Brainlab EXACTRAC INFRAREDMONITORING User manual

EXACTRAC
INFRARED
MONITORING®
Version 1.0
Clinical User Guide
Revision 1.1
Copyright 2011, Brainlab AG Germany. All rights reserved.

Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0 3
TABLE OF CONTENTS
TABLE OF CONTENTS
GENERAL INFORMATION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Contact Data and Legal Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Contact Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Legal Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Symbols Used in This Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Using the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Compatibility with Medical Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Brainlab Medical Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Brainlab Medical Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Non-Brainlab Medical Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Non-Brainlab Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Training and Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Data Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Confidentiality and Protection Against Unauthorized Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
ABOUT EXACTRAC IR MONITORING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
What is ExacTrac IR Monitoring? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
HARDWARE OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
ExacTrac Hardware Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Available Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

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IR System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
IR Tracking Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Components for System Calibration and Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
ExacTrac System Electronics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
General Notes on Electrical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
ExacTrac Infrared Monitoring Power Distribution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
ExacTrac Operating Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Storage and Cleaning Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
SYSTEM CALIBRATION AND QA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
The Couch/Linac Coordinate System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Activating Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Isocenter Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Calibrating the Isocenter Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Verifying the Isocenter Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
SYSTEM STARTUP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
System Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Standard ExacTrac Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
ExacTrac Startup Using the Timer Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Starting the ExacTrac Infrared Monitoring Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Software Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Software Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
General System Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
View Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Body Marker Accuracy Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Reminder Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

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PATIENT MONITORING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Patient Monitoring Workflow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Using Infrared Body Markers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Infrared Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Creating a New Patient File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Performing Infrared Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Using the Beam Interlock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Using Video Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Storing Video Reference Images . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Comparing Reference and Live Images . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Generating Treatment Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
SYSTEM SHUTDOWN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Shutting Down the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Closing Down the Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Closing Down the Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
SYSTEM MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Safety Inspection Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
General Inspection Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Annual Inspection Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Weekly and Monthly Inspection Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Safety Inspection Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Performing Electrical Inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Overview of Electrical Safety Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Documentation of Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Visual Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
Protective Earth Resistance Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Leakage Current Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

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Testing the Earth Leakage Current Breaker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Functionality Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Troubleshooting the Isolation Transformer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Handling Damaged Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
When the System Should Not Be Used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Returning Damaged Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
EXACTRAC INFRARED MONITORING
TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Troubleshooting Detection of Infrared Body Markers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
The Principle of Body Marker Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Automatically Solving Ambiguities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
LICENSING INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Licensing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
STATUS ICONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Status Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
INDEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0 7
1 GENERAL INFORMATION
1.1 Chapter Overview
1.1.1 Contents
Topics Covered
Section See
Contact Data and Legal Information Page 8
Symbols Page 10
Intended Use Page 11
Compatibility with Medical Devices Page 12
Training and Documentation Page 16

8 Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0
1.2 Contact Data and Legal Information
1.2.1 Contact Data
Support If you cannot find information you need in this guide, or if you have questions or problems, contact
Brainlab support:
Feedback Despite careful review, this manual may contain errors.
Please contact us at [e-mail] if you have suggestions as to how we can improve
this manual.
Manufacturer Brainlab AG
Kapellenstr. 12
85622 Feldkirchen
Germany
Region Telephone Email
United States and Canada Tel: [phone]
Fax: [phone] [email protected]m
Africa, Asia, Australia,
Europe Tel: [phone] Fax: [phone]
[email protected]Latin America Tel: [phone]
Fax: [phone]
Japan Tel: [phone]
Fax: [phone]
France and
French-speaking regions Tel: [phone] [email protected]

Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0 9
1.2.2 Legal Information
Copyright This guide contains proprietary information protected by copyright. No part of this guide may be re-
produced or translated without express written permission of Brainlab.
Brainlab
Trademarks •
BrainSCAN ™is a trademark of Brainlab AG.
• ExacTrac
®is a registered trademark of Brainlab AG in Germany and/or the US.
• iPlan
®
is a registered trademark of Brainlab AG in Germany and/or the US.
• Novalis
®is a registered trademark of Brainlab AG in Germany and/or the US.
Non-Brainlab
Trademarks • Exact®is a registered trademark of Varian Medical Systems, Inc.
•Microsoft
®and Windows®are registered trademarks of Microsoft Corporation.
Integrated 3rd-
Party Software • This software is based in part on the work of the Independent JPEG Group.
• This product includes software developed by the Apache Software Foundation
(http://www.apache.org).
• This product includes software licensed under the GNU General Public License
(see “LICENSING INFORMATION” on page 103).
CE Label
Disposal
Instructions Only dispose of electrical and electronic equipment in accordance with statutory regulations. For in- formation regarding the WEEE (Waste Electrical and Electronic Equipment) directive, visit:
www.brainlab.com/weee
Sales in US US federal law restricts this device to sale by or on the order of a physician.
• The CE label shows that the Brainlab product complies with the essential re-
quirements of Medical Device Directive (MDD).
• According to the MDD (Council Directive 93/42/EEC),
ExacTrac is a Class IIb
product.

10 Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0
1.3 Symbols
1.3.1 Symbols Used in This Guide
Warnings
Warnings are indicated by triangular warning symbols. They contain safety-critical in-
formation regarding possible injury, death or other serious consequences associated
with equipment misuse.
Cautions
Cautions are indicated by circular caution symbols. They contain safety-critical infor-
mation regarding possible problems with the device. Such problems include device
malfunctions, device failure, damage to device or damage to property.
Notes NOTE: Notes are formatted in italic type and indicate additional useful hints.

Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0 11
1.4 Intended Use
1.4.1 Using the System
Indications for Use This submission describes a system that is intended to be used to place patients at the isocenter of
a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. The ExacTrac system
uses optical tracking of infrared reflecting markers as the method of locating the position of the pa-
tient. The ExacTrac system consists of infrared cameras, computer workstation, reflective markers
and calibrations tools.
Careful Hardware
Handling
System components and accessory instrumentation comprise precise mechanical
parts. Handle them carefully.
Only trained medical personnel may operate system components and accessory in-
strumentation.
Operator Profile
ExacTrac system components and accessory devices may only be operated by trained
medical personnel.
Symbols on
Hardware
Components
Plausibility Review
Before patient treatment, review the plausibility of all information input to and output
from the system.
Symbol Explanation
s Class I Type B equipment according to IEC 60601-1
Attention! Consult accompanying documents

12 Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0
1.5 Compatibility with Medical Devices
1.5.1 Brainlab Medical Instruments
Compatible
Brainlab Medical
Instruments
ExacTrac Infrared Monitoring is compatible with the following instruments.
Tracking
Accessories
Calibration
Accessories
Additional
Accessories
Other Brainlab
Instruments Additional instrumentation may become available after release of this manual. Contact Brainlab sup- port if you have any questions regarding instrument compatibility with Brainlab software.
Only devices and spare parts specified by Brainlab may be used with ExacTrac Infra-
red Monitoring
. Using unauthorized devices/spare parts may adversely affect the safe-
ty and/or the effectiveness of ExacTrac Infrared Monitoring and endanger the safety of
the patient, user and/or environment.
Brainlab Tracking Accessories Comment
ExacTrac Infrared Body Marker
Spheres Used for patient tracking
ET Marker Sockets Sockets for fast and reproducible body marker at-
tachment, used in conjunction with adhesive pads
ExacTrac Reflective Marker Spheres Marker spheres for device tracking
Brainlab Calibration Accessories Comment
ET Isocenter Phantom Used for isocenter calibration with the linac lasers
Additional Brainlab Accessories Comment
Brainlab Imaging Couch Top Low density carbon fiber imaging couch tops for
improved X-ray image quality

Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0 13
1.5.2 Brainlab Medical Software
Authorization
Only authorized Brainlab employees may install software on the Brainlab system. Do
not install or remove any software applications.
Other Brainlab
Software If you are running software versions other than those specified above, contact Brainlab support for clarification regarding compatibility with Brainlab devices.
Only Brainlab medical software specified by Brainlab may be installed and used with
the system.

14 Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0
1.5.3 Non-Brainlab Medical Devices
Compatible Non-
Brainlab Medical
Devices
ExacTrac Infrared Monitoring is compatible with any linear accelerator equipped with an IGRT Po-
sitioning System.
Other Non-Brainlab
Devices
Using medical device combinations which have not been authorized by Brainlab may
adversely affect safety and/or effectiveness of the devices and endanger safety of pa-
tient, user and/or environment.
Only Brainlab support is authorized to modify the hardware configuration of the Exac-
Trac workstation. Unauthorized modifications may adversely affect system operation.

Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0 15
1.5.4 Non-Brainlab Software
Authorization
Only authorized Brainlab employees may install software on Brainlab systems. The
user may not install or remove any software applications.
Only Brainlab support is authorized to modify the software configuration of the work-
station. Unauthorized modifications may adversely affect system operation. If a virus
scanner is installed, it must be configured to not run in the background while Exac-
Trac Infrared Monitoring
is in operation.
Other Non-Brainlab
Software
Only non-Brainlab software applications specified by Brainlab may be installed and
used with
ExacTrac Infrared Monitoring .

16 Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0
1.6 Training and Documentation
1.6.1 Training
Brainlab Training To ensure safe and appropriate use, before using the system all users should participate in a training
program held by a Brainlab representative.
Supervised
Support Before using the system for surgical procedures where computer-aided navigation is considered es-
sential:
• Simulate a sufficient number of complete procedures on sawbones and/or cadavers.
• Use the system in operations where computer-aided navigation may be desirable but not
essential. A Brainlab representative must be present at such operations to provide guidance
where necessary.
Responsibility
This system solely provides assistance to the surgeon and does not substitute or re-
place the surgeon’s experience and/or responsibility during its use.

Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0 17
1.6.2 Documentation
Intended Audience • This guide provides an introduction and reference for the effective and correct use of Brainlab’s
ExacTrac system.
• This guide is written for all members of the clinical team who use or handle the ExacTrac sys-
tem or parts of it.
• You should read this guide carefully and acquaint yourself sufficiently with the system before
use.
Reading User
Guides The user guides describe complex medical devices and surgical navigation software that must be used with care.
It is important that all users of system, instruments and software:
• Read the user guides carefully before handling the equipment
• Have access to the user guides at all times
Available User
Guides
Quick Reference
Guides
Quick Reference Guides are available for most software applications and for some complex instru-
ments. They provide condensed information on using the software or hardware, and are intended
as a supplement to the User Guides.
NOTE: Quick Reference Guides do not replace the User Guides.
User Guide Contents
Software User Guides • Overview of treatment planning and image-guided navigation • Description of OR system setup
• Detailed software instructions
Instrument User Guides Detailed instructions on instrument handling
Cleaning, Disinfection and
Sterilization Guide Details on cleaning, disinfecting and sterilizing instruments
System User Guides Comprehensive information on system setup
Technical User Guide Detailed technical information on the system, including specifica-
tions and compliances

18 Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0
1.7 Data Protection
1.7.1 Confidentiality and Protection Against Unauthorized Access
Regional
Legislation In the
ExacTrac Infrared Monitoring software, patient data is identified by the patient’s name and
a unique ID. For this reason, it must be handled in accordance with the relevant confidentiality leg-
islation and protected against unauthorized access. In the United States, patient data must be han-
dled in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
Access to System
Hardware The
ExacTrac workstation is housed in a cabinet with a front and rear door. Both doors should be
locked to prevent unauthorized access, and the key stored in a secure location. The control panels
(see “ExacTrac Operating Panels” on page 30) can still be operated via the openings on the front
door.
The cabinet must either be appropriately protected against public access or installed
in a location that can be supervised at all times.
It is the hospital’s responsibility to ensure cabinet security outside of working hours.
Access to
Electronic Data The Windows XP operating system provides user authentication that protects against unauthorized access to patient data. All login and password information should be handled by the hospital network
administrator, and all personnel operating the
ExacTrac system instructed to log off the system after
use. A password-protected screensaver can be implemented to provide additional security.
Access to Printouts As ExacTrac Infrared Monitoring treatment reports (see “Generating Treatment Reports” on
page 74) contain the patient name and ID, the printer must be located in a secure area and the print-
outs protected against unauthorized access.
Data Backup In order to protect against patient data loss, the ExacTrac Infrared Monitoring patient folders
should either be backed up on DVD, or stored using network-based archiving.
System Disposal As confidential patient data is stored on the hard drive of the ExacTrac workstation, this data must
either be securely erased, or the hard drive physically destroyed before system disposal.
Simply erasing the data from the hard drive does not provide sufficient protection
against data retrieval. A dedicated software application must be used so that the data
cannot be recovered.

Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0 19
2 ABOUT EXACTRAC IR
MONITORING
2.1 Chapter Overview
2.1.1 Contents
Topics Covered
Section See
What is ExacTrac IR Monitoring? Page 20

20 Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0
2.2 What is ExacTrac IR Monitoring?
2.2.1 Overview
General
Information ExacTrac IR Monitoring enables you to monitor a patient’s position after the patient has been posi- tioned for treatment.
Features With ExacTrac IR Monitoring you can:
• Use a streamlined workflow of infrared monitoring once a patient has been set up to isocenter
position by third party IGRT set-up.
• Define a reference position of IR markers relative to the isocenter.
• Define tolerances for individual patients to detect whether their current position is OK / reduced
/ low accuracy and an optional beam cut-off tolerance.
• Display the deviation in the lateral, longitudinal and vertical directions to the stored reference
position.
• Monitor the patient positions by video, using a reference video image and displaying a video
subtraction image.
• Use an optional automatic beam interlock to cut off the treatment beam if the patient position
moves outside the defined tolerance.
• Use archiving and printout functionality.