Troubleshooting Guide; Explanation Of Symbols - CooperSurgical 47-9005 Instrucciones De Uso

47-9005 • Adult Esophageal Balloon Catheter • Instructions for Use (English) (Continued)
Catheter Placement
12. Turn the 3-way stopcock open to the syringe and extension
tube. Evacuate all the air from the balloon by pulling back on
the syringe plunger and then allowing the plunger to return to a
non-vacuum position. Use of a glass syringe avoids creating a
vacuum in the balloon catheter.
13. Turn the 3-way stopcock off to the extension tube, remove the
syringe and fill the syringe with 1 cc (ml) of air.
14. Attach the syringe to the 3-way stopcock; open the ay stopcock
from the syringe to the extension tube. Introduce 1 cc (ml)
of air into the balloon. The balloon will now be semi inflated.
An incorrect amount of air in the balloon will adversely affect
pressure wave performance. (see Trouble Shooting Guide).
15. After 1 cc (ml) of air is injected, turn the stopcock off to the
syringe, and open from the extension tube to the transducer to
read pressure from the catheter.
If no or a damped pressure signal is seen, the catheter may
need to be advanced further into the thoracic cavity or may be
kinked on itself and needs to be withdrawn.
In the absence of diaphragmatic paralysis, the pressure
recorded should be negative on inspiration. A positive
inspiratory pressure recording may indicate gastric placement
and the catheter should be pulled back.
Pressures taken through the "Y" connector are for balloon
placement only. The stylet, luer cap and "Y" connector are
bonded into a single unit and must be removed from the
catheter before taking pressure measurements for clinical
purposes.
16. Once the catheter has been positioned properly, disconnect
the extension tube from the stylet "Y" connector and remove
the stylet assembly from the catheter. Excessive curvature
of the catheter may cause the stylet to bind in the catheter
making removal difficult. If the stylet binds in the catheter
during removal, instruct the patient to raise their head to
straighten the catheter.
Pressure Data Acquisition
17. After removing the stylet assembly, reattach the extension tube
to the luer of the catheter and repeat steps 12 through 15.
18. Radiographic placement of the balloon is recommended to
verify proper balloon placement.
19. When the catheter is properly positioned it can be secured with
tape to prevent extubation or movement.
20. Take pressure measurements.
Note: For tolerance specifications and degree of accuracy for
the pressure readings, refer to the pressure measuring device
manufacturer's Instructions for Use (IFU).
21. Upon completion of the pressure measurements, deflate the
catheter prior to removal.
22. Dispose of in accordance with all applicable Federal, State and
local Medical/Hazardous waste practices.
TROUBLE SHOOTING GUIDE
Problem
Pressure waveform flat on top
Pressure waveform flat on
bottom
Pressure waveform all
position
Pressure waveform is
dampened
Pressure waveform is flat with
CPAP

EXPLANATION OF SYMBOLS

Reorder Number
REF
Batch Code
LOT
Use by Date
Sterilized using Irradiation
STERILE R
U.S. Federal law restricts this device to sale by or on the
R Only
x
order of a physician.
2
Do not re-use
!
Caution
Consult instructions for use
Do not use if package is damaged
Authorized Representative in the European Community.
EC REP
Manufacturer
LATEX
Not made with natural latex rubber.
© 2018 CooperSurgical, Inc.
Made in the USA
3
Cause
Not enough air in balloon.
Too much air in balloon.
Too much air in balloon.
Balloon may be in stomach.
Transducer not zeroed to
atmosphere. Patient position
may need adjustment.
Too much air in balloon.
Air/fluid interface in pressure
line.
Do not use fluid.
Added pressure from CPAP
requires additional air in balloon
- 1 cc (ml) more for a CPAP of
5-10 cm H 2 O.