Profound Sonalleve MR-HIFU Manuals

Manuals and User Guides for Profound Sonalleve MR-HIFU. We have 1 Profound Sonalleve MR-HIFU manual available for free PDF download: Instructions For Use Manual

Profound Sonalleve MR-HIFU Instructions For Use Manual (195 pages)

Brand: Profound | Category: Medical Equipment | Size: 5.23 MB

Table of Contents
3
Introduction to Sonalleve MR-HIFU
7
About Sonalleve MR-HIFU
7
About this Manual
7
Notations
8
Intended Use
9
Sonalleve Desmoid Application
10
Operator Profile
11
Compatibility
11
Compliance
12
Training
12
Installation Instructions
12
System Classification
13
Safety
14
General Safety
14
Contraindications and Restrictions
16
Heat and Specific Absorption Rate (SAR)
17
Specific Absorption Rate (SAR)
17
Specific Energy Dose (SED)
18
Heat Load Induced by Ultrasound
18
Cooling the Patient
18
Clothing and Environmental Conditions
19
Contrast Agents and Medication
19
Emergency Stop and Safety Devices
20
Patient Emergency Stop Button (PESB)
20
Safety Device (SD)
21
Software Abort Sonication Button
22
Emergency Procedures
22
Magnetic Safety
22
Mechanical and Electrical Safety
22
Protecting the Equipment against Liquids
23
Chemical Safety
24
Explosion Safety
24
Fire Safety
24
Battery Safety
25
Electromagnetic Compatibility (EMC)
25
Network Safety, Data Security and Privacy
25
Malware Detection
27
Remote Desktop
27
Reporting of Incidents
27
Safety Improvements
27
Symbols and Labels on the Equipment
28
System Overview
34
Main System Components
34
Sonalleve Console
40
Sonalleve Generator Cabinet
40
Patient Accessories
40
Acoustic Contact Liquid
41
Other Accessories
42
The Discfill Tool
43
Technical Specifications
43
Ultrasound Field Distributions
44
Treatment Methods
47
Basic Concepts
47
Patient Selection
50
Sonication Method
50
Electronic Deflection
51
Temperature Monitoring
51
Thermal Dose Limits
51
Thermal Dose and Temperature Monitoring
52
Monitoring Near-Field Heating
54
Cooling Time
55
Temperature Limits
56
Motion Detection
56
Misplaced Heating or Motion Artefact
57
User Interface
58
Overview
58
Starting the Sonalleve MR-HIFU Application
58
Selecting the Configuration
58
Selecting between the Therapy and Standalone Mode
60
Exiting Therapy
61
Exiting the Sonalleve MR-HIFU Application
62
Therapy Application Screen Layout
63
Therapy Wizard
63
Viewing Images
65
Basic Viewing Tools
66
Advanced Viewing Tools
67
Overlay Tools
68
Adding, Selecting and Removing Objects
73
Controlling and Monitoring the Sonication
74
System Status Display
75
Sonication Buttons
78
Temperature and Thermal Dose
79
Temperature Curve
80
Message Area
82
Reporting and Logging
82
Generating Reports
82
Taking Snapshots
82
Viewing and Exporting Logs
83
Saving and Recovering Your Work
84
Language Settings
87
Keyboard Shortcuts
88
Workflow
89
Overview
89
Preparing the Equipment
89
Connecting the Sonalleve Table Top
89
Preparing the Table Top for the Patient
92
Preparing the Patient
93
Positioning the Patient on the Table
94
Verifying the Patient Positioning
95
Scanning the Planning Images
98
Preparing the Monitor Scan
98
Therapy Planning
103
Starting Therapy in the Sonalleve MR-HIFU Application
103
Entering Patient Information
103
Retrieving the Image Sets
104
Defining the Planning Target Volume
105
Defining the Tissue Boundary
106
Positioning the Treatment Volume
109
Beam Shaping
112
Preparing the System for Sonication
115
Hardware Initialization
115
Scanning Temperature Mapping
116
Test Sonication
117
Therapy
120
Replanning
120
Planning the Sonication Order
121
Determining the Correct Frequency Level for a Treatment Cell
121
Determining the Correct Power Level for a Treatment Cell
121
Adjusting the Sonication Duration for a Regular Treatment Cell
123
Sonicating
123
Reviewing the Sonication Results During the Cooling Time
125
Registration
126
Scanning Other Protocols from the Sonalleve Console
129
Saving the Treatment Data
129
Post Treatment
129
Error Recovery
130
Removing the Sonalleve Table Top
131
Sonalleve Table Top Storage
131
Maintenance
132
Routine Maintenance
132
Planned Maintenance Program
132
User Routine Checks Program
132
Sonalleve MR-HIFU Quality Assurance (QA) Procedure
137
Preparing the QA Phantom for Use
139
Performing the QA Test
143
QA Test Troubleshooting
147
Storing the QA Phantom
148
Cleaning and Disinfection
149
Cleaning the System
150
Cleaning the Vacuum Cushion
150
Cleaning the Discfill Tool
150
Making Degassed Acoustic Contact Liquid
150
Ultrasound Protection
151
System Error and Warning Messages
154
Errors
154
Warnings
155
Informational Messages
156
Product Disposal
157
Introduction
157
Passing the Product on to Another User
157
Final Disposal of the Product
157
Disposal of Patient Accessories
158
Disposal of the Sonalleve QA Phantom
158
Appendices
161
Using the Air Pump with Air Bags and Vacuum Cushions
161
Temperature Conversion
163
Comparing Thermal Dose Volumes and Non-Perfused Volumes
163
Estimating Thermal Dose Volumes
163
Calculating Non-Perfused Volumes (NPV)
164
Estimating NPV on Sonalleve Console
165
QA Test Result Table
166
Copying Sonalleve MR-HIFU Treatment Data to DVD
166
Copying DICOM Images
166
Copying Saved State Data
167
Security and Privacy Features
169
Access Control
169
Audit Trail
170
Network Time Synchronization
170
Other Security and Privacy Features Addressed
171
Hospital Administrator and User Accounts
172
About Accounts
172
Creating a New User/Administrator Account
173
Deleting an Account
174
Features for Advanced Users and Administrators
174
Partial Standalone Modes
174
Changing the Site Default Configuration
175
Automatic Backup of Configuration Changes in Research Mode
176
Advanced Maintenance Procedures
176
Adding Water to Discfill
177
Removing Air from the Filling Hose
177
Error and Warning Messages
178
Instructions for Use
194
Legal Notices
194
Profound REACH Statements
194

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Profound Sonalleve MR-HIFU Instructions For Use Manual (195 pages)

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