ThermaChoice UBT System Service Manual
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P/N 01035 Rev. C
Section One
System Overview
Figure 1-1
Device Description
The THERMACHOICE™II UBT System is a software-controlled device
designed to ablate uterine tissue by thermal energy. The system is comprised of a
single-use balloon catheter, a reusable controller, umbilical cable, and power cord.
The THERMACHOICE™II UBT catheter is designed for use only with the
THERMACHOICE™II UBT controller.
The balloon catheter is 1) connected to the controller, 2) inserted through the
cervix into the uterus, 3) filled with sterile, injectable fluid (plain 5% dextrose in
water – D
5
W) carefully stabilizing the pressure to 160-180 mmHg pressure, and
4) activated to thermally ablate endometrial tissue by maintaining a temperature
of approximately 87°C (188°F) for 8 minutes.
The THERMACHOICE™II UBT controller is designed to work with 3 different
versions of the balloon catheter. They are:
a)
Balloon catheter version 2.0
: This balloon catheter has a fluid circulation
mechanism inside the balloon.
b)
Balloon catheter version 1.4
: This version does not have a fluid circulation
mechanism inside the balloon.