Galil Visual-ICE MRI, Руководство пользователя

Страница: 19 / 122

Visual-ICE
™
MRI Cryoablation System
1-9
1.7.4 After Use
•
Depressurize the system after the cryoablation procedure is completed (reference Section 7.1).
•
Warn people near the system about loud noise before manually depressurizing the system.
• Do not unlock the locking bar for any needle channel if the GAS Pressure Indicator LED is solid
white. Unlocking the locking bars when the channels are under pressure could result in forceful
ejection of the needle connectors.
• Cut the needle and dispose of the used needle in a biohazard container in accordance with
hospital and safety regulations.
•
Clean the Visual-ICE MRI Cryoablation System by following the instructions in Section 9.1. Do not
use cleaning agents such as Betadine or bleach solution, which may damage the touch screen.
•
To avoid confusion at the beginning of a new procedure, ensure that the
o Manual Vent Valve is closed
o
Argon Shutoff Valve is in the GAS ON position
1.8 Potential Adverse Events
Potential adverse events which may be associated with the use of cryoablation may be organ
specific or general and may include, but are not limited to abscess, adjacent organ injury, allergic/
anaphylactoid reaction, angina/ coronary ischemia, arrhythmia, atelectasis, bladder neck
contracture, bladder spasms, bleeding/hemorrhage, creatinine elevation, creation of false
urethral passage, cystitis, death, deep vein thrombosis (DVT), delayed/non healing, diarrhea,
disseminated intravascular coagulation (DIC), ecchymosis, edema/swelling, ejaculatory dysfunction,
erectile dysfunction (organic impotence), fever, fistula, genitourinary perforation, glomerular
filtration rate elevation, hematoma, hematuria, hypertension, hypotension, hypothermia,
idiosyncratic reaction, ileus, impotence, infection, injection site reaction, myocardial infarction,
nausea, neuropathy, obstruction, organ failure pain, pelvic pain, pelvic vein thrombosis,
penile tingling/numbness, perirenal fluid collection, pleural effusion, pneumothorax, probe site
paresthesia, prolonged chest tube drainage, prolonged intubation, pulmonary embolism, pulmonary
insufficiency/failure, rectal pain, rectourethral fistula, renal artery/renal vein injury, renal capsule
fracture, renal failure, renal hemorrhage, renal infarct, renal obstruction, renal vein thrombosis,
scrotal edema, sepsis, skin burn/frostbite, 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, wound
complication, and wound infection.