IceCure Medical Ltd.
DSR3210000 rev. D
ProSense™
Confidential
User Manual
12
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2
SAFETY NOTES
While this manual is designed to provide instructions in the use of the
ProSense™
cryoablation system, it is not intended to take the place of the user training course which
must be completed before using the system.
This chapter defines the different types of safety notices that appear in the manual.
2.1
Warnings and cautions
Safety notices appear throughout the manual and take one of the following forms:
Warning
- this notice is called a Warning: it deals with danger to people.
Warning
It is dangerous for people to do this.
Caution
- this notice is called a Caution: it deals with danger to equipment and data.
Caution
It is dangerous for equipment and data to do this.
2.2
Basic safety principles
All the safety issues explained in this manual are grouped within the following areas of
responsibility:
2.2.1
Ownership
Warning
U.S. federal law restricts this device to sale by or on order of a physician.
2.2.2
Qualification
Warning
Any procedures using this system must be performed by licensed
practitioners or board-certified doctors who are trained and experienced
in the use of this system.
Warning
Do not attempt to perform any troubleshooting or corrective action
beyond those specified in the following guide. Any malfunction not listed
in the guide, or one that persists after the recommended action has been
taken, must be referred to IceCure Medical
.
