IceCure
™
Medical Ltd.
DSR3200000 rev. G
ProSense
™
Confidential
User Manual
28
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infection and thermal injury to the skin, injection site reaction, myocardial infarction,
nausea, neuropathy, obstruction, organ failure, pain, pelvic pain, pelvic vein thrombosis,
penile tingling/numbness, perirenal fluid collection, mild vaginal staining, pneumonia,
empyema, hemoptysis, lung collapse, thrombosis (evolved risk for patient with an existing
AV fistula), phrenic nerve palsy, cough, back pain, skin injury, pulmonary emboli, Loss of
speech (temporary aphasia from recurrent laryngeal nerve damage, arm paresis, burn,
hemorrhage, pneumonitis, Respiratory failure/arrest, Hemothorax, pneumonia,
empyema, lung collapse, thrombosis (evolved Risk for pt. with an existing AV fistula),
phrenic nerve palsy, subcutaneous emphysema, death due to Acute respiratory distress
syndrome, pulmonary emboli, tumor recurrence, hemorrhage, dyspnea, hematoma
pleural effusion, pneumothorax, cryoprobe site paresthesia, prolonged chest tube
drainage, prolonged intubation, pulmonary embolism, pulmonary insufficiency / failure,
rectal pain, renal fracture, renal infract, genitourinary perforation, glomerular filtration
rate elevation, transfusion, infection lumbar radiculopathy, transfusion, acute bowel
injury, colorenal fistula, exuberant local disease, infection lumbar radiculopathy,
myocardial infraction, transfusion, acute bowel injury, colorenal fistula, exuberant local
disease, renal artery/renal vein injury, renal capsule fracture, renal failure, renal
hemorrhage, renal infarct, renal obstruction, renal vein thrombosis, rectourethral fistula,
scrotal edema, sepsis, skin burn, stricture of the collection system or ureters, stroke,
thrombosis/thrombus/embolism, transient ischemic attack, tumor seeding, UPJ
obstruction/injury, urethral sloughing, urethral stricture, urinary fistula, urinary
frequency/ urgency, urinary incontinence, urinary leak, urinary renal leakage, urinary
retention/ oliguria, urinary tract infection, vagal reaction, voiding complication including
irritative voiding symptoms, vomiting and wound complication. muscular injury, pain,
swelling, Osteonecrosis, osteomyelitis, Chondrolysis (rapid and sudden damage to the
cartilage results in arthritis), damage to Osteocartilage structure, Nerve Palsy, Motor
Dysfunction, Peri-ablational neuropathies, swelling up to compartment syndrome, bowel
damage, urinary tract damage, pericardial effusion in (in chest wall ablations), avascular
necrosis of femur head, ureteral stricture, tumor recurrence.
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.
2.7
Disposal
The WEEE symbol indicates that this system contains electrical and electronic
components that must be collected and disposed of separately
. Never dispose of
electrical and electronic components in general municipal waste receptacles. Electrical
and electronic equipment contain hazardous substances which, when disposed of
incorrectly, may leak into the ground. This can contribute to soil and water pollution
which is hazardous to human health and endangers wildlife. Therefore, such equipment
must not be disposed of in landfill sites or incinerators.
