Tyco Shiley TracheoSoft User manual

Shiley™ TracheoSoft™
XLT Extended Length Tracheostomy Tube
XLT Extended Length Disposable Inner Cannula
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Symbols 77

2
xxXLTCD xxXLTCP xxXLTUD xxXLTUP xxXLTIN
Cat. No. Cuff Inner
Cannula Obturator Neck
Strap TTH Distal
Extension Proximal
Extension
xxXLTCD X X X X X X
xxXLTCP X X X X X X
xxXLTUD X X X X X
xxXLTUP X X X X X
xxXLTIN X
Table 1
XX = First 2 Digits of Product Code Designated to the Inner Diameter.

3
Cat. No.
Inner
Cannula
I.D. (mm)
Outer
Cannula
O.D. (mm)
Total Length
(mm) A
(mm) B
(mm) C
(mm) Cuff Resting
Diameter (mm)
Leak Test Inflation
Volume (cc)
50XLTCD 5.0 9.6 90 48.0 5.0 37.0 29.2 27
50XLTUD 5.0 9.6 90 48.0 5.0 37.0 50XLTCP 5.0 9.6 90 33.0 20.0 37.0 29.2 27
50XLTUP 5.0 9.6 90 33.0 20.0 37.0 60XLTCD 6.0 11.0 95 49.0 8.0 38.0 31.3 28
60XLTUD 6.0 11.0 95 49.0 8.0 38.0 60XLTCP 6.0 11.0 95 34.0 23.0 38.0 31.8 28
60XLTUP 6.0 11.0 95 34.0 23.0 38.0 70XLTCD 7.0 12.3 100 49.0 12.0 39.0 35.0 31
70XLTUD 7.0 12.3 100 49.0 12.0 39.0 70XLTCP 7.0 12.3 100 34.0 27.0 39.0 35.0 31
70XLTUP 7.0 12.3 100 34.0 27.0 39.0 80XLTCD 8.0 13.3 105 50.0 15.0 40.0 35.0 31
80XLTUD 8.0 13.3 105 50.0 15.0 40.0 80XLTCP 8.0 13.3 105 35.0 30.0 40.0 35.0 31
80XLTUP 8.0 13.3 105 35.0 30.0 40.0
Table 2

4
Cat. No. Cat. No.
XLT Disposable
Inner Cannula For use with XLT
Tracheostomy Tube Inner Cannula I.D. (mm) Inner Cannula Length
(mm)
50XLTIN 50XLTUP
50XLTCP
50XLTUD
50XLTCD
5.0 90
60XLTIN 60XLTUP
60XLTCP
60XLTUD
60XLTCD
6.0 95
70XLTIN 70XLTUP
70XLTCP
70XLTUD
70XLTCD
7.0 100
80XLTIN 80XLTUP
80XLTCP
80XLTUD
80XLTCD
8.0 105
Table 3

5
Shiley™ TracheoSoft™
This instruction insert applies to the following
Shiley & Shiley TracheoSoft products:
XLT Extended Length Tracheostomy Tube - Distal Extension - Cuffed
XLT Extended Length Tracheostomy Tube - Proximal Extension - Cuffed
XLT Extended Length Tracheostomy Tube - Distal Extension - Cuffless
XLT Extended Length Tracheostomy Tube - Proximal Extension - Cuffless
XLT Extended Length Disposable Inner Cannula
LOT
Directions for Use
Indications
The devices are intended for use in providing tracheal access for airway
management.
WARNINGS
• The Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and
obturator are single patient use medical devices and usage should not
exceed twenty-nine (29) days. Frequent and routine changes of the
tracheostomy tube and accessories are recommended and should be
evaluated by the qualified physician.
• The Shiley TracheoSoft XLT Extended Length Disposable Inner Cannula,
neck strap and Shiley TTH Tracheostomy Tube Holder are disposable medical
devices and are designed for single use and should not be cleaned or reused.
• Carefully read these instructions prior to use. These instructions
are applicable only to the Shiley TracheoSoft XLT Extended Length
Tracheostomy Tubes, Shiley TracheoSoft XLT Extended Length
Disposable Inner Cannula.
• The products packaged in the tray inside the box are sterile unless the
package is opened or damaged. Do not resterilize. Do not expose to
temperatures above 120°F (49°C).
• The Shiley TracheoSoft XLT Extended Length Disposable Inner Cannula
provided in this package can only be replaced by a Shiley TracheoSoft
XLT Extended Length Disposable Inner Cannula of the same size and
catalog number.
• A Shiley TracheoSoft XLT Extended Length Disposable Inner Cannula
must be in place to mechanically ventilate the patient.
• During and after attachment of respiratory or anesthesia tubing connectors
to the Shiley TracheoSoft XLT Extended Length Disposable Inner Cannula,
avoid application of excessive rotational, linear, or rocking forces on the
tubing and/or connectors to prevent damage to the tracheostomy tube.
• Because of its special design, the Shiley TracheoSoft XLT Extended
Length Disposable Inner Cannula requires careful handling during
insertion and removal. When inserting an inner cannula, use a smooth,
uniform and consistent motion, using the least amount of force
necessary for complete insertion.
ENGLISH