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3.1 Warnings
• You MUST return to your physician’s office for all scheduled
follow-up visits while using the AspireAssist. Failure to have
medical monitoring while using the system could lead to
serious complications and possibly death.
• You MUST perform Aspiration Therapy after all or most
meals. As you lose weight, the length of the external A-Tube
will be permanently shortened by a physician or nurse.
Eating meals without aspiration therapy could lead to
weight re-gain. If a lot of weight is regained, part of the
A-Tube could pull out of the stomach due to the tube being
too short for the additional belly fat. If this occurs, a surgical
procedure may be required to remove the entire A-Tube. If
you re-gain more than 5% body weight that you previously
lost at an earlier follow-up point, your physician may
determine that you have become non-compliant with the
therapy and the A-Tube may need to be removed.
• You
MUST
return to your physician if the Skin-Port begins to
feel tight for any reason, including weight gain or improper
initial installation, while you are in any position (seated,
standing, etc). Excessive tension on the A-Tube from the
Skin-Port could cause part of the A-Tube to pull out of the
stomach.
• Solely perform Aspiration Therapy 20 – 30 minutes after
eating the three (3) major meals per day. Excessive aspiration
could lead to serious complications.
• Only fill the Reservoir with clean water. Use of contaminated
water or other liquids could harm your stomach.
• If taking prescription medicine, please consult your
physician to determine if the dose should be changed with
weight loss.
• Do not manipulate the A-Tube or Skin-Port at any time after
installation. Excess tension or torque on the A-Tube or
Skin-Port can result in enlargement of the stoma tract
resulting in gastric leakage, or movement of the internal
bumper resulting in tissue damage.
• Do not take medication with meals that are aspirated
because you may not get the appropriate dose of medicine.
Take oral medications at least 2 hours prior to
performing Aspiration Therapy.
• The Emergency Clamp should be stored in the carry bag at
all times. If the Skin-Port becomes disconnected from the
A-Tube at any time, immediately attach the Emergency
Clamp to the A-Tube to prevent leakage of stomach contents
and A-Tube migration in the stoma tract. Seek medical
attention immediately for re-attachment of the Skin-Port.
• Do not engage in any activities that are below 5-ft of water
(e.g. swimming, scuba, diving, etc.) while the A-Tube is
implanted.
• The Companion device should be thoroughly washed at
least once each day to avoid bacteria growth within the
device itself, or its accessories.
• Do not insert any foreign objects between the Skin-Port and
the skin because this can damage to the A-Tube.
• Avoid carrying packages/objects against the abdomen.
Excessive weight on the Skin-Port could cause damage or
irritate the skin around the A-Tube.
• If the device leaks stomach content onto your skin, rinse the
affected area with water to prevent skin irritation.
• Stop water infusion immediately if you unexpectedly start to
cough. An overfull stomach could cause fluid to enter your
lungs.
• Do not attempt to open the Skin-Port valve by any other
means besides the Connector. If the Skin-Port valve is left
partially opened because of non-recommended
manipulation, stomach contents can leak and cause skin
irritation.
• If you notice increased irritation, redness, discharge, or pain
around the skin underneath the Skin-Port at any time,
contact your physician immediately. It could be a sign of
infection or A-Tube migration in the stoma tract.
3.2 Cautions
• You must be in a standing position with the Companion
below the belly for the system to operate.
• If the Companion is set to the drain mode (i.e. Companion
lever down,) aspiration will automatically begin once the
Connector is attached to the Skin-Port and its lever fully
pushed clockwise, so ensure that the Drain Tube is properly
positioned over a toilet or collection container before
connecting the Connector to the Skin-Port.
• Before the first use of the Companion, the tubes and lanyard
will be cut to custom length by the physician.
• Only the Connector should be directly attached to the Skin-
Port.
• Verify that both the Companion and Skin-Port do not have
any damage before connecting each together to start
aspiration.
• Do not attempt to take apart the Companion. Tampering
with the Companion could cause the device to function
incorrectly.
• Use caution when attaching or disconnecting the Connector
to the Skin-Port. If the Connector lever gets jammed, do not
push harder. Remove the Connector and start the process
over. Consult your physician if the problem persists.
• Lubricants are not required for operation of the device, but
if implemented, only use water-based lubricants.