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IceCure™ Medical Ltd.
DMS-7064 rev. C
ProSense™
Confidential
User Manual
76
European User Manual
5.2.6.6
Handling Cryoprobe Mechanical Failure
During any phase of the procedure, if the cryoprobe is identified to have any mechanical
damage, please follow the instructions below:
1.
Press the red emergency stop button.
2.
Wait for 60 seconds.
3.
If the cryoprobe is in the patient
’s body
, wait for passive
Thaw
if necessary and remove
the cryoprobe gently.
4.
Pay attention that the cryoprobe is removed completely.
5.
Securely disengage the cryoprobe into sterile sheets
–
Make sure the tip is pointed in a
safe direction.
6.
If the cryoprobe cannot be screwed out of the cryohandle.
the system should not be turned on before disengaging the cryoprobe from the
cryohandle.
7.
Close the handle plug on the cryohandle.
8.
Start the system, using the ON/OFF switch on the back side of the system.
9.
To release the Emergency Stop button, turn it in the direction of the arrows
10.
If required, wait for the Dewar to lowered down and perform a new procedure with full
Dewar and a new cryoprobe while maintaining sterility.
5.2.6.7
System functional test
Perform a functional test to ensure system efficacy and safety per the following
instructions and per the screens presented in the figures below:
•
Prepare a container full of
sterile
water/saline.
•
Remove the cryoprobe cover that protects the tip.
•
Insert the cryoprobe into the container and press TEST on the touch screen.