IceCure Medical Ltd.
DSR3210000 rev. D
ProSense™
Confidential
User Manual
14
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2.2.5
Clinical Assessment
2.2.6
Warning
Practitioners should be aware of the possibility of imaging findings at the site
of a cryoablated area. Practitioners should inquire if a patient has a history of
cryoablation.
Warning
Exercise caution when treating patients who have had previous difficulty
with surgical procedures or local anesthesia.
Warning
Safety and effectiveness of the ProSense™ cryoab
lation system in pregnant
women has not been established. Physicians should exercise caution when
using the cryoablation system in pregnant women.
Warning
The handle and hose portions of the ProSense™ cryoablation system may
become cold during the cryoablation procedure. Operators should consider
insulating these parts in order to prevent discomfort to the patient.
Warning
The supplier a
nd manufacturer of the ProSense™ cryoablation system do not
claim that it will be useful for assisting with the treatment of any particular
condition or set of circumstances. Full responsibility for assessing the
potential benefit of the system for a given medical condition lies with the
practitioner.
While experience has shown that the system is useful for certain applications
in cryosurgery, no representation or warranty is made that the system is
useful for any specific person or condition.
Warning
For patients with breast implants, you must document that adequate
distance exists between the lesion and the implant to ensure that the ablated
lesion will not contact or jeopardize the implant, and there is enough space
to create the required margins.
