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IceCure ProSense FAS3000000-2 manual available for free PDF download: User Manual
IceCure ProSense FAS3000000-2 User Manual (133 pages)
Cryoablation System
Brand:
IceCure
| Category:
Medical Equipment
| Size: 5.97 MB
Table of Contents
Table of Contents
2
Overview
8
Introduction
8
Intended Use
8
Indications for Use
8
Prosense™ Qualified Users
10
Clinical Decisions
10
Contraindications
10
Qualified Technician
10
Advanced Operator
11
Safety Notes
12
Warnings and Cautions
12
Basic Safety Principles
12
Ownership
12
Qualification
12
Training
13
Clarity
13
Clinical Assessment
13
Voltage and Power Ratings
15
Installation and Setup
15
Proper Use
15
Cyber Security
18
Operating Warnings
19
Liquid Nitrogen
20
Danger - Explosion and Fire Hazard
21
Opening the Dewar Compartment
21
Liquid Nitrogen Safety
21
Burn Hazards
24
Grounding
24
Sterility
24
Mechanical Handling of Hose and Cryohandle
25
Emergencies and Errors
25
Emergency Stop Button
25
Emergencies Causing Procedure Halt
25
Predictable Adverse Events
26
General Surgery/ Minimal Invasive Procedures
26
Anesthesia
27
Cryoablation Procedure in General
27
Percutaneous Ablation Procedure
27
Laparoscopic Procedure
28
Breast - Fibroadenoma and Breast Cancer
28
Urology - Renal and Prostate
28
Thoracic Surgery - Lung and Cardiac Arrhythmia
28
Liver
29
Musculoskeletal
29
Gynecology
29
Confidential User Manual
29
Dermatology
29
General Predictable Adverse Events When Using the Introducers
30
Disposal
30
Compliance
30
Compliance with International Safety Standards
30
Equipment Classification
30
Accompanying Labels
30
Figure 1: ON/OFF Switch Label
32
Figure 2: Emergency Stop Button Label
32
Figure 3: System Identification Labels
32
Figure 4: Prosense™ Straight Handle Identification Labels
33
Figure 5: Follow Instructions for Use
33
Figure 6: High Voltage Caution
33
Figure 7: Label 6 - Line Voltage Danger
33
Figure 8: Foot Pedal
33
Figure 9: Risk of Explosion Label
34
Figure 10: Single Use Cryoprobe Label
34
Figure 11: Color Tag Labels for Cryoprobes (A) and Introducers (B), and Their Location on the External Box
34
Figure 12: Single Use Temperature Sensor Label
35
Figure 13: Liquid Nitrogen Dewar Label
35
Figure 14: Black Dewar Label
35
Figure 15: Cold Area Sticker
35
Figure 16: Empty LN2 Dewars Sticker
35
Figure 17: BF Applied Parts Symbol
36
Figure 18: Holder Label
36
Figure 19: Shipping and Storage Conditions Sticker
36
Important Symbols and Labels
37
Figure 20: Shipping Label
37
Figure 21: Crate Opening Restriction Sticker
37
Figure 22: Single Use Introducer Labels
37
System Description
42
Introduction
42
Concept of Operation
42
Major Components
42
Figure 23: Front and Back View of the Prosense™ Cryoablation System with Numbered
42
Main Chassis
43
Emergency Stop Button
43
Figure 24: Prosense™ Transportation Rollers & Brakes
43
Flexible Hose
44
Touch Screen and User Manual Activation
44
Figure 25: Emergency Stop Button
44
Figure 26: Touch Screen Display before a Cryoablation Procedure
45
Figure 27: User Manual Navigation Panel
45
Cryohandle and Cryoprobe
46
Figure 28: Hose, Cryohandle and Connected Cryoprobe
46
Figure 29: 90 Degrees Cryohandle (no 1) and Connected Cryoprobe (no 2)
46
Figure 30: Straight Cryohandle and Connected Cryoprobe
46
Holder - Optional (Not Available in some Regions, E.g. China)
47
Figure 31: Handle Plug Holder and Handle Plug
47
Figure 32: Cryohandle Closed with the Plug on the Handle Holder
47
Foot Pedal (Not Available in some Regions, E.g. China)
48
Temperature Sensor (TS)
48
Figure 33: Holder and Its Position Within the CT Machine
48
Figure 34: Action Button as Displayed on Screen (Several of the Options)
48
Figure 35: Foot Pedal
48
Figure 36: Temperature Sensor and Its Components
49
Dewar Storage Cases
50
Operational Details
50
Figure 37: Temperature Display of Sensor in the Bottom-Right Corner of the Screen
50
Figure 38: Dewar Storage Cases - the Correct Way to Put the Dewars Inside the Storage
50
Starting the System
51
Figure 39: System Is Loading Screen
51
System Functional Tests
52
Cryoablation Procedure
52
Extraction Step
52
Figure 40: Main Menu Screen
52
Installation and Setup
53
Space and Positioning Requirements
53
Setup Warnings and Cautions
53
Electrical Requirements
54
For Countries in Which Local Line Voltage Is 100-127 VAC
54
For Countries in Which Local Line Voltage Is 220-240 VAC
54
Shipment Components
54
Installation
55
Operating the System
56
Procedure Overview
56
Pre-Operational Stages
56
Preparing the System for Procedure
56
Preparing the Patient for Procedure
57
Figure 41 : Schematic Illustration of Placement of the System and Patient
57
Switching on the Prosense™ Cryoablation System
58
Figure 42: System Is Loading Screen
58
Cryohandle
59
Figure 43: Main Menu Screen
59
Figure 44: Action Button as Displayed on Screen (Several of the Options)
59
Figure 45: Extraction Button as Displayed on Screen
59
General Settings
60
Figure 46: Activating the Settings Option from the Main Menu Screen
60
Figure 47: Settings Screen
60
Figure 48: Language Selection Screen
61
Figure 49:Technician Mode Screen
61
Figure 50: Export Log Screen
62
Preparing the System for Treatment
63
Figure 51: Windows® Date and Time Properties Screen
63
Figure 52: Preparing the System for Treatment by Pressing Prepare for Treatment on Main
64
Figure 53: Dewar Preparation Screen
64
Figure 54: Frost on the Dewar Opening
65
Figure 55: Freezing Has Stopped Pop-Up Message
65
Figure 56: Correct Insertion and Positioning of the Dewar - Bottom First
67
Figure 57: Insertion of the Dewar - Head First, Leaning Forward
67
Figure 58: Insertion of the Dewar - Bottom First, Leaning Backwards
67
Figure 59: Dewar Door Open Warning
68
Figure 60: Ice Ball Measurement Ranges
69
Figure 61: Cryoprobe (the Figure Is for Illustration Only)
71
Figure 62: Cryoprobe Registration Screen
72
Figure 63: Invalid Serial Number Warning
72
Figure 64 : "PEEL HERE" Label
73
Figure 65: Cryoprobe Connection Screen
74
Figure 66: Wait for Functional Test Screen
77
Figure 67: Functional Test Screen
77
Figure 68: Functional Test - Visual Inspection Screens
78
Cryoprobe Positioning
79
Figure 69: Pre-Planning Trajectory Needle Insertion in Breast Applications
80
Figure 70: Select Organ
80
Figure 71: Lesion Size Value
81
Figure 72: Planned Margin
81
Treatment Selection
82
Figure 73: Calculated Result N/A
82
Figure 74: Treatment Selection Screen
82
Figure 75: Edit Presets in the Main Menu Screen
83
Figure 76: Define a Treatment Protocol by Choosing Setup Presets on the Treatment
83
Figure 77: Steps for Adding a Protocol
85
Figure 78: Edit Preset Screen
85
Operational Stages
86
Safe Operation in Percutaneous Procedures
86
Preliminaries
86
Figure 79: Choosing the Manual Mode Option
86
Figure 80: Introducer Shaft Length
88
Figure 81: Illustration of FAP7200000 Cryoprobe Markings on the Cryoprobe
88
Freeze Step
89
Figure 82: Left: Pause Button Available; Right: Pause in Progress, Play Button Available
90
Figure 83: Manual Mode Screen: Press on Freeze to Start the Freeze Step
90
Figure 84: Freeze Screen in Manual Mode
91
Figure 85: Thaw Screen in Manual Mode
91
Figure 86: Extraction Screen in Manual Mode
92
Figure 87: Automatic Mode Screen: Press on Start to Begin the Freeze Step
93
Figure 88: Freeze Screen in Automatic Mode
93
Thaw
94
Extraction
94
Figure 89: Extraction Screen During Procedure
95
Figure 90: Extraction Screen
95
Figure 91: Completed Screen with 3 Options: Extraction, Relocate and Finish
96
Figure 92: Passive Thaw Screen
97
Figure 93: Completed Screen Without Extraction Option
97
Figure 94: Cryoprobe Placement Calculation Screen During Relocate
98
Figure 95: Dewar Replacement Screen
98
Figure 96: Dewar Replacement Finished Screen
98
Show Last Treatment
99
Figure 97: Last Treatment Screen after Relocation
99
Figure 98: Last Treatment Screen after more than 3 Freeze Steps Without Relocation
99
Replace (Refill) the Dewar During a Cryoablation Procedure
100
Figure 99: Last Treatment Screen after up to 3 Freeze Steps
100
Figure 100: Replace Dewar Option Question
100
Figure 101: Lowering the Dewar During Thaw Screen
101
Figure 102: Replace Dewar Screen
101
Figure 103: Replacement Done Follow up Screen
102
Figure 104: Replacement was Completed before the Thaw Ended
102
Figure 105: Replacement was Completed after the Thaw Ended
103
Figure 106: Replacement During Freeze, in Case of Empty Dewar
103
Post-Operational Stages
104
Removing the Temperature Sensor from Tissue
104
Figure 107: Procedure Stopped Due to Low Liquid Nitrogen
104
Figure 108: Extraction Completed Screen
104
Removing the Cryoprobe from the Cryohandle
105
Disassembling the Support Device - Hose-Holder
105
Disassembling the Temperature Sensor
105
Figure 109: Safe to Remove Cryoprobe
105
Exiting the Prosense™ Cryoablation System Treatment Mode
106
Figure 110: Protocol Completed Screen
106
Figure 111: Main Menu Screen
106
General Advice for Patients
107
System Failures
107
Prosense™ Cryoablation System Failure
107
Figure 112: System Shutdown Screen
107
Prosense™ Cryoablation System Touch Screen Failure
108
Figure 113: System Fail Example Screen
108
Figure 114: Emergency Stop Button Located on the Main Chassis
109
Computer Interface
110
The Technician Menu
110
Reading the Screen
110
System Messages
110
Status Messages
110
Figure 115: a Sample Touch Screen
110
Figure 116: Status Message Example
110
Warning Messages
111
Error Messages
111
Figure 117: Warning Message Format Example
111
Figure 118: Error Message Format Example
111
Accessories
113
Cryoprobe
113
Figure 119: Cryoprobe Components (the Figure Is for Illustration Only)
113
Introducer
114
Figure 120: Illustration of Mandrel (A) the Cannula with the Mandrel Inserted (B)
114
Foot Pedal (Not Available in some Regions, E.g. China)
115
Temperature Sensor (Not Available in some Regions, E.g. China)
115
Holder (Not Available in some Regions, E.g. China)
115
System Maintenance
116
General Cleaning
116
Sterility
117
Periodic Servicing
117
Figure 121: Counter of the Remaining Procedures before Maintenance at the Bottom of the Main Menu Screen
117
Troubleshooting
118
General
118
Troubleshooting Guide
118
Prosense™ Cryoablation System - Step-By-Step Procedure
123
System Specifications
124
Limited Warranty Certificate
125
Customer Complaint Form
126
Report Customer Complaint
127
Cryoablation Clinical References
128
Manufacturer's Declaration of the EUT
131
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