Viewray Mridian system 4.5 User manual

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.

This page intentionally left blank.

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

photocopied, reproduced or translated into another language without written permission

from ViewRay, Inc.

ViewRay, Inc., has taken care to ensure the accuracy of this document; however, ViewRay Inc.

assumes no liability for errors or omissions and reserves the right to make changes without

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

particular purpose.

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

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

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

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

names are trademarks or registered trademarks of their respective holders.

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.

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

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

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

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 to treatment.

The MRIdian system must be operated according to the intended use and only

by qualified persons with the necessary knowledge in accord with country-

specific regulations.

All personnel must complete user training before operating the system. The user must be

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

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 opens. From that dropdown menu Click > About MRIdian®

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

Technical and performance data for the system is in “Technical Manual for the

MRIdian System” (L-0016) that was supplied with the system.

ViewRay, Inc. MRIdian® system L-0009 Release 4.5 v

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

vi MRIdian® system L-0009 Release 4.5 ViewRay,

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

ViewRay, Inc. MRIdian® system L-0009 Release 4.5 vii

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

viii MRIdian® system L-0009 Release 4.5 ViewRay,

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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