COOK Medical Frova Mode D'emploi page 4

INSTRUCTIONS FOR USE
1. Lubricate an appropriately sized single lumen endotracheal tube and the
distal tip of the catheter introducer.
2. If desired, prior to placement, the endotracheal tube may be preloaded
onto the proximal portion of the catheter introducer.
3. Using laryngoscopy, introduce the tip of the introducer beyond the
epiglottis and advance it in a straight line toward the glottis.
4. Advance the introducer into the trachea, approximately 2-3 cm. If
resistance is encountered, do not force the introducer; instead, it should
be gently rotated and advanced.
5. Remove the stiffening stylet and continue to advance the catheter
introducer into the trachea for no more than 10 cm, the distance being
determined by the size of the patient. NOTE: During introduction, you
may feel tracheal rings.
6. Confirm catheter position using standard methods (e.g., capnography,
breath sounds, x-ray).
7. Maintaining position of the introducer, advance the endotracheal tube
into the trachea to the appropriate distance.
8. Maintaining position of the endotracheal tube, remove the introducer
and laryngoscope.
9. Confirm correct position of the endotracheal tube using standard
methods, (e.g., breath sounds, capnography, X-ray, and endotracheal tube
device labeling).
NOTE: If necessary, oxygen may be given during the procedure, by
utilizing the Rapi-Fit Adapters
Use of the Rapi-Fit® Adapter
Rapi-Fit adapters should only be used when oxygen requirements are
high and intubation is unsuccessful. Use of an oxygen source should only
be considered if the patient has sufficient egression of the insufflated gas
volume. If an oxygen source is used for insufflation, begin at a lower pressure
and work up gradually. Observe the chest for outward and inward movements
to confirm oxygen insufflation and egression. Pulse oximetry and oral air flow
should be carefully monitored as well. In cases of upper airway obstruction,
gas discharge from the patient's lungs may require more time.
1. To attach the Rapi-Fit Adapter, position the adapter on the Frova, then
push the white collar forward and lock into position. (Fig. 1)
2. To remove the adapter, pull the white collar back to release, and then
remove from the Frova. (Fig. 2)
CATHETER OXYGENATION
The Frova Intubation Catheter is designed for both positive airway pressure
ventilation (Rapi-Fit Adapter - 15 mm connector) and jet ventilation (Rapi-Fit
Adapter - Luer lock connector) for both adult and pediatric patients. In the
table below, delivered minute volume, and measured average maximum
airway pressure are given for jet ventilation in adult and pediatric patients
with healthy lung tissue.
Catheter Oxygenation
Real Part
Number (RPN)
C-CAE-8.0-35-
FII-01
1
The test conditions were used in an active model. See Testing Conditions table for
additional details.
Patient Subgroup
and Age Range
Infant > 1 month
to 2 years
Child > 2 years to
12 years
Adolescent
> 12 years
through 21 years
Adult > 21 years
Delivered
Minute
Volume
1
(L/min)
0.7
0.3
0.2
0.8
4
Measured Airway
Pressure
1
(cm H O)
2
Mean Maximum
10.3 15.0
3.7 13.4
3.4 4.0
4.0 5.2