Warnings; Cautions - Aspire Assist Manuel D'utilisation

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.
10
• 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.