IceCure™ Medical Ltd.
DMS-7064 rev. C
ProSense™
Confidential
User Manual
30
European User Manual
General predictable adverse events when using the introducers
Trauma to tissue, incomplete treatment, infection, user accidental injury, needle seeding.
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)
Equipment classification
•
Electric shock protection: Class I, Type BF.
•
Protection against ingress of liquids: ordinary equipment.
•
Not suitable for use in presence of flammable anesthetic mixture with air or
nitrous oxide.
Accompanying labels
Part Number
Label description
Figure
MLS1000002
ON/OFF Switch label on the rear panel
MLS1000003
Emergency Stop button label
MLS3080104
System Identification labels
with the manufacturer’s
name and address, date of manufacture, unit model
