Contraindications - COOK Medical Retrograde Intubation Set Gebrauchsanweisung

RETROGRADE INTUBATION SETS
CAUTION: U.S. federal law restricts this device to sale by or on the
order of a physician (or properly licensed practitioner).
DEVICE DESCRIPTION
Retrograde Intubation Sets consist of the following components:
• Introducer needle
• Catheter introducer needle
• .038 inch wire guide with two positioning marks, 20 cm from each
end
• Radiopaque catheter
• Syringe
INTENDED USE
The Retrograde Intubation Set is intended to assist in the placement
of an endotracheal tube during difficult or emergency airway access
procedures where visualization of the vocal cords is not possible
secondary to secretions, blood and/or anatomic anomalies.
Refer to the table below for sizing information.
Retrograde Intubation

CONTRAINDICATIONS

• Ongoing coagulopathy
• Obscure cricothyroid anatomy
• Infection of cricothyroid membrane
• Mass (i.e., goiter)
WARNINGS
None known
PRECAUTIONS
• This product is intended for use by physicians trained and
experienced in retrograde intubation techniques. Standard
techniques for retrograde intubation should be employed.
• The 6.0 French set can only be used in placement of endotracheal
tubes whose ID is 2.5 mm or larger.
• The 11.0 French set can only be used in placement of endotracheal
tubes whose ID is 4 mm or larger.
• The 14.0 French set can only be used in placement of endotracheal
tubes whose ID is 5 mm or larger.
INSTRUCTIONS FOR USE
1. After prepping access site in standard fashion, advance either the
introducer needle (attached to syringe) or the catheter introducer
needle (attached to syringe) in a cephalad direction through
cricothyroid membrane and into trachea. Confirm positioning via
free-flow aspiration of air into syringe. (Fig. 1)
2. If using introducer needle, remove syringe, leaving needle in
place. If using catheter introducer needle, remove needle and
syringe, leaving catheter in place.
3. Advance "J" end of wire guide through catheter or needle and up
into trachea in a cephalad direction until tip of wire guide can be
retrieved through the patient's mouth or nose. NOTE: The black
positioning marks on wire guide should be visible both at access
site and where wire guide exits nares or mouth. (Fig. 2) This will
ensure that enough wire is exposed orally or nasally for control of
subsequent catheter introduction.
4. Remove catheter or needle, leaving wire guide in place.
5. Advance radiopaque catheter antegrade over wire guide
via mouth or nose and into trachea until tenting is noted at
cricothyroid access site. (Fig. 3)
NOTE: Alternatively, after initial wire guide positioning, a
fiberoptic bronchoscope may be used for direct visualization of
endotracheal tube placement. Wire guide may be placed through
suction port of fiberoptic scope.
6. With catheter in position, advance endotracheal tube over catheter
and into position below the level of the vocal cords. (Fig. 4)
NOTE: Always maintain control and position of wire guide during
advancement of endotracheal tube.
7. Remove wire guide and catheter from endotracheal tube, advance
endotracheal tube to optimal position, and inflate balloon cuff if
provided.
8. Verify position and secure in standard fashion. (Fig. 5)
HOW SUPPLIED
Supplied sterilized by ethylene oxide gas in peel-open packages.
Intended for one-time use. Sterile if package is unopened or
Set Size
6.0 Fr
11.0 Fr
14.0 Fr
For Use With Endotracheal
Tube (ID)
2.5 mm or larger
4.0 mm or larger
5.0 mm or larger
5
ENGLISH