Laryngectomy Tube; Contraindications; Potential Complications - inhealth technologies Blom-Singer StomaSoft Laryngectomy Tube Mode D'emploi

Laryngectomy Tube Instructions for Use
DEVICE DESCRIPTION
The Laryngectomy Tube (Tube) is a
flexible silicone tube that is available in
many sizes. It comes in both fenestrated
and non-fenestrated models.
INDICATIONS FOR USE
The Tube is designed for use by a single
patient to maintain tracheostoma patency
after laryngectomy and allow attachment
of stoma accessories.

CONTRAINDICATIONS

The Tube should only be used by people that have been trained on its use. It is not meant for use in radiation
therapy. The Tube should not be used when experiencing inflammation, infection, bleeding, discharge, or
coughing. The Tube is not meant for use with mechanical ventilators.
CAUTIONS
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
PRECAUTIONS
Wash hands with soap and water prior to handling the Tube.
Only use a lint-free cloth or tissue to dry the Tube to avoid getting lint into the airway.
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 Tube. Use of other accessories may result
in complications.
WARNINGS
Never insert any cleaning device into the laryngectomy tube while the tube is positioned in the neck.
Always clean the device after it has been removed.
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.
Modifications should not be attempted to the Tube.

POTENTIAL COMPLICATIONS

Complications that require potential removal of the Tube, cleaning, and/or medical treatment include but
are not limited to: stoma contamination/infection, accidental inhalation of an inappropriately sized Tube
into the airway, structural failure from excessive usage and/or cleaning, and obstruction of the Tube by
mucus.
4 I 37889-01A
ENGLISH
Fenestrations
Insertion Tip
Tube
Funnel
For
Accessory
Attachment