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IceCure ProSense Manuals
Manuals and User Guides for IceCure ProSense. We have
2
IceCure ProSense manuals available for free PDF download: User Manual, Instructions For Use
IceCure ProSense User Manual (131 pages)
Cryoablation system
Brand:
IceCure
| Category:
Medical Equipment
| Size: 5 MB
Table of Contents
Table of Contents
2
1 Overview
8
Introduction
8
Intended Use
8
Indications for Use
8
Prosense™ Qualified Users
10
Clinical Decisions
10
Qualified Technician
11
Advanced Operator
11
2 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
21
Voltage and Power Ratings
22
Liquid Nitrogen Safety
22
Burn Hazards
24
Grounding
24
Sterility
25
Mechanical Handling of Hose and Cryohandle
25
Emergencies and Errors
26
Emergency Stop Button
26
Emergencies Causing Procedure Halt
26
Adverse Events
27
Disposal
27
Compliance
27
Compliance with International Safety Standards
27
Equipment Classification
28
Accompanying Labels
28
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)
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 10: Label 10 - Single Use Temperature Sensor MLT8000001 Rev. H
31
Figure 11: Label 11 - Liquid Nitrogen Dewar - MLS1000001 Rev. E
31
Figure 9: Label 9 - Single Use Probe (Various Options of Shapes, Tip, Length and Sizes)
31
Figure 12: Label 12 - Black Dewar - MLS1000015 Rev. B
32
Figure 13: Label 13 - Cold Area - MLS1000010 Rev. B
32
Figure 14: Label 14- Empty LN2 Dewars - MLS1000012 Rev. a
32
Figure 15: Label 15- Applied Parts - MLS1000014 Rev. a
32
Figure 16: Label 16- Holder - MLG1000006 Rev. B
33
Figure 17: Label 17- Shipping Art Work MLS3080002 Rev. a
33
Figure 18: Label 18- Shipping Art Work UCG1000025
33
Figure 19: Label 19- Only Icecure Technician Is Authorized to Open the Crate MLS1000013
34
Important Symbols and Labels
34
3 System Description
38
Introduction
38
Concept of Operation
38
Major Components
39
Figure 20: Front and Back View of the Prosense™ Cryoablation System with Numbered Components
39
Emergency Stop Button
40
Figure 21: the Prosense™ Transportation Rollers & Brakes
40
Figure 22: the Emergency Stop Button
40
Main Chassis
40
Figure 23: the Touch Screen Display before a Cryoablation Procedure
41
Flexible Hose
41
Touch Screen and User Manual Activation
41
Figure 24: the User Manual Screen
42
Figure 25: the User Manual Table of Contents
42
Cryohandle and Cryoprobe
43
Figure 26: the User Manual Screen
43
Figure 27: the Hose, Cryohandle and Connected Cryoprobe
43
Figure 28: the 90 Degrees Cryohandle (no 1) and Connected Cryoprobe (no 2)
44
Figure 29: Handle Plug Holder and Handle Plug
44
Figure 30: the Cryohandle on the Handle Plug Holder
45
Figure 31: the Holder and the Holder Position Within the CT Machine
45
Holder - Optional (Not Available in some Regions, E.g. China)
45
Figure 32: the Action Button as Displayed on Screen (Several of the Options)
46
Figure 33: the Foot Pedal
46
Foot Pedal (Not Available in some Regions, E.g. China)
46
Temperature Sensor (TS)
46
Figure 34: the Temperature Sensor and Its Components
47
Dewar Storage Cases
48
Figure 35: Temperature Display of Sensor in the Procedure Screen (See no 1)
48
Operational Details
49
Starting the System
49
Figure 36: Dewar Storage Cases - the Correct Way to Put the Dewars Inside the Storage Shelf
49
System Pre-Tests
50
Figure 37: the System Is Loading Screen
50
Figure 38: the Main Menu Screen
50
Figure 40: the System Is Loading Screen
50
Figure 41: the Main Menu Screen
50
Cryoablation Procedure
51
EXTRACTION Step
51
4 Installation and Setup
52
Space and Positioning Requirements
52
Setup Warnings and Cautions
52
Electrical Requirements
53
For Countries in Which Local Line Voltage Is 100-127 VAC
53
For Countries in Which Local Line Voltage Is 220-240 VAC
53
Shipment Components
53
Installation
54
5 Operating the System
55
Procedure Overview
55
Pre-Operational Stages
55
Preparing the System for Procedure
55
Preparing the Patient for Procedure
56
Figure 39 : Schematic Illustration of Placement of the System and Patient
56
Switching on the Prosense™ Cryoablation System
57
Cryohandle
58
General Settings
58
Figure 42: the Action Button as Displayed on Screen (Several of the Options)
58
Figure 43: the EXTRACTION Button as Displayed on Screen
58
Figure 44: Activating the Settings Option from the Main Menu Screen
58
Figure 45: the Settings Screen
59
Figure 46: Language Selection Screen
59
Figure 47:Technician Mode Screen
60
Figure 48: Export Log Screen
61
Figure 49: the Windows™ Date and Time Properties Screen
61
Preparing the System for Treatment
62
Figure 50: Preparing the System for Treatment by Pressing Prepare for Treatment (No. 1) on Main Menu Screen
62
Figure 51: the Dewar Preparation Screen
62
Figure 52: Frost on the Dewar Border
63
Figure 53: Correct Insertion and Positioning of the Dewar - Bottom First - Make Sure It's Positioned Freely in the Base
65
Figure 54: Insertion of the Dewar - Head First - Might Cause Wrong Positioning of Dewar Leaning Forward
65
Figure 55: Insertion of the Dewar
65
Treatment Selection
79
Operational Stages
84
Safe Operation in Percutaneous Procedures
84
Preliminaries
84
Freeze Cycle
87
Pause Option
87
Thaw
92
EXTRACTION Process
92
Show Last Treatment
97
Replace (Refill) the Dewar During a Cryoprocedure
99
Post-Operational Stages
104
Removing the Temperature Sensor from Tissue
104
Removing the Cryoprobe from the Cryohandle
104
Disassembling the Support Device - Hose-Holder
105
Disassembling the Temperature Sensor
105
Exiting the Prosense™ Cryoablation System Treatment Mode
105
Instruct Patients
106
System Failures
107
Prosense™ Cryoablation System Failure
107
Prosense™ Cryoablation System Touch Screen Failure
108
6 Computer Interface
110
The Technician Menu
110
Reading the Screen
110
System Messages
111
Status Messages
111
Warning Messages
111
Error Messages
112
7 Accessories
113
Cryoprobe
113
Single Use Sterile Cryoprobe
113
The Foot Pedal (Not Available in some Regions, E.g. China)
114
The Temperature Sensor (Not Available in some Regions, E.g. China)
114
The Holder (Not Available in some Regions, E.g. China)
115
Shelf Life
115
8 System Maintenance
116
General Cleaning
116
Sterility
117
Periodic Servicing
117
9 Troubleshooting
119
General
119
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
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IceCure ProSense Instructions For Use (4 pages)
Cryoablation System
Brand:
IceCure
| Category:
Medical Equipment
| Size: 0 MB
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