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DSR3200000
IceCure DSR3200000 Manuals
Manuals and User Guides for IceCure DSR3200000. We have
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IceCure DSR3200000 manual available for free PDF download: User Manual
IceCure DSR3200000 User Manual (137 pages)
Brand:
IceCure
| Category:
Medical Equipment
| Size: 5 MB
Table of Contents
Table of Contents
2
Overview
8
Introduction
8
Intended Use
8
Indications for Use
9
Prosense™ Qualified Users
10
Clinical Decisions
10
Contraindications
11
Qualified Technician
11
Advanced Operator
11
Safety Notes
12
Warnings and Cautions
12
Basic Safety Principles
12
Ownership
12
Qualification
12
Training
13
Clarity
13
Clinical Assessment
14
Installation and Setup
16
Proper Use
17
Operating Warnings
19
Liquid Nitrogen
21
Danger - Explosion and Fire Hazard
21
Opening the Dewar Compartment
22
Voltage and Power Ratings
22
Liquid Nitrogen Safety
22
Burn Hazards
24
Grounding
25
Sterility
25
Mechanical Handling of Hose and Cryohandle
26
Emergencies and Errors
26
Emergency Stop Button
26
Emergencies Causing Procedure Halt
27
Adverse Events
27
Disposal
28
Compliance
29
Compliance with International Safety Standards
29
Equipment Classification
29
Accompanying Labels
29
Figure 1: Label 1 ON/OFF Mechanical Button - MLS1000002 Rev. B
30
Figure 2: Label 2 - Emergency Stop - MLS1000003 Rev. B
30
Figure 3: Label 3 - Identification - MLS3080104 Rev. a (220-240 VAC) MLS3080103 Rev. a (100 - 127 VAC)
31
Figure 4: Label 4 - Follow Instructions for Use MLS 1000005 Rev D
31
Figure 5: Label 5 - High Voltage Caution - MLS1000006 Rev. B
31
Figure 6: Label 6 - Line Voltage Danger - MLS1000007 Rev. B
31
Figure 7: Label 7 - Foot Pedal - MLS1000008 Rev. B
31
Figure 8: Label 8 - Risk of Explosion - MLS1000009 Rev. B
32
Figure 9: Label 9 - Single Use Cryoprobe (Various Options of Shapes, Tip, Length and Sizes)
32
Figure 10: Label 10 - for Illustration Only, Color Tag Labels for Cryoprobes (A) and
32
Figure 11: Label 11 - Single Use Temperature Sensor MLT8000101 Rev. a
33
Figure 12: Label 12 - Liquid Nitrogen Dewar - MLS1000001 Rev. E
33
Figure 13: Label 13 - Black Dewar - MLS1000015 Rev. B
33
Figure 14: Label 14 - Cold Area - MLS1000010 Rev. B
34
Figure 15: Label 15- Empty LN2 Dewars - MLS1000012 Rev. a
34
Figure 16: Label 16- Applied Parts - MLS1000014 Rev. a
34
Figure 17: Label 17- Holder - MLG1000008 Rev. B
34
Figure 18: Label 18- Shipping Art Work MLS3080002 Rev. a
35
Figure 19: Label 19- Shipping Art Work UCG1000025
35
Figure 20: Label 20- Only Icecure Technician Is Authorized to Open the Crate MLS1000013
35
Important Symbols and Labels
36
Figure 21: Label 21- Single Use Introducers (Various Options of Length and Sizes) for Example: MLC9000100, MLC9100100 Rev. a
36
System Description
40
Introduction
40
Concept of Operation
40
Major Components
41
Figure 22: Front and Back View of the Prosense™ Cryoablation System with Numbered
41
Main Chassis
42
Emergency Stop Button
42
Figure 23: the Prosense™ Transportation Rollers & Brakes
42
Figure 24: the Emergency Stop Button
42
Flexible Hose
43
Touch Screen and User Manual Activation
43
Figure 25: the Touch Screen Display before a Cryoablation Procedure
43
Figure 26: the User Manual Screen
44
Figure 27: the User Manual Table of Contents
44
Cryohandle and Cryoprobe
45
Figure 28: the User Manual Screen
45
Figure 29: the Hose, Cryohandle and Connected Cryoprobe
45
Figure 30: the 90 Degrees Cryohandle (no 1) and Connected Cryoprobe (no 2)
46
Figure 31: Handle Plug Holder and Handle Plug
46
Holder - Optional (Not Available in some Regions, E.g. China)
47
Figure 32: the Cryohandle Closed with the Plug on the Handle Holder
47
Figure 33: the Holder and the Holder Position Within the CT Machine
47
Foot Pedal (Not Available in some Regions, E.g. China)
48
Temperature Sensor (TS)
48
Figure 34: the Action Button as Displayed on Screen (Several of the Options)
48
Figure 35: the Foot Pedal
48
Figure 36: the Temperature Sensor and Its Components
49
Figure 37: Temperature Display of Sensor in the Procedure Screen (See no 1)
49
Dewar Storage Cases
50
Operational Details
50
Figure 38: Dewar Storage Cases - the Correct Way to Put the Dewars Inside the Storage
50
Starting the System
51
Figure 39: the System Is Loading Screen
51
Figure 40: the Main Menu Screen
51
System Pre-Tests
52
Cryoablation Procedure
52
EXTRACTION Step
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: the System Is Loading Screen
58
Cryohandle
59
General Settings
59
Figure 43: the Main Menu Screen
59
Figure 44: the Action Button as Displayed on Screen (Several of the Options)
59
Figure 45: the EXTRACTION Button as Displayed on Screen
59
Figure 46: Activating the Settings Option from the Main Menu Screen
60
Figure 47: the 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: the Windows™ Date and Time Properties Screen
63
Figure 52: Preparing the System for Treatment by Pressing Prepare for Treatment (No. 1) on Main Menu Screen
64
Figure 53: the Dewar Preparation Screen
64
Figure 54: Frost on the Dewar Border
65
Figure 55: Correct Insertion and Positioning of the Dewar - Bottom First - Make Sure It's
67
Figure 56: Insertion of the Dewar - Head First - Might Cause Wrong Positioning of Dewar
67
Figure 57: Insertion of the Dewar
67
Figure 58: Dewar Door Open Warning
68
Figure 59: Ice Ball Isotherms of Prosense™ Cryoprobe from Experiments in Gel at Room Temperature
71
Figure 60: Pre-Planning Trajectory Needle Insertion
73
Figure 61: the Cryoprobe (the Figure Is for Illustration Only)
73
Figure 62: Cryoprobe Registration Screen
74
Figure 63: Invalid Serial Number Warning
74
Figure 64 : "PEEL HERE" Label
75
Figure 65: Cryoprobe Connection Screen
75
Figure 66: Cryoprobe Reading Failed
76
Figure 67: Cryoprobe Already Used
76
Figure 68: Cryoprobe Expired
77
Figure 69: Wait for Functional Test Screen
79
Figure 70: Functional Test Screen
79
Figure 71: Functional Test - Visual Inspection Screens
80
Treatment Selection
81
Figure 72: Treatment Selection Screen
82
Figure 73: Define a Treatment Protocol by Choosing Setup Presets on the Treatment Selection Screen (See no 1)
83
Figure 74: Edit Presets in the Main Menu Screen (See no 2)
83
Figure 75: Editing an Existing Protocol (See no 1) or Adding a New One (See no 2)
84
Figure 76: Steps for Adding a Protocol
85
Figure 77: Edit Preset Screen
86
Operational Stages
87
Safe Operation in Percutaneous Procedures
87
Preliminaries
87
Figure 78: Choosing the Manual Mode Option (See no 1)
87
Freeze Cycle
89
Figure 79: Introducer Shaft Length
89
Figure 80: Illustration of FAP7200000 Cryoprobe Markings on the Probe
89
Pause Option
90
Figure 81: Pause (no 1) and Play (no 2) Buttons During the Freeze Cycle
91
Figure 82: Manual Mode Screen: Press on Freeze to Start the Freeze Cycle
92
Figure 83: Freeze Screen in Manual Mode
92
Figure 84: THAW Screen in Manual Mode
92
Figure 85: Extraction Screen in Manual Mode
93
Figure 86: Automatic Mode Screen: Press on Start to Begin the Freeze Cycle
94
Thaw
95
EXTRACTION Process
95
Figure 87: Freeze Screen in Automatic Mode
95
Figure 88: the EXTRACTION Screen During Procedure
97
Figure 89: the Extraction Screen
97
Figure 90: Completed Screen with 3 Options: Extraction, Relocate and Finish
98
Figure 91: the Passive THAW Screen
99
Figure 92: Completed Screen Without Extraction Option
99
Figure 93: Treatment Selection Screen During Relocate
100
Figure 94: Dewar Replacement Screen
100
Figure 95: Dewar Replacement Finished Screen
100
Show Last Treatment
101
Figure 96: Last Treatment Screen after Relocation
101
Figure 97: Last Treatment Screen after more than 3 Freeze Cycles Without Relocation
101
Replace (Refill) the Dewar During a Cryoprocedure
102
Figure 98: Last Treatment Screen after up to 3 Freeze Cycles
102
Figure 99: Replace Dewar Option Question
102
Figure 100: Lowering the Dewar During THAW Screen
103
Figure 101: the Replace Dewar Screen and Press Ok to Continue
103
Figure 102: the Replacement Done Follow up Screen
104
Figure 103: Replacement was Completed before the THAW Ended
104
Figure 104: Replacement was Completed after the THAW Ended
105
Figure 105: Replacement During Freeze, in Case of Empty Dewar
105
Figure 106: Procedure Stopped Due to Low Nitrogen
106
Figure 107: EXTRACTION Completed Screen
106
Post-Operational Stages
107
Removing the Temperature Sensor from Tissue
107
Removing the Cryoprobe from the Cryohandle
107
Figure 108: Safe to Remove Cryoprobe
107
Disassembling the Support Device - Hose-Holder
108
Disassembling the Temperature Sensor
108
Exiting the Prosense™ Cryoablation System Treatment Mode
108
Figure 109: Protocol Completed Screen. Pressing on the "Main Menu" Icon (See No. 1)
108
Instruct Patients
109
Figure 110: the Main Menu Screen. to Shut down the System, Press on the Shutdown Icon
109
Figure 111: the System Shutdown Screen. Press "OK" to Proceed (See no 2)
109
System Failures
110
Prosense™ Cryoablation System Failure
110
Figure 112: System Fail Example Screen
110
Prosense™ Cryoablation System Touch Screen Failure
111
Figure 113: the Emergency Stop Button Located on the Main Chassis (See No. 1)
111
Computer Interface
113
The Technician Menu
113
Reading the Screen
113
Figure 114: a Sample Touch Screen
113
System Messages
114
Status Messages
114
Warning Messages
114
Figure 115: Status Message Example
114
Figure 116: Warning Message Format Example Pressing the OK Button will Indicate You Have Read this Message and will Dismiss the Popup
114
Error Messages
115
Figure 117: Error Message Format Example
115
Accessories
116
Cryoprobe
116
Single Use Sterile Cryoprobe
116
Figure 118: the Cryoprobe Components (the Figure Is for Illustration Only)
116
The Foot Pedal
117
The Temperature Sensor
117
The Holder
118
Shelf Life
118
System Maintenance
119
General Cleaning
119
Sterility
120
Periodic Servicing
120
Figure 119: Counter of the Remaining Procedure before Maintenance (See no 1) at the
121
Troubleshooting
122
General
122
Troubleshooting Guide
122
Prosense™ Cryoablation System - Step-By-Step Procedure
127
System Specifications
128
Limited Warranty Certificate
129
Customer Complaint Form
130
Report Customer Complaint
131
Cryoablation Clinical References
132
Manufacturer's Declaration of the EUT
135
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