Covidien Shiley 115-50OR Mode D'emploi page 4

• 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). Expert clinical judgment
must be used when prescribing treatment involving use of this substance to help prevent situations of cuff leaks
due to pinholes. The same authors report that lidocaine hydrochloride solution does not have this effect.
• Various bony anatomical structures (e.g., teeth, turbinates) within the intubation routes or any intubation tools with
sharp surfaces present a threat to maintaining cuff integrity. Care must be taken to avoid damaging the
thin-walled cuffs during insertion which would create the need to subject the patient to the trauma of extubation
and re-intubation. If cuff is damaged, the tube should not be used.
• Diffusion of nitrous oxide mixture, oxygen or air may 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 resistance 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.
• Do not overinflate cuff. Ordinarily, the cuff pressure should not exceed 25 cm H
Grenvik recommend maintaining a seal pressure at or below 25 cm H
A: Proper use of large diameter, large residual cuffs. Critical Care Medicine Vol. 1, No. 3: 153-154, 1973). Overinflation
can result in tracheal damage, rupture of the cuff with subsequent deflation, or in cuff distortion which may lead to
airway blockage.
• Minimal Occluding Volume or Minimum Leak techniques should be used in conjunction with an intracuff pressure
measuring device in selecting the sealing pressure. Cuff pressure should continue to be monitored thereafter, and
any deviation from the selected seal pressure should be investigated and corrected immediately.
• Deflate cuff prior to repositioning the tube. Movement of the tube with cuff inflated could result in patient injury,
requiring possible medical intervention or damage to the cuff, requiring a tube change. When complete evacuation
of the air from the cuff is accomplished, a definite vacuum will be noted in the syringe and the tracheal tube pilot
balloon is collapsed. Verify correct placement of the tube after each repositioning.
• Syringes, 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.
WARNINGS/PRECAUTIONS (General)
• RAE Tracheal Tube with TaperGuard cuff are designed to fit the average patient, and accordingly, the distance from
the distal tip to bend may be either too long or too short for a given patient. Expert clinical judgment should be
exercised in selection of the appropriate size tracheal tube for each given patient with the awareness that in a
patient whose airway is shorter than average, endobronchial intubation may result, or in a patient whose airway
is longer than average, impingement of the cuff on the cords may result. The RAE Tracheal Tube with TaperGuard
cuff design utilizes an increase in the tip-to-bend length as the I.D. size increases, to correspond to the observed
correlation between patient size and length of the airway. If the tip-to-bend length appears inappropriate for a
given patient, consideration should be give to use of a RAE tube with a smaller or larger I.D. to change the length
correspondingly.
• It is essential to verify that the tube position remains correct after intubation, especially when a patient's postion or
the tube placement is altered. Any tube mal-position should be corrected immediately.
• Exposure to elevated temperatures and ultraviolet light should be avoided during storage.
• Should extreme flexing (chin-to-chest) of the head or movement of the patient (e.g., to a lateral or prone position)
be anticipated after intubation, use of a reinforced tracheal tube should be considered.
• The 15 mm tracheal tube connector is loosely seated. 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 ventilator or anesthesia equipment may make secure mating
with the tracheal tube 15 mm connector difficult. Use only with equipment having standard 15 mm connectors.
• Minimize the traction exerted by the breathing circuit on the 15 mm connector.
• Intubation and extubation should be performed following currently accepted medical techniques.
• If lubricating jellies are used in conjunction with the tracheal tube, follow manufacturer's application instructions.
Excessive amounts of jelly 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.
• 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.
O (Carroll, R.G., and Grenvik,
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O. Carroll and
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