IceCure™ Medical Ltd.
DMS-7063 rev. C
ProSense™
Confidential
User Manual
13
US User Manual
Warning
Safety and effectiveness of the
ProSense™
cryoablation system in pregnant
women has not been established. Physicians should exercise caution when
using the cryoablation system in pregnant women.
Warning
The cryohandle 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 and 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
Practices of cryoablation for women with breast implants have not been
established. 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.
Warning
Do not rely solely on the temperature sensor measurement. Always monitor
the procedure using Ultrasound or other appropriate imaging systems.
Caution
Artifacts from the devices may appear in the Ultrasound or CT image.
Warning
Temperature sensor and cryoprobe insertion and navigation within tissue
must be done under guidance of an appropriate imaging device.
