Device Description; Intended Use; Contraindications - COOK Medical Rapi-Fit Gebrauchsanweisung

ENGLISH
COOK AIRWAY EXCHANGE CATHETERS
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 Cook Airway Exchange Catheter (CAE) is a blunt-tipped radiopaque catheter
with centimeter markings to help facilitate the removal and exchange of an
endotracheal tube (ETT). 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

INTENDED USE

The Cook Airway Exchange Catheter is intended for endotracheal tube
exchange in adult and pediatric patients.
The 8 French catheter is recommended for placement of an endotracheal tube
with an inner diameter of 3 mm or larger.
When used for high-pressure oxygenation with a Luer Lock connector, the
8 French catheter is recommended for patients older than 1 month of age.
The 11 French catheter is recommended for placement of an endotracheal
tube with an inner diameter of 4 mm or larger.
When used for high-pressure oxygenation with a Luer Lock connector, the
11 French catheter is recommended for patients older than 2 years of age.
The 14 French catheter is recommended for placement of an endotracheal
tube with an inner diameter of 5 mm or larger.
When used for high-pressure oxygenation with a Luer Lock connector, the
14 French catheter is recommended for patients older than 2 years of age.
The 19 French catheter is recommended for placement of an 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
• Possible allergic reactions (e.g., to butyl rubber) should be considered.
• Advancing the catheter beyond the carina may introduce additional
procedural risks and trauma.
• Attention should be paid to the insertion depth of a Cook Airway
Exchange Catheter (CAE) into the patient's airway and correct tracheal
position of replacement endotracheal tube (ETT). Markers on the CAE refer
to distance from the distal tip of catheter.
• Take care to avoid injuring the epiglottis, glottis, trachea, bronchi, or lung
parenchyma, and to avoid perforation the sinus pyriformis while using this
device.
• Ensure proper sizing of the CAE within an ETT (including double-lumen
ETT).
• To avoid barotrauma, ensure that the tip of the CAE 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.
• Oxygen insufflation may not be appropriate for all patient subgroups
and with all products. Please refer to the Catheter Oxygenation Table for
product and patient subgroup details.
• 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 CAE prior
to oxygen delivery. Failure to properly secure the adapter to the CAE may
result in hypoxia and serious adverse events.
• Using high-pressure oxygenation with a Luer lock connector in the infant
patient subpopulation (> 1 month to 2 years) has only been evaluated with
the 8 French catheter; using larger catheters with this subpopulation is not
recommended.
• For the 19 French catheter, high-pressure oxygenation with a 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 O.
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