1 Product Description
1.1 Intended Use
The Galil Medical disposable Single-Point 1.5 Thermal Sensor™ and patented
Multi-Point 1.5 Thermal Sensor™ devices are components used in conjunction
with a Galil Medical Cryoablation System when performing cryoablative destruction
of tissue, to aid the physician's assessment that the Freezing/Thawing cycles meet
the desired treatment protocol.
NOTE: These instructions are applicable to both the Single-Point 1.5 Thermal
Sensor (TS) and the Multi-Point 1.5 Thermal Sensor (MTS). Collectively, these
sensors are referred to as TS/MTS.
It is recommended that TS and/or MTS be inserted into strategic locations in the
tissue prior to the procedure so the acquired temperature readings will provide
useful information about the progress of the Freezing and Thawing processes.
These real time temperature readings can be used to monitor the temperature of
the tissue being ablated and to monitor the temperature of tissue not intended to
be ablated.
1.2 Technical Description
Each TS/MTS has a sharp cutting tip, a shaft with circumferential marks, a color-
coded handle, tubing, and an electrical connector. The shaft marks on the TS/MTS
are shown in Fig 1, below. All components are illustrated in Fig 2.
1
5
#
Shaft Marks
1
Thick Marks Start
2
Thin Marks Start
3
Single-thick Mark
4
Double-thick Mark
5
Triple-thick Mark
Single-Point 1.5 Thermal Sensor™ and Multi-Point 1.5 Thermal Sensor™
2
3
Description
20 mm from tip, in 10 mm intervals
25 mm from tip, in 5 mm intervals
Located 50 mm from tip
Located 100 mm from tip
Located 150 mm from tip
Fig 1. TS/MTS Shaft Marks
4
5
1
