IceCure ProSense, User Manual

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IceCure Medical Ltd.
DSR3210000 rev. D ProSense™
Confidential User Manual
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5.6.1
ProSense™ cryoablation system failure ...................................................... 107
5.6.2
ProSense™ cryoablation system touch screen failure ................................. 108
6 COMPUTER INTERFACE ....................................................................................... 110
6.1 The technician menu ........................................................................................... 110
6.2 Reading the screen .............................................................................................. 110
6.3 System messages ................................................................................................. 111
6.3.1 Status messages ............................................................................................ 111
6.3.2 Warning messages ....................................................................................... 111
6.3.3 Error messages ............................................................................................. 112
7 ACCESSORIES ......................................................................................................... 113
7.1 Cryoprobe ............................................................................................................ 113
7.1.1 Single use sterile cryoprobe ......................................................................... 113
7.2 The foot pedal (Not available in some regions, e.g. China) ................................ 114
7.3 The temperature sensor (Not available in some regions, e.g. China) ................. 114
7.4 The Holder (Not available in some regions, e.g. China) ..................................... 115
7.5 Shelf life .............................................................................................................. 115
8 SYSTEM MAINTENANCE ..................................................................................... 116
8.1 General cleaning .................................................................................................. 116
8.2 Sterility ................................................................................................................ 117
8.3 Periodic servicing ................................................................................................ 117
9 TROUBLESHOOTING ............................................................................................. 119
9.1 General ................................................................................................................ 119
9.2 Troubleshooting guide ........................................................................................ 120
10
ProSense™ cryoablation system - Step-by-Step procedure ...................................... 124
11 SYSTEM SPECIFICATIONS ................................................................................... 125
12 LIMITED WARRANTY CERTIFICATE ................................................................ 126
13 CUSTOMER COMPLAINT FORM ......................................................................... 127
14 REPORT CUSTOMER COMPLAINT ..................................................................... 128
15
Manufacturer’s Declaration of the EUT .................................................................... 129
Figures
Figure 1: Label 1 ON/OFF mechanical button - MLS1000002 Rev. B .............................. 29
Figure 2: Label 2 - Emergency Stop - MLS1000003 Rev. B .............................................. 29
Figure 3: Label 3 - Identification - MLS3180001 Rev. E (220-240 VAC)
MLS3080003 Rev. D (110 – 127 VAC) .............................................................................. 29
Figure 4: Label 4 - Follow instructions for use MLS 1000005 Rev D ................................ 29
Figure 5: Label 5 - High voltage caution - MLS1000006 Rev. B ....................................... 30
Figure 6: Label 6 - Line voltage danger - MLS1000007 Rev. B ......................................... 30
Figure 7: Label 7 - Foot pedal - MLS1000008 Rev. B ........................................................ 30
Figure 8: Label 8 - Risk of Explosion - MLS1000009 Rev. B ............................................ 30
Figure 9: Label 9 - Single use probe (various options of shapes, tip, length and sizes) -
MLP7000001 Rev. J ............................................................................................................ 31
Figure 10: Label 10 - Single use temperature sensor MLT8000001 Rev. H ....................... 31
Figure 11: Label 11 - Liquid nitrogen Dewar - MLS1000001 Rev. E ............................... 31
Figure 12: Label 12 - Black Dewar - MLS1000015 Rev. B ................................................ 32
Figure 13: Label 13 – Cold area - MLS1000010 Rev. B ..................................................... 32