Contraindications - COOK Medical Melker Gebrauchsanweisung

ENGLISH
MELKER CUFFED EMERGENCY
CRICOTHYROTOMY CATHETER SET
CAUTION: U.S. federal law restricts this device to sale by or on the order of
a physician (or properly licensed practitioner).
DEVICE DESCRIPTION
The Melker Cuffed Emergency Cricothyrotomy Catheter Set consists of
an airway catheter, scalpel, syringe, curved dilator, Trousseau dilator,
tracheostomy tube tape and tracheal hook.
INTENDED USE
The Melker Cuffed Emergency Cricothyrotomy Catheter Set is intended to
establish emergency airway access when endotracheal intubation cannot be
performed. Airway access is achieved utilizing the surgical technique via the
cricothyroid membrane.

CONTRAINDICATIONS

None known.
WARNINGS
The Melker Cuffed Emergency Cricothyrotomy Catheter Set is not specifically
designed for pediatric applications. Use with pediatric patients should be
determined by the attending physician. Consideration should be given to the
following medical and anatomic conditions and/or therapies:
• Distorted anatomy
• Subcutaneous abscess
• Hematoma
• Scarring/radiation
• Coagulopathies or systemic thrombolytic therapy
PRECAUTIONS
• This product is intended for use by physicians trained and experienced in
proper emergency airway techniques. Standard emergency techniques for
a surgical cricothyrotomy should be employed.
• Patients in need of cricothyrotomy may have significant spinal injury. In
patients who have sustained significant trauma, the cervical spine should
be immobilized throughout the procedure, if possible.
• Whenever possible and appropriate, utilize aseptic technique and local
anesthetic for the procedure.
INSTRUCTIONS FOR USE
Surgical Technique
1. Identify the cricothyroid membrane between the cricoid and thyroid
cartilages.
2. Firmly immobilize the larynx and make a vertical, midline skin incision
down to the depth of the laryngeal structures. (Fig. 1)
3. Make a horizontal membrane incision near the inferior edge of the
cricothyroid membrane. (Fig. 2) NOTE: The index finger may be moved
aside or may remain in the wound, palpating the inferior edge of the
thyroid cartilage, to "guide" the scalpel to the membrane. NOTE: A low
cricothyroid incision avoids the superior cricothyroid vessels, which run
transversely near the top of the membrane.
4. Insert the tracheal hook, oriented transversely. After insertion, apply
cephalad traction to the inferior margin of the thyroid cartilage. (Fig. 3)
5. Insert the Trousseau dilator a short distance into the incision and enlarge
the opening vertically. (Fig. 4)
6. Advance the handled dilator with the blunt tip, blunt end first, into the
connector end of the airway catheter until the handle stops against the
connector. (Fig. 5)
NOTE: This step may be performed prior to beginning the procedure. Use
of lubrication on the surface of the dilator may enhance fit and placement
of the emergency airway catheter.
7. Insert the cuffed emergency airway access assembly between the
blades of the Trousseau dilator, into the airway. As the assembly is
passed between the blades, rotate the Trousseau dilator 90 degrees
counterclockwise, orienting the blades longitudinally in the airway to
facilitate passage of the airway assembly. (Fig. 6)
8. Fully insert the cuffed emergency airway access assembly.
9. Remove dilator and instruments. (Fig. 7)
10. Inflate the cuff using a syringe; an 8-10 mL volume in the cuff will yield a
cuff diameter of 22-29 mm. (Fig. 8) The inflation and deflation procedure
is at the discretion of the physician.
WARNING: Inflation of the cuff with more than 20 mL is not
recommended.
11. Fix the emergency airway catheter in place with the cloth tracheostomy
tape strip in a standard fashion.
12. Connect the emergency airway catheter, using its standard 15 mm
connector, to an appropriate ventilatory device.
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