IceCure Medical Ltd.
DSR3000000 rev.L
Confidential
User Manual
12
IceSense3™
2.2.5
Clinical assessment
Warning
Practitioners should be aware of the possibility of mammographic findings at the site of a
cryoablated fibroadenoma. Practitioners should enquire 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
IceSense3™
cryoablation system
in pregnant women has not
been established. Physicians should exercise caution when using
IceSense3™
cryoablation
system
in pregnant women.
Warning
The handle and hose portions of the IceSense3™
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 and manufacturer of the IceSense3™ 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
See 5.2.2
See 5.2.2
