Covidien Shiley - Instructions for Use; Tube Preparation; Cuff and Inflation Testing

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four sizes: 4, 6, 8, and 10. Additional Disposable Inner Cannula (DIC) in the same sizes
are available separately.
Cued models (DCT, DFEN) have a thin wall, high volume, low pressure cu to
minimize pressure in the trachea. When inated, the cu conforms to the natural
shape of the trachea providing a seal at low intracu pressure. The cu ination line
has a luer valve with an integral pilot balloon to indicate cu ination.
The red Disposable Decannulation Plug (DDCP) can be used to occlude the proximal
end of the outer cannula, forcing the patient to breathe through the fenestrations and
upper airway tract during the weaning process. The Disposable Decannulation Plug
is available in a universal size that ts all four sizes of the Shiley Disposable Cannula
Tracheostomy Tubes (DFEN, DCFS, DCFN) and can be purchased separately.
Indications for Use
The devices are intended for use in providing tracheal access for airway management.
The fenestrated devices (DFEN, DCFN) are also indicated when the use of fenestrations
is desirable in order to safely and eectively wean a tracheostomy patient. When
used in conjunction with the Disposable Decanulation Plug (DDCP), the fenestrated
tracheostomy tube can provide a means of weaning and/or phonation for the patient.
Use of the Disposable Decannulation Plug with the fenestrated tracheostomy tubes
forces air through the fenestrations and around the tube, and into the upper airway
and vocal cords.
CAUTION:
The Shiley Tracheostomy Tube is classied as a disposable medical device.
Frequent and routine changes of the Tracheostomy Tube are recommended.
The manufacturer recommends that the Tracheostomy Tube usage not exceed
twenty-nine (29) days. Frequent and routine changes of the Tracheostomy Tube
and accessories are recommended and should be evaluated by the attending
physician.
The Disposable Inner Cannula (DIC) and the Disposable Decannulation Plug
(DDCP) are designed for single use and should not be cleaned or reused.
Instructions
Tube Preparation
1. Selection of trach tube size is left to the discretion of the physician. Patients in the
home care environment should be carefully instructed by a home care provider in the
proper use and handling of this device.
Pre-Insertion Cu and Ination Test
NOTE: Refer to Tables 1 and 2 for Leak Test Ination Volumes. Ination volumes
are for test purposes only. Consult the physician or Home Health Care Provider for
the appropriate ination volume/pressure when the tube is positioned within the
trachea.