A-A-51654 Tube, Tracheostomy, Disposable (Low Pressure Cuff, Shiley)This commercial item description covers sterile, disposable, soft plastic, low pressure cuff tracheostomy tube, Shiley style, suitable for long term ventilation of tracheostomy patients who do not require high ventilation pressures.

Pages 1 - 2 - 3 - 4 - 5 - 6

A-A-51654B

Sizes. The following sizes of Shiley tracheostomy tubes are covered by this document:

Size	O.D.	I.D.	Length
4	8.5 mm (26.0 Fr)	5.0 mm	67 mm
6	10.0 mm (30.0 Fr)	7.0 mm	78 mm
8	12.0 mm (36.0 Fr)	8.5 m	84 mm
10	13.0 mm (39.0 Fr)	9.0 mm	84 mm

Inner cannula. The tracheostomy tube shall have a removable inner cannula with a twist lock and integral 15 mm connector. The inner cannula shall be easily removed and cleaned to maintain a patient airway without removing the outer tube. Inner cannula proximal end design shall conform to American
Standard Specification ANSI Z79.2.

Obturator. Item shall be provided with a smooth tapered obturator to simplify insertion and minimize trauma.

Sterility. The tracheostomy tube shall be sterile in accordance with the USP or AAMI requirements. Sterility assurance level shall be 0.000001.

Pyrogenocity and toxicity. The tracheostomy tube shall be free from pyrogens, non-toxic, and in accordance with the USP for Class IV plastics.

Workmanship. The tracheostomy shall be free from defects which may detract from its appearance or impair its serviceability. Components shall be free from cuts, tears, weak sections, flash dust, grease, or other foreign matter.

Unit.

Sizes 4, 6, and 8.

Each (EA). One tracheostomy tube, of one size, and type only as specified, constitutes one unit. The individual package shall be a sealed peel-open type container capable of maintaining sterility of contents unless the package is damaged or opened.

�