VIEWRAY MRIdian System 4.5, MRIdian 4.1 Operator's Manual

Page 1

Operator’s Manual

for the

MRIdian® System 4.5

For Software Release 4.5 November 2016 Document No. L-0009

This document contains the confidential and proprietary information of ViewRay, Inc. Neither this document nor any of the information contained is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by ViewRay, Inc.

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This page intentionally left blank.

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ViewRay, Inc., has taken care to ensure the accuracy of this document; however, ViewRay Inc. assumes no liability f further notice to any products herein to improve reliability, function or design.

ViewRay provides this manual without warranty of any kind, either implied or expressed, including particular purpose.

This document contains proprietary information that is protected by copyright. ViewRay Inc.

eserves the right to revise this publication and to make changes in content from time to time

r without obligation on the part of ViewRay to provide notification of such revision or change.

but not limited to, the implied warranties of merchantability and fitness for a

or errors or omissions and reserves the right to make changes without

Additional Manuals

To download a PDF of this manual visit www.viewray.com/resource_center_home and sign in with your username and password.

Trademark Information

ViewRay is a trademark of ViewRay, Inc.

MRIdian is a trademark of ViewRay, Inc.

Windows names are trademarks or registered trademarks of their respective holders.

® is a registered trademark of Microsoft® Corporation. Other brand or product

Patent Information

The MRIdian® system is protected by one or more patents.

Visit www.ViewRay.com/patents for a complete list of MRIdian system patents.

ViewRay Inc. MRIdian® system L-0009 Release 4.5 i

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Contacting Support

Support services are available without charge during the initial warranty period.

For service:

Telephone—1.855.286.8875

To submit system issues or product improvement requests online:

www.viewray.com/resource_center_service

European Authorized Representative:

MedPass International Ltd.

Winsor House Bretforton

Evesham, Worcestershire.

WR11 7JJ, United Kingdom

ii MRIdian® system L-0009 Release 4.5 ViewRay Inc.

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CAUTION: The MRIdian® system is for PRESCRIPTION USE ONLY. Federal law restricts the device to sale by or on the order of a physician, or licensed healthcare provider.

Intended Use

The MRIdian system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

The MRIdian system may be contraindicated for patients with implants due to the presence of the MRI magnetic field. All patients must be screened for MRI compatibility prior t

The MRIdian system must be operated according to the intended use and only by qualified persons with the necessary knowledge in accord with countryspecific regula

tions.

o treatment.

All personnel must complete user training before operating the system. The user must be familiar system, the user must read and understand the operator’s manual.

To find the software version your system is running Click > the MRIdian icon and a dropdown menu op

with all potential hazards and all safety guidelines. In addition, before using the

ens. From that dropdown menu Click > About MRIdian®

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Technical and performance data for the system is in “Technical Manual for the MRIdian System” (L-0016) that was supplied with the system.

iv MRIdian® system L-0009 Release 4.5 ViewRay Inc.

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Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii

Chapter 1: MRIdian® System Overview . . . . . . . . . . . . . . . . . .1

1.1 System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1.2 MRIdian® System Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

1.3 Treatment Planning and Delivery Software. . . . . . . . . . . . . . . . . . . . 4

1.4 System Logging Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

1.4.1 Creating a Support Package of Log Files . . . . . . . . . . . . . . . . . . . . . . .5

1.5 System Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

1.6 Uninterruptible Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

1.7 System Status Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

1.8 Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

1.9 Imaging System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

1.10 Cooling System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

1.10.1 Magnetic Shielding. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10

1.10.2 Gradient System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

1.11 Patient Handling System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

1.12 Receive Coils. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

1.12.1 Coil Sockets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14

1.13 Radiation Therapy Delivery System . . . . . . . . . . . . . . . . . . . . . . . . 14

1.13.1 Radioactive Source and Shielding. . . . . . . . . . . . . . . . . . . . . . . . . . .15

1.13.2 Multi-leaf Collimator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

1.14 Patient Communication System . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

1.14.1 Patient Headphones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

1.14.2 Treatment Room Speakers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

1.14.3 Treatment Room Microphones . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

1.14.4 Flat-Panel Display Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

1.14.5 Intercom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

1.14.6 Video Camera . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

1.15 Electronics Cabinets. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

1.16 About this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Chapter 2:Safety Information and Alerts . . . . . . . . . . . . . . . .21

2.1 Safety Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

2.1.1 Definition of Hazard Levels and Symbols . . . . . . . . . . . . . . . . . . . . . .22

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2.1.2 General MRIdian® System Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

2.2 Product Performance Liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24

2.2.1 Electrical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

2.3 Guidance and Declaration for Electromagnetic Compatibility . . . .25

2.3.1 Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

2.3.2 Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

2.4 Treatment Room Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31

2.4.1 Slipping and Falling Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

2.4.2 Pinch Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

2.5 Patient Transport Safety and Communication . . . . . . . . . . . . . . . . . 32

2.5.1 Patient Transport System Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

2.5.2 Patient Alert for Patient-Initiated Communication . . . . . . . . . . . . . 32

2.5.3 Communicating with the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

2.6 Laser Positioning Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33

2.7 Imaging Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34

2.7.1 MR Safety Screening . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

2.7.2 Magnetic Field Emergency Procedures . . . . . . . . . . . . . . . . . . . . . . 35

2.7.3 Devices Contraindicated for MRI. . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

2.7.4 Patients Typically Contraindicated for MRI. . . . . . . . . . . . . . . . . . . 36

2.7.5 Pre-screening Prior to Imaging or Treatment on the MRIdian® System37

2.7.6 MR Worker Screening and Reporting Requirements . . . . . . . . . . . 38

2.7.7 Safety Screening Form, MR Hazard Checklist and Patient Instructions39

2.7.8 Supervision of Patients and Equipment . . . . . . . . . . . . . . . . . . . . . . 41

2.8 Artifacts and Imaging Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

2.9 Controlled Access Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42

2.9.1 Fringe Field Effects on Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

2.9.2 MR Restricted Access Sign. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

2.10 Exposure to RF Electromagnetic Fields . . . . . . . . . . . . . . . . . . . . . .44

2.10.1 Warming of Body Tissue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

2.10.2 Noticeable Effects on the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . 46

2.11 Peripheral Nerve Stimulation (dB/dt) . . . . . . . . . . . . . . . . . . . . . . .46

2.11.1 Operating Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

2.11.2 First Level Controlled Operating Mode . . . . . . . . . . . . . . . . . . . . . 47

2.12 Current Loops . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48

2.13 Effects of Antenna. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49

2.14 Risks of Non-MR Safe Monitoring and Interventional Devices . . . 50

2.15 Hazardous Noise Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50

2.16 Magnet Quench. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

2.16.1 Half Quenches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

2.16.2 Gauss Line After a Patient-End Magnet Quench . . . . . . . . . . . . . . 52

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2.16.3 Gauss Line After a Service-End Magnet Quench . . . . . . . . . . . . . . .55

2.17 Fire Safety in the Treatment Room . . . . . . . . . . . . . . . . . . . . . . . . 56

2.18 Measurement Phantom Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

2.18.1 Contact with Phantom Fluid Spills . . . . . . . . . . . . . . . . . . . . . . . . . .57

2.18.2 Risks Due to Aerosol Formation . . . . . . . . . . . . . . . . . . . . . . . . . . . .58

2.19 Radiation Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

2.19.1 Radiation Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58

2.19.2 Exposure Control for Operators . . . . . . . . . . . . . . . . . . . . . . . . . . . .59

2.19.3 Audible Radiation Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59

2.19.4 Radiation Safety Interlocks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60

2.20 Emergency Response Plans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

2.21 Unintended Radiation (Stuck Source) Exposure . . . . . . . . . . . . . . 61

2.22 Using the E-Stop in an Emergency . . . . . . . . . . . . . . . . . . . . . . . . . 62

2.23 Emergency Magnet Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

2.23.1 Magnet Emergency Discharge Button . . . . . . . . . . . . . . . . . . . . . . .63

2.23.2 Emergency Quench Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64

2.23.3 Rescuing the Patient in an Emergency . . . . . . . . . . . . . . . . . . . . . . .64

Chapter 3:System Coordinates . . . . . . . . . . . . . . . . . . . . . . . .67

3.1 MRIdian® System Coordinates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

3.1.1 Direction Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67

3.1.2 Gantry Coordinate System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68

3.1.3 Gantry Rotation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69

3.1.4 Beam Limiting Coordinate System. . . . . . . . . . . . . . . . . . . . . . . . . . .69

3.1.5 Beam’s Eye View of Multi-Leaf Collimator (MLC). . . . . . . . . . . . . . .70

3.1.6 Orientation of an MLC Relative to the Gantry . . . . . . . . . . . . . . . . .71

3.1.7 MLC Orientation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72

3.1.8 Planning and Visualization using Coordinate System. . . . . . . . . . . .73

Chapter 4:System and Administrative Tasks . . . . . . . . . . . . .77

4.1 Starting Up the Planning Consoles . . . . . . . . . . . . . . . . . . . . . . . . . . 77

4.2 Starting Up the Delivery System . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

4.2.1 Additional Treatment Delivery Console Checks . . . . . . . . . . . . . . . .81

4.3 Shutting Down the Planning System . . . . . . . . . . . . . . . . . . . . . . . . 82

4.4 Shutting Down the Delivery and MRI Systems . . . . . . . . . . . . . . . . 82

4.5 Logging on to System Administration. . . . . . . . . . . . . . . . . . . . . . . . 84

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4.6 Adding Users to the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

4.7 User Group Rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87

4.8 Editing User Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87

4.9 Resetting a User Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .88

4.10 Using Global Structures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

4.10.1 Editing Structures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

4.11 Managing Templates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91

4.11.1 Renaming Templates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

4.11.2 Removing Templates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

4.11.3 Exporting Templates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

4.11.4 Importing a Template . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

Chapter 5:Prescription and Patient Management . . . . . . . . 99

5.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .99

5.1.1 Organization of Patient Management Information. . . . . . . . . . . . 100

5.2 Adding New Patients. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .101

5.3 Adding a Patient Photo . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .102

5.4 Using the Patient Information Features . . . . . . . . . . . . . . . . . . . . .103

5.5 Filtering the Patient List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .104

5.5.1 Sorting the Patient List. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

5.6 Editing Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .106

5.7 Editing Patient Notes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .107

5.8 Adding a Diagnosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .108

5.8.1 Editing a Diagnosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

5.9 Entering a Prescription . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .110

5.10 Entering TNM Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .112

5.11 Using Treatment Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .113

5.12 Adding Structure, Dose, and Point Constraints . . . . . . . . . . . . . .114

5.12.1 Customizing a Structure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116

5.12.2 Setting Structure Constraints . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117

5.12.3 Adding a Point Constraint . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118

5.13 Adding a Primary Reference. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .118

5.14 Plan Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .120

5.14.1 Scheduling Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

5.14.2 Viewing the Delivery Calendar . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

5.14.3 Assigning Treatment Plans to Fractions . . . . . . . . . . . . . . . . . . . 122

5.14.4 Locking Treatment Fractions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

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5.14.5 Unlocking Treatment Fractions. . . . . . . . . . . . . . . . . . . . . . . . . . . 125

5.14.6 Discontinuing Fractions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

5.14.7 Undoing Discontinue Fraction . . . . . . . . . . . . . . . . . . . . . . . . . . . 128

5.14.8 Reviewing Individual Fraction Deliveries . . . . . . . . . . . . . . . . . . . 129

5.14.9 Viewing the Delivery Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

5.14.10 Viewing the Tracking Points Chart . . . . . . . . . . . . . . . . . . . . . . . 133

5.14.11 Generating a New Plan After a Fraction Review . . . . . . . . . . . . 134

5.14.12 Completion Plans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

5.15 Setting QA Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

5.16 Comparing Plans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

5.17 Hiding Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144

5.18 Patient Archive and Restore System (PARS) . . . . . . . . . . . . . . . . 146

5.18.1 Archiving Patient Plan Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

5.18.2 Restoring Patients after Purging. . . . . . . . . . . . . . . . . . . . . . . . . . 149

5.18.3 Exporting Patient Plan Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150

5.18.4 Importing MRIdian Treatment Plan Data. . . . . . . . . . . . . . . . . . . 151

5.18.5 PARS Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

5.18.6 Status Refresh and Filter Options . . . . . . . . . . . . . . . . . . . . . . . . . 154

5.19 Deleting Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

5.20 Returning to Prescription . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156

5.21 Screen to PDF capture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156

Chapter 6: Treatment Planning . . . . . . . . . . . . . . . . . . . . . . .159

6.1 Treatment Planning Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . 159

6.1.1 The MRIdian System Treatment Planning Process . . . . . . . . . . . . 159

6.2 Patient Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161

6.3 Creating a New Plan. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162

6.4 Selecting an Existing Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

6.5 Loading a Plan. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164

6.5.1 Viewing Only. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165

6.6 Adding Images to a Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165

6.7 Importing Images and RTDOSE from DICOM. . . . . . . . . . . . . . . . . 168

6.8 Importing Images and RTDOSE from DICOM Files . . . . . . . . . . . . 171

6.9 Importing Structures/Contours. . . . . . . . . . . . . . . . . . . . . . . . . . . . 175

6.10 Importing Points. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178

6.11 Exporting MRIdian Data via DICOM . . . . . . . . . . . . . . . . . . . . . . . 179

6.12 Removing Slices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181

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6.13 Interpolating and Editing Image Sets. . . . . . . . . . . . . . . . . . . . . . .183

6.14 Creating a 4D Series . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .184

6.15 Viewing a 4D Series . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .187

6.16 Image Orientation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .188

6.17 Viewing Images . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .190

6.17.1 Ortho MPR and 3D Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191

6.17.2 Using Multiplanar (MPR) Lines . . . . . . . . . . . . . . . . . . . . . . . . . . . 191

6.17.3 Using Window/Level Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192

6.17.4 Using the Zoom Tool . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193

6.17.5 Using the Pan Tool . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193

6.17.6 Using the Measurement Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . 193

6.17.7 Using the Point Tool. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193

6.17.8 Using the Length Tool . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194

6.17.9 Image Orientation Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194

6.18 Using the Display Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .196

6.19 Removing Overlays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .196

6.20 Contouring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .197

6.20.1 Adding Structures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197

6.20.2 Expanding Structures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199

6.20.3 Auto-Contouring Skin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200

6.20.4 Using the Draw Contours Tools. . . . . . . . . . . . . . . . . . . . . . . . . . . 200

6.20.5 Interpolating Contours. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203

6.20.6 Keyboard Shortcuts and Context Menu Options. . . . . . . . . . . . . 203

6.20.7 Using the Clean Up Tools. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205

6.20.8 Using the Boolean Tool . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206

6.20.9 Using Iso-Intensity Contouring . . . . . . . . . . . . . . . . . . . . . . . . . . . 209

6.20.10 Using Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212

6.20.11 Saving Auto-Contouring Templates . . . . . . . . . . . . . . . . . . . . . . 213

6.20.12 Auto-Contouring Using a Saved Template . . . . . . . . . . . . . . . . . 214

6.20.13 Approving Contours . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215

6.21 Image Registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .216

6.21.1 Registration Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216

6.21.2 Advanced Registration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220

6.21.3 Aligning Volumes Using Overlays . . . . . . . . . . . . . . . . . . . . . . . . . 232

6.22 Using Image Masks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .234

6.23 Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .239

6.23.1 Adding Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 240

6.23.2 Using 3-Point Landing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 241

6.23.3 Fine-tuning Point Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 241

6.23.4 Setting Points at the Center of a Structure . . . . . . . . . . . . . . . . . 242

6.23.5 Manually Placing Points. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 242

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6.23.6 Entering Values for Point Placement. . . . . . . . . . . . . . . . . . . . . . . . . . . . 243

6.23.7 Deleting Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244

6.23.8 Renaming a Point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244

6.24 Couch and Isocenter Placement . . . . . . . . . . . . . . . . . . . . . . . . . . 245

6.24.1 Finding Valid Isocenters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 246

6.25 Beams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 247

6.25.1 Beams Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 247

6.25.2 Placing a Beam Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 248

6.25.3 Locking Same-Isocenter Beam Groups. . . . . . . . . . . . . . . . . . . . . 249

6.25.4 Changing a Single Beam Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250

6.25.5 Adding Pseudo-Arc Beams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250

6.25.6 Manually Adjusting Beam Angles . . . . . . . . . . . . . . . . . . . . . . . . . 251

6.25.7 Adjusting Beam Angles Using Beam Values. . . . . . . . . . . . . . . . . 251

6.25.8 Saving Beam Templates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251

6.25.9 Loading Beams from Templates . . . . . . . . . . . . . . . . . . . . . . . . . . 251

6.25.10 Deleting Beam Groups. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 253

6.26 Setting MLCs for Conformal Beams . . . . . . . . . . . . . . . . . . . . . . . 254

6.27 Viewing Structures from the Beam’s Eye View . . . . . . . . . . . . . . 256

6.28 Viewing the Complete Irradiated Area Outline . . . . . . . . . . . . . . 256

6.29 Setting Electron Densities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 257

6.29.1 Use CT Only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 258

6.29.2 Use Structure Densities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 259

6.30 Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 260

6.30.1 IMRT Prescription Offset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 261

6.30.2 Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 263

6.30.3 Using IMRT Efficiency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 263

6.30.4 Setting the Resolution for the Dose Grid . . . . . . . . . . . . . . . . . . . 264

6.31 IMRT Interdigitation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 265

6.32 MRIdian® System Algorithms . . . . . . . . . . . . . . . . . . . . . . . . . . . . 265

6.33 Dose Optimization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 266

6.34 Optimizing Dose for IMRT and Conformal Beams. . . . . . . . . . . . 270

6.35 Advanced Dose Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 272

6.35.1 Changing Structure Constraints After Optimizing Dose . . . . . . . 274

6.36 Normalizing the Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 275

6.36.1 Fixed Conformal Beams. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 276

6.36.2 Plan Evaluation Tools. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 278

6.36.3 Isodose Lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 279

6.36.4 Saving Isodose Line Templates . . . . . . . . . . . . . . . . . . . . . . . . . . . 281

6.36.5 Loading a Saved Isodose Line Template. . . . . . . . . . . . . . . . . . . . 283

6.37 Managing Motion Using Isodose Lines. . . . . . . . . . . . . . . . . . . . . 283

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6.38 RealTarget® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .285

6.38.1 Numerical Margins and Structure Boundaries. . . . . . . . . . . . . . . 287

6.38.2 Finding Valid Spatial Integrity Region for RealTarget . . . . . . . . . 287

6.38.3 Real-Time RealTarget. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 288

6.38.4 RealTarget Delay and Wait Time. . . . . . . . . . . . . . . . . . . . . . . . . . 288

6.39 Treatment Plan Evaluation and Approval . . . . . . . . . . . . . . . . . . .288

6.39.1 Calculating Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 289

6.40 Comparing Two Plans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .290

6.41 Comparing 2 Plans that have 2 Prescriptions . . . . . . . . . . . . . . . .291

6.42 Setting Registration Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .292

6.43 Approving a Treatment Plan. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .294

6.44 Remote Connectivity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .295

Chapter 7: Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 297

7.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .297

7.2 Time-Varying Magnetic Fields (dB/dt) and Peripheral Nerve Stimula-

tion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .297

7.3 Managing Images . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .299

7.4 Searching for Images. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .299

7.5 Importing Images from PACS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .300

7.6 Importing DICOM Images from Files . . . . . . . . . . . . . . . . . . . . . . . .302

7.7 Exporting Images . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .304

7.8 Viewing Images . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .305

7.9 Imaging. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .305

7.10 Adding a New Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .306

7.11 Using the Patient Sidebar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .307

7.12 Searching for Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .308

7.13 Editing Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .308

7.14 Filtering the Patient List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .309

7.15 Sorting the Patient List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .310

7.16 Acquiring Images . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .310

7.16.1 Acquiring Low Resolution Images . . . . . . . . . . . . . . . . . . . . . . . . 311

7.16.2 Acquiring a High Resolution Image. . . . . . . . . . . . . . . . . . . . . . . . 312

7.16.3 Field of View Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 312

7.17 Setting Image Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .312

7.18 Saving Images . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .313

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7.19 Deleting Images. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 315

7.20 Simulating Treatment Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . 316

7.20.1 Preview Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 317

7.20.2 Saving a Ciné. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 317

7.21 RealViewer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 319

7.21.1 Exporting a Ciné . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 320

Chapter 8:Patient Set-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . .321

8.1 Patient Transport Safety and Communication . . . . . . . . . . . . . . . 321

8.1.1 Pinch Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 321

8.1.2 Slipping and Falling Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 321

8.2 Monitoring the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 321

8.2.1 Intercom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 322

8.2.2 Squeeze Bulb . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 322

8.2.3 Using Patient Headphones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 324

8.3 Patient Set-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 324

8.4 Displays and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 325

8.5 Couch Control Buttons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 327

8.6 Buttons Available On The in-Room Control Panel Only . . . . . . . . 329

8.7 Understanding the Stored Couch Position. . . . . . . . . . . . . . . . . . . 329

8.8 Patient Load Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 330

8.9 Loading and Positioning the Patient Without A Stored Couch Position 331

8.10 Patient Positioning Using Stored Couch Position . . . . . . . . . . . . 332

8.11 Couch Motion Control Lockout. . . . . . . . . . . . . . . . . . . . . . . . . . . 332

Chapter 9:Treatment Delivery. . . . . . . . . . . . . . . . . . . . . . . .335

9.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 335

9.2 Powering Up the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 335

9.3 Retrieving the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 336

9.4 Loading the Plan for Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 337

9.4.1 Treating More than One Daily Fraction . . . . . . . . . . . . . . . . . . . . . 337

9.5 Using Daily Images to Position the Patient . . . . . . . . . . . . . . . . . . 338

9.5.1 Acquiring a High-Resolution Image . . . . . . . . . . . . . . . . . . . . . . . . 341

9.5.2 Registering Daily Images . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 341

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9.6 Finding the Couch Shift . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .343

9.6.1 Manually Finding the Couch Shift . . . . . . . . . . . . . . . . . . . . . . . . . 344

9.6.2 Automatically Finding the Couch Shift . . . . . . . . . . . . . . . . . . . . . . 347

9.6.3 Set to Center of Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 348

9.7 Saving the Patient’s Couch Position. . . . . . . . . . . . . . . . . . . . . . . . .348

9.8 Viewing Beams on the Positioning Screen . . . . . . . . . . . . . . . . . . .349

9.9 Editing Contours for Patient Positioning . . . . . . . . . . . . . . . . . . . . .349

9.9.1 Editing Rule-Based Contours . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 350

9.10 Predicting Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .351

9.10.1 Normalizing New Plan to Prescription . . . . . . . . . . . . . . . . . . . . . 356

9.11 Editing New Plan in Planning Workflow . . . . . . . . . . . . . . . . . . . .357

9.12 Treating with Re-Optimized Dose . . . . . . . . . . . . . . . . . . . . . . . . .358

9.13 New Plan Comparison Export. . . . . . . . . . . . . . . . . . . . . . . . . . . . .360

9.14 Checking RealTarget Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . .361

9.15 Using Tracking Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .363

9.16 RealTarget Preview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .364

9.16.1 Tracking Result and Decision. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 366

9.16.2 Beam On and ROI% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 366

9.16.3 Correlation Graph. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 367

9.17 Applying a 2D Shift . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .368

9.18 Delivering a Treatment Fraction . . . . . . . . . . . . . . . . . . . . . . . . . .370

9.19 Treatment Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .372

9.20 Delivering a Multi-Isocenter Plan. . . . . . . . . . . . . . . . . . . . . . . . . .373

9.21 Ending Treatment Early . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .374

9.21.1 Adding Completion Plans to the Delivery Calendar . . . . . . . . . . 376

9.22 Consolidating Treatment Fractions . . . . . . . . . . . . . . . . . . . . . . . .380

9.23 Monitoring Treatment Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . .381

9.24 Two-Headed Treatment Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . .383

Chapter 10:Quality Assurance . . . . . . . . . . . . . . . . . . . . . . . 389

10.1 Recommended QA Tests and Procedures . . . . . . . . . . . . . . . . . . .389

10.1.1 Recommended Frequencies for QA Tests . . . . . . . . . . . . . . . . . . 390

10.2 Accessing the QA Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .393

10.3 Plan QA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .394

10.3.1 Creating a QA Plan from a Treatment Plan . . . . . . . . . . . . . . . . . 394

10.3.2 Exporting Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 397

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10.3.3 Saving a QA Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 399

10.3.4 Positioning Couch on Points Screen for a QA Plan. . . . . . . . . . . 400

10.4 Localization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 404

10.5 CT to Relative Electron Density. . . . . . . . . . . . . . . . . . . . . . . . . . . 406

10.5.1 Adding and Removing Look-Up Table Data Points. . . . . . . . . . . 407

10.6 Viewing Delivery Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 411

10.7 SNR/Uniformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 414

10.8 Source Tracking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 415

10.9 Calibration Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 416

10.10 Spatial Integrity QA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 420

10.11 Daily Laser Alignment Calibration Test . . . . . . . . . . . . . . . . . . . 425

10.12 Sealed Source Leak Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 426

10.13 MLC Speed Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 429

10.14 Optional Physics QA Tools. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 432

Chapter 11:Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .437

11.1 Cleaning the LCD Monitor and Video Display . . . . . . . . . . . . . . . 437

11.2 Cleaning Plugs and Connectors. . . . . . . . . . . . . . . . . . . . . . . . . . . 437

11.3 Cleaning RF Coils and Positioning Aids. . . . . . . . . . . . . . . . . . . . . 437

11.4 Cleaning the Patient Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 437

11.5 Cleaning System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . 438

11.6 Electrical Cabinets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 438

Chapter 12:Receive Coils . . . . . . . . . . . . . . . . . . . . . . . . . . . .439

12.1 Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 440

12.2 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 441

12.3 Coil Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 441

12.4 Decoupling Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 441

12.5 Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 442

12.6 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 445

12.7 Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 445

12.8 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 446

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Mechanical Source Retraction Procedure . . . . . . . . . . . . . . 447

INDEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 451

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1.1 System Overview

The MRIdian system is a hybrid medical device for radiation treatment that combines a magnetic resonance imaging system (MRIS) with a Cobalt-60 (Co-60) radiation delivery system (RDS). The imaging and radiotherapy fields of view are coincident permitting imaging of the patient at the radiotherapy isocenter before and during treatment. The MRIdian system is operated with the MRIdian Treatment Planning and Delivery Software (TPDS).

The MRIdian radiation delivery system (RDS) consists o 120 degrees apart on a radiotherapy ring gantry. The radiation isocenter is in the middle of the imaging field of view, permitting imaging at the radiotherapy isocenter before and during therapy. The RDS includes:

f three Cobalt-60 sources mounted

 Radioactive Source  Gantry and Base  Source Shielding Heads and Movement Mechanism  Multi-leaf Collimators  Patient Handling System  Radiation Therapy Control System and Console

The sealed sources are housed in source-shielding heads made of Tungsten Alloy and Deplete base located in the gap between the two magnets. The sources are positioned for therapy (BEAM ON), standby (BEAM HOLD) and shielding (BEAM OFF) by a source movement controller. The beams from the sources are shaped to conform to the target using a doublefocused multi-leaf collimator.

The RT (Radiation Therapy) Control system is the central point of control designed to provide fail-sa (RTC) and the Auxiliary Controller (AUXC)

d Uranium encased with stainless steel. The heads are mounted on a ring gantry and

fe operation of the MRIdian system. It consists of the Radiation Therapy Controller

The RTC is the primary controller and the AUXC is the secondary controller and provides safety co

ntrol functions in the event of an RTC failure. The RTC and AUXC control and monitor

 Gantry Rotation  Source Movement Control (SMC)  MLC Control System  Patient Handling System  Emergency Stops and System Safety Interlocks

 AC and DC Power Distribution

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1.2 MRIdian® System Training

Before using the MRIdian system, physicians, physicists, dosimetrists, therapists, and nurses must be trained. It is highly recommend that at least one person assume the role of “super user” and be involved in all phases of training. The super user would likely hold administrative rights and train new employees on the system as needed.

On-site training and training for additional users is available from ViewRay. For further information, contact your local ViewRay representative.

The following table lists training topics and recommended participants.

Topic Recommended participants

MD Physicist CMD RTT Nurse

System safety

MRI safety issues and emergency procedures including the controlled access area, emergency field shut down and emergency actions in the event of a quench.

Radiation safety issues and emergency procedures

Site safety and emergency procedure including fire precautions

Patient safety, loading, and immobilization

Patient emergency medical procedures

    

System operation

System start-up procedures Daily system maintenance inspection

Daily calibration and QA Use of coordinate systems Use of laser alignment system MRIdian MR imaging basics

Patient body and head coils (utilization, placement, and CT simulation)

Imaging protocols Console operation

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   

       

     

        

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Image acquisition for simulation and planning

System administration and image management

System start-up

System administration

System operation

Managing patient records

DICOM image handling and administration

Image registration

Contouring, dose calculation, and prescriptions

Entering and editing patient diagnoses

Dose prescription and Dose Volume Constraints

Density assignment and correction

   

  



  

 

Couch placement

Segmentation of Targets

Segmentation of Organs At Risk

Isocenter placement

Point placement

Dose normalization

Calculating and optimizing dose

Plan review and approval

Comparing multiple plans

Plan evaluation

Final approval of plan

Setup and patient positioning

  



  

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Retrieving patient for treatment

Loading plans for delivery

Acquiring daily images

Using daily Images to position patients

Dose prediction and adaptive optimization

On-table dose prediction

Reoptimizing dose

Comparing a new plan to the original plan

QA, review, and treatment with a reoptimized plan

Magnetic Resonance Treatment Control (MRTC) and motion management

Dose delivery review

   

Target and OAR position tracking

Soft-tissue tracking verification using treatment “movies”

Registering and adding a test phantom to the system

Imaging and importing image sets from a phantom

Treatment planning for a phantom

Plan review and QA for a phantom

Delivering treatment to a phantom

   

 

  

 

  

1.3 Treatment Planning and Delivery Software

The MRIdian® Treatment Planning and Delivery Software (TPDS) enables the clinician to create treatment delivery and QA plans for the MRIdian system. The TPDS includes applications for reviewing, prescribing, tracking, and correcting the course of patient treatment.

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The TPDS operates on both a remote treatment planning workstation and on the treatment delivery system. On remote workstations, treatment plans may be created to pre-plan treatment using volumetric CT, MRI, or PET images.

The TPDS is designed to create optimized IMRT, conformal, and combinations of IMRT and

onformal treatment plans for delivery on the MRIdian IGRT System. The software system

c also functions as an archival system to archive all patient data that is required for treatment planning and all data acquired during treatment delivery.

During power-up of the treatment delivery system the operator must confirm acceptance of the communication connection on the MRIS console. The connection has not been accepted.

system will not permit treatment requiring imaging if this

1.4 System Logging Overview

The MRIdian® system automatically time stamps and logs operational, security, error, and warning messages from all the subsystem components. These logs can be retrieved by ViewRay service personnel for troubleshooting and system repair.

1.4.1 Creating a Support Package of Log Files

If you encounter a problem using the system you can open a Support Package to log the problem and report it to ViewRay Service.

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Press > Ctrl + Alt + F9 and the ViewRay Support Package information box will open.

1.5 System Messages

There are four categories of system messages:

 Information  Warning  Error

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 Critical Error

Chapter 1: MRIdian® System Overview

1.6 Uninterruptible Power Supply

Every console is equipped with an uninterruptible (battery) power supply (Eaton 9PX5KP1). If power is lost to the main power supply (AC power), the system will run on battery power for 7 minutes and then shut down automatically.

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As soon as the system detects loss of AC power, the screen will display the following message:

When the system no longer detects the UPS connection, the user will receive the following warning message:

The system has an auto-save feature that runs in the background on all planning consoles and saves locally every 2 minutes. There is a similar

eature on treatment delivery consoles. If the system is shut down due to a

f power outage and loss of UPS battery power, the next time the treatment delivery system is powered up the system will retrieve the treatment data and issue a message to the operator that the system has detected and will retrieve incomplete treatment delivery data.

1.7 System Status Icons

The user interface displays icons that represent system status. Those icons are at the bottom, right of the user interface.

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1.8 Environmental Requirements

Equipment Room: 15°C to 24°C, 40 to 80% Relative Humidity

Treatment Room: 18°C to 22°C, 40 to 60% Relative Humidity

Operator Room: 15°C to 30°C, 40 to 80% Relative Humidity

Electrical: 380/4

Electrical Type: Pr

System Type: B Applied

Coil Type: BF Applie

Mode of Operation: Con

Ingress Protection Rating: IP

80VAC, 50/60 Hz, 150A

otection Against Electrical Shock Class I Equipment

Part

d Part

tinuous

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1.9 Imaging System

The MRIdian Magnetic Resonance Imaging System (MRIS) is a 0.35T horizontal field MRI. The superconducting magnet, RF coils, and gradient coil have been engineered by design to allow operation with the radiotherapy gantry of the MRIdian system.

Three soft-tissue imaging planes can be captured continuously during treatment without e

xposing the patient to unnecessary ionizing radiation. If the tumor or a critical structure moves beyond a physician-defined boundary, the treatment beam is automatically paused; when the structure moves back into the target zone, treatment automatically resumes. Physicians can set both spatial and time thresholds for pausing treatment delivery, controlling for the motion of a patient's organs based on real-time 4D MRI data.

During patient scanning, if there is an imaging error the following popup will be displayed on the MRIdian

system console

Click > OK and then go to the MRI host console and dismiss the error message. After dismissing the error message you can return to the MRIdian console and resume imaging. For further instructions on imaging your patient see “Acquiring Images” on page 310 and “Using

Daily Images to Position the Patient” on page 338.

1.10 Cooling System

Because the magnet is a super-conducting magnet, it is filled with liquid helium as a coolant to maintain the magnetic field. Following installation, the magnet is adjusted to the desired operating field strength.

The ramped-up magnet does not require additional ele field. However, a refrigeration system must be constantly operating to keep the liquid helium from boiling off.

1.10.1 Magnetic Shielding

To minimize the effects of the magnetic fringe field on the environment, the magnet is equipped with active super-conducting shielding.

ctric power to maintain the magnetic

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1.10.2 Gradient System

The gradient system is a whole body gradient system. The gradient coils alter the static magnetic field to specifically focus it on a selected part of the body enabling image “slices”. The rapid on-and-off switching of the gradient magnets creates the “clanging” noise during image acquisition.

The gradient system consists of three gradient coils, each oriented on one of the three

oordinates--x,y, and z.

During an image acquisition, each of the three gradient coils are switched on and off many

es for spatial encoding and for signal refocusing. The gradient system has a maximum

tim strength of 18 mT/m and a maximum slew rate 200 T/m/s. The compliance volume of the gradient system is a cylinder with its axis coinciding with the magnet axis and with a radius of

0.35 m.

1.11 Patient Handling System

The patient handling system consists of the patient couch/table, and the control panel for the operator to set up the patient and control the bore environment for patient comfort. The couch controls allow the operator to lower the table for patient access, and position the couch longitudinally, vertically and laterally.

The control panels are described in detail in Chapter 8. See “Displays and Indicators” on

page 325.

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The table top is equipped with indexing notches compatible with available indexing devices that lock down patient immobilization devices. The notched-style indexing points are 5 cm in diameter, spaced 28 cm between notch centers, and 46.75 cm across table width from notch center to notch center.

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Positioning patients’ immobilization devices using the same index notches each time increases target accuracy.

1.12 Receive Coils

There are two types of receive coils—a torso receive coil and a head and neck receive coil.

The torso receive coils are a two-part, 12-eleme above and below the patient and plugged into the patient couch. Each half (upper and lower) of the coil has 6 elements. Each of the 12 coil elements functions as an independent receiver. The MR image is constructed from the hydrogen nuclei resonance detected by all of the individual receivers.

The head and neck coils are a two-part 10-element, phase array coil. E lower) of the coil has 5 elements. For more information on the coils see “Receive Coils” on

page 439.

nt, phase array coil. The coils are placed

ach half (upper and

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1.12.1 Coil Sockets

There are four coil sockets on the patient couch for attaching the receive coils. One is located on each corner of the couch.

1.13 Radiation Therapy Delivery System

The MRIdian® Radiation Therapy Delivery System (RDS) consists of a three-headed 60Cobalt radiation therapy unit mounted on a ring gantry. The radiation isocenter is in the middle of the magnetic resonance imaging field of view, enabling imaging at the radiotherapy isocenter before and during therapy.

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1.13.1 Radioactive Source and Shielding

The MRIdian system has three shielding heads—one for each 60Cobalt source. The shielding heads are made of tungsten and depleted uranium encased in 300 series stainless steel. Within each head there is a source drawer encased in a shuttle for additional protection.

1.13.2 Multi-leaf Collimator

Each shielding head has a beam-shaping multi-leaf collimator (MLC). Each leaf is doubly focused so the leaf edges and the leaf ends project to within 1 mm of the source focus point. The aperture on the source heads restricts the MLC field to a 27.3 cm square field at radiotherapy isocenter.

1.14 Patient Communication System

The patient communication system consists of:

 Patient Headphones

 Treatment Room Speakers

 Treatment Room Microphones

 Flat-Panel Display Monitor

 Intercom

 Video Camera

 Squeeze Bulb

1.14.1 Patient Headphones

The patient headphones plug into the patient couch and can play music and are used to speak with the patient.

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1.14.2 Treatment Room Speakers

The treatment room speakers broadcast from the control room to the treatment room.

1.14.3 Treatment Room Microphones

There are two microphones built into the patient handling system. There is also a microphone located at each end of the magnet.

1.14.4 Flat-Panel Display Monitor

Display monitor inside the control room that streams video from treatment room.

1.14.5 Intercom

The intercom system allows verbal communication between the patient and operator.

1. Listen-mode volume control

2. Broadcast-to-patient volume control

3. Speakers

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4. Speak Button (Hold Down to broadcast to patient)

5. Music on/off

6. Listen (press once to turn on for duration of scan)

7. Microphone

1.14.6 Video Camera

The video camera is installed in the treatment room and used to visually monitor patients during scanning and treatments.

1.15 Electronics Cabinets

There are two electronics cabinets—The TCC and the ACC. They house the power distribution transformer, power supplies, computer system and water-to-water heat exchangers.

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(1) Gradient cabinet

(2) MRI control cabinet

(3) System separator

Once installed, the electronics cabinets are fixed equipment and should ONLY be moved by ViewRay Service Personnel.

1.16 About this Manual

The manual contains step-by-step instructions for operating the ViewRay System. This manual includes information on the following topics:

System Overview: Provides general information about the ViewRay System and instructions

in how to use the manual.

Safety Information and Alerts: READ THIS SECTION BEFORE OPERATING THE ViewRay

System. The safety section provides general, patient, operator, MR, radiation, electrical and

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fire safety, interlock explanations, location of emergency stop buttons and contains procedures for magnet quench, and patient emergency during treatment or scanning,

System Coordinates: Explains the MRIdian system three-dimensional coordinate system

and has direction definitions.

Start-Up and Administrative Tasks: Contains start-up and shut-down instructions for the

planning and delivery consoles and all administrative tasks.

Treatment Planning: Provides instructions for creating a treatment plan, importing data

from DICOM, adding and fusing images, optimizing the dose prescription, setting RealTarget parameters.

Imaging: Instructions for importing and exporting images, using the magnetic resonance

imaging system (MRIS) for patient image management, patient imaging and for simulating a treatment delivery.

Patient Set-Up: Includes an overview of all the components of the patient handling system

and instructions for positioning your patients.

Prescription and Patient Management: Provides instructions for the basic tasks of

registering a patient, viewing, approving, disapproving, and exporting patient data, patient positioning, imaging, setting up rapid treatment, and procedures for fault modes.

Treatment Delivery: Provides instructions for delivering a treatment plan and for using on-

table treatment planning which includes contouring, dose prediction, re-optimization, plan approval, and delivery of radiation treatment.

Quality Assurance: Contains step-by-step instructions for the MRIdian system quality

assurance procedures and recommended frequencies for all QA procedures.

Cleaning: Instructions for cleaning the equipment

Receive Coils: Detailed information about coil use, placement, precautions, cleaning, and service.

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TABLE 1. Instruction conventions used in this manual

Numbered lists

Arrow >

Are action steps

Indicates an action sequence,

for example:

Click > Plan



Bold

Indicates the result of an action step

Screens and button names, dialog

boxes, menu items, and user actions

are all set in bold

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Chapter 2: Safety Information and

Chapter 2: Safety Information and Alerts

2.1 Safety Introduction

The MRIdian® system has specific safety requirements in the following areas:

 A strong magnetic field is always present in the treatment room requiring special

non-ferrous (non-magnetic) equipment and screening of individuals prior to entry to this environment. See “Imaging Safety” on page 34.

 The patient handling system requires careful use by the operator to prevent injury

from pinch points or collision with the system bore. See “Treatment Room Safety” on

page 31.

 Noise from the MRIdian® MRIS during imaging may be hazardous and should be

reduced through the use of hearing protection. See “Hazardous Noise Levels” on

page 50.

 Radioactive sealed sources that contain

treatment. Possession of these sources requires compliance with a Radiation Safety Program and exposure monitoring. See “Radiation Precautions” on page 58.

Co are used for the radiotherapy

 Positioning lasers may pose a hazard to the eyes of the operator and patient if the

laser beam is aimed directly at the eyes. See “Laser Positioning Safety” on page 33.

 The MRIdian system is not suitable for use in the presence of flammable mixtures or

materials. Ensure there are NO flammable mixtures or materials in the treatment room where cryogens are located.

Keeping yourself and your patients safe is always the top priority. As a healthcare worker you

n increase safety by knowing your work environment and the answers to these safety

c questions:

• What adverse things can happen?

• What are the consequences?

How do I prevent adverse and potentially harmful situations from happening?

•

How should I respond to an emergency situation?

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Chapter 2: Safety Information and Alerts

This safety chapter is designed to answer those questions as they pertain to using the MRIdian system. The chapter is organized into the following sections: General Safety, MR Safety, Radiation Safety, Electrical Safety, Treatment Room Safety and Emergency Procedures.

To ensure your safety and the safety of your patients, it is very important that you read this chapter and familiarize yourself with the system and its safety requirements and precautions.

2.1.1 Definition of Hazard Levels and Symbols

Danger indicates a major hazard situation which presents a highly probable threat of serious injury or death.

system.

Warning indicates a potentially hazardous situation, which, if not avoided, has the potential to result in serious injury or death.

Caution indicates a potentially hazardous situation which may result in minor to moderate injury.

NOTE indicates an important reminder or message not related to personal injury.

General warning. Indicates an important consideration when using the

Indicates a magnetic field alert.

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Indicates a radiation alert.

Indicates an electricity alert.

Indicates a Type B applied part and that leakage is in compliance with IEC60601-1

This symbol means FOLLOW OPERATING INSTRUCTIONS.



2.1.2 General MRIdian® System Safety

The MRIdian system is a radiation therapy device with an integrated magnetic resonance (MR) system for imaging. Improper use of the MRIdian system can result in serious injury or death. Be sure to read and understand

 It is the responsibility of the Radiation Oncology site to ensure that applicable

national, state and local requirements, regulations, and ordinances affecting the MRIdian® System equipment and its radionuclide are met. Specific questions about regulatory requirements should be directed to your Authority Having Jurisdiction, the site Physicist of Record, and the Radiation Safety Officer.



 When operating the MRIdian system always follow the procedures and monitoring

requirements established by your facility’s Radiation Safety Officer.

all the safety information.

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Chapter 2: Safety Information and Alerts

 When operating the MRIdian system always obey all DANGER, WARNING and

CAUTION statements that are given with the procedures in this manual.

 Follow your facility's Universal Precautions practices to prevent infection and cross-

contamination.

 Ensure that all MR workers and patients have Magnetic Resonance Safety Training

and Screening and that it includes (Electromagnetic Field) EMF safety precautions BEFORE entering the treatment room. It is generally accepted that no published evidence exists supporting cumulative or long-term EMF effects from MR exposure.

 The possible physiological effects of exposure to a static magnetic field are dizziness,

vertigo, and a metallic taste in the mouth. Patient or MR worker exposure to the static magnetic field can be minimized by staying away from the magnet and avoiding rapid movements of the head while in the static magnetic field.

 Extra precaution is advised for pregnant MR workers. Local regulations may apply.

State limits for MR workers may not apply when an MR worker is pregnant.

 MR workers and janitorial staff for MR suite must not have electronic or metallic

implants or piercings. MR workers must be screened for previous occupational activities which may have caused accidental lodging of ferromagnetic materials, such as

dded metal fragments from military or work activities.

embe

 The facility must develop and use an MR Screening Form to identify any conditions,

due to professional activity, past medical history, present medical state, or otherwise, that would prohibit an MR worker or patient from safely entering the MR environment of the treatment room. ALL individuals must complete the screening BEFORE entering the MR environment.

 Follow all applicable national and local requirements and regulations regarding

material and equipment decommissioning and disposal.

2.2 Product Performance Liability

If the MRIdian ®System is not used in accordance with the operator’s manual, ViewRay accepts no responsibility for the safety, reliability and performance

system. The performance of this device was tested on the finished

of the device. The device was made according to established procedures and industry standards, such as IEC 60601-1, 60601-1-2, 60601-2-11, 60601-2-33. Unauthorized modifications made to this device can void the warranties and may create the potential for hazards for which ViewRay cannot accept responsibility. Connect ONLY items that are specified as part of the ME equipment.

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2.2.1 Electrical Safety

To avoid the risk of electric shock, the system must be connected to a supply mains with protective earth.

2.3 Guidance and Declaration for Electromagnetic Compatibility

2.3.1 Precautions

To maintain the safety of the system, ensure all installation and connections to the MRIdian system are performed by ViewRay or ViewRay authorized pe

Electrical wires and cables should be inspected periodically to ensur

e the insulation has not been damaged, all connections

are secure, and there are no indications of damage.

rsonnel.

To maintain electrical safety, the operator’s station must be correctly connected to all peripherals.

All peripheral equipment not specified for use in the CONTROLLED ACCESS AREA, may be functi

onally disrupted by electromagnetic interference of the MR equipment, and conversely,

the peripheral equipment may disrupt the functioning of the MR equipment.

Only equipment marked MR-Safe by its manufacturer should be used in the treatment room

Do not take any electronic devices into the equipment room, such as cell phones, pagers, or radio-frequency ID devices.

treatment room, operator's console, or

2.3.2 Electromagnetic Compatibility

The MRIdian® system was tested for radiated emissions and immunity and complies with the requirements of IEC 60601-1-2. All testing was performed outside of the “controlled access area”. However, the components inside of the RF-shielded room were connected and they were fully operational when the EMC testing was performed; therefore, the test results

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tested for radiated RF immunity at the follo wing frequencies:

GHz.

Amplifier 9 K Hz to 2080 MHz for 80MHz

GHz u sed to test 2. 4 GHz

represent the entire system and not only those components of the system that are outside of the RF-shielded room. The test results are only valid with the standard system cabling that is also the prerequisite for the complete functionality of the system (also including all components inside the RF-shielded room).

Medical electrical equipment needs special precautions regarding EMC and needs to be ins

talled and put into service according to the EMC information provided in the

accompanying documents.

Electromagnetic compatibility is the ability of equipment or a system to function satisfactorily in its

electromagnetic environment without introducing intolerable electromagnetic

disturbance to anything in that environment.

Portable and mobile RF communications equipment can affect medical electrical equipment.

The MRIdian is classified as a large and permanently installed equipment per IEC 60601-1-2. The exemption according to the

equirement 36.202.3b) 9 of this standard has been used and the

r equipment was not tested for radiated RF immunity over the entire frequency range of 80 MHz to 2.5 GHz.

The ViewRay system has been

Modulation characteristic: si nusoidal 1 KHz, 80% AM Test Level: 3V/m

Signal generators with amplifier: R&S Logperiodic Antenna with IFI Power

Fixed equipment or system cabling, which cannot be removed by the user, is not listed. This cabling is part of the system and was regarded at all EMC-

80 MHz through 1000 MHz, 1.2 GHz and 2.4

through 1000 MHz Kenwoo d Licensed t ransmitter range 1.2-1.3

GHz u sed to test 1. 2 GHz Linksys licensed tran smitter ran ge 2.40-2.48

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Chapter 2: Safety Information and

considerations. Without this cabling there is no complete functionality of the system.

The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by the manuf

acturer of the equipment or system as replacement parts for internal components, may result in increased emission or decreased immunity of the equipment or system.

Guidance and Manufacturer's Declaration- Electromagnetic Emissions

The MRIdian® system is intended for use in the

electromagnetic environment specified in the following tables. The customer or the user of the MRIdian system should ensure that it is used in such an environment.

IEC60601-1-2 Table 1 Guidance and Manufacturer’s Declaration—Electromagnetic Emissions

Emissions test Compliance Electromagnetic environment – guidance

Line Conducted Emissions CISPR 11

Class A;

2.6dB below the

limits

The MRIdian system must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.

Radiated RF Emissions CISPR 11

Class A;1.0dB below the limi

The MRIdian system must be used only in a shielded location with a minimum RF shielding effectiveness. For each

cable that exits the shielded location, a minimum filter attenuation of 80dB from 10-20MHz, 100dB from 20-80MHZ and 80dB from 80-100MHz

Harmonic Emissions IEC 61000-3-2

N/A

Standard applies to equipment rated < 16 Amps,

for the MRIdian system this is the treatment delivery and planning console only.

Voltage Fluctuations and Flicker IEC 61000-3-3

N/A Standard applies to equipment rated < 16

Amps,

for the MRIdian system this is the treatment delivery and planning console only.

It is essential that the actual shielding effectiveness and filter attenuation be verified at the location.

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The MRIdian system should ONLY be used with manufacturer-labeled MR-Safe

equipment. MR-Safe equipment has no significant influence on the quality of imag

e information from the MR system. Furthermore, the characteristics of

the MR-Safe equipment are not affected by the MR system.

Guidance and Manufacturer’s Declaration of Electromagnetic Immunity

IEC60601-1-2 Table 2 Guidance and Manufacturer's Declaration—Electromagnetic Immunity

Immunity test IEC 60601 Test

Level

ImmunityElectrosta

tic

±6 kV contact

±8 kV air Discharge (ESD) IEC 61000-4-2

Electrical Fast Transients and

rsts

Bu IEC 61000-4-4

Surges IEC 61000-4-5

±2 kV for power

supply lines

±1 kV for signal

nes > 3m

±1 kV differential

mode

±2 kV common

Voltage Dips and Short Interruptions IEC 61000-4-11

0% V

cycle 

40% V

70% V

Nom

- 0.5

-5 cycle 

-25

cycle 

0% V

Nom -

5 sec.

Compliance Level Electromagnetic environment –

idance

±6 kV contact ±8 kV air

Floors should be wood, concrete or ceramic

tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

±2 kV for power supply lines ±1 kV for signal

lin

±1 kV differential mode ±2 kV common

Mains power quality should be

that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment.

mode

0% V

40% V

70% V

0% V

-0.5 cycle 

Nom

– 5 sec.

Nom

-5 cycle 

-25 cycle 

Standard applies to equipment rated <

16 Amps, for the MRIdian system this is the treatment delivery and planning console only. As delivered with the MRIdian system, both consoles are connected to an uninterruptible power supply.

Power

requency (50/

F 60 Hz) magnetic field IEC 610004-8

3 A/m 3A/m Power frequency magnetic fields

ould be at levels characteristic

sh of a typical location in a typical commercial or hospital environment.

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IEC60601-1-2 Tables 4, 8- Electromagnet

Immunity test IEC 60601 Test

Level

Conducted

isturbances,

D Induced by RF Fields IEC 61000-4-6

Radiated RF Electroma Fields IEC 61000-4-3

gnetic

3 V RMS

0.15 MHz to 80 MHz

3V/m 80MHz to

2.5 GHz

Compliance Level

3 V RMS N/

3V/m 80 MHz to 1000 MHz:

ic Immunity

Electromagnetic environment – guidance

d = 1.0 √P

1.2GHz to 2.4 GHz: d = 0.1√P where P is the maximum output power rating of the transmit according to the transmitter manufacturer and d is distance in meters (m). Fi fixed RF transmitters, as determined by an electromagnetic site survey, less than the compliance level in each frequency range. Inte the vicinity of equipment marked with the following symbol:

ter in watts (W)*

the recommended separation

eld strengths from

should be

rference may occur in

Note 1: At 80 MHz and 1000 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all si

tuations. Electromagnetic propagation is

affected by absorption and reflection from structures, objects and people.

Note 3: It is essential that the actual shielding effectiveness and filter attenuation of the

shielded loc

ation be verified to ensure that they meet the minimum specification.

* Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)

telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength outside the shielded location in which the MRIdian system is used exceeds [field strength] V/m, the MRIdian system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as relocating the MRIdian system or using a shielded location with a higher RF shielding effectiveness and filter attenuation.

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Recommended Separate Distances between Portable and Mobile RF

Communications Equipment and the MRIdian system.

IEC60601-1-2 Table 6

The MRIdian system equipment should not be moved from its installation position, or stacked, because testing was conducted with the system in the installation position.

2.1 Proper Patient Identification

Selection of the incorrect treatment plan over a number of treatment fractions can result in serious injury to the patient.

Before entering a patient into the system, make sure each patient is

eened for MR safety. See “MR Safety Screening” on page 35.

scr

 Verify that the patient photo and patient information correctly

identifies the patient you are about to treat.

 Make sure you select the correct patient plan and procedure for

the patient.

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2.4 Treatment Room Safety

2.4.1 Slipping and Falling Hazards

Clean up all spills from the floor and the patient table before allowing another patient to enter the treatment room. Make sure the floor is c

ompletely dry before admitting another patient to the treatment

room.

Follow your facility’s Infections Control and Universal Precautions.

Make sure all cables and hoses are routed out of all pathways in the treatment room so they will not

cause a patient or healthcare worker to trip and fall.

2.4.2 Pinch Points

Pinch points created by manual and automatic movement of the patient couch may cause serious injury.

Before and during movement of the patient couch ensure the operator’s and patient’s hands,

ers, toes, linens, clothing, catheters, etc., stay clear of all moving parts, especially

fing between tabletop and tunnel aperture (bore).

Ensure that patients keep their arms and hands close to their bodies to avoid a pinch point

een the table beam (surface the couch rolls on) and patient couch.

betw

Also see "Fire Safety in the Treatment Room” on page 56.

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2.5 Patient Transport Safety and Communication

2.5.1 Patient Transport System Safety

Collisions and injuries can occur when using the patient table. Observe all warning and safety signs on the MRIdian system.

Follow these precautions:

Explain all the expected table movements to patients.

 Ensure that there are no persons or objects which could collide with the

movement of the patient table top.

 Ensure that the patient’s hair, hands, fingers, toes, linens, catheters, and

clothing do not hang off the patient table.

 Make sure that IV tubes and MR coils do not hang over and that IV needles

remain in the patient during table movement.

 In case of hazardous conditions, press the E-Stop button to stop couch

movement.

 Monitor the patient visually and listen with the Intercom system for any sign

of patient distress.

2.5.2 Patient Alert for Patient-Initiated Communication

Patients may use the patient alert to initiate a visual or auditory alert. The visual alert is an LED display on the intercom. The auditory alert is a activated by a squeeze bulb.

There are two types of auditory alerts:

 A continuous tone over the intercom

 A brief feedback signal via the patient’s headset and wall speaker

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2.5.3 Communicating with the Patient

All patients should be monitored during treatment. An Intercom system is supplied for monitoring and communicating with patients. For an illustration of the intercom with parts labeled see "Patient Communication System” on page 15. (A video monit

To listen to the patient:

1. Press > Listen button

The Listen LED lights up and the intercom is in the Listen mode. Sounds from

the treatment room are transmitted to the control room.

2. Press > Listen button again.

 The Listen LED light goes out and the Listen mode is disabled.

To speak to the patient:

1. Press and hold the Speak button.

or is also provided.)

 The intercom is in the Speak mode as long as you hold down the Speak button.

2.6 Laser Positioning Safety

To ensure your lasers are properly aligned, follow the laser alignment protocol

"Daily Laser Alignment Calibration Test” on page 425

Even momentary eye exposure from a laser pointer can cause discomfort and

emporary visual impairment.

Never point a laser directly at anyone’s eyes.

Never look directly at a laser.

Never view a laser beam using an optical instrument.

Do not point a laser at mirror-like su dangerous to the eyes as a direct beam.

rfaces. A reflected beam can be as

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2.7 Imaging Safety

Once energized the magnet is ALWAYS on even when no imaging is taking place.

The super-conducting magnet generates a strong homogeneous magnetic field with a field s

trength of 0.35T

Magnetizable objects introduced into the magnetic field become projectiles and can cause serious injury or death.

anted magnetizable objects can move inside the patient

Impl and cause serious injury or death.

Life-support devices and emergency care equipment not specified or recommended for use in the

magnetic field may be disturbed and this equipment may in turn also disturb the

proper functioning of the MR equipment.

The MRIdian® system is only to be used with MR-Safe equipment as defined in ASTM F2503-08* and labeled as such by the equipmen

MR Safe environments. MR Safe items include nonconducting, nonmagnetic items such as a plastic Petri dish. An item may be determined to be MR Safe by providing a scientifically based rationale rather than test data.

MR Conditional is in a specified MRI environment with specified conditions of use. Field conditions that define the MRI environment include static magnetic field strength, spatial gradient, dB/dt (time varying magnetic fields), radio frequency (RF) fields, and specific absorption rate (SAR)

MR Unsafe ar

is defined in ASTM F2503-08 as an item that poses no known hazards in all MR

defined as an item that has been demonstrated to pose no known hazards

e items that are known to pose hazards in all MRI environments.

t manufacturer.

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2.7.1 MR Safety Screening

The facility must develop and use an MR Screening Form to ensure all electrically conducting objects are removed and to identify any conditions, due

o professional activity, past medical history, present medical state, or

t otherwise, that would prohibit a person from safely entering the MR environment of the treatment room. ALL individuals must complete the screening BEFORE entering the MR environment. "Pre-screening Prior to

Imaging or Treatment on the MRIdian® System” on page 37.

2.7.2 Magnetic Field Emergency Procedures

Before working with the MRIdian® system familiarize yourself with the location and function of ALL the emergency switches. difference between the E-Stop button, which stops table movements and move Emergency Discharge Button, which is ONLY used in the event that someone is trapped inside the bore of the magnet by a metal object.

See “Emergency Response Plans” on page 60 and "Using the E-Stop in an Emergency” on page 62.

s the sources in emergency situations, and the Magnet

2.7.3 Devices Contraindicated for MRI

Even devices labeled MRI-Safe might be capable of causing injury if the manufacturers instructions for positioning electrically conducting leads are not followed.

 Do not use resuscitation devices such as defibrillators or oxygen bottles which

are not MR-safe in the treatment room.

 Do not use transport trolleys, moveable beds, stretchers or other transport

devices that consist of magnetizable parts. All such equipment has to be marked MR-Safe by its manufacturer.

 Do not take any electronic devices into the treatment room, operator’s console,

or equipment room, such as cell phones, pagers, or radio-frequency ID devices.

Know the

 Do not wear or carry any magnetizable objects, for example, watches, pens,

scissors, clipboards, tag clips, credit cards, etc., into the treatment room.

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All peripheral equipment not specified for use in the CONTROLLED ACCESS AREA, may be functionally disrupted

y electromagnetic interference of the MR equipment, and

b conversely, the peripheral equipment may disrupt the functioning of the MR equipment. Only equipment marked

MR-Safe by its manufacturer should be used in the treatment room

ALWAYS FOLLOW THESE PRECAUTIONS

 Only authorized persons should enter the treatment area.

 Use only MR-safe devices in the treatment room, operator’s console, or

equipment room, and strictly follow manufacturer’s instructions with respect to electrically conducting lead positioning or the devices may cause injury.

 Every person who will enter the treatment room, operator’s console, or equipment room

must be trained in MR safety procedures and screened for compatibility, including emergency responders. (See “MR Safety Screening” on page 35.)

 Ensure the janitorial staff is fully trained in MR safety and they use only non-ferromagnetic

cleaning devices.

 Service work on the system must be performed by ViewRay personnel or ViewRay

authorized designees only.

2.7.4 Patients Typically Contraindicated for MRI

Do not allow anyone to enter the treatment room before MR training and pre-screening is completed.

 Do not image or allow in the treatment room anyone with electronic or metallic implants

such as cardiac pacemakers, ICDs, cochlear implants, stimulators, or insulin pumps, SwanGanz catheters with thermodilution tips, aneurysm clips in the brain, implanted neurostimulators, artificial anus, transdermal adhesive dressing, metallic spirals for contraception, metal or other unidentifiable foreign body in the eyes, or shrapnel or other metal fragment(s) near a vital organ.

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2.7.5 Pre-screening Prior to Imaging or Treatment on the MRIdian

1. Patients for whom use of the MRIdian system is contraindicated.

This includes patients who have metallic implants or activated implants (e.g., cardiac pacemakers) because the magnetic and electromagnetic fields may produce strong attraction and/or torque to the implant or may interfere with the operation of these devices. This applies also to patients who rely on electrically, magnetically or mechanically activated life support systems. Scanning patients with intracranial aneurysm clips is also contraindicated unless the physician is certain the clip is not magnetically active.

2. Patients having a higher than normal likelihood of needing emergency medical treatment, endent of the physical environment of the MRIdian system.

indep

In terms of the need for medical supervision, particular imaging or treatment with the MRIdian system in the following cases: Patients with greater than normal potential for cardiac arrest, patients who are likely to develop seizures, or claustrophobic reactions, decompensated cardiac patients, febrile patients, and patients with impaired ability to perspire, patients who are unconscious, heavily sedated, or confused, and with whom no reliable communication can be maintained, and examinations which are carried out at room temperature above 24 degrees C or relative humidity above 60%. See

"Uninterruptible Power Supply” on page 7.

® System

All individuals undergoing imaging or treatment on the MRIdian system must first be pre-screened in accordance with ACR Guidance Document for Safe MR

actices: 2007. There are 3 classes of patients who either should not undergo

Pr MR imaging or who must be imaged using particular caution. Those three classes are:

electrically, magnetically or mechanically

caution is required in performing

3. Patients having a higher than normal likelihood of needing emergency medical treatment

to the elevated values of the applied fields, when the MRIdian® system operates within

due the First Level Controlled Operating Mode as described in "Operating Modes” on page 46.

This class includes patients with implanted surgical clips (hemostatic clips) or other

erromagnetic material, patients engaged in occupations or activities which may cause

f accidental lodging of ferromagnetic materials, or who may have imbedded metal fragments from military activities, neonates and infants (for whom data establishing safety are lacking), patients with permanent (tattoo) eye-liner or with facial make-up (severe eye irritation has been reported), patients with compromised thermoregulatory systems (e.g. neonates, low birth weight infants, certain cancer patients), patients with metallic implants, because they may cause artifacts in images due to magnetic field distortion, patients with implanted prosthetic heart valves, and pregnant patients (the safety of magnetic resonance examination has not been completely established for embryos and fetuses).

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Carefully monitor any changes in the each patient’s health and any procedures the patient has undergone that would re-screening to determine if the patient is a candidate for MR imaging or would require special monitoring during MR imaging.

require a complete

2.7.6 MR Worker Screening and Reporting Requirements

 All MR workers must undergo an MR screening procedure as part of their employment interview process to ensure their safety in the MR environment.

 All MR per procedure, or surgery they experience or undergo in which a ferromagnetic metallic object or device may have been introduced within or on them.

sonnel must immediately report to the MR medical director any trauma,

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2.7.7 Safety Screening Form, MR Hazard Checklist and Patient

Instructions

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2.7.8 Supervision of Patients and Equipment

All patients must receive monitoring during procedures. Monitor the patient visually using the video camera and also listen using the intercom system for any signs of patient distress.

Ensure medical supervision is provided when the additional information in "Operating Modes” on page 46.

Continually monitor the system during treatment and procedures and immediately act upon

y system faults or errors.

first level mode of operation is used. See

2.8 Artifacts and Imaging Errors

Due to their magnetizability, foreign objects in the area of the magnet bore cause strong local distortions of the basic field and lead to image artifacts.

oreign objects can also heat up and cause heat injuries to the patient.

F Depending on the level of distortion, tumor tracking or radiation planning may be impaired or completely impossible.

Use the following precautions to protect patients from electrical-conducting heat injuries and

o prevent incorrect MR-tracking due to image artifacts:

 Ensure patients remove all electrically conducting objects such as necklaces,

rings, earrings, piercing, braces, hair bands, etc.

 Ensure patients remove all electrically conducting clothing such as bras or belts.

 Inform patients that permanent eyeliners and tattoos may contain ingredients

that can cause image artifacts or severe eye and/or skin irritations during MR imaging and instruct patients to remove all makeup prior to treatment.

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2.9 Controlled Access Area

A magnetic fringe field surrounds the magnet and has an attractive force on metallic objects. You must clearly mark off, restrict access, and exercise MR safety procedures anywhere the magnetic field is 5 gauss or higher. See “MR Restricted Access Sign” on page 44. It is the responsibility of the facility to follow any local statutory requirements with respect to access

o the controlled area.

2.9.1 Fringe Field Effects on Devices

A magnetic fringe field greater than 5 gauss (0.5mT) can interfere with electronic

implants and other devices such a watches, credit cards and data on computer disks. Outside this area the electromagnetic interference level complies with IEC 60601-1-2:2001.

Fringe Field Lines — Magnet Axis View

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2.9.2 MR Restricted Access Sign

The following sign must be posted at all entrances to the 5-gauss and higher area. No MR workers or patients should be allowed in this area without MR training, pre-screening and authorization.

2.10 Exposure to RF Electromagnetic Fields

During the course of an MR scan, the patient's body absorbs energy from the RF field generated by the transmitter coil. The RF field causes excitation of the atomic nuclei in the human body, and the receive coils receive the returned signals.

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2.10.1 Warming of Body Tissue

During the radio frequency pulses that are part of the MR scan, the patient’s body is exposed to RF output in the form of electromagnetic radiation. The output absorbed by the patient depends on body weight and is indicated as the W/kg.

The specific absorption rate obtainable with the MRIdian® system is set to the acceptable limits for normal operating mode, according to currently publi

shed literature including IEC guidelines.

specific absorption rate (SAR), expressed as

The body temperature increases when the SAR r cooling capacity. The patient’s ability to dissipate surplus heat is made more difficult as the room temperature and relative humidity increase. Ensure the room temperature does not exceed 24C (75F) and the relative humidity does not exceed 60%.

The use of an air conditioning system and/or appropriate temperature control devices may be necessar

The Operator is responsible for monitoring the functionality of the air conditioning system as

ell as the temperature and relative humidity inside the treatment room for the comfort and

w safety of patients.

The energy absorbed in the course of MR imaging warms the tissue. The heat generated is dissip perspiration and blood flow.

y to ensure the appropriate temperature and humidity.

If the room temperature and/or relative humidity is higher than the levels specified above, compliance with the SAR limits according to FDA (Food and Drug Administration) or IEC (International Electrotechnical Commission) regulations may no longer be assured.

ated by the thermoregulation mechanisms of the patient, such as, increased

ate exceeds the limit set by the body’s

Unacceptably high local SAR values may lead to RF burns. At high values, the SAR that is

xposed evenly across the body adversely affects the patient's thermoregulation and the

e cardiovascular system.

The body temperature increases if the patient absorbs more energy per unit of time than can be dissip increase in temperature.

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2.10.2 Noticeable Effects on the Patient

During MR imaging, patients may experience heat sensations on the skin and may begin to perspire. Their pulse rate may increase as well. The individual effects vary from patient to patient. Following the MR imaging, the body will cool off and the pulse rate will return to normal.

2.11 Peripheral Nerve Stimulation (dB/dt)

Magnetic Resonance Imaging is based, in part, on the use of time-varying magnetic fields (dB/dt) which are produced by electric current field gradient coils.

These field gradients must be switched on and off rapidly (typically in less than a thousandth of a second) to obtain images. And, by electromagnetic induction they generate electric fields in the conducting tissues of the body.

These induced electric fields in the body can cause uncomfortable stimulation of the peripheral nerves which is often perceived by the patient as a tingling or tapping sensation. Although this peripheral nerve stimulation may cause some discomfort for the patient, it is not harmful.

The MRIdian® MRIS uses a high-performance gradient system which has the potential to induce peripheral nerve stimulation (PNS) in patients and MR workers during scans.

2.11.1 Operating Modes

The MRIdian MRI has two operating modes:

• Normal Mode

• First Level Controlled Operating Mode

Normal Mode is a lower gradient power mode.

First Level Controlled Mode has a higher gradient output. The higher the gradient output the

higher the probability and the intensity of peripheral nerve stimulation. Gradient output levels are based on current literature related to safety, including IEC guidelines

Main Magnet (Bo): The MRIdian MRIS operates in the Normal Operating Mode for Bo at all times. According to IEC 60601-2-33 (3rd Edition), a field strength of less than 3T is in the

Normal Operating Mode. The MRIdian® system operates at 0.35T.

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SAR: The MRIdian MRIS operates in the Normal Operating Mode for SAR at all times.

According to IEC 60601-2-33 (3rd Edition), a SAR of less than 2 W/kG in the whole body is in the Normal Operating Mode. Because of the 0.35T field strength, the MRIS does not exceed

1.2 W/kG, and is therefore always in the Normal Operating Mode.

dB/dt: Th for dB/dt. Patients may experience peripheral nerve stimulation, or a twitching sensation, during scans. In situations where the system enters the First Level Controlled Mode for dB/dt, the operator will receive a dialog box warning indicating that the particular sequence is in the First Controlled Mode for dB/dt. The operator is required to acknowledge this warning before continuing the scan. Operation of the system in the Second Controlled Mode for dB/dt is prevented by software controls.

e MRIdian 0.35T magnet is capable of operating in the First Level Controlled Mode

2.11.2 First Level Controlled Operating Mode

All treatment cinés are in the First Level Controlled Operating Mode for dB/dt. See

"Peripheral Nerve Stimulation (dB/dt)” on page 46

The system alerts the operator when a scan will enter the First Level Controlled Operating

by displaying the following warning:

Mode

You must OK the First Level Controlled Operating Mode by taking the deliberate action of Clicking > OK.

You must inform your patient of the possibility of peripheral nerve stimulation and remain in

onstant audio and visual contact with the patient.

Operators must receive training in methods to minimize adverse health effects of high

adient magnetic fields.

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It is the responsibility of the operator to decide whether to scan using the First Level Controlled Operating Mode considering both the possible need for physiological monitoring and the potential risks versus benefits to the patient.

To reduce the physiological effects, patients should be cautioned to remain still while the

ystem is in the First Level Controlled Operating Mode.

Compatibility of tools and accessories may also decr magnetic field increases. Care should be taken when using tools and accessories in First Level Controlled Operating Mode.

There may be country-specific regulations and guidelines on patient monitoring during First Level Controlled Operating Modes.

ease as the time-varying (gradient)

2.12 Current Loops

Dangerous current loops may be generated when parts of the patient’s body touch. These loops may lead to burns or increase the probability

timulation.

of s

 Ensure the patient’s body parts are not touching to form current loops and explain to the

patient not to allow body parts to make contact during the treatment imaging.

 Ensure the patient does not wear wet clothing or clothing dampened by perspiration.  Ensure sufficient ventilation during the imaging and treatment.

 Use positioning aids such as blankets or dry material that are both permeable to air and at

least 5 millimeters thick.

 Use caution when using transdermal patches because they may cause burns to underlying

skin.

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Chapter 2: Safety Information and

2.13 Effects of Antenna

Looped cables, such as RF coils, ECG lines, and patient monitoring devices, show an exceptionally high capability of receiving RF fields. The loops will function as r to levels leading to second or third degree skin burns.



Ensure that receive coil cables and any accessory cables do NOT create a loop.



Position the receive coil cable in a way which does not contact the patient’s skin.



Avoid placement of the patient’s body or extremities against the RF transmit coil surface.

 Ensur examinations.

 MR w minimized by staying inside the Treatment Control Room which is outside the 5 Gauss line.

e there are no unconnected receive coils or electric cables present during

orkers may also be exposed to heating caused by RF radiation. Exposure can be

eceive antennas and may warm

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2.14 Risks of Non-MR Safe Monitoring and Interventional Devices

Non-MR safe patient monitoring devices may measure erroneous values because of RF field interference.

 Use only MR-safe vital parameter measurement devices for monitoring. Only equipment

labeled as MR-safe by its manufacturer should be used with the MRIdian® system.

Ensure any ECG electrodes and leads are labeled as MR-safe by the manufacturer



and that they have not passed their expiration date.

 Ensure any interventional device used has shielded electronics to reduce

interference with MR signal.

 Follow your facility's protocol for monitoring sedated or unconscious patients.

These patients are unable to alert operators of excessive heating and associated tissue damage so they must be monitored closely.

2.15 Hazardous Noise Levels

The MRIdian® system generates substantial acoustic noise in the treatment room during treatment. Temporary or permanent hearing

The recommendations below are based on measurements made on the MRIdian MRIS in the mode pr scale, dB, is used when describing sound power. Sound levels are designated by an A indicating the sound was measured on the A scale of a standard sound level meter at slow response. The FDA released updated guidelines for acoustic noise levels associated with the operation of MR systems, on July 14, 2003, as follows: a MR device should not produce noise having a peak unweighted sound pressure level greater than 140 dB, or A-weighted root mean square (rms) sound pressure level greater than 99dBA with hearing protection in place.

oducing the worst case clinical scan conditions [ISO 1999.] The logarithmic decibel

loss can occur if adequate hearing protection is not used.

orm patients about the noise generated during treatment.

 Inf

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 Use only MR-safe hearing protection, either a headset or earplugs, to protect

patients against injury. Special training must be provided to operators for the proper placement of hearing protection, especially for cases where standard ear cuffs, plugs, or other protection cannot easily be applied.

 The patient and any MR worker present in the treatment room during MR imaging

must wear hearing protection.

 Sound levels in the control room with all doors closed should not exceed 75dB(A).

Operators should use hearing protection as required per site. The exposure of pa tients and MR workers to noise may be regulated through local, state, and countryspecific laws.

 Hearing protection of 20 dB must be used in the treatment room during scanning

to reduce A-weight rms sound pressure levels to 99dB(A).

 Anaesthetized and sedated patient may have less than normal protection against

high sound pressure and therefore must be provided with hearing protection.

 Inform patients about the noise the system makes and caution them to remain still

to avoid injuries.

 Infants, young children, pregnant women and their fetuses, and the elderly may

experience high levels of anxiety which increases their perception of sound pressure levels. Take special precautions to provide sufficient hearing protection for these patients.

2.16 Magnet Quench

Spontaneous magnet quenches are rare, but you should know how to respond if one does occur.

A magnet quench is the rapid release of the gaseous cryogens that produce the superconducting magnetic field. A magnet quench releases helium vapor that escapes through the quench vent; however, in order to prevent the risk of asphyxiation due to oxygen displacement, personnel should evacuate the area during a quench.

Each of the two superconducting magnets is equipped with a burst disk sensor that will detect the pressure change caused by the onset of a quench and will open the interlock and retract the sources, putting them into the OFF and LOCKED state. The fault is logged by the system. ViewRay Service must be called to clear the fault and restore the system.

Warning signs that a quench is happening are:

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• Noise

• Condensation on the quench vent

• Warning from the system that the magnetic field has collapsed

Also see "Emergency Magnet Shutdown” on page 63.

Follow the instructions for your treatment room oxygen monitor and ensure everyone is evacuated from the treatment room if the oxygen monitor alarm is triggered.

2.16.1 Half Quenches

Because the MRIdian® system contains two separate magnets, a half quench is possible. If only one magnet quenches, the 5 gauss (0.5mT) line shifts.

2.16.2 Gauss Line After a Patient-End Magnet Quench

Gauss lines in the X/Y-Z Plane

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Gauss Lines in the Z = 0 plane after a half-magnet quench

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2.16.3 Gauss Line After a Service-End Magnet Quench

Gauss lines in the Z/Y - Z plane

Gauss Lines in the Z = 0 plane after a half-magnet quench

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2.17 Fire Safety in the Treatment Room

In the event of fire, the fire has to be extinguished with methods safe in an MR environment. Firefighters must be able to take appropriate MR-safe actions immediately. Your local firefighting responders must be familiar with your MR system, its location, and the specialized firefighting techniques necessary for safety in an MR environment.

Before initial start-up of the MRIdian® system, the facility using the system is responsible for informing the fire department about the MR system and the hazards of using magnetizable objects.

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The following devices/materials may be used for firefighting:

 Non-magnetic CO

extinguisher

 Self-contained, non-magnetic compressed air respiratory apparatus

 Airtight chemical protective suit

2.18 Measurement Phantom Safety

Phantoms are filled with water-based nickel sulfate solutions. Other components may include sodium chloride, sodium phosphate buffers, as

ell as copper sulfate, lactates and acetates.

The fluids are sealed in the measurement phantoms. When measurement phantoms are the RF coils, there is no physical contact with measurement phantom fluids.

used as intended, within the scope of quality assessments of

2.18.1 Contact with Phantom Fluid Spills

When handling phantom fluid spills wear protective clothing (gloves, work coat, goggles). and follow the listed precautions:

 Wear a mask with a filter for anorganic vapors if aerosols (inhalable droplets)

are formed.

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 Do not use damaged phantoms.

 Avoid skin contact with phantom fluid.

 Change contaminated clothing immediately.

 Do not eat, drink, or smoke.

 Ensure phantom fluid does not enter the waste water.

 Dispose of phantom fluid in compliance with local and national regulations.

 Follow the instructions in the Material Safety Data Sheet that was included with

the phantom.

2.18.2 Risks Due to Aerosol Formation

If phantom fluid has escaped, inhalable droplets (aerosols) containing nickel may form if there is a fire or if atomization has been caused by strong air currents. Carcinogenic effects cannot be ruled out if these aerosols are absorbed by the body.

2.19 Radiation Precautions

The MRIdian® system delivers ionizing radiation during treatment delivery.

Extended exposure to the radiation beam can cause

erious injury or death. The treatment room

s unoccupied except for the patient being treated during the BEAM ON state.

2.19.1 Radiation Safety

The MRIdian system uses 3 sealed sources of 60Cobalt for the delivery of radiation therapy. Each source has an activity level of 12,000-15,000 curies (Ci) at the time of installation. See

“General MRIdian® System Safety” on page 23.

must be

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When the sources are retracted and locked into the shielding heads and in the Off position, radiation exposure in the treatment room is reduced to background levels, and the room is safe for cleaning and patient set-up activity. When the sources are moved to the Beam Hold position, they are still retracted, but not locked.

Special tools are required to access the source. These t secured by a trustworthy and responsible person designated by the site.

ools are provided by ViewRay and

ALERT: When the sources are moved to the Beam On position for treatment,

high levels of radioactivity are present and no one except the patient being

eated should be in the treatment room.

 Verify that the patient identification and approved treatment plan match



prior to starting therapy to avoid unnecessary radiation exposure and the

possible irradiation of healthy tissue.

2.19.2 Exposure Control for Operators

Radiation dose is determined by the amount of time you are exposed to a radioactive source, the distance you are from that radioactive source, and any intervening shielding.

By minimizing the time you are near a radioactive source, using shielding, and maintaining

tance from the source, your total radiation exposure will remain well within the acceptable

dis and safe level.

Consult your facility’s Radiation Safety Officer if you want more information about the principles of

radiation exposure and dose.

2.19.3 Audible Radiation Alert

Each delivery station is equipped with an audible radiation alert that beeps whenever the radiation beam is on.

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2.19.4 Radiation Safety Interlocks

The Radiation Safety Interlocks on the MRIdian® system are designed to control radiation exposure by automatically retracting the source into the Off position whenever any of the following occur:

 The door to the treatment room is opened

 There is a power outage

 The E-Stop button is pushed

 The system detects a malfunction

Follow your facility's Radiation Safety Program and exposure monitoring requirements at all tim

es when entering the treatment room.

Do not disable any system interlocks, or attempt to operate the system if the interlocks are not functioning properly.

2.20 Emergency Response Plans

Each facility should develop emergency response plans for the MRIdian® System.

The Emergency Response Plans should take into consideration the following:

Unintended radiation exposure: See “Unintended Radiation (Stuck Source) Exposure” on



page 61.

 Emer



gency Magnet Shutdown: See “Emergency Magnet Shutdown” on page 63.

Rescuing the patient: See “Rescuing the Patient in an Emergency” on page 64.

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 Sites should identify and plan emergency medical procedures that are safe in the presence

of the magnetic field, so the appropriate and necessary treatment can be given to a patient who feels ill or is injured during an examination.

2.21 Unintended Radiation (Stuck Source) Expo-

sure

When the MRIdian® RT Control system detects a stuck source, the operator receives this system message on the user interface.

The following events are initiated by the system:

1. Sources are moved to the OFF position by a dedicated pneumatic system.

2. Patient table retracts from the bore.

3. Gantry rotates and places the head with the movement fault into the 90 position where gravity can assist in moving the source into the off position.

4. Multi-Leaf Collimators close.

5. The Auxiliary Radiation Shield closes.

6. A system inhibit interlock is enabled to prevent treatment.

After the system retracts the patient table, do the following:

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Remove your patient from the treatment room.

Close the treatment room door.

Contact your RSO and follow your facility

Contact ViewRay Service.

If the gantry control system is also inoperable and does not move the stuck source to the loading position, a mechanical retraction procedure can be initia

ted. This should only be done with consultation and oversight by your facility's RSO. This procedure is described in "Mechanical Source Retraction

Procedure” on page 447 which is provided as an attachment to this manual.

The provided non-magnetic Allen wrench needed for this procedure must be

ept close to the treatment room entrance at all times.

’s Emergency Response Plan.

2.22 Using the E-Stop in an Emergency

Pressing the E-Stop will retract the sources to the locked, fully shielded position, and stop any patient couch movement. There are four E-Stop buttons in the treatment room and one on the Treatment Control Panel.

The E-Stop must be reset after use. Turn the knob clockwise to reset.

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2.23 Emergency Magnet Shutdown

If someone is trapped inside the magnet, pushing the MAGNET EMERGENCY DISCHARGE BUTTON (see next page) will initiate an emergency quench of the magnet. The term “quench” is used to describe the rapid boil off of the cryogens (subzero-temperature liquid refrigerants) that keep the magnet cooled and in a superconducting state. Without cryogens the magnet loses its magnetic field. See “Emergency Quench Procedure” on page 64, and "Rescuing the

Patient in an Emergency” on page 64.

All cryogen liquids produce large volumes of gas when they vaporize.

When a quench is initiated you MUST evacuate the treatment room immediately to avoid

asphyxiated in the event the gases fail to vent properly out of the treatment room and

being displace all the oxygen.

Skin contact with cryogens will cause cryogenic burns of the skin and freeze underlying tissue.

2.23.1 Magnet Emergency Discharge Button

ONLY USE THE MAGNET EMERGENCY DISCHARGE BUTTON FOR EMERGENCIES WHERE IMMEDIATE SHUTDOWN OF THE MAGNET IS NEEDED, SUCH AS A PERSON TRAPPED IN THE BORE OR PINNED TO THE MAGNET BY A METAL OBJECT.

Costly reactivation activities are required after a magnet quench and the system will be inoperable for at least one week.

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2.23.2 Emergency Quench Procedure

1. Push the Magnet Emergency Discharge Button

 There will be loud sounds (hissing, gurgling) as the helium boils off. The

magnetic field will decrease to a negligible level within 60 seconds.

Rescue the patient, or, whomever has been trapped by an object and the

force of the magnetic field.

3. Stay out from under the quench vent.

 The liquid helium boils off during a quench and condensation will occur on the

quench vent pipe and can drip down and cause frostbite.

Leave the scan room.

 The helium is vented outside through the quench vent during a quench.

However, it is possible for helium to escape and fill the room causing oxygen displacement and the danger of asphyxiation.

5. Call ViewRay Service. It is

Condensation of air oxygen occurs during the escape of ultra cold helium gas and increases

sk of fire. Make sure there is no smoking or use of equipment that discharges electrical

the ri sp

arks or fire.

Even though the magnet decreases to a negligible level within 60 seconds after pressing the MAGNET EMERGENCY DISCHARGE BUTTON, it will take five minut

es for the magnetic field to be completely extinguished.

important to service a quenched magnet immediately.

2.23.3 Rescuing the Patient in an Emergency

IF COUCH MOVEMENT IS CREATING THE EMERGENCY SITUATION

1. Press the E-Stop to stop all couch movement.

2. Rescue the patient.

After the emergency, the E-Stop must be reset. Pull the E-Stop button up to reset.

IF THE PATIENT IS HAVING AN EMERGENCY MEDICAL SITUATION AND YOU MUST REMOVE

PATIENT FROM THE BORE

THE

Press the HOME button on the couch control panel. The couch will automatically withdraw

om the bore.

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Press the Table Release Button on the side of the out of the bore.

couch and manually pull the patient table

After using the Table Release Button, it must be pressed again to reset.

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3.1 MRIdian® System Coordinates

The MRIdian system uses 3-dimensional coordinate systems to fully specify the geometric location of the data throughout the various systems. This includes: cobalt sources, multi-leaf collimator positions, radiation beam trajectories, couch location and MR, CT, PET images. The coordinates’ systems are described in Cartesian coordinates.

3.1.1 Direction Definitions

 The front of the machine is defined as the face of the machine where the couch

enters the machine

The back of the machine is defined as the face opposite the front of the machine

 The top of the machine is the face of the machine closest to the ceiling

 The bottom of the machine is the face of the machine closest to the floor

 The left of the machine is on the observer’s left when the observer is standing

facing the front of the machine

 The right of the machine is on the observer’s right when the observer is standing

facing the front of the machine

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In accordance with IEC 61217, the MRIdian® system has a fixed right-handed coordinate system with the coordinate system origin at the isocenter of the machine.

The “+Z” axis is aligned towards the top of the machine and the “-Z' axis towards the bottom of the machine. The aligned towards the front of the machine. The “+X” axis is aligned towards the right of the machine and the “-X” axis is aligned towards the left of the machine.

The radiation source location for the “0°” position is indicated by the red dot with label “S,” tha

t is the radiation source is aligned on the “+Z” axis. The isocenter is illustrated by the white

dot with label “Io.”

“+Y” axis is aligned toward the back of the machine and “-Y” axis is

3.1.2 Gantry Coordinate System

The gantry at its “0°” position.

The gantry system is coincident with the fixed system and “Io” and “Ig” are at the same location. The fixed system is the mother system for the gantry system. The gantry coordinate system rotates with the gantry and can only rotate about the Y axis.

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In this system the “+Z” axis is aligned towards the top of the machine and the “-Z” axis towards the bottom of the machine. The “+Y” axis is aligned toward the back of the machine and “-Y” axis is aligned towards the front of the machine. The “+X” axis is aligned towards the right of the machine and the “-X” axis is aligned towards the left of the machine.

3.1.3 Gantry Rotation

Positive (Clockwise) gantry rotation is illustrated below. The view is from the front of the gantry and the angle is slightly greater than 90

.

3.1.4 Beam Limiting Coordinate System

There are three beam-limiting devices (multi-leaf collimators), each located 120 degrees apart from the other. The beam limiting coordinate system is the same as that of the gantry. The beam limiting devices rotate with the gantry. When one beam limiting device is at the “0°” position, its coordinate system is defined with the same axis orientation as the gantry system. The source “S” and origin “Ib” are at the same position.

The “+Z” axis is aligned to the top of the machine and the “-Z” axis to the bottom of the

ne.

machi

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The “+Y” axis is aligned to the back of the machine and “-Y” axis is aligned to the front of the machine.

The “+X” axis is aligned to the right of the machine and the “-X” axis is aligned to the left of the machi

ne.

3.1.5 Beam’s Eye View of Multi-Leaf Collimator (MLC)

The movement of the MRIdian system's MLC is restricted to the plus and minus “X” directions.

The MLC leaves below show an open position of limiting device is shown relative to the couch and gantry. This view of the MLC is considered a beam's eye because it is pointed toward the gantry isocenter.

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3.1.6 Orientation of an MLC Relative to the Gantry

The diagram below shows the orientation of an MLC relative to the gantry. The diagram is at the “0” gantry position and is looking down at the gantry from above.

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3.1.7 MLC Orientation

The figure below shows the MLC and Beam limiting coordinate system for gantry angles of 0, 90, 180, and 270. “ g” is only indicated for the 90°.

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3.1.8 Planning and Visualization using Coordinate System

The visualization system displays the Multi-planar reconstruction (MPR) planes as depicted in the three following diagrams.

In each diagram the image is shown in a black square. The orientation on the user interface (UI) scr

The axial, lateral and vertical images are always displayed in the fixed coordinate system. Not

that for all three orientations, the patient is shown head first, supine, going into the gantry from the front.

In this system the “+Z” axis is aligned to the top of the machine and the “-Z” axis to the bot the machine and the “-X” axis is aligned to the left of the machine.

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een is the same orientation as the square in the top left corner of each diagram.

tom of the machine. The “+/-Y” axis is not visible. The “+X” axis is aligned to the right of

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Axial MPR Image:

The axial image is viewed as if looking into the gantry from the front.

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Vertical MPR Image:

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Lateral MPR Image:

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Chapter 4: System and Administrative Tasks

4.1 Starting Up the Planning Consoles

Your system is ready for use after power-on and the Windows® login prompt appears on the screen.

ter your username and password in the login prompt window.

1. En

Click >

OK.

 Once logged in, the MRIdian® software will automatically start up. You may not

exit the MRIdian system software while the system is running. Several system startup checks will be performed when the software starts up. These checks include:

Activation check—Checks that the software has been activated for use by ViewRay



personnel during installation.

 CRC check—Check

 Database check—Ch

database.

Graphics check—Checks that the system has the required Visage dongle for the



visualization rendering license.

 Auto-save check—Check

previously shut down due to power-loss or an error and a plan file was auto-saved, the user will be offered the option to restore the plan to the last auto-saved state.

MRIdian system software is only authorized for use on ViewRay-provided computers, workstations/hardware. MRIdian system software may not be

ferred to other computer systems. If that is attempted, the software

trans activation check will fail, preventing startup.

s that system files have not been modified or corrupted.

ecks that the software can connect to the MRIdian system

s if an auto-save file exists. For example, if the system was

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4.2 Starting Up the Delivery System

1. Push the RT toggle switch to the ON position.

2. Push the Power button on the Treatment Delivery computer.

 The scr

een will boot up and the RT system will initially be listed as offline.

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3. Wait for the RT system to boot. It will take approximately 5 minutes for the RT system to boot.

During the RT booting process RT faults may appear on the UI. Those faults must be cleared before turning the MRI on.

 You will know the RT system has booted properly when the light next to RT is green

and the RT system status is Ready.

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4. Press the MRI ON button on the remote switch box.

5. The MrVCheck message will appear on the Siemens console. Click > OK.

6. While the MRI is booting a critical MRI system connection error will appear on the RIdian® system UI.

7. Enter your username and password and Cli

ck > Authenticate.

 A connection request will appear on the Siemens console.

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8. Click > Accept on the connection request.

Chapter 4: System and Administrative Tasks

The system is now ready for treatment delivery.

4.2.1 Additional Treatment Delivery Console Checks

When a Treatment Delivery console is started, the following additional treatment-based checks are performed:

Services Connection Check—The console system will connect to the services



system upon startup. If the connection is not made, the system will disable the application and retry for several seconds. After a waiting period, the application will start up as a planning-only system until the next shutdown.



RT Connection Check— If the connection is not made, the system will disable the

application and retry for several seconds. After a waiting period, the application will start up as a planning-only system until the next shutdown.

Delivery Records Check—Upon connection to the RT system, the console will



check the database for any incomplete delivery records. If any incomplete records exist, the console will attempt to retrieve the treatment delivery data from the RT system and then perform post-treatment processing to determine dose. If no

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delivery data exists on the RT system, a service user must update the delivery record.

Unknown Treatment Delivery Data Check—Upon connection to the RT system,



the console will check the RT system for existing delivery data. If the database contains no records of delivery, but a delivery data set exists on the RT system, ViewRay Service user must clear the data from the RT system.

4.3 Shutting Down the Planning System

Before shutting down the system, ensure the system is not still processing or running tasks. Also ensure open plans have been saved, if saving is

ed. It is recommended to perform shut down while on the software

desir home screen.

To shut down, press the hard power button on the computer console.

At times, the system may automatically restart itself to recover from system errors. In the

ely event that this occurs, call ViewRay Service to report the error and obtain any

unlik necessary assistance for restarting.

It is recommended to shut down systems on a periodic basis. Shutting down will allow the Window When turned off, the system is protected against power surges due to electrical storms or other conditions.

s operating system to perform file maintenance and “housekeeping” procedures.

4.4 Shutting Down the Delivery and MRI Systems

1. Turn the RT System OFF.

2. From the Siemens console menu bar Click > System.



This will open a dropdown menu.

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