IceCure Medical Ltd.
DSR3210000 rev. D
ProSense™
Confidential
User Manual
27
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reporting or making note of the error message, switch OFF the mechanical
ON/OFF button and unplug the electrical cable.
2.6
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.
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.
Contact your local authority or place of purchase regarding responsible
disposal/recycling.
Dispose of the Cryoprobe, Temperature-Sensor and Cryohandle sleeve
in accordance
with institutional policy. Do not reuse; do not re-sterilize.
All single use devices are considered to be medical waste and must be disposed of in
accordance with medical waste laws and hospital standards
. Sharp objects, such as the
Cryoprobe and temperature sensor, must be disposed of in an adapted container.
2.8
Compliance
2.8.1
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)
