IceCure™ Medical Ltd.
DMS-7063 rev. C
ProSense™
Confidential
User Manual
23
US User Manual
Burn hazards
The Cryoprobe tip can reach very low temperatures.
Warning
Portions of the cryoprobe other than the freeze zone, including the plastic
cover that is located near the cryoprobe handle, may become cold and cause
tissue damage. If unwanted freezing occurs, stop the functional test process
by pressing "Cancel".
Warning
Portions of the cryoprobe other than the freeze zone, including the plastic
cover that is located near the cryoprobe handle, may become cold and cause
tissue damage. If unwanted freezing occurs, immediately stop the freezing
process.
To prevent injury, cryoprobes must be closely observed during use for signs
of unwanted freezing.
Grounding
Warning
To avoid risk of electric shock, this equipment must only be connected to an
electricity network with protective grounding.
Sterility
Warning
Cryoprobes, temperature sensors, introducers, and sterile sleeves are single-
use devices supplied in single use sterile packaging.
Reprocessing single-use devices affects their performance and can cause cross-
contamination.
Warning
After finishing the cryoablation procedure on a patient, remove and safely
discard the single-use cryoprobe, temperature sensor, introducers, and
sterile sleeve.
Warning
For each new procedure, ensure that the previously used single-use
cryoprobe, temperature sensor, introducers, and sterile sleeve have been
removed and discarded. Any used cryoprobe, introducer, and temperature
sensor must be disposed of as used sharp biohazard waste.
