Covidien Shiley Gebrauchsanleitung Seite 5

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Shiley
TM
Tracheostomy Tube Cuffless
Disposable Inner Cannula
4UN65A 6.5 mm
5UN70A 7.0 mm
6UN75A 7.5 mm
7UN80A 8.0 mm
8UN85A 8.5 mm
9UN90A 9.0 mm
10UN10A 10.0 mm
Instructions for Use
POST FOR USE BY ALL TRACHEOSTOMY CARE PERSONNEL
Description
The Shiley™ Tracheostomy Tube Cuffless ("tracheostomy tube") is a dual cannula tracheostomy tube
with a disposable inner cannula. It contains an integrated 15 mm connector for use with standard
ventilation and anesthesia equipment.
The tracheostomy tube has a radiopaque, bio compatible outer cannula constructed of polyvinyl
chloride. A pliable neck plate allows conformity to individual neck anatomies and contains two
suture holes. The tapered tracheostomy tube tip is compatible with percutaneous insertion. The
smooth, rounded tip obturator facilitates insertion. The disposable inner cannula is translucent for
easy inspection and allows for airway maintenance.
This tracheostomy tube can be used with or without the disposable inner cannula included in the
package (and also available separately; reference 10006780 for part numbers). However, use of the
inner cannula is recommended.
Indications for Use
The Shiley™ Tracheostomy Tube Cuffless is intended to provide tracheal access for airway management.
The Shiley™ Tracheostomy Tube Cuffless is also intended for use with Percutaneous Dilatational
Tracheotomy (PDT) procedures.
warnIngs
• When using a laser or electrosurgical device in conjunction with this or other tracheal tubes,
care must be taken to avoid contact with the tube. Such contact, especially in the presence
of oxygen-enriched mixtures or nitrous oxide containing 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).
• The tracheostomy tube and neck strap cannot be adequately resterilized by the user in order
to facilitate safe reuse and are therefore intended for single patient use. Attempts to resterilize
this device may result in product failure and increased risks to the patient.
• Sterile only if the protective tray and cover are not open, damaged, or broken. Do not
resterilize. Do not expose to temperatures above 120˚F (49˚C).
• Prior to use, handle with due care to prevent user contamination.
• The disposable inner cannula is designed for single use and should not be cleaned or reused.
• When using a disposable inner cannula, it can only be replaced by a Shiley disposable inner
cannula of the same size.
Identification of a substance
that is contained or present
within the product or packaging.
Identification of a substance
that is not contained or present
within the product or packaging.
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