Contraindications - COOK Medical Frova Mode D'emploi

FROVA INTUBATING INTRODUCER
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 Frova Intubating Introducer is an 8.0 French, 35 cm long radiopaque
catheter introducer with centimeter markings and a blunt, curved tip that can
be passed blindly into the trachea to facilitate intubation. Contains no natural
rubber latex.
The device consists of the following components:
• Radiopaque catheter
• Rapi-Fit adapter – 15 mm connector
• Rapi-Fit adapter – Luer lock connector
• Stiffening stylet
INTENDED USE
The Frova Intubating Introducer is intended to facilitate endotracheal
intubation in adult and pediatric patients where visualization of the glottis is
inadequate.
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.

CONTRAINDICATIONS

Do not use this device if the epiglottis cannot be visualized when performing
direct laryngoscopy (i.e., Grade IV Cormack & Lehane laryngoscopy
classification).
WARNINGS
• Advancing the catheter beyond the carina may introduce additional
procedural risks and trauma.
• Attention should be paid to the insertion depth of the Frova Intubating
Introducer into the patient's airway and correct tracheal position of
replacement endotracheal tube (ETT). Markers on the Frova Intubating
Introducer 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 perforating the sinus pyriformis while using
this device.
• Ensure proper sizing of the Frova Intubating Introducer within the
endotracheal tube.
• To avoid barotrauma, ensure that the tip of the Frova 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 Frova
Intubating Introducer prior to oxygen delivery. Failure to properly secure
the adapter to the introducer may result in hypoxia, hypoxemia, and
serious adverse events.
PRECAUTIONS
• This product is intended for use by clinicians trained and experienced in
airway management techniques.
• This product is not intended for intravascular use.
• This product should not be used in replacement of endotracheal tubes
whose inner diameter is smaller than 3 mm.
• The use of capnography is highly recommended to confirm intubation.
• It is recommended that a sterile lubricant be applied to the Frova and new
endotracheal tube prior to their introduction into the patient.
• This device is not recommended for definitive, long-term airway
management.
POTENTIAL ADVERSE EVENTS
• Barotrauma
• Pneumothorax
• Hypoxia
• Perforation of the trachea, bronchi, or lung parenchyma
• Injury to the epiglottis
• Catheter migration
• Failed endotracheal tube placement
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