Device Cleaning And Care; Disposal Instructions - inhealth technologies Blom-Singer Instrucciones De Uso

Blom-Singer Indwelling Voice Prostheses
®
minutes, the inserter should visibly move forward into the voice prosthesis; the clinician should
see this forward movement indicating that the gel cap has dissolved and that the esophageal
flange has deployed. To confirm valve function, use a small wax curette or equivalent gauge
instrument to gently open the tracheal valve while the patient swallows their saliva or water.
The clinician should see the properly positioned esophageal valve at the other end and no
leakage.
Safety Strap Detachment
The device is designed to include the optional detachment of the safety strap following
confirmation that the voice prosthesis esophageal flange is securely positioned within the
esophageal lumen against the anterior wall of the esophagus. Removal of the safety strap is an
optional procedure. Once deployment of the esophageal flange has been confirmed, detach
the safety strap from the tracheal flange at the area of reduced safety strap width, where it
meets the tracheal flange, by cutting carefully with scissors (diagram 12).
The safety strap should not be detached from the device if:
y Use of a laryngectomy tube or button may potentially dislodge the device.
y A patient has previously had a device that is larger in diameter than the device being
inserted
y The diameter of the TEP is dilated significantly larger than the device diameter.
y The health of the stoma tissue or physical condition of the patient is in question.
Do not detach the safety strap from the device in the instances cited above. Tape the safety
strap to the peristomal skin and confirm security of the device.
Device Removal
The device is not permanent and requires periodic replacement: it is intended for six (6)
months of use, but this duration should be determined per clinical evaluation and appropriate
consultation with the clinician.
Removal of the device should only be completed by grasping the tracheal flange of the
device securely with a locking hemostat. Pull gently and firmly until the voice prosthesis is fully
withdrawn. Insert a dilator or dilator-sizer of the appropriate diameter and tape it in position for
five minutes prior to inserting a new device.

DEVICE CLEANING AND CARE

The following information should be made clear to the patient regarding the routine care and
cleaning of the indwelling voice prosthesis. The purpose of cleaning the prosthesis is to remove
blockage of its lumen that impairs the patient's ability to voice while the voice prosthesis is in
the patient's TEP. Cleaning should be done by using the Blom-Singer Cleaning Brush and the
Blom-Singer Flushing Device. Please refer to the Voice Prosthesis Cleaning System instructions
for use for complete instructions on how to use the cleaning devices.
Caution: Use only the Blom-singer cleaning devices. Do not insert objects other than the Blom-
Singer cleaning devices into the voice prosthesis as this may cause damage or dislodgement
of the voice prosthesis or its components. Cleaning of the indwelling voice prosthesis should
only be done in front of a mirror with a bright light focused directly on the stoma so that the
open end of the voice prosthesis is clearly visible. Only use a lint free cloth or tissue to dry the
device. Use of non-lint free materials may leave debris, which can be aspirated into the airway.
Do not use solvents or petroleum-based products for cleaning or lubricating the device. These
materials may damage the silicone or cause the device to not work properly.
SPECIAL STORAGE AND/OR HANDLING CONDITIONS
Only the gel caps packaged with the device have special storage and/or handling conditions.
They must be kept dry and out of direct sunlight.

DISPOSAL INSTRUCTIONS

This product is not biodegradable and can be considered contaminated when used. Carefully
dispose of this device per local guidelines.
10 I 37924-01B