Cleaning Instructions; Directions For Use - apollo endosurgery ORBERA365 Manual Del Usuario

11.1

CLEANING INSTRUCTIONS

In the event that the product becomes contaminated prior to
use, it should not be used but should be returned to the
manufacturer.
CAUTION: DO NOT SOAK THE PRODUCT IN A
DISINFECTANT because the silicone elastomer may
absorb some of the solution which could subsequently leach
out and cause tissue reaction.
11.2 DISPOSAL
Dispose of any used or explanted device's or device
components in accordance with any local regulations for
medical waste.
12.

DIRECTIONS FOR USE

The IGB is supplied positioned within the Placement
Catheter Assembly. Inspect the package seal and the
Placement Catheter Assembly for damage prior to use. It
should not be used if any damage is noted. A back-up IGB
should be available at the time of placement.
DO NOT REMOVE THE IGB FROM THE PLACEMENT
CATHETER ASSEMBLY.
A Fill Kit is provided to assist with the IGB deployment.
CAUTION: If the IGB becomes separated from the catheter
or sheath prior to placement, do not attempt to use the IGB
or reinsert the IGB into the sheath.
12.1 IGB PLACEMENT AND FILLING
Prepare the patient for endoscopy. Inspect the esophagus
and stomach endoscopically and then remove the
endoscope. If there are no contraindications, insert the
Placement Catheter Assembly containing the IGB gently
down the esophagus and confirm that it is below the lower
esophageal sphincter and well within the stomach cavity
before removing the guidewire (if present) and proceeding.
The small size of the Placement Catheter Assembly allows
ample space for the endoscope to be reinserted for
observing the IGB filling steps.
12.2 IGB FILLING
Using aseptic technique, place the Fill Kit spike into the
sterile saline bag. Attach a sterile syringe to the valve of the
Fill Kit and prime it. Connect the Luer-Lock connector on the
Placement Catheter to the Fill Kit valve. Proceed to deploy
the IGB, verifying with the endoscope that the IGB is within
the stomach.
CAUTION: Fill the IGB with sterile saline. An aseptic
technique, similar to changing IV fluids (e.g. use of clean or
sterile gloves, sterile syringe, etc.), is recommended.
Though the cause of hyperinflation is unknown, it may be
caused by fungal or bacterial microbes contaminating the
balloon. One recommended
contaminating the
microorganisms that
hyperinflation.
mitigation is to
saline within the balloon
may lead to spontaneous
CAUTION: During the filling process the Placement
Catheter must remain slack. If the catheter is under tension
during this process, the tip of the catheter may dislodge from
the IGB, preventing further IGB deployment.
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.
12.2.1. Filling Recommendations
The expandable design of the IGB permits a fill volume
range of 400cc (minimum) to a maximum of 700cc. The
IGB should not be under-filled or over-filled with volumes
<400cc or >700cc, as under- or over-filling the IGB could
cause higher risk for serious side effects, such as
migration (under-filled IGB) or gastric rupture/perforation
(over-filled IGB). Once filled, the IGB is not adjustable.
To determine ideal IGB size to produce the greatest weight
loss effectiveness, two (2) independent reviewers
searched PubMed and Embase to identify full-length IGB
clinical studies. A total of 80 studies with 8,506 patients
were included in this meta-analysis of global data. Figure
5, meta-regression analysis of IGB fill volume correlation
with total body weight loss (TBWL), demonstrates fill
volume ranges from 500cc to 700cc. Results at 6 months
do not seem to differ with volume (p=0.24).
based on this, the recommendation should be filling
volume between 500cc to 650cc; however the pivotal
clinical study's safety and effectiveness data for this device
was only tested with fill volumes of 550cc ± 50cc.
Figure 5: Meta-regression analysis of IGB fill volume correlation with total
Note: the size of the circles on the graph corresponds with the study size. Figure courtesy of Dr.
Barham Abu-Dayyeh.
The following filling recommendations are provided to
avoid inadvertent damage to the valve of the balloon or
premature detachment from the Placement Catheter:
• Always use the IGB Fill Kit provided.
• Always use a sterile 50cc syringe to fill the IGB. Use
of smaller syringes can result in very high pressures
of 30, 40, and even 50 psi, which can damage the IGB
valve.
• With a sterile 50cc syringe, each filling stroke should
avoid
be done slowly (minimum of 10 seconds) and steadily.
with
Slow, steady filling will avoid the generation of high
pressure to the valve.
8
IGB Fill Volume at 6 months
body weight loss (TBWL). 1
1 Therefore,