Warnings And Precautions - inhealth technologies Blom-Singer Instrucciones De Uso

Blom-Singer ® Dilation/Sizing System
4. Note the marker that is closest to the entrance of the TE
puncture (diagram 12). Read the size number on the Voice
Prosthesis Sizer and select a Blom-Singer Voice Prosthesis of
corresponding size. If the measurement is between two markers,
select the longer one.
DEVICE CLEANING: Puncture Dilator
The Puncture Dilator may be cleaned and reused by a single
patient as follows: Clean the Puncture Dilator thoroughly with a
mild detergent and rinse under a strong flush of tap water. Dry
the dilator with sterile gauze. Once a dilator has been cleaned and
dried completely, it should be stored in a clean, reclosable plastic
bag until its next use. Always handle with clean hands and avoid
touching portions of the dilator that will enter the puncture.
Precaution: Never clean the device while the dilator is in position
in the neck. Always clean the dilator after it has been removed.
INSTITUTION STERILIZATION AND REUSE
INSTRUCTIONS
The devices of the Blom-Singer Dilation/Sizing System may be
cleaned and steam sterilized for reuse by multiple patients as
follows: Clean thoroughly with a mild detergent and rinse with
water. Sterilize unwrapped in a standard autoclave at 132—
135°C for 3 minutes. Do not sterilize the device in the original
packaging. The device may be reused to a limit of 100 times.
Inspect the device routinely for structural damage. If there are
tears, cracks, or structural damage, do not continue to use. Do not
sterilize the sizer inserter.

WARNINGS AND PRECAUTIONS

The components of the Blom-Singer Dilation/Sizing System are
medically prescribed devices. Initial sizing and instructions in
their use must be provided by a qualified physician or speech
pathologist trained in the use of these particular devices.
The Blom-Singer Voice Prosthesis Sizer and Dilator-Sizer are medical
devices and should be used only by a physician or licensed speech
pathologist trained in their use. The Voice Prosthesis Sizer is not a
valved voice prosthesis and cannot function as such.
If there are any tears, cracks, or structural damage, do not
continue to use this device.
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