IceCure™ Medical Ltd.
DMS-7063 rev. C
ProSense™
Confidential
User Manual
28
US User Manual
Thoracic surgery: Lung and cardiac arrhythmia
Mild/moderate
adverse events
:
frostbite, respiratory failure, pneumothorax, Hemothorax,
pleural effusion, pneumonia, empyema, hemoptysis, lung collapse, thrombosis, phrenic
nerve palsy, Pain, fever, cough, back pain, skin injury, pulmonary emboli, Loss of speech
(temporary aphasia from laryngeal nerve damage), arm paresis, burn, hemorrhage,
pneumonitis.
Severe
adverse events
:
respiratory failure/arrest, pneumothorax, hemothorax, pleural
effusion, pneumonia, empyema, lung collapse, thrombosis, phrenic nerve palsy,
subcutaneous emphysema, death due to Acute respiratory distress syndrome, pulmonary
emboli,
prolonged
chest
tube
drainage,
prolonged
intubation
pulmonary
insufficiency/failure, hemorrhage, dyspnea, atelectasis.
General predictable adverse events for using the introducer
Trauma to tissue, incomplete treatment, infection, user accidental injury, needle seeding.
necrosis of femur head, ureteral stricture, tumor recurrence.
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.
Contact your local authority or place of purchase regarding responsible
disposal/recycling.
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.
Compliance
Compliance with international safety standards
The cryoablation system was designed and built according to international standards.
•
EN 60601-1 Standard for safety of Medical equipment
•
European MDD 93/42/EEC
•
EN 60601-1-2 Standards for Electromagnetic compatibility of medical electrical
equipment (See chapter 16 -
Manufacturer’s Declaration of the EUT)
