Recommended Procedure - Allurion Elipse Mode D'emploi

Patients should be available to follow-up with their
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physician throughout the therapy period, particularly
if they experience symptoms including but not limited
to persistent nausea, vomiting, dehydration, and/or
abdominal pain.
Use Elipse Gastric Balloon System products
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by "Use By" date.
Store the Elipse Gastric Balloon System indoors at room
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temperature (approximately 20°C/70°F) in the original
packaging. Prolonged exposure to sunlight, heat,
or moisture may result in product damage.
Inspect products for damage before use. Do not use
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products that have been damaged in any way.
Damaged products may cause complications.
Do not soak products in disinfectant prior to use.
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Do not autoclave products.
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Recommended Procedure

1. Elipse Practice Capsule
1.1. Elipse Practice Capsule swallowing is recommended
prior to Elipse Device placement. The Elipse Practice
Capsule is ready for the patient to swallow after it is
removed from the packaging.
1.2. Allow the patient to place the Elipse Practice Capsule
in mouth and swallow with liquid as needed.
1.3. Reassure the patient that even if the Practice Capsule
cannot be swallowed, it is possible to swallow the
device with the assistance of a Stylet.
2. Device and Patient Preparation
2.1. Confirm patient has not eaten solid food for at least
8 hours and liquids for at least 2 hours prior to the
placement. Elipse Device is ready for the patient
to swallow after it is removed from the packaging.
2.2. Hang Filler Bag inside Pressure Infusor with Filler
Bag Septum Port pointing downward.
2.3. Hang Pressure Infusor on IV stand. See Figure 7.
2.4. Twist to remove the cover over the Septum Port.
See Figure 8.
2.5. Confirm Blue Stopcock is closed. Pierce Septum
Port with Spike of Extension Hose. See Figure 9.
Figure 7: Filler Bag and Pressure Infusor on IV stand
Figure 8: Removal of Septum Port Cover from Filler Bag
Figure 9: Filler Bag and Extension Hose Assembly
3. Elipse Device Delivery to Stomach
3.1. Place the Capsule on the very back of the tongue
and have the patient swallow with water as needed.
Do not allow the patient to bite or chew the Catheter.
Warning: Never anesthetize the oropharynx prior to
swallowing the device. Anesthetizing the oropharynx
by a spray or solution can lead to aspiration of water
or the device and respiratory arrest.
Warning: Do not lubricate or wet the Capsule prior
to swallowing.
3.2. If the patient cannot swallow the Capsule after
several swallowing attempts within a few minutes,
use the alternative method described in 3.3.
3.3. Alternatively, the Elipse Stylet can be inserted into
the Delivery Catheter and used to assist patient
swallowing by guiding the Elipse Device past the
oropharynx as the patient swallows. See Figures
10a and 10b for Elipse Stylet assembly.
Stylet
Figure 10a: Elipse™ Stylet entering Delivery Catheter
Figure 10b: Elipse™ Stylet and Delivery Catheter
Connectors engaged
Warning: If using the Stylet to assist the Delivery
Catheter, the Delivery Catheter must only be used
after the Stylet is completely inserted into the catheter
and its hub is locked into the Delivery Catheter
Connector. Use of a partially inserted Stylet can lead
to severe patient injury.
Warning: When using the Stylet to assist with
Device swallowing, very gentle force is applied to
the Stylet-stiffened Catheter at the same time as the
patient swallows. Excessive force can result in Stylet
perforation of the Capsule and severe patient harm.
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Delivery Catheter