Warnings And Precautions - inhealth Blom-Singer Mode D'emploi

Blom‑Singer HME/HumidiFilter
®
BLOM‑SINGER® HME/HUMIDIFILTER® SYSTEM
PRODUCT DESCRIPTION
The Blom-Singer HME/Humidifilter Systems are available in the following options:
• HME Cartridge (diagram 1) – supplied in a package of 30 HME Cartridges (EasyFlow® or ClassicFlow®
options); pre-assembled, 24-hour use and single-use; contains: a HumidiFilter foam filter for
heat and moisture exchange (top view, diagram 1A-a), an EasyTouch™ speech button (top view,
diagram 1A-b) that is depressed to occlude the stoma for talking, a MucusShield™ occluder (bottom
view, diagram 1B-a) to protect from mucus secretions, a finger-lip (side view, diagram 1C-a) for ease
of removal of the HME Cartridge from the laryngectomy tube or tracheostoma/adhesive housing;
front and side airflow vents to maximize airflow (side view, diagram 1C-b).
• HumidiFilter® Holder (diagram 2) and Foam Filters (diagram 3) – supplied as one holder; a
lightweight plastic holder for HumidiFilter Foam Filter (filters are supplied separately); the holder
and filters require assembly; the holder is reusable and filters are single-use.
• ATSV II HumidiFilter® Cap (diagram 4) and 7 Foam Filters – supplied as 1 cap and 7 foam filters,
only to be paired with ATSV-II hands-free device; requires assembly; the cap is reusable and the
foam filters are single-use; twist-on plastic cap holds a HumidiFilter Foam Filter and fits over the
Blom-Singer Adjustable Tracheostoma Valve (ATSV II) hands-free device; replacement filters are
supplied separately.
Attachment of the above HME/HumidiFilter systems to the tracheostoma (opening through
neck into trachea or "wind pipe") can be achieved through the use of a Blom‑Singer
StomaSoft Laryngectomy Tube or Blom‑Singer Tracheostoma/Adhesive Housing, supplied
separately.
INDICATIONS (Reasons to prescribe the device or procedure)
The Blom-Singer HME/HumidiFilter system is designed to provide the laryngectomee with humidified,
warmed, and filtered air. The Blom-Singer HME/HumidiFilter system may be used by laryngectomees:
esophageal speakers, electrolarynx users, and tracheoesophageal voice prosthesis users.
CONTRAINDICATIONS (Reasons that make it inadvisable to prescribe the particular device
or procedure)
The HME/HumidiFilter system should not be placed over a tracheostomal airway if its presence
obstructs respiration.

WARNINGS AND PRECAUTIONS

The HME Cartridge and Humidifilter Foam Filters may be used only once by one patient. They may
not be reused. There is a risk of infection if reused. If there are tears, cracks, or structural damage to
the device, discontinue use. Care should be exercised when inserting or removing HME devices to
avoid aspiration (inhalation) of the voice prosthesis or HME. In the unlikely event that this should
occur, you should attempt to cough the device out of the windpipe. Immediately seek medical
attention if unsuccessful.
The following complications may occur with devices of this type, but are infrequent. They include:
• Stoma contamination or infection which may require use of appropriate antibiotics.
• Irritation, including skin irritation around the stoma.
• Labored breathing, which may occur if the device is heavily soiled, clogged with mucus, or not
changed regularly.
6 I 37602-01H
System Instructions for Use
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