Veldana Medical Cavaterm plus Mode D'emploi page 6

1 The catheter shaft in vagina can be inspected by speculum
exam ; the catheter shaft is marked every 1 cm indicating
the distance from the balloon (Fig. 1, K). Prior to the proce-
dure, the cervical canal length should have been measured
with Hegar dilator, and the measured length should
correspond to the inspected marked length on the shaft.
2 If balloon position is still in doubt after catheter shaft in-
spection or sufficient inspection is not possible, abdominal
ultrasound can be performed to confirm the intrauterine
position of the balloon.
3 If there is still doubt concerning the balloon position after
catheter shaft inspection and abdominal ultrasound, or
sufficient abdominal ultrasound examination is not
possible, the ablation procedure should be abort.
NotE
In case of suspected uterine perforation or rupture,
laparoscopic or hysteroscopic assessment should be
performed depending the level of risk.
• The catheter tubing contains electrical wires. Do not cut
the catheter tubing unless the catheter is detached from the
central unit.
• If the catheter does not function as expected, please cleanse
it with water, put it in a hermetic bag and send it back to
Veldana Medical SA via your supplier in order to allow the
manufacturer to perform investigations.
prECautioNs
• In all cases vaginal ultrasound screening is necessary in order
to ensure minimal myometrio thickness of 12 mm throughout
the uterus.
• In case of pretreatment with GnRH agonist or medroxy-
progesterone acetate (MPA), a vaginal ultrasound has to be
performed within 10 days prior to the Cavaterm™ procedure
to evaluate the minimal myometrio thickness of 12 mm
throughout the uterus.
• In case of history of previous endometrial ablation, a vaginal
ultrasound has to be performed to evaluate the minimal
myometrio thickness of 12 mm throughout the uterus.
• Always fill the balloon with glucose solution 5%. Other fluids
may cause failure of the system.
• If the catheter cannot be removed when pressing the YELLOW
stop key, insure the system pressure is below 30 mmHg by
emptying the balloon. Note that the catheter cannot be
removed if the system (heat and pump) is activated.
• Do not attempt to remove the catheter from the central unit as
long as you can hear a humming sound. The humming sound
means that the system is activated and there are mechanical
operations occurring. Removing at this time can damage the
system.
4 | EN