Device Description; Warnings And Precautions - Freudenberg Medical InHealth Technologies Blom-Singer Instrucciones De Uso

Blom‑Singer Laryngectomy Tubes Instructions for Use
®

DEVICE DESCRIPTION

The Blom-Singer® and Blom-Singer® StomaSoft™ Laryngectomy Tubes (tubes) are made of
flexible silicone and are available in many sizes. The standard Blom-Singer® Laryngectomy Tube
is available in a sterile (by gamma irradiation), non-fenestrated option, and does not allow the
attachment of any HME or
other stoma accessories.
The StomaSoft™ is
available non-sterile in
both fenestrated and
non-fenestrated models,
and allows for attachment
of HME and other stoma
accessories.
A fenestrated (having small
openings or holes) tube
may be used simultaneously
with a voice prosthesis to
facilitate unrestricted airflow
for tracheoesophageal voice.
INDICATIONS FOR USE
The tube is designed for use
by a single patient to maintain
tracheostoma patency after
total laryngectomy. The
StomaSoft™ model also allows attachment of HME and other stoma accessories.
CONTRAINDICATIONS
The tube should only be used by clinicians and patients that have been trained in its use.
Carefully monitor the tracheostoma tissue during radiation therapy. The tube should not be
used when experiencing inflammation, infection, bleeding, discharge, or excessive coughing.
The tube is not meant for use with mechanical ventilators. The tube should not be used if its
presence obstructs breathing.

WARNINGS AND PRECAUTIONS

The clinician is to instruct the patient on the usage of the device and to provide the patient
these Instructions For Use. Wash hands with soap and water prior to handling the tube. Only
use a lint-free cloth to wipe the tube to avoid getting lint into the airway. Do not sterilize or re-
sterilize the device. Do not use solvent or petroleum-based products for cleaning or lubricating
the tube; these materials may damage the tube. Only Blom-Singer® stoma accessories can be
used with the StomaSoft™ Tube; use of other accessories may result in complications. Never
insert any cleaning device into the tube while it is positioned in the neck; only clean the device
after it has been removed from the tracheostoma. The tube is for single patient use only and
must not be shared between patients; infection can occur with shared use, which could lead to
illness or serious injury. Inspect the tube before each use for physical damage, such as cracks or
tears, and do not use if damaged. If physical damage is found, contact InHealth Technologies
Product Complaints. Do not make modifications to the tube. Do not use the tube in the event
of the packaging or sterile packaging being damaged or unintentionally opened prior to use;
6 I 37889-01B
ENGLISH
Fenestrations
Funnel
Insertion Tip
Tube
For
Accessory
Attachment