ENDOTRACHEAL TUBE
INTENDED USE / INDICATIONS
An Endotracheal Tube is used in general anaesthesia, intensive care and emergency medicine for airway management and mechanical ventilation. The tube is
inserted into a patient’s trachea through the patient’s nose or mouth in order to
ensure that the airway is not closed off and that air is able to reach the lungs.
CONTRAINDICATIONS
• Use of Endotracheal Tubes in procedures, which will involve the use of a LASER
or an electrosurgical active electrode in the immediate area of the device is contraindicated.
• Patients who are suffering from the serious throat edema/ inammation, hemorrhage or neck vertebra trauma are not recommended to use Endotracheal Tubes.
WARNINGS / PRECAUTIONS (Cuff-related)
• As these devices may have been subjected to handling, storage conditions or
reparation which compromised functional integrity; each tube’s cuff, pilot balloon
and valve should be tested by ination prior to use. If dysfunction is detected in
any part of the ination system, the tube should not be used.
• The use of Lidocaine Topical Aerosol has been associated with the formation of
pinholes in PVC cuffs. 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 the 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. Inating the cuff with the gas mixture which will contact
its external surface is recommended as a means to reduce the extent of such
diffusion.
• Do not overinate cuff. Ordinarily, the cuff pressure should not exceed 25 cm
H2O.
• 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.
• Deate cuff prior to repositioning the tube. Movement of the tube with cuff inated
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 denite vacuum will be noted in the syringe and the
endotracheal 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
ination valve for extended period of time. The resulting stress could crack the
valve housing and allow the cuff to deate.
WARNINGS / PRECAUTIONS (General)
• When a patient’s position or the tube placement is altered after intubation, it is
essential to verify that the tube position remains correct. Any tube displacement
should be corrected immediately.
• Exposure to elevated temperatures and ultraviolet light should be avoided during
storage.
• Should extreme exing (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 endotracheal tube should be considered.
• Non-standard dimensioning of some connectors on ventilatory or anesthesia
equipment may make secure mating with the endotracheal tube 15 mm connector
difcult. Use only with equipment having standard 15 mm connectors.
• Expert clinical judgment should be exercised in the selection of the appropriate
size endotracheal tube for each individual patient.
• Intubation and extubation should be performed following currently accepted
medical techniques.
• The user should be alert for anatomical variations including the length of the
airway.
Reliance on the precut indicator should not, in any case, be substituted for expert
clinical judgment.
• If lubricating jellies are used in conjunction with the endotracheal tube, follow
manufacturer’s application instructions. Excessive amounts of jelly can dry on the
inner surface of the endotracheal tube resulting in either a lubricant plug or a clear
lm 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.
ADVERSE REACTIONS
Initially, most patients complain about the breathing tube feeling uncomfortable. It
often makes patients cough or gag. Over the time the patients get used to the tube
and the initial discomfort fades. During intubating, the respiratory tract may be hurt.
Directions
CUFFED
1. Prior to intubation, deate the cuff completely.
2. After intubation, inate the cuff using the minimum volume of air required to
provide an effective seal.
3. Immediately after cuff ination, auscultate both lung elds. If breath sounds
diminished over one lung eld or absent over one or both elds adjust the tube as
required.
4. Endotracheal Tube placement should be conrmed by viewing the position of the
tube tip with a chest radiograph.
UNCUFFED
1. Choose proper endotracheal tube size.
2. After intubation auscultate both lung elds. If breath sounds diminished over one
lung eld or absent over one or both elds, adjust the tube as required.
3. Endotracheal tube placement should be conrmed by viewing the position of the
tube tip with chest radiograph.
Warning
CUFFED
1. Single use only.
2. Sterile if package is unopened or undamaged.
3. Do not resterilize.
4. Do not expose to temperaures above 49°.
UNCUFFED
1. Single use only.
2. Sterile if package is unopened or undamaged.
3. Do not resterilize.
4. Store in a dry, cool and dark place.
Storage conditions
- Do not expose to temperatures above 49°C.
- Store in a dry, cool and dark place.
- Protect product from moisture and excessive heat.
- Avoid prolonged exposure to ultraviolet and uorescent light.
- Store in manner preventing crushing.
- Stock rotation on rst in rst out basis.
Medical Device complies
with Directive 93/42/EEC
Sterilized using ethylene
oxide
Keep away from sunlight Keep in a cool, dry place
Date of manufacture
CUFFED: 34387 - 34388 - 34389 - 34390 - 34391 - 34392 - 34393 - 34394 - 34395 - 34396
UNCUFFED: 34385 - 34386
Well Lead Medical Co., Ltd.
C-4 Jinhu Industrial Estate, Hualong,
511434 Panyu, Guangzhou, People’s Republic of China
Made in China
Shanghai International Holding Corp. GmbH (Europe)
Eiffestraße 80, 20537 Hamburg, Germany
Lot number Product code
Manufacturer
Imported by :
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
Disposable device,
do not re-use
Don’t use if package
is damaged
Authorized representative in
the European community
Do not resterilize
z
Expiration date
z
0123
M34385-GB-Rev.4-01.21
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