CooperSurgical 47-9005 Mode D'emploi page 2

DEVICE DESCRIPTION
The set contains an 33.9 in. (86 cm) closed-end catheter with a
balloon of 3.7 in. (9.5 cm) length. The catheter has depth markings to
aid in positioning the balloon in the lower third of the thoracic cavity.
(See Figure 1.)
A stylet with a "Y" connector is provided to allow pressure readings
during placement to aid in positioning.
A pressure extension tube with male/female luer and a 3-way
stopcock is provided for connection to pressure measurement
instruments. Not made with natural rubber latex.
Stylet Female Luer
Balloon
WARNINGS
•
If the catheter meets obstruction, DO NOT FORCE THE
CATHETER. Remove it and insert it through the other naris.
•
Avoid placement of the catheter in the trachea to avoid risk of
airway obstruction or trauma to the respiratory system.
•
Particular care should be taken if the patient has an endotracheal
tube in place, as devices of this nature tend to direct the catheter
into the trachea.
•
Do not insert the stylet while the catheter is in the patient as there
is a chance that the stylet could exit through a catheter shaft
balloon hole, puncture the balloon and cause injury.
•
Contents supplied sterile. Do not use if sterile barrier is damaged.
•
For single use only. Do not reuse, reprocess or resterilize. Reuse,
reprocessing or resterilization may compromise the structural
integrity of the device and/or lead to device failure which, in turn,
may result in patient injury, illness or death. Reuse, reprocessing
or resterilization may also create a risk of contamination of the
device and/or cause patient infection or cross-infection, including,
but not limited to, the transmission of infectious disease(s) from
one patient to another. Contamination of the device may lead to
injury, illness or death of the patient. Dispose of in accordance
with all applicable Federal, State, and local Medical/Hazardous
waste practices.
CAUTION: U.S. Federal law restricts this device to sale by or on the
order of a physician.
INTENDED USE/INDICATIONS
The balloon catheter is inserted by nasal intubation into the
esophagus for monitoring and measuring intrathoracic pressure
changes related to respiration. It is intended for use in pulmonary
function studies, sleep apnea diagnostic studies and for patients on
mechanical ventilation.
CONTRAINDICATIONS
Use of the esophageal catheter is contraindicated in patients with
diseases such as esophageal ulcerations, tumors, diverticulitis,
bleeding varices or in patients with sinusitis, epistaxis or recent
nasopharyngeal surgery.
47-9005 • Adult Esophageal Balloon Catheter
Instructions for Use (English)
Catheter
Figure 1
PRECAUTIONS
The stylet and "Y" connector are bonded into a single unit and
should be removed from the catheter before taking final pressure
measurements (pressure measurements for placement can be done
with the stylet in place).
ADVERSE EVENTS
None known.
PATIENT COUNSELING INFORMATION
Have the patient be NPO for 4 hours prior to catheter insertion.
The patient should be instructed to wait for numbness to vanish
before eating.
INSTRUCTIONS FOR USE
Patient/Catheter Preparation
1. Have available for use an emesis basin, tissues, a protective
drape, topical anesthetic, water-soluble lubricant and a 1 to 5 cc
(ml) glass syringe.
2. Select a naris with the best airflow for catheter insertion.
3. If necessary apply a suitable topical anesthetic (e.g. 2-4%
Lidocaine Spray) to the patient's nasal passage and throat.
4. Remove the sterile radiopaque catheter with the stylet from its
protective package.
5. Remove the yellow protective sleeve from the catheter and
discard.
6. Apply water-soluble lubricant to the distal tip of the catheter.
7. With the patient's head in a neutral position or flexed slightly
forward, slowly insert the catheter through the naris and
hypopharynx using a gentle advancing motion.
8. Avoid placement of the catheter in the trachea. Tracheal
placement can be identified by patient choking or airway
obstruction causing an increase in airway resistance and
pressure.
9. To estimate depth in which to place catheter calculate the
product of the patient's height x 0.288.
10. Advance the catheter to the calculated depth mark. (If the
catheter meets obstruction, DO NOT FORCE THE CATHETER.
Remove it and insert it through the other naris.) At this depth,
the balloon will be entering the thoracic cavity.
11. Attach the extension tubing to the "Y" connector of the stylet,
a syringe and an isolated physiologic transducer to the 3-way
stopcock. (See Figure 2.)
Stylet "Y"
Connector
Extension
Tube
Figure 2
2
Catheter
Syringe
Pressure
Transducer
Tubing
3-Way
Stopcock