Apollo ORBERA Intragastric Balloon System Bedienungsanleitung Seite 8

WARNING: Rapid fill rates will generate high pressure
which can damage the ORBERA® System valve or
cause premature detachment.
The following filling recommendations are provided
to avoid inadvertent valve damage or premature
detachment:
• Always use the ORBERA® System fill kit provided.
• Always use a 50 cc or 60 cc syringe. Use of smaller
syringes can result in very high pressures of 30, 40,
and even 50 psi, which can damage the valve.
• With a 50 cc or 60 cc syringe, each filling stroke
should be done slowly (minimum of 10 seconds) and
steadily. Slow, steady filling will avoid the generation
of high pressure in the valve.
• Filling should always be completed under direct
visualization (gastroscopy). Integrity of the valve
should be confirmed by observing the valve lumen
as the balloon fill tube is removed from the valve.
• A balloon with a leaking valve must be removed
immediately. A deflated balloon can result in a
bowel obstruction, which can result in death.
Bowel obstructions have occurred as a result of
unrecognized or untreated balloon deflation.
Note: Any balloons which leak should be returned Apollo
Endosurgery with a complete returned product field note
describing the event. Your assistance with our continuing
quality improvement efforts is appreciated.
A minimum fill volume of 400 ml is required for the
balloon to deploy completely from the placement
assembly. After filling the balloon, remove the fill kit from
the fill tube. Connect a syringe directly to the fill tube
Luer-Lock and produce a gentle suction on the placement
catheter by withdrawing the plunger of the syringe. You
will not withdraw fluid as the valve will seal with the
vacuum created.
CAUTION: If more than 5 ml of fluid can be removed
from the balloon, replace the balloon. Fluid cannot
be removed from the balloon using the fill tube
because the tip of the fill tube does not extend to the
end of the valve.
When filled, the balloon is released by pulling the fill
tube gently while the balloon is against the tip of the
endoscope or the lower esophageal sphincter. Continue
to pull the fill tube until it is out of the self-sealing valve.
After release, the balloon should be visually inspected.
ORBERA® SYSTEM PLACEMENT AND INFLATION
(STEP-BY-STEP)
1. Prepare the patient according to hospital protocol
for gastroscopy.
2. Perform gastroscopic inspection of esophagus
and stomach.
3. Remove gastroscope.
4. Where there are no contraindications:
a. Lubricate the ORBERA® System placement
sheath with surgical lube-gel.
b. Move the ORBERA® System gently down the
esophagus and into the stomach.
5. Reinsert the endoscope while the balloon is in situ
to observe filling steps. The balloon must be below
the lower esophageal sphincter and well within the
stomach cavity.
6. Remove the guide wire from the fill tube.
7. Attach the 3-way stopcock and 50 cc syringe to the
Luer-Lock. Insert filling kit spike into the saline bag
fill tube.
8. Slowly fill the balloon with sterile saline, 50 cc
at a time. Repeat up to 700 cc (14 strokes).
Recommended full volume is up to 700 cc.
minimum fill volume is 400 cc.
9. After the last stroke pull back on plunger to create a
vacuum in the valve to ensure closure.
10. Gently pull the tubing out and check valve for
leakage.
BALLOON REMOVAL (STEP-BY-STEP)
1. Anesthetize per hospital and physician
recommendations for gastroscope procedures.
2. Insert the gastroscope into the patient's stomach.
3. Get a clear view of the filled balloon through the
gastroscope.
4. Insert a needle instrument down the working
channel of the gastroscope.
5. Use the needle instrument to puncture the balloon.
6. Push distal end of tubing through the balloon shell.
7. Remove the needle from the tubing sleeve.
8. Apply suction to the tube until all fluid is evacuated
from the balloon.
9. Remove the tubing from the balloon and out of the
working channel of the gastroscope.
10. Insert a 2-pronged wire grasper through the working
channel of the gastroscope.
11. Grab the balloon with the hooked grasper (ideally at
the opposite end of valve if possible).
12. Administer 5 mg. of Buscopan to relax esophageal
muscles for when the balloon is extracted through
the neck region.
13. With a firm grasp on the balloon, slowly extract the
balloon up the esophagus.
14. When the balloon reaches the throat, hyperextend
the head to allow for a more gradual curve and easier
extraction.
15. Remove the balloon from the mouth.
BALLOON REPLACEMENT
If a balloon needs to be replaced, the instructions
for ORBERA® System Removal and ORBERA® System
Placement and Inflation are followed. If the balloon has
not lost volume at the time of removal, the replacement
balloon may be the same volume as the balloon which is
removed. However, if the previous balloon has deflated
prior to removal, the recommended fill volume for the
replacement balloon is the measured volume of the
balloon removed.
CAUTION: A larger initial fill volume in the
replacement balloon may result in severe nausea,
vomiting or ulcer formation.
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