Contraindications - Halyard MICROCUFF Benutzerhandbuch

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Rx Only: Federal (USA) law restricts this device to sale by or on the order of a physician.
Description
HALYARD* MICROCUFF* Subglottic Suctioning Endotracheal Tubes are adult endotracheal tubes available in a variety of sizes. Refer to
the package label for specific size. HALYARD* MICROCUFF* Subglottic Suctioning Endotracheal Tubes are designed with a polyurethane
High Volume Low Pressure cuff and have an attached pilot balloon with a one-way Luer-slip adapter. HALYARD* MICROCUFF* Subglottic
Suctioning Endotracheal Tubes are supplied sterile with a standard 15 mm connector, have a radiopaque line, and have graduated depth
markings in centimeters, which indicate the distance to the distal tip.
HALYARD* MICROCUFF* Subglottic Suctioning Endotracheal Tubes are available in adult sizes with a Murphy Eye. They include a separate
lumen with a dorsal opening above the cuff to provide access to the subglottic space. The subglottic space is reached via a normally open
suction valve which includes a one-way port for rinsing the subglottic space with sterile saline (0.90% Sodium Chloride solution) or
administering an air bolus to assist in maintaining suction lumen patency.
Indications
HALYARD* MICROCUFF* Subglottic Suctioning Endotracheal Tubes are indicated for airway management by oral intubation of the trachea
and for the removal of secretions that accumulate in the subglottic space.

Contraindications

As with any PVC endotracheal tube, use of HALYARD* MICROCUFF* Endotracheal Tubes in procedures which will involve the use of a laser
beam or electrosurgical active electrode in the immediate area of the device is contraindicated. Contact of the endotracheal tube with a
laser beam or electrosurgical active electrode, especially in the presence of oxygen-enriched mixtures, could result in rapid combustion of
the endotracheal tube with harmful thermal effects and with emission of corrosive and toxic products, including hydrochloric acid (HCI).
Warnings
• Deflate cuff prior to repositioning the tube. Movement of the endotracheal tube with cuff inflated could result in
patient injury or damage to the cuff, requiring a tube change.
• Do not over inflate cuff. Over inflation may result in airway damage.
• Do not reuse, reprocess, or resterilize this medical device. Reuse, reprocessing, or resterilization may 1) adversely
affect the known biocompatibility characteristics of the device, 2) compromise the structural integrity of the device,
3) lead to the device not performing as intended, or 4) create a risk of contamination and cause the transmission of
infectious diseases resulting in patient injury, illness, or death.
Cautions:
General
• Do not use if package has been previously opened or damaged.
• Exposure to elevated temperatures and ultraviolet light should be avoided during storage.
• Intubation and extubation should be performed using currently accepted medical techniques.
• Each tube's cuff, pilot balloon, and valve should be tested by inflation before use.
• Avoid damaging the cuff during intubation. If the cuff is damaged, the tube should not be used.
• Inflation of cuff by "feel" or by using a measured amount of air is not recommended since resistance is an unreliable guide during
inflation. In selecting the sealing pressure, an intracuff pressure measuring device should be used in conjunction with minimal
Occluding Volume or Minimum Leak techniques. Cuff pressure should be monitored. Any deviation from the selected seal pressure
should be investigated and corrected immediately.
• Should extreme chin-to-chest flexing of the head or movement of the patient (e.g., to a lateral or a prone position) be anticipated
after intubation, use of a reinforced endotracheal tube should be considered.
• When the patient's position is altered after intubation, it is essential to verify that the tube position remains correct in the new patient
position.
• Tubes should be securely anchored to avoid unnecessary tube movement.
• Seat the connector firmly in both the endotracheal tube and adapter on the ventilation equipment to prevent disconnection during
use.
• A bite block should be used in cases where the patient may bite down and flatten the endotracheal tube.
• Non-standard dimensioning of some connectors on ventilators or anesthesia equipment may make secure mating with the
endotracheal tube's 15 mm connector difficult.
• Good clinical judgment should be used when selecting complementary devices, such as bronchoscopes and tracheal suction catheters,
which are intended to be inserted through the endotracheal tube. One clinical review recommends using a suction catheter with
outer diameter no greater than 70% of the inner diameter of the endotracheal tube.
• The inflation line check valve may interfere with Magnetic Resonance Imaging (MRI) picture clarity. Ensure the valve is positioned
away from the area being scanned.
• Diffusion of nitrous oxide mixture, oxygen, or air may either increase or decrease cuff volume and pressure. To decrease such diffusion,
inflating the cuff with the same gas mixture that will contact the cuffs external surface is recommended.
• Diffusion of water molecules through the polyurethane cuff may lead to the formation of condensate within the inflation system.
Condensation in the cuff does not impact product performance; however, condensation in the pilot balloon may lead to inaccurate
cuff pressure readings when measured with a cuff pressure manometer. Minimal Occluding Volume or Minimal Leak Techniques are
not affected by condensation and may be used to maintain an adequate seal.
• Three-way stopcocks or other devices should not be left inserted in the inflation valve for extended periods of time. The resulting
stress could crack the valve housing and allow the cuff to deflate.
• The use of lidocaine topical aerosol has been associated with the formation of pinholes in PVC cuffs (Jayasuriya, K.D., and Watson, W.F.:
P.V.C. Cuffs and Lignocaine-based Aerosol, Brit. J. Ann. 53:1368, 1981). The same authors report that lidocaine hydrochloride solution
does not have this effect. Lab tests with polyurethane cuffs have shown to produce similar negative interactions as PVC cuffs with
lidocaine topical aerosol. Also similar to PVC cuffs, lab testing showed polyurethane cuffs did not have these negative interactions with
lidocaine hydrochloride solution.
• Follow the manufacturer's application instructions when using lubricating jellies with endotracheal tubes. If excessive amounts of
jelly dry onto the inner surface of the endotracheal tube, it could result in either a lubricant plug or a clear film that partially or totally
blocks the airway.
• HALYARD* MICROCUFF* Subglottic Suctioning Tubes should be monitored to detect and correct possible occlusion of the suction port
caused by thickened secretions or the entrapment of tracheal mucosa. Possible steps to prevent or correct occlusion of the suction
port may include monitoring and adjusting cuff pressure according to currently accepted guidelines, periodically releasing suction or
switching to intermittent suction if applicable, and either rinsing with saline or administering an air bolus into the suction lumen.
Adverse Reactions
Reported adverse reactions associated with the use of tracheal tubes are many and diverse. Standard textbooks and the scientific
literatures should be consulted for specific adverse reaction information.
The order of listing is alphabetical and 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; barotrauma is a potential complication of the use of this catheter for oxygen delivery, especially
in patients with compromised lung conditions (ie, previous pneumothoraces, pulmonary fibrosis, COPD, previous lung resection/
lobectomies, etc).
HALYARD MICROCUFF
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Subglottic Suctioning Endotracheal Tube
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