Covidien Shiley 18710S, Instructions For Use Manual

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• Do not abrade the plastic sheath of the stylet on the sharp edges of the
15mm connector during insertion or removal from the tracheal tube.
If the stylet sheath is torn, cut, or lacerated while reshaping the stylet,
do not use for intubation as a damaged sheath presents an increased
hazard of separation during withdrawal of the stylet.
Note: The performance information shown on page 73 was collected using
a Rigid Cylinder Trachea Model bench test that is intended to provide a
comparison of the sealing characteristics of tracheal tube cuffs only in a
laboratory setting and is not configured or intended to predict performance
in the clinical setting.
Adverse Reactions
The following adverse reactions have been reported to be associated with
the use of cuffed endotracheal tubes during the intubation procedure,
during the intubation period, or subsequent to extubation. The order of
listing does not indicate frequency or severity. Reported adverse reactions
include: abrasion of the arytenoid cartilage vocal process; cartilage
necrosis; cicatrix formation; consequences of failure to ventilate including
death; damage to the perichondrium; development of dense or diffuse
fibrosis invading the entire glottic area; emphysema; endobronchial
aspiration; endobronchial intubation (hypoxemia); endotracheobronchial
aspiration; epistaxis; esophageal intubation (stomach distention);
excoriated membranes of the pharynx; eye trauma; fibrin deposition;
formation of subglottic web; fracture-luxation of cervical column (spinal
injury); fragmentation of cartilage; glottic edema (supraglottic, subglottic
retroarytenoidal); granuloma of the inner arytenoid area; infections
(laryngitis, sinusitis, abscess, respiratory tract infection); inflammation;
intermittent aphonia and recurrent sore throat; laryngeal fibrosis; laryngeal
granulomas and polyps; laryngeal obstruction; laryngeal stenosis; laryngeal
ulcers; laryngotracheal membranes and webs; membraneous glottic
congestion; membraneous tracheobronchitis; mild edema of the epiglottis;
mucosal sloughing; paresis of the hypoglossal and/or lingual nerves;
perforation of esophagus; perforation of the trachea; pneumothorax;
replacement of the trachea wall with scar tissue; respiratory obstruction;
retrobulbar hemorrhage; retropharyngeal abscess; retropharyngeal
dissection, rupture of the trachea; sore throat, dysphagia; stricture of nostril;
stridor; subglottic annular cicatricial stenosis; submucosal hemorrhage,
submucous puncture of the larynx; superficial epithelial abrasion;
swallowed tube; synechia of the vocal cords; teeth trauma; tissue burns;
tracheal bleeding; tracheal stenosis; trauma to lips, tongue, pharynx, nose,
trachea, glottis, palate, tonsil, etc.; traumatic lesions of the larynx and
trachea; ulcerations exposing cartilaginous rings and minor erosions at cuff
site; ulceration of the lips, mouth, pharynx; ulcers of the arytenoid; vocal
cord congestion; vocal cord paralysis, and vocal cord ulcerations.
ADDITIONAL COPIES OF INSTRUCTIONS
Copies of these Instructions are available at no charge visiting
www.covidien.com, or by calling Covidien, or its authorized distributors.
Also, permission is hereby granted under Covidien copyrights to purchasers
of products obtained with Covidien or its authorized distributors to make
additional copies of these instructions for use by such purchasers.