IceCure™ Medical Ltd.
DMS-7063 rev. C
ProSense™
Confidential
User Manual
25
US 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.
Known and 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.
Urology: Renal and Prostate
Mild/moderate
adverse events: adjacent organ injury, allergic reaction, bleeding, DVT,
cystitis , Hematuria, hypotension, Idiosyncratic reaction, ileus, infection, pleural effusion,
pneumothorax, cryoprobe site paresthesia, mild renal failure, renal infract, voiding
dysfunction, urinary tract obstruction, hematomas, ejaculatory dysfunction, erectile
dysfunction, penile paresthesia, pelvic pain, perineal pain.
Severe
adverse events: abscess, adjacent organ injury, renal artery/renal vein injury,
anaphylactic reaction, coronary ischemia, myocardial infraction, bleeding, death, DVT,
hypotension, pulmonary embolism, severe renal failure, stroke, Idiosyncratic reaction,
ileus, infection lumbar radiculopathy, pelvic vein thrombosis, pleural effusion,
pneumothorax, renal hemorrhage , severe urinary tract obstruction, renal vein thrombosis,
rectourethral fistula, scrotal edema, ureteral stricture, renal infract, sepsis, urinary tract
leak, urethral sloughing, urethral stricture, urinary fistula, urinary frequency/urgency,
