Allurion Elipse Mode D'emploi page 7

Warning: When using the Stylet to assist with
Device swallowing, do not allow the Device to
progress more than 10 cm beyond the oropharynx
(approximately 30 cm from the lips). Allowing the
Device to progress more than 10 cm beyond the
oropharynx may result in patient harm and difficulty
removing the Stylet. During Stylet removal, instruct
the patient to sit up with a neutral spine with the
head tilted back. Keep the Stylet straight and up
during withdrawal and minimize bending. This is
essential to reduce friction during withdrawal.
An assistant should hold the Delivery Catheter
while the physician slowly removes the Stylet to
avoid buckling the Catheter.
3.4. Use markings on Delivery Catheter to assess length
swallowed. See Figure 11 for marking locations.
Warning: Delivery Catheter length markings are
approximate and for reference only. They cannot
replace x-ray or fluoroscopy to confirm location.
Warning: To avoid premature detachment of the
Delivery Catheter from the Balloon, completely
unfasten Stylet connector from Delivery Catheter
prior to pulling Stylet out.
30 CM
40 CM
Figure 11: Delivery Catheter length markings
(not to scale). Length dimensions are approximate.
Warning: Once the Stylet is removed, continue
to have the patient drink water to facilitate distal
esophageal transit of device into the stomach.
3.5. Confirm that the Capsule has reached the stomach
with fluoroscopy and/or abdominal x-ray. Proper
position is indicated if the Capsule, Balloon, and/or
Balloon radiopaque marker is visible in the stomach.
The radiopaque marker is a small ring located on
the inside of the Balloon. If the Capsule remains at
or above the lower esophageal sphincter, ask the
patient to take a deep breath to decrease the
intra-abdominal pressure. In addition, swallowing
a carbonated beverage helps at this stage.
Warning: To avoid esophageal trauma, do not fill the
Balloon until the capsule is confirmed to be in the
stomach with x-ray and/ or fluoroscopy.
4. Elipse Device Filling
4.1. Remove the protective cap from the Blue Stopcock
Connector.
4.2. Connect the Delivery Catheter to the Blue Stopcock
Connector.
4.3. Open the Blue Stopcock. See Figure 12A.
4.4. Close the White Stopcock on the Pressure Infusor
(Figure 12B). If the Pressure Regulator is in the
"down" position (Figure 12C), click the blue button
to set to "up" position (Figure 12D).
50 CM
Figure 12: Stopcocks and Pressure
Regulator Positions for Filling
4.5. Pump the Inflation Bulb until the pressure regulator
indicates a pressure of 300 mmHg.
4.6. Maintain pressure at 300 mmHg until the Flow
Indicator chamber shows a constant stream of fluid.
Proceed to step 4.10 when flow begins. If the Flow
Indicator shows only slow drops of fluid, the Capsule
is not fully open. If the Flow Indicator does not show
a constant stream of fluid within 10 minutes, proceed
to the alternative filling method starting in step 4.7.
Warning: Lack of flow could be an indication that the
Elipse Device is still in the esophagus. Be certain
the Capsule is in the stomach before proceeding
to alternate filling method in step 4.7.
4.7. Alternatively, move the Pressure Regulator to "down"
position (Figure 12C) and increase pressure to
450 mmHg until the Flow Indicator shows a constant
stream of fluid. After a constant stream of fluid is
achieved, return the Pressure Regulator to the "up"
position (Figure 12D). The Pressure Regulator will
hiss while self-correcting pressure to 300 mmHg.
4.8. When the Flow Indicator exhibits a constant stream,
the capsule is open. Continue to pump the Inflation
Bulb until the Pressure Regulator indicates a pressure
of 300 mmHg. The Pressure Regulator will hiss
while self-correcting if it is over pressurized.
4.9. Pump the Inflation Bulb as needed during filling
to maintain a pressure in the "green zone" of the
Pressure Regulator. The Pressure Regulator will
hiss while self-correcting if it is over pressurized.
4.10. If at any point during filling it becomes necessary
to stop filling and empty the Balloon, close the
Blue Stopcock. Disconnect the Delivery Catheter
from the Blue Stopcock Connector and connect it
to the Syringe. Pull back on the Syringe to evacuate
Filling Fluid. Partially filled Balloons must be
endoscopically punctured, aspirated and removed.
(See 6. Endoscopic Elipse Balloon Removal.)
5. Elipse Balloon Detachment
5.1. After Filling Fluid has completely emptied from Filler
Bag, close the Blue Stopcock (Figure 13A).
5.2. Rotate the White Stopcock to deflate the Pressure
Infusor. Allow the Pressure Infusor to fully deflate
(Figure 13B).
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