Dilation/Sizing System; How Supplied - inhealth technologies Blom-Singer Instrucciones De Uso

ENGLISH
BLOM-SINGER® DILATION/SIZING SYSTEM
The Blom-Singer Dilation/Sizing System is designed to facilitate
dilating and measuring of the tracheoesophageal puncture
tract (TEP) in preparation for insertion of a Blom-Singer voice
prosthesis. Included in the system is a Puncture Dilator that
also prevents closure of the tracheoesophageal puncture and
aspiration of fluids when the voice prosthesis is removed.
INDICATIONS
The Blom-Singer Dilation/Sizing System is indicated for
dilation, measuring, and maintaining an open passage of the
tracheoesophageal puncture for tracheoesophageal voice
restoration following total laryngectomy. The Blom-Singer Sizing
System is a measurement device used by physicians and qualified
speech pathologists to select the appropriate voice prosthesis
length.
CONTRAINDICATIONS
The components of the Blom-Singer Dilation/Sizing System are
medical devices and should only be used by individuals with
experience and training in the use and care of tracheoesophageal
puncture prosthetic devices.
These devices should not be placed in a small tracheostomal
airway if its presence obstructs breathing. These devices are not
valved voice prostheses and do not function like one.
Placement of the 18 French Puncture Dilator or Dilator-Sizer is
contraindicated in a tracheoesophageal puncture that has dilated
substantially beyond the diameter of a conventional 16 French
Blom-Singer voice prosthesis. Likewise, the 22 French Puncture
Dilator or Dilator-Sizer should not be used in a puncture that has
dilated substantially beyond the diameter of a 20 French Blom-
Singer voice prosthesis.

HOW SUPPLIED

The components of the Dilation/Sizing System are supplemental
devices to the Blom-Singer Voice Restoration System. The system
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