IceCure™ Medical Ltd.
DMS-7064 rev. C
ProSense™
Confidential
User Manual
26
European User Manual
Warning
When an error message is displayed and a procedure is aborted, disengage
the cryoprobe only after you are instructed to do so by the system.
Alternatively, follow the instruction provided in section 5.3.5. Failure to
follow the system instructions increases the risk of a liquid nitrogen related
accident.
Warning
In case of software crash, switch OFF the mechanical ON/OFF switch and
unplug the electrical cable.
Call
IceCure™
Medical for technical service before restarting the
ProSense™
cryoablation system.
Warning
When the system shuts itself down due to an error, contact
IceCure™
Medical and describe the error message shown on the screen as precisely as
possible. Do not attempt to reuse the system before contacting
IceCure™
Medical. After reporting or making note of the error message, switch OFF the
mechanical ON/OFF switch and unplug the electrical cable.
Predictable Adverse Events
Warning
Regulatory requirements mandate that serious adverse events be reported
to the relevant regulatory authorities. Users must notify
IceCure™
Medical of
all serious adverse events, including serious adverse device reactions, no
later than 24 hours following receipt of such information.
General surgery/ Minimal Invasive Procedures
•
Mild/moderate
adverse events: infection, bleeding, pain, fever, thermal injury, injury to
adjacent organs, pneumonia, fall, internal adhesions, incomplete treatment changes in
the laboratory parameters-elevation in aspartate aminotransferase and/ or alanine
aminotransferase level (this reflects hepatocellular damage), minimal self-limited serum
bilirubin level elevation, hemorrhage, hematoma, myoglobinemia, pleural effusion,
hemothorax, , pneumothorax, thrombosis, diarrhea, nausea, deep vein thrombosis (DVT),
transient ischemic attack, hypertension, hypothermia, treatment site reaction, local
neuropathy, frostbite, skin burn, vagal reaction, vomiting, needle seeding, user accidental
injury.
