Customer Release Notes RTC Software Patch 2.1.1

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1 Customer Release Notes RTC Software Patch Sept

2 Product Doc ID Notice HIPAA Copyright MRIdian Linac Treatment Planning and Delivery System Software (Part #) Information in this release is subject to change without notice and does not represent a commitment on the part of ViewRay. ViewRay is not liable for errors contained in this release note or for incidental or consequential damages in connection with furnishing or use of this material. ViewRay products and services are specifically designed to include features that help our customers comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) ViewRay Inc. All rights reserved. Produced in the USA. ViewRay, Inc REV [SEPT 2017] 1

3 Introduction The MRIdian Linac System Treatment Planning and Delivery System Software is an end-to-end software system for operating the MRIdian Linac system. CAUTION: The MRIdian Linac 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. Contacting Support Support services are available without charge during the initial warranty period. If you require support or wish to provide feedback, contact ViewRay Inc. using one of the methods listed below. For service: Telephone Submit system issues or product improvement requests online via: European Authorized Representative: MedPass International Ltd, Winsor House Bretforton, Eversham, Worcestershire, WR11 7JJ, United Kingdom REV [SEPT 2017] ViewRay, Inc.

4 The MRIdian Linac RTC Software Patch V2.1.1 This new version of software does not require recalculation of patient plans that are currently on treatment; however, ViewRay recommends users carefully read the changes listed in these release notes to determine any quality assurance procedures you may deem necessary. Please contact ViewRay if you require further clarification on any of the items below. This software patch is dedicated to some new features and code improvements to fix known issues in the Radiation Therapy Controller Software. The changes that have been made are minor and most likely will not be exposed to the user. The Radiation Therapy Controller (RTC) is a subsystem of the RT Control System and is the primary computer that executes the plan and controls delivery of the beams. The RT Control System is responsible for executing a treatment plan and monitoring its execution to ensure proper delivery as per instructions. The RT Control system s primary purpose is to control the treatment delivery from the time the Beam On button is pressed until delivery finishes or is interrupted with a fault, this includes gantry angle positioning, MLC positioning, and dose delivery, while also monitoring interlocks The fixes and new features implemented in this release are listed below. Please contact ViewRay if you require further clarification on any of the items below. Fixes 1. While the MLC is performing its secondary check, the MLC often failed due to the Secondary Check Sensor Communication error. This error was also reported soon after patient information or a treatment plan was loaded. Code improvements incorporated in this release will result in a reduction of the secondary check sensor communication errors. 2. There have been instances where in Log Manager File Write Failure on RT Control System error message was reported immediately after the final beam was delivered. Code improvements in this release will reduce the frequency of Log Manager File Write Failure and Heart Beat Timer faults. New Implementations 1. Changes in the RTC software have been made so that the BEAM ON light on the Treatment Control Panel turns on only after the gantry and the MLC leaves have reached the required positions for the delivery of the first beam in a plan. ViewRay, Inc REV [SEPT 2017] 3

5 2. The software in this release supports an alternate HV gun driver design This does not affect existing installations. However, since the software that configures the gun driver has been updated, additional QA may be warranted. 3. Addition of a dark current dose rate interlock This interlock keeps track of the average dark current dose rate measured as the average over a pre-defined time interval and ensures that the average dose rate does not exceed 0.1% of the expected therapeutic dose rate. The interlock trips, if the average dose rate exceeds the threshold. No change in behavior of the system is expected from user s point of view during normal operation REV [SEPT 2017] ViewRay, Inc.

6 Office Locations ViewRay Headquarters 2 Thermo Fisher Way Oakwood Village, Ohio Phone: Fax: West Coast Office 815 E Middlefield Rd Mountain View, CA Phone:

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