IceCure™ Medical Ltd.
DMS-7064 rev. C
ProSense™
Confidential
User Manual
10
European User Manual
ProSense™
Qualified users
You are a qualified
ProSense™
cryoablation system user only if you meet all of the
following criteria:
You are a board-certified medical practitioner licensed in your country.
You have taken a certified
ProSense™
cryoablation system training course.
You have read and understood all relevant material accompanying the
ProSense™
cryoablation system.
Warning
If you do not meet the above criteria, do not use the
ProSense™
cryoablation system.
Practitioners electing to be
ProSense™
cryoablation system users must attend a training
course prior to using the system. The course is taught by
IceCure™
Medical certified
personnel.
Warning
Do not use this system if you have not been adequately trained in its use.
Clinical decisions
The practitioner is solely responsible for all clinical use of the
ProSense™
cryoablation
system and for any results obtained with the device.
Cryotherapy is beneficial in a variety of applications. However, sole responsibility for
determining when and how to use the system with a given patient and for a particular
medical condition lies with the practitioner.
Use of
ProSense™
cryoablation system in special populations, such as pregnant women,
has not been established.
For further details, refer to Section 1.3
–
Indications for use.
Contraindications
Severe infection, uncorrectable coagulopathy, hemodynamic or respiratory instability.
Qualified technician
Only a technician trained by
IceCure™
Medical is qualified to service the
ProSense™
cryoablation system.
