Veldana Medical Cavaterm plus Mode D'emploi page 4

iNDiCatioN
The Cavaterm™ system is intended to ablate the endometrial
lining of the uterus in premenopausal women with menorrhagia
(excessive uterine bleeding) due to benign causes for whom
childbearing is complete.
CoNtraiNDiCatioNs
• Undiagnosed uterine bleeding.
• Any premalignant or malignant condition by histology e.g.
adenomatous hyperplasia.
• Any anatomical or pathological condition significantly deform-
ing the uterine cavity and thus preventing the balloon from
laying uniformly on the endometrium e.g. septum, fibroids.
NotE
Fibroids under 2 cm are not considered to significantly deform
the uterine cavity and thus are not a contraindication.
• Any condition associated with a myometrio thickness less
than 12 mm (at the fundus and wall thickness must be uniform)
e.g. cesarean section scars, GnRH pretreatment, prior gyneco-
logical surgery.
• Any condition leading to uterine wall weakness irrespective of
myometrio thickness e.g. vascular malformation of the wall,
or history of classical cesarean section.
• Any recent uterine damage or trauma.
• Pregnancy or any desire to become pregnant in the future.
• Uterine cavity length less than 4 cm or more than 10 cm
(from the isthmus to the fundus).
• Cervical canal length more than 6 cm.
• Active infection of the internal and external genitalia.
• Active urinary tract infection.
warNiNgs
In order to ensure safe use of the Cavaterm™ plus device, it is
imperative that this section is carefully reviewed (see also
Warnings and precautions in the central unit operator's manual).
• Before using the Cavaterm™ plus catheter, make sure that all
components are contained in the sealed package (Fig. 1). If a
component is missing, please do not use the catheter. Return it
to Veldana Medical SA via your supplier.
• The Cavaterm™ plus catheter is to be used only by qualified
physicians who have received appropriate training regarding
the use of the system.
2 | EN