WARNINGS:
CAREFULLY READ THESE INSTRUCTIONS PRIOR TO USE. THESE INSTRUCTIONS
ARE APPLICABLE ONLY TO THE SHILEY DISPOSABLE CANNULA TRACHEOSTOMY
TUBES (DCT, DFEN, DCFS, DCFN) AND DISPOSABLE INNER CANNULAE (DIC).
STERILE ONLY IF THE PROTECTIVE BAG IS NOT OPEN, DAMAGED OR BROKEN. DO
NOT RESTERILIZE. DO NOT EXPOSE TO TEMPERATURES ABOVE 120°F (49°C).
WHEN USING A LASER IN CONJUNCTION WITH THESE DEVICES, CARE MUST
BE TAKEN TO AVOID CONTACT OF THE LASER BEAM WITH THE TUBE. SUCH
CONTACT, ESPECIALLY IN THE PRESENCE OF OXYGEN-ENRICHED MIXTURES,
COULD RESULT IN RAPID COMBUSTION OF THE TUBE WITH HARMFUL THERMAL
EFFECTS AND WITH EMISSION OF CORROSIVE AND TOXIC COMBUSTION
PRODUCTS, INCLUDING HYDROCHLORIC ACID (HCl).
DURING AN MRI SCAN THE PILOT BALLOON SHOULD BE SECURED NEAR THE Y
CONNECTOR OF THE VENTILATOR CIRCUIT AT LEAST 3 CM FROM THE AREA OF
INTEREST TO PREVENT MOVEMENT AND IMAGE DISTORTION.
STERILE. Sterilized with ethylene oxide. For single patient use only.
CAUTION: Federal law (U.S.A.) restricts this device to sale by or on the order of
a physician.
CAUTIONS:
The Shiley Tracheostomy Tube and Accessory Products are composed of medical
grade plastics which do not contain latex material.
Precautions should be taken when discarding any of the tracheostomy tube
devices and accessories. Disposal of medical devices should be made in
accordance with applicable national regulations for biologically hazardous
waste.
Contents of Packages - Refer to Table 5.
Description - Refer to Tables 1 through 4 for Sizing Dimensions
NOTE: The sizing dimensions as noted on Panel 1 refer to the I.D. as the inside
diameter of the inner cannula at the smallest location. O.D. is the outside diameter
of the outer cannula (not including cuff features). Length is the distance from the
neck plate to the distal tip on the tube's centerline.
The Shiley DisposableTracheostomy Tubes (DCT, DFEN, DCFS and DCFN) are
double cannula tracheostomy tubes with disposable inner cannula and snap-lock
connector. The Shiley Tracheostomy Tubes have a radiopaque, biocompatible outer
cannula constructed of polyvinyl chloride. A swivel neck plate allows conformity to
individual neck anatomies. The Disposable Inner Cannula (DIC) with 15 mm snaplock
connector, is translucent for easy inspection and can be used with standard respiratory
equipment. The smooth, rounded tip obturator facilitates insertion. The Shiley
Disposable Cannula Tracheostomy Tubes (DCT, DFEN, DCFS and DCFN) are available in
4