Covidien Shiley 18710, Инструкция по эксплуатации

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10. Check to verify that cuff inflation system is not leaking. Integrity of the
system should be verified periodically during the intubation period.
Any deviation from the selected seal pressure should be investigated
and corrected immediately.
11. The device should be secured in the patient's airway following
currently accepted medical techniques.
12. Follow hospital procedures regarding the suctioning of the airway
lumen to remove secretions.
13. Prior to extubation, deflate the cuff by inserting a syringe into the valve
housing and removing the gas mixture until a definite vacuum is noted
in the syringe and the pilot balloon is collapsed.
14. Extubate the patient following currently accepted medical techniques.
15. Discard the endotracheal tube.
WARNINGS
• Each tube’s cuff, pilot balloon and valve should be tested by
inflation prior to use. If dysfunction is detected in any part of the
inflation system, the tube should not be used and be returned.
• Do not overinflate the cuff. Ordinarily, the cuff pressure should
not exceed 25 cmH
2
O. Overinflation can result in tracheal damage,
rupture of the cuff with subsequent deflation, or in cuff distortion
which may lead to airway blockage.
• Deflate the cuff prior to repositioning the tube. Movement of the
tube with the cuff inflated could result in patient injury, requiring
possible medical intervention or damage to the cuff.
• Various bony anatomical structures (e.g., teeth, turbinates) within
the airway or any intubation tools with sharp surfaces might
jeopardize cuff integrity. Damage to the thin-walled cuff during
insertion will subject the patient to the risk of extubation and
re-intubation. If the cuff is damaged, the tube should not be used.
• It is essential to verify that the tube position remains correct
after intubation, especially when a patient’s position or the tube
placement is altered. Any tube mal-position should be corrected
immediately.
• If extreme flexion of the head (chin-to-chest), movement of the
patient (e.g., to a lateral or prone position), or tube compression
is anticipated after intubation, use of a reinforced tracheal tube
should be considered.
• Syringes, three-way stopcocks or other devices should not be left
inserted in the inflation valve for an extended period of time. The
resulting stress could crack the valve housing and allow the cuff to
deflate.
• 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.
Cautions
• The use of Lidocaine Topical Aerosol has been associated with the
formation of pinholes in PVC cuffs. Lidocaine hydrochloride solution
has been reported not to have this effect.
• Diffusion of nitrous oxide, oxygen or air can either increase or decrease
cuff volume and pressure. Inflating the cuff with the gas mixture which
will contact its external surface is recommended as a means to reduce
the extent of such diffusion.
• Inflation of the cuff by “feel” alone or by using a measured amount
of air is not recommended since compliance is an unreliable guide
during inflation. Intracuff pressure should be closely monitored with
a pressure measuring device. The pilot balloon is only intended to
indicate the presence of pressure or vacuum in the cuff and is not
intended to provide an indication of pressure level.
• Avoid exposure to elevated temperatures and ultraviolet light during
storage.
• The 15mm connector is seated so that it can be removed with
effort if pre-cutting of the tube is desired. Follow the SUGGESTED
DIRECTIONS FOR USE to evaluate the tube and connector for suitability
if pre-cutting is considered. Always assure the connector is firmly
seated in both the tracheal tube and the breathing circuit to prevent
disconnection during use.
• Non-standard dimensioning of some connectors on ventilatory or
anesthesia equipment may make secure mating with the tracheal tube
15mm connector difficult. Use only with equipment having standard
15mm connectors.
• If the device is lubricated prior to insertion, follow manufacturer’s
application instructions. Excessive amounts of lubricant can dry on the
inner surface of the tracheal tube resulting in either a lubricant plug or
a clear film that partially or totally blocks the airway.
• Use of lubricating jelly to ease connector reinsertion is not
recommended as it may contribute to accidental disconnections.
Note:
The performance information shown on page 74 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