COOK Medical Aintree Catheter Mode D'emploi page 5

AINTREE INTUBATION CATHETER WITH RAPI-FIT®
ADAPTERS
CAUTION: U.S. federal law restricts this device to sale by or on the order of
a physician (or a properly licensed practitioner).
DEVICE DESCRIPTION
The Aintree Intubation Catheter (AIC) is a 19 French, blunt-tipped, radiopaque
catheter with centimeter markings. The catheter has a 4.7 mm inner diameter
(ID), appropriate for a bronchoscope with a maximum outer diameter of
4.2 mm. Does not contain natural rubber latex.
The device consists of the following components:
• Radiopaque catheter
• Rapi-Fit adapter - 15 mm connector
• Rapi-Fit adapter - Luer lock connector
• Double swivel connector
INTENDED USE
The Aintree Intubation Catheter is intended for exchange of a supraglottic
airway device (SAD) to an endotracheal tube (ETT) under bronchoscopic
assistance, and for ETT exchange in adult and pediatric patients.
The 19 French catheter is recommended for use with a supraglottic airway
device and placement of a single-lumen endotracheal tube with an inner
diameter of 7 mm or larger.
When used for high-pressure oxygenation with a Luer lock connector, the
19 French catheter is recommended for patients older than 12 years of age.
CONTRAINDICATIONS
None known
WARNINGS
• Advancing the catheter beyond the carina may introduce additional
procedural risks and trauma.
• Attention should be paid to the insertion depth of the AIC into the
patient's airway and correct tracheal position of replacement ETT. Markers
on the AIC refer to distance from the distal tip of catheter.
• Take care to avoid injuring the epiglottis, glottis, trachea, bronchi, and lung
parenchyma, and to avoid perforating the sinus pyriformis, while using
this device.
• Ensure proper sizing of the AIC within the ETT or SAD.
• To avoid barotrauma, ensure that the tip of the AIC is always above the
carina, preferably 2-3 cm.
• Use of the Rapi-Fit adapter for oxygenation may be associated with a risk
of barotrauma.
• Use of an oxygen source should be considered only if the patient has
sufficient egression of the insufflated gas volume.
• If a high-pressure oxygen source is used for insufflation (e.g., jet ventilator),
begin at a lower pressure (i.e., 5 psi) and work up gradually. Rising chest
wall, pulse oximetry, and oral air flow should be carefully monitored.
• Ensure that the Rapi-Fit Adapter is securely connected to the AIC prior
to oxygen delivery. Failure to properly secure the adapter to the AIC may
result in hypoxia and serious adverse events.
• High-pressure oxygenation with Luer lock connector should only be used
in patients older than 12 years of age. If used in patients 12 years old or
younger, the maximum airway pressure may be higher than 28 cm H
PRECAUTIONS
• This product is intended for use by clinicians trained and experienced in
airway management techniques. Standard techniques for placement and
exchange of ETTs or SADs should be employed.
• This product is not intended for intravascular use.
• The AIC should slide easily onto the bronchoscope. If it does not slide
easily, there is a risk that the catheter may become lodged on the
bronchoscope and cause damage.
• This product should not be used in replacement of ETTs or SADs whose
inner diameter is smaller than 7 mm.
• The use of capnography is highly recommended to confirm intubation.
• A pulse oximeter is recommended during the use of this device.
• It is recommended that a sterile lubricant or sterile water be applied to the
AIC, bronchoscope, and new ETT or SAD prior to their introduction into
the patient.
• Do not attempt to place a bronchoscope through the Rapi-Fit adapter. The
adapter must be removed prior to scope insertion.
• When using an SAD, ensure the cuff is properly inflated (if applicable) and
breath sounds are present.
• This device is not recommended for definitive, long-term airway management.
• The potential effects of phthalates on pregnant/nursing women or
children have not been fully characterized and there may be concern for
reproductive and developmental effects.
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ENGLISH
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