Veldana Medical Cavaterm plus Mode D'emploi page 5

• The Cavaterm™ plus catheter is for single-use and must not
be reused.
• The Cavaterm™ plus catheter must not be resterilised.
Resterilisation may lead to failure of the catheter.
• The balloon adjustment device should be adjusted accordingly
to the measured cavity length. A balloon length adjusted
longer than the uterine cavity would risk burning the cervical
canal and the cervix. If the measured cavity length is between
the units of the marked cavity length scale, the shorter unit
should be used. For example, if the measured cavity length
is 4.7 or 4.8 cm, the length should be adjusted to 4.5 cm.
• The balloon adjustment device should be secured tightly.
Failing to secure it tightly may lead to an inappropriate balloon
length and heating of the cervical canal.
• Never exceed a pressure of 240 mmHg. Overpressure may
lead to uterine rupture.
• If a pressure of 230-240 mmHg cannot be reached after filling
with 30 ml of glucose, then interrupt the filling procedure.
Empty the balloon and remove the catheter from the patient.
Fill balloon with 10 ml of glucose 5% (50 mg/ml) and inspect
for leaks. If a leak is found replace the catheter with a new
one and restart the procedure. If no leaks are found, do not
reinsert the balloon catheter. The possible cause of this has to
be determined including the possibility of uterine rupture or
perforation and it should be reconsidered treating the patient
with the Cavaterm™ system.
• If multiple or continuous fluid infusions are required to main-
tain the target pressure of 230-240 mmHg, consider possibility
of uterine rupture or perforation. Uterine relaxation can cause
a slow decrease of pressure and the pressure would easily be
readjusted with a single minor fluid infusion with syringe's
plunger rotation.
• Never fill the balloon with more than 30 ml of glucose
solution 5%. Exceeding volume may lead to uterine rupture.
• Do not block the drain tube of the Cavaterm™ plus catheter.
In case of high pressure the central unit will open a valve that
will allow excess liquid to drain through the tube.
• Do not attempt to fill the balloon without having the connector
fully inserted into the central unit. Doing so can damage the
catheter.
• Do not use excessive force when introducing the catheter
into the uterus. If a resistance is felt, dilate to Hegar 7. Then
attempt to reintroduce the catheter. If resistance to catheter
placement persists, abort the procedure.
• Ensure that the catheter remains in position (Fig. 9) during the
duration of the treatment. Misplacement of the catheter during
the treatment may lead to cervical canal burn.
• Do not start the procedure if there is any question concerning
balloon position. If question exists, verify the balloon position
by the following steps :
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