How Supplied; Cleaning Instructions; Directions For Use - Apollo ORBERA Intragastric Balloon System Bedienungsanleitung

• Death due to complications related to intestinal
obstruction, gastric perforation, or esophageal
perforation, is possible.
• Esophageal obstruction. Once the balloon has been
inflated in the stomach, the balloon could be pushed
back into the esophagus. If this occurs, surgery or
endoscopic removal could be required.
• Injury to the digestive tract during placement of
the balloon in an improper location such as in the
esophagus or duodenum. This could cause bleeding
or even perforation, which could require a surgical
correction for control.
• Insufficient or no weight loss.
• Temporary weight-loss treatments have been shown
to have poor long-term success rates (weight-loss
maintenance) in severely obese patients.
• Adverse health consequences resulting from
weight loss.
• Gastric discomfort, feelings of nausea and vomiting
following balloon placement as the digestive system
adjusts to the presence of the balloon.
• Continuing nausea and vomiting. This could result
from direct irritation of the lining of the stomach
or as a result of the balloon blocking the outlet of
the stomach. It is even theoretically possible that
the balloon could prevent vomiting (not nausea or
retching) by blocking the inlet to the stomach from
the esophagus.
• A feeling of heaviness in the abdomen.
• Abdominal or back pain, either steady or cyclic.
• Gastroesophageal reflux.
• Influence on digestion of food.
• Blockage of food entering into the stomach.
• Bacterial growth in the fluid which fills the balloon.
Rapid release of this fluid into the intestine could
cause infection, fever, cramps and diarrhea.
• Injury to the lining of the digestive tract as a result
of direct contact with the balloon, grasping forceps,
or as a result of increased acid production by the
stomach. This could lead to ulcer formation with
pain, bleeding or even perforation. Surgery could be
necessary to correct this condition.
• Balloon deflation and subsequent replacement.
• Acute pancreatitis as a result of injury to the pancreas
by the balloon. Patients experiencing any symptoms
of acute pancreatitis should be counseled to seek
immediate care. Symptoms may include nausea,
vomiting, abdominal or back pain, either steady or
cyclic. If abdominal pain is steady, pancreatitis may
have developed.
• Spontaneous over inflation of an indwelling balloon
with symptoms including intense abdominal pain,
swelling of the abdomen (abdominal distension) with
or without discomfort, difficulty breathing, and/or
vomiting. Patients experiencing any of these symptoms
should be counseled to seek immediate care.
• Note that continued nausea and vomiting could
result from direct irritation of the lining of the
stomach, as a result of the balloon blocking
the outlet of the stomach, or hyperinflation of
the balloon.
COMPLICATIONS OF ROUTINE ENDOSCOPY INCLUDE:
• Adverse reaction to sedation or local anesthetic.
• Abdominal cramps and discomfort from the air used
to distend the stomach.
• Sore or irritated throat following the procedure.
• Aspiration of stomach contents into the lungs.
• Cardiac or respiratory arrest (these are extremely rare
and are usually related to severe underlying medical
problems).
• Digestive tract injury or perforation.

HOW SUPPLIED

Each ORBERA® System contains a balloon positioned
in a Placement Catheter Assembly. All are supplied
NONSTERILE and FOR SINGLE USE ONLY. All components
should be handled carefully.

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.

DIRECTIONS FOR USE

The balloon is supplied positioned within the Placement
Catheter Assembly. Inspect the Placement Catheter
Assembly for damage. It should not be used if any
damage is noted. A standby ORBERA® System should be
available at the time of placement.
DO NOT REMOVE THE BALLOON FROM THE
PLACEMENT CATHETER ASSEMBLY.
A filling system is provided to assist in the balloon
deployment.
Note: If the balloon becomes separated from the sheath
prior to placement, do not attempt to use the balloon or
reinsert the balloon into the sheath.
BALLOON PLACEMENT AND INFLATION
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 balloon
gently down the esophagus and into the stomach. The
small size of the Placement Catheter Assembly allows
ample space for the endoscope to be reinserted for
observing the balloon filling steps.
When it has been confirmed that the balloon is below the
lower esophageal sphincter and well within the stomach
cavity, remove the guide wire.
Fill the balloon with sterile saline. Place the filling system
spike into the sterile saline bottle or bag fill tube. Attach
a syringe to the filling system valve and prime the filling
system. Connect the Luer-Lock connector on the fill tube
to the filling system valve. Proceed to deploy the balloon,
verifying with the endoscope that the balloon is within
the stomach (see filling recommendations below).
Note: During the filling process the fill tube must
remain slack. If the fill tube is under tension during the
intubation process, the fill tube may dislodge from the
balloon, preventing further balloon deployment.
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