apollo endosurgery ORBERA365 Manual Del Usuario página 9

WARNING: Rapid fill rates will generate high pressure
which can damage the IGB valve or cause premature
detachment from the tip of the Placement Catheter.
Filling should always be completed under direct
•
visualization (gastroscopy). Integrity of the IGB valve
should be confirmed by observing the valve lumen as
the Placement Catheter is removed from valve of the
IGB.
• An IGB with a leaking valve must be removed
immediately. A partially filled IGB can result in a bowel
obstruction, which can result in death. Bowel
obstructions
unrecognized
collapse).
Note: Any IGB that leaks should be returned to Apollo
Endosurgery with a completed product return field note
describing the event. Your assistance with our continuing
quality improvement efforts is appreciated.
A minimum fill volume of 400cc is required for the IGB to
deploy completely from the Placement Catheter. After
filling the IGB, remove the Fill Kit from the catheter.
When filled, the IGB is released by pulling the Placement
Catheter gently while the IGB is against the tip of the
endoscope or the lower esophageal sphincter.
Continue to pull the Placement Catheter until it has
detached from the IGB's self-sealing valve. Once
detached, the placement of the IGB should be visually
inspected as well as for the presence of any fluid leaks.
12.3 IGB PLACEMENT AND FILLING (STEP-BY-STEP)
1. Prepare the patient according to hospital protocol for
sedation and endoscopy.
2. Perform endoscopic inspection of the esophagus and
stomach.
3. Remove endoscope.
4. If there are no contraindications:
a. Lubricate the sheath of the Placement Catheter
assembly with surgical lube-gel.
b. Gently insert the Placement Catheter into the
esophagus and into the stomach.
5. Reinsert the endoscope while the IGB is in situ to observe
filling steps. The IGB MUST be below the lower
esophageal sphincter and well within the stomach cavity.
6. If present, remove the guidewire from the placement
catheter.
7. Attach the sterile 50cc syringe to the Luer lock of the Fill
Kit's 3-way stopcock and then insert the spike of the Fill
Kit into a bag of sterile normal saline solution for injection
(.9 NS).
8. Slowly fill the IGB with sterile saline, 50cc at a time.
Repeat up to a minimum fill volume of 400cc to a
maximum fill volume of 700cc (14 strokes).
9. Gently remove the Placement Catheter and inspect the
IGB valve for leakage.
have occurred as a
or untreated IGB deflation
12.4 IGB REMOVAL (STEP-BY-STEP)
1. Ensure that the patient has been on a liquid diet for 72
hours and NPO (i.e. nothing by mouth) for a minimum of
12 hours before attempting removal. Whether this
regimen has been followed or not (i.e. in the case of an
urgent removal), due to the potential for residual gastric
contents in some patients, additional precautions for
aspiration should be considered. In higher risk patients
with signs and symptoms suggestive of severely
delayed
obstruction, a focused physical examination for
abdominal distension and/or succussion splash should
be performed, followed by radiographic evaluation if
result of
succussion splash is absent and the epigastrium is full
(i.e.
or tender. If radiographic evaluation is positive for
distended stomach with or without an antral IGB, then
nasogastric decompression should be considered, the
airway should be secured, and general anesthesia
employed.
2. Prepare the patient according to hospital protocol for
sedation
administering a smooth muscle relaxant such as
intravenous glucagon to relax the esophageal sphincter.
3. Insert the endoscope into the patient's stomach.
4. Assess for the presence of food. If food is present in the
stomach the procedure should be delayed. If emergent
removal, the airway should be protected prior to
proceeding.
5. Get a clear view of the filled IGB using the endoscope.
6. Insert a sheathed needle catheter down the working
channel of the endoscope.
7. Use the advanced exposed needle to puncture the IGB.
8. Push the needle catheter through the IGB shell and well
into the IGB.
9. Remove the needle from the catheter.
10. Apply suction to the deeply inserted catheter until all
fluid is evacuated from the IGB.
11. Remove the catheter from the IGB and out of the
working channel of the endoscope.
12. Insert a long jaw or wire prong grasper through the
working channel of the endoscope.
13. Grab the IGB with the grasper (ideally at the opposite
end of valve if possible).
14. With a firm grasp on the IGB, slowly extract the IGB up
the esophagus.
15. When the IGB reaches the upper esophageal sphincter,
hyperextend the head to straighten the passage out of
the esophagus and throat, allowing for an easier
extraction.
16. Remove the IGB from the mouth.
9
gastric emptying and/or
and endoscopy. Additionally,
gastric outlet
consider