Hologic Affirm ASY-03949 Manuals

Manuals and User Guides for Hologic Affirm ASY-03949. We have 1 Hologic Affirm ASY-03949 manual available for free PDF download: User Manual

Hologic Affirm ASY-03949 User Manual (194 pages)

Prone Biopsy System

Brand: Hologic | Category: Medical Equipment | Size: 31 MB

Table of Contents
5
List of Figures
11
List of Tables
15
1: Introduction
17
Intended Use
17
Indications for Use
17
Contraindications
17
Essential Performance
17
System Capabilities
18
User Profiles
18
Mammography Technologist
18
Radiologists, Surgeons
18
Medical Physicist
18
Training Requirements
19
Quality Control Requirements
19
Where to Find the Installation Instructions
19
Where to Find Technical Description Information
19
Warranty Statement
20
Technical Support
20
Product Complaints
20
Hologic Cybersecurity Statement
20
Symbols
21
Symbol Description
22
Descriptions of Warnings, Cautions, and Notes
23
2: General Information
25
System Overview
25
Figure 1: Affirm Prone Biopsy System
25
C-Arm Overview
26
Figure 2: C-Arm Overview
26
Safety Information
27
Warnings and Precautions
27
Emergency off Switches
31
Interlocks
31
Compliance
31
Compliance Requirements
31
Figure 3: Emergency off Switch Functionality
31
Compliance Statements
33
Label Locations
34
Figure 4: Label Locations
34
Table 1: System Labels
35
3: System Controls and Indicators
37
System Power Controls
37
Figure 5: System Power Controls
37
C-Arm Controls
38
Figure 6: C-Arm Controls and Displays
38
Biopsy Arm Controls
39
Figure 7: Biopsy Arm - Detailed View
39
Control Handle Controls
40
Footswitch Controls
40
Figure 8: Control Handle -- Detailed View
40
Figure 9: Footswitch - Detailed View
40
Patient Platform Controls
41
Figure 10: Patient Platform Controls
41
Acquisition Workstation Controls
42
Figure 11: Acquisition Workstation Controls
42
4: Startup, Functional Tests, and Shutdown
43
How to Start the System
43
Figure 12: Startup Screen
43
Log in
44
Figure 13: Select an Operator (Log In) Screen
44
Functional Tests
45
Compression Functional Tests
45
Table 2: Compression Tests
45
C-Arm Movement Functional Tests
46
Patient Platform Functional Tests
46
Table 3: C-Arm Tests
46
Table 4: Patient Platform Tests
46
Emergency off Switches Functionality
47
How to Turn off the System
47
How to Remove All Power from the System
47
Figure 14: Emergency off Switch Functionality
47
5: User Interface - Control Monitor
49
Select Function to Perform Screen
49
Figure 15: Select Function to Perform Screen
49
About the Taskbar
50
Table 5: Taskbar Menus
50
Select Patient Screen
52
Figure 16: Select Patient Screen
52
Open a Patient
53
Table 6: the Select Patient Screen
53
Add a New Patient
54
Edit the Patient Information
54
Delete a Patient
54
Figure 17: Add Patient Screen
54
Filters for Patients
55
Figure 18: Filter Tab in the Patient Filter Screen
55
Table 7: Filter Tab Options (Require Access Privileges)
56
Refresh the Worklist
57
Query the Worklist
57
Admin
57
Log out
57
Procedure Screen
58
Figure 19: Procedure Screen
58
How to Use the Implant Present Button
59
Add a Procedure
59
Table 8: the Procedure Screen
59
Figure 20: Add Procedure Dialog Box
60
Add a View
61
Figure 21: Add View Screen
61
Edit a View
62
How to Remove a View
62
Figure 22: Edit View Screen
62
Procedure Info
63
Figure 23: the Procedure Info Window
63
Close a Patient
64
How to Access the Image Review Features
64
How to Access the Biopsy Options
64
Output Groups
65
Select an Output Group
65
Add or Edit an Output Group
65
Figure 24: Output Groups Field
65
Custom Output
66
Figure 25: an Example Custom Output Group
66
On-Demand Outputs
67
Archive
67
Export
68
Figure 26: on Demand Archive Screen
68
Print
69
Figure 27: Print Screen
70
Figure 28: Stereo Pair Print Screen
71
6: User Interface - Biopsy Control Module
73
Biopsy Control Module Screens
73
Home Screen
73
Figure 29: Home Screen
73
About the Taskbar for the Biopsy Control Module
74
Figure 30: Taskbar for the Biopsy Control Module
74
Target Guidance Screen
75
Figure 31: Target Guidance Screen
75
Figure 32: Select Target Screen
77
Figure 33: Jog Mode Screen
78
Figure 34: AEC Adjust Screen
79
7: Images
81
Image Display Screen
81
Figure 35: Image Display Screen
81
Conventional Imaging Sequence of Events
82
Tomosynthesis Imaging Sequence of Events
82
How to Set the Exposure Parameters
82
Select the Exposure Mode
82
How to Use the AEC Sensor
82
How to Acquire an Image
83
Figure 36: Exposure in Progress
83
Figure 37: Exposure Complete
83
How to Accept a Rejected Image
84
How to Correct and Reprocess Implant Images
84
If the Image Is Not Accepted
84
How to Review the Images
85
Figure 38: Tools Tab
85
The Image Review Tools Tab
86
Figure 39: Image Review Tools
86
Other Image Review Tools
87
Figure 40: Exposure Index
87
Figure 41: Display Modes
87
Slice Indicator
88
Figure 42: Slice Indicator
88
8: Biopsy
89
Biopsy Approach
89
Biopsy Coordinate System
90
Biopsy Views
91
Biopsy Tab
91
Biopsy Options
92
Lesion Targeting in a 2D Biopsy Procedure
94
Lateral Needle Approach
95
Verify the Position of the Biopsy Device
95
Lesion Targeting in a 3D Biopsy Procedure
96
Lateral Needle Approach
97
Verify the Position of the Biopsy Device
97
Project Targets on Post-Fire Scout Image
98
Lesion Targeting Using Multi-Pass
98
Post Biopsy
101
9: Accessories
103
Maximum Comfort Package
103
Table 9: Installation and Use of the Maximum Comfort Package
103
Table 10: Installation of the Arm through Maximum Comfort Package
105
Biopsy Paddles
106
Table 11: Use of the Arm through Maximum Comfort Package
106
How to Install or Remove a Paddle
107
Biopsy Devices and Components
108
Needle Guides
108
Biopsy Device Adapter
109
Biopsy Device
110
Equipment Drape Set
111
Symbols
113
Accessory Cart
114
Pad Hangers
114
Paddle Holders
115
10: Sample Clinical Sequences
117
Example Stereotactic Biopsy Procedure
117
Example Tomography Biopsy Procedure
118
Example Sequence of Operation
119
11: Quality Control
125
Required Quality Control Procedures
125
Table 12: Required Procedures
125
How to Access Quality Control Tasks
126
QAS Test
128
Gain Calibration
131
Geometry Calibration
132
12: Care and Cleaning
133
Cleaning
133
12.1.1 General Information about Cleaning
133
12.1.2 for General Cleaning
133
12.1.3 How to Clean the Biopsy Control Module Screen
134
12.1.4 to Prevent Possible Injury or Equipment Damage
134
General Information about Equipment Drapes
135
Preventive Maintenance Schedule for the User
136
Table 13: Operator Preventive Maintenance Schedule
136
Preventive Maintenance Schedule for Service
137
Table 14: Service Engineer Preventive Maintenance
137
13: System Administration Interface
139
The Admin Screen
139
Table 15: Admin Screen Functions
139
The about Screen
141
Change the User Language Preference
142
How to Access the System Tools
142
13.4.1 System Tools for the Radiologic Technologist Manager
143
Table 16: Radiologic Technologist Manager-System Tools Functions
143
13.4.2 Remote Access to Image Reports
144
Archive Tool
146
Appendix A Specifications
149
Product Measurements
149
Operation and Storage Environment
150
General Conditions for Operation
150
General Conditions for Transport and Storage
151
Electrical Input
151
Generator/Gantry
151
Acquisition Workstation
151
Gantry Technical Information
151
C-Arm
151
Compression System
152
Biopsy Guidance Module
152
X-Ray Tube
152
X-Ray Beam Filtration and Output
152
X-Ray Generator
153
Table 17: Maximum Ma as a Function of Kv
153
Image Receptor Technical Information
154
Shielding
154
Acquisition Workstation Technical Information
154
Network Environment
154
Acquisition Workstation Cart
154
Appendix B System Messages and Alerts
155
Error Recovery and Troubleshooting
155
Types of Messages
155
Fault Levels
155
System Messages
156
Table 18: System Messages
156
UPS Messages
158
Appendix C: Use in a Mobile Environment
159
General Information
159
Conditions for Safety and Other Precautions
159
Specifications for Mobile Use
160
Shock and Vibration Limits
160
Prepare the System for Travel
160
Prepare the System for Use
166
Test the System after Travel
166
Functional Tests after Travel
166
Quality Control Tests after Travel
166
Appendix D Dose Conversion Tables for the Medical Physicist
167
Appendix Ecnr Correction for Biopsy
171
CNR Correction for Stereotactic Biopsy
171
AEC Table 0 (Standard Stereotactic Biopsy Dose)
171
AEC Table 1 (EUREF Stereotactic Biopsy Dose)
171
CNR Correction for Biopsy under Tomosynthesis Option
171
AEC Table 0 (Tomosynthesis Option: Standard Tomo Dose)
171
AEC Table 1 (EUREF Tomosynthesis Biopsy Dose)
171
Appendix F: Technique Tables
173
Recommended Technique Table for Stereotactic Procedures
173
Recommended Technique Table for Tomosynthesis Procedures
174
Appendix G: Ancillary Parts for Biopsy
175
Hologic Factory-Verified Biopsy Devices
175
Table 19: Hologic Factory-Verified Biopsy Devices
175
Appendix H: Technical References
177
Electromagnetic Compatibility
177
Table 20: Electronic Emissions
177
Table 21: Electromagnetic Immunity Part 1
178
Table 22: Electromagnetic Immunity Part 2
179
Table 23: Separation Distances for RF Equipment
180
Rated Maximum Output Power of Transmitter
180
Appendix I: Forms
181
QAS Test Checklist
181
Geometry Calibration
183
Gain Calibration
185
Glossary of Terms
187
Index
189

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