –
The Provox GuideWire may get stuck in or be interfered
by the pharyngeal mucosal wall. With slight pressure, the Provox
GuideWire will generally bend near the tip and slide upwards
towards the pharynx. Stop the procedure if the general bending
does not help.
Hemorrhage/Bleeding of the puncture –
Slight bleeding from
the edges of the tracheoesophageal (TE) puncture may occur
during intended use of Provox GuideWire and generally resolves
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